[Federal Register Volume 66, Number 53 (Monday, March 19, 2001)]
[Rules and Regulations]
[Page 15352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-6808]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

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: 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, this action temporarily delays for 60 days the effective date 
of the rule entitled Protection of Human Subjects, published in the 
Federal Register on January 17, 2001, 66 FR 3878.
    That rule concerns Protection of Human Subjects, Additional 
Protections for Pregnant Women and Human Fetuses Involved in Research, 
and Pertaining to Human In Vitro Fertilization. To the extent that 5 
U.S.C. section 553 applies to this action, it is exempt from notice and 
comment because it constitutes a rule of procedure under 5 U.S.C. 
section 553(b)(A).
    Alternatively, the Department's implementation of this rule without 
opportunity for public comment, effective immediately upon publication 
today in the Federal Register, is based on the good cause exceptions in 
5 U.S.C. section 553(b)(B) and 553(d)(3)--Seeking public comment and 
delaying the effective date of this rule would be impracticable, and 
contrary to the public interest. The temporary 60-day delay in 
effective date is necessary to give Department officials the 
opportunity for further review and consideration of regulations that 
had been published in the Federal Register as of January 20, 2001, but 
had not yet taken effect as of that date. Given the imminence of the 
effective date, seeking prior public comment on this temporary delay 
would have been impracticable, as well as contrary to the public 
interest in the orderly promulgation and implementation of regulations.

DATES: The effective date of the Final Rule, Protection of Human 
Subjects, published in the Federal Register on January 17, 2001, at 66 
FR 3878 is delayed for 60 days, from March 19, 2001 to a new effective 
date of May 18, 2001.

FOR FURTHER INFORMATION CONTACT: Melody Lin, Ph.D., Office for Human 
Research Protections (OHRP) 6100 Executive Blvd., Suite 3B01, 
Rockville, MD 20892-7505. Telephone 301-496-7005. Email 
[email protected].

    Dated: January 14, 2001.
Tommy G. Thompson,
Secretary.
[FR Doc. 01-6808 Filed 3-15-01; 12:17 pm]
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