§ 360b. New animal drugs

Footnotes

1. 1 See References in Text note below.
2. 2 So in original. Probably should be “Alimentarius”.
3. 3 So in original. Probably should be “clause (iii)(III)”.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Animal Drug Amendments of 1968

   Pub. L. 90–399 § 101(b) · 82 Stat. 342

   Enacted · 21 U.S.C. § 360b

   June 25, 1938, ch. 675, § 512, as added Pub. L. 90–399, § 101(b), July 13, 1968, 82 Stat. 343

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 512, as added Pub. L. 90–399, § 101(b), July 13, 1968, 82 Stat. 343

   Enacted provision · exact public law section
   (b) Chapter V of such Act is amended by adding at the end thereof 79 Stat. 227. 21 USC 351–360a. the following: “Sec. 512. “new animal dregs (a) (1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for the purposes of section 501(a)(5) and section 402(a) (2) (D) unless— Supra. Post, p. 352. “(A) there is in effect an approval of an application filed pursuant to subsection (b) of this section with respect to such use or intended use of such drug, “(B) such drug, its labeling, and such use conform to such approved application, and “(C) in the case of a new animal drug subject to subsection (n) of this section and not exempted therefrom by regulations it is from a batch with respect, to which a certificate or release issued pursuant to subsection (n) is in effect with respect to such drug. A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a manufacturer, packer, or distributor of such drug for use in the manufacture of animal feed in any State unless at the time of such removal such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or notice from the Secretary, to the effect that, with respect to the use of such drug in animal feed, such consignee— “(i) is the holder of an approved application under subsection (m) of this section; or “(ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of an approved application under subsection (m) of this sect ion. “(2) An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed, be deemed unsafe for the purposes of section 501(a)(6) Supra. unless— “(A) there is in effect an approval of an application filed pursuant to subsection (b) of this section with respect to such drug, as used in such animal feed, “(B) there is in effect an approval of an application pursuant to subsection (m) (1) of this section with respect to such animal feed, and “(C) such animal feed, its labeling, and such use conform to the conditions and indications of use published pursuant to subsection (i) of this section and to the application with respect thereto approved under subsection (m) of this section. “(3) A new animal drug or an animal feed bearing or containing a new animal drug shall not be deemed unsafe for me purposes pi Ante, p. 343. section 501 (a) (5) or (6) if such article is for investigational use and conforms to the terms of an exemption in effect with respect thereto under section 512 (j). “(b) Any person may file with the Secretary an application with respect to any intended use or uses of a new animal drug. Such person shall submit to the Secretary as a part of the application (1) full reports of investigations which have been made to show whether or not such drug is safe and effective for use; (2) a full list of the articles used as components of such drug; (3) a full statement of the composition of such drug; (4) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug; (5) such samples of such drug and of the articles used as components thereof, of any animal feed for use in or on which such drug is intended, and of the edible portions or products I before or after slaughter) of animals to which such drug (directly or in or on animal feed) is intended to be administered, as the Secretary may require; (6) specimens of the labeling proposed to be used for such drug, or in case such drug is intended for use in unit mill feed, proposed labeling appropriate for such use, and specimens of the labeling for the drug to ne manufactured, packed, or distributed by the applicant; (7) a description of practicable methods for determining the quantity, if any, of such drug in or on food, and any substance formed in or on food, because of its use; and (8) the proposed tolerance or withdrawal period or other use restrictions for such drug if any tolerance or withdrawal period or other use restrictions are required in order to assure that the proposed use of such drug will be safe. “(c) Within one hundred and eighty days after the filing of an application pursuant to subsection (b), or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either (1) issue an order approving I he application if he then finds that none of the grounds for denying approval specified in subsection (d) applies, or (2) give the applicant notice of an opportunity for a hearing before the Secretary under subsection (d) on the question whether such application is approvable. If the applicant elects to accept the opportunity for a hearing by written request within thirty days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary’s order thereon shall lie issued within ninety days after the date fixed by the Secretary for filing final briefs. “(d) (1) If the Secretary finds, after due notice to the applicant in accordance with subsection (c) and giving him an opportunity for a hearing, in accordance with said subsection, that— “(A) the investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; “(B) the results of such tests show that such drug is unsafe for use under such conditions or do not show that such drug is safe for use under such conditions; “(C) the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to preserve its identity, strength, quality, and purity; “(D) upon the basis of the information submitted to him as part of the application, or upon the basis of any other information before him with respect to such drug, he has insufficient information to determine whether such drug is safe for use under such conditions; “(E) evaluated on the basis of the information submitted to him as part of the application and any other information before him with respect to such drug, there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; “(F) upon the basis of the information submitted to him as part of the application or any other information before him with respect to such drug, the tolerance limitation proposed, if any, exceeds that reasonably required to accomplish the physical or other technical effect for which the drug is intended; “(G) based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; or “(H) such drug induces cancer when ingested by man or animal or, after tests which are appropriate for the evaluation of the safety of such drug, induces cancer in man or animal, except that the foregoing provisions of this subparagraph shall not apply with respect to such drug if the Secretary finds that, under the conditions of use specified in proposed labeling and reasonably certain to be followed in practice (i) such drug will not adversely affect the animals for which it is intended, and (ii) no residue of such drug will be found (by methods of examination prescribed or approved by the Secretary by regulations, which regulations shall not be subject to subsections (c), (d), and (h)), in any edible portion of such animals after slaughter or in any food yielded by or derived from the living animals; he shall issue an order refusing to approve the application. If, after such notice and opportunity for hearing, the Secretary finds that subparagraphs (A) through (II) do not apply, he shall issue an order approving the application. “(2) In determining whether such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, the Secretary shall consider, among other relevant factors, (A) the probable consumption of such drug and of any substance formed in or on food because of the use of such drug, (B) the cumulative effect on man or animal of such drug, taking into account any chemically or pharmacologically related substance, (C) safety factors which in the opinion of experts, qualified by scientific training and experience to evaluate the safety of such drugs, are appropriate for the use of animal experimentation data, and (D) whether the conditions of use prescribed, recommended, or suggested in the proposed labeling are reasonably certain to be followed in practice. Any order issued under this subsection refusing to approve an application shall state the findings upon which it is based. “(3) As used in this subsection and subsection (e), the term ‘substantial “Substantial evidence.” evidence’ means evidence consisting of adequate and well-controlled investigations, including field investigation, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. “(e) (1) The Secretary shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application filed pursuant to subsection (b) with respect to any new animal drug if the Secretary finds— “(A) that experience or scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved; “(B) that new evidence not contained in such application or not available to the Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated together with the evidence available to the Secretary when the application was approved, shows that such drug is not. shown to be safe for use under the conditions of use upon the basis of which the application was approved or that subparagraph (H) of paragraph (1) of subsection (d) applies to such drug; “(C) on the basis of new information before him with respect to such drug, evaluated together with the evidence available to him when the application was approved, that there is a lack of substantial evidence that such drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling thereof: “(D) that the application contains any untrue statement of a material fact; or “(E) that the applicant has made any changes from the stand-point of safety or effectiveness beyond the variations provided for in the application unless he has supplemented the application by filing with the Secretary adequate information respecting all such changes and unless there is in effect an approval of (he supplemental application. The supplemental application shall be treated in the same manner as the original application. If the Secretary (or in his absence the officer acting as Secretary) finds that there is an imminent hazard to the health of man or of the animals for which such drug is intended, he may suspend the approval of such application immediately, and give the applicant prompt notice of his action and afford the applicant the opportunity for an expedited hearing under this subsection: but the authority conferred by this sentence to suspend the approval of an application shall not be delegated. “(2) The Secretary may also, after due notice and opportunity for hearing to the applicant, issue an order withdrawing the approval of an application with respect to any new animal drug under this section if the Secretary finds— “(A) that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports in accordance with a regulation or order under subsection (1), or the applicant has refused to permit access to, or copying or verification of, such records as required by paragraph (2) of such subsection; “(B) that on the basis of new information before him, evaluated together with the evidence before him when the application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of such drug are inadequate to assure and preserve its i and purity and were not made adequate within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or “(C) that on the basis of new information before him, evaluated together with the evidence before him when the application was approved, the labeling of such drug, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of. “(3) Any order under this subsection shall state the findings upon which it is based. “(f) Whenever the Secretary finds that the facts so require, he shall revoke any previous order under subsection (d), (e), or (m) refusing, withdrawing, or suspending approval of an application and shall approve such application or reinstate such approval, as may be appropriate. “(g) Orders of the Secretary issued under this section (other than orders issuing, amending, or repealing regulations) shall be served (1) in person by any officer or employee of the department designated by the Secretary or (2) by mailing the order by registered mail or by certified mail addressed to the applicant or respondent at his last known address in the records of the Secretary. “(h) An appeal may be taken by the applicant from an order of the Secretary refusing or withdrawing approval of an application filed under subsection (b) or (m) of this section. The provisions of subsection (h) of section 505 of this Act shall govern any such appeal. 52 Stat. 1052; 76 Stat. 784, 785. 21 USC 355. Publication In Federal Register. “(i) When a new animal drug application filed pursuant to subsection (b) is approved, the Secretary shall by notice, which upon publication shall be effective as a regulation, publish in the Federal Register the name and address of the applicant and the conditions and indications of use of the new animal drug covered by such application, including any tolerance and withdrawal period or other use restrictions and. if such new animal drug is intended for use in animal feed, appropriate purposes and conditions of use (including special labeling requirements) applicable to any animal feed for use in which such drug is approved, and such other information, upon the basis of which such application was approved, as the Secretary deems necessary to assure the safe and effective use of such drug. Upon withdrawal of approval of such new animal drug application or upon its suspension, the Secretary shall forthwith revoke or suspend, as the case may be, the regulation published pursuant to this subsection (i) insofar as it is based on the approval of such application. “(j) To the extent consistent with the public health, the Secretary Exemptions. shall promulgate regulations for exempting from the operation of this section new animal drugs, and animal feeds bearing or containing new animal drugs, intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of animal drugs. Such regulations may, in the discretion of the Secretary, among other conditions relating to the protection of the public health, provide for conditioning such exemption upon rhe establishment and maintenance of such records, and the making of such reports to the Secretary, by the manufacturer or the sponsor of the investigation of such article, of data (including but not limited to analytical reports by investigators) obtained as a result of such investigational use of such article, as the Secretary finds will enable him to evaluate the safety and effectiveness of such article in the event of the filing of an application pursuant to this section. Such regulations, among other things, shall set forth the conditions (if any) upon which animals treated with such articles, and any products of such animals (before or after slaughter), may be marketed for food use. “(k) While approval of an application for a new animal drug is effective, a food shall not, by reason of bearing or containing such drug or any substance formed in or on (lie food because of its use in accordance with such application (including the conditions and indi-cations of use prescribed pursuant to subsection (i)), be considered adulterated within the meaning of clause (1) of section 402(a). “(l) (1) In the case of any new animal drug for which an approval of an application tiled pursuant to subsection (b) is in effect, the applicant shall establish and maintain such records, and make such reports to the Secretary, of data relating to experience and other data or information, received or otherwise obtained by such applicant with respect to such drug, or with respect to animal feeds bearing or containing such drug, as the Secretary may by general regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination, whether there is or may be ground for invoking subsection (e) or subsection (m) (4) of this section. Such regulation or order shall provide, where the Secretary deems it to be appropriate, for the examination, upon request, by the persons to whom such regulation or order is applicable, of similar information received or otherwise obtained by the Secretary. “(2) Every person required under this subsection to maintain records, and every person in charge or custody thereof, shall, upon request, of an officer or employee designated by the Secretary, permit, such officer ox employee at alt reasonable times to have access to and copy and verify such records. “(m) (1) Any person may file with the Secretary an application with respect to any intended use or uses of an animal feed bearing or containing a new animal drug. Such person shall submit to the Secretary as part of the application (A) a full statement of the composition of such animal feed, (B) an identification of the regulation or regulations (relating to the new animal drug or drugs to be used in such feed), published pursuant to subsection (i), on which he relies as a basis for approval of his application with respect to the use of such drug in such feed, (C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such animal feed, (I)) specimens of the labeling proposed to be used for such animal feed, and (E) if so requested by the Secretary, samples of such animal feed or components thereof. “(2) Within ninety days after the filing of an application pursuant to subsection (m) (1), or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall either (A) issue an order approving the application if he then finds that none of the grounds for denying approval specified in paragraph (3) applies, or (B) give the applicant notice of an opportunity for a hearing before the Secretary under paragraph (3) on the question whether such application is approvable. The procedure governing such a hearing shall be the procedure set forth in the hist two sentences of subsection (c). “(3) If the Secretary, after due notice to the applicant in accordance with paragraph (2) and giving him an opportunity for a hearing in accordance with such paragraph, finds, on the basis of information submitted to him as part of the application or on the basis of any other information before him— “(A) that there is not in effect a regulation under subsection (i) (identified in such application) on the basis of which such application may be approved; “(B) that such animal feed (including the proposed use of any new animal drug therein or thereon) does not conform to an applicable regulation published pursuant to subsection (i) referred to in the application, or that the purposes and conditions or indications of use prescribed, recommended, or suggested in the labeling of such feed do not conform to the applicable pur-poses and conditions or indications of use (including warnings) published pursuant to subsection (i) or such labeling omits or fails to conform to other applicable information published pursuant to subsection (i); “(C) that the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such animal feed are inadequate to preserve the identity, strength, quality, and purity of the new animal drug therein; or “(D) that, based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he shall issue an order refusing to approve the application. If, after such notice and opportunity for hearing, the Secretary finds that subparagraphs (A) through (D) do not apply, he shall issue an order approving the application. An order under this subsection approving an application with respect to an animal feed bearing or containing a new animal drug shall be effective only while there is in effect a regulation pursuant to subsection (i), on the basis of which such application (or a supplement thereto) was approved, relating to the use of such drug in or on such feed. “(4) (A) The Secretary shall, after due notice and opportunity for hearing to the applicant, issue an order withdrawing approval of an application with respect to any animal feed under this subsection if the Secretary finds— “(i) that the application contains any untrue statement of a material fact; or “(ii) that the applicant has made any changes from the stand-point of safety or effectiveness beyond the variations provided for in the application unless he has supplemented the application by filing with the Secretary adequate information respecting all such changes and unless there is in effect an approval of the supplemental application. The supplemental application shall be treated in the same manner as the original application. If the Secretary (or in his absence the officer acting as Secretary) finds that there is an imminent hazard to the health of man or of the animals for which such animal feed is intended, he may suspend the approval of such application immediately, and give the applicant prompt notice of his action and afford the applicant the opportunity for an expedited hearing under this subsection; but the authority conferred by this sentence shall not be delegated. “(B) Tie Secretary may also, after due notice and opportunity for hearing to the applicant, issue an order withdrawing the approval of an application with respect to any animal feed under this subsection if the Secretary finds— “(i) that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports in accordance with a regulation or order under paragraph (5) (A) of this subsection, or the applicant has refused to permit access to, or copying or verification of, such records as required by subparagraph (B) of such paragraph; “(ii) that on the basis of new information before him, evaluated together with the evidence before him when such application was approved, the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of such animal feed are inadequate to assure and preserve the identity, strength, quality, and purity of the new animal drug therein, and were not made adequate within a reasonable time after receipt of written notice from the Secretary, specifying the matter complained of; or “(iii) that on the basis of new information before him, evaluated together with the evidence before him when the application was approved, the labeling of such animal feed, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of. “(C) Any order under paragraph (4) of this subsection shall state the findings upon which it is based. “(5) In the case of any animal feed for which an approval of an application filed pursuant to this subsection is in effect— “(A) the applicant shall establish and maintain such records, and make such reports lo the Secretary, or (at the option of the Secretary) to the appropriate person or persons holding an approved application filed under subsection (b), as the Secretary may by general regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary hi order to enable the Secretary to determine, or facilitate a determination, whether there is or may be ground for invoking subsection (e) or paragraph (4) of this subsection. “(B) every person required under this subsection to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records. “(n) (1) The Secretary, pursuant to regulations promulgated by him, shall provide for the certification of batches of a new animal drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, or any derivative thereof. A batch of any such drug shall be certified if an approval of an application filed pursuant to subsection (b) is effective with respect to such drug and such drug has the characteristics of identity and such batch has the characteristics of strength, quality, and purity upon the basis of which the application was approved, but shall not otherwise be certified. Prior to the effective date of such regulations the Secretary, in lieu of certification, shall issue a release for any batch which, in his judgment, may be released without risk as to the safety and efficacy of its use. Such release shall prescribe the date of its expiration and other conditions under which it shall cease to be effective as to such batch and as to portions thereof. “(2) Regulations providing for such certifications shall contain such provisions as are necessary to carry out the purposes of this subsection. including provisions prescribing— “(A) tests and methods of assay to determine compliance with applicable standards of identity and of strength, quality, and purity J “(B) effective periods for certificates, and other conditions under which they shall cease to be effective as to certified batches and as to portions thereof; “(C) administration and procedure; and “(D) such fees, specified in such regulations, as are necessary to provide, equip, and maintain an adequate certification service. Such regulations shall prescribe only such tests and methods of assay as will provide for certification or rejection within the shortest time consistent with the purposes of this subsection. “(3) Whenever, in the judgment of the Secretary, the requirements of this subsection with respect to any drug or class of drugs are not necessary to insure that such drug conforms to the standards of identity, strength, quality, and purity applicable thereto under paragraph (1) of this subsection, the Secretary shall promulgate regulations exempting such drug or class of drugs from such requirements. The provisions of subsection (c) of section 507 of this Act (other than the 59 Stat. 464; 76 Stat. 786. 21 USC 357. Exemptions. first sentence thereof) shall apply under this paragraph. “(4) The Secretary shall promulgate regulations exempting from any requirement of this subsection— “(A) drugs which are to be stored, processed, labeled, or repacked at establishments other than those where manufactured, on condition that such drugs comply with all such requirements upon removal from such establishments; and “(B) drugs which conform to applicable standards of identity, strength, quality, and purity prescribed pursuant to this subsection and are intended for use in manufacturing other drugs. “(5) On petition of any interested person for the issuance, amendment, or repeal of any regulation contemplated by this subsection, the procedure shall be in accordance with subsection (f) of section 507 of this Act. “(6) Where any drug is subject to this subsection and not exempted therefrom by regulations, the compliance of such drug with sections 501(b) and 502(g) shall be determined by the application of the 52 Stat. 1049. 21 USC 351, 352. standards of strength, quality, and purity applicable under paragraph (1) of this subsection, the tests and methods of assay applicable under provisions of regulations referred to in paragraph (2) (A) of this subsection, and the requirements of packaging and labeling on the basis of which the application with respect to such drug filed under subsection (b) of this section was approved.”

2. 1988

   Generic Animal Drug and Patent Term Restoration Act

   Pub. L. 100–670 § 107(a)(2) · 102 Stat. 3971

   Struck · 21 U.S.C. § 360b(a)(1)(C)

   Pub. L. 100–670, § 107(a)(2), struck out subpar. (C) which read as follows: “in the case of a new animal drug subject to subsection (n) of this section and not exempted therefrom by regulations it is from a batch with respect to which a certificate or release issued pursuant to subsection (n) of this section is in effect with respect to such drug.”

   Source evidence

   Code amendment note
   Subsec. (a)(1)(C). Pub. L. 100–670, § 107(a)(2), struck out subpar. (C) which read as follows: “in the case of a new animal drug subject to subsection (n) of this section and not exempted therefrom by regulations it is from a batch with respect to which a certificate or release issued pursuant to subsection (n) of this section is in effect with respect to such drug.”

   Enacted provision · exact public law section
   (2) Section 512(a)(1) (21 U.S.C. 360b(a)(1)) is amended by inserting “and” at the end of subparagraph (A), by striking out “, and” at the end of subparagraph (B) and inserting in lieu thereof a period, and by striking out subparagraph (C).

3. 1988

   Generic Animal Drug and Patent Term Restoration Act

   Pub. L. 100–670 title I · 102 Stat. 3971

   1. Amended · 21 U.S.C. § 360b(b)

      Pub. L. 100–670, §§ 101(a), 102(a), designated existing provisions as par. (1)

   2. Redesignated · 21 U.S.C. § 360b(b)

      Pub. L. 100–670, §§ 101(a), 102(a), redesignated cls. (1) to (8) as cls. (A) to (H), respectively

   3. Added · 21 U.S.C. § 360b(b)

      Pub. L. 100–670, §§ 101(a), 102(a), added par. (2)

   4. Inserted · 21 U.S.C. § 360b(b)

      Pub. L. 100–670, §§ 101(a), 102(a), inserted provisions at end of par. (1) which require applicant to file with application, patent number and expiration date of any patent which claims new animal drug, to amend application to include such information if patent which claims such drug or method of using such drug is issued after filing date but before approval of application, and to publish such information upon approval

   Source evidence

   Code amendment note
   Subsec. (b). Pub. L. 100–670, §§ 101(a), 102(a), designated existing provisions as par. (1), redesignated cls. (1) to (8) as cls. (A) to (H), respectively, added par. (2), and inserted provisions at end of par. (1) which require applicant to file with application, patent number and expiration date of any patent which claims new animal drug, to amend application to include such information if patent which claims such drug or method of using such drug is issued after filing date but before approval of application, and to publish such information upon approval.

   Enacted provision · exact public law
   TITLE I— NEW ANIMAL DRUG APPLICATIONS SEC. 101. ABBREVIATED NEW ANIMAL DRUG APPLICATIONS. (a) General Rule.— Section 512(b) (21 U.S.C. 360b) is amended— (1) by inserting “(1)” after “(b)”, (2) by redesignating clauses (1) through (8) as clauses (A) through (H), respectively, and (3) by adding at the end the following: “(2) Any person may file with the Secretary an abbreviated application for the approval of a new animal drug. An abbreviated application shall contain the information required by subsection (n).”. (b) Application Requirements.— Section 512 is amended by striking Labeling. out subsection (n) and inserting in lieu thereof the following: “(n) (1) An abbreviated application for a new animal drug shall contain— “(A) (i) except as provided in clause (ii), information to show that the conditions of use or similar limitations (whether in the labeling or published pursuant to subsection (i)) prescribed, recommended, or suggested in the labeling proposed for the new animal drug have been previously approved for a new animal drug listed under paragraph (4) (hereinafter in this subsection referred to as an ‘approved new animal drug’), and “(ii) information to show that the withdrawal period at which residues of the new animal drug will be consistent with the tolerances established for the approved new animal drug is the same as the withdrawal period previously established for the approved new animal drug or, if the withdrawal period is proposed to be different, information showing that the residues of the new animal drug at the proposed different withdrawal period will be consistent with the tolerances established for the approved new animal drug; “(B) (i) information to show that the active ingredients of the new animal drug are the same as those of the approved new animal drug, and “(ii) if the approved new animal drug has more than one active ingredient, and if one of the active ingredients of the new animal drug is different from one of the active ingredients of the approved new animal drug and the application is filed pursuant to the approval of a petition filed under paragraph (3)— “(I) information to show that the other active ingredients of the new animal drug are the same as the active ingredients of the approved new animal drug, “(II) information to show either that the different active ingredient is an active ingredient of another approved new animal drug or of an animal drug which does not meet the requirements of section 201(w), and “(III) such other information respecting the different active ingredients as the Secretary may require; “(C) (i) if the approved new animal drug is permitted to be used with one or more animal drugs in animal feed, information to show that the proposed uses of the new animal drug with other animal drugs in animal feed are the same as the uses of the approved new animal drug, and “(ii) if the approved new animal drug is permitted to be used with one or more other animal drugs in animal feed, and one of the other animal drugs proposed for use with the new animal drug in animal feed is different from one of the other animal drugs permitted to be used in animal feed with the approved new animal drug, and the application is filed pursuant to the approval of a petition filed under paragraph (3)— “(I) information to show either that the different animal drug proposed for use with the approved new animal drug in animal feed is an approved new animal drug permitted to be used in animal feed or does not meet the requirements of section 201(w) when used with another animal drug in animal feed, “(II) information to show that other animal drugs proposed for use with the new animal drug in animal feed are the same as the other animal drugs permitted to be used with the approved new animal drug, and “(III) such other information respecting the different animal drug or combination with respect to which the petition was filed as the Secretary may require, “(D) information to show that the route of administration, the dosage form, and the strength of the new animal drug are the same as those of the approved new animal drug or, if the route of administration, the dosage form, or the strength of the new animal drug is different and the application is filed pursuant to the approval of a petition filed under paragraph (3), such information respecting the route of administration, dosage form, or strength with respect to which the petition was filed as the Secretary may require; “(E) information to show that the new animal drug is bioequivalent to the approved new animal drug, except that if the application is filed pursuant to the approval of a petition filed under paragraph (3) for the purposes described in subparagraph (B) or (C), information to show that the active ingredients of the new animal drug are of the same pharmacological or therapeutic class as the pharmacological or therapeutic class of the approved new animal drug and that the new animal drug can be expected to have the same therapeutic effect as the approved new animal drug when used in accordance with the labeling; “(F) information to show that the labeling proposed for the new animal drug is the same as the labeling approved for the approved new animal drug except for changes required because of differences approved under a petition filed under paragraph (3), because of a different withdrawal period, or because the new animal drug and the approved new animal drug are produced or distributed by different manufacturers; “(G) the items specified in clauses (B) through (F) of subsection (b)(1); “(H) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the approved new animal drug or which claims a use for such approved new animal drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under subsection (b)(1) or (c)(3)— “(i) that such patent information has not been filed, “(ii) that such patent has expired, “(iii) of the date on which such patent will expire, or “(iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new animal drug for which the application is filed; and “(I) if with respect to the approved new animal drug information was filed under subsection (b)(1) or (c)(3) for a method of use patent which does not claim a use for which the applicant is seeking approval of an application under subsection (c)(2), a statement that the method of use patent does not claim such a use. The Secretary may not require that an abbreviated application contain information in addition to that required by subparagraphs (A) through (H). “(2) (A) An applicant who makes a certification described in paragraph (1)(G)(iv) shall include in the application a statement that the applicant will give the notice required by subparagraph (B) to— “(i) each owner of the patent which is the subject of the certification or the representative of such owner designated to receive such notice, and “(ii) the holder of the approved application under subsection (c)(1) for the drug which is claimed by the patent or a use of which is claimed by the patent or the representative of such holder designated to receive such notice. “(B) The notice referred to in subparagraph (A) shall state that an application, which contains data from bioequivalence studies, has been filed under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of such drug before the expiration of the patent referred to in the certification. Such notice shall include a detailed statement of the factual and legal basis of the applicant’s opinion that the patent is not valid or will not be infringed. “(C) If an application is amended to include a certification described in paragraph (1)(G)(iv), the notice required by subparagraph (B) shall be given when the amended application is filed. “(3) If a person wants to submit an abbreviated application for a new animal drug— “(A) whose active ingredients, route of administration, dosage form, or strength differ from that of an approved new animal drug, or “(B) whose use with other animal drugs in animal feed differs from that of an approved new animal drug, such person shall submit a petition to the Secretary seeking permission to file such an application. The Secretary shall approve a petition for a new animal drug unless the Secretary finds that— “(C) investigations must be conducted to show the safety and effectiveness, in animals to be treated with the drug, of the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed which differ from the approved new animal drug, or “(D) investigations must be conducted to show the safety for human consumption of any residues in food resulting from the proposed active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed for the new animal drug which is different from the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed of the approved new animal drug. The Secretary shall approve or disapprove a petition submitted under this paragraph within 90 days of the date the petition is submitted. “(4) (A) (i) Within 60 days of the date of the enactment of this subsection, the Secretary shall publish and make available to the public a list in alphabetical order of the official and proprietary name of each new animal drug which has been approved for safety and effectiveness before the date of the enactment of this subsection. “(ii) Every 30 days after the publication of the first list under clause (i) the Secretary shall revise the list to include each new animal drug which has been approved for safety and effectiveness under subsection (c) during the 30 day period. “(iii) When patent information submitted under subsection (b)(1) or (c)(3) respecting a new animal drug included on the list is to be published by the Secretary, the Secretary shall, in revisions made under clause (ii), include such information for such drug. “(B) A new animal drug approved for safety and effectiveness before the date of the enactment of this subsection or approved for safety and effectiveness under subsection (c) shall, for purposes of this subsection, be considered to have been published under subparagraph (A) on the date of its approval or the date of enactment, whichever is later. “(C) If the approval of a new animal drug was withdrawn or suspended under subsection (c)(2)(G) or for grounds described in subsection (e) or if the Secretary determines that a drug has been withdrawn from sale for safety or effectiveness reasons, it may not be published in the list under subparagraph (A) or, if the withdrawal or suspension occurred after its publication in such list, it shall be immediately removed from such list— “(i) for the same period as the withdrawal or suspension under subsection (c)(2)(G) or (e), or “(ii) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons. A notice of the removal shall be published in the Federal Register. Federal Register, publication. “(5) If an application contains the information required by clauses (A), (G), and (H) of subsection (b)(1) and such information— “(A) is relied on by the applicant for the approval of the application, and “(B) is not information derived either from investigations, studies, or tests conducted by or for the applicant or for which the applicant had obtained a right of reference or use from the person by or for whom the investigations, studies, or tests were conducted, such application shall be considered to be an application filed under subsection (b)(2). “(o) For purposes of this section, the term ‘patent’ means a patent issued by the Patent and Trademark Office of the Department of Commerce.”. (c) Application Approval.— Section 512(c) is amended (1) by 21 USC 360b. inserting “(1)” after “(c)”, by redesignating clauses (1) and (2) as clauses (A) and (B), and by adding at the end the following: “(2) (A) Subject to subparagraph (C), the Secretary shall approve an abbreviated application for a drug unless the Secretary finds— “(i) the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity; “(ii) the conditions of use prescribed, recommended, or suggested in the proposed labeling are not reasonably certain to be followed in practice or, except as provided subparagraph (B), information submitted with the application is insufficient to show that each of the proposed conditions of use or similar limitations (whether in the labeling or published pursuant to subsection (i)) have been previously approved for the approved new animal drug referred to in the application; “(iii) information submitted with the application is insufficient to show that the active ingredients are the same as those of the approved new animal drug referred to in the application; “(iv) (I) if the application is for a drug whose active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed is the same as the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed of the approved new animal drug referred to in the application, information submitted in the application is insufficient to show that the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed is the same as that of the approved new animal drug, or “(II) if the application is for a drug whose active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed is different from that of the approved new animal drug referred to in the application, no petition to file an application for the drug with the different active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed was approved under subsection (n)(3); “(v) if the application was filed pursuant to the approval of a petition under subsection (n)(3), the application did not contain the information required by the Secretary respecting the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed which is not the same; “(vi) information submitted in the application is insufficient to show that the drug is bioequivalent to the approved new animal drug referred to in the application, or if the application is filed under a petition approved pursuant to subsection (n)(3), information submitted in the application is insufficient to show that the active ingredients of the new animal drug are of the same pharmacological or therapeutic class as the pharmacological or therapeutic class of the approved new animal drug and that the new animal drug can be expected to have the same therapeutic effect as the approved new animal drug when used in accordance with the labeling; “(vii) information submitted in the application is insufficient to show that the labeling proposed for the drug is the same as the labeling approved for the approved new animal drug referred to in the application except for changes required because of differences approved under a petition filed under subsection (n)(3), because of a different withdrawal period, or because the drug and the approved new animal drug are produced or distributed by different manufacturers; “(viii) information submitted in the application or any other information available to the Secretary shows that (I) the inactive ingredients of the drug are unsafe for use under the conditions prescribed, recommended, or suggested in the labeling proposed for the drug, (II) the composition of the drug is unsafe under such conditions because of the type or quantity of inactive ingredients included or the manner in which the inactive ingredients are included, or (III) in the case of a drug for food producing animals, the inactive ingredients of the drug or its composition may be unsafe with respect to human food safety; “(ix) the approval under subsection (b)(1) of the approved new animal drug referred to in the application filed under subsection (b)(2) has been withdrawn or suspended for grounds described in paragraph (1) of subsection (e), the Secretary has published a notice of a hearing to withdraw approval of the approved new animal drug for such grounds, the approval under this paragraph of the new animal drug for which the application under subsection (b)(2) was filed has been withdrawn or suspended under subparagraph (G) for such grounds, or the Secretary has determined that the approved new animal drug has been withdrawn from sale for safety or effectiveness reasons; “(x) the application does not meet any other requirement of subsection (n); or “(xi) the application contains an untrue statement of material fact. “(B) If the Secretary finds that a new animal drug for which an application is submitted under subsection (b)(2) is bioequivalent to the approved new animal drug referred to in such application and that residues of the new animal drug are consistent with the tolerances established for such approved new animal drug but at a withdrawal period which is different than the withdrawal period approved for such approved new animal drug, the Secretary may establish, on the basis of information submitted, such different withdrawal period as the withdrawal period for the new animal drug for purposes of the approval of such application for such drug. “(C) Within 180 days of the initial receipt of an application under subsection (b)(2) or within such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall approve or disapprove the application. “(D) The approval of an application filed under subsection (b)(2) shall be made effective on the last applicable date determined under the following: “(i) If the applicant only made a certification described in clause (i) or (ii) of subsection (n)(1)(G) or in both such clauses, the approval may be made effective immediately. “(ii) If the applicant made a certification described in clause (iii) of subsection (n)(1)(G), the approval may be made effective on the date certified under clause (iii). “(iii) If the applicant made a certification described in clause Courts, U.S. (iv) of subsection (n)(1)(G), the approval shall be made effective immediately unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of 45 days from the date the notice provided under subsection (n)(2)(B)(i) is received. If such an action is brought before the expiration of such days, the approval shall be made effective upon the expiration of the 30 month period beginning on the date of the receipt of the notice provided under subsection (n)(2)(B) or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action, except that if before the expiration of such period— “(I) the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of the court decision, “(II) the court decides that such patent has been infringed, the approval shall be made effective on such date as the court orders under section 271(e)(4)(A) of title 35, United States Code, or “(III) the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of such court decision. In such an action, each of the parties shall reasonably cooperate in expediting the action. Until the expiration of 45 days from the date the notice made under subsection (n)(2)(B) is received, no action may be brought under section 2201 of title 28, United States Code, for a declaratory judgment with respect to the patent. Any action brought under section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business. “(iv) If the application contains a certification described in clause (iv) of subsection (n)(1)(G) and is for a drug for which a previous application has been filed under this subsection containing such a certification, the application shall be made effective not earlier than 180 days after— “(I) the date the Secretary receives notice from the applicant under the previous application of the first commercial marketing of the drug under the previous application, or “(II) the date of a decision of a court in an action described in subclause (III) holding the patent which is the subject of the certification to be invalid or not infringed, whichever is earlier. “(E) If the Secretary decides to disapprove an application, the Secretary shall give the applicant notice of an opportunity for a hearing before the Secretary on the question of whether such application is approvable. If the applicant elects to accept the opportunity for hearing by written request within 30 days after such notice, such hearing shall commence not more than 90 days after the expiration of such 30 days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary’s order thereon shall be issued within 90 days after the date fixed by the Secretary for filing final briefs. “(F) (i) If an application submitted under subsection (b)(1) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b)(1), is approved after the date of the enactment of this paragraph, no application may be submitted under subsection (b)(2) which refers to the drug for which the subsection (b)(1) application was submitted before the expiration of 5 years from the date of the approval of the application under subsection (b)(1), except that such an application may be submitted under subsection (b)(2) after the expiration of 4 years from the date of the approval of the subsection (b)(1) application if it contains a certification of patent invalidity or noninfringement described in clause (iv) of subsection (n)(1)(G). The approval of such an application shall be made effective in accordance with subparagraph (B) except that, if an action for patent infringement is commenced during the one-year period beginning 48 months after the date of the approval of the subsection (b) application, the 30 month period referred to in subparagraph (C)(iii) shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the subsection (b) application. “(ii) If an application submitted under subsection (b)(1) for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application approved under such subsection, is approved after the date of enactment of this paragraph and if such application contains reports of new clinical or field investigations (other than bioequivalence or residue studies) and, in the case of food producing animals, human food safety studies (other than bioequivalence or residue studies) essential to the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submitted under subsection (b)(2) for the conditions of approval of such drug in the subsection (b)(1) application effective before the expiration of 3 years from the date of the approval of the application under subsection (b)(1) for such drug. “(iii) If a supplement to an application approved under subsection (b)(1) is approved after the date of enactment of this paragraph and the supplement contains reports of new clinical or field investigations (other than bioequivalence or residue studies) and, in the case of food producing animals, human food safety studies (other than bioequivalence or residue studies) essential to the approval of the supplement and conducted or sponsored by the person submitting the supplement, the Secretary may not make the approval of an application submitted under subsection (b)(2) for a change approved in the supplement effective before the expiration of 3 years from the date of the approval of the supplement. “(iv) An applicant under subsection (b)(1) who comes within the provisions of clause (i) of this subparagraph as a result of an application which seeks approval for a use solely in non-food producing animals, may elect, within 10 days of receiving such approval, to waive clause (i) of this subparagraph, in which event the limitation on approval of applications submitted under subsection (b)(2) set forth in clause (ii) of this subparagraph shall be applicable to the subsection (b)(1) application. “(v) If an application (including any supplement to a new animal drug application) submitted under subsection (b)(1) for a new animal drug for a food-producing animal use, which includes an active ingredient (including any ester or salt of the active ingredient) which has been the subject of a waiver under subparagraph (B)(iv) is approved after the date of enactment of this paragraph, and if the application contains reports of clinical or field investigations or human food safety studies (other than bioequivalence or residue studies) essential to the new approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application (including any supplement to such application) submitted under subsection (b)(2) for the new conditions of approval of such drug in the subsection (b)(1) application effective before the expiration of five years from the date of approval of the application under subsection (b)(1) for such drug. The provisions of this paragraph shall apply only to the first approval for a food-producing animal use for the same applicant after the waiver under subparagraph (B)(iv). “(G) If an approved application submitted under subsection (b)(2) for a new animal drug refers to a drug the approval of which was withdrawn or suspended for grounds described in paragraph (1) or (2) of subsection (e) or was withdrawn or suspended under this subparagraph or which, as determined by the Secretary, has been withdrawn from sale for safety or effectiveness reasons, the approval of the drug under this paragraph shall be withdrawn or suspended— “(i) for the same period as the withdrawal or suspension under subsection (e) or this subparagraph, or “(ii) if the approved new animal drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons. “(H) For purposes of this paragraph: “(i) The term ‘bioequivalence’ means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a new animal drug and becomes available at the site of drug action. “(ii) A new animal drug shall be considered to be bioequivalent to the approved new animal drug referred to in its application under subsection (n) if— “(I) the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the approved new animal drug referred to in the application when administered at the same dose of the active ingredient under similar experimental conditions in either a single dose or multiple doses; “(II) the extent of absorption of the drug does not show a significant difference from the extent of absorption of the approved new animal drug referred to in the application when administered at the same dose of the active ingredient under similar experimental conditions in either a single dose or multiple doses and the difference from the approved new animal drug in the rate of absorption of the drug is intentional, is reflected in its proposed labeling, is not essential to the attainment of effective drug concentrations in use, and is considered scientifically insignificant for the drug in attaining the intended purposes of its use and preserving human food safety; or “(III) in any case in which the Secretary determines that the measurement of the rate and extent of absorption or excretion of the new animal drug in biological fluids is inappropriate or impractical, an appropriate acute pharmacological effects test or other test of the new animal drug and, when deemed scientifically necessary, of the approved new animal drug referred to in the application in the species to be tested or in an appropriate animal model does not show a significant difference between the new animal drug and such approved new animal drug when administered at the same dose under similar experimental conditions. If the approved new animal drug referred to in the application for a new animal drug under subsection (n) is approved for use in more than one animal species, the bioequivalency information described in subclause (I), (II), and (III) shall be obtained for one species, or if the Secretary deems appropriate based on scientific principles, shall be obtained for more than one species. The Secretary may prescribe the dose to be used in determining bioequivalency under subclause (I), (II), or (III). To assure that the residues of the new animal drug will be consistent with the established tolerances for the approved new animal drug referred to in the application under subsection (b)(2) upon the expiration of the withdrawal period contained in the application for the new animal drug, the Secretary shall require bioequivalency data or residue depletion studies of the new animal drug or such other data or studies as the Secretary considers appropriate based on scientific principles. If the Secretary requires one or more residue studies under the preceding sentence, the Secretary may not require that the assay methodology used to determine the withdrawal period of the new animal drug be more rigorous than the methodology used to determine the withdrawal period for the approved new animal drug referred to in the application. If such studies are required and if the approved new animal drug, referred to in the application for the new animal drug for which such studies are required, is approved for use in more than one animal species, such studies shall be conducted for one species, or if the Secretary deems appropriate based on scientific principles, shall be conducted for more than one species.”. SEC. 102. PATENT INFORMATION. (a) Section 512(b).— Section 512(b)(1) of such Act is amended by 21 USC 360b. adding at the end the following: “The applicant shall file with the application the patent number and the expiration date of any patent which claims the new animal drug for which the applicant filed the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. If an application is filed under this subsection for a drug and a patent which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, the applicant shall amend the application to include the information required by the preceding sentence. Upon approval of the application, the Secretary shall publish Public information. information submitted under the two preceding sentences.”. (b) Other Sections.— (1) Section 512(c) is amended by adding at the end the 21 USC 360b. following: “(3) If the patent information described in subsection (b)(1) could not be filed with the submission of an application under subsection (b)(1) because the application was filed before the patent information was required under subsection (b)(1) or a patent was issued after the application was approved under such subsection, the holder of an approved application shall file with the Secretary the patent number and the expiration date of any patent which claims the new animal drug for which the application was filed or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. If the holder of an approved application could not file patent information under subsection (b)(1) because it was not required at the time the application was approved, the holder shall file such information under this subsection not later than 30 days after the date of the enactment of this sentence, and if the holder of an approved application could not file patent information under subsection (b)(1) because no patent had been issued when an application was filed or approved, the holder shall file such information under this subsection not later than 30 days after the date the patent involved is issued. Upon the submission of patent information under Public information. 21 USC 360b. this subsection, the Secretary shall publish it.”. (2) The first sentence of section 512(d)(1) is amended by redesignating subparagraphs (G) and (H) as subparagraphs (H) and (I), respectively and by inserting after subparagraph (F) the following: “(G) the application failed to contain the patent information prescribed by subsection (b)(1);”. (3) The second sentence of section 512(d)(1) is amended by striking out “(H)” and inserting in lieu thereof “(G)”. (4) The first sentence of section 512(e)(1) is amended by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively, and by inserting after subparagraph (C) the following: “(D) the patent information prescribed by subsection (c)(3) was not filed within 30 days after the receipt of written notice from the Secretary specifying the failure to file such information;”. SEC. 103. REGULATIONS. (a) General Rule.— The Secretary of Health and Human Services shall promulgate, in accordance with the notice and comment requirements of section 553 of title 5, United States Code, such regulations as may be necessary for the administration of section 512 of the Federal Food, Drug, and Cosmetic Act, as amended by sections 101 through 103 of this title, within one year of the date of enactment of this Act. (b) Transition.— During the period beginning 60 days after the date of enactment of this Act and ending on the date regulations promulgated under subsection (a) take effect, abbreviated new animal drug applications may be submitted in accordance with the provisions of section 314.55 and part 320 of title 21 of the Code of Federal Regulations and shall be considered as suitable for any drug which has been approved for safety and effectiveness under section 512(c) of the Federal Food, Drug, and Cosmetic Act before the date of enactment of this Act. If any such provision of section 314.55 or part 320 is inconsistent with the requirements of section 512 of the Federal Food, Drug, and Cosmetic Act (as amended by this title), the Secretary shall consider the application under the applicable requirements of section 512 (as so amended). SEC. 104. SAFETY AND EFFECTIVENESS DATA. Section 512 (as amended by section 101(b) of this title) is amended by adding at the end the following: “(p) (1) Safety and effectiveness data and information which has been submitted in an application filed under subsection (b)(1) for a drug and which has not previously been disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown— “(A) if no work is being or will be undertaken to have the application approved, “(B) if the Secretary has determined that the application is not approvable and all legal appeals have been exhausted, “(C) if approval of the application under subsection (c) is withdrawn and all legal appeals have been exhausted, “(D) if the Secretary has determined that such drug is not a new drug, or “(E) upon the effective date of the approval of the first application filed under subsection (b)(2) which refers to such drug or upon the date upon which the approval of an application filed under subsection (b)(2) which refers to such drug could be made effective if such an application had been filed. “(2) Any request for data and information pursuant to paragraph (1) shall include a verified statement by the person making the request that any data or information received under such paragraph shall not be disclosed by such person to any other person— “(A) for the purpose of, or as part of a plan, scheme, or device for, obtaining the right to make, use, or market, or making, using, or marketing, outside the United States, the drug identified in the application filed under subsection (b)(1), and “(B) without obtaining from any person to whom the data and information are disclosed an identical verified statement, a copy of which is to be provided by such person to the Secretary, which meets the requirements of this paragraph.”. SEC. 105. VETERINARY PRESCRIPTION DRUGS. Section 503 (21 U.S.C. 353) is amended by adding at the end thereof the following new subsection: “(c) (1) (A) A drug intended for use by animals other than man which— “(i) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary for its use, is not safe for animal use except under the professional supervision of a licensed veterinarian, or “(ii) is limited by an approved application under subsection (b) of section 512 to use under the professional supervision of a licensed veterinarian, shall be dispensed only by or upon the lawful written or oral order of a licensed veterinarian in the course of the veterinarian’s professional practice. “(B) For purposes of subparagraph (A), an order Is lawful if the order— “(i) is a prescription or other order authorized by law, “(ii) is, if an oral order, promptly reduced to writing by the person lawfully filling the order, and filed by that person, and “(iii) is refilled only if authorized in the original order or in a subsequent oral order promptly reduced to writing by the person lawfully filling the order, and filed by that person. “(C) The act of dispensing a drug contrary to the provisions of this Fraud. paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale. “(2) Any drug when dispensed in accordance with paragraph (1) of this subsection— “(A) shall be exempt from the requirements of section 502, except subsections (a), (g), (h), (1)(2), (i)(3), and (p) of such section, and “(B) shall be exempt from the packaging requirements of subsections (g), (h), and (p) of such section, if— “(i) when dispensed by a licensed veterinarian, the drug bears a label containing the name and address of the practitioner and any directions for use and cautionary statements specified by the practitioner, or “(ii) when dispensed by filling the lawful order of a licensed veterinarian, the drug bears a label containing the name and address of the dispenser, the serial number and date of the order or of its filling, the name of the licensed veterinarian, and the directions for use and cautionary statements, if any, contained in such order. The preceding sentence shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail. “(3) The Secretary may by regulation exempt drugs for animals other than man subject to section 512 from the requirements of paragraph (1) when such requirements are not necessary for the protection of the public health. “(4) A drug which is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement ‘Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.’. A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the statement specified m the preceding sentence.”. SEC. 106. DRUGS PRIMARILY MANUFACTURED USING BIOTECHNOLOGY. Notwithstanding section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act, the Secretary of Health and Human Services may not approve an abbreviated application submitted under such section for a new animal drug which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques. SEC. 107. CONFORMING AMENDMENTS. (a) Batch Certification.— (1) Section 201(w) (21 U.S.C. 321(w)) is amended by striking out “; or” at the end of paragraph (2) and inserting in lieu thereof a period and by striking out paragraph (3). (2) Section 512(a)(1) (21 U.S.C. 360b(a)(1)) is amended by inserting “and” at the end of subparagraph (A), by striking out “, and” at the end of subparagraph (B) and inserting in lieu thereof a period, and by striking out subparagraph (C). (b) Title 28.— Section 2201(b) of title 28, United States Code, is amended by inserting “or 512” after “505”. SEC. 108. EFFECTIVE DATE. The Secretary of Health and Human Services may not make an approval of an application submitted under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2)) effective before January 1, 1991.

4. 1988

   Generic Animal Drug and Patent Term Restoration Act

   Pub. L. 100–670 title I · 102 Stat. 3971

   1. Amended · 21 U.S.C. § 360b(c)

      Pub. L. 100–670, §§ 101(c), 102(b)(1), designated existing provisions as par. (1)

   2. Redesignated · 21 U.S.C. § 360b(c)

      Pub. L. 100–670, §§ 101(c), 102(b)(1), redesignated cls. (1) and (2) as cls. (A) and (B), respectively

   3. Added · 21 U.S.C. § 360b(c)

      Pub. L. 100–670, §§ 101(c), 102(b)(1), added pars. (2) and (3)

   Source evidence

   Code amendment note
   Subsec. (c). Pub. L. 100–670, §§ 101(c), 102(b)(1), designated existing provisions as par. (1), redesignated cls. (1) and (2) as cls. (A) and (B), respectively, and added pars. (2) and (3).

   Enacted provision · exact public law
   TITLE I— NEW ANIMAL DRUG APPLICATIONS SEC. 101. ABBREVIATED NEW ANIMAL DRUG APPLICATIONS. (a) General Rule.— Section 512(b) (21 U.S.C. 360b) is amended— (1) by inserting “(1)” after “(b)”, (2) by redesignating clauses (1) through (8) as clauses (A) through (H), respectively, and (3) by adding at the end the following: “(2) Any person may file with the Secretary an abbreviated application for the approval of a new animal drug. An abbreviated application shall contain the information required by subsection (n).”. (b) Application Requirements.— Section 512 is amended by striking Labeling. out subsection (n) and inserting in lieu thereof the following: “(n) (1) An abbreviated application for a new animal drug shall contain— “(A) (i) except as provided in clause (ii), information to show that the conditions of use or similar limitations (whether in the labeling or published pursuant to subsection (i)) prescribed, recommended, or suggested in the labeling proposed for the new animal drug have been previously approved for a new animal drug listed under paragraph (4) (hereinafter in this subsection referred to as an ‘approved new animal drug’), and “(ii) information to show that the withdrawal period at which residues of the new animal drug will be consistent with the tolerances established for the approved new animal drug is the same as the withdrawal period previously established for the approved new animal drug or, if the withdrawal period is proposed to be different, information showing that the residues of the new animal drug at the proposed different withdrawal period will be consistent with the tolerances established for the approved new animal drug; “(B) (i) information to show that the active ingredients of the new animal drug are the same as those of the approved new animal drug, and “(ii) if the approved new animal drug has more than one active ingredient, and if one of the active ingredients of the new animal drug is different from one of the active ingredients of the approved new animal drug and the application is filed pursuant to the approval of a petition filed under paragraph (3)— “(I) information to show that the other active ingredients of the new animal drug are the same as the active ingredients of the approved new animal drug, “(II) information to show either that the different active ingredient is an active ingredient of another approved new animal drug or of an animal drug which does not meet the requirements of section 201(w), and “(III) such other information respecting the different active ingredients as the Secretary may require; “(C) (i) if the approved new animal drug is permitted to be used with one or more animal drugs in animal feed, information to show that the proposed uses of the new animal drug with other animal drugs in animal feed are the same as the uses of the approved new animal drug, and “(ii) if the approved new animal drug is permitted to be used with one or more other animal drugs in animal feed, and one of the other animal drugs proposed for use with the new animal drug in animal feed is different from one of the other animal drugs permitted to be used in animal feed with the approved new animal drug, and the application is filed pursuant to the approval of a petition filed under paragraph (3)— “(I) information to show either that the different animal drug proposed for use with the approved new animal drug in animal feed is an approved new animal drug permitted to be used in animal feed or does not meet the requirements of section 201(w) when used with another animal drug in animal feed, “(II) information to show that other animal drugs proposed for use with the new animal drug in animal feed are the same as the other animal drugs permitted to be used with the approved new animal drug, and “(III) such other information respecting the different animal drug or combination with respect to which the petition was filed as the Secretary may require, “(D) information to show that the route of administration, the dosage form, and the strength of the new animal drug are the same as those of the approved new animal drug or, if the route of administration, the dosage form, or the strength of the new animal drug is different and the application is filed pursuant to the approval of a petition filed under paragraph (3), such information respecting the route of administration, dosage form, or strength with respect to which the petition was filed as the Secretary may require; “(E) information to show that the new animal drug is bioequivalent to the approved new animal drug, except that if the application is filed pursuant to the approval of a petition filed under paragraph (3) for the purposes described in subparagraph (B) or (C), information to show that the active ingredients of the new animal drug are of the same pharmacological or therapeutic class as the pharmacological or therapeutic class of the approved new animal drug and that the new animal drug can be expected to have the same therapeutic effect as the approved new animal drug when used in accordance with the labeling; “(F) information to show that the labeling proposed for the new animal drug is the same as the labeling approved for the approved new animal drug except for changes required because of differences approved under a petition filed under paragraph (3), because of a different withdrawal period, or because the new animal drug and the approved new animal drug are produced or distributed by different manufacturers; “(G) the items specified in clauses (B) through (F) of subsection (b)(1); “(H) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the approved new animal drug or which claims a use for such approved new animal drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under subsection (b)(1) or (c)(3)— “(i) that such patent information has not been filed, “(ii) that such patent has expired, “(iii) of the date on which such patent will expire, or “(iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new animal drug for which the application is filed; and “(I) if with respect to the approved new animal drug information was filed under subsection (b)(1) or (c)(3) for a method of use patent which does not claim a use for which the applicant is seeking approval of an application under subsection (c)(2), a statement that the method of use patent does not claim such a use. The Secretary may not require that an abbreviated application contain information in addition to that required by subparagraphs (A) through (H). “(2) (A) An applicant who makes a certification described in paragraph (1)(G)(iv) shall include in the application a statement that the applicant will give the notice required by subparagraph (B) to— “(i) each owner of the patent which is the subject of the certification or the representative of such owner designated to receive such notice, and “(ii) the holder of the approved application under subsection (c)(1) for the drug which is claimed by the patent or a use of which is claimed by the patent or the representative of such holder designated to receive such notice. “(B) The notice referred to in subparagraph (A) shall state that an application, which contains data from bioequivalence studies, has been filed under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of such drug before the expiration of the patent referred to in the certification. Such notice shall include a detailed statement of the factual and legal basis of the applicant’s opinion that the patent is not valid or will not be infringed. “(C) If an application is amended to include a certification described in paragraph (1)(G)(iv), the notice required by subparagraph (B) shall be given when the amended application is filed. “(3) If a person wants to submit an abbreviated application for a new animal drug— “(A) whose active ingredients, route of administration, dosage form, or strength differ from that of an approved new animal drug, or “(B) whose use with other animal drugs in animal feed differs from that of an approved new animal drug, such person shall submit a petition to the Secretary seeking permission to file such an application. The Secretary shall approve a petition for a new animal drug unless the Secretary finds that— “(C) investigations must be conducted to show the safety and effectiveness, in animals to be treated with the drug, of the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed which differ from the approved new animal drug, or “(D) investigations must be conducted to show the safety for human consumption of any residues in food resulting from the proposed active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed for the new animal drug which is different from the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed of the approved new animal drug. The Secretary shall approve or disapprove a petition submitted under this paragraph within 90 days of the date the petition is submitted. “(4) (A) (i) Within 60 days of the date of the enactment of this subsection, the Secretary shall publish and make available to the public a list in alphabetical order of the official and proprietary name of each new animal drug which has been approved for safety and effectiveness before the date of the enactment of this subsection. “(ii) Every 30 days after the publication of the first list under clause (i) the Secretary shall revise the list to include each new animal drug which has been approved for safety and effectiveness under subsection (c) during the 30 day period. “(iii) When patent information submitted under subsection (b)(1) or (c)(3) respecting a new animal drug included on the list is to be published by the Secretary, the Secretary shall, in revisions made under clause (ii), include such information for such drug. “(B) A new animal drug approved for safety and effectiveness before the date of the enactment of this subsection or approved for safety and effectiveness under subsection (c) shall, for purposes of this subsection, be considered to have been published under subparagraph (A) on the date of its approval or the date of enactment, whichever is later. “(C) If the approval of a new animal drug was withdrawn or suspended under subsection (c)(2)(G) or for grounds described in subsection (e) or if the Secretary determines that a drug has been withdrawn from sale for safety or effectiveness reasons, it may not be published in the list under subparagraph (A) or, if the withdrawal or suspension occurred after its publication in such list, it shall be immediately removed from such list— “(i) for the same period as the withdrawal or suspension under subsection (c)(2)(G) or (e), or “(ii) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons. A notice of the removal shall be published in the Federal Register. Federal Register, publication. “(5) If an application contains the information required by clauses (A), (G), and (H) of subsection (b)(1) and such information— “(A) is relied on by the applicant for the approval of the application, and “(B) is not information derived either from investigations, studies, or tests conducted by or for the applicant or for which the applicant had obtained a right of reference or use from the person by or for whom the investigations, studies, or tests were conducted, such application shall be considered to be an application filed under subsection (b)(2). “(o) For purposes of this section, the term ‘patent’ means a patent issued by the Patent and Trademark Office of the Department of Commerce.”. (c) Application Approval.— Section 512(c) is amended (1) by 21 USC 360b. inserting “(1)” after “(c)”, by redesignating clauses (1) and (2) as clauses (A) and (B), and by adding at the end the following: “(2) (A) Subject to subparagraph (C), the Secretary shall approve an abbreviated application for a drug unless the Secretary finds— “(i) the methods used in, or the facilities and controls used for, the manufacture, processing, and packing of the drug are inadequate to assure and preserve its identity, strength, quality, and purity; “(ii) the conditions of use prescribed, recommended, or suggested in the proposed labeling are not reasonably certain to be followed in practice or, except as provided subparagraph (B), information submitted with the application is insufficient to show that each of the proposed conditions of use or similar limitations (whether in the labeling or published pursuant to subsection (i)) have been previously approved for the approved new animal drug referred to in the application; “(iii) information submitted with the application is insufficient to show that the active ingredients are the same as those of the approved new animal drug referred to in the application; “(iv) (I) if the application is for a drug whose active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed is the same as the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed of the approved new animal drug referred to in the application, information submitted in the application is insufficient to show that the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed is the same as that of the approved new animal drug, or “(II) if the application is for a drug whose active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed is different from that of the approved new animal drug referred to in the application, no petition to file an application for the drug with the different active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed was approved under subsection (n)(3); “(v) if the application was filed pursuant to the approval of a petition under subsection (n)(3), the application did not contain the information required by the Secretary respecting the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed which is not the same; “(vi) information submitted in the application is insufficient to show that the drug is bioequivalent to the approved new animal drug referred to in the application, or if the application is filed under a petition approved pursuant to subsection (n)(3), information submitted in the application is insufficient to show that the active ingredients of the new animal drug are of the same pharmacological or therapeutic class as the pharmacological or therapeutic class of the approved new animal drug and that the new animal drug can be expected to have the same therapeutic effect as the approved new animal drug when used in accordance with the labeling; “(vii) information submitted in the application is insufficient to show that the labeling proposed for the drug is the same as the labeling approved for the approved new animal drug referred to in the application except for changes required because of differences approved under a petition filed under subsection (n)(3), because of a different withdrawal period, or because the drug and the approved new animal drug are produced or distributed by different manufacturers; “(viii) information submitted in the application or any other information available to the Secretary shows that (I) the inactive ingredients of the drug are unsafe for use under the conditions prescribed, recommended, or suggested in the labeling proposed for the drug, (II) the composition of the drug is unsafe under such conditions because of the type or quantity of inactive ingredients included or the manner in which the inactive ingredients are included, or (III) in the case of a drug for food producing animals, the inactive ingredients of the drug or its composition may be unsafe with respect to human food safety; “(ix) the approval under subsection (b)(1) of the approved new animal drug referred to in the application filed under subsection (b)(2) has been withdrawn or suspended for grounds described in paragraph (1) of subsection (e), the Secretary has published a notice of a hearing to withdraw approval of the approved new animal drug for such grounds, the approval under this paragraph of the new animal drug for which the application under subsection (b)(2) was filed has been withdrawn or suspended under subparagraph (G) for such grounds, or the Secretary has determined that the approved new animal drug has been withdrawn from sale for safety or effectiveness reasons; “(x) the application does not meet any other requirement of subsection (n); or “(xi) the application contains an untrue statement of material fact. “(B) If the Secretary finds that a new animal drug for which an application is submitted under subsection (b)(2) is bioequivalent to the approved new animal drug referred to in such application and that residues of the new animal drug are consistent with the tolerances established for such approved new animal drug but at a withdrawal period which is different than the withdrawal period approved for such approved new animal drug, the Secretary may establish, on the basis of information submitted, such different withdrawal period as the withdrawal period for the new animal drug for purposes of the approval of such application for such drug. “(C) Within 180 days of the initial receipt of an application under subsection (b)(2) or within such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall approve or disapprove the application. “(D) The approval of an application filed under subsection (b)(2) shall be made effective on the last applicable date determined under the following: “(i) If the applicant only made a certification described in clause (i) or (ii) of subsection (n)(1)(G) or in both such clauses, the approval may be made effective immediately. “(ii) If the applicant made a certification described in clause (iii) of subsection (n)(1)(G), the approval may be made effective on the date certified under clause (iii). “(iii) If the applicant made a certification described in clause Courts, U.S. (iv) of subsection (n)(1)(G), the approval shall be made effective immediately unless an action is brought for infringement of a patent which is the subject of the certification before the expiration of 45 days from the date the notice provided under subsection (n)(2)(B)(i) is received. If such an action is brought before the expiration of such days, the approval shall be made effective upon the expiration of the 30 month period beginning on the date of the receipt of the notice provided under subsection (n)(2)(B) or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action, except that if before the expiration of such period— “(I) the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of the court decision, “(II) the court decides that such patent has been infringed, the approval shall be made effective on such date as the court orders under section 271(e)(4)(A) of title 35, United States Code, or “(III) the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent is invalid or not infringed, the approval shall be made effective on the date of such court decision. In such an action, each of the parties shall reasonably cooperate in expediting the action. Until the expiration of 45 days from the date the notice made under subsection (n)(2)(B) is received, no action may be brought under section 2201 of title 28, United States Code, for a declaratory judgment with respect to the patent. Any action brought under section 2201 shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business. “(iv) If the application contains a certification described in clause (iv) of subsection (n)(1)(G) and is for a drug for which a previous application has been filed under this subsection containing such a certification, the application shall be made effective not earlier than 180 days after— “(I) the date the Secretary receives notice from the applicant under the previous application of the first commercial marketing of the drug under the previous application, or “(II) the date of a decision of a court in an action described in subclause (III) holding the patent which is the subject of the certification to be invalid or not infringed, whichever is earlier. “(E) If the Secretary decides to disapprove an application, the Secretary shall give the applicant notice of an opportunity for a hearing before the Secretary on the question of whether such application is approvable. If the applicant elects to accept the opportunity for hearing by written request within 30 days after such notice, such hearing shall commence not more than 90 days after the expiration of such 30 days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary’s order thereon shall be issued within 90 days after the date fixed by the Secretary for filing final briefs. “(F) (i) If an application submitted under subsection (b)(1) for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b)(1), is approved after the date of the enactment of this paragraph, no application may be submitted under subsection (b)(2) which refers to the drug for which the subsection (b)(1) application was submitted before the expiration of 5 years from the date of the approval of the application under subsection (b)(1), except that such an application may be submitted under subsection (b)(2) after the expiration of 4 years from the date of the approval of the subsection (b)(1) application if it contains a certification of patent invalidity or noninfringement described in clause (iv) of subsection (n)(1)(G). The approval of such an application shall be made effective in accordance with subparagraph (B) except that, if an action for patent infringement is commenced during the one-year period beginning 48 months after the date of the approval of the subsection (b) application, the 30 month period referred to in subparagraph (C)(iii) shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the subsection (b) application. “(ii) If an application submitted under subsection (b)(1) for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application approved under such subsection, is approved after the date of enactment of this paragraph and if such application contains reports of new clinical or field investigations (other than bioequivalence or residue studies) and, in the case of food producing animals, human food safety studies (other than bioequivalence or residue studies) essential to the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submitted under subsection (b)(2) for the conditions of approval of such drug in the subsection (b)(1) application effective before the expiration of 3 years from the date of the approval of the application under subsection (b)(1) for such drug. “(iii) If a supplement to an application approved under subsection (b)(1) is approved after the date of enactment of this paragraph and the supplement contains reports of new clinical or field investigations (other than bioequivalence or residue studies) and, in the case of food producing animals, human food safety studies (other than bioequivalence or residue studies) essential to the approval of the supplement and conducted or sponsored by the person submitting the supplement, the Secretary may not make the approval of an application submitted under subsection (b)(2) for a change approved in the supplement effective before the expiration of 3 years from the date of the approval of the supplement. “(iv) An applicant under subsection (b)(1) who comes within the provisions of clause (i) of this subparagraph as a result of an application which seeks approval for a use solely in non-food producing animals, may elect, within 10 days of receiving such approval, to waive clause (i) of this subparagraph, in which event the limitation on approval of applications submitted under subsection (b)(2) set forth in clause (ii) of this subparagraph shall be applicable to the subsection (b)(1) application. “(v) If an application (including any supplement to a new animal drug application) submitted under subsection (b)(1) for a new animal drug for a food-producing animal use, which includes an active ingredient (including any ester or salt of the active ingredient) which has been the subject of a waiver under subparagraph (B)(iv) is approved after the date of enactment of this paragraph, and if the application contains reports of clinical or field investigations or human food safety studies (other than bioequivalence or residue studies) essential to the new approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application (including any supplement to such application) submitted under subsection (b)(2) for the new conditions of approval of such drug in the subsection (b)(1) application effective before the expiration of five years from the date of approval of the application under subsection (b)(1) for such drug. The provisions of this paragraph shall apply only to the first approval for a food-producing animal use for the same applicant after the waiver under subparagraph (B)(iv). “(G) If an approved application submitted under subsection (b)(2) for a new animal drug refers to a drug the approval of which was withdrawn or suspended for grounds described in paragraph (1) or (2) of subsection (e) or was withdrawn or suspended under this subparagraph or which, as determined by the Secretary, has been withdrawn from sale for safety or effectiveness reasons, the approval of the drug under this paragraph shall be withdrawn or suspended— “(i) for the same period as the withdrawal or suspension under subsection (e) or this subparagraph, or “(ii) if the approved new animal drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons. “(H) For purposes of this paragraph: “(i) The term ‘bioequivalence’ means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a new animal drug and becomes available at the site of drug action. “(ii) A new animal drug shall be considered to be bioequivalent to the approved new animal drug referred to in its application under subsection (n) if— “(I) the rate and extent of absorption of the drug do not show a significant difference from the rate and extent of absorption of the approved new animal drug referred to in the application when administered at the same dose of the active ingredient under similar experimental conditions in either a single dose or multiple doses; “(II) the extent of absorption of the drug does not show a significant difference from the extent of absorption of the approved new animal drug referred to in the application when administered at the same dose of the active ingredient under similar experimental conditions in either a single dose or multiple doses and the difference from the approved new animal drug in the rate of absorption of the drug is intentional, is reflected in its proposed labeling, is not essential to the attainment of effective drug concentrations in use, and is considered scientifically insignificant for the drug in attaining the intended purposes of its use and preserving human food safety; or “(III) in any case in which the Secretary determines that the measurement of the rate and extent of absorption or excretion of the new animal drug in biological fluids is inappropriate or impractical, an appropriate acute pharmacological effects test or other test of the new animal drug and, when deemed scientifically necessary, of the approved new animal drug referred to in the application in the species to be tested or in an appropriate animal model does not show a significant difference between the new animal drug and such approved new animal drug when administered at the same dose under similar experimental conditions. If the approved new animal drug referred to in the application for a new animal drug under subsection (n) is approved for use in more than one animal species, the bioequivalency information described in subclause (I), (II), and (III) shall be obtained for one species, or if the Secretary deems appropriate based on scientific principles, shall be obtained for more than one species. The Secretary may prescribe the dose to be used in determining bioequivalency under subclause (I), (II), or (III). To assure that the residues of the new animal drug will be consistent with the established tolerances for the approved new animal drug referred to in the application under subsection (b)(2) upon the expiration of the withdrawal period contained in the application for the new animal drug, the Secretary shall require bioequivalency data or residue depletion studies of the new animal drug or such other data or studies as the Secretary considers appropriate based on scientific principles. If the Secretary requires one or more residue studies under the preceding sentence, the Secretary may not require that the assay methodology used to determine the withdrawal period of the new animal drug be more rigorous than the methodology used to determine the withdrawal period for the approved new animal drug referred to in the application. If such studies are required and if the approved new animal drug, referred to in the application for the new animal drug for which such studies are required, is approved for use in more than one animal species, such studies shall be conducted for one species, or if the Secretary deems appropriate based on scientific principles, shall be conducted for more than one species.”. SEC. 102. PATENT INFORMATION. (a) Section 512(b).— Section 512(b)(1) of such Act is amended by 21 USC 360b. adding at the end the following: “The applicant shall file with the application the patent number and the expiration date of any patent which claims the new animal drug for which the applicant filed the application or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. If an application is filed under this subsection for a drug and a patent which claims such drug or a method of using such drug is issued after the filing date but before approval of the application, the applicant shall amend the application to include the information required by the preceding sentence. Upon approval of the application, the Secretary shall publish Public information. information submitted under the two preceding sentences.”. (b) Other Sections.— (1) Section 512(c) is amended by adding at the end the 21 USC 360b. following: “(3) If the patent information described in subsection (b)(1) could not be filed with the submission of an application under subsection (b)(1) because the application was filed before the patent information was required under subsection (b)(1) or a patent was issued after the application was approved under such subsection, the holder of an approved application shall file with the Secretary the patent number and the expiration date of any patent which claims the new animal drug for which the application was filed or which claims a method of using such drug and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner engaged in the manufacture, use, or sale of the drug. If the holder of an approved application could not file patent information under subsection (b)(1) because it was not required at the time the application was approved, the holder shall file such information under this subsection not later than 30 days after the date of the enactment of this sentence, and if the holder of an approved application could not file patent information under subsection (b)(1) because no patent had been issued when an application was filed or approved, the holder shall file such information under this subsection not later than 30 days after the date the patent involved is issued. Upon the submission of patent information under Public information. 21 USC 360b. this subsection, the Secretary shall publish it.”. (2) The first sentence of section 512(d)(1) is amended by redesignating subparagraphs (G) and (H) as subparagraphs (H) and (I), respectively and by inserting after subparagraph (F) the following: “(G) the application failed to contain the patent information prescribed by subsection (b)(1);”. (3) The second sentence of section 512(d)(1) is amended by striking out “(H)” and inserting in lieu thereof “(G)”. (4) The first sentence of section 512(e)(1) is amended by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively, and by inserting after subparagraph (C) the following: “(D) the patent information prescribed by subsection (c)(3) was not filed within 30 days after the receipt of written notice from the Secretary specifying the failure to file such information;”. SEC. 103. REGULATIONS. (a) General Rule.— The Secretary of Health and Human Services shall promulgate, in accordance with the notice and comment requirements of section 553 of title 5, United States Code, such regulations as may be necessary for the administration of section 512 of the Federal Food, Drug, and Cosmetic Act, as amended by sections 101 through 103 of this title, within one year of the date of enactment of this Act. (b) Transition.— During the period beginning 60 days after the date of enactment of this Act and ending on the date regulations promulgated under subsection (a) take effect, abbreviated new animal drug applications may be submitted in accordance with the provisions of section 314.55 and part 320 of title 21 of the Code of Federal Regulations and shall be considered as suitable for any drug which has been approved for safety and effectiveness under section 512(c) of the Federal Food, Drug, and Cosmetic Act before the date of enactment of this Act. If any such provision of section 314.55 or part 320 is inconsistent with the requirements of section 512 of the Federal Food, Drug, and Cosmetic Act (as amended by this title), the Secretary shall consider the application under the applicable requirements of section 512 (as so amended). SEC. 104. SAFETY AND EFFECTIVENESS DATA. Section 512 (as amended by section 101(b) of this title) is amended by adding at the end the following: “(p) (1) Safety and effectiveness data and information which has been submitted in an application filed under subsection (b)(1) for a drug and which has not previously been disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown— “(A) if no work is being or will be undertaken to have the application approved, “(B) if the Secretary has determined that the application is not approvable and all legal appeals have been exhausted, “(C) if approval of the application under subsection (c) is withdrawn and all legal appeals have been exhausted, “(D) if the Secretary has determined that such drug is not a new drug, or “(E) upon the effective date of the approval of the first application filed under subsection (b)(2) which refers to such drug or upon the date upon which the approval of an application filed under subsection (b)(2) which refers to such drug could be made effective if such an application had been filed. “(2) Any request for data and information pursuant to paragraph (1) shall include a verified statement by the person making the request that any data or information received under such paragraph shall not be disclosed by such person to any other person— “(A) for the purpose of, or as part of a plan, scheme, or device for, obtaining the right to make, use, or market, or making, using, or marketing, outside the United States, the drug identified in the application filed under subsection (b)(1), and “(B) without obtaining from any person to whom the data and information are disclosed an identical verified statement, a copy of which is to be provided by such person to the Secretary, which meets the requirements of this paragraph.”. SEC. 105. VETERINARY PRESCRIPTION DRUGS. Section 503 (21 U.S.C. 353) is amended by adding at the end thereof the following new subsection: “(c) (1) (A) A drug intended for use by animals other than man which— “(i) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary for its use, is not safe for animal use except under the professional supervision of a licensed veterinarian, or “(ii) is limited by an approved application under subsection (b) of section 512 to use under the professional supervision of a licensed veterinarian, shall be dispensed only by or upon the lawful written or oral order of a licensed veterinarian in the course of the veterinarian’s professional practice. “(B) For purposes of subparagraph (A), an order Is lawful if the order— “(i) is a prescription or other order authorized by law, “(ii) is, if an oral order, promptly reduced to writing by the person lawfully filling the order, and filed by that person, and “(iii) is refilled only if authorized in the original order or in a subsequent oral order promptly reduced to writing by the person lawfully filling the order, and filed by that person. “(C) The act of dispensing a drug contrary to the provisions of this Fraud. paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale. “(2) Any drug when dispensed in accordance with paragraph (1) of this subsection— “(A) shall be exempt from the requirements of section 502, except subsections (a), (g), (h), (1)(2), (i)(3), and (p) of such section, and “(B) shall be exempt from the packaging requirements of subsections (g), (h), and (p) of such section, if— “(i) when dispensed by a licensed veterinarian, the drug bears a label containing the name and address of the practitioner and any directions for use and cautionary statements specified by the practitioner, or “(ii) when dispensed by filling the lawful order of a licensed veterinarian, the drug bears a label containing the name and address of the dispenser, the serial number and date of the order or of its filling, the name of the licensed veterinarian, and the directions for use and cautionary statements, if any, contained in such order. The preceding sentence shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail. “(3) The Secretary may by regulation exempt drugs for animals other than man subject to section 512 from the requirements of paragraph (1) when such requirements are not necessary for the protection of the public health. “(4) A drug which is subject to paragraph (1) shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement ‘Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.’. A drug to which paragraph (1) does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the statement specified m the preceding sentence.”. SEC. 106. DRUGS PRIMARILY MANUFACTURED USING BIOTECHNOLOGY. Notwithstanding section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act, the Secretary of Health and Human Services may not approve an abbreviated application submitted under such section for a new animal drug which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques. SEC. 107. CONFORMING AMENDMENTS. (a) Batch Certification.— (1) Section 201(w) (21 U.S.C. 321(w)) is amended by striking out “; or” at the end of paragraph (2) and inserting in lieu thereof a period and by striking out paragraph (3). (2) Section 512(a)(1) (21 U.S.C. 360b(a)(1)) is amended by inserting “and” at the end of subparagraph (A), by striking out “, and” at the end of subparagraph (B) and inserting in lieu thereof a period, and by striking out subparagraph (C). (b) Title 28.— Section 2201(b) of title 28, United States Code, is amended by inserting “or 512” after “505”. SEC. 108. EFFECTIVE DATE. The Secretary of Health and Human Services may not make an approval of an application submitted under section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(b)(2)) effective before January 1, 1991.

5. 1988

   Generic Animal Drug and Patent Term Restoration Act

   Pub. L. 100–670 § 102(b)(3) · 102 Stat. 3971

   Substituted · 21 U.S.C. § 360b(d)(1)

   Pub. L. 100–670, § 102(b)(3), substituted “(G)” for “(H)” in last sentence

   Source evidence

   Code amendment note
   Subsec. (d)(1). Pub. L. 100–670, § 102(b)(3), substituted “(G)” for “(H)” in last sentence.

   Enacted provision · exact public law section
   (3) The second sentence of section 512(d)(1) is amended by striking out “(H)” and inserting in lieu thereof “(G)”.

6. 1988

   Generic Animal Drug and Patent Term Restoration Act

   Pub. L. 100–670 § 102(b)(2) · 102 Stat. 3971

   1. Added · 21 U.S.C. § 360b(d)(1)(G)(I)

      Pub. L. 100–670, § 102(b)(2), added subpar. (G)

   2. Redesignated · 21 U.S.C. § 360b(d)(1)(G)(I)

      Pub. L. 100–670, § 102(b)(2), redesignated former subpars. (G) and (H) as (H) and (I), respectively

   Source evidence

   Code amendment note
   Subsec. (d)(1)(G) to (I). Pub. L. 100–670, § 102(b)(2), added subpar. (G) and redesignated former subpars. (G) and (H) as (H) and (I), respectively.

   Enacted provision · exact public law section
   (2) The first sentence of section 512(d)(1) is amended by redesignating subparagraphs (G) and (H) as subparagraphs (H) and (I), respectively and by inserting after subparagraph (F) the following: “(G) the application failed to contain the patent information prescribed by subsection (b)(1);”.

7. 1988

   Generic Animal Drug and Patent Term Restoration Act

   Pub. L. 100–670 § 102(b)(4) · 102 Stat. 3971

   1. Added · 21 U.S.C. § 360b(e)(1)(D)(F)

      Pub. L. 100–670, § 102(b)(4), added subpar. (D)

   2. Redesignated · 21 U.S.C. § 360b(e)(1)(D)(F)

      Pub. L. 100–670, § 102(b)(4), redesignated former subpars. (D) and (E) as (E) and (F), respectively

   Source evidence

   Code amendment note
   Subsec. (e)(1)(D) to (F). Pub. L. 100–670, § 102(b)(4), added subpar. (D) and redesignated former subpars. (D) and (E) as (E) and (F), respectively.

   Enacted provision · exact public law section
   (4) The first sentence of section 512(e)(1) is amended by redesignating subparagraphs (D) and (E) as subparagraphs (E) and (F), respectively, and by inserting after subparagraph (C) the following: “(D) the patent information prescribed by subsection (c)(3) was not filed within 30 days after the receipt of written notice from the Secretary specifying the failure to file such information;”.

8. 1988

   Generic Animal Drug and Patent Term Restoration Act

   Pub. L. 100–670 § 101(b) · 102 Stat. 3971

   1. Added · 21 U.S.C. § 360b(n); 21 U.S.C. § 360b(o)

      Pub. L. 100–670, § 101(b), added subsecs. (n) and (o)

   2. Struck · 21 U.S.C. § 360b(n); 21 U.S.C. § 360b(o)

      Pub. L. 100–670, § 101(b), struck out former subsec. (n) which related to certification of new drugs containing penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, and release prior to certification

   Source evidence

   Code amendment note
   Subsecs. (n), (o). Pub. L. 100–670, § 101(b), added subsecs. (n) and (o) and struck out former subsec. (n) which related to certification of new drugs containing penicillin, streptomycin, chlortetracycline, chloramphenicol, or bacitracin, and release prior to certification.

   Enacted provision · exact public law section
   (b) Application Requirements.— Section 512 is amended by striking Labeling. out subsection (n) and inserting in lieu thereof the following: “(n) (1) An abbreviated application for a new animal drug shall contain— “(A) (i) except as provided in clause (ii), information to show that the conditions of use or similar limitations (whether in the labeling or published pursuant to subsection (i)) prescribed, recommended, or suggested in the labeling proposed for the new animal drug have been previously approved for a new animal drug listed under paragraph (4) (hereinafter in this subsection referred to as an ‘approved new animal drug’), and “(ii) information to show that the withdrawal period at which residues of the new animal drug will be consistent with the tolerances established for the approved new animal drug is the same as the withdrawal period previously established for the approved new animal drug or, if the withdrawal period is proposed to be different, information showing that the residues of the new animal drug at the proposed different withdrawal period will be consistent with the tolerances established for the approved new animal drug; “(B) (i) information to show that the active ingredients of the new animal drug are the same as those of the approved new animal drug, and “(ii) if the approved new animal drug has more than one active ingredient, and if one of the active ingredients of the new animal drug is different from one of the active ingredients of the approved new animal drug and the application is filed pursuant to the approval of a petition filed under paragraph (3)— “(I) information to show that the other active ingredients of the new animal drug are the same as the active ingredients of the approved new animal drug, “(II) information to show either that the different active ingredient is an active ingredient of another approved new animal drug or of an animal drug which does not meet the requirements of section 201(w), and “(III) such other information respecting the different active ingredients as the Secretary may require; “(C) (i) if the approved new animal drug is permitted to be used with one or more animal drugs in animal feed, information to show that the proposed uses of the new animal drug with other animal drugs in animal feed are the same as the uses of the approved new animal drug, and “(ii) if the approved new animal drug is permitted to be used with one or more other animal drugs in animal feed, and one of the other animal drugs proposed for use with the new animal drug in animal feed is different from one of the other animal drugs permitted to be used in animal feed with the approved new animal drug, and the application is filed pursuant to the approval of a petition filed under paragraph (3)— “(I) information to show either that the different animal drug proposed for use with the approved new animal drug in animal feed is an approved new animal drug permitted to be used in animal feed or does not meet the requirements of section 201(w) when used with another animal drug in animal feed, “(II) information to show that other animal drugs proposed for use with the new animal drug in animal feed are the same as the other animal drugs permitted to be used with the approved new animal drug, and “(III) such other information respecting the different animal drug or combination with respect to which the petition was filed as the Secretary may require, “(D) information to show that the route of administration, the dosage form, and the strength of the new animal drug are the same as those of the approved new animal drug or, if the route of administration, the dosage form, or the strength of the new animal drug is different and the application is filed pursuant to the approval of a petition filed under paragraph (3), such information respecting the route of administration, dosage form, or strength with respect to which the petition was filed as the Secretary may require; “(E) information to show that the new animal drug is bioequivalent to the approved new animal drug, except that if the application is filed pursuant to the approval of a petition filed under paragraph (3) for the purposes described in subparagraph (B) or (C), information to show that the active ingredients of the new animal drug are of the same pharmacological or therapeutic class as the pharmacological or therapeutic class of the approved new animal drug and that the new animal drug can be expected to have the same therapeutic effect as the approved new animal drug when used in accordance with the labeling; “(F) information to show that the labeling proposed for the new animal drug is the same as the labeling approved for the approved new animal drug except for changes required because of differences approved under a petition filed under paragraph (3), because of a different withdrawal period, or because the new animal drug and the approved new animal drug are produced or distributed by different manufacturers; “(G) the items specified in clauses (B) through (F) of subsection (b)(1); “(H) a certification, in the opinion of the applicant and to the best of his knowledge, with respect to each patent which claims the approved new animal drug or which claims a use for such approved new animal drug for which the applicant is seeking approval under this subsection and for which information is required to be filed under subsection (b)(1) or (c)(3)— “(i) that such patent information has not been filed, “(ii) that such patent has expired, “(iii) of the date on which such patent will expire, or “(iv) that such patent is invalid or will not be infringed by the manufacture, use, or sale of the new animal drug for which the application is filed; and “(I) if with respect to the approved new animal drug information was filed under subsection (b)(1) or (c)(3) for a method of use patent which does not claim a use for which the applicant is seeking approval of an application under subsection (c)(2), a statement that the method of use patent does not claim such a use. The Secretary may not require that an abbreviated application contain information in addition to that required by subparagraphs (A) through (H). “(2) (A) An applicant who makes a certification described in paragraph (1)(G)(iv) shall include in the application a statement that the applicant will give the notice required by subparagraph (B) to— “(i) each owner of the patent which is the subject of the certification or the representative of such owner designated to receive such notice, and “(ii) the holder of the approved application under subsection (c)(1) for the drug which is claimed by the patent or a use of which is claimed by the patent or the representative of such holder designated to receive such notice. “(B) The notice referred to in subparagraph (A) shall state that an application, which contains data from bioequivalence studies, has been filed under this subsection for the drug with respect to which the certification is made to obtain approval to engage in the commercial manufacture, use, or sale of such drug before the expiration of the patent referred to in the certification. Such notice shall include a detailed statement of the factual and legal basis of the applicant’s opinion that the patent is not valid or will not be infringed. “(C) If an application is amended to include a certification described in paragraph (1)(G)(iv), the notice required by subparagraph (B) shall be given when the amended application is filed. “(3) If a person wants to submit an abbreviated application for a new animal drug— “(A) whose active ingredients, route of administration, dosage form, or strength differ from that of an approved new animal drug, or “(B) whose use with other animal drugs in animal feed differs from that of an approved new animal drug, such person shall submit a petition to the Secretary seeking permission to file such an application. The Secretary shall approve a petition for a new animal drug unless the Secretary finds that— “(C) investigations must be conducted to show the safety and effectiveness, in animals to be treated with the drug, of the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed which differ from the approved new animal drug, or “(D) investigations must be conducted to show the safety for human consumption of any residues in food resulting from the proposed active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed for the new animal drug which is different from the active ingredients, route of administration, dosage form, strength, or use with other animal drugs in animal feed of the approved new animal drug. The Secretary shall approve or disapprove a petition submitted under this paragraph within 90 days of the date the petition is submitted. “(4) (A) (i) Within 60 days of the date of the enactment of this subsection, the Secretary shall publish and make available to the public a list in alphabetical order of the official and proprietary name of each new animal drug which has been approved for safety and effectiveness before the date of the enactment of this subsection. “(ii) Every 30 days after the publication of the first list under clause (i) the Secretary shall revise the list to include each new animal drug which has been approved for safety and effectiveness under subsection (c) during the 30 day period. “(iii) When patent information submitted under subsection (b)(1) or (c)(3) respecting a new animal drug included on the list is to be published by the Secretary, the Secretary shall, in revisions made under clause (ii), include such information for such drug. “(B) A new animal drug approved for safety and effectiveness before the date of the enactment of this subsection or approved for safety and effectiveness under subsection (c) shall, for purposes of this subsection, be considered to have been published under subparagraph (A) on the date of its approval or the date of enactment, whichever is later. “(C) If the approval of a new animal drug was withdrawn or suspended under subsection (c)(2)(G) or for grounds described in subsection (e) or if the Secretary determines that a drug has been withdrawn from sale for safety or effectiveness reasons, it may not be published in the list under subparagraph (A) or, if the withdrawal or suspension occurred after its publication in such list, it shall be immediately removed from such list— “(i) for the same period as the withdrawal or suspension under subsection (c)(2)(G) or (e), or “(ii) if the listed drug has been withdrawn from sale, for the period of withdrawal from sale or, if earlier, the period ending on the date the Secretary determines that the withdrawal from sale is not for safety or effectiveness reasons. A notice of the removal shall be published in the Federal Register. Federal Register, publication. “(5) If an application contains the information required by clauses (A), (G), and (H) of subsection (b)(1) and such information— “(A) is relied on by the applicant for the approval of the application, and “(B) is not information derived either from investigations, studies, or tests conducted by or for the applicant or for which the applicant had obtained a right of reference or use from the person by or for whom the investigations, studies, or tests were conducted, such application shall be considered to be an application filed under subsection (b)(2). “(o) For purposes of this section, the term ‘patent’ means a patent issued by the Patent and Trademark Office of the Department of Commerce.”.

9. 1988

   Generic Animal Drug and Patent Term Restoration Act

   Pub. L. 100–670 § 104 · 102 Stat. 3971

   Added · 21 U.S.C. § 360b(p)

   Pub. L. 100–670, § 104, added subsec. (p)

   Source evidence

   Code amendment note
   Subsec. (p). Pub. L. 100–670, § 104, added subsec. (p).

   Enacted provision · exact public law section
   SEC. 104. SAFETY AND EFFECTIVENESS DATA. Section 512 (as amended by section 101(b) of this title) is amended by adding at the end the following: “(p) (1) Safety and effectiveness data and information which has been submitted in an application filed under subsection (b)(1) for a drug and which has not previously been disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown— “(A) if no work is being or will be undertaken to have the application approved, “(B) if the Secretary has determined that the application is not approvable and all legal appeals have been exhausted, “(C) if approval of the application under subsection (c) is withdrawn and all legal appeals have been exhausted, “(D) if the Secretary has determined that such drug is not a new drug, or “(E) upon the effective date of the approval of the first application filed under subsection (b)(2) which refers to such drug or upon the date upon which the approval of an application filed under subsection (b)(2) which refers to such drug could be made effective if such an application had been filed. “(2) Any request for data and information pursuant to paragraph (1) shall include a verified statement by the person making the request that any data or information received under such paragraph shall not be disclosed by such person to any other person— “(A) for the purpose of, or as part of a plan, scheme, or device for, obtaining the right to make, use, or market, or making, using, or marketing, outside the United States, the drug identified in the application filed under subsection (b)(1), and “(B) without obtaining from any person to whom the data and information are disclosed an identical verified statement, a copy of which is to be provided by such person to the Secretary, which meets the requirements of this paragraph.”.

10. 1991

    Pub. L. 102–108 § 2(e) · 105 Stat. 549

    Substituted · 21 U.S.C. § 360b(e)(1)(B)

    Pub. L. 102–108 substituted “(I)” for “(H)”

    Source evidence

    Code amendment note
    Subsec. (e)(1)(B). Pub. L. 102–108 substituted “(I)” for “(H)”.

    Enacted provision · exact public law section
    (e) Animal Drugs.— Section 512(e)(1)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(e)(1)(B)) is amended by striking out “(H)” and inserting in lieu thereof “(I)”.

11. 1993

    Nutrition Labeling and Education Act Amendments of 1993

    Pub. L. 103–80 § 3(r)(1) · 107 Stat. 773

    Inserted · 21 U.S.C. § 360b(c)(2)(A)(ii)

    Pub. L. 103–80, § 3(r)(1), inserted “in” after “except as provided”

    Source evidence

    Code amendment note
    Subsec. (c)(2)(A)(ii). Pub. L. 103–80, § 3(r)(1), inserted “in” after “except as provided”.

    Enacted provision · exact public law section
    (1) in subsection (c)(2)(A)(ii), by inserting “in” after “provided”,

12. 1993

    Nutrition Labeling and Education Act Amendments of 1993

    Pub. L. 103–80 § 3(r)(2) · 107 Stat. 773

    Substituted · 21 U.S.C. § 360b(c)(2)(F)(i)

    Pub. L. 103–80, § 3(r)(2), substituted “subparagraph (D)(iii)” for “subparagraph (C)(iii)”

    Source evidence

    Code amendment note
    Subsec. (c)(2)(F)(i). Pub. L. 103–80, § 3(r)(2), substituted “subparagraph (D)(iii)” for “subparagraph (C)(iii)”.

    Enacted provision · exact public law section
    (2) in subsection (c)(2)(F)(i), by striking out “(C)(iii)” and inserting in lieu thereof “(D)(iii)”,

13. 1993

    Nutrition Labeling and Education Act Amendments of 1993

    Pub. L. 103–80 § 3(r)(3) · 107 Stat. 773

    Substituted · 21 U.S.C. § 360b(c)(2)(H)(ii)

    Pub. L. 103–80, § 3(r)(3), substituted “subclauses” for “subclause” after “bioequivalency information described in” in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (c)(2)(H)(ii). Pub. L. 103–80, § 3(r)(3), substituted “subclauses” for “subclause” after “bioequivalency information described in” in concluding provisions.

    Enacted provision · exact public law section
    (3) in subsection (c)(2)(H), by striking out “subclause” the first time it appears and inserting in lieu thereof “subclauses”,

14. 1993

    Nutrition Labeling and Education Act Amendments of 1993

    Pub. L. 103–80 § 3(r)(4) · 107 Stat. 773

    Substituted · 21 U.S.C. § 360b(d)(1)

    Pub. L. 103–80, § 3(r)(4), substituted “subparagraphs (A) through (I)” for “subparagraphs (A) through (G)” in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (d)(1). Pub. L. 103–80, § 3(r)(4), substituted “subparagraphs (A) through (I)” for “subparagraphs (A) through (G)” in concluding provisions.

    Enacted provision · exact public law section
    (4) in subsection (d)(1), by striking out “subparagraphs (A) through (G)” and inserting in lieu thereof “subparagraphs (A) through (I)”, and

15. 1993

    Nutrition Labeling and Education Act Amendments of 1993

    Pub. L. 103–80 § 3(r)(5) · 107 Stat. 773

    1. Substituted · 21 U.S.C. § 360b(n)(1)

       Pub. L. 103–80, § 3(r)(5), substituted “section 321(v) of this title” for “section 321(w) of this title” in subpars. (B)(ii)(II) and (C)(ii)(I)

    2. Substituted · 21 U.S.C. § 360b(n)(1)

       Pub. L. 103–80, § 3(r)(5), substituted “through (I)” for “through (H)” in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (n)(1). Pub. L. 103–80, § 3(r)(5), substituted “section 321(v) of this title” for “section 321(w) of this title” in subpars. (B)(ii)(II) and (C)(ii)(I) and substituted “through (I)” for “through (H)” in concluding provisions.

    Enacted provision · exact public law section
    (5) in subsection (n)(1)— (A) by striking out “201(w)” in subparagraphs (B)(ii)(I). and (C)(ii)(1) and inserting in lieu thereof “201(w)”, and (B) by striking out in the last sentence “(H)” and inserting in lieu thereof “(I)”.

16. 1994

    Animal Medicinal Drug Use Clarification Act of 1994

    Pub. L. 103–396 § 2(a) · 108 Stat. 4153

    Added · 21 U.S.C. § 360b(a)(4); 21 U.S.C. § 360b(a)(5)

    Pub. L. 103–396, § 2(a), added pars. (4) and (5)

    Source evidence

    Code amendment note
    Subsec. (a)(4), (5). Pub. L. 103–396, § 2(a), added pars. (4) and (5).

    Enacted provision · exact public law section
    (a) General Rule.— Section 512(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(a)) is amended by adding the following new paragraphs at the end: “(4) (A) Except as provided in subparagraph (B), if an approval of an application filed under subsection (b) is in effect with respect to a particular use or intended use of a new animal drug, the drug shall not be deemed unsafe for the purposes of paragraph (1) and shall be exempt from the requirements of section 502(f) with respect to a different use or intended use of the drug, other than a use in or on animal feed, if such use or intended use— “(i) is by or on the lawful written or oral order of a licensed veterinarian within the context of a veterinarian-client-patient relationship, as defined by the Secretary; and “(ii) is in compliance with regulations promulgated by the Secretary that establish the conditions for such different use or intended use. The regulations promulgated by the Secretary under clause (ii) may prohibit particular uses of an animal drug and shall not permit such different use of an animal drug if the labeling of another animal drug that contains the same active ingredient and which is in the same dosage form and concentration provides for such different use. “(B) If the Secretary finds that there is a reasonable probability that a use of an animal drug authorized under subparagraph (A) may present a risk to the public health, the Secretary may— “(i) establish a safe level for a residue of an animal drug when it is used for such different use authorized by subparagraph (A); and “(ii) require the development of a practical, analytical method for the detection of residues of such drug above the safe level established under clause (i). The use of an animal drug that results in residues exceeding a safe level established under clause (i) shall be considered an unsafe use of such drug under paragraph (1). Safe levels may be established under clause (i) either by regulation or order. “(C) The Secretary may by general regulation provide access to the records of veterinarians to ascertain any use or intended use authorized under subparagraph (A) that the Secretary has determined may present a risk to the public health. “(D) If the Secretary finds, after affording an opportunity for public comment, that a use of an animal drug authorized under subparagraph (A) presents a risk to the public health or that an analytical method required under subparagraph (B) has not been developed and submitted to the Secretary, the Secretary may, by order, prohibit any such use. “(5) If the approval of an application filed under section 505 is in effect, the drug under such application shall not be deemed unsafe for purposes of paragraph (1) and shall be exempt from the requirements of section 502(f) with respect to a use or intended use of the drug in animals if such use or intended use— “(A) is by or on the lawful written or oral order of a licensed veterinarian within the context of a veterinarian-client-patient relationship, as defined by the Secretary; and “(B) is in compliance with regulations promulgated by the Secretary that establish the conditions for the use or intended use of the drug in animals.”.

17. 1994

    Animal Medicinal Drug Use Clarification Act of 1994

    Pub. L. 103–396 § 2(b)(2) · 108 Stat. 4153

    Inserted · 21 U.S.C. § 360b(e)(1)(A)

    Pub. L. 103–396, § 2(b)(2), inserted before semicolon at end “or the condition of use authorized under subsection (a)(4)(A)”

    Source evidence

    Code amendment note
    Subsec. (e)(1)(A). Pub. L. 103–396, § 2(b)(2), inserted before semicolon at end “or the condition of use authorized under subsection (a)(4)(A)”.

    Enacted provision · exact public law section
    (2) Section 512(e).— Section 512(e)(1)(A) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 360b(e)(1)(A)) is amended by inserting before the semicolon the following: “or the condition of use authorized under subsection (a)(4)(A)”.

18. 1994

    Animal Medicinal Drug Use Clarification Act of 1994

    Pub. L. 103–396 § 2(b)(3) · 108 Stat. 4153

    Substituted · 21 U.S.C. § 360b(l)(1)

    Pub. L. 103–396, § 2(b)(3), substituted “relating to experience, including experience with uses authorized under subsection (a)(4)(A),” for “relating to experience”

    Source evidence

    Code amendment note
    Subsec. (l)(1). Pub. L. 103–396, § 2(b)(3), substituted “relating to experience, including experience with uses authorized under subsection (a)(4)(A),” for “relating to experience”.

    Enacted provision · exact public law section
    (3) Section 512(1).— Section 512(1)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(1)(1)) is amended by striking “relating to experience” and inserting “relating to experience, including experience with uses authorized under subsection (a)(4)(A),”.

19. 1996

    Animal Drug Availability Act of 1996

    Pub. L. 104–250 § 6(a) · 110 Stat. 3151

    Amended · 21 U.S.C. § 360b(a)(1)

    Pub. L. 104–250, § 6(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for the purposes of section 351(a)(5) and section 342(a)(2)(D) of this title unless—

    Source evidence

    Code amendment note
    Subsec. (a)(1). Pub. L. 104–250, § 6(a), amended par. (1) generally. Prior to amendment, par. (1) read as follows: “A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for the purposes of section 351(a)(5) and section 342(a)(2)(D) of this title unless—

    “(A) there is in effect an approval of an application filed pursuant to subsection (b) of this section with respect to such use or intended use of such drug, and “(B) such drug, its labeling, and such use conform to such approved application. A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a manufacturer, packer, or distributor of such drug for use in the manufacture of animal feed in any State unless at the time of such removal such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or notice from the Secretary, to the effect that, with respect to the use of such drug in animal feed, such consignee— “(i) is the holder of an approved application under subsection (m) of this section; or “(ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of an approved application under subsection (m) of this section.”

    Enacted provision · exact public law section
    (a) Section 512(a).— Paragraphs (1) and (2) of section 512(a) (21 U.S.C. 360b(a)) are amended to read as follows: “(a) (1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for the purposes of section 501(a)(5) and section 402(a)(2)(D) unless — “(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such use or intended use of such drug, and “(B) such drug, its labeling, and such use conform to such approved application. A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a manufacturer, packer, or distributor of such drug for use in the manufacture of animal feed in any State unless at the time of such removal such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or notice from the Secretary, to the effect that, with respect to the use of such drug in animal feed, such consignee (i) holds a license issued under subsection (m) and has in its possession current approved labeling for such drug in animal feed; or (ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of a license issued under subsection (m). “(2) An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed be deemed unsafe for the purposes of section 501(a)(6) unless— “(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such drug, as used in such animal feed, “(B) such animal feed is manufactured at a site for which there is in effect a license issued pursuant to subsection (m)(1) to manufacture such animal feed, and “(C) such animal feed and its labeling, distribution, holding, and use conform to the conditions and indications of use published pursuant to subsection (i).”.

20. 1996

    Animal Drug Availability Act of 1996

    Pub. L. 104–250 § 6(a) · 110 Stat. 3151

    Amended · 21 U.S.C. § 360b(a)(2)

    Pub. L. 104–250, § 6(a), amended par. (2) generally. Prior to amendment, par. (2) read as follows: “An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed, be deemed unsafe for the purposes of section 351(a)(6) of this title unless—

    Source evidence

    Code amendment note
    Subsec. (a)(2). Pub. L. 104–250, § 6(a), amended par. (2) generally. Prior to amendment, par. (2) read as follows: “An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed, be deemed unsafe for the purposes of section 351(a)(6) of this title unless—

    “(A) there is in effect an approval of an application filed pursuant to subsection (b) of this section with respect to such drugs, as used in such animal feed, “(B) there is in effect an approval of an application pursuant to subsection (m)(1) of this section with respect to such animal feed, and “(C) such animal feed, its labeling, and such use conform to the conditions and indications of use published pursuant to subsection (i) of this section and to the application with respect thereto approved under subsection (m) of this section.”

    Enacted provision · exact public law section
    (a) Section 512(a).— Paragraphs (1) and (2) of section 512(a) (21 U.S.C. 360b(a)) are amended to read as follows: “(a) (1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for the purposes of section 501(a)(5) and section 402(a)(2)(D) unless — “(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such use or intended use of such drug, and “(B) such drug, its labeling, and such use conform to such approved application. A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a manufacturer, packer, or distributor of such drug for use in the manufacture of animal feed in any State unless at the time of such removal such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or notice from the Secretary, to the effect that, with respect to the use of such drug in animal feed, such consignee (i) holds a license issued under subsection (m) and has in its possession current approved labeling for such drug in animal feed; or (ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of a license issued under subsection (m). “(2) An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed be deemed unsafe for the purposes of section 501(a)(6) unless— “(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such drug, as used in such animal feed, “(B) such animal feed is manufactured at a site for which there is in effect a license issued pursuant to subsection (m)(1) to manufacture such animal feed, and “(C) such animal feed and its labeling, distribution, holding, and use conform to the conditions and indications of use published pursuant to subsection (i).”.

21. 1996

    Animal Drug Availability Act of 1996

    Pub. L. 104–250 § 4 · 110 Stat. 3151

    Added · 21 U.S.C. § 360b(a)(6)

    Pub. L. 104–250, § 4, added par. (6)

    Source evidence

    Code amendment note
    Subsec. (a)(6). Pub. L. 104–250, § 4, added par. (6).

    Enacted provision · exact public law section
    SEC. 4. IMPORT TOLERANCES. Section 512(a) (21 U.S.C. 360b(a)) is amended by adding the following new paragraph at the end: “(6) For purposes of section 402(a)(2)(D), a use or intended use of a new animal drug shall not be deemed unsafe under this section if the Secretary establishes a tolerance for such drug and any edible portion of any animal imported into the United States does not contain residues exceeding such tolerance. In establishing such tolerance, the Secretary shall rely on data sufficient to demonstrate that a proposed tolerance is safe based on similar food safety criteria used by the Secretary to establish tolerances for applications for new animal drugs filed under subsection (b)(1). The Secretary may consider and rely on data submitted by the drug manufacturer, including data submitted to appropriate regulatory authorities in any country where the new animal drug is lawfully used or data available from a relevant international organization, to the extent such data are not inconsistent with the criteria used by the Secretary to establish a tolerance for applications for new animal drugs filed under subsection (b)(1). For purposes of this paragraph, ‘relevant international organization’ means the Codex Alimenterius Commission or other international organization deemed appropriate by the Secretary. The Secretary may, under procedures specified by regulation, revoke a tolerance established under this paragraph if information demonstrates that the use of the new animal drug under actual use conditions results in food being imported into the United States with residues exceeding the tolerance or if scientific evidence shows the tolerance to be unsafe.”.

22. 1996

    Animal Drug Availability Act of 1996

    Pub. L. 104–250 § 2(d) · 110 Stat. 3151

    Added · 21 U.S.C. § 360b(b)(3)

    Pub. L. 104–250, § 2(d), added par. (3)

    Source evidence

    Code amendment note
    Subsec. (b)(3). Pub. L. 104–250, § 2(d), added par. (3).

    Enacted provision · exact public law section
    (d) Presubmission Conference.— Section 512(b) (21 U.S.C. 360b(b)) is amended by adding at the end the following: “(3) Any person intending to file an application under paragraph (1) or a request for an investigational exemption under subsection (j) shall be entitled to one or more conferences prior to such submission to reach an agreement acceptable to the Secretary establishing a submission or an investigational requirement, which may include a requirement for a field investigation. A decision establishing a submission or an investigational requirement shall bind the Secretary and the applicant or requestor unless (A) the Secretary and the applicant or requestor mutually agree to modify the requirement, or (B) the Secretary by written order determines that a substantiated scientific requirement essential to the determination of safety or effectiveness of the animal drug involved has appeared after the conference. No later than 25 calendar days after each such conference, the Secretary shall provide a written order setting forth a scientific justification specific to the animal drug and intended uses under consideration if the agreement referred to in the first sentence requires more than one field investigation as being essential to provide substantial evidence of effectiveness for the intended uses of the drug. Nothing in this paragraph shall be construed as compelling the Secretary to require a field investigation”.

23. 1996

    Animal Drug Availability Act of 1996

    Pub. L. 104–250 § 2(b)(1) · 110 Stat. 3151

    1. Substituted · 21 U.S.C. § 360b(c)(2)(F)(ii); 21 U.S.C. § 360b(c)(2)(F)(iii)

       Pub. L. 104–250, § 2(b)(1), substituted “substantial evidence of the effectiveness of the drug involved, any studies of animal safety, or,” for “reports of new clinical or field investigations (other than bioequivalence or residue studies) and,”

    2. Substituted · 21 U.S.C. § 360b(c)(2)(F)(ii); 21 U.S.C. § 360b(c)(2)(F)(iii)

       Pub. L. 104–250, § 2(b)(1), substituted “required for the approval” for “essential to the approval”

    Source evidence

    Code amendment note
    Subsec. (c)(2)(F)(ii), (iii). Pub. L. 104–250, § 2(b)(1), substituted “substantial evidence of the effectiveness of the drug involved, any studies of animal safety, or,” for “reports of new clinical or field investigations (other than bioequivalence or residue studies) and,” and “required for the approval” for “essential to the approval”.

    Enacted provision · exact public law section
    (1) Clauses (ii) and (iii) of section 512(c)(2)(F) (21 U.S.C. 360b(c)(2)(F)) are each amended— (A) by striking “reports of new clinical or field investigations (other than bioequivalence or residue studies) and,” and inserting “substantial evidence of the effectiveness of the drug involved, any studies of animal safety, or,”; and (B) by striking “essential to” and inserting “required for”.

24. 1996

    Animal Drug Availability Act of 1996

    Pub. L. 104–250 § 2(b)(2) · 110 Stat. 3151

    1. Substituted · 21 U.S.C. § 360b(c)(2)(F)(v)

       Pub. L. 104–250, § 2(b)(2), substituted “clause (iv)” for “subparagraph (B)(iv)”

    2. Substituted · 21 U.S.C. § 360b(c)(2)(F)(v)

       Pub. L. 104–250, § 2(b)(2), substituted “substantial evidence of the effectiveness of the drug involved, any studies of animal safety,” for “reports of clinical or field investigations”

    3. Substituted · 21 U.S.C. § 360b(c)(2)(F)(v)

       Pub. L. 104–250, § 2(b)(2), substituted “required for the new approval” for “essential to the new approval”

    Source evidence

    Code amendment note
    Subsec. (c)(2)(F)(v). Pub. L. 104–250, § 2(b)(2), substituted “clause (iv)” for “subparagraph (B)(iv)” in two places, “substantial evidence of the effectiveness of the drug involved, any studies of animal safety,” for “reports of clinical or field investigations” and “required for the new approval” for “essential to the new approval”.

    Enacted provision · exact public law section
    (2) Section 512(c)(2)(F)(v) (21 U.S.C. 360b(c)(2)(F)(v)) is amended— (A) by striking “subparagraph (B)(iv)” each place it appears and inserting “clause (iv)”; (B) by striking “reports of clinical or field investigations” and inserting “substantial evidence of the effectiveness of the drug involved, any studies of animal safety,”; and (C) by striking “essential to” and inserting “required for”.

25. 1996

    Animal Drug Availability Act of 1996

    Pub. L. 104–250 § 3 · 110 Stat. 3151

    Amended · 21 U.S.C. § 360b(d)(1)(F)

    Pub. L. 104–250, § 3, amended subpar. (F) generally. Prior to amendment, subpar. (F) read as follows: “upon the basis of the information submitted to him as part of the application or any other information before him with respect to such drug, the tolerance limitation proposed, if any, exceeds that reasonably required to accomplish the physical or other technical effect for which the drug is intended;”

    Source evidence

    Code amendment note
    Subsec. (d)(1)(F). Pub. L. 104–250, § 3, amended subpar. (F) generally. Prior to amendment, subpar. (F) read as follows: “upon the basis of the information submitted to him as part of the application or any other information before him with respect to such drug, the tolerance limitation proposed, if any, exceeds that reasonably required to accomplish the physical or other technical effect for which the drug is intended;”.

    Enacted provision · exact public law section
    SEC. 3. LIMITATION ON RESIDUES. Section 512(d)(1)(F) (21 U.S.C. 360b(d)(1)(F)) is amended to read as follows: “(F) upon the basis of information submitted to the Secretary as part of the application or any other information before the Secretary with respect to such drug, any use prescribed, recommended, or suggested in labeling proposed for such drug will result in a residue of such drug in excess of a tolerance found by the Secretary to be safe for such drug;”.

26. 1996

    Animal Drug Availability Act of 1996

    Pub. L. 104–250 § 2(a) · 110 Stat. 3151

    Amended · 21 U.S.C. § 360b(d)(3)

    Pub. L. 104–250, § 2(a), amended par. (3) generally. Prior to amendment, par. (3) read as follows: “As used in this subsection and subsection (e) of this section, the term ‘substantial evidence’ means evidence consisting of adequate and well-controlled investigations, including field investigation, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.”

    Source evidence

    Code amendment note
    Subsec. (d)(3). Pub. L. 104–250, § 2(a), amended par. (3) generally. Prior to amendment, par. (3) read as follows: “As used in this subsection and subsection (e) of this section, the term ‘substantial evidence’ means evidence consisting of adequate and well-controlled investigations, including field investigation, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.”

    Enacted provision · exact public law section
    (a) Original Applications.— Paragraph (3) of section 512(d) (21 U.S.C. 360b(d)) is amended to read as follows: “(3) As used in this section, the term ‘substantial evidence’ means evidence consisting of one or more adequate and well controlled investigations, such as— “(A) a study in a target species; “(B) a study in laboratory animals; “(C) any field investigation that may be required under this section and that meets the requirements of subsection (b)(3) if a presubmission conference is requested by the applicant; “(D) a bioequivalence study; or “(E) an in vitro study; by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof.”.

27. 1996

    Animal Drug Availability Act of 1996

    Pub. L. 104–250 § 2(c) · 110 Stat. 3151

    Added · 21 U.S.C. § 360b(d)(4)

    Pub. L. 104–250, § 2(c), added par. (4)

    Source evidence

    Code amendment note
    Subsec. (d)(4). Pub. L. 104–250, § 2(c), added par. (4).

    Enacted provision · exact public law section
    (c) Combination Drugs.— Section 512(d) (21 U.S.C. 360b(d)), as amended by subsection (a) is amended by adding at the end the following: “(4) In a case in which an animal drug contains more than one active ingredient, or the labeling of the drug prescribes, recommends, or suggests use of the drug in combination with one or more other animal drugs, and the active ingredients or drugs intended for use in the combination have previously been separately approved for particular uses and conditions of use for which they are intended for use in the combination— “(A) the Secretary shall not issue an order under paragraph (1)(A), (1)(B), or (1)(D) refusing to approve the application for such combination on human food safety grounds unless the Secretary finds that the application fails to establish that— “(i) none of the active ingredients or drugs intended for use in the combination, respectively, at the longest withdrawal time of any of the active ingredients or drugs in the combination, respectively, exceeds its established tolerance; or “(ii) none of the active ingredients or drugs in the combination interferes with the methods of analysis for another of the active ingredients or drugs in the combination, respectively; “(B) the Secretary shall not issue an order under paragraph (1)(A), (1)(B), or (1)(D) refusing to approve the application for such combination on target animal safety grounds unless the Secretary finds that— “(i) (I) there is a substantiated scientific issue, specific to one or more of the active ingredients or animal drugs in the combination, that cannot adequately be evaluated based on information contained in the application for the combination (including any investigations, studies, or tests for which the applicant has a right of reference or use from the person by or for whom the investigations, studies, or tests were conducted); or “(II) there is a scientific issue raised by target animal observations contained in studies submitted to the Secretary as part of the application; and “(ii) based on the Secretary’s evaluation of the information contained in the application with respect to the issues identified in clauses (i) (I) and (II), paragraph (I)’(A), (B), or (D) apply; “(C) except in the case of a combination that contains a nontopical antibacterial ingredient or animal drug, the Secretary shall not issue an order under paragraph (1)(E) refusing to approve an application for a combination animal drug intended for use other than in animal feed or drinking water unless the Secretary finds that the application fails to demonstrate that— “(i) there is substantial evidence that any active ingredient or animal drug intended only for the same use as another active ingredient or animal drug in the combination makes a contribution to labeled effectiveness; “(ii) each active ingredient or animal drug intended for at least one use that is different from all other active ingredients or animal drugs used in the combination provides appropriate concurrent use for the intended target population; or “(iii) where based on scientific information the Secretary has reason to believe the active ingredients or animal drugs may be physically incompatible or have disparate dosing regimens, such active ingredients or animal drugs are physically compatible or do not have disparate dosing regimens; and “(D) the Secretary snail not issue an order under paragraph (1)(E) refusing to approve an application for a combination animal drug intended for use in animal feed or drinking water unless the Secretary finds that the application fails to demonstrate that— “(i) there is substantial evidence that any active ingredient or animal drug intended only for the same use as another active ingredient or animal drug in the combination makes a contribution to the labeled effectiveness; “(ii) each of the active ingredients or animal drugs intended for at least one use that is different from all other active ingredients or animal drugs used in the combination provides appropriate concurrent use for the intended target population; “(iii) where a combination contains more than one nontopical antibacterial ingredient or animal drug, there is substantial evidence that each of the nontopical anti-bacterial ingredients or animal drugs makes a contribution to the labeled effectiveness; or “(iv) where based on scientific information the Secretary has reason to believe the active ingredients or animal drugs intended for use in drinking water may be physically incompatible, such active ingredients or animal drugs intended for use in drinking water are physically compatible.”.

28. 1996

    Animal Drug Availability Act of 1996

    Pub. L. 104–250 § 5(c) · 110 Stat. 3151

    Inserted · 21 U.S.C. § 360b(i)

    Pub. L. 104–250, § 5(c), inserted “and any requirement that an animal feed bearing or containing the new animal drug be limited to use under the professional supervision of a licensed veterinarian” after “(including special labeling requirements”

    Source evidence

    Code amendment note
    Subsec. (i). Pub. L. 104–250, § 5(c), inserted “and any requirement that an animal feed bearing or containing the new animal drug be limited to use under the professional supervision of a licensed veterinarian” after “(including special labeling requirements”.

    Enacted provision · exact public law section
    (c) Conforming Amendment.— Section 512 (21 U.S.C. 360b) is amended in subsection (i) by inserting after “(including special labeling requirements” the following: “and any requirement that an animal feed bearing or containing the new animal drug be limited to use under the professional supervision of a licensed veterinarian”.

29. 1996

    Animal Drug Availability Act of 1996

    Pub. L. 104–250 § 6(b) · 110 Stat. 3151

    1. Amended · 21 U.S.C. § 360b(m)

       Pub. L. 104–250, § 6(b), amended subsec. (m) generally

    2. Substituted · 21 U.S.C. § 360b(m)

       Pub. L. 104–250, § 6(b), substituting provisions relating to application for feed mill licenses, including approval, refusal, revocation, and suspension of such licenses, and provisions for record and reporting requirements for, as well as exemption from, such licenses, for provisions relating to application for uses of animal feed containing new animal drug, including required contents, approval, refusal, and withdrawal of approval or suspension of such usage applications, and provisions for record and reporting requirements of such usage applications

    Source evidence

    Code amendment note
    Subsec. (m). Pub. L. 104–250, § 6(b), amended subsec. (m) generally, substituting provisions relating to application for feed mill licenses, including approval, refusal, revocation, and suspension of such licenses, and provisions for record and reporting requirements for, as well as exemption from, such licenses, for provisions relating to application for uses of animal feed containing new animal drug, including required contents, approval, refusal, and withdrawal of approval or suspension of such usage applications, and provisions for record and reporting requirements of such usage applications.

    Enacted provision · exact public law section
    (b) Section 512(m).— Section 512(m) (21 U.S.C. 360b(m)) is amended to read as follows: “(m) (1) Any person may file with the Secretary an application for a license to manufacture animal feeds bearing or containing new animal drugs. Such person shall submit to the Secretary as part of the application (A) a full statement of the business name and address of the specific facility at which the manufacturing is to take place and the facility’s registration number, (B) the name and signature of the responsible individual or individuals for that facility, (C) a certification that the animal feeds bearing or containing new animal drugs are manufactured and labeled in accordance with the applicable regulations published pursuant to subsection (i), and (D) a certification that the methods used in, and the facilities and controls used for, manufacturing, processing, packaging, and holding such animal feeds are in conformity with current good manufacturing practice as described in section 501(a)(2)(B). “(2) Within 90 days after the filing of an application pursuant to paragraph (1), or such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall (A) issue an order approving the application if the Secretary then finds that none of the grounds for denying approval specified in paragraph (3) applies, or (B) give the applicant notice of an opportunity for a hearing before the Secretary under paragraph (3) on the question whether such application is approvable. The procedure governing such a hearing shall be the procedure set forth in the last two sentences of subsection (c)(1). “(3) If the Secretary, after due notice to the applicant in accordance with paragraph (2) and giving the applicant an opportunity for a hearing in accordance with such paragraph, finds, on the basis of information submitted to the Secretary as part of the application, on the basis of a preapproval inspection, or on the basis of any other information before the Secretary— “(A) that the application is incomplete, false, or misleading in any particular; “(B) that the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such animal feed are inadequate to preserve the identity, strength, quality, and purity of the new animal drug therein; or “(C) that the facility manufactures animal feeds bearing or containing new animal drugs in a manner that does not accord with the specifications for manufacture or labels animal feeds bearing or containing new animal drugs in a manner that does not accord with the conditions or indications of use that are published pursuant to subsection (i), the Secretary shall issue an order refusing to approve the application. If, after such notice and opportunity for hearing, the Secretary finds that subparagraphs (A) through (C) do not apply, the Secretary shall issue an order approving the application. An order under this subsection approving an application for a license to manufacture animal feeds bearing or containing new animal drugs shall permit a facility to manufacture only those animal feeds bearing or containing new animal drugs for which there are in effect regulations pursuant to subsection (i) relating to the use of such drugs in or on such animal feed. “(4) (A) The Secretary shall, after due notice and opportunity for hearing to the applicant, revoke a license to manufacture animal feeds bearing or containing new animal drugs under this subsection if the Secretary finds— “(i) that the application for such license contains any untrue statement of a material fact; or “(ii) that the applicant has made changes that would cause the application to contain any untrue statements of material fact or that would affect the safety or effectiveness of the animal feeds manufactured at the facility unless the applicant has supplemented the application by filing with the Secretary adequate information respecting all such changes and unless there is in effect an approval of the supplemental application. If the Secretary (or in the Secretary’s absence the officer acting as the Secretary) finds that there is an imminent hazard to the health of humans or of the animals for which such animal feed is intended, the Secretary may suspend the license immediately, and give the applicant prompt notice of the action and afford the applicant the opportunity for an expedited hearing under this subsection; but the authority conferred by this sentence shall not be delegated. “(B) The Secretary may also, after due notice and opportunity for hearing to the applicant, revoke a license to manufacture animal feed under this subsection if the Secretary finds— “(i) that the applicant has failed to establish a system for maintaining required records, or has repeatedly or deliberately failed to maintain such records or to make required reports in accordance with a regulation or order under paragraph (5)(A) of this subsection or section 504(a)(3)(A), or the applicant has refused to permit access to, or copying or verification of, such records as required by subparagraph (B) of such paragraph or section 504(a)(3)(B); “(ii) that on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when such license was issued, the methods used in, or the facilities and controls used for, the manufacture, processing, packing, and holding of such animal feed are inadequate to assure and preserve the identity, strength, quality, and purity of the new animal drug therein, and were not made adequate within a reasonable time after receipt of written notice from the Secretary, specifying the matter complained of; “(iii) that on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when such license was issued, the labeling of any animal feeds, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of; or “(iv) that on the basis of new information before the Secretary, evaluated together with the evidence before the Secretary when such license was issued, the facility has manufactured, processed, packed, or held animal feed bearing or containing a new animal drug adulterated under section 501(a)(6) and the facility did not discontinue the manufacture, processing, packing, or holding of such animal feed within a reasonable time after receipt of written notice from the Secretary specifying the matter complained of. “(C) The Secretary may also revoke a license to manufacture animal feeds under this subsection if an applicant gives notice to the Secretary of intention to discontinue the manufacture of all animal feed covered under this subsection and waives an opportunity for a hearing on the matter. “(D) Any order under this paragraph shall state the findings upon which it is based. “(5) When a license to manufacture animal feeds bearing or containing new animal drugs has been issued— “(A) the applicant shall establish and maintain such records, and make such reports to the Secretary, or (at the option of the Secretary) to the appropriate person or persons holding an approved application filed under subsection (b), as the Secretary may by general regulation, or by order with respect to such application, prescribe on the basis of a finding that such records and reports are necessary in order to enable the Secretary to determine, or facilitate a determination, whether there is or may be ground for invoking subsection (e) or paragraph (4); and “(B) every person required under this subsection to maintain records, and every person in charge or custody thereof, shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to and copy and verify such records. “(6) To the extent consistent with the public health, the Secretary may promulgate regulations for exempting from the operation of this subsection facilities that manufacture, process, pack, or hold animal feeds bearing or containing new animal drugs.”.

30. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 title I § 124(b) · 111 Stat. 2296

    Added · 21 U.S.C. § 360b(c)(4)

    Pub. L. 105–115 added par. (4)

    Source evidence

    Code amendment note
    Subsec. (c)(4). Pub. L. 105–115 added par. (4).

    Enacted provision · exact public law section
    (b) Animal Drugs.— Section 512(c) (21 U.S.C. 360b(c)) is amended by adding at the end the following: “(4) A drug manufactured in a pilot or other small facility may be used to demonstrate the safety and effectiveness of the drug and to obtain approval for the drug prior to manufacture of the drug in a larger facility, unless the Secretary makes a determination that a full scale production facility is necessary to ensure the safety or effectiveness of the drug.”.

31. 1998

    Pub. L. 105–277 div. A § 101(a)(tVII)(s737) · 112 Stat. 2681

    Inserted · 21 U.S.C. § 360b(d)(4)(D)(iii)

    Pub. L. 105–277 inserted before semicolon “, except that for purposes of this clause, antibacterial ingredient or animal drug does not include the ionophore or arsenical classes of animal drugs”

    Source evidence

    Code amendment note
    Subsec. (d)(4)(D)(iii). Pub. L. 105–277 inserted before semicolon “, except that for purposes of this clause, antibacterial ingredient or animal drug does not include the ionophore or arsenical classes of animal drugs”.

    Enacted provision · exact public law section
    Sec. 101. For programs, projects or activities in the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 1999, provided as follows, to be effective as if it had been enacted into law as the regular appropriations Act: AN ACT Making appropriations for Agriculture, Rural Development, Food and Drug Administration, and Related Agencies programs for the fiscal year ending September 30, 1999, and for other purposes. Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 1999.

32. 1999

    District of Columbia Appropriations Act, 2000

    Pub. L. 106–113 div. B § 1000(a)(9)(tIV)(s4732)(b)(11) · 113 Stat. 1501

    Substituted · 21 U.S.C. § 360b(o)

    Pub. L. 106–113 substituted “United States Patent and Trademark Office” for “Patent and Trademark Office of the Department of Commerce”

    Source evidence

    Code amendment note
    Subsec. (o). Pub. L. 106–113 substituted “United States Patent and Trademark Office” for “Patent and Trademark Office of the Department of Commerce”.

    Effective date note
    Amendment by Pub. L. 106–113 effective 4 months after Nov. 29, 1999, see section 1000(a)(9) [title IV, § 4731] of Pub. L. 106–113, set out as a note under section 1 of Title 35, Patents.

33. 2004

    Minor Use and Minor Species Animal Health Act of 2004

    Pub. L. 108–282 § 102(b)(5)(I) · 118 Stat. 891

    1. Added · 21 U.S.C. § 360b(a)(1); 21 U.S.C. § 360b(a)(2)

       Pub. L. 108–282, § 102(b)(5)(I), added pars. (1) and (2)

    2. Struck · 21 U.S.C. § 360b(a)(1); 21 U.S.C. § 360b(a)(2)

       Pub. L. 108–282, § 102(b)(5)(I), struck out former pars. (1) and (2) which deemed as unsafe new animal drugs and animal feed bearing or containing a new animal drug which did not have in effect certain approvals

    Source evidence

    Code amendment note
    Subsec. (a)(1), (2). Pub. L. 108–282, § 102(b)(5)(I), added pars. (1) and (2) and struck out former pars. (1) and (2) which deemed as unsafe new animal drugs and animal feed bearing or containing a new animal drug which did not have in effect certain approvals.

    Enacted provision · exact public law section
    (I) Section 512(a) of the Federal Food, Drug, and Cosmetic Act is 21 USC 360b. amended by striking paragraphs (1) and (2) and inserting the following: “(1) A new animal drug shall, with respect to any particular use or intended use of such drug, be deemed unsafe for purposes of section 501(a)(5) and section 402(a)(2)(C)(ii) unless— “(A) there is in effect an approval of an application filed pursuant to subsection (b) with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such approved application; “(B) there is in effect a conditional approval of an application filed pursuant to section 571 with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to such conditionally approved application; or “(C) there is in effect an index listing pursuant to section 572 with respect to such use or intended use of such drug in a minor species, and such drug, its labeling, and such use conform to such index listing. A new animal drug shall also be deemed unsafe for such purposes in the event of removal from the establishment of a manufacturer, packer, or distributor of such drug for use in the manufacture of animal feed in any State unless at the time of such removal such manufacturer, packer, or distributor has an unrevoked written statement from the consignee of such drug, or notice from the Secretary, to the effect that, with respect to the use of such drug in animal feed, such consignee (i) holds a license issued under subsection (m) and has in its possession current approved labeling for such drug in animal feed; or (ii) will, if the consignee is not a user of the drug, ship such drug only to a holder of a license issued under subsection (m). “(2) An animal feed bearing or containing a new animal drug shall, with respect to any particular use or intended use of such animal feed be deemed unsafe for purposes of section 501(a)(6) unless— “(A) there is in effect— “(i) an approval of an application filed pursuant to subsection (b) with respect to such drug, as used in such animal feed, and such animal feed and its labeling, distribution, holding, and use conform to such approved application; “(ii) a conditional approval of an application filed pursuant to section 571 with respect to such drug, as used in such animal feed, and such animal feed and its labeling, distribution, holding, and use conform to such conditionally approved application; or “(iii) an index listing pursuant to section 572 with respect to such drug, as used in such animal feed, and such animal feed and its labeling, distribution, holding, and use conform to such index listing; and “(B) such animal feed is manufactured at a site for which there is in effect a license issued pursuant to subsection (m)(1) to manufacture such animal feed.” .

34. 2004

    Minor Use and Minor Species Animal Health Act of 2004

    Pub. L. 108–282 § 102(b)(5)(J) · 118 Stat. 891

    Substituted · 21 U.S.C. § 360b(b)(3)

    Pub. L. 108–282, § 102(b)(5)(J), substituted “under paragraph (1), section 360ccc of this title, or a request for an investigational exemption under subsection (j)” for “under paragraph (1) or a request for an investigational exemption under subsection (j)”

    Source evidence

    Code amendment note
    Subsec. (b)(3). Pub. L. 108–282, § 102(b)(5)(J), substituted “under paragraph (1), section 360ccc of this title, or a request for an investigational exemption under subsection (j)” for “under paragraph (1) or a request for an investigational exemption under subsection (j)”.

    Enacted provision · exact public law section
    (J) Section 512(b)(3) of the Federal Food, Drug, and Cosmetic Act is 21 USC 360b. amended by striking “under paragraph (1) or a request for an investigational exemption under subsection (j)” and inserting “under paragraph (1), section 571, or a request for an investigational exemption under subsection (j)”.

35. 2004

    Minor Use and Minor Species Animal Health Act of 2004

    Pub. L. 108–282 § 102(b)(2) · 118 Stat. 891

    Substituted · 21 U.S.C. § 360b(c)(2)(F)(ii); 21 U.S.C. § 360b(c)(2)(F)(iii); 21 U.S.C. § 360b(c)(2)(F)(v)

    Pub. L. 108–282, § 102(b)(2), substituted “(other than bioequivalence studies or residue depletion studies, except residue depletion studies for minor uses or minor species)” for “(other than bioequivalence or residue studies)”

    Source evidence

    Code amendment note
    Subsec. (c)(2)(F)(ii), (iii), (v). Pub. L. 108–282, § 102(b)(2), substituted “(other than bioequivalence studies or residue depletion studies, except residue depletion studies for minor uses or minor species)” for “(other than bioequivalence or residue studies)”.

    Enacted provision · exact public law section
    (2) Three-year exclusivity for minor use and minor species approvals.— Section 512(c)(2)(F) (ii), (iii), and (v) of the Federal Food, Drug, and Cosmetic Act 21 USC 360b. is amended by striking “(other than bioequivalence or residue studies)” and inserting “(other than bioequivalence studies or residue depletion studies, except residue depletion studies for minor uses or minor species)” every place it appears.

36. 2004

    Minor Use and Minor Species Animal Health Act of 2004

    Pub. L. 108–282 § 102(b)(5)(K) · 118 Stat. 891

    Substituted · 21 U.S.C. § 360b(d)(4)

    Pub. L. 108–282, § 102(b)(5)(K), substituted “have previously been separately approved pursuant to an application submitted under subsection (b)(1)” for “have previously been separately approved” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (d)(4). Pub. L. 108–282, § 102(b)(5)(K), substituted “have previously been separately approved pursuant to an application submitted under subsection (b)(1)” for “have previously been separately approved” in introductory provisions.

    Enacted provision · exact public law section
    (K) Section 512(d)(4) of the Federal Food, Drug, and Cosmetic Act is amended by striking “have previously been separately approved” and inserting “have previously been separately approved pursuant to an application submitted under section 512(b)(1)”.

37. 2004

    Minor Use and Minor Species Animal Health Act of 2004

    Pub. L. 108–282 § 102(b)(3) · 118 Stat. 891

    Added · 21 U.S.C. § 360b(d)(5)

    Pub. L. 108–282, § 102(b)(3), added par. (5)

    Source evidence

    Code amendment note
    Subsec. (d)(5). Pub. L. 108–282, § 102(b)(3), added par. (5).

    Enacted provision · exact public law section
    (3) Scope of review for minor use and minor species applications.— Section 512(d) of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end the following new paragraph: “(5) In reviewing an application that proposes a change to add an intended use for a minor use or a minor species to an approved new animal drug application, the Secretary shall reevaluate only the relevant information in the approved application to determine whether the application for the minor use or minor species can be approved. A decision to approve the application for the minor use or minor species is not, implicitly or explicitly, a reaffirmation of the approval of the original application.” .

38. 2004

    Minor Use and Minor Species Animal Health Act of 2004

    Pub. L. 108–282 § 102(b)(5)(L) · 118 Stat. 891

    Substituted · 21 U.S.C. § 360b(f)

    Pub. L. 108–282, § 102(b)(5)(L), substituted “subsection (d), (e), or (m), or section 360ccc(c), (d), or (e) of this title” for “subsection (d), (e), or (m)”

    Source evidence

    Code amendment note
    Subsec. (f). Pub. L. 108–282, § 102(b)(5)(L), substituted “subsection (d), (e), or (m), or section 360ccc(c), (d), or (e) of this title” for “subsection (d), (e), or (m)”.

    Enacted provision · exact public law section
    (L) Section 512(f) of the Federal Food, Drug, and Cosmetic Act is amended by striking “subsection (d), (e), or (m)” and inserting “subsection (d), (e), or (m), or section 571 (c), (d), or (e)”.

39. 2004

    Minor Use and Minor Species Animal Health Act of 2004

    Pub. L. 108–282 § 102(b)(5)(M) · 118 Stat. 891

    Substituted · 21 U.S.C. § 360b(g)

    Pub. L. 108–282, § 102(b)(5)(M), substituted “this section, or section 360ccc of this title” for “this section”

    Source evidence

    Code amendment note
    Subsec. (g). Pub. L. 108–282, § 102(b)(5)(M), substituted “this section, or section 360ccc of this title” for “this section”.

    Enacted provision · exact public law section
    (M) Section 512(g) of the Federal Food, Drug, and Cosmetic Act is amended by striking “this section” and inserting “this section, or section 571”.

40. 2004

    Minor Use and Minor Species Animal Health Act of 2004

    Pub. L. 108–282 § 102(b)(5)(N) · 118 Stat. 891

    1. Substituted · 21 U.S.C. § 360b(i)

       Pub. L. 108–282, § 102(b)(5)(N), substituted “subsection (b) or section 360ccc of this title” for “subsection (b)”

    2. Inserted · 21 U.S.C. § 360b(i)

       Pub. L. 108–282, § 102(b)(5)(N), inserted “or upon failure to renew a conditional approval under section 360ccc of this title” after “or upon its suspension”

    Source evidence

    Code amendment note
    Subsec. (i). Pub. L. 108–282, § 102(b)(5)(N), substituted “subsection (b) or section 360ccc of this title” for “subsection (b)” and inserted “or upon failure to renew a conditional approval under section 360ccc of this title” after “or upon its suspension”.

    Enacted provision · exact public law section
    (N) Section 512(i) of the Federal Food, Drug, and Cosmetic Act is amended by striking “subsection (b)” and inserting “subsection (b) or section 571” and by inserting “or upon failure to renew a conditional approval under section 571” after “or upon its suspension”.

41. 2004

    Minor Use and Minor Species Animal Health Act of 2004

    Pub. L. 108–282 § 102(b)(5)(O) · 118 Stat. 891

    Substituted · 21 U.S.C. § 360b(l)(1)

    Pub. L. 108–282, § 102(b)(5)(O), substituted “subsection (b) or section 360ccc of this title” for “subsection (b)”

    Source evidence

    Code amendment note
    Subsec. (l)(1). Pub. L. 108–282, § 102(b)(5)(O), substituted “subsection (b) or section 360ccc of this title” for “subsection (b)”.

    Enacted provision · exact public law section
    (O) Section 512(l)(1) of the Federal Food, Drug, and Cosmetic Act is amended by striking “subsection (b)” and inserting “subsection (b) or section 571”.

42. 2004

    Minor Use and Minor Species Animal Health Act of 2004

    Pub. L. 108–282 § 102(b)(5)(P) · 118 Stat. 891

    Substituted · 21 U.S.C. § 360b(m)(1)(C)

    Pub. L. 108–282, § 102(b)(5)(P), substituted “applicable regulations published pursuant to subsection (i) or for indexed new animal drugs in accordance with the index listing published pursuant to section 360ccc–1(e)(2) of this title and the labeling requirements set forth in section 360ccc–1(h) of this title” for “applicable regulations published pursuant to subsection (i)”

    Source evidence

    Code amendment note
    Subsec. (m)(1)(C). Pub. L. 108–282, § 102(b)(5)(P), substituted “applicable regulations published pursuant to subsection (i) or for indexed new animal drugs in accordance with the index listing published pursuant to section 360ccc–1(e)(2) of this title and the labeling requirements set forth in section 360ccc–1(h) of this title” for “applicable regulations published pursuant to subsection (i)”.

    Enacted provision · exact public law section
    (P) Section 512(m)(1)(C) of the Federal Food, Drug, and Cosmetic Act is amended by striking “applicable regulations published pursuant to subsection (i)” and inserting “applicable regulations published pursuant to subsection (i) or for indexed new animal drugs in accordance with the index listing published pursuant to section 572(e)(2) and the labeling requirements set forth in section 572(h)”.

43. 2004

    Minor Use and Minor Species Animal Health Act of 2004

    Pub. L. 108–282 § 102(b)(5)(Q) · 118 Stat. 891

    Inserted · 21 U.S.C. § 360b(m)(3)

    Pub. L. 108–282, § 102(b)(5)(Q), inserted “or an index listing pursuant to section 360ccc–1(e) of this title” after “subsection (i)” in subpar. (C) and concluding provisions

    Source evidence

    Code amendment note
    Subsec. (m)(3). Pub. L. 108–282, § 102(b)(5)(Q), inserted “or an index listing pursuant to section 360ccc–1(e) of this title” after “subsection (i)” in subpar. (C) and concluding provisions.

    Enacted provision · exact public law section
    (Q) Section 512(m)(3) of the Federal Food, Drug, and Cosmetic Act is amended by inserting “or an index listing pursuant to section 572(e)” after “subsection (i)” each place it appears.

44. 2004

    Minor Use and Minor Species Animal Health Act of 2004

    Pub. L. 108–282 § 102(b)(5)(R) · 118 Stat. 891

    Substituted · 21 U.S.C. § 360b(p)(1); 21 U.S.C. § 360b(2)(A)

    Pub. L. 108–282, § 102(b)(5)(R), (S), substituted “subsection (b)(1) or section 360ccc(a) of this title” for “subsection (b)(1)”

    Source evidence

    Code amendment note
    Subsec. (p)(1), (2)(A). Pub. L. 108–282, § 102(b)(5)(R), (S), substituted “subsection (b)(1) or section 360ccc(a) of this title” for “subsection (b)(1)”.

    Enacted provision · exact public law section
    (R) Section 512(p)(1) of the Federal Food, Drug, and Cosmetic Act is amended by striking “subsection (b)(1)” and inserting “subsection (b)(1) or section 571(a)”.

45. 2008

    Animal Drug User Fee Amendments of 2008

    Pub. L. 110–316 title I § 105(a) · 122 Stat. 3509

    Added · 21 U.S.C. § 360b(l)(3)

    Pub. L. 110–316 added par. (3)

    Source evidence

    Code amendment note
    Subsec. (l)(3). Pub. L. 110–316 added par. (3).

    Enacted provision · exact public law section
    (a) Reports.— Section 512(l) (21 U.S.C. 360b(l)) is amended by adding at the end the following: “(3) (A) In the case of each new animal drug described in paragraph (1) that contains an antimicrobial active ingredient, the sponsor of the drug shall submit an annual report to the Secretary on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. “(B) Each report under this paragraph shall specify the amount of each antimicrobial active ingredient— “(i) by container size, strength, and dosage form; “(ii) by quantities distributed domestically and quantities exported; and “(iii) by dosage form, including, for each such dosage form, a listing of the target animals, indications, and production classes that are specified on the approved label of the product. “(C) Each report under this paragraph shall— “(i) be submitted not later than March 31 each year; “(ii) cover the period of the preceding calendar year; and “(iii) include separate information for each month of such calendar year. “(D) The Secretary may share information reported under this paragraph with the Antimicrobial Resistance Task Force established under section 319E of the Public Health Service Act. “(E) The Secretary shall make summaries of the information reported under this paragraph publicly available, except that— “(i) the summary data shall be reported by antimicrobial class, and no class with fewer than 3 distinct sponsors of approved applications shall be independently reported; and “(ii) the data shall be reported in a manner consistent with protecting both national security and confidential business information.” .

46. 2015

    Improving Regulatory Transparency for New Medical Therapies Act

    Pub. L. 114–89 § 2(a)(3)(A) · 129 Stat. 698

    Added · 21 U.S.C. § 360b(q)

    Pub. L. 114–89 added subsec. (q)

    Source evidence

    Code amendment note
    Subsec. (q). Pub. L. 114–89 added subsec. (q).

    Enacted provision · exact public law section
    (A) In general.— Section 512 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b) is amended by adding at the end the following: “(q) Date of Approval in the Case of Recommended Controls Under the CSA.— “(1) In general.— In the case of an application under subsection (b) with respect to a drug for which the Secretary provides notice to the sponsor that the Secretary intends to issue a scientific and medical evaluation and recommend controls under the Controlled Substances Act, approval of such application shall not take effect until the interim final rule controlling the drug is issued in accordance with section 201(j) of the Controlled Substances Act. “(2) Date of approval.— For purposes of this section, with respect to an application described in paragraph (1), the term ‘date of approval’ shall mean the later of— “(A) the date an application under subsection (b) is approved under subsection (c); or “(B) the date of issuance of the interim final rule controlling the drug.” .

47. 2016

    21st Century Cures Act

    Pub. L. 114–255 div. A title III § 3088(b) · 130 Stat. 1033

    Added · 21 U.S.C. § 360b(a)(1)(D)

    Pub. L. 114–255 added subpar. (D)

    Source evidence

    Code amendment note
    Subsec. (a)(1)(D). Pub. L. 114–255 added subpar. (D).

    Enacted provision · exact public law section
    (b) New Animal Drugs.— Section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(a)(1)) is amended— (1) in subparagraph (B), by striking “or” at the end; (2) in subparagraph (C), by striking the period and inserting “; or”; and (3) by inserting after subparagraph (C) the following: “(D) there is in effect an authorization pursuant to section 564 with respect to such use or intended use of such drug, and such drug, its labeling, and such use conform to any conditions of such authorization.” .

48. 2018

    Animal Drug and Animal Generic Drug User Fee Amendments of 2018

    Pub. L. 115–234 title III § 301(a) · 132 Stat. 2427

    Added · 21 U.S.C. § 360b(b)(4)

    Pub. L. 115–234 added par. (4)

    Source evidence

    Code amendment note
    Subsec. (b)(4). Pub. L. 115–234 added par. (4).

    Enacted provision · exact public law section
    (a) New Animal Drug Applications and Abbreviated Applications for a Generic New Animal Drug.— Section 512(b) (21 U.S.C. 360b(b)) is amended by adding at the end the following: “(4) Beginning on October 1, 2018, all applications or submissions pursuant to this subsection shall be submitted by electronic means in such format as the Secretary may require.” .

49. 2021

    Pub. L. 117–9 § 1(a)(2) · 135 Stat. 255

    Substituted · 21 U.S.C. § 360b(c)(2)(F)

    Pub. L. 117–9 substituted “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))” for “active ingredient (including any ester or salt of the active ingredient)” in cls. (i), (ii), and (v)

    Source evidence

    Code amendment note
    Subsec. (c)(2)(F). Pub. L. 117–9 substituted “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))” for “active ingredient (including any ester or salt of the active ingredient)” in cls. (i), (ii), and (v).

    Enacted provision · exact public law section
    (2) in section 512(c)(2)(F) (21 U.S.C. 360b(c)(2)(F)), by striking “active ingredient (including any ester or salt of the active ingredient)” each place it appears and inserting “active moiety (as defined by the Secretary in section 314.3 of title 21, Code of Federal Regulations (or any successor regulations))”;

56 of 64 references resolved to an enrolled provision · 8 partial