Part I Overview Information


Department of Health and Human Services

Participating Organizations
Centers for Disease Control and Prevention (CDC), (www.cdc.gov)

Components of Participating Organizations
National Center for HIV, STD and TB Prevention (NCHSTP/CDC), (www.cdc.gov/nchstp/od/nchstp.html)

Title: Rapid Test Algorithms for Diagnosis of HIV infection and Improved Linkage to Care

The CDC policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH

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

Announcement Type: New

Request For Applications (RFA) Number: RFA-PS-06-002

Catalog of Federal Domestic Assistance Number(s):
93.94
0  HIV Prevention Activities – Health Department Based

Key Dates
Release Date: February 21, 2006
Letter of Intent Receipt Date: March 13, 2006
Application Receipt Date: April 10, 2006
Peer Review Date: 06/2006
Council Review Date: 07/2006
Earliest Anticipated Start Date: September 1, 2006
Expiration Date: April 11, 2006

Due Date for E.O. 12372
Due no later than 60 days after the application receipt date.

Additional Overview Content

Executive Summary

Table of Contents

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
    1. Research Objectives

Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

Section III. Eligibility Information
    1. Eligible Applicants
        A. Eligible Institutions
        B. Eligible Individuals
    2.Cost Sharing or Matching
    3.Other - Special Eligibility Criteria

Section IV. Application and Submission Information
    1. Address to Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
        A. Receipt and Review and Anticipated Start Dates
            1. Letter of Intent
        B. Sending an Application
        C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
        A. Additional Review Criteria
        B. Additional Review Considerations
        C. Sharing Research Data
        D. Sharing Research Resources
    3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements  
        A. Cooperative Agreement Terms and Conditions of Award
            1. Principal Investigator Rights and Responsibilities
            2. CDC Responsibilities
            3. Collaborative Responsibilities
    3. Reporting

Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)
    4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations


Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The CDC and NCHSTP are committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA).  This RFA addresses “Healthy People 2010” priority area(s) of: access to health care, disability and secondary conditions, community-based programs, HIV and public health infrastructure, and is in alignment with National Center for HIV, STD and TB Prevention and the Division of HIV/AIDS Prevention performance goal(s) to: (1) increase the motivation of at-risk individuals to know their infection status and decrease real and perceived barriers to HIV testing; and (2) increase the proportion of persons diagnosed with HIV who are successfully linked to medical care no later than 3 months after learning their HIV status or re-identified being infected but out of care.  For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.

Background

The current diagnostic algorithm for human immunodeficiency virus (HIV) infection in the US was developed in the late 1980s, and published in the Morbidity and Mortality Weekly Report in 1989.  It uses an enzyme-linked immunosorbent assay (EIA) to screen for antibodies indicative of HIV infection, followed by an HIV Western blot or HIV immunofluorescence assay (IFA) for confirmation of all EIA repeatedly reactive specimens.  Since the publication of the current algorithm, the sensitivity and specificity of HIV screening tests approved by the US Food and Drug Administration (FDA) has increased.  The sensitivity and specificity of the confirmatory Western blot and IFA tests now lag behind the screening tests that they are intended to confirm.  This results in a large number of negative or indeterminate confirmatory tests which require considerable effort by public health departments to follow-up and resolve.  Rapid HIV screening tests have also been developed and have received the approval of the FDA.  These tests have demonstrated comparable sensitivity and specificity with current generation EIAs.  Some of these tests have also received waived status under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) allowing for their use outside of traditional laboratory settings.  Studies of rapid testing have shown that many clients who test positive in preliminary testing do not return for their confirmatory result (which may take a week or more before it is available), and it is unknown whether these persons receive confirmatory testing elsewhere or if they are linked to care for HIV. 

The World Health Organization (WHO) has developed recommendations for the use of multiple HIV antibody tests for diagnosis of HIV infection.  Phase III of the WHO guidelines for selection of HIV testing algorithms includes prospective testing of potential algorithms in settings of likely use.  These “alternative algorithms” have been adopted in many international settings, where the use of Western blot or IFA is impractical due to the high technical proficiency required to perform these tests, or due to costs. 

Although the FDA-approved package insert permits the use of rapid HIV tests in multi-test algorithms, no specific guidance for use of multiple rapid HIV tests for the diagnosis of HIV infection in the US currently exists.  With the availability of FDA-approved HIV rapid screening tests that are both highly sensitive and specific, alternative diagnostic algorithms that do not rely on Western blot confirmation are needed.  Such an algorithm would provide three advantages over current practice.  First, it would reduce the need to perform WB tests and eliminate negative or indeterminate WB results for HIV-infected persons.  Second, it would nearly eliminate problems associated with informing non-infected persons of a positive preliminary rapid HIV test result, pending confirmation with Western blot or IFA.  Finally, use of multiple FDA approved rapid point of care tests would eliminate the need to follow up on persons who do not return for confirmation of their preliminary positive results, and would permit immediate referral to medical care for positives whose infection status is confirmed at the point of testing.

Objectives

Study Sites

To meet the above objectives, each applicant must select a minimum of three distinct testing sites (study sites) to implement one or more rapid HIV test diagnostic algorithm.  The number of study sites selected should yield a minimum of 100 new HIV diagnoses (preference will be given to applicants that can identify at least 250 new HIV diagnoses) within an 18-month period.  In order to demonstrate feasibility of using a rapid test algorithm outside a laboratory setting, at least one selected HIV test site should be non-traditional--defined as: (1) not having an onsite laboratory that is CLIA-certified to conduct moderate complexity diagnostic tests; and (2) not being either a public health department or private health care clinic.  In addition to at least one non-traditional study site, applicants should propose a mix of other study sites including hospital outpatient clinics, emergency departments, urgent-care clinics, correctional facilities, sexually transmitted disease clinics, and publicly-funded HIV counseling and testing sites.  All study test sites must have at least one year of experience using one or more FDA-approved rapid HIV tests.  Applicants must select at least an equal number of comparison HIV test sites that can serve as matched controls, where the multiple rapid test algorithm will not be implemented, but where counseling and testing data already collected can be used comparatively to evaluate the effect of the rapid test algorithm on receipt of test results and use of HIV medical care. 

Enrollment and HIV Testing

In accordance with pre-existing HIV test consent procedures at participating sites, all clients who consent for rapid HIV testing and who have a preliminary positive initial rapid test result will be asked to provide sufficient anticoagulated venipuncture whole-blood specimens for conducting: (1) up to two additional rapid HIV tests; (2) supplemental testing using the conventional EIA/WB-IFA algorithm; and (3) a quantitative HIV viral load test.  Depending on the test site and availability of a third FDA-approved CLIA-waived rapid HIV test, collaborating sites will implement a rapid test serial algorithm employing either 2 or 3 rapid tests based on different antigen preparations and/or different test principles.  As part this algorithm, if the first rapid HIV test is positive, at least one additional rapid test will be conducted on site.  If the second rapid HIV test is negative and a third rapid test is available, the third test will be used either onsite or in a reference laboratory.  Persons who test HIV-positive with at least two different rapid HIV tests will be considered HIV positive by the rapid-test algorithm and will be referred to care.  In accordance with current rapid HIV test guidelines, all persons with at least one preliminary positive rapid HIV test result will also be provided their definitive HIV diagnosis based on their conventional EIA/WB-IFA test results.  Persons with discordant rapid test results or who test positive via the rapid algorithm and negative or indeterminate with the conventional EIA/WB-IFA diagnostic algorithm will undergo a quantitative viral load test for detection of HIV virus and follow-up testing in accordance with local procedures until their HIV infection status is resolved serologically.  Applicants should design their proposals based on an 18-month period to evaluate one or more rapid HIV test diagnostic algorithms for each of the collaborating test sites.  The remaining six-month period will allow enough follow-up time to resolve all discordant HIV test results, for data management and analysis, and tracking use of HIV medical care services as described below.

Data Collection

HIV Testing data

Each of the study and comparison test sites must have a pre-existing data system that routinely collects patient-level data on all patients undergoing HIV testing and that is capable of submitting data to CDC electronically after all patient identifiers are removed.  The pre-existing data collection system should routinely collect data that is at least 75% complete (preference will be given to applicants that can demonstrate data collection > 90% complete) for each of the following: test site, age, race, sex, HIV risk group, and HIV test information.  HIV test information must be able to discriminate each of the rapid and conventional tests used, types of specimens on which tests are performed, receipt of preliminary and confirmed test results, date of testing, date preliminary and confirmed results were received, and referral to HIV health care.  As part of efforts to evaluate differences in receipt of confirmed HIV test results, and referral to and use of health care, applicants will also use pre-existing data collection systems to compare these outcomes observed at algorithm sites to those from at least an equal number of comparison HIV test sites that can serve as matched controls, where the multiple rapid test algorithm will not be implemented.  In addition to routinely collected client-level data, applicants must be able to track costs associated with conducting rapid HIV testing, identifying persons newly diagnosed with HIV infection, and referring newly diagnosed persons to HIV care at all algorithm implementation and comparison sites. 

Use of HIV Care

Use of HIV medical care is defined as having at least one CD4-cell count or quantitative HIV viral load reported in the state or local HIV/AIDS surveillance database within the six-month period following their definitive diagnosis.  The proportion of HIV-infected clients who use HIV medical-care services within 3 and 6 months of their definitive diagnosis obtained at study and comparison test sites will be evaluated.  Documentation of receipt of CD4-cell count or HIV viral load determination will be made primarily by use of reporting of such test results as part of a mandatory laboratory reporting system in the state.  State or local HIV/AIDS surveillance and laboratory databases containing de-duplicated patient level data (surveillance data in which duplicate records from unique patients are identified, discrepancies between records are resolved and from which a final summary of data for each unique patient can be created) will be used to determine the percentage of HIV-infected persons identified through the rapid test diagnostic algorithm or in the comparison, non-alternative algorithm sites who show evidence of using HIV medical care within three and six months of their initial positive rapid test results.  In order to evaluate the effect of a rapid test algorithm on linkage to care, to the extent possible, practices for referral to care should be standardized and consistent with local practice at both algorithm implementation sites and the comparison sites.    

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the U 18 award mechanism(s).

The CDC U 18 is a cooperative agreement award mechanism. In the cooperative agreement mechanism, the Principal Investigator retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with CDC staff being substantially involved as a partner with the Principal Investigator, as described under the Section VI. 2. Administrative Requirements, "Cooperative Agreement Terms and Conditions of Award".

2. Funds Available

The participating CIO, NCHSTP, intends to commit approximately $500,000, including direct and indirect costs, in FY 2006 to fund 2-3 awards. The average award amount will be approximately $250,000 including direct and indirect costs for the first 12-month budget period. An applicant may request a project period of up to 2 years. An applicant may request up to $300,000 for the first 12-month budget period. The approximate total project period funded amount is $500,000. The anticipated start date for new awards is September 1, 2006.

All estimated funding amounts are subject to availability of funds.

If you request a funding amount greater than the ceiling of the award range, your application will be considered non-responsive, and will not be entered into the review process. You will be notified that your application did not meet the submission requirements.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation; see NOT-OD-05-004.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

A Bona Fide Agent is an agency/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.

1.B. Eligible Individuals
Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is 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.

2. Cost Sharing or Matching

Cost sharing, matching, or cost participation is not required for this program.

The most current Grants Policy statement can be found at: http://grants.nih.gov/grants/policy/gps/

3. Other-Special Eligibility Criteria

Eligible applicants (as outlined in eligibility criteria) must supply evidence of having:

Documentation of eligibility must be included as Appendix A of the application.

A sufficiently high level of HIV morbidity is required of participating sites to evaluate the feasibility, performance, and cost-effectiveness of a rapid HIV test diagnostic algorithm within the required time frame.  To meet the objectives of this research study, high quality and complete demographic, risk, and HIV test data that is routinely collected on all persons undergoing HIV testing at participating sites is required.  Because of these requirements, funding preference will be given to applicants that can provide evidence of having:

NOTE:  This announcement is not intended to replace existing funding for standard HIV antibody testing. Eligible applicants must choose sites that already have experience offering rapid testing for HIV antibodies.  As such, applicants should build the research components described in this announcement on top of existing infrastructure, including routine offering of rapid HIV antibody testing at the point of service and supplemental testing for confirmation of preliminary positive rapid test results according to CDC guidelines. 

This announcement is intended to supplement these existing activities and applicants should not include costs for the first rapid test in a rapid test algorithm or their standard algorithm (EIA followed by Western Blot or IFA) for confirmation of a preliminary positive rapid test in their proposed budgets.

If your application is incomplete or non-responsive 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.

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.

Section IV. Application and Submission Information


1. Address to Request Application Information

The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance contact GrantsInfo, Telephone (301) 435-0714, Email: GrantsInfo@nih.gov.

CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

2. Content and Form of Application Submission

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a Dun & Bradstreet (D&B) Data Universal Numbering System number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

3. Submission Dates and Times

All requested information must be received in the CDC Procurement and Grants Office by 4:00 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 LOI and application content, submission address, and deadline.  It supersedes information provided in the application instructions.  If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and will be discarded. You will be notified that you did not meet the submission requirements.

Otherwise, CDC will not notify you upon receipt of your submission.  If you have a question about the receipt of your application, first contact your courier.  If you still have a question, contact the PGO-TIMS staff at: 770-488-2700.  Before calling, please wait two to three days after the submission deadline.  This will allow time for submissions to be processed and logged.

3.A. Receipt, Review and Anticipated Start Dates

Letter of Intent Receipt Date: March 13, 2006

Application Receipt Date(s): April 10, 2006
Peer Review Date: 06/2006
Council Review Date: 07/2006
Earliest Anticipated Start Date: September 1, 2006

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CIO staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A

The letter of intent should be sent to:

Amy L. Sandul, Scientific Program Administrator
Extramural Research Program Office
National Center for HIV, STD and TB Prevention
Centers for Disease Control and Prevention
Mailstop E - 07
1600 Clifton Road,  NE
Atlanta, GA  30333
Telephone: (404) 639-6485
FAX: (404) 639-8600
Email: ASandul@cdc.gov

3.B. Sending an Application

Applications follow the PHS 398 application instructions for content and formatting of your applications.  If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement.

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and one signed photocopy in one package to:

Technical Information Management Section – RFA PS06-002
CDC, Procurements and Grants Office
2920 Brandywine Road
Atlanta, GA  30341
At the time of submission, three additional copies of the application, including the appendix material, must be sent to:

Michael Vance, Grants Technical Assistant
Extramural Research Program Office
National Center for HIV, STD and TB Prevention
Centers for Disease Control and Prevention
Mailstop  E - 07
1600 Clifton Road, NE
Atlanta, GA   30333

Telephone: (404) 639 - 8006
FAX: (404) 639 - 8600
Email: MVance@cdc.gov

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness and responsiveness by NCHSTP and PGO. Incomplete and non-responsive applications will not be reviewed.

4. Intergovernmental Review

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. Click on the following link to get the current SPOC list: http://www.whitehouse.gov/omb/grants/spoc.html

5. Funding Restrictions

All CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the PHS Grants Policy Statement.

Additional guidance can be found at NIH Grants Policy Statement.

Restrictions, which must be taken into account while writing your budget, are as follows:

6. Other Submission Requirements

This announcement is intended to supplement existing activities and applicants should not include costs for the first rapid test in a rapid test algorithm or their standard algorithm (EIA followed by Western Blot or IFA) for confirmation of a preliminary positive rapid test in their proposed budgets.

Awardees must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.  "Award Administration Information".

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 a provisional rate, the agreement should be less than 12 months of age. 

Your research plan should address activities to be conducted over the entire project period.

Plan for Sharing Research Data
The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants may wish to describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not any conditions will be placed on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

Sharing Research Resources

PHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (PHS Grants Policy Statement http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.)  Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://www.cdc.gov/od/pgo/forminfo.htm ).  See Section VI.3. Reporting.

Section V. Application Review Information


1. Criteria
Only the review criteria described below will be considered in the review process.

Preference will be given to applicants that can identify at least 250 new HIV diagnoses in the project period specified.  

The following will be considered in making funding decisions:

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by OPHR in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of CDC-supported research are to advance the understanding of health promotion and prevention of disease, injury, and disability, and enhance preparedness.  In the written comments, reviewers will be asked to evaluate the application in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals. 

Significance: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? How does the applicant propose that these data will assist in HIV prevention and care activities? 

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the applicant demonstrate an understanding of the project objectives, methods, and activities as outlined in Section I.1 above?  Does the applicant demonstrate the required HIV laboratory reporting infrastructure, experience, and HIV morbidity as outlined in Section III.3?  Does the applicant demonstrate the ability to collect high quality and complete demographic, risk, and HIV test data routinely for all persons undergoing HIV testing at participating sites, as described in Section III.3?  Does the applicant demonstrate laboratory capacity to perform the supplemental HIV testing required to implement this program?  Has the applicant selected and adequately described a minimum of three study sites in which to implement this study?  Has the applicant described the current HIV rapid testing capacity at these sites?  Has the applicant adequately described the type and sequence of rapid HIV tests to be used as part of their testing algorithm and quality assurance/quality control procedures to be implemented concurrently with the proposed algorithmHas the applicant demonstrated that the known prevalence of HIV infection at participating algorithm implementation sites is such that collectively a minimum of 100 and preferably 250 HIV-positive persons are expected to be identified during an 18-month evaluation period? Has the applicant appropriately addressed each of the objectives identified in Section I.1 above?  Has the applicant described milestones or process measures designed to ensure the successful completion of each of these objectives?  Are the process measures and milestones reasonable and appropriately time-phased?        

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area? Does the applicant describe current practices that might be affected by implementation of a rapid testing algorithm, e.g. the procedures for consenting to HIV testing, HIV case reporting, standardized HIV testing data collections, and testing for primary HIV infection with HIV nucleic acid test technologies? Does the applicant provide a plan to integrate a rapid testing algorithm with these other practices?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)? Does the applicant have sufficient staff to conduct this research?  Do the job descriptions and curricula vitae for proposed and current staff indicate that they are appropriate for overseeing implementation of a rapid testing algorithm for diagnosis of HIV infection in multiple sites, for performing the necessary laboratory-based supplemental testing, for ensuring follow-up of all persons with discordant HIV test results, and for accessing and utilizing HIV/AIDS surveillance data to measure linkage to care for all HIV-infected persons identified in this project and at reasonable comparison sites that have not yet implemented such an algorithm

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support? Has the applicant demonstrated the required laboratory reporting infrastructure, HIV morbidity, quality of data routinely collected and experience according to the following criteria (also provided in Section III.3):  1) State laws/rules/regulations that mandate reporting of all CD4 laboratory tests, regardless of test value (i.e., no cutoff level) and/or reporting of all HIV viral load laboratory tests regardless of test value (i.e. no cutoff level) directly from the laboratory conducting the test; OR  2) the authority to interpret existing State laws/rules/regulations to meet the above eligibility criteria; AND 3) demonstrated ability to check for duplication and link records within the laboratory reporting systems described above, using either a name-based HIV infection reporting system or a system with demonstrated, comparable ability to check for duplicate records and match unique individuals; AND  4) demonstrated their ability to newly diagnose a minimum of 100 HIV-infected persons in an 18-month period in all sites implementing a rapid test algorithm combined and provide data on a minimum of 100 HIV-infected persons from at least an equal number of comparison sites where a rapid test algorithm will not be implemented; AND  5) demonstrated for each testing site included in the study (both algorithm and comparison sites) their ability to routinely collect and transmit to CDC electronic client-level data for all persons undergoing HIV testing that is at least 75% complete for each of the following types of data: test site, age, race, sex, risk-group, and HIV test information.  Does the HIV test information collected/accessed include the rapid and conventional tests used, types of specimens on which these tests are used, receipt of preliminary and confirmed test results, dates of testing and receipt of preliminary and confirmed results, and referral to HIV medical care?

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398). http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional CDC Requirements under AR-1 Human Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.

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.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Data Sharing Plan: The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.

2.D. Sharing Research Resources

Program staff will be responsible for the administrative review of the plan for sharing research data.

PHS policy requires that grant award recipients make unique research resources readily
The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the data and resource sharing plans with the awardee before recommending funding of an application. The final version of the data and resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590 http://www.cdc.gov/od/pgo/forminfo.htm). See Section VI.3. Reporting .

3. Anticipated Announcement and Award Dates

The anticipated date of award is September 1, 2006.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the Principal Investigator will also receive a written critique called a Summary Statement.

Those applicants under consideration for funding will be contacted by CDC for additional information.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.  The NoA signed by the Grants Management Officer (GMO) is the authorizing document.  This document will be mailed and/or emailed to the recipient fiscal officer identified in the application. 

Selection of the application for award is not an authorization to begin performance.  Any cost incurred before receipt of the NoA is at the recipient’s risk.  These costs may be reimbursed only to the extent considered allowable pre-award costs.  See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about policy requirements.  For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. Additional requirements can be found in Section VIII. Other Information of this document or on the CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.
 

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement U 18 an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the CDC as defined above.

2.A.1. Principal Investigator Rights and Responsibilities

The Principal Investigator will have the primary responsibility for:

Provide the following four electronic databases: (1) counseling and testing data on all persons undergoing rapid testing at study and comparison sites; (2) an extraction of HIV/AIDS surveillance and laboratory data which provide a proxy measure for linkage to care among all newly identified HIV infected clients who test positive at study and comparison sites during the study period, as described under “Use of HIV Care” above; (3) program evaluation data; and (4) costs associated with using a rapid HIV test diagnostic algorithm and comparison data for costs associated with current standard practice.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and CDC policies.

2.A.2. CDC Responsibilities

A CDC Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Additionally, an agency program official or CIO program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

2.A.3. Collaborative Responsibilities

Not Applicable

3. Reporting

You must provide CDC with an original, plus two hard copies of the following reports:

1.  Interim/Grant Progress Report, (use form PHS 2590, OMB Number 0925-0001, rev. 9/04 as posted on the CDC website) no less than 120 days prior to the end of the current budget period.  The progress report will serve as your non-competing continuation application.
2.Annual Progress Report, due 90 days after the end of the budget period.
3. Financial status report, no more than 90 days after the end of the budget period.
4. Final financial and performance reports, no more than 90 days after the end of the project period.

These reports must be forward by U.S. Postal Service or Express Delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement.

Although the financial plans of the CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon 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.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Amy L. Sandul, Scientific Program Administrator
Extramural Research Program Office
National Center for HIV, STD and TB Prevention
Centers for Disease Control and Prevention
Mailstop  E - 07
1600 Clifton Road, NE
Atlanta, GA  30333
Telephone: (404) 639-6485
FAX: (404) 639 - 8600
Email: ASandul@cdc.gov

2. Peer Review Contacts:

M. Chris Langub, PhD
Office of Public Health Research
Centers for Disease Control and Prevention
Mail stop D - 72
1600 Clifton Road,  NE
Atlanta, GA  30333
Telephone: (404) 639-4640
FAX: (404) 639-4903
Email: MLangub@cdc.gov

3. Financial or Grants Management Contacts:

Deborah Mercy, Grants Management Specialist
Procurement and Grants Office
Centers for Disease Control and Prevention
Mailstop E – 15
2900 Brandywine Road
Atlanta, GA  30341
Telephone: (404) 639-8265
FAX: (404) 639-8095
Email: DMercy@cdc.gov

4. General Questions Contacts:

Technical Information Management Section
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA  30341
Telephone:  770-488-2700
Email:  PGOTIM@cdc.gov

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). Additional CDC Requirements under AR-1 Human Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.

Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

HIV/AIDS Confidentiality Provisions

Recipients must have confidentiality and security provisions to protect data collected through HIV/AIDS surveillance, including copies of local data release policies; employee training in confidentiality provisions; State laws, rules, or regulations pertaining to the protection or release of surveillance information; and physical security of hard copies and electronic files containing confidential surveillance information.

Describe laws, rules, regulations, or health department policies that require or permit the release of patient-identifying information collected under the HIV/AIDS surveillance system to entities outside the public health department; describe also the measures the health department has taken to ensure that persons reported to the surveillance system are protected from further or unlawful disclosure.

Some projects may require Institutional Review Board (IRB) approval or a certificate of confidentiality.

Patient Care

Ensure that all STD or HIV infected patients enrolled in the proposed project will be linked to an appropriate local care system that can address their specific needs, such as medical care, counseling, social services, and therapy.

Executive Order 12372 Review

Applications are subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (E.O.) 12372. The order sets up a system for State and local governmental review of proposed Federal assistance applications. Applicants should contact their State single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State process. For proposed projects serving more than one State, the applicant is advised to contact the SPOC for each State affected.

Click on the following link to get the current SPOC list  http://www.whitehouse.gov/omb/grants/spoc.html

Indian tribes must request tribal government review of their applications.

SPOCs or tribal governments that have recommendations about an application submitted to CDC should send them, in a document bearing the program announcement number, no more than 60 days after the application deadline date, to:

Deborah Mercy, Grants Management Specialist
Procurement and Grants Office
Announcement Number RFA PS06-002
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road
Atlanta, Georgia 30341-4146

CDC does not guarantee to accept or justify its non-acceptance of recommendations that are received more than 60 days after the application deadline.

Smoke-Free Workplace Requirements

CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.

Healthy People 2010

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Lobbying Restrictions

Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

In addition no part of CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation

It remains permissible to use CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.

Recipients of CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of CDC funds should give close attention to isolating and separating the appropriate use of CDC funds from non-CDC funds. CDC also cautions recipients of CDC funds to be careful not to give the appearance that CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

Accounting System Requirements

The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.

Capability Assessment

It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.

Small, Minority, And Women-owned Business

It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:

1.  Place small, minority, women-owned business firms on bidders mailing lists.
2.  Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
3.   Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
4.   Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.  

Research Integrity

The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (http://ori.hhs.gov./policies/statutes.shtml).

For example:

Section 93.301 Institutional assurances.(a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.

Health Insurance Portability and Accountability Act Requirements

Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions.  The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency.  CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

Release and Sharing of Data

The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the CDC data sharing agreement will be released as follows:

a.    In a timely manner.
b.    Completely, and as accurately as possible.
c.    To facilitate the broader community.
d.    Developed in accordance with CDC policy on Releasing and Sharing Data.

April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) www.4.law.cornell.edu/uscode/5/5/552/html.

Applications must include a copy of the applicant's Data Release Plan.  Applicants should provide CDC with appropriate documentation on the reliability of the data.  Applications submitted without the required Plan may be ineligible for award.  Award will be made when reviewing officials have approved an acceptable Plan.  The successful applicant and the Program Manager will determine the documentation format.  CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality. 


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