[Federal Register Volume 61, Number 119 (Wednesday, June 19, 1996)]
[Notices]
[Pages 31128-31131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-15560]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement 628]
Outcome Evaluations of HIV/AIDS Prevention Interventions
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1996 funds for a cooperative agreement
program to conduct outcome evaluations of existing innovative
interventions designed to reduce the transmission of the human
immunodeficiency virus (HIV).
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 Human Immunodeficiency
Virus (HIV) Infection. (For ordering a copy of ``Healthy People 2000,''
see the section ``Where To Obtain Additional Information.'')
Authority
This program is authorized under Sections 301 and 317(k)(2), of the
Public Health Service Act (42 U.S.C. 241 and 247b(k)(2)) as amended.
Smoke-Free Workplace
CDC strongly encourages all recipients to provide a smoke-free
workplace and to promote the nonuse 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, day
care, health care, and early childhood development services are
provided to children.
Eligible Applicants
Applications may be submitted by public and private, nonprofit and
for-profit organizations and governments and their agencies. Thus,
universities, colleges, research institutes, hospitals, other public
and private organizations, State and local health departments or their
bona fide agents or instrumentalities, federally recognized Indian
tribal governments, Indian tribes or Indian tribal organizations, and
small, minority- and/or women-owned businesses are eligible to apply.
Note: Organizations described in section 501(c)(4) of the
Internal Revenue Code of 1986 that engage in lobbying are not
eligible to receive Federal grant/cooperative agreement funds.
Availability of Funds
Approximately $500,000 is available in FY 1996 to fund
approximately three awards each evaluating a different intervention
strategy in a different high-risk population. It is expected that the
average award will be $150,000, ranging from $125,000 to $175,000.
Awards are expected to begin on or about September 30, 1996, and will
be made for a 12-month budget period within a project period of up to
three years. Funding estimates may vary and are subject to change.
Continuation awards within the project period will be made on the
basis of satisfactory progress and the availability of funds.
Definitions
For the purposes of this program, an Innovative HIV Prevention
Intervention is an HIV prevention strategy that has not been
extensively researched in the context in which it is being applied or
one that represents a new approach to the integration of known
prevention strategies. The terms Outcome Evaluation and Effectiveness
Study are used somewhat interchangeably and refer to the design and
methods used to assess the short- or long-term effects that can be
reasonably attributed to the intervention.
The term HIV Community Planning Priorities are priorities based
upon the epidemiologic profile of HIV in a community as determined by
the Community Planning Group (CPG). For example, if a CPG determined
that there is a significant problem of HIV intravenous drug (ID) use in
the community then the funding of HIV prevention strategy for ID use
would be a priority for HIV community planning.
Purpose
The purpose of this program is to support intervention
effectiveness studies that assess social, behavioral, programmatic, and
policy outcomes of specific innovative HIV prevention interventions.
These outcome evaluations should assess prevention interventions that
are innovative, have new components or involve the innovative
application of interventions that are commonly employed (e.g. HIV
counseling and testing) and have potentially broad relevance to the
field of HIV prevention. These evaluation studies will use methods
common to rigorous outcome evaluation research (e.g. comparison groups,
individual baseline data, cohorts, cross-sectional surveys) within the
limits of the funding available and appropriately matched to the nature
and size of the intervention.
This program is designed to provide evaluation resources to
organizations that might not otherwise have the resources to determine
the effectiveness of their programs. Funds are intended solely to
implement the evaluation and not to support the intervention itself.
Interventions being evaluated should target high-risk populations (e.g.
men who have sex with men, injection drug users and their partners,
youth in high risk situations).
Lastly, this program is to devise practical, yet reasonably
rigorous, outcome evaluation methods and designs that integrate both
qualitative and quantitative data, possibly from multiple sources, in
the analysis and interpretation of the findings.
Program Requirements
The application should demonstrate the applicant's ability to
design and implement the evaluation, analyze the data, and disseminate
the findings. In conducting activities to achieve the purpose of this
program, the recipient will be responsible for the activities under A.
(Recipient Activities), and CDC will be responsible for the activities
listed under B. (CDC Activities).
A. Recipient Activities
Recipients will be asked to attend meetings in Atlanta
approximately twice a year to brief CDC staff on the project and
discuss key decisions. Additionally the recipient should expect to host
periodic (up to 4 per year) site visits by the CDC project officer.
1. Prepare a detailed evaluation protocol, including a description
of the intervention and how it is innovative, the study research
questions, proposed methods, including sampling, assessment, and
analysis plans, draft measurement instruments, and project timelines.
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2. Develop measures to evaluate the intervention. New instruments
should be field-tested.
3. Develop procedures to ensure confidentiality and informed
consent when appropriate and obtain IRB clearances as needed.
4. Recruit study subjects and comparison groups according to the
evaluation design.
5. Conduct individual baseline and repeat assessments according to
the evaluation design.
6. Establish data management systems, analyze and interpret the
data.
7. Prepare a final report for CDC, including submission of a
cleaned data set.
8. Prepare a paper that summarizes the results and recommends
future research and describes programmatic implications.
9. Present the findings locally. Collaborate with other recipients
in presenting the findings at national meetings.
B. CDC Activities
1. Assist the recipient in planning and implementing the
evaluation, including providing technical guidance in the development
of the study design, data collection instruments, selection of
comparison groups, outcome measures, data collection protocols, and
pretesting of methods and instruments.
2. Provide project oversight and technical assistance.
3. Assist in analyzing the data and interpreting the results.
4. Assist in presenting the findings.
Evaluation Criteria
Before submitting an application, applicants will need to identify
an innovative behavioral or social HIV prevention intervention that is
designed to reduce risk behaviors by high-risk persons or within high-
risk communities. Communities may be defined by geopolitical boundaries
or by relational affiliations (e.g., men who have sex with men, African
American community, youth in high risk situations).
Evaluation criteria are based upon the responsiveness to, and the
quality of, specific information requested in the ``Application
Content'' section of the program announcement included in the
application kit.
1. Justification and Significance of the Intervention (30 Points)
The degree to which the intervention is innovative, i.e., new or
represents a new approach to the integration of known prevention
strategies and has not yet been extensively evaluated in the context in
which it is being applied. The extent to which the intervention has
broader significance or relevance for HIV prevention. In determining
significance, consideration will be given to the degree to which the
selected intervention is based on behavioral or social science theory,
public health practice or program experience and the relevant research
literature, including a description of the social and contextual issues
if relevant. Degree to which clear intervention goals and objectives
are articulated. Degree to which the behavioral or social interventions
complement other biomedical or socioenvironmental interventions. The
degree to which the proposed activity is significant to HIV prevention.
The degree to which the intervention is generalizable.
2. Evidence That Target Population Reflects HIV Community Planning
Priorities (10 Points)
Degree to which the local, regional or State HIV prevention
community plan, especially the epidemiologic profile and behavioral
data, were used in the selection of the intervention. The degree to
which the target population is described clearly and concisely.
Evidence that the intervention has access to sufficient numbers of the
target population to show intervention effects is also important.
3. Soundness of the Evaluation Plan (30 Points)
The extent to which the evaluation plan, including the stated
research or evaluation question, study design and methods, comparison
groups, data collection instruments and plans for analysis, are
scientifically sound and capable of producing the intended results. The
degree to which the plan is clear, complete, and includes time-related
milestones that CDC and recipients can use to gauge progress. The
degree to which plans for data management, analysis, and interpretation
are appropriate and reflect the intention to collaborate with CDC.
Reasonableness of plans for collecting and integrating qualitative and
quantitative data from multiple sources.
4. Adequacy of the Dissemination Plan (10 Points)
Degree to which a dissemination plan is articulated. Evidence that
the applicant is committed to disseminating findings locally and
collaborating with CDC in disseminating findings nationally. The degree
to which the applicant is committed to collaborating with CDC in
coauthoring papers.
5. Evidence of Collaboration and Capacity To Undertake the Evaluation
(20 Points)
Quality of supporting evidence (letters and memorandums of
agreement) that the applicant has the full support of all specified
collaborators. The degree to which the applicant has the scientific and
programmatic capacity and proven track record in successfully
designing, implementing and completing similar evaluations, either
alone or in partnership with the proposed collaborator. The degree to
which the affected population seems to be involved in planning the
evaluation. (To obtain specific information on the community plan for
your location, please contact your local health department.)
In addition, 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. This includes:
a. The proposed plan for the inclusion of both sexes and racial and
ethnic minority populations for appropriate representation.
b. The appropriateness of the proposed justification when
representation is limited or absent.
c. Whether the design of the study is adequate to measure
differences when warranted.
d. Whether the plans for recruitment and outreach for study
participants include the process of establishing partnerships with
community(ies) and recognition of mutual benefits.
6. Budget (Not Scored)
The extent to which the budget is reasonable, itemized, clearly
justified, and consistent with intended use of funds.
Funding Preferences
All applicants are encouraged to provide evidence of support from
their local health departments. Preference will be given to applicants
who collaborate with representatives of target populations at highest
risk for HIV infection and who are served by the program being
evaluated. Special consideration will be given to applications to
evaluate innovative interventions to integrate or link multiple
intervention components, for example, provision of HIV counseling and
testing services by nongovernmental organizations (NGOs) that serve
high-risk communities and also provide innovative behavior-change
services.
[[Page 31130]]
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 (other than federally recognized
Indian tribal governments) should contact their State Single Point of
Contact (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. A
current list of SPOCs is included in the application kit. If SPOCs have
any State process recommendations on applications submitted to CDC,
they should send them to Van Malone, Grants Management Officer, Grants
Management Branch, Procurement and Grants Office, Centers for Disease
Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300,
Mailstop E15, Atlanta, GA 30305, no later than 30 days after the
application deadline (the appropriation for this financial assistance
program was received late in the fiscal year and would not allow for an
application receipt date which would accommodate the 60-day State
recommendation process period). The granting agency does not guarantee
to ``accommodate or explain'' for State process recommendations it
receives after that date.
Indian tribes are strongly encouraged to request tribal government
review of the proposed application. If tribal governments have any
tribal process recommendations on applications submitted to the CDC,
they should forward them to Van Malone, Grants Management Officer,
Grants Management Branch, Procurement and Grants Office, Centers for
Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE.,
Room 300, Mailstop E15, Atlanta, GA 30305. This should be done no later
than 30 days after the application deadline date. The granting agency
does not guarantee to ``accommodate or explain'' for tribal process
recommendations it receives after that date.
Public Health System Reporting Requirements
This program is subject to the Public Health System Reporting
Requirements. Under these requirements, all community-based
nongovernmental 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 no later than the receipt date of the Federal application. The
appropriate State and/or local health agency is determined by the
applicant. 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 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 Single Point of
Contact (SPOC) or directly from the applicant.
Catalog of Federal Domestic Assistance Number
The Catalog of Federal Domestic Assistance number is 93.941.
Other Requirements
Paperwork Reduction Act
Projects that involve the collection of information from 10 or more
individuals and funded by cooperative agreement will be subject to
review by the Office of Management and Budget (OMB) under the Paperwork
Reduction Act.
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. In addition to other applicable
committees, Indian Health Service (IHS) institutional review committees
also must review the project if any component of IHS will be involved
or will support the research. If any American Indian community is
involved, its tribal government must also approve that portion of the
project applicable to it. The applicant will be responsible for
providing assurance in accordance with the appropriate guidelines and
form provided in the application kit.
Women, Racial and Ethnic Minorities
It is the policy of the Centers for Disease Control and Prevention
(CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR)
to ensure that individuals of both sexes and the various racial and
ethnic groups will be included in CDC/ATSDR-supported research projects
involving human subjects, whenever feasible and appropriate. Racial and
ethnic groups are those defined in OMB Directive No. 15 and include
American Indian, Alaskan Native, Asian, Pacific Islander, Black and
Hispanic. Applicants shall ensure that racial and ethnic minority
populations are appropriately represented in applications for research
involving human subjects. Where clear and compelling rationale exist
that inclusion is inappropriate or not feasible, this situation must be
explained as part of the application. 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, pages 47947-47951,
dated Friday, September 15, 1995.
Application Submission and Deadline
The original and two copies of the application PHS Form 5161-1 (OMB
Number 0937-0189) must be submitted to Van Malone, Grants Management
Officer, Grants Management Branch, Procurement and Grants Office,
Centers for Disease Control and Prevention, 255 East Paces Ferry Road,
NE., Room 300, Mailstop E-15, Atlanta, GA 30305, on or before August 5,
1996.
1. Deadline: Applications shall be considered as meeting the
deadline if they are either:
a. Received on or before the deadline; or
b. Sent on or before the deadline date and received in time for
submission to the objective review committee. (Applicants must request
a legibly dated U.S. Postal Service postmark or obtain a legibly dated
receipt from a commercial carrier or the U.S. Postal Service. Private
metered postmarks will not be acceptable 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 in the current competition and will be returned
to the applicant.
Where To Obtain Additional Information
To receive additional written information call (404) 332-4561. You
[[Page 31131]]
will be asked to leave your name, address, and telephone number and
will need to refer to Announcement 628. You will receive a complete
program description, information on application procedures and
application forms. If you have questions after reviewing the contents
of all the documents, business management technical assistance may be
obtained from Adrienne Brown, 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-15, Atlanta, GA 30305, telephone (404) 842-6634,
email:<[email protected]>. Programmatic technical assistance be
obtained from Deborah L. Rugg, Ph.D., Program Evaluation Branch,
Division of HIV/AIDS Prevention, National Center for HIV, STD, and TB
Prevention, Centers for Disease Control and Prevention, 1600 Clifton
Road, NE., Mailstop E-59, Atlanta, GA 30333, telephone (404) 639-0952,
FAX (404) 639-0923, e-mail: <[email protected]>.
Please refer to Announcement 628 when requesting information and
submitting an application.
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.
Internet Home Page
The announcement will be available on one of two Internet sites on
the publication date: CDC's home page at <http://www.cdc.gov>, or at
the Government Printing Office home page (including free access to the
Federal Register) at <http://www.access.gpo.gov.>.
There may be delays in mail delivery and difficulty in reaching the
CDC Atlanta offices during the 1996 Summer Olympics. Therefore, CDC
suggests using Internet, following all instructions in this
announcement and leaving messages on the contact person's voice mail
for more timely responses to any questions.
Dated: June 11, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 96-15560 Filed 6-18-96; 8:45 am]
BILLING CODE 4163-18-P