[Federal Register Volume 64, Number 108 (Monday, June 7, 1999)]
[Notices]
[Pages 30332-30335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-14280]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Program Announcement 99089]


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

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1999 funds for a cooperative agreement 
program for the technology translation and transfer of effective HIV 
prevention behavioral interventions. This program addresses the 
``Healthy People 2000'' priority area for Human Immunodeficiency Virus 
(HIV) Infection.
    HIV/AIDS researchers have developed and tested prevention 
interventions that aim to reduce sex-related and drug-related risk 
behaviors. A number of these interventions have credible evidence of 
effectiveness, defined as reporting positive and significant results on 
an HIV-relevant behavioral or health outcome. The purposes of this 
project are to:
    (1) Translate effective HIV prevention interventions whose original 
research was conducted with methodological rigor, preferably at 
multiple sites with multiple populations at risk;
    (2) Develop packages of materials in collaboration with health 
departments, community-based organizations, and/or other prevention 
providers and consumers, that prevention providers can use to replicate 
the interventions in non-research field situations; and
    (3) Study the process of technology transfer, using the prevention 
packages in at least one field setting supported by training, quality 
assurance, and technical assistance.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit 
organizations and governments and their agencies. Thus, universities, 
colleges, research institutions, hospitals, other public and private 
organizations, State and local health departments or their bona fide 
agents, federally recognized Indian tribal governments, Indian tribes 
or Indian tribal organizations.

    Note: Pub. L. 104-65 states that an organization described in 
section 501(c)(4) of the Internal Revenue Code of 1986 that engages 
in lobbying activities is not eligible to receive Federal funds 
constituting an award, grant, cooperative agreement, contract, loan, 
or any other form.

C. Availability of Funds

    Approximately $350,000 is available in FY 1999 to fund 
approximately two awards. The average award will be $175,000 and the 
range will be $150,000 to $200,000. It is expected that the awards will 
begin on or about September 30, 1999, and will be made for a 12-month 
budget period within a project period of up to two years. Funding 
estimates may vary and are subject to change based on availability of 
funds. An application requesting greater than $200,000 (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, purchase of furniture or computers, and rental of 
facilities will not be funded under this program.

D. Program Requirements

    In conducting activities to achieve the purpose of this 
announcement, 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 are:
    a. Develop the (1) intervention portion of the prevention package 
and (2) preliminary versions of the training materials and technical 
assistance protocols to guide the field site implementation and produce 
a limited number of prevention packages.
    b. Identify at least one organization or field setting for the case 
study.
    c. Develop a process evaluation plan.
    Recipient activities for the second year of activity include: 
Initiate and complete the field site case study, initiate and complete 
the process evaluation, and revise training materials based upon the 
case study results. The program requirements for the second year 
include publishing and distributing results.

2. CDC Activities

    a. Host a meeting with the successful applicants within 60 days of 
the notice of grant 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 user for a case study with the 
prevention package.
    d. Monitor and evaluate scientific and operational accomplishments 
of this project through frequent telephone contact and review of 
technical reports and interim data analyses.
    e. Conduct site visits to assess program progress and mutually 
solve problems, as needed.

E. Application Content

    Develop applications in accordance with PHS Form 5161-1 (OMB Number 
0937-0189) and the instructions and format provided below.
    Submit the original and two copies of PHS Form 5161-1 (OMB Number 
0937-0189) and the original and two copies of the application. The 
application may not exceed 20 double-spaced pages, excluding abstract, 
table of contents, and appendices. Submit the original and each copy of 
the application Unstapled Unbound. Print all material double-spaced, in 
a 12-point or larger font size on 8 \1/2\'' by 11'' paper, with at 
least 1'' margins, and printed on one side only. 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. Number each page of the 
appendices also, e.g., for Appendix # 1, the pages should be numbered: 
A1-1, A1-2, A1-3. 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 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:

[[Page 30333]]

1. Effective Behavioral Intervention

    a. Identify the principal investigator(s) and name and location of 
the agency(ies) that originally developed, conducted, and evaluated the 
intervention research. Indicate whether the study was part of a multi-
site project with multiple populations at risk.
    b. Provide letters of support from original developers of the 
intervention other than the applicant (e.g., PIs at the other sites) 
indicating their intent to collaborate on a section of the intervention 
materials that will discuss generalizability 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 prevention 
package.
    d. Describe the study's positive results on behavioral or health 
outcomes, including how these results are both statistically and 
practically significant.
    e. Include in the appendix a copy of any reports, that have been 
submitted for publication or published in peer reviewed journals, 
describing the study design and the 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 a prevention package in terms of risk 
of target population and potential for generalizability to other target 
groups.
    g. Describe the feasibility of implementation by other 
organizations, particularly those with limited resources.

2. Prevention Package

    a. Describe the prevention package. Include descriptions of:
    (1) The overall concept, format, and objectives, e.g., 
appropriateness for intended audience, description of intervention and 
the science behind it, target populations for whom the intervention 
would be appropriate;
    (2) Pre-implementation phase, e.g., core elements related to this 
phase, time line of necessary steps, collaborators, training materials, 
material resources, facilities, staff (numbers, time, and skills), and 
cost categories for conducting the intervention;
    (3) Implementation phase, e.g., core elements related to this 
phase, protocols for implementing the intervention and ensuring quality 
and consistency and providing technical assistance, identification of 
barriers to implementation and how they may be overcome, and process 
evaluation methods; and
    (4) Maintenance phase, e.g., 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 CBOs, and consumers) will be involved in the 
development of the package. Describe the planned procedures for how 
these collaborators will be identified.
    c. Present a time line for developing the prevention package.

3. Plan To Identify Field Site(s) To Implement the Package in Year Two

    a. Discuss a plan to identify and recruit potential users within 
your state (i.e., where the training and implementation and evaluation 
will be feasible within the budget constraints) and indicate any which 
already have shown interest in or may be interested in implementing 
this intervention.
    b. Elaborate on the criteria and mechanism for selecting the 
user(s) who will implement the package.

    Note: The agency that originally conducted the intervention is 
excluded from consideration as a potential user, 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 
package, including provision of training and direct technical 
assistance from the recipient to the selected user(s) and plans for 
assisting selected user(s) find additional funds, if relevant.
    b. Discuss procedures to assist user(s) to implement the package, 
drawing upon the user's 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) 
Maintenance of the core elements during the intervention phases as 
specified in the prevention package, (2) quality of intervention 
delivery according to the methods described in the package, (3) quality 
of recipient's technical assistance and its delivery, (4) the impact of 
barriers to implementation on the case study (e.g., accuracy of record 
keeping, user's employee recruitment and retention, participant 
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 prevention package.

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 proposed activities 
including the process evaluation.
    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 programs.
    c. Demonstrate that the staff have the expertise to complete this 
project, including ability to produce the intervention package, e.g., 
include examples of previously developed fact sheets, 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 the strengths each brings to 
this project. Include their curriculum vitae in the appendix.
    e. Describe access to graphics expertise for production and editing 
of the intervention package.
    f. Describe equipment and facilities to be used for the proposed 
activities.
    g. Briefly describe compliance regarding the inclusion of women, 
ethnic, and racial groups in the proposed activities.

7. Budget

    Provide a detailed, line-item budget for the project; justify each 
line-item. Plan for at least two trips to Atlanta to meet with CDC 
representatives.

F. Submission and Deadline

    Submit the original and two copies of PHS 5161-1 (OMB Number 0937-
0189). Forms are in the application kit. On or before July 20, submit 
the application to: Brenda Hayes, Grants Management Specialist, Grants 
Management Branch, Procurement and Grants Office, Program Announcement 
98089, Centers for Disease Control and Prevention (CDC), 2920 
Brandywine Road, NE, Room 3000, Atlanta, Georgia 30341-4146.
    If your application does not arrive in time for submission to the 
independent review group, it will not be considered in the current 
competition unless you can provide proof that you mailed it on or 
before the deadline (i.e., receipt from U.S. Postal Service or a 
commercial

[[Page 30334]]

carrier; private metered postmarks are not acceptable).

G. Evaluation Criteria

    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 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, the data collection and 
analyses are completed, and the findings show significant positive 
results for changing HIV risk behavior or health outcomes. If this 
evidence is present, also consider:
    a. The original research with this intervention was conducted and 
completed preferably with multiple target populations at multiple 
sites, especially with persons at increased risk of HIV infection.
    b. The applicant addresses the feasibility of implementing the 
prevention package by organizations with limited resources.

2. Prevention Package (15 Percent)

    Level of detail in the outline of the proposed package, for pre-
implementation, implementation, and maintenance phases, e.g., for 
materials for the package itself, for training, and for technical 
assistance protocols. Clarity of described format, concepts, intended 
audiences, and objectives. Justification of the appropriateness of the 
package's objectives, format, and concepts to the intended users' needs 
and capabilities. Adequacy of planned input from HIV prevention 
programs into the development of the package. Adequacy of planned 
materials' review, pretesting, and revision. Adequacy of time scheduled 
for completing the proposed steps of the package's development.

3. Plan To Identify Field Site(s) To Implement the Package (10 Percent)

    Recognition of which agencies are not eligible to implement the 
package. Quality of plan to identify eligible potential users which 
target populations for whom the intervention is appropriate and 
interest them in adopting the package during year two of the project. 
Selection of active methods to identify and solicit potential users. 
Adequacy of criteria and mechanism for selecting the users to implement 
the package in year two.

4. Strategy To Assist Implementation (15 Percent)

    Clarity of the strategy to assist selected users in adopting and 
implementing the behavioral intervention, e.g., training plan. 
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, e.g., provision of on-call 
technical assistance. Plan to help selected users find additional funds 
for implementing the package, if relevant.

5. Plan To Evaluate Implementation Process (15 Percent)

    Feasibility and appropriateness of the applicant's plan to evaluate 
the selected user's implementation of the intervention as specified in 
the replication package. Thorough and realistic selection of process 
measures to evaluate.

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 Points)

    a. Demonstrated Capacity.
    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 materials development and 
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 includes:
    1. The proposed plan for the inclusion of both women 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 communities and recognition of mutual benefits.

7. Does the Application Adequately Address the Requirements of Title 45 
CFR Part 46 for the Protection of Human Subjects?

____Yes    ____No

Comments:--------------------------------------------------------------

8. 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.

H. Other Requirements

1. Technical Reporting Requirements

    An original and two copies of semi-annual progress reports are 
required. Timelines for the semi-annual reports will be established at 
the time of award. Final financial status and performance reports are 
required no later than 90 days after the end of the project period. All 
reports are submitted to the Grants Management Branch, CDC.
    At the completion of two years of funding, recipients will be 
expected to share prevention packages with representatives of the 
original agencies that conducted the interventions on which the 
products are based, if different from those of the recipient.
    The following additional requirements are applicable to this 
program. For a complete description of each, see Attachments in the 
application kit.

AR98-1  Human Subjects Requirements
AR98-2  Requirements for Inclusion of Women, Racial and Ethnic 
Minorities in Research
AR98-4  HIV/AIDS Confidentiality Provisions
AR98-5  HIV Program Review Panel Requirements
AR98-7  Executive Order 12372 Review
AR98-8  Public Health System Reporting Requirements
AR98-9  Paperwork Reduction Act Requirements
AR98-10  Smoke-Free Workplace Requirements
AR98-11  Healthy People 2000
AR98-12  Lobbying Restrictions

I. Authority and Catalog of Federal Domestic Assistance Number

    This program is authorized under sections 301 and 317(k), of the 
Public Health Service Act [42 U.S.C. 241 and

[[Page 30335]]

247b(k)], as amended. The Catalog of Federal Domestic Assistance number 
is 93.941.

J. Where To Obtain Additional Information

    To receive additional written information and to request an 
application kit, call 1-888-Grants4 (1-888-472-6874). You will be asked 
to leave your name and address and will be instructed to identify the 
Announcement number of interest. Please refer to Program Announcement 
99089 when you request information. See also the CDC home page on the 
Internet: http://www.cdc.gov. You may view or download this and other 
Program Announcements, and download application forms at this site.
    If you have questions after reviewing the contents of all the 
documents, business management technical assistance may be obtained 
from: Brenda Hayes, Grants Management Specialist, Grants Management 
Branch, Procurement and Grants Office, Program Announcement 98089, 
Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, 
NE, Room 3000, Atlanta, GA 30341, telephone (770) 488-2720, Email: 
[email protected].
    For program technical assistance, contact: 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-37, Atlanta, GA 30333, telephone (404) 
639-1914, Email: [email protected].
    Please refer to Announcement number 99089 when requesting 
information and submitting an application.

    Dated: June 1, 1999.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 99-14280 Filed 6-4-99; 8:45 am]
BILLING CODE 4163-18-P