Transplant Amendments Act of 1990
PL 101-616 (S.2946), enacted 11/16/1990

PUBLIC LAW 101-616—NOV. 16, 1990 
104 STAT. 3279 
Public Law 101-616 
101st Congress 
An Act 
To amend the Public Health Service Act to revise and extend the program establish-
ing the National Bone Marrow Donor Registry, and for other purposes. 
Be it enacted by the Senate and House of Representatives 
of the 
United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the "Transplant Amendments Act of 
1990". 
SEC. 2. TABLE OF CONTENTS. 
Sec. 1. Short title. 
Sec. 2. Table of contents. 
TITLE I—NATIONAL BONE MARROW DONOR REGISTRY 
Sec. 101. Establishment of a National Bone Marrow Donor Registry. 
Sec. 102. Savings provisions. 
TITLE II—ORGAN TRANSPLANTS 
Sec. 201. Assistance for organ procurement organizations. 
Sec. 202. Organ procurement and transplantation network. 
Sec. 203. General provisions respecting grants and contracts. 
Sec. 204. Administration. 
Sec. 205. Report. 
Sec. 206. Study by General Accounting Office and authorization of appropriations. 
Sec. 207. Effective date. 
TITLE III—SEVERABILITY 
Sec. 301. Severability. 
Nov. 16, 1990 
[S. 2946] 
Transplant 
Amendments 
Act of 1990. 
42 u s e 201 
note. 
TITLE I—NATIONAL BONE MARROW 
DONOR REGISTRY 
SEC. 101. ESTABLISHMENT OF A NATIONAL BONE MARROW DONOR REG-
ISTRY. 
(a) REGISTRY.—Title III of the Public Health Service Act (42 U.S.C. 
301 et seq.) is amended— 
(1) by redesignating parts I, J, and K as parts J, K, and L, 42 USC 275 et 
respectively; and 
%eQ-' 280b et seq., 
(2) by inserting after section 377 (as added by section 207 of 280cefseg. 
this Act) the following new part: 
"PART I—NATIONAL BONE MARROW DONOR 
REGISTRY 
"SEC. 379. NATIONAL REGISTRY. 
"(a) ESTABLISHMENT.—The Secretary shall by contract establish 
and maintain a National Bone Marrow Donor Registry (referred to 
in this part as the 'Registry') that meets the requirements of this 
42 USC 274k. 
Government 
contracts. 
104 STAT. 3280 
PUBLIC LAW 101-616—NOV. 16, 1990 
section. The Registry shall be under the general supervision of the 
Secretary, and under the direction of a board of directors that shall 
include representatives of marrow donor centers, marrow trans-
plant centers, persons with expertise in the social science, and the 
general public. 
"(b) FUNCTIONS.—The Registry shall— 
"(1) establish a system for finding marrow donors suitably 
matched to unrelated recipients for bone marrow transplan-
tation; 
"(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 unre-
lated 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 minor-
ity group; 
"(4) provide information to physicians, other health care 
professionals, and the public regarding bone marrow transplan-
tation; 
"(5) recruit potential bone marrow donors; 
"(6) collect, analyze, and publish data concerning bone 
marrow donation and transplantation; and 
"(7) support studies and demonstration projects for the pur-
pose of incre£ising the number of individuals, especially minori-
ties, who are willing to be marrow donors. 
"(c) CRITERIA, STANDARDS, AND PROCEDURES.—Not later than 180 
days after the date of enactment of this part, the Secretary shall 
establish and enforce, for entities participating in the program, 
including the Registry, individual marrow donor centers, marrow 
donor registries, marrow collection centers, and marrow transplant 
centers— 
"(1) quality standards and standards for tissue typing, obtain-
ing the informed consent of donors, and providing patient ad-
vocacy; 
"(2) donor selection criteria, based on established medical 
criteria, to protect both the donor and the recipient and to 
prevent the transmission of potentially harmful infectious dis-
eases such £is the viruses that cause hepatitis and the etiologic 
agent for Acquired Immune Deficiency Syndrome; 
"(3) procedures to ensure the proper collection and transpor-
tation of the marrow; 
"(4) 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 stand-
ards 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 trans-
plant centers; 
"(5) standards that— 
PUBLIC LAW 101-616—NOV. 16, 1990 
104 STAT. 3281 
Public 
information. 
"(A) require the establishment of a system of strict con-
fidentiality of records relating to the identity, address, HLA 
type, and managing marrow donor center for marrow 
donors and potential marrow donors; and 
"(B) prescribe the purposes for which the records de-
scribed in subparagraph (A) may be disclosed, and the 
circumstances and extent of the disclosure; and 
"(6) in the case of a marrow donor center or marrow donor 
registry participating in the program, procedures to ensure the 
establishment of a method for integrating donor files, searches, 
and general procedures of the center or registry with the 
Registry. 
"(d) COMMENT PROCEDURES.—The Secretary shall establish and 
provide information to the public on procedures, which may include 
establishment of a policy advisory committee, under which the 
Secretary shall receive and consider comments from interested 
persons relating to the manner in which the Registry is carrying out 
the duties of the Registry under subsection (b) and complying with 
the criteria, standards, and procedures described in subsection (c). 
"(e) CONSULTATION.—The Secretary shall consult with the board of 
directors of the Registry and the bone marrow donor program of 
the Department of the Navy in developing policies affecting the 
Registry. 
"(f) APPUCATION.—To be eligible to enter into a contract under Regulations 
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. 
"(g) ELIGIBILITY.—Entities eligible to receive a contract under this 
section shall include private nonprofit entities. 
"(h) RECORDS.— 
"(1) RECORDKEEPING.—Each recipient of a contract or sub-
contract 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. 
"(i) PENALTIES FOR DISCLOSURE.—Any person who discloses the 
content of any record referred to in subsection (c)(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 (c)(5)(B), shall be imprisoned for not more 
than 2 years or fined in accordance with title 18, United States Code, 
or both. 
"(j) AUTHORIZATION OF APPROPRIATIONS.—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. 
104 STAT. 3282 
PUBLIC LAW 101-616—NOV. 16, 1990 
42 use 274/. 
"SEC. 379A. STUDY BY THE GENERAL ACCOUNTING OFFICE. 
"(a) IN GENERAL.—The Comptroller General of the United States 
shall conduct a study that evaluates— 
"(1) the costs and benefits of the search process for an unre-
lated bone marrow donor among different marrow donor reg-
istries; 
"(2) the extent to which marrow donor registries protect 
donor confidentiality; 
"(3) the relationship between the Registry, individual marow 
donor centers, and other marrow donor registries; 
"(4) the effectiveness and appropriateness of policies and 
procedures of marrow donor centers, marrow transplant cen-
ters, and marrow donor registries, including— 
"(A) the process of donor recruitment, including the 
policy of asking each donor whether the donor would want 
to donate more than one time; 
"(B) the maintenance and updating of donor files; and 
"(C) the policy of initially typing donors for A/B antigens 
only instead of initially tjrping for both A/B and D/R 
antigens; 
"(5) the ability of the marrow donor registries to incorporate 
changes in medical research and clinical practice; and 
"(6) the costs associated with tissue typing. 
"(b) REPORT.—Not later than 1 year after the date of enactment of 
this part, the Comptroller General shall complete the study required 
under subsection (a) and submit to the Committee on Energy and 
Commerce of the House of Representatives and the Committee on 
Labor and Human Resources of the Senate a report describing the 
findings made by the study and recommendations for legislative 
reform.". 
(b) CONFORMING AMENDMENT.—Section 373 of the Act (42 U.S.C. 
274a) is amended— 
(1) in the section heading, by striking "and Bone Marrow 
Resristrv' 
(2) by striking "(a)"; and 
(3) by striking out subsection (b). 
42 use 274k 
SEC. 102. SAVINGS PROVISIONS. 
"° • 
(a) IN GENERAL.—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, 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 (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. 
PUBLIC LAW 101-616—NOV. 16, 1990 
104 STAT. 3283 
TITLE II—ORGAN TRANSPLANTS 
SEC. 201. ASSISTANCE FOR ORGAN PROCUREMENT ORGANIZATIONS. 
(a) SECTION HEADING.—Section 371 of the Public Health Service 
Act (42 U.S.C. 273) is amended in the section heading by striking 
"assistance for". 
(b) AUTHORITY REGARDING CERTAIN GRANTS.— 
(1) SPECIAL PROJECTS.—Section 371(a)(3) of the Act (42 U.S.C. 
273(a)(3)) is amended by striking "may make grants for special 
projects" and inserting the following: 'may make grants to, and 
enter 
into contracts 
with, 
qualified 
organ 
procurement 
organizations described in subsection (b) and other nonprofit 
private entities for the purpose of carrying out special projects". 
(2) CONSIDERATIONS IN MAKING CERTAIN GRANTS.—Section 
371(a) of the Act (42 U.S.C. 273(a)) is amended by striking 
paragraph (4). 
(c) SERVICE AREA OF QUALIFIED ORGAN PROCUREMENT ORGANI-
ZATIONS.— 
(1) IN GENERAL.—Subparagraph (E) of section 371(bXl) of the 
Act (42 U.S.C. 273(b)(1)(E)) is amended to read as follows: 
"(E) has a defined service area that is of sufficient size to 
assure maximum effectiveness in the procurement and 
equitable distribution of organs, and that either includes an 
entire metropolitan statistical area (as specified by the 
Director of the Office of Management and Budget) or does 
not include any part of the area,". 
(2) CONFORMING AMENDMENT.—Section 402(c)(3) of the Health 
Omnibus Programs Extension of 1988 (Public Law 100-607; 42 
U.S.C. 273 note) is repealed. 
(d) EFFECTIVENESS REGARDING NUMBER OF ORGANS PROCURED.— 
Section 371(b) of the Public Health Service Act (42 U.S.C. 273(b)) is 
amended— 
(1) by redesignating paragraph (2) as paragraph (3); and 
(2) by inserting after paragraph (1) the following new para-
graph: 
"(2)(A) Not later than 90 days after the date of the enactment of Federal 
this paragraph, the Secretary shall publish in the Federal Register a Register, 
notice of proposed rulemaking to establish criteria for determining 
^^ ^'^^ ^°"" 
whether an entity meets the requirement established in paragraph 
am. 
"(B) Not later than 1 year after the date of enactment of this 
paragraph, the Secretary shall publish in the Federal Register a 
final rule to establish the criteria described in subparagraph (A).". 
(e) TECHNICAL CORRECTION REGARDING PUBLIC LAW 100-607.— 
Section 402(c)(2) of the Health Omnibus Progranis Extension of 1988 
(Public Law 100-607; 102 Stat. 3115) is amended by inserting "at the 42 USC 273. 
end" after "the comma". 
SEC. 202. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK. 
(a) MINIMUM QUAUFICATIONS OF CONTRACTOR.—Section 372G3)(1) of 
the Public Health Service Act (42 U.S.C. 27403)(1)) is amended— 
(1) in subparagraph (A), by striking "which is not engaged in 
any activity unrelated to organ procurement" and inserting 
"that has an expertise in organ procurement and transplan-
tation"; and 
(2) in subparagraph (B), to read as follows: 
104 STAT. 3284 
PUBLIC LAW 101-616—NOV. 16, 1990 
"(B) have a board of directors— 
"(i) that includes representatives of organ procurement 
organizations (including organizations that have received 
grants under section 371), transplant centers, voluntary 
health associations, and the general public; and 
Establishment. 
"(ii) that shall establish an executive committee and 
other committees, whose chairpersons shall be selected to 
ensure continuity of leadership for the board.". 
(b) RESPONSIBIUTIES OF NETWORK.—Section 372(b)(2) of the Act (42 
U.S.C. 274(bX2)) is amended— 
(1) in subparagraph (D)— 
(A) by inserting "nationwide" after "organizations in 
the"; and 
(B) by inserting "equitably among transplant patients" 
after "organs"; 
(2) by striking "and" at the end of subparagraph (I); 
(3) by striking the period at the end of subparagraph (J) and 
inserting ", and ; and 
(4) by adding at the end the following new subparagraphs: 
"(K) work actively to increase the supply of donated organs. 
Reports. 
"(L) submit to the Secretary an ginnual report containing 
information on the comparative costs and patient outcomes at 
each transplant center affiliated with the organ procurement 
and transplantation network.". 
(c) TECHNICAL CORRECTION.—Section 372(bX2XF) of the Act (42 
U.S.C. 274(bX2XF)) is amended by striking "compatability" and 
inserting "compatibility". 
42 use 274 
(d) EFFECTIVE DATE.—The amendments made by subsection (a) 
Jiote. 
shall become effective on December 31,1990. 
SEC. 203. GENERAL PROVISIONS RESPECTING GRANTS AND CONTRACTS. 
Section 374 of the Public Health Service Act (42 U.S.C. 274b) is 
amended— 
(1) in subsection (a), by striking "No grant" and all that 
follows through "373" the first place that the term appears and 
inserting the following: "No grant may be made under this 
part"; 
(2) in subsection (b)— 
(A) by striking paragraph (1) and redesignating para-
graphs (2) and (3) as paragraphs (1) and (2), respectively; 
(B) by striking "section 371" in paragraph (1) (as so 
redesignated) and inserting "section 371(aXl)"; 
(C) by striking "paragraphs (2) and (3) of section 371(a)" in 
the first sentence of paragraph (2) (as so redesignated), and 
inserting "section 371(aX2)"; and 
(D) by adding at the end the following new paragraph: 
"(3) Grants or contracts under section 371(aX3) may be made for 
not more than 3 years."; and 
(3) in subsection (c)— 
(A) by inserting "or contract" after "grant" in the first 
sentence of pargigraph (1); 
(B) by inserting "and contracts" after "grants" each place 
the term appears in the second sentence of paragraph (1); 
and 
(C) by inserting "or contract" after "grant" each place 
the term appears in subparagraphs (A) and (B) of para-
graph (2). 
PUBLIC LAW 101-616—NOV. 16, 1990 
104 STAT. 3285 
SEC. 204. ADMINISTRATION. 
(a) IDENTIFIABLE ADMINISTRATIVE UNIT.—Section 375 of the Public 
Health Service Act (42 U.S.C. 274c) is amended in the matter 
preceding paragraph (1) by striking ", during fiscal years 1985 
through 1990,". 
(b) 
STRIKING OF EXPIRED REQUIREMENT REGARDING 
CERTAIN 
REPORTS.—Section 375 of the Act (42 U.S.C. 274c) is amended— 
(1) in paragraph (3), by striking "receiving funds under sec-
tion 371"; and 
(2) in paragraph (4), to read as follows: 
"(4) provide information— 
"(i) to patients, their families, and their physicians about 
transplantation; and 
"(ii) to patients and their families about the resources 
available nationally and in each State, and the comparative 
costs and patient outcomes at each transplant center affili-
ated with the organ procurement and transplantation net-
work, in order to assist the patients and families with the 
costs associated with transplantation.". 
SEC. 205. REPORT. 
Section 376 of the Public Health Service Act (42 U.S.C. 274d) is 
amended in the first sentence, by striking "The Secretary" and all 
that follows through "publish" and inserting "Not later than Feb-
ruary 10 of 1991 and of each second year thereafter, the Secretary 
shall publish, and submit to the Committee on Energy and Com-
merce of the House of Representatives and the Committee on Labor 
and Human Resources of the Senate.". 
SEC. 206. STUDY BY GENERAL ACCOUNTING OFFICE AND AUTHORIZA-
TION OF APPROPRIATIONS. 
(a) IN GENERAL.—Part H of title III of the Public Health Service 
Act (42 U.S.C. 273 et seq.) is amended by adding at the end the 
following new sections: 
"SEC. 377. STUDY BY GENERAL ACCOUNTING OFFICE. 
42 USC 274f. 
"(a) IN GENERAL.—The Comptroller General of the United States 
shall conduct a study for the purpose of determining— 
"(1) the extent to which the procurement and allocation of 
organs have been equitable, efficient, and effective; 
"(2) the problems encountered in the procurement and alloca-
tion; and 
"(3) the effect of State required-request laws. 
"(b) REPORT.—Not later than January 7, 1992, the Comptroller 
General of the United States shall complete the study required in 
subsection (a) and submit to the Committee on Energy and Com-
merce of the House of Representatives, and to the Committee on 
Labor and Human Resources of the Senate, a report describing the 
findings made as a result of the study. 
"SEC. 378. AUTHORIZATION OF APPROPRIATIONS. 
42 USC 274g. 
"For the purpose of carrying out this part, there are authorized to 
be appropriated $8,000,000 for fiscal year 1991, and such sums as 
may be necessary for each of the fiscal years 1992 and 1993.". 
(b) CONFORMING AMENDMENT.—Section 371 of the Public Health 
Service Act (42 U.S.C. 273) is amended by striking subsection (c). 
104 STAT. 3286 
PUBLIC LAW 101-616—NOV. 16, 1990 
42 u s e 273 
SEC. 207. EFFECTIVE DATE. 
Except as otherwise provided in this title, the amendments made 
by this title shall become effective on October 1, 1990, or on the date 
of the enactment of this Act, whichever occurs later. 
TITLE III—SEVERABILITY 
42 u s e 273 
SEC. 301. SEVERABILITY. 
If any provision of this Act, amendment made by this Act, or 
application of the provision or amendment to any person or cir-
cumstance is held to be unconstitutional, the remgdnder 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. 
Approved November 16, 1990. 
LEGISLATIVE HISTORY—S. 2946: 
SENATE REPORTS: No. 101-530 (eomm. on Labor and Human Resources). 
CONGRESSIONAL RECORD, Vol. 136 (1990): 
Oct. 25, considered and passed Senate. 
Oct. 26, considered and passed House. 
o