23718 Federal Register / Vol. 66, No. 90 / Wednesday, May 9, 2001 / Notices

Sponsor NADA No. Product

(Drug)

21 CFR Cite Affected

(Sponsor Drug Labeler Code)

.................................................................... NADA 110–350 Dexamethasone Injection ......... 522.540(b)(2)(ii) (000402)

.................................................................... NADA 117–973 Prednisolone Sodium Succinate

for Injection.

522.1884(c) (000402)

Therefore, under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10), redelegated to the Center

for Veterinary Medicine (21 CFR 5.84),

and in accordance with § 514.115

Withdrawal of approval of applications

(21 CFR 514.115), notice is given that

approval of NADAs 44–585, 45–578,

45–737, 45–848, 48–915, 97–567, 97–

615, 110–349, 110–350, 110–440, and

117–973, and all supplements and

amendments thereto, is hereby

withdrawn, effective May 21, 2001.

In a final rule published elsewhere in

this issue of the Federal Register, FDA

is amending the animal drug regulations

to reflect the withdrawal of approval of

these NADAs.

Dated: May 2, 2001.

Stephen F. Sundlof,

Director, Center for Veterinary Medicine.

[FR Doc. 01–11620 Filed 5–8–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Request for Nominations for Members

on Public Advisory Committees in the

Center for Drug Evaluation and

Research

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is requesting

nominations for members to serve on

the public advisory committees in the

Center for Drug Evaluation and

Research. Nominations will be accepted

for current vacancies and vacancies that

will or may occur on the committees

during the next 16 months.

FDA has a special interest in ensuring

that women, minority groups, and the

physically handicapped are adequately

represented on advisory committees

and, therefore, extends particular

encouragement to nominations for

appropriately qualified female,

minority, and physically handicapped

candidates. Final selection from among

qualified candidates for each vacancy

will be determined by the expertise

required to meet specific agency needs

and in a manner to ensure appropriate

balance of membership.

DATES: Because scheduled vacancies

occur on various dates throughout each

year, no cutoff date is established for

receipt of nominations.

ADDRESSES: All nominations and

curricula vitae should be sent to the

addresses below.

FOR FURTHER INFORMATION CONTACT:

Regarding nominations, except for

consumer representatives: John

Treacy, Center for Drug Evaluation

and Research (HFD–21), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–

827–7001, e-mail:

treacy@cder.fda.gov.

Regarding nominations for consumer

representatives: Maureen Hess,

Office of Consumer Affairs (HFE–

50), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–827–5006, e-mail:

mhess@oc.fda.gov.

SUPPLEMENTARY INFORMATION: FDA is

requesting nominations of members for

the following 16 advisory committees

for vacancies listed below. Individuals

should have expertise in the activity of

the committee.

1. Advisory Committee for

Pharmaceutical Science: Two vacancies

occurring immediately, two vacancies

occurring October 31, 2001, and six

vacancies occurring October 31, 2002,

including that of the consumernominated member.

2. Advisory Committee for

Reproductive Health Drugs: Four

vacancies occurring immediately, four

vacancies occurring June 30, 2001, and

three vacancies occurring June 30, 2002.

3. Anesthetic and Life Support Drugs

Advisory Committee: Five vacancies

occurring immediately, and four

vacancies occurring March 31, 2002,

including that of the consumernominated member.

4. Anti-Infective Drugs Advisory

Committee: Five vacancies occurring

November 30, 2001, and three vacancies

occurring November 30, 2002.

5. Antiviral Drugs Advisory

Committee: Three vacancies occurring

immediately, three vacancies occurring

October 31, 2001, and two vacancies

occurring October 31, 2002.

6. Arthritis Advisory Committee: Two

vacancies occurring September 30,

2001, and four vacancies occurring

September 30, 2002.

7. Cardiovascular and Renal Drugs

Advisory Committee: Three vacancies

occurring June 30, 2001, including that

of the consumer-nominated member,

and four vacancies occurring June 30,

2003.

8. Dermatologic Drugs Advisory

Committee: Seven vacancies occurring

immediately, four vacancies occurring

August 31, 2001, and four vacancies

occurring August 31, 2002, including

that of the consumer-nominated

member.

9. Endocrinologic and Metabolic

Drugs Advisory Committee: One

vacancy occurring immediately, one

vacancy occurring June 30, 2001, and

four vacancies occurring June 30, 2002.

10. Gastrointestinal Drugs Advisory

Committee: Three vacancies occurring

June 30, 2001, and two vacancies

occurring June 30, 2002.

11. Medical Imaging Drugs Advisory

Committee: Ten vacancies occurring

immediately, three vacancies occurring

June 30, 2001, and two vacancies

occurring June 30, 2002, including that

of the consumer-nominated member.

12. Nonprescription Drugs Advisory

Committee: Four vacancies occurring

immediately, including that of the

consumer-nominated member, one

vacancy occurring on May 30, 2001, and

four vacancies occurring May 31, 2002.

13. Oncologic Drugs Advisory

Committee: Two vacancies occurring

June 30, 2001, and three vacancies

occurring June 30, 2002.

14. Peripheral and Central Nervous

Systems Drugs Advisory Committee:

Seven vacancies occurring immediately.

15. Psychopharmacologic Drugs

Advisory Committee: Two vacancies

occurring June 30, 2001, and four

vacancies occurring June 30, 2002,

including that of the consumernominated member.

16. Pulmonary-Allergy Drugs

Advisory Committee: Two vacancies

occurring immediately, two vacancies

occurring May 31, 2001, including that

of the consumer-nominated member,

and five vacancies occurring May 31,

2002.

Function

The functions of the 16 committees

listed above are to review and evaluate

available scientific, technical, and

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