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).

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.”

Section 102 of title I of Pub. L. 101–616 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 [section 274a (b) of this title] (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.”

Pub. L. 109–129, § 2, Dec. 20, 2005, 119 Stat. 2550, provided that:

“(a) In General.—The Secretary of Health and Human Services shall enter into one-time contracts with qualified cord blood banks to assist in the collection and maintenance of 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 [subsec. (c) of this section], 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 [section 274l of this title], as amended by this Act.

“(c) Related Cord Blood Donors.—

“(1) In general.—The Secretary shall establish a 3-year demonstration project under which qualified cord blood banks receiving a contract under this section may use a portion of the funding under such contract for the collection and storage of cord blood units for a family where a first-degree relative has been diagnosed with a condition that will benefit from transplantation (including selected blood disorders, malignancies, metabolic storage disorders, hemoglobinopathies, and congenital immunodeficiencies) at no cost to such family. Qualified cord blood banks collecting cord blood units under this paragraph shall comply with the requirements of paragraphs (1), (2), (3), and (5) of subsection (b).

“(2) Availability.—Qualified cord blood banks that are operating a program under paragraph (1) shall provide assurances that the cord blood units in such banks will be available for directed transplantation until such time that the cord blood unit is released for transplantation or is transferred by the family to the C.W. Bill Young Cell Transplantation Program in accordance with guidance or regulations promulgated by the Secretary.

“(3) Inventory.—Cord blood units collected through the program under this section shall not be counted toward the 150,000 inventory goal under the C.W. Bill Young Cell Transplantation Program.

“(4) Report.—Not later than 90 days after the date on which the project under paragraph (1) is terminated by the Secretary, the Secretary shall submit to Congress a report on the outcomes of the project that shall include the recommendations of the Secretary with respect to the continuation of such project.

“(d) 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;

“(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; and

“(3) 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 [subsec. (d)(4) of this section] (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.

“(e) 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 10 years. The Secretary shall ensure that no Federal funds shall be obligated under any such contract after the earlier of—

“(A) the date that is 3 years after the date on which the contract is entered into; or

“(B) September 30, 2010.

“(2) Extensions.—Subject to paragraph (1)(B), the Secretary may extend the period of funding under a contract under this section to exceed a period of 3 years if—

“(A) the Secretary finds that 150,000 new units of high-quality cord blood have not yet been collected pursuant to this section; and

“(B) the Secretary does not receive an application for a contract under this section from any qualified cord blood bank that has not previously entered into a contract under this section or the Secretary determines that the outstanding inventory need cannot be met by the one or more qualified cord blood banks that have submitted an application for a contract under this section.

“(3) Preference.—In considering contract extensions under paragraph (2), the Secretary shall give preference to qualified cord blood banks that the Secretary determines have demonstrated a superior ability to satisfy the requirements described in subsection (b) and to achieve the overall goals for which the contract was awarded.

“(f) Regulations.—The Secretary may promulgate regulations to carry out this section.

“(g) 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 [this section], 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 ‘first-degree relative’ means a sibling or parent who is one meiosis away from a particular individual in a family.

“(5) The term ‘qualified cord blood bank’ has the meaning given to that term in section 379(d)(4) of the Public Health Service Act [subsec. (d)(4) of this section], as amended by this Act.

“(6) The term ‘Secretary’ means the Secretary of Health and Human Services.

“(h) Authorization of Appropriations.—

“(1) Existing funds.—Any amounts appropriated to the Secretary for fiscal year 2004 or 2005 for the purpose of assisting in the collection or maintenance of cord blood shall remain available to the Secretary until the end of fiscal year 2007.

“(2) Subsequent fiscal years.—There are authorized to be appropriated to the Secretary $15,000,000 for each of fiscal years 2007, 2008, 2009, and 2010 to carry out this section.

“(3) Limitation.—Not to exceed 5 percent of the amount appropriated under this section in each of fiscal years 2007 through 2009 may be used to carry out the demonstration project under subsection (c).”

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.

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.

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.