Union Calendar No. 152

103D CONGRESS

1ST SESSION H. R. 2659

[Report No. 103–272]

A BILL

To amend the Public Health Service Act to revise

tation of organs and of bone marrow.and extend programs relating to the transplanSEPTEMBER 30, 1993

Reported with an amendment, committed to the Commitordered to be printed tee of the Whole House on the State of the Union, and
IB

Union Calendar No. 152

103D CONGRESS

1ST SESSION H. R. 2659

[Report No. 103–272]

To amend the Public Health Service Act to revise and extend programs

relating to the transplantation of organs and of bone marrow.

IN THE HOUSE OF REPRESENTATIVES

JULY 15, 1993

Mr. WAXMAN (for himself, Mr. HALL of Texas, Mr. ROWLAND, Mr. TOWNS,

Mr. UPTON, Mr. KLUG, and Mr. FRANKS of Connecticut) introduced the

following bill; which was referred to the Committee on Energy and Commerce

SEPTEMBER 30, 1993

Reported with an amendment, committed to the Committee of the Whole

House on the State of the Union, and ordered to be printed

[Strike out all after the enacting clause and insert the part printed in italic]

[For text of introduced bill, see copy of bill as introduced on July 15, 1993]

A BILL

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,
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1 SECTION 1. SHORT TITLE.

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

3 Marrow Transplantation Amendments of 1993’’.

4 SEC. 2. ORGAN PROCUREMENT ORGANIZATIONS.

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

6 Service Act (42 U.S.C. 273(a)) is amended—

7 (1) by striking paragraphs (2) and (3); and

8 (2) by inserting after paragraph (1) the follow9 ing paragraph:

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

11 into contracts with, qualified organ procurement organiza12 tions described in subsection (b) and other public or non13 profit private entities for the purpose of—

14 ‘‘(i) planning and conducting programs to pro15 vide information and education to the public on the

16 need for organ donations; and

17 ‘‘(ii) training individuals in requesting such do18 nations.

19 ‘‘(B) In making awards of grants and contracts under

20 subparagraph (A), the Secretary shall give priority to car21 rying out the purpose described in such subparagraph with

22 respect to minority populations.’’.

23 (b) REQUIREMENTS REGARDING QUALIFIED ORGAN

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

25 Public Health Service Act (42 U.S.C. 273(b)) is amended—

26 (1) in paragraph (1)—
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1 (A) in the matter preceding subparagraph

2 (A)—

3 (i) by striking ‘‘organization for which

4 grants may be made under subsection (a)

5 is’’ and inserting ‘‘organization described in

6 this subsection is’’; and

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

8 inserting ‘‘paragraph (3)’’;

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

10 subparagraph 2 ems to the left; and

11 (C) in subparagraph (G)—

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

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

14 advisory board which’’ and inserting the

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

16 advisory board, in the case of a hospital17 based organization) which’’; and

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

19 ‘‘members’’ and all that follows and insert20 ing the following: ‘‘individuals who have re21 ceived a transplant of an organ, individuals

22 who are part of the family of an individual

23 who has donated an organ, and individuals

24 who have been medically referred to receive

25 a transplant of an organ (or individuals
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1 who are part of the family of individuals

2 who have been so referred), which individ3 uals shall in the aggregate constitute not

less than 1 4 ⁄3 of the membership of the board

5 and which members shall, to the extent

6 practicable, be residents of the service area

7 involved,’’; and

8 (2) in paragraph (3)—

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

10 subparagraph to read as follows:

11 ‘‘(A)(i) With respect to each hospital or other en12 tity in its service area that has facilities for organ do13 nations, the organization shall have an effective agree14 ment with the entity under which the entity identifies

15 potential organ donors and notifies the organization,

16 subject to clause (ii).

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

18 of clause (i) to the extent determined by the Secretary

19 to be necessary to promote organ donation and the eq20 uitable allocation of organs.’’;

21 (B)(i) in the matter preceding subpara22 graph (A), by striking ‘‘shall—’’ and inserting

23 ‘‘shall comply with the following:’’;
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1 (ii) in each of subparagraphs (B) through

2 (K), by inserting ‘‘The organization shall’’ before

3 the first word of the subparagraph;

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

5 (I), by striking the comma at the end and insert6 ing a period; and

7 (iv) in subparagraph (J), by striking ‘‘,

8 and’’ and inserting a period;

9 (C) in subparagraph (E)—

10 (i) by inserting ‘‘(i)’’ after the sub11 paragraph designation; and

12 (ii) by adding at the end the following

13 clauses:

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

15 (iii), ensure that the system under clause (i) allocates

16 each type of organ on the basis of a single list, main17 tained exclusively by the organization, of individuals

18 who have been medically referred to a transplant cen19 ter in the service area of the organization in order to

20 receive a transplant of the type of organ with respect

21 to which the list is maintained, and who are citizens

22 or permanent resident aliens of the United States.

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

24 Secretary may, with respect to the service area of the

25 organization, waive the requirement of clause (ii) re-
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1 garding a single list if the Secretary determines that

2 the waiver is necessary to ensure the equitable alloca3 tion of organs of the type involved and maximize the

4 opportunities for successful outcomes of transplants of

5 such organs.’’; and

6 (D) in subparagraph (H), by striking ‘‘par7 ticipate’’ and all that follows through ‘‘372’’ and

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

9 abide by the rules and requirements of, the

10 Organ Procurement and Transplantation Net11 work established under section 372’’.

12 SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION

13 NETWORK.

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

15 U.S.C. 274(b)) is amended—

16 (1) in paragraph (1)—

17 (A) in subparagraph (A), by striking ‘‘and’’

18 after the comma at the end; and

19 (B) by striking subparagraph (B) and in20 serting the following subparagraphs:

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

22 more than 32 members, whose membership includes—

23 ‘‘(i) representatives of organ procurement

24 organizations, transplant centers, and voluntary

25 health associations; and
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1 ‘‘(ii) individuals who have received a trans2 plant of an organ, individuals who are part of

3 the family of an individual who has donated an

4 organ, and individuals who have been medically

5 referred to receive a transplant of an organ (or

6 individuals who are part of the family of indi7 viduals who have been so referred), which indi8 viduals shall in the aggregate constitute not less

than 1 9 ⁄3 of the membership of the board; and

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

11 an executive committee and other committees, the

12 chairs of which shall be selected to ensure continuity

13 of leadership for the board.’’; and

14 (2) in paragraph (2)—

15 (A) by striking ‘‘shall—’’ in the matter pre16 ceding subparagraph (A) and all that follows

17 through the end of clause (i) of such subpara18 graph and inserting the following: ‘‘shall—

19 ‘‘(A) establish (in one location or through re20 gional centers)—

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

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

23 have been medically referred to receive a

24 transplant of the type of organ with respect

25 to which the list is maintained and who are
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1 citizens or permanent resident aliens of the

2 United States (which list shall include the

3 names of all individuals included on lists in

4 effect under section 371(b)(3)(E)), and

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

6 have been so referred and who are in the

7 United States but are not such citizens or

8 such aliens, and’’; and

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

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

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

12 period at the end and inserting a comma;

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

14 period at the end and inserting a comma; and

15 (iv) by adding at the end the following sub16 paragraphs:

17 ‘‘(M) establish the condition that, with respect to

18 the type of organ involved, the list under subclause

19 (II) of subparagraph (A)(i) may be considered in al20 locating an organ only if no individual on the list

21 under subclause (I) of such subparagraph is a medi22 cally appropriate recipient for the organ,

23 ‘‘(N) submit to the Secretary for review and ap24 proval any change in the amount of fees imposed by

25 the Network for the registration of individuals on the
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1 lists maintained under subparagraph (A)(i) (which

2 change is deemed to be approved if the Secretary does

3 not provide otherwise before the expiration of the 30-

4 day period beginning on the date on which the change

5 is submitted to the Secretary),

6 ‘‘(O) make available to the Secretary such infor7 mation, books, and records regarding the Network as

8 the Secretary may require, and

9 ‘‘(P) meet such criteria regarding compliance

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

11 SEC. 4. NATIONAL BONE MARROW DONOR REGISTRY.

12 (a) IN GENERAL.—

13 (1) TRANSFER OF PROGRAM.—Section 379(a) of

14 the Public Health Service Act (42 U.S.C. 274k(a)) is

15 amended in the first sentence by inserting after ‘‘Sec16 retary’’ the following: ‘‘, acting through the Adminis17 trator of the Health Resources and Services Adminis18 tration,’’.

19 (2) TRANSITIONAL AND SAVINGS PROVISIONS.—

20 (A) With respect to amounts made available

21 under appropriations Acts for the purpose of

22 carrying out the program transferred pursuant

23 to paragraph (1) from the National Institutes of

24 Health, the transfer of the program may not be
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1 construed as affecting the availability of such

2 amounts for such purpose.

3 (B) The Secretary shall ensure that, for fis4 cal 1994, the number of employees of the Depart5 ment of Health and Human Services who are en6 gaged in carrying out the program transferred

7 by paragraph (1) is not less than the number of

8 employees who were so engaged on June 28,

9 1993.

10 (b) PATIENT ADVOCACY; RECRUITMENT OF DONORS.—

11 Section 379 of the Public Health Service Act (42 U.S.C.

12 274k) is amended—

13 (1) in subsection (b)—

14 (A) in paragraph (2), by striking ‘‘estab15 lish’’ and all that follows and inserting the fol16 lowing: ‘‘establish a program for patient advo17 cacy in accordance with subsection (j);’’; and

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

19 and all that follows and inserting the following:

20 ‘‘establish a program for the recruitment of bone

21 marrow donors in accordance with subsection

22 (k);’’;

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

24 (3) by inserting after subsection (i) the following

25 subsections:
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1 ‘‘(j) PATIENT ADVOCACY.—For purposes of subsection

2 (b)(2), a program for patient advocacy is established in ac3 cordance 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 to

7 serve as an advocate on behalf of—

8 ‘‘(A) individuals who are registered with the

9 Registry to become a recipient of a transplant

10 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 the

17 Secretary may establish.

18 ‘‘(k) RECRUITMENT OF DONORS.—For purposes of sub19 section (b)(5), a program for the recruitment of bone mar20 row donors is established in accordance with this subsection

21 if—

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

23 Registry, and in each subsequent stage of the process

24 of recruitment, the program provides to the individ25 ual information regarding the possibility that, if it is
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1 determined that it is medically inappropriate for the

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

3 sibling of the individual may nevertheless be a medi4 cally 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 possibil20 ity that the individual is a medically appropriate

21 donor for the patient; and

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

23 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 strik4 ing ‘‘conduct’’ in the matter preceding paragraph (1) and

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

6 study for the purpose of—

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

8 carried out under section 379 maintains the confiden9 tiality of the identity of individuals who are enrolled

10 with the Registry;

11 ‘‘(2) assessing the extent to which such individ12 uals cooperate with the Registry when the Registry re13 quests the individuals to undergo supplemental testing

14 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 man26 agement services provided under section 379(j)(3) are
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1 effective in assisting patients in receiving the trans2 plants 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 should

15 be implemented to ensure that the Registry provides

16 for such individuals a probability of locating a bio17 logically unrelated, medically appropriate donor that

18 is reasonably equivalent to the probability that exists

19 with respect to Caucasian individuals who have been

20 so referred; and

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

23 for a donor of bone marrow, when considered in light

24 of the fees imposed by the Registry, constitute a sig-
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1 nificant obstacle to individuals in obtaining a trans2 plant of bone marrow.’’.

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

4 Section 379A(b) of the Public Health Service Act (42 U.S.C.

5 274l(b)) is amended by striking ‘‘1 year’’ and all that fol6 lows through ‘‘this part’’ and inserting the following: ‘‘2

7 years after the date of the enactment of the Organ and Bone

8 Marrow Transplantation Amendments of 1993’’.

9 SEC. 6. TRANSFER OF PROGRAMS; MISCELLANEOUS CON10 FORMING AMENDMENTS.

11 (a) IN GENERAL.—The Public Health Service Act (42

12 U.S.C. 201 et seq.), as amended by the preceding provisions

13 of this Act, is amended—

14 (1) by striking title XVIII;

15 (2)(A) by transferring sections 371 through 377

16 from the current placement of such sections;

17 (B) by redesignating such sections as sections

18 1801 through 1807, respectively;

19 (C) by inserting such sections, in the appropriate

20 sequence, after title XVII; and

21 (D) by inserting before section 1801 (as so redes22 ignated) 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 from

6 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 redes13 ignated) the following:

14 ‘‘PART B—NATIONAL BONE MARROW DONOR REGISTRY’’;

15 and

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

17 2008(i)(2)(B) of Public Law 103–43)—

18 (A) by striking the part designations and

19 headings for each of parts H and I; and

20 (B) by redesignating parts J through N as

21 parts H through L, respectively.

22 (b) CROSS-REFERENCES; OTHER CONFORMING

23 AMENDMENTS.—Title XVIII of the Public Health Service

24 Act, as added by subsection (a) of this section, is amended—

25 (1) in section 1801(b)(3)—
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1 (A) in subparagraph (C), by striking ‘‘sec2 tion 372(b)(2)(E)’’ and inserting ‘‘section

3 1802(b)(2)(E)’’; and

4 (B) in subparagraph (H), by striking ‘‘sec5 tion 372’’ and inserting ‘‘section 1802’’;

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

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

8 1801(b)(3)(E)’’;

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

10 and inserting ‘‘section 1806’’;

11 (4) in section 1804—

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

13 372 or 373’’ and inserting ‘‘section 1802 or

14 1803’’;

15 (B) in subsection (b)—

16 (i) in paragraph (1), by striking ‘‘sec17 tion 371(a)(1)’’ and inserting ‘‘section

18 1801(a)(1)’’;

19 (ii) by striking paragraph (2);

20 (iii) by redesignating paragraph (3) as

21 paragraph (2); and

22 (iv) in paragraph (2) (as so redesig23 nated), by striking ‘‘section 371(a)(3)’’ and

24 inserting ‘‘section 1801(a)(2)’’;
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1 (C) in subsection (c), by striking ‘‘section

2 371 or 373’’ each place such term appears and

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

4 (D) in subsection (d)—

5 (i) in paragraph (2), by striking ‘‘sec6 tion 373’’ and inserting ‘‘section 1803’’; and

7 (ii) by adding at the end the following

8 paragraph:

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

10 aliens of the United States’ means individuals who

11 are citizens or nationals of the United States, or who

12 are aliens lawfully admitted for permanent residence

13 in the United States (or otherwise permanently resid14 ing in the United States under color of law).’’;

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

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

17 subsection (a) and inserting the following:

18 ‘‘STUDY BY GENERAL ACCOUNTING OFFICE

19 ‘‘SEC. 1807. (a) IN GENERAL.—The Comptroller Gen20 eral’’;

21 (6) in section 1805(3), by striking ‘‘section 372’’

22 and inserting ‘‘section 1802’’;

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

24 that follows through ‘‘The Secretary’’ in the first sen25 tence in subsection (a) and inserting the following:
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1 ‘‘NATIONAL REGISTRY

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

3 and

4 (8) in section 1813—

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

6 through ‘‘The Comptroller General’’ in subsection

7 (a) and inserting the following:

8 ‘‘STUDY BY GENERAL ACCOUNTING OFFICE

9 ‘‘SEC. 1813. (a) IN GENERAL.—The Comptroller Gen10 eral’’; and

11 (B) in subsection (a)—

12 (i) in paragraph (1), by striking ‘‘sec13 tion 379’’ and inserting ‘‘section 1811’’;

14 (ii) in paragraph (4), by striking ‘‘sec15 tion 379(k)’’ and inserting ‘‘section

16 1811(k)’’; and

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

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

19 1811(j)(3)’’.

20 SEC. 7. INFORMATION, EDUCATION, AND TRAINING RE21 GARDING TRANSPLANTATION OF BONE MAR22 ROW.

23 Part B of title XVIII of the Public Health Service Act,

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

25 after section 1811 the following section:
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1 ‘‘INFORMATION, EDUCATION, AND TRAINING

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

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

4 nonprofit private entities for the purpose of—

5 ‘‘(1) planning and conducting programs to pro6 vide information and education to the public on the

7 need for donations of bone marrow; and

8 ‘‘(2) training individuals in requesting such do9 nations.

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

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

12 Secretary shall give priority to carrying out the purpose

13 described in such subsection with respect to minority popu14 lations.’’.

15 SEC. 8. AUTHORIZATION OF APPROPRIATIONS FOR NEW

16 TITLE XVIII.

17 Title XVIII of the Public Health Service Act, as added

18 by section 6(a) of this Act, is amended by adding at the

19 end the following part:

20 ‘‘PART C—GENERAL PROVISIONS

21 ‘‘AUTHORIZATION OF APPROPRIATIONS

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

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

24 appropriated $20,000,000 for fiscal year 1994, and such
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1 sums as may be necessary for each of the fiscal years 1995

2 and 1996.’’.

3 SEC. 9. STUDY REGARDING SYSTEM FOR ALLOCATION OF

4 ORGANS.

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

6 Human Services (in this section referred to as the ‘‘Sec7 retary’’) shall conduct a study for the purpose of determin8 ing the feasibility, fairness, and enforceability of allocating

9 organs in the United States based solely upon the clinical

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

11 involved, with no consideration given to the geographic area

12 in which the transplant is to be performed or the geographic

13 area in which the donation of the organ is made.

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

15 the enactment of this Act, the Secretary shall submit to the

16 Committee on Energy and Commerce of the House of Rep17 resentatives, and to the Committee on Labor and Human

18 Resources of the Senate, a report describing the findings

19 made in the study required in subsection (a) and the actions

20 taken by the Secretary to implement changes consistent

21 with the findings.

22 SEC. 10. ISSUANCE OF REGULATIONS.

23 (a) ORGAN PROCUREMENT AND TRANSPLANTATION

24 NETWORK.—

25 (1) IN GENERAL.—
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1 (A) Not later than the expiration of the 90-

2 day period beginning on the date of the enact3 ment of this Act, the Secretary of Health and

4 Human Services (in this section referred to as

5 the ‘‘Secretary’’) shall issue a proposed rule to

6 establish regulations for criteria under part A of

7 title XVIII of the Public Health Service Act (as

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

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

10 year period beginning on the date of the enact11 ment of this Act, the Secretary shall issue a final

12 rule to establish the regulations described in sub13 paragraph (A).

14 (2) CONSIDERATION OF CERTAIN BYLAWS AND

15 POLICIES.—In developing regulations under para16 graph (1), the Secretary shall consider the bylaws and

17 policies of the United Network for Organ Sharing (es18 tablished by contract under section 1802 of the Public

19 Health Service Act, as redesignated by section 6(a) of

20 this Act), as contained in the document entitled ‘‘By21 laws and Policies of the United Network for Organ

22 Sharing’’.

23 (3) FAILURE TO ISSUE REGULATIONS BY DATE

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

25 under subparagraph (B) of paragraph (1) before the
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1 expiration of the period specified in such subpara2 graph—

3 (A) the proposed rule issued under subpara4 graph (A) of such paragraph is upon such expi5 ration deemed to be the final rule under sub6 paragraph (B) of such paragraph (and shall re7 main in effect until the Secretary issues a final

8 rule under such subparagraph); or

9 (B) if no such proposed rule is issued before

10 such expiration, the bylaws and policies specified

11 in paragraph (2) and in effect upon such expira12 tion are deemed to be the final rule under para13 graph (1)(B) (and shall remain in effect until

14 the Secretary issues a final rule under such

15 paragraph).

16 (b) NATIONAL BONE MARROW DONOR REGISTRY.—

17 (1) IN GENERAL.—

18 (A) Not later than the expiration of the 90-

19 day period beginning on the date of the enact20 ment of this Act, the Secretary shall issue a pro21 posed rule to establish regulations for standards,

22 criteria, and procedures under part B of title

23 XVIII of the Public Health Service Act (as added

24 by section 6(a) of this Act).
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1 (B) Not later than the expiration of the 1-

2 year period beginning the date of the enactment

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

4 to establish the regulations described in subpara5 graph (A).

6 (2) CONSIDERATION OF CERTAIN BYLAWS AND

7 POLICIES.—In developing regulations under para8 graph (1), the Secretary shall consider the bylaws and

9 policies of the entity that operates the National Bone

10 Marrow Donor Registry pursuant to a contract under

11 section 1811 of the Public Health Service Act (as re12 designated by section 6(a) of this Act).

13 (3) FAILURE TO ISSUE REGULATIONS BY DATE

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

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

16 expiration of the period specified in such subpara17 graph—

18 (A) the proposed rule issued under subpara19 graph (A) of such paragraph is upon such expi20 ration deemed to be the final rule under sub21 paragraph (B) of such paragraph (and shall re22 main in effect until the Secretary issues a final

23 rule under such subparagraph); or

24 (B) if no such proposed rule is issued before

25 such expiration, the bylaws and policies specified
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1 in paragraph (2) and in effect upon such expira2 tion are deemed to be the final rule under para3 graph (1)(B) (and shall remain in effect until

4 the Secretary issues a final rule under such

5 paragraph).

6 SEC. 11. EFFECTIVE DATES.

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

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

9 Except as provided in subsection (b), such amendments take

10 effect October 1, 1993, or upon the date of the enactment

11 of this Act, whichever occurs later.

12 (b) QUALIFIED ORGAN PROCUREMENT ORGANIZA13 TIONS.—

14 (1) IN GENERAL.—Except as provided in para15 graph (2), the amendments made by section 2 take ef16 fect January 1, 1994. Before such date, section 371 of

17 the Public Health Service Act, as in effect on the day

18 before the date of the enactment of this Act, continues

19 to be in effect.

20 (2) ADDITIONAL PROVISION.—The amendment

21 made by section 2(b)(2)(A) (relating to effective agree22 ments with entities with facilities for organ dona23 tions) takes effect upon the expiration of the 180-day

24 period beginning on the date on which a final rule

25 takes effect under section 10(a). Before such amend-
26

•HR 2659 RH

1 ment takes effect under the preceding sentence, section

2 371(b)(3)(A) of the Public Health Service Act, as in

3 effect on the day before the date of the enactment of

4 this Act, continues to be in effect.

HR 2659 RH——2