[Federal Register Volume 59, Number 218 (Monday, November 14, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27985]


[[Page Unknown]]

[Federal Register: November 14, 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

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

 

Review of Regulations for General Biologics and Licensing and for 
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 
February 13, 1995, the comment periods for two documents published in 
the Federal Register of June 3, 1994 (59 FR 28821 and 28822, 
respectively). The documents requested comments on the agency's intent 
to review certain biological regulations. FDA is taking this action to 
allow additional opportunity for public comment, including an 
opportunity to comment at an upcoming public meeting concerning the 
biologic regulations under review. The comments received will be part 
of the public record for these two documents.

DATES: Written comments by February 13, 1995.

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 Jean M. Olson, 
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 (59 
FR 28821 and 28822 respectively), 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). The documents announced that 
the agency would begin reviewing certain biologics regulations. 
Interested persons were given until August 17, 1994, to respond to the 
documents. In the Federal Register of August 17, 1994 (59 FR 42193), 
FDA extended the comment periods to November 15, 1994. This decision 
was based on requests to allow additional time for public comment.
    The Biotechnology Industry Organization and the Pharmaceutical 
Research and Manufacturers of America have requested a public meeting 
to allow for the presentation of comments regarding the agency's intent 
to review the biologics regulations. FDA agrees that a public meeting 
is useful, therefore, it intends to hold a public meeting to allow all 
interested persons to present their comments. FDA will announce the 
date, time, and place of the meeting in the Federal Register at a later 
date. A transcript of the comments presented at the above mentioned 
public meeting and written comments resulting from the meeting will be 
made a part of the public docket. Thus, FDA is extending the comment 
periods for both documents to February 13, 1995.
    Interested persons may, on or before February 13, 1995, 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: November 7, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-27985 Filed 11-10-94; 8:45 am]
BILLING CODE 4160-01-F