[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
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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 http://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: [email protected]
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: [email protected]
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