11098 Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Notices

Request for Nominations for

Representatives of Consumer and

Industry Interests on Public Advisory

Panels or Committees

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

nominations for consumer and industry

representatives to serve on certain

device panels of the Medical Devices

Advisory Committee and on the

National Mammography Quality

Assurance Advisory Committee in the

Center for Devices and Radiological

Health. Nominations will be accepted

for current vacancies and for those that

will or may occur through February 28,

1996.

FDA has a special interest in ensuring

that women, minority groups,

individuals with disabilities, and small

businesses are adequately represented

on advisory committees and, therefore,

encourages nominations for

appropriately qualified candidates from

these groups, as well as nominations

from small businesses that manufacture

medical devices subject to the

regulations.

DATES: Nominations should be received

by May 1, 1995.

ADDRESSES: All nominations and

curricula vitae for industry

representatives shall be submitted in

writing to Kathleen L. Walker (address

below). All nominations and curricula

vitae for consumer representatives shall

be submitted in writing to Martha F.

Waugh (address below).

FOR FURTHER INFORMATION CONTACT:

Regarding industry representatives:

Kathleen L. Walker, Center for

Devices and Radiological Health

(HFZ–17), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850, 301–443–

6932.

Regarding consumer interests: Martha

F. Waugh, Office of Consumer

Affairs (HFE–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–

5006.

SUPPLEMENTARY INFORMATION: FDA is

requesting nominations for members

representing consumer and industry

interests for the vacancies listed below:

Committee or Panel

Approximate Date Representative is Needed

Consumer Industry

Clinical Chemistry and Clinical Toxicology Devices Panel ........................... NV ............................................... February 28, 1996

Dental Products Panel:

.

Drugs ......................................................................................................... NV ............................................... October 31, 1995

Cosmetics .................................................................................................. NV ............................................... October 31, 1995

Ear, Nose, and Throat Devices Panel .......................................................... October 31, 1995 ....................... NV

Gastroenterology and Urology Devices Panel .............................................. NV ............................................... December 31, 1995

General and Plastic Surgery Devices Panel ................................................. NV ............................................... August 31, 1995

Hematology and Pathology Devices Panel ................................................... February 28, 1996 ...................... February 28, 1996

Microbiology Devices Panel .......................................................................... NV ............................................... February 28, 1996

Orthopedic and Rehabilitation Devices Panel .............................................. August 31, 1995 ......................... NV

Radiological Devices Panel ........................................................................... January 31, 1996 ....................... NV

National Mammography Quality Assurance Advisory Committee ................ January 31, 1996 ....................... NA

NV = No vacancy

NA = Not applicable

Functions

Medical Device Panels

The functions of the panels are to: (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 Federal Food, Drug, and Cosmetic

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.

The Dental Products Panel also

functions at times as a dental drug

panel. The functions of the drug panel

are to: (1) Evaluate and recommend

whether various prescription drug

products should be changed to over-thecounter status; (2) evaluate data and

make recommendations concerning the

approval of new dental drug products

for human use; (3) evaluate data and

make recommendations concerning

drug products that may also be

cosmetics; and (4) using the Plaque

Subcommittee, review and evaluate data

concerning the safety and effectiveness

of active ingredients, and combinations

thereof, of various currently marketed

dental drug products for human use,

and the adequacy of their labeling. The

subcommittee will advise on the

promulgation of monographs

establishing conditions under which

these drugs are generally recognized as

safe and effective and not misbranded.

National Mammography Quality

Assurance Advisory Committee

The functions of the committee are to

advise the Food and Drug

Administration on: (1) Developing

appropriate quality standards and

regulations for mammography facilities;

(2) developing appropriate standards

and regulations for bodies accrediting

mammography facilities under this

program; (3) developing regulations

with respect to sanctions; (4) developing

procedures for monitoring compliance

with standards; (5) establishing a

mechanism to investigate consumer

complaints; and (6) reporting new

developments concerning breast

imaging which should be considered in

the oversight of mammography

facilities.

The committee will also determine

whether there exists a shortage of

mammography facilities in rural and

health professional shortage areas and

the effects of personnel or other
Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Notices 11099

requirements on access to the services of

such facilities in such areas; and

whether there will exist a sufficient

number of medical physicists after

October 1, 1999, and the costs and

benefits of compliance with these

requirements.

Consumer and Industry Representation

Medical Device Panels

Section 520(f)(3) of the Federal Food,

Drug, and 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 as members one nonvoting

representative of consumer interests and

one nonvoting representative of

interests of the medical device

manufacturing industry.

National Mammography Quality

Assurance Advisory Committee

Section 354n of the Public Health

Service Act (42 U.S.C. 263b), as

amended by the Mammography Quality

Standards Act of 1992, provides that at

least four of the individuals nominated

for membership should be from among

national breast cancer or consumer

health organizations with expertise in

mammography. The committee may

include one technically qualified

member who is identified with

consumer interests.

Nomination Procedures

Consumer Representatives

Any interested person may nominate

one or more qualified persons as a

member of a particular advisory

committee or panel to represent

consumer interests as identified in this

notice. Self-nominations are also

accepted. To be eligible for selection,

the applicant’s experience and/or

education will be evaluated against

Federal civil service criteria for the

position to which the person will be

appointed.

Nominations shall include a complete

curriculum vitae of each nominee and

shall state that the nominee is aware of

the nomination, is willing to serve as a

member, and appears to have no conflict

of interest that would preclude

membership. FDA will ask the potential

candidates to provide detailed

information concerning such matters as

financial holdings, employment, and

research grants and/or contracts to

permit evaluation of possible sources of

conflict of interest. The nomination

should state whether the nominee is

interested only in a particular advisory

committee or panel or in any advisory

committee or panel. The term of office

is up to 4 years, depending on the

appointment date.

Industry Representatives

Any organization in the medical

device manufacturing industry (industry

interests) wishing to participate in the

selection of an appropriate member of a

particular panel may nominate one or

more qualified persons to represent

industry interests. Persons who

nominate themselves as industrial

representatives for the panels will not

participate in the selection process. It is,

therefore, recommended that all

nominations be made by someone with

an organization, trade association, or

firm who is willing to participate in the

selection process.

Nominees shall be full-time

employees of firms that manufacture

products that would come before the

panel, or consulting firms that represent

manufacturers. Nominations shall

include a complete curriculum vitae of

each nominee. The term of office is up

to 4 years, depending on the

appointment date.

Selection Procedures

Consumer Representatives

Selection of members representing

consumer interests is conducted

through procedures which include use

of a consortium of consumer

organizations which has the

responsibility for recommending

candidates for the agency’s selection.

Candidates should possess appropriate

qualifications to understand and

contribute to the committee’s work.

Industry Representatives

Regarding nominations for members

representing the interests of industry, a

letter will be sent to each person that

has made a nomination, and to those

organizations indicating an interest in

participating in the selection process,

together with a complete list of all such

organizations and the nominees. This

letter will state that it is the

responsibility of each nominator or

organization indicating an interest in

participating in the selection process to

consult with the others in selecting a

single member representing industry

interests for the panel within 60 days

after receipt of the letter. If no

individual is selected within 60 days,

the agency will select the nonvoting

member representing industry interests.

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: February 21, 1995.

Linda A. Suydam,

Interim Deputy Commissioner for Operations.

[FR Doc. 95–4911 Filed 2–28–95; 8:45 am]

BILLING CODE 4160–01–F

Request for Nominations for Voting

Members on Public Advisory Panels or

Committees in the Center for Devices

and Radiological Health

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

nominations for voting members to

serve on certain device panels of the

Medical Devices Advisory Committee

and on the National Mammography

Quality Assurance Advisory Committee

in the Center for Devices and

Radiological Health (CDRH).

Nominations will be accepted for

current vacancies and those vacancies

that will or may occur through February

28, 1996.

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: Because scheduled vacancies

occur on various dates throughout each

year, no cutoff date is established for the

receipt of nominations. However, when

possible, nominations should be

received at least 6 months before the

date of scheduled vacancies for each

year, as indicated in this notice.

ADDRESSES: All nominations and

curricula vitae for the panels should be

sent to Nancy J. Pluhowski, Center for

Devices and Radiological Health (HFZ–

400), Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850.

All nominations and curricula vitae

for the National Mammography Quality

Assurance Advisory Committee should

be sent to Charles K. Showalter, Center

for Devices and Radiological Health

(HFZ–240), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850.

FOR FURTHER INFORMATION CONTACT:

Kathleen L. Walker, Center for Devices

and Radiological Health (HFZ–17), Food

and Drug Administration, 1350 Piccard

Dr., Rockville, MD 20850, 301–443–

6932.

SUPPLEMENTARY INFORMATION: FDA is

requesting nominations of voting

members for the vacancies listed below.

1. Anesthesiology and Respiratory

Therapy Devices Panel: One vacancy

occurring November 30, 1995; general

anesthesiologists, anesthesiologists

specializing in regional anesthesia,

physicians with expertise in ventilatory

support, or nurse anesthetists.