Amendments to this announcement can be found in red.

ATTENTION: Grants.gov and the CDC are moving from PureEdge based grant application forms to forms that use Adobe Reader software. Most electronic submissions to the CDC on or after January 1, 2009 will require the use of the new Adobe-based forms. Although the overall process of finding opportunities, downloading application packages and preparing forms remains the same, if you are writing or renewing an electronic grant application it is important to understand the changes that are on the way and begin preparing now to ensure a smooth application submission process.   Install the Grants.gov recommended version of Adobe Reader. Grants.gov requires that applicants use specific versions of Adobe Reader 8.1.3 or higher. You can check Grants.gov’s Download Software page for directions on how to download free Adobe Reader software. Be aware that incorrect versions of Adobe Reader will prevent successful submission of your application to Grants.gov!

 

IMPORTANT: If you have already downloaded the application packages for these announcements, you must download new packages that include the new Adobe application forms.

For questions or concerns regarding this transition, please contact the CDC Procurement and Grants Office at 770-488-2700 or pgotim@cdc.gov or Grants.gov at 1-800-518-4726 or support@grants.gov.

Part I Overview Information


 

United States Department of Health and Human Services (HHS)

 

Issuing Organization

National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (NCIPC/CDC) at http://www.cdc.gov/ncipc/


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:  Youth Violence Prevention through Economic, Environmental, and Policy Change (U01)

 

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement might differ from those used by the HHS National Institutes of Health (NIH).  If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information. 

 

Authority:  Sections 301(a) and 392(a)(3) of the Public Health Service Act (42 U.S.C. Sections 241(a) and 280b-1a, 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-09-009 

Catalog of Federal Domestic Assistance Number(s):  93.136, Injury Prevention and Control Research and State and Community Based Programs

 

Key Dates

Release/Posted Date:
Letter of Intent Receipt Date:
 January 26, 2009.
Application Submission Receipt Date(s):
 February 23, 2009
Peer Review Date(s):
 April – May, 2009
Council Review Date(s):
 May – June 2009

Earliest Anticipated Start Date(s):  September, 2009

Expiration Date: One day after application due date

Additional Information to Be Available Date: Technical assistance will be available for potential applicants during one conference call to be held on January 22, 2009 from 1:00  p.m. to 2:30 p.m. (Eastern time). The conference can be accessed by calling: 1-866-771-6423 and entering the passcode: 6139831. Questions and answers from this call will be posted with the announcement on www.grants.gov.

 

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 (NCIPC) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This RFA addresses “Healthy People 2010” priority area of injury and violence prevention and is in alignment with NCIPC performance goal to conduct a targeted program of research to prevent injury-related death and disability.  For more information, see www.healthypeople.gov and http://intra-apps.cdc.gov/fmo/.

 

 

Purpose

 

The purpose of this program of research is to assess the efficacy or effectiveness of interventions and policies designed to change the economic or environmental characteristics of a community to reduce rates of youth violence perpetration and victimization. Youth violence has been linked to a variety of factors, including individual, family, community, and societal characteristics. Although much research has been conducted on interventions to change the characteristics of individuals and families, less research has focused on evaluating interventions and policies designed to change community economic or environmental factors.

 

Background

A number of community characteristics increase the probability of youth violence. Crime and violence tend to be high in areas in which at least 20 percent of the residents are poor (Lamison-White, 1996). These areas are often characterized by high concentrations of poverty and unemployment, high levels of residential instability, family disruption, crowded housing, drug-distribution networks, and low community participation (Sampson & Lauritsen, 1994; Tolan, Gorman-Smith, & Henry, 2003). These areas also tend to have high rates of school dropouts, high rates of substance abuse and teenage pregnancy, and a disproportionate number of households headed by women (Eller, 1996; Proctor & Dalaker, 2002; Reiss & Roth, 1993). In addition to their demographic characteristics, economically poor neighborhoods differ from more affluent neighborhoods in a number of ways. Poor neighborhoods tend to be characterized by disorganization, and as a result, frequently lack effective social controls (Chung & Steinberg, 2006; Elliot et al., 1996; Sampson, Raudenbush, & Earls, 1997). High levels of social disorganization also limit the ability of community residents to supervise and control adolescent peer groups, especially gangs (Sampson & Lauritsen, 1994).

 

Policies and interventions focused on addressing community characteristics associated with crime and violence have the potential to impact rates of youth violence. For example, past research suggests that policies focused on relocating disadvantaged families to more affluent neighborhoods may contribute to at least short term reductions in youth arrests for violent crime (Kling & Liebman, 2004). However, the overall benefits of relocation appear to vary for male and female youth and by the type of educational, emotional, physical, or behavioral outcome examined (Kling, Ludwig, & Katz, 2004), suggesting the need for further research to better understand the impacts of such policies and other interventions on rates of youth violence. Similarly, research suggests that modifications to the built environment, such as improvements to the pedestrian environment (e.g., lighting and improved landscaping) and architectural changes (e.g., porches, balconies, increased residential space) can contribute to relative reductions in calls to law enforcement and some crimes, such as prostitution and narcotics violations, possibly through increases in social capital and intolerance of criminal activity (Carter, Carter, & Dannenberg, 2003). However, the ability of approaches focused on changing the social and physical environment to reduce violent crime, particularly youth violence, remains unclear.

 

 

Research Objective

 

Research funded under this announcement is expected to further our understanding of how interventions and policies implemented to change the economic and environmental characteristics of communities can reduce violence. A clear distinction is made here between community-based interventions, which are programs that are implemented in the community and/or by a community-based organization targeting change in individual- or family-level factors (e.g., youth conflict resolution skills, parenting skills, job skills, knowledge about violence etc.), from interventions and policies targeting changes in the economic or environmental characteristics of the community, such as those described above (e.g., neighborhood or community concentrations of poverty, residential instability, neighborhood disorganization, supervision and control of adolescents, the physical environment, etc.).

 

 

 

The specific research objective of this program is to evaluate the efficacy or effectiveness of primary prevention interventions, programs, strategies, and policies that focus on the economic or environmental characteristics of communities rather than community-based interventions and strategies that focus on criminal justice responses (e.g., community policing, arrest strategies). The proposed research should be designed to do both of the following:

 

1. Detail one or more specific interventions for altering variables at the level of the community, rather than propose a process for determining which interventions are appropriate for the chosen community.

 

2. Assess the effects of only one strategy or policy designed to change community characteristics, not a larger multi-level intervention trial (a multi-level intervention trial is defined here as one that addresses the effects of community factors in combination with one or more components that address individual-level or family-level factors).

 

Multi-level intervention trials and research evaluating strategies involving community-based interventions (as described above) or interventions proposing to change only the characteristics of individuals or families will be considered non-responsive.

 

Strategies to address economic or environmental community characteristics include:

•           Strategies to improve the physical and social characteristics of neighborhoods (e.g., through environmental design changes). Promising modifications to the physical environment include not only design elements that inhibit violence or reduce opportunities for violent behavior (e.g., natural surveillance, access management), but also use of the built environment to promote opportunities for positive social interactions and a sense of ownership, order, and belonging.

•           Strategies and policies to improve financial, housing, and/or employment opportunities in impoverished areas (e.g., through economic development schemes, such as business improvement districts or other public policy initiatives, such as reforms in public assistance and housing).

•           Efforts to deconcentrate areas with high rates of poverty and violence (e.g., through reforms in economic assistance programs and housing).

•           Strategies or policies to increase formal and/or informal supervision of youth (e.g., through changes in school, afterschool, or other community or organizational policies and processes).

•           Strategies or policies to reduce community density and availability of alcohol and drugs.

 

Recipients are expected to evaluate a new or an ongoing intervention or policy that targets modifiable characteristics of the community that are empirically associated with increased risk of youth violence and/or protective factors that buffer against risks for youth violence. Funds are intended to support new evaluations assessing the efficacy or effectiveness of policies and interventions on youth violence outcomes. Applicants currently evaluating interventions or policies designed to change characteristics of a community on other outcomes (e.g., drug use, physical activity etc.), as opposed to supplementing or extending data collection on youth violence outcomes already under investigation, are also encouraged to apply.

 

Scientific Standards

Research funded under this announcement is expected to adhere to high scientific standards, and to incorporate the following elements:

 

 

Whenever feasible, collection of information on the economic costs of the intervention or policy implementation from the programmatic and societal perspectives to perform cost analyses or other economic evaluation is encouraged. For example, it is possible to collect cost data when implementing a new intervention or policy, or it may be possible  to retrospectively collect relevant data on the costs associated with implementing the intervention or policy. For effective interventions, it is possible to do cost-effectiveness studies. To be comparable to other cost-effectiveness studies, the studies should adhere to the guidelines in the following references:

 

Gold MR, Siegel JE, Russell LB, Weinstein MC.  Cost-effectiveness in Health and Medicine.  New York: Oxford University Press, 1996.

http://www.oup.com/us/catalog/general/subject/Medicine/PublicHealth/?view=usa&ci=0195108248

 

Haddix AC, Teutsch SM, Corso, PS. Prevention Effectiveness: A Guide to Decision Analysis and Economic Evaluation. Second Edition. New York: Oxford University Press, 2003.

http://www.oup.com/us/catalog/general/subject/Medicine/PublicHealth/?view=usa&ci=9780195148978#

 

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

 

Section II. Award Information


 

1. Mechanism(s) of Support

 

This funding opportunity will use the U01 activity code.

The HHS/CDC U01 is a cooperative agreement assistance instrument. Under the cooperative agreement assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, and 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 $1,000,000 (including direct and indirect costs) in FY2009 to fund up to two awards.  The average award amount will be $500,000 (including direct and indirect costs) for the first 12-month budget period.  An applicant may request a project period of up to 5 years.  An applicant may request up to $500,000 for the first 12-month budget period (including direct and indirect costs). An applicant may request up to $2,500,000 maximum for the entire project period. The approximate total project period funded amount is $2,500,000 per award or $5,000,000 for both awards (including direct and indirect costs). The anticipated start date for new awards is September, 2009.

All estimated funding amounts are subject to availability of funds.

 

Guidance for completing a detailed justified budget can be found on the CDC Website, at the following address:  http://www.cdc.gov/od/pgo/funding/budgetguide.htm.

 

If an applicant requests a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements.

 

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the CIO (s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

 

Section III. Eligibility Information


 

1. Eligible Applicants

1.A. Eligible Institutions

 

You may submit an application 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. 

2. Cost Sharing or Matching

Cost sharing, matching, or cost participation is not required.

 

The most current HHS Grants Policy Statement is available at:

http://www.hhs.gov/grantsnet/adminis/gpd/

 

3. Other-Special Eligibility Criteria

 

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.

 

To be considered responsive to this announcement, the principal investigator (on behalf of the applicant institution) must provide:

 

 

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 Grants.gov/Apply and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at the following:

·         Grants.gov Get Registered, http://www.grants.gov/applicants/get_registered.jsp

·         eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm

IMPORTANT: both the applicant organization, as well as the PD/PI must register in eRA Commons for an application to be accepted electronically. The Credentials Log-In, referenced in Section IV. 2. Content and Form of Application Submission, is obtained through Step #3 in the required actions below.

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

The following three steps are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov Get Registered,  http://www.grants.gov/applicants/get_registered.jsp

·         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.

·         If Foreign Institutions are listed in Section III.1.A. Eligible Institutions, include the following bullet: Applicants outside the US are required to include a NATO Commercial and Government Entity (NCAGE) number on their CCR registration. See section IV.2. Content and Form of Application Submission, for instructions.

·         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 Prepare to Apply,  http://era.nih.gov/ElectronicReceipt/preparing.htm

·         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. 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.”

In addition to the instructions provided in the SF424 (R&R) for writing the Project Summary/Abstract, structure the Project Summary/Abstract using the following components: (1) statement of the problem, (2) purpose of the proposed research, (3) methods, including study population, data sources and any statistical analyses to be performed, and (4) implications for prevention.

The Project Summary/Abstract should :

·         State the hypotheses

·         Describe the objectives and specific aims

·         State the importance of the research and how it is innovative

·         Outline the methods that will be used to accomplish the goals

·         Use language  that is simple and easy to understand for a broad audience

You must include a research plan with your application. Your research plan should address activities to be conducted over the entire project period.

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)

SF424 Form Project Summary/Abstract
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 U01 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)  A detailed budget justification prepared using  CDC Budget Guidance (http://www.cdc.gov/od/pgo/funding/grants/Budget_Guidelines.doc) must be submitted with the application. 


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, 2009.
Application Submission Receipt Date(s):
February 23, 2009.
Peer Review Date(s):  
April - May, 2009

Council Review Date(s):  May – June 2009 

Earliest Anticipated Start Date(s):  September, 2009

 

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, fax or email to:

 

NCIPC Extramural Resources Team

CDC, National Center for Injury Prevention and Control

 

Address for Express Mail or Delivery Service:

4770 Buford Hwy NE

Bldg 106, 9th Floor, Room 09.008

Atlanta, GA  30341

 

Address for U.S. Postal Service Mail:

4770 Buford Hwy NE, Mailstop F-63

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.  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. 

 

This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission address, and deadline.  It supersedes information provided in the application instructions.  If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.

 

If you still have a question, contact the PGO-TIMS staff at: 770-488-2700.  Before calling, please wait two to three days after the submission deadline.  This will allow time for HHS/CDC to process and log submissions.

 

Technical Information Management Section – RFA-CE-09-009

CDC, Procurements and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA  30341

Phone:  770-488-2700 EST


3.C. Application Processing

HHS/CDC must receive applications on or before 5:00 P.M. Eastern Standard Time on the application submission date(s) described above (Section IV.3.A.). If HHS/CDC receives an application after that submission date and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

·         If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the CDC, PGO, Technical Information Management Section, after two business days.

·         Prior to the submission deadline, the AOR/SO can “Reject” the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken.  Please remember that some warnings may not be applicable or may need to be addressed after application submission.

·         If the two day window falls after the submission deadline, the AOR/SO will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn’t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. HHS/CDC will not penalize the applicant for an eRA Commons or Grants.gov system issue.

·         If the AOR/SO chooses to “Reject” the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the CDC late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment and must refer only to Commons errors and/or technical errors.

·         Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

Upon receipt, applications will be evaluated for completeness and responsiveness by 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

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

 

Additional guidance can be found at HHS Grants Policy Statement.

 

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.

 

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.”

 

Travel costs for up to two people including the PI for one reverse site visit to HHS/CDC in Atlanta on an annual basis should be included.

 

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 unresponsive and ineligible for review.

 

The following materials may be included in the Appendix:

Up to 5 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

 

  • Publications in press:  Include only a publication list with a link to the publicly available on-line journal article or the NIH Pub Med Central (PMC) submission identification number. Do not include the entire article.
  • Manuscripts accepted for publication but not yet published: The entire article may be submitted electronically as a .pdf attachment.
  • Manuscripts published but a publicly available online journal link is not available:  The entire article may be submitted electronically as a .pdf attachment.
  • Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents.
  • Graphic images of gels, micrographs, etc. provided that the image (may be reduced in size) is also included within the (stated) page limit of Items 2-5 of the Research Plan component. No images may be included in the Appendix that are not also represented within the Research Plan.

Please note the following restriction on appendix attachments: The Research Plan Appendix attachments are limited to 10 attachments.  Appendices are uploaded as attachments in the PHS 398 Research Plan form, in field #18, within the electronic application package.  An applicant will receive an error message if the number of appendix attachments exceeds 10, which will result in an unsuccessful submission of the application.  You may include more than one publication, or other allowable appendix material, within one attachment; however, do not let your attachments exceed 10.

Do not 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.  If an applicant proposes a total budget that is below $500,000 then a data sharing plan is not required and the HHS/CDC steps outlined in this section do not apply.

 

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not the awardee will place any conditions on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.

 

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25 Release and Sharing of Data. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

 

Awardees must agree to Section VI.2.A., "Cooperative Agreement.”

 

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.

·         Applications that do not address the objectives listed in Part II, Section 1 Research Objectives, will not be funded even if they rank higher than other applications that address the required objectives.

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.
  • These applications will be reviewed for scientific merit using current NIH/CDC criteria (a scoring system of 100-500 points) to evaluate the methods and scientific quality of the application.
  • Those applications judged to be competitive will be recommended by the initial review group for a secondary review.
  • Receive a written critique; and

Receive a second level of review by NCIPC Board of Scientific Counselors (BSC) to make funding recommendations based on responsiveness of applications to program priorities as stated in this FOA, Section V.1. Criteria.  BSC members will vote, in a closed session, on funding recommendations.  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.

  • 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 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? Does the applicant address the research objectives as stated in Section I? Are the targeted community characteristics and youth violence outcomes clearly described and appropriate? Is the potential effectiveness of the proposed intervention to change community characteristics and thereby reduce youth violence theoretically justified and supported with epidemiologic, methodological, and behavioral research? If the proposal includes implementation in addition to evaluation, how feasible is the implementation of the intervention or policy as proposed? Can the intervention reasonably be predicted to produce the expected reductions in youth violence? Is the setting for implementation appropriate? Does the research design allow for a rigorous examination of the effectiveness of the intervention or policy in reducing youth violence, including assessment of relative change in youth violence over time? Are descriptions of sampling methods, sample size and power estimates, and data collection measures well described, justified, and do they adequately address the central research question in the announcement?  Are plans for assessing implementation processes and fidelity clear and appropriate?  Does the applicant provide a strong rationale for why an economic evaluation can not be conducted or provide an appropriate plan for conducting an economic evaluation? Does the applicant provide evidence supporting their ability to access relevant data?    


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? If collaborations are being proposed, are the partners and their skills and expertise well described? Can proposed collaborations reasonably be expected to improve the quality of the implementation and evaluation of the intervention or policy? Does the applicant have appropriate access to the target community?

 

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

 

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. 

 

The secondary review will be conducted by the Board of Scientific Counselors (BSC). 

The BSC 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:

·         The comments and recommendations of the primary review including the application’s priority score as the primary factor in the selection process.

·         The relevance and balance of proposed research relative to the HHS/CDC/NCIPC programs priorities and the research objectives identified in this FOA.

·         The availability of funds.

·         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, recommendations by the secondary review committee and the extramural research program staff, consultation with HHS/CDC/NCIPC senior staff.

 

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).

 

Inclusion of children as participants in research involving human subjects:

Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of children (i.e., individuals under the age of 21) in the proposed research? This includes: (1) The proposed plan to include child populations for appropriate representation; (2) The proposed justification when representation is limited or absent (see Section 2, item 10, Inclusion of Children of the Research Plan component of the SF424 (R&R).


2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed?  Is each budget category realistic and justified in terms of the aims and methods?  The evaluation of the budget should not affect the priority score.

2.C. Sharing Research Data

 

Data Sharing Plan: HHS/CDC will assess the reasonableness of the data sharing plan.  However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy. Program staff will be responsible for the administrative review of the plan for sharing research data.

 

2.D. Sharing Research Resources

Not applicable.


3. Anticipated Announcement and Award Dates

 

Grantees will be notified in September 2009 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.

 

CDC may grant expanded authority to eligible grantees under this announcement. 

 

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 U01, an "assistance" instrument (rather than an "acquisition" instrument) in which substantial HHS/CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in, and otherwise working jointly with, the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole; although specific tasks and activities may be shared among the awardees and the HHS/CDC may share specific tasks and activities, as defined above.


2.A.1. Recipient Rights and Responsibilities

 

The Recipient will have the primary responsibility for the following:

 

  • Designing and conducting research to address the described research objectives of this cooperative agreement.
  • Partnering effectively with any outside entities expected to participate in the proposed research. Such partnerships should be well-defined and documented by letters of support detailing the nature and extent of involvement or memorandums of understanding. 
  • Establishing goals and objectives that are realistic, measurable, and time-oriented for all phases of the project.
  • Developing a research protocol involving human subjects for Institutional Review Board (IRB) review and approval by all cooperating institutions participating in the research project, including CDC if applicable.
  • Designing, developing, and monitoring intervention components and implementation protocols as appropriate.
  • Designing, developing, and if necessary piloting evaluation protocols, instruments, and data management procedures.
  • Assess the economic costs of program implementation (as applicable) for use in economic evaluation.
  • Analyzing data and disseminating findings in peer-reviewed journals and presentations at scientific conferences and other meetings.
  • Participating in one reverse site visit with CDC in Atlanta on an annual basis.

    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 and/or Project Officer will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

 

  • Providing scientific and programmatic consultation and technical assistance for the design and implementation of this research.
  • Assist in developing a research protocol involving human subjects for Institutional Review Board (IRB) review and approval by all cooperating institutions participating in the research project, including CDC if applicable.
  • Collaborating with the grantee to ensure human subjects assurances are in place as needed.
  • Participating in the analysis, interpretation, and dissemination of study findings.
  • Monitoring and evaluating the scientific and operational accomplishments of the project through conference calls, site visits, and review of technical reports. 


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. If you would like to change reporting requirement (i.e. quarterly, semi annual) see instructions above and insert. Add Information Here.

2.      Annual progress report is due 90 days after the end of the budget period.

3.      Financial status report, no more than 90 days after the end of the budget period.

4.      Final financial and performance reports, no more than 90 days after the end of the project period/budget year.

 

Recipient Organization must forward these reports by the U.S. Postal Service or express delivery to the Grants Management Specialist listed in the “Agency Contacts” section of this FOA.

 

Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.

 

Section VII. Agency Contacts


 

HHS/CDC encourages your inquiries concerning this FOA and welcomes the opportunity to answer questions from potential applicants. Inquiries can fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

 

Joanne Klevens, M.D., Ph.D.
Division of Violence Prevention (DVP)

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 F-63

Atlanta, GA  30341
Telephone: (770) 488-1386
Email:  JKlevens@cdc.gov

 

2. Peer Review Contacts:

 

Felix Rogers, Ph. D.

Scientific Review Administrator

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 F-62

Atlanta, GA  30341

Telephone: (770) 488-4334
Email: JFelixRogers@cdc.gov

 

3. Financial or Grants Management Contacts:

 

Barbara R. Benyard

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) 488-2757
Email: RBenyard@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/erpo/faqs.htm.

 

Additional Information to Be Available Date: Technical assistance will be available for potential applicants during one conference call to be held on January 22, 2009 from 1:00  p.m. to 2:30 p.m. (Eastern time). The conference can be accessed by calling: 1-866-771-6423 and entering the passcode: 6139831.

 

 

Section VIII. Other Information


 

Required Federal Citations

Human Subjects Protection:
Federal regulations (45 CFR Part 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).   Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on the Internet at the following address: http://www.cdc.gov/od/pgo/funding/ARs.htm.

Requirements for Inclusion of Women and Racial and Ethnic Minorities in Research

It is the policy of the Centers for Disease Control and Prevention (CDC) and the Agency for Toxic Substances and Disease Registry (ATSDR) to ensure that individuals of both sexes and the various racial and ethnic groups will be included in CDC/ATSDR-supported research projects involving human subjects, whenever feasible and appropriate. Racial and ethnic groups are those defined in OMB Directive No. 15 and include American Indian or Alaska Native, Asian, Black or African American, Hispanic or Latino, Native Hawaiian or Other Pacific Islander. Applicants shall ensure that women, racial and ethnic minority populations are appropriately represented in applications for research involving human subjects. Where clear and compelling rationale exist that inclusion is inappropriate or not feasible, this situation must be explained as part of the application. This policy does not apply to research studies when the investigator cannot control the race, ethnicity, and/or sex of subjects. Further guidance to this policy is contained in the Federal Register, Vol. 60, No. 179, pages 47947-47951, and dated Friday, September 15, 1995.

 

INCLUSION OF PERSONS UNDER THE AGE OF 21 IN RESEARCH
The policy of CDC is that persons under the age of 21 must be included in all human subjects research that is conducted or supported by CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all CDC-conducted or CDC-supported research involving human subjects, including research that is otherwise exempt in accordance with Sections 101(b) and 401(b) of 45 C.F.R. Part 46, HHS Policy for the Protection of Human Subjects. Therefore, proposals for research involving human subjects must include a description of plans for including persons under the age of 21. If persons under the age of 21 will be excluded from the research, the application or proposal must present an acceptable justification for the exclusion.

In an extramural research plan, the investigator should create a section titled "Participation of persons under the age of 21." This section should provide either a description of the plans to include persons under the age of 21 and a rationale for selecting or excluding a specific age range, or an explanation of the reason(s) for excluding persons under the age of 21 as participants in the research. When persons under the age of 21 are included, the plan must also include a description of the expertise of the investigative team for dealing with individuals at the ages included, the appropriateness of the available facilities to accommodate the included age groups, and the inclusion of a sufficient number of persons under the age of 21 to contribute to a meaningful analysis relative to the purpose of the study. Scientific review groups at CDC will assess each application as being acceptable or unacceptable in regard to the age-appropriate inclusion or exclusion of persons under the age of 21 in the research project, in addition to evaluating the plans for conducting the research in accordance with these provisions.

The inclusion of children (as defined by the applicable law of the jurisdiction in which the research will be conducted) as subjects in research must be in compliance with all applicable subparts of 45 C.F.R. Part 46, as well as with other pertinent federal laws and regulations.

The policy of inclusion of persons under the age of 21 in CDC-conducted or CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.

 

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 2010

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This 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.

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:

  1. In a timely manner
  2. Completely, and as accurately as possible
  3. To facilitate the broader community
  4. Developed in accordance with CDC policy on Releasing and Sharing Data, April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) http://www.cdc.gov/od/foia/index.htm.

Applications must include a copy of the applicant's Data Release Plan.  Applicants should provide 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.  If the proposed budget is below $500,000, a data sharing plan is not required.

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.

 

Questions and Answers

What is meant by "project narrative" in the SF424 (R&R)?

The "project narrative" attachment is required in the SF424 (R&R). As described in the SF424 (R&R) application guide, the project narrative should describe the relevance of the research. Using no more than two or three sentences, describe the relevance of this research to public health. In this section, be succinct and use plain language that can be understood by a general, lay audience.

Does the target community have to be a city?  How small or how large does the target community need to be? 

The FOA does not specify the location or size of a target community but the size of the target community needs to be sufficiently large enough to provide stable rates over time.

Can an observational study be proposed?    

 Experimental designs are strongly encouraged; however we realize that quasi-experimental designs, including time series may be appropriate if justified by the needs and constraints of a particular setting.

 Is secondary data analysis of a previous trial appropriate for this application?

As long as youth violence outcomes have not already been analyzed, secondary data analysis of current or ongoing interventions designed to change other outcomes are permissible.  Supplementing or extending data collection on youth violence outcomes already under investigation are not allowed. 

 

 

CDC Home Page: http://www.cdc.gov

CDC Funding Web Page: http://www.cdc.gov/od/pgo/funding/FOAs.htm  

CDC Forms Web Page: http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm