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.
11100 Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Notices

2. Circulatory System Devices Panel:

Three vacancies occurring June 30,

1995; interventional cardiologists,

electrophysiologists, invasive (vascular)

radiologists, vascular and cardiothoracic

surgeons, and cardiologists with special

interest in congestive heart failure.

3. Clinical Chemistry and Clinical

Toxicology Devices Panel: Three

vacancies occurring February 28, 1996;

doctors of medicine or philosophy with

experience in clinical chemistry,

clinical toxicology, clinical pathology,

clinical laboratory medicine, or

oncology.

4. Dental Products Panel: Two

vacancies occurring October 31, 1995;

dentists who have experience with

lasers, endosseous implants, and

temporomandibular joint implants; or

experts in bone physiology relative to

the oral and maxillofacial area.

5. Ear, Nose, and Throat Devices

Panel: One vacancy occurring October

31, 1995; audiologists, otolaryngologists,

neurophysiologists, statisticians, or

electrical or biomedical engineers.

6. Gastroenterology and Urology

Devices Panel: Three vacancies

occurring December 31, 1995;

nephrologists, urologists, and

gastroenterologists with expertise in

diagnostic and therapeutic management

of adult and pediatric patient

populations.

7. Hematology and Pathology Devices

Panel: One vacancy occurring February

28, 1996; cytopathologists and

histopathologists; hematologists (blood

banking, coagulation, and hemostatis);

molecular biologists (nucleic acid

amplification techniques), and

hematopathologists (oncology).

8. Immunology Devices Panel: Two

vacancies occurring February 28, 1996;

medical or surgical oncologists

experienced with tumor markers, or

clinical immunologists.

9. Microbiology Devices Panel: One

vacancy occurring February 28, 1996;

infectious disease clinicians; clinical

microbiologists with expertise in

antimicrobial and antimycobacterial

susceptibility testing and chemotherapy;

clinical virologists with expertise in

diagnosis and assays; clinical

oncologists experienced with antitumor

resistance and susceptibility; and

molecular biologists.

10. Neurological Devices Panel: Two

vacancies occurring November 30, 1995;

neurologists, biomedical engineers,

interventional neuroradiologists,

neurosurgeons with interest in medical

devices, or persons experienced with

neurological devices with a strong

background in biostatistics.

11. Obstetrics and Gynecology Devices

Panel: One vacancy occurring January

31, 1996; experts in reproductive

endocrinology, endoscopy,

electrosurgery, laser surgery, assisted

reproductive technologies, and

contraception.

12. Ophthalmic Devices Panel: Two

vacancies occurring October 31, 1995;

ophthalmologists specializing in

glaucoma, surgical pediatric

ophthalmology (experienced in

correction of aphakia), retinal diseases

or corneal diseases; and optometrists

with expertise in contact lenses.

13. Orthopedic and Rehabilitation

Devices Panel: One vacancy occurring

August 31, 1995; orthopedic surgeons

experienced with prosthetic ligament

devices, joint implants, or spinal

instrumentation; physical therapists

experienced in spinal cord injuries,

neurophysiology, electrotherapy, and

joint biomechanics; rheumatologists; or

biomedical engineers.

14. Radiological Devices Panel: One

vacancy occurring January 31, 1996;

physicians and scientists with expertise

in nuclear medicine, diagnostic or

therapeutic radiology, mammography,

thermography, transillumination,

hyperthermia, bone densitometry,

magnetic resonance, computed

tomography, or ultrasound.

15. National Mammography Quality

Assurance Advisory Committee: Four

vacancies occurring January 31, 1996;

physicians, practitioners, and other

health professionals, whose clinical

practice, research specialization, or

professional expertise include a

significant focus on mammography.

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 a 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 FDA 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

requirements on access to the services of

such facilities in such areas; whether

there will exist a sufficient number of

medical physicists after October 1, 1999,

and the costs and benefits of compliance

with these requirements.

Qualifications

Medical Device Panels

Persons nominated for membership

on the panels shall have adequately

diversified experience appropriate to

the work of the panel in such fields as

clinical and administrative medicine,

engineering, biological and physical
Federal Register / Vol. 60, No. 40 / Wednesday, March 1, 1995 / Notices 11101

sciences, statistics, and other related

professions. The nature of specialized

training and experience necessary to

qualify the nominee as an expert

suitable for appointment may include

experience in medical practice,

teaching, and/or research relevant to the

field of activity of the panel. The

particular needs at this time for each

panel are shown above. The term of

office is up to 4 years, depending on the

appointment date.

National Mammography Quality

Assurance Advisory Committee

Persons nominated for membership

should be physicians, practitioners, and

other health professionals, whose

clinical practices, research

specializations, or professional expertise

include a significant focus on

mammography. Prior experience on

Federal public advisory committees in

the same or similar subject areas will

also be considered relevant professional

expertise. The particular needs for this

committee are shown above. The term of

office is up to 4 years, depending on the

appointment date.

Nomination Procedures

Any interested person may nominate

one or more qualified persons for

membership on one or more of the

advisory panels or the National

Mammography Quality Assurance

Advisory Committee. Self-nominations

are also accepted. Nominations shall

include a complete curriculum vitae of

each nominee, current business address

and telephone number, 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.

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. 95–4910 Filed 2–28–95; 8:45 am]

BILLING CODE 4160–01–F

Health Resources and Services

Administration

Program Announcement for Contracts

for the Disadvantaged Health

Professions Faculty Loan Repayment

Program for Fiscal Year 1995

The Health Resources and Services

Administration (HRSA) announces that

applications for contracts for fiscal year

(FY) 1995, for the Disadvantaged Health

Professions Faculty Loan Repayment

Program (FLRP) are now being accepted

under section 738(a) of the Public

Health Service Act (The Act).

In FY 1995, approximately $823,000

is available for competing applications

for the Disadvantaged Health

Professions Faculty Loan Repayment

Program. It is expected that 30 contracts

averaging $27,433 ($13,717 per year for

two years) will be supported with these

funds.

Previous Funding Experience

Previous funding experience

information is provided to assist

potential applicants to make better

informed decisions regarding

submission of an application for this

program. In fiscal years 1991, 1992,

1993 and 1994, HRSA entered into a

total of 129 contracts under this

program, averaging $25,030 ($12,515 per

year for 2 years).

Purpose

The purpose of the Disadvantaged

Health Professions Faculty Loan

Repayment Program (FLRP) is to attract

disadvantaged health professions

faculty members for accredited health

professions schools. The program

provides a financial incentive for

degree-trained health professions

personnel from disadvantaged

backgrounds who will serve as members

of the faculties of those schools. The

FLRP is directed at those individuals

available to serve immediately or within

a short time as ‘‘new’’ full-time faculty

members. Loan repayment may be

provided only for an individual who has

not been a member of the faculty of any

school at any time during the 18-month

period preceding the date on which the

Secretary receives the request of the

individual for a repayment contract (i.e.,

‘‘new’’ faculty).

Section 738(b) makes available grants

and contracts with schools of medicine,

osteopathic medicine, dentistry,

veterinary medicine, optometry,

podiatric medicine, pharmacy, public

health, health administration, clinical

psychology and other public or private

nonprofit health or educational entities

to assist in increasing the number of

underrepresented minority faculty.

Section 738(b) will be implemented as

a separate program.

Eligible Individuals

Individuals from disadvantaged

backgrounds are eligible to compete for

participation in the FLRP if they:

1. Have degrees in medicine,

osteopathic medicine, dentistry,

nursing, pharmacy, podiatric medicine,

optometry, veterinary medicine, public

health or clinical psychology; or

2. Are enrolled in an approved

graduate training program in one of the

health professions listed above; or

3. Are enrolled as full-time students

in the final year of health professions

training, leading to a degree from an

eligible school.

Established faculty members are not

eligible to apply for funds under the

FLRP. Only individuals that have not

taught in the last 18 (eighteen) months

prior to application to the program will

be considered.

Statutory Requirements

Prior to submitting an application for

a contract for loan repayment,

individuals must sign a contract with an

eligible school, as prescribed by the

Secretary, setting forth the terms and

conditions of the FLRP. This contract

with the school must require the

individual to serve as a full-time

member of the faculty, as determined by

the school, for not less than 2 years,

whereby the school agrees to pay, for

each year, a sum (in addition to faculty

salary) equal to that paid by the

Secretary towards the repayment of

principal due on the applicant’s health

professions educational loans.

Additionally, the individual involved

may not have been a member of the

faculty of any school at any time during

the last 18 months prior to application

to the program.

Eligible Schools

Eligible schools are public or

nonprofit private accredited schools of

medicine, nursing, as defined in section

853 of the Act, osteopathic medicine,

dentistry, pharmacy, podiatric

medicine, optometry, veterinary

medicine or public health, or schools

that offer graduate programs in clinical

psychology and which are located in

States as provided in section 799 of the

Act.

Provisions of the Loan Repayment

Program

Section 738(a) authorizes repayment,

for any year for which repayments are

made, not to exceed 20 percent of the

outstanding principal and interest on