Part I Overview Information
United States Department of Health and Human Services (HHS)
Issuing Organization
Centers for Disease Control and Prevention (CDC) at http://www.cdc.gov/
Participating Organizations
Centers for Disease Control and Prevention (CDC) at http://www.cdc.gov/
Components of Participating Organizations
Centers for Disease Control and Prevention (CDC) at http://www.cdc.gov/, Coordinating Center for Health Promotion (CCHP), National Center on Birth Defects and Developmental Disabilities (NCBDDD/CDC) at http://www.cdc.gov/ncbddd/
Title: Data Coordinating Center for Autism and Other Developmental Disabilities Research and Epidemiologic Studies (U10)
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: This program is authorized under Sections 301, 311 and 317 (C) of the Public Health Service Act, (42 U.S.C., Sections 241, 243 and 247b-4), as amended.
Announcement Type: Competitive Continuation
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-DD-09-002
Catalog of Federal Domestic Assistance Number(s): 93.283 Centers for Disease Control and Prevention Investigations and Technical Assistance
Key Dates
Release/Posted Date:
Letter of Intent Receipt Date:
NA
Application
Submission Receipt Date:
February 19, 2009
Peer Review Date:
March
2009
Council Review
Date:
April 2009
Earliest Anticipated Start Date: June 1, 2009
Additional Information to Be Available Date: NA
Expiration Date: February 20, 2009
Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.
Additional Overview Content
Executive Summary
· This funding opportunity announcement (FOA) solicits a Cooperative Agreement (U10) proposal to coordinate and manage the data from the Centers for Autism and Developmental Disabilities Research and Epidemiology.
· The participating organization intends to commit a total of $700,000.00 in FY 2009 to this FOA, including direct and indirect costs.
· An award issued under this FOA is contingent upon the availability of funds and the submission of a meritorious application.
· Number of awards: One
· Budget Period, Project Period, and Award Amounts: The award ceiling for the first 12-month budget period is $700,000.00 in total funds. The total project period for an application submitted in response to this FOA may not exceed three years.
· Eligible Organization: Only Michigan State University is eligible to submit an application in response to this FOA.
· See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites: http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General.doc (MS Word); http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General.pdf (PDF)
· For general information on SF424 (R&R) Application and Electronic Submission, see these the following Web sites: SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm; General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/
· HHS/CDC Telecommunications for the hearing impaired is available at the following number: TTY 770-488-2783.
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 on Birth Defects and Developmental Disabilities (NCBDDD) 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 areas of Substance Abuse. Alcohol, Tobacco, and Other Drugs, and Maternal, Infant, and Child Health and is in alignment with NCBDDD performance goal(s) to identify and evaluate at least five new risk factors for birth defects and developmental disabilities. For more information, www.healthypeople.gov. and
http://intra-apps.cdc.gov/fmo/
Nature of the Research Opportunity
This funding opportunity announcement (FOA) will support the coordination and management of the data from the Centers for Autism and Developmental Disabilities Research and Epidemiology (CADDRE). The data collected from CADDRE will be used to support epidemiologic studies related to Autism Spectrum Disorders (ASD) and other related developmental disabilities.
Background
The Children’s Health Act of 2000 mandated CDC to establish autism surveillance and research programs to address the number, incidence, and causes of autism and related developmental disabilities. Under the provisions of this act, NCBDDD funded five Centers for Autism and Developmental Disabilities Research and Epidemiology: Johns Hopkins University, Kaiser Foundation Research Institute, the University of Pennsylvania, the Colorado Department of Public Health and Environment, and the University of North Carolina at Chapel Hill. CDC, NCBDDD serves as the sixth CADDRE site.
The primary activity for the CADDRE program is the conduct of a collaborative, multisite epidemiologic study of risk factors for autism, called the Study to Explore Early Development (SEED). In support of CADDRE activities and SEED specifically, CDC also funded a Data Coordinating Center in 2004 at Michigan State University to develop and host the CADDRE Information System (CIS). The CADDRE Network initiated enrollment into SEED in Winter 2007/08 utilizing the CIS.
The objective of the CIS is to provide a secure, centralized, web-based, automated-workflow system to support all of the study activities for SEED. The centralized approach improves study quality by standardizing workflows and processes across all sites, and by providing end-to-end data management. As a unified facility with a single login, the CIS supports all study protocol activities including:
· batch import of potential participant demographics;
· participant tracing and tracking;
· recruitment;
· participant mailings;
· standardized instrument scoring;
· double-data entry of paper forms;
· Quality control workflows and reports;
· data management tools and reports;
· staff tasks scheduling and staff calendar;
· tracking participant incentives and reimbursements;
· barcode labeling of participant study materials and biosamples;
· biosample management:
· barcoding specimen containers, tracking shipment/receipt by central lab, specimen quality control results, scheduling obtaining second specimens, status of samples in freezers;
· presentation of study instruments and associated data entry;
· computer-assisted telephone interviews (CATI);
· medical record abstraction and medical record request tracking;
· coding of open data fields; and
· study management report suite and custom report generation.
The CIS comprises >800 browser pages, yet it presents the user with simple interface achieved via a workflow-oriented design. Users begin at the Portal Page and individual- and role-based task lists and a flexible event generation system automatically guide the user to the specific tasks that should be performed next. Tasks are presented depending upon the functional role of the user logged in. The workflow-oriented CIS represents a modern multi-site study information system that comprehensively supports the execution of study activities of SEED, and enforces standardized study procedures with the expectation of improved data quality and consistent study execution.
The primary activities for the DCC in the first funding cycle (2004-2009) were CIS development and launch in support of SEED implementation.
Scientific Knowledge to be Achieved
The primary impact of the CADDRE Program is its unique contribution as the only federally-funded multi-site collaborative network with an explicit epidemiologic focus for its research activities in autism. SEED also has several unique features that will yield significant value to the extant research on autism:
· it will be significantly larger than any other federally-funded epidemiologic study of autism, with a total of 2700 children and their families enrolled over the 5-year study period (900 with autism, 900 with other neurodevelopmental impairments, and 900 from the general population). In contrast, the CHARGE Study, another population-based epidemiologic study, will have enrolled approximately 700 children and their families over the first 5-year study period. Not only does the larger CADDRE sample size increase study power and statistical precision overall, but also enhances our capability for stratified analysis of phenotypic subtypes within the ASD case group as well as stratification across all subject groups;
· it is also the only multi-site study – to be implemented in 6 different geographic regions across the United States, each with a distinct sociodemographic profile. It is possible that the genetic and non-genetic risk factor profiles also differ across these regions. Thus, the combined results from all 6 sites will be much more generalizable to the US population than results from other single-site studies;
· it will ascertain study subjects from multiple sources within each of the 6 regions. This will result in a study sample that is more representative of the target population of children with autism, other neurodevelopmental disorders, and typically developing children in each catchment area;
· the ASD case ascertainment approach not only identifies children with a previous autism diagnosis or special education exceptionality, but also involves screening children who have a broad net of related diagnoses/exceptionalities in order to identify undiagnosed cases – an important consideration for the target age group of 30-60 months;
· the study research goals and corresponding data collection batteries will allow novel data analysis compared to other studies, but also intentionally overlaps certain other studies’ goals thus permitting replication of other study findings;
· finally, the sample and data to be collected as part of SEED in the current funding cycle will undoubtedly be the foundation for ongoing research activities – “Phase 1” with the potential in later cycles for adding more subjects to augment the data pool, for longitudinal data collection of enrolled participants, and/or additional special data collection at one or more sites.
The centralized tracking and data management capabilities provided by the CIS were designed explicitly to handle the data volumes and complexity of SEED. Without the CIS, CADDRE’s ability to achieved SEED scientific goals would be seriously impaired.
Data activities related to other birth conditions and developmental disabilities may be added in the future, based on needs.
Research Objectives and Experimental Approach
This FOA builds upon the activities and accomplishments funded under Program Announcement 04014 by supporting the DCC that coordinates and facilitates the data collection for epidemiologic studies, and stores the data collected from the six CADDRE sites. The DCC provides a centralized, web-based, automated-workflow system that supports all of the study activities for SEED. The primary objectives/activities of this competing continuation project are:
1. Data Quality Management.
Maintain data quality throughout the course of SEED using both staff input and computerized data quality procedures to ensure that data quality standards are being implemented across all logical data units.
2. Finalize Any Ongoing Development and Develop New Functionality as Needed.
Finalizing any outstanding module development would be a key priority. Develop new functionality for the CADDRE CIS as needs arise, balancing responsiveness and prudent resource allocation for all requests for new development.
3. Medical Coding.
Complete development and implementation of medical coding procedures for an anticipated 1.2 million text fields.
4. Staff Capabilities.
Maintain staff expertise to build and support best practices in providing informatics requirements for the scientific and analytic dimensions of SEED. This may include training existing staff and/or hiring new staff.
5. System Maintenance.
Maintain servers and SEED databases throughout the life of the SEED project, including steps to ensure that CADDRE applications and databases both increase in performance and size to securely store and process the increasing volume of project data.
6. Application Maintenance.
Maintain CIS code and database stored procedure code throughout the life of the SEED project and ensure that code is refined and well commented to support end-of-study transfer of code and data to CDC.
7. Site and User Support.
Continue to accept reports and respond to requests for CIS enhancements through its user support line and via email. Continue to develop CIS report-making capabilities to support SEED tasks and enhance monitoring of study progress.
8. Data Sharing and Availability.
Maintain and enhance codebook to effectively communicate SEED database features to users. Develop mechanisms for site staff to make site-level queries of data. Respond to CADDRE Data Sharing Committee requests for preparation and distribution of analytic data sets. All data source code, websites, and system documentation collected hereunder will be transferred to CDC at the end of the project for archive and dissemination, as appropriate.
9. Data Visualization Support.
Assist all study staff in the application of software to provide graphical visualization of study data throughout the study.
10. Intellectual Contributions and Communication.
Continue to communicate technical aspects of the CADDRE project effectively to all study staff and partners. Contribute to the scientific, executive and analytic decision making as requested. Participate in appropriate scientific meetings and conferences to present posters and papers aimed at communicating development in research informatics pertaining to autism research.
See Section VIII, Other Information - Required Federal Citations, for policies
related to this announcement.
Section II. Award
Information
1. Mechanism of Support
This funding opportunity will use the U10 activity code. The HHS/CDC U10 is a cooperative agreement assistance instrument. Under the U10 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) NCBDDD intends to commit approximately $700,000.00 in FY 2009 to fund one application for a 12-month period. The award amount will be $700,000.00 for a 12-month budget period. This amount includes direct and indirect costs. The applicant may request a project period of up to three years. The approximate total project period funded amount is $3,500,000.00. The anticipated start date for new award is June 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, 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
Michigan State University (MSU) is the only institution eligible to submit an application in response to this FOA. MSU was competitively awarded the initial Data Coordinating Center (DCC) award under Program Announcement 04014 and has collaborated with the six sites collecting SEED data since May 2004. In collaboration with the sites, MSU has developed the web-based CADDRE Information System (CIS) used to collect, track, and analyze the SEED data. The CIS was developed specifically to meet CADDRE SEED's unique needs and no alternative information system exists. A change in the DCC awardee would cause serious delay and disrupt progress on SEED due to loss of knowledgeable staff and expertise associated with the development and maintenance of the CIS. The CIS is a very intricate and complicated system. It connects to a proprietary system, Internet System for Assessing Autistic Children (ISAAC), which MSU has contracted with for data storage and analysis of psychometric instruments. Thus startup by another grantee would require extensive time and it is unlikely that the system could be duplicated or implemented in a seamless manner that would prevent loss of time and progress on the critical study cycle and objectives being carried out by the six CADDRE sites. In addition, the development for CIS is still ongoing; it is critical that the same development team be maintained throughout the development process to ensure consistency and interoperability throughout the system. It is critical at this point in the middle of the study that the knowledge and infrastructure be maintained during the data collection and analysis phase. The SEED grantees are currently in the field utilizing the system; a minimum six month delay is not tenable at this juncture.
2. Cost Sharing or Matching
Cost sharing is not required under this announcement.
3. Other-Special Eligibility Criteria
Not applicable
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.htm
IMPORTANT: 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
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:
NA
Application Submission Receipt Date: February 19, 2009
Peer Review Date (s): March 2009
Council Review Date (s): April 2009
Earliest Anticipated Start Date:
June 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.
If you still have a
question about the receipt of your application, 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.
Technical Information Management Section – DD09-002
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 CCHP 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.
The HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.
4. Intergovernmental Review
Executive Order 12372 does not apply to this program.
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.
Additional guidance can be found at HHS Grants Policy Statement (see the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc.).
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.
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”.
The applicants’ research plan 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 ten 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
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.
Sharing Research Resources
HHS
policy requires that grant award recipients make unique research resources
readily available for research purposes to qualified individuals within the
scientific community after publication (see the HHS Grants
Policy Statement
http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc.)
Investigators responding to this funding opportunity should include a plan for
sharing research resources addressing how unique research resources will be
shared or explain why sharing is not possible.
The adequacy of
the resources sharing plan and any related data sharing plans will be considered
by the HHS/CDC Program staff of the funding organization when making
recommendations about funding applications. The effectiveness of the resource
sharing will be evaluated as part of the administrative review of each
non-competing Grant Progress Report (PHS 2590,http://grants.nih.gov/grants/funding/2590/2590.htm).
See
Section VI.3. Reporting.
Section V.
Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
· Availability of funds
· Relevance of program priorities and the priorities of the U.S. Department of Health and Human Services
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 CCHP 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 CCHP
· 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?
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?
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?
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)?
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?
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 affect 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.
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
The CDC Procurement and Grants will notify the successful applicant in a
pre-award conference call and provide a notice of award.
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 those
applicants under consideration for funding for additional information.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the Grants Management Officer (GMO) is the authorizing document. 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
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 the
primary responsibility for the following:
1. Provide oversight of all management and administrative aspects of the project, including maintaining an adequate staffing plan to support project activities.
2. Support the development and implementation all scientific aspects of the study protocol, including ongoing data collection and follow-up, quality control, data analyses and interpretation, and preparing peer–reviewed publications and presentations.
3. Finalize any ongoing development and develop new functionality as needed.
4. Implement medical coding.
5. Maintain servers and SEED databases
6. Maintain CIS code and database stored procedure code.
7. Assist staff in application of software and effectively communicate database features to all users.
8. Provide site and user support and develop and maintain CIS report-making capabilities.
9. Prepare and coordinate the submission of the study protocol to the designated IRB(s) and ensure that the protocol(s) is(are) conducted in compliance with the terms and conditions of the IRB approval.
10. Maintain the confidentiality of the study data.
11. Participate in monthly coordinating committee meetings and periodic in-person CADDRE meetings and provide input into the agenda.
12. Implementation of a plan to transfer the data and source code to CDC or the next DCC awardee at the end of the funding period. Upon completion of the project period, a copy of the system and all data developed for this project (including all code, SQL scripts required to recreate the database, and any supporting files) will be transferred to CDC or the next DCC awardee for use and/or modification. The recipient organization will not retain custody of or have primary rights to the information, data, and software developed under this award.
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:
There are two separate CDC scientific roles – Scientific Collaborator and Scientific Program Officer
In this cooperative agreement, a CDC Scientist (Scientific Collaborator) within the National Center on Birth Defects and Developmental Disabilities (NCBDDD) is an equal partner with scientific and programmatic involvement during the conduct of the project through technical assistance, advice and coordination
Scientific Collaborators will:
1. Use their experience in studies of this nature to advise the project on specific questions regarding the project-developed protocol, and collaborate on the development of new protocol;
2. Support grantee activities in data management, data analysis, intervention design, formats for presenting research findings, and in comparing project-developed evaluation formats with other research projects and activities known to CDC;
3. Provide scientific consultation and technical assistance on questions related to epidemiology, statistical and power calculations, and data storage and tracking formats used in other CDC sponsored research that could be advantageous to the project;
4. Assist in the analysis, interpretation, and reporting of findings in the literature that can serve a broad range of scientific interests; and
5. Facilitate the monthly conference calls with the coordinating committee; and
CDC Scientific Program Officer (SPO)
The CDC CCHP Extramural Research Program Office (ERPO)will appoint a SPO, apart from the NCBDDD Scientific Collaborator who will:
1. Serve as the Program Official for the funded research institutions.
2. Carry out continuous review of all activities to ensure objectives are being met.
3. Attend Coordinating Committee meetings for purposes of assessing overall progress and for program evaluation purposes.
4. Provide scientific consultation and technical assistance in the conduct of the project as requested.
5. Conduct site visits to recipient institutions to monitor performance against approved project objectives.
Additionally, an HHS/CDC agency program official 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
The planning and implementation of the cooperative aspects of the study will be effected by a Coordinating Committee (CC) consisting of the Principal Investigator (PI) from the organization receiving the award under this announcement, the CDC Scientific Collaborator, and the PI’s of the CADDRE awards. The CC will address issues of common concern throughout the life of the project. Organizations serving as sub-contractors under both awarded projects are not considered members of the Coordinating Committee.
At periodic CC meetings (up to three) the group will: (1) make recommendations on the study protocol and data collection approaches; (2) discuss common elements of protocols as they relate to intervention components; (3) discuss the target populations that have been or will be recruited; (4) identify and recommend solutions to unexpected study problems; and (5) discuss ways to efficiently coordinate study activities and best practices.
Each full member will have one vote. Awardee members of the Coordinating
Committee (including a CDC member) should accept and implement policies approved
by the Committee.
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 website, 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 prior to 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.
Recipient Organization must forward these reports by 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:
1. Scientific/Research Contacts:
2. Peer Review Contacts:
Extramural Research Program Office Centers for Disease Control and Prevention 4770 Buford Hwy, NE, MS-92 Atlanta, GA 30341 Telephone: (770) 498-6422
3. Financial or Grants Management Contacts:
4. General Questions Contacts:
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.
Public Health System Reporting Requirements
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.
Security Clearance
Requirement
All individuals who will be performing work under a grant or cooperative agreement in a HHS/CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardees employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at HHS/CDC must undergo a security clearance process.
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.
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.
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