§ 360cc. Protection for drugs for rare diseases or conditions

Footnotes

1. 1 See References in Text note below.

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

   Pub. L. 97–414 § 2(a) · 96 Stat. 2049

   Enacted · 21 U.S.C. § 360cc

   June 25, 1938, ch. 675, § 527, as added Pub. L. 97–414, § 2(a), Jan. 4, 1983, 96 Stat. 2050

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 527, as added Pub. L. 97–414, § 2(a), Jan. 4, 1983, 96 Stat. 2050

   Enacted provision · exact public law section
   (a) Chapter V of the Federal Food, Drug, and Cosmetic Act is amended by adding at the end the following: “Subchapter B— Drugs for Rare Diseases or Conditions “Sec. 525. “recommendations for investigations of drugs for rare diseases or conditions (a) The sponsor of a drug for a disease or condition 21 USC 360aa. which is rare in the States may request the Secretary to provide written recommendations for the non-clinical and clinical investigations which must be conducted with the drug before— “(1) it may be approved for such disease or condition under section 505, or 21 USC 355. “(2) if the drug is a biological product, before it may be licensed for such disease or condition under section 351 of the 42 USC 262. Public Health Service Act. If the Secretary has reason to believe that a drug for which a request is made under this section is a drug for a disease or condition which is rare in the States, the Secretary shall provide the person making the request written recommendations for the non-clinical and clinical investigations which the Secretary believes, on the basis of information available to the Secretary at the time of the request under this section, would be necessary for approval of such 21 USC 355. drug for such disease or condition under section 505 or licensing under section 351 of the Public Health Service Act for such disease or condition. “(b) The Secretary shall by regulation promulgate procedures for the implementation of subsection (a). “Sec. 526. “designation of drugs for rare diseases or conditions (a) (1) The manufacturer or the sponsor of a drug may request the Secretary to designate the drug as a drug for a rare disease or condition. If the Secretary finds that a drug for which a request is submitted under this subsection is being or will be investigated for a rare disease or condition and— “(A) if an application for such drug is approved under section 505, or “(B) if the drug is a biological product, a license is issued under section 351 of the Public Health Service Act, the approval or license would be for use for such disease or condition, the Secretary shall designate the drug as a drug for such disease or condition. A request for a designation of a drug under this subsection shall contain the consent of the applicant to notice being given by the Secretary under subsection (b) respecting the designation of the drug. “(2) “Rare disease or condition.” For purposes of paragraph (1), the term ‘rare disease or condition’ means any disease or condition which occurs so infrequently in the United States that there is no reasonable expectation that the cost of developing and making available in the United States a drug for such disease or condition will be recovered from sales in the United States of such drug. Determinations under the preceding sentence with respect to any drug shall be made on the basis of the facts and circumstances as of the date the request for designation of the drug under this subsection is made. “(b) Notice. Notice respecting the designation of a drug under subsection (a) shall be made available to the public. “(c) The Secretary shall by regulation promulgate procedures for the implementation of subsection (a). “Sec. 527. “protection for unpatented drugs for rare diseases or conditions (a) Except as provided in subsection (b), if the Secretary— “(1) approves an application filed pursuant to section 505(b), or “(2) issues a license under section 351 of the Public Health Service Act for a drug designated under section 526 for a rare disease or Ante, p. 2050. condition and for which a United States Letter of Patent may not be issued, the Secretary may not approve another application under section 505(b) or issue another license under section 351 of the 21 USC 355. 42 USC 262. Public Health Service Act for such drug for such disease or condition for a person who is not the holder of such approved application or of such license until the expiration of seven years from the date of the approval of the approved application or the issuance of the license. Section 505(c)(2) does not apply to the refusal to approve an application under the preceding sentence. “(b) If an application filed pursuant to section 505(b) is approved for a drug designated under section 526 for a rare disease or condition or a license is issued under section 351 of the Public Health Service Act for such a drug and if a United States Letter of Patent may not be issued for the drug, the Secretary may, during the seven-year period beginning on the date of the application approval or of the issuance of the license, approve another application under section 505(b), or, if the drug is a biological product, issue a license under section 351 of the Public Health Service Act, for such drug for such disease or condition for a person who is not the holder of such approved application or of such license if— “(1) The Secretary finds, after providing the holder notice and opportunity for the submission of views, that in such period the holder of the approved application or of the license cannot assure the availability of sufficient quantities of the drug to meet the needs of persons with the disease or condition for which the drug was designated; or “(2) such holder provides the Secretary in writing the consent of such holder for the approval of other applications or the issuance of other licenses before the expiration of such seven-year period. “Sec. 528. “open protocols for investigations of drugs for rare diseases or conditions If a drug is designated under section 526 as a 21 USC 360dd. drug for a rare disease or condition and if notice of a claimed exemption under section 505(i) or regulations issued thereunder is filed for such drug, the Secretary shall encourage the sponsor of such drug to design protocols for clinical investigations of the drug which may be conducted under the exemption to permit the addition to the investigations of persons with the disease or condition who need the drug to treat the disease or condition and who cannot be satisfactorily treated by available alternative drugs.”.

2. 1984

   Drug Price Competition and Patent Term Restoration Act of 1984

   Pub. L. 98–417 title I § 102(b)(6) · 98 Stat. 1585

   Substituted · 21 U.S.C. § 360cc(a); 21 U.S.C. § 360cc(b)

   Pub. L. 98–417 substituted “section 355” for “section 355(b)” wherever appearing

   Source evidence

   Code amendment note
   Subsecs. (a), (b). Pub. L. 98–417 substituted “section 355” for “section 355(b)” wherever appearing.

   Enacted provision · exact public law section
   (6) Subsections (a) and (b) of section 527 of such Act are each 21 USC 360cc. amended by striking out “505(b)” each place it occurs and inserting in lieu thereof “505.”

3. 1985

   Orphan Drug Amendments of 1985

   Pub. L. 99–91 § 2(3) · 99 Stat. 387

   Struck · 21 U.S.C. § 360cc

   Pub. L. 99–91, § 2(3), struck out “unpatented” before “drugs” in section catchline

   Source evidence

   Code amendment note
   Pub. L. 99–91, § 2(3), struck out “unpatented” before “drugs” in section catchline.

   Enacted provision · exact public law section
   (3) by striking out “unpatented” in the title of the section.

   Effective date note
   Amendment by Pub. L. 99–91 effective Aug. 15, 1985, see section 8(b) of Pub. L. 99–91, set out as a note under section 360aa of this title.

4. 1985

   Orphan Drug Amendments of 1985

   Pub. L. 99–91 · 99 Stat. 387

   1. Struck · 21 U.S.C. § 360cc(a)

      Pub. L. 99–91, §§ 2(1), 3(a)(3)(A)–(D), struck out “or” at end of par. (1)

   2. Added · 21 U.S.C. § 360cc(a)

      Pub. L. 99–91, §§ 2(1), 3(a)(3)(A)–(D), added par. (2)

   3. Redesignated · 21 U.S.C. § 360cc(a)

      Pub. L. 99–91, §§ 2(1), 3(a)(3)(A)–(D), redesignated former par. (2) as (3)

   4. Struck · 21 U.S.C. § 360cc(a)

      Pub. L. 99–91, §§ 2(1), 3(a)(3)(A)–(D), struck out “and for which a United States Letter of Patent may not be issued” after “rare disease or condition”

   5. Inserted · 21 U.S.C. § 360cc(a)

      Pub. L. 99–91, §§ 2(1), 3(a)(3)(A)–(D), inserted in first sentence “, issue another certification under section 357 of this title,” after “section 355 of this title” the second time it appeared

   6. Inserted · 21 U.S.C. § 360cc(a)

      Pub. L. 99–91, §§ 2(1), 3(a)(3)(A)–(D), inserted “, of such certification,” after “holder of such approved application”

   7. Inserted · 21 U.S.C. § 360cc(a)

      Pub. L. 99–91, §§ 2(1), 3(a)(3)(A)–(D), inserted “, the issuance of the certification,” after “approval of the approved application”

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 99–91, §§ 2(1), 3(a)(3)(A)–(D), struck out “or” at end of par. (1), added par. (2), redesignated former par. (2) as (3), struck out “and for which a United States Letter of Patent may not be issued” after “rare disease or condition”, inserted in first sentence “, issue another certification under section 357 of this title,” after “section 355 of this title” the second time it appeared, inserted “, of such certification,” after “holder of such approved application”, and inserted “, the issuance of the certification,” after “approval of the approved application”.

   Effective date note
   Amendment by Pub. L. 99–91 effective Aug. 15, 1985, see section 8(b) of Pub. L. 99–91, set out as a note under section 360aa of this title.

5. 1985

   Orphan Drug Amendments of 1985

   Pub. L. 99–91 · 99 Stat. 387

   1. Struck · 21 U.S.C. § 360cc(b)

      Pub. L. 99–91, §§ 2(2), 3(a)(3)(E)–(K), struck out “and if a United States Letter of Patent may not be issued for the drug” after “such a drug”

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

      Pub. L. 99–91, §§ 2(2), 3(a)(3)(E)–(K), substituted “, if a certification is issued under section 357 of this title for such a drug, or if a license” for “or a license”

   3. Inserted · 21 U.S.C. § 360cc(b)

      Pub. L. 99–91, §§ 2(2), 3(a)(3)(E)–(K), inserted “, of the issuance of the certification under section 357 of this title,” after “application approval”

   4. Struck · 21 U.S.C. § 360cc(b)

      Pub. L. 99–91, §§ 2(2), 3(a)(3)(E)–(K), struck out “, if the drug is a biological product,” before “issue a license”

   5. Inserted · 21 U.S.C. § 360cc(b)

      Pub. L. 99–91, §§ 2(2), 3(a)(3)(E)–(K), inserted “, issue another certification under section 357 of this title,” after “section 355 of this title”

   6. Inserted · 21 U.S.C. § 360cc(b)

      Pub. L. 99–91, §§ 2(2), 3(a)(3)(E)–(K), inserted “, of such certification,” after “holder of such approved application”

   7. Inserted · 21 U.S.C. § 360cc(b)

      Pub. L. 99–91, §§ 2(2), 3(a)(3)(E)–(K), inserted “, of such certification,” after “application” in par. (1)

   8. Inserted · 21 U.S.C. § 360cc(b)

      Pub. L. 99–91, §§ 2(2), 3(a)(3)(E)–(K), inserted “, issuance of other certifications,” after “other applications” in par. (2)

   Source evidence

   Code amendment note
   Subsec. (b). Pub. L. 99–91, §§ 2(2), 3(a)(3)(E)–(K), struck out “and if a United States Letter of Patent may not be issued for the drug” after “such a drug”, substituted “, if a certification is issued under section 357 of this title for such a drug, or if a license” for “or a license”, inserted “, of the issuance of the certification under section 357 of this title,” after “application approval”, struck out “, if the drug is a biological product,” before “issue a license”, inserted “, issue another certification under section 357 of this title,” after “section 355 of this title”, inserted “, of such certification,” after “holder of such approved application”, inserted “, of such certification,” after “application” in par. (1), and inserted “, issuance of other certifications,” after “other applications” in par. (2).

   Effective date note
   Amendment by Pub. L. 99–91 effective Aug. 15, 1985, see section 8(b) of Pub. L. 99–91, set out as a note under section 360aa of this title.

6. 1993

   Nutrition Labeling and Education Act Amendments of 1993

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

   1. Struck · 21 U.S.C. § 360cc(b)

      Pub. L. 103–80 struck out extraneous comma before “or issue a license under section 262” in introductory provisions

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

      Pub. L. 103–80 substituted “the” for “The” at beginning of par. (1)

   Source evidence

   Code amendment note
   Subsec. (b). Pub. L. 103–80 struck out extraneous comma before “or issue a license under section 262” in introductory provisions and substituted “the” for “The” at beginning of par. (1).

   Enacted provision · exact public law section
   (v) Section 527.— Section 527(b) (21 U.S.C. 36Occ(b)) is amended— (1) by striking out “507„” and inserting in lieu thereof “507”, and (2) in paragraph (1), by striking out “The” and inserting in lieu thereof “the”.

7. 1997

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 § 125(b)(2)(J) · 111 Stat. 2296

   1. Struck · 21 U.S.C. § 360cc(a)

      Pub. L. 105–115, § 125(b)(2)(J), struck out “, issue another certification under section 357 of this title,” before “or issue another license” in closing provisions

   2. Inserted · 21 U.S.C. § 360cc(a)

      Pub. L. 105–115, § 125(b)(2)(J), inserted “or” at end of par. (1)

   3. Redesignated · 21 U.S.C. § 360cc(a)

      Pub. L. 105–115, § 125(b)(2)(J), redesignated par. (3) as (2)

   4. Struck · 21 U.S.C. § 360cc(a)

      Pub. L. 105–115, § 125(b)(2)(J), struck out former par. (2) which read as follows: “issues a certification under section 357 of this title, or”

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 105–115, § 125(b)(2)(J), struck out “, issue another certification under section 357 of this title,” before “or issue another license” in closing provisions, inserted “or” at end of par. (1), redesignated par. (3) as (2), and struck out former par. (2) which read as follows: “issues a certification under section 357 of this title, or”.

   Enacted provision · exact public law section
   (J) Section 527(a) (21 U.S.C. 360cc(a)) is amended by inserting “or” at the end of paragraph (1), by striking paragraph (2), by redesignating paragraph (3) as paragraph (2), and by striking “, issue another certification under section 507,”.

8. 1997

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 § 125(b)(2)(K) · 111 Stat. 2296

   Struck · 21 U.S.C. § 360cc(b)

   Pub. L. 105–115, § 125(b)(2)(K), in introductory provisions, struck out “, if a certification is issued under section 357 of this title for such a drug,” after “rare disease or condition”, “, of the issuance of the certification under section 357 of this title,” after “application approval”, “, issue another certification under section 357 of this title,” after “application under section 355 of this title”, and “, of such certification,” after “approved application”

   Source evidence

   Code amendment note
   Subsec. (b). Pub. L. 105–115, § 125(b)(2)(K), in introductory provisions, struck out “, if a certification is issued under section 357 of this title for such a drug,” after “rare disease or condition”, “, of the issuance of the certification under section 357 of this title,” after “application approval”, “, issue another certification under section 357 of this title,” after “application under section 355 of this title”, and “, of such certification,” after “approved application”.

   Enacted provision · exact public law section
   (K) Section 527(b) (21 U.S.C. 360cc(b)) is amended by striking “, if a certification is issued under section 507 for such a drug,”, “, of the issuance of the certification under section 507,”, “, issue another certification under section 507,”, “, of such certification,”, “, of the certification,”, and “, issuance of other certifications,”.

9. 1997

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 § 125(b)(2)(K) · 111 Stat. 2296

   Struck · 21 U.S.C. § 360cc(b)(1)

   Pub. L. 105–115, § 125(b)(2)(K), struck out “, of the certification,” after “holder of the approved application”

   Source evidence

   Code amendment note
   Subsec. (b)(1). Pub. L. 105–115, § 125(b)(2)(K), struck out “, of the certification,” after “holder of the approved application”.

   Enacted provision · exact public law section
   (K) Section 527(b) (21 U.S.C. 360cc(b)) is amended by striking “, if a certification is issued under section 507 for such a drug,”, “, of the issuance of the certification under section 507,”, “, issue another certification under section 507,”, “, of such certification,”, “, of the certification,”, and “, issuance of other certifications,”.

10. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 125(b)(2)(K) · 111 Stat. 2296

    Struck · 21 U.S.C. § 360cc(b)(2)

    Pub. L. 105–115, § 125(b)(2)(K), struck out “, issuance of other certifications,” after “approval of other applications”

    Source evidence

    Code amendment note
    Subsec. (b)(2). Pub. L. 105–115, § 125(b)(2)(K), struck out “, issuance of other certifications,” after “approval of other applications”.

    Enacted provision · exact public law section
    (K) Section 527(b) (21 U.S.C. 360cc(b)) is amended by striking “, if a certification is issued under section 507 for such a drug,”, “, of the issuance of the certification under section 507,”, “, issue another certification under section 507,”, “, of such certification,”, “, of the certification,”, and “, issuance of other certifications,”.

11. 2002

    Rare Diseases Orphan Product Development Act of 2002

    Pub. L. 107–281 § 4 · 116 Stat. 1992

    Struck · 21 U.S.C. § 360cc(a)

    Pub. L. 107–281, in concluding provisions, struck out “, of such certification,” after “such approved application” and “, the issuance of the certification,” after “approval of the approved application”

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 107–281, in concluding provisions, struck out “, of such certification,” after “such approved application” and “, the issuance of the certification,” after “approval of the approved application”.

    Enacted provision · exact public law section
    SEC. 4. TECHNICAL AMENDMENT. Section 527(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360cc(a)) is amended in the matter following paragraph (2)— (1) by striking of such certification,”; and (2) by striking “, the issuance of the certification,”.

12. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 607(a)(1) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 360cc(a)

    Pub. L. 115–52, § 607(a)(1), substituted “the same drug for the same disease or condition” for “such drug for such disease or condition” in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 115–52, § 607(a)(1), substituted “the same drug for the same disease or condition” for “such drug for such disease or condition” in concluding provisions.

    Enacted provision · exact public law section
    (1) in subsection (a), in the matter following paragraph (2), by striking “such drug for such disease or condition” and inserting “the same drug for the same disease or condition”;

13. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 607(a)(2)(A) · 131 Stat. 1005

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

    Pub. L. 115–52, § 607(a)(2)(A), in introductory provisions, substituted “During the 7-year period described in subsection (a) for an approved application under section 355 of this title or license under section 262 of title 42, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if” for “If an application filed pursuant to section 355 of this title is approved for a drug designated under section 360bb of this title for a rare disease or condition or if a license is issued under section 262 of title 42 for such a drug, the Secretary may, during the seven-year period beginning on the date of the application approval or of the issuance of the license, approve another application under section 355 of this title or issue a license under section 262 of title 42, for such drug for such disease or condition for a person who is not the holder of such approved application or of such license if”

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 115–52, § 607(a)(2)(A), in introductory provisions, substituted “During the 7-year period described in subsection (a) for an approved application under section 355 of this title or license under section 262 of title 42, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if” for “If an application filed pursuant to section 355 of this title is approved for a drug designated under section 360bb of this title for a rare disease or condition or if a license is issued under section 262 of title 42 for such a drug, the Secretary may, during the seven-year period beginning on the date of the application approval or of the issuance of the license, approve another application under section 355 of this title or issue a license under section 262 of title 42, for such drug for such disease or condition for a person who is not the holder of such approved application or of such license if”.

    Enacted provision · exact public law section
    (A) in the matter preceding paragraph (1), by striking “If an application” and all that follows through “such license if” and inserting “During the 7-year period described in subsection (a) for an approved application under section 505 or license under section 351 of the Public Health Service Act, the Secretary may approve an application or issue a license for a drug that is otherwise the same, as determined by the Secretary, as the already approved drug for the same rare disease or condition if”;

14. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 607(a)(2)(B) · 131 Stat. 1005

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

    Pub. L. 115–52, § 607(a)(2)(B), substituted “of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure” for “notice and opportunity for the submission of views, that in such period the holder of the approved application or of the license cannot assure”

    Source evidence

    Code amendment note
    Subsec. (b)(1). Pub. L. 115–52, § 607(a)(2)(B), substituted “of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure” for “notice and opportunity for the submission of views, that in such period the holder of the approved application or of the license cannot assure”.

    Enacted provision · exact public law section
    (B) in paragraph (1), by striking “notice” and all that follows through “assure” and inserting “of exclusive approval or licensure notice and opportunity for the submission of views, that during such period the holder of the exclusive approval or licensure cannot ensure”; and

15. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 607(a)(2)(C) · 131 Stat. 1005

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

    Pub. L. 115–52, § 607(a)(2)(C), substituted “the holder provides” for “such holder provides”

    Source evidence

    Code amendment note
    Subsec. (b)(2). Pub. L. 115–52, § 607(a)(2)(C), substituted “the holder provides” for “such holder provides”.

    Enacted provision · exact public law section
    (C) in paragraph (2), by striking “such holder provides” and inserting “the holder provides”; and

16. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 607(a)(3) · 131 Stat. 1005

    Added · 21 U.S.C. § 360cc(c)(e)

    Pub. L. 115–52, § 607(a)(3), added subsecs. (c) to (e)

    Source evidence

    Code amendment note
    Subsecs. (c) to (e). Pub. L. 115–52, § 607(a)(3), added subsecs. (c) to (e).

    Enacted provision · exact public law section
    (3) by adding at the end the following: “(c) Condition of Clinical Superiority.— “(1) In general.— If a sponsor of a drug that is designated under section 526 and is otherwise the same, as determined by the Secretary, as an already approved or licensed drug is seeking exclusive approval or exclusive licensure described in subsection (a) for the same rare disease or condition as the already approved drug, the Secretary shall require such sponsor, as a condition of such exclusive approval or licensure, to demonstrate that such drug is clinically superior to any already approved or licensed drug that is the same drug. “(2) Definition.— For purposes of paragraph (1), the term ‘clinically superior’ with respect to a drug means that the drug provides a significant therapeutic advantage over and above an already approved or licensed drug in terms of greater efficacy, greater safety, or by providing a major contribution to patient care. “(d) Regulations.— The Secretary may promulgate regulations for the implementation of subsection (c). Beginning on the date of enactment of the FDA Reauthorization Act of 2017, until such time as the Secretary promulgates regulations in accordance with this subsection, the Secretary may apply any definitions set forth in regulations that were promulgated prior to such date of enactment, to the extent such definitions are not inconsistent with the terms of this section, as amended by such Act. “(e) Demonstration of Clinical Superiority Standard.— To assist sponsors in demonstrating clinical superiority as described in subsection (c), the Secretary— “(1) upon the designation of any drug under section 526, shall notify the sponsor of such drug in writing of the basis for the designation, including, as applicable, any plausible hypothesis offered by the sponsor and relied upon by the Secretary that the drug is clinically superior to a previously approved drug; and “(2) upon granting exclusive approval or licensure under subsection (a) on the basis of a demonstration of clinical superiority as described in subsection (c), shall publish a summary of the clinical superiority findings.” .

17. 2020

    Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act

    Pub. L. 116–260 div. BB title III § 323 · 134 Stat. 1182

    Added · 21 U.S.C. § 360cc(c)(3)

    Pub. L. 116–260 added par. (3)

    Source evidence

    Code amendment note
    Subsec. (c)(3). Pub. L. 116–260 added par. (3).

    Enacted provision · exact public law section
    SEC. 323. COMMITMENT AUTHORITY AND APPROPRIATIONS. (a) Commitment Authority.— Section 1102(b) of the CARES Act (Public Law 116–136) Ante, p. 660. is amended— (1) in paragraph (1)— (A) in the paragraph heading, by inserting “and second draw” after “PPP”; (B) by striking “August 8, 2020” and inserting “March 31, 2021”; (C) by striking “paragraph (36)” and inserting “paragraphs (36) and (37)”; and (D) by striking “ $659,000,000,000” and inserting “ $806,450,000,000”; and (2) by adding at the end the following: “(3) 2021 7(a) loan program level and funding.— Notwithstanding the amount authorized under the heading ‘Small Business Administration—Business Loans Program Account’under the Financial Services and General Government Appropriations Act, 2021 for commitments for general business loans authorized under paragraphs (1) through (35) of section 7(a) of the Small Business Act (15 U.S.C. 636(a)), commitments for general business loans authorized under paragraphs (1) through (35) of section 7(a) of the Small Business Act (15 U.S.C. 636(a)) shall not exceed $75,000,000,000 for a combination of amortizing term loans and the aggregated maximum line of credit provided by revolving loans during the period beginning on the date of enactment of this Act and ending on September 30, 2021.” . (b) Clarification of Secondary Market Cap.— Section 1107(b) of the CARES Act (15 U.S.C. 9006(b)) Ante, p. 302. is amended by inserting “with respect to loans under any paragraph of section 7(a) of the Small Business Act (15 U.S.C. 636(a))” before “shall not exceed”. (c) Rescission.— With respect to unobligated balances under the heading “Small Business Administration—Business Loans Program Account, CARES Act” as of the day before the date of enactment of this Act, $146,500,000,000 shall be rescinded and deposited into the general fund of the Treasury. (d) Direct Appropriations.— (1) New direct appropriations for ppp loans, second draw loans, and the mbda.— There is appropriated, out of amounts in the Treasury not otherwise appropriated, for the fiscal year ending September 30, 2021, to remain available until expended, for additional amounts— (A) $284,450,000,000 under the heading “Small Business Administration—Business Loans Program Account, CARES Act”, for the cost of guaranteed loans as authorized under paragraph (36) or (37) of section 7(a) of the Small Business Act (15 U.S.C. 636(a)), as amended and added by this Act, including the cost of any modifications to any loans guaranteed under such paragraph (36) that were approved on or before August 8, 2020, of which— (i) not less than $15,000,000,000 shall be for guaranteeing loans under such paragraph (36) or (37) made by community financial institutions, as defined in section 7(a)(36)(A) of the Small Business Act (15 U.S.C. 636(a)(36)(A)); (ii) not less than $15,000,000,000 shall be for guaranteeing loans under such paragraph (36) or (37) made by— (I) insured depository institutions (as defined in section 3 of the Federal Deposit Insurance Act (12 U.S.C. 1813)) with consolidated assets of less than $10,000,000,000; (II) credit unions (as defined in section 7(a)(36)(A) of the Small Business Act (15 U.S.C. 636(a)(36)(A))) with consolidated assets of less than $10,000,000,000; or (III) institutions of the Farm Credit System chartered under the Farm Credit Act of 1971 (12 U.S.C. 2001 et seq.) with consolidated assets of less than $10,000,000,000 (not including the Federal Agricultural Mortgage Corporation); (iii) not less than $15,000,000,000 shall be for guaranteeing loans under paragraph (36) of section 7(a) of the Small Business Act (15 U.S.C. 636(a)), as amended by this Act, that are— (I) made to eligible recipients with not more than 10 employees; or (II) in an amount that is not more than $250,000 and made to an eligible recipient that is located in a neighborhood that is a low-income neighborhood or a moderate-income neighborhood, for the purposes of the Community Reinvestment Act of 1977 (12 U.S.C. 2901 et seq.); (iv) not less than $35,000,000,000 shall be for guaranteeing loans under paragraph (36) of section 7(a) of the Small Business Act (15 U.S.C. 636(a)), as amended by this Act, to eligible recipients that have not previously received a loan under such paragraph (36); and (v) not less than $25,000,000,000 shall be for guaranteeing loans under paragraph (37) of section 7(a) of the Small Business Act (15 U.S.C. 636(a)), as added by this Act, that are— (I) made to eligible entities with not more than 10 employees; or (II) in an amount that is not more than $250,000 and made to an eligible entity that is located in a neighborhood that is a low-income neighborhood or a moderate-income neighborhood, for the purposes of the Community Reinvestment Act of 1977 (12 U.S.C. 2901 et seq.); (B) $25,000,000 under the heading “Department of Commerce—Minority Business Development Agency” for the Minority Business Development Centers Program, including Specialty Centers, for necessary expenses, including any cost sharing requirements that may exist, for assisting minority business enterprises to prevent, prepare for, and respond to coronavirus, including identifying and accessing local, State, and Federal government assistance related to such virus; (C) $50,000,000 under the heading “Small Business Administration—Salaries and Expenses” for the cost of carrying out reviews and audits of loans under subsection (l) of section 7A of the Small Business Act, as redesignated, transferred, and amended by this Act; (D) $20,000,000,000 under the heading “Small Business Administration—Targeted EIDL Advance” to carry out section 331 of this Act, of which $20,000,000 shall be made available to the Inspector General of the Small Business Administration to prevent waste, fraud, and abuse with respect to funding made available under that section; (E) $57,000,000 for the program established under section 7(m) of the Small Business Act (15 U.S.C. 636(m)) of which— (i) $50,000,000 shall be to provide technical assistance grants under such section 7(m) under the heading “Small Business Administration—Entrepreneurial Development Programs”; and (ii) $7,000,000 shall be to provide direct loans under such section 7(m) under the heading “Small Business Administration—Business Loans Program Account”; (F) $1,918,000,000 under the heading “Small Business Administration—Business Loans Program Account” for the cost of guaranteed loans as authorized by paragraphs (1) through (35) of section 7(a) of the Small Business Act (15 U.S.C. 636(a)), including the cost of carrying out sections 326, 327, and 328 of this Act; (G) $3,500,000,000 under the heading “Small Business Administration—Business Loans Program Account, CARES Act” for carrying out section 325 of this Act; and (H) $15,000,000,000 under the heading “Small Business Administration—Shuttered Venue Operators” to carry out section 324 of this Act. (2) Modification of set-asides.— (A) In general.— Notwithstanding paragraph (1)(A), if the Administrator makes the determination described in subparagraph (B) of this paragraph, the Administrator may reduce the amount of any allocation under paragraph (1)(A) to be such amount as the Administrator may determine necessary. (B) Requirements for determination.— The determination described in this subparagraph is a determination by the Administrator that— (i) is not made earlier than 25 days after the date of enactment of this Act; (ii) it is not reasonably expected that a type of entity described in paragraph (1)(A) will make, or receive, as applicable, the minimum amount of loans necessary to meet the applicable allocation under paragraph(1)(A); and (iii) it is reasonably expected that the total amount of loans guaranteed under paragraph (36) or (37) of section 7(a) of the Small Business Act (15 U.S.C. 636(a)), as amended and added by this Act, will equal substantially all of the amount permitted by available funds by March 31, 2021. (3) Appropriations for the office of inspector general.— (A) In general.— Effective on the date of enactment of this Act, the remaining unobligated balances of funds from amounts made available for “Small Business Administration—Office of Inspector General” under section 1107(a)(3) of the CARES Act (15 U.S.C. 9006(a)(3)), are hereby rescinded. (B) Funding.— (i) In general.— There is appropriated, for an additional amount, for the fiscal year ending September 30, 2021, out of amounts in the Treasury not otherwise appropriated, an amount equal to the amount rescinded under subparagraph (A), to remain available until expended, under the heading “Small Business Administration—Office of Inspector General”. (ii) Use of funds.— The amounts made available under clause (i) shall be available for the same purposes, in addition to other funds as may be available for such purposes, and under the same authorities as the amounts made available under section 1107(a)(3) of the CARES Act (15 U.S.C. 9006(a)(3)).

18. 2026

    Pub. L. 119–75 § 6605(a)(1) · 140 Stat. 701

    Substituted · 21 U.S.C. § 360cc(a)

    Pub. L. 119–75, § 6605(a)(1), substituted “same approved use or indication within such rare disease or condition” for “same disease or condition” in concluding provisions

    Unresolved: Pub. L. 119–75 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (a). Pub. L. 119–75, § 6605(a)(1), substituted “same approved use or indication within such rare disease or condition” for “same disease or condition” in concluding provisions.

19. 2026

    Pub. L. 119–75 § 6605(a)(2)(A) · 140 Stat. 701

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

    Pub. L. 119–75, § 6605(a)(2)(A), substituted “same approved use or indication for which such 7-year period applies to such already approved or licensed drug” for “same rare disease or condition” in introductory provisions

    Unresolved: Pub. L. 119–75 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 119–75, § 6605(a)(2)(A), substituted “same approved use or indication for which such 7-year period applies to such already approved or licensed drug” for “same rare disease or condition” in introductory provisions.

20. 2026

    Pub. L. 119–75 § 6605(a)(2)(B) · 140 Stat. 701

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

    Pub. L. 119–75, § 6605(a)(2)(B), inserted “, relating to the approved use or indication,” after “the needs”

    Unresolved: Pub. L. 119–75 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (b)(1). Pub. L. 119–75, § 6605(a)(2)(B), inserted “, relating to the approved use or indication,” after “the needs”.

21. 2026

    Pub. L. 119–75 § 6605(a)(3) · 140 Stat. 701

    Substituted · 21 U.S.C. § 360cc(c)(1)

    Pub. L. 119–75, § 6605(a)(3), substituted “same use or indication for which the already approved or licensed drug was approved or licensed” for “same rare disease or condition as the already approved drug”

    Unresolved: Pub. L. 119–75 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (c)(1). Pub. L. 119–75, § 6605(a)(3), substituted “same use or indication for which the already approved or licensed drug was approved or licensed” for “same rare disease or condition as the already approved drug”.

22. 2026

    Pub. L. 119–75 § 6605(a)(4) · 140 Stat. 701

    Added · 21 U.S.C. § 360cc(f)

    Pub. L. 119–75, § 6605(a)(4), added subsec. (f)

    Unresolved: Pub. L. 119–75 was not found in the local Statutes at Large index.

    Source evidence

    Code amendment note
    Subsec. (f). Pub. L. 119–75, § 6605(a)(4), added subsec. (f).

19 of 39 references resolved to an enrolled provision · 15 partial · 5 unresolved