[Federal Register Volume 63, Number 132 (Friday, July 10, 1998)]
[Notices]
[Pages 37383-37387]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18389]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention
[Announcement 98098]


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

A. Purpose

    The Centers for Disease Control and Prevention (CDC) announces the 
availability of fiscal year (FY) 1998 funds for a cooperative agreement 
program for the technology translation and transfer of effective HIV 
prevention interventions. This program addresses the ``Healthy People 
2000'' priority area of Human Immunodeficiency Virus (HIV) Infection.
    In order to slow the spread of HIV/AIDS, researchers have developed 
and tested prevention interventions that aim to reduce sex-related and 
drug-related

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risk behaviors. As a result of these studies, a number of interventions 
with credible evidence of effectiveness have been identified. This 
project will be a case study of the translation and transfer of an 
effective intervention in a non-research setting.
    The purpose of this project is to enhance access to and use of 
effective interventions by service providers nationwide. Recipients 
will develop prevention packages that are readily useable by service 
providers. Recipients will develop prevention packages and refine them 
as they are piloted in the field setting. This will serve as a case 
study of the technology transfer process.
    The specific purposes of this program are to: (1) Translate an 
individual or small group HIV prevention intervention (especially those 
targeted to persons at increased risk of HIV infection) with credible 
evidence of effectiveness, i.e., an effective intervention. This first 
activity is to be done in collaboration with health departments, 
community-based organizations, or other service delivery providers who 
can provide feedback and advice; (2) Develop a prevention package that 
includes training materials and technical assistance protocols as well 
as the intervention itself; and (3) Study the process of technology 
transfer, using the prevention package in a field setting.

B. Eligible Applicants

    Applications may be submitted by public and private nonprofit and 
for-profit 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.
    However, since the purpose of this technology translation and 
transfer project is to build on successful research projects, 
applicants must clearly demonstrate that their intervention has been 
tested under rigorous study design criteria (including the use of a 
control or comparison group) and found to be effective with significant 
positive results for changing HIV risk behavior. The applicant must 
have evidence that a report on this effective intervention has been 
submitted for publication or has been published in a peer-reviewed 
journal.

    Note: Public Law 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 $400,000 is available in FY 1998 to fund 
approximately 2 awards. It is expected that the average award will be 
$190,000, ranging from $180,000 to $200,000. It is expected that the 
awards will begin on or about September 30, 1998, 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. An application requesting greater than $200,000 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 2 will be 
dependent on the completion of required activities for year 1. 
Applicants should anticipate that a portion of year 2 funding may be 
used in the field setting (approximately $20,000) as needed to 
implement the program.

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

    a. Develop the intervention portion of the prevention package.
    (1) The recipient will develop the package in collaboration with 
representatives of HIV prevention service delivery programs, e.g., 
health departments, community-based organizations (CBOs).
    (2) Prevention packages should include:
    (a) Language and format that are understandable and attractive to 
service providers who are nonresearchers.
    (b) A full description of the intervention, including the 
background and the target population.
    (c) A list and description of the core elements for the pre-
implementation, implementation, and maintenance phases.
    (d) Protocols for implementing the intervention and ensuring its 
quality and consistency.
    (e) Specific guidelines for overcoming barriers to implementation.
    (f) A list of all staff, facility, and material resources needed to 
conduct the intervention, including level of staff skill and time 
commitment, and cost breakdowns.
    (g) A time line of specific steps for setting up the intervention.
    (h) A bibliography of publications based on the intervention.
    b. Develop the training and technical assistance portion of the 
prevention package.
    (1) The recipient should develop training materials that can be 
used in preparing providers to use the prevention package. These 
materials will assist the user with pre-implementation and 
implementation tasks necessary to undertake the intervention during 
year 2. The materials should emphasize experiential learning and other 
active methods associated with skill building.
    (2) The recipient should develop an outline for providing technical 
assistance which identifies the likely technical assistance requests 
that users may make and an appropriate response for each request.
    c. Produce a limited number of draft prevention packages.
    The recipient will produce draft packages using less costly 
materials than those to be used in the final product, but without 
changing the overall effect, e.g., less heavy stock paper for binding 
covers but with same logo or design, notebook rather than bound.
    d. Identify an organization or field setting for case study.
    (1) Compile a list of HIV prevention service 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 potential 
users);
    (2) Create approaches to establish linkages with the potential 
users and strategies to market the prevention package to them.
    (3) Select ways to inform potential users who express interest 
about the availability of a case study experience.
    (4) Develop a written agreement with the organization selected for 
the case study (for this announcement, such organization will be 
referred to as the user).
    e. Develop the evaluation plan.
    (1) Data should be both quantitative and qualitative and should 
include

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observations and reports that permit assessment of the fit between the:
    (a) core elements specified in the prevention package and the 
content of the implementation.
    (b) methods specified in the prevention package and the delivery of 
the intervention, but no behavioral or health outcomes data should be 
collected.
    (2) Process data should include observations and reports of:
    (a) barriers to implementation and how they impacted the case study
    (b) solutions to barriers
    (c) cost containment strategies.
    During the second year, the recipient will complete the development 
of training materials, technical assistance outlines, and process 
evaluation protocols necessary to initiate the case study. Data 
collection will take place throughout the case study or for 
approximately 6 months (based on an estimated delivery of one program 
per week). The final three months of the project will be used to 
analyze the process data and refine the prevention package.
    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.
    f. At the end of the two year project, CDC, in addition to the 
authors, may distribute the package.

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, 
index, and appendices. Submit the original and each copy of the 
application UNSTAPLED and 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 index 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:

1. Effective intervention

    a. Identify the principal investigator(s) and name and location of 
the agency(ies) that originally developed, conducted, and evaluated the 
small group or individual level intervention research.
    b. Provide written permission from the original developers of the 
intervention to develop and market materials that may be original or 
derived for the prevention package.
    c. Describe the study's positive results on behavioral or health 
outcomes, including how these results are both statistically and 
practically significant.
    d. Include in the appendix, a copy of any reports that describe the 
study design and the positive behavioral or health outcomes of a small 
group or individual level intervention that have been submitted for 
publication or published in peer reviewed journals. This portion of the 
appendix should be labeled as ``Intervention Study Design and 
Results.''
    e. Substantiate the need for a prevention package in terms of risk 
of target population and potential for generalizability to other target 
groups.
    f. 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) Target populations for whom the intervention would be 
appropriate;
    (2) Pre-implementation phase, including specific steps for setting 
up the intervention, necessary collaborators, necessary materials, 
other resources, staff commitment (numbers and time) and skills for 
conducting the intervention, and training materials;
    (3) Implementation phase, including 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, including how to deal with issues of staff 
turnover and retraining.
    b. Explain how staff from HIV prevention programs (e.g., health 
departments and CBOs) within the applicant's state or within close 
proximity to the applicant's home city 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. Field site for implementation of the package in year two (2)

    a. Discuss a plan to identify and recruit potential users within 
your state or within close proximity to your home city 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).
    b. Discuss procedures to involve user(s) in implementing the 
package, including use of user's existing staff and resources, and to 
identify barriers to implementation and how to overcome them. 
Feasibility and sustainability of the intervention with existing 
resources are important for the successful adoption and maintenance of 
the package.

5. Plan to evaluate the implementation process

    Describe the plan for evaluating the process of implementing the 
prevention package. The plan should address (unless not applicable): 
(1) methods, (2) quality assurance monitoring of intervention delivery 
including documentation of intervention episodes, (3) employee 
recruitment and retention, (4) participant recruitment, (5) accuracy

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and completeness of record keeping, and (6) costs of intervention 
delivery.

6. Capacity

    a. Demonstrate capacity to conduct the proposed activities 
including the process evaluation.
    b. Describe the proposed staffing, show percentages of each staff 
member's commitment to this and other projects, and division of duties 
and responsibilities for this project; include brief position 
descriptions for existing and proposed personnel.
    c. Demonstrate that the staff have the expertise to complete this 
project, including ability to produce the intervention product(s). 
Demonstration of this capability would 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.

7. Budget

    Provide a detailed, line-item budget for the project; justify each 
line-item, including the need for any proposed consultants and 
contractors. 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 August 17, 1998, 
submit the application to: Maggie Slay Warren, Grants Management 
Specialist, Grants Management Branch, Procurement and Grants Office, 
Announcement 98098, Centers for Disease Control and Prevention (CDC), 
Room 300, 255 East Paces Ferry Road, NE., M/S E-15, Atlanta, Georgia 
30305-2209.
    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 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. Behavioral Intervention (20 percent)

    The applicant must clearly demonstrate the effectiveness of the 
proposed small-group or individual-level intervention in a report that 
has been submitted for publication or has been published in a peer-
reviewed journal. This is an absolute criterion. If this evidence is 
not present, score as zero.
    a. The intervention is directed to small groups or individuals, 
especially persons at increased risk of infection.
    b. The applicant provides justification if proposing to conduct the 
intervention with any groups other than the initial target population.
    c. 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 description or outline of the proposed 
package, including materials, protocols, and guidelines. Clarity of 
described format and 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 input from HIV prevention programs into the development of 
the package. Adequacy of planned materials' review, pretesting, and 
revision of materials as needed. 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)

    Quality of plan to identify appropriate and eligible 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. Strategy to Assist Implementation (15 percent)

    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, including 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 (15 percent)

    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's demonstrates that 
proposed staff have 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. 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 (10 percent)

    This includes:
    a. The proposed plan for the inclusion of both women and racial and 
ethnic minority populations for appropriate representation.
    b. The proposed justification when representation is limited or 
absent.
    c. A statement as to whether the design of the study is adequate to 
measure differences when warranted.
    d. 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.

8. Does the application adequately address the requirements of Title 45 
CFR Part 46 for the protection of human subjects?

______YES
______No
Comments:____________________

9. Budget (not scored)

    Extent to which the budget is reasonable, itemized, clearly 
justified,

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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

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 2 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.

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 12373 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 247b], as amended. The 
Catalog of Federal Domestic Assistance number is 93.941.

J. Where to Obtain Additional Information

    To receive additional written information, call (888) 472-6874. You 
will be asked to leave your name, address, and telephone number. Please 
refer to Program Announcement 98098 when you request information. For a 
complete program description, information on application procedures, an 
application package, and business management technical assistance, 
contact: Maggie Slay Warren, Grants Management Specialist, Grants 
Management Branch, Procurement and Grants Office Announcement 98098, 
Centers for Disease Control and Prevention (CDC), Room 300, 255 East 
Paces Ferry Road, NE., M/S E-15, Atlanta, GA 30305-2209 telephone (404) 
842-6797. Email address http://www[email protected]
    See also the CDC home page on the Internet: http://www.cdc.gov
    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-44, Atlanta, GA 30333 telephone (404) 
639-8302 email: [email protected]">[email protected]
    Please refer to Announcement number 98098 when requesting 
information and submitting an application.

    Dated: July 6, 1998.
John L. Williams,
Director, Procurement and Grants Office, Centers for Disease Control 
and Prevention (CDC).
[FR Doc. 98-18389 Filed 7-9-98; 8:45 am]
BILLING CODE 4163-18-P