21212 Federal Register / Vol. 60, No. 83 / Monday, May 1, 1995 / Notices

human resources development. Data

management responsibilities include the

development of automated system

applications to support and enhance

program, fiscal, administrative and

quality control operations, and the

compilation and analysis of data on

demographic and service trends that

assist in monitoring and oversight

responsibilities. Statistical analysis

functions include the review of state

and federal sampling procedures. The

Office is responsible for the effective

and efficient management of internal

ACF automation processes and for

oversight of state systems projects for

ACF programs. In coordination with

other Regional Office components, it

monitors state systems projects and is

the focal point for technical assistance

to states and grantees on the

development and enhancement of

automated systems.

The Office represents the Regional

Administrator on administrative matters

and on internal and State systems

matters with ACF central office, states,

contractors and grantees. It alerts the

Regional Administrator to problems or

issues that have significant implications

for functional areas under its

jurisdiction.

C. The Office of Family Security is

headed by an Assistant Regional

Administrator who reports to the

Regional Administrator and consists of:

Child Support Enforcement Division;

AFDC/JOBS Division; and Youth and

Family Services Division.

The Office is responsible for

providing centralized program, financial

management and technical

administration of certain ACF formula,

entitlement and discretionary programs,

such as Aid to Families with Dependent

Children (AFDC), Child Support

Enforcement, Jobs Opportunities and

Basic Skills Training (JOBS), Child

Welfare Services, Family Preservation

and Support, Foster Care and Adoption

Assistance, Child Abuse and Neglect,

and Runaway and Homeless Youth. It is

also responsible for managing all

aspects of the AFDC quality control

function.

A Financial/Grants Management

Officer is located in the Office of Family

Security to provide expertise in

business and other non-programmatic

areas of grants administration and to

help ensure that grantees fulfill

requirements of laws, regulations, and

administrative policies.

The Office establishes regional

financial management priorities;

reviews cost allocation plans; and

makes recommendations to the Regional

Administrator to 1) approve, defer or

disallow claims for federal financial

participation in ACF formula and

entitlement programs and 2) approve or

disallow costs under ACF discretionary

grant programs. As applicable, it makes

recommendations on the clearance and

closure of audits of state and grantee

programs, paying particular attention to

deficiencies that decrease the efficiency

and effectiveness of ACF programs and

taking steps to resolve such deficiencies.

The Office represents the Regional

Administrator in dealing with ACF

central office, states and grantees on all

program and financial management

policy matters for programs under its

jurisdiction. It alerts the Regional

Administrator to problems or issues that

have significant implications for the

programs.

D. The Office of Family Supportive

Services is headed by an Assistant

Regional Administrator who reports to

the Regional Administrator and consists

of: New Jersey and Caribbean Division;

and New York State Division.

The Office is responsible for

providing a centralized program,

financial management and technical

administration of certain ACF formula,

entitlement, block and discretionary

programs, such as Head Start, Child

Care and Development Block Grant

Program, Title IV-A Child Care, and

Developmental Disabilities.

A Financial/Grants Management

Officer is located in the Office of Family

Supportive Services to provide expertise

in business and other non-programmatic

areas of grants administration and to

help ensure that grantees fulfill

requirements of laws, regulations, and

administrative policies.

The Office establishes regional

financial management priorities;

reviews cost allocation plans; and

makes recommendations to the Regional

Administrator to: (1) Approve, defer or

disallow claims for federal financial

participation in ACF formula and

entitlement programs; and (2) approve

or disallow costs under ACF

discretionary grant programs. As

applicable, it makes recommendations

on the clearance and closure of audits

of state and grantee programs, paying

particular attention to deficiencies that

decrease the efficiency and effectiveness

of ACF programs and taking steps to

resolve such deficiencies.

The Office represents the Regional

Administrator in dealing with ACF

central office, states and grantees on all

program and financial management

policy matters for programs under its

jurisdiction. It alerts the Regional

Administrator to problems or issues that

have significant implications for the

programs.

Dated: April 24, 1995.

Mary Jo Bane,

Assistant Secretary for Children and Families.

[FR Doc. 95–10592 Filed 4–28–95; 8:45 am]

BILLING CODE 4184–01–P

Centers for Disease Control and

Prevention

[Announcement 535]

Grant for Prevention of the Secondary

Conditions Related to Autism and

Pervasive Developmental Disorder;

Notice of Availability of Funds for

Fiscal year 1995

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1995

funds for a grant to evaluate programs

to prevent secondary conditions related

to autism and pervasive developmental

disorder in children.

The Public Health Service (PHS) is

committed to achieving the health

promotion and disease prevention

objectives of ‘‘Healthy People 2000,’’ a

PHS-led national activity to reduce

morbidity and mortality and improve

the quality of life. This announcement

is related to priority area of Diabetes and

Chronic Disabling Conditions. (To order

a copy of ‘‘Healthy People 2000,’’ see

WHERE TO OBTAIN ADDITIONAL

INFORMATION section.)

Authority

This grant program is authorized

under Section 301 and 317 (42 U.S.C.

241 and 247b) of the Public Health

Service Act, as amended.

Smoke-Free Workplace

PHS strongly encourages all grant

recipients to provide a smoke-free

workplace and to promote the nonuse of

all tobacco products, and Public Law

103–227, the Pro-Children Act of 1994,

prohibits smoking in certain facilities

that receive Federal funds in which

education, library, day care, health care,

and early childhood development

services are provided to children.

Eligible Applicants

Applications may be submitted by

public and private, nonprofit and for

profit, organizations and governments

and their agencies. Thus, universities,

colleges, research institutions, hospitals,

other public and private organizations,

State and local governments or their

bona fide agents, and small, minorityand/or women-owned businesses are

eligible to apply.

Applicants must have an existing

program which provides services to
Federal Register / Vol. 60, No. 83 / Monday, May 1, 1995 / Notices 21213

children with autism and their families,

and must be able to demonstrate a

current caseload of at least 300 families

through provision of data indicating the

number of families currently receiving

services.

Only one application from each

eligible applicant will be accepted.

Availability of Funds

Approximately $300,000 is available

in FY 1995 to fund 1 grant. It is

expected that the award will begin on or

about September 1, 1995, and will be

made for a 12-month budget and project

period. Funding estimates may vary and

are subject to change.

Continuation awards within the

project period will be made on the basis

of satisfactory progress and the

availability of funds.

Purpose

The purpose of this grant program is

to:

A. Develop and evaluate a

comprehensive program which includes

parent training and addresses the

critical factor of familial stress, for the

prevention of secondary conditions in

children with autism.

B. Disseminate the methodology and

result of the program.

C. Provide guidance to other

organizations implementing similar

interventions.

Program Requirements

In conducting the activities to achieve

the purpose of this program, the

recipient shall be responsible for the

activities listed below.

1. Develop and implement a

comprehensive program which includes

parental training and addresses the

critical factor of familial stress, to

prevent secondary conditions in young

children with autism.

2. Develop and implement an

evaluation plan to assess the

effectiveness of the program.

3. Develop training materials to

support the program.

4. Disseminate the findings and

materials.

Evaluation Criteria

The application will be reviewed and

evaluated according to the following

criteria:

1. Understanding of the Project 20%

Responsiveness to the objectives of

the grant program, including the

understanding of the purpose of the

grant program.

2. Technical Approach 30%

Strength of the application in

describing: the proposed planning

process, including specific planning

objectives, strategies for achieving these

objectives, a proposed schedule for

achieving these objectives; and the

population to be served.

3. Capability and Experience 30%

Demonstration of capability to

conduct a project of this nature,

including reputation in the field and

ability to demonstrate a pre-eminent

position as an appropriate organization

to carry out this project, and successful

experience in conducting and

evaluating similar projects.

4. Staffing and Management Resources

20%

Demonstration that proposed Project

Director is knowledgeable regarding

autism and the prevention of its

secondary conditions, as evidenced by

publications, program summaries, or

other materials that document prior

work, and has committed significant

time to the project. Demonstration that

other professional staff have appropriate

training and experience in the area of

autism and the prevention of secondary

conditions, as evidenced by

publications, program summaries, or

other materials that document prior

work. Demonstration of ability to

provide facilities and other necessary

resources.

5. Budget (not scored)

Extent to which the project budget is

reasonable, clearly justified, and

consistent with the intended use of

funds.

Executive Order 12372 Review

This program is not subject to the

Executive Order 12372 review.

Public Health System Reporting

Requirements

This program is not subject to the

Public Health System Reporting

Requirements.

Catalog of Federal Domestic Assistance

Number

The Catalog of Federal Domestic

Assistance Number is 93.283.

Other Requirements

Human Subjects

If the proposed project involves

research on human subjects, the

applicant must comply with the

Department of Health and Human

Services Regulations, 45 CFR Part 46,

regarding the protection of human

subjects. Assurance must be provided to

demonstrate that the project will be

subject to initial and continuing review

by an appropriate institutional review

committee. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and forms provided in the

application kit.

Application Submission and Deadline

The applicant must submit an original

and five copies of the application PHS

Form 398 (OMB Number 0925–0001) to

Henry S. Cassell, III, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–13, Atlanta, GA 30305, on or

before June 15, 1995.

Deadline:

1. Applications shall be considered as

meeting a deadline if they are either:

A. Received at the above address on

or before the deadline date, or

B. Sent on or before the deadline date

to the above address, and received in

time for the review process. Applicants

should request a legibly dated U.S.

Postal Service postmark or obtain a

legibly dated receipt from a commercial

carrier or the U.S. Postal Service. Private

metered postmarks shall not be

acceptable as proof of timely mailings.

2. Applications which do not meet the

criteria above are considered late

applications and will be returned to the

applicant.

Where To Obtain Additional

Information

To receive additional written

information call (404) 332–4561. You

will be asked to leave your name,

address, and phone number, and will

need to refer to Announcement 535.

You will receive a complete program

description, information on application

procedures, and application forms.

If you have questions after reviewing

the contents of all documents, business

management technical assistance may

be obtained from Lisa G. Tamaroff,

Grants Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 300,

Mailstop E–13, Atlanta, GA 30305,

telephone (404) 842–6796.

Programmatic technical assistance may

be obtained from Robert J. Delaney,

Division of Birth Defects and

Developmental Disabilities, National

Center for Environmental Health,

Centers for Disease Control and

Prevention (CDC), 4770 Buford

Highway, Mailstop F–34, Atlanta, GA

30341, or by calling (404) 488–7150.

A copy of ‘‘Healthy People 2000’’

(Full Report, Stock No. 017–001–00474–
21214 Federal Register / Vol. 60, No. 83 / Monday, May 1, 1995 / Notices

0) or ‘‘Healthy People 2000’’ (Summary

Report, Stock No. 017–001–00473–1)

referenced in the INTRODUCTION may be

obtained through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

Dated: April 24, 1995.

Joseph R. Carter,

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 95–10591 Filed 4–28–95; 8:45 am]

BILLING CODE 4163–18–P

Food and Drug Administration

[Docket No. 93F–0050]

E. I. du Pont de Nemours and Co.;

Withdrawal of Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to future

filing, of a food additive petition (FAP

3B4360) proposing that the food

additive regulations be amended to

provide for the safe use of

perfluoroalkylethyl acrylate copolymer,

produced by the copolymerization of

perfluoroalkylethyl acrylate, octadecyl

methacrylate, vinylidene chloride, 2-

hydroxyethyl methacrylate and

polyoxyethylene methacrylate, as an oil

and water repellant in paper and

paperboard intended for food-contact

use.

FOR FURTHER INFORMATION CONTACT:

Hortense S. Macon, Center for Food

Safety and Applied Nutrition (HFS–

216), Food and Drug Administration,

200 C St. SW., Washington, DC 20204,

202–418–3086.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

March 12, 1993 (58 FR 13603), FDA

announced that a food additive petition

(FAP 3B4360) had been filed by E. I. Du

Pont de Nemours and Co., Du Pont

Chemicals, Jackson Laboratory,

Chamber Works, Deepwater, NJ 08023.

The petition proposed to amend the

food additive regulations in § 176.170

Components of paper and paperboard

in contact with aqueous and fatty foods

(21 CFR 176.170) to provide for the safe

use of perfluoroalkylethyl acrylate

copolymer, produced by the

copolymerization of perfluoroalkylethyl

acrylate, octadecyl methacrylate,

vinylidene chloride, 2-hydroxyethyl

methacrylate, and polyoxyethylene

methacrylate, as an oil and water

repellant in paper and paperboard

intended for food-contact use. Du Pont

has now withdrawn the petition without

prejudice to a future filing (21 CFR

171.7).

Dated: April 11, 1995.

Alan M. Rulis,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 95–10645 Filed 4–28–95; 8:45 am]

BILLING CODE 4160–01–F

[FDA–225–94–3000]

Memorandum of Understanding

Between the Food and Drug

Administration and the National

Institutes of Health

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is providing

notice of a memorandum of

understanding (MOU) between FDA and

the National Institutes of Health (NIH).

The purpose of this MOU is to establish

a relationship between the Center for

Drug Evaluation and Research, FDA,

and the Epilepsy Branch, National

Institute of Neurological Diseases and

Stroke, NIH, so that joint experiments

can be conducted relating to drug

metabolism and drug-drug interactions.

DATES: The agreement became effective

December 13, 1993.

FOR FURTHER INFORMATION CONTACT: Jerry

M. Collins, Center for Drug Evaluation

and Research (HFD–400), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–443–

4750.

SUPPLEMENTARY INFORMATION: In

accordance with 21 CFR 20.108(c),

which states that all written agreements

and memoranda of understanding

between FDA and others shall be

published in the Federal Register, the

agency is publishing notice of this

memorandum of understanding.

Dated: April 25, 1995.

William B. Schultz,

Deputy Commissioner for Policy.

Memorandum of Understanding Between the

U.S. Department of Health and Human

Services, National Institutes of Health,

National Institute of Neurological Diseases

and Stroke, Epilepsy Branch and the U.S.

Department of Health and Human Services,

Food and Drug Administration, Center for

Drug Evaluation and Research

I. Purpose

The purpose of the proposed Memorandum

of Understanding (MOU) is to establish a

relationship between the Center for Drug

Evaluation and Research (CDER), Food and

Drug Administration, and the Epilepsy

Branch, National Institute of Neurological

Diseases and Stroke, so that joint

experiments can be conducted relating to

drug metabolism and drug-drug interactions.

II. Background

Drug metabolism and drug-drug

interactions represent significant issues for

the FDA’s mission to ensure safe and

effective drugs with adequate instructions for

use. For both metabolism and interactions,

studies in vitro can provide substantial

information needed for drug development

and regulation. Review and laboratory

scientists in CDER have become increasingly

involved in the development of the

technology for testing in vitro, and its

application to modern drug development and

regulation.

The Antiepileptic Drug Development

(ADD) Program of the National Institute of

Neurological Disorders and Stroke (NINDS)

was established to collaborate with the

private sector and academia effective and

safe drugs for the treatment of seizures in

epileptic patients. The ADD Program

includes preclinical pharmacodynamic and

pharmacokinetic as well as clinical

investigations. The Preclinical Pharmacology

Section of the Epilepsy Branch is responsible

for identifying potential compounds through

a multistage screening program. At present,

drug-drug interactions are found by chance,

as new therapeutic agents proceed through

the developmental process and enter clinical

trials with comedicated epileptic patients. A

critical need exists to establish possible drugdrug interactions prior to the initiation of

clinical trials.

III. Substance of Agreement

Staff of both the FDA’s Division of Clinical

Pharmacology and the Preclinical

Pharmacology Section, Epilepsy Branch,

NINDS will collaborate in determining

metabolic pathways and potential drug-drug

interactions of ADD Program compounds.

The basic technology for evaluating drugdrug interactions exists in the FDA’s

laboratory through the use of human liver

slices and subcellular fractions. The division

of labor for these studies are based on the

expertise and equipment found in each

laboratory. Analytical methods for the

identification and quantification of

metabolites of the experimental compounds

and clinically effective antiepileptic drugs

will be developed in both laboratories under

a mutual agreement based on available

resources. The compounds will be supplied

by the Epilepsy Branch following an

agreement with the pharmaceutical sponsor.

All data from these studies will remain

confidential as stipulated under the present

NINDS ADD Program preclinical

confidentiality agreement. Any information

obtained or generated under this

Memorandum of Understanding will not be

disclosed by FDA staff to anyone outside

FDA or NINDS without permission from

NINDS or the pharmaceutical sponsor.