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
Federal Register / Vol. 62, No. 225 / Friday, November 21, 1997 / Notices 62325

room 121, 8800 Wisconsin Ave.,

Bethesda, MD. This meeting will be

held by a telephone conference call. A

speaker telephone will be provided in

the conference room to allow public

participation in the meeting.

Contact Person: Nancy T. Cherry or

Denise H. Royster, Center for Biologics

Evaluation and Research (HFM–21),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–0314, 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 upto-date information on this meeting.

Agenda: The committee will discuss

the intramural scientific program of the

Laboratory of Enteric and Sexually

Transmitted Diseases.

Procedure: On December 4, 1997,

from 12:30 p.m. to 1:15 p.m., and 2:30

p.m. to 3:30 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 November 26, 1997. Oral

presentations from the public will be

scheduled between approximately 2:30

p.m. and 3:30 p.m. Time allotted for

each presentation may be limited. Those

desiring to make formal oral

presentations should notify the contact

person before November 26, 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 4, 1997, from 1:15 p.m. to

2:30 p.m., the meeting will be closed to

permit discussion where disclosure

would constitute a clearly unwarranted

invasion of personal privacy (5 U.S.C.

552b(c)(6)). The meeting will be closed

to discuss personal information

concerning individuals associated with

the research program.

FDA regrets that it was unable to

publish this notice 15 days prior to the

December 4, 1997, Vaccines and Related

Biological Products Advisory

Committee meeting. Because the agency

believes there is some urgency to bring

this issue to public discussion and

qualified members of the Vaccines and

Related Biological Products Advisory

Committee were available at this time,

the Commissioner 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: November 17, 1997.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 97–30613 Filed 11-20-97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Vaccine 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 11, 1997, 10:30 a.m.

to 5:45 p.m., and December 12, 1997, 8

a.m. to 5 p.m.

Location: Holiday Inn Bethesda,

Versailles Ballrooms I and II, 8120

Wisconsin Ave., Bethesda, MD.

Contact Person: Nancy T. Cherry or

Denise H. Royster, Center for Biologics

Evaluation and Research (HFM–21),

Food and Drug Administration, 1401

Rockville Pike, Rockville, MD 20852,

301–827–0314, 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 upto-date information on this meeting.

Agenda: On December 11, 1997, the

committee will meet in closed session to

discuss trade secret and/or confidential

commercial information relevant to

pending investigational new drug

applications or pending product

licensing applications. On December 12,

1997, in open session, the committee

will consider the safety and efficacy of

a new vaccine for the prevention of

Rotavirus Diarrhea in children. The

vaccine, RotaShieldTM, is made for

infant indication by Wyeth-Lederle

Vaccines and Pediatrics.

Procedure: On December 12, 1997,

from 9:30 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 1:30

p.m. and 2:30 p.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 11, 1997, from 10:30 a.m. to

5:45 p.m., and on December 12, 1997,

from 8 a.m. to 9:30 a.m., the meeting

will be closed to permit discussion and

review of trade secret and/or

confidential information. These portions

of the meeting will be closed to discuss

pending investigational new drug

applications or pending product

licensing applications (5 U.S.C.

552b(c)(4)).

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. 97–30708 Filed 11–20–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

[BPO–151–N]

Medicare and Medicaid Programs;

Quarterly Listing of Program

Issuances—Second Quarter 1997

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: This notice lists HCFA

manual instructions, substantive and

interpretive regulations, and other

Federal Register notices that were

published during April, May, and June

of 1997 that relate to the Medicare and

Medicaid programs. It also identifies

certain devices with investigational

device exemption numbers approved by

the Food and Drug Administration that

may be potentially covered under

Medicare.

Section 1871(c) of the Social Security

Act requires that we publish a list of