Influenza Vaccination of Children and Accompanying Adults: Mass Vaccination vs Vaccination in Routine Care, 25067-25071 [05-9451]

Agencies

• Centers for Disease Control and Prevention
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 70, Number 91 (Thursday, May 12, 2005)]
[Notices]
[Pages 25067-25071]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-9451]


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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: //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: https://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 https://www.dunandbradstreet.com 
or call 1-866-705-5711. For more information, see the CDC Web site at: 
https://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: https://
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: https://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: https://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: https://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