Part I Overview Information
United States Department of Health and Human Services (HHS)
Issuing Organization
Centers for Disease Control and Prevention (NCHHSTP/CDC) at http://www.cdc.gov/nchhstp/
Participating
Organizations
Centers for Disease Control and Prevention (CDC) at http://www.cdc.gov/
Components of
Participating Organizations
Coordinating Center for Infectious Diseases (CCID/CDC) at http://www.cdc.gov/about/organization/ccid/html.
Title: Screening Targeted Populations to Interrupt On-going Chains of Transmission with Enhanced Partner Notification – The STOP Study (U01)
The
policies, guidelines, terms, and conditions of the HHS Centers for Disease
Control and Prevention (CDC) stated in this announcement might differ from those
used by the HHS National Institutes of Health (NIH). If written guidance for
completing this application is not available on the CDC website, then CDC will
direct applicants elsewhere for that information.
Authority:
Sections
317(k)(2) and 318 of the Public Health Service Act (42 U.S.C. Sections
247b(k)(2) and 247c), as amended
Announcement Type: New
Instructions for Submission of Electronic Research Applications:
NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide.
This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply.)
A registration process is necessary before submission, and applicants are strongly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.
Two steps are required for on time submission:
1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Standard Time on the application submission receipt date (see “Key Dates” below.)
2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.
Funding Opportunity Announcement (FOA) Number: RFA-PS-09-004
Catalog of Federal Domestic
Assistance Number(s):
93.943
Key Dates
Release/Posted Date: December 22, 2008
Earliest Anticipated Start Date(s): September 30, 2009
Expiration Date: TBD
Due Date for E.O. 12372
Due no later than 60 days after the application receipt date.
Additional Overview Content
Funding Opportunity Announcement Glossary: FOA Glossary Terminology
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
2.Cost Sharing or Matching
3.Other - Special Eligibility Criteria
Section IV. Application and Submission Information
1. 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. Submitting an Application to CDC
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
1. Recipient Rights and Responsibilities
2. HHS/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 National Center for HIV, Viral Hepatitis, STD, and TB (Tuberculosis) Prevention (NCHHSTP) of CDC within HHS is 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 of HIV/AIDS and is in alignment with NCHHSTP’s performance goals to 1) By 2010, reduce by 25 percent the number of new HIV infections in the United States, as measured by a reduction in the number of HIV infections diagnosed each year among people under 25 years of age, from 2,100 in the year 2000 to approximately 1,600 in the year 2010; 2) decrease the number of persons at high risk for acquiring or transmitting HIV infection; and 3) by 2010, increase by 13 percent the proportion of HIV-infected people who know they are infected, as measured by the proportion diagnosed before progression to AIDS (baseline: 76 percent in 2000; target for 2010: 85 percent). For more information: www.healthypeople.gov and http://intra-apps.cdc.gov/fmo/.
CDC announces the availability of fiscal year (FY) 2009 funds for a cooperative agreement program called the STOP (Screening Targeted Populations to Interrupt Ongoing Chains of Transmission with Enhanced Partner Notification) study to evaluate acute HIV infection (AHI) screening linked to enhanced partner notification and contact tracing.
Pertinent Background:
Identifying individuals during AHI is an important opportunity for HIV prevention. AHI is defined as the time between HIV acquisition and seroconversion [1]. Because standard HIV enzyme immunoassays (EIAs) only test for the presence of antibodies to HIV, a “window period” exists in which a person will test negative for HIV antibodies despite the presence of infection. Because individuals with AHI are highly infectious, have de facto recently engaged in high-risk behaviors, and are often unaware of their HIV status, they may contribute substantially to the spread of HIV [2]. Although the duration of AHI is short (3–4 weeks), studies from Uganda, Canada, and London have suggested that a disproportionate number (approximately 50%) of new HIV infections are acquired by onward transmission from an individual with AHI [3-5]. This propagation of HIV infection by individuals with AHI is called an “ongoing chain of transmission.” Fortunately, most HIV-infected persons take measures to reduce their risk of transmitting HIV to others after they learn of their infection [6-8]. Therefore, identifying persons with AHI is an especially important opportunity for HIV prevention and is a major justification to screen for AHI in high-risk/high-incidence venues [9]. Although, AHI can be detected with nucleic acid amplification testing (NAAT) of EIA-negative specimens [10–13], it requires a specialized laboratory and may be difficult to perform in a timely manner. A novel method to detect AHI prior to the development of HIV antibodies (seroconversion) is by screening with a more sensitive EIA, such as the 4th-generation EIA which detects both HIV antibody (IgG and IgM) and p24 antigen. The p24 antigen is a major core protein of HIV that can be detected early after HIV infection and before an antibody response has been generated and therefore may be as effective as NAAT at detecting HIV infections prior to seroconversion.
Identifying AHI, however, is only the first step necessary to interrupt “ongoing chains of HIV transmission.” AHI screening will only prevent on-going HIV transmission if persons with AHI are located in a timely manner and their sexual contacts are efficiently traced, counseled, and tested for HIV to break the chain of ongoing transmission. Without timely partner notification the opportunity to interrupt ongoing chains of HIV transmission will be lost. Traditional partner notification/contact tracing programs have only been able to locate a minority (8% in one report) of the potential partners [6] and in general are highly underused. Partners identified and tested through such programs, however, have high rates of HIV positivity (10%–40%) [6], illustrating the importance of identifying and testing this high-risk population. Multiple barriers contribute to the low efficiency of current partner notification/contact tracing methods including a limited capacity to trace partners who can only be identified by a cell phone number, an internet user ID, or an e-mail address. Novel and innovative strategies are needed to improve partner notification/ contact tracing for these pseudonymous contacts. Several health departments have demonstrated that sex partners can be effectively contacted using email and online chat room screen names [14-17] and internet-based partner notification by health departments has also been shown to be highly acceptable to men who have sex with men (MSM) [18].
Scientific knowledge to be achieved:
CDC is proposing a study to evaluate the yield of AHI screening with a 4th-generation enzyme immunoassay (EIA) compared to NAAT in high-risk/high-incidence settings such as sexually transmitted disease clinics, bathhouses, gay community centers, substance abuse clinics, emergency departments, internet sexual meeting websites [with testing performed at a prearranged location], or other venues proposed by the applicant (Project Purpose #1). AHI screening will be coupled with partner notification/referral services to interrupt ongoing chains of HIV transmission (Project Purpose #2). Sites will be selected to ensure that study participants are broadly representative of the race/ethnicity, gender, and transmission risk categories of the U.S. HIV epidemic and there will be an emphasis on enrolling participants who are: (1) black or African American, (2) Hispanic or Latino, and (3) men who have sex with men (MSM).
FOA Objectives:
Applicants must address both objectives in the research plan section of their application:
● Objective 1: To evaluate the yield, cost-effectiveness, and feasibility of screening for acute HIV infection (AHI) with a 4th generation enzyme immunoassay (EIA) in high-risk/high-incidence settings compared to pooled nucleic acid amplification testing (NAAT).
All consenting participants will be screened with a rapid EIA at point of care, a 4th-generation EIA, and NAAT (Figure 1). Persons who test rapid EIA negative but 4th-generation EIA and/or NAAT positive will be presumed to have AHI. FDA-approved confirmatory testing with a conventional EIA, western blot, and repeat NAAT will be performed to confirm HIV infection and AHI status prior to notifying study participants. The primary scientific purpose for objective #1 will be to compare the yield of 4th generation EIA compared with NAAT for AHI detection. Participants will be notified of their confirmatory test results within 48 hours after the results are available. HIV-infected participants will be linked to medical care (including CD4 cell count and viral load testing) and participants with AHI will also be referred to AHI clinical and seroconversion studies.
All study participants will also receive screening and clinical referral for syphilis, hepatitis B and hepatitis C virus infection. Advanced testing technologies, such as dual testing platforms for HIV and syphilis and/or HIV and hepatitis C, will also be considered for inclusion in the testing algorithm.
Given the advantages of rapid testing which provide immediate on-site results to facilitate and improve partner notification/contact tracing, several investigational point of care rapid tests for AHI will be evaluated that directly detect HIV p24 antigen or RNA. Decisions on which emerging technologies to test will be made based on cost and availability at the time the study prepares to enroll participants.
By testing participants in high-risk/high-incidence venues, the investigators will also encounter individuals in the earliest stage of HIV infection (the “eclipse” phase) who will test both NAAT and EIA negative. An extension of AHI screening to maximize its yield is to retest individuals at particularly high risk of recent HIV infection who test HIV negative for AHI at their initial screening. Operationally, such retesting could consist of retesting every 4 weeks for 3 months, and might be accomplished by having these individuals return to a designated testing site (e.g. the health department) or by having individuals perform a self-administered HIV test at home (e.g., Clearview Complete HIV 1/2) and send their results to the health department.
● Objective 2: To evaluate the yield, cost-effectiveness, and feasibility of enhanced partner notification / contact tracing techniques linked to AHI screening.
A local health department field investigator (Disease Intervention Specialist) hired for this study will immediately perform contact tracing and partner notification for all new HIV diagnoses. All STOP study investigators will agree on an enhanced partner notification/contact tracing protocol that combines traditional methods (provider referral model) with these novel communication methods, such as short message service (SMS)-text messaging, internet chat-room, email, and electronic notification card (e.g., www.inspot.org) communications.
The primary scientific purpose for objective #2 will be to evaluate the yield of these enhanced partner notification/contact tracing techniques. Internet-based techniques will enhance (not replace) traditional contact tracing and partner notification. These communications will maintain electronic confidentiality or anonymity of the index case and partners and will provide detailed instructions on how to contact the health department and get tested for HIV. Contacts will also be tested for AHI using the same algorithm (Figure 1). Participants with AHI will be prioritized for partner services with a goal to locate and test their partners within 7 – 10 days of AHI diagnosis.
Using data collected from partner services and peer referrals social network analysis will also be performed to enhance contact tracing and to describe transmission networks among participants with AHI compared to a subset of participants with established HIV infection and a subset of participants who test HIV negative.
All HIV-infected participants will also have pol gene sequencing to determine the incidence of antiretroviral resistance among participants with AHI compared to participants with established HIV infection. Pol gene sequences will also be used for molecular phylogenetic studies to evaluate for clusters of HIV transmission.
Both the social network and molecular phylogenetic data will be analyzed in real-time to further enhance contact tracing and partner notification efforts.
The ultimate goal of this project is to demonstrate a cost-effective model for AHI screening in high-risk/high-incidence settings that can be adopted by local health departments throughout the United States as a public health program to reduce HIV transmission. In summary, this study will demonstrate that the efficient diagnosis of AHI can reduce the spread of HIV by identifying highly infectious individuals, interrupting “onward chains of transmission,” and preventing new infections among high-risk HIV-negative partners.
Reference List
1) Quinn TC. JAMA 1997 July 2;278(1):58–62. 2) Pilcher CD et al. J Infect Dis 2004 May 15;189(10):1785-92. 3) Wawer MJ et al. J Infect Dis 2005 May 1;191(9):1403–9. 4) Brenner BG et al. J Infect Dis 2007 April 1;195(7):951–9. 5) Lewis F et al. PLoS Med 2008 March 18;5(3):e50. 6) Golden MR et al. Sex Transm Dis 2004 December;31(12):709–12. 7) Brewer DD et al. Sex Transm Dis 2005 March;32(3):189-93. 8) MMWR Morb Mortal Wkly Rep 2005 June 24;54(24):601-5. 9) Branson BM et al. MMWR Recomm Rep 2006 September 22;55(RR-14):1–17. 10) Patel P et al. J Acquir Immune Defic Syndr 2006 May;42(1):75–9. 11) Pilcher CD et al. N Engl J Med 2005 May 5;352(18):1873–83. 12) Pilcher CD et al. JAMA 2002 July 10;288(2):216–21. 13) Stekler J et al. AIDS 2005 August 12;19(12):1323–5. 14) Klausner JD et al. JAMA 2000 July 26;284(4):447-9. 15) MMWR Morb Mortal Wkly Rep 2004 February 20;53(6):129-31. 16) MMWR Morb Mortal Wkly Rep 2003 December 19;52(50):1229-32. 17) Vest JR et al. Sex Transm Dis 2007 November;34(11):840-5. 18) Mimiaga MJ et al. Sex Transm Dis 2008 February;35(2):111-6.
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 U01 activity code.
The HHS/CDC U01 is a cooperative agreement assistance instrument. Under the U01 assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and with HHS/CDC staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.
2. Funds Available
The participating Centers, Institutes and Offices (CIO) of NCHHSTP intend to commit approximately $500,000 including direct and indirect costs in FY2009 to fund 3–5 applications. The average award amount will range from $100,000 to $166,666, including both direct and indirect costs for the first 12-month budget period. An applicant may request a project period of up to 4 years. An applicant may request up to a maximum of $166,666 for the first 12-month budget period; $443,333 for the second year (FY2010); $747,833 for the third year (FY2011); and $342,166 for the fourth year (FY2012). The approximate total project period funded amount is $5,100,000 which will fund 3-5 applications for 4 years. The anticipated start date for new awards is September 30, 2009.
· Year 1: Grantees will identify and partner with 3 or more high-risk/high-incidence venues to conduct HIV screening. Grantees and partners will develop procedures for HIV testing in these venues and for reporting of results as well as partner notification using internet-based techniques. Partner organizations should serve a large number of African American and Hispanic men who have sex with men (MSM). Grantees and their partners will then identify the specific factors affecting the implementation of HIV screening and enhanced partner notification techniques based on their past experience and a review of published research and programmatic literature. Grantees may also obtain information through conversations with local and state health departments and the CDC. These factors will be considered during the development of this study protocol. Grantees will submit a protocol to local and CDC Institutional Review Boards (IRB)(CDC IRB only if CDC is engaged) and will obtain other approvals as needed.· Year 2: Upon receipt of IRB and any other needed approvals, grantees will implement an HIV screening program with enhanced partner notification strategies at the selected high-risk/high-incidence venues (largely serving African-American and Hispanic MSM). Grantees will evaluate the effectiveness of the HIV screening program using a pre-/post assessment or some other appropriate design and make necessary changes for the success of the program. Grantees will monitor and report the outcomes of HIV screening and enhanced partner notification to the CDC on a monthly basis.
· Year 3: Continue implementation and evaluation of the HIV screening program and enhanced partner notification techniques. Conduct preliminary data analyses of process and outcome data collected during implememtnation.
· Year 4: Grantees will submit all study data to the CDC in an analyzable format. All data will be submitted to the CDC within 6 months of completion of data collection. In addition, grantees will complete a final report that summarizes the main outcomes of the study, such as number of persons tested, number of persons identified with HIV infection and acute HIV infection, etc. The report will also describe lessons learned. Grantees will work with their partners and the CDC to disseminate the findings of this project through presentations at local and national conferences, and scientific publications.
All estimated funding amounts are subject to availability of funds.
If an applicant requests a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.
Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. 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 and the receipt of a sufficient number of meritorious applications.
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. Attach this documentation behind the first page of your application form, or for electronic applications, use a PDF file and attach as “Other Documents” and label as appropriate.
Limited Eligibility Justification: HIV is a major public health problem in the US and it is therefore necessary to conduct research to improve our prevention strategies. CDC funds HIV surveillance and prevention activities in all states, who in turn work with local health departments and community organizations to implement HIV prevention programs. State and local health departments are responsible for and have authority to perform all HIV partner notification / contact tracing services within their jurisdiction. It is therefore critical that state and local health departments lead this study. For these reasons, we have limited eligibility for this FOA to state and local health departments because a critical component of this study performs partner notification / contact tracing services to prevent future HIV infections,
The state and local health departments, however, generally do not conduct HIV prevention activities in isolation. These health departments often partner with academic and community-based organizations to provide HIV services within their community. We are therefore encouraging health departments to collaborate with academic and community-based organizations for this study as well.
2. Cost Sharing or Matching
Cost sharing, matching funds, or cost participation are not required.
3. Other-Special
Eligibility Criteria
If your application is incomplete or non-responsive to the special requirements
listed in this section, it will not enter into the review process.
Section IV. Application and Submission Information
To download a SF424 (R&R) Application Package and SF424 (R&R) Application Instructions for completing the SF424 (R&R) forms for this FOA, link to Grants.gov/Apply and follow the directions provided on that Web site.
A one-time registration is required for institutions/organizations at the following:
· Grants.gov Get Registered,http://www.grants.gov/applicants/get_registered.jsp · eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htmIMPORTANT: both the applicant organization, as well as, the PD/PI must register in eRA Commons for an application to be accepted electronically. The Credentials Log-In, referenced in Section IV. 2. Content and Form of Application Submission, is obtained through Step #3 in the required actions below.
PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.
The following three steps are required before an applicant institution/organization can submit an electronic application, as follows:
1) Organizational/Institutional Registration in Grants.gov Get Registered, http://www.grants.gov/applicants/get_registered.jsp
2) Organizational/Institutional Registration in the eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm
3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.
Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.
Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the eRA Commons. The HHS/CDC strongly encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs complete all necessary registrations.
1. Request Application Information
Applicants must download the SF424 (R&R) application forms and SF424 (R&R)
Application Guide for this FOA through
Grants.gov/Apply.
Note: Only
the forms package directly attached to a specific FOA can be used. You will not
be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from
another FOA); although some of the "Attachment" files may be useable for more
than one FOA.
For further assistance, contact PGO TIMS: Telephone
770-488-2700, Email: PGOTIM@cdc.gov
HHS/CDC
Telecommunications for the hearing impaired: TTY
770-488-2783.
2. Content and Form of
Application Submission
Prepare all applications using the SF424 (R&R) application forms and in accordance with the
SF424 (R&R) Application Guide (MS Word or PDF).The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by HHS/CDC (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”
The research plan should be no more than 25 pages, single-spaced, and printed on one side, with 11-point font, no more than six lines per inch, with half-inch margins all around. All tables, graphs, figures, diagrams, and charts must be included in the 25-page limit. There is no requirement to use all 25 pages; however, pages exceeding 25 will not be read or considered in the scoring. The plan should address activities to be conducted over the entire project period. The narrative, at a minimum, should include background information on HIV/AIDS epidemiology (e.g., prevalence, estimated incidence, if known, affected population and their demographics, etc.) in the proposed community and the need for AHI screening, AHI research objectives, methods, evaluation, budget, and time line. In addition to the 25-page narrative, applicants must include two appendices containing letters of support from community groups and other institutions, and curriculum vitas (CVs) of key personnel.
The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/Apply will include all applicable components, mandatory and optional. A completed application in response to this FOA will include the following components:
Required Components:
SF424
(R&R) (Cover component)
Research & Related Project/Performance Site
Locations
Research & Related Other Project Information
Research & Related
Senior/Key Person
Research & Related
Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist
Optional Components:
PHS398 Cover Letter File
Research & Related Sub award Budget Attachment(s)
Form
Note: While both budget components are included in the SF424 (R&R) forms package, the CDC U01 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)
3. Submission Dates and Times
See Section IV.3.A for details
3. A. Submission,
Review and Anticipated Start Dates
Letter of Intent Receipt Date:
Not
Applicable
Application Submission Receipt Date(s): February 20, 2009
Peer Review Date (s): April 2009
Council Review Date (s): June 2009
Earliest
Anticipated Start Date:
September
30, 2009
3.A.1. Letter of
Intent
A letter of intent is not applicable to this funding opportunity announcement.
3.B. Submitting an Application to CDC
If the instructions in this announcement differ in any way from the 424 R&R instructions, follow the instructions in this announcement.
To submit an application in response to this FOA, applicants should access this FOA via Grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov. The applicants’ Authorized Organization Representative (AOR) will receive an e-mail notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives the application.
All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Standard Time on the deadline date. If an applicant submits materials 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 HHS/CDC receives your submission after closing because of : (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 have the opportunity to submit documentation of the carrier’s guarantee. If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline.
This announcement is the definitive guide on 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 HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.
Otherwise, HHS/CDC will not notify you upon receipt of your paper 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 HHS/CDC to process and log submissions.
3.C. Application
Processing
HHS/CDC must receive
applications on or before 5:00 P.M.
Eastern Standard Time on the application submission date(s) described above
(Section IV.3.A.). If HHS/CDC receives an application after that submission date
and time, the application may be delayed in the review process or not reviewed.
Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.
· If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the CDC, PGO, Technical Information Management Section, after two business days.
· Prior to the submission deadline, the AOR/SO can “Reject” the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken. Please remember that some warnings may not be applicable or may need to be addressed after application submission.
· If the two day window falls after the submission deadline, the AOR/SO will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn’t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. HHS/CDC will not penalize the applicant for an eRA Commons or Grants.gov system issue.
· If the AOR/SO chooses to “Reject” the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the CDC late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment and must refer only to Commons errors and/or technical errors.
· Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.
Upon receipt, applications will be evaluated for completeness and responsiveness by the Coordinating Center for Infectious Diseases (CCID) and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications.
There will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons.
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 HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Restrictions, which applicants must take into account while writing their budgets, are as follows:
· Funds related to conducting research involving human subjects will be restricted until the appropriate assurances and Institutional Review Board approvals are in place. Awardees may not enroll human subjects until they receive a revised Notice of Award from the Procurement and Grants Office lifting the human subject’s restriction. · Reimbursement of pre-award costs is not allowed.
6. Other Submission
Requirements
Awardees upon acceptance of Notice of Award (NoA), 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. If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under “Other Attachments”, and title it appropriately.
Applicants’ research plan(s) should address activities they will conduct over the entire project period.
The HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.
Research Plan Component Sections
While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a PDF extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments. Your research plan must not exceed 25 pages. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.
The following materials may be included in the Appendix:
Up to 3 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.
· Publications in press: Include only a publication list with a link to the publicly available on-line journal article or the NIH Pub Med Central (PMC) submission identification number. Do not include the entire article. · Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment. · Manuscripts published but a publicly available online journal link is not available: The entire article may be submitted electronically as a PDF attachment. · Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. · Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan component. No images may be included in the Appendix that are not also represented within the Research Plan.
Please note the following restriction on appendix attachments: The Research Plan Appendix attachments are limited to 10 attachments. Appendices are uploaded as attachments in the PHS 398 Research Plan form, in field #18, within the electronic application package. An applicant will receive an error message if the number of appendix attachments exceeds 10, which will result in an unsuccessful submission of the application. You may include more than one publication, or other allowable appendix material, within one attachment; however, do not let your attachments exceed 10.”
Do not to use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.
Plan for Sharing Research Data
De-identified sets of data compiled from information collected at the participating sites will be processed by, housed at, and disseminated by CDC for analyses. Applicants are therefore not required to provide individual research data sharing plans as part of this application. Applicants must agree that if selected they agree 1) to submit data collected under this cooperative agreement to CDC; and, 2) to clear all publications and presentations derived either from site-specific or from aggregate data collected under this agreement through the CDC Division of HIV/AIDS Prevention.
All
applicants must include a plan for sharing research data in their application.
The HHS/CDC data sharing policy is available at
http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements #25
(AR-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
Not applicable.
Section V. Application Review Information
Only the
review criteria described below will be considered in the review process.
1) Black or African American participants;
2) Hispanic or Latino participants; and
3) Men who have sex with men (MSM).
The study will attempt to enroll participants with race/ethnicity and transmission category characteristics that are broadly representative of the US HIV epidemic. As reference, the race/ethnicity of new infections in the US from 2003 - 2006 was estimated to be:
Black or African American 50%
Hispanic or Latino 16%
White 32%
Asian/Pacific Islander 2%
American Indian or Alaska Native <1%
The transmission category of new infections in the US from 2003 - 2006 was estimated to be:
MSM (Men who have sex with men) 56%
Heterosexual Females 21%
Heterosexual Males 9%
IDU (Injecting Drug Users) 11%
MSM/IDU 3%
A funding preference will be given to applicants who demonstrate an ability to enroll black or African American participants, Hispanic or Latino participants, and/or men who have sex with men (MSM).
· Applications that do not address both the required objectives listed in Part II, Section 1 may not be funded even if they rank higher than other applications that address both objectives. · Proposals may be funded out of rank order based on geographic diversity and sub-populations served, · Applications may not be funded if data from all funded sites does not allow for pooling of data.
2. Review and Selection
Process
Applications that are complete and responsive to the FOA will be evaluated for
scientific and technical merit by an appropriate peer review group convened by
CCID in accordance with the review criteria stated below.
As
part of the initial merit review, all applications will:
· Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score
· Receive a written critique; and
· Receive a second level of review by HHS/CDC CCID to make funding recommendations based on responsiveness of applications to program priorities as stated in this FOA.
· Applications submitted in response to this FOA will compete for available funds with all other eligible applications. The criteria listed in Section V.1. will be considered in making funding decisions.
The goals of HHS/CDC-supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness. In the written comments, evaluate the application to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed by the reviewers and considered in assigning the overall score, weighting them and weighted, as appropriate for each applications.
· Significance
· Approach
· Innovation
· Investigators
· Environment
Note that an application does not
need to be strong in all categories to be judged likely to have major scientific
impact and thus deserve a high priority score. For example, an investigator may
propose to carry out important work that by its nature is not innovative but is
essential to move a field forward.
Significance:
Does this
study address an important problem? If the applicant achieves the aims of the
application, how will it advance scientific knowledge or clinical practice? What
will be the effect of these studies on the concepts, methods, technologies,
treatments, or preventative interventions that drive this field? Does the
applicant address the importance of screening for acute HIV infection (AHI)?
Does the applicant discuss the relative advantages and disadvantages of AHI
screening with a more sensitive enzyme immunoassay (EIA), such as the
4th-generation EIA, in high-risk/high-incidence settings compared to pooled
nucleic acid amplification testing (NAAT)? Does the applicant provide rationale
for comparing AHI screening with 4th-generation EIA to NAAT (objective #1)? Does
the applicant discuss how identifying AHI might impact HIV transmission? Does
the applicant provide rationale for offering additional HIV testing (e.g.,
home-based testing with Clearview Complete HIV 1/2 test kits) for a subset of
high-risk participants who screen negative for AHI? Does the applicant provide
rationale for evaluating enhanced partner notification / contact tracing
techniques coupled to AHI screening (primary scientific objective #2)? Does the
applicant currently demonstrate effort, willingness, and success in contacting
HIV-infected clients tested confidentially who do not return for their test
results? Does the applicant discuss how partner notification / contact tracing
can be improved with internet chat room, electronic notification card, e-mail,
and short message service (SMS) text messaging techniques? Does the applicant
address how social network analysis and molecular phylogenetic analysis could
advance scientific knowledge of transmission dynamics and improve public health
practice?
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 understanding of the research objectives as evidenced by the quality of the proposed research plan and specific study design and methods? Does the applicant provide plans for recruitment and outreach of study participants from the proposed target population (i.e. black or African American participants, Hispanic or Latino participants, and/or men who have sex with men (MSM))? Does the applicant outline how the enrollment and HIV testing will occur within their proposed study venues? How feasible is the study plan to recruit and enroll study participants in a culturally appropriate manner? Does the applicant address required follow-up activities (i.e. partner notification and testing) and methods to complete these activities in a timely manner? Does the applicant address what changes are necessary to their routine HIV testing program in order to prioritize partner services for participants with AHI with a goal of locating and HIV testing partners within 7–10 days? Does the applicant describe their current partner services practices including whether they currently use a provider referral model where the partner is notified by a health department specialist who has been specifically trained to locate and notify partners of their possible exposure and link them to medical, prevention, and support services, while protecting the index patient’s confidentiality? Does the plan provide for protecting study participants and ensuring confidentiality? Does the applicant provide a reasonable timeline for the completion of the awardees’ activities? Does the study plan demonstrate that plans for recruitment and outreach for study participants will include establishing and/or maintaining partnerships with local communities? Does the study plan show evidence of establishing a partnership with community organizations to consult on all aspects of conducting the study? Does the study plan demonstrate how study participants will be linked to prevention and medical services as needed (i.e. referring a high risk HIV-negative participant for additional prevention counseling or ensuring participants receive access to appropriate medical care for a positive sexually transmitted disease test result, such as syphilis or viral hepatitis)?
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 demonstrate an understanding of novel techniques for partner services (e.g., contact tracing and partner notification aided by internet chat room, electronic notification card, e-mail, and short message service (SMS) text messaging techniques and by social networking and molecular phylogenetic data) and an ability to incorporate these techniques into their existing partner services? Does the applicant currently use novel techniques for partner services (e.g., contact tracing and partner notification aided by internet chat room, electronic notification card, e-mail, short message service (SMS) text messaging techniques)? Does the applicant propose using and provide specific examples of novel techniques to enhance partner services for this study? Does the applicant explain that policies and protocols are in place to ensure electronic confidentiality or anonymity of the index case and partners are assured for internet-based partner notification? Does the applicant explain how structural and bureaucratic barriers (e.g. lack of access to computers, firewalls that bar access to websites with “sexual content”, and late night (1:00 to 5:00 AM) chat room hours) to staff use of the Internet for partner notification will be overcome? Does the applicant propose how molecular phylogenetic data can be used to enhance case investigation and reduce HIV transmission?
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 investigator have experience with AHI screening? Has the investigator been involved in AHI screening efforts? Does the investigator demonstrate strong community partnerships and access to predominantly black or African American and Hispanic or Latino communities that are disproportionately affected by the HIV/AIDS epidemic, as evidenced by letters of support? Does the investigator demonstrate strong community partnerships and access to men who have sex with men (MSM) communities that are disproportionately affected by the HIV/AIDS epidemic, as evidenced by letters of support? Does the investigator demonstrate the ability to recruit study participants and obtain valid data through the use of culturally appropriate methods and instruments? Does the investigator demonstrate that their project team has the training, expertise, and time to deliver enhanced contact tracing and partner notification? Does the investigator have the appropriate training and skills to conduct this AHI study? Does the investigator demonstrate the epidemiologic, behavioral, clinical, administrative, and management experience needed to conduct this proposed study? Does the investigator have documented basic capacity/support in data management and analysis to conduct this study?
Environment: Does the scientific environment in which the applicant will do the work 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? Does the applicant have collaborative arrangements with potential study venues (e.g., sexually transmitted disease (STD) clinics, bathhouses, gay community centers, substance abuse clinics, emergency departments, internet sexual meeting sites, or others proposed by the applicant) that have documented high rates of new HIV diagnoses, as evidenced by letters of support? Do these collaborative arrangements allow for participant recruiting and HIV testing to take place at the study venues? Does the applicant provide a list of potential high-risk/high-incidence venues at which the study will be performed? Does the applicant provide estimates for the number of people who will be screened for AHI at each venue and estimates of the HIV prevalence rate at each venue? Do the planned venues for the study have access to adequate numbers of the proposed target population (i.e. black or African American participants, Hispanic or Latino participants, and/or men who have sex with men (MSM))? Does the applicant provide estimates of the rates of new HIV diagnoses per 1,000 people screened at potential study venues that would qualify as high-risk/high-incidence settings? Does the applicant have a strong relationship with the partner services unit and the ability to augment the current program by hiring a dedicated field investigator to perform and coordinate partner notification/contact tracing for all new AHI diagnoses with a goal of locating and HIV testing partners within 7–10 days? Does the applicant have a strong partnership with a local laboratory that is already conducting or has the capacity to conduct acute HIV screening including performing pooled nucleic acid amplification testing (NAAT), as evidenced by letters of support? Does the applicant have access to qualified personnel with realistic and sufficient percentage time commitments relative to each phase of the study timeline? Does the applicant have the appropriate facilities and staff to conduct this study? Does the applicant provide a description of duties, percentage time commitments, and responsibilities of project personnel including clear lines of authority and supervisory capacity over the field work, administrative, data management, and statistical aspects of the research? How adequate are the plans for facilities, equipment, assessment programming, data processing, and analysis capacity, and systems for management of data security and participant confidentiality in achieving the study objectives? Does the applicant provide a detailed budget for the total project period that includes a staffing plan and list of activities for each project year? Documentation of the above requirements must be included in the application. This includes, but is not limited to letters indicating involvement in HIV/AIDS research or HIV/AIDS-related publications, curriculum vitae and/or letters of support.
2.A. Additional
Review Criteria
In addition to the above criteria, the following items will be considered in the determination of scientific merit and the priority score:
Protection of Human Subjects from Research Risk: When human subjects are involved, HHS/CDC will assess the available protections from research risk that relate to their participation in the proposed research. [see the Research Plan, Section 2, item 8 on Human Subjects in the SF424 (R&R)] http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.
Inclusion of Women and Minorities in Research:
Does the application adequately address the HHS/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 (see Section 2, item 9 Inclusion or Women and Minorities of the Research Plan component of the SF424 (R&R). .
Biohazards:
If applicants propose the applicant has proposed materials or procedures that
are potentially hazardous to research personnel and/or the environment, HHS/CDC
will determine if the proposed protection is adequate.
2.B. Additional
Review Considerations
Budget and Period of Support: The reasonableness of the proposed budget and the
appropriateness of the requested period of support in relation to the proposed
research may be assessed by the reviewers. Is the number of person months listed
for the effort of the PD/PI appropriate for the work proposed? Is each budget
category realistic and justified in terms of the aims and methods? The
evaluation of the budget should not effect the priority score.
2.C. Sharing
Research Data
Not Applicable
2.D. Sharing
Research Resources
Not Applicable
3. Anticipated
Announcement and Award Dates
Earliest
Anticipated Award Date is September 30, 2009.
Section VI. Award Administration Information
1. Award Notices
After the peer review of the application is completed, the applicant
organization will receive a written critique called a “Summary Statement.”
The
applicant organization and the PD/PI will be able to access the Summary
Statement via the eRA Commons.
HHS/CDC will contact t
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. HHS/CDC will mail and/or e-mail this document 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
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 are available Section VIII. Other Information of this document or
on the HHS/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.
The following terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a courteous copy to the PD/PI at the time of award.
2.A. Cooperative
Agreement
The
following terms of award are in addition to, and not in lieu of, otherwise
applicable Office of Management and Budget (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/CDC grant administration policies.
The
administrative and funding instrument used for this program will be the
cooperative agreement U01 an "assistance" instrument (rather than an
"acquisition" instrument), in which substantial HHS/CDC programmatic involvement
with the awardees is anticipated during the performance of the activities. Under
the cooperative agreement, the HHS/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 HHS/CDC may share specific
tasks and activities, as defined above.
2.A.1. Recipient
Rights and Responsibilities
The
Recipient will have primary responsibility for the following:
· Planning, directing, and executing the proposed project with CDC staff being substantially involved as a partner. · Collaborate with other award recipients and CDC to develop a single, unified protocol for the STOP study and to submit the protocol for IRB review and approval. Protocol development activities will include the development of AHI screening algorithms, data collection instruments, specimen collection protocols, and data management procedures. · Obtain a Certificate of Confidentiality from CDC. · Identify, recruit, obtain informed consent from, and enroll an adequate number of study participants as determined by the study protocol and the program requirements. · Follow study participants as determined by the study protocols. · Establish procedures to maintain the rights and confidentiality of all study participants. · Perform laboratory tests and data analysis as determined in the study protocols. · Present and submit the study (or its various components) for publication in a peer-reviewed journal and presentation at scientific meetings after completion of the study. · Participate in conference calls with CDC project officer(s) and research team. · Host CDC project officer(s) for site visits. · Agree to collaborate and share data with other awardees and CDC, and transfer data for central analysis at prespecified intervals.
·
Attend initial and annual meetings with other CDC-funded grantees to promote research dissemination and networking among investigators, grantee should budget for this travel.
Recipient
Organization will retain custody of and have primary rights to the information,
data and software developed under this award, subject to U.S. Government rights
of access consistent with current HHS/CDC policies.
2.A.2. HHS/CDC
Responsibilities
An
HHS/CDC Project Scientist will have substantial programmatic involvement that is
above and beyond the normal stewardship role in awards, as described below:
· Provide technical assistance as needed in the design and conduct of the research. · Facilitate and assist in the development of a research protocol for Institutional Review Board (IRB) review by all cooperating institutions participating in the research project. If CDC is engaged in the research, the HHS/CDC IRB will review and approve the protocol initially and on at least an annual basis until the research project is completed. · Obtain Office of Management and Budget (OMB) approval per the Paperwork Reduction Act. · Assist as needed in designing a data management system. · Facilitate storing of aggregate data with participating recipients. · Assist as needed in performance of selected laboratory tests. · Collaborate with the investigators on analysis and interpretation of data and on dissemination, and publication of results if CDC contribution merits this. · Conduct site visits to ensure that venues are properly selected, collaborations outlined in proposals are true, the community is involved in the research activities, and investigators are complying with the research protocol. · Conduct initial and annual meetings of the study investigators to facilitate the exchange of research progress among recipients and to offer additional technical expertise for the conduct of research.
Additionally, an HHS/CDC 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 NoA.
2.A.3. Collaborative
Responsibilities
Not
applicable
3. Reporting
Recipient Organization
must provide HHS/CDC with an original,
plus two hard copies of the following reports:
· Additional Requested Information.
2. Financial status report, no more than 90 days after the end of the budget period. 3. An annual report, due 90 days before end of budget period, of study activities including: · Total number of participants tested for HIV infection · Summary of HIV test results · Summary of partner notification / contact tracing activities · Additional requested information 4. Final financial and performance reports, no more than 90 days after the end of the project period.
Recipient Organization must forward these reports by way of the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this FOA.
Although the financial plans of the HHS/CDC 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
HHS/CDC encourages your inquiries concerning this FOA and welcomes the opportunity to answer questions from potential applicants. Inquiries can fall into three areas: scientific/research, peer review, and financial or grants management issues:
Dr. Shoukat Qari
Scientific Program Administrator
Extramural Programs
Strategic Science and Program Unit
Coordinating Center for Infectious Diseases
Centers for Diseases Control
U.S. Department of Health and Human Services
1600 Clifton Rd. MS E-60
Atlanta, GA 30333
Telephone: (404) 498-2274
Fax: (404) 498-2626
Email: SQari@cdc.gov
2. Peer Review
Contacts:
Gregory Anderson, MPH, MS
Scientific Review Administrator
Extramural Programs
Strategic Science and Program Unit
Coordinating Center for Infectious Diseases
Centers for Diseases Control
U.S. Department of Health and Human Services
1600 Clifton Rd. MS E-60
Atlanta, GA 30333
Telephone: (404) 498- 2275
Fax: (404) 498-2626
Email:
GAnderson@cdc.gov
3. Financial or
Grants Management Contacts:
Julia L.
Valentine
Grants
Management Officer
Procurement and Grants Office, Branch 1
Center for
Disease Control and Prevention
U.S.
Department of Health and Human Services
2920
Brandywine Road, MS E-15
Atlanta,
GA 30341
Telephone:
(404) 639-8051
Fax: (404)
639-8095
Email:
jxv1@cdc.go
4. General Questions
Contacts:
Technical Information Management Section
CDC Procurement and Grants Office
U.S. Department of Health and Human Services
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 (45 CFR Part 46) 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 HHS/CDC Requirements under AR-1 Human Subjects Requirements can be
found on the Internet at the following address:
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.
INCLUSION OF PERSONS UNDER THE AGE OF
21 IN RESEARCH
The policy of CDC is that persons under the age of 21 must be included in all
human subjects research that is conducted or supported by CDC, unless there are
scientific and ethical reasons not to include them. This policy applies to all
CDC-conducted or CDC-supported research involving human subjects, including
research that is otherwise exempt in accordance with Sections 101(b) and 401(b)
of
45 C.F.R. Part 46, HHS Policy for the Protection
of Human Subjects. Therefore, proposals for research involving human
subjects must include a description of plans for including persons under the age
of 21. If persons under the age of 21 will be excluded from the research, the
application or proposal must present an acceptable justification for the
exclusion.
In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.
The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.
The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.
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.
HIV Program Review Panel Requirements
Compliance with Content of AIDS-Related Written Materials, Pictorials, Audiovisuals, Questionnaires, Survey Instruments, and Educational Sessions (June 1992) is required.
To meet the requirements for a program review panel, you are encouraged to use an existing program review panel, such as the one created by the State health department's HIV/AIDS prevention program. If you form your own program review panel, at least one member must be an employee (or a designated representative) of a State or local health department. List the names of the review panel members on the Assurance of Compliance form, CDC 0.1113. Submit the program review panel's report that all materials have been approved.
If the proposed project involves hosting a conference, submit the program review panel's report stating that all materials, including the proposed conference agenda, have been approved. Submit a copy of the proposed agenda with the application.
Before funds are used to develop
educational materials, determine whether suitable materials already exist in the
CDC National Prevention Information Network (NPIN).
The website can be found at;
http://www.nchstp.cdc.gov/od/infocenter/npin.htm.
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.
Specs or tribal governments that have recommendations about an application submitted to HHS/CDC should send them, in a document bearing the program announcement number, no more than 60 days after the application deadline date, to:
Julie L.
Valentine, Grants Management Specialist
Procurement and Grants Office
Announcement Number PS09-004
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road
Atlanta, Georgia 30341-4146
HHS/CDC does not guarantee to accept or justify its non-acceptance of recommendations that are received more than 60 days after the application deadline.
This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based non-governmental organizations submitting health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:
A. A copy of the face page of the application (SF 424).
B. A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:
1. A description of the population to be served.
2. A summary of the services to be provided.
3. A description of the coordination plans with the appropriate state and/or local health agencies.
If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.
Paperwork Reduction Act Requirements
Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB).
Smoke-Free Workplace Requirements
HHS/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.
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 FOA is related to one or more of the priority areas. Potential applicants
may obtain a copy of "Healthy People 2010" at
www.healthypeople.gov
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 HHS/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, HHS/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 HHS/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 HHS/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 HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/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.
Proof of Non-profit Status
Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.
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 (ORI) (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.
Compliance with Executive Order 13279
Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations. All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS. If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance. A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above. A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols. In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization=s name, select its board members on a religious basis, and include religious references in its organization=s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities. For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site:
http://www.whitehouse.gov/government/fbci/
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. HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and HHS/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 HHS/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) http://www.cdc.gov/od/foia/index.htm.
Applications must include a copy of the applicant's Data Release Plan. Applicants should provide HHS/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. HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.
National Historic Preservation Act of 1966
(Public Law 89-665, 80 Stat. 915)
The grantee’s signature on the grant application attests to their: (1) knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to ensure all grant related activities are in compliance with referenced public law, as stated:
a. Section 106 of the National Historic Preservation Act (NHPA) states:The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking, shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register. The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.
b.
Additionally, the NHPA also contains the following excerpt that forbids “anticipatory demolition:”Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.
Conference Disclaimer and Use of Logos
Disclaimer: Where a conference is funded by a grant or cooperative agreement, a sub grant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:
“Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) . The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”
Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003). Neither the HHS nor the CDC logo can be used on conference materials under a grant, cooperative agreement, contract or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer. It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.
CDC Home Page: http://www.cdc.gov
CDC Funding Web Page: http://www.cdc.gov/od/pgo/funding/FOAs.htm
CDC Forms Web Page:
http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm