Sec. 2. CORD BLOOD INVENTORY
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## SEC. 2 CORD BLOOD INVENTORY **[**[42 U.S.C. 274k note](/us/usc/t42/s274k)**]** ###
(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, 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, 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 (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, 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, 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.
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Sec. 2
CORD BLOOD INVENTORY
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