[Federal Register Volume 64, Number 93 (Friday, May 14, 1999)]
[Notices]
[Pages 26419-26421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12205]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99118]


Cooperative Agreement for Applied Research on Surveillance of 
Vaccine Preventable Diseases in Managed Care Settings; Notice of 
Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) National 
Immunization Program (NIP) in cooperation with the Office of Prevention 
Research, announces the availability of fiscal year (FY) 1999 funds for 
a cooperative agreement program for Applied Research on Surveillance of 
Vaccine Preventable Diseases in Managed Care Settings.
    The purpose of this program is to fund research designed to enhance 
the ability of managed care organizations to conduct surveillance for 
vaccine preventable diseases in the United States. This program 
addresses the ``Healthy People 2000'' priority area of Immunization and 
Infectious Diseases.

B. Eligible Applicants

    Applications may be submitted by public and private non-profit and 
for profit organizations and by governments and their agencies; that 
is, universities, colleges, research institutions, hospitals, managed 
care organizations, small, minority-owned businesses, other public and 
private nonprofit and profit 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 $435,000 will be available in FY 1999 to award up to 
two projects. It is expected that the average award will be $217,500. 
It is expected that the awards will begin on or about September 1, 
1999, and will be made for a 12-month budget period within a project 
period of 1 year. Funding estimates may change.

D. Program Interests

    Applications must address a programmatic interest area as noted 
below. Applications which propose research studies whose findings have 
a high probability of being translated into new recommendations for 
vaccine use by national advisory bodies or whose findings are likely to 
lead to decreases in vaccine preventable disease morbidity or mortality 
are encouraged. Examples of possible projects are also given below; 
these examples are not to be considered as an exhaustive list but 
include projects NIP views as exemplifying the priority areas.

1. Disease Burden

    The use of surveillance information to better define the magnitude 
of the disease burden posed by vaccine preventable diseases. In 
particular, there is interest in the disease burden posed by diseases 
recently made vaccine preventable or about to be made vaccine 
preventable. Second, there is interest in the disease burden posed by 
diseases which have been vaccine preventable but where the vaccine is 
being considered for use in new target groups.
    For example, there is interest in improving the detection of 
pertussis in adolescents and enhancing clinical and laboratory 
diagnosis to define disease burden in this group.

2. New Approaches to Surveillance

    The use of managed care information systems to facilitate 
ascertainment and reporting of cases of vaccine preventable diseases.
    For example, there is interest in the use of electronic medical 
records to identify potential cases of vaccine preventable diseases for 
clinical and epidemiological follow-up and for reporting to public 
health agencies.
    Also, there is interest in the evaluation of different approaches 
for improving the clinical index of suspicion and the application of 
appropriate diagnostic methods to detect uncommon vaccine preventable 
diseases.

3. Vaccine Impact

    Monitoring the impact of vaccination programs through the use of 
surveillance data.
    For example, there is interest in estimating the impact of 
rotavirus vaccine in decreasing utilization of health care services.

E. Program Requirements

    In conducting activities to achieve the purposes of this program, 
the recipient will be responsible for the activities under 1. Recipient 
Activities, and CDC will be responsible for the activities under 2. CDC 
Activities.

1. Recipient Activities

    (a) Design the study: Determine the approaches to take in 
addressing the questions of interest in the study and develop a study 
protocol.
    (b) Implement the study protocol: Conduct the study according to 
the protocol and will resolve problems in study implementation as they 
arise.
    (c) Analyze data: Plan the analytic approach to be taken to 
understand and interpret the principal findings from the study.
    (d) Prepare manuscripts and publish results: Prepare a written 
manuscript describing the main study findings for publication in a peer 
reviewed journal.

2. CDC Activities

    (a) Provide technical and programmatic information: CDC scientists 
will provide current scientific and programmatic information relevant 
to the project.
    (b) Assist in executing the study: CDC scientists will collaborate 
as appropriate in each phase of the study including design, 
implementation, analysis, and publication. Depending on the project 
funded and on availability, CDC may provide laboratory support.
    (c) Assist in the development of a research protocol for 
Institutional Review Board (IRB) review by all cooperating institutions 
participating in the research project.
    The CDC IRB will review and approve the protocol initially and on 
at least an annual basis until the research project is completed.
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.

F. Submission and Deadline

Letter of Intent (LOI)

    Your letter of intent should identify the announcement number, the 
intended submission deadline, name the principal investigator, and 
specify the study area addressed by the proposed project. The letter of 
intent must be submitted on or before June 15, 1999, to: Sharron Orum, 
Grants Management Specialist, Grants Management Branch, Procurement and 
Grants Office, Announcement 99118, Centers for Disease Control and 
Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-
4146.

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Application

    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) on or before July 15, 1999, to: Sharron Orum, Grants 
Management Specialist, Grants Management Branch, Procurement and Grants 
Office, Announcement 99118, Centers for Disease Control and Prevention 
(CDC), 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146.
    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 
orderly processing. (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

    Applications that are complete and responsive may be subjected to a 
preliminary evaluation (triage) by a peer review group to determine if 
the application is of sufficient technical and scientific merit to 
warrant further review; 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 by Peer Review, programmatic priorities 
and needs as determined by the secondary review panel, and the 
availability of funds.
    A. The first review will be a peer review of all applications. 
Evaluation factors will include:
    1. The specific aims of the research project, i.e. the objectives 
and the hypothesis to be tested.
    2. The background of the proposal, e.g., the basis for the present 
proposal, a critical evaluation of existing knowledge, and the 
knowledge gaps which the proposal is intending to fill.
    3. The description of the expected outcome(s), their relevance to 
program goals, and the extent to which the research findings are likely 
to improve surveillance of vaccine preventable diseases.
    4. The adequacy of the study plan that describes the specific, 
measurable objectives and the methods by which the objectives will be 
achieved.
    5. The progress of preliminary studies, if any, pertinent to the 
application.
    6. The adequacy of the proposed research design, approaches, and 
methodology to carry out the research, including quality assurance 
procedures and plans for data management and statistical analyses.
    7. Qualifications, adequacy, and appropriateness of personnel to 
accomplish the proposed activities.
    8. The degree of commitment and cooperation of other interested 
parties (as evidenced by letters detailing the nature and extent of the 
involvement).
    9. The reasonableness of the proposed budget to the proposed 
research.
    10. Adequacy of existing and proposed facilities and resources.
    11. Inclusion of Women and Racial and Ethnic Minorities in 
Research.
    The degree to which the applicant has 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.
12. Human Subjects
    The extent to which the application adequately addresses the 
requirements of Title 45 CFR Part 46 for the protection of human 
subjects.
    B. The second review will be conducted by a secondary review 
committee of senior Federal officials. The factors to be considered 
will include:
    1. The results of the peer review.
    2. The significance of the proposed activities in relation to the 
priorities and objectives stated in Healthy People 2000;
    3. National needs.
    4. Budgetary considerations.
    5. Program balance among the major areas of interest:
    (a) Disease Burden.
    (b) New Approaches to Surveillance.
    (c) Vaccine Impact.

H. Other Requirements

Technical Reporting Requirements

    Provide CDC with original plus two copies of:
    1. Progress reports semiannual;
    2. Financial status report, no more than 90 days after the end of 
the budget period; and
    3. Final financial status 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 Attachment I in the 
application kit.

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
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 Sections 301 and 307 of the Public 
Health Service Act, 42 U.S.C. section 241 and 242l. The Catalog of 
Federal Domestic Assistance Number is 93.185.

J. Where To Obtain Additional Information

    This and other CDC Announcements may be downloaded from the CDC 
Internet homepage http://www.cdc.gov. Click on ``funding.''
    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, Announcement 99118, Centers for 
Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, 
Atlanta, GA 30341-4146, Telephone: (770) 488-2716, E-mail: 
SPO[email protected].

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    For program technical assistance, contact: Roger Bernier, PhD, MPH, 
National Immunization Program, Centers for Disease Control and 
Prevention, 1600 Clifton Road, NE., MS-E05, Atlanta, Georgia, 30333, 
Telephone: (404) 639-8204, E-mail: [email protected].

    Dated: May 10, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC)
[FR Doc. 99-12205 Filed 5-13-99; 8:45 am]
BILLING CODE 4163-18-P