[Federal Register Volume 64, Number 68 (Friday, April 9, 1999)]
[Notices]
[Pages 17395-17397]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8848]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Program Announcement 99108]
Cooperative Agreement for Promoting Investigator-Initiated
Prevention Research in Managed Care; Notice of Availability of Funds
A. Purpose
The Centers for Disease Control and Prevention (CDC) Epidemiology
Program Office, Division of Prevention Research and Analytic Methods in
cooperation with the Office of Prevention Research, announces the
availability of fiscal year (FY) 1999 funds for a cooperative agreement
program for investigator-initiated prevention research in managed care
settings. Despite spending significantly more money per capita on
health than any other country in the world, recommended and effective
preventive services are not routinely delivered in the United States.
The primary purpose of this program is to fund research designed to
increase the utilization of priority preventive services in the United
States. Desirable secondary outcomes include: (1) Improvements in
surveillance and information systems, (2) furthering the science of
performance measurement, (3) novel public-private partnerships for
health, and (4) interventions which reduce racial and ethnic
disparities in the receipt of priority preventive services.
This program relates to the following priority areas of ``Healthy
People 2000'': Immunization and infectious disease, sexually
transmitted diseases, tobacco, heart disease and stroke, cancer, and
clinical preventive services.
B. Eligible Applicants
Applications are invited from non-profit and for-profit managed
care plans and their affiliated research entities and membership
organizations.
Applicant Requirements:
1. A principal investigator (PI) who has conducted research in
managed care settings, published findings in peer-reviewed journals,
and has specific authority and responsibility to carry out the proposed
project.
2. Demonstrated experience (on the applicant's project team) in
conducting, evaluating, and publishing prevention or health services
research in peer reviewed journals.
3. Effective and well-defined working relationships within the
performing organization and with outside entities to ensure successful
implementation of proposed activities.
4. A match between the applicant's proposed theme and research
objectives and the program interests described in this notice.
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 $750,000 will be available in FY 1999 to award 3-5
projects. Funding will range from approximately $150,000 to $250,000
per award. Awards are expected to begin on or about September 1, 1999,
for 12-month budget period within a project period of up to two years.
Proposals for one year projects are encouraged. Funding estimates may
change.
Continuation awards for projects with approved two year project
periods 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 purposes of this program,
the recipient will be responsible for the activities under Recipient
Activities, and CDC will be responsible for the activities under CDC
Activities.
Recipient Activities
1. Design and conduct a prevention research project addressing one
or more of the following questions:
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a. Evaluating the ability of health plans to monitor the delivery
of one or more priority preventive services;
b. Estimating the delivery of one or more priority preventive
services, particularly those not measurable via available
administrative data, and assessing the validity of such estimates;
c. Evaluating health plan structural, environmental, and
organizational factors associated with the delivery of one or more
priority preventive services;
d. Evaluating interventions designed to increase the use of one or
more priority preventive services.
2. Collect, analyze, interpret, present and publish research
project results.
CDC Activities
1. Provide technical assistance, advice and coordination; and
assure that CDC guidelines regarding conflict of interest,
Institutional Review Boards (IRBs), etc., are followed.
2. Assist in the monitoring of field data collection, helping to
ensure standardization in methods; and assist in the interpretation and
reporting of the collected information.
3. Assist by providing advice in the management and technical
performance of the investigation.
4. Assist in promoting project findings to the scientific community
at large.
E. Application Content
Your application should include:
1. A narrative description of the project's focus that justifies
the need and presents the scientific basis for the proposed research.
This focus should be grounded in the information provided in this
program announcement and in applicable sections of ``Healthy People
2000.''
2. A description of the expected outcome(s) and their relevance to
reducing morbidity, mortality, disability and economic loss.
3. Specific, measurable, time-phased objectives.
4. A detailed plan describing the methods by which the objectives
will be achieved, including their sequence.
5. A comprehensive evaluation plan.
6. A description of the principal investigator's role and
responsibilities.
7. A description of the proposed project staff regardless of
funding source. It should include: Title, qualifications, experience,
percentage of time which will be devoted to the project, project
responsibilities, and the portion of salary which will be paid for
under this proposal.
8. A description of other activities which are related to, but will
not be supported by the grant.
9. When applicable, a description of the involvement of other
participating organizations/groups and their relationship to the
proposed project. Include a clear statement of roles and commitments
including letters of support.
10. A detailed one year budget and, when applicable, a projected
second year budget.
An applicant organization has the option of having specific
employee salary and fringe benefit figures omitted from copies of the
application which will be made available to outside review groups. To
exercise this option, the applicant must use asterisks, on the original
and five copies of the application, to indicate those individuals for
whom salaries and fringe benefits are not shown. 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 salary and fringe
amounts shown. This budget page will be reserved for internal staff use
only.
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 in the application kit. On or before June 7, 1999
submit the application to: Sharron Orum, Grants Management Specialist,
Procurement and Grants Office, Grants Management Branch, Centers for
Disease Control and Prevention (CDC), 2920 Brandywine, Room 3000,
Atlanta, Georgia 30341, Announcement 99108.
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
objective review. (Applicants must request a legibly dated U.S. Postal
Service postmark or a legibly dated receipt from a commercial carrier
or U.S. Postal Service. Private metered postmarks shall not be
acceptable as proof of date and time of 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
Upon receipt, applications will be reviewed by CDC staff for
completeness and responsiveness as outlined under Eligible Applicants,
subtitle, Applicant Requirements (Items 1-4). Incomplete applications
and applications that are not responsive will be returned to the
applicant without further consideration. Applications that are complete
and responsive may be subjected to a preliminary evaluation by a peer
review group to determine if the application is of sufficient technical
and scientific merit to warrant further review (triage); the CDC will
withdraw from further consideration applications judged to be
noncompetitive and promptly notify the principal investigator/program
director and the official signing for the applicant organization. Those
applications judged to be competitive will be further evaluated by a
dual review process. Awards will be made based on priority score
ranking by the Disease, Disability, and Injury Prevention and Control
Special Emphasis Panel (SEP) appointed by CDC, programmatic priorities
and needs as determined by a secondary review committee, and the
availability of funds.
The first review in the dual review process will be the peer review
of all competitive applications by the SEP. Reviewers will comment on
the following aspects of the application (significance, approach,
innovation, investigators, and environment) in their written critiques
in order to judge the likelihood that the proposed research will have a
substantial impact on the pursuit of program goals. Each of these
criteria will be addressed and considered by the reviewers in assigning
the overall score, weighing them as appropriate for each application.
Note that the application does not have to be strong in all categories
to be judged likely to have a major scientific impact and thus deserve
a high priority score. For example, an investigator may propose to
carry out important work that by its nature is not innovative but is
essential to move a field forward.
The SEP will also evaluate the appropriateness of the proposed
project budget; the adequacy of plans to include racial and ethnic
minorities and their subgroups, children and both genders as
appropriate to the scientific goals of the research; the provisions for
the protection of human subjects; and the safety of the research
environment.
1. Significance: Does the study address a significant issue or
problem affecting the monitoring, delivery, and/or evaluation of
priority preventive services? If the aims of this application are
achieved how will scientific knowledge be advanced? How will the
public's health be advanced?
2. Approach: Are the conceptual framework, design, methods, and
analyses adequately developed, well-integrated, and appropriate to the
aims of the project? Does the applicant acknowledge potential problem
areas and consider alternative tactics? Are
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there plans to regularly evaluate progress toward the stated
objective(s)? Is an appropriate work plan included?
Has the applicant met the CDC Policy requirements regarding the
inclusion of women, ethnic, and racial groups in the proposed research?
This includes:
a. The proposed plan for the inclusion of both sexes and racial and
ethnic minority populations for appropriate representation.
b. The proposed justification when representation is limited or
absent.
c. A statement as to whether the design of the study is adequate to
measure differences when warranted.
d. 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. Innovation: Does the project employ novel concepts, approaches,
or methods? Are its aims innovative? Does it challenge existing
paradigms? Will it test the efficacy of new methodologies or
technologies?
4. Investigator(s): Is the principal investigator an experienced
researcher? Have any of the investigators conducted research in the
area of proposed study?
5. Environment: Will the proposed research setting contribute to
the probability of success? Does the proposed study take advantage of
any unique features of research setting? Are there any collaborative
agreements? Is there evidence of institutional/organizational support?
Is there evidence of appropriate interest, commitment, and cooperation
among the investigators and other interested parties as evidenced by
letters detailing the nature and extent of involvement?
6. Human Subjects: Does the application adequately address the
requirements of 45 CFR Part 46 for the protection of human subjects?
7. Biohazards: Are any hazards procedures proposed which would
affect the safety and well-being of the research subjects and/or
investigators?
8. Budget: Does the proposed budget seem appropriate? Does the
proposed study length seem reasonable? Would you propose any
modifications?
The secondary review committee, in the course of its review, will
consider the following factors:
a. The results of the peer review (SEP).
b. The significance of the proposed activities in relation to the
priorities and objectives stated in Healthy People 2000 and this
program announcement.
c. National needs.
d. Program balance including currently funded research and
organizational considerations.
e. Budgetary considerations.
H. Other Requirements
Technical Reporting Requirements Provide CDC with original plus two
copies of:
1. An annual progress report;
2. A financial status report, no more than 90 days after the end of
the budget period; and
3. A final financial status and performance reports, no more than
90 days after the end of the project period.
Send all reports to: Sharron Orum, Grants Management Specialist,
Procurement and Grants Office, Grants Management Branch, Centers for
Disease Control and Prevention (CDC), 2920 Brandywine, Room 3000,
Atlanta, GA 30341.
The following additional requirements are applicable to this
program. For a complete description of each, see Attachment 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-8................................... Public Health System Reporting
Requirements.
AR-9................................... Paperwork Reduction Act
Requirements.
AR-10.................................. Smoke-Free Workplace
Requirements.
AR-11.................................. Healthy People 2000.
AR-12.................................. Lobbying Restrictions.
I. Authority and Catalog of Federal Domestic Assistance Number
This program is authorized under the Public Health Service Act [42
U.S.C. sections 301 and 317(k)(2)], as amended. The Catalog of Federal
Domestic Assistance number is 93.283.
J. Where to Obtain Additional Information
Please refer to Program Announcement Number 99108 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: Sharron Orum, Grants
Management Specialist, Grants Management Branch, Procurement and Grants
Office, Centers for Disease Control and Prevention (CDC), 2920
Brandywine, Room 3000, Atlanta, GA 30341, Telephone: (770) 488-2716,
Email address: spo2@cdc.gov.
See also the CDC home page on the Internet: http://www.cdc.gov.
For program technical assistance, contact: Betsy L. Thompson,
Centers for Disease Control and Prevention (CDC), Epidemiology Program
Office, Div. of Prevention Research and Analytic Methods, Rm 1050B,
1600 Clifton Road, M/S D01, Atlanta, GA 30333, Telephone: (404) 639-
3806, Email address: bst0@cdc.gov.
Dated: April 5, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention (CDC).
[FR Doc. 99-8848 Filed 4-8-99; 8:45 am]
BILLING CODE 4163-18-P
