[Federal Register: March 30, 2004 (Volume 69, Number 61)]
[Notices]
[Page 16568-16572]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30mr04-73]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Evaluation of Parents Claiming Exemptions to School Entry
Immunization Requirements
Announcement Type: New.
Funding Opportunity Number: 04091.
Catalog of Federal Domestic Assistance Number: 93.185.
Key Dates:
Letter of Intent Deadline: April 29, 2004.
Application Deadline: June 1, 2004.
I. Funding Opportunity Description
Authority: Public Health Service Act, Section 317(k)(1), 42
U.S.C. 247b(k)(1), as amended.
Purpose: The purpose of the program is to characterize the
attitudes of parents who elect to claim immunization exemptions for
their children and to develop a method that can be used to assess
immunization exemption rates, attitudes, and practices among parents
and providers within a particular geographic area.
Immunizations are considered one of the most effective means to
prevent serious, life-threatening diseases. Currently, all states have
laws that require proof of immunization for school entrance.
Immunization exceptions exist in all states and may be claimed for a
variety of reasons including medical, religious, or philosophical
reasons.
In recent years, some states have experienced an increase in the
rate of immunization exemptions claimed. Previous research suggests
that the rate of immunization exemptions may be related to several
factors including the amount of effort needed to claim an exemption
compared to the amount of effort needed to actually fulfill the
immunization requirement. Anecdotal reports claim that the increase may
be due to new vaccine requirements (i.e. hepatitis B and varicella) and
to increasing parental opposition to vaccination, potentially spurred
by vaccine safety concerns.
Reasons for claiming an exemption have not been thoroughly
evaluated. When a parent claims an exemption it is unknown if the
parent opposes all vaccines, one particular vaccine series, or simply
does not have time to bring his/her child to a healthcare provider to
get the last dose of vaccine in a series. It is also unknown what role
the physician plays (if any) in a parent's decision to claim an
exemption. Understanding why parents claim exemptions can help the
Centers for Disease Control and Prevention (CDC) to ensure that
exemptions are used appropriately and that parents are knowledgeable
about their options.
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
performance goal for the Centers for Disease Control and Prevention's
National Immunization Program (NIP) to reduce the number of indigenous
cases of vaccine-preventable diseases.
Research Objectives: To identify reasons for immunization
exemptions
[[Page 16569]]
from the parent and provider perspectives and provide a better
understanding of why immunization exemptions are claimed.
Specific research objectives:
1. Evaluate the rate of exemptions over time within a specific
geographic area (at least one state) with respect to:
a. Geographic distribution of exemptions (e.g., county, school
district, school grade etc.)
b. Timing of introduction of new vaccine requirements or
legislation.
c. Reports of adverse health events purportedly associated with
vaccines or vaccine components.
2. Select schools with high or increasing rates of exemptions
within a particular geographic area and identify, characterize, and
describe the types of immunization exemptions claimed by parents and
their providers.
a. For parents, describe and compare parents claiming an exemption
for their child to parents not claiming exemptions.
b. Evaluate and compare the health care providers of parents
claiming and not claiming an exemption.
3. Evaluate the research project area to determine the disease risk
or outbreak potential from vaccine-preventable diseases.
4. Based on findings from objectives 1, 2, and
3, develop a method (including data collection instruments and
analytical tools) that can be used to assess immunization exemption
rates, attitudes, and practices among parents and providers.
Activities:
Awardee activities for this program are as follows:
1. Develop methods for analyzing state exemption data.
2. Develop appropriate state selection criteria. Select and enroll
states.
3. Develop methods for identifying, sampling, and surveying parents
who have and have not claimed an exemption for their child. Survey
information should include demographic characteristics, including
vaccination status of children; attitudes towards vaccination,
including perceived benefits and risks; sources of vaccine information;
reasons for claiming (or not) an exemption. Include a description of
the survey instrument, statistical analysis, and outcome measures.
4. Develop methods for identifying, sampling, and surveying
healthcare providers of children whose parents have and have not
claimed an exemption. Survey data should include opinions regarding
vaccination and exemptions; the role they play (if any) in influencing
parents to opt for/against immunization/exemption; and, whether they
are claiming medical exemptions for their patients based on parental
pressure. Include a description of the survey instrument, statistical
analysis, and outcome measures.
5. Develop a method that can be used to assess immunization
exemption rates, attitudes, and practices among parents, as described
in Specific Research Objective 3 above.
6. Develop a method that can be used to assess immunization
exemption rates, attitudes, and practices among providers, as described
in Specific Research Objective 4 above.
7. Collect and analyze data.
8. 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:
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. Contribute subject matter expertise in the areas of
epidemiologic methods and statistical analysis, 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.
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: $200,000.
Approximate Number of Awards: One.
Approximate Average Award: $200,000 (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: $200,000.
Anticipated Award Date: August 15, 2004.
Budget Period Length: 12 months.
Project Period Length: Two 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
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.
[[Page 16570]]
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): 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, and telephone
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:
GrantsInfo@nih.gov.
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 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. Program Participants. Provide a justification and description of
the specific state and schools targeted, including past and current
exemption data and demographic and geographic characteristics. In
addition, the proposal should provide evidence that the recipient has
the capacity and state or local support necessary to recruit
participants, including providers and parents of children sampled at
participating schools. Describe how the study sample(s) is defined. A
description of how recruitment, retention and referral of participants
will be handled should also be included.
4. Methods. Describe methods and sources of data for assessing
trends in exemption data. Describe methods for sampling children (with
exemptions and without) from participating schools. Describe topic
areas and potential questions to be examined with providers and
parents. If any materials are not extant, the methods and timeframe for
measure development and pilot testing should be given.
5. Project Management. Provide evidence of the expertise, capacity,
and support necessary to successfully implement the project. 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.
6. Collaborative Efforts. List and describe any current and
proposed collaborations with government and 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.
7. Data Sharing and Release: Describe plans for the sharing and
release of data.
8. Budget. Applications must be submitted in a modular grant
format. The modular grant format simplifies the preparation of the
budget in these applications by limiting the level of budgetary detail.
Applicants request direct costs in $25,000 modules. Section C of the
research grant application instructions for the PHS 398 (rev. 5/2001)
is available at: http://grants.nih.gov/grants/funding/phs398/phs398.html.
This includes step-by-step guidance for preparing modular
grants. Additional information on modular grants is available at:
http://grants.nih.gov/grants/funding/modular/modular.htm.
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/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 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 p.m. Eastern Time on the deadline
date. If you send your application by the
[[Page 16571]]
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
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, Email:
BGardner@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 04091, 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?
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:
Applicants must have an established relationship
with the state immunization program and they must provide documentation
of support from the state immunization program.
Experience with state immunization exemption
rate data and ability to justify increasing exemption rates in the
selected state(s).
Ability to perform immunization-related research
as demonstrated by peer-reviewed publications in the field.
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
[[Page 16572]]
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 NIP. 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 NIP 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
NIP 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:
Mr. Gary Edgar, Extramural Project Officer, CDC, National
Immunization Program, 1600 Clifton Road NE., Mailstop E-52, Atlanta, GA
30333, Phone: (404) 639-8787, E-mail: GWE1@CDC.GOV.
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: BGardner@CDC.GOV.
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) 488-2747, E-mail: jtr4@CDC.GOV.
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. 04-7015 Filed 3-25-04; 1:52 pm]
BILLING CODE 4163-18-P