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 this study was to be submitted to Congress not later than Oct. 1, 2001, and not before Jan. 1, 2001. COMPLIANCE WITH NEW REQUIREMENTS FOR OFFICE OF PATIENT ADVOCACY Pub. L. 105–196, § 6, July 16, 1998, 112 Stat. 636, pro- vided that with respect to requirements for the office of patient advocacy under subsec. (d) of this section, the Secretary of Health and Human Services was to ensure that, not later than 180 days after Oct. 1, 1998, such of- fice was in compliance with all requirements that were additional to the requirements under this section in ef- fect with respect to patient advocacy on the day before July 16, 1998. § 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 informa- tion in a standardized electronic format with re- spect to patients described in subsection (a), di- agnosis, 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 award- ed a contract under this section to submit to the Secretary an annual report concerning patient outcomes with respect to each transplant cen- ter, 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 individ- ually identifiable information available to the public in the form of summaries and data sets to encourage medical research and to provide infor- mation to transplant programs, physicians, pa- tients, entities awarded a contract under section 274k of this title 1 donor registries, and cord blood banks. (July 1, 1944, ch. 373, title III, § 379A, as added Pub. L. 105–196, § 3, July 16, 1998, 112 Stat. 635; amended Pub. L. 109–129, § 3(b), Dec. 20, 2005, 119 Stat. 2561.) 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), Nov. 16, 1990, 104 Stat. 3282, related to study by General Ac- counting Office, prior to repeal by Pub. L. 105–196, §§ 3, 7, July 16, 1998, 112 Stat. 635, 637, effective Oct. 1, 1998. AMENDMENTS 2005—Pub. L. 109–129, amended section generally, sub- stituting provisions relating to the stem cell thera- peutic outcomes database for provisions relating to the bone marrow scientific registry. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective Oct. 1, 1998, see section 7 of Pub. L. 105–196, set out as an Effective Date of 1998 Amendment note under section 274k of this title. § 274l–1. Definitions In this part: (1) The term ‘‘Advisory Council’’ means the advisory council established by the Secretary under section 274k(a)(1) of this title. (2) The term ‘‘bone marrow’’ means the cells found in adult bone marrow and peripheral blood. (3) The term ‘‘outcomes database’’ means the database established by the Secretary under section 274l of this title. (4) The term ‘‘Program’’ means the C.W. Bill Young Cell Transplantation Program estab- lished under section 274k of this title. (July 1, 1944, ch. 373, title III, § 379A–1, as added Pub. L. 109–129, § 3(c), Dec. 20, 2005, 119 Stat. 2562.) § 274m. Authorization of appropriations For the purpose of carrying out this part, there are authorized to be appropriated $31,009,000 for each of fiscal years 2022 through 2026. (July 1, 1944, ch. 373, title III, § 379B, as added Pub. L. 105–196, § 4(2), July 16, 1998, 112 Stat. 636; amended Pub. L. 109–129, § 3(d), Dec. 20, 2005, 119 Stat. 2562; Pub. L. 111–264, § 2(d), Oct. 8, 2010, 124 Stat. 2792; Pub. L. 114–104, § 2(b), Dec. 18, 2015, 129 Stat. 2216; Pub. L. 117–15, § 2(d), May 26, 2021, 135 Stat. 278.)