E7-14498. Advisory Committee; Risk Communication Advisory Committee; Establishment

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the establishment of the Risk Communication Advisory Committee in the Office of Planning, Office of the Commissioner. This document adds the Risk Communication Advisory Committee to the agency's list of standing advisory committees.

DATES:

This rule is effective July 27, 2007. Authority for the committee being established will end on June 19, 2009, unless the Commissioner formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT:

Lee Zwanziger, Office of Planning, Office of Commissioner (HFP-1), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2895, Fax [phone] or [e-mail]

SUPPLEMENTARY INFORMATION:

Under the Federal Advisory Committee Act of October 6, 1972 (Public Law 92-463 (5 U.S.C. app. 2)); section 904 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 394), as amended by the Food and Drug Administration Revitalization Act (Public Law 101-635); and 21 CFR 14.40(b), FDA is announcing the establishment of the Risk Communication Advisory Committee by the Commissioner. The committee advises the Commissioner of Food and Drugs (the Commissioner) and designees on strategies and programs designed to communicate with the public about the risks and benefits of FDA-regulated products so as to facilitate optimal use of these products. The committee also reviews and evaluates research relevant to such communication to the public by both FDA and other entities. It also facilitates interactively sharing risk and benefit information with the public to enable people to make informed independent judgments about use of FDA-regulated products.

The Risk Communication Advisory Committee will be composed of a core of 15 voting members including the Chair. Members and the chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of risk communication, social marketing, health literacy, cultural competency, journalism, bioethics, and other relevant behavioral and social sciences. Some members will be selected to provide experiential insight on the communication needs of the various groups who use FDA-regulated products. The latter may include patients and patients' family members, health professionals, communicators in health, medicine and science, persons affiliated with consumer, specific disease, or patient safety advocacy groups. Depending on the meeting topic(s), at least one nonvoting member identified with relevant industry interests may be invited from existing members of other FDA Advisory Committees.

Under 5 U.S.C. 553(b)(3)(B) and (d) and 21 CFR 10.40 (d) and (e), the agency finds good cause to dispense with notice and public comment procedures and to proceed to an immediate effective date on this rule. Notice and public comment and a delayed effective date are unnecessary and are not in the public interest as this final rule merely adds the name of the Risk Communication Advisory Committee, already established by charter, to the list of standing advisory committees in 21 CFR 14.100.

Therefore, the agency is amending 21 CFR 14.100(a) as set forth below.

List of Subjects in 21 CFR Part 14

• Administrative practice and procedure
• Advisory committees
• Color additives
• Drugs
• Radiation protection

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 14 is amended as follows:

PART 14—PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

1. The authority citation for 21 CFR part 14 continues to read as follows:

Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201, 262, 263b 264; Pub. L. 107-109; Pub. L. 108-155.

2. Section 14.100 is amended by adding paragraph (a)(4).

§ 14.100

List of standing advisory committees.

(a) * * *

(4) Risk Communication Advisory Committee.

(i) Date established: June 19, 2007.

(ii) Function: The committee advises the Commissioner and designees on strategies and programs designed to communicate to the public the risks and benefits of FDA-regulated products so as to facilitate optimal use of these products. The committee also reviews and evaluates research relevant to such communication to the public by both FDA and other entities. It also facilitates interactively sharing risk and benefit information with the public to enable people to make informed independent judgments about use of FDA-regulated products.

Dated: July 17, 2007.

Randall W. Lutter,

Deputy Commissioner for Policy.