60250 Federal Register / Vol. 62, No. 216 / Friday, November 7, 1997 / Notices

conduct relating to the regulation of a

drug product under the act. Dr. Anthony

has failed to request a hearing and,

therefore, has waived his opportunity

for a hearing concerning this action.

EFFECTIVE DATE: November 7, 1997.

ADDRESSES: Application for termination

of debarment to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Leanne Cusumano, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

On July 26, 1993, the U.S. District

Court for the Western District of

Tennessee accepted Dr. Anthony’s plea

of guilty and entered judgment against

him for, among other counts, one count

of trading prescription drug samples, a

Federal felony offense under section

503(c)(1) of the act (21 U.S.C. 353(c)(1)).

This felony conviction was based on the

unlawful trade of a drug sample of

Ansaid Tablets, which was not intended

to be sold but rather was intended to

promote the sale of the drug, in

exchange for the drug Rocephin.

As a result of this conviction, FDA

served Dr. Anthony by certified mail on

October 12, 1994, a notice proposing to

permanently debar him from providing

services in any capacity to a person that

has an approved or pending drug

product application, and offered him an

opportunity for a hearing on the

proposal. The proposal was based on a

finding, under section 306(a)(2)(B) of

the act (21 U.S.C. 335a(a)(2)(B)), that Dr.

Anthony was convicted of a felony

under Federal law for conduct relating

to the regulation of a drug product. Dr.

Anthony was given 30 days to file

objections and request a hearing. Dr.

Anthony did not file objections or

request a hearing. His failure to request

a hearing constitutes a waiver of his

opportunity for a hearing and a waiver

of any contentions concerning his

debarment.

II. Findings and Order

Therefore, the Director of the Center

for Drug Evaluation and Research, under

section 306(a) of the act, and under

authority delegated to her (21 CFR

5.99(b)), finds that Dr. James Michael

Anthony has been convicted of a felony

under Federal law for conduct relating

to the regulation of a drug product.

As a result of the foregoing finding,

Dr. James Michael Anthony is

permanently debarred from providing

services in any capacity to a person with

an approved or pending drug product

application under sections 505, 507,

512, or 802 of the act (21 U.S.C. 355,

357, 360b, or 382), or under section 351

of the Public Health Service Act (42

U.S.C. 262), effective November 7, 1997

(sections 306(c)(1)(B) and (c)(2)(A)(ii)

and 201(dd) (21 U.S.C. 321(dd))). Any

person with an approved or pending

drug product application who

knowingly uses the services of Dr.

Anthony, in any capacity, during his

period of debarment, will be subject to

civil money penalties (section 307(a)(6)

of the act (21 U.S.C. 335b(a)(6))). If Dr.

Anthony, during his period of

debarment, provides services in any

capacity to a person with an approved

or pending drug product application, he

will be subject to civil money penalties

(section 307(a)(7) of the act). In

addition, FDA will not accept or review

any abbreviated new drug applications

or abbreviated antibiotic drug

applications submitted by or with the

assistance of Dr. Anthony during his

period of debarment.

Any application by Dr. Anthony for

termination of debarment under section

306(d)(4) of the act should be identified

with Docket No. 93N–0451 and sent to

the Dockets Management Branch

(address above). All such submissions

are to be filed in four copies. The public

availability of information in these

submissions is governed by 21 CFR

10.20(j). Publicly available submissions

may be seen in the Dockets Management

Branch between 9 a.m. and 4 p.m.,

Monday through Friday.

Dated: October 29, 1997,

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 97–29399 Filed 11–6–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Advisory Council; Notice of Meeting

In accordance with section 10(a)(2) of

the Federal Advisory Committee Act

(Pub. L. 92–463), announcement is

made of the following National

Advisory body are scheduled to meet

during the month of December 1997:

Name: HRSA Aids Advisory

Committee.

Time: December 2–3, 1997 9:00 a.m.

Place: Loews L’Enfant Hotel, 80

L’Enfant Plaza, S.W., Washington, D.C.

20024.

The meeting is open to the public.

Agenda: The topics to be discussed

include the reorganization of the Ryan

White CARE Act programs; Clinical

Guidelines; and Access to Combination

Therapies and Adherence Issues.

Anyone requiring information

regarding the subject Committee should

contact Joan Holloway, HIV/AIDS

Bureau, Health Resources and Services

Administration, Room 7–13, Parklawn

Building, 5600 Fishers Lane, Rockville,

Maryland 20857, Telephone (301) 443–

9530.

Agenda Items are subject to change as

priorities dictate.

Dated: November 3, 1997.

Jane M. Harrison,

Advisory Committee Management Office,

HRSA.

[FR Doc. 97–29482 Filed 11–6–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; 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

National Institute of Child Health and

Human Development Special Emphasis

Panel (SEP) meeting:

Name of Sep: Initiation of Human Labor:

Prevention of Prematurity.

Date: November 6–7, 1997.

Time: November 6—7:30 p.m.–10 p.m.;

November 7—8:30 a.m.—adjournment.

Place: University of South West Medical

Center/Dallas, 5323 Harry Hines Boulevard,

Dallas, Texas 75235.

Contact Person: Gopal M. Bhatnagar, Ph.D.,

Scientific Review Administrator, NICHD,

6100 Executive Boulevard, Room 5E01,

Rockville, MD 20852, Telephone: 301–496–

1485.

Purpose/Agenda: To evaluate and review a

research grant application.

This meeting will be closed in accordance

with the provisions set forth in sections

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

discussion of this application could reveal

confidential trade secrets or commercial

property such as patentable material and

personal information concerning individuals

associated with the application, the

disclosure of which would constitute a

clearly unwarranted invasion of personal

privacy.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.
Federal Register / Vol. 62, No. 216 / Friday, November 7, 1997 / Notices 60251

(Catalog of Federal Domestic Assistance

Program Nos. [93.864, Population Research

and No. 93.865, Research for Mothers and

Children], National Institute of Health, HHS)

Dated: October 31, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, National

Institutes of Health.

[FR Doc. 97–29409 Filed 11–6–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

National Institute of Child Health and

Human Development; 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 Division

of Research Grants Special Emphasis

Panel (SEP) meetings:

The meeting will be open to the

public to provide concept review of

proposed contract solicitations.

Individuals who plan to attend and

need special assistance, such as sign

language interpretation or other

reasonable accommodations, should

inform the Contact Person listed below

in advance of the meeting.

Name of Sep: ‘‘A Study on the Evaluation

of a Community-Based Intervention to

Improve Pregnancy Outcomes and Reduced

Perinatal Mortality In a Rural District of

Balochistan, Pakistan’’ (Teleconference).

Date: November 19, 1997.

Time: 1 p.m. (ET)–adjournment.

Place: 6100 Executive Boulevard, Room

5E01 Rockville, Maryland 29852.

Contact Person: Hameed Khan, Ph.D.,

Scientific Review Administrator, NICHD,

6100 Executive Boulevard, Room 5E01,

Telephone: 301–496–1485.

Agenda: To provide concept review of

proposed contract solicitations.

This notice is being published less than 15

days prior to the meeting due to the urgent

need to meet timing limitations imposed by

the review and funding cycle.

(Catalog of Federal Domestic Assistance

Programs Nos. [93.864, Population Research

and No. 93.865, Research for Mothers and

Children], National Institutes of Health, HHS)

Dated: October 31, 1997.

LaVerne Y. Stringfield,

Committee Management Officer, National

Institute of Health.

[FR Doc. 97–29410 Filed 11–16–97; 8:45 am]

BILLING CODE 4140–01–M

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4180–N–03]

Announcement of Funding Awards;

Community Development Block Grant

Program for Indian Tribes and Alaska

Native Villages Fiscal Year 1997

AGENCY: Office of the Assistant

Secretary for Public and Indian

Housing, HUD.

ACTION: Announcement of funding

awards.

SUMMARY: In accordance with section

102(a)(4)(C) of the Department of

Housing and Urban Development

Reform Act of 1989, this document

notifies the public of funding awards for

Fiscal Year 1997 for the Community

Development Block Grant (CDBG)

Program for Indian Tribes and Alaska

Native Villages. The purpose of this

Notice is to publish the names and

addresses of the award winners and the

amount of the awards made available by

HUD to provide assistance to the Indian

Tribes and Alaska Native Villages.

FOR FURTHER INFORMATION CONTACT:

Robert Barth, Office of Native American

Programs, Office of Public and Indian

Housing, Department of Housing and

Urban Development, P.O. Box 36003,

450 Golden Gate Avenue, San

Francisco, CA 94102; telephone (415)

436–8122 (this is not a toll-free

number). Hearing or speech-impaired

individuals may access this number via

TTY by calling the toll-free Federal

Information Relay Service at 1–800–

877–8339.

SUPPLEMENTARY INFORMATION: The CDBG

Program for Indian Tribes and Alaska

Native Villages is authorized by Title I,

Housing and Community Development

Act of 1974, as amended (42 U.S.C. 5301

et seq.); sec. 7(d) of the Department of

Housing and Urban Development Act

(42 U.S.C. 3535(d)); 24 CFR part 953.

This Notice announces FY 1997

funding to be used to assist in the

development of viable Indian and

Alaska Native communities, including

decent housing, a suitable living

environment, and economic

opportunities. The FY 1997 awards

announced in this Notice were selected

for funding consistent with the

provisions in the Notice of Funding

Availability (NOFA) published in the

Federal Register on April 11, 1997 (62

FR 17976) and the amendment notice

published on July 21, 1997 (62 FR

39006).

The Catalog of Federal Domestic

Assistance number for the CDBG

Program for Indian Tribes and Alaska

Native Villages is 14.862.

In accordance with section

102(a)(4)(C) of the Department of

Housing and Urban Development

Reform Act of 1989 (103 Stat. 1987, 42

U.S.C. 3545), the Department is hereby

publishing the names, addresses, and

amounts of those awards as shown in

Appendix A.

Dated: October 31, 1997.

Kevin Emanuel Marchman,

Acting Assistant Secretary for Public and

Indian Housing.

APPENDIX A.—FISCAL YEAR 1997; CDBG PROGRAM FOR INDIAN TRIBES AND ALASKA NATIVE VILLAGES; RECIPIENTS OF

FUNDING DECISIONS

Funding recipient

(Name and Address)

Amount

approved

Eastern/Woodlands ONAP

Bad River Band of Lake Superior Chippewa Indians, P.O. Box 39, Odanah, WI 54861 ................................................................... $231,888

Boise Forte Band of the Minnesota Chippewa Tribe, P.O. Box 16, Nett Lake, MN 55772 ............................................................... 300,000

Eastern Band of Cherokee Indians of North Carolina, P.O. Box 455, Cherokee, NC 28719 ............................................................ 300,000

Forest County Potawatomi Community of Wisconsin Potawatomi Indians, P.O. Box 340, Crandon, WI 54520 ............................... 300,000

Fond du Lac Band of the Minnesota Chippewa Tribe, 1720 Big Lake Road, Cloquet, MN 55720 ................................................... 300,000

Ho-Chunk Nation of Wisconsin, W9814 Airport Road, P.O. Box 667, Black River Falls, WI 54615 ................................................. 300,000

Houlton Band of Maliseet Indians of Maine, RR 33 Box 450, Houlton ME 04730 ............................................................................. 300,000

La Courte Oreilles Band of Lake Superior Chippewa Indians, Route 2, Box 2700, Hayward, WI 54843 ......................................... 300,000

Lac du Flambeau Band of Lake Superior Chippewa Indians, P.O. Box 667, Lac du Flambeau, WI 54538 ..................................... 600,000

Leech Lake Band of the Minnesota Chippewa Tribe, RR 3 Box 100, Cass Lake, MN 56633 .......................................................... 300,000

Oneida Nation of New York, 223 Genesee Street, Oneida, NY 13421 .............................................................................................. 299,904

Passamaquody Indian Tribe at Indian Township, P.O. Box 301, Princeton, ME 04668 .................................................................... 300,000