49520 Federal Register / Vol. 62, No. 183 / Monday, September 22, 1997 / Notices

collection of information to OMB for

review and clearance.

Importer’s Entry Notice (OMB Control

Number 0910–0046—Extension)

Section 801 of the Federal Food, Drug,

and Cosmetic Act (the act) (21 U.S.C.

381) charges FDA with the

responsibility for assuring that foreignorigin FDA-regulated foods, drugs,

cosmetics, medical devices, and

radiological health products offered for

import into the United States meet the

same requirements of the act as do

domestic products, and for preventing

shipments from entering the country if

they are not in compliance.

The information collected by FDA

consists of the following: Product code,

an alpha-numeric series of characters

that identifies each product FDA

regulates; FDA country of origin, the

country where the FDA-registered or

FDA-responsible firm is located; FDA

manufacturer, the party who

manufactured, grew, assembled, or

otherwise processed the goods (if more

than one, the last party who

substantially transformed the product);

shipper, the party responsible for

packing, consolidating, or arranging the

shipment of the goods to their final

destination; quantity and value of the

shipment; and, if appropriate,

affirmation of compliance, a code that

conveys specific FDA information, such

as registration number, foreign

government certification, etc. This

information is collected electronically

by the entry filer via the U.S. Customs’

Automated Commercial System at the

same time he/she files an entry for

import with the U.S. Customs Service.

FDA uses the information to make

admissibility decisions about FDAregulated products offered for import

into the United States.

FDA estimates the burden of this

collection of information as follows:

TABLE I.—ESTIMATED ANNUAL REPORTING BURDEN

No. of respondents Annual frequency per

response Total annual responses Hours per response Total hours

2,505 1,212.54 3,037,426 0.07 229,693

There are no capital costs or operating and maintenance costs associated with this collection.

The source of the estimate for the

number of respondents is the number of

importers who submitted entry data for

foreign-origin FDA-regulated products

in 1996. The estimated reporting burden

is based on information obtained by

contacting several past respondents.

Dated: September 12, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–25020 Filed 9–19–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Notice of a Cooperative Agreement

With the National Association of

People With AIDS

The Health Resources and Services

Administration’s (HRSA) HIV/AIDS

Bureau announces that it will enter into

an umbrella cooperative agreement with

the National Association of People with

AIDS (NAPWA).

The purpose of this cooperative

agreement is to assist NAPWA in

expanding and enhancing its HIV

training and technical assistance

activities with the ultimate goal of

improving the health status and access

to care for people infected with or

affected by HIV/AIDS. Activities will

include but not be limited to developing

materials, guides, and conferences for

HRSA’s Ryan White programs. HRSA

will provide consultation, including

administrative and technical assistance

as needed, for the execution and

evaluation of all aspects of this

cooperative agreement. HRSA will also

participate and/or collaborate with the

NAPWA in any workshops or symposia

to exchange current information,

opinions, and research findings to the

Ryan White grantees during this

agreement.

Authorizing Legislation

This cooperative agreement is

authorized under Section 2692 of the

PHS Act.

Background

Assistance will be provided to the

National Association of People with

AIDS. No other applications are

solicited. NAPWA is the only

organization capable of administering

this cooperative agreement because it

has:

1. Developed, expanded, and

managed an infrastructure to coordinate

and implement various programs within

local communities and organizations

that deal extensively with individuals

most directly affected by the HIV/AIDS

epidemic. The association established

national initiatives—e.g., conferences,

public policy education program

(including policy forums), technical

assistance programs and publications

(including newsletters, action alerts and

training manuals) that provide a

foundation upon which to develop,

promote, and manage HIV-related health

programs for Ryan White grantees aimed

at preventing and reducing unnecessary

morbidity and mortality rates.

2. Established itself and its members

as a national association of people

affected by HIV/AIDS who serve as

leaders and experts in planning,

developing, implementing, promoting,

and evaluating HIV-related education

and policy campaigns, both nationally

and locally, aimed at reducing the

impact of HIV in minority populations

and improving the minority

community’s overall well being.

3. Developed a base of critical

knowledge, skills, and abilities related

to serving HIV-infected individuals with

a range of HIV-related health and social

problems. NAPWA has worked with the

Federal Government, academic

institutions, and health groups on

mutually beneficial education, research,

and health endeavors relating to the goal

of reducing HIV-related mortality and

has the national leadership needed to

assist Ryan White health care

professionals to work more effectively

with people living with HIV/AIDS.

4. Developed national network of

individuals, community-based

organizations, and state, regional, and

national health and civil rights

organizations committed to addressing

the HIV service, treatment, and research

needs of individuals affected and

infected by HIV and AIDS.

Approximately $200,000 is available

in fiscal year (FY) 1997 for a 12-month

budget period within a project period of

3 years. Continuation awards within the

project period will be made on the basis

of satisfactory progress and the

availability of funds.
Federal Register / Vol. 62, No. 183 / Monday, September 22, 1997 / Notices 49521

Where To Obtain Additional

Information

If you are interested in obtaining

additional information regarding this

project, contact Joan Holloway, HIV/

AIDS Bureau, HRSA, 5600 Fishers Lane,

Room 7–13, Rockville, Maryland 20857

or telephone (301) 443–9530.

Dated: September 15, 1997.

Claude Earl Fox,

Acting Administrator.

[FR Doc. 97–25019 Filed 9–21–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Notice of a Cooperative Agreement

With the National Minority AIDS

Council

The Health Resources and Services

Administration’s (HRSA) HIV/AIDS

Bureau announces that it will enter into

an umbrella cooperative agreement with

the National Minority AIDS Council

(NMAC). This cooperative agreement

will establish the broad programmatic

framework in which specific projects

can be funded.

The purpose of this cooperative

agreement is to assist NMAC in

expanding and enhancing its HIV

training and technical assistance to

Ryan White Comprehensive AIDS

Resources Emergency (CARE) Act

providers servicing racial and ethnic

minority populations, with the ultimate

goal of improving the health status of

minorities and disadvantaged people.

HRSA will provide consultation,

including administrative and technical

assistance as needed, for the execution

and evaluation of all aspects of this

cooperative agreement. Activities will

include but not be limited to developing

materials, guides, and conferences for

HRSA’s Ryan White programs. HRSA

will also participate and/or collaborate

with the NMAC in any workshops or

symposia to exchange current

information, opinions, and research

findings during this agreement.

Authorizing Legislation

This cooperative agreement is

authorized under Section 2692 of the

PHS Act.

Background

Assistance will be provided to the

National Minority AIDS Council. No

other applications are solicited. NMAC

is the only organization capable of

administering this cooperative

agreement because it has:

1. Developed, expanded, and

managed an infrastructure to coordinate

and implement various programs within

local communities and organizations

that deal extensively with HIV in each

of the ethnic minority populations

served by the Ryan White CARE Act

programs of HRSA. The Council

established national initiatives—e.g.,

conferences, public policy education

program (including policy forums),

technical assistance programs and

publications (including newsletters,

action alerts and training manuals) that

provide a foundation upon which to

develop, promote, and manage HIVrelated health programs aimed at

preventing and reducing unnecessary

morbidity and mortality rates among

racial and ethnic minority populations.

2. Established itself and its members

as a national association of professionals

who serve as leaders and experts in

planning, developing, implementing,

promoting and evaluating HIV-related

education and policy campaigns, both

nationally and locally, aimed at

reducing the impact of HIV in minority

populations and improving the minority

community’s overall well being.

3. Developed a base of critical

knowledge, skills, and abilities related

to serving minority individuals and

organizations with a range of HIVrelated health and social problems.

Through the collective efforts of its

members, community-based

organizations, and volunteers, NMAC

has demonstrated (1) the ability to work

with minority and non-minority

organizations, the Federal Government,

academic institutions, and health

groups on mutually beneficial

education, research, and health

endeavors relating to the goal of health

promotion and disease prevention

among racial and ethnic minority

populations; (2) the national leadership

necessary to focus the nation’s attention

on minority-related HIV issues; and (3)

the leadership needed to assist Ryan

White health care professionals to work

more effectively with racial/ethnic

minority communities.

4. Developed a national network of

individuals, community-based

organizations, and state, regional, and

national health and civil rights

organizations committed to addressing

the HIV service, treatment, and research

needs of individuals effected and

infected by HIV and AIDS.

Approximately $200,000 is available

in fiscal year (FY) 1997 for a 12-month

budget period within a project period of

3 years. Continuation awards within the

project period will be made on the basis

of satisfactory progress and the

availability of funds.

Where To Obtain Additional

Information

If you are interested in obtaining

additional information regarding this

project, contact Joan Holloway, HIV/

AIDS Bureau, HRSA, 5600 Fishers Lane,

Room 7–13, Rockville, Maryland 20857

or telephone (301) 443–9530.

Dated: September 15, 1997.

Claude E. Fox,

Acting Administrator.

[FR Doc. 97–25017 Filed 9–19–97; 8:45 am]

BILLING CODE 4160–15–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Proposed Review Criteria for Grants

for the National Research Service

Awards: Primary Care Research for

Fiscal Year 1998

The Health Resources and Services

Administration (HRSA) National

Research Service Awards: Primary Care

Research (NRSA) institutional training

grants (T32) are provided to accredited

public or private nonprofit schools of

medicine, osteopathy, dentistry, or a

public or private nonprofit hospital or

other entity which is affiliated with an

entity that has received grants or

contracts under section 747, 748, or 749

of the PHS Act, agrees to use the

funding for research in primary medical

care, and is located in a State. The

NRSA program is authorized by Title IV,

Section 487(d)(3)(A) of the Public

Health Service Act.

Proposed Review Criteria

The following criteria are proposed

for National Research Service Awards in

primary care research:

1. Program Characteristics

Objectives, design, and direction of

the research training program—

including the probability of achieving

stated goals.

Substantive and methodological

content of the proposed program and its

relevance to the Program Objectives

noted above, including relevant

descriptions of courses and experiential

opportunities offered and/or required.

The extent to which proposed

approaches address areas in need of

research given changes in the health

care delivery system.

2. Program Support and Organizational

Structure and Plans

The institutional training

environment, including the level of