01-6808. Protection of Human Research Subjects: Delay of Effective Date

AGENCY:

Department of Health and Human Services (DHHS).

ACTION:

Final rule; delay of effective date.

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 [phone]. Email [e-mail].

Dated: January 14, 2001.

Tommy G. Thompson,

Secretary.