[Federal Register Volume 68, Number 39 (Thursday, February 27, 2003)]
[Notices]
[Page 9092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-4568]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03N-0059]


Pharmaceutical Current Good Manufacturing Practices for the 21st 
Century: A Risk-Based Approach; Establishment of a Public Docket

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing that it 
is establishing a public docket for information relevant to the 
agency's current good manufacturing practice (CGMP) initiative 
concerning the regulation of pharmaceutical manufacturing and product 
quality. This action is intended to ensure that all information 
submitted to FDA on the CGMP initiative regarding a risk-based approach 
to the regulation of pharmaceutical manufacturing and product quality 
is available to all interested persons in a timely fashion.

ADDRESSES:  The public dockets are located in the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. The public dockets can be accessed directly 
under the docket number provided and on the agency's site at http://www.fda.gov/ohrms/dockets.

FOR FURTHER INFORMATION CONTACT:  Maureen A. Hess, Center for Drug 
Evaluation and Research (HFD-6), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5461.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 21, 2002, FDA announced that it is undertaking a 
significant new initiative to enhance the regulation of pharmaceutical 
manufacturing and product quality. The initiative entitled 
``Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach,'' 
applies to veterinary drugs and human drugs, including biological drug 
products. Additional detailed information describing the scope and 
purpose of the initiative can be found on the Internet at www.fda.gov/bbs/topics/NEWS/2002/NEW00829.html. FDA has received recommendations on 
how the agency should implement various aspects of, as well as, the 
overall CGMP initiative and encourages further recommendations. To 
provide timely public access to these recommendations, FDA is 
establishing a public docket through which interested persons can have 
access to these recommendations and other information submitted to FDA. 
FDA expects to place submissions it receives on this initiative in the 
public docket.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding the CGMP 
initiative. Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two hard copies of any mailed 
comments, except that individuals may submit one hard 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 Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: February 21, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-4568 Filed 2-26-03; 8:45 am]
BILLING CODE 4160-01-S