United States Department of Health and Human Services (HHS)
Participating
Organizations
Centers for Disease Control and Prevention (CDC) at http://www.cdc.gov/
Components of
Participating Organizations
National Center for Injury
Prevention and Control (NCIPC/CDC) at http://www.cdc.gov/ncipc/
Title: Feasibility of Acute Concussion Management in the Emergency Department (U49)
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: Section 301 and 393A of the Public Health Service Act (42 U.S.C. Sections 241 and 280b-1b), as amended.
Announcement
Type:
New
Instructions for Submission of Electronic Research Applications:
If you do not have access to the Internet, or if you have difficulty accessing the forms online, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGOTIMS) staff. For this, or further assistance, contact PGO TIMS: Telephone (770) 488-2700, Email: PGOTIM@cdc.gov.
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-CE-08-006
Catalog of Federal Domestic Assistance Number(s):Key Dates
Release/Posted
Date: November
7, 2007
Letter of Intent Receipt Date: January 15, 2008
Application Submission Receipt Date(s): February 15, 2008
Peer Review Date(s): March
– April, 2008
Council Review Date(s): May
– June, 2008
Earliest
Anticipated Start Date(s):August 1, 2008
Additional
Information to Be Available Date: Technical assistance will be available for potential applicants
during one conference call. The call for eligible applicants will be held on January
10, 2008 from 2:00 p.m. to 3:30 p.m. (Eastern Time). The conference can be
accessed by calling 1-866-704-7564, stating the conference call leader name:
Ms. Lady Patterson and entering pass code 1314492. The leader is Dr. Jean A. Langlois
Expiration
Date: February 16, 2008
Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.
Additional Overview Content
Executive Summary
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. 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 Injury Prevention and Control 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 injury and violence prevention and is in alignment with NCIPC performance goal(s) to Increase the capacity of injury prevention and control programs to address the prevention of injuries and violence. Conduct a targeted program of research to reduce injury-related disability. For more information, see www.healthypeople.gov and http://intra-apps.cdc.gov/fmo/.
The purpose of this solicitation is to announce the availability of fiscal year (FY) 2008 funds to support one cooperative agreement to field test the Acute Concussion Evaluation (ACE) and Care Plan. The proposed study will evaluate the feasibility of implementing the ACE within an emergency department setting. This program addresses the “Healthy People 2010” focus area(s) of Injury and Violence Prevention. Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center for Injury Prevention and Control: Conduct a targeted program of research to reduce injury-related death and disability.
Background:
Early identification, assessment, and management of concussion or mild traumatic brain injury (MTBI) is critical to reducing the risk of re-injury and facilitating recovery. Recent research on young athletes suggests that this is particularly important for children and youth who are more vulnerable to concussions (Webbe and Barth, 2003; Lovell et al., 2004; McKeever and Schatz, 2003) and require a longer time to recover (Field et al., 2003; Lovell et al, 2003; McClincy et al., 2006). Failure to properly diagnose and manage concussion, especially in the young athlete, may lead to long-term adverse consequences (Gaetz et al., 2000; Collins et al., 2002; Guskiewicz et al, 2003), severe brain injury associated with second impact syndrome (Cantu 1998; Bailes et al 2001; CDC 1997) or death (Cantu 1998; CDC 1997)
Several studies conducted in a wide range of primary care settings, including the emergency department, have shown that there is a lack of consistency in the approaches used for identifying, assessing (Blostein and Jones, 2003) and managing (Bazarian et al., 2001; Blostein and Jones, 2003; Willer and Leddy, 2006; Pleacher et al., 2006) patients with concussion. A number of grading systems and guidelines for managing concussion have been published (Peloso et al, 2004; Buzzini and Guskiewicz 2006), many of which were developed to guide decisions about return to play among athletes. However, findings from recent sports concussion research has led to a trend away from use of grading systems toward an assessment of recovery (Aubry et al. Vienna statement) of postconcussion symptoms (Lovell and Collins, 1998) in part because guidelines and grading systems do not adequately account for individual differences in duration of recovery. These studies suggested that new tools for assessment and management of concussion in primary care settings were needed.
Few studies have investigated the impact of interventions during the acute recovery phase on outcomes of mild TBI. However, one study in children (Ponsford et l., 2001) and a similar study of adults (Ponsford et al, 2002) conducted with patients recruited from emergency departments during the acute recovery phase reported that one-time provision of an information booklet outlining symptoms associated with mild TBI and suggesting coping strategies reduced anxiety and lowered the incidence of ongoing problems compared with a control group of patients who received standard care. Although to our knowledge, no published studies have investigated the impact of serial follow-up of MTBI patients, preliminary results from an ongoing CDC-funded study suggest that receiving multiple episodes of telephone counseling may decrease the negative impact of MTBI-related symptoms (Kathleen Bell, personal communication, July 2007).
To address the need for an assessment and management tool for primary care providers that is based on the latest evidence and clinical experience, in collaboration with CDC staff, researchers from Children’s National Medical Center, Washington, DC, and the University of Pittsburgh developed the Acute Concussion Evaluation (ACE) and the ACE care plan (CDC, 2007). The ACE was developed to provide physicians with an evidence-based protocol to conduct an initial evaluation and diagnosis of patients (both children and adults) with known or suspected mild TBI (toolkit). In paper and pencil form, it provides systematic guidance for assessing key components for diagnosing an MTBI and serves as the basis for management and referral recommendations provided by the ACE care plan. Originally developed and implemented in sports concussion clinics, these tools were further refined for use in wide range of primary care settings, including emergency departments and pediatric offices. They were developed to provide physicians with a more individualized assessment of MTBI and to help guide the management and recovery, as well as the referral of patients with such injuries. An important component of the ACE is the emphasis on periodic follow-up and reassessment of patients over time.
The ACE and ACE care plan are being disseminated widely as part of CDC’s recently revised Heads Up! Brain Injury in Your Practice tool kit and can be found online at http://www.cdc.gov/ncipc/tbi/physicians_tool_kit.htm. A modified version of the ACE for use in the emergency department is also available from the Centers for Disease Control and Prevention.
Although the ACE has been reviewed by a wide range of practicing primary care physicians including ED physicians, has been focus group tested, and anecdotal reports of successful implementation within a pediatric office practice have been received, formal research is needed to evaluate the feasibility of implementing it within other settings, especially the emergency department.
Research Objectives:
Design:
Research under this announcement is expected to adhere to high scientific standards, and to incorporate the following elements:
References:
Aubry M, Cantu R, Dvorak J, et al. Summary and agreement statement of the first International Conference on Concussion in Sport, Vienna 2001. Br J Sports Med 2002;36:10-13.
Bailes JE, Hudson V. Classification of sport-related head trauma: a spectrum of mild to severe injury. J Athl Train 2001;36:236-243.
Bazarian JJ, Veenema T, Brayer AF, Lee E. Knowledge of concussion guidelines among practitioners caring for children. Clinical Pediatrics 2001; April:207-212.
Blostein P, Jones SJ. Identification and evaluation of patients with mild traumatic brain injury: results of a national survey of Level I trauma centers. J Trauma 2003;55:450-453.
Buzzini SRR, Guskiewicz KM. Sport-related concussion in the young athlete. Curr Opin Pediatr 2006:18:376-382.
Cantu RC. Second-impact syndrome. Clin Sports Med 1998;17:37-44.
Centers for Disease Control and Prevention (CDC), National Center for Injury Prevention and Control. Heads Up: Brain Injury in Your Practice. Atlanta (GA): Centers for Disease Control and Prevention; 2007.
Centers for Disease Control and Prevention (CDC). MMWR Morb Mortal Wkly Rep 1997; 46: 224-227.
Collins MW, Lovell MR, Iverson GL, et al. Cumulative effects of concussion in high school athletes. Neurosurgery 2002;51:1175-1181.
Gaetz M, Goodman D, Weinberg H. Electrophysiological evidence for the cumulative effects of concussion. Brain Inj 2000;14:1077-1088.
Field M, Collins MW, Lovell MR, Maroon J. Does age play a role in recovery from sports-related concussion? A comparison of high school and collegiate athletes. J Pediatr 2003;142:546-553.
Guskiewicz KM, McCrea M, Marshall SW, et al. Cumulative effects associated with recurrent concussion in collegiate football players: the NCAA Concussion Study. JAMA 2003;290:2549-2555.
Lovell MR, Collins MW. Neuropsychological assessment of the college football player. J Head Trauma Rehabil 1998;13:9-26.
Lovell MR, Collins MW, Iverson GL, et al. Recovery from mild concussion in high school and collegiate athletes. J Neurosurg 2003;98:296-301.
Lovell MR, Collins MW, Iverson GL, et al. Grade 1 or “ding” concussions in high school athletes. Am J Sports Med 2004;32:47-54.
McClincy MP, Lovell MR, Pardini J, et al. Recovery from sports concussion in high school athletes. Brain Inj 2006;20:33-39.
McKeever CK, Schatz P. Current issues in the identification, assessment, and management of concussions in sports-related injuries. Appl Neuropsychol 2003;10:4-11.
Peloso PM, Carroll LJ, Cassidy D, et al. Critical evaluation of the existing guidelines on mild traumatic brain injury. J Rehabil Med 2004; Suppl. 43:106-112.
Ponsford J, Willmott C, Rothwell A, et al. Impact of early intervention on outcome following mild head injury in adults. J Neurol Neurosurg 2002;73:330-332.
Ponsford J, Willmott C, Rothwell A, et al. Impact of early intervention on outcome after mild traumatic brain injury in children. Pediatrics 2001;108;1297-1303.
Pleacher MD, Dexter WW. Concussion management by primary care providers. Br J Sports Med 2006;40:e2 (http://www.bjsportsmed.com/dgi/content/full/40/1/e2)
Webbe FM, Barth JT. Short-term and long-term outcome of athletic closed head injuries. Clin Sports Med 2003;22:577-592.
Willer B, Leddy JJ. Management of concussion and post-concussion syndrome. Current treatment options in neurology 2006;8:415-426.
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 U49 activity code.
The HHS/CDC U49 is a cooperative agreement assistance instrument. Under the U49 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 (CIOs) (NCIPC) intend to commit approximately $250,000 including direct and indirect costs dollars in FY2008 to fund 1 application. The average award amount will be $250,000 including direct and indirect costs for the first 12-month budget period. An applicant may request a project period of up to two years. An applicant may request up to $250,000 for the first 12-month budget period. The approximate total project period funded amount is $500,000. The anticipated start date for new awards is August 1, 2008.
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 if your organization has any of the following characteristics:
A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application. If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status. Attach this documentation behind the first page of your application form or for electronic applications, use a .pdf file and attach as “Other Documents” and label as appropriate.
Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.
2. Cost
Sharing or Matching
Cost sharing, matching, or cost participation is not
required.
3. Other-Special Eligibility Criteria
If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.
Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.
The most current HHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc
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:
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.
If you do not have access to the Internet, or if
you have difficulty accessing the forms online, you may contact the CDC
Procurement and Grants Office Technical Information Management Section
(PGOTIMS) staff. For this, or 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 Subaward 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: January 15, 2008
Application
Submission Receipt Date(s): February 15, 2008
Peer Review
Date: March – April, 2008
Council Review
Date: May – June, 2008
Earliest
Anticipated Start Date: August 1, 2008
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent
that includes the following information:
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV.3.A
The letter of intent should be sent by mail, fax or email to:
NCIPC Extramural Resources Team
CDC, National Center for Injury Prevention and Control
Address for Express Mail or Delivery Service:
2945 Flowers Rd. S.
Yale Building, Room 2054
Atlanta, GA 30341
Address for U.S. Postal Service Mail:
4770 Buford Hwy. NE, Mailstop K-62
Atlanta, GA 30341
FAX: (770) 488-1662
Telephone: (770) 488-4037
Email: CIPERT@cdc.gov
3.B. Submitting an Application to CDC
If the instructions in this announcement differ in any way from the SF424 R&R instructions, follow the instructions in this announcement.
To submit an application in response to this FOA, applicants should access this FOA via http://www.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 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.
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.
Upon receipt, applications will be evaluated for completeness and responsiveness by NCIPC 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.
Executive Order 12372 does not apply to this program.
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:
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 Organizational 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 non-responsive 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.
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 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
Note: HHS/CDC normally requires a plan for sharing research data. However, only proposals submitted to NCIPC for individual research projects of $500,000 or more in total (direct and indirect) costs per year require the applicant to include a data-sharing plan. Because the ceiling for this FOA is below $500,000, a data sharing plan is not required and the HHS/CDC steps outlined in this section do not apply.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered in the review process.
2.
Review and Selection Process
Applications
that are complete and responsive to the RFA will be evaluated for scientific
and technical merit by an appropriate peer review group convened by NCIPC in accordance with the review criteria
stated below.
As part of the
initial merit review, all applications will:
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 as appropriate for each application.
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 work will be done contribute to the probability of
success? Do the proposed studies benefit from unique features of the scientific
environment, or subject populations, or employ useful collaborative
arrangements? Is there evidence of institutional support?
2.A. Additional Review Criteria
In addition to
the above criteria, the following items will continue to be considered in the
determination of scientific merit and the priority score:
Application Review
The primary review will be a peer review conducted by HHS/CDC/NCIPC Initial Review Group (IRG). Applications may be subjected to a preliminary evaluation (streamline review) by the IRG to determine if the application is of sufficient technical and scientific merit to warrant further review. HHS/CDC/NCIPC will withdraw from further consideration applications judged to be noncompetitive and promptly notify the principal investigator/program director and the official signing for the applicant organization. Those applications judged to be competitive will be further evaluated by the IRG. These applications will be reviewed for scientific merit using current NIH criteria (a scoring system of 100 - 500 points) to evaluate the methods and scientific quality of the application.
The secondary review will be conducted by the current Science and Program Review Subcommittee (SPRS) of the Advisory Committee for Injury Prevention and Control (ACIPC) or equivalent board of scientific counselors. Only SPRS members will vote on funding recommendations, and their recommendations will be carried to the entire ACIPC for voting by the ACIPC members in closed session. If any further review is needed by the ACIPC regarding the recommendations of the SPRS, the factors considered will be the same as those considered by the SPRS.
The ACIPC Federal agency experts will be invited to attend the secondary review and will receive modified briefing books (i.e., abstracts, strengths and weaknesses from summary statements, and extramural research program office staff briefing materials). ACIPC Federal agency experts will be encouraged to participate in deliberations when applications address overlapping areas of research interest, so that unwarranted duplication in federally-funded research can be avoided and special subject area expertise can be shared. The HHS/CDC/NCIPC Division Associate Directors for Science (ADS) or their designees will attend the secondary review to assist extramural research program office staff to assure that research priorities of the announcement are understood and to provide background regarding current research priorities.
The ACIPC committee’s responsibility is to develop funding recommendations for the HHS/CDC/NCIPC Director based on the results of the primary review, the relevance and balance of proposed research relative to the HHS/CDC/NCIPC programs and priorities, and to assure that unwarranted duplication of federally-funded research does not occur. The secondary review committee has the latitude to recommend to the HHS/CDC/NCIPC Director to reach over better ranked proposals in order to assure maximum impact and balance of proposed research. The factors to be considered will include:
All awards will be determined by the Director of the HHS/CDC/NCIPC based on priority scores assigned to applications by the primary review committee IRG, recommendations by the secondary review committee and the extramural research program staff, consultation with HHS/CDC/NCIPC senior staff, and the availability of funds.
Continued Funding
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)] located at, 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 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
Not applicable. Only proposals submitted to NCIPC for individual research projects of $500,000 or more in total (direct and indirect) costs per year require the applicant to include a data-sharing plan. Because the ceiling for this FOA is below $500,000, a data sharing plan is not required.
2.D. 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
Grantees will be notified in July by HHS/CDC’s
Procurement and Grants Office (PGO) if their applications were selected for
funding.
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 policy requirements. For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html. Additional requirements are available in Section VIII. Other Information on this document or on the CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.
The
following terms and conditions will be incorporated into the NoA and will be
provided to the appropriate institutional official and a courtesy 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 U49, 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:
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.
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.
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:
Jean Langlois, PhD
Division:
Division of Injury Response
National Center for Injury
Prevention and Control
Centers for Disease Control and Prevention (CDC)
U.S. Department of Health and Human
Services
4770 Buford Hwy, NE, Mailstop F41
Atlanta, GA 30341
Telephone:
(770) 488-1478
FAX:
770 488-4338
Email:
JAL7@cdc.gov
2. Peer
Review Contacts:
Felix Rogers, Ph.D., MPH
Scientific Review Administrator
National Center for Injury
Prevention and Control
Centers for Disease Control and Prevention (CDC)
4770 Buford Hwy, NE, Mailstop K-02
Atlanta, GA 30341
Telephone: (770) 488-4334
FAX: (770) 488-4422
Email: frogers@cdc.gov
3. Financial or Grants Management Contacts:
Lisa Williams
Procurement and Grants Office
Centers
for Disease Control and Prevention
U.S. Department of Health and Human Services
2920
Brandywine Road, MS K-70
Atlanta,
GA 30341
Telephone:
(770) 488-2897
FAX: (770) 488-2670
Email: lrw3@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
5. Special Guidelines for Technical Assistance:
NCIPC Website: For additional help in preparing your grant application please see the “frequently asked questions” section on the NCIPC webpage at: http://www.cdc.gov/ncipc/res-opps/2004pas.htm.
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.
Use of
Animals in Research:
Recipients of
PHS support for activated involving live, vertebrate animals must comply with
PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf)
as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm),
and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm)
as applicable. Additional HHS/CDC Requirements under AR-3 Animal Subjects
Requirements can be found at 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.
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.
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
CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.
Healthy People 2010The Public Health Service (PHS) is committed to
achieving the health promotion and disease prevention objectives of
"Healthy People 2010," a PHS-led national activity for setting
priority areas. This PA is related to one or more of the priority areas.
Potential applicants may obtain a copy of "Healthy People 2010" at www.healthypeople.gov.
Lobbying
Restrictions
Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.
In addition no part of CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.
Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, 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.
Prohibition on Use of CDC Funds for Certain Gun Control Activities
The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."
Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.
In addition to the restrictions in the Anti-Lobbying Act, HHS/CDC interprets the language in the HHS/CDC's Appropriations Act to mean that HHS/CDC's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.
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.
Small, Minority, And Women-owned Business
It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:
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 CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.
Release and Sharing of Data
The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the CDC data sharing agreement will be released as follows:
When required (see note below) applications must include a copy of the applicant's Data Release Plan. Applicants should provide CDC with appropriate documentation on the reliability of the data. Applications submitted without the required Plan may be ineligible for award. Award will be made when reviewing officials have approved an acceptable Plan. The successful applicant and the Program Manager will determine the documentation format. HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.
Note: Only proposals submitted to NCIPC for individual research projects of $500,000 or more in total (direct and indirect) costs per year require the applicant to include a data-sharing plan. Because the ceiling for this FOA is below $500,000, a data sharing plan is not required.
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 subgrant 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.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
Office of Extramural Research (OER) |
National Institutes of Health (NIH) 9000 Rockville Pike Bethesda, Maryland 20892 |
Department of Health and Human Services (HHS) |
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