[Federal Register Volume 61, Number 118 (Tuesday, June 18, 1996)] [Notices] [Pages 30906-30909] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 96-15382] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES [Announcement 630] Formative Behavioral Intervention Research on the Prevention of Sexual Transmission of HIV by HIV-Seropositive Men Introduction The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 1996 funds for a cooperative agreement program for the prevention of the sexual transmission of HIV by men who have tested positive for HIV infection. CDC is committed to achieving the health promotion and disease prevention objectives of ``Healthy People 2000,'' a national activity to reduce morbidity and mortality and improve the quality of life. This announcement is related to the priority area of Human Immunodeficiency Virus (HIV) Infection. (For ordering a copy of ``Healthy People 2000,'' see the section ``Where to Obtain Additional Information.'') Authority This program is authorized under Sections 301 and 317(k)(2), of the Public Health Service Act (42 U.S.C. 241 and 247b(k)(2)) as amended. Smoke-Free Workplace CDC strongly encourages all recipients to provide a smoke-free workplace and to promote the nonuse of all tobacco products, and Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, and early childhood development services are provided to children. [[Page 30907]] Eligible Applicants Applications may be submitted by public and private, nonprofit and for-profit organizations and governments and their agencies. Thus, universities, colleges, research institutes, hospitals, other public and private organizations, State and local health departments or their bona fide agents or instrumentalities, federally recognized Indian tribal governments, Indian tribes or Indian tribal organizations, and small, minority or women-owned businesses are eligible to apply. Availability of Funds Approximately $750,000 is available in FY 1996 to fund approximately three awards. It is expected that the average award will be $250,000, ranging from $225,000 to $275,000. Awards are expected to begin on or about September 30, 1996, and will be made for a 12-month budget period within a project period of up to two years. Funding estimates may vary and are subject to change. Continuation awards within the project period will be made on the basis of satisfactory progress and the availability of funds. Purpose The purpose of this announcement is to stimulate formative research on behavioral intervention strategies to further reduce HIV transmission by men who know that they are HIV-seropositive. Funding under this cooperative agreement will support the collection of qualitative and quantitative data in the development and evaluation of pilot behavioral intervention programs for HIV-seropositive men. These intervention activities should be designed to motivate and support HIV- seropositive men in sustaining sexual practices that reduce the risk and prevent HIV transmission to seronegative partners. It is expected that cooperative agreement recipients will conduct the formative research according to a common protocol that will be developed collaboratively with other cooperative agreement recipients including CDC. The intervention, or its core elements, will be piloted and evaluated on a limited basis during the award period. The ultimate goal of this formative research is the identification of potential intervention strategies for HIV-seropositive men that are appropriate for implementation in community settings (e.g., local health departments, community-based organizations, health maintenance organizations) and that merit further evaluation to determine their effectiveness in sustaining reduced-risk sexual practices. Program Requirements In conducting activities to achieve the purpose of this program the recipient will be responsible for the activities under A. (Recipient Activities), and CDC will be responsible for the activities listed under B. (CDC Activities). A. Recipient Activities 1. Collaborate with other recipients to refine research and intervention protocols and data collection instruments. 2. Establish procedures to maintain the rights and confidentiality of all study participants, including review of research activities by applicant's and CDC's Internal Review Board (IRB). 3. Identify, recruit, obtain informed consent, and enroll an adequate number of research participants according to procedures specified in the study protocol. 4. Conduct interviews and other assessments according to the research protocol. 5. Summarize data and conduct analyses for the recipient's own site. 6. Establish a standardized format for data entry to facilitate cross-site analyses. 7. Collaborate with other recipients in the preparation and dissemination of research findings in peer-reviewed journals and at professional meetings. B. CDC Activities 1. Host a meeting(s) of the award recipients to plan key aspects of the research program. CDC will convene additional meetings as needed. 2. Act as mediator on the recipients' collaborative design of this research, including data collection protocols and instruments, and intervention protocols. 3. Monitor, coordinate, and evaluate scientific and operational conduct and accomplishments of this research project in order to keep all recipients on track with the common protocols and their timelines. 4. Coordinate cross-site data aggregation and the analysis of aggregate data. 5. Participate in the preparation of study findings for publication and presentation. 6. Conduct site visits to assess program progress and mutually solve problems, as needed. Evaluation Criteria Applications that meet the eligibility requirements will be reviewed and evaluated according to the following criteria: 1. Familiarity with and access to HIV-seropositive men (20 points). a. Extent of applicant's knowledge of issues faced by HIV- seropositive men and experience in working with this population; b. Existence of linkages to facilitate recruitment from and referral to programs providing services for HIV-seropositive men and; c. Feasibility of plans to involve HIV positive men, their advocates, or service providers in the development of research and intervention activities. (1) 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 will be documented. (2) The proposed plan for the inclusion of racial and ethnic minority populations for appropriate representation. (3) The proposed justification when representation is limited or absent. 2. Formative research plan (25 points). a. Quality of the proposed formative research plan, including research questions, methodology, sampling strategies, data summary methods, and procedures for obtaining subjects' consent and protecting their confidentiality and; b. Thoroughness of description of proposed study group(s). 3. Intervention research plan (20 points). a. Quality, feasibility, and theoretical bases of the suggested behavioral intervention; b. Appropriateness of the suggested research design, including recruitment and randomization of subjects, process and outcome measures, schedule for data collection; c. Adequacy of methods for obtaining informed consent, maintaining participant confidentiality, and addressing any potential ethical issues associated with the suggested research strategy and; d. A statement as to whether the design of the study is adequate to measure racial and ethnic differences when warranted. 4. Research and intervention capability (25 points). a. Ability of the applicant to perform the technical aspects of the project as reflected in the training, research, and behavioral intervention experience of the applicant's staff; b. Applicant's expertise in the application of qualitative and quantitative data collection methods used in behavioral science and; [[Page 30908]] c. Quality and outcomes of applicant's previous HIV intervention and research efforts. 5. Staffing, facilities, and time line (10 points). a. Availability of qualified and experienced personnel with sufficient time dedicated to the proposed project. Presence of behavioral scientists in key leadership positions on the project; b. Clarity of the described duties and responsibilities of project personnel; c. Stated agreement to work collaboratively with CDC and other cooperative agreement recipients in developing common research, intervention, and evaluation protocols and to disseminate study findings; d. Adequacy of the facilities, equipment, data management resources, and systems for ensuring data security and; e. Specificity and reasonableness of time line. 6. Budget (not scored). Extent to which the budget is reasonable, itemized, clearly justified, and consistent with the intended use of the funds. Funding Priorities This announcement is for formative research proposals that lead to the development of innovative pilot programs for reducing HIV transmission by men who know they are HIV positive. Priority will be given to projects that focus on reducing the sexual risk of HIV transmission by HIV-seropositive men who are (1) men who have sex with men (regardless of sexual identity) or (2) male injecting drug users. Involvement of HIV-seropositive men, their advocates, or service providers in the design of research and intervention activities is required. Based upon available funding, applications will be accepted for behavioral intervention studies targeting other high-risk populations that have not been adequately addressed. Interested persons are invited to comment on the proposed funding priorities. All comments received on or before July 24, 1996, will be considered before the final funding priority is established. If the funding priorities should change as a result of any comments received, a revised Announcement will be published in the Federal Register prior to the final selection of awards. Written comments should be addressed to: Van Malone, Grants Management Officer, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E15, Atlanta, GA 30305. Executive Order 12372 Review Applications are subject to Intergovernmental Review of Federal Programs as governed by Executive Order (E.O.) 12372. E.O. 12372 sets up a system for State and local government review of proposed Federal assistance applications. Applicants (other than federally recognized Indian tribal governments) should contact their State Single Point of Contact (SPOC) as early as possible to alert them to the prospective applications and receive any necessary instructions on the State process. For proposed projects serving more than one State, the applicant is advised to contact the SPOC for each affected State. A current list of SPOCs is included in the application kit. If SPOCs have any State process recommendations on applications submitted to CDC, they should send them to Van Malone, Grants Management Officer, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E15, Atlanta, GA 30305, no later than 30 days after the application deadline (the appropriation for this financial assistance program was received late in the fiscal year and would not allow for an application receipt date which would accommodate the 60-day State recommendation process period). The granting agency does not guarantee to ``accommodate or explain'' for State process recommendations it receives after that date. Indian tribes are strongly encouraged to request tribal government review of the proposed application. If tribal governments have any tribal process recommendations on applications submitted to the CDC, they should forward them to Van Malone, Grants Management Officer, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E15, Atlanta, GA 30305. This should be done no later than 30 days after the application deadline date. The granting agency does not guarantee to ``accommodate or explain'' for tribal process recommendations it receives after that date. Public Health System Reporting Requirements This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based nongovernmental applicants must prepare and submit the items identified below to the head of the appropriate State and/or local health department agency(s) in the program area(s) that may be impacted by the proposed project no later than the receipt date of the Federal Application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided: A. A copy of the face page of the application (SF 424). B. A summary of the project that should be titled ``Public Health System Impact Statement'' (PHSIS), not exceed one page, and include the following: 1. A description of the population to be served; 2. A summary of the services to be provided and; 3. A description of the coordination plans with the appropriate State and/or local health agencies. If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant. Catalog of Federal Domestic Assistance Number The Catalog of Federal Domestic Assistance number is 93.941. Other Requirements Paperwork Reduction Act Projects that involve the collection of information from 10 or more individuals and funded by the cooperative agreement will be subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act. Human Subjects If the proposed project involves research on human subjects, the applicant must comply with the Department of Health and Human Services Regulations, 45 CFR Part 46, regarding the protection of human subjects. Assurance must be provided to demonstrate that the project will be subject to initial and continuing review by an appropriate institutional review committees. In addition to other applicable committees, Indian Health Service (IHS) institutional review committees also must review the project if any component of IHS will be involved or will support the research. If any American Indian community is involved, its tribal government must also approve that portion of the project applicable to it. The applicant will be responsible for providing assurance in accordance with the appropriate [[Page 30909]] guidelines and form provided in the application kit. Racial and Ethnic Minorities It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian, Alaskan Native, Asian, Pacific Islander, Black and Hispanic. Applicants shall ensure that racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, dated Friday, September 15, 1995. HIV/AIDS Requirements Recipients must comply with the document entitled Content of AIDS- Related Written Materials, Pictorials, Audiovisuals, Questionnaires, Survey Instruments, and Educational Sessions (June 1992), a copy of which is included in the application kit. At least one member of the program review panel must be an employee (or designated representative) of the health department consistent with the Content guidelines. The names of the review panel members must be listed on the Assurance of Compliance for CDC 0.1113, which is also included in the application kit. The recipient must submit, as an attachment to the quarterly summaries, the program review panel's report that all material have been reviewed and approved. Application Submission and Deadlines 1. Preapplication Letter of Intent A non-binding letter of intent-to-apply is required from potential applicants. An original and two copies of the letter should be submitted to the Grants Management Branch, CDC (see ``Applications'' for the address). It should be postmarked no later than July 24, 1996. The letter should identify the announcement number, name of principal investigator, and specify the activity(ies) to be addressed by the proposed project. The letter of intent does not influence review or funding decisions, but it will enable CDC to plan the review more efficiently, and will ensure that each applicant receives timely and relevant information prior to application submission. 2. Applications An original and two copies of the application PHS Form 5161-1 (OMB Number 0937-0189) must be submitted to Van Malone, Grants Management Officer, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E- 15, Atlanta, GA 30305, on or before August 19, 1996. 3. Deadlines A. Applications shall be considered as meeting the deadline if they are either: 1. Received on or before the deadline date; or 2. Sent on or before the deadline date and received in time for submission to the objective review group. (Applicants must request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or the U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.) B. Applications that do not meet the criteria in 3.A.1. or 3.A.2. above are considered late applications. Late applications will not be considered in the current competition and will be returned to the applicant. Where to Obtain Additional Information To receive additional written information call (404) 332-4561. You will be asked to leave your name, address, and telephone number and will need to refer to Announcment 630. You will receive a complete program description, information on application procedures and application forms. If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from Adrienne Brown, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 255 East Paces Ferry Road, NE., Room 300, Mailstop E-15, Atlanta, GA 30305, telephone (404) 842-6634, email: <[email protected]>. Programmatic technical assistance may be obtained from 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]>. Please refer to Announcement 630 when requesting information and submitting an application. Potential applicants may obtain a copy of ``Healthy People 2000,'' (Full Report, Stock No. 017-001-00474-0) or ``Healthy People 2000,'' (Summary Report, Stock No. 017- 001-00473-1) referenced in the Introduction, through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325, telephone (202) 512-1800. Internet Home Page The announcement will be available on one of two Internet sites on the publication date: CDC's home page at <http://www.cdc.gov>, or at the Government Printing Office home page (including free access to the Federal Register) at <http://www.access.gpo.gov.>. There may be delays in mail delivery and difficulty in reaching the CDC Atlanta offices during the 1996 Summer Olympics. Therefore, CDC suggests using Internet, following all instructions in this announcement and leaving messages on the contact person's voice mail for more timely responses to any questions. Dated: June 11, 1996. Joseph R. Carter, Acting Associate Director for Management and Operations, Centers for Disease Control and Prevention (CDC). [FR Doc. 96-15382 Filed 6-17-96; 8:45 am] BILLING CODE 4163-18-P