[Federal Register Volume 60, Number 5 (Monday, January 9, 1995)]
[Proposed Rules]
[Pages 2351-2352]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-460]



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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 60, No. 5 / Monday, January 9, 1995 / 
Proposed Rules
[[Page 2351]]

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 for 
Blood Establishments and Blood Products; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
meeting for interested persons to express their comments regarding the 
biologics regulations that the agency intends to review (21 CFR parts 
600, 601, 606, 607, 610, 640, and 660). In the Federal Register of June 
3, 1994 (59 FR 28821 and 28822, respectively), FDA issued two 
documents, ``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), that 
announced that FDA was intending to review certain biologics 
regulations and requested public comments regarding those regulations. 
The comment periods have been extended twice and will close on February 
13, 1995. The purpose of the public meeting is to allow additional 
opportunity for public comment concerning the biologics regulations 
that the agency is reviewing.

DATES: The public meeting will be held on January 26, 1995, from 1:30 
p.m. to 5:30 p.m. Submit written notices of participation and written 
copies or summaries of oral presentations and the approximate amount of 
time needed for the presentation by January 19, 1995. Submit written 
comments regarding the biologics regulations under review by February 
13, 1995.

ADDRESSES: The public meeting will be held at the Parklawn Bldg., 
conference rooms D and E, 5600 Fishers Lane, Rockville, MD 20857. 
Submit written notices of participation and written copies or summaries 
of oral presentations and the approximate amount of time needed for the 
presentation to Timothy W. Beth, Center for Biologics Evaluation and 
Research (HFM-635), Food and Drug Administration, 1401 Rockville Pike, 
Rockville, MD 20852-1448 or FAX at 301-443-3874. Submit written 
comments regarding the review of general biologics and licensing 
regulations identified with docket number 94N-0066 and written comments 
regarding the review of regulations for blood establishments and blood 
products identified with docket number 94N-0080 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, ``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 the agency's intent to 
review biologics regulations, 21 CFR parts 600, 601, 606, 607, 610, 
640, and 660, and requested written comments from the public. 
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, in response to 
requests to allow for additional time for public comment. In the 
Federal Register of November 14, 1994 (59 FR 56448), FDA extended the 
comment periods to February 13, 1995, based on requests to hold a 
public meeting regarding the biologics regulations under review.
    The Biotechnology Industry Organization and the Pharmaceutical 
Research and Manufacturers of America 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 
would be useful, and therefore, is holding a public meeting to allow 
all interested persons to present their comments. Representatives from 
the Center for Biologics Evaluation and Research (CBER) will chair the 
public meeting.
    Every effort will be made to accommodate each person who wants to 
participate in the public meeting. However, each person who wants to 
ensure his or her participation in the meeting is encouraged, by close 
of business on January 19, 1995, to: (1) File a written notice of 
participation containing the name, address, phone number, facsimile 
number, affiliation, if any, of the participant, topic of the 
presentation, and approximate amount of time requested for the 
presentation; and (2) submit a copy or summary of their presentation. 
The requested information, including the written notice of 
participation, may be submitted to the contact person (address above).
    Before the meeting, CBER will determine the amount of time assigned 
to each person and the approximate scheduled time for each 
presentation. A schedule showing the persons making presentations will 
be filed with the Dockets Management Branch (address above) and mailed 
or FAX'ed to each participant before the meeting. Interested persons 
attending the meeting who did not request an opportunity to make a 
presentation will be given the opportunity to make an oral presentation 
at the conclusion of the meeting, as time permits.
    All public comments received at the public meeting and all written 
comments submitted to the Dockets Management Branch by February 13, 
1995, will be considered in the review of the regulations to determine 
whether they should be revised, rescinded, or continued without change. 
After careful review of the public comments, FDA intends to publish a 
proposed rule to amend those regulations that FDA deems appropriate.
    Interested persons may, on or before February 13, 1995, submit 
written comments regarding the biologics regulations the agency intends 
to review (21 CFR parts 600, 601, 606, 607, 610, [[Page 2352]] 640, and 
660) 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.
    Transcripts of the public meeting may be requested in writing from 
the Freedom of Information Office (HFI-35), Food and Drug 
Administration, rm. 12A-16, 5600 Fishers Lane, Rockville, MD 20857, 
approximately 15 working days after the meeting, at a cost of 10 cents 
per page. The transcript of the public meeting and copies of 
information and comments submitted to the meeting record will be 
available for examination at the Dockets Management Branch (address 
above) approximately 15 working days after the meeting, between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: January 4, 1995.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 95-460 Filed 1-4-95; 3:01 pm]
BILLING CODE 4160-01-F