[Federal Register: May 12, 2005 (Volume 70, Number 91)]
[Notices]
[Page 25067-25071]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12my05-95]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Influenza Vaccination of Children and Accompanying Adults: Mass
Vaccination vs Vaccination in Routine Care
Announcement Type: New.
Funding Opportunity Number: RFA IP05-094.
Catalog of Federal Domestic Assistance Number: 93.185.
Letter of Intent Deadline: June 13, 2005.
Application Deadline: June 27, 2005.
I. Funding Opportunity Description
Authority: Section 311 [42 U.S.C. 243] and 317(k)(1) [42 U.S.C.
247b(k)(1)] of the Public Health Service Act, as amended.
Background: Epidemics of influenza have been responsible for an
average of approximately 36,000 deaths/year in the United States during
1990-1999. Influenza viruses also can cause pandemics, during which
rates of illness and death from influenza-related complications can
increase worldwide. Influenza viruses cause disease among all age
groups. Rates of infection are highest among children, but rates of
serious illness and death are highest among persons aged greater than
or equal to 65 years and persons of any age who have medical conditions
that place them at increased risk for complications from influenza.
[[Page 25068]]
Influenza vaccination is the primary method for preventing the
disease and its severe complications. In 2004, the Advisory Committee
on Immunization Practices (ACIP) recommended that healthy children aged
6-23 months be vaccinated against influenza because they are at
increased risk for influenza-related hospitalization. In addition,
vaccination is recommended for their household contacts and out-of-home
caregivers. Vaccination is also recommended for contacts of children
aged zero to five months because influenza vaccines have not been
approved by FDA for use among children aged greater than six months.
Purpose: The purpose of the program is to fund research to conduct
an incremental economic evaluation of vaccination of healthy children
aged 6-23 months, and the adults who accompany them, in mass
vaccination clinic settings compared with vaccination at routine health
care visits. The new ACIP recommendations may affect the capacity of
the pediatric health care infrastructure to provide vaccination
services. We want to know whether mass clinics are an economically and
financially viable alternative to providing influenza vaccination
during routine visits. This question must be answered from the societal
perspective, but the perspective of the pediatric health care provider
is also important because that is the level at which implementation
would likely occur.
Mass vaccination clinics could include scheduled or walk-in visits
for influenza vaccination conducted in a variety of ways. For example,
influenza vaccination can be offered on specified days each week during
flu season, during a specified time period in a certain month, in
schools or other specialty clinics, and could incorporate the offering
of vaccine to adults who accompany children to be vaccinated.
Applicants are encouraged to estimate costs under the widest variety of
possible conditions.
This program addresses the ``Healthy People 2010'' focus area(s) of
Immunization and Infectious Diseases.
Measurable outcomes of the program will be in alignment with the
performance goal for the Centers for Disease Control and Prevention's
(CDC) National Immunization Program (NIP) to reduce the number of
indigenous vaccine-preventable diseases.
Research Objectives:
To estimate the societal- and provider-perspective
incremental cost-effectiveness of influenza vaccination of healthy
children aged 6-23 months and, if possible, adults who accompany them
in mass vaccination clinic settings compared with vaccination at
routine health care visits.
To estimate the opportunity costs associated with mass
vaccination clinics.
To assess the effect of practice type, including pediatric
and family medicine, solo and multiple physician/multiple specialty
settings, on cost-effectiveness.
To assess the acceptability of mass vaccination clinics to
providers and parents of patients compared with vaccination in routine
scheduled visits.
Activities: Awardee activities for this program are as follows:
Identify or develop theoretical and empirical models for
analyzing the incremental cost-effectiveness of vaccination of healthy
children aged 6-23 months, and if possible the adults who accompany
them, in (1) mass vaccination clinic settings and (2) at private
routine health care facilities.
Identify appropriate theoretical and empirical models for
assessing the acceptability of mass vaccination clinics to providers
and parents of patients.
Develop a study design suitable for data collection and
analysis.
Categorize the resources required to provide influenza
vaccination in the two settings, including resources reallocated by the
use of mass vaccination clinics.
Determine sites, methods, and feasibility of protocol
prior to implementation.
Identify key staff and established resources/expertise
available to develop study models.
Collaboratively disseminate research findings in peer
reviewed publications and for use in determining national policy.
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:
Provide CDC investigator(s) to monitor the cooperative
agreement as project officer(s).
Participate as active project team members in the
development, implementation and conduct of the research project and as
coauthors of all scientific publications that result from the project.
Provide technical assistance on the selection and
evaluation of data collection and data collection instruments.
Assist in the development of research protocols for
Institutional Review Boards (IRB) review. The CDC IRB will review and
approve the project protocol initially and on at least an annual basis
until the research project is completed.
Contribute subject matter expertise in the areas of
epidemiologic methods and statistical analysis, health economics, and
survey research consultation.
Participate in the analysis and dissemination of
information, data and findings from the project, facilitating
dissemination of results.
Serve as liaisons between the recipients of the project
award and other administrative units within the CDC.
Facilitate meetings between awardee and CDC to coordinate
planned efforts and review progress.
II. Award Information
Type of Award: Cooperative Agreement.
CDC involvement in this program is listed in the Activities Section
above.
Mechanism of Support: U01.
Fiscal Year Funds: 2005.
Approximate Total Funding: $150,000. (Includes direct and indirect
costs. This amount is an estimate, and is subject to availability of
funds.)
Approximate Number of Awards: 1.
Approximate Average Award: $150,000. (Includes direct and indirect
costs. This amount is for the first 12-month budget period.)
Floor of Award Range: None.
Ceiling of Award Range: $150,000. (Includes direct and indirect
costs. This ceiling is for the first 12-month budget period.)
Anticipated Award Date: August 31, 2005.
Budget Period Length: 12 months.
Project Period Length: 2 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 are limited to public and private nonprofit
organizations and by governments and their agencies, such as: (For
profit organizations are not eligible under Section 317(k)(1) [42
U.S.C. 247b(k)(1) of the Public Health Service Act, as amended.)
Public nonprofit organizations
Private nonprofit organizations
Small, minority, women-owned businesses
Universities
Colleges
[[Page 25069]]
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.
III.2. Cost Sharing or Matching
Matching funds are not required for this program.
III.3. Other
If you request a funding amount greater than the ceiling of the
award range, your application will be considered non-responsive, and
will not be entered into the review process. You will be notified that
your application did not meet the submission requirements.
Special Requirements: 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.
Late applications will be considered non-responsive. See
section ``IV.3. Submission Dates and Times'' for more information on
deadlines.
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.
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.
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. 9/2004). Forms and instructions are
available in an interactive format on the CDC Web site, at the
following Internet address: http: //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: 2
Font size: 12-point unreduced
Double 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, telephone number, and FAX
number of the Principal Investigator
Names of other key personnel
Participating institutions
Number and title of this Announcement
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 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/pubcommt1.htm.
This announcement uses the non-modular budgeting format.
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: June 13, 2005.
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 27, 2005.
Explanation of Deadlines: LOIs must be received in the CDC Office
of Public Health Research (OPHR) and applications must be received in
the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the
deadline date. If you submit your LOI or application by the United
States Postal Service or commercial delivery service, you must ensure
that the carrier will be able to guarantee delivery by the closing date
and time. If CDC receives your submission 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 submission as having
been received by the deadline.
This announcement is the definitive guide on LOI and application
content, 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
[[Page 25070]]
notified that you did not meet the submission requirements.
CDC will not notify you upon receipt of your submission. If you
have a question about the receipt of your LOI or application, first
contact your courier. If you still have a question concerning your LOI,
contact the OPHR staff at 404-371-5277. If you still have a question
concerning your application, contact the PGO-TIM staff at: 770-488-
2700. Before calling, please wait two to three days after the
submission deadline. This will allow time for submissions 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 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:
Funds relating to the conduct of research will not be
released until the appropriate assurances and Institutional Review
Board approvals are in place.
Reimbursement of pre-award costs is not allowed.
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
IV.6. Other Submission Requirements
LOI Submission Address: Submit your LOI by express mail or delivery
service to: Mary Lerchen, DrPH, Scientific Review Administrator, CDC/
Office of Public Health Research, One West Court Square, Suite 7000, MS
D-72. telephone: 404-371-5277. Fax: 404-371-5215. e-mail:
MLerchen@cdc.gov.
Application Submission Address: Submit the original and one hard
copy of your application by mail or express delivery service to:
Technical Information Management--RFA IP05-094, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
At the time of submission, four additional copies of the
application, and all appendices must be sent to: Mary Lerchen, DrPH,
Scientific Review Administrator, CDC/Office of Public Health Research,
One West Court Square, Suite 7000, MS D-72. telephone: 404-371-5277.
Fax: 404-371-5215. e-mail: MLerchen@cdc.gov.
Applications may not be submitted electronically at this time.
V. Application Review Information
V.1. Criteria
Applicants 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 equally 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 review 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? How likely are the findings to be
generalizable and applicable to other settings in which mass
vaccination clinics would be considered as an alternative to
vaccination during routine health care visits?
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?
Innovation: Does the project employ novel concepts, approaches or
methods, i.e. model building? Are the aims original and innovative? To
the extent necessary, 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? Does the investigator have a history of
conducting economic and systems research? 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? Are letters of support included, if
appropriate?
Additional Review Criteria: In addition to the above criteria, the
following items will be considered in the determination of scientific
merit and priority score:
The applicant must demonstrate the ability to access both
mass and routine clinic settings by providing letters of intent to
collaborate with the applicant on behalf of clinics.
Ability to effectively implement a large community or
hospital system-based influenza vaccination program. The applicant must
demonstrate the ability to conduct economic analyses in public health,
including but not limited to expertise in incremental cost-
effectiveness analysis as evidenced by a record of publication in peer-
reviewed journals
Ability to conduct time studies and system evaluations, as
evidenced by a record of publication in peer-reviewed journals. Such
studies may include but not be limited to assessing health care system
performance, productivity, and capacity.
Protection of Human Subjects from Research Risks: Does the
application adequately address the requirements of Title 45 Part 46 for
the protection of human subjects? The involvement of human subjects and
protections from research risk relating to their participation in the
proposed research will be assessed.
Inclusion of Women and Minorities in Research: Does the application
adequately address the CDC Policy requirements regarding the inclusion
of
[[Page 25071]]
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. The priority
score should not be affected by the evaluation of the budget.
V.2. Review and Selection Process
Applications will be reviewed for completeness by the Procurement
and Grants Office (PGO) and for responsiveness by the OPHR. 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 announcement
will be evaluated for scientific and technical merit by an appropriate
peer review group or charter study section, a Special Emphasis Panel
(SEP), convened by the OPHR in accordance with the review criteria
listed above. As part of the initial merit review, all applications
will:
Undergo a process in which only those applications deemed
to have the highest scientific merit by the review group, generally the
top half of the applications under review, will be discussed and
assigned a priority score.
Receive a written critique.
Receive a second programmatic level review by the Office
of Science, National Immunization Program.
Undergo a peer review by a Special Emphasis Panel. The SEP
will be selected from the NIH pool of scientists or recommendations
from the National Immunization Program to serve as reviewers on SEPs.
Applications will be ranked for the secondary review according to
scores submitted by the SEP. Only those applications deemed to have the
highest scientific merit by the review group, generally the top half of
the applications under review, will be discussed and assigned a
priority score.
Award Criteria: Criteria that will be used to make award decisions
during the programmatic review include:
Scientific merit (as determined by peer review)
Availability of funds
Programmatic priorities
V.3. Anticipated Announcement and Award Dates
Award Date: August 31, 2005.
VI. Award Administration Information
VI.1. Award Notices
Successful applicants will receive a Notice of Award (NoA) from the
CDC Procurement and Grants Office. The NoA shall be the only binding,
authorizing document between the recipient and CDC. The NoA 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-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-24 Health Insurance Portability and Accountability Act
Requirements
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. 9/2004 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 additional elements:
a. Progress Toward Measures of Effectiveness.
b. Additional Information Requested by Program.
2. Financial status 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
We encourage inquiries concerning this announcement.
For general questions, 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: Susan Chu, PhD, MSPH,
Extramural Program Official, Centers for Disease Control and
Prevention, National Immunization Program, MS E-05, 1600 Clifton Road
NE, . Atlanta, GA 30333. Telephone: 404-639-8727. E-mail: SChu@cdc.gov.
For questions about peer review, contact: Mary Lerchen, DrPH,
Scientific Review Administrator, CDC/Office of Public Health Research,
One West Court Square, Suite 7000, MS D-72. Telephone: 404-371-5277.
Fax: 404-371-5215. E-mail: MLerchen@cdc.gov.
For financial, grants management, or budget assistance, contact:
Mattie Jackson, Grants Management Specialist, CDC Procurement and
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-
488-2696. E-mail: mij3@cdc.gov.
VIII. Other Information
This and other CDC funding opportunity announcements can be found
on the CDC Web site, Internet address: http://www.cdc.gov. Click on
``Funding'' then ``Grants and Cooperative Agreements.''
Dated: May 6, 2005.
William P. Nichols,
Director, Procurement and Grants Office, Centers for Disease Control
and Prevention.
[FR Doc. 05-9451 Filed 5-11-05; 8:45 am]
BILLING CODE 4163-18-P