36242 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Item No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Requests for designation as U.S. CAB 12 1 12 24 288

Premarket reports by EC CAB’s 20 5 100 40 4,000

Quality system reports by EC CAB’s 20 5 100 32 3,200

Total 7,488

1There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Item No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

Records of evaluation of premarket submissions by

EC CAB’s 20 5 100 10 1,000

Records of evaluation of quality systems 20 5 100 10 1,000

Total 2,000

1There are no capital costs or operating and maintenance costs associated with this collection of information.

The burdens are explained as follows:

II. Reporting

A. Requests for Designation as U.S. CAB

Under this program, U.S. firms may

apply for designation as a U.S. CAB.

Such designation will enable that firm

to perform third-party evaluations of

U.S. products for export to the EC.

Likewise, European firms may apply to

be designated as EC CAB’s, which will

enable them to perform third-party

evaluations of products to be exported

to the United States. The application for

nomination as an EC CAB does not

represent a paperwork burden subject to

the PRA because the designation

procedure is an internal process which

is required by, and administered by,

European authorities. Only the

application for designation as a U.S.

CAB represents a paperwork burden

under the PRA. The agency anticipates,

based on discussions with the National

Institute of Science and Technology of

the U.S. Department of Commerce and

officials of other standards

organizations, that approximately 12

applications for designation as U.S.

CAB’s will be received.

B. Premarket Reports

Under this program, EC CAB’s will be

able to perform third-party evaluations

for certain products produced in Europe

for export to the United States. EC

CAB’s would be required to submit to

FDA reports of their evaluations. Based

upon information gathered during the

negotiation of the U.S./EC MRA, the

agency anticipates that European

manufacturers will request third-party

evaluation for approximately 100

medical device products annually. The

agency further estimates, based on

dialogue with EC officials, that 20 firms

will be designated to act as EC CAB’s.

C. Quality System Reports

Under this program, EC CAB’s will be

able to perform third-party evaluations

of the quality systems established by

manufacturers of European products

produced for export to the United

States. EC CAB’s would be required to

submit to FDA reports of their

evaluations. Based upon information

gathered during the negotiation of the

U.S./EC MRA, the agency anticipates

that European manufacturers will

request third-party evaluations for

approximately 100 medical device

products annually. The agency

estimates that 20 EC CAB’s will perform

these evaluations.

III. Recordkeeping

As stated previously, firms designated

as EC CAB’s will be able to perform

third-party evaluations of quality

systems and premarket submissions for

certain products produced for export to

the United States. Such evaluation will

be conducted consistent with FDA’s

regulatory requirements, and FDA will

require the reviewers to keep, in their

records, a copy of the report that they

submit to FDA for each evaluation. The

agency anticipates that 100 premarket

reports and 100 quality system reports

will be generated and required to be

maintained by EC CAB’s annually.

Thus, the agency estimates that 100

records of evaluations of quality systems

and premarket submissions will be

retained by the designated EC CAB’s.

Based on experience with the Third

Party Review Pilot Program, which was

announced in the Federal Register of

April 3, 1996 (61 FR 14789), the agency

anticipates that each recordkeeper will

require no more than 2 hours of

recordkeeping per review. The agency is

estimating 5 reviews per respondent;

therefore, the total number of hours per

recordkeeper is 10.

Dated: June 24, 1998.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 98–17602 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Request for Nominations for

Nonvoting 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 nonvoting consumer

representatives and nonvoting industry

representatives to serve on certain

device panels of the Medical Devices

Advisory Committee in the Center for

Devices and Radiological Health

(CDRH). Nominations will be accepted

for current vacancies and for those that

will or may occur through June 30,

1999.

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,
Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices 36243

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 (insert date 30 days after date of

publication in the Federal Register), for

vacancies listed in this notice.

ADDRESSES: All nominations and

curricula vitae for consumer

representatives should be submitted in

writing to Annette J. Funn (address

below). All nominations and curricula

vitae (which includes nominee’s office

address and telephone number) for

industry representatives should be

submitted in writing to Kathleen L.

Walker (address below).

FOR FURTHER INFORMATION CONTACT:

Regarding consumer representatives:

Annette Funn, Office of Consumer

Affairs (HFE–88), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

5006.

Regarding industry representatives:

Kathleen L. Walker, Office of

Systems and Management (HFZ–

17), CDRH, Food and Drug

Administration, 2098 Gaither Rd.,

Rockville, MD 20850, 301–594–

1283, ext. 114.

SUPPLEMENTARY INFORMATION: FDA is

requesting nominations for nonvoting

members representing consumer and

industry interests for the vacancies

listed below:

Medical Devices Panels

Approximate Date Representative is Needed

Consumer Industry

Circulatory System Devices Panel July 1, 1999 NV

Immunology Devices Panel March 1, 1999 NV

Obstetrics and Gynecology Devices Panel NV February 1, 1999

NV = No vacancy

Function

The functions of the medical device

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.

Consumer and Industry Representation

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.

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 industry

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
36244 Federal Register / Vol. 63, No. 127 /Thursday, July 2, 1998 / Notices

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: June 26, 1998.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 98–17601 Filed 7–1–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Request for Nominations for Voting

Members 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 voting members to

serve on certain device panels of the

Medical Devices Advisory Committee,

the Device Good Manufacturing Practice

Advisory Committee, and the Technical

Electronic Product Radiation Safety

Standards Committee in the Center for

Devices and Radiological Health

(CDRH). Nominations will be accepted

for current vacancies and those that will

or may occur through June 30, 1999.

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 device panels

should be sent to Nancy J. Pluhowski,

Office of Device Evaluation (HFZ–400),

CDRH, Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850.

All nominations and curricula vitae

for health professionals, industry

representatives, and government

representatives for the Device Good

Manufacturing Practice Advisory

Committee should be sent to Sharon

Kalokerinos, CDRH (HFZ–300),

Food and Drug Administration,

2094 Gaither Rd., Rockville, MD

20850.

All nominations and curricula vitae

for government and industry

representatives for the Technical

Electronic Product Radiation Safety

Standards Committee should be

sent to Orhan Suleiman, CDRH

(HFZ–240), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850.

All nominations and curricula vitae

for general public representatives

for the Device Good Manufacturing

Practice Advisory Committee and

the Technical Electronic Product

Radiation Safety Standards

Committee should be sent to

Annette Funn, Office of Consumer

Affairs (HFE–88), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Kathleen L. Walker, Center for Devices

and Radiological Health (HFZ–17), Food

and Drug Administration, 2098 Gaither

Rd., Rockville, MD 20850, 301–594–

1283, ext. 114.

SUPPLEMENTARY INFORMATION: FDA is

requesting nominations of voting

members for vacancies listed below.

1. Circulatory System Devices Panel:

Two vacancies occurring June 30, 1999;

interventional cardiologists,

electrophysiologists, invasive (vascular)

radiologists, vascular and cardiothoracic

surgeons, and cardiologists with special

interest in congestive heart failure.

2. Clinical Chemistry and Clinical

Toxicology Devices Panel: One vacancy

occurring February 28, 1999; doctors of

medicine or philosophy with experience

in clinical chemistry, clinical

toxicology, clinical pathology, clinical

laboratory medicine, or oncology.

3. Dental Products Panel: Three

vacancies immediately, one vacancy

occurring October 31, 1998; dentists

who have expertise in the areas of

lasers, endosseous implants,

temporomandibular joint implants,

dental materials and/or endodontics; or

experts in bone physiology relative to

the oral and maxillofacial area.

4. Ear, Nose, and Throat Devices

Panel: One vacancy occurring October

31, 1998; audiologists, otolaryngologists,

neurophysiologist, statisticians, or

electrical or biomedical engineers.

5. General Hospital and Personal Use

Devices Panel: Three vacancies

immediately, one vacancy occurring

December 31, 1998; internists,

pediatricians, neonatologists,

gerontologists, nurses, biomedical

engineers or microbiologists/infection

control practitioners or experts.

6. Hematology and Pathology Devices

Panel: Two vacancies occurring

February 28, 1999; cytopathologists and

histopathologists; hematologists (blood

banking, coagulation and hemostasis);

molecular biologists (nucleic acid

amplification techniques), and

hematopathologists (oncology).

7. Immunology Devices Panel: One

vacancy immediately, one vacancy

occurring February 28, 1999; persons

with experience in medical, surgical, or

clinical oncology, internal medicine,

clinical immunology, allergy, molecular

diagnostics, human genetics testing or

clinical laboratory medicine.

8. Microbiology Devices Panel: Three

vacancies immediately, one vacancy

occurring February 28, 1999; infectious

disease clinicians; clinical

microbiologists with expertise in

antimicrobial and antimycobacterial

susceptibility testing, chemotherapy and

in vitro diagnostic (IVD) applications;

clinical virologists with expertise in

clinical diagnosis and IVD assays;

clinical oncologists experienced with

antitumor resistance and susceptibility;

and molecular biologists.

9. Obstetrics and Gynecology Devices

Panel: Two vacancies occurring January

31, 1999; experts in reproductive

endocrinology, endoscopy,

electrosurgery, laser surgery, assisted

reproductive technologies, and

contraception; biostatisticians and

engineers with experience in obstetrics/

gynecology devices; urogynecologists;

experts in breast care; and experts in

gynecology in the older patient.

10. Orthopaedic and Rehabilitation

Devices Panel: Two vacancies occurring

August 31, 1998; 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.

11. Radiological Devices Panel: Two

vacancies occurring January 31, 1999;

physicians and scientists with expertise

in nuclear medicine, diagnostic or

therapeutic radiology, mammography,

thermography, transillumination,

hyperthermia cancer therapy, bone

densitometry, magnetic resonance,

computed tomography, or ultrasound.

12. Device Good Manufacturing

Practice Advisory Committee: Four

vacancies immediately, one government

representative, one health professional,

one industry representative, and one

general public representative; five