[Federal Register Volume 59, Number 158 (Wednesday, August 17, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-20198]


[[Page Unknown]]

[Federal Register: August 17, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 600, 601, 606, 607, 610, 640, and 660

[Docket Nos. 94N-0066 and 94N-0080]

 

Review of Regulations for General Biologics and Licensing and 
Blood Establishments and Blood Products; Extension of Comment Periods

AGENCY: Food and Drug Administration, HHS.

ACTION: Intent to review regulations; extension of comment periods.

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SUMMARY: The Food and Drug Administration (FDA) is extending to 
November 15, 1994, the comment periods for two documents. The documents 
requested comments on FDA's intent to review certain biologics 
regulations, and were published in the Federal Register of June 3, 1994 
(59 FR 28821 and 28822, respectively). FDA is taking this action in 
response to requests to allow additional time for public comment.

DATES: Written comments by November 15, 1994.

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

FOR FURTHER INFORMATION CONTACT: Timothy W. Beth or Stephen M. Ripley, 
Center for Biologics Evaluation and Research (HFM-635), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-594-
3074.

SUPPLEMENTARY INFORMATION: In the Federal Register of June 3, 1994 (58 
FR 28821, 28822), FDA issued two documents entitled ``Review of General 
Biologics and Licensing Regulations'' (Docket No. 94N-0066) and 
``Review of Regulations for Blood Establishments and Blood Products'' 
(Docket No. 94N-0080). Interested persons were given until August 17, 
1994, to respond to the documents.
    The American Blood Resources Association has requested a 90-day 
extension of the comment periods for the two above mentioned documents. 
The Biotechnology Industry Organization and the Pharmaceutical Research 
and Manufacturers of America have requested a 60-day extension for the 
general biologics and licensing regulations document. In order to allow 
interested persons to fully respond to the requests for comments, FDA 
believes it is in the public interest to extend the comment period to 
allow interested persons to carefully review the regulations and submit 
written comments. Therefore, FDA is granting the request by extending 
the comment periods for both documents to November 15, 1994. Interested 
persons may, on or before November 15, 1994, submit written comments to 
the Dockets Management Branch (address above). Two copies of any 
comments are to be submitted, except that individuals may submit one 
copy. Comments are to 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: August 12, 1994.
Ronald G. Chesemore,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 94-20198 Filed 8-12-94; 2:56 pm]
BILLING CODE 4160-01-F