[Federal Register Volume 65, Number 99 (Monday, May 22, 2000)]
[Notices]
[Pages 32105-32107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-12743]


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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 non-pregnant, 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 Obstetrical-Gynecological 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 time-framed objectives.
    3. A detailed plan describing the approach to be taken in 
implementing

[[Page 32106]]

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 alcohol-exposed 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.

[[Page 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: [email protected].
    For program technical assistance, contact:

Dr. Louise Floyd, (770) 488-7370, Email address: [email protected] .

    OR

Connie Granoff, (770) 488-7513, Email address: [email protected]. 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