[Federal Register Volume 61, Number 146 (Monday, July 29, 1996)]
[Proposed Rules]
[Pages 39371-39372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-19158]


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[[Page 39372]]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 210 and 211

[Docket No. 95N-0362]
RIN 0910-AA45


Current Good Manufacturing Practice; Proposed Amendment of 
Certain Requirements for Finished Pharmaceuticals; Extension of Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
September 30, 1996, the comment period for the proposed rule that would 
revise the current good manufacturing practice (CGMP) regulations for 
finished pharmaceuticals. The proposed rule was published in the 
Federal Register of May 3, 1996 (61 FR 20104). The proposal would 
clarify certain manufacturing, quality control, and documentation 
requirements and would ensure that the regulations more accurately 
encompass CGMP. The agency is taking this action based on a request for 
an extension of the comment period.

DATES: Written comments by September 30, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:
    Thomas C. Kuchenberg, Center for Drug Evaluation and Research (HFD-
7), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 
20855, 301-594-1046; or
    John M. Dietrick, Center for Drug Evaluation and Research (HFD-
325), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 
20855, 301-594-0098; or
    William G. Marnane, Center for Veterinary Medicine (HFV-143), Food 
and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-
594-0678; or
    Nancy Roscioli, Center for Biologics Evaluation and Research (HFM-
205), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852-1448, 301-827-3031.

SUPPLEMENTARY INFORMATION: In the Federal Register of May 3, 1996 (61 
FR 20104), FDA published a proposed rule that would clarify certain 
manufacturing, quality control, and documentation requirements and 
would ensure that the regulations more accurately encompass CGMP. In 
addition, the proposed rule would update the requirements for process 
and methods validation to incorporate guidance previously issued to 
industry to reflect current practice. The agency proposed these 
revisions to the CGMP regulations to enhance the integrity of the drug 
manufacturing process and the safety of drug products. The proposal 
gave interested persons the opportunity to submit written comments by 
August 1, 1996.
    FDA has received a request from the Nonprescription Drug 
Manufacturers Association (NDMA) to extend the comment period. NDMA 
asked that the comment period be extended to permit the nonprescription 
drug industry to prepare and submit comments to FDA.
    FDA has carefully considered this request and has decided to extend 
the comment period in which interested persons may evaluate the 
proposed rule and submit comments to the agency. Accordingly, the 
comment period for submission of comments by any interested person is 
extended to September 30, 1996.
    Interested persons may, on or before September 30, 1996, submit to 
the Dockets Management Branch (address above) written comments 
regarding this proposal. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Received comments may be seen in the office above 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 19, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-19158 Filed 7-26-96; 8:45 am]
BILLING CODE 4160-01-F