[Congressional Bills 103th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2659 Reported in House (RH)]

                                                 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 and extend programs 
     relating to the transplantation of organs and of bone marrow.

_______________________________________________________________________

                           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





                                                 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.

    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 ``Organ and Bone Marrow 
Transplantation Amendments of 1993''.

SEC. 2. ORGAN PROCUREMENT ORGANIZATIONS.

    (a) In General.--Section 371(a) of the Public Health Service Act 
(42 U.S.C. 273(a)) is amended--
            (1) by striking paragraphs (2) and (3); and
            (2) by inserting after paragraph (1) the following 
        paragraph:
    ``(2)(A) The Secretary may make grants to, and enter into contracts 
with, qualified organ procurement organizations described in subsection 
(b) and other public or nonprofit private entities for the purpose of--
            ``(i) planning and conducting programs to provide 
        information and education to the public on the need for organ 
        donations; and
            ``(ii) training individuals in requesting such donations.
    ``(B) In making awards of grants and contracts under subparagraph 
(A), the Secretary shall give priority to carrying out the purpose 
described in such subparagraph with respect to minority populations.''.
    (b) Requirements Regarding Qualified Organ Procurement 
Organizations.--Section 371(b) of the Public Health Service Act (42 
U.S.C. 273(b)) is amended--
            (1) in paragraph (1)--
                    (A) in the matter preceding subparagraph (A)--
                            (i) by striking ``organization for which 
                        grants may be made under subsection (a) is'' 
                        and inserting ``organization described in this 
                        subsection is''; and
                            (ii) by striking ``paragraph (2)'' and 
                        inserting ``paragraph (3)'';
                    (B) in subparagraph (E), by moving the subparagraph 
                2 ems to the left; and
                    (C) in subparagraph (G)--
                            (i) in the matter preceding clause (i), by 
                        striking ``has a board of directors or an 
                        advisory board which'' and inserting the 
                        following: ``has a board of directors (or an 
                        advisory board, in the case of a hospital-based 
                        organization) which''; and
                            (ii) in clause (i)(II), by striking 
                        ``members'' and all that follows and inserting 
                        the following: ``individuals who have received 
                        a transplant of an organ, individuals who are 
                        part of the family of an individual who has 
                        donated an organ, and individuals who have been 
                        medically referred to receive a transplant of 
                        an organ (or individuals who are part of the 
                        family of individuals who have been so 
                        referred), which individuals shall in the 
                        aggregate constitute not less than \1/3\ of the 
                        membership of the board and which members 
                        shall, to the extent practicable, be residents 
                        of the service area involved,''; and
            (2) in paragraph (3)--
                    (A) in subparagraph (A), by amending the 
                subparagraph to read as follows:
            ``(A)(i) With respect to each hospital or other entity in 
        its service area that has facilities for organ donations, the 
        organization shall have an effective agreement with the entity 
        under which the entity identifies potential organ donors and 
        notifies the organization, subject to clause (ii).
            ``(ii) The Secretary may waive the requirement of clause 
        (i) to the extent determined by the Secretary to be necessary 
        to promote organ donation and the equitable allocation of 
        organs.'';
                    (B)(i) in the matter preceding subparagraph (A), by 
                striking ``shall--'' and inserting ``shall comply with 
                the following:'';
                    (ii) in each of subparagraphs (B) through (K), by 
                inserting ``The organization shall'' before the first 
                word of the subparagraph;
                    (iii) in each of subparagraphs (B) through (I), by 
                striking the comma at the end and inserting a period; 
                and
                    (iv) in subparagraph (J), by striking ``, and'' and 
                inserting a period;
                    (C) in subparagraph (E)--
                            (i) by inserting ``(i)'' after the 
                        subparagraph designation; and
                            (ii) by adding at the end the following 
                        clauses:
            ``(ii) The organization shall, subject to clause (iii), 
        ensure that the system under clause (i) allocates each type of 
        organ on the basis of a single list, maintained exclusively by 
        the organization, of individuals who have been medically 
        referred to a transplant center in the service area of the 
        organization in order to receive a transplant of the type of 
        organ with respect to which the list is maintained, and who are 
        citizens or permanent resident aliens of the United States.
            ``(iii) Upon the request of the organization, the Secretary 
        may, with respect to the service area of the organization, 
        waive the requirement of clause (ii) regarding a single list if 
        the Secretary determines that the waiver is necessary to ensure 
        the equitable allocation of organs of the type involved and 
        maximize the opportunities for successful outcomes of 
        transplants of such organs.''; and
                    (D) in subparagraph (H), by striking 
                ``participate'' and all that follows through ``372'' 
                and inserting the following: ``be a member of, and 
                abide by the rules and requirements of, the Organ 
                Procurement and Transplantation Network established 
                under section 372''.

SEC. 3. ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK.

    Section 372(b) of the Public Health Service Act (42 U.S.C. 274(b)) 
is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A), by striking ``and'' after 
                the comma at the end; and
                    (B) by striking subparagraph (B) and inserting the 
                following subparagraphs:
            ``(B) have a board of directors composed of not more than 
        32 members, whose membership includes--
                    ``(i) representatives of organ procurement 
                organizations, transplant centers, and voluntary health 
                associations; and
                    ``(ii) individuals who have received a transplant 
                of an organ, individuals who are part of the family of 
                an individual who has donated an organ, and individuals 
                who have been medically referred to receive a 
                transplant of an organ (or individuals who are part of 
                the family of individuals who have been so referred), 
                which individuals shall in the aggregate constitute not 
                less than \1/3\ of the membership of the board; and
            ``(C) establish, through such board of directors, an 
        executive committee and other committees, the chairs of which 
        shall be selected to ensure continuity of leadership for the 
        board.''; and
            (2) in paragraph (2)--
                    (A) by striking ``shall--'' in the matter preceding 
                subparagraph (A) and all that follows through the end 
                of clause (i) of such subparagraph and inserting the 
                following: ``shall--
            ``(A) establish (in one location or through regional 
        centers)--
                    ``(i) with respect to each type of organ--
                            ``(I) a national list of individuals who 
                        have been medically referred to receive a 
                        transplant of the type of organ with respect to 
                        which the list is maintained and who are 
                        citizens or permanent resident aliens of the 
                        United States (which list shall include the 
                        names of all individuals included on lists in 
                        effect under section 371(b)(3)(E)), and
                            ``(II) a national list of individuals who 
                        have been so referred and who are in the United 
                        States but are not such citizens or such 
                        aliens, and''; and
                    (B)(i) in subparagraph (J), by striking ``and'' 
                after the comma at the end;
                    (ii) in subparagraph (K), by striking the period at 
                the end and inserting a comma;
                    (iii) in subparagraph (L), by striking the period 
                at the end and inserting a comma; and
                    (iv) by adding at the end the following 
                subparagraphs:
            ``(M) establish the condition that, with respect to the 
        type of organ involved, the list under subclause (II) of 
        subparagraph (A)(i) may be considered in allocating an organ 
        only if no individual on the list under subclause (I) of such 
        subparagraph is a medically appropriate recipient for the 
        organ,
            ``(N) submit to the Secretary for review and approval any 
        change in the amount of fees imposed by the Network for the 
        registration of individuals on the lists maintained under 
        subparagraph (A)(i) (which change is deemed to be approved if 
        the Secretary does not provide otherwise before the expiration 
        of the 30-day period beginning on the date on which the change 
        is submitted to the Secretary),
            ``(O) make available to the Secretary such information, 
        books, and records regarding the Network as the Secretary may 
        require, and
            ``(P) meet such criteria regarding compliance with this 
        part as the Secretary may establish.''.

SEC. 4. NATIONAL BONE MARROW DONOR REGISTRY.

    (a) In General.--
            (1) Transfer of program.--Section 379(a) of the Public 
        Health Service Act (42 U.S.C. 274k(a)) is amended in the first 
        sentence by inserting after ``Secretary'' the following: ``, 
        acting through the Administrator of the Health Resources and 
        Services Administration,''.
            (2) Transitional and savings provisions.--
                    (A) With respect to amounts made available under 
                appropriations Acts for the purpose of carrying out the 
                program transferred pursuant to paragraph (1) from the 
                National Institutes of Health, the transfer of the 
                program may not be construed as affecting the 
                availability of such amounts for such purpose.
                    (B) The Secretary shall ensure that, for fiscal 
                1994, the number of employees of the Department of 
                Health and Human Services who are engaged in carrying 
                out the program transferred by paragraph (1) is not 
                less than the number of employees who were so engaged 
                on June 28, 1993.
    (b) Patient Advocacy; Recruitment of Donors.--Section 379 of the 
Public Health Service Act (42 U.S.C. 274k) is amended--
            (1) in subsection (b)--
                    (A) in paragraph (2), by striking ``establish'' and 
                all that follows and inserting the following: 
                ``establish a program for patient advocacy in 
                accordance with subsection (j);''; and
                    (B) in paragraph (5), by striking ``recruit'' and 
                all that follows and inserting the following: 
                ``establish a program for the recruitment of bone 
                marrow donors in accordance with subsection (k);'';
            (2) by striking subsection (j); and
            (3) by inserting after subsection (i) the following 
        subsections:
    ``(j) Patient Advocacy.--For purposes of subsection (b)(2), a 
program for patient advocacy is established in accordance with this 
subsection if--
            ``(1) the program is headed by a director;
            ``(2) with respect to the procurement of bone marrow, the 
        program provides that the Director is to serve as an advocate 
        on behalf of--
                    ``(A) individuals who are registered with the 
                Registry to become a recipient of a transplant from a 
                biologically unrelated donor;
                    ``(B) the families of such individuals; and
                    ``(C) the physicians involved;
            ``(3) the program provides case management services for 
        such individuals, families, and physicians; and
            ``(4) the program meets such other criteria as the 
        Secretary may establish.
    ``(k) Recruitment of Donors.--For purposes of subsection (b)(5), a 
program for the recruitment of bone marrow donors is established in 
accordance with this subsection if--
            ``(1) in recruiting an individual to enroll in the 
        Registry, and in each subsequent stage of the process of 
        recruitment, the program provides to the individual information 
        regarding the possibility that, if it is determined that it is 
        medically inappropriate for the individual to be a donor for 
        the patient involved, a sibling of the individual may 
        nevertheless be a medically appropriate donor for the patient;
            ``(2) in the case of an individual who is enrolled with the 
        Registry, the program provides for annual (or more frequent) 
        informational mailings to each such individual, which mailings 
        concern the status of the activities of the Registry;
            ``(3) the program provides for the training of counselors 
        to meet individually with individuals who are so enrolled and 
        who, pursuant to the Registry, have been requested to undergo 
        confirmatory testing pursuant to a search for bone marrow for a 
        particular patient;
            ``(4) in the case of an individual described in paragraph 
        (3), the program provides to the individual a general 
        description of the medical condition of the patient involved 
        and an assessment of the possibility that the individual is a 
        medically appropriate donor for the patient; and
            ``(5) the program meets such other criteria as the 
        Secretary may establish.''.

SEC. 5. STUDY BY GENERAL ACCOUNTING OFFICE.

    (a) In General.--Section 379A(a) of the Public Health Service Act 
(42 U.S.C. 274l(a)) is amended by striking ``conduct'' in the matter 
preceding paragraph (1) and all that follows and inserting the 
following: ``conduct a study for the purpose of--
            ``(1) assessing the extent to which the program carried out 
        under section 379 maintains the confidentiality of the identity 
        of individuals who are enrolled with the Registry;
            ``(2) assessing the extent to which such individuals 
        cooperate with the Registry when the Registry requests the 
        individuals to undergo supplemental testing regarding the 
        donation of bone marrow;
            ``(3) assessing, in the case of such individuals who have 
        been determined to be medically appropriate donors of bone 
        marrow for the patients involved, the extent to which such 
        individuals are willing to make a donation of bone marrow;
            ``(4) assessing the extent to which activities carried out 
        pursuant to section 379(k) provide information to the 
        individuals involved that is sufficient for the individuals to 
        make informed decisions regarding the donation of bone marrow;
            ``(5) assessing the extent to which the case management 
        services provided under section 379(j)(3) are effective in 
        assisting patients in receiving the transplants involved;
            ``(6) developing recommendations on improving the program 
        of the Registry, including proposals to increase the number of 
        transplants with successful outcomes while maintaining the 
        confidentiality of the identity of the individuals authorizing 
        the donations of bone marrow;
            ``(7) assessing the extent to which efforts to recruit 
        minority individuals to enroll in the Registry have been 
        successful;
            ``(8) assessing, in the case of minority individuals who 
        have been medically referred to receive a transplant of bone 
        marrow, the measures that should be implemented to ensure that 
        the Registry provides for such individuals a probability of 
        locating a biologically unrelated, medically appropriate donor 
        that is reasonably equivalent to the probability that exists 
        with respect to Caucasian individuals who have been so 
        referred; and
            ``(9) assessing the extent to which the fees imposed by 
        transplant centers with respect to the search for a donor of 
        bone marrow, when considered in light of the fees imposed by 
        the Registry, constitute a significant obstacle to individuals 
        in obtaining a transplant of bone marrow.''.
    (b) Date Certain for Submission of Report.--Section 379A(b) of the 
Public Health Service Act (42 U.S.C. 274l(b)) is amended by striking 
``1 year'' and all that follows through ``this part'' and inserting the 
following: ``2 years after the date of the enactment of the Organ and 
Bone Marrow Transplantation Amendments of 1993''.

SEC. 6. TRANSFER OF PROGRAMS; MISCELLANEOUS CONFORMING AMENDMENTS.

    (a) In General.--The Public Health Service Act (42 U.S.C. 201 et 
seq.), as amended by the preceding provisions of this Act, is amended--
            (1) by striking title XVIII;
            (2)(A) by transferring sections 371 through 377 from the 
        current placement of such sections;
            (B) by redesignating such sections as sections 1801 through 
        1807, respectively;
            (C) by inserting such sections, in the appropriate 
        sequence, after title XVII; and
            (D) by inserting before section 1801 (as so redesignated) 
        the following:

      ``TITLE XVIII--TRANSPLANTATION OF ORGANS AND OF BONE MARROW

                   ``Part A--Organ Transplantation'';

            (3)(A) by striking section 378;
            (B) by transferring sections 379 and 379A from the current 
        placement of such sections;
            (C) by redesignating such sections as sections 1811 and 
        1813, respectively;
            (D) by inserting such sections, in the appropriate 
        sequence, at the end of title XVIII (as so designated); and
            (E) by inserting before section 1811 (as so redesignated) 
        the following:

            ``Part B--National Bone Marrow Donor Registry'';

        and
            (4) in title III (as amended by section 2008(i)(2)(B) of 
        Public Law 103-43)--
                    (A) by striking the part designations and headings 
                for each of parts H and I; and
                    (B) by redesignating parts J through N as parts H 
                through L, respectively.
    (b) Cross-References; Other Conforming Amendments.--Title XVIII of 
the Public Health Service Act, as added by subsection (a) of this 
section, is amended--
            (1) in section 1801(b)(3)--
                    (A) in subparagraph (C), by striking ``section 
                372(b)(2)(E)'' and inserting ``section 1802(b)(2)(E)''; 
                and
                    (B) in subparagraph (H), by striking ``section 
                372'' and inserting ``section 1802'';
            (2) in section 1802(b)(2)(A)(i)(I), by striking ``section 
        371(b)(3)(E)'' and inserting ``section 1801(b)(3)(E)'';
            (3) in section 1803, by striking ``section 376'' and 
        inserting ``section 1806'';
            (4) in section 1804--
                    (A) in subsection (a), by striking ``section 372 or 
                373'' and inserting ``section 1802 or 1803'';
                    (B) in subsection (b)--
                            (i) in paragraph (1), by striking ``section 
                        371(a)(1)'' and inserting ``section 
                        1801(a)(1)'';
                            (ii) by striking paragraph (2);
                            (iii) by redesignating paragraph (3) as 
                        paragraph (2); and
                            (iv) in paragraph (2) (as so redesignated), 
                        by striking ``section 371(a)(3)'' and inserting 
                        ``section 1801(a)(2)'';
                    (C) in subsection (c), by striking ``section 371 or 
                373'' each place such term appears and inserting 
                ``section 1801 or 1803''; and
                    (D) in subsection (d)--
                            (i) in paragraph (2), by striking ``section 
                        373'' and inserting ``section 1803''; and
                            (ii) by adding at the end the following 
                        paragraph:
            ``(3) The term `citizens or permanent resident aliens of 
        the United States' means individuals who are citizens or 
        nationals of the United States, or who are aliens lawfully 
        admitted for permanent residence in the United States (or 
        otherwise permanently residing in the United States under color 
        of law).'';
            (5) in section 1807, by striking ``sec.'' and all that 
        follows through ``The Comptroller General'' in subsection (a) 
        and inserting the following:

                  ``study by general accounting office

    ``Sec. 1807. (a) In General.--The Comptroller General'';
            (6) in section 1805(3), by striking ``section 372'' and 
        inserting ``section 1802'';
            (7) in section 1811, by striking ``sec.'' and all that 
        follows through ``The Secretary'' in the first sentence in 
        subsection (a) and inserting the following:

                          ``national registry

    ``Sec. 1811. (a) Establishment.--The Secretary''; and
            (8) in section 1813--
                    (A) by striking ``sec.'' and all that follows 
                through ``The Comptroller General'' in subsection (a) 
                and inserting the following:

                  ``study by general accounting office

    ``Sec. 1813. (a) In General.--The Comptroller General''; and
                    (B) in subsection (a)--
                            (i) in paragraph (1), by striking ``section 
                        379'' and inserting ``section 1811'';
                            (ii) in paragraph (4), by striking 
                        ``section 379(k)'' and inserting ``section 
                        1811(k)''; and
                            (iii) in paragraph (5), by striking 
                        ``section 379(j)(3)'' and inserting ``section 
                        1811(j)(3)''.

SEC. 7. INFORMATION, EDUCATION, AND TRAINING REGARDING TRANSPLANTATION 
              OF BONE MARROW.

    Part B of title XVIII of the Public Health Service Act, as added by 
section 6(a) of this Act, is amended by inserting after section 1811 
the following section:

                 ``information, education, and training

    ``Sec. 1812. (a) In General.--The Secretary may make grants to, and 
enter into contracts with, public or nonprofit private entities for the 
purpose of--
            ``(1) planning and conducting programs to provide 
        information and education to the public on the need for 
        donations of bone marrow; and
            ``(2) training individuals in requesting such donations.
    ``(b) Priorities in Making Grants.--In making awards of grants and 
contracts under subsection (a), the Secretary shall give priority to 
carrying out the purpose described in such subsection with respect to 
minority populations.''.

SEC. 8. AUTHORIZATION OF APPROPRIATIONS FOR NEW TITLE XVIII.

    Title XVIII of the Public Health Service Act, as added by section 
6(a) of this Act, is amended by adding at the end the following part:

                      ``Part C--General Provisions

                   ``authorization of appropriations

    ``Sec. 1821. For the purpose of carrying out this title (other than 
section 1801(a)(1)), there are authorized to be appropriated 
$20,000,000 for fiscal year 1994, and such sums as may be necessary for 
each of the fiscal years 1995 and 1996.''.

SEC. 9. STUDY REGARDING SYSTEM FOR ALLOCATION OF ORGANS.

    (a) In General.--The Secretary of Health and Human Services (in 
this section referred to as the ``Secretary'') shall conduct a study 
for the purpose of determining the feasibility, fairness, and 
enforceability of allocating organs in the United States based solely 
upon the clinical need of the patient involved and the viability of the 
organ involved, with no consideration given to the geographic area in 
which the transplant is to be performed or the geographic area in which 
the donation of the organ is made.
    (b) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Secretary shall submit to the Committee on Energy and 
Commerce of the House of Representatives, and to the Committee on Labor 
and Human Resources of the Senate, a report describing the findings 
made in the study required in subsection (a) and the actions taken by 
the Secretary to implement changes consistent with the findings.

SEC. 10. ISSUANCE OF REGULATIONS.

    (a) Organ Procurement and Transplantation Network.--
            (1) In general.--
                    (A) Not later than the expiration of the 90-day 
                period beginning on the date of the enactment of this 
                Act, the Secretary of Health and Human Services (in 
                this section referred to as the ``Secretary'') shall 
                issue a proposed rule to establish regulations for 
                criteria under part A of title XVIII of the Public 
                Health Service Act (as added by section 6(a) of this 
                Act).
                    (B) Not later than the expiration of the 1-year 
                period beginning on the date of the enactment of this 
                Act, the Secretary shall issue a final rule to 
                establish the regulations described in subparagraph 
                (A).
            (2) Consideration of certain bylaws and policies.--In 
        developing regulations under paragraph (1), the Secretary shall 
        consider the bylaws and policies of the United Network for 
        Organ Sharing (established by contract under section 1802 of 
        the Public Health Service Act, as redesignated by section 6(a) 
        of this Act), as contained in the document entitled ``Bylaws 
        and Policies of the United Network for Organ Sharing''.
            (3) Failure to issue regulations by date certain.--If the 
        Secretary fails to issue a final rule under subparagraph (B) of 
        paragraph (1) before the expiration of the period specified in 
        such subparagraph--
                    (A) the proposed rule issued under subparagraph (A) 
                of such paragraph is upon such expiration deemed to be 
                the final rule under subparagraph (B) of such paragraph 
                (and shall remain in effect until the Secretary issues 
                a final rule under such subparagraph); or
                    (B) if no such proposed rule is issued before such 
                expiration, the bylaws and policies specified in 
                paragraph (2) and in effect upon such expiration are 
                deemed to be the final rule under paragraph (1)(B) (and 
                shall remain in effect until the Secretary issues a 
                final rule under such paragraph).
    (b) National Bone Marrow Donor Registry.--
            (1) In general.--
                    (A) Not later than the expiration of the 90-day 
                period beginning on the date of the enactment of this 
                Act, the Secretary shall issue a proposed rule to 
                establish regulations for standards, criteria, and 
                procedures under part B of title XVIII of the Public 
                Health Service Act (as added by section 6(a) of this 
                Act).
                    (B) Not later than the expiration of the 1-year 
                period beginning the date of the enactment of this Act, 
                the Secretary shall issue a final rule to establish the 
                regulations described in subparagraph (A).
            (2) Consideration of certain bylaws and policies.--In 
        developing regulations under paragraph (1), the Secretary shall 
        consider the bylaws and policies of the entity that operates 
        the National Bone Marrow Donor Registry pursuant to a contract 
        under section 1811 of the Public Health Service Act (as 
        redesignated by section 6(a) of this Act).
            (3) Failure to issue regulations by date certain.--If the 
        Secretary fails to issue a final rule under subparagraph (B) of 
        paragraph (1) before the expiration of the period specified in 
        such subparagraph--
                    (A) the proposed rule issued under subparagraph (A) 
                of such paragraph is upon such expiration deemed to be 
                the final rule under subparagraph (B) of such paragraph 
                (and shall remain in effect until the Secretary issues 
                a final rule under such subparagraph); or
                    (B) if no such proposed rule is issued before such 
                expiration, the bylaws and policies specified in 
                paragraph (2) and in effect upon such expiration are 
                deemed to be the final rule under paragraph (1)(B) (and 
                shall remain in effect until the Secretary issues a 
                final rule under such paragraph).

SEC. 11. EFFECTIVE DATES.

    (a) In General.--The amendments described in this Act are made upon 
the date of the enactment of this Act. Except as provided in subsection 
(b), such amendments take effect October 1, 1993, or upon the date of 
the enactment of this Act, whichever occurs later.
    (b) Qualified Organ Procurement Organizations.--
            (1) In general.--Except as provided in paragraph (2), the 
        amendments made by section 2 take effect January 1, 1994. 
        Before such date, section 371 of the Public Health Service Act, 
        as in effect on the day before the date of the enactment of 
        this Act, continues to be in effect.
            (2) Additional provision.--The amendment made by section 
        2(b)(2)(A) (relating to effective agreements with entities with 
        facilities for organ donations) takes effect upon the 
        expiration of the 180-day period beginning on the date on which 
        a final rule takes effect under section 10(a). Before such 
        amendment takes effect under the preceding sentence, section 
        371(b)(3)(A) of the Public Health Service Act, as in effect on 
        the day before the date of the enactment of this Act, continues 
        to be in effect.
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