[Federal Register: April 26, 2004 (Volume 69, Number 80)]
[Notices]
[Page 22531-22535]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ap04-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Annual Influenza Vaccine Effectiveness Estimates in Healthy and
High-risk Populations
Announcement Type: New.
Funding Opportunity Number: 04109.
Catalog of Federal Domestic Assistance Number: 93.283.
Key Dates:
Letter of Intent Deadline: May 11, 2004.
Application Deadline: June 10, 2004.
Executive Summary: Annual estimates of influenza vaccine
effectiveness are important to assess the protection against influenza
provided by vaccination. These studies will help determine the degree
of protective immunity provided by the vaccine in years when the
vaccine contains a virus that is antigenically different from the
predominantly circulating strain as well as in years where the vaccine
and circulating viruses are well-matched. The results will provide
information that is beneficial to future vaccine strain decisions and
help guide policy development for influenza vaccination
recommendations. This cooperative agreement seeks to support
researchers with access to pediatric and adult populations to conduct
vaccine efficacy studies each year beginning in the fall of 2004.
I. Funding Opportunity Description
Authority: This program is authorized under sections 301(a) and
317(k)(1) of the Public Health Service Act, [42 U.S.C. sections
241(a) and 247b(k)(1)], as amended.
Purpose: Each year, on average, influenza results in 36,000 deaths
in the United States. Influenza vaccination is the best way to prevent
influenza and its severe complications. Each year the Advisory
Committee for Immunization Practices (ACIP) reviews the annual
recommendations for influenza vaccination and uses new studies or other
evidence gained over the previous years to decide if there should be
new target groups for immunization. The current target groups for
immunization include groups that are at increased risk for influenza
related complications, such as the elderly (i.e., persons 65 years of
age and older) and persons with certain chronic medical conditions.
Persons aged 50 to 64, because of the likelihood of chronic medical
conditions, and caretakers (health-care workers and household contacts)
who have frequent contact with people who have high-risk conditions are
also recommended for vaccination to reduce the likelihood of
transmitting influenza to high-risk groups.
Over the years, the results from studies on the effectiveness and
efficacy of influenza vaccination in preventing influenza-like illness
or laboratory-confirmed influenza infection have varied. In addition,
vaccine effectiveness or efficacy is dependent on the age group and
health care status of the group being studied. Vaccine effectiveness
and efficacy estimates tend to be higher in healthy, immunocompentent
people, whereas, studies have shown lower effectiveness in the elderly.
In years when the vaccine match is suboptimal, estimates of
[[Page 22532]]
vaccine effectiveness tend to be even lower and in some cases the
vaccine has had zero effectiveness against preventing influenza-like
illness. Because of the simplicity of design and availability of
existing data, many more studies of vaccine effectiveness using
influenza-like illness as the outcome of interest have been conducted
than have studies using laboratory-confirmed influenza as the outcome.
Studies which measure effectiveness of the vaccine in preventing
influenza-like illness can underestimate efficacy because other
respiratory pathogens co-circulate during influenza season and often
present as influenza-like illness, thus lowering the effectiveness
estimates for influenza vaccine. In contrast studies that measure
effectiveness among persons with laboratory-confirmed influenza
infections among those who present with influenza-like illness give a
better estimate of the vaccine's ability to prevent influenza
infection.
This program announcement seeks to support epidemiologic studies,
(e.g., cohort or case control) designed to provide annual vaccine
effectiveness, with laboratory confirmation of influenza illness,
estimates at regular intervals throughout the influenza season, with a
final estimate at the end of the season. These data will provide better
estimates of the benefits of influenza vaccine and will be valuable in
guiding vaccine policy development. In addition, these data are also
critical in understanding the effectiveness of annual vaccination in
seasons when the vaccine strain is less well-matched to the strains
circulating. Over time, such data may provide data to help improve
vaccine strain selection.
These studies should be designed to provide estimates of the
effectiveness of influenza vaccine in reducing laboratory confirmed
illness among vaccinated persons, both among pediatric and adult age
groups, on an annual basis, during the influenza season and at the end
of the influenza season. This program addresses the ``Healthy People
2010'' focus area of immunization and infectious diseases.
Measurable outcomes of the program will be in alignment with the
following performance goal for the National Center for Infectious
Diseases (NCID): Protect Americans from infectious diseases.
Research Objectives: Provide annual estimates of influenza vaccine
effectiveness in reducing lab-confirmed cases of influenza illness
among pediatric and adult populations both during the influenza season
and at the end of the influenza season.
Activities: Awardee activities for this program are as follows:
Identify populations in which prospective cohort
or case control studies can be implemented to measure vaccine
effectiveness in reducing laboratory-confirmed influenza illness among
pediatric and/or adult groups.
Develop protocols to address the research
objective that include collection of appropriate risk factor data,
vaccination information and other information regarding the study
participants that will be needed for data analysis. Methods must be
specified to reduce potential sources of bias (e.g., confounding by
indication) that may affect studies of vaccination effectiveness.
Describe the epidemiologic and laboratory
methodologies that will be used to determine influenza illness.
Begin enrolling participants for the first year
of the study prior to vaccination for the 2004 influenza season.
Describe a timeframe for enrollment, conducting the study, collection
of specimens and completion of the study.
Develop a plan that will provide and report
estimates of vaccine efficacy on an on-going basis to CDC during the
study, depending on the circulation of influenza, with final results at
the end of each influenza season. Describe the methodology that will be
used to determine periodic estimates of vaccine effectiveness
throughout the season and final results. Describe sample sizes you
propose to use. Respondents should have experience with the conduct of
clinical trials, as p-spending methods and other techniques to address
multiple statistical tests using data from a single individual.
In a cooperative agreement, CDC staff is substantially involved in
the program activities, above and beyond routine grant monitoring.
CDC Activities for this program are as follows:
Participate in the review of study design,
interpretation, analysis, dissemination and publication of results
including co-authorship.
Characterize select viral isolates obtained from
the study for determining the antigenic and genetic characteristics of
virus isolates from study participants.
Provide surveillance data, such as virologic
information and influenza-like illness information for the region of
the country and or state in which the study is taking place during the
influenza season.
II. Award Information
Type of Award: Cooperative Agreement.
CDC involvement in this program is listed in the Activities Section
above.
Fiscal Year Funds: 2004.
Approximate Total Funding: $500,000.
Approximate Number of Awards: One to two.
Approximate Average Award: $250,000-$500,000 (This amount is for
the first 12-month budget period, and includes both direct and indirect
costs).
Floor of Award Range: None.
Ceiling of Award Range: None.
Anticipated Award Date: August 16, 2004.
Budget Period Length: 12 months.
Project Period Length: Three years.
Throughout the project period, CDC's commitment to continuation of
awards will be conditioned on the availability of funds, evidence of
satisfactory progress by the recipient (as documented in required
reports), and the determination that continued funding is in the best
interest of the Federal Government.
III. Eligibility Information
III.1. Eligible Applicants
Applications may be submitted by public and private nonprofit
organizations and by governments and their agencies, such as:
Public nonprofit organizations.
Private nonprofit organizations.
Universities.
Colleges.
Research institutions.
Hospitals.
Community-based organizations.
Faith-based organizations.
Federally recognized Indian tribal governments.
Indian tribes.
Indian tribal organizations.
State and local governments or their Bona Fide
Agents (this includes the District of Columbia, the Commonwealth of
Puerto Rico, the Virgin Islands, the Commonwealth of the Northern
Marianna Islands, American Samoa, Guam, the Federated States of
Micronesia, the Republic of the Marshall Islands, and the Republic of
Palau).
Political subdivisions of States (in
consultation with States).
A Bona Fide Agent is an agency/organization identified by the state
as eligible to submit an application under the state eligibility in
lieu of a state application. If you are applying as a bona fide agent
of a state or local government, you must provide a letter from the
state or local government as documentation of your status. Place this
documentation behind the first page of your application form.
[[Page 22533]]
III.2. Cost Sharing or Matching
Matching funds are not required for this program.
III.3. Other
If your application is incomplete or non-responsive to the
requirements listed in this section, it will not be entered into the
review process. You will be notified that your application did not meet
submission requirements.
Your application must:
Provide evidence that you have access to the
populations needed for conducting large-scale epidemiologic studies.
Describe the methods that will be used to
determine lab confirmation of influenza illness and provide background
on experience of the entity in conducting the confirmation.
Describe the time frame for enrollment,
intermittent assessments and reporting of vaccine effectiveness and a
final report.
Provide evidence of support and ability for any
collaborating partners.
Individuals Eligible to Become Principal Investigators: Any
individual with the skills, knowledge, and resources necessary to carry
out the proposed research is invited to work with their institution to
develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are
always encouraged to apply for CDC programs.
Note: Title 2 of the United States Code section 1611 states that
an organization described in section 501(c)(4) of the Internal
Revenue Code that engages in lobbying activities is not eligible to
receive Federal funds constituting an award, grant, or loan.
IV. Application and Submission Information
IV.1. Address To Request Application Package
To apply for this funding opportunity, use application form PHS 398
(OMB number 0925-0001 rev. 5/2001). Forms and instructions are
available in an interactive format on the CDC Web site, at the
following Internet address: http://www.cdc.gov/od/pgo/forminfo.htm.
Forms and instructions are also available in an interactive format
on the National Institutes of Health (NIH) Web site at the following
Internet address: http://grants.nih.gov/grants/funding/phs398/phs398.html
.
If you do not have access to the Internet, or if you have
difficulty accessing the forms on-line, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGO-TIM) staff at: 770-488-2700. Application forms can be mailed to
you.
IV.2. Content and Form of Application Submission
Letter of Intent (LOI). Your LOI must be written in the following
format:
Maximum number of pages: 1.
Font size: 12-point unreduced.
Single spaced.
Paper size: 8.5 by 11 inches.
Page margin size: One inch.
Printed only on one side of page.
Written in plain language, avoid jargon.
Your LOI must contain the following information:
Descriptive title of the proposed research.
Name, address, E-mail address, and telephone number
of the Principal Investigator.
Names of other key personnel.
Participating institutions.
Number and title of this Program Announcement (PA).
Application: Follow the PHS 398 application instructions for
content and formatting of your application. For further assistance with
the PHS 398 application form, contact PGO-TIM staff at 770-488-2700, or
contact GrantsInfo, Telephone (301) 435-0714, E-mail:
GrantsInfo@nih.gov.
Your research plan should be single spaced and address activities
to be conducted over the entire project period.
You are required to have a Dun and Bradstreet Data Universal
Numbering System (DUNS) number to apply for a grant or cooperative
agreement from the Federal government. Your DUNS number must be entered
on line 11 of the face page of the PHS 398 application form. The DUNS
number is a nine-digit identification number, which uniquely identifies
business entities. Obtaining a DUNS number is easy and there is no
charge. To obtain a DUNS number, access http://www.dunandbradstreet.com or
call 1-866-705-5711.
For more information, see the CDC Web site at: http://www.cdc.gov/od/pgo/funding/pubcommt.htm
.
This PA uses just-in-time concepts. It also uses the modular
budgeting as well as non-modular budgeting formats. See: http://grants.nih.gov/grants/funding/modular/modular.htm
for additional
guidance on modular budgets. Specifically, if you are submitting an
application with direct costs in each year of $250,000 or less, use the
modular budget format. Otherwise, follow the instructions for non-
modular budget research grant applications.
Additional requirements that may require you to submit additional
documentation with your application are listed in section ``VI.2.
Administrative and National Policy Requirements.''
IV.3. Submission Dates and Times
LOI Deadline Date: May 11, 2004.
CDC requests that you send a LOI if you intend to apply for this
program. Although the LOI is not required, not binding, and does not
enter into the review of your subsequent application, the LOI will be
used to gauge the level of interest in this program, and to allow CDC
to plan the application review.
Application Deadline Date: June 10, 2004.
Explanation of Deadlines: Applications must be received in The
Procurement and Grants Office by 4 p.m. eastern time on the deadline
date. If you send your application by the United States Postal Service
or commercial delivery service, you must ensure that the carrier will
be able to guarantee delivery of the application by the closing date
and time. If CDC receives your application after closing due to: (1)
Carrier error, when the carrier accepted the package with a guarantee
for delivery by the closing date and time, or (2) significant weather
delays or natural disasters, you will be given the opportunity to
submit documentation of the carriers guarantee. If the documentation
verifies a carrier problem, CDC will consider the application as having
been received by the deadline.
This announcement is the definitive guide on application submission
address and deadline. It supersedes information provided in the
application instructions. If your application does not meet the
deadline above, it will not be eligible for review, and will be
discarded. You will be notified that your application did not meet the
submission requirements.
CDC will not notify you upon receipt of your application. If you
have a question about the receipt of your application, first contact
your courier. If you still have a question, contact the PGO-TIM staff
at: 770-488-2700. Before calling, please wait two to three days after
the application deadline. This will allow time for applications to be
processed and logged.
IV.4. Intergovernmental Review of Applications
Your application is subject to Intergovernmental Review of Federal
Programs, as governed by Executive Order (EO) 12372. This order sets up
a system for state and local governmental review of proposed federal
assistance applications. You should contact your
[[Page 22534]]
state single point of contact (SPOC) as early as possible to alert the
SPOC to prospective applications, and to receive instructions on your
state's process. Click on the following link to get the current SPOC
list: http://www.whitehouse.gov/omb/grants/spoc.html.
IV.5. Funding Restrictions
Restrictions, which must be taken into account while writing your
budget, are as follows:
There is a restriction on the use of these funds
for laboratory equipment and construction.
If you are requesting indirect costs in your budget, you must
include a copy of your indirect cost rate agreement. If your indirect
cost rate is a provisional rate, the agreement should be less than 12
months of age.
Awards will not allow reimbursement of pre-award costs.
IV.6. Other Submission Requirements
LOI Submission Address: Submit your LOI by express mail, delivery
service, fax, or e-mail to: Barbara Stewart, Centers for Disease
Control and Prevention, National Center for Infectious Diseases, 1600
Clifton Road, NE., Mail Stop C-19, Atlanta, GA 30333, Phone: 404-639-
0044, Fax: 404-639-2469, E-mail Address: bsg2@cdc.gov.
Application Submission Address: Submit the original and five hard
copies of your application by mail or express delivery service to:
Technical Information Management--PA 04109, CDC Procurement
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
Applications may not be submitted electronically at this time.
V. Application Review Information
V.1. Criteria
You are required to provide measures of effectiveness that will
demonstrate the accomplishment of the various identified objectives of
the cooperative agreement. Measures of effectiveness must relate to the
performance goals stated in the ``Purpose'' section of this
announcement. Measures must be objective and quantitative, and must
measure the intended outcome. These measures of effectiveness must be
submitted with the application and will be an element of evaluation.
The goals of CDC-supported research are to advance the
understanding of biological systems, improve the control and prevention
of disease and injury, and enhance health. In the written comments,
reviewers will be asked to evaluate the application in order to judge
the likelihood that the proposed research will have a substantial
impact on the pursuit of these goals.
The scientific review group will address and consider each of the
following criteria in assigning the application's overall score,
weighting them as appropriate for each application. The application
does not need to be strong in all categories to be judged likely to
have 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 criteria are as follows:
Significance: Does this study address an important problem? If the
aims of the application are achieved, how will scientific knowledge be
advanced? What will be the effect of these studies on the concepts or
methods that drive this field?
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? Has the applicant outlined a
reasonable plan for obtaining vaccine effectiveness results at
reasonable intervals throughout the study and at the end?
Innovation: Does the project employ novel concepts, approaches or
methods? Are the aims original and innovative? Does the project
challenge existing paradigms or develop new methodologies or
technologies?
Investigator: Is the investigator appropriately trained and well-
suited to carry out this work? Is the work proposed appropriate to the
experience level of the principal investigator and other researchers
(if any)?
Environment: Does the scientific environment in which the work will
be done contribute to the probability of success? Do the proposed
experiments take advantage of unique features of the scientific
environment or employ useful collaborative arrangements? Is there
evidence of institutional support?
Additional Review Criteria: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and priority score:
Study Populations:
(1) Has the applicant described the populations to which they will
have ready access to for conducting this study?
Laboratory Confirmation:
(1) Has the applicant described the methods that will be used to
determine lab confirmation of influenza illness?
(2) Has the applicant provided background and experience for the
entity conducting the laboratory testing?
Study Timeline and Protocol:
(1) Has the applicant described a timeframe for enrollment,
conducting the study, assessment, reporting and completion of the
study?
Protection of Human Subjects from Research Risks: Does the
application adequately address the requirements of Title 45 CFR Part 46
for the protection of human subjects? This will not be scored; however,
an application can be disapproved if the research risks are
sufficiently serious and protection against risks is so inadequate as
to make the entire application unacceptable.
Inclusion of Women and Minorities in Research: Does the application
adequately address the CDC Policy requirements regarding the inclusion
of women, ethnic, and racial groups in the proposed research? This
includes: (1) The proposed plan for the inclusion of both sexes and
racial and ethnic minority populations for appropriate representation;
(2) the proposed justification when representation is limited or
absent; (3) a statement as to whether the design of the study is
adequate to measure differences when warranted; and (4) 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.
Budget: The reasonableness of the proposed budget and the requested
period of support in relation to the proposed research.
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO) and for responsiveness by NCID. Incomplete
applications and applications that are non-responsive to the
eligibility criteria will not advance through the review process.
Applicants will be notified that their application did not meet
submission requirements.
Applications that are complete and responsive to the PA will be
evaluated for scientific and technical merit by an appropriate peer
review group or charter study section convened by NCID in accordance
with the review criteria listed above. As part of the initial merit
review, all applications may:
Undergo a process in which only those
applications deemed to have the highest scientific merit, generally the
top half of the applications under review, will be discussed and
assigned a priority score.
Receive a written critique.
[[Page 22535]]
Receive a second level review by CDC senior
staff.
Award Criteria: Criteria that will be used to make award decisions
include:
Scientific merit (as determined by peer review).
Availability of funds.
Programmatic priorities.
A multiple range of study designs, from database
studies to prospective cohort studies, will be considered for funding,
but priority will be given to projects that include analysis of test
confirmed influenza cases.
V.3. Anticipated Announcement and Award Dates
Anticipated Award Date: August 16, 2004.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a Notice of Grant Award (NGA)
from the CDC Procurement and Grants Office. The NGA shall be the only
binding, authorizing document between the recipient and CDC. The NGA
will be signed by an authorized Grants Management Officer, and mailed
to the recipient fiscal officer identified in the application.
Unsuccessful applicants will receive notification of the results of
the application review by mail.
VI.2. Administrative and National Policy Requirements
45 CFR Part 74 and Part 92
For more information on the Code of Federal Regulations, see the
National Archives and Records Administration at the following Internet
address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.
The following additional requirements apply to this project:
AR-1 Human Subjects Requirements.
AR-2 Requirements for Inclusion of Women and Racial
and Ethnic Minorities in Research.
AR-3 Animal Subject Requirements.
AR-7 Executive Order 12372.
AR-10 Smoke-Free Workplace Requirements.
AR-11 Healthy People 2010.
AR-12 Lobbying Restrictions.
AR-15 Proof of Non-Profit Status.
AR-22 Research Integrity.
AR-23 States and Faith-Based Organizations.
AR-25 Release and Sharing of Data.
Additional information on these requirements can be found on the
CDC Web site at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm
.
VI.3. Reporting
You must provide CDC with an original, plus two hard copies of the
following reports:
1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 5/2001 as posted on the CDC Web site) no less than 90 days
before the end of the budget period. The progress report will serve as
your non-competing continuation application, and must contain the
following elements:
a. Current Budget Period Activities Objectives.
b. Current Budget Period Financial Progress.
c. New Budget Period Program Proposed Activity Objectives.
d. Budget.
e. Additional Requested Information.
f. Measures of Effectiveness.
2. Financial status report and annual progress report, no more than
90 days after the end of the budget period.
3. Final financial and performance reports, no more than 90 days
after the end of the project period.
These reports must be mailed to the Grants Management Specialist
listed in the ``Agency Contacts'' section of this announcement.
VII. Agency Contacts
For general questions about this announcement, contact: Technical
Information Management Section, CDC Procurement and Grants Office, 2920
Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2700.
For scientific/research issues, contact: Dr. Mary Lerchen, Acting
Director, Office of Extramural Research, CDC, National Center for
Infectious Diseases, 1600 Clifton Road, NE., Mailstop: C-19, Atlanta,
GA 30333, Telephone: 404-639-0043, E-mail: mll0@cdc.gov.
For questions about peer review, contact: Barbara Stewart, CDC,
National Center for Infectious Diseases, 1600 Clifton Road, NE.,
Mailstop: C-19, Atlanta, GA 30333, Telephone: 404-639-0044, E-mail:
bsg2@cdc.gov.
For financial, grants management, or budget assistance, contact:
Lynn Walling, Contract Specialist, CDC Procurement and Grants Office,
2920 Brandywine Road, Atlanta, GA 30341, Telephone: 770-488-2612, E-
mail: lqw5@cdc.gov.
VIII. Other Information
None.
Dated: April 20, 2004.
William P. Nichols,
Acting Director, Procurement and Grants Office, Centers for Disease
Control and Prevention.
[FR Doc. 04-9371 Filed 4-23-04; 8:45 am]
BILLING CODE 4163-18-P