[Federal Register Volume 64, Number 108 (Monday, June 7, 1999)] [Notices] [Pages 30335-30339] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-14281] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Program Announcement 99098] Strengthening HIV/AIDS and STD Prevention Through Use of Behavioral Data in Programmatic Decision Making; Notice of Availability of Funds A. Purpose The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 1999 funds for competitive cooperative agreement awards to (1) Better understand state and local decision- making processes that involve the use of HIV- and STD-related behavioral data, and (2) enhance the availability and utilization of high-quality HIV/STD behavioral data for meeting the needs of HIV/AIDS and STD prevention program planners. Use of scientifically credible behavioral data is expected to strengthen HIV/AIDS/STD prevention by enhancing decision makers' ability to target priority populations, precisely design programs that address local HIV risk factors, and respond quickly to changing prevention needs within their jurisdictions. This Program Announcement addresses the Healthy People 2000 priority areas of (18) HIV infection, (19) Sexually Transmitted Diseases, and (22) Surveillance and Data Systems. Effective HIV/AIDS and STD prevention programs include the development, implementation, and evaluation of HIV behavioral risk- reduction interventions that address the specific needs of at-risk populations within their communities. To help achieve these objectives, public health decision makers need accurate, timely, and relevant data about HIV/STD risk behaviors and their determinants for groups within their jurisdictions. However, in some jurisdictions, HIV/STD behavioral risk data may be incomplete, unavailable, of poor quality, or out of date. In other areas, useful data are available but may not be effectively used in HIV and STD prevention program planning. This process is intended to support research to answer several overarching questions: (1) How are HIV/AIDS/STD prevention decisions made? (2) How do behavioral data currently inform these decisions? (3) What gaps currently exist with respect to the match between available behavioral data and current decision-making needs? (4) What data and analyses can address key program decisions for setting community HIV/ STD prevention priorities? (5) How can decision makers make better use of existing data? (6) In what measurable ways can HIV/STD prevention programs be improved by enhancements in the capacity of local decision makers to use behavioral data? B. Eligible Applicants Assistance will be provided only to the health departments of States or their bona fide agents, including the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Mariana Islands, American Samoa, Guam, federally recognized Indian tribal governments, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau. In consultation with States, assistance may be provided to political subdivisions of States. C. Availability of Funds Approximately $600,000 is available in FY 1999 to make up to 3 awards. CDC anticipates that the average award amount will range from $180,000 to $220,000 for the first year of the project. An application requesting more than $220,000 (including indirect costs) will not be considered for review and will be returned to the applicant. Awards are expected to begin on or about September 30, 1999. Initial awards will be made for a 12-month budget period, with support anticipated for a project period of up to 4 years. Limited funds are anticipated to be available for the fourth year to support dissemination. These estimates may vary and are subject to change. Continuation awards within the project period will be made on the basis of satisfactory progress as evidenced by required reports and the availability of funds. Use of Funds Funds may not be used to support laboratory testing; salary for medical personnel to perform clinical services; pharmaceuticals; or facility rental. D. Program Requirements In conducting activities to achieve the purpose of this Program Announcement, recipients will be responsible for activities under ``Recipient Activities,'' and CDC will be responsible for the activities under ``CDC Activities'' listed below. 1. Recipient Activities a. Phase I: Baseline Study Phase: Design and conduct a baseline study that systematically describes current HIV and STD prevention program decision-making processes in your jurisdiction, with specific attention to behavioral data. Focus should be on decision making by health departments and associated community planning groups and on the data used to support these purposes. Include evaluation of the data for decision making purposes in terms of its availability, scientific quality, and utility. Note gaps in data quality, availability, or interpretability that constrain decision making. b. Meetings and Collaboration: Meet and collaborate with other recipients and CDC staff in the design, revision, and implementation of all aspects of the [[Page 30336]] project. Meetings will occur twice yearly. c. Phase II: Intervention Activities: Design and implement activities to address the quality, availability, interpretation, or application of behavioral data with respect to the jurisdiction's HIV/ STD prevention needs. Activities should address data gaps or barriers to data utilization identified in the baseline study. d. Evaluation: Evaluate the effects of intervention activities on jurisdictional HIV/STD program decision making and associated outcomes, including changes in policy, service delivery, resource allocation, or risk behavior monitoring. e. Dissemination of Findings: Disseminate findings of the baseline and intervention studies in peer-reviewed scientific journals and at professional and community meetings. f. Obtain Permissions and Consent: Obtain all needed permissions, consent, and reviews for carrying out project activities, including Institutional Review Board (IRB) clearances at the local level and provide documentation and materials necessary for review and approval by CDC IRB. 2. CDC Activities a. Assist recipients in the design, revision, and implementation of all project protocols: (1) Host an initial meeting to review and coordinate proposals and conduct subsequent follow up meetings. (2) Conduct site visits, as needed, for each recipient. Monitor site activities and progress toward meeting project objectives. (3) Work with recipient staff, as needed, to resolve research and implementation issues related to project protocols. This includes the provision of technical assistance during the baseline study and the intervention phase. b. Provide general project oversight: (1) Review and assist with or provide guidance on behavioral surveys, sampling, questionnaire design, rapid assessment methodologies, data analysis techniques, and ethnographic methodologies, as well as other elements of protocol design or methods. (2) Participate in analysis of data gathered from program activities; assist in reporting and disseminating results. (3) Conduct site visits, as needed, to assess program progress and evaluate progress reports to ensure that objectives are being accomplished and terms and conditions of the award are being met. (4) Assist in development of research protocols resulting from this project that are subject to Institutional Review Board (IRB) review by all cooperating institutions participating in the research project. The CDC IRB will review and approve the protocol initially and on an annual basis until the research project is completed. E. Application Content Submit a proposal that includes plans for addressing all activities outlined in the program requirements section. The application may not exceed 30 double-spaced pages, excluding table of contents, abstract, and appendices (appendices are the appropriate location for references, publications, resumes, MOA, sample reports, and other supportive documents). Print all materials double-spaced, in a 12 point or larger font size, on one side of 8\1/2\'' by 11'' paper with at least 1'' margins. Number each page. Submit your application unbound and unstapled. Applications that exceed the 30-page limit, excluding attachments, will not be reviewed and will be returned to the applicant. Achieving the main objectives of this project will require participation from HIV community planning groups and may benefit from the participation of academic researchers, particularly in areas such as decision making models, development of new data systems, and specialized data management or analysis functions. Therefore, applicants should demonstrate evidence of strong collaborative partnerships among these parties. Memoranda of agreement (MOA) showing existence of, or intent to collaborate with the applicant must accompany the proposal for funding. MOA should delineate the specific roles and activities to be performed by the collaborating partners. Use the following outline to organize their proposals: 1. Title and Abstract: The title and abstract should be a clear 1- page summary of the applicant's proposal. 2. Background: Describe the HIV/AIDS epidemic in your jurisdiction, recent STD epidemiology, and the programmatic responses, i.e., funding priorities and prevention efforts. Whenever possible, cite specific data and sources referenced, e.g., epidemiologic characteristics, behavioral risk factors, or documented community conditions that place groups at elevated HIV/STD risk within the jurisdiction. Note changes in HIV/STD prevalence and incidence rates, with special attention to populations that have recently emerged as a major focus of programmatic intervention. Finally, describe the characteristics of HIV and STD prevention programs developed over the past 5 to 10 years within the jurisdiction. 3. Assessment of Existing Data: Describe current content, utility, adequacy, and scientific merit (e.g., reliability, validity, sampling methodology) of behavioral data available to the applicant. Also describe uses of these data in HIV program decision making. Provide similar descriptions for relevant sources of biomedical or other epidemiological data for use in local HIV and STD prevention decision making. Relevant CDC-sponsored data sources, as well as data from academic sources, vital statistics registries, census data, or case data from other public agencies should be included, as appropriate. 4. Phase I: Baseline Study Phase: Describe: a. The proposed baseline study to examine HIV and STD prevention program decision making, with particular attention given to the current use of behavioral data, as well as other data types. For the purposes of this study, ``decision making'' is defined as those activities that involve program planning, development, monitoring, and evaluation, as well as allocation of financial, personnel, and material resources. Similarly, ``decision makers'' include those individuals or groups within the jurisdiction who have authority for determining how these actions are carried out in HIV and STD prevention programs. Describe who the key decision makers are in the locality and provide a summary of their responsibilities within their respective groups or organizations. b. Key decision making factors and how they will be measured. c. The overall research design to be used for the baseline study. d. Approaches for identifying the role behavioral data currently have in decision making, as well as ways to identify potential gaps or needs related to behavioral data and HIV prevention in the jurisdiction. If formal or theoretical models of decision making are proposed, describe them and cite appropriate literature in the list of references. e. Evaluate existing sources of data, particularly behavioral data, in terms of availability, scientific quality, timeliness, ease of analysis and interpretation, as well as utility for prevention program decision making. f. Plans for using baseline study results to develop a descriptive or empirical decision-making model for the jurisdiction that incorporates better utilization of behavioral data. g. All data collection methods and instruments to be used. [[Page 30337]] h. Anticipated approaches to data management, specific analysis techniques, and software tools. 5. Phase II: Intervention Phase: Describe: a. The anticipated study design for addressing potential gaps or needs identified during the baseline study, e.g., pre and post- intervention comparison, quasi-experimental, experimental. b. The anticipated features of the intervention activities, i.e., what steps are anticipated for enhancing the availability, quality, or use of behavioral data in decision making. c. How intervention activities are to be carried out. d. Key decision makers. e. Anticipated barriers and facilitators of data use. f. All assessment or evaluation methods and instruments to be used to assess the effects of these intervention activities on HIV and STD prevention program decision making, e.g., sampling, procedures for review of archival documents, key informant interviews, ethnographic observation, surveys, or other methods. g. How changes in key-decision making variables will be measured in relation to anticipated changes in the quality, availability, or use of behavioral data. h. Plans for data management, specific analysis techniques, and software tools. i. How the methods, variables, and instruments used during the intervention (including evaluation) will provide comparability with methods, variables, and instruments used in the baseline study. 6. Staffing Plan and Organizational Commitment: The application should: a. Explain the proposed staffing plan and organizational commitment for the baseline and the intervention phases, including the percentage of time each staff member will commit to the project. b. Provide evidence that the proposed staff have the capacity and experience to conduct all the proposed activities. c. Include copies of curriculum vitae for the staff in the appendix of the proposal. d. Include copies of previous staff publications in the appendix, if relevant. e. Provide evidence of strong collaborative partnerships between HIV prevention program decision makers, community planning groups, and academic researchers. Describe collaborations in detail, and provide signed and dated copies of MOA and letters of support between participating partners. 7. Dissemination Plan: Describe plans for disseminating findings from the baseline study and the intervention through peer-reviewed scientific journals and presentation to appropriate professional and community audiences. Meetings such as the CDC-sponsored HIV Prevention Summit, as well as more academic meetings, should be considered. 8. Time Line: Provide a detailed time line for completion of all the proposed activities, including anticipated meetings with other recipients and CDC staff. It is expected that the baseline study will require 9-12 months, while implementation, evaluation, and dissemination of the intervention activities and associated findings will require the remainder of the 4-year project period. 9. Permissions and Human Subjects: Describe plans for obtaining all formal permissions and reviews needed for carrying out project activities, including human subjects protection (Institutional Review Board) plans, as well as procedures for safeguarding data collected during the project. Application adequately addresses the requirements of 45 CFR part 46 for the protection of human subjects. Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research are met. Documentation of study design adequacy measure group differences is present. Documentation of recruitment and outreach plans for study participants includes the process of establishing partnerships with community(ies) and recognition of mutual benefits. 10. Budget: Provide a detailed, line-item budget for carrying out all proposed activities, including travel expenses for meetings with other recipients and CDC staff and a budget narrative that justifies each line item. F. Submission and Deadline Submit the original and two copies of the complete application along with Form PHS 5161-1 (OMB Number 0937-0189). On or before July 20, 1999, submit the application to: Brenda Hayes, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention, 2920 Brandywine Road, Room 3000, Mail Stop E-15, Atlanta, GA 30341-4146. Applications shall be considered as meeting the deadline if they are either received on or before the deadline date or sent on or before the deadline date and received in time for submission to the independent review group. (Applicants must request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or U.S. Postal Service. Private metered postmarks shall not be acceptable as proof of timely mailing.) Applications that do not meet these criteria are considered to be late, will not be considered, and will be returned to the applicant. G. Evaluation Criteria Each application will be evaluated individually against the following criteria by an independent review group appointed by CDC. 1. Background (10 Points) a. Quality, completeness, and specificity of the description of HIV/AIDS and STD epidemiology within the applicant's jurisdiction. b. Quality, completeness, and specificity of the description of programmatic response to prevention needs over the past 5 to 10 years. c. Adequacy of appropriate supporting data and reference citations. 2. Assessment of Existing Data (10 Points) Quality, completeness, and specificity of the description of the content, utility, and adequacy of existing behavioral data for the applicant's jurisdiction, along with known uses of these data in current HIV program decision making. Similar descriptions of other data, such as biomedical or epidemiological information used in HIV and STD program decision making. Appropriate sources should be cited in the references. 3. Phase I: Baseline Study Plans (25 Points) a. Clarity, completeness, and scientific quality of the plans to conduct a baseline study on how behavioral and other types of data are used in local HIV and STD prevention program decision making. b. Clarity, scientific credibility, and feasibility of plans for all baseline study components including overall research design; sampling plan; methods and data collection protocols and instruments; description and measurement of key variables related to decision making, as well as potential barriers and facilitators that may contribute to the quality, availability, and use of data in HIV and STD prevention programs; data management and analysis plans; and appropriate software tools. c. Quality of the explanation of how results will be used to develop a model of decision making for the jurisdiction; the model will delineate the role of behavioral data relative to other factors [[Page 30338]] that might influence HIV and STD program decision making. d. Quality of plans to identify specific needs and gaps related to behavioral data important for HIV and STD program decision making, including the extent to which needs and gaps related to women and racial and ethnic minority populations are addressed. 4. Phase II: Intervention Plans (30 Points) a. Clarity, completeness, and scientific quality of the plans to conduct and evaluate an intervention to address the gaps identified in the baseline study. Intervention activities should focus on enhancing data quality, availability, or utilization as they relate to HIV and STD prevention decision making. b. Clarity, scientific credibility, and feasibility of plans for all intervention components, including overall intervention design; anticipated types of intervention activities; methods and data collection protocols, variables, and instruments needed for evaluating the intervention; sampling, data management and analysis plans; and appropriate software tools. c. Comparability of evaluation methods and data used during intervention phase with those used during the baseline study. d. Likelihood that the intervention will improve the quality and availability of behavioral data, promote their use in decision-making and improve the overall quality and effectiveness of the local HIV prevention programs. e. Likelihood that the evaluation plans and methods can accurately document these improvements in a scientifically credible manner. 5. Staffing Plan and Organizational Commitment (10 Points) Clarity of proposed staffing plan. Participating staff and organizations are qualified, committed, and available for carrying out the proposed activities. Strong evidence is provided that documents relevant staff experience and capabilities. Copies of curriculum vitae or resumes are included in an appendix. Roles of participating individuals and organizations are clearly described and are adequate for completing the proposed work. Detailed and dated memoranda of agreement or letters of support, written on appropriate institutional letterhead, are provided in an appendix. Evidence is included of past collaboration between the participating organizations or individual staff. Applicant describes a strong commitment to collaborate with other recipients and CDC staff involved with the project. 6. Dissemination Plans (5 Points) Quality, completeness, and specificity of plans for disseminating findings from the baseline and intervention phases of the project. Include plans for written publications in peer-reviewed scientific journals and presentation to appropriate professional and community audiences. 7. Time Line (5 Points) A detailed, clear, complete, and feasible time line is provided. Time line includes plans for participating in meetings with other recipients and CDC staff, as described in the Recipient Activities section of this Program Announcement. 8. Permissions and Human Subjects (5 Points) Includes plans for human subject review (Institutional Review Board [IRB]) as well as procedures for safeguarding data and other information or records gathered during the project. Clear and appropriate plans are provided for obtaining all formal permissions and reviews needed for the project at all levels (i.e, applicable local IRBs; provide necessary documentation for review by CDC IRB). Does the application adequately address the requirements of 45 CRF part 46 for the protection of human subjects? ____ Yes ____No Comments:-------------------------------------------------------------- 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 9. Budget (Not Scored) A detailed line item budget is provided. Budget expenditures are well-justified and appropriate. Budget includes line-items for attending project meetings described in the Recipient Activities section of this Program Announcement. Travel for these meetings should be budgeted with Atlanta as the destination for all meetings, although the location may rotate among sites. H. Other Requirements 1. Technical Reporting Requirements. Provide CDC with original plus two copies of semiannual progress reports, 30 days after the end of each reporting period. The progress reports must include the following for each program, function, or activity involved: a. Progress in achieving stated goals. b. Reasons that any goals were not met. c. A description of steps taken to overcome barriers to accomplishing the goals for the period. 2. Financial status report, no more than 90 days after the end of the budget period. 3. Final financial status and performance reports, no more than 90 days after the end of the project period. 4. 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 and Racial and Ethnic Minorities in Research AR98-4 HIV/AIDS Confidentiality Provisions AR98-5 HIV Program Review Panel Requirements AR98-7 Executive Order 12372 Review 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 Section 301 and 317 (k) (2) of the Public Health Service Act (42 U.S.C. 241 and 247b(k) (2) as amended. The catalog of Federal Domestic Assistance Number is 93.941. J. Where to Obtain Additional Information To receive additional written information and to request an application kit, call 1-888-GRANTS4 (1-888-472-6874). You will be asked to leave your name and address and will be instructed to identify the Announcement number of interest (99098). You may view or download this and other CDC/ATSDR Program Announcements, and download application forms, at the following web site: HTTP://WWW.CDC.GOV If you have questions after reviewing the contents of all the documents, business management technical [[Page 30339]] assistance may be obtained from: Brenda Hayes, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Room 3000, Atlanta, Georgia 30341-4146, Telephone: (770) 488-2720, Email: [email protected]. Programmatic technical assistance can be obtained from: Robert Kohmescher, Behavioral Intervention Research Branch, Division of HIV/ AIDS Prevention, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, NE, Mailstop E-37, Atlanta, GA 30333, Telephone: 404-639- 1900, Fax: 404-639-1950, Email: [email protected]. See also the CDC home page on the Internet: HTTP://WWW.CDC.GOV. Dated: June 1, 1999. John L. Williams, Director, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC). [FR Doc. 99-14281 Filed 6-4-99; 8:45 am] BILLING CODE 4163-18-P