00-14424. 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 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 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: [e-mail]

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: [e-mail]

Dated: June 2, 2000.

John L. Williams,

Director, Procurement and Grants Office, Centers for Disease Conrol and Prevention (CDC).