[Federal Register Volume 64, Number 100 (Tuesday, May 25, 1999)] [Notices] [Pages 28196-28200] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-13141] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention (CDC) [Announcement Number 99067] Cooperative Agreement for an Evaluation Research Study in the Area of Aggression and Interpersonal Youth Violence; 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 a cooperative agreement to identify organizations to participate in a multiple site violence prevention evaluation study. This program addresses the ``Healthy People 2000'' priority area of Violent and Abusive Behavior. The purpose of this prevention study is to determine the effectiveness of a middle school-based, social cognitive intervention to reduce violence, and to determine the impact of including a community-based intervention that complements the school-based activities. CDC is seeking applicants interested in collaborating with other recipients funded under this announcement in the development and implementation of the violence prevention evaluation study. B. Eligible Applicants Applications may be submitted by public and private nonprofit and for-profit organizations and by governments and their agencies; that is universities, colleges, research institutions, hospitals, other public and private nonprofit organizations, State, local governments or their bona fide agents, and federally recognized Indian tribal governments, Indian tribes, or Indian tribal organizations. Note: Pub. L. 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 $1,700,000 is available in FY 1999 to fund three awards. It is expected that the average award will be $565,000, ranging from $400,000 to $600,000. It is expected that the awards will begin on or about September 30, 1999 and will be made for a 12-month budget period within a project period up to four years. Funding estimates may change. [[Page 28197]] 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. 1. Use of Funds The initial budget period (Year 1) will serve as a planning year to prepare projects for institutional review, develop and plan the specific social-cognitive intervention to be implemented in the school setting and the specific community programming that will be used to complement the school-based efforts, develop the common protocol, determine which participants will serve as intervention and comparison groups, determine training needs and staffing requirements for implementation years, and develop instruments. Program implementation is expected to take place in Years 2 and 3. The final year of the project period will be utilized for data analysis, the writing of final reports, and dissemination activities. 2. Budgets Budgets should include costs for travel for two project staff to attend three planning meetings (10/99, 2/00, and 6/00) in Atlanta with CDC staff and other cooperative agreement recipients. D. Funding Preferences Important considerations for funding under this announcement are a national geographic balance among the potential study sites. Priority will also be given to competing applications that demonstrate an existing collaboration in middle schools utilizing social cognitive interventions to reduce violence. E. Program Requirements In conducting activities to achieve the purpose of this program, the recipient will be responsible for the activities listed under 1. (Recipient Activities), and CDC will be responsible for the activities listed under 2. (CDC Activities): 1. Recipient Activities a. Design and develop intervention components, data collection instruments, implementation and evaluation study protocols, and data management procedures. b. Collaborate with other cooperative agreement recipients in the development and evaluation of intervention components, analysis of data, and dissemination of results. c. Establish goals and realistic, measurable, and time-oriented objectives for all phases of the project. d. Pilot test research instruments for data collection. e. Recruit, obtain informed consent from, and enroll an adequate number of study participants as determined by the study protocol and program requirements. f. Collect and compile monitoring (process) and outcome data. g. Pool data for analyses and publication and develop and analyze site-specific data. h. Publish results in peer review journals or other appropriate distribution. 2. CDC Activities a. Provide technical assistance in the design and conduct of the research. b. Provide technical advice and guidance in the development of study protocols, consent forms, and data collections forms. c. Assist in the development of a research protocol for Institutional Review Board review by all cooperating institutions participating in the research project. The CDC Institutional Review Board will review and approve the protocol initially and on at least an annual basis until the research project is complete d. Assist in designing a data management system. e. Arrange for information sharing among the various projects and facilitate coordination of research activities among the different sites. f. Assist in the analyses of research information and presentation and publication of research findings. g. Assist in the transfer of information and methods developed in these projects to other prevention programs. F. Application Content Use the information in the Program Requirements, Other Requirements, and Evaluation Criteria sections to develop the application content. Your application will be evaluated on the criteria listed, so it is important to follow them in laying out your program. The application may not exceed 25 double-spaced pages in length, excluding appendices (the abstract, budget justification, and attachments) (i.e., letters of commitment, data collections forms, resumes, etc). Applicants should provide a one-page abstract of the proposal. Number all pages clearly and sequentially and include a complete index to the application and appendices. The original and each copy of the application must be submitted UNSTAPLED and UNBOUND. Print all material, double spaced, in a 12-point or larger font on 8\1/2\ by 11 paper, with at least 1'' margins and printed on one side only. The application should include a general introduction, followed by one narrative subsection per application content element in the order in which the elements appear below. Each narrative subsection should be labeled with the element title and contain all of the information needed to evaluate that element of the application (except for curriculum vita, references, and letters of support, which are appropriate for the appendices). The application content elements are outlined below for all research issues. 1. Abstract A one page summary of the application outlining the target population and location of intervention activities, experience delivering the intervention components, experience with evaluation research methods and the management of complex interventions, project management and staffing, and proposed collaborations. 2. Description of the Target Population The application needs to identify the specific target population for the study and the location or setting in which the intervention activities will take place. The application should include the following information: a. Identification of the various middle schools to participate in the evaluation study and description of their demographic characteristics (i.e. type of school--public, private/parochial, urban, rural, size of school, grade levels, composition of student population, e.g., gender, race/ethnicity, percentage of students receiving reduced or free meals; IOWA basic skills scores and grade equivalencies). b. Demographic information for study participants (e.g., targeted age group or grade levels, sex, race/ethnic background). c. Pertinent available morbidity and violence-related data (e.g., physical fights or injury-related incidents at school, weapon-carrying, suspension/expulsion rates, absenteeism) (See Addendum 2 for definition of high incidence of physical fighting and weapon-carrying). d. The prevalence or incidence within the target group of any cognitive, attitudinal, or behavioral characteristics that will be influenced by the intervention. e. Projected sample size per school for the evaluation study, including statistical power calculations to justify sample size and expected levels of attrition on final sample size and power. [[Page 28198]] f. Demographic characteristic of neighborhood (i.e. population size, race/ethnicity, socioeconomic status, unemployment rates, county- level aggravated assault and homicide rates, high school drop-out rates) (See Addendum 2 for definition of high incidence of homicide). g. Applicant must describe the capacity, feasibility, and/or prior experience of the targeted schools to link with appropriate community- based organizations or mental health or social service agencies (e.g., do the selected schools have any experience with parent training activities, after-school programs, or have referral mechanisms in place for children in need of additional social or counseling services?). h. The applicant should include a detailed description of the procedures that makes the applicant compliant with CDC's Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research. The applicant's procedures should include: (1) A 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. 3. Access to Target Population a. This section should provide evidence that the applicant or a full working partner has access to the target population for proposed intervention and evaluation activities. b. The application should include letters of commitment from the targeted schools indicating knowledge of proposed activities (i.e., implementation and evaluation of a social cognitive intervention and appropriate community-based programming to complement the school-based activities) and agreement to provide access to the target population, facilities, and relevant records (e.g., aggregate-level suspension/ expulsion, absenteeism, disciplinary data). c. Letters of commitment should indicate a willingness to facilitate the implementation of intervention activities and collection of appropriate evaluation data. 4. Experience Delivering Intervention Components a. The applicant should provide a detailed description and documented support (e.g., abstracts, presentations, published peer- reviewed manuscripts) of prior experience in the area of youth violence prevention and experience with designing and implementing school-based, social-cognitive interventions and any related intervention components (e.g., parent training, mental health/psychological services, mentoring, after-school programs, etc). b. The applicant should describe the types of programs previously delivered; the frequency, intensity, and duration of previous programs; the settings and targeted age groups; and the manner in which previous programs were staffed and monitored. 5. Experience with Evaluation Research a. Applicants should provide a detailed description and documented support (e.g., abstracts, presentations, published peer-reviewed manuscripts) of prior experience with the management of complex intervention trials, prior experience or the experience of a full working partner in evaluation research methods, and their ability or the ability of a full working partner to collect, manage, and analyze both quantitative and qualitative data. b. Applicants should describe the nature and scope of programs previously evaluated; the types of evaluation designs utilized for these studies, the targeted age groups evaluated; and the settings in which the evaluations took place. c. This section should also describe familiarity with various statistical approaches for analyzing complex evaluation data (e.g., ANCOVA, MANOVA, Hierarchical Linear Modeling, Growth Curve Analysis, Repeated Measures Analysis, Mixed Effects Models, etc.) and any prior experience with analyzing and modeling multi-level prevention data. 6. Project Management and Staffing Plan a. The applicant should demonstrate the availability of staff and facilities to carry out Year 1 planning and development activities. b. The applicant should describe in detail each existing or proposed position for the planning year by job title, function, general duties, and activities for which that position will be involved. It should include the level of effort and allocation of time for each project activity by staff position. If the identity of any individual who will fill a position is known, his/her name and curriculum vitae should be attached. c. Management operation principles, structure, and organization should be described. d. This section should also describe available resources and facilities for processing and maintaining data for analysis. 7. Collaboration a. This section should describe and document current and proposed collaborations between schools, community-based organizations, and university or other research organizations working with the specified target population. b. The application should include letters of commitment and/or memoranda of understanding which specify precisely the nature of past, present, and proposed collaborations, and the products/services or other activities that will be provided by and to the applicant through the collaboration on the proposal. c. The applicant should describe their willingness to collaborate with the other cooperative agreement recipients funded under this announcement on all phases of the project (e.g., development and evaluation of intervention components, analysis of data, and dissemination of results). d. The applicant should further describe current or past funding that has been received for similar projects and the outcomes of these projects. Evidence should be provided that these funds do not duplicate already funded components of ongoing projects. 8. Human Subjects a. The applicant should describe the degree to which human subjects may be at risk and what protections will be in place to assure protection and confidentiality. b. The applicant should demonstrate that it has adequately addressed the requirements of Title 45 CFR Part 46 for the protection of human subjects. 9. Budget Provide a detailed budget for each priority activity to be undertaken during the planning year, with accompanying justification of all operating expenses that is consistent with the stated activities under this program announcement. Applicants should be precise about the purpose of each budget item and should itemize calculations wherever appropriate. [[Page 28199]] G. Application Submission and Deadline 1. Letter of Intent Although not a prerequisite of application (optional), a non- binding letter of intent-to-apply is requested from potential applicants. The letter should identify the announcement number, name of principal investigator, and specify the priority area to be addressed by the proposed project. The letter of intent does not influence review or funding decisions, but it will enable CDC to determine the level of interest in the announcement and to plan the review more efficiently. On or before June 11, 1999, submit the letter of intent to the Grants Management Specialist identified in the ``Where to Obtain Additional Information'' section of this announcement. 2. Application Submit the original and two copies of the application PHS-5161-1 (OMB Number 0925-0001). Forms are in the application kit. On or before July 19, 1999, submit the application to the Grants Management Specialist identified in the ``Where to Obtain Additional Information'' section of this announcement. a. Deadline: 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 orderly processing. 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. b. Late applications: Applications which do not meet the criteria in a.1 or a.2 above are considered late applications, will not be considered, and will be returned to the applicant. H. Evaluation Criteria Applications which are complete and determined to be responsive will be subjected to a preliminary evaluation (triage) by a Special Emphasis Panel (SEP) to determine if the application is of sufficient technical and scientific merit to warrant further review by the SEP. CDC will withdraw from further consideration applications judged to be noncompetitive and promptly notify the principal investigator/program director and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated individually against the following criteria by a Special Emphasis Panel (Maximum 100 total points): 1. Description of Target Population (10 Points) a. The extent to which the target population is clearly identified, has a high incidence or prevalence of the risk factors to be influenced by intervention activities, and supported with appropriate demographic, morbidity and violence-related data. b. The extent to which the settings for the intervention components are clearly described; adequate for reaching the target population; and suggest a need for violence prevention programming. c. The extent to which the capacity, feasibility, and/or experience of the targeted schools to link with appropriate community-based resources or programming is described and documented. d. The extent to which sample size estimates, power estimates, and anticipated attrition of the target population are clarified, reasonable, and sufficient for evaluation activities. e. 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. 2. Access to the Target Population (15 Points) a. The extent to which targeted schools are identified and access to the target population is demonstrated. b. The extent to which applicant provides proof of commitment from the targeted schools (e.g., letters from school principals indicating knowledge of proposed activities and agreement to provide access to the target population, relevant records, facilities) and their willingness to facilitate the implementation of intervention activities and collection of appropriate evaluation data. 3. Experience Delivering Intervention Components (25 Points) a. The extent to which the applicant has documented (e.g., abstracts, presentations, peer-reviewed publications) prior experience designing and implementing school-based, social-cognitive interventions and related community intervention components (e.g., parent training, mental health/psychological services, after-school programs, mentoring, etc). b. The extent to which applicant's prior experience, or that of a full working partner, is relevant to proposed activities under this program announcement, reflects a high degree of expertise, and is sufficient for accomplishing proposed activities under this announcement. 4. Experience With Evaluation Research (25 Points) a. The extent to which applicant demonstrates prior experience managing complex intervention trials, prior experience with evaluation research methods, and has the capacity and relevant expertise to collect, manage, and analyze both quantitative and qualitative data. b. The extent to which the applicant demonstrates expertise and familiarity with a range of statistical approaches for analyzing complex evaluation data (e.g., ANCOVA, MANOVA, Repeated Measures Analysis), and has prior experience with analyzing and modeling multi- level prevention data (e.g., using Hierarchical Linear Modeling, Growth Curve Analysis, Mixed Effects Models). 5. Project Management and Staffing Plan (10 Points) a. The extent to which the research team and other project personnel are clearly described, appropriately assigned (i.e., duties, responsibilities, time allocation), and have pertinent training, skills, qualifications, and experiences. b. The extent to which the applicant or a full working partner has the capacity to successfully complete proposed implementation activities and the facilities, equipment, and data management resources to successfully complete proposed evaluation activities. c. The extent to which management operation, structure, and/or organization is described. 6. Collaboration (15 Points) a. The extent to which the applicant is willing to collaborate with the other cooperative agreement recipients funded under this announcement on all phases of the project (e.g., the development and evaluation of intervention components, analysis of data, and dissemination of results). b. The extent to which the necessary partners are clearly described and their qualifications and intentions to participate explicitly stated. The extent to which the applicant provides proof of commitment (e.g., letters of commitment and/or memoranda of understanding) from proposed collaborators (other than school partners) for project activities. c. Evidence should be provided that these funds do not duplicate already funded components of ongoing projects. [[Page 28200]] 7. Human Subjects (Not Scored) The extent to which procedures for the protection of human subjects are described and adequately address the requirements of the Department of Health and Human Resources (45 CFR part 46) for the protection of human subjects. 8. Budget (Not Scored) The extent to which the budget request is clearly explained, adequately justified, reasonable, sufficient for proposed year 1 activities and consistent with the intended use of these cooperative agreement funds. I. Other Requirements Technical Reporting Requirements Provide CDC with the original and two copies of: 1. A semiannual progress report no later than 30 days after the end of each six month period. Semiannual progress reports should include: a. A brief description of the project; b. A comparison of the actual accomplishments to the goals and objectives established for the period; c. Documentation of both the reason for the deviation and the anticipated corrective action or deletion of the activity from the project if established goals and objectives were not accomplished or were delayed; and d. Other pertinent information, including the analysis of information collected. 2. Financial status reports are required no later than 90 days after the end of each budget period. 3. Final financial status and performance reports are required 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. The following additional requirements are applicable to this program. For a complete description of each, see Addendum 1. AR-1 Human Subjects Requirements AR-2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research AR-9 Paperwork Reduction Act Requirements AR-10 Smoke-Free Workplace Requirements AR-11 Healthy People 2000 AR-12 Lobbying Restrictions AR-13 Prohibition on Use of CDC Funds for Certain Gun Control Activities J. Authority and Catalog of Federal Domestic Assistance Number This program is authorized under section 301(a), 391, and 393 (42 U.S.C. 241(a), 280b, and 280b-1a) of the Public Health Service Act, as amended. The Catalog of Federal Domestic Assistance number is 93.262. K. Where To Obtain Additional Information This and all other CDC Announcements may be found and downloaded from the CDC homepage. Internet address: http://www.cdc.gov (click on funding). 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. If you have questions after reviewing the contents of all the documents, business management technical assistance may be obtained from: Ricky Willis, Grants Management Specialist, Grants Management Branch, Procurement and Grants Office, Announcement 99067, Centers for Disease Control and Prevention 2920 Brandywine Road, Suite 3000, Mailstop E-13, Atlanta, GA 30341-4146; Telephone (770) 488-2719; E- mail: [email protected] For program technical assistance contact: Wendy Watkins, Project Officer, National Center for Injury Prevention and Control, Centers for Disease Control and Prevention, 4770 Buford Highway, NE, Mailstop K-60, Atlanta, GA 30341;Telephone (770)-488-1567; E-mail address: [email protected] Dated: May 19, 1999. John L. Williams, Director, Procurement and Grants Office, Centers for Disease Control, and Prevention (CDC). [FR Doc. 99-13141 Filed 5-24-99; 8:45 am] BILLING CODE 4163-18-P