PUBLIC LAW 109–129—DEC. 20, 2005
119 STAT. 2561
‘‘(k) CONTRACTS.— ‘‘(1) APPLICATION.—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. ‘‘(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 Secretary. ‘‘(l) ELIGIBILITY.—Entities eligible to receive a contract under this section shall include private nonprofit entities. ‘‘(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 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. ‘‘(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 audits 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, United States Code, or both.’’. (b) STEM CELL THERAPEUTIC OUTCOMES DATABASE.—Section 379A of the Public Health Service Act (42 U.S.C. 274l) is amended to read as follows:
Regulations.
‘‘SEC. 379A. 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 information in a standardized electronic format with respect to patients described in subsection (a), diagnosis, 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 awarded a contract under this section to submit to the Secretary an annual report concerning patient outcomes with respect to each transplant center, based on data collected and maintained by the entity pursuant to this section.
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