[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] ======================================================================= ----------------------------------------------------------------------- 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 [[Page 37384]] 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 [[Page 37385]] 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 [[Page 37386]] 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, [[Page 37387]] 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