Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices 46441 

any industry organizations interested in 

participating in the selection of a pool 

of nonvoting industry representative 

candidates available to serve as 

temporary nonvoting members on its 

Risk Communication Advisory 

Committee (the Committee) for the 

Office of the Commissioner notify FDA 

in writing. A nominee may either be 

self-nominated or nominated by an 

organization to serve as a nonvoting 

industry representative. Nominations 

for the pool will be accepted effective 

with this notice. 

DATES: Any industry organization 

interested in participating in the 

selection of a pool of appropriate 

candidates for temporary nonvoting 

membership to represent industry 

interests must send a letter stating the 

interest to FDA by October 9, 2009, for 

vacancies listed in the notice. 

Concurrently, nomination material for 

prospective candidates should be sent to 

FDA by October 9, 2009. 

ADDRESSES: All letters of interest and 

nominations should be submitted in 

writing to Lee L. Zwanziger (see FOR

FURTHER INFORMATION CONTACT). 

FOR FURTHER INFORMATION CONTACT: Lee 

L. Zwanziger, Office of Policy, Planning 

and Budget, Office of the Commissioner, 

Food and Drug Administration, 5600 

Fishers Lane, rm. 14–90, 301–827–2895, 

fax: 301–827–4050, RCAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

agency requests nominations for a pool 

of nonvoting industry representative 

candidates for the Risk Communication 

Advisory Committee. 

I. The Risk Communication Advisory 

Committee 

The Risk Communication Advisory 

Committee advises the Commissioner of 

Food and Drugs 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. The 

Committee 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 FDA hopes to identify a pool of 

individuals who would have expertise 

in risk communication and would be 

identified with the interests of various 

segments of regulated industry. The 

Commissioner, or designee, shall have 

the authority to select one or more 

individuals to serve temporarily as 

nonvoting members; the number of 

temporary members selected for a 

particular meeting will depend on the 

meeting topic(s). 

II. Selection Procedure 

Any industry organization interested 

in participating in the selection of 

appropriate nonvoting member 

candidates to represent industry 

interests should send a letter stating that 

interest to the FDA contact (see 

ADDRESSES) within 30 days of 

publication of this document (see 

DATES). Within the subsequent 30 days, 

FDA will send a letter to each 

organization that has expressed an 

interest, attaching a complete list of all 

such organizations, and a list of all 

nominees along with their current 

resumes. The letter will also state that 

it is the responsibility of the interested 

organizations in each industry segment 

to confer with one another and to select 

one or two candidates (allowing for an 

alternate) from the segment for the pool 

within 60 days after the receipt of the 

FDA letter. For this purpose, 

‘‘segments’’ should be understood in 

correspondence with the eight links 

listed on the FDA Web site: Food; drugs; 

medical devices; vaccines, blood and 

biologics; animal and veterinary; 

cosmetics; radiation-emitting products; 

and tobacco products (http:// 

www.fda.gov). The interested 

organizations are not bound by the list 

of nominees in selecting candidates. 

However, if no individuals are selected 

within 60 days, the Commissioner of 

Food and Drugs will select temporary 

nonvoting members as needed to 

represent industry interests. 

III. Application Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Within the 30 

days, the following information should 

be sent to the FDA contact person: A 

current curriculum vitae of each 

nominee, current business and/or home 

address, telephone number, e-mail 

address, and the name of the committee 

of interest. FDA will forward all 

nominations to the organizations 

expressing interest in participating in 

the selection process for the committee. 

(Persons who nominate themselves as 

nonvoting industry representatives will 

not participate in the selection process). 

FDA has a special interest in ensuring 

that women, minority groups, 

individuals with physical disabilities 

and small businesses are adequately 

represented on its advisory committees, 

and therefore, encourages, nominations 

for appropriately qualified candidates 

from these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: September 2, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21554 Filed 9–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0410] 

Request for Notification from Industry 

Organizations Interested in 

Participating in the Selection Process 

for Nonvoting Industry 

Representatives on Medical Device 

Advisory Committee Panels and 

Request for Nonvoting Industry 

Representatives on Medical Device 

Advisory Committee Panels 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting that 

any industry organization interested in 

participating in the selection of 

nonvoting industry representatives to 

serve on certain device panels of the 

Medical Devices Advisory Committee in 

the Center for Devices and Radiological 

Health notify FDA in writing. A 

nominee may either be self-nominated 

or nominated by an organization to 

serve as a nonvoting industry 

representative. Nominations will be 

accepted for current vacancies effective 

with this notice. 

DATES: Any industry organizations 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

FDA by October 9, 2009, for the 

vacancies listed in this notice. 

Concurrently, nomination materials for 

prospective candidates should be sent to 

FDA by October 9, 2009. 

ADDRESSES: Send all letters of interest 

and nominations to Kathleen L. Walker 

(see FOR FURTHER INFORMATION CONTACT). 

FOR FURTHER INFORMATION CONTACT: 

Kathleen L. Walker, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 5238, Silver Spring, 

MD 20993, 301–796–5964, e-mail: 

kathleen.walker@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

520(f)(3) of the Federal Food, Drug, and 


cprice-sewell on DSK2BSOYB1PROD with NOTICES
46442 Federal Register / Vol. 74, No. 173 / Wednesday, September 9, 2009 / Notices 

Cosmetic Act (the act) (21 U.S.C. 

360j(f)(3)), as amended by the Medical 

Device Amendments of 1976, provides 

that each medical device panel include 

one nonvoting member to represent the 

interests of the medical device 

manufacturing industry. 

FDA is requesting nominations for 

nonvoting members representing 

industry interests for the following 

vacancies listed in table 1 of this 

document. 

TABLE 1. 

Medical Devices Panels Approximate Date Needed 

Dental Products Panel November 1, 2009 

General Hospital and Personal Use Devices Panel January 1, 2010 

Hematology and Pathology Devices Panel March 1, 2010 

Immunology Devices Panel March 1, 2010 

Ophthalmic Devices Panel November 1, 2009 

I. Functions 

The functions of the medical device 

panels are listed as follows: (1) Review 

and evaluate data on the safety and 

effectiveness of marketed and 

investigational devices and make 

recommendations for their regulation, 

(2) advise the Commissioner of Food 

and Drugs regarding recommended 

classification or reclassification of these 

devices into one of three regulatory 

categories, (3) advise on any possible 

risks to health associated with the use 

of devices, (4) advise on formulation of 

product development protocols, (5) 

review premarket approval applications 

for medical devices, (6) review 

guidelines and guidance documents, (7) 

recommend exemption to certain 

devices from the application of portions 

of the act, (8) advise on the necessity to 

ban a device, (9) respond to requests 

from the agency to review and make 

recommendations on specific issues or 

problems concerning the safety and 

effectiveness of devices, and (10) make 

recommendations on the quality in the 

design of clinical studies regarding the 

safety and effectiveness of marketed and 

investigational devices. 

II. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the 

contact person (see FOR FURTHER

INFORMATION CONTACT) within 30 days of 

publication of this notice. Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations, 

and a list of all nominees along with 

their current resumes. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for a particular device panel. 

The interested organizations are not 

bound by the list of nominees in 

selecting a candidate. However, if no 

individual is selected within the 60 

days, the Commissioner of Food and 

Drugs will select the nonvoting member 

to represent industry interests. 

III. Qualifications 

Persons nominated for the device 

panels should be full time employees of 

firms that manufacture products that 

would come before the panel, or 

consulting firms that represent 

manufacturers, or have similar 

appropriate ties to industry. 

IV. Application Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Within the 30 

days, the following information should 

be sent to the FDA contact person (see 

FOR FURTHER INFORMATION CONTACT): A 

current curriculum vitae of each 

nominee, current business and/or home 

address, telephone number, e-mail 

address, and the name of the device 

panel of interest. FDA will forward all 

nominations to the organizations 

expressing interest in participating in 

the selection process for the device 

panel. (Persons who nominate 

themselves as nonvoting industry 

representatives will not participate in 

the selection process). 

FDA has a special interest in ensuring 

that women, minority groups, 

individuals with physical disabilities, 

and small businesses are adequately 

represented on its advisory committees, 

and therefore, encourages nominations 

for appropriately qualified candidates 

from these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: September 2, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–21555 Filed 9–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0412] 

Request for Nominations for Voting 

and Nonvoting Consumer 

Representative Members on Public 

Advisory Committees and Panels 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is requesting 

nominations for voting and nonvoting 

consumer representatives to serve on 

the National Mammography Quality 

Assurance Advisory Committee 

(NMQAAC) and certain devices panels 

of the Medical Devices Advisory 

Committee in the Center for Devices and 

Radiological Health (CDRH). 

FDA has a special interest in ensuring 

that women, minority groups, and 

individuals with disabilities are 

adequately represented on advisory 

committees and, therefore, encourages 

nominations of qualified candidates 

from these groups. 

DATES: Nominations will be accepted for 

current vacancies and for those that will 

or may occur through October 31, 2010. 

Because vacancies occur on various 


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