Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Notices 23719

medical data concerning the safety and

effectiveness of marketed and

investigational human drugs for use in

the area of medical specialties,

indicated by the title of the committee,

and to make appropriate

recommendations to the Commissioner

of Food and Drugs.

Criteria for Members

Persons nominated for membership

on the committees described above must

have adequately diversified research

and/or clinical experience appropriate

to the work of the committee in such

fields as anesthesiology, surgery,

internal medicine, infectious disease,

asthma, rheumatology, microbiology,

pediatrics, ophthalmology, cardiology,

clinical/medical oncology, hematology,

radiology, nuclear medicine,

biostatistics, epidemiology,

dermatopathology/immunodermatology,

dermatology, psychopharmacology,

neurochemistry, neuropharmacology,

endocrinology, obstetrics and

gynecology, reproductive

endocrinology, gastroenterology,

pharmacology, clinical pharmacology,

hepatology, virology, pharmaceutical

manufacturing, bioavailability and

bioequivalence research,

pharmacokinetics, neurology,

psychiatry, psychology,

neuropharmacology, neuropathology,

pulmonary disease, allergy,

immunology, clinical immunology, or

other appropriate areas of expertise.

The specialized training and

experience necessary to qualify the

nominee as an expert suitable for

appointment is subject to review, but

may include experience in medical

practice, teaching, research, and/or

public service relevant to the field of

activity of the committee. The term of

office is up to 4 years.

Criteria for Consumer-Nominated

Members

FDA currently attempts to place on

each of the committees described above

one voting member who is nominated

by consumer organizations. These

members are recommended by a

consortium of 12 consumer

organizations which has the

responsibility for screening,

interviewing, and recommending

consumer-nominated candidates with

appropriate scientific credentials.

Candidates are sought who are aware of

the consumer impact of committee

issues, but who also possess enough

technical background to understand and

contribute to the committee’s work. This

would involve, for example, an

understanding of research design,

benefit/risk and the legal requirements

for safety and efficacy of the products

under review, and considerations

regarding individual products. The

agency notes, however, that for some

advisory committees, it may require

such nominees to meet the same

technical qualifications and specialized

training required of other expert

members of the committee. The term of

office for these members is up to 4

years. Nominations for all committees

listed above are invited for

consideration for membership as

openings become available.

Nomination Procedure

Any interested person may nominate

one or more qualified persons for

membership on one or more of the

advisory committees. Nominations shall

specify the committee for which the

nominee is recommended. Nominations

shall state that the nominee is aware of

the nomination, is willing to serve as a

member of the advisory committee, and

appears to have no conflict of interest

that would preclude committee

membership. Potential candidates will

be asked by FDA to provide detailed

information concerning such matters as

financial holdings, consultancies, and

research grants or contracts in order 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: May 2, 2001.

Bonnie H. Malkin,

Special Assistant to the Senior Associate

Commissioner.

[FR Doc. 01–11619 Filed 5–8–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Obstetrics and Gynecology Devices

Panel of the Medical Devices Advisory

Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of the Committee: Obstetrics

and Gynecology Devices Panel of the

Medical Devices Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on May 21, 2001, 1 p.m. to 5 p.m.,

and May 22, 2001, 8 a.m. to 5 p.m.

Location: Holiday Inn, Walker/

Whetstone Rooms, Two Montgomery

Village Ave., Gaithersburg, MD.

Contact Person: Joyce M. Whang,

Center for Devices and Radiological

Health (HFZ–470), Food and Drug

Administration, 9200 Corporate Blvd.,

Rockville, MD 20850, 301–594–1180, or

FDA Advisory Committee Information

Hotline, 1–800–741–8138 (301–443–

0572 in the Washington, DC area), code

12524. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On May 21, 2001, the

committee will discuss a supplement to

a premarket approval application (PMA)

for an intrapartum fetal pulse oximeter.

The committee will also hear a

presentation on the clinical trial of an

intrapartum fundal pressure belt

intended to reduce the incidence of

operative deliveries. On May 22, 2001,

in the morning session, the committee

will discuss air and gas emboli

associated with operative hysteroscopy.

In the afternoon session, the committee

will discuss uterine artery embolization.

Background information and questions

to the committee will be available to the

public on May 18, 2001, on the Internet

at http://www.fda.gov/cdrh/

panelmtg.html.

Procedure: On May 21, 2001, from 1

p.m. to 5 p.m. and May 22, 2001, from

10 a.m. to 5 p.m., the meeting is open

to the public. Interested persons may

present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by May 11, 2001. On May 21,

2001, oral presentations from the public

will be scheduled between

approximately 1:30 p.m. and 2 p.m., and

on May 22, 2001, oral presentations

from the public will be scheduled

between approximately 11:30 a.m. and

11:45 a.m., and between approximately

2:45 p.m. and 3 p.m. Time allotted for

each presentation may be limited. Those

desiring to make formal presentations

should notify the contact person before

May 11, 2001, and submit a brief

statement of the general nature of the

evidence or arguments they wish to

present, the names and address of

proposed participants, and an

indication of the approximate time

requested to make their presentation.

Closed Committee Deliberations: On

May 22, 2001, from 8 a.m. to 10 a.m.,

the meeting will be closed to the public

to permit FDA to present to the

23720 Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Notices

committee trade secret and/or

confidential commercial information (5

U.S.C. 552b(c)(4)) regarding pending

and future device issues. In addition,

the committee will discuss and review

trade secret and/or confidential

commercial information presented by a

sponsor.

FDA regrets that it was unable to

publish this notice 15 days prior to the

May 21 and 22, 2001, Obstetrics and

Gynecology Devices Panel of the

Medical Devices Advisory Committee

meeting. Because the agency believes

there is some urgency to bring these

issues to public discussion and

qualified members of the Obstetrics and

Gynecology Devices Panel of the

Medical Devices Advisory Committee

were available at this time, the

Commissioner of Food and Drugs

concluded that it was in the public

interest to hold this meeting even if

there was not sufficient time for the

customary 15-day public notice.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 4, 2001.

Bonnie Malkin,

Special Assistant to the Senior Associate

Commissioner.

[FR Doc. 01–11732 Filed 5–4–01; 4:54 pm]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Amended

Notice of Meeting

Notice is hereby given of a change in

the meeting of the Advisory Committee

to the Director, National Cancer

Institute, May 10, 2001, 12 pm to May

10, 2001, 1 pm, National Cancer

Institute, National Institutes of Health,

9000 Rockville Pike, Building 31, Room

11A03, Bethesda, MD 20892 which was

published in the Federal Register on

April 19, 2001, 66 FR 20152.

The meeting will be held on

Thursday, May 24, 2001. The meeting is

open to the public.

Dated: May 1, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–11595 Filed 5–8–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Amended

Notice of Meeting

Notice is hereby given of a change in

the meeting of the National Cancer

Institute Special Emphasis Panel, April

30, 2001, 8 a.m. to May 1, 2001, 5 p.m.,

Ramada Inn Rockville, 1775 Rockville

Pike, Rockville, MD 20852 which was

published in the Federal Register on

April 19, 2001, 66 FR 20151.

The meeting will be held on

Thursday, May 24 and Friday, May 25,

2001. The meeting is closed to the

public.

Dated: May 1, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–11599 Filed 5–8–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Closed Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the following

meeting.

The meeting will be closed to the

public in accordance with the

provisions set forth in sections

552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Cancer

Institute, Special Emphasis Panel, Molecular

Pathways of Bladder Cancer Progression.

Date: May 23, 2001.

Time: 12 p.m. to 4:30 p.m.

Agenda: To review and evaluate grant

applications and/or proposals.

Place: National Cancer Institute, Grants

Review Branch, Division of Extramural

Activities, 6116 Executive Boulevard, Room

8127, Bethesda, MD 20892 (Telephone

Conference Call).

Contact Person: Michael B. Small, Ph.D,

Scientific Review Administrator, Grants

Review Branch, Division of Extramural

Activities, National Cancer Institute, National

Institutes of Health, 6116 Executive

Boulevard, Room 8127, Bethesda, MD 20892,

301/402–0996.

This notice is being published less than 15

days prior to the meeting due to the timing

limitations imposed by the review and

funding cycle.

Any interested person may file written

comments with the committee by forwarding

the statement to the Contact Person listed on

this notice. The statement should include the

name, address, telephone number and when

applicable, the business or professional

affiliation of the interested person.

(Catalogue of Federal Domestic Assistance

Program Nos. 93.392, Cancer Construction;

93.393, Cancer Cause and Prevention

Research; 93.394, Cancer Detection and

Diagnosis Research; 93.395, Cancer

Treatment Research; 93.396, Cancer Biology

Research; 93.397, Cancer Centers Support;

93.398, Cancer Research Manpower; 93.399,

Cancer Control, National Institutes of Health,

HHS)

Dated: May 1, 2001.

LaVerne Y. Stringfield,

Director, Office of Federal Advisory

Committee Policy.

[FR Doc. 01–11600 Filed 5–8–01; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Cancer Institute; Notice of

Meeting

Pursuant to section 10(d) of the

Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is hereby given of the meeting of the

National Cancer Advisory Board.

The meeting will be open to the

public as indicated below, with

attendance limited to space available.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

notify the Contact Person listed below

in advance of the meeting.

A portion of the meeting will be

closed to the public in accordance with

the provisions set forth in sections

552b(c)(4), and 552b(6), Title 5 U.S.C.,

as amended. The grant applications and

the discussions could disclose

confidential trade secrets or commercial

property such as patentable material,

and personal information concerning

individuals associated with the grant

applications, the disclosure of which

would constitute a clearly unwarranted

invasion of personal privacy.

Name of Committee: National Cancer

Advisory.

Date: May 22, 2001.

Open: 8:45 a.m. to 12 p.m..

Agenda: Program reports and

presentations; Business of the board.