[Federal Register Volume 65, Number 111 (Thursday, June 8, 2000)]
[Notices]
[Pages 36446-36448]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14424]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 00127]


Developing a Model System for the Collection, Analysis, and 
Dissemination of Data on Genetic Tests; 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 a Model System for the Collection, Analysis, and 
Dissemination of Data on Genetic Tests. 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 area of Public Health Infrastructure. For the conference copy of 
``Healthy People 2010,'' visit the Internet site: http://www.health.gov/healthypeople>.
    The purpose of the program is to develop and evaluate a model 
system to assess the availability, quality, and usefulness of existing 
data on DNA-based genetic tests and testing algorithms. These data are 
needed to facilitate the appropriate transition of genetic tests from 
investigational settings to clinical and public health practice. By 
identifying data gaps and needs, this project can influence the way 
that genetic testing data are collected and analyzed in the future.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private nonprofit organizations, State and local governments or 
their bona fide agents, and federally recognized Indian tribal 
governments, Indian tribes, or Indian tribal organizations.

    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 $200,000 is available in FY 2000 to fund one award. 
It is expected that the award 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

[[Page 36447]]

on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds.

Use of Funds

    Funds may not be used to support genetic testing or generate new 
genetic test results.

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). Please see Addendum II (in the 
application kit) for important additional information.

1. Recipient Activities

    a. Develop a comprehensive plan including time-phased and 
measurable objectives and proposed methods for implementing and 
evaluating the project.
    b. Identify all applicable laws and develop procedures to protect 
confidentiality and maintain the anonymity of all test results.
    c. Using experts, identify three DNA-based tests to guide in the 
finding, collection, and analysis of relevant data (published and 
unpublished).
    d. Evaluate the availability, quality, and usefulness of data, 
identify data gaps and needs, and design simple and common data formats 
that support pooled analysis and comparison among studies.
    e. Determine the core data elements needed (test- and population-
specific) and assess the analytic validity, clinical validity and 
clinical utility of the studied genetic tests.
    f. Develop and test a model system for actively collecting, 
analyzing, and disseminating aggregate data.
    g. Evaluate the model system and summarize its strengths and 
limitations in transitioning genetic tests to clinical and public 
health practice and describe possible future enhancements.
    h. Publish and disseminate results.

2. CDC Activities

    a. Provide technical assistance and oversight of all project 
activities.
    b. Assist in identifying DNA test experts to participate in 
collaborative analysis.
    c. Provide scientific guidance in establishing selection criteria 
for the genetic tests to be studied.
    d. Present project findings to relevant agencies and the 
Secretary's Advisory Committee on Genetic Testing.
    e. Provide staff expertise in the implementation of the model 
system to be developed.

E. Application Content

    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 your program 
plan. The narrative should be no more than 25 single-spaced pages, 
printed on one side, with one inch margins, and unreduced font. The 
application must be submitted unstapled and unbound.

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.
    On or before August 4, 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 Objective Review Panel. (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. Background (15 Points)

    The extent to which the applicant demonstrates an understanding of 
the program objectives by including a critical review of existing 
approaches to assessing the performance of DNA-based tests in public 
health applications.

2. Qualifications and Experience (25 Points)

    The extent to which the applicant:
    a. Identifies a principal investigator with demonstrated ability to 
carry out the proposed project,
    b. Documents access to the necessary administrative, clinical, 
genetic, epidemiologic, laboratory, data management and statistical 
talent needed to carry out the project, and
    c. Describes a project team that is experienced in collecting, 
organizing, analyzing, and interpreting DNA-based data on different 
conditions.

3. Plan and Objectives (20 Points)

    a. The extent to which the applicant presents a well-defined 
project plan, including time-phased, measurable objectives.
    b. The extent to which the applicant includes letters of support 
indicating the nature and extent of collaboration of key experts.

4. Methods (25 Points)

    The extent to which the applicant describes detailed methods for 
implementing the project, including:
    a. Identifying, recruiting, and collaborating with key experts,
    b. Ensuring data anonymity and protecting confidentiality,
    c. Identify available data for three DNA-based tests, identifying 
data gaps, and developing common data formats,
    d. Determining core data elements and performing critical analysis,
    e. Developing and testing a system for organizing and updating 
aggregate data sets, and disseminating results.

5. Evaluation (15 Points)

    The extent to which the applicant:
    a. Describes a plan to evaluate the ability of the model to 
collect, analyze, and disseminate data on genetic tests to facilitate 
their use in clinical and public health practice, and
    b. Provides an evaluation plan that allows measurement of progress 
toward the achievement of the stated objectives.

6. Budget (Not Scored)

    The extent to which the budget is reasonable, clearly justified, 
and consistent with the intended use of grant funds. All budget 
categories should be itemized.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Annual 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.
    The following additional requirements are applicable to this

[[Page 36448]]

program. For a complete description of each, see Addendum I in the 
application kit.

AR-7  Executive Order 12372 Review
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 CDC announcements may be downloaded through the CDC 
Home Page on the Internet at http://www.cdc.gov> (click on Funding). 
Please refer to Program Announcement Number 00127 when requesting 
information. 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: Mattie B. Jackson, Grants Management Specialist, Grants 
Management Branch, Procurement and Grants Office, Centers for Disease 
Control and Prevention, E-13, Room 3000, 2920 Brandywine Road, Atlanta, 
GA 30341-4146, Telephone number: 770-488-2718, Email address: 
<a href="/cdn-cgi/l/email-protection#6b060201582b080f08450c041d"><span class="__cf_email__" data-cfemail="e08d898ad3a0838483ce878f96">[email protected]</span></a>
    For program technical assistance, contact: Marta Gwinn, MD, MPH, 
Senior Medical Epidemiologist, Office of Genetics and Disease 
Prevention, National Center for Environmental Health Centers for 
Disease Control and Prevention, K-28, 4770 Buford Highway, NE, Atlanta, 
GA 30341-3724, Telephone number: 770-488-3235, Email address: 
<a href="/cdn-cgi/l/email-protection#2845444f19684b4c4b064f475e"><span class="__cf_email__" data-cfemail="80edece7b1c0e3e4e3aee7eff6">[email protected]</span></a>

    Dated: June 2, 2000.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Conrol and 
Prevention (CDC).
[FR Doc. 00-14424 Filed 6-7-00; 8:45 am]
BILLING CODE 4163-18-P


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