Federal Register / Vol. 62, No. 216 / Friday, November 7, 1997 / Notices 60249

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Submission for OMB Review;

Comment Request

Title: Head Start Program Information

Report (PIR).

OMB No.: 0980–0017.

Description: The Head Start Act

requires that the Program Information

Report (PIR) information is collected

from Head Start grantees and delegate

agencies. Data elements are primarily in

the areas of management, class activity,

health profile and home environment.

Principle user of the date include local

program management, ACF regional

management, ACYF central office

management, management of services to

children with disabilities, and

dissemination to other interested

parties.

Respondents: Head Start Grantees and

Delegate Agencies.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

PIR .................................................................................................................... 2,078 4 3.35 6,691

Estimated Total Annual Burden

Hours: 6,691.

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, Division of

Information Resource Management

Services, 370 L’Enfant Promenade, S.W.,

Washington, D.C. 20447, Attn: ACF

Reports Clearance Officer.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street,

N.W., Washington, D.C. 20503, Attn:

Ms. Wendy Taylor.

Dated: November 3, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–29468 Filed 11–6–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Submission for OMB Review;

Comment Request

Title: Collection of Child Welfare data

under the Voluntary Cooperative

Information System (VCIS).

OMB No.: 0970–0129.

Description: The objective of VCIS is

to provide current data on the

characteristics of children in, and the

flow of children through, State foster

care and adoption systems. These data

also are utilized to identify State and

national trends for the types of children

in care, the settings in which children

receive care, and the outcomes of

substitute care episodes.

The VCIS data are used to respond to

requests for current data on children in

foster care as well as those awaiting

adoption and recently adopted. These

data are also used for preparing

Congressional testimony and reports,

proposing policy and legislative

changes, determining foster care and

adoption trends and projections, and

making budget forecasts. In addition,

the VCIS data are made available to

researchers and evaluators as well as the

media. These data also appeared in the

1996 Green Book, which contains

background material and data on

programs within the jurisdiction of the

Congressional Committee on Ways and

Means.

Respondents: State Governments,

Guam, Virgin Islands, Puerto Rico and

District of Columbia.

Annual burden estimates

Instrument:

VCIS Survey:

Number of Respondents .. 54

Number of Responses per

Respondent ................... 1

Average Burden Hours

per Response ................. 3

Total Burden

Hours .............. 162

Estimated Total Annual Burden Hours:

162.

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, Division of

Information Resource Management

Services, 370 L’Enfant Promenade, SW.,

Washington, DC 20447, Attn: ACF

Reports Clearance Officer.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street, NW.,

Washington, DC 20503, Attn: Ms.

Wendy Taylor.

Dated: November 3, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–29469 Filed 11–6–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 93N–0451]

James Michael Anthony; Final

Debarment Order

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is issuing an

order under the Federal Food, Drug, and

Cosmetic Act (the act) permanently

debarring James Michael Anthony,

M.D., 130 North McLean, Memphis, TN

38104, from providing services in any

capacity to a person that has an

approved or pending drug product

application. FDA bases this order on a

finding that Dr. Anthony was convicted

of a felony under Federal law for
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.