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
National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention (NCHHSTP), at http://www.cdc.gov/nchhstp/
Authority:
Sections
301 and 318 of the Public Health Service Act (42 U.S.C. Sections 241 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 may 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-09-008
Catalog of Federal Domestic
Assistance Number(s):
93.941
Key Dates
Release/Posted Date: December 19, 2008
Letter of Intent Receipt Date: Not Applicable
Application Submission Receipt Date(s):
February
17, 2009
Peer
Review Date(s):
April 2009
Council
Review Date(s):
June 2009
Earliest Anticipated Start Date(s): September 1, 2009
Additional Information to Be Available Date: Add Information Here
Expiration Date: TBD
Due Date for E.O. 12372
Due no later than 60 days after the application receipt date.
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
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/AIDS, Viral Hepatitis, STD and TB 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(s) of HIV and is in alignment with NCHHSTP performance goal(s) to develop and implement effective HIV prevention interventions. For more information, www.healthypeople.gov.
The purpose of this funding opportunity announcement (FOA) is to support operational research (also known as operations research) to:
(1) Identify specific factors affecting the successful implementation by community-based HIV prevention organizations of currently available evidence-based interventions (EBIs); and
(2) Develop, implement, and evaluate strategies for addressing those factors that negatively affect the implementation of EBIs.
For the purpose of this FOA, operational research is defined as systematic research that uses qualitative and/or quantitative methods to improve the delivery of HIV prevention services. Operational research can contribute to these improvements by offering HIV prevention providers information and tools that can be used to increase the efficiency, effectiveness, and quality of the HIV prevention services they deliver, and the availability, accessibility, and acceptability of services desired by persons who use HIV prevention services.
The intended purpose of this FOA is to directly benefit community-based HIV prevention organizations that implement EBIs. Furthermore, strategies identified and evaluated in this FOA will be used to help local organizations to improve their HIV/AIDS prevention efforts in their communities.
Throughout the United States, community-based organizations (CBOs), AIDS service organizations (ASOs), and faith-based organizations (FBOs) implement evidence-based interventions (EBIs) for populations at high-risk for acquiring or transmitting Human Immunodeficiency Virus (HIV), with support from CDC’s Diffusion of Effective Behavioral Intervention (DEBI) Project; (for further details see www.effectiveinterventions.org). To further assist local HIV/AIDS prevention efforts, CDC supports the provision of HIV prevention-focused training and technical assistance to community-based HIV prevention service providers through four regional Prevention Training Centers (PTCs; also referred to as Part II-PTCs). The four Part-II PTCs assist local CBOs, ASOs, and FBOs with the implementation of EBIs for diverse populations. The Part II PTC’s are the only national network of regional training centers funded to work in collaboration with researchers, university staff, and government officials to develop curricula on HIV programs, train CBO and other agency providers on implementation procedures, and provide technical assistance on adapting interventions to achieve efficacious outcomes. However, the PTCs and many local HIV prevention organizations have noted persistent challenges to successful EBI implementation. These challenges include, but are not limited to, recruitment and retention of hard-to-reach intervention clients and qualified program staff; selection of EBIs that are sufficiently responsive to the unique social, contextual, and cultural needs of target populations served by local HIV prevention organizations; building capacity to appropriately adapt and implement EBIs; and the design and conduct of process evaluation and quality assurance activities. Factors such as these can negatively affect intervention delivery and possibly reduce the effectiveness and efficiency of the HIV prevention intervention programs.
Two awards will be made over a 4-year project period to Part II-PTCs with experience providing technical assistance to organizations implementing behavioral interventions. It is expected that Part II-PTCs receiving awards will formally partner with five or more CBOs, ASOs, or FBOs in their respective regions that have knowledge of or have experienced persistent difficulties when implementing EBIs supported by the DEBI Project (henceforth referred to as DEBIs). PTCs will establish memoranda of agreements with partner HIV prevention organizations. These five or more organizations will form an advisory group to assist the PTC to identify the most critical challenges and to develop innovative strategies to address them. PTCs and their partners will also be expected to work in close collaboration with CDC.
The primary focus of this announcement concerns factors that can negatively affect the successful implementation of DEBIs by HIV prevention organizations. Therefore, we expect that applicants and their local HIV prevention organization partners will focus primarily on identifying and addressing factors that create recurrent barriers or challenges to implementing DEBIs, and developing, implementing, and assessing strategies to address them. However, applicants and their partners may also identify factors that facilitate the implementation of DEBIs, thereby contributing to knowledge about the conditions that are associated with successful implementation of DEBIs.
Examples of factors that can affect DEBI implementation and may be addressed by applicants and their partners include but are not limited to:
o
Recruiting and retaining hard-to-reach target populations at high risk for acquiring or transmitting HIV,o
Recruiting and retaining qualified staff,o
Selecting DEBI interventions that are sufficiently responsive to the unique social, contextual, and cultural needs of target populations served by local HIV prevention organizations,o
Building capacity to appropriately adapt and implement DEBIs, ando
Designing and conducting process evaluation and quality assurance activities.
Once grantees and their partners have identified factors that create persistent challenges or difficulties associated with delivery of DEBIs, together they will develop innovative strategies to address at least two of the most frequently reported challenges. PTCs will then implement the strategies to address the challenges to DEBI delivery and will evaluate the effectiveness of the strategies using a pre-/post assessment or some other appropriate design with an appropriate sample of HIV prevention organizations that have experienced persistent challenges implementing DEBIs. These organizations will represent a diversity of organizational capacity levels (e.g., agency size or amount of HIV prevention funding), target populations (e.g., race/ethnicity, risk behaviors), geographic locations (e.g., urban and rural; areas hardest-hit by the HIV epidemic), and DEBIs.
The intent of this funding opportunity is to enable grantees to develop and implement strategies that can be implemented by HIV prevention organizations to improve the delivery of DEBIs, and to assess these strategies when implemented by local HIV prevention organizations so that strategies found to be effective can be made available to other CBOs that experience similar problems with DEBIs. Moreover, it is intended that PTCs and HIV prevention organizations implementing DEBIs will use the findings of this evaluation to improve the quality of HIV prevention services they deliver.
Part II-PTC grantees must address all of following activities in their research plan over a 4-year period:
· Year 1: Grantees will partner with 5 or more HIV prevention organizations (both directly- and indirectly-funded by CDC) that implement DEBIs within their region. Partner organizations should be knowledgeable of and/or have experienced persistent difficulties when implementing currently available DEBIs. Grantees and their partners will then identify the specific factors affecting the implementation of DEBIs based on their past experience providing training, technical assistance, and capacity building assistance to HIV prevention service providers and as service providers; and a review of published research and programmatic literature. Grantees may also obtain information through conversations with CDC-funded capacity building assistance providers, local and state health departments, and the CDC. Grantees will develop strategies to address at least two of the most frequently reported challenges to implementing DEBIs faced by their HIV prevention partner organizations, and develop methods to assess the effectiveness of the strategies for improving DEBI implementation. The intent of these activities is to develop innovative strategies that can be used by HIV prevention organizations that implement DEBIs. Strategies must not rely solely on training or provision of technical assistance. 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 the innovative strategies with an appropriate sample of HIV prevention organizations representing a diversity of organizational capacity levels (e.g., agency size or amount of HIV prevention funding), target populations (e.g., race/ethnicity, risk behaviors), geographic locations (e.g., urban and rural; areas hardest-hit by the HIV epidemic), and DEBIs. This sample of HIV prevention organizations must not include the original five or more HIV prevention organization partners. Grantees will evaluate the effectiveness of the innovative strategies using a pre-/post assessment or some other appropriate design. Grantees will monitor and report the process of strategy implementation as well as the outcomes of the strategy that are selected to improve DEBI implementation.
· Year 3: Continue implementation and evaluation of the strategies. Conduct analysis of process and outcome data collected during and after implementing strategies. If applicable, outcome monitoring indicators can be used from CDC’s Program Evaluation and Monitoring System (PEMS).
· Year 4: Grantees will complete a report for CDC. The report will describe the process and methods used to identify challenges that affect DEBI implementation. The report will also describe the strategies, lessons learned, and evaluation findings. Grantees will work with the original 5 or more HIV prevention organization partners to disseminate the findings of this operational research project through presentations at local and national conferences, and scientific publications. Grantees will also disseminate information on lessons learned and successful strategies to other HIV prevention organizations through mechanisms such as toolkits, guides, training curricula, the Internet, or Podcasts.
· Throughout the project period: Monitor the procedures and actions taken to develop and implement strategies to address DEBI implementation challenges.
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)(s) NCHHSTP intends to commit approximately $350,000 including direct and indirect costs dollars in FY2009 to fund two applications over a four-year project period. The average award amount per grantee will be $175,000 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 $175,000 for the first 12-month budget period, $400,000 for the second year; $400,000 for the third year; and $300,000 for the fourth year. Increased funding is thus proposed for years 2, 3 and 4 relative to year 1 to reflect the increased anticipated cost of the activities including staffing costs and supplies that are expected to result from full implementation of the study activities in years 3 through 5 as described in detail in the Objectives section. The approximate total project period funded amount per awardee will be $1,275,000. The anticipated start date for new awards is September 1, 2009.
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.
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:
Eligible applicants are grantees under CDC Program Announcement PS06-606: Sexually Transmitted Diseases/Human Immunodeficiency Virus Prevention Training Centers (PTC) Part II.
Eligibility for this operational research is limited to Prevention Training Centers (PTCs) funded under PS06-606 – Part II because the purpose of this funding opportunity announcement is to support operational research to identify specific factors affecting the successful implementation of evidence-based interventions (EBIs) by community-based HIV prevention organizations, and to develop, implement, and evaluate strategies to reduce or eliminate the challenges face by community-based HIV prevention organizations in implementing DEBIs. The Prevention Training Centers – Part II are the only organizations who meet all of the following criteria necessary for successful completion of the project: 1) experience providing training and technical assistance on evidence-based interventions (EBIs) identified by CDC through the Diffusion of Effective Behavioral Interventions (DEBI) project: 2) established relationships with community-based (CBO), faith-based (FBO) and other AIDS service organizations (ASOs) in each PTC’s region; and 3) established collaborations with university researcher staff with experience conducting operational or intervention research using appropriate research study designs and methods.
The Prevention Training Centers (PTC) – Part II are the only national network of regional training centers, created in partnership with health departments and universities, who offer state of the art education and training on evidenced-based interventions (EBI) identified by CDC through the Diffusion of Effective Behavioral Interventions (DEBI) project and the skills that support their successful implementation and program evaluation. PTC’s have a broad range of experience and understanding in the implementation and development of these EBIs. Organizations that are not familiar with the DEBI project and/or challenges experienced by CBOs in implementing EBIs will not be able to complete this project in a timely manner.
In order to conduct this project, it is critical to have existing relationships with HIV Prevention service providers that implement EBIs. PTCs not only have experience providing training on EBIs funded under the DEBI Project, but they have strong relationships with CBOs, FBOs and ASOs implementing these EBIs. Awardees under this new program announcement must be able to complete several activities described in the program announcement within the first budget year including identification of the most common challenges community-based agencies face and development and implementation of strategies to address these challenges. Because PTCs already have strong relationships with these agencies, they will be well positioned to complete all these activities in the required deadline. Agencies without these established relationships would need extra time to establish them and thus may not be able to complete all project activities in the project period.
PTCs are also the only regional network of agencies that have an established collaboration with researchers and other university staff with experience conducting operational or intervention research. Agencies without this research experience would not be able to complete the operational research during the project period.
In summary, the PTCs are the only organizations that have both the infrastructure and the
established relationships to complete all of the activities in the project period.
2. Cost Sharing or Matching
Cost sharing, matching, or cost participation are not required.
3. Other-Special Eligibility Criteria
Only studies proposed for conduct in the United States and its territories are eligible for consideration.
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 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 17, 2009
Peer Review Date (s): April 2009
Council Review Date (s): June 2009
Earliest
Anticipated Start Date:
September
1, 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 Letter Of Intent (LOI) and application content, submission address, and deadline. It supersedes information provided in the application instructions. If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and 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.
If submitting a paper application, it must be prepared using the 424 R&R instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and three signed photocopy(s) to the following address:
Technical Information Management Section – PS09-008
CDC, Procurements and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA 30341
Phone: 770-488-2700 EST
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 relating to the conduct of 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 five 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
The
precise content of the data-sharing plan will vary, depending on the data being
collected and how the investigator is planning to share the data. Applicants
should describe briefly the expected schedule for data sharing, the format of
the final dataset, the documentation they will provide, whether or not any
analytic tools also will be provided, whether or not a data-sharing agreement
will be required and, if so, a brief description of such an agreement (including
the criteria for deciding who can receive the data and whether or not the
awardee will place any conditions on their use), and the mode of data sharing
(e.g., under their own auspices by mailing a disk or posting data on their
institutional or personal website, through a data archive or enclave).
References to data sharing may also be appropriate in other sections of the
application.
All
applicants must include a plan for sharing research data in their application.
The HHS/CDC data sharing policy is available at
http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25
Release and Sharing of Data. All investigators responding to this funding
opportunity should include a description of how final research data will be
shared, or explain why data sharing is not possible.
The
reasonableness of the data sharing plan or the rationale for not sharing
research data will be assessed by the reviewers. However, reviewers will not
factor the proposed data sharing plan into the determination of scientific merit
or the priority score.
Section V. Application Review Information
1. Criteria
Only the
review criteria described below will be considered in the review process.
·
Scientific merit of the proposed project as determined by peer review·
Availability of funds·
Relevance of program priorities and the priorities of the U.S. Department of Health and Human Services·
Applications that do not conduct all the required activities listed in Part II, Section 1 may not be funded even if they rank higher than other applications that conduct all the required objectives.·
Proposals may be funded out of rank order based on geographic diversity.·
Applications may not be funded if data from all funded sites does not allow for pooling of data.·
Applicants must include each of the following in an appendix labeled Appendix A otherwise they may not be funded1. Memoranda of agreement with five or more partner community-based organization (CBO), AIDS service organization (ASO), faith-based organization (FBO), or other organizations that implement DEBIs to persons at high risk for acquiring or transmitting HIV.
2. A detailed description of past experience in assisting HIV prevention organizations to address one or more of the following challenges implementing DEBIs:
I. Recruiting and retaining qualified staff,
II. Recruiting and retaining hard-to-reach target populations at high risk for acquiring or transmitting HIV,
III. Selecting DEBIs that are sufficiently responsive to the unique social, contextual, and cultural needs of target populations served by local HIV prevention organizations,
IV. Building capacity to appropriately adapt and implement DEBIs, and
V. Designing and conducting process evaluation and quality assurance activities.
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
· 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?
Are the proposed study
activities likely to have a positive impact on HIV prevention? Does the
applicant’s experience providing training and technical assistance to HIV
prevention organizations facilitate the development of innovative strategies
that will improve the implementation of DEBIs?
Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics? Does the applicant demonstrate an understanding of the challenges or barriers experienced by local HIV prevention organizations in their region when implementing currently available DEBIs? Does the applicant provide evidence of having prior knowledge of these challenges and barriers? Does the applicant clearly describe the sources of information for descriptions of challenges that are provided? If the applicant provides evidence of understanding these issues and has systematically studied them in the past, how has the applicant addressed these challenges? Does the applicant propose specific methods to partner and collaborate with five or more HIV prevention organization partners for this activity that have knowledge of persistent difficulties or challenges when implementing DEBIs? Does the applicant describe the criteria and mechanisms for selecting these partner HIV prevention organizations? Does the applicant provide memoranda of understanding with each proposed partner HIV prevention organization? How feasible are the study plans to involve the proposed five or more HIV prevention partners in the development of operational research activities? Does the applicant have a plan to develop two or more strategies with partner HIV prevention organizations to overcome the identified challenges? Does the applicant propose innovative strategies to identify and reduce barriers when implementing DEBIs? Does the applicant describe an appropriate research design? Will the applicant’s proposed conceptual framework, design, methods, and analyses lead to the identification of factors affecting successful DEBI implementation and potential solutions? Does the applicant’s plan include activities to identify, clarify, and analyze challenges experienced by HIV prevention organizations implementing DEBIs? Does the applicant’s plan include how to assess the utility of these strategies for use by partner and other agencies for addressing similar barriers to delivering DEBIs? Does the applicant’s plan for operational research include process monitoring and evaluation of the newly developed strategies? Does the applicant provide plans for recruitment and selection of a diverse sample of HIV prevention organizations to evaluate the strategies? Does the proposed plan to recruit a sample of HIV prevention organizations address diversity of capacity level (e.g., size of agency and level of HIV prevention funding), high-risk populations served (e.g., race/ethnicity, risk behaviors), geographic locations, and DEBIs? Does the applicant sufficiently describe a process for sharing all data collected with the funding agency and other collaborating partners? Are sufficient protection procedures in place to ensure data security? Is the proposed timeline sufficiently detailed, complete, and realistic for a 4-year project period?
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 propose a novel approach to addressing challenges implementing DEBIs? Does the applicant describe a novel method that is responsive to HIV prevention organizations’ experience in implementing DEBIs? Does the applicant describe why they think their plan to develop innovative strategies will be successful? Does the applicant demonstrate prior promise or sufficient background to accomplish the development, implementation, and evaluation of strategies to address challenges implementing DEBIs?
Does the applicant demonstrate an understanding of the research objectives of this announcement as evidenced by the quality of the proposed plan for operational research, specific study design and research methods? Does the applicant have a thorough understanding of the proposed DEBIs? Does the applicant demonstrate experience conducting research with HIV prevention organizations? Does the applicant have experience conducting operational research and program evaluation? Does the applicant demonstrate the ability to collect, manage, and analyze accurate data in a timely manner?
Does the applicant have the appropriate training and skills to implement newly developed strategies with a sample of HIV prevention organizations? Does the applicant have prior experience collaborating with other agencies?
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 planned location for the study allow for diversity of HIV prevention organizations within the applicant’s region? Does the applicant provide sufficient evidence that they can successfully work with the proposed partner HIV prevention organizations? How adequate are the plans for facilities, equipment, assessment programming, data processing, analysis capacity, and systems for management of data security and participant confidentiality in achieving the research objectives?
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). .
Care and Use of Vertebrate Animals in Research:
If
applicants plan to use vertebrate animals in the project, HHS/CDC will assess
the five items described under Section 2, item 12 Vertebrate Animals of the
Research Plan component of the SF424 (R&R).
Additional
HHS/CDC Requirements under AR-3 Animal Subjects Requirements are available on
the Internet at the following address:
http://www.cdc.gov/od/pgo/funding/ARs.htm.
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
Data Sharing Plan: HHS/CDC will assess the reasonableness of the data sharing plan. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy. All data collected under this cooperative agreement will be shared with the CDC lead scientist and other collaborators on a schedule determined by the CDC investigator.
2.D. Sharing
Research Resources
HHS
policy requires that recipients of grant awards make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication. Please see
http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs. Investigators
responding to this funding opportunity should include a plan on sharing research
resources.
Program staff will be responsible for
the administrative review of the plan for sharing research resources.
The
adequacy of the resources sharing plan will be considered by Program staff of
the funding organization when making recommendations about funding applications.
The effectiveness of the resource sharing will be evaluated as part of the
administrative review of each non-competing Grant Progress Report (HHS/PHS 2590
http://grants.nih.gov/grants/funding/2590/2590.htm).
See Section VI.3. Reporting .
3. Anticipated
Announcement and Award Dates
Earliest anticipated award date is
September 1, 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
Recipient will have primary responsibility for the following:
·
The recipient of this FOA is the Part II-PTC. The primary responsibility of the recipient is to develop partnerships and memoranda of understanding with five or more agencies that are sufficiently knowledgeable of the needs of local HIV prevention organizations.·
Planning, directing, and executing the proposed project with CDC staff being substantially involved as a partner.·
Identifying challenges that HIV prevention organizations face when implementing DEBIs. · Developing innovative strategies to address DEBI implementation challenges. This will directly benefit community-based HIV prevention agencies by helping them improve their capacity to successfully implement DEBIs.·
Developing a research plan. · Identifying an appropriate sample of HIV prevention organizations that report difficulties implementing DEBIs to evaluate the newly developed innovative strategies. · Developing and pilot testing data collection instruments to evaluate strategies. · Developing stringent safeguards for protecting the rights and confidentiality of participants. · Submitting Institutional Review Board (IRB) protocols for local and CDC IRB (if CDC is considered engaged in the research) review, as well as documents needed for any other reviews or needed approvals. · Attending periodic meeting(s), as appropriate, at CDC and elsewhere to finalize the research protocol and provide progress updates, grantee should budget for that travel. · Ensuring data entry, security, and quality/accuracy.·
Conducting data analysis. · Evaluating the strategies for improved DEBI implementation.· Disseminating the findings in a manner that will assist HIV prevention and other organizations to overcome challenges and barriers related to implementing DEBIs. Grantees can use mechanisms such as toolkits, guides, training curricula, the Internet, or Podcasts.
· Submitting final report to CDC Project Officer.
· When feasible, shared measures will be used and recipient organizations' site-specific information, data, and software developed under this award will be combined and made available for analyses by all recipient organizations and CDC, subject to U.S. Government rights of access consistent with current HHS and applicable HHS/CDC policies.
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:
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
· Preparing an IRB protocol for approval at the local and CDC levels, as well as any other needed reviews and approvals. · Performing appropriate data analyses as determined by the study collaborators. · Share all data and collaborate with other investigators to answer common research questions. · Participating in periodic conference calls and meetings with collaborators. · Assessing HIV prevention organization capacity, considering types of target populations, and DEBIs used. · Conducting data analyses with collaborators and presenting and publishing research findings if CDC contribution merits.
3. Reporting
Recipient Organization must provide HHS/CDC with an original, plus two hard copies of the following reports:
1.
Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHS/CDC Web site, http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.htm, no less than 120 days before the end of the current budget period. The progress report will serve as the non-competing continuation application. 2. Financial status report, no more than 90 days after the end of the budget period. 3. Final financial and performance reports, no more than 90 days after the end of the project period. 4. Annual progress report due 90 days after the end of the budget 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
Coordinating Center for Infectious Diseases
Centers for Diseases Control and Prevention
U.S. Department of Health and Human Services
CDC 1600 Clifton Rd. MS E-60
Atlanta, GA 30333
Tel: 404 498 2274
Fax: 404 498 2626
Email: SQari@cdc.gov
2. Peer Review
Contacts:
Greg Anderson, MPH, MS
Scientific Review Administrator
Extramural Programs
Coordinating Center for Infectious Diseases
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services
CDC 1600 Clifton Rd. MS E-60
Atlanta, GA 30333
Tel: 404 498 2275
Fax: 404 498 2626
Email: GAnderson@cdc.gov
3. Financial or
Grants Management Contacts:
Angie
Tuttle, Grants Management Specialist
Procurement and Grants Office
Center for Disease
Control and Prevention
U.S.
Department of Health and Human Services
2920
Brandywine Road MS E-15
Atlanta, Georgia 30341-4146
Telephone:
(404) 639-8305
Fax: (404)
639-8095
Email:
ATuttle@cdc.gov
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:
Angie
Tuttle, Grants Management Specialist
Procurement and Grants Office
Announcement Number PS09-008
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.
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.
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