Surveillance of HIV/AIDS Related Events Among Persons Not Receiving Care, 38152-38157 [05-13016]

Download as PDF 38152 Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices study section convened by NCHSTP in accordance with the review criteria listed above. As part of the initial merit review, all applications may: • Undergo a process in which only those applications deemed to have the highest scientific merit by the review group, generally the top half of the applications under review, will be discussed and assigned a priority score. • Receive a written critique. • Receive a second programmatic level review by the NCHSTP. Award Criteria: Criteria that will be used to make award decisions during the programmatic review include: • Scientific merit (as determined by peer review) • Availability of funds • Programmatic priorities.’’ And replace with: ‘‘An objective review panel will evaluate complete and responsive applications according to the criteria listed in Section V.1. Criteria, above. The objective review will be performed by CDC employees, at least three voting panelists, and a nonvoting chairperson. All panelists will be from outside of the funding center. Each objective reviewer will have expertise in research, disease prevention behavioral interventions, or disease prevention programs. Each application will be worth 100 points and the panel will assign your application a score using the scored evaluation criteria as specified in the ‘‘V.1. Criteria’’ section above. Your application will be ranked based on this score. Applications will be considered for funding in order of score and rank as determined by the review panel.’’ On page 32629, Second column, Section VII. Agency Contacts, please delete the following: ‘‘For questions about peer review, contact: Mary Lerchen, DrPH, Scientific Review Administrator, Office of Public Health Research, Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop D72, Atlanta, GA 30333, Telephone: 404–371–5277, Fax: 404– 371–5215, E-mail: mlerchen@cdc.gov’’; and replace with: ‘‘For questions about the objective review, contact: Beth Wolfe, CDC, NCHSTP, OD, FASO; 1600 Clifton Road NE. M.S. E–07; Atlanta, GA 30333; Telephone: 404–639–8531; Email: eow1@cdc.gov. On page number 32629, Second column, Section VII. Agency Contacts, please delete the following: ‘‘For scientific/research issues, contact: Amy L. Sandul, Extramural Program Official, Office of the Associate Director for Science, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS E07, Atlanta, Georgia 30333, Telephone: 404–639–6485, Fax: VerDate jul<14>2003 18:11 Jun 30, 2005 Jkt 205001 404–639–8600, E-mail: ASandul@cdc.gov’’; and replace with: ‘‘For scientific/research issues, contact Kim Williams, PhD, Project Officer, CDC, NCHSTP, DHAP, IRS, PRB; 1600 Clifton Road N.E. M.S. E–37; Atlanta, GA 30333; Telephone: 404–639–6157; E-mail: ktw5@cdc.gov..’’ Dated: June 27, 2005. Alan A. Kotch, Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention. [FR Doc. 05–13014 Filed 6–30–05; 8:45 am] BILLING CODE 4163–18–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Surveillance of HIV/AIDS Related Events Among Persons Not Receiving Care Announcement Type: New. Funding Opportunity Number: PS05– 085. Catalog of Federal Domestic Assistance Number: 93.944. Key Dates: Application Deadline: August 1, 2005. Executive Summary: HIV/AIDS surveillance data have been used for describing the epidemic, planning prevention and treatment activities, developing treatment guidelines, advocating for resources, and allocating and prioritizing available resources within communities. The Health Resources Services Administration (HRSA) uses HIV/AIDS surveillance data from states to estimate severity of need to allocate nearly two billion in funding for HIV-related ambulatory care and support services available annually through the Ryan White Comprehensive AIDS Resources Emergency (CARE) Act. A committee from the Institute of Medicine (IOM) recently reviewed, at the request of Congress, the status of HIV/AIDS surveillance. In the resulting report, three populations of interest were outlined; • Persons infected with HIV, who do not have a diagnosis of HIV and are not receiving care. • Persons infected with HIV, who have a diagnosis of HIV but are not receiving care. • Persons infected with HIV, who have a diagnosis of HIV and are receiving care. Understanding how many and which persons in a community have a diagnosis of HIV but are not receiving care is critically important for PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 estimating the community’s resource needs. Of the estimated 850,000– 950,000 HIV-infected persons in the United States, an estimated 75 percent know they are infected. Of these, an estimated 50 percent do not have evidence of having received any medical care for their HIV infection. One of the goals of CDC’s Advancing HIV Prevention initiative is to provide HIV testing outside of traditional medical settings, and to increase linkage to HIV care for those whose HIV test results are positive. Because of treatment advances, more people with HIV infection are living longer and healthier lives. Persons who know they are infected can benefit from prophylaxis for opportunistic infections, monitoring of their immune status, and, when recommended, treatment with antiretroviral drugs. Additionally, new HIV therapies may reduce the degree of infectiousness by lowering viral load and thereby reducing HIV transmission. Therefore, to determine the extent of medical services and resources that will be needed for persons who are infected with HIV, but who have not received medical care, it is critically important to quantify and describe the number in this population. In addition, determining factors related to not receiving care will be important in designing effective interventions for linking persons to care. A supplemental surveillance system designed to produce population-based estimates of persons who have a diagnosis of HIV and are receiving care has been developed. Federal awards were made to 26 health departments to collect clinical and behavioral data among persons who have a diagnosis of HIV and are receiving care. Supplemental surveillance systems that collect data about those persons infected with HIV who are and are not receiving care will provide critically needed information on the quality of care and severity of need for care; barriers to receiving care; prevention; and support services at the local level. This information will assist local planning groups (i.e., community planning groups and local planning councils) in determining local allocation of CDC and Ryan White CARE Act funds. Additionally, this type of supplemental surveillance data will provide a means of evaluating new prevention initiatives (e.g., Advancing HIV Prevention) that focus on the provision of prevention services and linkage to care for persons living with HIV (PLWHA) infection. E:\FR\FM\01JYN1.SGM 01JYN1 Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices I. Funding Opportunity Description Authority: Sections 317(k)(2) and 318(c) of the Public Health Service Act (42 U.S.C. Sections 247b(k)(2) and 247c(c)), as amended. Purpose: The purpose of the program is to develop a supplemental HIV/AIDS surveillance system to identify persons who have a diagnosis of HIV infection and who are not receiving care. The collected data will be used to determine the potential added resources that will be required when this population is linked to care. This program addresses the Healthy People 2010 focus area(s) of: • Access to health care. • Disability and secondary conditions. • Community-based programs. • HIV. • Mental health. • Public health infrastructure. Measurable outcomes of the program will be in alignment with one or more of the following performance goal(s) for the National Center for HIV, STD and TB Prevention (NCHSTP) and the Division of HIV/AIDS Prevention (DHAP) Strategic Plan: • By 2010, increase to at least 80 percent the proportion of HIV-infected people who are linked to appropriate prevention, care, and treatment services, as measured by those who report having received some form of medical care within three months of their HIV diagnosis (2001 baseline: 79 percent). • Strengthen the capacity nationwide to monitor the epidemic; develop and implement effective HIV prevention interventions; and evaluate prevention programs. The data from this project will provide information that is necessary for developing and implementing effective interventions for linking prevention, treatment, and care, and encouraging the use of these services by HIV-infected persons who are not receiving care. Research Objectives: • To identify persons who have a diagnosis of HIV, but who are not receiving care. • To ascertain barriers to receiving care through patient interview. • To determine the clinical status of persons who have a diagnosis of HIV infection, but who are not receiving care, to estimate the added resources that would be required when these individuals are linked to care. Activities: Awardee activities for this program are as follows: • Collaborate with CDC to develop and review the required protocols. • Collaborate with CDC to develop and review the required data collection instruments. VerDate jul<14>2003 18:11 Jun 30, 2005 Jkt 205001 • Participate in required training activities. • Attend, as soon as feasible after awarding of funds, a principal investigators’ meeting at CDC to review and finalize the project protocol and data collection instruments. • Use state HIV/AIDS surveillance databases and supplemental laboratory databases to identify HIV-infected persons who are not receiving care. • Share with CDC the list of HIV infected persons not receiving care, by study code number but without identifiers, to determine whether all, or a representative sample of, HIV-infected persons not receiving care will be interviewed. • Conduct personal interviews of all, or a representative sample of, persons with HIV not receiving care to collect: demographic data; HIV testing history; high-risk drug use and sexual behaviors; reasons for not using health care; and other variables determined in collaboration with CDC. • If respondent consents, collect a sample of blood, such as a dried blood spot from a finger-stick, for further laboratory testing to include CD4 count, HIV viral load, and resistance testing. • Ship blood specimens for testing to participating laboratories according to shipping protocol. • Work with CDC to develop the database and database management capability for this project. • Collect and maintain a database of linked interview and laboratory data; maintain this information in an electronic database; periodically transmit this data to CDC with patient unique identifiers. No individual patient names will be transmitted to CDC. • Protect data in accordance with Appendix C of CDC’s Guidelines for HIV/AIDS Surveillance. Applicant must ensure that the program requirements detailed in the security standards are attained. • Participate in periodic conference calls and grantee meetings with other funded sites and CDC. • Disseminate findings jointly with CDC and other participating sites, particularly analyzing and summarizing data from local sites. • Participate in evaluation activities. In a cooperative agreement, CDC staff is substantially involved in the program activities, above and beyond routine grant monitoring. CDC Activities for this program are as follows: • Coordinate the development and review of the required protocols. • Coordinate the development and review of the required data collection instruments. PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 38153 • Convene a principal investigators’ meeting to review and finalize the project protocol and data collection instruments. • Participate in joint conference calls, grantee meetings, and site visits. • Assist project sites in compiling a list of HIV-infected persons not receiving care and describing that population. • On the basis of data submitted to CDC, determine whether all or a representative sample of HIV-infected persons not receiving care will be interviewed at each project site. • Provide training and technical support for interviewers, including technical support for the collection of blood, laboratory testing, electronic data collection, and data transfer to CDC. • Provide training and technical support for data management and data analysis of interview and laboratory data. • Jointly disseminate findings, particularly analyzing and summarizing aggregate data from all participating sites. II. Award Information Type of Award: Cooperative Agreement. CDC involvement in this program is listed in the Activities section above. Mechanism of Support: U01. Fiscal Year Funds: 2005. Approximate Total Funding: $1,500,000. (This amount is for the first 12-month budget period. This amount is an estimate and is subject to availability of funds.) Approximate Number of Awards: Four to Six. Approximate Average Award: $250,000. (This amount is for the first 12-month budget period.) Floor of Award Range: None. Ceiling of Award Range: $300,000. (This ceiling is for the first 12-month budget period.) Anticipated Award Date: August 31, 2005. Budget Period Length: 12 months. Project Period Length: Four years. Throughout the project period, CDC’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports), and the determination that continued funding is in the best interest of the federal government. III. Eligibility Information III.1. Eligible Applicants Because of the critical need to understand populations of persons with E:\FR\FM\01JYN1.SGM 01JYN1 38154 Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices a diagnosis of HIV who are receiving care and those who are not receiving care, eligible applicants are limited to those health departments or their bona fide agents in the jurisdictions randomly sampled by the RAND Corporation in a national probability sample and awarded funding under Program Announcement 04155, entitled ‘‘Morbidity and Risk Behavior Surveillance.’’ The following are the eligible jurisdictions: California; Chicago, Illinois; Delaware; Florida; Georgia; Houston, Texas; Illinois; Indiana; Los Angeles, California; Maryland; Massachusetts; Michigan; Mississippi; New Jersey; New York; New York City, New York; North Carolina; Oregon; Pennsylvania; Philadelphia, Pennsylvania; Puerto Rico; San Francisco, California; South Carolina; Texas; Virginia; and Washington. Eligibility is further restricted to sites (among those listed above) that: • Have mandated and implemented HIV infection reporting. • Have state laws/rules/regulations that mandate reporting of either all CD4 laboratory tests, regardless of test value (i.e., no cutoff level). OR Have all detectable HIV viral load laboratory tests. OR Have the authority to interpret existing state laws/rules/regulations to meet the above eligibility criteria. • Have implemented the laboratoryreporting requirement stated above (see the second eligibility criterion above) for at least one year. Eligible applicants are limited to the health departments in the jurisdictions randomly sampled by the RAND Corporation in a national probability sample and awarded funding under Program Announcement 04155, entitled ‘‘Morbidity and Risk Behavior Surveillance,’’ due to their participation in the initial phases of this research study. The study was initiated in response to a need for high-quality, population-based data on quality of care and severity of need for care, prevention, and support services on the local level to assist local planning groups (i.e., Community Planning Groups and local planning councils) in determining local allocation of CDC and Ryan White CARE Act funds. In order to implement a supplemental surveillance system, which will address these data needs, CDC developed a study design, which will rely on a national probability sample of persons with HIV infection to generate nationally representative estimates of clinical outcomes and HIV-related VerDate jul<14>2003 18:11 Jun 30, 2005 Jkt 205001 behaviors. The Health Care Services and Utilization Survey, conducted in the mid-1990s by the RAND CORPORATION, demonstrated the methodology as appropriate for this purpose. Briefly, CDC contracted with the RAND Corporation to draw a nationally representative sample of states using probability proportional to size methods. Based on availability of resources, 20 states were selected by RAND. In the 20 selected states, HIV care providers were randomly selected to participate in the study. For patients randomly selected from these providers, data on HIV care was abstracted from medical records, and the patients were offered participation in an interview. CDC has piloted these methods for population-based patient selection since 1998 in 12 areas in the Survey of HIV Disease and Care (SHDC) project. It is imperative to the fidelity and integrity of this research study that the recipients funded under Program Announcement 04155 are the only eligible entities for program activities proposed under this announcement, due to the nature of the activities already conducted by recipients, and the linkage and correlation between activities completed and study findings and the proposed activities. Eligible applicants may designate a bona fide agent to apply on behalf of their state. A bona fide agent is an agency or organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Place this documentation behind the first page of your application form. III.2. Cost Sharing or Matching Matching funds are not required for this program. III.3. Other CDC will accept and review applications with budgets greater than the ceiling of the award range. Special Requirements: If your application is incomplete or nonresponsive to the requirements listed in this section, it will not be entered into the review process. You will be notified that your application did not meet submission requirements. • Late applications will be considered nonresponsive. See Section ‘‘IV.3. Submission Dates and Times’’ for more information on deadlines. • Eligible applicants (as outlined in eligibility criteria) must supply evidence of having all of the following: PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 • Award of funds through PA 04155. You must include a copy of Notice of Award (NoA) for Program Announcement (PA) 04155 in the appendix. • State laws/rules/regulations that mandate HIV infection reporting. • State laws/rules/regulations that mandate all CD4 laboratory tests regardless of test value (i.e., no cutoff level). Copies of state laws/rules/ regulations must be submitted as part of the application in the appendix, and the applicant must refer to the specific language that addresses the eligibility criteria. OR All detectable HIV viral load laboratory tests OR The authority to interpret existing state laws/rules/regulations to meet eligibility criteria. Include a letter of justification, on official health department letterhead stationary, signed by the health department official who has the authority to interpret state laws/ rules/regulations, if interpretation of state laws/rules/regulations for reportable conditions has been used to justify eligibility. • Implemented the laboratory reporting requirement stated above (see second eligibility criteria above) for at least 1 year. • Documentation of eligibility must be included in the application in the appendix. Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive federal funds constituting an award, grant, or loan. Individuals Eligible to Become Principal Investigators: Any individuals who have the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC programs. IV. Application and Submission Information IV.1. Address to Request Application Package To apply for this funding opportunity, use application form PHS 398 (OMB number 0925–0001, rev. 5/2001). Forms and instructions are available in an interactive format on the CDC Web site, at the following Internet address: https://www.cdc.gov/od/pgo/ forminfo.htm. E:\FR\FM\01JYN1.SGM 01JYN1 Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices Forms and instructions are also available in an interactive format on the National Institutes of Health (NIH) Web site at the following Internet address: https://grants.nih.gov/grants/funding/ phs398/phs398.html. If you do not have access to the Internet, or if you have difficulty accessing the forms on-line, you may phone the CDC Procurement and Grants Office Technical Information Management Section (PGO–TIM) staff at 770–488–2700, and they will mail the application forms to you. IV.2. Content and Form of Application Submission Application: Follow the PHS 398 application instructions for content and formatting of your application. If the PHS 398 instructions differ in any way from those in this announcement, follow the instructions in this announcement. For further assistance with the PHS 398 application form, contact PGO–TIM staff at 770–488– 2700, or contact GrantsInfo, Telephone, (301) 435–0714, E-mail: GrantsInfo@nih.gov. Your research plan should address activities to be conducted over the entire project period. You are required to have a Dun and Bradstreet Data Universal Numbering System (DUNS) number to apply for a grant or cooperative agreement from the Federal government. Your DUNS number must be entered on line 11 of the face page of the PHS 398 application form. The DUNS number is a nine-digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy and there is no charge. To obtain a DUNS number, access https://www.dunandbradstreet.com or phone 1–866–705–5711. For more information, go to https://www.cdc.gov/ od/pgo/funding/pubcommt.htm. This announcement uses just-in-time concepts. This announcement uses nonmodular budgeting format. Additional requirements to submit additional documentation with your application are listed in Section ‘‘VI.2. Administrative and National Policy Requirements.’’ IV.3. Submission Dates and Times Application Deadline Date: August 1, 2005. Explanation of Deadlines: Applications must be received in the CDC Procurement and Grants Office by 4 p.m. Eastern Time on the deadline date. If you submit your application by the United States Postal Service or commercial delivery service, you must VerDate jul<14>2003 18:11 Jun 30, 2005 Jkt 205001 ensure that the carrier will be able to guarantee delivery by the closing date and time. If CDC receives your submission after closing due to: (1) Carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you will be given the opportunity to submit documentation of the carrier’s guarantee. If the documentation verifies a carrier problem, CDC will consider the submission as having been received by the deadline. This announcement is the definitive guide on the content of applications, addresses for submission, and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline above, it will not be eligible for review and will be discarded. You will be notified that your application did not meet the submission requirements. CDC will not notify you that your submission has been received. If you have a question about the receipt of your application, first contact your courier. If you still have a question, phone the PGO–TIM staff at 770–488– 2700, but please wait two to three days after the submission deadline. This will allow time for submissions to be processed and logged. IV.4. Intergovernmental Review of Applications Your application is subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (EO) 12372. This order sets up a system for state and local governmental review of proposed federal assistance applications. You should contact your state single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications, and to receive instructions on your state’s process. For the current SPOC list, go to https:// www.whitehouse.gov/omb/grants/ spoc.html. IV.5. Funding Restrictions Restrictions, which you must take into account while writing your budget, are as follows: • Funds relating to the conduct of research will not be released until the appropriate assurances and Institutional Review Board approvals are in place. • Reimbursement of pre-award costs is not allowed. If you are requestiing indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement. If PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 38155 your indirect cost rate is provisional, the agreement should have been made within the past 12 months. IV.6. Other Submission Requirements Application Submission Address: Submit the original and one hard copy of your application by mail or express delivery service to: Technical Information Management—RFA# PS05– 085, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Applications may not be submitted electronically at this time. V. Application Review Information V.1. Criteria Applicants are required to provide measures of effectiveness that will show that they have accomplished the various identified objectives of the cooperative agreement. Measures of effectiveness must relate to the performance goals stated in the ‘‘Purpose’’ section of this announcement. Measures must be objective and quantitative and must measure the intended outcome. These measures of effectiveness must be submitted with the application and will be an element of evaluation. Reviewers will be asked to evaluate the likelihood that the proposed research will have a substantial effect on the pursuit of the goals of CDCsupported research. These goals are as follows: • To advance the understanding of biological systems. • To improve the control and prevention of disease and injury. • To enhance health. The application will be evaluated against the following criteria: Methods (40 points): Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Are the proposed methods feasible? Will they accomplish the program goals? Will they address the required follow-up activities and methods in a timely manner? Are the objectives reasonable, time-phased, and measurable? Does the applicant provide reasonable methods to evaluate progress toward the timely accomplishment of objectives? Is documentation provided which supports the applicant’s ability to locate and enroll potentially hard-to-reach populations (e.g., data about sexually transmitted diseases or HIV partner counseling and referral programs, other research or surveillance projects)? Capacity (30 points): Is the investigator appropriately trained and E:\FR\FM\01JYN1.SGM 01JYN1 38156 Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers (if any)? Does the applicant have the appropriate staff to conduct this research? Do the job descriptions and curricula vitae for proposed and current staff indicate that they are appropriate for identifying and locating persons who have a diagnosis of HIV and who are not receiving care? Do the current or proposed staffs have the ability to conduct face-to-face interviews outside of an office setting? Does the current or proposed staff have the ability and the appropriate state-required qualifications to collect blood? Significance (20 points): Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field? What is the extent to which data have or will assist in HIV prevention and care activities? Objective (10 points): Does the applicant provide objectives which are reasonable, time-phased, and measurable? Does the applicant provide reasonable methods to evaluate their progress toward the timely accomplishment of the objectives? Additional Review Criteria: In addition to the above criteria, the following items will be considered in the determination of scientific merit and priority score: Protection of Human Subjects from Research Risks: Does the application adequately address the requirements of Title 45 CFR Part 46 for the protection of human subjects? This will be scored; an application can be disapproved if the research risks are sufficiently serious and protection against risks is so inadequate as to make the entire application unacceptable. Inclusion of Women and Minorities in Research: Does the application adequately address 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; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships VerDate jul<14>2003 18:11 Jun 30, 2005 Jkt 205001 with community(ies) and recognition of mutual benefits. Budget (Reviewed but not scored): The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. V.2. Review and Selection Process Applications will be reviewed for completeness by the Procurement and Grants Office (PGO) staff, and for responsiveness by NCHSTP. Incomplete applications and applications that are non-responsive to the eligibility criteria will not advance through the review process. Applicants will be notified the application did not meet submission requirements. An objective review panel comprised of CDC staff, outside of the funding division, will evaluate complete and responsive applications according to the criteria listed in the ‘‘V.1. Criteria’’ section above. The objective review process will follow the policy requirements as stated in the GPD 2.04 [https://198.102.218.46/doc/gpd204.doc.] Award Criteria: Award decisions during the programmatic review will be based on the following: • Scientific merit (as determined by the objective review panel). • Availability of funds. • Programmatic priorities. • Funding of applications in rank order as determined by the objective review panel. V.3. Anticipated Announcement and Award Dates August 31, 2005. VI. Award Administration Information VI.1. Award Notices Successful applicants will receive a Notice of Award (NoA) from the CDC Procurement and Grants Office. The NoA shall be the only binding, authorizing document between the recipient and CDC. The NoA will be signed by an authorized Grants Management Officer and mailed to the recipient fiscal officer identified in the application. Unsuccessful applicants will receive notification of the results of the application review by mail. VI.2. Administrative and National Policy Requirements 45 CFR Part 74 and Part 92 For more information on the Code of Federal Regulations, see the National Archives and Records Administration at https://www.access.gpo.gov/nara/cfr/cfrtable-search.html. The following additional requirements apply to this project: PO 00000 Frm 00067 Fmt 4703 Sfmt 4703 • AR–1 Human Subjects Requirements • AR–2 Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research • AR–4 HIV/AIDS Confidentiality Provisions • AR–5 HIV Program Review Panel Requirements • AR–6 Patient Care • AR–7 Executive Order 12372 • AR–8 Public Health System Reporting Requirements • AR–9 Paperwork Reduction Act Requirements • AR–10 Smoke-Free Workplace Requirements • AR–11 Healthy People 2010 • AR–12 Lobbying Restrictions • AR–14 Accounting System Requirements • AR–22 Research Integrity • AR–23 States and Faith-Based Organizations • AR–24 Health Insurance Portability and Accountability Act Requirements • AR–25 Release and Sharing of Data Additional information on these requirements can be found on the CDC Web site at the following Internet address: https://www.cdc.gov/od/pgo/ funding/ARs.htm. VI.3. Reporting You must provide CDC with an original plus two hard copies of the following reports: 1. Interim progress report, (use form PHS 2590, OMB Number 0925–0001, rev. 5/2001 as posted on the CDC Web site) no less than 90 days before the end of the budget period. The progress report will serve as your non-competing continuation application and must contain the following elements: a. Current Budget Period Activities and Objectives. b. Current Budget Period Financial Progress. c. New Budget Period Program Proposed Activities and Objectives. d. Budget. e. Measures of Effectiveness. f. Additional Requested Information. 2. Financial status report, no more than 90 days after the end of the budget period. 3. Final financial and performance reports, no more than 90 days after the end of the project period. These reports must be mailed to the Grants Management Specialist listed in the Agency Contacts section of this announcement. VII. Agency Contacts We encourage inquiries concerning this announcement. E:\FR\FM\01JYN1.SGM 01JYN1 Federal Register / Vol. 70, No. 126 / Friday, July 1, 2005 / Notices For general questions, contact: Technical Information Management Section, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770–488–2700. For scientific/research issues, contact: Norma S. Harris, PhD, Project Office, National Center for HIV, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop E–46, Atlanta, GA 30333. Telephone: 404–639–2090. Fax: 404– 639–8640. E-mail: NHarris@cdc.gov. For questions about the objective review, contact: Beth Wolfe, Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop E–07, Atlanta, GA 30333. Telephone: 404–639–8531. Fax: 404–639–8629. E-mail: Bwolfe@cdc.gov. For financial, grants management, or budget assistance, contact: Julia Valentine, Grants Management Specialist, CDC Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770–488–2732. E-mail: jxv1@cdc.gov. VIII. Other Information This and other CDC funding opportunity announcements can be found at https://www.cdc.gov. Click on ‘‘Funding’’ then ‘‘Grants and Cooperative Agreements.’’ Dated: June 27, 2005. Alan A. Kotch, Acting Director, Procurement and Grants Office, Centers for Disease Control and Prevention. [FR Doc. 05–13016 Filed 6–30–05; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Administration on Children, Youth and Families, Children’s Bureau; Consortium for Longitudinal Studies of Child Abuse and Neglect (LONGSCAN) Announcement Type: Initial. Funding Opportunity Number: HHS– 2005–ACF–ACYF–CA–0087. CFDA Number: 93.670. Due Dates for Applications: Application is due August 10, 2005. Executive Summary: The purpose of these grants is to support a fourth implementation phase of the Consortium for Longitudinal Studies of Child Abuse and Neglect, which is conducting and coordinating prospective studies of young children who are at risk or who have already experienced maltreatment. These VerDate jul<14>2003 18:11 Jun 30, 2005 Jkt 205001 studies are expected to contribute to the knowledge of the etiology and consequences of child maltreatment, and provide new insights into the prevention, identification and treatment of maltreatment. Priority Area 1 I. Funding Opportunity Description The purpose of these grants is to support a fourth implementation phase of the Consortium for Longitudinal Studies of Child Abuse and Neglect, which is conducting and coordinating prospective studies of young children who are at risk or who have already experienced maltreatment. These studies are expected to contribute to the knowledge of the etiology and consequences of child maltreatment, and provide new insights into the prevention, identification and treatment of maltreatment. Background LONGSCAN is a consortium of prospective studies designed to examine the life course of young children who are at risk of maltreatment or who have already been maltreated. Currently, the total projected sample size is about 1,500 children who are recruited at age four or younger. Baseline data is collected through child and primary caretaker interviews on all children in each of the studies at age four. Teacher assessments on each child are collected at subsequent follow-ups after the child enters school. The studies use common data collection instruments and a common developmental perspective so that applied analyses of data as well as comparisons among sites and sitespecific analyses can be accomplished. To date, the specific common measurement batteries have been selected for ages four, six, eight and twelve, and data have been collected on twelve-year-olds in some sites. Tracking is carried out annually. Each site is responsible for selecting and maintaining a sample to follow at the designated data points for up to twenty years. The study duration of twenty years has been selected for conceptual reasons only, and the actual duration of the effort will be contingent upon the availability of financial support. The Principal Investigators have signed and abide by a Governance Agreement that describes the operating structure of the Executive Board and seven Committees (Publication, Measures, Human Subjects, Communication, Field Procedures and Tracking, Data Handling and Analysis, Funding and Development) and policies related to ownership, local analysis and PO 00000 Frm 00068 Fmt 4703 Sfmt 4703 38157 authorship. The Executive Board and Committees meet twice a year and use the Internet in between to discuss issues that arise and to reach agreement on the most appropriate procedures and actions to take. Samples of children for the five sites vary by their level of risk and exposure to maltreatment. The studies include children identified at birth as at risk; children identified as at risk in pediatric clinics during their first year of life; children identified as at risk due to a report to a child protective services agency; children in treatment because of maltreatment; and children who have been removed from their families and placed in foster care following maltreatment. In addition to the common measures, each site also is collecting data. For example, one site has recruited children in their first year of life and has a special focus on use of videotaped observations of parent-child interactions as a means of assessing attachment and bonding. Two sites are obtaining information on the role of the fathers in caring for the children. As the grantees complete their fifteenth year of work, the sites have completed recruitment of their samples; collected site-specific data; selected, piloted and trained on administering measures for the age four, six, eight, and twelve, fourteen, and sixteen-year old follow-ups; developed procedures and conducted annual contact interviews with the samples; developed forms; and conducted CPS record reviews for their samples. During the first fifteen years of implementation, the Coordinating Center has provided for coordination of cross-site activities including measurement selection and development; production of instruments, operational manuals and training for site staff; development of the data entry system and training of site staff in entry and analysis; receipt and checks for the data; development, maintenance, documentation and distribution to sites of datasets; and conducted cross-site analyses. All sites will have completed the data collection on the four-, six-, and eight-year-olds, and most will have completed the data collection for twelve-year-olds. Consortium members have written papers and presented individually and on panels at various national professional conferences. The Administration on Children, Youth and Families’ (ACYF) Children’s Bureau seeks to fund a fourth phase of the Consortium for Longitudinal Studies to enable the completion of all data collection for children at ages twelve and sixteen in these samples, and to E:\FR\FM\01JYN1.SGM 01JYN1

Agencies

[Federal Register Volume 70, Number 126 (Friday, July 1, 2005)]
[Notices]
[Pages 38152-38157]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-13016]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Surveillance of HIV/AIDS Related Events Among Persons Not 
Receiving Care

    Announcement Type: New.
    Funding Opportunity Number: PS05-085.
    Catalog of Federal Domestic Assistance Number: 93.944.
    Key Dates: Application Deadline: August 1, 2005.
    Executive Summary: HIV/AIDS surveillance data have been used for 
describing the epidemic, planning prevention and treatment activities, 
developing treatment guidelines, advocating for resources, and 
allocating and prioritizing available resources within communities. The 
Health Resources Services Administration (HRSA) uses HIV/AIDS 
surveillance data from states to estimate severity of need to allocate 
nearly two billion in funding for HIV-related ambulatory care and 
support services available annually through the Ryan White 
Comprehensive AIDS Resources Emergency (CARE) Act.
    A committee from the Institute of Medicine (IOM) recently reviewed, 
at the request of Congress, the status of HIV/AIDS surveillance. In the 
resulting report, three populations of interest were outlined;
     Persons infected with HIV, who do not have a diagnosis of 
HIV and are not receiving care.
     Persons infected with HIV, who have a diagnosis of HIV but 
are not receiving care.
     Persons infected with HIV, who have a diagnosis of HIV and 
are receiving care.
    Understanding how many and which persons in a community have a 
diagnosis of HIV but are not receiving care is critically important for 
estimating the community's resource needs. Of the estimated 850,000-
950,000 HIV-infected persons in the United States, an estimated 75 
percent know they are infected. Of these, an estimated 50 percent do 
not have evidence of having received any medical care for their HIV 
infection. One of the goals of CDC's Advancing HIV Prevention 
initiative is to provide HIV testing outside of traditional medical 
settings, and to increase linkage to HIV care for those whose HIV test 
results are positive. Because of treatment advances, more people with 
HIV infection are living longer and healthier lives. Persons who know 
they are infected can benefit from prophylaxis for opportunistic 
infections, monitoring of their immune status, and, when recommended, 
treatment with antiretroviral drugs. Additionally, new HIV therapies 
may reduce the degree of infectiousness by lowering viral load and 
thereby reducing HIV transmission.
    Therefore, to determine the extent of medical services and 
resources that will be needed for persons who are infected with HIV, 
but who have not received medical care, it is critically important to 
quantify and describe the number in this population. In addition, 
determining factors related to not receiving care will be important in 
designing effective interventions for linking persons to care.
    A supplemental surveillance system designed to produce population-
based estimates of persons who have a diagnosis of HIV and are 
receiving care has been developed. Federal awards were made to 26 
health departments to collect clinical and behavioral data among 
persons who have a diagnosis of HIV and are receiving care. 
Supplemental surveillance systems that collect data about those persons 
infected with HIV who are and are not receiving care will provide 
critically needed information on the quality of care and severity of 
need for care; barriers to receiving care; prevention; and support 
services at the local level. This information will assist local 
planning groups (i.e., community planning groups and local planning 
councils) in determining local allocation of CDC and Ryan White CARE 
Act funds. Additionally, this type of supplemental surveillance data 
will provide a means of evaluating new prevention initiatives (e.g., 
Advancing HIV Prevention) that focus on the provision of prevention 
services and linkage to care for persons living with HIV (PLWHA) 
infection.

[[Page 38153]]

I. Funding Opportunity Description

    Authority: Sections 317(k)(2) and 318(c) of the Public Health 
Service Act (42 U.S.C. Sections 247b(k)(2) and 247c(c)), as amended.

    Purpose: The purpose of the program is to develop a supplemental 
HIV/AIDS surveillance system to identify persons who have a diagnosis 
of HIV infection and who are not receiving care. The collected data 
will be used to determine the potential added resources that will be 
required when this population is linked to care. This program addresses 
the Healthy People 2010 focus area(s) of:
     Access to health care.
     Disability and secondary conditions.
     Community-based programs.
     HIV.
     Mental health.
     Public health infrastructure.
    Measurable outcomes of the program will be in alignment with one or 
more of the following performance goal(s) for the National Center for 
HIV, STD and TB Prevention (NCHSTP) and the Division of HIV/AIDS 
Prevention (DHAP) Strategic Plan:
     By 2010, increase to at least 80 percent the proportion of 
HIV-infected people who are linked to appropriate prevention, care, and 
treatment services, as measured by those who report having received 
some form of medical care within three months of their HIV diagnosis 
(2001 baseline: 79 percent).
     Strengthen the capacity nationwide to monitor the 
epidemic; develop and implement effective HIV prevention interventions; 
and evaluate prevention programs.
    The data from this project will provide information that is 
necessary for developing and implementing effective interventions for 
linking prevention, treatment, and care, and encouraging the use of 
these services by HIV-infected persons who are not receiving care.
    Research Objectives:
     To identify persons who have a diagnosis of HIV, but who 
are not receiving care.
     To ascertain barriers to receiving care through patient 
interview.
     To determine the clinical status of persons who have a 
diagnosis of HIV infection, but who are not receiving care, to estimate 
the added resources that would be required when these individuals are 
linked to care.
    Activities:
    Awardee activities for this program are as follows:
     Collaborate with CDC to develop and review the required 
protocols.
     Collaborate with CDC to develop and review the required 
data collection instruments.
     Participate in required training activities.
     Attend, as soon as feasible after awarding of funds, a 
principal investigators' meeting at CDC to review and finalize the 
project protocol and data collection instruments.
     Use state HIV/AIDS surveillance databases and supplemental 
laboratory databases to identify HIV-infected persons who are not 
receiving care.
     Share with CDC the list of HIV infected persons not 
receiving care, by study code number but without identifiers, to 
determine whether all, or a representative sample of, HIV-infected 
persons not receiving care will be interviewed.
     Conduct personal interviews of all, or a representative 
sample of, persons with HIV not receiving care to collect: demographic 
data; HIV testing history; high-risk drug use and sexual behaviors; 
reasons for not using health care; and other variables determined in 
collaboration with CDC.
     If respondent consents, collect a sample of blood, such as 
a dried blood spot from a finger-stick, for further laboratory testing 
to include CD4 count, HIV viral load, and resistance testing.
     Ship blood specimens for testing to participating 
laboratories according to shipping protocol.
     Work with CDC to develop the database and database 
management capability for this project.
     Collect and maintain a database of linked interview and 
laboratory data; maintain this information in an electronic database; 
periodically transmit this data to CDC with patient unique identifiers. 
No individual patient names will be transmitted to CDC.
     Protect data in accordance with Appendix C of CDC's 
Guidelines for HIV/AIDS Surveillance. Applicant must ensure that the 
program requirements detailed in the security standards are attained.
     Participate in periodic conference calls and grantee 
meetings with other funded sites and CDC.
     Disseminate findings jointly with CDC and other 
participating sites, particularly analyzing and summarizing data from 
local sites.
     Participate in evaluation activities.
    In a cooperative agreement, CDC staff is substantially involved in 
the program activities, above and beyond routine grant monitoring.
    CDC Activities for this program are as follows:
     Coordinate the development and review of the required 
protocols.
     Coordinate the development and review of the required data 
collection instruments.
     Convene a principal investigators' meeting to review and 
finalize the project protocol and data collection instruments.
     Participate in joint conference calls, grantee meetings, 
and site visits.
     Assist project sites in compiling a list of HIV-infected 
persons not receiving care and describing that population.
     On the basis of data submitted to CDC, determine whether 
all or a representative sample of HIV-infected persons not receiving 
care will be interviewed at each project site.
     Provide training and technical support for interviewers, 
including technical support for the collection of blood, laboratory 
testing, electronic data collection, and data transfer to CDC.
     Provide training and technical support for data management 
and data analysis of interview and laboratory data.
     Jointly disseminate findings, particularly analyzing and 
summarizing aggregate data from all participating sites.

II. Award Information

    Type of Award: Cooperative Agreement.
    CDC involvement in this program is listed in the Activities section 
above.
    Mechanism of Support: U01.
    Fiscal Year Funds: 2005.
    Approximate Total Funding: $1,500,000.
    (This amount is for the first 12-month budget period. This amount 
is an estimate and is subject to availability of funds.)
    Approximate Number of Awards: Four to Six.
    Approximate Average Award: $250,000.
    (This amount is for the first 12-month budget period.)
    Floor of Award Range: None.
    Ceiling of Award Range: $300,000.
    (This ceiling is for the first 12-month budget period.)
    Anticipated Award Date: August 31, 2005.
    Budget Period Length: 12 months.
    Project Period Length: Four years.
    Throughout the project period, CDC's commitment to continuation of 
awards will be conditioned on the availability of funds, evidence of 
satisfactory progress by the recipient (as documented in required 
reports), and the determination that continued funding is in the best 
interest of the federal government.

III. Eligibility Information

III.1. Eligible Applicants

    Because of the critical need to understand populations of persons 
with

[[Page 38154]]

a diagnosis of HIV who are receiving care and those who are not 
receiving care, eligible applicants are limited to those health 
departments or their bona fide agents in the jurisdictions randomly 
sampled by the RAND Corporation in a national probability sample and 
awarded funding under Program Announcement 04155, entitled ``Morbidity 
and Risk Behavior Surveillance.'' The following are the eligible 
jurisdictions: California; Chicago, Illinois; Delaware; Florida; 
Georgia; Houston, Texas; Illinois; Indiana; Los Angeles, California; 
Maryland; Massachusetts; Michigan; Mississippi; New Jersey; New York; 
New York City, New York; North Carolina; Oregon; Pennsylvania; 
Philadelphia, Pennsylvania; Puerto Rico; San Francisco, California; 
South Carolina; Texas; Virginia; and Washington.
    Eligibility is further restricted to sites (among those listed 
above) that:
     Have mandated and implemented HIV infection reporting.
     Have state laws/rules/regulations that mandate reporting 
of either all CD4 laboratory tests, regardless of test value (i.e., no 
cutoff level).
     OR
    Have all detectable HIV viral load laboratory tests.
     OR
    Have the authority to interpret existing state laws/rules/
regulations to meet the above eligibility criteria.
     Have implemented the laboratory-reporting requirement 
stated above (see the second eligibility criterion above) for at least 
one year.
    Eligible applicants are limited to the health departments in the 
jurisdictions randomly sampled by the RAND Corporation in a national 
probability sample and awarded funding under Program Announcement 
04155, entitled ``Morbidity and Risk Behavior Surveillance,'' due to 
their participation in the initial phases of this research study. The 
study was initiated in response to a need for high-quality, population-
based data on quality of care and severity of need for care, 
prevention, and support services on the local level to assist local 
planning groups (i.e., Community Planning Groups and local planning 
councils) in determining local allocation of CDC and Ryan White CARE 
Act funds.
    In order to implement a supplemental surveillance system, which 
will address these data needs, CDC developed a study design, which will 
rely on a national probability sample of persons with HIV infection to 
generate nationally representative estimates of clinical outcomes and 
HIV-related behaviors. The Health Care Services and Utilization Survey, 
conducted in the mid-1990s by the RAND CORPORATION, demonstrated the 
methodology as appropriate for this purpose. Briefly, CDC contracted 
with the RAND Corporation to draw a nationally representative sample of 
states using probability proportional to size methods. Based on 
availability of resources, 20 states were selected by RAND. In the 20 
selected states, HIV care providers were randomly selected to 
participate in the study. For patients randomly selected from these 
providers, data on HIV care was abstracted from medical records, and 
the patients were offered participation in an interview. CDC has 
piloted these methods for population-based patient selection since 1998 
in 12 areas in the Survey of HIV Disease and Care (SHDC) project. It is 
imperative to the fidelity and integrity of this research study that 
the recipients funded under Program Announcement 04155 are the only 
eligible entities for program activities proposed under this 
announcement, due to the nature of the activities already conducted by 
recipients, and the linkage and correlation between activities 
completed and study findings and the proposed activities.
    Eligible applicants may designate a bona fide agent to apply on 
behalf of their state. A bona fide agent is an agency or organization 
identified by the state as eligible to submit an application under the 
state eligibility in lieu of a state application. If you are applying 
as a bona fide agent of a state or local government, you must provide a 
letter from the state or local government as documentation of your 
status. Place this documentation behind the first page of your 
application form.

III.2. Cost Sharing or Matching

    Matching funds are not required for this program.

III.3. Other

    CDC will accept and review applications with budgets greater than 
the ceiling of the award range.
    Special Requirements: If your application is incomplete or 
nonresponsive to the requirements listed in this section, it will not 
be entered into the review process. You will be notified that your 
application did not meet submission requirements.
     Late applications will be considered nonresponsive. See 
Section ``IV.3. Submission Dates and Times'' for more information on 
deadlines.
     Eligible applicants (as outlined in eligibility criteria) 
must supply evidence of having all of the following:
     Award of funds through PA 04155. You must include a copy 
of Notice of Award (NoA) for Program Announcement (PA) 04155 in the 
appendix.
     State laws/rules/regulations that mandate HIV infection 
reporting.
     State laws/rules/regulations that mandate all CD4 
laboratory tests regardless of test value (i.e., no cutoff level). 
Copies of state laws/rules/regulations must be submitted as part of the 
application in the appendix, and the applicant must refer to the 
specific language that addresses the eligibility criteria.
    OR
    All detectable HIV viral load laboratory tests
    OR
    The authority to interpret existing state laws/rules/regulations to 
meet eligibility criteria. Include a letter of justification, on 
official health department letterhead stationary, signed by the health 
department official who has the authority to interpret state laws/
rules/regulations, if interpretation of state laws/rules/regulations 
for reportable conditions has been used to justify eligibility.
     Implemented the laboratory reporting requirement stated 
above (see second eligibility criteria above) for at least 1 year.
     Documentation of eligibility must be included in the 
application in the appendix.


    Note: Title 2 of the United States Code Section 1611 states that 
an organization described in Section 501(c)(4) of the Internal 
Revenue Code that engages in lobbying activities is not eligible to 
receive federal funds constituting an award, grant, or loan.


    Individuals Eligible to Become Principal Investigators: Any 
individuals who have the skills, knowledge, and resources necessary to 
carry out the proposed research are invited to work with their 
institution to develop an application for support. Individuals from 
underrepresented racial and ethnic groups as well as individuals with 
disabilities are always encouraged to apply for CDC programs.

IV. Application and Submission Information

IV.1. Address to Request Application Package

    To apply for this funding opportunity, use application form PHS 398 
(OMB number 0925-0001, rev. 5/2001). Forms and instructions are 
available in an interactive format on the CDC Web site, at the 
following Internet address: https://www.cdc.gov/od/pgo/forminfo.htm.

[[Page 38155]]

    Forms and instructions are also available in an interactive format 
on the National Institutes of Health (NIH) Web site at the following 
Internet address: https://grants.nih.gov/grants/funding/phs398/
phs398.html.
    If you do not have access to the Internet, or if you have 
difficulty accessing the forms on-line, you may phone the CDC 
Procurement and Grants Office Technical Information Management Section 
(PGO-TIM) staff at 770-488-2700, and they will mail the application 
forms to you.

IV.2. Content and Form of Application Submission

    Application: Follow the PHS 398 application instructions for 
content and formatting of your application. If the PHS 398 instructions 
differ in any way from those in this announcement, follow the 
instructions in this announcement. For further assistance with the PHS 
398 application form, contact PGO-TIM staff at 770-488-2700, or contact 
GrantsInfo, Telephone, (301) 435-0714, E-mail: GrantsInfo@nih.gov.
    Your research plan should address activities to be conducted over 
the entire project period.
    You are required to have a Dun and Bradstreet Data Universal 
Numbering System (DUNS) number to apply for a grant or cooperative 
agreement from the Federal government.
    Your DUNS number must be entered on line 11 of the face page of the 
PHS 398 application form. The DUNS number is a nine-digit 
identification number, which uniquely identifies business entities. 
Obtaining a DUNS number is easy and there is no charge. To obtain a 
DUNS number, access https://www.dunandbradstreet.com or phone 1-866-705-
5711. For more information, go to https://www.cdc.gov/od/pgo/funding/
pubcommt.htm.
    This announcement uses just-in-time concepts.
    This announcement uses non-modular budgeting format.
    Additional requirements to submit additional documentation with 
your application are listed in Section ``VI.2. Administrative and 
National Policy Requirements.''

IV.3. Submission Dates and Times

    Application Deadline Date: August 1, 2005.
    Explanation of Deadlines: Applications must be received in the CDC 
Procurement and Grants Office by 4 p.m. Eastern Time on the deadline 
date. If you submit your application by the United States Postal 
Service or commercial delivery service, you must ensure that the 
carrier will be able to guarantee delivery by the closing date and 
time. If CDC receives your submission after closing due to: (1) Carrier 
error, when the carrier accepted the package with a guarantee for 
delivery by the closing date and time, or (2) significant weather 
delays or natural disasters, you will be given the opportunity to 
submit documentation of the carrier's guarantee. If the documentation 
verifies a carrier problem, CDC will consider the submission as having 
been received by the deadline.
    This announcement is the definitive guide on the content of 
applications, addresses for submission, and deadline. It supersedes 
information provided in the application instructions. If your 
application does not meet the deadline above, it will not be eligible 
for review and will be discarded. You will be notified that your 
application did not meet the submission requirements.
    CDC will not notify you that your submission has been received. If 
you have a question about the receipt of your application, first 
contact your courier. If you still have a question, phone the PGO-TIM 
staff at 770-488-2700, but please wait two to three days after the 
submission deadline. This will allow time for submissions to be 
processed and logged.

IV.4. Intergovernmental Review of Applications

    Your application is subject to Intergovernmental Review of Federal 
Programs, as governed by Executive Order (EO) 12372. This order sets up 
a system for state and local governmental review of proposed federal 
assistance applications. You should contact your state single point of 
contact (SPOC) as early as possible to alert the SPOC to prospective 
applications, and to receive instructions on your state's process. For 
the current SPOC list, go to https://www.whitehouse.gov/omb/grants/
spoc.html.

IV.5. Funding Restrictions

    Restrictions, which you must take into account while writing your 
budget, are as follows:
     Funds relating to the conduct of research will not be 
released until the appropriate assurances and Institutional Review 
Board approvals are in place.
     Reimbursement of pre-award costs is not allowed.
    If you are requestiing indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement.
    If you are requesting indirect costs in your budget, you must 
include a copy of your indirect cost rate agreement. If your indirect 
cost rate is provisional, the agreement should have been made within 
the past 12 months.

IV.6. Other Submission Requirements

    Application Submission Address: Submit the original and one hard 
copy of your application by mail or express delivery service to: 
Technical Information Management--RFA PS05-085, CDC 
Procurement and Grants Office, 2920 Brandywine Road, Atlanta, GA 30341.
    Applications may not be submitted electronically at this time.

V. Application Review Information

V.1. Criteria

    Applicants are required to provide measures of effectiveness that 
will show that they have accomplished the various identified objectives 
of the cooperative agreement. Measures of effectiveness must relate to 
the performance goals stated in the ``Purpose'' section of this 
announcement. Measures must be objective and quantitative and must 
measure the intended outcome. These measures of effectiveness must be 
submitted with the application and will be an element of evaluation.
    Reviewers will be asked to evaluate the likelihood that the 
proposed research will have a substantial effect on the pursuit of the 
goals of CDC-supported research. These goals are as follows:
     To advance the understanding of biological systems.
     To improve the control and prevention of disease and 
injury.
     To enhance health.
    The application will be evaluated against the following criteria:
    Methods (40 points): Are the conceptual framework, design, methods, 
and analyses adequately developed, well-integrated, and appropriate to 
the aims of the project? Does the applicant acknowledge potential 
problem areas and consider alternative tactics? Are the proposed 
methods feasible? Will they accomplish the program goals? Will they 
address the required follow-up activities and methods in a timely 
manner? Are the objectives reasonable, time-phased, and measurable? 
Does the applicant provide reasonable methods to evaluate progress 
toward the timely accomplishment of objectives? Is documentation 
provided which supports the applicant's ability to locate and enroll 
potentially hard-to-reach populations (e.g., data about sexually 
transmitted diseases or HIV partner counseling and referral programs, 
other research or surveillance projects)?
    Capacity (30 points): Is the investigator appropriately trained and

[[Page 38156]]

well suited to carry out this work? Is the work proposed appropriate to 
the experience level of the principal investigator and other 
researchers (if any)? Does the applicant have the appropriate staff to 
conduct this research? Do the job descriptions and curricula vitae for 
proposed and current staff indicate that they are appropriate for 
identifying and locating persons who have a diagnosis of HIV and who 
are not receiving care? Do the current or proposed staffs have the 
ability to conduct face-to-face interviews outside of an office 
setting? Does the current or proposed staff have the ability and the 
appropriate state-required qualifications to collect blood?
    Significance (20 points): Does this study address an important 
problem? If the aims of the application are achieved, how will 
scientific knowledge be advanced? What will be the effect of these 
studies on the concepts or methods that drive this field? What is the 
extent to which data have or will assist in HIV prevention and care 
activities?
    Objective (10 points): Does the applicant provide objectives which 
are reasonable, time-phased, and measurable? Does the applicant provide 
reasonable methods to evaluate their progress toward the timely 
accomplishment of the objectives?
    Additional Review Criteria: In addition to the above criteria, the 
following items will be considered in the determination of scientific 
merit and priority score:
    Protection of Human Subjects from Research Risks: Does the 
application adequately address the requirements of Title 45 CFR Part 46 
for the protection of human subjects? This will be scored; an 
application can be disapproved if the research risks are sufficiently 
serious and protection against risks is so inadequate as to make the 
entire application unacceptable.
    Inclusion of Women and Minorities in Research: Does the application 
adequately address 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; and (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.
    Budget (Reviewed but not scored): The reasonableness of the 
proposed budget and the requested period of support in relation to the 
proposed research.

V.2. Review and Selection Process

    Applications will be reviewed for completeness by the Procurement 
and Grants Office (PGO) staff, and for responsiveness by NCHSTP. 
Incomplete applications and applications that are non-responsive to the 
eligibility criteria will not advance through the review process. 
Applicants will be notified the application did not meet submission 
requirements.
    An objective review panel comprised of CDC staff, outside of the 
funding division, will evaluate complete and responsive applications 
according to the criteria listed in the ``V.1. Criteria'' section 
above. The objective review process will follow the policy requirements 
as stated in the GPD 2.04 [https://198.102.218.46/doc/gpd204.doc.]
    Award Criteria: Award decisions during the programmatic review will 
be based on the following:
     Scientific merit (as determined by the objective review 
panel).
     Availability of funds.
     Programmatic priorities.
     Funding of applications in rank order as determined by the 
objective review panel.

V.3. Anticipated Announcement and Award Dates

    August 31, 2005.

VI. Award Administration Information

VI.1. Award Notices

    Successful applicants will receive a Notice of Award (NoA) from the 
CDC Procurement and Grants Office. The NoA shall be the only binding, 
authorizing document between the recipient and CDC. The NoA will be 
signed by an authorized Grants Management Officer and mailed to the 
recipient fiscal officer identified in the application.
    Unsuccessful applicants will receive notification of the results of 
the application review by mail.

VI.2. Administrative and National Policy Requirements

45 CFR Part 74 and Part 92
    For more information on the Code of Federal Regulations, see the 
National Archives and Records Administration at https://
www.access.gpo.gov/nara/cfr/cfr-table-search.html.
    The following additional requirements apply to this project:
     AR-1 Human Subjects Requirements
     AR-2 Requirements for Inclusion of Women and Racial and 
Ethnic Minorities in Research
     AR-4 HIV/AIDS Confidentiality Provisions
     AR-5 HIV Program Review Panel Requirements
     AR-6 Patient Care
     AR-7 Executive Order 12372
     AR-8 Public Health System Reporting Requirements
     AR-9 Paperwork Reduction Act Requirements
     AR-10 Smoke-Free Workplace Requirements
     AR-11 Healthy People 2010
     AR-12 Lobbying Restrictions
     AR-14 Accounting System Requirements
     AR-22 Research Integrity
     AR-23 States and Faith-Based Organizations
     AR-24 Health Insurance Portability and Accountability Act 
Requirements
     AR-25 Release and Sharing of Data
    Additional information on these requirements can be found on the 
CDC Web site at the following Internet address: https://www.cdc.gov/od/
pgo/funding/ARs.htm.

VI.3. Reporting

    You must provide CDC with an original plus two hard copies of the 
following reports:
    1. Interim progress report, (use form PHS 2590, OMB Number 0925-
0001, rev. 5/2001 as posted on the CDC Web site) no less than 90 days 
before the end of the budget period. The progress report will serve as 
your non-competing continuation application and must contain the 
following elements:
    a. Current Budget Period Activities and Objectives.
    b. Current Budget Period Financial Progress.
    c. New Budget Period Program Proposed Activities and Objectives.
    d. Budget.
    e. Measures of Effectiveness.
    f. Additional Requested Information.
    2. Financial status report, no more than 90 days after the end of 
the budget period.
    3. Final financial and performance reports, no more than 90 days 
after the end of the project period.
    These reports must be mailed to the Grants Management Specialist 
listed in the Agency Contacts section of this announcement.

VII. Agency Contacts

    We encourage inquiries concerning this announcement.

[[Page 38157]]

    For general questions, contact: Technical Information Management 
Section, CDC Procurement and Grants Office, 2920 Brandywine Road, 
Atlanta, GA 30341. Telephone: 770-488-2700.
    For scientific/research issues, contact: Norma S. Harris, PhD, 
Project Office, National Center for HIV, STD, and TB Prevention, 
Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop 
E-46, Atlanta, GA 30333. Telephone: 404-639-2090. Fax: 404-639-8640. E-
mail: NHarris@cdc.gov.
    For questions about the objective review, contact: Beth Wolfe, 
Centers for Disease Control and Prevention, 1600 Clifton Road, Mailstop 
E-07, Atlanta, GA 30333. Telephone: 404-639-8531. Fax: 404-639-8629. E-
mail: Bwolfe@cdc.gov.
    For financial, grants management, or budget assistance, contact: 
Julia Valentine, Grants Management Specialist, CDC Procurement and 
Grants Office, 2920 Brandywine Road, Atlanta, GA 30341. Telephone: 770-
488-2732. E-mail: jxv1@cdc.gov.

VIII. Other Information

    This and other CDC funding opportunity announcements can be found 
at https://www.cdc.gov. Click on ``Funding'' then ``Grants and 
Cooperative Agreements.''

    Dated: June 27, 2005.
Alan A. Kotch,
Acting Director, Procurement and Grants Office, Centers for Disease 
Control and Prevention.
[FR Doc. 05-13016 Filed 6-30-05; 8:45 am]
BILLING CODE 4163-18-P
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