[Federal Register Volume 64, Number 91 (Wednesday, May 12, 1999)]
[Notices]
[Pages 25506-25508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-11928]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99116]


Cooperative Agreement for Applied Research on New Vaccines; 
Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC), National 
Immunization Program 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 New Vaccines. 
This program addresses the ``Healthy People 2000'' priority area of 
Immunization and Infectious Diseases. The purpose of the program is to 
initiate an extramural applied research program focused on new 
vaccines.

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, 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: Public Law 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.

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C. Availability of Funds

    Approximately $725,000 is available in FY 1999 to fund 2 to 3 
awards. It is expected that the average award will range from $225,000 
to $350,000 to begin on or about September 30, 1999, and will be made 
for a 12-month budget period within a project period of up to 3 years. 
Funding estimates may change.
    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.

D. Programmatic Interests

    Cooperative agreement applications for research projects that 
address clinical, epidemiologic, or health services delivery questions 
about new vaccines are being sought. The focus of the cooperative 
agreement is to eliminate gaps in the available information about new 
vaccines or their use which is impeding the fullest application of 
vaccines and their maximum impact on disease. Such gaps may exist for 
numerous reasons including the small size of populations studied in 
pre-licensure trials, or the lack of diversity in the populations 
studied. 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.
    Applications must address a programmatic interest area as noted 
below. Examples of possible projects are also given below; these 
examples are not to be considered as an exhaustive list but include 
projects which NIP views as merely exemplifying the priority areas.

1. Clinical or Epidemiologic Research

    a. Clinical or epidemiologic topics about new vaccines (including 
varicella, rotavirus).
    For example, there is programmatic interest in assessing the safety 
and immunogenicity of varicella vaccine among asthmatic children and 
determining the best immunization regimen. Also, there is interest in 
learning more about the safety and immunogenicity of rotavirus vaccine 
among premature infants.
    b. Clinical or epidemiologic topics about existing vaccines that 
have the potential to be recommended for universal use (including 
hepatitis A). For example, there is programmatic interest in examining 
the efficacy of a single dose of hepatitis A vaccine in conferring long 
lasting protection.
    c. Clinical or epidemiologic topics about new vaccines expected to 
be licensed for universal use (including conjugate pneumococcal, live 
influenza vaccines). For example, there is interest in assessing 
correlates of protection for pneumococcal vaccine and determining 
optimal approaches to preventing pneumococcal infection among high risk 
groups such as those with sickle cell disease.
    d. Clinical or epidemiologic topics about the diseases prevented by 
new vaccines (including disease burden, impact of vaccination, risk 
factors for disease). For example, there is interest in defining the 
impact of pneumococcal vaccine on health care utilization and on 
diagnostic and management practices for children with high fever or 
common respiratory infections.

2. Health Services Research

    Health services delivery topics about the implementation of new 
vaccine policies and recommendations.
    For example, there is interest in what factors influence providers' 
implementation of new vaccines, including the insurance coverage, 
parental out-of-pocket costs, and factors influencing decisions by 
purchasers of health care, insurers of health care, and managed care 
organizations about coverage for new vaccines.

E. Program Requirements

    In conducting activities to achieve this program, the recipient 
shall be responsible for the activities listed under 1. Recipient 
Activities, and CDC shall be responsible for conducting activities 
listed 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 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 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 may collaborate 
as appropriate in each phase of the study including design, 
implementation, analysis, and publication. CDC may provide laboratory 
support, depending on the project funded and the availability of 
services.
    (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 Priorities, Cooperative 
Activities, 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 99116, Centers for Disease Control and 
Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-
4146.

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 99116, 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 submission to the 
review process. (Applicants must request a legibly dated U.S. Postal 
Service postmark or obtain a legibly dated receipt from a

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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 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 score and programmatic priorities as determined by a 
secondary review panel, and the availability of funds.
    The first review will be a peer review on all applications. Factors 
to be considered 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 specific 
vaccine preventable disease knowledge gaps which the proposal intends 
to fill.
    3. The significance and originality of the proposed research.
    4. The progress of preliminary studies, if any, pertinent to the 
application.
    5. 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.
    6. The extent to which the research findings are likely to fill 
important information gaps about new vaccines and lead to new vaccine 
preventable disease policies and recommendations by advisory groups or 
feasible, cost-effective interventions.
    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.
    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. Program balance among the two major areas of interest: (a) The 
clinical and epidemiologic topics surrounding new vaccines and the 
diseases they prevent, and (b) the health services delivery and program 
implementation topics.
    3. Budgetary considerations.

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
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 you 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 99116, Centers for Disease Control and Prevention (CDC), 
2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146, Telephone: 
(770) 488-2716, E-mail: [email protected]
    For program technical assistance, contact: Roger Bernier, PhD, MPH, 
Associate Director for Science, 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 6, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 99-11928 Filed 5-11-99; 8:45 am]
BILLING CODE 4163-18-P