[Federal Register Volume 62, Number 101 (Tuesday, May 27, 1997)]
[Notices]
[Pages 28711-28716]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-13744]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Announcement Number 794]
Immunization Registry Targeted Research Projects; Notice of
Availability of Funds for Fiscal Year 1997
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1997 funds for cooperative agreement
[[Page 28712]]
research projects to identify solutions to problems which currently
impair progress in the development and operation of immunization
registries.
CDC is committed to achieving the health promotion and disease
prevention objectives of Healthy People 2000, a national activity to
reduce morbidity and mortality and improve the quality of life. This
announcement is related to the priority area of Immunization and
Infectious Diseases. (For ordering a copy of Healthy People 2000, see
the section Where to Obtain Additional Information.)
Authority
This program is authorized under sections 317 (42 U.S.C. 247b) and
311 (42 U.S.C. 243) of the Public Health Service Act as amended, and
the National Childhood Vaccine Injury Act (42 U.S.C. 300aa-1, et seq.).
Smoke-Free Workplace
CDC strongly encourages all grant recipients to provide a smoke-
free workplace and to promote the non-use of all tobacco products, and
Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in
certain facilities that receive Federal funds in which education,
library, child care, health care, and early childhood development
services are provided to children.
Eligible Applicants
Eligible applicants include nonprofit organizations. Thus, State
and local health departments, other State and local government
agencies, universities, colleges, research institutions, hospitals,
other public and private non-profit organizations, including small,
minority and/or women-owned non-profit businesses are eligible to
apply.
An organization described in section 501(c)(4) of the Internal
Revenue Code of 1986 which engages in lobbying activities shall not be
eligible to receive Federal funds constituting an award, grant, loan,
or any other form.
Applications will be considered for funding to conduct a study to
address a single research question. The research question chosen should
be clearly indicated in the 1-page response to the Program Requirements
which is to appear as the first page of text in the application.
Availability of Funds
Approximately $1,000,000 is available in FY 1997 to fund up to ten
cooperative agreements. It is expected that the average award will be
$100,000 per year (including direct and indirect costs), ranging from
$50,000 to $150,000, with awards being made on or before September 30,
1997. The awards will be made for 12-month budget periods within a
project period of up to 2 years. Final funding amounts may differ from
the amounts above and are subject to change based on the availability
of funds.
Cooperative agreement applications which exceed the $150,000
(including direct and indirect costs) per year will be returned to the
applicant as non-responsive.
Continuation awards within the project period will be made on the
basis of satisfactory progress and the availability of funds.
Use of Funds
Allowable Uses
Funds should be targeted for implementation, management, and
evaluation of the project. Funds can support personnel and the purchase
of modest amounts of hardware and software for data collection,
analysis, and project management and evaluation purposes.
Prohibited Uses
Cooperative agreement funds through this project cannot be used for
(1) Construction, (2) renovation, (3) the purchase or lease of
passenger vehicles or vans, or (4) supplanting any current applicant
expenditures.
Restrictions on Lobbying
Applicants should be aware of restrictions on the use of HHS funds
for lobbying of Federal or State legislative bodies. Under the
provisions of 31 U.S.C. 1352 (which has been in effect since December
23, 1989), recipients (and their subtier contractors) are prohibited
from using appropriated Federal funds (other than profits from a
Federal contract) for lobbying Congress or any Federal agency in
connection with the award of a particular contract, grant, cooperative
agreement, or loan. This includes grants/cooperative agreements that,
in whole or in part, involve conferences for which Federal funds cannot
be used directly or indirectly to encourage participants to lobby or to
instruct participants on how to lobby.
In addition, the FY 1997 HHS Appropriations Act, which became
effective October 1, 1996, expressly prohibits the use of 1997
appropriated funds for indirect or ``grass roots'' lobbying efforts
that are designed to support or defeat legislation pending before State
legislatures. This new law, Section 503 of Public Law 104-208, provides
as follows:
Section 503(a) No part of any appropriation contained in this Act
shall be used, other than for normal and recognized executive-
legislative relationships, for publicity or propaganda purposes, for
the preparation, distribution, or use of any kit, pamphlet, booklet,
publication, radio, television, or video presentation designed to
support or defeat legislation pending before the Congress, * * * except
in presentation to the Congress or any State legislative body itself.
(b) No part of any appropriation contained in this Act shall be
used to pay the salary or expenses of any grant or contract recipient,
or agent acting for such recipient, related to any activity designed to
influence legislation or appropriations pending before the Congress or
any State legislature.
Department of Labor, Health and Human Services, and Education, and
Related Agencies Appropriations Act, 1997, as enacted by the Omnibus
Consolidated Appropriations Act, 1997, Division A, Title I, Section
101(e), Public Law 104-208 (September 30, 1996).
Background
Immunization registries, particularly community-based immunization
registries (in which both public and private immunization providers
participate) are vital to the efforts of the National Immunization
Program (NIP) to achieve and maintain high immunization levels.
Key defining characteristics of a ``fully developed'' immunization
registry at this point in time include: (1) A mechanism for including
all births in the target area; (2) system functionality to support
parental or guardian recall of children whose immunizations are past
due; (3) ability to help prevent ``missed opportunities'' by
automatically evaluating immunization status at every visit; and, (4)
ability to assess immunization coverage at levels of individual
providers, clinics, and geographic localities.
Immunization registries are now being implemented in all States and
many localities. This represents a substantial public health
investment. There is reason to believe that registries will achieve
their potential to help in meeting national immunization goals.
However, the development and operation of registries is complicated by
the absence of essential information about them including specific,
systematically collected information on their cost, the best methods
for developing and maintaining them, and optimal system architectures.
Accordingly, NIP will support investigation of the research questions
[[Page 28713]]
posed in this program announcement to begin supplying this key
information.
Purpose
The purposes of this program are to (1) Increase collective
knowledge about the dimensions of these problems, (2) yield bona fide
information upon which solutions to these problems can be based, and
(3) identify problematic aspects which point to the need for further
research to yield additional workable solutions.
Programmatic Priorities
Select the focus of the proposed research project from among the
following specific research questions (proposed research must be in one
of the following):
1. What are the most efficient methods for assuring each child has
a unique identification in an immunization registry (i.e., un-
duplicating records)?
2. What are the direct and indirect costs of maintaining a fully
developed community immunization registry?
3. What are the most effective ways to both secure and maintain the
active participation of private providers in an immunization registry?
4. How effective and feasible is it to adapt existing billing and/
or patient management systems to obtain accurate and complete
immunization information for entry into a registry?
To assist in making this selection, please refer to ``Guidelines to
Help Determine Effective Answers to Immunization Registry Research
Questions'' (included in the application kit), for thoughts on some of
the possible dimensions of these research questions.
Program Requirements
The following are application requirements. Please respond with a
clear but succinct description and supportive references regarding how
each of the statements apply in the case of your application:
1. The applying institution, organization, or agency has a track
record of successful health economics research, health services
research, or health information systems research.
2. The applying institution, organization, or agency employs or can
engage investigators in the fields of economics, health services
research, or information systems research who have direct experience at
establishing, working with, and/or researching immunization programs or
related topics, and with a corresponding record of substantial
publication in the peer-reviewed scientific literature.
3. The applying institution, organization, or agency is designating
one such experienced and published investigator as this project's
principal investigator.
4. The principal investigator on this project has access to an
immunization registry to the extent, and for the time, necessary to
carry out this project.
Provide a succinct but informative response to each application
requirement. Your response must not exceed 1 page. As evidence of
meeting the requirements, you may either present independent
attachments or make reference to appropriate text in, or attachments
to, the body of your application. Your response may follow your Table
of Contents, but must appear as the first page of the text of your
application and be titled, ``Program Requirements.'' An affirmative
response to Requirements 1-4 is required to qualify for further review.
Cooperative Activities
In conducting activities of this program, the recipient shall be
responsible for the activities under A. below and CDC shall be
responsible for conducting activities under B. below.
A. Recipient Activities
1. Implement the proposed study design developed to answer the
specific research question which is the selected focus of this research
project.
2. Implement an evaluation plan designed to determine the extent to
which the chosen research question is answered.
3. Specify remaining or newly identified aspects of the research
question.
4. Completely document the process involved in answering each
aspect of the research question.
5. Publish the results of the research in a peer-reviewed health
sciences or medical journal.
B. CDC Activities
1. Provide epidemiologic, programmatic, and educational
consultation and technical assistance in planning, operating,
improving, and evaluating the research project.
2. Provide ongoing technical assistance to principal investigators
to ensure that they are able to avoid the retesting of flawed or failed
techniques, systems, or approaches from prior efforts of various U.S.
immunization programs which are known to NIP/CDC, but which may not be
common knowledge.
3. Provide technical assistance and oversight to ensure that a
rigorous scientific approach is taken in this project.
4. Cooperate in the preparation and publication of study results.
Application Contents
Applicants must use the following format for the narrative portion
of their applications. Single spacing is optional, but an applicant
must observe the specified page limitations and use no less than a 12-
point font. Applicants should include a Table of Contents (not to
exceed 1 page) to provide a guide for locating key topics. Applicants
should also provide an abstract of the proposed program (not to exceed
1 page) that summarizes the research question to be addressed, the
priority activities to be undertaken to successfully answer the
research question, the principal investigator's educational and
professional backgrounds and research experience, and the registry to
be used for the purposes of this research.
When developing the application, applicants should refer to the
relevant program requirements and guidance to address A.-F. below,
which correspond to review and evaluation criteria in the next section.
A. Rationale for the Research Question Chosen To Be Addressed (Not to
Exceed 1 Page)
Describe the research question chosen to be addressed and the
rationale for this selection. Included in this should be an explanation
of why this question is a priority for the investigator(s) and what
types of interest, experience, or expertise the investigator(s) bring
to the particular problem inherent in the chosen research question, and
the anticipated value to immunization registry development or
operations that a workable solution is likely to mean.
B. Objectives of the Research (Not to Exceed 1 Page)
Itemize the objectives and time lines of the research in relation
to the chosen research question. If a second year is necessary to
answer the chosen research question, itemize the objectives and time
lines that will take the project to a successful conclusion.
C. Design of the Research (Not to Exceed 3 Pages)
Describe the proposed methodology of the research, how it is
expected that various activities will result in answering the chosen
research question, and how the design will ensure generalizability of
the findings. This description should include, as appropriate, (a) the
proposed plan for the inclusion of both sexes and racial
[[Page 28714]]
and ethnic minority populations for appropriate representation; (b) the
proposed justification when such representation is limited or absent;
(c) a statement as to whether the design of the study is adequate to
measure differences when warranted; and (d) a statement as to whether
the plans for recruitment and outreach for study participants include
the process of establishing partnerships with community(ies) and
recognitions of mutual benefits.
D. Background and Experience of the Principal Investigator and the
Applying Institution, Organization, or Agency (Not to Exceed 2 Pages)
Describe the educational and professional background of the
principal investigator, and document the relevant experience of the
principal investigator and qualifications of the applying institution,
organization, or agency for carrying out health economics, health
services, or information systems research.
E. Immunization Registry To Be Used for the Research (Not to Exceed 2
Pages)
Trace the history of the registry, describe the hardware, software,
capacity, and access mechanisms for the registry, describe the owner(s)
of the registry, and describe the principal investigator's ability to
alter or manipulate it for the purposes of carrying out this research
project. Describe the commitment of the registry owner(s) (if other
than the applicant), which will be a public health agency in most
cases, for collaboration on this project. If applicable, attach
documentation (e.g., a letter of support, a preliminary memorandum-of-
agreement, a contractual proposal) from the registry owner(s) providing
collaboration details, including the terms of access to the registry,
and any specified limits to collaboration for the purposes of this
project.
F. Budget and Budget Justification (Not to Exceed 4 Pages)
Provide a detailed budget with justification describing resources
needed to address all aspect of the proposed research plan. The budget
should be consistent with the intended use of these cooperative
agreement funds and with the objectives of this project. If the project
is anticipated to extend beyond a 1-year project period, include an
estimated itemization and level of budgetary needs for the second
budget period.
Evaluation Criteria
Upon receipt, applications will be screened by CDC staff for
completeness and responsiveness as outlined under the previous heading,
``Program Requirements'' (A.-F.). Incomplete applications and
applications which are not responsive will be returned to the applicant
without further consideration.
Applications accepted for full review will be evaluated according
to the following criteria:
A. Rationale for the Research Question Chosen To Be Addressed
The extent to which the rationale for the chosen research question
(1) Is based on the interest, experience, and/or expertise of the
investigator(s) with immunization registries, and (2) clearly
communicates the anticipated value to immunization registry development
or operations that a workable effective solution is likely to mean. (10
Points)
B. Objectives of the Research
The extent to which the objectives of the chosen research question
and are numerically measurable, specific, realistic, and time-phased,
and that project time lines are reasonable; if a second year is
necessary to answer the chosen research question, the extent to which
those objectives and time lines meet these same criteria. (15 Points)
C. Design of the Research
The extent to which the proposed methodology of the research is
scientifically sound, realistic, appears likely to answer the chosen
research question, and will produce generalizable findings; and, if
appropriate, the degree to which the applicant has met the CDC policy
requirements regarding the inclusion of women, ethnic, and racial
groups in the proposed research as specified in the Application
Contents section. (35 Points)
D. Background and Experience of the Principal Investigator and of the
Applying Institution, Organization, or Agency
The extent to which the educational and professional background of
the principal investigator, and relevant experience and expertise of
the principal investigator and qualifications of the applying
institution, organization, or agency, give confidence that the chosen
research question will be answered. (20 Points)
E. Immunization Registry To Be Used for the Research
The extent to which (1) The registry used in carrying out this
research project is sufficiently typical of registries around the
country so that a solution to the research question will have the
broadest possible application, (2) the principal investigator has
sufficient access and ability to alter or manipulate it for the
purposes of carrying out this research project, and (3) if applicable,
the attached evidence of collaboration specifies the commitment of the
registry owner(s) and provides collaboration details, including the
terms of access to the registry and any specified limits to
collaboration for the purposes of this project. (20 Points)
F. Budget and Budget Justification
The extent to which the budget is reasonable, consistent with the
intended use of these cooperative agreement funds, and consistent with
the objectives of this research project; and if a 2-year project period
is requested, the extent to which the estimated needs for a second
budget period are appropriately reflected. (Not scored)
Funding Priorities
To the extent that there are a sufficient number of high-ranking
applications, NIP/CDC plans to make awards that will address each of
the four research questions.
Technical Reporting Requirements
Semi-annual progress reports in a CDC-approved format are required
of all cooperative agreement recipients. Time lines for the semi-annual
reports will be established at the time of award, but are typically due
30 days after the end of the month which ends the semi-annual period.
The narrative progress reports must include the following for each goal
or activity involved in the study: (1) A comparison of actual
accomplishments to the objectives established for the period; (2) the
reasons for slippage if established goals were not met; and (3) other
pertinent information essential to evaluating progress; and (4) data
pertaining to various project activities.
The annual financial status report and performance reports are
required no later than 90 days after the end of the budget period.
Submit the original and two copies of the reports to the Grants
Management Branch, CDC.
Executive Order 12372 Review
Applications are subject to Intergovernmental Review of Federal
Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets
up a system for State and local government review of proposed Federal
assistance applications. Applicants should contact their State Single
Point of Contact
[[Page 28715]]
(SPOC) as early as possible to alert them to the prospective
applications and receive any necessary instructions on the State
process. For proposed projects serving more than one State, the
applicant is advised to contact the SPOC for each affected State. The
application kit includes a current list of SPOCs. If the SPOCs have any
State process recommendations on applications submitted to CDC, they
should send them to Lisa G. Tamaroff, Grants Management Specialist,
Grants Management Branch, Procurement and Grants Office, Centers for
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE.,
Atlanta, Georgia 30305, no later than 60 days after the application due
date. Please include the Program Announcement Number and Program Title
on the letter.
Public Health System Reporting Requirement
This program is subject to the Public Health System Reporting
Requirements. Under these requirements, all community-based non-
governmental applicants must prepare and submit the items identified
below to the head of the appropriate State and/or local health
agency(s) in the program area(s) that may be impacted by the proposed
project by the receipt date of the Federal application. The applicant
determines the appropriate State and/or local health agency. The
following information must be provided:
A. A copy of the face page of the application (SF 424).
B. A summary of the project that should be titled ``Public Health
System Impact Statement'' (PHSIS), not to exceed one page, and include
the following:
1. A description of the population to be served;
2. A summary of the services to be provided; and
3. A description of the coordination plans with the appropriate
State and/or local health agencies.
If the State and/or local health official should desire a copy of
the entire application, it may be obtained from the State Single Point
of Contact (SPOC) or directly from the applicant.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance number is 93.268.
Other Requirements
Human Subjects
If the proposed project involves research on human subjects, the
applicant must comply with the Department of Health and Human Services
Regulations, 45 CFR part 46, regarding the protection of human
subjects. Assurance must be provided to demonstrate that the project
will be subject to initial and continuing review by an appropriate
institutional review committee. The applicant will be responsible for
providing assurance in accordance with the appropriate guidelines and
forms provided in the application kit.
Women and Minority Inclusion Policy
It is the policy of CDC to ensure that women and racial and ethnic
groups will be included in CDC-supported research projects involving
human subjects, whenever feasible and appropriate.
Racial and ethnic groups are defined in OMB Directive No. 15 and
include American Indian, Alaskan Native, Asian, Pacific Islander,
Black, and Hispanic. Applicants shall ensure that women, racial and
ethnic minority populations are appropriately represented in
applications for research involving human subjects. Where a clear and
compelling rationale exists that inclusion is inappropriate or not
feasible, this situation must be explained as part of the application.
In conducting the review of applications for scientific merit,
review groups will evaluate proposed plans for inclusion of minorities
and both sexes as part of scientific assessment and assigned score.
This policy does not apply to research studies when the investigator
cannot control the race, ethnicity, and/or sex of subjects. Further
guidance to this policy is contained in the Federal Register, Vol. 60,
No. 179, Friday, September 15, 1995, pages 47947-47951.
Application Submission and Deadline
A. Preapplication Letter of Intent
Although not a prerequisite of application, a non-binding letter of
intent-to-apply is requested from potential applicants. The letter
should be submitted to the Grants Management Specialist (whose address
is reflected in section B., ``Applications''). It should be postmarked
no later than one month prior to the planned submission deadline (e.g.,
June 29 for a July 29, 1997 submission). The letter should identify the
announcement number, and the name of the applicant institution. The
letter of intent does not influence review or funding decisions, but it
will enable CDC to plan the review more efficiently and thereby
potentially benefit all applicants.
B. Application
The application should be carefully completed, following the
directions provided in this program announcement. The original and two
copies of the application PHS Form 5161-1 (OMB Number 0937-0189) must
be submitted to Lisa G. Tamaroff, Grants Management Specialist, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300,
Mailstop E-13, Atlanta, Georgia 30305, on or before July 29, 1997.
1. Deadline
Applications will be considered as meeting the deadline if they are
either:
a. Received on or before the deadline date; or
b. Sent on or before the deadline date and received in time for
submission to the review process. Applicants must request a legibly
dated U.S. Postal Service postmark or obtain a legibly dated receipt
from a commercial carrier or U.S. Postal Service. Private metered
postmarks shall not be acceptable as proof of timely mailing.
2. Late Applications
Applications that do not meet the criteria in 1.a. or 1.b. above
are considered late applications. Late applications will not be
considered and will be returned to the applicant.
Where To Obtain Additional Information
To receive additional written information call (404) 332-4561. You
will be asked to leave your name, address, and telephone number and
will need to refer to Announcement 794. You will receive a complete
program description, information on application procedures and
application forms.
If you have questions after reviewing the contents of all
documents, business management technical assistance may be obtained
from Lisa Tamaroff, Grants Management Specialist, Grants Management
Branch, Procurement and Grants Office, Centers for Disease Control and
Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E-
13, Atlanta, Georgia 30305, telephone (404) 842-6796; Internet address:
lgt1@cdc.gov
Programmatic technical assistance may be obtained from Robert
Linkins, Data Management Division, National Immunization Program,
Centers for Disease Control and Prevention (CDC), Building 12,
Corporate Square Boulevard, Mailstop E-62, Atlanta, Georgia 30333,
telephone (404) 639-8728; Internet address: RXL3@cdc.gov
[[Page 28716]]
Please refer to Announcement Number 794 when requesting information
and submitting an application.
This and other CDC announcements are also available through the CDC
homepage on the Internet. The address for the CDC homepage is http://
www.cdc.gov.
CDC will not send application kits by facsimile or express mail.
Potential applicants may obtain a copy of Healthy People 2000 (Full
Report, Stock No. 017-001-00474-0) or Healthy People 2000 (Summary
Report, Stock No. 017-001-00473-1) referenced in the Introduction
through the Superintendent of Documents, Government Printing Office,
Washington, DC 20402-9325, telephone: 202-512-1800.
Dated: May 20, 1997.
Joseph R. Carter,
Acting Associate Director for Management and Operations Centers for
Disease Control and Prevention (CDC).
[FR Doc. 97-13744 Filed 5-23-97; 8:45 am]
BILLING CODE 4163-18-P
