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

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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 Start Printed Page 56677several 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. Start Printed Page 56678

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: nfp6@cdc.gov.

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: dcs6@cdc.gov.

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Dated: November 5, 2001.

Rebecca O'Kelley,

Acting Chief, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC).

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[FR Doc. 01-28148 Filed 11-8-01; 8:45 am]

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