Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Notices 62323

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Rose

E. Cunningham, Center for Drug

Evaluation and Research (HFD–6), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

6779.

SUPPLEMENTARY INFORMATION: In the

Federal Register of July 31, 1997 (62 FR

41061), FDA announced that it would

be holding a public hearing on

September 12, 1997, concerning the

requirements for the content and format

of the pregnancy subsection of labeling

for human prescription drugs. The

public hearing was intended to elicit

comments on the practical utility,

effects, and limitations of the current

pregnancy labeling categories in order to

help the agency identify the range of

problems associated with the categories

and to identify and evaluate options that

might address identified problems.

Interested persons were given until

November 12, 1997, to submit written

comments on these issues. Because of

the complexity and importance of the

issues raised by pregnancy labeling, the

Pharmaceutical Research and

Manufacturers of America has requested

an additional 60 days to prepare

comments.

Interested persons may, on or before

January 12, 1998, submit to the Dockets

Management Branch (address above)

written comments on this subject. Two

copies of any comments are to be

submitted, except that individuals may

submit one copy. Comments are to be

identified with Docket No. 97N–0289.

Received comments may be seen in the

office above between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: November 13, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–30561 Filed 11–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Antiviral Drugs Advisory Committee;

Notice of Subcommittee 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). The meeting will be open to the

public.

Name of Committee: Subcommittee

meeting of the Antiviral Drugs Advisory

Committee on immunosuppressive

drugs. General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues. Date and Time: The meeting will be

held on January 14, 1998, 8:30 a.m. to

5 p.m.

Location: Quality Suites, Potomac

Ballroom, Three Research Ct., Rockville,

MD.

Contact Person: Rhonda W. Stover or

John B. Schupp, Center for Drug

Evaluation and Research (HFD–21),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–5455, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12531.

Please call the Information Line for upto-date information on this meeting. Agenda: On January 14, 1998, the

subcommittee will discuss new drug

application (NDA) 50–722, CellCept

(mycophenolate mofetil), Syntex, USA,

Inc., for immunosuppression following

cardiac transplantation. Procedure: 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 January 7, 1998. Oral

presentations from the public will be

scheduled between approximately 11

a.m. and 12 m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before January 7, 1998, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation. Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: November 14, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–30705 Filed 11–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Blood Products 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). The meeting will be open to the

public.

Name of Committee: Blood Products

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on December 11, 1997, 8 a.m. to 6

p.m., and December 12, 1997, 8 a.m. to

3:30 p.m.

Location: DoubleTree Hotel, Plazas I,

II, and III, 1750 Rockville Pike,

Rockville, MD.

Contact Person: Linda A. Smallwood,

Center for Biologics Evaluation and

Research (HFM–350), Food and Drug

Administration, 1401 Rockville Pike,

Rockville, MD 20852, 301–827–3514, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12388. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: On December 11, 1997, the

committee will discuss and provide

recommendations on the issue of FDA’s

donor deferral policy regarding men

who have had sex with another man

even one time since 1977.

On the morning of December 12,

1997, the committee will sit as a

medical device panel and make

recommendations on the issue of in

vitro diagnostic detection of human

immunodeficiency virus (HIV) viral

load, sponsor, Roche Molecular

Systems. In the afternoon, the

Committee will hear an informational

presentation on hepatitis C virus (HCV)

risk in sexual partners of positive

individuals.

Procedure: 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 December 1, 1997. Oral

presentations from the public will be

scheduled between approximately 1

p.m. and 4:30 p.m., on December 11,

1997, and between approximately 10

a.m. and 11 a.m. and 2 p.m. and 3 p.m.,

on December 12, 1997. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before December 1, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and
62324 Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Notices

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: November 14, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–30615 Filed 11-20-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Clinical Chemistry and Clinical

Toxicology 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 Committee: Clinical

Chemistry and Clinical Toxicology

Devices Panel of the Medical Devices

Advisory Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on December 10, 1997, 9:30 a.m. to

5 p.m.

Location: Corporate Bldg., conference

room 020B, 9200 Corporate Blvd.,

Rockville, MD.

Contact Person: Sharon K.

Lappalainen, Center for Devices and

Radiological Health (HFZ–440), Food

and Drug Administration, 2098 Gaither

Rd., Rockville, MD 20850, 301–594–

1243, ext. 144, or FDA Advisory

Committee Information Line, 1–800–

741–8138 (301–443–0572 in the

Washington, DC area), code 12514.

Please call the Information Line for upto-date information on this meeting.

Agenda: The committee will provide

advice and recommendations to the

agency regarding a premarket approval

application for a salivary estriol enzyme

immunoassay that is to be used as a risk

assessment marker for spontaneous

preterm labor and preterm delivery.

Procedure: On December 10, 1997,

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 December 3, 1997. Oral

presentations from the public will be

scheduled between approximately 10

a.m. and 11 a.m. Time allotted for each

presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before December 3, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Closed Committee Deliberations: On

December 10, 1997, from 9:30 a.m. to 10

a.m., the meeting will be closed to

permit discussion and review of trade

secret and/or confidential information

(5 U.S.C. 552b(c)(4)). FDA staff will

present to the committee confidential

information regarding pending or future

submissions.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: November 17, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–30707 Filed 11–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Pulmonary-Allergy Drugs 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). The meeting will be open to the

public.

Name of Committee: PulmonaryAllergy Drugs Advisory Committee. General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on December 15, 1997, 8 a.m. to 5

p.m.

Location: Ramada Inn, Embassy

Ballroom, 8400 Wisconsin Ave.,

Bethesda, MD.

Contact Person: Leander B. Madoo,

Center for Drug Evaluation and Research

(HFD–21), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–5455, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12545. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The Committee will discuss

the safety and efficacy of new drug

application (NDA) 20–793, CafcitTM

(caffeine citrate injection, 10 milligram/

milliliter), Roxane Laboratories, Inc., for

intravenous or oral use in the treatment

of apnea of prematurity.

Procedure: 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 December 5, 1997. Oral

presentations from the public will be

scheduled between approximately 8:30

a.m. and 9:30 a.m. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before December 5, 1997, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: November 14, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–30616 Filed 11–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Vaccines and Related Biological

Products 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 Committee: Vaccines and

Related Biological Products Advisory

Committee.

General Function of the Committee:

To provide advice and

recommendations to the agency on FDA

regulatory issues.

Date and Time: The meeting will be

held on December 4, 1997, 12:30 p.m. to

3:30 p.m.

Location: Food and Drug

Administration, Bldg. 29, conference