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. Start Printed Page 38153
I. Funding Opportunity Description
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.
- 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.
- 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.
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 Start Printed Page 38154a 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).
Have all detectable HIV viral load laboratory tests.
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.
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.
All detectable HIV viral load laboratory tests
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.
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: http://www.cdc.gov/od/pgo/forminfo.htm. Start Printed 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: http://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 http://www.dunandbradstreet.com or phone 1-866-705-5711. For more information, go to http://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 http://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
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 Start Printed Page 38156well 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 [http://184.108.40.206/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 http://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: http://www.cdc.gov/od/pgo/funding/ARs.htm.
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.
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. Start Printed 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: email@example.com.
VIII. Other Information
This and other CDC funding opportunity announcements can be found at http://www.cdc.gov. Click on “Funding” then “Grants and Cooperative Agreements.”Start Signature
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