[Federal Register Volume 64, Number 244 (Tuesday, December 21, 1999)]
[Rules and Regulations]
[Page 71626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-33276]



[[Page 71625]]

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Part VII





Department of Health and Human Services





_______________________________________________________________________



CFR Part 121



Organ Procurement and Transplantation Network; Final Rule Amendment, 
Stay of Final Rule, and Additional Comment Period; Final Rule

  Federal Register / Vol. 64, No. 244 / Tuesday, December 21, 1999 / 
Rules and Regulations  

[[Page 71626]]



DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Part 121


Organ Procurement and Transplantation Network; Final Rule 
Amendment, Stay of Final Rule, and Additional Comment Period

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Final Rule Amendment, Stay of Final Rule, and Additional 
Comment Period.

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SUMMARY: Section 413 of the Ticket to Work and Work Incentives 
Improvement Act of 1999, signed into law by the President on December 
17, 1999, provides that the Organ Procurement and Transplantation 
Network (OPTN) Final Rule published on April 2, 1998, together with the 
amendments published on October 20, 1999, shall not become effective 
before March 16, 2000. This document announces a stay of the final 
rule, consistent with section 413, announces that the public may submit 
comments on the final rule, as amended, for a 60-day period, and amends 
a compliance deadline in the final rule, as amended.

DATES: Under Section 413 of the Ticket to Work and Work Incentives 
Improvement Act of 1999 (H.R. 1180, signed into law by the President on 
December 17, 1999 published on April 2, 1998 (63 FR 16296), as amended 
by the final rule published on October 20, 1999 (64 FR 56650), is 
stayed effective December 17, 1999 through March 15, 2000. The 
amendment to 42 CFR 121.8 is effective on March 16, 2000. To ensure 
consideration, comments on the final rule as amended must be received 
by February 22, 2000.

ADDRESSES: Written comments should be submitted to Lynn Rothberg 
Wegman, Acting Director, Division of Transplantation, Office of Special 
Programs, HRSA, 5600 Fishers Lane, Room 7C-22, Rockville, Maryland 
20857. The comments submitted will be available for public inspection 
and copying at the address listed above.

FOR FURTHER INFORMATION CONTACT: Lynn Rothberg Wegman, at the address 
listed above, telephone 301-443-7577.

SUPPLEMENTARY INFORMATION: On April 2, 1998 (63 FR 16296), the 
Secretary of Health and Human Services published in the Federal 
Register as 42 CFR part 121 a final rule governing the operation of the 
Organ Procurement and Transplantation Network.
    As a result of the enactment of section 4002 of the Fiscal Year 
1998 Supplemental Appropriations Act, Public Law 105-174, the comment 
period was extended until August 31, 1998, and the final rule was not 
to become effective before October 1, 1998. On July 1, 1998, the 
Department published a document in the Federal Register announcing the 
extension of the comment period and the delay until October 1, 1998, of 
the effective date of the final rule. (63 FR 35847.) In addition, 
several of the dates contained in provisions of the final rule were 
also amended in the July 1, 1998, document.
    On October 21, 1998, Public Law 105-277, the Omnibus Consolidated 
and Emergency Supplemental Appropriations Act, 1999, became effective. 
Section 101(f) of Division A of the public law enacted the Department 
of Labor, Heath and Human Services, Education, and Related Agencies 
Appropriations Act for Fiscal Year 1999. Section 213 of that Act 
provided that the final rule at 42 CFR part 121 was not to become 
effective before the expiration of the 1-year period beginning on the 
date of enactment of that Act. Section 213 also called for the 
Institute of Medicine to study several aspects of the final rule and of 
the organ transplant system generally and encouraged the Department to 
meet with representatives of the OPTN. The Institute's report, issued 
in July 1999, the public comments received on the April 2, 1998, rule, 
and extensive consultation with representatives of the OPTN. The 
Institute's report, issued in July 1999, the public comments received 
on the April 2, 1998, rule, and extensive consultation with 
representatives of the OPTN informed the Department's deliberations on 
possible revisions to the rule. The result was the Department's 
issuance on October 20, 1999 (64 FR 56650), of amendment sot the final 
rule, with an effective date for the rule as amended of November 19, 
1999.
    It is this amended rule that is subject to the provisions of 
section 413 of the Ticket to Work and Work Incentives Improvement Act 
of 1999. The rule is not to become effective before March 16, 2000. As 
provided in section 413(b)W, comments may be submitted for a period 
ending on February 22, 2000. The Department will consider any revisions 
that may be appropriate based on our review of the comments.
    Section 121.8(e)(2) within part 121, as amended on October 20, 
1999, established a compliance deadline of February 15, 2000, for the 
OPTN to transmit to the Secretary revised policies and supporting 
documentation for liver allocation. Because we do not seek to have the 
deadline occur during the period when the regulation is stayed, we have 
decided to extend the deadline to March 16, 2000.

List of Subjects in 42 CFR Part 121

    Health care, Hospitals, Organ transplantation, Reporting and 
recordkeeping requirements.

    Dated: December 16, 1999.
Claude Earl Fox,
Administrator, Health Resources and Services Administration.

    Approved: December 17, 1999.
Donna E. Shalala,
Secretary.

    Accordingly, 42 CFR Part 121 is amended as follows:

PART 121--ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK

    1. The authority citation for part 121 continues to read as 
follows:

    Authority: Sections 215, 371-376 of the Public Health Service 
Act (42 U.S.C. 216, 273-274d); sections 1102, 1106, 1138 and 1871 of 
the Social Security Act (42 U.S.C. 1302, 1306, 1320b-8 and 1395hh).


Sec. 121.8  [Amended]

    2. Effective March 16, 2000, in Sec. 121.8, paragraph (e)(2) is 
amended by revising the words ``February 15, 2000'' to read ``March 16, 
2000''.

[FR Doc. 99-33276 Filed 12-20-99; 10:11am]
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