07-887. Draft Guidance for Industry on Advisory Committee Meetings: Preparation and Public Availability of Information Given to Advisory Committee Members; Availability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.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Advisory Committee Meetings—Preparation and Public Availability of Information Given to Advisory Committee Members.”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Submit written or electronic comments on the draft guidance document by April 30, 2007.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Submit written requests for single copies of the draft guidance to Office of Policy (HF-11), Office of the Commissioner, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.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 Submit written comments on the draft guidance to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.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: [phone], e-mail: [e-mail].

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FDA is announcing the availability of a draft guidance for industry entitled “Advisory Committee Meetings—Preparation and Public Availability of Information Given to Advisory Committee Members.”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 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.