1
See References in Text note below.
and—2
So in original. The semicolon probably should be a comma.
References in Text
Paragraph (2), referred to in subsec. (b)(1), meaning paragraph (2) of subsec. (b) of this section, was redesignated paragraph (3) by [section 201(d)(1) of Pub. L. 101–616]. See 1990 Amendment note below.
The Social Security Act, referred to in subsec. (b)(1)(C), is [act Aug. 14, 1935, ch. 531], [49 Stat. 620]. Title XVIII of the Social Security Act is classified generally to subchapter XVIII (§ 1395 et seq.) of chapter 7 of this title. For complete classification of this Act to the Code, see section 1305 of this title and Tables.
Paragraph (1)(E), referred to in subsec. (b)(2)(A), meaning par. (1)(E) of subsec. (b) of this section, probably should refer to par. (1)(F) of subsec. (b) after the redesignations by [section 701(c)(1) of Pub. L. 106–505], section 1(a)(1) [title II, § 219(b)(1)] of [Pub. L. 106–554], and [section 2(a)(3)(B) of Pub. L. 113–51], which successively redesignated such subpar. (E) as (F), (G), and (F). See 2000 and 2013 Amendment notes below.
Prior Provisions
A prior section 273, [act July 1, 1944, ch. 373, title III, § 371], as added [July 28, 1956, ch. 772], title II, § 201, [70 Stat. 709], authorized grants to the Territory of Alaska for an integrated mental health program, prior to repeal by [Pub. L. 86–70, § 31(b)(1)], June 25, 1959, [73 Stat. 148], effective July 1, 1959.
A prior section 371 of act July 1, 1944, added by [act Aug. 3, 1956, ch. 907, § 1], [70 Stat. 960], was renumbered section 381 and classified to section 275 of this title, prior to repeal by [Pub. L. 99–158, § 3(b)], Nov. 20, 1985, [99 Stat. 879].
Amendments
2023—Subsec. (b)(1)(H)(i)(III). [Pub. L. 118–14] substituted “histocompatibility or an individual” for “histocompatability or an individual”.
2013—Subsec. (b)(1)(E), (F). [Pub. L. 113–51, § 2(a)(3)(A)], (B), redesignated subpars. (F) and (G) as (E) and (F), respectively, and struck out former subpar. (E) which was identical to subpar. (D).
Subsec. (b)(1)(G). [Pub. L. 113–51, § 2(a)(3)(C)], substituted “(G) has a director” for “(H) has a director”. Former subpar. (G) redesignated (F).
Subsec. (b)(1)(H)(i)(V). [Pub. L. 113–51, § 2(a)(3)(D)(i)], substituted “paragraph (3)(G)” for “paragraph (2)(G)”.
Subsec. (b)(1)(H)(ii). [Pub. L. 113–51, § 2(a)(3)(D)(ii)], substituted “paragraph (3)” for “paragraph (2)”.
Subsec. (b)(3)(C). [Pub. L. 113–51, § 2(a)(2)], substituted “including arranging for testing with respect to identifying organs that are infected with human immunodeficiency virus (HIV)” for “including arranging for testing with respect to preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome”.
2004—Subsec. (a)(3). [Pub. L. 108–216] struck out par. (3) which read as follows: “The Secretary may make grants to, and enter into contracts with, qualified organ procurement organizations described in subsection (b) of this section and other nonprofit private entities for the purpose of carrying out special projects designed to increase the number of organ donors.”
Subsec. (c). [Pub. L. 108–362] added subsec. (c).
2000—Subsec. (b)(1)(D) to (H). [Pub. L. 106–554] added subpar. (D) identical to that added by [Pub. L. 106–505] and redesignated former subpars. (D) to (G), respectively, as (E) to (G) and (H) relating to director and such other staff obtaining organs from donors in its service area. Additional amendment directing realignment of margin of subpar. (F) could not be executed after amendment by [Pub. L. 106–505].
[Pub. L. 106–505] added subpar. (D), redesignated former subpars. (D) to (G), respectively, as (E) to (G) and (H) relating to board of directors or advisory board, and realigned margin of subpar. (F).
1990—[Pub. L. 101–616, § 201(a)], substituted “Organ procurement organizations” for “Assistance for organ procurement organizations” in section catchline.
Subsec. (a)(3). [Pub. L. 101–616, § 201(b)(1)], substituted “may make grants to, and enter into contracts with, qualified organ procurement organizations described in subsection (b) of this section and other nonprofit private entities for the purpose of carrying out special projects” for “may make grants for special projects”.
Subsec. (a)(4). [Pub. L. 101–616, § 201(b)(2)], struck out par. (4) which set forth factors to consider in making grants.
Subsec. (b)(1)(E). [Pub. L. 101–616, § 201(c)(1)], amended subpar. (E) generally. Prior to amendment, subpar. (E) read as follows: “has a defined service area which is a geographical area of sufficient size such that (unless the service area comprises an entire State) the organization can reasonably expect to procure organs from not less than 50 donors each year and which either includes an entire standard metropolitan statistical area (as specified by the Office of Management and Budget) or does not include any part of such an area,”.
Subsec. (b)(1)(G)(i)(III). [Pub. L. 101–616, § 201(e)], made technical correction to [Pub. L. 100–607, § 402(c)(2)]. See 1988 Amendment note below.
Subsec. (b)(2), (3). [Pub. L. 101–616, § 201(d)], added par. (2) and redesignated former par. (2) as (3).
Subsec. (c). [Pub. L. 101–616, § 206(b)], struck out subsec. (c) which authorized appropriations for subsec. (a) grants for fiscal years 1988 through 1990.
1988—Subsec. (a)(2). [Pub. L. 100–607, § 402(a)(1)], inserted “consolidation,” after “initial operation,”.
Subsec. (a)(3). [Pub. L. 100–607, § 402(a)(2)], added par. (3). Former par. (3) redesignated (4).
Subsec. (a)(4). [Pub. L. 100–607, § 402(a)(2)], redesignated former par. (3) as (4).
Subsec. (a)(4)(C). [Pub. L. 100–607, § 402(a)(3)], added subpar. (C).
Subsec. (b)(1)(E). [Pub. L. 100–607, § 402(c)(1)(A)], substituted “size such that” for “size which”, and “the organization can reasonably expect to procure organs from not less than 50 donors each year” for “will include at least fifty potential organ donors each year”.
Subsec. (b)(1)(G)(i)(III). [Pub. L. 100–607, § 402(c)(2)], as amended by [Pub. L. 101–616, § 201(e)], inserted “or an individual with a doctorate degree in a biological science with knowledge, experience, or skill in the field of histocompatibility” before comma at end.
Subsec. (b)(2)(C). [Pub. L. 100–607, § 402(c)(1)(B)], substituted “274(b)(2)(E) of this title, including arranging for testing with respect to preventing the acquisition of organs that are infected with the etiologic agent for acquired immune deficiency syndrome,” for “274(b)(2)(D) of this title,”.
Subsec. (b)(2)(E). [Pub. L. 100–607, § 402(c)(1)(C)], substituted “organs equitably among transplant patients” for “organs among transplant centers and patients”.
Subsec. (b)(2)(K). [Pub. L. 100–607, § 402(c)(1)(D)], added subpar. (K).
Subsec. (c). [Pub. L. 100–607, § 402(d)], amended subsec. (c) generally. Prior to amendment, subsec. (c) read as follows: “For grants under subsection (a) of this section there are authorized to be appropriated $5,000,000 for fiscal year 1985, $8,000,000 for fiscal year 1986, and $12,000,000 for fiscal year 1987.”
Statutory Notes and Related Subsidiaries
Effective Date of 1990 Amendment
[Pub. L. 101–616, title II, § 207], Nov. 16, 1990, [104 Stat. 3286], provided that: “Except as otherwise provided in this title, the amendments made by this title [enacting sections 274f and 274g of this title, amending this section and sections 274 and 274b to 274d of this title, and repealing provisions set out as a note below] shall become effective on October 1, 1990, or on the date of the enactment of this Act [Nov. 16, 1990], whichever occurs later.”
Effective Date of 1988 Amendment
[Pub. L. 100–607, title IV, § 402(c)(3)], Nov. 4, 1988, [102 Stat. 3115], as amended by [Pub. L. 101–274], Apr. 23, 1990, [104 Stat. 139], which provided that the amendment made by [section 402(c)(1)(A) of Pub. L. 100–607], amending this section, was not to apply to an organ procurement organization designated under section 1320b–8(b) of this title until Jan. 1, 1992, was repealed by [Pub. L. 101–616, title II, § 201(c)(2)], Nov. 16, 1990, [104 Stat. 3283].
Short Title
For short title of [Pub. L. 98–507], which enacted this part as the “National Organ Transplant Act”, see [section 1 of Pub. L. 98–507], set out as a Short Title of 1984 Amendments note under section 201 of this title.
Severability
[Pub. L. 101–616, title III, § 301], Nov. 16, 1990, [104 Stat. 3286], provided that: “If any provision of this Act [enacting sections 274f, 274g, 274k, and 274l of this title, amending this section and sections 274 to 274d of this title, enacting provisions set out as notes under this section and sections 274 and 274k of this title, and repealing provisions set out as a note above], amendment made by this Act, or application of the provision or amendment to any person or circumstance is held to be unconstitutional, the remainder of this Act, the amendments made by this Act, and the application of the provisions or amendments to any person or circumstance shall not be affected.”
Certification of Organ Procurement Organizations
[Pub. L. 106–505, title VII, § 701(b)], Nov. 13, 2000, [114 Stat. 2346], and [Pub. L. 106–554, § 1(a)(1) [title II, § 219(a)]], Dec. 21, 2000, [114 Stat. 2763], 2763A–28, provided that: “Congress makes the following findings:“(1)
Organ procurement organizations play an important role in the effort to increase organ donation in the United States.
“(2)
The current process for the certification and recertification of organ procurement organizations conducted by the Department of Health and Human Services has created a level of uncertainty that is interfering with the effectiveness of organ procurement organizations in raising the level of organ donation.
“(3)
The General Accounting Office [now Government Accountability Office], the Institute of Medicine, and the Harvard School of Public Health have identified substantial limitations in the organ procurement organization certification and recertification process and have recommended changes in that process.
“(4)
The limitations in the recertification process include:
“(A)
An exclusive reliance on population-based measures of performance that do not account for the potential in the population for organ donation and do not permit consideration of other outcome and process standards that would more accurately reflect the relative capability and performance of each organ procurement organization.
“(B)
A lack of due process to appeal to the Secretary of Health and Human Services for recertification on either substantive or procedural grounds.
“(5)
The Secretary of Health and Human Services has the authority under section 1138(b)(1)(A)(i) of the Social Security Act (
42 U.S.C. 1320b–8(b)(1)(A)(i)) to extend the period for recertification of an organ procurement organization from 2 to 4 years on the basis of its past practices in order to avoid the inappropriate disruption of the nation’s organ system.
“(6)
The Secretary of Health and Human Services can use the extended period described in paragraph (5) for recertification of all organ procurement organizations to—
“(A)
develop improved performance measures that would reflect organ donor potential and interim outcomes, and to test these measures to ensure that they accurately measure performance differences among the organ procurement organizations; and
“(B)
improve the overall certification process by incorporating process as well as outcome performance measures, and developing equitable processes for appeals.”
Study Regarding Immunosuppressive Drugs
[Pub. L. 106–310, div. A, title XXI, § 2101(b)], Oct. 17, 2000, [114 Stat. 1156], required the Secretary of Health and Human Services to provide for a study to determine the costs of immunosuppressive drugs provided to children pursuant to organ transplants and to determine the extent to which health plans and health insurance covered such costs, and related issues, and to submit the report to Congress by Dec. 31, 2001.
Study on Hospital Agreements With Organ Procurement Agencies
[Pub. L. 103–432, title I, § 155(b)], Oct. 31, 1994, [108 Stat. 4439], directed Office of Technology Assessment to conduct study to determine efficacy and fairness of requiring a hospital to enter into agreement under subsec. (b)(3)(A) of this section with organ procurement agency for service area in which such hospital is located and impact of such requirement on efficacy and fairness of organ procurement and distribution, and to submit to Congress, not later than 2 years after Oct. 31, 1994, report containing findings of such study and implications of such findings with respect to policies affecting organ procurement and distribution.
Task Force on Organ Procurement and Transplantation
[Pub. L. 98–507, title I], §§ 101–105, Oct. 19, 1984, [98 Stat. 2339–2342], directed Secretary of Health and Human Services, not later than 90 days after Oct. 19, 1984, to establish a Task Force on Organ Transplantation to conduct comprehensive examinations, prepare an assessment and report, and submit advice as to regulation of the medical, legal, ethical, economic, and social issues presented by human organ procurement and transplantation, with the final report due not later than 12 months after the Task Force is established and the Task Force to terminate 3 months thereafter.
Bone Marrow Registry Demonstration and Study
[Pub. L. 98–507, title IV, § 401], Oct. 19, 1984, [98 Stat. 3268], directed Secretary of Health and Human Services to hold a conference on the feasibility of establishing and the effectiveness of a national registry of voluntary bone marrow donors not later than 9 months after Oct. 19, 1984, and if the conference found that it was feasible to establish a national registry of voluntary donors of bone marrow and that such a registry was likely to be effective in matching donors with recipients, the Secretary was to establish a registry of voluntary donors of bone marrow not later than six months after the completion of the conference, and further directed the Secretary, acting through the Assistant Secretary for Health, to study the establishment and implementation of the registry to identify the issues presented by the establishment of such a registry, to evaluate participation of bone marrow donors, to assess the implementation of the informed consent and confidentiality requirements, and to determine if the establishment of a permanent bone marrow registry was needed and appropriate, and to report the results of the study to Congress not later than two years after the date the registry was established.