[Federal Register Volume 74, Number 138 (Tuesday, July 21, 2009)]
[Rules and Regulations]
[Page 35801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-17218]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14

[Docket No. FDA-2009-N-0310]


Advisory Committee; Risk Communication Advisory Committee; 
Termination and Recharter

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
termination and the recharter of the Risk Communication Advisory 
Committee (the committee). These actions are needed to implement the 
Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food 
and Drug Administration Amendments Act of 2007, to change the committee 
from a discretionary to a statutory committee. This document also 
amends the agency's regulations which list advisory committees to 
reflect that the Risk Communication Advisory Committee has been 
rechartered and to revise the function statement.

DATES: This rule is effective July 21, 2009. The committee is being 
rechartered and the new charter will remain in effect until amended or 
terminated by the Commissioner of Food and Drugs (the Commissioner) or 
designee.

FOR FURTHER INFORMATION CONTACT: Lee Zwanziger, Office of Policy and 
Planning (HFP-1), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-2895, FAX: 301-827-4050, or e-mail: 
[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 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 termination and the recharter of the committee by the 
Commissioner. The committee advises the Commissioner and designees on 
methods to effectively communicate risks associated with products 
regulated by FDA, and in discharging responsibilities as they relate to 
helping ensure safe and effective drugs for human use and any other 
product for which FDA has regulatory responsibility. The committee also 
reviews and evaluates 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. In addition, the 
committee 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 using FDA-
regulated products.
    The 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 fields 
such as social marketing, health literacy, and other relevant areas. 
Members will include experts on risk communication; experts on emerging 
postmarket drug risks; and individuals knowledgeable about and 
experienced in the work of patient, consumer, and health professional 
organizations. Members will be invited to serve for overlapping terms 
of up to 4 years. Almost all non-Federal members of this committee 
serve as Special Government Employees. 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; and persons affiliated with consumer, 
specific disease, or patient safety advocacy groups. The Commissioner 
or designee shall also have the authority to select from a group of 
individuals nominated by industry to serve temporarily as nonvoting 
members who are identified with industry interests. The number of 
temporary members selected for a particular meeting will depend on the 
meeting topic(s).
    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 amends the 
information in Sec.  14.100 (21 CFR 14.100) to reflect the rechartering 
of the committee and to revise the function statement.
    Therefore, the agency is amending Sec.  14.100(a)(4)(i) and 
(a)(4)(ii) as set forth in the regulatory text of this document.

List of Subjects in 21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

0
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

0
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.

0
2. Section 14.100 is amended by revising paragraphs (a)(4)(i) and 
(a)(4)(ii) to read as follows:


Sec.  14.100  List of standing advisory committees.

* * * * *
    (a) * * *
    (4) * * *
    (i) Date Rechartered: July 9, 2009.
    (ii) Function: The committee reviews and evaluates 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.
* * * * *

    Dated: July 10, 2009.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E9-17218 Filed 7-20-09; 8:45 am]
BILLING CODE 4160-01-S