[Federal Register Volume 72, Number 39 (Wednesday, February 28, 2007)]
[Notices]
[Pages 9008-9009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-887]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0021]


Draft Guidance for Industry on Advisory Committee Meetings: 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availability of a draft guidance for industry entitled ``Advisory 
Committee Meetings--Preparation and Public Availability of Information 
Given to Advisory Committee Members.'' This guidance is intended to 
provide information to industry sponsors, applicants, and petitioners 
on the development, preparation, or submission of briefing materials 
that will be given to advisory committee members as background 
information prior to open FDA advisory committee meetings. The guidance 
will help sponsors develop, organize, and submit advisory committee 
briefing materials for public release and should help minimize the time 
and resources spent in preparing these materials for public 
availability. The guidance also describes the process FDA intends to 
follow when we make briefing materials available to the public.

DATES: Submit written or electronic comments on the draft guidance 
document by April 30, 2007. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to Office of Policy (HF-11), Office of the Commissioner, Food 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 the office in processing 
your request. Submit written comments on the draft guidance to Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: Poppy Kendall, Food and Drug 
Administration (HF-11), 5600 Fishers Lane, Rockville, MD 20857, 301-
827-3360, FAX: 301-594-6777, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Advisory Committee Meetings--Preparation and Public 
Availability of Information Given to Advisory Committee Members.'' This 
guidance will help sponsors develop, prepare, and submit advisory 
committee briefing materials and should help minimize the time and 
resources spent in preparing these materials for public availability. 
The guidance also describes the process FDA intends to follow when we 
make briefing materials available to the public. The term ``briefing 
materials'' is used to describe the package of information that we 
provide to advisory committee members before a meeting, and that 
usually contains information prepared by us and/or the sponsor (if the 
meeting involves an application or particular product). In addition, 
the Appendices to the draft guidance provide 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 disclosure under the Freedom of 
Information Act (FOIA) (5 U.S.C. 552), we intend to post the publicly 
available version of the briefing materials on our Web site at least 2 
full business days before the advisory committee meeting is scheduled 
to occur. With respect to meetings for which the briefing materials do 
not contain information that could be considered exempt from disclosure 
under FOIA, we will probably make the briefing materials available on 
our Web site more than 2 full business days before the advisory 
committee meeting is schedule to occur. In the latter case, we 
anticipate that meetings subject to this timeline will normally address 
general matters such as guidance documents and policy issues related to 
FDA-regulated products.
    This draft guidance, which will harmonize the preparation and 
public availability of information given to advisory committee members 
for all products regulated by FDA, replaces three previously issued 
draft guidances: (1) ``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;'' (2) 
``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;'' and (3) ``Availability of Information Given 
to Advisory Committee Members in Connection With the Center for Devices 
and Radiological Health Open Public Panel Meetings.'' An important goal 
of this guidance is to help ensure that briefing materials are made 
available to the public as provided under section 10(b) of the Federal

[[Page 9009]]

Advisory Committee Act (5 U.S.C. app. 2). The guidance includes 
recommendations on how to identify information that is exempt from 
public disclosure under the FOIA.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 the approach satisfies the requirements of the applicable statutes 
and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
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. The draft guidance and received 
comments may be seen in the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/opacom/morechoices/industry/guidedc.htm.

    Dated: January 24, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-887 Filed 2-26-07; 8:45 am]
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