E8-18001. Guidance for Food and Drug Administration Advisory Committee Members and Food and Drug Administration Staff: Voting Procedures for Advisory Committee Meetings; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance document for FDA advisory committee members and FDA staff entitled “Voting Procedures for Advisory Committee Meetings.” This document is intended to provide guidance on advisory committee voting procedures that should be used when votes are taken during advisory committee meetings. It does not define when votes should be taken. 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in this issue of the Federal Register, FDA is announcing the availability of three additional guidances and one draft guidance, intended to improve FDA's advisory committee procedures.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 guidance for FDA advisory committee members and FDA staff entitled “Voting Procedures for Advisory Committee Meetings,” dated August 2008. FDA's advisory committees provide independent and expert advice on scientific, technical, and policy matters related to the development and evaluation of products regulated by FDA. Advisory committees are a valuable resource to FDA, and they make an important contribution to the agency's decisionmaking processes. Although advisory committees provide recommendations to FDA, the agency makes the final decisions.

Advisory committees typically communicate advice or recommendations to the agency in two ways. First, FDA learns from the discussion and exchange that occurs among advisory committee members, and from individual recommendations and suggestions made during the discussion of any advisory committee meeting. Second, advisory committees often vote on a question or series of questions posed to the committee during a committee meeting.

Votes can be an effective means of communicating with FDA because they provide feedback on discrete questions. These questions are generally scientific in nature and can involve a range of subjects, including evaluation of postmarket safety data or premarket assessment of a product's risk/benefit profile. Because all members vote on the same question, the results help FDA gauge a committee's collective view on complex, multi-faceted issues. This view helps inform the agency's own deliberations on scientific and regulatory matters.

This guidance recommends adopting uniform voting procedures to help maximize the integrity and meaning of voting results. In developing these recommendations, FDA was mindful of the legal requirements of the Federal Advisory Committee Act, other relevant statutes (e.g., the Federal Food, Drug, and Cosmetic Act), regulations (e.g., 21 CFR part 14), guidance, policies, and the goals of FDA's of advisory committee program.

FDA issued a draft of this guidance on November 19, 2007 (72 FR 65046), and gave interested persons an opportunity to comment on the agency's proposal. FDA carefully evaluated the comments submitted to that docket and considered them in preparation of the guidance.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This guidance document represents the agency's current thinking on uniform procedures that should be used for the voting process when votes are taken during advisory committee meetings. 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.

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. Received comments may be seen 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.

Electronic Access:

Persons with access to the Internet may obtain the document at: http://www.regulations.gov.

Dated: August 1, 2008.

Randall W. Lutter,

Deputy Commissioner for Policy.