[Federal Register Volume 69, Number 61 (Tuesday, March 30, 2004)]
[Notices]
[Pages 16572-16576]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-7014]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Economic Studies of Vaccines and Immunization Policies, Programs, 
and Practices

    Announcement Type: New.
    Funding Opportunity Number: 04092.
    Catalog of Federal Domestic Assistance Number: 93.185.
    Key Dates:
    Letter of Intent Deadline: April 29, 2004.
    Application Deadline: June 1, 2004.
    SPOC Notification Deadline: April 29, 2004. For more information, 
see section ``IV.4. Intergovernmental Review of Applications.''

[[Page 16573]]

I. Funding Opportunity Description

    Authority: Public Health Services Act, Section 317(k)(1), 42 
U.S.C. 247b(k)(1), as amended.

    Purpose: The purpose of the program is to provide important 
economic information about vaccines and immunization policies, 
programs, and practices. As new vaccines or vaccine combinations are 
developed, economic studies provide increasingly valuable data about 
the costs of program implementation and maintenance, the medical costs 
that can be averted by vaccine use, the costs of adverse events 
associated with vaccines, and the changes in health utilities resulting 
from their use. These data assist decision makers as they balance the 
health burden and economic costs of disease against vaccination costs 
when they make immunization recommendations.
    This program addresses the ``Healthy People 2010'' focus area of 
Immunization and Infectious Diseases.
    Measurable outcomes of the program will be in alignment with 
performance goal of the Centers for Disease Control and Prevention's 
(CDC) National Immunization Program (NIP) to reduce the number of 
indigenous cases of vaccine-preventable diseases.
    Research Objectives: To generate economic information needed to 
inform and guide immunization policy, program, and practice decisions.
    Activities: Awardee activities for this program are as follows:
    1. Assemble a research team with demonstrated experience in 
conducting health economic studies of vaccine preventable diseases from 
multiple perspectives. To produce research results compatible with 
other CDC economic research, this team must be able to conduct 
quantitative research in the areas of cost-effectiveness, cost-utility, 
and cost-benefit analysis.
    2. Conduct activities addressing (a) and (b) below. The subject of 
activity (a) is a varicella vaccine to prevent zoster infection in 
adults and the elderly. Clinical trials of the vaccine are now 
underway. The purpose of the study is to provide important health 
economic information useful to the immunization decision making process 
once the clinical trials are completed. There is currently little 
information about the health values and utilities associated with 
herpes zoster infection, prevention of infection, and possible adverse 
events associated with a potential vaccine. Hence CDC's interest in 
innovative approaches to valuation of the benefits associated with this 
vaccine. Additional studies will be conducted as described in (b) 
below. Specific protocols for activities conducted under (1) and (2) 
must be developed collaboratively by the awardee and CDC.
    (a) Conduct a utility analysis of vaccinating adults against zoster 
infection, including the associated adverse events. Primary data 
collection methods will be employed to obtain stated-preferences and 
utilities about willingness to avoid zoster infection and adverse 
events. Study focus will be on survey design and implementation, 
measurement of health state values and utilities, and translation into 
quality-adjusted life-years. The study will be designed so that the 
resulting data will be compatible with data that are obtained through 
the vaccine clinical trials. The analysis will complement other 
economic studies of vaccines being conducted at CDC.
    (b) Develop and conduct as many as three additional applied studies 
in vaccine economics to be decided upon in collaboration with CDC 
staff. The awardee must have the flexibility to accommodate changes in 
specific studies and priorities as CDC's need for information changes.
    Examples of potential areas of interest for future studies include:
    (1) Evaluation of coverage rates, costs, and implementation 
barriers for new or modified childhood, adolescent, and adult vaccines.
    (2) Evaluation of coverage rates and costs of vaccine delivery to 
children, adolescents, and adults in traditional and non-traditional 
health care settings or other alternative settings
    (3) Development and application of innovative, quantitative 
epidemiologic and economic methods to provide data to support decisions 
about vaccine policies, programs, and practices.
    (4) Routinely evaluate progress in achieving the purpose of this 
program.
    (5) Analyze and interpret data from the program studies, and 
publish and disseminate findings in collaboration with CDC.
    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:
    1. Provide CDC investigator(s) to monitor the cooperative agreement 
as project officer(s).
    2. 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.
    3. Provide technical assistance on the selection and evaluation of 
data collection and data collection instruments.
    4. 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.
    5. Provide subject matter expertise in the areas of epidemiologic 
methods and statistical analysis, health economics, and survey research 
consultation
    6. Participate in the analysis and dissemination of information, 
data and findings from the project, facilitating dissemination of 
results.
    7. Serve as liaisons between the recipients of the project award 
and other administrative units within the CDC.
    8. Facilitate an annual meeting between awardee and CDC to 
coordinate planned efforts and review progress.
    9. Analyze and interpret data from studies, and publish and 
disseminate findings in collaboration with CDC.

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: $400,000.
    Approximate Number of Awards: One.
    Approximate Average Award: $400,000 (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: $400,000.
    Anticipated Award Date: August 15, 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

[[Page 16574]]

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.
    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: 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)
    A LOI is required and must be written in the following format:
     Maximum number of pages: Three
     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, telephone number, 
and fax number of the Principal Investigator
     Names of other key personnel
     Participating institutions
     Number and title of this Program Announcement 
(PA)
     Summary of proposed activities and description 
of study design, methods, and analyses
    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: [email protected].
    The Program Announcement Title and number must appear in the 
application.
    You must include a research plan with your application. The 
research plan should be double spaced and be no more than 25 pages.
    Your application will be evaluated on the criteria listed under 
Section V. Application Review Information, so it is important to follow 
them, as well as the Research Objectives and the Administrative and 
National Policy Requirements (AR's), in laying out your research plan.
    Your research plan should address activities to be conducted over 
the entire project period. The research plan should consist of the 
following information:
    1. Abstract. It is especially important to include an abstract that 
reflects the project's focus, because the abstract will be used to help 
determine the responsiveness of the application.
    2. Program Goals and Objectives. Describe the goals and objectives 
the proposed research is designed to achieve in the short and long 
term. Specific research questions and hypotheses should be included.
    3. Methods. Provide detailed methods of completing activity (a) 
described in Section I, including the collection of data to develop 
utilities associated with vaccination, and recruitment of participants 
if appropriate. Provide information to demonstrate how these data will 
be compatible with data obtained through relevant vaccine clinical 
trials. If any materials are not extant, the methods and timeframe for 
measure development and pilot testing should be given. Describe 
approach and any past experience relevant to completing activity (b) 
described in Section I.
    4. Project Management. Provide evidence of the expertise, capacity, 
and support necessary to successfully implement the project with an 
emphasis on team members with expertise necessary to conduct activities 
(a) and (b) described in Section 1. Each existing or proposed staff 
position for the project should be described by job title, function, 
general duties, level of effort, and allocation of time. Management 
operation principles, structure, and organization should also be noted.
    5. Collaborative Efforts. List and describe any current and 
proposed collaborations with government or health agencies or other 
researchers that will impact this project. Include letters of support 
and memoranda of understanding that specify the nature of past, 
present, and proposed collaborations, and the products/services/
activities that will be provided by and to the applicant.
    6. Data Sharing and release: Describe plans for the sharing and 
release of data (See AR-25 for additional information).
    7. Project Budget: Provide a detailed budget for each activity 
undertaken, with accompanying justification of all operating expenses 
that is consistent with the stated objectives and planned activities of 
the project.
    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 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.
    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: April 29, 2004.
    A letter of Intent (LOI) is required for this Program Announcement. 
The LOI will not be evaluated or scored. Your letter of intent will be 
used to estimate the potential reviewer workload and to avoid conflicts 
of interest during the review. If you do not submit a LOI, you

[[Page 16575]]

will not be allowed to submit an application.
    Application Deadline Date: June 1, 2004.
    Explanation of Deadlines: Applications must be received in the CDC 
Procurement and Grants Office by 4:00 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 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

    None.
    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:
    Ms. Beth Gardner, Scientific Review Administrator, CDC, National 
Immunization Program, 1600 Clifton Road, NE., Mailstop E-05, Atlanta, 
GA 30333, Phone: 404-639-6101, Fax: 404-639-0108, E-mail: 
[email protected].
    Application Submission Address: Submit the original and five hard 
copies of your application by mail or express delivery service to: 
Technical Information Management-PA 04092, 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 it's 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?
    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:
    (1) Ability to assemble a research team with demonstrated 
experience in conducting health economic studies of vaccine preventable 
diseases from multiple perspectives using the following approaches:
    (a) modeling of epidemiologic and economic phenomena, (b) measuring 
health-related utilities associated with disease, disease prevention, 
and vaccine-associated adverse events, (c) estimating monetary values 
for reduced risk of disease and for reduced morbidity and mortality, 
(d) constructing decision-analytic models, and (e) conducting cost-
effectiveness, cost-utility, and cost-benefit analyses.
    (2) Demonstrated publication record using the types of analyses in 
(1) above and in the fields of epidemiology and vaccine economics.
    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

[[Page 16576]]

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 National 
Immunization Program. 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 National Immunization 
Program 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.
     Receive a second level programmatic review by a 
National Immunization Program panel.
    Award Criteria: Criteria that will be used to make award decisions 
include:
     Scientific merit (as determined by peer review)
     Availability of funds
     Programmatic priorities

V.3. Anticipated Announcement and Award Dates

    Anticipated Application Deadline Date: May 2004.
    Anticipated Award Date: August 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-7, Executive Order 12372 Review
     AR-10, Smoke-Free Workplace Requirements
     AR-11, Healthy People 2010
     AR-12, Lobbying Restrictions
     AR-15, Proof of Non-Profit Status (If 
applicable)
     AR-22, Research Integrity
     AR-24, Health Insurance Portability and 
Accountability Act Requirements
    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 website) 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:
    Mark L. Messonnier, M.S., Ph.D., Project Officer, Lead Economist, 
CDC, National Immunization Program, 1600 Clifton Rd., NE., Mailstop 
E52, Atlanta, Georgia 30333, Telephone: (404) 639-8218, E-mail: 
[email protected].
    For questions about peer review, contact:
    Ms. Beth Gardner, Scientific Review Administrator, CDC, National 
Immunization Program, 1600 Clifton Road, NE., Mailstop E-05, Atlanta, 
GA 30333, Phone: 404-639-6101, E-mail: [email protected].
    For financial, grants management, or budget assistance, contact:
    Jesse L. Robertson, Grants Management Specialist, CDC Procurement 
and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341, Telephone: 
770-488-27347, E-mail: [email protected].

VIII. Other Information

    National Immunization Program, Centers for Disease Control and 
Prevention, Internet address: http://www.cdc.gov/nip.

    Dated: March 24, 2004.
Edward J. Schultz,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 04-7014 Filed 3-25-04; 1:52 pm]
BILLING CODE 4163-18-P