[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
