Section 2 of the Stem Cell Therapeutic and Research Act of 2005, referred to in subsec. (d)(2)(A)(iv), (B), is section 2 of Pub. L. 109–129,
2021—Subsec. (a)(7). Pub. L. 117–15, § 2(a), added par. (7).
Subsec. (d)(2)(B). Pub. L. 117–15, § 2(b)(2), struck out at end “If the Secretary cannot identify a project as described in the preceding sentence, the Secretary shall submit a plan, not later than 180 days after the date on which the Secretary was required to identify such a project, to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives for expanding collection of high quality cord blood units, consistent with the requirements under the National Cord Blood Inventory program under section 2 of the Stem Cell Therapeutic and Research Act of 2005 and the inventory goal. Each such plan shall be made available to the public.”
Pub. L. 117–15, § 2(b)(1), made technical amendment to directory language of Pub. L. 114–104, § 2(a)(2). See 2015 Amendment note below.
Subsec. (o). Pub. L. 117–15, § 2(c), added subsec. (o).
2015—Subsec. (d)(2)(B). Pub. L. 114–104, § 2(a)(2), as amended by Pub. L. 117–15, § 2(b)(1), inserted “including remote collection,” after “goal of increasing collections of high quality cord blood units,”.
Pub. L. 114–104, § 2(a)(1), substituted “expanding collection” for “expanding remote collection”.
2010—Subsec. (a)(6). Pub. L. 111–264, § 2(b)(1), added par. (6) and struck out former par. (6) which read as follows: “The Secretary, acting through the Advisory Council, shall submit to the Congress—
“(A) an annual report on the activities carried out under this section; and
“(B) not later than 6 months after
Subsec. (d)(2). Pub. L. 111–264, § 2(b)(2)(A), designated existing provisions as subpar. (A), inserted heading, redesignated former subpars. (A) to (H) as cls. (i) to (viii), respectively, of subpar. (A), added cl. (iv) and struck out former cl. (iv) which related to studies and demonstration and outreach projects for the purpose of increasing cord blood donation, and added subpars. (B) and (C).
Subsec. (d)(3)(A). Pub. L. 111–264, § 2(b)(2)(B), substituted “(2)(A)(i)” for “(2)(A)”.
Subsec. (f)(5)(A). Pub. L. 111–264, § 2(b)(3), added subpar. (A) and struck out former subpar. (A) which read as follows: “require the establishment of a system of strict confidentiality of records relating to the identity, address, HLA type, and managing marrow donor center for marrow donors and potential marrow donors; and”.
2005—Pub. L. 109–129 amended section generally, substituting provisions relating to the C.W. Bill Young Cell Transplantation Program for provisions relating to the National Bone Marrow Donor Registry.
1998—Subsec. (a). Pub. L. 105–196, § 2(a), substituted “(referred to in this part as the ‘Registry’) that has the purpose of increasing the number of transplants for recipients suitably matched to biologically unrelated donors of bone marrow, and that meets” for “(referred to in this part as the ‘Registry’) that meets” and substituted “under the direction of a board of directors meeting the following requirements:” and pars. (1) to (4) for “under the direction of a board of directors that shall include representatives of marrow donor centers, marrow transplant centers, persons with expertise in the social science, and the general public.”
Subsec. (b)(2) to (8). Pub. L. 105–196, § 2(b)(1), added pars. (2) to (7), redesignated former par. (7) as (8), and struck out former pars. (2) to (6) which read as follows:
“(2) establish a system for patient advocacy, separate from mechanisms for donor advocacy, that directly assists patients, their families, and their physicians in the search for an unrelated marrow donor;
“(3) increase the representation of individuals from racial and ethnic minority groups in the pool of potential donors for the Registry in order to enable an individual in a minority group, to the extent practicable, to have a comparable chance of finding a suitable unrelated donor as would an individual not in a minority group;
“(4) provide information to physicians, other health care professionals, and the public regarding bone marrow transplantation;
“(5) recruit potential bone marrow donors;
“(6) collect, analyze, and publish data concerning bone marrow donation and transplantation; and”.
Subsecs. (c), (d). Pub. L. 105–196, § 2(c), (d), added subsecs. (c) and (d). Former subsecs. (c) and (d) redesignated (e) and (f), respectively.
Subsec. (e). Pub. L. 105–196, § 2(c), redesignated subsec. (c) as (e). Former subsec. (e) redesignated (g).
Subsec. (e)(4). Pub. L. 105–196, § 2(e), added par. (4) and struck out former par. (4) which read as follows: “standards that require the provision of information to patients, their families, and their physicians at the start of the search process concerning—
“(A) the resources available through the Registry;
“(B) all other marrow donor registries meeting the standards described in this paragraph; and
“(C) in the case of the Registry—
“(i) the comparative costs of all charges by marrow transplant centers incurred by patients prior to transplantation; and
“(ii) the success rates of individual marrow transplant centers;”.
Subsec. (f). Pub. L. 105–196, § 2(c), (g)(1), redesignated subsec. (d) as (f) and substituted “subsection (e)” for “subsection (c)”. Former subsec. (f) redesignated (h).
Subsecs. (g) to (i). Pub. L. 105–196, § 2(c), redesignated subsecs. (e) to (g) as (g) to (i), respectively. Former subsecs. (h) and (i) redesignated (j) and (k), respectively.
Subsec. (j). Pub. L. 105–196, § 2(c), redesignated subsec. (h) as (j) and struck out heading and text of former subsec. (j). Text read as follows: “There are authorized to be appropriated to carry out this section $15,000,000 for fiscal year 1991 and such sums as may be necessary for each of fiscal years 1992 and 1993.”
Subsec. (k). Pub. L. 105–196, § 2(c), (g)(2), redesignated subsec. (i) as (k) and substituted “subsection (e)(5)(A)” for “subsection (c)(5)(A)” and “subsection (e)(5)(B)” for “subsection (c)(5)(B)”.
Subsec. (l). Pub. L. 105–196, § 2(f), added subsec. (l).
Pub. L. 117–15, § 2(b)(1),
Pub. L. 105–196, § 7,
Pub. L. 101–616, title I, § 102, “(a) This title [enacting this section and section 274l of this title and amending section 274a of this title], and the amendments made by this title, shall not affect any legal document, including any order, regulation, grant, or contract, in effect on the date of enactment of this Act [“(b) A legal document described in subsection (a) or an order issued in a lawsuit described in subsection (a) shall continue in effect until modified, terminated, or revoked.“(c) In any administrative proceeding or lawsuit described in subsection (a), parties shall take appeals, and officials shall hold proceedings and render judgments, in the same manner and with the same effect as if this title had not been enacted.”
Pub. L. 109–129, § 2, “(a) The Secretary of Health and Human Services shall enter into contracts with qualified cord blood banks to assist in the collection and maintenance of the inventory goal of at least 150,000 new units of high-quality cord blood to be made available for transplantation through the C.W. Bill Young Cell Transplantation Program and to carry out the requirements of subsection (b).“(b) The Secretary shall require each recipient of a contract under this section—“(1) to acquire, tissue-type, test, cryopreserve, and store donated units of cord blood acquired with the informed consent of the donor, as determined by the Secretary pursuant to section 379(c) of the Public Health Service Act [42 U.S.C. 274k(c)], in a manner that complies with applicable Federal and State regulations;“(2) to encourage donation from a genetically diverse population;“(3) to make cord blood units that are collected pursuant to this section or otherwise and meet all applicable Federal standards available to transplant centers for transplantation;“(4) to make cord blood units that are collected, but not appropriate for clinical use, available for peer-reviewed research;“(5) to make data available, as required by the Secretary and consistent with section 379(d)(3) of the Public Health Service Act (42 U.S.C. 274k(d)(3)), as amended by this Act, in a standardized electronic format, as determined by the Secretary, for the C.W. Bill Young Cell Transplantation Program; and“(6) to submit data in a standardized electronic format for inclusion in the stem cell therapeutic outcomes database maintained under section 379A of the Public Health Service Act [42 U.S.C. 274l], as amended by this Act.“(c) To seek to enter into a contract under this section, a qualified cord blood bank shall submit an application to the Secretary at such time, in such manner, and containing such information as the Secretary may reasonably require. At a minimum, an application for a contract under this section shall include a requirement that the applicant—“(1) will participate in the C.W. Bill Young Cell Transplantation Program for a period of at least 10 years beginning on the last date on which the recipient of a contract under this section receives Federal funds under this section;“(2) will make cord blood units collected pursuant to this section available through the C.W. Bill Young Cell Transplantation Program in perpetuity or for such time as determined viable by the Secretary;“(3) will provide a plan to increase cord blood unit collections at collection sites that exist at the time of application, assist with the establishment of new collection sites, or contract with new collection sites;“(4) will annually provide to the Secretary a plan for, and demonstrate, ongoing measurable progress toward achieving self-sufficiency of cord blood unit collection and banking operations; and“(5) if the Secretary determines through an assessment, or through petition by the applicant, that a cord blood bank is no longer operational or does not meet the requirements of section 379(d)(4) of the Public Health Service Act [42 U.S.C. 274k(d)(4)] (as added by this Act) and as a result may not distribute the units, transfer the units collected pursuant to this section to another qualified cord blood bank approved by the Secretary to ensure continued availability of cord blood units.“(d) “(1) Except as provided in paragraph (2), the term of each contract entered into by the Secretary under this section shall be for a period of at least 10 years beginning on the last date on which the recipient of a contract under this section receives Federal funds under this section. The Secretary shall ensure that no Federal funds shall be obligated under any such contract after the date that is 5 years after the date on which the contract is entered into, except as provided in paragraphs (2), (3), and (4).“(2) The Secretary may extend the period of funding under a contract under this section to exceed a period of 5 years if—“(A) the Secretary finds that the inventory goal described in subsection (a) has not yet been met;“(B) the Secretary does not receive an application for a contract under this section meeting the requirements under subsection (c) from any qualified cord blood bank that has not previously entered into a contract under this section; or“(C) the Secretary determines that the outstanding inventory need cannot be met by the qualified cord blood banks under contract under this section.“(3) A qualified cord blood bank shall be eligible for a 5-year extension of a contract awarded under this section, as described in paragraph (2), provided that the qualified cord blood bank—“(A) demonstrates a superior ability to satisfy the requirements described in subsection (b) and achieves the overall goals for which the contract was awarded;“(B) provides a plan for how the qualified cord blood bank will increase cord blood unit collections at collection sites that exist at the time of consideration for such extension of a contract, assist with the establishment of new collection sites, or contract with new collection sites; and“(C) annually provides to the Secretary a plan for, and demonstrates, ongoing measurable progress toward achieving self-sufficiency of cord blood unit collection and banking operations.“(4) The Secretary shall take into consideration the best scientific information available in order to maximize the number of cord blood units available for transplant when entering into contracts under this section, or when extending a period of funding under such a contract under paragraph (2).“(5) In extending contracts pursuant to paragraph (3), and determining new allocation amounts for the next contract period or contract extension for such cord blood bank, the Secretary shall take into account the number of cord blood units banked in the National Cord Blood Inventory by a cord blood bank during the previous contract period, in addition to consideration of the ability of such cord blood bank to increase the collection and maintenance of additional, genetically diverse cord blood units.“(e) The Secretary may promulgate regulations to carry out this section.“(f) In this section:“(1) The term ‘C.W. Bill Young Cell Transplantation Program’ means the C.W. Bill Young Cell Transplantation Program under section 379 of the Public Health Service Act [42 U.S.C. 274k], as amended by this Act.“(2) The term ‘cord blood donor’ means a mother who has delivered a baby and consents to donate the neonatal blood remaining in the placenta and umbilical cord after separation from the newborn baby.“(3) The term ‘cord blood unit’ means the neonatal blood collected from the placenta and umbilical cord of a single newborn baby.“(4) The term ‘qualified cord blood bank’ has the meaning given to that term in section 379(d)(4) of the Public Health Service Act [42 U.S.C. 274k(d)(4)], as amended by this Act.“(5) The term ‘Secretary’ means the Secretary of Health and Human Services.“(g) To carry out this section, there is authorized to be appropriated $23,000,000 for each of fiscal years 2022 through 2026.”
Pub. L. 105–196, § 2(b)(2),
Pub. L. 105–196, § 5,
Pub. L. 105–196, § 6,