Federal Register / Vol. 63, No. 109 / Monday, June 8, 1998 / Notices 31221

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 98079]

State Grants to Support the Evaluation

of 5 A Day Nutrition Programs

Introduction

The Centers for Disease Control and

Prevention (CDC), in partnership with

the National Cancer Institute (NCI),

announces the availability of fiscal year

(FY) 1998 funds for grants to support

the evaluation of State and community

5 A Day nutrition intervention

programs. This announcement

addresses one required component,

which is the ‘‘5 A Day Evaluation’’ for

supporting the evaluation of 5 A Day for

Better Health nutrition intervention

programs. 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. (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 Pub. L. 103–227, the ProChildren 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,

clearly-defined, measurable, long-range

5 A Day for Better Health projects in a

specific community channel.

Availability of Funds

Approximately $450,000 is available

in FY 1998 to fund approximately 6

awards. It is expected that the average

award will be $75,000 ranging from

$55,000 to $90,000 for a 5 A Day for

Better Health project in a specific

community channel, preferably focusing

on interventions in minority-based

population subgroups (i.e. American

Indian, Asian, Pacific Islander, African

American, Hispanic, elderly, low

socioeconomic status, or the very

young). It is expected that the awards

will begin on or about September 30,

1998, 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.

Restrictions On Lobbying

Applicants should be aware of

restrictions on the use of Department of

Health and Human Services (HHS)

funds for lobbying of Federal or State

legislative bodies. Under the provisions

of 31 U.S.C. section 1352 (which has

been in effect since December 23, 1989),

recipients (and their sub-tier

contractors) are prohibited from using

appropriated Federal funds (other than

profits from Federal contract) for

lobbying Congress or any Federal

agency in connection with the award of

a particular contract, grants cooperative

agreement, or loan. This includes

grants/cooperative agreements that, in

whole or in part, involve conferences for

which Federal funds cannot be used

directly or indirectly to encourage

participants to lobby or to instruct

participants on how to lobby. In

addition, the FY 1998 Department of

Labor, Health and Human Services, and

Education, and Related Agencies

Appropriations Act (Pub. L. 105–78)

states in Section 503(a) and (b) no part

of any appropriation contained in this

Act shall be used, other than for normal

and recognized executive-legislative

relations, for publicity or propaganda

purposes, for the preparation,

distribution, or use of any kit, pamphlet,

booklet, publication, radio, television,

or video presentation designed to

support or defeat legislation pending

before the Congress or any State

legislature, except in presentation to the

Congress or any State legislative body

itself. No part of any appropriation

contained in this Act shall be used to

pay the salary or expenses of any grant

or contract recipient, or agent acting for

such recipient, related to any activity

designed to influence legislation or

appropriations pending before the

Congress or any State legislature.

Background

The Surgeon General’s Report on

Nutrition and Health in 1988 noted that

two-thirds of all deaths are due to

diseases associated with diet. The report

also says that the three most important

personal habits that influence health are

smoking, alcohol consumption, and

diet. For the two out of three adults who

do not drink alcohol excessively or

smoke, the single most important

personal choice influencing long-term

health is what they eat. Improving

dietary intake and physical activity

levels of minority populations

(American Indian, Asian, Pacific

Islander, African American, Hispanic,

elderly, low socioeconomic status, or

the very young) could substantially

extend productive lives and reduce the

human and financial costs of chronic

disease, disability, and premature death

within population subgroups that suffer

a disproportionate cancer burden.

Using effective nutrition education

strategies to reach under served

minority populations in order to initiate

successful behavior change are critical

since healthy eating practices are more

likely to be obtained with welldeveloped, culturally-sensitive,

linguistically appropriate intervention

methods that are effective in reaching

the targeted audience and assist in

transforming the local environment.

Modifications in the environment help

promote, support, and institutionalize

healthy eating practices, and as this

transformation occurs in various

channels, community norms will be

transformed also. Culturally sensitive

and linguistically appropriate

interventions combined with

environmental support can promote

lifelong healthy eating practices. The

Healthy People 2000 national objectives

include an objective intended to reduce

the current high burden of chronic

disease and premature death: increase

fruit and vegetable intake (from 2.5 to 5

servings per day). To date, progress is

slow achieving this objective through

culturally specific, linguistically

appropriate interventions and

environmental community approaches,

especially among minorities and

economically disadvantaged Americans

who are at increased risk for many

chronic diseases. The 5 A Day for Better

Health Program is a nationwide effort,

lead by the National Cancer Institute

(NCI), to achieve the Healthy People
31222 Federal Register / Vol. 63, No. 109 / Monday, June 8, 1998 / Notices

2000 objective for five or more servings

per day of fruits and vegetables. The

CDC is collaborating with NCI to

support the activities of State health

departments in the implementation and

evaluation of the State 5 A Day

activities.

Purpose

These awards will support State

efforts to evaluate 5 A Day nutrition

intervention programs. Emphasis will be

placed on:

(1) Evaluation of a community

intervention’s impact on knowledge,

attitude, awareness and behavioral

change in minority-based population

groups (such as elderly, young children

or low-income groups, and ethnic

groups such as, but not exclusive to,

American Indians, Asians, Pacific

Islanders, African Americans or

Hispanics) which have low fruit and

vegetable intakes or have a

disproportionately greater risk for

cancer;

(2) Testing the effects of culturally

sensitive and linguistically appropriate

strategies within a community

intervention designed to increase the

consumption of fruits and vegetables in

minority population subgroups and

promote other related lifestyle behaviors

which are recognized covariates that

influence fruit and vegetable

consumption; or

(3) Evaluation of communication

channels (radio, tv, print media) which

target the specific minority population

subgroups identified as part of 5 A Daybased community intervention

campaigns.

Program Requirements

Applicants should propose an

evaluation plan for a clearly defined,

established, long-range effort in one or

more specific community channels 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

The applicant is licensed with NCI

and has developed an ongoing 5 A Day

Program. 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 is 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 postintervention outcome measures when

compared with pre-intervention

measures. Sample sizes should give

adequate power (80 percent) to detect

these changes. If the appropriate design

expertise does not exist within the State

health department, inclusion of an

organization with the necessary design

expertise on the project team, such as a

university affiliate, is recommended.

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 changes, are

encouraged.

Technical Reporting Requirements

An original and two copies of a final

progress report and financial status

report are required no later than 90 days

after the end of the budget/project

period. Final financial and performance

reports are required no later than 90

days after the end of the budget/project

period. All reports are submitted to the

Grants Management Branch,

Procurement and Grants Office, CDC.

The progress reports must include the

following for each program, function, or

activity involved: (1) A comparison of

the actual accomplishments to the goals

established for the period; (2) the

reasons for slippage if established goals

were not met; and (3) other pertinent

information including, when

appropriate, analysis and explanation of

unexpectedly high costs for

performance.

Application Content

Applications must be developed in

accordance with Form PHS–5161–1

(Revised May 1996, OMB Number

0937–0189), information contained in

this program announcement, and

instructions provided in this section.

A 10-page narrative, excluding the

budget and attachments, is required and

must contain the following information:

A. Background

Provide a brief but clear description of

a current long-range project in one or

more specific community channels

including project goals and objectives,

target group, methodology of

intervention, and length of time of the

current project.

B. Program Plan

Provide a realistic, time phased, and

specific work plan including evaluation

goals, objectives, methods, and

outcomes to be achieved during the 12-

month period; and a clear plan to

evaluate the current long-range effort in

a particular channel or channels and

assess the impact of those activities with

measures of process and outcomes

related to the targeted audience.

Examples of potential evaluation

projects might include but are not

limited to the following:

a. Evaluation of the process and

impact of instituting a community

neighborhood 5 A Day project targeting

for example minority, elderly, youth, or

low-income groups and its effect on

perceived barriers, attitudes, beliefs,

dietary behaviors and fruit and

vegetable consumption.

b. Evaluation of innovative

measurement techniques appropriate for

targeted minority audiences and their

perceptions/response to the current 5 A

Day Program recommendations of 5 to 9

servings of fruits and vegetables daily.

c. Evaluate the impact of a 5 A Day

media and/or education campaign on

knowledge, attitudes, and behaviors of

targeted minority community members,

with a focus on issues of awareness

translating to action/behavioral stages of

change and changes in fruit and

vegetable consumption. (e.g. food

assistance program like Women Infant

Children (WIC) or other communitybased program combined with a media

intervention).

d. Evaluate an intervention that

promotes healthy dietary choices (5 A

Day) and physical activity in a defined

community setting with a focus on the

effect of affiliated environmental

change(s) on behavior.

C. Capacity

Document the expertise of the

evaluation team by including the

curriculum vitae (limited to 1 page

attachment per person) for key members

of the team. If sufficient evaluation

expertise is not available in the State

health department, States are strongly

encouraged to work with an academic

institution in the design, data collection,

and analysis activities for this

evaluation. For interventions involving
Federal Register / Vol. 63, No. 109 / Monday, June 8, 1998 / Notices 31223

administrative changes, describe the

infrastructure that is or will be in place

to support the administrative change

once made in the defined setting.

D. Human Subjects

Documentation that human subject

assurances are met, either through

copies of approved protocols or notation

of the institutional review committee

that will review the project, particularly

if the intervention targets children or

pregnant women. Should human

subjects review be required, the

proposed work plan should incorporate

time lines for such development and

review activities.

E. Budget

Provide a detailed budget and lineitem justification that is consistent with

the stated objectives, purpose, and

planned activities of the project. (Not to

be counted as part of the 10 page

narrative.)

An original and two copies of the

application are required. Pages should

be numbered, and an index to the

application and appendix must be

included. The original and each copy of

the application must be submitted

unstapled and unbound. All materials

must be typewritten, single-spaced, with

unreduced type on 81⁄2′′ by 11′′ paper,

with at least 1′′ margins, headers and

footers, and printed on one side only.

Materials that should be part of the

basic plan will not be accepted if placed

in the appendix. Appendix material

should not exceed 25 pages. Please do

not include reports (or portions thereof),

journal articles, mass media articles, or

presentations of national statistical data.

Evaluation Criteria (100 Points)

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, measurable 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. Human Subjects: (Not Weighted)

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 there are

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.

E. Budget: (Not Weighted)

The extent to which the applicant

provides a detailed budget and line-item

justification that is consistent with the

evaluation plan.

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, Georgia 30305,

no later than 30 days after the

application deadline. 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, Georgia

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 work

plan should incorporate time lines for

such development and review activities.

Women, Racial and Ethnic Minorities

It is the policy of the CDC to ensure

that women and racial and ethnic

groups will be included in CDCsupported research projects involving
31224 Federal Register / Vol. 63, No. 109 / Monday, June 8, 1998 / Notices

human subjects, whenever feasible and

appropriate. Racial and ethnic groups

are those defined in OMB Directive No.

15 and include American Indian or

Alaskan Native, Asian, Black or African

American, Native Hawaiian or Other

Pacific Islander, and Hispanic or Latino.

Applicants shall ensure that women and

racial and ethnic minority populations

are appropriately represented in

applications for research involving

human subjects. Where clear and

compelling rationale exist that inclusion

is not feasible, this situation must be

explained as part of the application. In

conducting the review of applications

for scientific merit, review groups will

evaluate proposed plans for inclusion of

minorities and both sexes as part of the

scientific assessment and assigned

score. 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, Friday,

September 15, 1995, pages 47947–

47951.

Application Submission and Deadline

The original and two copies of the

application PHS Form 5161–1 (Revised

5/96, 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 July 1, 1998.

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 and will be returned to

the applicant.

Where To Obtain Additional

Information

To receive additional written

information, call (888) 472–6874. You

will be asked to leave your name,

address, and telephone number. Please

refer to Announcement 98079. You will

receive a complete program description,

information on application procedures,

and application forms. If you have

questions after reviewing the contents of

all the documents, business

management technical assistance may

be obtained from Sheryl L. Heard,

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, Mail

Stop E–18, Atlanta, GA 30305,

telephone (404) 842–6802; electronic

mail at slh3@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., Mail Stop K–26, Atlanta,

GA 30341–3724, telephone (770) 488–

6019, fax (770) 488–6000, or Internet or

CDC WONDER electronic mail at

sak2@cdc.gov.

You may obtain this announcement

from CDC’s homepage at http://

www.cdc.gov.

Please refer to Program

Announcement 98079 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.

Dated: June 1, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–15122 Filed 6–5–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0362]

Draft Guidance for Industry on Stability

Testing of Drug Substances and Drug

Products; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Stability Testing of

Drug Substances and Drug Products.’’

The draft guidance provides

recommendations regarding the stability

studies that should be performed to

support new drug applications,

abbreviated new drug applications,

investigational new drug applications,

biologics license applications, product

license applications, and supplements

to these applications.

DATES: Written comments on the draft

guidance may be submitted by

September 9, 1998. General comments

on agency guidance documents are

welcome at any time.

ADDRESSES: Copies of this draft

guidance are available on the Internet at

http://www.fda.gov/cder/guidance/

index.htm or http://www.fda.gov/cber/

guidelines.htm. Submit written requests

for single copies of the draft guidance

entitled ‘‘Stability Testing of Drug

Substances and Drug Products’’ to the

Drug Information Branch (HFD–210),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, or to the Office of

Communication, Training, and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research, Food and Drug

Administration, 1401 Rockville Pike,

Rockville MD 20852–1448. Send one

self-addressed adhesive label to assist

the office in processing your request.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Kenneth J. Furnkranz, Center for Drug

Evaluation and Research (HFD–

625), Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855–2737, 301–

827–5848, or

Rebecca A. Devine, Center for

Biologics Evaluation and Research

(HFM–10), 1401 Rockville Pike,

Rockville, MD 20852, 301–827–

0373.

SUPPLEMENTARY INFORMATION: FDA is

announcing the availability of a draft

guidance for industry entitled ‘‘Stability

Testing of Drug Substances and Drug

Products.’’ The draft guidance provides

recommendations regarding the stability

studies that should be performed by

pharmaceutical applicants to support

applications submitted to the Center for