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

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Information about this document as published in the Federal Register.

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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-Start Printed Page 31320profit 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. Start Printed Page 31321

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 Start Printed Page 31322(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 Start Printed Page 31323report 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: lzm2@cdc.gov.

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: ccs1@cdc.gov.

Start Signature

Dated: May 4, 2002.

Sandra R. Manning,

Director, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC).

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[FR Doc. 02-11565 Filed 5-8-02; 8:45 am]

BILLING CODE 4163-18-P