[Federal Register Volume 61, Number 112 (Monday, June 10, 1996)]
[Notices]
[Pages 29389-29393]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-14550]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Announcement 627]
Replication of Effective HIV Behavioral Interventions
Introduction
The Centers for Disease Control and Prevention (CDC) announces the
availability of fiscal year (FY) 1996 funds for a cooperative agreement
program for replicating HIV behavioral interventions which have been
found to be effective in intervention research studies. This
announcement supports the development and implementation of plans,
materials, and training to accomplish the replication of the
intervention in one site.
The 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 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), of the
Public Health Service Act [42 U.S.C. 241 and 247b], 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 $900,000 is available in FY 1996 to fund
approximately 5 awards. It is expected that the average award will be
$200,000, ranging from $175,000 to $225,000. It is expected that the
awards will begin on or about September 30, 1996, and will be made for
a 12-month budget period within a project period of 2 years. Funding
estimates may vary and are subject to change based on availability of
funds.
[[Page 29390]]
Continuation awards within the project period will made on the
basis of satisfactory progress and the availability of funds.
Priority may be given to selecting a wide range of target
populations to be addressed by funded interventions, including those
that historically have been addressed by few such interventions.
Collection of new or supplemental data, data entry, purchase of
furniture or computers, and rental of facilities or equipment will not
be funded under this program.
Definitions
For the purposes of this announcement, the following definitions
are applicable. Replication is defined as the creation of materials and
protocols developed from research-based, technological innovations or
effective interventions and their dissemination to prevention programs
or from one practice site to another for adoption. The term community-
level intervention means an approach to HIV prevention that (1) results
from a mobilization of community members and institutions; (2) can be
expected to reach a large proportion of the population at risk in their
daily setting; (3) may involve outreach and facility-based services;
and (4) can be expected to be effective at altering individual
behaviors and community norms.
Purpose
These awards will expand the present practice of HIV behavioral
risk prevention by: (1) encouraging collaboration between researchers
and HIV prevention programs, (2) developing strategies for the
dissemination of effective HIV behavioral interventions, (3) creating
plans, materials, and training for their implementation, and (4)
facilitating experience in local and regional dissemination of
research-based interventions to enable HIV prevention organizations to
adopt behavioral interventions that have been shown to be effective.
The goal of this activity is to enhance the capacity of local HIV
prevention organizations to implement and sustain effective and
feasible behavioral interventions by making intervention materials and
training more widely available, and to encourage collaboration between
researchers and HIV prevention programs. Applications based on
community-level behavioral interventions, and innovative and effective
interventions that have not been widely adopted are encouraged. The
replication strategies and materials package should be generalizable to
broad behavioral risk groups or involve a method that can be adapted or
tailored to the needs and circumstances of one of the priority
populations identified by the applicant's State or local community
planning group.
Program Requirements
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
During the first year, recipients will develop the package of
materials and protocols and find users interested in participating in
an implementation pretest. During the second year, the package will be
refined based on users' pretest experience and need for the recipient's
assistance. The program requirements for the first year of activity
are:
1. Develop a package of materials, protocols, and guidance to
enable the adoption of the effective behavioral intervention. The
recipient will develop the package with the involvement of HIV
prevention programs, e.g., health departments and community-based
organizations (CBOs), within the applicant's own State or within close
proximity to applicant's home city.
a. The package will be written in language understandable to
nonresearchers and will contain:
(1) A full description of the behavioral intervention;
(2) A list of target populations for whom the intervention would be
appropriate;
(3) A time line of specific steps and costs for setting up the
intervention;
(4) A list of the types of agencies needed for collaboration on the
intervention and approaches to establishing linkages with them;
(5) A list of all necessary materials, other resources, staff
commitment (numbers and time) and skills, and cost breakdowns for
conducting the intervention;
(6) Protocols for implementing the intervention and ensuring its
quality and consistency;
(7) Specific guidelines for overcoming barriers to implementation;
(8) Methods and procedures for evaluating process, outcome, and
cost-effectiveness of the intervention; and
(9) A bibliography of publications based on the intervention.
b. The package should include practical examples of implementation
from the original intervention and should contain copies of all
relevant materials.
2. Create a strategy to publicize and market the package.
a. During the first year, the recipient will:
(1) Compile a list of HIV prevention agencies in the recipient's
State or within close proximity to the recipient's city, which target
populations for whom the intervention is appropriate; (For this
announcement, such agencies will be referred to as the intended users.)
(2) Select ways to inform intended users about the availability of
the package. This strategy will be used to identify intended users who
are interested in implementing the package with the technical
assistance of the recipient.
b. At the end of the 2-year project, the final package will be
submitted to CDC for further distribution.
c. The recipient may also continue to distribute the package.
3. Develop a plan to assist the implementation of the package. In
order to refine the package developed in year 1:
a. The recipient will develop a plan to assist the adoption and
implementation of the behavioral intervention by selected user(s)
during year 2.
b. The plan will include:
(1) Procedures for collecting process data, e.g., on unforeseen
barriers to implementation, solutions to barriers, and cost
containment; and
(2) Hands-on guidance and direct technical assistance with other
intervention components.
4. Establish a plan to evaluate the implementation of the
replication package. The recipient will establish a plan to evaluate
the implementation of the behavioral intervention. Such evaluation data
may:
a. Be qualitative or quantitative; and
b. Include an assessment of the fidelity of the implementation to
the methods and protocols presented in the package; but
c. Not include data on outcomes of the behavioral intervention.
5. Select and confirm interested users to adopt the package for
year 2. By the end of the year 1, the recipient will:
a. Have publicized and marketed the package to intended users (as
defined in Recipient Activity 2);
b. Select at least one intended user from those who have expressed
interest and confirm their willingness to participate in year 2; and
c. Send the selected user the package and guidance on its
implementation.
(1) Limited funds may be available to support implementation of the
[[Page 29391]]
behavioral intervention; however, the users are encouraged to find
funds to initiate and sustain the intervention or may redirect their
own resources.
Continued funding for year 2 will be dependent on the completion of
required activities for year 1. In year 2, the intervention will be
implemented and evaluated.
B. CDC Activities
1. Host a meeting with the successful applicants within 60 days of
the notice of grant award.
2. Provide technical assistance in the general operation of this
HIV prevention project.
3. Consult on the choice of users selected to pretest the
replication package.
4. Monitor and evaluate scientific and operational accomplishments
of this project through frequent telephone contact and review of
technical reports and interim data analyses.
5. Conduct site visits to assess program progress and mutually
solve problems, as needed.
Evaluation Criteria
Applications will be reviewed and evaluated according to the
following criteria:
1. Behavioral Intervention (20 points total).
a. Description and justification (8 points). The agency that
originally developed or evaluated the intervention is the applicant or
will be working in partnership with the applicant. Thoroughness of the
description of the intervention that will be the object of the
replication efforts. Quality of the intervention design, components,
and methods. Appropriateness of its theoretical basis for the target
population and intervention method. Appropriateness of the intervention
methods for the target population. Convincing need for the
intervention's replication. Feasibility of implementation by other
organizations with limited resources. Documented permission from the
original developers of the proposed behavioral intervention to
publicize and market replication materials and protocols generated from
the intervention.
The quality of the applicant's response to the item Women, Racial
and Ethnic Minorities as cited in the ``APPLICATION CONTENT'' section
of the program announcement included in the application kit.
b. Documented effectiveness (12 points). Thoroughness of the
description of the intervention's completed and evaluated research.
Extent of the intervention's effectiveness, as defined in the
Application Content. Inclusion of publications.
2. Description of the Replication Package (15 points).
Level of detail in the description or outline of the proposed
package, including materials, protocols, and guidelines. Clarity of
described intended audiences, objectives, format, and concepts.
Justification of the appropriateness of the package's objectives,
format, and concepts to the intended users' needs and capabilities.
Adequacy of input from HIV prevention programs into the development of
the package. Adequacy of planned materials' review and pretesting.
Adequacy of time scheduled for completing the proposed steps of the
package's development.
3. Description of Plan to Identify Users to Implement the Package
(15 points).
Quality of plan to identify appropriate, intended users and
interest them in adopting the package during year 2 of the project.
Selection of proactive methods to identify and solicit intended users.
Adequacy of criteria and mechanism for selecting the users for
implementing the package in year 2, including match of the
intervention's target population with the user's community planning
priorities. Recognition that the agency that originally conducted the
intervention is excluded from implementing the package.
4. Description of Strategy to Assist Implementation (15 points).
Clarity of the strategy to assist selected users in adopting and
implementing the behavioral intervention. Understanding of barriers to
implementation and how to overcome them. Plan to assist selected users
in implementing the intervention by using their existing resources and
staff. Plan to help selected users find additional funds for
implementing the package, if relevant.
5. Description of Plan to Evaluate Implementation (15 points).
Feasibility and appropriateness of the plan to evaluate the
selected user's implementation of the intervention as specified in the
replication package. Thorough and realistic selection of intervention
components to evaluate.
6. Demonstrated Capacity (20 points).
Overall ability of the applicant to perform the proposed activities
as reflected in their staff's and consultant's qualifications,
experience with material development and dissemination, and
demonstrated familiarity with HIV behavioral interventions, in general,
and the intervention to be publicized, in particular. The nature and
extent of any partnership between researchers and HIV prevention
programs. Adequacy of existing support staff, equipment, and
facilities.
7. Budget (Not scored).
Extent to which the budget is reasonable, itemized, clearly
justified, and consistent with the intended use of the funds.
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
[[Page 29392]]
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
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 appropriate
institutional review committees. 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, and dated Friday,
September 15, 1995.
HIV/AIDS Requirements
Recipients must comply with the document entitled Content of AIDS-
Related Written Materials, Pictorials, Audiovisuals, Questionnaires,
Survey Instruments, and Educational Sessions (June 1992) (a copy is in
the application kit). To meet the requirements for a program review
panel, recipients are encouraged to use an existing program review
panel, such as the one created by the State health department's HIV/
AIDS prevention program. If the recipient forms its own program review
panel, at least one member must be an employee (or designated
representative) of a State or local health department. The names of the
review panel members must be listed on the Assurance of Compliance for
CDC 0.1113, which is also included in the application kit. The
recipient must submit the program review panel's report that indicates
all materials have been reviewed and approved.
Application Submission and Deadlines
1. Preapplication Letter of Intent
A non-binding letter of intent-to-apply is required from potential
applicants. An original and two copies of the letter should be
submitted to the Grants Management Branch, CDC (see ``Applications'' in
the following paragraph). It should be postmarked no later than July
15, 1996. The letter should identify the announcement number, name of
principal investigator, and specify the activity(ies) to be addressed
by the proposed project. The letter of intent does not influence review
or funding decisions, but it will enable CDC to plan the review more
efficiently, and will ensure that each applicant receives timely and
relevant information prior to application submission.
2. Applications
An 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 (CDC), 255 East Paces Ferry
Road, NE., Room 300, Mailstop E-15, Atlanta, GA 30305, on or before
August 15, 1996.
3. Deadlines
A. Applications shall be considered as meeting the deadline if they
are either:
(1.) Received on or before the deadline date; or
(2.) Sent on or before the deadline date and received in time for
submission to the objective review group. (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 shall not be acceptable as proof of timely mailing.)
B. Applications that do not meet the criteria in 3.A.(1.) or
3.A.(2.) 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 information call (404) 332-4561. You will be
asked to leave your name, address, and phone number and will need to
refer to Announcement 627. 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:
[[Page 29393]]
asm1@opspgo1.em.cdc.gov>. Programmatic technical assistance may be
obtained from Robert Kohmescher, Division of HIV/AIDS Prevention,
National Center for HIV/STD/TB Prevention, Centers for Disease Control
and Prevention (CDC), 1600 Clifton Road, NE., Mailstop E-44, Atlanta,
GA 30333, telephone (404) 639-8302, email: rnk1@cidhiv2.em.cdc.gov>.
Please refer to Announcement 627 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 applicants use Internet, follow all instructions in this
announcement and leave messages on the contact person's voice mail for
more timely responses to questions.
Dated: June 4, 1996.
Joseph R. Carter,
Acting Associate Director for Management and Operations, Centers for
Disease Control and Prevention (CDC).
[FR Doc. 96-14550 Filed 6-07-96; 8:45 am]
BILLING CODE 4163-18-P
