Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA 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 entitled “Guidance for the Public, FDA Advisory Committee Members, and FDA Staff: The Open Public Hearing at FDA Advisory Committee Meetings.” We are issuing the guidance to provide information on how the public may participate at the open public hearing (OPH) portion of FDA advisory committee meetings. The guidance also provides recommendations regarding financial disclosure by persons participating in the OPH portion of advisory committee meetings.

DATES:

Submit electronic or written comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of this guidance to the Office of Special Medical Programs, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5103, Silver Spring, MD 20993. Send one self-addressed adhesive label to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. Submit electronic comments on the guidance to http://www.regulations.gov. 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.

FOR FURTHER INFORMATION CONTACT:

Michael Ortwerth, Office of Special Medical Programs, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5103, Silver Spring, MD 20993, e-mail: Michael.Ortwerth@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

In the February 15, 2005, issue of the Federal Register (70 FR 7747), FDA issued a notice announcing the availability of a draft guidance entitled “The Open Public Hearing; FDA Advisory Committee Meetings.” The guidance is intended for members of the public who choose to participate in the OPH portion of an FDA advisory committee meeting.

FDA issues guidance documents for FDA staff, applicants and sponsors of regulated products, and the public that describe the agency's current thinking on a regulatory matter, including its interpretation of, and policies regarding, statutes and regulations. FDA's advisory committees provide independent expert advice and recommendations to the agency on scientific, technical, and policy matters related to FDA-regulated products. Although advisory committees provide recommendations to FDA, FDA makes the final decisions on any matters considered by an advisory committee (21 CFR 14.5). Under 21 CFR 14.25(a), every meeting of an FDA advisory committee includes an OPH session during which interested persons may present relevant information or views orally or in writing. The hearing session is conducted in accordance with the procedures set forth in 21 CFR 14.29.

FDA encourages participation from all public stakeholders in our decisionmaking processes. We issued the draft guidance to answer questions about how the public may participate at an OPH session. Participants may include, but are not limited to, general members of the public, individuals or spokespersons from the regulated industry, consumer advocacy groups, and professional organizations, societies, and associations. The guidance provides information on such matters as how to submit a request to speak at an OPH session, logistical procedures, and disclosure of financial relationships relevant to the meeting topic.

We received two comments on the draft guidance. In response to the comments and at our own initiative, we have revised the guidance in several respects, including with regard to how the OPH session is conducted and instructions regarding financial disclosure.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's thinking on participation in the OPH portion of FDA 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) either electronic or written comments regarding this document. It is only necessary to send one set of comments. It is no longer necessary to send two copies of mailed comments. Identify comments 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.

III. Electronic Access

Persons with access to the Internet may obtain the guidance at http://www.fda.gov/oc/advisory/default.htm.