[Federal Register: August 5, 2008 (Volume 73, Number 151)]
[Notices]
[Page 45457-45458]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05au08-64]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0425] (formerly Docket No. 2007D-0021)
Guidance for Industry: Advisory Committee Meetings--Preparation
and Public Availability of Information Given to Advisory Committee
Members; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Industry: Advisory
Committee Meetings--Preparation and Public Availability of Information
Given to Advisory Committee Members,'' dated August 2008. This document
provides guidance to industry sponsors, applicants, and petitioners who
develop, prepare, or submit briefing materials that will be given to
advisory committee members as background information before an open FDA
advisory committee meeting. The guidance announced in this notice
finalizes the draft guidance of the same title dated February 2007.
Elsewhere in this issue of the Federal Register, FDA is announcing the
availability of three additional guidances and one draft guidance,
intended to improve FDA's advisory committee procedures.
DATES: The guidance is effective August 5, 2008. Submit written or
electronic comments on agency guidances at any time.
ADDRESSES: Submit written requests for single copies of the guidance
to the Office of Policy (HF-11), Office of the Commissioner, Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. Send one
self-addressed adhesive label to assist that office in processing your
requests. Submit telephone requests to 800-835-4709 or 301-827-1800.
See the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
Submit written comments on the guidance to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Jill Hartzler Warner, Office of
Policy, Planning, and Preparedness (HF-11), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3370.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Guidance for Industry: Advisory Committee Meetings--Preparation and
Public Availability of Information Given to Advisory Committee
Members,'' dated August 2008. This guidance is intended to provide
information to industry sponsors, applicants, and petitioners on the
development, preparation, and submission of briefing materials that
will be provided to advisory committee members as background
information prior to open FDA advisory committee meetings. The guidance
is intended to help minimize the time and resources spent in preparing
such materials for public availability. The guidance also describes the
process FDA intends to follow when we make briefing materials available
to the public.
An important goal of the guidance is to help ensure that briefing
materials are made available to the public in accordance with section
10(b) of the Federal Advisory Committee Act (FACA) (5 U.S.C. app. 2).
We interpret FACA to require that, with respect to any open advisory
committee meeting convened under FACA, whenever practicable and subject
to any applicable exemptions under the Freedom of Information Act
(FOIA) (5 U.S.C. 552), those materials that we provide to advisory
committee members in connection with that meeting must be made
available for public inspection and copying either before or at the
time of the advisory committee meeting.
In the guidance, the term ``briefing materials'' is used to
describe the package of information that FDA provides to advisory
committee members before a meeting. The briefing materials for a
particular meeting generally include information prepared by FDA and/or
the sponsor (if the meeting involves a product application or otherwise
involves a particular product). This guidance includes (in the
Appendices) timelines for preparing and submitting briefing materials
to FDA.
For open advisory committee meetings for which the briefing
materials may contain information that, under certain circumstances,
could be considered to be exempt from public disclosure under FOIA, we
intend to:
Post a publicly available version of the briefing
materials on FDA's Web site at least 2 full business days before the
meeting is scheduled to occur.
For meetings for which the briefing materials do not contain
information that, under certain circumstances, could be considered to
be exempt from public disclosure under FOIA, such as many meetings
concerning guidance documents and policy issues, we will try to:
Make the briefing materials available on FDA's Web site
more than 2 full business days before the meeting.
In the Federal Register of February 28, 2007 (72 FR 9008), FDA
announced the availability of the draft guidance of the same title
dated February 2007. FDA received a number of comments on the draft
guidance and those comments were considered as the guidance was
finalized. In addition, editorial changes were made to improve clarity.
This guidance finalizes the draft guidance and replaces three
previously issued draft guidance documents entitled: (1) ``Guidance for
Industry: Disclosing Information Provided to Advisory Committees in
Connection With Open Advisory Committee Meetings Related to the Testing
or Approval of New Drugs and Convened by the Center for Drug Evaluation
and Research, Beginning on January 1, 2000,'' dated December 1999; (2)
``Guidance for Industry: Disclosing Information Provided to Advisory
Committees in Connection With Open Advisory Committee Meetings Related
to the Testing or Approval of Biologic Products and Convened by the
Center for Biologics Evaluation and Research,'' dated February 2001;
and (3) ``Availability of Information Given to Advisory Committee
Members in Connection With CDRH Open Public Panel Meetings; Draft
Guidance for Industry and FDA Staff,'' dated July 18, 2001.
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
[[Page 45458]]
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the guidance.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. A copy of the guidance and received
comments are available for public examination in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the guidance at
http://www.regulations.gov.
Dated: August 1, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-17997 Filed 8-4-08; 8:45 am]
BILLING CODE 4160-01-S