[Federal Register: Volume 59, No. 104/Wednesday, June 1, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 46

RIN 0905-AC52


Health and Human Services Policy for Protection of Human Subjects
Research

AGENCY: Department of Health and Human Services (HHS).

ACTION: Final rule.

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SUMMARY: The Department of Health and Human Services (HHS) is amending
its Human Subjects Protection regulations to rescind the provision
requiring prior review and advice from an Ethical Advisory Board for
research applications and proposals involving in vitro fertilization
(IVF) of human ova as a prerequisite to funding by HHS and its
components. The provision was nullified by the National Institutes of
Health Revitalization Act of 1993. The regulations are being amended to
reflect this statutory nullification. Institutional Review Board (IRB)
review and approval of applications and proposals involving in vitro
fertilization (IVF) of human ova continues to be required in accordance
with other provisions of the Human Subjects Protection regulations.
Furthermore, the Secretary may still exercise the option of seeking
advice from an Ethical Advisory Board on ethical issues, including IVF,
raised by research applications and proposals.

EFFECTIVE DATE: This amendment is effective on June 1, 1994.

FOR FURTHER INFORMATION CONTACT: F. William Dommel, Jr., J.D.,
Office of Protection from Research Risks (OPRR), National Institutes of Health,
Building 31, room 5B63, 9000 Rockville Pike, Bethesda, Maryland 20892-001,
telephone (301) 496-7005 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION: HHS is amending its Human Subjects
Protection regulations at 45 CFR part 46, subpart B, by rescinding
paragraph (d) of section 204 of the regulations. This provision of the
regulations was nullified by section 121(c) of the NIH Revitalization
Act of 1993, Public Law 103-43, enacted on June 10, 1993, and therefore
no longer has any legal effect. HHS is rescinding paragraph (d) of
section 204 now so that the regulations will accurately reflect the
statutory nullification of the requirement for Ethical Advisory Board
review of research involving the in vitro fertilization of human ova,
as a prerequisite for funding by HHS and its components.

Notice, public comment, and delayed effective date have been waived
for this amendment based on a finding of good cause. These procedures
for ensuring public participation in the rulemaking process and time
for compliance are unnecessary because the substantive change has
already been made by Public Law 103-43. Furthermore, it is a change
that relieves a restriction on the funding of research by HHS and its
components.

Regulatory Impact Statement

The Secretary has examined this final rule in accordance with the
requirements in Executive Order 12866, Regulatory Planning and Review,
and has determined that it will not: (1) Have an annual effect on the
economy of $100 million or more or adversely affect in a material way
the economy, a sector of the economy, productivity, competition, jobs,
the environment, public health or safety, or State, local, or tribal
governments or communities; (2) create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(3) materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
Executive Order No. 12866. Therefore, it does not require: (1) An
assessment of benefits anticipated from the action; (2) an assessment
of costs anticipated from the action; or (3) an assessment of costs and
benefits of potentially effective and reasonably feasible alternatives
to the proposed regulations.

Regulatory Flexibility Act

The Secretary certifies that the final rule will not have a
significant economic impact on a substantial number of small entities.
Therefore a regulatory flexibility analysis, as defined under the
Regulatory Flexibility Act of 1980 (5 U.S.C. chapter 6), is not
required.

Paperwork Reduction Act of 1980

This final rule does not contain any information collection
requirements subject to Office of Management and Budget (OMB) review
and approval under the Paperwork Reduction Act of 1980 (44 U.S.C.
chapter 35).

Catalogue of Federal Domestic Assistance

The Catalogue of Federal Domestic Assistance (CFDA) numbered
program affected by this final rule is: 93.891

List of Subjects in 45 CFR Part 46

Health, Human research subjects.

Dated: January 31, 1994.
Philip R. Lee,
Assistant Secretary for Health.

Approved: April 7, 1994.
Donna E. Shalala,
Secretary.

For the reasons set out in the preamble, subpart B of part 46,
title 45 of the Code of Federal Regulations is amended as set forth
below.

PART 46--PROTECTION OF HUMAN SUBJECTS

1. The authority citation for part 46 is revised to read as
follows:

Authority: 5 U.S.C. 301; 42 U.S.C. 289.

Sec. 46.204 [Amended]

2. Paragraph (d) of Sec. 46.204 is removed.

[FR Doc. 94-13273 Filed 5-31-94; 8:45 am]
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