[Federal Register Volume 66, Number 34 (Tuesday, February 20, 2001)]
[Rules and Regulations]
[Page 10815]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-4141]



[[Page 10815]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 21 CFR Parts 314 and 601

[Docket No. 99N-1852]


Postmarketing Studies for Approved Human Drug and Licensed 
Biological Products; Status Reports; Delay of Effective Date

AGENCY: Food and Drug Administration, HHS.

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 
``Regulatory Review Plan,'' published in the Federal Register on 
January 24, 2001 (66 FR 7702), this action temporarily delays for 60 
days the effective date of the rule entitled ``Postmarketing Studies 
for Approved Human Drug and Licensed Biological Products; Status 
Reports,'' published in the Federal Register on October 30, 2000 (65 FR 
64607).

DATES: The effective date of the ``Postmarketing Studies for Approved 
Human Drug and Licensed Biological Products; Status Reports,'' amending 
21 CFR parts 314 and 601 published in the Federal Register on October 
30, 2000 (65 FR 64607), is delayed for 60 days, from February 27, 2001, 
to a new effective date of April 30, 2001.

FOR FURTHER INFORMATION CONTACT: Paula S. McKeever, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION: The rule concerns the requirements for 
annual postmarketing status reports for approved human drug and 
biological products, and requires applicants to submit annual status 
reports for certain postmarketing studies of licensed biological 
products. The rule describes the types of postmarketing studies covered 
by these status reports, the information to be included in the reports, 
and the type of information that the Food and Drug Administration would 
consider appropriate for public disclosure. The rule will implement 
specific provisions of the Food and Drug Administration Modernization 
Act of 1997 (FDAMA). To the extent that 5 U.S.C. 553 applies to this 
action, it is exempt from notice and comment because it constitutes a 
rule of procedure under 5 U.S.C. 553(b)(A). Alternatively, the agency's 
implementation of this action 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. 553(b)(B) and (d)(3). 
Seeking public comment is impracticable, unnecessary and contrary to 
the public interest. The temporary 60-day delay in effective date is 
necessary to give Department of Health and Health and Human Services 
(Department) officials the opportunity for further review and 
consideration of new regulations, consistent with the Assistant to the 
President's memorandum of January 20, 2001, sent to all executive 
departments and agencies. Given the imminence of the effective date, 
seeking prior public comment on this temporary delay would have been 
impractical, as well as contrary to the public interest in the orderly 
issuance and implementation of regulations. The imminence of the 
effective date is also good cause for making this action effective 
immediately upon publication. As originally published in the Federal 
Register on October 30, 2000, this rule would have required some firms 
to file annual progress reports for postmarketing study commitments 
shortly after February 27, 2001, if the anniversary date of U.S. 
approval of the application of the drug or licensed biological product 
under postmarketing study commitment fell on or shortly after February 
27, 2001. An immediate effective date for this rule delaying 
implementation is necessary to assure that those applicants are not 
singled out and required to submit postmarketing study reports before 
Department officials have had the opportunity for further review and 
consideration of this regulation.

    Dated: February 13, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-4141 Filed 2-16-01; 8:45 am]
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