[Federal Register Volume 66, Number 218 (Friday, November 9, 2001)]
[Notices]
[Pages 56676-56678]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-28148]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02006]


Epidemiologic Studies of Reproductive and Developmental 
Outcomes--Denmark; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for a cooperative agreement 
program for Epidemiologic Studies of Reproductive and Developmental 
Outcomes. This program addresses the ``Healthy People 2010'' focus area 
Maternal, Infant, and Child Health.
    The purpose of the program is to investigate risk factors for poor 
reproductive and developmental outcomes including, but not limited to, 
autism, cerebral palsy, and fetal alcohol effects. Important risk 
factors include, but may not be limited to, adverse intrauterine 
exposures such as infection, alcohol and genetic conditions.

B. Eligible Applicants

    Assistance will be provided only to the Danish Medical Research 
Council (DMRC), in the Danish Ministry of Information Technology and 
Research. No other applications are solicited.
    Denmark has a singular combination of national public health data 
systems currently in place that are not found elsewhere in the U.S. or 
abroad. These data systems are developed and maintained by the Danish 
government/DMRC which is solely responsible for granting access to 
them. In the Danish government, the DMRC represents the most 
comprehensive scientific knowledge in Danish medical research and is 
responsible for providing financial and advisory support for medical 
research in Denmark. Among its supportive functions, the DMRC is 
responsible for promoting significant research tasks, especially in 
areas where the Danish research environment has special qualifications 
(such as the national data systems), and international research 
cooperation. This program falls within the jurisdiction of the DMRC.
    The unique combination of Danish data systems includes nearly 200 
long-established national disease and administrative registries and a 
long-established national biobank of archived newborn blood samples. 
Many of these data systems have been established for

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several decades and have national coverage, thereby including 
information on thousands of individuals over time. These systems are 
regularly accessed by researchers to investigate a variety of health 
issues such as time trends in disease or disease characteristics that 
require large data bases. The data systems also include the Danish 
National Birth Cohort (DNBC) of 100,000 pregnant women and their 
children. The DNBC is uniquely conducting serial biosampling of the 
mother and newborn (to be archived in a biobank) and serial interviews 
of the mother concerning her health and behavior during pregnancy and 
postnatal development of her child. This unique combination of Danish 
data systems, that can be readily linked by a universal personal 
identifier, provides the necessary information (such as health, 
medical, and sociodemographic information) to carry out this program. 
Also, because these data systems contain information on large numbers 
of individuals over long periods of time, studies of relatively rare 
outcomes, such as autism and cerebral palsy, can be made with an 
unusually high level of statistical power.

    Note: Title 2 of the United States Code, section 1611 states 
that an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant, or loan.

C. Availability of Funds

    Approximately $580,000 is available in FY 2002 to fund this award. 
It is expected that the award will begin on or about February 1, 2002, 
and will be made for a 12-month budget period within a project period 
of up to three 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

    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. Develop and implement epidemiologic studies of reproductive and 
developmental outcomes. The studies could include, but may not be 
limited to, (1) evaluation of pre-, peri-, and postnatal risk factors, 
including genetic factors and environmental exposures, and (2) 
identification of biomarkers.
    b. Disseminate the findings in the form of reports, presentations 
to public and professional audiences, and published manuscripts.

2. CDC Activities

    a. Provide, if requested, epidemiologic, statistical, and technical 
assistance throughout the study including development and 
implementation of studies.
    b. Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project. The CDC IRB will review and 
approve the protocol initially and on at least an annual basis until 
the research project is completed.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. The 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 single-spaced pages, 
printed on one side, with one inch margins, and unreduced font.

F. Submission and Deadline

    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions on the Errata Instruction Sheet for 
PHS 398). Forms are available in the application kit and at the 
following Internet address: www.cdc.gov/od/pgo/forminfo.htm
    On or before December 1, 2001, submit the application to the Grants 
Management Specialist identified in the ``Where to Obtain Additional 
Information'' section of this announcement.
    Deadline: The application shall be considered as meeting the 
deadline if they are either:
    1. Received on or before the deadline date; or
    2. 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 which do not meet the criteria in 1. or 2. above 
will be returned to the applicant.

G. Evaluation Criteria

    The application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.

1. Understanding the Problem (20 Points)

    a. Extent to which applicant has a clear understanding of the 
requirements and purpose of the cooperative agreement.
    b. Extent to which applicant understands the issues and challenges 
associated with developing and implementing epidemiologic studies of 
reproductive and developmental outcomes.

2. Goals and Objectives (20 Points)

    a. Extent to which applicant clearly describes the goals and 
objectives of the project.
    b. Extent to which applicant's goals and objectives are consistent 
with the stated goals and purpose of this announcement.
    c. 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:
    (1) The proposed plan for the inclusion of both sexes and racial 
and ethnic minority populations for appropriate representation.
    (2) The proposed justification when representation is limited or 
absent.
    (3) A statement as to whether the design of the study is adequate 
to measure differences when warranted.
    (4) 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.

3. Description of Program and Methodology (40 Points)

    Extent to which applicant describes the studies' methods including:
    a. Study hypotheses and design,
    b. Target population,
    c. Relevant data sources and linkages,
    d. Data base assembly,
    e. Laboratory methods (where applicable), and
    f. analytic approach.

4. Evaluation Plan (10 Points)

    Extent to which applicant describes an evaluation plan that will 
monitor reliability, progress, timeliness, and completeness of the 
objectives and activities of the project.

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5. Staffing and Management System (10 Points)

    a. Extent to which key personnel have the qualifications, skills, 
and experience in epidemiologic and laboratory methods, data 
management, and analysis to develop and implement analytic studies of 
reproductive and developmental outcomes.
    b. Extent to which the applicant has the ability to manage and 
coordinate the project.
    c. Extent to which there is appropriate dedicated staff time to 
develop and implement the project.
    d. Extent to which the applicant provides an appropriate time line 
and includes activities and personnel responsibilities.
    e. Extent to which the applicant demonstrates an organizational 
structure (include an organizational chart) and facilities/space/
equipment that are adequate to carry out the activities of the program.

6. Human Subjects Review (Not Scored).

    The extent to which the applicant complies with 45 CFR Part 46 for 
the protection of human subjects.

7. Budget (Not Scored).

    The extent to which the budget is reasonable, clearly justified, 
and consistent with the intended use of funds.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of--
    1. Annual progress reports (English language only);
    2. Financial status report, no more than 90 days after the end of 
the budget period (in US Dollars); 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.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I of the 
announcement 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
AR-22  Research Integrity

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 307 of the Public Health 
Service Act, [42 U.S.C. section 2421], as amended. The Catalog of 
Federal Domestic Assistance number is 93.184.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address--http://www.cdc.gov. Click on ``Funding'' then 
``Grants and Cooperative Agreements.''
    To obtain business management technical assistance, contact: Nancy 
Pillar, Grants Management Specialist, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention, Announcement 02006, 2920 Brandywine Road, Room 3000, 
Atlanta, GA 30341-4146, Telephone number: 770-488-2716, Email: 
[email protected].
    For program technical assistance, contact: Diana Schendel, Ph.D., 
Centers for Disease Control and Prevention, National Center on Birth 
Defects and Developmental Disabilities, 4770 Buford Highway, Mail Stop 
F-15, Atlanta, Georgia 30341, Telephone number: 770-488-7359, Email: 
[email protected].

    Dated: November 5, 2001.
Rebecca O'Kelley,
Acting Chief, Grants Management Branch, Procurement and Grants Office, 
Centers for Disease Control and Prevention (CDC).
[FR Doc. 01-28148 Filed 11-8-01; 8:45 am]
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