[Federal Register Volume 64, Number 100 (Tuesday, May 25, 1999)] [Notices] [Pages 28200-28203] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 99-13140] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Program Announcement 99100] Human Immunodeficiency Virus (HIV) Related Applied Research and Professional Education Projects; Notice of Availability of Funds A. Purpose The Centers for Disease Control and Prevention (CDC) announces the availability of funds beginning in fiscal year (FY) 1999 for cooperative agreements to conduct human immunodeficiency virus (HIV) related applied research and professional education in the control and prevention of HIV. The purpose of this program is to encourage new and innovative methods to further the prevention of HIV infection. Projects that will be considered for funding are applied research or professional education for the control and prevention of HIV. This program addresses the ``Healthy People 2000'' priority areas of HIV Infection, Sexually Transmitted Diseases, and Immunization and Infectious Diseases. National Program Goals CDC's national strategic goals for the programs supported by the National Center for HIV, STDs and TB Prevention are: 1. Increase public understanding of, involvement in, and support for HIV, STDs, and TB prevention. 2. Ensure completion of therapy for persons identified with active TB or TB infection. 3. Prevent or reduce behaviors or practices that place persons at risk for HIV and STDs infection or, if already infected, place others at risk. 4. Increase individual knowledge of HIV sero status and improve referral systems to appropriate prevention and treatment services. 5. Assist in building and maintaining the necessary State, local, and community infrastructure and technical capacity to carry out necessary prevention programs. 6. Strengthen the current systems and develop new systems to accurately monitor HIV, STDs, and TB, as a basis for assessing and directing prevention programs. B. Eligible Applicants Eligible applicants will include universities, colleges, research institutions, hospitals, public and private non-profit organizations, community-based, national, and regional organizations, State and local governments or their bona fide agents or instrumentalities, federally recognized Indian Tribal governments, Indian tribes or 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 $500,000 is available in FY 1999 to fund approximately four awards. It is expected that the average award will be $125,000, ranging from $100,000-$300,000. Funding estimates [[Page 28201]] are subject to change. It is expected that awards will begin in September, 1999, and will be made for a 12 month budget period within a project period of up to three years. Funding estimates are subject to change. Continued support in future years will be based on the availability of funds and success in demonstrating progress toward achievement of objectives. Program Priority Areas Funding Priorities Interested persons are invited to comment on the proposed funding priorities. All comments received within 30 days after publication in the Federal Register will be considered before the final funding priority is established. If the funding priority changes because of comments received, a revised announcement will be published in the Federal Register, and revised applications will be accepted before the final selections are made. Address comments to the Grants Management Specialist listed in the ``Where to Obtain Additional Information'' section of this announcement. 1. Among HIV-infected persons receiving medical care, prevent development of opportunistic infections and prevent or delay progression to AIDS and death. 2. Develop, pilot, evaluate, and transfer technology of HIV rapid testing and counseling strategies. 3. Among national organizations representing health professionals who provide prenatal or neonatal care, assist in the national dissemination of perinatal HIV transmission information, resources, and interventions to pediatricians, obstetricians, family practitioners, nurse practitioners, and other health care providers. 4. The identification and characterization of recently HIV-infected persons in specific populations or geographic areas; or the assessment of HIV incidence in selected high-risk populations or social networks in geographically-defined communities where HIV incidence is known or expected to be high; or use of HIV incidence data to evaluate prevention interventions. 5. Develop and implement methods to improve access to care of HIV- infected person and to reduce HIV associated morbidity and mortality among persons in medical care. 6. Pilot test, implement, and evaluate perinatal HIV transmission prevention programs to domestic and global prevention partners, e.g., ministries of health, UNAIDS, UNICEF. D. Program Requirements Recipient activities to achieve the purposes of this program will vary by project. CDC will be responsible for the activities under CDC Activities. 1. Recipient Activities (applied research). a. Complete the development of the research protocol. b. Carry out the activities according to the approved protocol. c. Ensure that appropriate approvals are secured for the protection of human subjects, Office of Management and Budget and Paperwork Reduction Act, privacy, confidentiality, and data security. d. Compile and disseminate findings. 2. Recipient Activities (professional education). a. Develop and disseminate HIV prevention education and training programs and materials. b. Evaluate the materials and their dissemination. c. Report and disseminate results and recommendations and relevant HIV prevention and education and training information to appropriate health-care providers, HIV/AIDS prevention and service organizations, and the general public. 3. CDC Activities. a. Monitor and evaluate scientific and operational accomplishments of the project through periodic site visits, frequent telephone calls, and review of technical reports and interim data analysis. b. For recipients whose project involves collaboration with a State or local health department, CDC will assist in facilitating the planning and implementation of the necessary linkages with local or State health departments and assist with the developmental strategies for applied clinical or prevention oriented research programs. c. Facilitate the technological and methodological dissemination of successful prevention and intervention models among appropriate target groups, such as, State and local health departments, community based organizations, and other health professionals. d. As requested, provide technical assistance in planning and evaluating strategies and protocols. E. Application Content Letter of Intent (LOI) Potential applicants must submit an original and two copies of a two-page typewritten Letter of Intent (LOI) that briefly describes the title of the project, purpose and need for the project, and funding priority which it addresses. Current recipients of CDC funding must provide the award number and title of the funded programs. No attachments, booklets, or other documents accompanying the LOI will be considered. LOI's will be reviewed by CDC program staff and an invitation to submit a full application will be made based on the documented need for the proposed project, relationship to funding priorities, and the availability of funds. LOI's may focus on more than one programmatic priority area. An invitation to submit a full application does not constitute a commitment by CDC to fund the applicant. Application Applications may be submitted only after a Letter of Intent has been approved by CDC and a written invitation from CDC has been extended to the prospective applicant. Applicants who are invited to submit a full application must submit the original and five copies of PHS-398 (OMB Number 0925-0001) (adhere to the instructions on the Errata Instruction Sheet for PHS 398). Forms are in the application kit. The application narrative should consist of: 1. Abstract (Not to exceed 1 page): An executive summary of your program covered under this announcement, specifying whether your program is applied research or professional education. 2. Program Plan (Not to exceed 10 pages): In developing the application under this announcement, please review the recipient activities and, in particular, evaluation criteria and respond concisely and completely. 3. Budget: Submit an itemized budget and supporting justification that is consistent with your proposed program plan. F. Submission and Deadlines Letter of Intent (LOI) One Original and Two Copies of the LOI must be postmarked on or before June 21, 1999. (Facsimiles Are Not Acceptable.) Application Submit the original and five copies of the application on Form PHS 398 (OMB Number 0925-0001). Forms are available at the following Internet address: HTTP://WWW.CDC.GOV/OD/PGO/FROMINFO.HTM or in the application kit. On or before July 23, 1999, submit your application to the Grants Management Specialist listed in [[Page 28202]] the ``Where to Obtain Additional Information'' section of this announcement. Deadline: Letters of Intent and Applications shall be considered as meeting the deadline if they are either: 1. Received on or before the deadline date, or 2. Postmarked on or before the deadline date and received in time for submission to the objective review committee. (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 late applications and will be returned to the applicant without review. G. Evaluation Criteria Letters of Intent responding to this announcement will be evaluated on the documented need for the proposed activities and the relationship to the listed funding priorities. Each application will be evaluated individually against the following criteria by an independent review group appointed by CDC. 1. Applied Research a. The inclusion of a brief review of the scientific literature pertinent to the study being proposed and specific research questions or hypotheses that will guide the research. The originality and need for the proposed research, the extent to which it does not replicate past or present research efforts, and how findings will be used to guide prevention and control efforts. (25 points) b. The quality of the plans to develop and implement the study, including 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 communities and recognition of mutual benefits. (25 points) c. Extent to which proposed activities, if well executed, support attaining project objectives. (25 points). d. Extent to which personnel involved in this project are qualified, including evidence of past achievements appropriate to the project, and realistic and sufficient time commitments. Evidence of adequacy of facilities and other resources supported to carry out the project. (25 points). e. Other (not scored). (1) Budget: Will be reviewed to determine the extent to which it is reasonable, clearly justified, consistent with the intended use of the funds, and allowable. All budget categories should be itemized. (2) Human Subjects: Does the application adequately address the requirements of Title 45 CFR part 46 for the protection of human subjects? 2. Professional Education a. Extent to which the applicant demonstrates the scientific soundness of the technology to be transferred. (25 points) b. The extent to which the applicant's description of the proposed material relates to HIV prevention and education, responds to a specific public health need, and can be expected to influence public health practices. (25 points) c. The adequacy and commitment of institutional resources to administer the program. (25 points) d. The degree to which the application demonstrates that all key personnel have education and expertise relative to its objectives. (25 points) e. Budget: Will be reviewed to determine the extent to which it is reasonable, clearly justified, consistent with the intended use of the funds, and allowable. All budget categories should be itemized. Funding decisions on approved applications will depend on the area of interest of the proposals, their relationship to NCHSTP National Program Goals, and the quality of the application. H. Other Requirements Technical Reporting Requirements Provide CDC with original plus two copies of: 1. An annual progress report, 2. Financial status report, no more than 90 days after the end of the budget period, and 3. Final financial status report and performance report, no more than 90 days after the end of the project period. Send all reports to the Grants Management Specialist identified in the ``Where to Obtain Additional Information'' section of this announcement. The following additional requirements are applicable to this program. For a complete description of each, see attachment 1 in the application kit. AR-1--Human Subjects Requirements (applied research only) AR-2--Inclusion of Women and Racial and Ethnic Minorities in Research Requirements (applied research only) AR-4--HIV/AIDS Confidentiality Provisions AR-5--HIV Program Review Panel Requirements AR-6--Patient Care Prohibitions AR-9--Paperwork Reduction Act Requirements AR-10--Smoke-Free Workplace Requirements AR-11--Healthy People 2000 AR-12--Lobbying Restrictions I. Authority and Catalog of Federal Domestic Assistance Number This program is authorized under the Public Health Service Act, section 317(k)(2)(42 U.S.C. 247b(k)(2)), as amended. The Catalog of Federal Domestic Assistance numbers are 93.941, HIV Demonstration, Research, Public and Professional Education; 93.943, Epidemiologic Research Studies of Acquired Immunodeficiency Syndrome (AIDS) and Human Immunodeficiency Virus (HIV) Infection in Selected Population Groups. J. Where to Obtain Additional Information To receive additional written information and to request an application kit, call 1-888-472-6874. You will be asked to leave your name and address and will be instructed to identify the announcement of interest. This and other CDC announcements are also available through the CDC home page on the Internet. The address for the CDC home page is HTTP:// www.cdc.gov. If you have questions after reviewing the contents of all documents, business management technical assistance may be obtained from: Sheryl Disler, Grants Management Specialist, Grants Management Branch, Centers for Disease Control and Prevention (CDC), 2920 Brandywine Road, Mailstop E-15, Room 3000, Atlanta, GA 30341-4146, telephone (770) 488-2756 or facsimile at (770) 488-2777, or INTERNET address: HTTP://[email protected] You may obtain programmatic technical assistance from: Peggy Bloom, National Center for HIV, STD and TB Prevention, Centers for Disease Control and Prevention (CDC), 1600 Clifton Road, NE, Atlanta, GA 30333, Telephone (404) 639-0927, INTERNET [[Page 28203]] address: HTTP://[email protected] Dated: May 19, 1999. John L. Williams, Director, Procurement and Grants Office, Centers for Disease Control and Prevention (CDC). [FR Doc. 99-13140 Filed 5-24-99; 8:45 am] BILLING CODE 4163-18-P