Title 42 — The Public Health and Welfare
Part I · Chapter 6A — Public Health Service
§ 274l. Stem cell therapeutic outcomes database
Statutory text
Establishment
The Secretary shall by contract establish and maintain a scientific database of information relating to patients who have been recipients of a stem cell therapeutics product (including bone marrow, cord blood, or other such product) from a donor.
Information
The outcomes database shall include information in a standardized electronic format with respect to patients described in subsection (a), diagnosis, transplant procedures, results, long-term follow-up, and such other information as the Secretary determines to be appropriate, to conduct an ongoing evaluation of the scientific and clinical status of transplantation involving recipients of a stem cell therapeutics product from a donor.
Annual report on patient outcomes
The Secretary shall require the entity awarded a contract under this section to submit to the Secretary an annual report concerning patient outcomes with respect to each transplant center, based on data collected and maintained by the entity pursuant to this section.
Publicly available data
The outcomes database shall make relevant scientific information not containing individually identifiable information available to the public in the form of summaries and data sets to encourage medical research and to provide information to transplant programs, physicians, patients, entities awarded a contract under section 274k of this title 1 donor registries, and cord blood banks.
Footnotes
- 1 So in original. Probably should be followed by a comma.
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.
National Bone Marrow Registry Reauthorization Act of 1998
Pub. L. 105–196 § 3 · 112 Stat. 631
Enacted · 42 U.S.C. § 274l
July 1, 1944, ch. 373, title III, § 379A, as added Pub. L. 105–196, § 3, July 16, 1998, 112 Stat. 635
Source evidence
Code source credit
July 1, 1944, ch. 373, title III, § 379A, as added Pub. L. 105–196, § 3, July 16, 1998, 112 Stat. 635Enacted provision · exact public law section
SEC. 3. RECIPIENT REGISTRY. Part I of title III of the Public Health Service Act (42 U.S.C. 274k et seq.) is amended by striking section 379A and inserting the following: “SEC. 379A. BONE MARROW SCIENTIFIC REGISTRY. “(a) Establishment of Recipient Registry.— The Secretary, acting through the Registry under section 379 (in this section referred to as the ‘Registry’), shall establish and maintain a scientific registry of information relating to patients who have been recipients of a transplant of bone marrow from a biologically unrelated donor “(b) Information.— The scientific registry under subsection (a) shall include information with respect to patients described in subsection (a), transplant procedures, and such other information as the Secretary determines to be appropriate to conduct an ongoing evaluation of the scientific and clinical status of transplantation involving recipients of bone marrow from biologically unrelated donors. “(c) Annual Report on Patient Outcomes.— The Registry shall annually submit to the Secretary a report concerning patient outcomes with respect to each transplant center. Each such report shall use data collected and maintained by the scientific registry under subsection (a). Each such report shall in addition include the data required in section 379(1) (relating to pretransplant costs).”.Stem Cell Therapeutic and Research Act of 2005
Pub. L. 109–129 § 3(b) · 119 Stat. 2550
Amended · 42 U.S.C. § 274l
Pub. L. 109–129, amended section generally
Substituted · 42 U.S.C. § 274l
Pub. L. 109–129, substituting provisions relating to the stem cell therapeutic outcomes database for provisions relating to the bone marrow scientific registry
Source evidence
Code amendment note
Pub. L. 109–129, amended section generally, substituting provisions relating to the stem cell therapeutic outcomes database for provisions relating to the bone marrow scientific registry.Enacted provision · exact public law section
(b) Stem Cell Therapeutic Outcomes Database.— Section 379A of the Public Health Service Act (42 U.S.C. 274l) is amended to read as follows: “SEC. 379A. STEM CELL THERAPEUTIC OUTCOMES DATABASE. “(a) Establishment.— The Secretary shall by contract establish and maintain a scientific database of information relating to patients who have been recipients of a stem cell therapeutics product (including bone marrow, cord blood, or other such product) from a donor. “(b) Information.— The outcomes database shall include information in a standardized electronic format with respect to patients described in subsection (a), diagnosis, transplant procedures, results, long-term follow-up, and such other information as the Secretary determines to be appropriate, to conduct an ongoing evaluation of the scientific and clinical status of transplantation involving recipients of a stem cell therapeutics product from a donor. “(c) Annual Report on Patient Outcomes.— The Secretary shall require the entity awarded a contract under this section to submit to the Secretary an annual report concerning patient outcomes with respect to each transplant center, based on data collected and maintained by the entity pursuant to this section. “(d) Publicly Available Data.— The outcomes database shall make relevant scientific information not containing individually identifiable information available to the public in the form of summaries and data sets to encourage medical research and to provide information to transplant programs, physicians, patients, entities awarded a contract under section 379 donor registries, and cord blood banks.” .
3 of 3 references resolved to an enrolled provision
Editorial Notes
Prior Provisions
A prior section 274l, act July 1, 1944, ch. 373, title III, § 379A, as added Pub. L. 101–616, title I, § 101(a)(2), , 104 Stat. 3282, related to study by General Accounting Office, prior to repeal by Pub. L. 105–196, §§ 3, 7, , 112 Stat. 635, 637, effective .
Amendments
2005—Pub. L. 109–129, amended section generally, substituting provisions relating to the stem cell therapeutic outcomes database for provisions relating to the bone marrow scientific registry.
Statutory Notes and Related Subsidiaries
Effective Date
Section effective , see section 7 of Pub. L. 105–196, set out as an Effective Date of 1998 Amendment note under section 274k of this title.
Credits
1944–2005 · 2 acts
- 1944July 1, 1944, ch. 373, title III, § 379A, as added Pub. L. 105–196, § 3, , 112 Stat. 635
- 2005amended Pub. L. 109–129, § 3(b), , 119 Stat. 2561.
Show as published
(July 1, 1944, ch. 373, title III, § 379A, as added Pub. L. 105–196, § 3, , 112 Stat. 635; amended Pub. L. 109–129, § 3(b), , 119 Stat. 2561.)