Federal Register / Vol. 65, No. 99 / Monday, May 22, 2000 / Notices 32105

Dated: May 16, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–12742 Filed 5–17–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00072]

Project CHOICES Efficacy Study;

Notice of Availability of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for a cooperative agreement

program for Project CHOICES (Changing

High-risk AlcOhol Use and Increasing

Contraception Effectiveness Study)

Efficacy Study. The purpose of the

study is to establish efficacy of Project

CHOICES, a behavioral intervention

approach to reducing alcohol-exposed

pregnancies, in a multi-site, randomized

clinical trial. Project CHOICES targets

non-pregnant women at high risk for an

alcohol-exposed pregnancy with a dual

focused intervention aimed at reducing

risk drinking and engaging in effective

contraception until risk drinking is

resolved. High-risk women will be

accessed in high prevalence,

community-based settings. CDC is

committed to achieving the health

promotion and disease prevention

objectives of ‘‘Healthy People 2010,’’ a

national activity to reduce morbidity

and morality and improve the quality of

life.

This announcement is related to the

focus areas of Substance Abuse: Alcohol

and Other Drugs; and Maternal, Infant,

and Child Health. For the conference

copy of ‘‘Healthy People 2010,’’ visit the

internet site: ≤http://www.health.gov/

healthypeople>

B. Eligible Applicants

Eligible applicants are limited to

those previously funded under Program

Announcement No. 746: Nova

Southeastern University, The University

of Texas—Houston, and Virginia

Commonwealth University.

These applicants have been funded by

CDC since 1997 to develop and

implement the Project CHOICES

Feasibility Study. This new cooperative

agreement would allow the grantees to

implement the study as a clinical trial.

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 that

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan, or any other form.

C. Availability of Funds

Approximately $900,000 is available

in FY 2000 to fund approximately 3

awards. It is expected that the average

award will be $300,000, ranging from

$250,000 to $350,000. It is expected that

the awards will begin on or about

September 30, 2000, and will be made

for a 12-month budget period within a

project period of up to 3 years. Funding

estimates may change.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

D. Program Requirements

Project CHOICES targets nonpregnant, fertile women, 18–44 years of

age, who are moderate to heavy alcohol

consumers. Potentially high prevalence

populations of targeted women have

been defined from previous studies,

including the Project CHOICES

Feasibility Study which is currently

underway. Applicants must select from

the following list of high prevalence

populations two settings in which they

will conduct the Project CHOICES

Efficacy Study: A jail; an alcohol and

drug treatment center; an ObstetricalGynecological clinic; a Sexually

Transmitted Disease (STD) Clinic; a

media-recruited population of high-risk

women; a Women, Infants, and Children

(WIC) clinic; or an HMO. Applicants

will then implement a behavior

intervention protocol drawn from the

Project CHOICES Feasibility study in

two selected settings. Applicants must

demonstrate the ability to maintain a

minimum of 200 women from each

selected setting (to be equally

randomized to experimental and control

groups) in the clinical study.

In conducting activities to achieve the

purpose of this program, the recipient

will be responsible for the activities

under 1. (Recipient Activities), and CDC

will be responsible for the activities

listed under 2. (CDC Activities).

1. Recipient Activities

a. Refine Project CHOICES protocol

and implement as a clinical trial in two

diverse settings.

b. Recruit and train staff in a timely

manner to ensure study implementation

within the 3-year project period.

c. Implement appropriate quality

assurance procedures to assure that

protocols for the efficacy study are being

properly implemented.

d. Develop manuscripts and

presentations describing the Project

CHOICES Efficacy Study, results and

recommendations.

2. CDC Activities

a. Assist in the development of a

research protocol for Institutional

Review Board (IRB) review by all

cooperating institutions participating in

the research project.

b. The CDC IRB will review and

approve the protocol initially and on at

least an annual basis until the research

project is completed.

c. Assist in the overall coordination of

the implementation and evaluation of

the intervention protocol.

d. Provide current scientific

information, and ensure adherence to

appropriate scientific standards

including human subject regulations.

E. Application Content

Applications

Use the information in the Program

Requirements, Other Requirements, and

Evaluation Criteria sections to develop

the application content. Your

application will be evaluated on the

criteria listed, so it is important to

follow them in laying out the program

plan. The narrative should be no more

than 25 double-spaced pages (excluding

attachments), printed on one side, with

one inch margins, and unreduced font.

Do not include any spiral or bound

materials or pamphlets.

Program Narrative (not to exceed 25

pages):

The Program narrative should follow

the PHS–398 (Rev. 4/98) application

and Errata sheet, and should include the

following information:

1. A demonstrated understanding of

the problem of FAS and other prenatal

alcohol-related conditions, and the role

of brief intervention and treatment

approaches to preventing these

disorders; a justification of the need for

the proposed study and the grantee’s

rationale for targeting the two selected

settings as ones in which high

prevalence populations of women at

risk for a alcohol-exposed pregnancy

can be accessed; and a description of

how this study addresses Health People

2010 Objectives and the

recommendations of the Institute of

Medicine report: Fetal Alcohol

Syndrome: Diagnosis, Epidemiology,

Prevention and Treatment.

2. Specific, measurable, and timeframed objectives.

3. A detailed plan describing the

approach to be taken in implementing

32106 Federal Register / Vol. 65, No. 99 / Monday, May 22, 2000 / Notices

the study and the methods by which the

objectives will be achieved and

evaluated, including their sequence. A

comprehensive evaluation plan must be

outlined.

4. A description of the cooperative

agreement’s principal investigator’s role

and responsibilities.

5. A description of all the project staff

regardless of their funding source. It

should include their title, qualifications,

experience, percentage of time each will

devote to the study, as well as that

portion of their salary to be paid by the

cooperative agreement.

6. A description of the involvement of

other entities that will relate to the

proposed project, (i.e. recruitment

settings), and letters of support as

appropriate.

7. A detailed first year’s budget for the

cooperative agreement with future

annual projections, if relevant. Awards

will be made for a project period of up

to three years.

An applicant organization has the

option of having specific salary and

fringe benefit amounts for individuals

omitted from the copies of the

application which are made available to

outside reviewing groups. To exercise

this option: on the original and five

copies of the application, the applicant

must use ‘‘asterisks’’ to indicate those

individuals for whom salaries and fringe

benefits are not shown; the salaries and

fringe benefits subtotals must still be

shown. In addition, the applicant must

submit an additional copy of page four

(Form PHS–398), completed in full,

with the asterisks replaced by the

salaries and fringe benefits. This budget

page will be reserved for internal staff

use only.

F. Submission and Deadline

Application

Submit the original and 5 copies of

PHS 398 (OMB Number 0925–0001).

Adhere to the instructions on the Errata

Instruction Sheet for PHS–398. Forms

are available at the following Internet

address: www.cdc.gov, or in the

application kit.

On or before July 17, 2000, submit the

application to the Grants Management

Specialist identified in the ‘‘Where to

Obtain Additional Information’’ section

of this announcement.

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 independent 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 acceptable as proof of timely

mailing.)

Late Applications: Applications

which do not meet the criteria in (a) or

(b) above are considered late

applications, will not be considered,

and will be returned to the applicant.

G. Evaluation Criteria

Each application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Applicant’s Understanding of the

Problem (10 percent): The extent to

which the applicant demonstrates an

understanding of the problem of FAS

and other alcohol-related birth defects,

alcohol use patterns of childbearing-age

women, and the maternal risk factors

which contribute to harmful alcohol use

during pregnancy. Also, a demonstrated

understanding of the process of

changing alcohol use behavior and of

why pregnancy postponement is an

important strategy for preventing

alcohol-exposed pregnancies.

2. Goals and Objectives (15 percent):

The extent to which the study goals are

clearly stated and the objectives are

specific, measurable, and time-phased.

Also, the extent to which a plan is

presented for evaluating the objectives.

3. Description of the Target

Population and Outline of Approach (20

percent): The extent to which the

applicant has provided a full and

comprehensive description of the target

population, including available

statistics which provide reasonable

justification for designating the group

targeted as high risk for an alcoholexposed pregnancy.

4. Plan of Operation (25 percent): The

extent to which the applicant has

provided an overall description of the

approach to be taken in conducting the

intervention trial. The applicant’s

description of its methods for alcohol

assessment, counseling and referral for

problem drinking, and provision of

family planning services to high-risk

clients. Applicant must also provide

adequate demonstration of its ability to

access a study population of at least 600

high-risk women annually, and to

follow a cohort of 200 high-risk women

for intervention activities.

Also to be evaluated under this

section is the degree to which the

applicant has met the CDC Policy

requirements regarding the inclusion of

women, ethnic, and racial groups in the

proposed research. This includes:

(a) The proposed plan for the

inclusion of women and racial and

ethnic minority populations for

appropriate representation;

(b) The proposed justification when

representation is limited or absent;

(c) A statement as to whether the

design of the study is adequate to

measure differences when warranted;

and

(d) A statement as to whether the

plans for recruitment and outreach for

study participants include the process

of establishing partnerships with

community(ies) and recognition of

mutual benefits.

5. Capacity to Conduct Project

Activities and Begin Study Operations

in a Timely Fashion (30 percent): The

extent to which the applicant has

provided information to support its

ability to conduct the activities of the

cooperative agreement including

documentation of previous research

experience in behavioral science

research focusing on women’s health

issues, and/or addictive disorders;

documentation of institutional support

for the project; demonstrated ability to

identify qualified personnel to fill key

positions (including principal

investigator, project coordinator, and

intervention coordinator) and begin

study activities in a timely fashion; and

a description of how space required for

the study will be acquired or

designated.

6. Budget Justification and Adequacy

of Facilities (not scored): The budget

will be evaluated for the extent to which

it is reasonable, clearly justified, and

consistent with the intended use of the

cooperative agreement funds. The

applicant shall describe and indicate the

availability of facilities and equipment

necessary to carry out this project.

7. Human Subjects Review (not

scored): Does the application adequately

address the requirements of Title 45

CFR Part 46 for the protection of human

subjects?

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Semiannual progress reports;

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial and performance

reports, no more than 90 days after the

end of the project period.

Send all reports to the Grants

Management Specialist identified in the

‘‘Where to Obtain Additional

Information’’ section of this

announcement.

Federal Register / Vol. 65, No. 99 / Monday, May 22, 2000 / Notices 32107

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment 1 in the

application kit.

AR–1 Human Subjects Requirements

AR–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR–9 Paperwork Reduction Act

Requirements

AR–10 Smoke-Free Workplace

Requirements

AR–11 Healthy People 2010

AR–12 Lobbying Restrictions

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

sections 301 and 317 of the Public

Health Service Act, 42 U.S.C. sections

241 and 247b, as amended. The Catalog

of Federal Domestic Assistance number

is 93.283.

J. Where To Obtain Additional

Information

This and other funding opportunities

may be found on the CDC home page on

the Internet: http://www.cdc.gov.

To receive additional written

information and to request an

application kit, call 1–888-GRANTS4

(1–888–472–6874). You will be asked to

leave your name and address and will

be instructed to identify the

Announcement number of interest.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained from:

William Paradies, Grants Management

Specialist, Grants Management Branch,

Procurement and Grants Office, Centers

for Disease Control and Prevention

(CDC), 2920 Brandywine Road, Room

3000, Atlanta, GA 30341–4146;

Telephone number: (770) 488–2721;

Email address: wep2@cdc.gov.

For program technical assistance,

contact:

Dr. Louise Floyd, (770) 488–7370, Email

address: rlf3@cdc.gov .

OR

Connie Granoff, (770) 488–7513, Email

address: clg4@cdc.gov. Division of

Birth Defects, Child Development,

and Disability and Health, National

Center for Environmental Health,

Centers for Disease Control and

Prevention 4770 Buford Highway, (F–

49), Atlanta, Georgia 30341–3724.

Dated: May 16, 2000.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 00–12743 Filed 5–19–00; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Centers for Disease Control and

Prevention

[Program Announcement 00094]

Cooperative Agreements for the

Development of State-Based Birth

Defects Surveillance Programs and the

Use of the Surveillance Data for Public

Health Programs; Notice of Availability

of Funds

A. Purpose

The Centers for Disease Control and

Prevention (CDC) announces the

availability of fiscal year (FY) 2000

funds for a cooperative agreement

program for developing and improving

birth defects surveillance and using

surveillance data to develop birth

defects prevention programs and

activities to improve the access of

children born with birth defects to

health services and early intervention

programs. CDC is committed to

achieving the health promotion and

disease prevention objectives of

‘‘Healthy People 2010’’, a national

activity to reduce morbidity and

mortality and improve the quality of

life. This announcement is related to the

focus areas of Substance Abuse,

Environmental Health, and Maternal,

Infant, and Child Health. For the

conference copy of ‘‘Healthy People

2010’’, visit the internet site: http://

www.health.gov/healthypeople.

The purpose of the program is to

support (1) the development,

implementation, expansion, and

evaluation of State based birth defects

surveillance systems; (2) the

development and implementation of

State based programs to prevent birth

defects; and (3) the development and

implementation of activities to improve

the access of children with birth defects

to health services and early intervention

programs.

B. Eligible Applicants

Applicants will be limited to those

not currently involved in CDC Program

Announcement 051 (Cooperative

Agreements for Enhanced State-Based

Birth Defects Surveillance and Use of

Surveillance Data to Guide Prevention

and Intervention Programs) and Program

Announcement 643 (Centers of

Excellence to Provide Surveillance,

Research, Services, and Evaluation

Aimed at Prevention of Birth Defects).

See Attachment 1 for a list of the States

funded under these program

announcements.

Assistance will be provided only to

the health departments of States or their

bona fide agents, including the District

of Columbia, the Commonwealth of

Puerto Rico, the Virgin Islands, the

Commonwealth of the Northern Mariana

Islands, American Samoa, Guam,

federally recognized Indian tribal

governments, the Federated States of

Micronesia, the Republic of the

Marshall Islands, and the Republic of

Palau. The eligible States are: Alabama,

Alaska, Arizona, Connecticut, Delaware,

Georgia, Idaho, Illinois, Indiana, Kansas,

Louisiana, Maryland, Minnesota,

Mississippi, Nebraska, North Dakota,

Ohio, Oregon, Pennsylvania, Rhode

Island, South Dakota, Tennessee,

Vermont, Virginia, Washington, West

Virginia, Wisconsin, and Wyoming.

Applicants may apply under one of two

categories:

Category 1—States/territories/tribes

with no birth defects surveillance

systems; or

Category 2—States/territories/tribes

with newly implemented or ongoing

surveillance systems.

In the cover letter to the application,

please state the category (1 or 2) for

which you are applying.

Note: Public Law 104–65 states that an

organization described in section 501(c)(4) of

the Internal Revenue Code of 1986 which

engages in lobbying activities is not eligible

to receive Federal funds constituting an

award, grant, cooperative agreement,

contract, loan, or any other form.

C. Availability of Funds

Approximately $800,000 is available

in FY 2000 to fund approximately 3–6

awards in Category 1 and 3–6 awards in

Category 2. It is expected that the

average award will be $100,000, ranging

from $50,000 to $150,000. The awards

will begin on or about September 30,

2000, and will be made for a 12-month

budget period within a project period of

up to 3 years. Funding estimates may

change.

Continuation awards within an

approved project period will be made

on the basis of satisfactory progress as

evidenced by required reports and the

availability of funds.

Use of Funds

These awards may be used for

personnel services, equipment, travel,

and other costs related to project

activities. Project funds may not be used