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42 U.S.C. § 274l — Stem cell therapeutic outcomes database

Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 274l — 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 274k of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section274k&num=0&edition=prelim) 11 So in original. Probably should be followed by a comma. donor registries, and cord blood banks.

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Source location: Title 42, Chapter 6A, § 274l; chapter-6a-public-health-service.md

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 274k — National Program

**(a) Establishment** The Secretary, acting through the Administrator of the Health Resources and Services Administration, shall by one or more contracts establish and maintain a C.W. Bill Young Cell Transplantation Program (referred to in this section as the “Program”), successor to the National Bone Marrow Donor Registry, that has the purpose of increasing the number of transplants for recipients suitably matched to biologically unrelated donors of bone marrow and cord blood, and that meets the requirements of this section. The Secretary may award a separate contract to perform each of the major functions of the Program described in paragraphs (1) and (2) of subsection (d) if deemed necessary by the Secretary to operate an effective and efficient system that is in the best interest of patients. The Secretary shall conduct a separate competition for the initial establishment of the cord blood functions of the Program. The Program shall be under the general supervision of the Secretary. The Secretary shall establish an Advisory Council to advise, assist, consult with, and make recommendations to the Secretary on matters related to the activities carried out by the Program. The members of the Advisory Council shall be appointed in accordance with the following: (1) Each member of the Advisory Council shall serve for a term of 2 years, and each such member may serve as many as 3 consecutive 2-year terms, except that— (A) such limitations shall not apply to the Chair of the Advisory Council (or the Chair-elect) or to the member of the Advisory Council who most recently served as the Chair; and (B) one additional consecutive 2-year term may be served by any member of the Advisory Council who has no employment, governance, or financial affiliation with any donor cente

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Federal law — U.S. Code and appendices · legal_authorities

42 U.S.C. § 274l — Stem cell therapeutic outcomes database

Page 525 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 274m 1 So in original. Probably should be followed by a comma. REPORT OF INSPECTOR GENERAL; PLAN REGARDING RELATIONSHIP BETWEEN REGISTRY AND DONOR CENTERS Pub. L. 105–196, § 2(b)(2), July 16, 1998, 112 Stat. 632, di- rected the Secretary of Health and Human Services to ensure that, not later than 1 year after July 16, 1998, the National Bone Marrow Donor Registry (under this section) developed, evaluated, and implemented a plan to effectuate efficiencies in the relationship between such Registry and donor centers. STUDY BY GAO Pub. L. 105–196, § 5, July 16, 1998, 112 Stat. 636, pro- vided that the Comptroller General was to conduct a study of the National Bone Marrow Donor Registry under this section to determine the extent to which the Registry had increased the representation of racial and ethnic minority groups among potential donors en- rolled with the Registry and whether the extent of in- crease resulted in a level of representation that met the standard established in subsec. (c)(1)(A) of this sec- tion, the extent to which patients in need of a trans- plant of bone marrow from a biologically unrelated donor, and the physicians of such patients, had been utilizing the Registry, the number of patients for whom the Registry began a preliminary but not complete search process and the reasons underlying such cir- cumstances, the extent to which the plan required in section 2(b)(2) of Pub. L. 105–196 (42 U.S.C. 274k note) had been implemented, and the extent to which the Registry, donor centers, donor registries, collection centers, transplant centers, and other appropriate enti- ties had been complying with subsec. (e) of this section; and provided that a report describing the findings of thi

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