[Federal Register Volume 62, Number 87 (Tuesday, May 6, 1997)]
[Proposed Rules]
[Page 24619]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-11713]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Ch. I

[Docket No. 96N-0417]
RIN 0910-AA59


Current Good Manufacturing Practice in Manufacturing, Packing, or 
Holding Dietary Supplements

AGENCY: Food and Drug Administration, HHS.

ACTION: Advance notice of proposed rulemaking; extension of comment 
period.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that it 
is extending to June 6, 1997, the comment period for the advance notice 
of proposed rulemaking on current good manufacturing practice (CGMP) in 
manufacturing, packing, or holding dietary supplements that published 
in the Federal Register of February 6, 1997 (62 FR 5700). This action 
is being taken in response to several requests from interested persons 
for an extension of the comment period on this document to allow a more 
thorough development of comments on FDA's request for information on 
whether requirements for manufacturing and handling dietary ingredients 
and dietary supplements may be addressed by a regulation based on the 
principles of Hazard Analysis and Critical Control Points (HACCP).

DATES: Written comments by June 6, 1997.

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: Robert J. Moore, Center for Food 
Safety and Applied Nutrition (HFS-456), Food and Drug Administration, 
200 C St. SW., Washington, DC 20204, 202-205-4605.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 6, 1997 
(62 FR 5700), FDA published an advance notice of proposed rulemaking on 
CGMP in manufacturing, packing, or holding dietary supplements (Docket 
No. 96N-0417). Interested persons were given until May 7, 1997, to 
comment on the advance notice of proposed rulemaking.
    FDA has received requests from two manufacturers, and two trade 
organizations representing manufacturers, of dietary supplements for an 
extension of the comment period. Three requests asked that the agency 
extend the comment period in order to provide more time for interested 
parties to develop comments on FDA's request for information on whether 
requirements for manufacturing and handling dietary ingredients and 
dietary supplements may be adequately addressed by a regulation based 
on the principles of HACCP. The requests stated that many dietary 
supplement manufacturers were not familiar with the HACCP concept, and 
additional time was needed to fully understand HACCP and its 
applicability to the development of CGMP for dietary supplements. After 
careful consideration of the requests submitted to the agency, FDA has 
decided to grant an extension of the comment period until June 6, 1997.
    Interested persons may, on or before June 6, 1997, submit to the 
Dockets Management Branch (address above) written comments regarding 
this advance notice of proposed rulemaking. Two copies of any comments 
are to be submitted, except that individuals may submit one copy. 
Comments should be identified with the appropriate 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: April 28, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-11713 Filed 5-5-97; 8:45 am]
BILLING CODE 4160-01-F