Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Rules and Regulations 35801 

Dated: July 16, 2009. 

Matthew S. Borman, 

Acting Assistant Secretary for Export 

Administration. 

[FR Doc. E9–17295 Filed 7–20–09; 8:45 am] 

BILLING CODE 3510–33–P 

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: 

Lee.Zwanziger@fda.hhs.gov. 

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 § 14.100 (21 CFR 

14.100) to reflect the rechartering of the 

committee and to revise the function 

statement. 

Therefore, the agency is amending 

§ 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. 

■ 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 

revising paragraphs (a)(4)(i) and (a)(4)(ii) 

to read as follows: 

§ 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 


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