42 U.S.C. § 274k — National Program

Page 517 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 274k 1 So in original. Probably should be ‘‘Procurement and’’. Health and Human Services, the Organ Pro- curement and Transplantation Network, in- terested members of the family of Stephanie Tubbs Jones, Dr. William H. Frist, and the Commission of Fine Arts; and (B) reviewed by the Citizens Coin Advisory Committee. (c) National medals The medals struck pursuant to this section are national medals for purposes of chapter 51 of title 31. (d) Striking and delivery of minimum-sized lots The Secretary of the Treasury shall strike and deliver to the Secretary of Health and Human Services no fewer than 100 medals at any time pursuant to an order by such Secretary. (e) Cost of medals Medals struck under this section and sold to the Secretary of Health and Human Services for distribution in accordance with this part shall be sold to the Secretary of Health and Human Services at a price sufficient to cover the cost of designing and striking the medals, including labor, materials, dies, use of machinery, and overhead expenses. (f) No expenditures in advance of receipt of fund (1) In general The Secretary of the Treasury shall not strike or distribute any medals under this part until such time as the Secretary of Health and Human Services certifies that sufficient funds have been received by such Secretary to cover the cost of the medals ordered. (2) Design in advance of order Notwithstanding paragraph (1), the Sec- retary of the Treasury may begin designing the medal at any time after October 14, 2008, and take such other action as may be nec- essary to be prepared to strike such medals upon receiving the certification described in such paragraph, including preparing dies and striking test pieces. (Pub. L. 110–413, § 4, Oct. 14, 2008, 122 Stat. 4339.) § 274i–3. Medals not treated as valuable consider- ation A medal under this part shall not be treated as valuable consideration for purposes of section 274e(a) of this title. (Pub. L. 110–413, § 5, Oct. 14, 2008, 122 Stat. 4340.) § 274i–4. Definitions For purposes of this part: (1) Organ The term ‘‘organ’’ has the meaning given such term in section 121.2 of title 42, Code of Federal Regulations. (2) Organ procurement organization The term ‘‘organ procurement organization’’ means a qualified organ procurement organi- zation described in section 273(b)(1) of this title. (3) Organ Procurement and Transplantation Network The term ‘‘Organ Procurementand 1 Trans- plantation Network’’ means the Organ Pro- curement and Transplantation Network estab- lished under section 274 of this title. (Pub. L. 110–413, § 6, Oct. 14, 2008, 122 Stat. 4340.) PART I—C.W. BILL YOUNG CELL TRANSPLANTATION PROGRAM Editorial Notes CODIFICATION Pub. L. 109–129, § 3(e), Dec. 20, 2005, 119 Stat. 2562, sub- stituted ‘‘C.W. Bill Young Cell Transplantation Pro- gram’’ for ‘‘National Bone Marrow Donor Registry’’ in part heading. Pub. L. 101–616, title I, § 101(a)(2), Nov. 16, 1990, 104 Stat. 3279, added part I ‘‘National Bone Marrow Donor Registry’’ and redesignated former part I ‘‘Biomedical Ethics’’ as J. Pub. L. 99–158, §§ 3(b), 11, Nov. 20, 1985, 99 Stat. 879, 883, added part I ‘‘Biomedical Ethics’’, and repealed former part I ‘‘National Library of Medicine’’. Pub. L. 91–212, § 10(a)(2), Mar. 13, 1970, 84 Stat. 66, re- designated part H ‘‘National Library of Medicine’’, as I. Former part I ‘‘Assistance to Medical Libraries’’ redes- ignated J. § 274k. National Program (a) Establishment The Secretary, acting through the Adminis- trator of the Health Resources and Services Ad- ministration, shall by one or more contracts es- tablish and maintain a C.W. Bill Young Cell Transplantation Program (referred to in this section as the ‘‘Program’’), successor to the Na- tional Bone Marrow Donor Registry, that has the purpose of increasing the number of trans- plants for recipients suitably matched to bio- logically unrelated donors of bone marrow and cord blood, and that meets the requirements of this section. The Secretary may award a sepa- rate contract to perform each of the major func- tions of the Program described in paragraphs (1) and (2) of subsection (d) if deemed necessary by the Secretary to operate an effective and effi- cient system that is in the best interest of pa- tients. The Secretary shall conduct a separate competition for the initial establishment of the cord blood functions of the Program. The Pro- gram 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 Page 518 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 274k (B) one additional consecutive 2-year term may be served by any member of the Advi- sory Council who has no employment, gov- ernance, or financial affiliation with any donor center, recruitment organization, transplant center, or cord blood bank. (2) A member of the Advisory Council may continue to serve after the expiration of the term of such member until a successor is ap- pointed. (3) In order to ensure the continuity of the Advisory Council, the Advisory Council shall be appointed so that each year the terms of approximately one-third of the members of the Advisory Council expire. (4) The membership of the Advisory Coun- cil— (A) shall include as voting members a bal- anced number of representatives including representatives of marrow donor centers and marrow transplant centers, representatives of cord blood banks and participating birth- ing hospitals, recipients of a bone marrow transplant, recipients of a cord blood trans- plant, persons who require such transplants, family members of such a recipient or fam- ily members of a patient who has requested the assistance of the Program in searching for an unrelated donor of bone marrow or cord blood, persons with expertise in bone marrow and cord blood transplantation, per- sons with expertise in typing, matching, and transplant outcome data analysis, persons with expertise in the social sciences, basic scientists with expertise in the biology of adult stem cells, and members of the general public; and (B) shall include as nonvoting members representatives from the Department of De- fense Marrow Donor Recruitment and Re- search Program operated by the Department of the Navy, the Division of Transplantation of the Health Resources and Services Admin- istration, the Food and Drug Administra- tion, and the National Institutes of Health. (5) Members of the Advisory Council shall be chosen so as to ensure objectivity and balance and reduce the potential for conflicts of inter- est. The Secretary shall establish bylaws and procedures— (A) to prohibit any member of the Advi- sory Council who has an employment, gov- ernance, or financial affiliation with a donor center, recruitment organization, transplant center, or cord blood bank from partici- pating in any decision that materially af- fects the center, recruitment organization, transplant center, or cord blood bank; and (B) to limit the number of members of the Advisory Council with any such affiliation. (6) The Secretary, acting through the Ad- ministrator of the Health Resources and Serv- ices Administration, shall submit to Congress an annual report on the activities carried out under this section. (7) The Secretary shall convene the Advisory Council at least two times each calendar year. (b) Accreditation The Secretary shall, through a public process, recognize one or more accreditation entities for the accreditation of cord blood banks. (c) Informed consent The Secretary shall, through a public process, examine issues of informed consent, including— (1) the appropriate timing of such consent; and (2) the information provided to the maternal donor regarding all of her medically appro- priate cord blood options. Based on such examination, the Secretary shall require that the standards used by the accredi- tation entities recognized under subsection (b) ensure that a cord blood unit is acquired with the informed consent of the maternal donor. (d) Functions (1) Bone marrow functions With respect to bone marrow, the Program shall— (A) operate a system for identifying, matching, and facilitating the distribution of bone marrow that is suitably matched to candidate patients; (B) consistent with paragraph (3), permit transplant physicians, other appropriate health care professionals, and patients to search by means of electronic access all available bone marrow donors listed in the Program; (C) carry out a program for the recruit- ment of bone marrow donors in accordance with subsection (e), including with respect to increasing the representation of racial and ethnic minority groups (including per- sons of mixed ancestry) in the enrollment of the Program; (D) maintain and expand medical contin- gency response capabilities, in coordination with Federal programs, to prepare for and respond effectively to biological, chemical, or radiological attacks, and other public health emergencies that can damage mar- row, so that the capability of supporting pa- tients with marrow damage from disease can be used to support casualties with marrow damage; (E) carry out informational and edu- cational activities in accordance with sub- section (e); (F) at least annually update information to account for changes in the status of indi- viduals as potential donors of bone marrow; (G) provide for a system of patient advo- cacy through the office established under subsection (h); (H) provide case management services for any potential donor of bone marrow to whom the Program has provided a notice that the potential donor may be suitably matched to a particular patient through the office established under subsection (h); (I) with respect to searches for unrelated donors of bone marrow that are conducted through the system under subparagraph (A), collect, analyze, and publish data in a stand- ardized electronic format on the number and percentage of patients at each of the various stages of the search process, including data regarding the furthest stage reached, the number and percentage of patients who are unable to complete the search process, and the reasons underlying such circumstances; Page 519 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 274k (J) support studies and demonstration and outreach projects for the purpose of increas- ing the number of individuals who are will- ing to be marrow donors to ensure a geneti- cally diverse donor pool; and (K) facilitate research with the appro- priate Federal agencies to improve the avail- ability, efficiency, safety, and cost of trans- plants from unrelated donors and the effec- tiveness of Program operations. (2) Cord blood functions (A) In general With respect to cord blood, the Program shall— (i) operate a system for identifying, matching, and facilitating the distribution of donated cord blood units that are suit- ably matched to candidate patients and meet all applicable Federal and State reg- ulations (including informed consent and Food and Drug Administration regula- tions) from a qualified cord blood bank; (ii) consistent with paragraph (3), allow transplant physicians, other appropriate health care professionals, and patients to search by means of electronic access all available cord blood units made available through the Program; (iii) allow transplant physicians and other appropriate health care professionals to reserve, as defined by the Secretary, a cord blood unit for transplantation; (iv) support and expand new and existing studies and demonstration and outreach projects for the purpose of increasing cord blood unit donation and collection from a genetically diverse population and expand- ing the number of cord blood unit collec- tion sites partnering with cord blood banks receiving a contract under the Na- tional Cord Blood Inventory program under section 2 of the Stem Cell Thera- peutic and Research Act of 2005, including such studies and projects that focus on— (I) remote collection of cord blood units, consistent with the requirements under the Program and the National Cord Blood Inventory program goal de- scribed in section 2(a) of the Stem Cell Therapeutic and Research Act of 2005; and (II) exploring novel approaches or in- centives to encourage innovative techno- logical advances that could be used to collect cord blood units, consistent with the requirements under the Program and such National Cord Blood Inventory pro- gram goal; (v) provide for a system of patient advo- cacy through the office established under subsection (h); (vi) coordinate with the qualified cord blood banks to support informational and educational activities in accordance with subsection (g); (vii) maintain and expand medical con- tingency response capabilities, in coordi- nation with Federal programs, to prepare for and respond effectively to biological, chemical, or radiological attacks, and other public health emergencies that can damage marrow, so that the capability of supporting patients with marrow damage from disease can be used to support casual- ties with marrow damage; and (viii) with respect to the system under subparagraph (A), collect, analyze, and publish data in a standardized electronic format, as required by the Secretary, on the number and percentage of patients at each of the various stages of the search process, including data regarding the fur- thest stage reached, the number and per- centage of patients who are unable to com- plete the search process, and the reasons underlying such circumstances. (B) Efforts to increase collection of high quality cord blood units 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 re- mote collection, consistent with the inven- tory 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 appro- priate. (C) Definition In this paragraph, the term ‘‘remote col- lection’’ means the collection of cord blood units at locations that do not have written contracts with cord blood banks for collec- tion support. (3) Single point of access; standard data (A) Single point of access The Secretary shall ensure that health care professionals and patients are able to search electronically for and facilitate ac- cess to, in the manner and to the extent de- fined 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. (B) Standard data 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 elec- tronic format that enables transplant physi- cians to compare among and between bone marrow donors and cord blood units to en- sure the best possible match for the patient. (4) Definition The term ‘‘qualified cord blood bank’’ means a cord blood bank that— (A) has obtained all applicable Federal and State licenses, certifications, registrations (including pursuant to the regulations of the Food and Drug Administration), and other authorizations required to operate and maintain a cord blood bank; (B) has implemented donor screening, cord blood collection practices, and processing Page 520 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 274k methods intended to protect the health and safety of donors and transplant recipients to improve transplant outcomes, including with respect to the transmission of poten- tially harmful infections and other diseases; (C) is accredited by an accreditation entity recognized by the Secretary under sub- section (b); (D) has established a system of strict con- fidentiality to protect the identity and pri- vacy of patients and donors in accordance with existing Federal and State law; (E) has established a system for encour- aging donation by a genetically diverse group of donors; and (F) has established a system to confiden- tially maintain linkage between a cord blood unit and a maternal donor. (e) Bone marrow recruitment; priorities; infor- mation and education (1) Recruitment; priorities The Program shall carry out activities for the recruitment of bone marrow donors. Such recruitment program shall identify popu- lations that are underrepresented among po- tential donors enrolled with the Program. In the case of populations that are identified under the preceding sentence: (A) The Program shall give priority to car- rying out activities under this part to in- crease representation for such populations in order to enable a member of such a popu- lation, to the extent practicable, to have a probability of finding a suitable unrelated donor that is comparable to the probability that an individual who is not a member of an underrepresented population would have. (B) The Program shall consider racial and ethnic minority groups (including persons of mixed ancestry) to be populations that have been identified for purposes of this para- graph, and shall carry out subparagraph (A) with respect to such populations. (2) Information and education regarding re- cruitment; testing and enrollment (A) In general The Program shall carry out informa- tional and educational activities, in coordi- nation 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 do- nors. Such information and educational ac- tivities shall include the following: (i) Making information available to the general public, including information de- scribing the needs of patients with respect to donors of bone marrow. (ii) Educating and providing information to individuals who are willing to serve as potential bone marrow donors. (iii) Training individuals in requesting individuals to serve as potential bone mar- row donors. (B) Priorities In carrying out informational and edu- cational activities under subparagraph (A), the Program shall give priority to recruiting individuals to serve as donors of bone mar- row for populations that are identified under paragraph (1). (3) Transplantation as treatment option In addition to activities regarding recruit- ment, the recruitment program under para- graph (1) shall provide information to physi- cians, other health care professionals, and the public regarding bone marrow transplants from unrelated donors as a treatment option. (4) Implementation of subsection The requirements of this subsection shall be carried out by the entity that has been award- ed a contract by the Secretary under sub- section (a) to carry out the functions de- scribed in subsection (d)(1). (f) Bone marrow criteria, standards, and proce- dures The Secretary shall enforce, for participating entities, including the Program, individual mar- row donor centers, marrow donor registries, marrow collection centers, and marrow trans- plant centers— (1) quality standards and standards for tis- sue typing, obtaining the informed consent of donors, and providing patient advocacy; (2) donor selection criteria, based on estab- lished medical criteria, to protect both the donor and the recipient and to prevent the transmission of potentially harmful infectious diseases such as the viruses that cause hepa- titis and the etiologic agent for Acquired Im- mune Deficiency Syndrome; (3) procedures to ensure the proper collec- tion and transportation of the marrow; (4) standards for the system for patient ad- vocacy operated under subsection (h), includ- ing standards requiring the provision of appro- priate information (at the start of the search process and throughout the process) to pa- tients and their families and physicians; (5) standards that— (A) require the establishment of a system of strict confidentiality to protect the iden- tity and privacy of patients and donors in accordance with Federal and State law; and (B) prescribe the purposes for which the records described in subparagraph (A) may be disclosed, and the circumstances and ex- tent of the disclosure; and (6) in the case of a marrow donor center or marrow donor registry participating in the program, procedures to ensure the establish- ment of a method for integrating donor files, searches, and general procedures of the center or registry with the Program. (g) Cord blood recruitment; priorities; informa- tion and education (1) Recruitment; priorities The Program shall support activities, in co- operation with qualified cord blood banks, for the recruitment of cord blood donors. Such re- cruitment program shall identify populations that are underrepresented among cord blood donors. In the case of populations that are identified under the preceding sentence: (A) The Program shall give priority to sup- porting activities under this part to increase Page 521 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 274k representation for such populations in order to enable a member of such a population, to the extent practicable, to have a probability of finding a suitable cord blood unit that is comparable to the probability that an indi- vidual who is not a member of an underrep- resented population would have. (B) The Program shall consider racial and ethnic minority groups (including persons of mixed ancestry) to be populations that have been identified for purposes of this para- graph, and shall support activities under subparagraph (A) with respect to such popu- lations. (2) Information and education regarding re- cruitment; testing and donation (A) In general In carrying out the recruitment program under paragraph (1), the Program shall sup- port informational and educational activi- ties 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 infor- mation and educational activities shall in- clude the following: (i) Making information available to the general public, including information de- scribing the needs of patients with respect to cord blood units. (ii) Educating and providing information to pregnant women who are willing to do- nate cord blood units. (iii) Training individuals in requesting pregnant women to serve as cord blood do- nors. (B) Priorities In carrying out informational and edu- cational activities under subparagraph (A), the Program shall give priority to sup- porting the recruitment of pregnant women to serve as donors of cord blood for popu- lations that are identified under paragraph (1). (3) Transplantation as treatment option In addition to activities regarding recruit- ment, the recruitment program under para- graph (1) shall provide information to physi- cians, other health care professionals, and the public regarding cord blood transplants from donors as a treatment option. (4) Implementation of subsection The requirements of this subsection shall be carried out by the entity that has been award- ed a contract by the Secretary under sub- section (a) to carry out the functions de- scribed in subsection (d)(2). (h) Patient advocacy and case management for bone marrow and cord blood (1) In general The Secretary shall establish and maintain, through a contract or other means determined appropriate by the Secretary, an office of pa- tient advocacy (in this subsection referred to as the ‘‘Office’’). (2) General functions The Office shall meet the following require- ments: (A) The Office shall be headed by a direc- tor. (B) The Office shall be staffed by individ- uals with expertise in bone marrow and cord blood therapy covered under the Program. (C) The Office shall operate a system for patient advocacy, which shall be separate from mechanisms for donor advocacy, and which shall serve patients for whom the Pro- gram is conducting, or has been requested to conduct, a search for a bone marrow donor or cord blood unit. (D) In the case of such a patient, the Office shall serve as an advocate for the patient by directly providing to the patient (or family members, physicians, or other individuals acting on behalf of the patient) individual- ized services with respect to efficiently uti- lizing the system under paragraphs (1) and (2) of subsection (d) to conduct an ongoing search for a bone marrow donor or cord blood unit and assist with information re- garding third party payor matters. (E) In carrying out subparagraph (D), the Office shall monitor the system under para- graphs (1) and (2) of subsection (d) to deter- mine whether the search needs of the pa- tient involved are being met, including with respect to the following: (i) Periodically providing to the patient (or an individual acting on behalf of the patient) information regarding bone mar- row donors or cord blood units that are suitably matched to the patient, and other information regarding the progress being made in the search. (ii) Informing the patient (or such other individual) if the search has been inter- rupted or discontinued. (iii) Identifying and resolving problems in the search, to the extent practicable. (F) The Office shall ensure that the fol- lowing data are made available to patients: (i) The resources available through the Program. (ii) A comparison of transplant centers regarding search and other costs that prior to transplantation are charged to patients by transplant centers. (iii) The post-transplant outcomes for in- dividual transplant centers. (iv) Information concerning issues that patients may face after a transplant. (v) Such other information as the Pro- gram determines to be appropriate. (G) The Office shall conduct surveys of pa- tients (or family members, physicians, or other individuals acting on behalf of pa- tients) to determine the extent of satisfac- tion with the system for patient advocacy under this subsection, and to identify ways in which the system can be improved to best meet the needs of patients. (3) Case management (A) In general In serving as an advocate for a patient under paragraph (2), the Office shall provide Page 522 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 274k individualized case management services di- rectly to the patient (or family members, physicians, or other individuals acting on behalf of the patient), including— (i) individualized case assessment; and (ii) the functions described in paragraph (2)(D) (relating to progress in the search process). (B) Postsearch functions In addition to the case management serv- ices described in paragraph (1) for patients, the Office shall, on behalf of patients who have completed the search for a bone mar- row donor or cord blood unit, provide infor- mation and education on the process of re- ceiving a transplant, including the post- transplant process. (i) Comment procedures The Secretary shall establish and provide in- formation 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. (j) Consultation In developing policies affecting the Program, the Secretary shall consult with the Advisory Council, the Department of Defense Marrow Donor Recruitment and Research Program oper- ated by the Department of the Navy, and the board of directors of each entity awarded a con- tract under this section. (k) Contracts (1) Application To be eligible to enter into a contract under this section, an entity shall submit to the Sec- retary and obtain approval of an application at such time, in such manner, and containing such information as the Secretary shall by regulation prescribe. (2) Considerations 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 Sec- retary. (l) Eligibility Entities eligible to receive a contract under this section shall include private nonprofit enti- ties. (m) Records (1) Recordkeeping 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 dis- position 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 effec- tive audit. (2) Examination of records 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 au- dits and examinations. (n) Penalties for disclosure 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. (o) Periodic review of state of science (1) Review Not less frequently than every 2 years, the Secretary, in consultation with the Director of the National Institutes of Health, the Com- missioner of Food and Drugs, the Adminis- trator 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. (2) Recommendations Not later than June 30, 2025, the Secretary shall— (A) complete the second review required by paragraph (1); and (B) informed by such review, submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives recommendations on the ap- propriateness of the inclusion of new types of therapies in the Program. (July 1, 1944, ch. 373, title III, § 379, as added Pub. L. 101–616, title I, § 101(a)(2), Nov. 16, 1990, 104 Stat. 3279; amended Pub. L. 105–196, § 2(a), (b)(1), (c)–(g), July 16, 1998, 112 Stat. 631–635; Pub. L. 109–129, § 3(a), Dec. 20, 2005, 119 Stat. 2553; Pub. L. 111–264, § 2(b), Oct. 8, 2010, 124 Stat. 2791; Pub. L. 114–104, § 2(a), Dec. 18, 2015, 129 Stat. 2216; Pub. L. 117–15, § 2(a)–(c), May 26, 2021, 135 Stat. 277.) Editorial Notes REFERENCES IN TEXT 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, Dec. 20, 2005, 119 Stat. 2550, which is set out as a note under this section. AMENDMENTS 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 de- scribed 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 En- ergy and Commerce of the House of Representatives for expanding collection of high quality cord blood units, Page 523 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 274k 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 collec- tions of high quality cord blood units,’’. Pub. L. 114–104, § 2(a)(1), substituted ‘‘expanding col- lection’’ 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 fol- lows: ‘‘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, re- designated 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 dem- onstration and outreach projects for the purpose of in- creasing cord blood donation, and added subpars. (B) and (C). Subsec. (d)(3)(A). Pub. L. 111–264, § 2(b)(2)(B), sub- stituted ‘‘(2)(A)(i)’’ for ‘‘(2)(A)’’. Subsec. (f)(5)(A). Pub. L. 111–264, § 2(b)(3), added sub- par. (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 iden- tity, address, HLA type, and managing marrow donor center for marrow donors and potential marrow donors; and’’. 2005—Pub. L. 109–129 amended section generally, sub- stituting 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 re- cipients suitably matched to biologically unrelated do- nors of bone marrow, and that meets’’ for ‘‘(referred to in this part as the ‘Registry’) that meets’’ and sub- stituted ‘‘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 as- sists 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 poten- tial donors for the Registry in order to enable an indi- vidual in a minority group, to the extent practicable, to have a comparable chance of finding a suitable unre- lated donor as would an individual not in a minority group; ‘‘(4) provide information to physicians, other health care professionals, and the public regarding bone mar- row 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 sub- secs. (c) and (d). Former subsecs. (c) and (d) redesig- nated (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 mar- row transplant centers incurred by patients prior to transplantation; and ‘‘(ii) the success rates of individual marrow trans- plant 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 sub- secs. (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 sub- sec. (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, pro- vided that the amendment made by section 2(b)(1) is ef- fective 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, pro- vided that: ‘‘This Act [see Short Title of 1998 Amend- ment note set out under section 201 of this title] takes effect October 1, 1998, or upon the date of the enact- ment 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 ad- ministrative 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 de- scribed 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; Page 524 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 274k 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 quali- fied 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 avail- able for transplantation through the C.W. Bill Young Cell Transplantation Program and to carry out the re- quirements 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 reg- ulations; ‘‘(2) to encourage donation from a genetically di- verse population; ‘‘(3) to make cord blood units that are collected pursuant to this section or otherwise and meet all ap- plicable 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 Sec- retary 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 for- mat, as determined by the Secretary, for the C.W. Bill Young Cell Transplantation Program; and ‘‘(6) to submit data in a standardized electronic for- mat for inclusion in the stem cell therapeutic out- comes 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 in- clude 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 recipi- ent 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 assess- ment, 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 Pub- lic 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 Sec- retary 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 re- quirements 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 out- standing 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 con- tract 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 consid- eration for such extension of a contract, assist with the establishment of new collection sites, or con- tract 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 Sec- retary shall take into consideration the best sci- entific information available in order to maximize the number of cord blood units available for trans- plant when entering into contracts under this sec- tion, 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 para- graph (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 addi- tional, 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 Transplan- tation 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 amend- ed 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 umbil- ical 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.’’ 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.)