Prevention Research Using Genetic Information To Prevent Disease and Improve Health; Notice of Availability of Funds

[Federal Register Volume 64, Number 85 (Tuesday, May 4, 1999)]
[Notices]
[Pages 23842-23844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11097]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99117]


Prevention Research Using Genetic Information To Prevent Disease 
and Improve Health; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC), Office of 
Genetics and Disease Prevention, in cooperation with the Office of 
Prevention Research, Office of the Director, announces the availability 
of fiscal year (FY) 1999 funds for a cooperative agreement program for 
Prevention Research Using Genetic Information to Prevent Disease and 
Improve Health.
    This program addresses the ``Healthy People 2000'' priority areas 
of Maternal and Infant Health, Heart Disease and Stroke, Cancer, and 
Diabetes and Chronic Disabling Conditions.
    The purpose of this program is to strengthen science for public 
health action, collaborate with healthcare partners for prevention, and 
promote healthy living at every stage of life and is consistent with 
the implementation of an agency-wide strategic plan for genetics and 
public health.
    The program will provide funding for conducting population-based 
research to:
    1. Assess how risk for disease and disability in well-defined 
populations is influenced by the interaction of human genetic variation 
with modifiable risk factors.
    2. Ensure that genetic tests and services are incorporated in 
population-based interventions that promote health and prevent disease 
and disability.

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: Pub. L. 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 $700,000 is available in FY 1999 to fund two awards. 
It is expected that the average award will be $350,000 to begin on or 
about September 30, 1999 for a 12-month budget period within a project 
period of up to 3 years. Funding estimates may vary and are subject to 
change.
    The maximum funding level for any award for year one will not 
exceed $400,000 (including both direct and indirect costs). 
Applications that exceed the funding cap of $400,000 will be excluded 
from the competition and returned to the applicant. 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

    Cooperative agreement funds will not be made available to support 
the provision of direct care, facility or capital outlay. Eligible 
applicants may enter into contracts, including consortia agreements (as 
set forth in the PHS Grants Policy Statement, dated April 1, 1994), as 
necessary to meet the requirements of the program and strengthen the 
overall application.

D. Programmatic Interests

    Immediate programmatic interest is focused on research in two 
categories:
    1. Epidemiologic research that assesses the interaction of 
modifiable risk factors (e.g., diet, chemical exposures, infections, 
lifestyle) with known genetic disease risk factors in well-defined 
populations, and demonstrates how this information can help target 
disease prevention efforts.
    2. Prevention effectiveness research that demonstrates in well 
defined populations the effectiveness and safety of using genetic 
information to prevent disease, disability and death by identifying 
persons at risk and carrying out appropriate interventions.
    For examples of research questions meeting these general criteria, 
see Addendum II (included in application kit).
    Proposals for research in either category must address at least one 
of the five following disease groups, which represent some of the 
leading causes of mortality, morbidity, and disability in the United 
States, and which have identifiable genetic and environmental risk 
factors:
    1. Cardiovascular disease.
    2. Cancer.
    3. Arthritis.
    4. Diabetes.
    5. Pediatric pulmonary disease (asthma, cystic fibrosis).
    Proposals addressing genetic traits (e.g., hemochromatosis) that 
contribute to development of more than one of these diseases (e.g., 
cancer, diabetes, and arthritis) will also be considered.
    Research studies proposed for either category must be community- or 
population-based, i.e, based on systematic samples of a population or 
on population-based registries. Proposals should seek to establish or 
strengthen collaborative efforts among public, private, and academic 
partners (e.g., state health departments, health maintenance 
organizations, and schools of public health) that can be sustained for 
subsequent research and program development. Proposals should also 
emphasize the potential applications of the research outcomes in 
guiding disease prevention program activities. An important component 
of such efforts is a commitment to training in the use of genetic 
information for public health and for developing community-based 
capacity for prevention program development.

E. Cooperative Activities

    The recipient will be responsible for conducting the activities 
under 1., below, and CDC will be responsible for conducting activities 
under 2., below:

1. Recipient Activities

    a. Develop a comprehensive protocol and plan for implementing 
either epidemiologic or prevention effectiveness research.
    b. Establish procedures to maintain the rights and confidentiality 
of all study participants including the identification of applicable 
laws.
    c. Disseminate results of research studies through paper and 
electronic publications and presentations.
    d. Serve as a resource for professional and public information and 
education in use of genetic information for public health.
    e. Develop collaboration among public, private, and academic 
partners

[[Page 23843]]

that can be sustained for subsequent research and program development 
(e.g., state health departments, health maintenance organizations, 
schools of public health)
    f. Participate in meetings with CDC and other investigators and 
relevant public health officials.

2. CDC Activities

    a. Provide up-to-date scientific information.
    b. Provide liaison among grantees and collaborating CDC Centers.
    c. Provide technical guidance in the development of study 
protocols, consent forms, and data collection forms.
    d. Coordinate research activities among sites, when appropriate.
    e. Convene meetings among collaborators to discuss preliminary 
findings and improve research outcomes.

F. Application Content

    1. A description of all the project staff regardless of their 
funding source. The description should include title, qualifications, 
experience, percentage of time each will devote to the project, as well 
as that portion of the salary to be paid by the cooperative agreement.
    2. A table of contents showing the page location of relevant 
application contents.
    3. A detailed budget for year one of the cooperative agreement.
    4. Budget projections for subsequent years.
    5. A biographical sketch for the Principal Investigator/Program 
Director and for all key personnel.
    6. A description of the involvement of other entities that will 
relate to the proposed project, if applicable, including public, 
private, and academic partners. The description should include evidence 
of support and a clear statement of roles.
    7. A description of the performance sites and capabilities.
    8. A description of those activities conducted by the applicant 
related to, but not supported by the cooperative agreement.
    9. A plan that justifies the research needs and describes the 
scientific basis for the research, the expected outcome, and the 
relevance of the findings to the Purpose of the Announcement.
    10. Specific, measurable, and time-framed objectives.
    11. A detailed plan describing the methods by which the objectives 
will be achieved.
    12. A comprehensive evaluation plan.
    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 review groups. To 
execute this option: on the original and five copies of the application 
(See Submission and Deadline), the applicant must use asterisks to 
indicate the individuals for whom salaries and fringe benefits are not 
shown; the subtotals must still be shown. In addition, the applicant 
must submit an additional copy of page four of 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.

G. Submission and Deadline

    Submit the original and five copies of PHS-398 (OMB Number 0925-
0001) (adhere to the instructions the Errata Instruction sheet for PHS 
398). Forms are in the application Kit. On or before June 30, 1999, 
submit the application to:
    Mattie Jackson, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Announcement #99117, Centers for 
Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, 
Atlanta, Georgia 30341-4146.
    Deadline: Applications shall be considered as meeting the deadline 
if they are either:
    1. Received at the above address on or before the deadline date; or
    2. Sent on or before the deadline date and received in time for 
submission to review committee. (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.

H. Evaluation Criteria

    Applications will be subjected to a preliminary evaluation (triage) 
by the Disease, Disability, and Injury Prevention and Control Special 
Emphasis Panel: Prevention Research Using Genetic Information to 
Prevent Disease and Improve Health, Program Announcement #99117, to 
determine if the application is of sufficient technical and scientific 
merit to warrant further review. CDC will withdraw from further 
consideration applications judged to be noncompetitive and promptly 
notify the principal investigator/program director and the official 
signing the applicant organization. Those applications judged to be 
competitive will be further evaluated by a dual review process.
    The primary review of all proposals will include:
    1. The specific aims of the research project, i.e., the broad long-
term objectives and the intended outcome of the specific research 
proposal in relation to the targeted areas described (see Programmatic 
Interests.)
    2. The background of the proposal, i.e., the basis for the present 
proposal, the critical evaluation of existing knowledge, and the 
specific identification of the knowledge gaps in the use of genetic 
information in public health, which the proposal intends to address.
    3. The significance and originality from a scientific or technical 
standpoint of the specific aims of the proposed research.
    4. The adequacy of the proposed research design, approaches, and 
methodology to carry out the research, including quality assurance 
procedures, plan for data management, and statistical analysis plan.
    5. The extent to which the research findings will lead to 
identifying and targeting modifiable risk factors that interact with 
genetic factors in causing disease, or will demonstrate the prevention 
effectiveness of using genetic information to prevent disease.
    6. The extent to which the evaluation plan will allow the 
measurement of progress toward the achievement of the stated 
objectives.
    7. A principal investigator who has conducted, evaluated, and 
published genetics research in peer-reviewed journals, and has specific 
authority and responsibility to carry out the proposed project.
    8. Qualifications and demonstrated experience on the applicant's 
project team in conducting relevant public health genetics studies and 
the appropriateness of personnel to accomplish the proposed activities.
    9. Effective and well-defined working relationships within the 
performing organization and with other interested, public, private, and 
academic partners (as evidenced by letters detailing the nature and the 
extent of the involvement).
    10. Adequacy of existing and proposed facilities and resources and 
the ability to carry out a research project on the use of genetics 
information in prevention research related to the specified disease 
groups (see Programmatic Interests).
    11. Gender and Minority Issues--The extent of plans to adequately 
include both sexes and minorities and their subgroups (as appropriate 
with the

[[Page 23844]]

scientific goals of the project), and to ensure the recruitment and 
retention of human subjects.
    12. Human Subjects--The quality of procedures for the protection of 
human subjects, and plans for documenting all procedures for compliance 
with applicable published regulations.
    The secondary review will be conducted by a panel of Senior Federal 
Officials based on the ranked proposals to assure maximal impact and 
balance of proposed research. The factors to be considered will 
include:
    1. The results of the primary review including the proposal's 
priority score as the primary factor in the selection process.
    2. The match between the proposal and the program announcement and 
programmatic interests.
    3. The relevance and balance of proposed research relative to CDC 
programs and priorities.
    4. The significance of the proposed activities in relation to the 
priorities and objectives stated in ``Health People 2000''.
    5. Geographic balance and budgetary considerations.

I. Other Requirements

Technical Reporting Requirements

    Provide CDC with an original plus two copies of
    1. Annual progress reports,
    2. Financial status report, no more that 90 days after the end of 
the budget period, and
    3. Final financial report and performance report, no more than 90 
days after the end of the project period.
    Send all reports to the Grants Management Specialist listed in 
Section K ``Where to Obtain Additional Information'.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Addendum I in the 
application package.

AR-1--Human Subjects Requirements
AR-2--Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-3--Public Health System Reporting Requirements
AR-10--Smoke-Free Workplace Requirements
AR-11--Healthy People 2000
AR-12--Lobbying Restrictions

J. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301 and 317 [42U.S.C.241 
and 247b] of the Public Health Service Act, as amended. The catalog of 
Federal Domestic Assistance number is 93.283.

K. Where To Obtain Additional Information

    This and other CDC announcements may be downloaded through the CDC 
homepage on the Internet at www.cdc.gov. Please refer to Program 
Announcement Number 99117 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 Jackson, Grant Management Specialist, Procurement and Grants 
Office, Centers for Disease Control and Prevention (CDC), 2920 
Brandywine Road, Room 3000, Atlanta, Georgia 30341-4146, Telephone: 
(770) 488-2718, Internet address: mij3@cdc.gov
    For program technical assistance contact: Marta Gwinn, M.D., 
M.P.H., Office of Genetics and Disease Prevention, Centers for Disease 
Control and Prevention (CDC), 4770 Buford Highway, NE, Mailstop K-28, 
Atlanta, Georgia 30341-3724, telephone (770) 488-3235, Internet 
address: mlg1@cdc.gov

    Dated: April 28, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 99-11097 Filed 5-3-99; 8:45 am]
BILLING CODE 4163-18-P