[Federal Register Volume 66, Number 97 (Friday, May 18, 2001)]
[Rules and Regulations]
[Page 27599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12755]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 46

RIN: 0925-AA14


Protection of Human Research Subjects: Delay of Effective Date

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

ACTION: Final Rule; Delay of Effective Date.

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SUMMARY: To give the Department an opportunity to obtain comment on 
three modifications to the rule entitled Protection of Human Subjects, 
Additional Protections for Pregnant Women and Human Fetuses Involved in 
Research, and Pertaining to Human In Vitro Fertilization, the 
Department is delaying until November 14, 2001 the effective date of 
the rule, which was published in the Federal Register on January 17, 
2001, 66 F.R. 3878, pending the Department's action on forthcoming 
notice of proposed rulemaking. The rule's effective date was previously 
delayed by 60 days on March 19, 2001, in accordance with the memorandum 
of January 20, 2001, from the Assistant to the President and Chief of 
Staff, entitled A Regulatory Review Plan, published in the Federal 
Register on January 24, 2001. See 66 F.R. 15352.

DATES: The final rule, Protection of Human Subjects, published in the 
Federal Register on January 17, 2001, at 66 F.R. 3878 and delayed on 
March 19, 2001 at 66 FR 15352 is further delayed until November 14, 
2001.

FOR FURTHER INFORMATION CONTACT: Irene Stith-Coleman, Ph.D., Office of 
Human Research Protections (OHRP) 200 Independence Avenue, S.W., Room 
733-E, Washington, D.C., 20201. Telephone 202-260-1587. Email 
[email protected].

SUPPLEMENTARY INFORMATION: On January 17, 2001, the Department of 
Health and Human Services (DHHS) published in the Federal Register a 
Final Rule, with an effective date of March 19, 2001 (66 Fed. Reg. 
3878), intended to amend Subpart B of 45 CFR Part 46 of the Code of 
Federal Regulations. These regulations provide additional protections 
for pregnant women and human fetuses involved in research.
    The Department has determined that there is a need to delay this 
rule's effective date in order to consider three limited aspects: (1) 
Whether paternal consent (when the father is readily available) should 
be obtained for participation in federally funded research that is 
directed solely at a fetus; (2) whether the definition of ``fetus'' 
should be modified so that it describes only the stage prior to 
delivery; and (3) whether the rule should be modified to make clear 
that fetuses of uncertain viability may be subjected to added risk only 
if the research is intended to enhance the probability of survival of 
the particular fetus to the point of viability. The Department will, 
therefore, very shortly issue a proposed rule to afford the public the 
opportunity to comment on these changes. In the meantime, current 
Subpart B remains in effect for the special protection of pregnant 
women and human fetuses involved in research.
    The notice and comment requirements of 5 U.S.C. section 553 do not 
apply to this delay of the rule's effective date, which is a rule of 
procedure. See 5 U.S.C. 553(b)(3)(A). To the extent that section 553 
applies in these circumstances, however, the Department finds that the 
action comes within that provision's good cause exceptions in that 
obtaining public comment is impracticable, unnecessary, and contrary to 
the public interest. See 5 U.S.C. 553(b)(3)(B). Given the imminence of 
the effective date, and the imminence of a new notice of proposed 
rulemaking, seeking prior public comment on this delay is 
impracticable, as well as contrary to the public interest in the 
orderly promulgation and implementation of regulations. Further, 
comment is unnecessary because no harm is caused by delay of the 
effective date of the regulations, as the current rule, 45 CFR part 46, 
Subpart B, Protection of Human Subjects, Additional Protections for 
Pregnant Women and Human Fetuses Involved in Research, and Pertaining 
to Human In Vitro Fertilization, published in the Federal Register on 
August 8, 1975 and amended January 11, 1978 and June 1, 1994, will 
remain in effect pending any further action by the Department, and any 
action taken will be subject to notice and comment before final 
publication.

    Dated: May 16, 2001.
Tommy G. Thompson,
Secretary.
[FR Doc. 01-12755 Filed 5-17-01; 8:45 am]
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