[Federal Register Volume 62, Number 164 (Monday, August 25, 1997)]
[Rules and Regulations]
[Pages 44891-44892]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-22555]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 314, 600, 601, 610, and 640

[Docket No. 95N-0329]


Biologics Regulations; Reporting Changes to an Approved 
Application; Open Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Announcement of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an open 
public meeting to discuss issues related to the agency's final rule 
entitled, ``Changes to an Approved Application'' announced previously 
in the Federal Register. The final rule amended the biologics 
regulations for reporting changes to an approved application reviewed 
in the Center for Biologics Evaluation and Research (CBER) and the 
corresponding drug regulations for reporting changes to an approved 
application for specified biotechnology products reviewed in the Center 
for Drug Evaluation and Research (CDER). The purpose of the meeting is 
to present the regulatory procedures set forth in the final rule and to 
solicit public comment on a portion of the final rule that addresses 
the use of a ``comparability protocol.''

DATES: The open public meeting will be held on Wednesday, September 24, 
1997, from 8:30 a.m. to 5 p.m. Registration for persons who want to 
participate at the meeting must be submitted to the agency by September 
3, 1997, including written copies or a brief summary of the 
presentation, or any written comments for possible discussion at the 
meeting. Preregistration for persons who want to attend the meeting 
should be received by September 18, 1997.

ADDRESSES: The open public meeting will be held at the Quality Hotel, 
8727 Colesville Rd., Silver Spring, MD 20910. Submit written requests 
for participation and written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,

[[Page 44892]]

Rockville, MD 20857, between 9 a.m. and 4 p.m., Monday through Friday. 
To expedite the processing, written notices of participation may also 
be FAXED to 301-827-3079. Two copies of any comments are to be 
submitted, except individuals may submit one copy. Comments should be 
identified with the docket number found in brackets in the heading of 
this notice.
    Those persons interested in attending this meeting should submit 
their registration information, including name, title, firm name, 
address, telephone and fax number, to Toni Toomer (address below).

FOR FURTHER INFORMATION CONTACT: Toni Toomer, Center for Biologics 
Evaluation and Research (HFM-49), Division of Manufacturers Assistance 
and Training, Food and Drug Administration, 1401 Rockville Pike, suite 
200N, Rockville, MD 20852-1448, 301-827-1310, FAX 301-827-3079.

SUPPLEMENTARY INFORMATION: In the Federal Register of July 24, 1997, 
FDA published a final rule entitled, ``Changes to an Approved 
Application'' (62 FR 39890) and two notices of availability announcing 
corresponding guidance documents entitled, ``Guidance for Industry: 
Changes to an Approved Application: Biological Products'' (62 FR 39904) 
and ``Guidance for Industry: Changes to an Approved Application for 
Specified Biotechnology and Specified Synthetic Biological Products'' 
(62 FR 39904).
    FDA is announcing an open public meeting to discuss regulatory 
issues related to the final rule. The first part of the meeting will 
include an agency presentation of the regulatory provisions of the 
final rule and a discussion of the corresponding guidance documents, 
followed by a question and answer session.
    In the second part of the meeting, the agency will solicit public 
comment on the use of a comparability protocol, which is an option 
available to applicants under the final rule. A comparability protocol 
describes the specific tests and validation studies and acceptable 
limits to be achieved to demonstrate the lack of adverse effect for 
specified types of changes on the safety or effectiveness of a product.
    Every effort will be made to accommodate each person who wants to 
participate in the public meeting. However, because presentations will 
be limited to the second part of the meeting, the agency may not be 
able to accommodate all requests for formal presentations. 
Nevertheless, each person may participate in the open discussion at the 
end of the meeting. Accordingly, each person who wants to participate 
in the meeting is encouraged to submit a written request for 
participation, by close of business on September 3, 1997, and to 
include the following information: (1) File a written request for 
participation containing the name, address, telephone and fax number, 
affiliation, if any, of the participant, and topic of the presentation, 
and (2) submit a copy or a brief summary of their presentation, or any 
written comments for possible discussion at the meeting. The requested 
information, including the written notice for participation, may be 
submitted to the Dockets Management Branch (address above). 
Registration at the site will be done on a space-available basis on the 
day of the open public meeting beginning at 8:30 a.m.
    Prior to the meeting, CBER will determine the schedule for the 
presenters. A schedule of the presenters will be filed with the Dockets 
Management Branch (address above) and mailed or faxed to each 
participant before the meeting. Interested persons attending the 
meeting who did not request an opportunity to make a presentation or 
those who did request an opportunity to make a presentation but due to 
the time limitations were not granted the request will be given the 
opportunity to make an oral presentation at the conclusion of the 
meeting, as time permits. There is no registration fee for this public 
meeting, but advance registration is suggested. Interested persons are 
encouraged to register early because space may be limited.
    FDA will consider information presented and discussed at the 
meeting and written comments submitted to the Dockets Management Branch 
(address above) in the development of future guidance documents.

    Dated: August 19, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-22555 Filed 8-22-97; 8:45 am]
BILLING CODE 4160-01-F