66 FR 34 pgs. -1 - Postmarketing Studies for Approved Human Drug andLicensed Biological Products; Status Reports; Delay of EffectiveDate
Type: RULEVolume: 66Number: 34Page: -1
Docket number: [Docket No. 99N-1852]
FR document: [FR Doc. 01-4141 Filed 2-16-01; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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 andLicensed Biological Products; Status Reports; Delay of EffectiveDate
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Final rule; delay of effectivedate.
SUMMARY:
In accordance with the memorandumof January 20, 2001, from the Assistant to the President andChief of Staff, entitled "Regulatory Review Plan," published inthe Federal Register on January 24, 2001 (66 FR 7702),this action temporarily delays for 60 days the effective date ofthe rule entitled "Postmarketing Studies for Approved Human Drugand Licensed Biological Products; Status Reports," published inthe Federal Register on October 30, 2000 (65 FR 64607).
DATES:
The effective date of the"Postmarketing Studies for Approved Human Drug and LicensedBiological Products; Status Reports," amending 21 CFR parts 314and 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 ruleconcerns the requirements for annual postmarketing status reportsfor approved human drug and biological products, and requiresapplicants to submit annual status reports for certainpostmarketing studies of licensed biological products. The ruledescribes the types of postmarketing studies covered by thesestatus reports, the information to be included in the reports,and the type of information that the Food and Drug Administrationwould consider appropriate for public disclosure. The rule willimplement specific provisions of the Food and Drug AdministrationModernization Act of 1997 (FDAMA). To the extent that 5 U.S.C.553 applies to this action, it is exempt from notice and commentbecause it constitutes a rule of procedure under 5 U.S.C.553(b)(A). Alternatively, the agency's implementation of thisaction without opportunity for public comment, effectiveimmediately 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, unnecessaryand contrary to the public interest. The temporary 60-day delayin effective date is necessary to give Department of Health andHealth and Human Services (Department) officials the opportunityfor further review and consideration of new regulations,consistent with the Assistant to the President's memorandum ofJanuary 20, 2001, sent to all executive departments and agencies.Given the imminence of the effective date, seeking prior publiccomment on this temporary delay would have been impractical, aswell as contrary to the public interest in the orderly issuanceand implementation of regulations. The imminence of theeffective date is also good cause for making this actioneffective immediately upon publication. As originally publishedin the Federal Register on October 30, 2000, this rulewould have required some firms to file annual progress reportsfor postmarketing study commitments shortly after February 27,2001, if the anniversary date of U.S. approval of the applicationof the drug or licensed biological product under postmarketingstudy commitment fell on or shortly after February 27, 2001. Animmediate effective date for this rule delaying implementation isnecessary to assure that those applicants are not singled out andrequired to submit postmarketing study reports before Departmentofficials have had the opportunity for further review andconsideration 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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