[Federal Register Volume 72, Number 144 (Friday, July 27, 2007)]
[Rules and Regulations]
[Pages 41221-41222]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-14498]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14


Advisory Committee; Risk Communication Advisory Committee; 
Establishment

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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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 301-827-5260 or 
[email protected]

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.

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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

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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.

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

[[Page 41222]]

Sec.  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.
[FR Doc. E7-14498 Filed 7-26-07; 8:45 am]
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