[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]



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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.

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    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

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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]]

<[email protected]>. 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: <[email protected]>.
    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