Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support.

 In order for the application to be deemed responsive and entered into the review process, the following additional requirements for the principal investigator must be met:

• The PI must have documented prior experience in conducting research on violence. This must be evidenced by at least one first-authored manuscript in violence prevention research published in a peer-reviewed journal.

• Only one application per PI will be accepted.

    2. Cost Sharing or Matching

Cost sharing is not required.

3. Other-Special Eligibility Criteria

• The overall match between the proposed research objectives and the program priorities as described under the heading “Research Objectives.”

• The applicant must provide evidence of access to a secondary data set that will be used for the proposed research. This evidence must be provided as documentation (e.g., memorandum of understanding, letter from data owners indicating access etc.) in the appendices.

The applicant must have effective and well-defined working relationships within any organizations and/or outside entities expected to participate in the proposed research or provide data for analysis. This should be evidenced by letters of support detailing the nature and extent of the involvement (include in appendices).

 
If your application is incomplete or non-responsive to the special requirements listed in this section, it will not be entered 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.

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 http://www.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 at http://www.grants.gov/GetStarted

Note: CDC strongly encourages all applicants (both Organizations and Project Directors/Principal Investigators [PD/PI]) to also register in Electronic Research Administration (eRA Commons) as soon as possible (see below). Although an eRA Commons account is not mandatory at this time, future FOAs may require your participation in eRA Commons to complete an electronic application submission through Grants.gov. Important information on registration can be obtained at the following:

·         eRA Commons Registration, Electronic Submission of Grant Applications

PD/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons as early as possible.

Applicant institutions/organizations should complete the following actions as soon as possible:

1) Organizational/Institutional Registration in Grants.gov Get Registered.

• Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.

• If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.

• The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.

• Direct questions regarding Grants.gov registration to:
  Grants.gov Customer Support
  Contact Center Phone: 800-518-4726
  Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
  Email support@grants.gov

2) Organizational/Institutional Registration in the eRA Commons

• To find out if an organization is already eRA Commons-registered, see the "List of Grantee Organizations Registered in eRA Commons.”

• Direct questions regarding the eRA Commons registration to:
  eRA Commons Help Desk
  Phone: 301-402-7469 or 866-504-9552 (Toll Free)
  TTY: 301-451-5939
  Business hours M-F 7:00 a.m. – 8:00 p.m. Eastern Time
  Email commons@od.nih.gov

3) Project Director/Principal Investigator (PD/PI) Registration in the eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

• The individual designated as the PD/PI on the application must also be registered in the eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.

• The PD/PI must hold a PD/PI account in the eRA Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.

• This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the eRA Commons.

• Both the PD/PI and AOR/SO need separate accounts in the eRA Commons since both hold different roles for authorization and to view the application process.

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.

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

Note: While both budget components are included in the SF424 (R&R) forms package, the CDC U49 (activity code) uses ONLY the PHS 398 Modular Budget. (Do not use the detailed Research & Related Budget.)

3. Submission Dates and Times

 See Section IV.3.A for details

3.A. Submission, Review and Anticipated Start Dates

Letter of Intent Receipt Date: January 26, 2007

Application Submission Receipt Date: February 28, 2007
Peer Review Date: May 2007
Council Review Date: July 2007
Earliest Anticipated Start Date: September 15, 2007

3.A.1. Letter of Intent

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

·         Descriptive title of proposed research.

·         Name, address, and telephone number of the Principal Investigator.

·         Names of other key personnel.

·         Participating institutions.

·         Number and title of this funding opportunity

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, email or fax 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
Email: CIPERT@cdc.gov

Telephone: (770) 488-4037

 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.  Applicants will receive an e-mail notice of receipt from 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.

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.

 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.

 Note that HHS/CDC will currently not be using the eRA Commons system for processing of electronic applications unless otherwise stated in the FOA. HHS/CDC encourages all applicants to get registered in eRA Commons to be able to review summary statements and review scores which can be found in eRA Commons.

 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 or non-responsive applications.

There will be an acknowledgement of receipt of applications from Grants.gov. 

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

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.

• Reimbursement of pre-award costs is not allowed.

• Funds will not be made available to support the provision of direct care. 

• Travel costs for one reverse site visit to HHS/CDC in Atlanta on an annual basis should be included.

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.

Research Plan Component Sections

While each section of the Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to better monitor formatting requirements such as page limits. All attachments must be provided to HHS/CDC in PDF format, filenames must be included with no spaces or special characters, and a PDF extension must be used. Do not include any information in a header or footer of the attachments. A header will be system-generated that references the PD/PI. Page numbers for the footer will be system-generated in the complete application, with all pages sequentially numbered; therefore, do not number the pages of your attachments.  Your research plan must not exceed 25 pages. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.

The following materials may be included in the Appendix:

Up to five publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

• Publications in press:  Include only a publication list with a link to the publicly available on-line journal article or the NIH Pub Med Central (PMC) submission identification number. Do not include the entire article.

• Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a PDF attachment.

• Manuscripts published but a publicly available online journal link is not available:  The entire article may be submitted electronically as a PDF attachment.

• Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.

• Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan component. No images may be included in the Appendix that are not also represented within the Research Plan.

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: 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 $200,000, a data sharing plan is not required.

 Sharing Research Resources

Not applicable.

 Section V. Application Review Information

 1. Criteria

Only the review criteria described below will be considered in the review process:

·         Scientific merit of the proposed project as determined by peer review

·         Availability of funds

·         Relevance of program priorities and the priorities of the U.S. Department of Health and Human Services

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:

• 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.

• Receive a second level of review by the Science and Program Review Subcommittee (SPRS) of the Secretary’s Advisory Committee for Injury Prevention and Control (ACIPC).

• 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 as appropriate for each application.

• 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 aims of the application are achieved, how will scientific knowledge or clinical practice be advanced? What will be the effect of these studies on the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

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?  Is the research design proposed appropriate to answer the research question? Are descriptions of sampling methods, sample size and power estimates, and data collection measures well described and justified? Are the measures of protective factors, risk factors, and violence outcomes concrete, specific, and directly relevant to the research objectives?  Does the data analytic plan appropriately account for the ecological levels on which specific factors occur and, if applicable, the longitudinal design of the study? Is there an appropriate work plan included Are protective factors from at least two ecological levels examined?

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)? Does the PI have documented prior experience in conducting youth violence prevention research?  

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 Science and Program Review Subcommittee (SPRS) of the Advisory Committee for Injury Prevention and Control (ACIPC).  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 project officer’s 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 in a similar capacity as the ACIPC Federal agency experts to assure that research priorities of the announcement are understood and to provide background regarding current research activities.  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 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 maximal impact and balance of proposed research.  The factors to be considered will include: