[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]


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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: 
[email protected]
    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: RXL[email protected]

[[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