[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
[[Page 25508]]
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: spo2@cdc.gov
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:
rhb2@cdc.gov
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
