[Printable PDF]
[Federal Register: February 20, 2001 (Volume 66, Number 34)]
[Rules and Regulations]
[Page 10815] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr20fe01-6]
[[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]
BILLING CODE 4160-01-S