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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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Start Preamble

Application Deadline: July 31, 2003.

A. 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. section 241 and 247b(k)), as amended. The Catalog of Federal Domestic Assistance number is 93.941.

B. Purpose

The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2003 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 of HIV.

The purpose of the program is to: (1) Support translation of the protocols for effective HIV prevention interventions, in which the original research was conducted with methodological rigor and which have not been packaged or widely adopted, into a package of materials that state, local, and non-profit prevention providers can use to implement the interventions in their non-research field situations; and (2) Support development of curricula for training provider agency staff who will implement the intervention on how to deliver the packaged intervention with fidelity and on technical skills needed to conduct the intervention, and technical assistance guidance manuals for providing technical assistance to future adopters of the intervention.

Measurable outcomes of the program will be in alignment with one or more of the following performance goals for the National Center for HIV, STD, and TB Prevention (NCHSTP): Strengthen the capacity nationwide to monitor the epidemic, develop and implement effective HIV prevention interventions and evaluate prevention programs and to also decrease the number of persons at high risk for acquiring or transmitting HIV infection.

C. Eligible Applicants

Applications may be submitted by non-profits organizations and by governments and their agencies in the United States; that is: public nonprofit organizations; private nonprofit organizations; for profit organizations; universities; colleges; research institutions; hospitals; community-based organizations; state and local governments or their bona fide agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau); political subdivisions of States (in consultation with States); small, minority, women owned businesses; technical schools; faith-based organizations; and federally recognized Indian tribal governments. If any of the aforementioned organizations, Start Printed Page 39094institutions, universities, research hospitals, etc., do not have the following qualifications they will not be eligible to apply for this program: (1) Researchers who have developed proven HIV behavioral prevention interventions; (2) persons with experience using protocols to conduct HIV behavioral interventions; or (3) persons with expertise in curricula and package development. If agencies are interested in applying for funding under this announcement but are not of a group listed as eligible, they are encouraged to partner with an eligible entity, combine their capacities, and submit a joint application. The eligible partner must be the lead applicant and must conduct at least 50 percent of the program's activities.

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.

D. Funding

Availability of Funds

Approximately $470,000 is available in FY 2003 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 15, 2003, and will be made for a 12-month budget period within a project period of up to two years. Funding estimates may change.

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 outcomes 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.

Recipient Financial Participation

Matching funds are not required for 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 at-risk populations among the proposals selected for funding. Interventions are sought for any population at risk of acquiring or transmitting HIV; however, the following populations are of particular interest: (1) Persons with HIV infection; (2) African American men having sex with men (MSM); (3) Hispanic MSM; (4) incarcerated persons; (5) sex workers, (6) transgender persons; and (7) persons living in rural areas whose behaviors put them at risk for HIV infection.

E. Program Requirements

In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities listed in 1. Recipient Activities, and CDC will be responsible for the activities listed in 2. CDC Activities.

1. Recipient Activities

The program requirements for the first year of activity include:

a. Develop the intervention package, including promotional or marketing material for program administrators, and preliminary versions of the training curricula in collaboration with HIV prevention providers and consumers.

b. Produce enough intervention packages so that each case study agency can receive one for each staff member delivering the intervention, the researcher's team has at least one package; and the CDC Project Officer has one package. The number of packages will depend upon the structure of the intervention, how many case study agencies test the package, and how many facilitators there are at each agency.

c. Identify at least two HIV prevention agencies, which are not collaborating on package development, for case study of the technology transfer process.

d. Develop a plan to evaluate the implementation process.

Program requirements for the second year of activity include:

a. Initiate the prevention agency case study using the intervention package, training curricula, 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 implementation 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. CDC will host two meetings per project year to facilitate the sharing of experiences and lessons learned by the recipients of this funding and the recipients of Replicating Effective Programs (REP) funding under other announcements.

b. Provide technical assistance in the general operation of this HIV prevention project, including but not limited to detailed advice on steps to accomplish the recipient activities, composition of community advisory boards, cost containment strategies for video production, package production issues (e.g., reading level, format, layout), topics to include in Memoranda of Agreement with case study agencies, strategies for collecting process measures and tracking implementation costs, and responses to recipient questions and requests.

c. Consult on the choice of prevention agencies for the case studies with the intervention package by suggesting selection criteria, assisting in identifying potential agencies in the event that a recipient has difficulty, and approving the final choices.

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. Project Officers will conduct monthly calls with individual recipients and monthly conference calls with all current recipients of REP funding, will read and edit iterations of the package and video scripts, and will make recommendations aimed at solving problems and improving the quality and timeliness of recipient activities.

e. Conduct at least one site visit per year to assess program progress and mutually solve problems, and additional visits as needed.

F. Content

Applications

The Program Announcement title and number must appear in the application. 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 Start Printed Page 39095plan. The narrative should be no more than 20 pages, double-spaced, printed on one side, with one-inch margins, and unreduced 12-point font.

The narrative should consist of a one-page abstract of the proposal, a complete table of contents to the application and its appendices, and text addressing each required element. 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, line item budget justification, and letters of support, which are appropriate for the appendices). The application's narrative content elements are:

1. 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 has 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.

2. 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 with a common protocol, 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 generalizing 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.

d. Describe the research's 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, which 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 the target population's risk and the intervention's potential for being generalized to other populations at risk for HIV infection.

g. Describe the feasibility of implementation by HIV prevention agencies, particularly those with limited resources, and the number of at-risk persons an agency could potentially reach with the intervention annually.

3. Plan for Intervention Package Development

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 short promotional or marketing materials 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) The intervention's 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) The intervention's 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) The intervention's 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.

4. 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 or nearby (i.e., where training, assistance, and evaluation will be feasible within budget constraints) and indicate any agencies that have already 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.

5. Methods 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 Start Printed Page 39096selected case study agencies. Describe plans for assisting selected users find additional funds, if it becomes necessary.

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.

6. Evaluation of 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 described 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.

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. Any application requesting greater than $235,000 (including indirect costs) will not be considered for review and will be returned to the applicant.

8. Performance Goals

Describe how the measurable outcomes of the program will be in alignment with one or more of the following performance goals:

a. Strengthen the capacity nationwide to monitor the epidemic, develop and implement effective HIV prevention interventions and evaluate prevention programs.

b. Decrease the number of persons at high risk for acquiring or transmitting HIV infection.

G. Submission and Deadline

Application Forms

Submit the signed original and two copies of PHS 5161-1 (OMB number 0920-0428). Forms are available at the following Internet address: http://www.cdc.gov/​od/​pgo/​forminfo.htm.

If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) at: 770-488-2700. Application forms can be mailed to you.

Submission Date, Time, and Address

The application must be received by 4 p.m. Eastern Time July 31, 2003. Submit the application to: Technical Information Management-PA# 03090, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146.

Applications may not be submitted electronically.

CDC Acknowledgement of Application Receipt

A postcard will be mailed by PGO-TIM, notifying you that CDC has received your application.

Deadline

Applications shall be considered as meeting the deadline if they are received before 4 p.m. Eastern Time on the deadline date. Any applicant who sends their application by the United States Postal Service or commercial delivery services must ensure that the carrier will be able to guarantee delivery of the application by the closing date and time. If an application is received after closing due to (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, CDC will, upon receipt of proper documentation, consider the application as having been received by the deadline.

Any application that does not meet the above criteria will not be eligible for competition, and will be discarded. The applicant will be notified of their failure to meet the submission requirements.

H. Evaluation Criteria

Application

Applicants are required to provide measures of effectiveness that will demonstrate the accomplishment of the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the purpose section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation.

An independent review group appointed by CDC will evaluate each application against the following criteria:

1. 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 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.

2. Effective Behavioral Intervention (20 points). Clear demonstration of the effectiveness of the proposed intervention in a report that has been: (1) Submitted to the institution funding the research; (2) submitted for publication, or published in a peer-reviewed journal. This is an absolute criterion.

To be considered effective, the intervention must have: (1) Tested using a control or comparison group with participants assigned randomly or without bias to study conditions; (2) measured using pre- and post-Start Printed Page 39097intervention outcomes; (3) retained at least 70 percent of the study participants; (4) completed the data collection and analyses; and (5) results that show significant positive findings (and no significant negative 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 persons with HIV infection, African American men having sex with men (MSM), Hispanic MSM, incarcerated persons, sex workers, transgender 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 and the number of at-risk persons an agency could reach.

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 with a common protocol, letters of participation from the same developers.

3. Plan for Intervention Package Development (15 points). 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, pre-testing, and revision. Adequacy of time scheduled for completing the proposed steps of the package's development and contents.

4. Plan to Identify Prevention Agencies to Implement the Packaged Intervention (15 points). Recognition of which agencies are not eligible to participate in the implementation case study. Quality of plan to identify eligible potential agencies with at-risk 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.

5. Methods to Assist Implementation (15 points). 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.

6. Evaluation of Implementation Process (10 points). 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.

7. Budget (Reviewed, but 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. Performance goals (Reviewed, but not scored). Extent to which the program's proposed measures will demonstrate effective accomplishment of the purposes and one or more performance goals of the cooperative agreement.

Does the application adequately address the requirements of Title 45 CFR Part 46 for the protection of human subjects? Not scored; however, an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable.

I. Other Requirements

Technical Reporting Requirements

Provide CDC with an original, plus two copies of:

1. Interim progress report, no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application, and must contain the following elements:

a. Current Budget Period Activities Objectives.

b. Current Budget Period Financial Progress.

c. New Budget Period Program Proposed Activity Objectives.

d. Detailed Line-Item Budget and Justification.

e. Additional Requested Information.

2. Financial status report, no more than 90 days after the end of the budget period.

3. Final financial and performance reports, no more than 90 days after the end of the project period.

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 print, 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.

Additional Requirements

The following additional requirements are applicable to this program. For a complete description of each, see Attachment I of the program announcement, as posted on the CDC web site.

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

J. Where To Obtain Additional Information

This and other CDC announcements, the necessary applications, and associated forms can be found on the CDC web site, Internet address: http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements”.

For general questions about this announcement, contact: Technical Start Printed Page 39098Information Management, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.

For business management and budget assistance, contact: Vincent Falzone, Grants Management Specialist, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Atlanta, GA 30341-4146, Telephone: 770-488-2700.

For program technical assistance, contact: Craig Studer, Deputy Branch Chief, Division of HIV/AIDS Prevention, National Center for HIV/STD/TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, NE, Mailstop E-37, Atlanta, GA 30333, Telephone: 404-639-5389, E-mail address: ccs1@cdc.gov.

Start Signature

Dated: June 25, 2003.

Sandra R. Manning,

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

End Signature End Preamble

[FR Doc. 03-16530 Filed 6-30-03; 8:45 am]

BILLING CODE 4163-18-P