[Federal Register Volume 73, Number 151 (Tuesday, August 5, 2008)]
[Notices]
[Pages 45457-45458]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-17997]


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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finalizes the draft guidance of the same title dated February 2007.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availability of three additional guidances and one draft guidance, 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:
    <bullet> 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:
    <bullet> 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