103D CONGRESS

1ST SESSION H. R. 2659

AN ACT

To amend the Public Health Service Act to revise

tation of organs and of bone marrow.and extend programs relating to the transplan-
103D CONGRESS

1ST SESSION H. R. 2659

AN ACT

To amend the Public Health Service Act to revise and extend

programs relating to the transplantation of organs and

of bone marrow.

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled,

3 SECTION 1. SHORT TITLE.

4 This Act may be cited as the ‘‘Organ and Bone

5 Marrow Transplantation Amendments of 1993’’.

6 SEC. 2. ORGAN PROCUREMENT ORGANIZATIONS.

7 (a) IN GENERAL.—Section 371(a) of the Public

8 Health Service Act (42 U.S.C. 273(a)) is amended—
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1 (1) by striking paragraphs (2) and (3); and

2 (2) by inserting after paragraph (1) the follow3 ing paragraph:

4 ‘‘(2)(A) The Secretary may make grants to, and enter

5 into contracts with, qualified organ procurement organiza6 tions described in subsection (b) and other public or non7 profit private entities for the purpose of—

8 ‘‘(i) planning and conducting programs to pro9 vide information and education to the public on the

10 need for organ donations; and

11 ‘‘(ii) training individuals in requesting such do12 nations.

13 ‘‘(B) In making awards of grants and contracts

14 under subparagraph (A), the Secretary shall give priority

15 to carrying out the purpose described in such subpara16 graph with respect to minority populations.’’.

17 (b) REQUIREMENTS REGARDING QUALIFIED ORGAN

18 PROCUREMENT ORGANIZATIONS.—Section 371(b) of the

19 Public Health Service Act (42 U.S.C. 273(b)) is amend20 ed—

21 (1) in paragraph (1)—

22 (A) in the matter preceding subparagraph

23 (A)—

24 (i) by striking ‘‘organization for which

25 grants may be made under subsection (a)
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1 is’’ and inserting ‘‘organization described

2 in this subsection is’’; and

3 (ii) by striking ‘‘paragraph (2)’’ and

4 inserting ‘‘paragraph (3)’’;

5 (B) in subparagraph (E), by moving the

6 subparagraph 2 ems to the left; and

7 (C) in subparagraph (G)—

8 (i) in the matter preceding clause (i),

9 by striking ‘‘has a board of directors or an

10 advisory board which’’ and inserting the

11 following: ‘‘has a board of directors (or an

12 advisory board, in the case of a hospital13 based organization) which’’; and

14 (ii) in clause (i)(II), by striking

15 ‘‘members’’ and all that follows and insert16 ing the following: ‘‘individuals who have re17 ceived a transplant of an organ, individuals

18 who are part of the family of an individual

19 who has donated an organ, and individuals

20 who have been medically referred to receive

21 a transplant of an organ (or individuals

22 who are part of the family of individuals

23 who have been so referred), which individ24 uals shall in the aggregate constitute not

less than 1 25 ⁄3 of the membership of the
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1 board and which members shall, to the ex2 tent practicable, be residents of the service

3 area involved,’’; and

4 (2) in paragraph (3)—

5 (A) in subparagraph (A), by amending the

6 subparagraph to read as follows:

7 ‘‘(A)(i) With respect to each hospital or other

8 entity in its service area that has facilities for organ

9 donations, the organization shall have an effective

10 agreement with the entity under which the entity

11 identifies potential organ donors and notifies the or12 ganization, subject to clause (ii).

13 ‘‘(ii) The Secretary may waive the requirement

14 of clause (i) to the extent determined by the Sec15 retary to be necessary to promote organ donation

16 and the equitable allocation of organs.’’;

17 (B)(i) in the matter preceding subpara18 graph (A), by striking ‘‘shall—’’ and inserting

19 ‘‘shall comply with the following:’’;

20 (ii) in each of subparagraphs (B) through

21 (K), by inserting ‘‘The organization shall’’ be22 fore the first word of the subparagraph;

23 (iii) in each of subparagraphs (B) through

24 (I), by striking the comma at the end and in25 serting a period; and
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1 (iv) in subparagraph (J), by striking ‘‘,

2 and’’ and inserting a period;

3 (C) in subparagraph (E)—

4 (i) by inserting ‘‘(i)’’ after the sub5 paragraph designation; and

6 (ii) by adding at the end the following

7 clauses:

8 ‘‘(ii) The organization shall, subject to clause

9 (iii), ensure that the system under clause (i) allo10 cates each type of organ on the basis of a single list,

11 maintained exclusively by the organization, of indi12 viduals who have been medically referred to a trans13 plant center in the service area of the organization

14 in order to receive a transplant of the type of organ

15 with respect to which the list is maintained, and who

16 are citizens or permanent resident aliens of the

17 United States.

18 ‘‘(iii) Upon the request of the organization, the

19 Secretary may, with respect to the service area of

20 the organization, waive the requirement of clause (ii)

21 regarding a single list if the Secretary determines

22 that the waiver is necessary to ensure the equitable

23 allocation of organs of the type involved and maxi24 mize the opportunities for successful outcomes of

25 transplants of such organs.’’; and
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1 (D) in subparagraph (H), by striking ‘‘par2 ticipate’’ and all that follows through ‘‘372’’

3 and inserting the following: ‘‘be a member of,

4 and abide by the rules and requirements of, the

5 Organ Procurement and Transplantation Net6 work established under section 372’’.

7 SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION

8 NETWORK.

9 Section 372(b) of the Public Health Service Act (42

10 U.S.C. 274(b)) is amended—

11 (1) in paragraph (1)—

12 (A) in subparagraph (A), by striking

13 ‘‘and’’ after the comma at the end; and

14 (B) by striking subparagraph (B) and in15 serting the following subparagraphs:

16 ‘‘(B) have a board of directors composed of not

17 more than 32 members, whose membership in18 cludes—

19 ‘‘(i) representatives of organ procurement

20 organizations, transplant centers, and voluntary

21 health associations; and

22 ‘‘(ii) individuals who have received a trans23 plant of an organ, individuals who are part of

24 the family of an individual who has donated an

25 organ, and individuals who have been medically
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1 referred to receive a transplant of an organ (or

2 individuals who are part of the family of indi3 viduals who have been so referred), which indi4 viduals shall in the aggregate constitute not less

than 1 5 ⁄3 of the membership of the board; and

6 ‘‘(C) establish, through such board of directors,

7 an executive committee and other committees, the

8 chairs of which shall be selected to ensure continuity

9 of leadership for the board.’’; and

10 (2) in paragraph (2)—

11 (A) by striking ‘‘shall—’’ in the matter

12 preceding subparagraph (A) and all that follows

13 through the end of clause (i) of such subpara14 graph and inserting the following: ‘‘shall—

15 ‘‘(A) establish (in one location or through re16 gional centers)—

17 ‘‘(i) with respect to each type of organ—

18 ‘‘(I) a national list of individuals who

19 have been medically referred to receive a

20 transplant of the type of organ with re21 spect to which the list is maintained and

22 who are citizens or permanent resident

23 aliens of the United States (which list shall

24 include the names of all individuals in-
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1 cluded on lists in effect under section

2 371(b)(3)(E)), and

3 ‘‘(II) a national list of individuals who

4 have been so referred and who are in the

5 United States but are not such citizens or

6 such aliens, and’’; and

7 (B)(i) in subparagraph (J), by striking

8 ‘‘and’’ after the comma at the end;

9 (ii) in subparagraph (K), by striking the

10 period at the end and inserting a comma;

11 (iii) in subparagraph (L), by striking the

12 period at the end and inserting a comma; and

13 (iv) by adding at the end the following sub14 paragraphs:

15 ‘‘(M) establish the condition that, with respect

16 to the type of organ involved, the list under

17 subclause (II) of subparagraph (A)(i) may be consid18 ered in allocating an organ only if no individual on

19 the list under subclause (I) of such subparagraph is

20 a medically appropriate recipient for the organ,

21 ‘‘(N) submit to the Secretary for review and ap22 proval any change in the amount of fees imposed by

23 the Network for the registration of individuals on

24 the lists maintained under subparagraph (A)(i)

25 (which change is deemed to be approved if the Sec-
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1 retary does not provide otherwise before the expira2 tion of the 30-day period beginning on the date on

3 which the change is submitted to the Secretary),

4 ‘‘(O) make available to the Secretary such in5 formation, books, and records regarding the Net6 work as the Secretary may require, and

7 ‘‘(P) meet such criteria regarding compliance

8 with this part as the Secretary may establish.’’.

9 SEC. 4. NATIONAL BONE MARROW DONOR REGISTRY.

10 (a) IN GENERAL.—

11 (1) TRANSFER OF PROGRAM.—Section 379(a)

12 of the Public Health Service Act (42 U.S.C.

13 274k(a)) is amended in the first sentence by insert14 ing after ‘‘Secretary’’ the following: ‘‘, acting

15 through the Administrator of the Health Resources

16 and Services Administration,’’.

17 (2) TRANSITIONAL AND SAVINGS PROVISIONS.—

18 (A) With respect to amounts made avail19 able under appropriations Acts for the purpose

20 of carrying out the program transferred pursu21 ant to paragraph (1) from the National Insti22 tutes of Health, the transfer of the program

23 may not be construed as affecting the availabil24 ity of such amounts for such purpose.
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1 (B) The Secretary shall ensure that, for

2 fiscal 1994, the number of employees of the De3 partment of Health and Human Services who

4 are engaged in carrying out the program trans5 ferred by paragraph (1) is not less than the

6 number of employees who were so engaged on

7 June 28, 1993.

8 (b) PATIENT ADVOCACY; RECRUITMENT OF DO9 NORS.—Section 379 of the Public Health Service Act (42

10 U.S.C. 274k) is amended—

11 (1) in subsection (b)—

12 (A) in paragraph (2), by striking ‘‘estab13 lish’’ and all that follows and inserting the fol14 lowing: ‘‘establish a program for patient advo15 cacy in accordance with subsection (j);’’; and

16 (B) in paragraph (5), by striking ‘‘recruit’’

17 and all that follows and inserting the following:

18 ‘‘establish a program for the recruitment of

19 bone marrow donors in accordance with sub20 section (k);’’;

21 (2) by striking subsection (j); and

22 (3) by inserting after subsection (i) the follow23 ing subsections:
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1 ‘‘(j) PATIENT ADVOCACY.—For purposes of sub2 section (b)(2), a program for patient advocacy is estab3 lished in accordance with this subsection if—

4 ‘‘(1) the program is headed by a director;

5 ‘‘(2) with respect to the procurement of bone

6 marrow, the program provides that the Director is

7 to serve as an advocate on behalf of—

8 ‘‘(A) individuals who are registered with

9 the Registry to become a recipient of a trans10 plant from a biologically unrelated donor;

11 ‘‘(B) the families of such individuals; and

12 ‘‘(C) the physicians involved;

13 ‘‘(3) the program provides case management

14 services for such individuals, families, and physi15 cians; and

16 ‘‘(4) the program meets such other criteria as

17 the Secretary may establish.

18 ‘‘(k) RECRUITMENT OF DONORS.—For purposes of

19 subsection (b)(5), a program for the recruitment of bone

20 marrow donors is established in accordance with this sub21 section if—

22 ‘‘(1) in recruiting an individual to enroll in the

23 Registry, and in each subsequent stage of the proc24 ess of recruitment, the program provides to the indi25 vidual information regarding the possibility that, if
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1 it is determined that it is medically inappropriate for

2 the individual to be a donor for the patient involved,

3 a sibling of the individual may nevertheless be a

4 medically appropriate donor for the patient;

5 ‘‘(2) in the case of an individual who is enrolled

6 with the Registry, the program provides for annual

7 (or more frequent) informational mailings to each

8 such individual, which mailings concern the status of

9 the activities of the Registry;

10 ‘‘(3) the program provides for the training of

11 counselors to meet individually with individuals who

12 are so enrolled and who, pursuant to the Registry,

13 have been requested to undergo confirmatory testing

14 pursuant to a search for bone marrow for a particu15 lar patient;

16 ‘‘(4) in the case of an individual described in

17 paragraph (3), the program provides to the individ18 ual a general description of the medical condition of

19 the patient involved and an assessment of the possi20 bility that the individual is a medically appropriate

21 donor for the patient; and

22 ‘‘(5) the program meets such other criteria as

23 the Secretary may establish.’’.
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1 SEC. 5. STUDY BY GENERAL ACCOUNTING OFFICE.

2 (a) IN GENERAL.—Section 379A(a) of the Public

3 Health Service Act (42 U.S.C. 274l(a)) is amended by

4 striking ‘‘conduct’’ in the matter preceding paragraph (1)

5 and all that follows and inserting the following: ‘‘conduct

6 a study for the purpose of—

7 ‘‘(1) assessing the extent to which the program

8 carried out under section 379 maintains the con9 fidentiality of the identity of individuals who are en10 rolled with the Registry;

11 ‘‘(2) assessing the extent to which such individ12 uals cooperate with the Registry when the Registry

13 requests the individuals to undergo supplemental

14 testing regarding the donation of bone marrow;

15 ‘‘(3) assessing, in the case of such individuals

16 who have been determined to be medically appro17 priate donors of bone marrow for the patients in18 volved, the extent to which such individuals are will19 ing to make a donation of bone marrow;

20 ‘‘(4) assessing the extent to which activities car21 ried out pursuant to section 379(k) provide informa22 tion to the individuals involved that is sufficient for

23 the individuals to make informed decisions regarding

24 the donation of bone marrow;

25 ‘‘(5) assessing the extent to which the case

26 management services provided under section
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1 379(j)(3) are effective in assisting patients in receiv2 ing the transplants involved;

3 ‘‘(6) developing recommendations on improving

4 the program of the Registry, including proposals to

5 increase the number of transplants with successful

6 outcomes while maintaining the confidentiality of the

7 identity of the individuals authorizing the donations

8 of bone marrow;

9 ‘‘(7) assessing the extent to which efforts to re10 cruit minority individuals to enroll in the Registry

11 have been successful;

12 ‘‘(8) assessing, in the case of minority individ13 uals who have been medically referred to receive a

14 transplant of bone marrow, the measures that

15 should be implemented to ensure that the Registry

16 provides for such individuals a probability of locating

17 a biologically unrelated, medically appropriate donor

18 that is reasonably equivalent to the probability that

19 exists with respect to Caucasian individuals who

20 have been so referred; and

21 ‘‘(9) assessing the extent to which the fees im22 posed by transplant centers with respect to the

23 search for a donor of bone marrow, when considered

24 in light of the fees imposed by the Registry, con-
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1 stitute a significant obstacle to individuals in obtain2 ing a transplant of bone marrow.’’.

3 (b) DATE CERTAIN FOR SUBMISSION OF REPORT.—

4 Section 379A(b) of the Public Health Service Act (42

5 U.S.C. 274l(b)) is amended by striking ‘‘1 year’’ and all

6 that follows through ‘‘this part’’ and inserting the follow7 ing: ‘‘2 years after the date of the enactment of the Organ

8 and Bone Marrow Transplantation Amendments of

9 1993’’.

10 SEC. 6. TRANSFER OF PROGRAMS; MISCELLANEOUS CON11 FORMING AMENDMENTS.

12 (a) IN GENERAL.—The Public Health Service Act

13 (42 U.S.C. 201 et seq.), as amended by the preceding pro14 visions of this Act, is amended—

15 (1) by striking title XVIII;

16 (2)(A) by transferring sections 371 through

17 377 from the current placement of such sections;

18 (B) by redesignating such sections as sections

19 1801 through 1807, respectively;

20 (C) by inserting such sections, in the appro21 priate sequence, after title XVII; and

22 (D) by inserting before section 1801 (as so re23 designated) the following:
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1 ‘‘TITLE XVIII—TRANSPLANTATION OF ORGANS

2 AND OF BONE MARROW

3 ‘‘PART A—ORGAN TRANSPLANTATION’’;

4 (3)(A) by striking section 378;

5 (B) by transferring sections 379 and 379A

6 from the current placement of such sections;

7 (C) by redesignating such sections as sections

8 1811 and 1813, respectively;

9 (D) by inserting such sections, in the appro10 priate sequence, at the end of title XVIII (as so des11 ignated); and

12 (E) by inserting before section 1811 (as so re13 designated) the following:

14 ‘‘PART B—NATIONAL BONE MARROW DONOR

15 REGISTRY’’;

16 and

17 (4) in title III (as amended by section

18 2008(i)(2)(B) of Public Law 103–43)—

19 (A) by striking the part designations and

20 headings for each of parts H and I; and

21 (B) by redesignating parts J through N as

22 parts H through L, respectively.

23 (b) CROSS-REFERENCES; OTHER CONFORMING

24 AMENDMENTS.—Title XVIII of the Public Health Service
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1 Act, as added by subsection (a) of this section, is amend2 ed—

3 (1) in section 1801(b)(3)—

4 (A) in subparagraph (C), by striking ‘‘sec5 tion 372(b)(2)(E)’’ and inserting ‘‘section

6 1802(b)(2)(E)’’; and

7 (B) in subparagraph (H), by striking ‘‘sec8 tion 372’’ and inserting ‘‘section 1802’’;

9 (2) in section 1802(b)(2)(A)(i)(I), by striking

10 ‘‘section 371(b)(3)(E)’’ and inserting ‘‘section

11 1801(b)(3)(E)’’;

12 (3) in section 1803, by striking ‘‘section 376’’

13 and inserting ‘‘section 1806’’;

14 (4) in section 1804—

15 (A) in subsection (a), by striking ‘‘section

16 372 or 373’’ and inserting ‘‘section 1802 or

17 1803’’;

18 (B) in subsection (b)—

19 (i) in paragraph (1), by striking ‘‘sec20 tion 371(a)(1)’’ and inserting ‘‘section

21 1801(a)(1)’’;

22 (ii) by striking paragraph (2);

23 (iii) by redesignating paragraph (3) as

24 paragraph (2); and
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1 (iv) in paragraph (2) (as so redesig2 nated), by striking ‘‘section 371(a)(3)’’

3 and inserting ‘‘section 1801(a)(2)’’;

4 (C) in subsection (c), by striking ‘‘section

5 371 or 373’’ each place such term appears and

6 inserting ‘‘section 1801 or 1803’’; and

7 (D) in subsection (d)—

8 (i) in paragraph (2), by striking ‘‘sec9 tion 373’’ and inserting ‘‘section 1803’’;

10 and

11 (ii) by adding at the end the following

12 paragraph:

13 ‘‘(3) The term ‘citizens or permanent resident

14 aliens of the United States’ means individuals who

15 are citizens or nationals of the United States, or

16 who are aliens lawfully admitted for permanent resi17 dence in the United States (or otherwise perma18 nently residing in the United States under color of

19 law).’’;

20 (5) in section 1807, by striking ‘‘SEC.’’ and all

21 that follows through ‘‘The Comptroller General’’ in

22 subsection (a) and inserting the following:

23 ‘‘STUDY BY GENERAL ACCOUNTING OFFICE

24 ‘‘SEC. 1807. (a) IN GENERAL.—The Comptroller

25 General’’;
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1 (6) in section 1805(3), by striking ‘‘section

2 372’’ and inserting ‘‘section 1802’’;

3 (7) in section 1811, by striking ‘‘SEC.’’ and all

4 that follows through ‘‘The Secretary’’ in the first

5 sentence in subsection (a) and inserting the follow6 ing:

7 ‘‘NATIONAL REGISTRY

8 ‘‘SEC. 1811. (a) ESTABLISHMENT.—The Secretary’’;

9 and

10 (8) in section 1813—

11 (A) by striking ‘‘SEC.’’ and all that follows

12 through ‘‘The Comptroller General’’ in sub13 section (a) and inserting the following:

14 ‘‘STUDY BY GENERAL ACCOUNTING OFFICE

15 ‘‘SEC. 1813. (a) IN GENERAL.—The Comptroller

16 General’’; and

17 (B) in subsection (a)—

18 (i) in paragraph (1), by striking ‘‘sec19 tion 379’’ and inserting ‘‘section 1811’’;

20 (ii) in paragraph (4), by striking ‘‘sec21 tion 379(k)’’ and inserting ‘‘section

22 1811(k)’’; and

23 (iii) in paragraph (5), by striking

24 ‘‘section 379(j)(3)’’ and inserting ‘‘section

25 1811(j)(3)’’.
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1 SEC. 7. INFORMATION, EDUCATION, AND TRAINING RE2 GARDING TRANSPLANTATION OF BONE MAR3 ROW.

4 Part B of title XVIII of the Public Health Service

5 Act, as added by section 6(a) of this Act, is amended by

6 inserting after section 1811 the following section:

7 ‘‘INFORMATION, EDUCATION, AND TRAINING

8 ‘‘SEC. 1812. (a) IN GENERAL.—The Secretary may

9 make grants to, and enter into contracts with, public or

10 nonprofit private entities for the purpose of—

11 ‘‘(1) planning and conducting programs to pro12 vide information and education to the public on the

13 need for donations of bone marrow; and

14 ‘‘(2) training individuals in requesting such do15 nations.

16 ‘‘(b) PRIORITIES IN MAKING GRANTS.—In making

17 awards of grants and contracts under subsection (a), the

18 Secretary shall give priority to carrying out the purpose

19 described in such subsection with respect to minority pop20 ulations.’’.

21 SEC. 8. AUTHORIZATION OF APPROPRIATIONS FOR NEW

22 TITLE XVIII.

23 Title XVIII of the Public Health Service Act, as

24 added by section 6(a) of this Act, is amended by adding

25 at the end the following part:
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1 ‘‘PART C—GENERAL PROVISIONS

2 ‘‘AUTHORIZATION OF APPROPRIATIONS

3 ‘‘SEC. 1821. For the purpose of carrying out this title

4 (other than section 1801(a)(1)), there are authorized to

5 be appropriated $20,000,000 for fiscal year 1994, and

6 such sums as may be necessary for each of the fiscal years

7 1995 and 1996.’’.

8 SEC. 9. STUDY REGARDING SYSTEM FOR ALLOCATION OF

9 ORGANS.

10 (a) IN GENERAL.—The Secretary of Health and

11 Human Services (in this section referred to as the ‘‘Sec12 retary’’) shall conduct a study for the purpose of determin13 ing the feasibility, fairness, and enforceability of allocating

14 organs in the United States based solely upon the clinical

15 need of the patient involved and the viability of the organ

16 involved, with no consideration given to the geographic

17 area in which the transplant is to be performed or the

18 geographic area in which the donation of the organ is

19 made.

20 (b) REPORT.—Not later than 1 year after the date

21 of the enactment of this Act, the Secretary shall submit

22 to the Committee on Energy and Commerce of the House

23 of Representatives, and to the Committee on Labor and

24 Human Resources of the Senate, a report describing the

25 findings made in the study required in subsection (a) and
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1 the actions taken by the Secretary to implement changes

2 consistent with the findings.

3 SEC. 10. ISSUANCE OF REGULATIONS.

4 (a) ORGAN PROCUREMENT AND TRANSPLANTATION

5 NETWORK.—

6 (1) IN GENERAL.—

7 (A) Not later than the expiration of the

8 90-day period beginning on the date of the en9 actment of this Act, the Secretary of Health

10 and Human Services (in this section referred to

11 as the ‘‘Secretary’’) shall issue a proposed rule

12 to establish regulations for criteria under part

13 A of title XVIII of the Public Health Service

14 Act (as added by section 6(a) of this Act).

15 (B) Not later than the expiration of the 1-

16 year period beginning on the date of the enact17 ment of this Act, the Secretary shall issue a

18 final rule to establish the regulations described

19 in subparagraph (A).

20 (2) CONSIDERATION OF CERTAIN BYLAWS AND

21 POLICIES.—In developing regulations under para22 graph (1), the Secretary shall consider the bylaws

23 and policies of the United Network for Organ Shar24 ing (established by contract under section 1802 of

25 the Public Health Service Act, as redesignated by
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1 section 6(a) of this Act), as contained in the docu2 ment entitled ‘‘Bylaws and Policies of the United

3 Network for Organ Sharing’’.

4 (3) FAILURE TO ISSUE REGULATIONS BY DATE

5 CERTAIN.—If the Secretary fails to issue a final rule

6 under subparagraph (B) of paragraph (1) before the

7 expiration of the period specified in such subpara8 graph—

9 (A) the proposed rule issued under sub10 paragraph (A) of such paragraph is upon such

11 expiration deemed to be the final rule under

12 subparagraph (B) of such paragraph (and shall

13 remain in effect until the Secretary issues a

14 final rule under such subparagraph); or

15 (B) if no such proposed rule is issued be16 fore such expiration, the bylaws and policies

17 specified in paragraph (2) and in effect upon

18 such expiration are deemed to be the final rule

19 under paragraph (1)(B) (and shall remain in

20 effect until the Secretary issues a final rule

21 under such paragraph).

22 (b) NATIONAL BONE MARROW DONOR REGISTRY.—

23 (1) IN GENERAL.—

24 (A) Not later than the expiration of the

25 90-day period beginning on the date of the en-
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1 actment of this Act, the Secretary shall issue a

2 proposed rule to establish regulations for stand3 ards, criteria, and procedures under part B of

4 title XVIII of the Public Health Service Act (as

5 added by section 6(a) of this Act).

6 (B) Not later than the expiration of the 1-

7 year period beginning the date of the enactment

8 of this Act, the Secretary shall issue a final rule

9 to establish the regulations described in sub10 paragraph (A).

11 (2) CONSIDERATION OF CERTAIN BYLAWS AND

12 POLICIES.—In developing regulations under para13 graph (1), the Secretary shall consider the bylaws

14 and policies of the entity that operates the National

15 Bone Marrow Donor Registry pursuant to a contract

16 under section 1811 of the Public Health Service Act

17 (as redesignated by section 6(a) of this Act).

18 (3) FAILURE TO ISSUE REGULATIONS BY DATE

19 CERTAIN.—If the Secretary fails to issue a final rule

20 under subparagraph (B) of paragraph (1) before the

21 expiration of the period specified in such subpara22 graph—

23 (A) the proposed rule issued under sub24 paragraph (A) of such paragraph is upon such

25 expiration deemed to be the final rule under
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1 subparagraph (B) of such paragraph (and shall

2 remain in effect until the Secretary issues a

3 final rule under such subparagraph); or

4 (B) if no such proposed rule is issued be5 fore such expiration, the bylaws and policies

6 specified in paragraph (2) and in effect upon

7 such expiration are deemed to be the final rule

8 under paragraph (1)(B) (and shall remain in

9 effect until the Secretary issues a final rule

10 under such paragraph).

11 SEC. 11. EFFECTIVE DATES.

12 (a) IN GENERAL.—The amendments described in this

13 Act are made upon the date of the enactment of this Act.

14 Except as provided in subsection (b), such amendments

15 take effect October 1, 1993, or upon the date of the enact16 ment of this Act, whichever occurs later.

17 (b) QUALIFIED ORGAN PROCUREMENT ORGANIZA18 TIONS.—

19 (1) IN GENERAL.—Except as provided in para20 graph (2), the amendments made by section 2 take

21 effect January 1, 1994. Before such date, section

22 371 of the Public Health Service Act, as in effect on

23 the day before the date of the enactment of this Act,

24 continues to be in effect.
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1 (2) ADDITIONAL PROVISION.—The amendment

2 made by section 2(b)(2)(A) (relating to effective

3 agreements with entities with facilities for organ do4 nations) takes effect upon the expiration of the 180-

5 day period beginning on the date on which a final

6 rule takes effect under section 10(a). Before such

7 amendment takes effect under the preceding sen8 tence, section 371(b)(3)(A) of the Public Health

9 Service Act, as in effect on the day before the date

10 of the enactment of this Act, continues to be in

11 effect.

Passed the House of Representatives October 5,

1993.

Attest:

Clerk.

HR 2659 EH——2

HR 2659 EH——3