42 U.S.C. § 274k
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:
The Secretary shall, through a public process, recognize one or more accreditation entities for the accreditation of cord blood banks.
The Secretary shall, through a public process, examine issues of informed consent, including-
Based on such examination, the Secretary shall require that the standards used by the accreditation entities recognized under subsection (b) ensure that a cord blood unit is acquired with the informed consent of the maternal donor.
With respect to bone marrow, the Program shall-
With respect to cord blood, the Program shall-
In carrying out subparagraph (A)(iv), not later than 1 year after October 8, 2010, and annually thereafter, the Secretary shall set an annual goal of increasing collections of high quality cord blood units, including remote collection, consistent with the inventory goal described in section 2(a) of the Stem Cell Therapeutic and Research Act of 2005 (referred to in this subparagraph as the "inventory goal"), and shall identify at least one project under subparagraph (A)(iv) to replicate and expand nationwide, as appropriate.
In this paragraph, the term "remote collection" means the collection of cord blood units at locations that do not have written contracts with cord blood banks for collection support.
The Secretary shall ensure that health care professionals and patients are able to search electronically for and facilitate access to, in the manner and to the extent defined by the Secretary and consistent with the functions described in paragraphs (1)(A) and (2)(A)(i), cells from bone marrow donors and cord blood units through a single point of access.
The Secretary shall require all recipients of contracts under this section to make available a standard dataset for purposes of subparagraph (A) in a standardized electronic format that enables transplant physicians to compare among and between bone marrow donors and cord blood units to ensure the best possible match for the patient.
The term "qualified cord blood bank" means a cord blood bank that-
The Program shall carry out activities for the recruitment of bone marrow donors. Such recruitment program shall identify populations that are underrepresented among potential donors enrolled with the Program. In the case of populations that are identified under the preceding sentence:
The Program shall carry out informational and educational activities, in coordination with organ donation public awareness campaigns operated through the Department of Health and Human Services, for purposes of recruiting individuals to serve as donors of bone marrow, and shall test and enroll with the Program potential bone marrow donors. Such information and educational activities shall include the following:
In carrying out informational and educational activities under subparagraph (A), the Program shall give priority to recruiting individuals to serve as donors of bone marrow for populations that are identified under paragraph (1).
In addition to activities regarding recruitment, the recruitment program under paragraph (1) shall provide information to physicians, other health care professionals, and the public regarding bone marrow transplants from unrelated donors as a treatment option.
The requirements of this subsection shall be carried out by the entity that has been awarded a contract by the Secretary under subsection (a) to carry out the functions described in subsection (d)(1).
The Secretary shall enforce, for participating entities, including the Program, individual marrow donor centers, marrow donor registries, marrow collection centers, and marrow transplant centers-
The Program shall support activities, in cooperation with qualified cord blood banks, for the recruitment of cord blood donors. Such recruitment program shall identify populations that are underrepresented among cord blood donors. In the case of populations that are identified under the preceding sentence:
In carrying out the recruitment program under paragraph (1), the Program shall support informational and educational activities in coordination with qualified cord blood banks and organ donation public awareness campaigns operated through the Department of Health and Human Services, for purposes of recruiting pregnant women to serve as donors of cord blood. Such information and educational activities shall include the following:
In carrying out informational and educational activities under subparagraph (A), the Program shall give priority to supporting the recruitment of pregnant women to serve as donors of cord blood for populations that are identified under paragraph (1).
In addition to activities regarding recruitment, the recruitment program under paragraph (1) shall provide information to physicians, other health care professionals, and the public regarding cord blood transplants from donors as a treatment option.
The requirements of this subsection shall be carried out by the entity that has been awarded a contract by the Secretary under subsection (a) to carry out the functions described in subsection (d)(2).
The Secretary shall establish and maintain, through a contract or other means determined appropriate by the Secretary, an office of patient advocacy (in this subsection referred to as the "Office").
The Office shall meet the following requirements:
In serving as an advocate for a patient under paragraph (2), the Office shall provide individualized case management services directly to the patient (or family members, physicians, or other individuals acting on behalf of the patient), including-
In addition to the case management services described in paragraph (1) for patients, the Office shall, on behalf of patients who have completed the search for a bone marrow donor or cord blood unit, provide information and education on the process of receiving a transplant, including the post-transplant process.
The Secretary shall establish and provide information to the public on procedures under which the Secretary shall receive and consider comments from interested persons relating to the manner in which the Program is carrying out the duties of the Program. The Secretary may promulgate regulations under this section.
In developing policies affecting the Program, the Secretary shall consult with the Advisory Council, the Department of Defense Marrow Donor Recruitment and Research Program operated by the Department of the Navy, and the board of directors of each entity awarded a contract under this section.
To be eligible to enter into a contract under this section, an entity shall submit to the Secretary and obtain approval of an application at such time, in such manner, and containing such information as the Secretary shall by regulation prescribe.
In awarding contracts under this section, the Secretary shall give consideration to the continued safety of donors and patients and other factors deemed appropriate by the Secretary.
Entities eligible to receive a contract under this section shall include private nonprofit entities.
Each recipient of a contract or subcontract under subsection (a) shall keep such records as the Secretary shall prescribe, including records that fully disclose the amount and disposition by the recipient of the proceeds of the contract, the total cost of the undertaking in connection with which the contract was made, and the amount of the portion of the cost of the undertaking supplied by other sources, and such other records as will facilitate an effective audit.
The Secretary and the Comptroller General of the United States shall have access to any books, documents, papers, and records of the recipient of a contract or subcontract entered into under this section that are pertinent to the contract, for the purpose of conducting audits and examinations.
Any person who discloses the content of any record referred to in subsection (d)(4)(D) or (f)(5)(A) without the prior written consent of the donor or potential donor with respect to whom the record is maintained, or in violation of the standards described in subsection (f)(5)(B), shall be imprisoned for not more than 2 years or fined in accordance with title 18, or both.
Not less frequently than every 2 years, the Secretary, in consultation with the Director of the National Institutes of Health, the Commissioner of Food and Drugs, the Administrator of the Health Resources and Services Administration, the Advisory Council, and other stakeholders, where appropriate given relevant expertise, shall conduct a review of the state of the science of using adult stem cells and birthing tissues to develop new types of therapies for patients, for the purpose of considering the potential inclusion of such new types of therapies in the Program.
Not later than June 30, 2025, the Secretary shall-
42 U.S.C. § 274k
EDITORIAL NOTES
REFERENCES IN TEXTSection 2 of the Stem Cell Therapeutic and Research Act of 2005, referred to in subsec. (d)(2)(A)(iv), (B), is section 2, Dec. 20, 2005 of Pub. L. 109-129, 119 Stat. 2550, which is set out as a note under this section.
AMENDMENTS2021-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 December 20, 2005, a report of recommendations on the scientific factors necessary to define a cord blood unit as a high-quality unit." 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).
STATUTORY NOTES AND RELATED SUBSIDIARIES
EFFECTIVE DATE OF 2021 AMENDMENT Pub. L. 117-15, §2(b)(1), May 26, 2021, 135 Stat. 277, provided that the amendment made by section 2(b)(1) is effective as if included in the enactment of the Stem Cell Therapeutic and Research Reauthorization Act of 2015 (Pub. L. 114-104).
EFFECTIVE DATE OF 1998 AMENDMENT Pub. L. 105-196, §7, July 16, 1998, 112 Stat. 637, provided that: "This Act [see Short Title of 1998 Amendment note set out under section 201 of this title] takes effect October 1, 1998, or upon the date of the enactment of this Act [July 16, 1998], whichever occurs later."
SAVINGS PROVISION Pub. L. 101-616, title I, §102, Nov. 16, 1990, 104 Stat. 3282, provided that: "(a) IN GENERAL.-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 [Nov. 16, 1990], or any administrative proceeding or lawsuit pending on the date, that relates to the bone marrow registry established under section 373(b) of the Public Health Service Act [42 U.S.C. 274a(b)] (as it existed before the amendment made by section 101(b) of this Act)."(b) CONTINUED EFFECT.-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) PROCEEDINGS.-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."
CORD BLOOD INVENTORY Pub. L. 109-129, §2, Dec. 20, 2005, 119 Stat. 2550, as amended by Pub. L. 111-264, §2(a), Oct. 8, 2010, 124 Stat. 2789; Pub. L. 114-104, §3, Dec. 18, 2015, 129 Stat. 2217; Pub. L. 117-15, §3, May 26, 2021, 135 Stat. 278, provided that:"(a) IN GENERAL.-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) REQUIREMENTS.-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) APPLICATION.-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) DURATION OF CONTRACTS.-"(1) IN GENERAL.-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) EXTENSIONS.-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) EXTENSION ELIGIBILITY.-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) CONSIDERATION OF BEST SCIENCE.-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) CONSIDERATION OF BANKED UNITS OF CORD BLOOD.-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) REGULATIONS.-The Secretary may promulgate regulations to carry out this section."(f) DEFINITIONS.-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) AUTHORIZATION OF APPROPRIATIONS.-To carry out this section, there is authorized to be appropriated $23,000,000 for each of fiscal years 2022 through 2026."
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, directed 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, provided 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 enrolled with the Registry and whether the extent of increase resulted in a level of representation that met the standard established in subsec. (c)(1)(A) of this section, the extent to which patients in need of a transplant 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 circumstances, 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 entities 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, provided 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 office was in compliance with all requirements that were additional to the requirements under this section in effect with respect to patient advocacy on the day before July 16, 1998.
- Administrator
- The term "Administrator" means the Administrator of General Services.
- Service
- The term "Service" means the Public Health Service;
- practices
- The term "practices" means design, financing, permitting, construction, commissioning, operation and maintenance, and other practices that contribute to achieving zero-net-energy buildings or facilities.
- project
- The terms "federally assisted housing" and "project" mean-(A) a public housing project (as such term is defined in section 3(b) of the United States Housing Act of 1937 [42 U.S.C. 1437a(b)] );(B) housing for which project-based assistance is provided under section 8 of the United States Housing Act of 1937 [42 U.S.C. 1437f] ;(C) housing that is assisted under section 1701q of title 12;(D) housing that is assisted under section 1701q of title 12, as such section existed before November 28, 1990;(E) housing financed by a loan or mortgage insured under section 1715l(d)(3) of title 12 that bears interest at a rate determined under the proviso of section 1715l(d)(5) of title 12;(F) housing insured, assisted, or held by the Secretary or a State or State agency under section 1715z-1 of title 12;(G) housing constructed or substantially rehabilitated pursuant to assistance provided under section 8(b)(2) of the United States Housing Act of 1937 [42 U.S.C. 1437f(b)(2)], as in effect before October 1, 1983, that is assisted under a contract for assistance under such section; and(H) housing that is assisted under section 8013 1 of this title.
- Director
- the term "Director" means the Chief Executive Officer of the Corporation for National and Community Service,
- Secretary
- the term "Secretary" means- (A) the Secretary of Education for purposes of subtitle A (other than section 3201),(B) the Secretary of Agriculture for purposes of the amendments made by section 3201, and(C) the Secretary of Health and Human Services for purposes of subtitle B,
- drug
- the term "drug" means- (A) a beverage containing alcohol,(B) a controlled substance, or(C) a controlled substance analogue,