[Federal Register Volume 67, Number 90 (Thursday, May 9, 2002)]
[Notices]
[Pages 31319-31323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-11565]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[Program Announcement 02137]


Technology Translation and Transfer of Effective HIV Prevention 
Behavioral Interventions; Notice of Availability of Funds

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 2002 funds for a cooperative agreement 
program for the technology translation and transfer of effective HIV 
prevention behavioral interventions. This program addresses the 
``Healthy People 2010'' focus area HIV. The purpose of the program is 
to:
    1. Support translation of the protocols of effective HIV prevention 
interventions, whose original research was conducted with 
methodological rigor and which have not been packaged or widely 
adopted, into a package of materials that prevention providers can use 
to implement the interventions in their non-research field situations.
    2. Support development of curricula for training provider agency 
staff who will implement the intervention and technical assistance 
guidance manuals for providing technical assistance to future adopters 
of the intervention.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit and 
for-

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profit organizations and by governments and their agencies; that is, 
universities, colleges, research institutions, hospitals, other public 
and private nonprofit and for-profit organizations, faith-based 
organizations, State and local governments or their bona fide agents, 
federally recognized Indian tribal governments, Indian tribes, or 
Indian tribal organizations, and small, minority, women-owned 
businesses.

    Note: Title 2 of the United States Code section 1611 states that 
an organization described in section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive Federal funds constituting an award, grant or loan.

C. Availability of Funds

    Approximately $470,000 is available in FY 2002 to fund 
approximately two awards. It is expected that the average award will be 
$215,000, ranging from $200,000 to $235,000. It is expected that the 
awards will begin on or about September 30, 2002 and will be made for a 
12-month budget period within a project period of up to two years. 
Funding estimates may change. An application requesting greater than 
$235,000 (including indirect costs) will not be considered for review 
and will be returned to the applicant.
    Continuation awards within an approved project period will be made 
on the basis of satisfactory progress as evidenced by required reports 
and the availability of funds. Continued funding for year two will be 
dependent on the completion of required activities for year one.

Use of Funds

    Collection of new or supplemental intervention research data, data 
entry and analysis other than for process evaluation of this project, 
purchase of furniture or computers, and rental of facilities will not 
be funded under this program.

Funding Priority

    CDC's intention is to support the packaging of interventions for 
target populations not currently represented in the Replicating 
Effective Programs collection of packages. This announcement is only 
for proposals that submit an HIV prevention intervention with 
demonstrated effectiveness in changing HIV/STD-related risk behavior or 
health outcomes. Consideration will be given to obtaining diversity of 
target populations among the proposals selected for funding. The 
following populations are of particular interest: (1) Incarcerated 
persons, (2) non-injection substance users, (3) HIV-infected persons, 
and (4) persons living in rural areas whose behaviors put them at risk 
for HIV infection.
    Interested persons are invited to comment on the proposed funding 
priority. All comments received within 30 days after publication in the 
Federal Register will be considered before the final funding priority 
is established. If the funding priority changes because of comments 
received, a revised announcement will be published in the Federal 
Register, and revised applications will be accepted before the final 
selections are made. Address comments to the Grants Management 
Specialist identified in the ``Where to Obtain Additional Information'' 
section of this announcement.

D. Program Requirements

    In conducting activities to achieve the purpose of this program, 
the recipient will be responsible for the activities under 1. 
(Recipient Activities), and CDC will be responsible for the activities 
listed under 2. (CDC Activities).
    1. Recipient Activities
    The program requirements for the first year of activity include:
    a. Develop the intervention package, including a promotional or 
marketing videotape for program administrators, and preliminary 
versions of the training curricula in collaboration with HIV prevention 
providers and consumers.
    b. Produce a limited number of intervention packages.
    c. Identify at least two HIV prevention agencies, that are not 
collaborating on package development, for case study of the technology 
transfer process.
    d. Develop a process evaluation plan.
    Program requirements for the second year of activity include:
    a. Initiate the prevention agency case study using the intervention 
package, training, quality assurance, and technical assistance.
    b. Complete the case study by achieving technology transfer with at 
least one of the selected agencies.
    c. Initiate and complete the process evaluation.
    d. Revise intervention and training materials based upon the case 
study results.
    e. Develop technical assistance guidance manuals based on transfer 
experience.
    f. Publish and distribute results.
    2. CDC Activities
    a. Host a meeting with the successful applicants within 60 days of 
the notice of award to discuss implementation of the project.
    b. Provide technical assistance in the general operation of this 
HIV prevention project.
    c. Consult on the choice of prevention agencies for the case 
studies with the intervention package.
    d. Monitor and evaluate scientific and operational accomplishments 
of this project through frequent telephone contact and review of 
technical reports, package iterations, and interim data analyses.
    e. Conduct site visits to assess program progress and mutually 
solve problems, as needed.

E. Application Content

    Use the information in the Program Requirements, Other 
Requirements, and Evaluation Criteria sections to develop the 
application content. Your application will be evaluated on the criteria 
listed, so it is important to follow them in laying out your program 
plan. The narrative should be no more than 20 double-spaced pages, 
printed on one side, with one-inch margins, and unreduced font.
    Provide a one-page abstract of the proposal and a complete table of 
contents to the application and its appendices. Beginning with the 
first page of text, number all pages clearly and sequentially, 
including each page in the appendices. Replace double-sided article 
reprints with a one-sided copy.
    Include a general introduction, followed by one narrative 
subsection for each of the numbered content elements per application, 
in the order in which the elements appear below. Label each narrative 
subsection with the element title and include all of the information 
needed to evaluate that element of the application (except for 
curriculum vitae, references, and letters of support, which are 
appropriate for the appendices). The application content elements are:
    1. Effective behavioral intervention
    a. Identify the principal investigator (PI); name and location of 
the institution(s) that originally developed, conducted, and evaluated 
the proposed intervention; and population(s) for whom the intervention 
was designed. Indicate whether the research was part of a multi-site 
project.
    b. If the research was part of a multi-site project, provide 
letters of support from original developers of the intervention other 
than the applicant (e.g., PIs at other sites), indicating their intent 
to collaborate on a portion of the intervention materials that will 
discuss generalization of the intervention to other target populations 
or settings.
    c. Where the applicant is not an original developer of the 
intervention, provide written permission from the intervention's 
original developers to develop and market materials for the 
intervention package.

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    d. Describe the research's positive results on behavioral or health 
outcomes, including how these results are both statistically and 
practically significant; and, if the intervention is community-level, 
how long the intervention was in operation before positive effects were 
detected.
    e. Include in the appendix a copy of any reports that have been 
submitted to the institution funding the research, have been submitted 
for publication, or have been published in peer reviewed journals, 
describing the study design and positive behavioral or health outcomes 
of the intervention. This portion of the appendix should be labeled as 
``Intervention Study Design and Results.''
    f. Substantiate the need for an intervention package in terms of 
target population's risk and potential for generalizability to other 
populations at risk for HIV infection.
    g. Describe the feasibility of implementation by HIV prevention 
agencies, particularly those with limited resources.
    2. Intervention package
    a. Describe the contents of the intervention package that will be 
developed. Include descriptions of:
    1. The overall concept, format, and objectives to be in text and in 
a short promotional or marketing videotape for program administrators, 
e.g., appropriateness for intended implementing agencies, description 
of the intervention and the science behind it, target populations for 
whom the intervention would be appropriate;
    2. Pre-implementation phase, e.g., intervention's core elements 
related to this phase, time line of necessary preparation steps, list 
of collaborators, training materials, material resources, facilities, 
staff (numbers, time commitment, and skills), and cost categories for 
conducting the intervention;
    3. Implementation phase, e.g., intervention's core elements related 
to this phase, protocols and examples for implementing the intervention 
and ensuring quality and consistency, identification of barriers to 
implementation and advice on how they may be overcome, and methods for 
process evaluation; and
    4. Maintenance phase, e.g., intervention's core elements related to 
this phase, how to deal with issues of staff turnover and retraining.
    b. Explain how staff from HIV prevention programs (e.g., health 
departments and community-based organizations) and/or other prevention 
providers and consumers in the applicant's geographic area will 
collaborate in the development of the intervention package. Describe 
the planned procedures for how these collaborators will be identified.
    c. Present a time line for developing and reviewing the 
intervention package and its components.
    3. Plan to identify prevention agencies for case study of 
implementing the packaged intervention in year two.
    a. Discuss a plan to identify and recruit potential implementers 
within your state (i.e., where training, assistance, and evaluation 
will be feasible within budget constraints) and indicate any agencies 
which already have shown interest in or may be interested in 
implementing the proposed intervention.
    b. Elaborate on the criteria and mechanism for selecting agencies 
that will participate in case studies of implementing the packaged 
intervention.

    Note: Any agency that participated in the intervention's 
original research is excluded from consideration as a potential 
implementer, as is any agency that currently or previously 
implemented the intervention.

    4. Strategy to assist implementation
    a. Describe the strategy to facilitate implementation of the 
packaged intervention, including development of training curricula, 
provision of training, and provision of direct technical assistance 
from the applicant to the selected implementers and plans for assisting 
selected users find additional funds, if relevant.
    b. Discuss procedures to assist selected agencies to implement the 
packaged intervention, drawing upon the agencies' existing staff and 
resources, and to identify barriers to implementation and how to 
overcome them.
    5. Plan to evaluate the implementation process
    a. Describe methods and measures to be used in assessing (1) 
fidelity to the intervention's core elements during the implementation 
phases as specified in the intervention package; (2) quality of 
intervention delivery according to the methods describe in the package; 
(3) quality of the applicant's technical assistance and its delivery; 
(4) impact of barriers to implementation on the case study (e.g., 
accuracy of record keeping, agency's staff recruitment and training, 
client recruitment); (5) effectiveness of solutions to barriers; (6) 
costs of intervention delivery and cost containment strategies; and (7) 
maintenance of collaborative relationships. No behavioral or health 
outcomes are to be evaluated.
    b. Describe plan to use the process evaluation results in 
finalizing the intervention package and the training curricula for 
agency staff and for the preparation of guidance manuals for future 
technical assistance providers.

    Note: The purpose of the program includes achieving technology 
transfer with at least one HIV prevention agency and studying the 
process. Selection of two or more implementing agencies may increase 
the likelihood of achieving technology transfer (i.e., entering 
implementation phase and conducting all intervention components) 
with at least one agency.

    6. Capacity, and 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.
    a. Demonstrate capacity to conduct the activities required for this 
project.
    b. Clearly describe the proposed staffing, e.g., show percentages 
of each staff member's commitment to this and other projects, the 
division of duties and responsibilities for this project, brief 
position descriptions for existing and proposed personnel, and any 
partnerships with HIV prevention agencies.
    c. Demonstrate that the applicant's staff have the expertise to 
complete this project, including ability to produce the intervention 
package, e.g., include examples of previously developed fact sheets, 
CD-Roms, web sites, or samples from other intervention packages.
    d. Name the staff members who are key to the completion of the 
project. Provide a brief description of their strengths that relate to 
this project. Include their curriculum vitae in the appendix.
    e. Describe access to graphics expertise for the editing and 
production of the intervention package in print and/or electronic 
formats.
    f. Briefly describe compliance regarding the inclusion of women, 
ethnic, and racial groups in the proposed activities or justification 
when representation is limited or absent.
    7. Budget: Provide a detailed, line-item budget for the project; 
justify each line-item. Plan for two trips to Atlanta each year to meet 
with CDC representatives.

F. Submission and Deadline

Application

    Submit the original and two copies of PHS 5161-1 (OMB Number 0937-
0189). Forms are available at the following Internet address: 
www.cdc.gov/od/pgo/forminfo.htm, or in the application kit. On or 
before July 15, 2002, submit the application to: Technical Information 
Management Section, PA #02137, Procurement and Grants Office, Centers 
for Disease Control and Prevention

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(CDC), 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146.
    Deadline: Applications shall be considered as meeting the deadline 
if they are received on or before the deadline date.
    Late Applications: Applications which do not meet the criteria 
above are considered late applications, will not be considered, and 
will be returned to the applicant.

G. Evaluation Criteria

    Measures of effectiveness that will demonstrate the accomplishment 
of the various identified objectives of the grant/cooperative 
agreement. Measures must be objective/quantitative and must measure the 
intended outcome. These Measures of Effectiveness shall be submitted 
with your application and shall be an element of evaluation.
    Each application will be evaluated individually against the 
following criteria by an independent review group appointed by CDC.
    1. Effective Behavioral Intervention (20 percent) Clear 
demonstration of the effectiveness of the proposed intervention in a 
report that has been submitted to the institution funding the research, 
has been submitted for publication, or has been published in a peer-
reviewed journal. This is an absolute criterion. To be considered 
effective, the intervention must have been tested using a control or 
comparison group with participants assigned randomly or without bias to 
study conditions, have measured pre-intervention and post-intervention 
outcomes, have completed the data collection and analyses, and have 
findings that show significant positive results for changing HIV/STD-
related risk behavior or health outcomes. If this evidence is present, 
also consider:
    a. The original research for this intervention was conducted and 
completed with a population at demonstrable risk for acquiring or 
transmitting HIV, preferably incarcerated persons, non-injection 
substance users, HIV-infected persons, or persons living in rural areas 
whose behaviors put them at risk for HIV infection.
    b. The feasibility of implementing the proposed intervention by 
agencies with limited resources.
    c. Letters of permission from the intervention's developer(s) to 
develop and market materials for the proposed intervention package and, 
if the intervention was from a multi-site project, letters of 
participation from the same developers.
    2. Intervention Package (15 percent) Level of detail in the outline 
of the proposed package, e.g., for overview, pre-implementation, 
implementation, and maintenance phases. Clarity of described formats, 
concepts, intended implementers, and objectives. Justification of the 
appropriateness of the package's objectives, format and concepts to the 
intended implementing agencies' needs and capabilities. Adequacy of 
planned identification of and input from collaborating HIV prevention 
programs and/or other prevention providers and consumers. Adequacy of 
planned materials' review, pretesting, and revision. Adequacy of time 
scheduled for completing the proposed steps of the package's 
development and contents.
    3. Plan to Identify Prevention Agencies to Implement the Packaged 
Intervention (10 percent) Recognition of which agencies are not 
eligible to participate in the implementation case study. Quality of 
plan to identify eligible potential agencies with target populations 
for whom the intervention is appropriate and to interest them in 
implementing the package during year two of the project. Selection of 
active methods to identify and solicit potential implementing agencies. 
Adequacy of criteria and mechanism for selecting at least two 
implementing agencies likely to achieve technology transfer.
    4. Strategy to Assist Implementation (15 percent) Clarity of the 
strategy to assist selected agencies in adopting and implementing the 
proposed intervention, e.g., outline of training curricula and training 
plan. Understanding of barriers to implementation and how to overcome 
them. Plan to assist selected users in implementing the entire 
intervention using their existing resources and staff, e.g., provision 
of proactive and on-call technical assistance. Plan to help selected 
agencies find additional funds for implementing the package in year 
two, if relevant.
    5. Plan to Evaluate Implementation Process (15 percent) Feasibility 
and appropriateness of the applicant's plan to evaluate the selected 
agencies' implementation of the intervention as specified in the 
intervention package. Thorough and realistic selection of process 
measures to evaluate. Adequacy of plans for revising intervention 
package and training materials based upon the case study results. 
Adequacy of plans for developing a technical assistance manual based on 
the agencies' and applicant's implementation and transfer experiences.
    6. Demonstrated Capacity, and 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 (25 percent)
    a. Overall ability of the applicant to perform the proposed 
activities as reflected in their staff's and consultants' 
qualifications and availability. The extent to which the applicant 
demonstrates that proposed staff have experience with developing 
materials in various formats, training, and process evaluation and have 
demonstrated familiarity with HIV behavioral interventions, 
particularly the intervention to be packaged. The nature of any 
partnership between researchers and HIV prevention programs. Adequacy 
of existing support staff, equipment, and facilities.
    b. 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:
    1.The proposed plan for the inclusion of both sexes and racial and 
ethnic minority populations for appropriate representation.
    2. The proposed justification when representation is limited or 
absent.
    3. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    4. A statement as to whether the plans for recruitment and outreach 
for study participants include the process of establishing partnerships 
with community(ies) and recognition of mutual benefits.
    7. Budget (not scored)
    Extent to which the budget is reasonable, itemized, clearly 
justified, and consistent with the intended use of the funds. Extent to 
which the budget includes itemizations, justifications, scope, and 
deliverables for consultants or contractors.
    8. The application must adequately address the requirements of 
Title 45 CFR Part 46 for the protection of human subjects.

H. Other Requirements

    Provide measures of effectiveness to evaluate the accomplishment of 
the various identified objectives of the cooperative agreement. These 
measures must be objective and quantitative and must measure the 
intended outcome. The submission of these measures shall be a data 
element to be submitted with, or incorporated into the annual progress 
reports.
Technical Reporting Requirements
    Provide CDC with original plus two copies of 1. Progress reports 
(annual); A brief, comprehensive narrative progress

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report should be submitted no later than 90 days after the end of the 
budget period. The progress report must include the following: (1) A 
comparison of the actual accomplishments to the objectives established; 
(2) the reasons for slippage if established objectives were not met; 
and (3) other pertinent information.
    2. Financial status report, no more than 90 days after the end of 
the project period.
    3. Final financial report and performance report, no more than 90 
days after the end of the project period.
    A fiscal Recipient Capability Assessment may be required with the 
potential awardee, prior or post award, in order to review their 
business management and fiscal capabilities regarding the handling of 
U.S. Federal funds.
    Send all reports to the Grants Management Specialist identified in 
the ``Where to Obtain Additional Information'' section of this 
announcement.
    At the completion of two years of funding, recipients will be 
expected to share printed, and possibly, electronic copies of the 
revised intervention packages with representatives of the agencies that 
implemented the intervention for the program's case studies, with CDC 
project officers, and with the intervention's developers, if different 
from the applicant.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachment I in the 
application kit.

AR-1  Human Subjects Requirements
AR-2  Requirements for Inclusion of Women and Racial and Ethnic 
Minorities in Research
AR-4  HIV/AIDS Confidentiality Provisions
AR-5  HIV Program Review Panel Requirements
AR-7  Executive Order 12372 Review
AR-8  Public Health System Reporting Requirements
AR-9  Paperwork Reduction Act Requirements
AR-10  Smoke-Free Workplace Requirements
AR-11  Healthy People 2010
AR-12  Lobbying Restrictions
AR-14  Accounting System Requirements
AR-15  Proof of Non-Profit Status

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under section 301 and 317(k) of the 
Public Health Service Act, (42 U.S.C. 24 and 247b(k), as amended]. The 
Catalog of Federal Domestic Assistance number is 93.941.

J. Where To Obtain Additional Information

    This and other CDC announcements can be found on the CDC home page 
Internet address--http://www.cdc.gov Click on ``Funding'' then ``Grants 
and Cooperative Agreements.''
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Lynn Mercer, Grants Management Officer, Grants Management Branch, 
Procurement and Grants Office, Centers for Disease Control and 
Prevention, 2920 Brandywine Road, Room 3000, Atlanta, GA 30341-4146. 
Telephone number: 770-488-2810. Email address: [email protected].
    For program technical assistance, contact: Craig Studer, 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-37, Atlanta, GA 30333. Telephone number: 404-639-5389. 
E-mail address: [email protected].

    Dated: May 4, 2002.
Sandra R. Manning,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 02-11565 Filed 5-8-02; 8:45 am]
BILLING CODE 4163-18-P