Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices 34843

Respondents Number of

respondents

Number of

responses/

respondent

Avg. burden/response

(in hrs.)

Total burden (in hrs.)

Adolescents and Adults .................................................................................................... 720 1 4.75 3420

Total ........................................................................................................................... 3640

4. The Second Longitudinal Study of

Aging (LSOA II)—(0920–0219)—

Revision—The Second Longitudinal

Study of Aging is a second generation,

longitudinal survey of a nationally

representative sample of civilian, noninstitutionalized persons 70 years of age

and older. Participation is voluntary,

and individually identified data are

confidential. It will replicate portions of

the first Longitudinal Study of Aging

(LSOA), particularly the causes and

consequences of changes in functional

status. LSOA II is also designed to

monitor the impact of changes in

Medicare, Medicaid, and managed care

on the health status of the elderly and

their patterns of health care utilization.

Both LSOAs are joint projects of the

National Center for Health Statistics

(NCHS) and the National Institute on

Aging (NIA).

The Supplement on Aging (SOA), part

of the 1984 National Health Interview

Survey (NHIS), established a baseline on

7,527 persons who were then aged 70

and older. The first LSOA reinterviewed

them in 1986, 1988 and 1990. Data from

the SOA and LSOA have been widely

used for research and policy analysis

relevant to the older population.

Approximately 10,000 persons aged

70 and over were interviewed for the

1994 National Health Interview Survey’s

second Supplement on Aging (SOA II)

between October of 1994 and March of

1996. LSOA II will reinterview the SOA

II sample three times: in 1997, 1999, and

2001. As in the first LSOA, these

reinterviews will be conducted using

computer assisted telephone

interviewing (CATI). Beyond that, LSOA

II will use methodological and

conceptual developments of the past

decade.

LSOA II will contain modules on

scientifically important and policyrelevant domains, including: (1)

assistance with activities of daily living,

(2) chronic conditions and impairments,

(3) family structure, relationships, and

living arrangements, (4) health opinions

and behaviors, (5) use of health,

personal care and social services, (6) use

of assistive devices and technologies, (7)

health insurance, (8) housing and longterm care, (9) social activity, (10)

employment history, (11) transportation,

and (12) cognition. This new data will

result in publication of new national

health statistics on the elderly and the

release of public use micro data files.

The total cost to the respondents is

estimated at $112,500.

Respondents Number of

respondents

Number of

responses/

respondent

Avg. burden/response

(in hrs.)

Total burden (in hrs.)

Sample adult ..................................................................................................................... 10,000 1 .75 7,500

Total ........................................................................................................................... 7,500

Dated: June 27, 1996.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

and Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–16947 Filed 7–2–96; 8:45 am]

BILLING CODE 4163–18–P

[Announcement 658]

State Grants to Support the Evaluation

of 5 A Day Nutrition Programs and

Physical Activity Programs

Introduction

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 1996

funds for grants to support the

evaluation of State and community

nutrition and physical activity

intervention programs.

This announcement addresses one

required component and one optional

component:

I. ‘‘5 A Day Evaluation’’ for supporting the

evaluation of 5 A Day for Better Health

nutrition intervention programs.

Applicants must apply for the 5 A Day

Evaluation component.

II. ‘‘Physical Activity Evaluation’’ for

supporting the evaluation of a physical

activity intervention. Application for the

Physical Activity Evaluation component

is optional.

The CDC is committed to achieving

the health promotion and disease

prevention objectives of ‘‘Healthy

People 2000’’ a national activity to

reduce morbidity and mortality and

improve the quality of life. This

announcement is related specifically to

the priority area of Nutrition with a

secondary emphasis on Physical

Activity and Fitness. (For ordering a

copy of ‘‘Healthy People 2000’’ see the

Section, ‘‘Where to Obtain Additional

Information.’’)

Authority

This program is authorized under

section 317(k)(2) [42 U.S.C. 247b(k)(2)]

of the Public Health Service Act, as

amended.

Smoke-Free Workplace

CDC encourages all grant recipients to

provide a smoke-free workplace and

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

Eligible applicants are the official

public health agencies of States or their

bona fide agents. This includes the

District of Columbia, American Samoa,

the Commonwealth of Puerto Rico, the

Virgin Islands, the Federated States of

Micronesia, Guam, the Northern

Mariana Islands, the Republic of the

Marshall Islands, the Republic of Palau,

and federally recognized Indian tribal

governments, that have established,
34844 Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices

clearly defined, evaluable, long-range 5

A Day for Better Health projects in a

specific community channel.

Availability of Funds

Approximately $600,000 is available

in FY 1996 to fund approximately 9

awards.

A. 5 A Day Evaluation:

Approximately $450,000 is available

to fund approximately 6 awards. It is

expected that the average award will be

$75,000 ranging from $60,000 to

$90,000 for a 5 A Day for Better Health

project in a specific community channel

(e.g., youth and civic clubs, after school

care programs, schools or preschools,

churches, service groups, food

assistance programs, worksites,

supermarkets, health clinics, media,

etc.).

B. Physical Activity Evaluation:

Approximately $150,000 is available

to fund approximately 3 awards to

evaluate physical activity interventions.

It is expected that the average award

will be $50,000 ranging from $35,000 to

$60,000. In order to be eligible for Part

B, applicants must apply for Part A.

It is expected that the awards will

begin on or about September 30, 1996,

and will be made for a 12-month budget

period within a project period of one

year. Funding estimates may vary and

are subject to change.

Awards under this announcement

will not be sufficient to fully support an

applicant’s proposed activities, but are

meant to be used in conjunction with

other resources—whether direct funding

or in-kind contributions—that the

applicant may have available.

Purpose

These awards will support State

efforts to evaluate nutrition and

physical activity intervention programs.

Emphasis will be placed on evaluations

of community interventions, preferably

through environmental approaches,

such as policy or administrative

changes, or testing the effects of

multiple strategies designed to increase

the consumption of fruits and vegetables

and to increase moderate-intensity (i.e.,

the equivalent of a brisk walk at 3 to 4

mph) physical activity.

Program Requirements

Program areas that will be supported

under this grant are:

A. 5 A Day Evaluation (required):

Evaluation of a 5 A Day intervention

in one or more specific community

channels.

B. Physical Activity Evaluation

(optional):

Evaluation of a physical activity

intervention in one or more specific

community channels.

Note: Use of the same or complementary

targeted populations for both the 5 A Day and

the Physical Activity evaluations is

encouraged.

Applicants should propose an

evaluation plan for a clearly defined,

established, long-range effort in a

specific community channel in

accordance with the following

definitions:

A. Clearly Defined:

Intervention objectives are clearly

stated; activities necessary to

accomplish objectives are described, to

include who is responsible for each

activity and when they will be

accomplished; and work is done within

a specific channel with a defined

targeted audience.

B. Established:

For the 5 A Day evaluation

component, the applicant is licensed

with the National Cancer Institute (NCI)

and has developed an ongoing 5 A Day

Program. For both evaluation

components, evaluating pretested or

piloted interventions is desirable.

C. Evaluation Plan:

Clear, measurable evaluation

objectives and expected outcomes are

defined with appropriate statistical

power. Use of current theoretical

frameworks to guide the evaluation

study is desirable. A combination of

process and impact objectives are also

desirable, with outcome objectives

where feasible. In designing the study,

consideration should be given to the

number of individuals or groups needed

to detect realistic changes in post

intervention outcome measures when

compared with pre-intervention

measures. Sample sizes should give

adequate power (80%) to detect these

changes. If the appropriate design

expertise does not exist within the State

health department, inclusion of a

university affiliate on the project team is

desirable.

D. Long Range:

The program is not just a single

activity at one point in time, but a

sustained effort involving appropriate

behavior change strategies. Programs

including environmental approaches,

such as administrative or policy

changes, are encouraged.

Evaluation Criteria

5 A Day Evaluation and Physical

Activity applications will be allocated

100 points each. Applications will be

reviewed and evaluated according to the

following criteria:

A. Background: (25 Points)

The degree to which the applicant

clearly describes a long range, clearly

defined, evaluable project, including a

description of the intervention targeted

population, method, and community

channel(s).

B. Program Plan: (45 Points)

The adequacy of the applicant’s plan

to carry out the evaluation within the

12-month time period, including the

specific objectives, methods, and

measures to be used in the evaluation.

C. Capacity: (30 Points)

The capabilities of the personnel

(including consultants where

appropriate) to carry out the evaluation.

D. Budget: (Not Weighted)

The extent to which the applicant

provides a detailed budget and line-item

justification that is consistent with the

evaluation plan.

E. Human Subjects: (Not Scored)

Whether or not exempt from the

Department of Health and Human

Services (HHS) regulations, are

procedures adequate for the protection

of human subjects? Recommendations

on the adequacy of protections include:

(1) Protections appear adequate and

there are no comments to make or

concerns to raise, (2) protections appear

adequate, but there are comments

regarding the protocol, (3) protections

appear inadequate and the ORG has

concerns related to human subjects; or

(4) disapproval of the application is

recommended because the research

risks are sufficiently serious and

protection against the risks are

inadequate as to make the entire

application unacceptable.

Executive Order 12372 Review

Applications are subject to

Intergovernmental Review of Federal

Programs as governed by Executive

Order (E.O.) 12372. E.O. 12372 sets up

a system for State and local government

review of proposed Federal assistance

applications. Applicants (other than

federally recognized Indian tribal

Governments) should contact their State

Single Point of Contact (SPOC) as early

as possible to alert them to the

prospective applications and receive

any necessary instructions on the State

process. For proposed projects serving

more than one State, the applicant is

advised to contact the SPOC of each

affected State. A current list of SPOCs

is included in the application kit. If

SPOCs have any State process

recommendations on applications

submitted to CDC, they should send

them to Sharron P. Orum, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers for Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 314,

Mailstop E–18, Atlanta, GA 30305, no

later than 30 days after the application

deadline. The appropriation for this
Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices 34845

financial assistance program was

received late in the fiscal year and

would not allow for an application date

which would accommodate the 60-day

State recommendation process period.

The Program Announcement Number

and Program Title should be referenced

on the document. The granting agency

does not guarantee to ‘‘accommodate or

explain’’ State process

recommendations it receives after that

date.

Indian tribes are strongly encouraged

to request tribal government review of

the proposed application. If tribal

governments have any tribal process

recommendations on applications

submitted to CDC, they should forward

them to Sharron P. Orum, Grants

Management Office, Grants Management

Branch, Centers for Disease Control and

Prevention (CDC), 255 East Paces Ferry

Road, NE., Room 314, Mailstop E–18,

Atlanta, GA 30305. This should be done

no later than 30 days after the

application deadline. The granting

agency does not guarantee to

‘‘accommodate or explain’’ for tribal

process recommendations it receives

after that date.

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

Paperwork Reduction Act

Projects that involve the collection of

information from 10 or more individuals

and funded by the cooperative

agreement will be subject to review by

the Office of Management and Budget

(OMB) under the Paperwork Reduction

Act.

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. In addition to other

applicable committees, Indian Health

Service (IHS) institutional review

committees also must review the project

if any component of IHS will be

involved or will support the research. If

any American Indian community is

involved, its tribal government must

also approve that portion of the project

applicable to it. The applicant will be

responsible for providing assurance in

accordance with the appropriate

guidelines and form provided in the

application kit. Should human subjects

review be required, the proposed

workplan should incorporate timelines

for such development and review

activities.

Women, Racial and Ethnic Minorities

It is the policy of the Centers for

Disease Control and Prevention (CDC)

and the Agency for Toxic Substances

and Disease Registry (ATSDR) to ensure

that individuals of both sexes and the

various racial and ethnic groups will be

included in CDC/ATSDR- supported

research projects involving human

subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian,

Alaskan Native, Asian, Pacific Islander,

Black and Hispanic. Applicants shall

ensure that women, racial and ethnic

minority populations are appropriately

represented in applications for research

involving human subjects. Where clear

and compelling rationale exist that

inclusion is inappropriate or not

feasible, this situation must be

explained as part of the application.

This policy does not apply to research

studies when the investigator cannot

control the race, ethnicity and/or sex of

subjects. Further guidance to this policy

is contained in the Federal Register,

Vol. 60, No. 179, pages 47947–47951,

Friday, September 15, 1995.

Application Submission and Deadline

The original and two copies of the

application PHS Form 5161–1 (Revised

7/92, OMB Number 0937–0189) must be

submitted to Sharron P. Orum, Grants

Management Officer, Grants

Management Branch, Procurement and

Grants Office, Centers For Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 314,

Mailstop E–18, Atlanta, GA 30305, on or

before August 2, 1996.

1. Deadline: Applications shall be

considered as meeting the deadline if

they are either:

(a) Received on or before the deadline

date; or

(b) Sent on or before the deadline date

and received in time for submission to

the objective review group. (Applicants

must request a legibly dated U.S. Postal

Service postmark or obtain a legibly

dated receipt from a commercial carrier

or U.S. Postal Service. Private metered

postmarks shall not be accepted as proof

of timely mailing.)

2. Late Applications: Applications

that do not meet the criteria in 1.(a) or

1.(b) above are considered late

applications. Late applications will not

be considered in the current

competition and will be returned to the

applicant.

Where To Obtain Additional

Information

A complete program description and

information on application procedures

are contained in the application

package. Business management

technical assistance may be obtained

from Albertha Carey, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Centers For Disease

Control and Prevention (CDC), 255 East

Paces Ferry Road, NE., Room 314,

Mailstop E–18, Atlanta, GA 30305,

telephone (404) 842–6508, fax (404)

842–6513, or Internet or CDC WONDER

electronic mail at

<ayc1@opspgo1.em.cdc.gov>.

Programmatic technical assistance

may be obtained from Sarah Kuester,

MS, RD, Division of Nutrition and

Physical Activity, National Center for

Chronic Disease Prevention and Health

Promotion, Centers for Disease Control

and Prevention (CDC), 4770 Buford

Highway, NE., Mailstop K–26, Atlanta,

GA 30341–3724, telephone (770) 488–

4281, fax (770) 488–4479, or Internet or

CDC WONDER electronic mail at

<sak2@ccddn1.em.cdc.gov>.

Please refer to Announcement

Number 658 when requesting

information and submitting an

application. Potential applicants may

obtain a copy of ‘‘Healthy People 2000’’

(Full Report; Stock No. 017–001–00474–

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

Report; Stock No. 017–001–00473–1)

referenced in the ‘‘Introduction’’

through the Superintendent of

Documents, Government Printing

Office, Washington, DC 20402–9325,

telephone (202) 512–1800.

There may be delays in mail delivery

and difficulty in reaching the CDC

Atlanta offices during the 1996 Summer

Olympics. Therefore, CDC suggests

applicants use Internet, follow all

instructions in this announcement, and

leave messages on the contact person’s

voice mail for more timely responses to

any questions.
34846 Federal Register / Vol. 61, No. 129 / Wednesday, July 3, 1996 / Notices

Dated: June 27, 1996.

Joseph R. Carter

Acting Associate Director for Management

and Operations, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 96–16946 Filed 7–02–96; 8:45 am]

BILLING CODE 4163–18–P

Administration for Children and

Families

Submission for OMB Review;

Comment Request

Title: Annual Survey of Refugees

(ORR–9).

OMB No.: 0970–0033.

Description: The Annual Survey of

Refugees collects information on the

economic circumstances of a random

sample of refugees, Amerasians, and

entrants who arrived in the U.S. during

the previous five years. The survey

focuses on their training, labor force

participation, and welfare utilization

rates. Data are segmented by region of

origin, State of resettlement, and

number of months since arrival. From

their responses, ORR reports on the

economic adjustment of refugees annual

deliberations of refugee admissions and

funding and by program managers in

formulating policies for the direction of

the Refugee Resettlement Program.

Respondents: State governments.

ANNUAL BURDEN ESTIMATES

Instrument

Number of

respondents

Number

of responses

per respondent

Average

burden

hours

per respondent

Total

burden

hours

ORR–9 ............................................................................................................................................................ 1,800 1 .75 1,350

Estimated Total Annual Burden Hours:

1,350.

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: June 26, 1996.

Larry Guerrero,

Director, Office of Information Management

Services.

[FR Doc. 96–16969 Filed 7–2–96; 8:45 am]

BILLING CODE 4184–01–M

Food and Drug Administration

[Docket No. 96N–0158]

Agency Information Collection

Activities; Proposed Collection;

Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995,

Federal agencies are required to publish

a notice in the Federal Register

concerning each collection of

information and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

a survey of hormone replacement

therapy (HRT) among women with a

previous diagnosis of endometrial

cancer.

DATES: Submit written comments on the

collection of information by September

3, 1996.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. All comments

should be identified with the docket

number found in brackets in the

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Charity B. Smith, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, rm. 16B–19, Rockville,

MD 20857, 301–827–1686.

SUPPLEMENTARY INFORMATION: Section

3506(c)(2)(A) of the Paperwork

Reduction Act of 1995 (44 U.S.C.

3506(c)(2)(A)) requires Federal agencies

to provide a 60-day notice in the

Federal Register concerning each

proposed collection of information.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c). To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information listed below.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’s estimate of the

burden of the proposed collection of

information, including the validity of

the methodology and assumptions used;

(3) ways to enhance the quality, utility,

and clarity of the information to be

collected; and (4) ways to minimize the

burden of the collection of information

on respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Survey of HRT Among Women With A

Previous Diagnosis of Endometrial

Cancer

Under FDA’s statutory authority to

conduct and sponsor research (21 U.S.C.