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.
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.
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.
Publicly available data
section 274k of this title1
July 1, 1944, ch. 373 Pub. L. 105–196, § 3112 Stat. 635 Pub. L. 109–129, § 3(b)119 Stat. 2561 (, title III, § 379A, as added , , ; amended , , .)
Editorial Notes
Prior Provisions
lact July 1, 1944, ch. 373, title III, § 379A Pub. L. 101–616, title I, § 101(a)(2)104 Stat. 3282 Pub. L. 105–196112 Stat. 635 A prior section 274, , as added , , , related to study by General Accounting Office, prior to repeal by , §§ 3, 7, , , 637, effective .
Amendments
Pub. L. 109–1292005—, amended section generally, substituting provisions relating to the stem cell therapeutic outcomes database for provisions relating to the bone marrow scientific registry.
Statutory Notes and Related Subsidiaries
Effective Date
section 7 of Pub. L. 105–196section 274k of this titleSection effective , see , set out as an Effective Date of 1998 Amendment note under .