[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:

[[Page 17396]]

    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

[[Page 17397]]

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: [email protected].
    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: [email protected].

    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