Part I Overview Information


United States Department of Health and Human Services (HHS)

Participating Organizations
Centers for Disease Control and Prevention (CDC) at http://www.cdc.gov/

Components of Participating Organizations
National Center for Injury Prevention and Control (NCIPC/CDC) at http://www.cdc.gov/ncipc/

Title: Translation Research to Prevent Motor Vehicle-Related Crashes and Injuries to Teen Drivers and Their Passengers (R01)

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 391(a) of the Public Health Service Act (42 U.S.C. Sections 241(a) and 280b(a)), as amended.  

Announcement Type:
New

Instructions for Submission of Electronic Research Applications:

If you do not have access to the Internet, or if you have difficulty accessing the forms online, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGOTIMS) staff.  For this, or further assistance, contact PGO TIMS: Telephone (770) 488-2700, Email: PGOTIM@cdc.gov.

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

This FOA must be read in conjunction with the application package instructions included with this announcement on Grants.gov/Apply for Grants (hereafter referred to as, Grants.gov/Apply.)

A registration process is necessary before submission, and applicants are strongly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Two steps are required for on time submission:

1) The application must be successfully received by Grants.gov no later than 5:00 p.m. Eastern Standard Time on the application submission receipt date (see “Key Dates” below.)

2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.

Funding Opportunity Announcement (FOA) Number: RFA-CE-08-004 

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: December 18, 2007
Letter of Intent Receipt Date: January 21, 2008
Application Submission Receipt Date(s): March 17, 2008
Peer Review Date(s): March - April, 2008
Council Review Date(s): May - June, 2008
Earliest Anticipated Start Date(s): September, 2008
Additional Information to Be Available Date: January 11, 2008
Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on January 11, 2008 from 1:30 p.m. to 3:00 p.m. (Eastern Time). The conference can be accessed by calling: 1-866-704-7564, stating the leader name: Ms Lady Patterson, and entering the passcode: 1314492.
Expiration Date: one day after application submission receipt date.

Due Date for E.O. 12372

Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
    1. Research Objectives

Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

Section III. Eligibility Information
    1. Eligible Applicants
        A. Eligible Institutions
    2. Cost Sharing or Matching
    3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
    1. Request Application Information
    2. Content and Form of Application Submission
    3. Submission Dates and Times
        A. Receipt and Review and Anticipated Start Dates
            1. Letter of Intent
        B. Submitting an Application to CDC
        C. Application Processing
    4. Intergovernmental Review
    5. Funding Restrictions
    6. Other Submission Requirements

Section V. Application Review Information
    1. Criteria
    2. Review and Selection Process
        A. Additional Review Criteria
        B. Additional Review Considerations
        C. Sharing Research Data
        D. Sharing Research Resources
    3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
    1. Award Notices
    2. Administrative and National Policy Requirements  
        A. Cooperative Agreement
            1. Recipient Rights and Responsibilities
            2. CDC Responsibilities
            3. Collaborative Responsibilities
    3. Reporting

Section VII. Agency Contact(s)
    1. Scientific/Research Contact(s)
    2. Peer Review Contact(s)
    3. Financial/ Grants Management Contact(s)
    4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The National Center for Injury Prevention and Control of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This FOA addresses “Healthy People 2010” priority area(s) of injury and violence prevention and is in alignment with NCIPC performance goal(s) to increase the capacity of injury prevention and control programs to address the prevention of injuries and violence.  It also supports CDC’s performance goals of prevention research involving sustainable and transferable community-based interventions.  For more information, see www.healthypeople.gov and http://intra-apps.cdc.gov/fmo/.

Purpose:

The announcement of this research opportunity represents a critical step in moving effective interventions into practice to ultimately save the lives of teen drivers and their passengers.  The purpose of this announcement is to solicit applications to conduct translation research to understand the best ways to promote the widespread adoption and institutionalization of evidence-based teen driving interventions.

Research Objectives:

The goal of this FOA is to accelerate the utilization of proven evidence-based interventions through translation research that includes dissemination, implementation, and diffusion of effective strategies into public health policy and practice to reduce motor vehicle injuries to teen drivers and their passengers.  Research on the development or testing of teen driving interventions is not a goal of this FOA.  Interdisciplinary collaboration is encouraged.

Submitted research proposals must consider one or a combination of the following research approaches;

1) Identify, test, and evaluate methodological tools for the successful dissemination, implementation, and diffusion of evidence-based teen driving programs, practices, or policies that retain fidelity and achieve positive outcomes for target populations;

2) Identify, test, and evaluate optimal strategies to enhance the widespread adoption and institutionalization of effective teen driving intervention programs, including the adaptability of interventions to other at risk populations and/or

3) Identify, test, and evaluate cost-effective teen driving strategies designed to implement evidence into practice, and subsequently into the framework of decision making within public health practice, systems and organizations and/or at the public policy level.

Applications should include in the research proposal the following characteristics:

Evaluation Plan

The evaluation plan must annotate a robust methodology to measure the interplay between system fidelity, the necessary adaptation of the intervention, and scalability.   Novel evaluation models are acceptable with justification or applicants may elect to use previously published models such as:

RE-AIM model that addresses Reach into the target population; Efficacy or effectiveness; Adoption by target settings or institutions; Implementation—consistency of delivery of intervention; and Maintenance of intervention effects in individuals and populations over time (Glasgow R, Lichtenstein E, Marcus AC, 2003), available at http://www.re-aim.org/

PRIME model – PRocess modeling in ImpleMEntation research: selecting a theoretical basis for interventions to change clinical practice by Anne E. Walker et al published in BMC Health Services Research 2003; 3:22 available at:  http://www.biomedcentral.com/1472-6963/3/22.

Key translation research questions to consider in the evaluation plan:

Reach – What were the key factors that determined who in the target audience were successfully or unsuccessfully reached?

Uptake (adoption) – What factors influenced organizations or individuals’ acceptance of the intervention (e.g., organizational structure, regulation, opinion leaders, and cultural norms)?

Feasibility – What is the realistic cost, time, facility space and human resources (e.g., number of staff and type of training) needed?

Fidelity – Describe how the fidelity of the intervention or system was compromised or deviated from the original research setting in which it was tested.

Adaptability – What key components of the intervention or the system were modified to increase adoptability or use?  Can the intervention vary, as needed, depending on the audience?

Health outcome – Measure the effectiveness of the intervention as a secondary measure.

Economic Cost – Was cost a factor in the implementers or target populations willingness to adopt the intervention? What opportunity (non-fiscal) costs were incurred?

Cultural context – Did the adaptation of the intervention to make it more culturally relevant result in loss of fidelity? Did this result in decreased effectiveness?

Classic health quantitative measures or patient outcome/impact results can be measured using tradition evaluation models.  Some examples follow:

Consolidated Standards of Reporting Trials (CONSORT) available at http://www.consort-statement.org/

Healthy People 2010 Leading Health Indicators available at http://www.healthypeople.gov/LHI/

Framework for Program Evaluation in Public Health available at http://www.cdc.gov/mmwr/PDF/rr/rr4811.pdf

Proposed research topics may include but are not limited to:   

Background

Unintentional injuries are a leading cause of death for Americans of all ages, regardless of gender, race, or economic status. CDC’s Injury Center is dedicated to reducing the number and severity of unintentional injuries through science-based, applied research and prevention programs.   Motor vehicle crashes are the leading cause of death for 15 to 20 years olds, accounting for 36% of all deaths in this age group.  In 2005, 7,460 young drivers within this age group were involved in fatal crashes and approximately 500,000 young drivers and passengers were injured.

Driving is especially dangerous for teens during the early stages of licensure, as novice drivers require months and even years to develop proficiency behind the wheel.  Teen drivers are uniquely at risk when first licensed, with crash rates nearly 12 times higher during the first weeks after licensure than among experienced drivers (McCartt, Shabanova, and Leaf, 2003).  The risk of motor vehicle crashes is higher among 16- to 19-year-olds than other age groups. Per mile driven, teen drivers ages 16 to 19 are four times more likely than older drivers to crash.  In 2002, the estimated economic cost of police-reported crashes (fatal and nonfatal) involving drivers ages 15 to 20 was $40.8 billion.

Motor vehicle injury prevention has much to offer injury prevention programs in general from the standpoint of existing effective interventions known to work (Taskforce on Community Preventive Services, 2004; Simons-Morton and Winston, 2006).  However, effective interventions are often underutilized and many are unrecognized by teens, parents, and policy makers.  Many other interventions (for example those that have been shown to work in population settings) have not been adapted or translated for use among teens. There is a need to design and conduct research that will improve reach, adoption, and uptake of effective interventions to reduce motor vehicle injuries to teenagers.

CDC’s ultimate goal is to increase the spread and usage of effective public health interventions based on “science that works” so that the greatest health impact for an individual, community or nation can be achieved with the greatest efficiency.   Although most researchers develop evidence-base interventions for public health practice, the rate of adoption and implementation is low due to various barriers and impediments. The existence of relevant and high quality research findings does not in itself assure good practice.  Despite extensive research on the efficacy and effectiveness of injury prevention interventions, little is know regarding effective methods for the broader dissemination, adoption, and implementation of strategies known to work (Sogolow, Sleet, Saul, 2007).  Evidence is mounting that a number of factors are critical to success in translation research, including: research incentives and policies, organizational and structural support, appropriate and targeted funding, formal monitoring and evaluation of the activity and its dissemination and impact, ongoing training for both researchers and practitioners, appropriate engagement with the target population, and a clear process for stakeholder selection, interaction and collaboration (Oldenburg, 1996).

Translation research broadly studies and examines factors that facilitate efficacious and effective translation of research into everyday public health policies and programs; evaluates the effectiveness of the administrative, management, policy, healthcare and public health practice decisions and/or use of research knowledge; and describes the experience and roles of the stakeholders, practitioners and participants.  Practitioners, researchers, and public health policy makers must work together to ensure that evidence-based public health interventions are successfully implemented for a significant, sustained, and measurable health impact. 

Research should focus on the translation of existing evidenced-based recommendations, programs, practices, policies, tools, and/or strategies and should utilize the findings of existing resources such as “The Guide to Community Preventive Services (The Community Guide)” the “Guide to Clinical Preventive Services” and “Cochrane reviews” at http://www.thecommunityguide.org.

Previous efforts to accelerate the translation of research into public health practice and policy often have not satisfactorily characterized the knowledge gap between evidence-based public health interventions and effective delivery; have not sufficiently evaluated the factors necessary for the successful adaptation of interventions or supporting infrastructure; and typically have not described the requirements for stakeholders’ collaboration to facilitate meaningful adoption by the target population or potential for broader public health uptake.  Dissemination of an intervention alone (e.g., guideline publication or widespread mailings) or implementation without a research framework or evaluation, is insufficient to address the gaps identified in this area of research.

Translation research needs to involve interdisciplinary cooperation and collaboration which uses theories, empirical findings, and methods from a variety of fields not traditionally associated with public health or injury-related research.   Relevant fields include information science; built environment; criminal justice; law and law enforcement, public administration and policy, decision science; organizational and management theory; economics; communication science; social marketing,  individual, group and systems-level behavioral change; anthropology; sociology; learning theory; and community psychology.  

Definition of Terms

For the purpose of this FOA, the following terminology is defined: 

Interdisciplinary collaboration refers to scientific endeavors in which a variety of disciplines work together closely from the outset to form a shared conceptual framework to address a problem. The CDC encourages interdisciplinary studies that cross the traditional boundaries within and between biological, behavioral, and social sciences, including collaboration between injury prevention, health promotion, engineering, economics, law, justice, and psychology. 

Translation research characterizes the sequence of events (i.e., process) in which a proven scientific discovery (i.e., evidence based public health intervention) is successfully institutionalized (i.e. integrated into established practice and policy).  In the context of this FOA, translation research does not encompass pure biomedical or formative basic science research (e.g., biomechanics, genomics, metabolic or etiology research).  It also does not include the conduct of an initial or replication intervention efficacy or effectiveness trial. Specifically, translation research in injury prevention is comprised of dissemination research, implementation research and diffusion research (Sogolow, Sleet, Saul, 2007).

Evidence-based interventions are a key component of translation research. Therefore, for the purposes of this FOA it is important to define and describe the characteristics of an evidence-based intervention:

•   Intervention is an intentional action (singular or constellation) designed for an individual, a community, or a region that alters a behavior, reduces risk or improves outcome.  Interventions can be a medical or behavioral therapy, modification to the natural or built environment, including engineering controls, public heath policy, public health program, health communication, or public health law.

In the context of an intervention it is extremely important to clarify the concept of “adaptation”, “adoption”, “fidelity”, “outcomes and impacts”, ”scalability” and sustainability which are interrelated and not mutually exclusive terms.

References

Glasgow R, Lichtenstein E, Marcus AC.  Why don’t we see more translation of health promotion research to practice? Rethinking the efficacy-to-effectiveness transition.  AM J Public Health 2003;93:1261-1267.

Sogolow, E S, Sleet, DA, Saul, J   Dissemination, Implementation and Widespread Use of Injury Prevention Interventions.    In Doll, L, Bonzo, S, Mercy, J, Sleet, D (Eds).  Handbook of Injury and Violence Prevention.  New York:   Springer, 2007

Simons-Morton BG, Winston, FK.  (2006). Translational research in child and adolescent transportation safety.  Evaluation and the Health Professions, 29:33-64

McCartt, AT, Shabanova, VI, Leaf, WA.  (2003). Driving experience, crashes, and traffic citations of teenage beginning drivers.  Accident Analysis and Prevention, 35(3), 683-691

Mowbray CT, Holter MC, Teague GB, Bybee D. Fidelity criteria: development, measurement, and validation. Am J Eval; 24:315-340.  Available from: URL:  http://aje.sagepub.com/cgi/content/abstract/24/3/315.

Oldenburg BF, Sallis JF,French ML,Owen N. Health promotion research and the diffusion and institutionalization of interventions. Health Education Research. 1999; 14: 121-130.

Taskforce on Community Preventive Services.  Guide to Community Preventive Services 2004.  Available at URL:  http://www.thecommunityguide.org/.

Sussman S, Valente TW, Rohrbach LA, Skara S, Pentz MA. Translation in the health professions: converting science into action. Eval Health Prof. 2006 Mar;29(1):7-32.

Other references are available at: http://wwwdev.cdc.gov/ncipc/res-opps/translation.htm

Helpful Resources

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 is a research grant and will use the R01 activity code.

This FOA uses just-in-time concepts. It also uses the non-modular budget format described in the SF424 Research and Related (R&R) Budget Component application instructions (see http://grants.nih.gov/grants/funding 424/index.htm/).

A detailed categorical budget for the “Initial budget Period” and the “Entire Proposed Period of Support” must be submitted with the application.

2. Funds Available

The participating Centers, Institutes, and Offices (CIOs) (NCIPC) intend to commit approximately $518,000 (direct and indirect costs) dollars in FY2008 to fund one application. The average award amount will be $518,000 (direct and indirect costs) per year.  An applicant may request a project period of up to four years. An applicant may request up to $518,000 (direct and indirect) during the first 12 month budget period. The approximate total project period funded amount is $518,000. The anticipated start date for new awards is September, 2008.

All estimated funding amounts are subject to availability of funds.

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

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application if your organization has any of the following characteristics:

A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application.  If you are applying as a bona fide agent of a state or local government, you must provide a letter from the state or local government as documentation of your status.  Attach this documentation behind the first page of your application form or for electronic applications, use a .pdf file and attach as “Other Documents” and label as appropriate. 

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/docs/HHSGPS_107.doc

3. Other-Special Eligibility Criteria

To be considered eligible, the application should propose one or a combination of the following research approaches; 1) Identify, test, and evaluate methodological tools for the successful dissemination, implementation, and diffusion of evidence-based programs, practices, or policies that retain fidelity and achieve positive outcomes for target populations; 2) Identify, test, and evaluate optimal strategies to enhance the widespread adoption and institutionalization of effective public health intervention programs, including the adaptability of interventions to other at risk populations and/or 3) Identify, test, and evaluate cost-effective strategies designed to implement evidence into practice, and subsequently into the framework of decision making within public health practice, systems and organizations and/or at the public policy level.

The application should propose research studies that address some aspect of the dissemination, implementation, and diffusion of existing evidenced-based programs, practices, and policies, to achieve broad measurable and sustainable public health improvements to reduce teen crashes and resultant injuries.

The application should outline and justify the factors including identifying barriers driving the dissemination, implementation, and diffusion.

The fidelity of the intervention must be documented and evaluated in the research design.  If the intervention is modified to adapt to another situation, then the applicant must describe how the fidelity of the intervention is maintained.

Broad stakeholder involvement should be outlined from the outset to include traditional and non-traditional research partners (e.g., federal/state or local government, education, community, public policy, politicians, private sector, non-profits, health systems, academics, coalitions and media).

The application should provide the rationale for the public health evidenced-based intervention and provide a full description of the setting of the delivery of the intervention, primary and secondary outcomes to be assessed, and the statistical analysis to be employed. 

The application must also address cost-effectiveness or sustainability of the proposed study design.  Sample size needs required or assumptions made to estimate an appropriate sample size should be detailed including the analysis plan to be used.

The application should propose the use of multiple measures such as the impact of the intervention as well as its feasibility, acceptability, and sustainability of the translation effort. 

The application should include an evaluation plan.  The evaluation plan must annotate a robust methodology to measure the interplay between system fidelity, the necessary adaptation of the intervention, and scalability.   Novel evaluation models are acceptable with justification or applicants may elect to use previously published models. 

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

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

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

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

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

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

2) Organizational/Institutional Registration in the eRA Commons Prepare to Apply,  http://era.nih.gov/ElectronicReceipt/preparing.htm

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

Note that if a PD/PI is also an HHS peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the eRA Commons. The HHS/CDC strongly encourages applicants to use the Grants.gov electronic applications process and have organizations and PD/PIs complete all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA) although some of the "Attachment" files may be useable for more than one FOA.

If you do not have access to the Internet, or if you have difficulty accessing the forms online, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGOTIMS) staff.  For this, or further assistance, contact PGO TIMS: Telephone (770) 488-2700, Email: PGOTIM@cdc.gov.

HHS/CDC Telecommunications for the hearing impaired: TTY 770-488-2783.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide (MS Word or PDF).

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by HHS/CDC (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, mandatory and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
Research & Related Budget
PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

Optional Components:
PHS398 Cover Letter File
Research & Related Subaward Budget Attachment(s) Form

Foreign Organizations

Several special provisions apply to applications submitted by foreign organizations:

For help from within the U.S., call 1-888-227-2423
For help from outside the U.S., call 1-269-961-7766
Email NCAGE@dlis.dla.mil for any problems in getting an NCAGE code

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 21, 2008
Application Submission Receipt Date(s): March 17, 2008
Peer Review Date: March - April, 2008
Council Review Date: May - June, 2008
Earliest Anticipated Start Date: September, 2008

3.A.1. Letter of Intent

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed in Section IV.3.A

The letter of intent should be sent by mail, fax or email to:

NCIPC Extramural Resources Team

CDC, National Center for Injury Prevention and Control

Address for Express Mail or Delivery Service:

2945 Flowers Rd. S.
Yale Building, Room 2054
Atlanta, GA  30341
Address for U.S. Postal Service Mail:
4770 Buford Hwy. NE, Mailstop K-62
Atlanta, GA 30341
FAX: (770) 488-1662
Telephone: (770) 488-4037
Email: CIPERT@cdc.gov

3.B. Submitting an Application to CDC

If the instructions in this announcement differ in any way from the SF424 R&R instructions, follow the instructions in this announcement.

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov.  The applicants’ Authorized Organization Representative (AOR) will receive an e-mail notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives the application. 

All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Standard Time on the deadline date. If an applicant submits materials by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time.  If HHS/CDC receives your submission after closing because of : (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you have the opportunity to submit documentation of the carrier’s guarantee.  If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline. 

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

Otherwise, HHS/CDC will not notify you upon receipt of your paper submission.  If you have a question about the receipt of your application, first contact your courier.  If you still have a question, contact the PGO-TIMS staff at: 770-488-2700.  Before calling, please wait two to three days after the submission deadline.  This will allow time for HHS/CDC to process and log submissions.

If submitting a paper application, it must be prepared using the 424 R&R instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and three signed photocopy(s) to the following address:

Technical Information Management Section – RFA-CE-08-004

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.

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

The HHS/CDC will not accept any application in response to this FOA that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

5. Funding Restrictions

All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

Restrictions, which applicants must take into account while writing their budgets, are as follows:

6. Other Submission Requirements

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 to10 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to the proposed project. Do not include manuscripts submitted for publication. Applicants should refer to instruction guides and specific Funding Opportunity Announcements (FOAs) to determine the appropriate limit on the number of publications that may be submitted for a particular program. Note that not all grant activity codes allow the inclusion of publications.

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

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the relevant policies and procedures may not be considered in the review process. Applicants are reminded to review specific FOAs for any additional program-specific guidance on Appendix material and other application requirements.

Plan for Sharing Research Data

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.

Sharing Research Resources

HHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (see the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc.)  Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by the HHS/CDC Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, http://grants.nih.gov/grants/funding/2590/2590.htm.)  See Section VI.3. Reporting.

Section V. Application Review Information


1. Criteria

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

Scientific merit of the proposed project as determined by peer review

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by NCIPC in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

The goals of HHS/CDC-supported research are to advance the understanding of health promotion and the prevention of disease, injury, and disability, and enhance preparedness. In the written comments, evaluate the application to judge the likelihood the proposed research will have a substantial impact on the pursuit of these goals. Each of these criteria will be addressed by the reviewers and considered in assigning the overall score, weighting them as appropriate for each application.

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
 
Significance: Does this study address an important problem? If the applicant achieves the aims of the application, how will it advance scientific knowledge or clinical practice? What will be the effect of these studies on the concepts, methods, technologies, treatments, or preventative interventions that drive this field?

Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?

Innovation: Is the project original and innovative? For example: Does the project challenge existing paradigms or clinical practice; address an innovative hypothesis or critical barrier to progress in the field? Does the project develop or employ novel concepts, approaches, methodologies, tools, or technologies for this area?

Investigators: Are the investigators appropriately trained and well suited to carry out this work? Is the work proposed appropriate to the experience level of the principal investigator and other researchers? Does the investigative team bring complementary and integrated expertise to the project (if applicable)?

Environment: Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed studies benefit from unique features of the scientific environment, or subject populations, or employ useful collaborative arrangements? Is there evidence of institutional support?

2.A. Additional Review Criteria

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Application Review

The primary review will be a peer review conducted by HHS/CDC/NCIPC Initial Review Group (IRG). Applications may be subjected to a preliminary evaluation (streamline review) by the IRG to determine if the application is of sufficient technical and scientific merit to warrant further review.  HHS/CDC/NCIPC will withdraw from further consideration applications judged to be noncompetitive and promptly notify the principal investigator/program director and the official signing for the applicant organization.  Those applications judged to be competitive will be further evaluated by the IRG. These applications will be reviewed for scientific merit using current NIH criteria (a scoring system of 100 - 500 points) to evaluate the methods and scientific quality of the application. 

The secondary review will be conducted by the current Science and Program Review Subcommittee (SPRS) of the Advisory Committee for Injury Prevention and Control (ACIPC) or equivalent board of scientific counselors.  Only SPRS members will vote on funding recommendations, and their recommendations will be carried to the entire ACIPC for voting by the ACIPC members in closed session.  If any further review is needed by the ACIPC regarding the recommendations of the SPRS, the factors considered will be the same as those considered by the SPRS.

The ACIPC Federal agency experts will be invited to attend the secondary review and will receive modified briefing books (i.e., abstracts, strengths and weaknesses from summary statements, and extramural research program office staff briefing materials).  ACIPC Federal agency experts will be encouraged to participate in deliberations when applications address overlapping areas of research interest, so that unwarranted duplication in federally-funded research can be avoided and special subject area expertise can be shared.  The HHS/CDC/NCIPC Division Associate Directors for Science (ADS) or their designees will attend the secondary review to assist extramural research program office staff to assure that research priorities of the announcement are understood and to provide background regarding current research priorities. 

The ACIPC committee’s responsibility is to develop funding recommendations for the HHS/CDC/NCIPC Director based on the results of the primary review, the relevance and balance of proposed research relative to the HHS/CDC/NCIPC programs and priorities, and to assure that unwarranted duplication of federally-funded research does not occur.  The secondary review committee has the latitude to recommend to the HHS/CDC/NCIPC Director to reach over better ranked proposals in order to assure maximum impact and balance of proposed research.  The factors to be considered will include:

All awards will be determined by the Director of the HHS/CDC/NCIPC based on priority scores assigned to applications by the primary review committee IRG, recommendations by the secondary review committee and the extramural research program staff, consultation with HHS/CDC/NCIPC senior staff, and the availability of funds.  The Director reserves the right to reach over better ranked proposals in order to maintain geographic diversity, preference to organizations in certain geographic areas, or preference to organizations who focus on minority groups.

Continued Funding

Continuation awards made after FY 2008, but within the project period, will be made on the basis of the availability of funds and the following criteria:

Protection of Human Subjects from Research Risk: When human subjects are involved, HHS/CDC will assess the available protections from research risk that relate to their participation in the proposed research [see the Research Plan, Section 2, item 8 on Human Subjects in the SF424 (R&R)] located at, http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements are available on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

Inclusion of Women and Minorities in Research:

Does the application adequately address the HHS/CDC Policy requirements regarding the inclusion of women, ethnic, and racial groups in the proposed research?  This includes: (1) The proposed plan for the inclusion of both sexes and racial and ethnic minority populations for appropriate representation; (2) The proposed justification when representation is limited or absent; (3) A statement as to whether the design of the study is adequate to measure differences when warranted; and (4) A statement as to whether the plans for recruitment and outreach for study participants include the process of establishing partnerships with community(ies) and recognition of mutual benefits (see Section 2, item 9 Inclusion or Women and Minorities of the Research Plan component of the SF424 (R&R).

Care and Use of Vertebrate Animals in Research: If applicants plan to use vertebrate animals in the project, HHS/CDC will assess the five items described under Section 2, item 12 Vertebrate Animals of the Research Plan component of the SF424 (R&R).   Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements are available on the Internet at the following address:  http://www.cdc.gov/od/pgo/funding/ARs.htm.

Biohazards: If applicants propose the applicant has proposed materials or procedures that are potentially hazardous to research personnel and/or the environment, HHS/CDC will determine if the proposed protection is adequate.

2.B. Additional Review Considerations

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

2.C. Sharing Research Data

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

3. Anticipated Announcement and Award Dates

Grantees will be notified in August by HHS/CDC’s Procurement and Grants Office (PGO) if their applications were selected for funding.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the applicant organization will receive a written critique called a “Summary Statement.”  The applicant organization and the PD/PI will be able to access the Summary Statement via the eRA Commons.

HHS/CDC will contact those applicants under consideration for funding for additional information.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the Grants Management Officer (GMO) is the authorizing document. HHS/CDC will mail and/or e-mail this document to the recipient fiscal officer identified in the application. 

Selection of the application for award is not an authorization to begin performance.  Any cost incurred before receipt of the NoA is at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about policy requirements.  For more information on the Code of Federal Regulations, see the National Archives and Records Administration at the following Internet address: http://www.access.gpo.gov/nara/cfr/cfr-table-search.html.  Additional requirements are available in Section VIII. Other Information on this document or on the CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.

The following terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a courtesy copy to the PD/PI at the time of award.
 

3. Reporting

Recipient Organization must provide HHS/CDC with an original, plus two hard copies of the following reports:

1.      Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHS/CDC website, http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.htm, no less than 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application.

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

3.      Final financial and performance reports, no more than 90 days after the end of the project period.

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

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

Section VII. Agency Contacts


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

1. Scientific/Research Contacts:

Adele M. Childress, Ph. D, M.S.P.H
Scientific Program Administrator
National Center for Injury Prevention and Control
Centers for Disease Control and Prevention (CDC)
4770 Buford Hwy, NE, Mailstop K-02
Telephone: (770) 488-4233
FAX: (770) 488-4422
Email: achildress@cdc.gov  

2. Peer Review Contacts:

Felix Rogers, Ph.D., MPH
Scientific Review Administrator
National Center for Injury Prevention and Control
Centers for Disease Control and Prevention (CDC)
4770 Buford Hwy, NE, Mailstop K-02
Atlanta, GA  30341
Telephone: (770) 488-4334
FAX: (770) 488-4422
Email: frogers@cdc.gov

3. Financial or Grants Management Contacts:

Pamela Render, Grants Management Specialist
CDC Procurement and Grants Office
2920 Brandywine Road
Atlanta, GA 30341
Telephone: 770-488-2712
FAX: 770-488-2670
E-mail: plr3@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:

Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on January 11, 2008 from 1:30 p.m. to 3:00 p.m. (Eastern Time). The conference call can be accessed by calling 1-866-704-7564, and stating the leader name: Ms. Lady Patterson, and entering the passcode: 1314492.

Participation in this conference call is not mandatory.

NCIPC Website:  For additional help in preparing your grant application please see the “frequently asked questions” section on the NCIPC webpage at:  http://www.cdc.gov/ncipc/res-opps/2004pas.htm.

Section VIII. Other Information


Required Federal Citations

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

Use of Animals in Research:
Recipients of PHS support for activated involving live, vertebrate animals must comply with PHS Policy on Humane Care and Use of Laboratory Animals (http://grants.nih.gov/grants/olaw/references/PHSPolicyLabAnimals.pdf) as mandated by the Health Research Extension Act of 1985 (http://grants.nih.gov/grants/olaw/references/hrea1985.htm), and the USDA Animal Welfare Regulations (http://www.nal.usda.gov/awic/legislat/usdaleg1.htm) as applicable.  Additional HHS/CDC Requirements under AR-3 Animal Subjects Requirements can be found at http://www.cdc.gov/od/pgo/funding/ARs.htm

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

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

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

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

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

Some projects may require Institutional Review Board (IRB) approval or a certificate of confidentiality.

Public Health System Reporting Requirements

This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based non-governmental organizations submitting health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:

A. A copy of the face page of the application (SF 424).

B. A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:

1.           A description of the population to be served.

2.           A summary of the services to be provided.

3.           A description of the coordination plans with the appropriate state and/or local health agencies.

If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.

Paperwork Reduction Act Requirements

Under the Paperwork Reduction Act, projects that involve the collection of information from 10 or more individuals and funded by a grant or a cooperative agreement will be subject to review and approval by the Office of Management and Budget (OMB).

Smoke-Free Workplace Requirements

CDC strongly encourages all recipients to provide a smoke-free workplace and to promote abstinence from all tobacco products. Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities that receive Federal funds in which education, library, day care, health care, or early childhood development services are provided to children.

Healthy People 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.

Small, Minority, And Women-owned Business

It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:

  1. Place small, minority, women-owned business firms on bidders mailing lists.
  2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
  3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
  4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.

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 organizations 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.

When required (see note below) applications must include a copy of the applicant's Data Release Plan.  Applicants should provide CDC with appropriate documentation on the reliability of the data.  Applications submitted without the required Plan may be ineligible for award.  Award will be made when reviewing officials have approved an acceptable Plan.  The successful applicant and the Program Manager will determine the documentation format.  HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality. 

National Historic Preservation Act of 1966

(Public Law 89-665, 80 Stat. 915)

The grantee’s signature on the grant application attests to their: (1) knowledge of the National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915); and (2) intent to ensure all grant related activities are in compliance with referenced public law, as stated:

a.      Section 106 of the National Historic Preservation Act (NHPA) states:

The head of any Federal agency, having direct or indirect jurisdiction over a proposed Federal or Federally assisted undertaking in any State and the head of any Federal department or independent state agency having authority to license any undertaking,  shall, prior to the approval of the expenditure of any Federal funds on the undertaking or prior to the issuance of any license, as the case may be, take into account the effect of the undertaking on any district, site, building, structure, or object that is included in or is eligible for inclusion in the National Register.  The head of any such Federal agency shall afford the Advisory Council on Historic Preservation established under Title II of this ACT a reasonable opportunity to comment with regard to such undertaking.

b.      Additionally, the NHPA also contains the following excerpt that forbids “anticipatory demolition:”

Each Federal agency shall ensure that the agency will not grant a loan, loan guarantee, permit, license, or other assistance to an applicant who, with intent to avoid the requirements of Section 106 of this Act, has intentionally, significantly, adversely affected a historic property to which the grant would relate or, having legal power to prevent it, allowed such significant adverse effect to occur, unless the agency, after consultation with the Council, determines that circumstances justify granting such assistance despite the adverse effect created or permitted by the applicant.

Conference Disclaimer and Use of Logos

Disclaimer: Where a conference is funded by a grant or cooperative agreement, a subgrant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:

“Funding for this conference was made possible [in part] by [insert grant or cooperative agreement award number] from the Centers for Disease Control and Prevention(CDC) or the Agency for Toxic Substances and Disease Registry (ATSDR) .  The views expressed in written conference materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.”

Logos: Neither the HHS nor the CDC (“CDC” includes ATSDR) logo may be displayed if such display would cause confusion as to the source of the conference or give the false appearance of Government endorsement. A non-federal entity’s unauthorized use of the HHS name or logo is governed by U.S.C. § 1320b-10, which prohibits the misuse of the HHS name and emblem in written communication. The appropriate use of the HHS logo is subject to the review and approval of the Office of the Assistant Secretary for Public Affairs (OASPA). Moreover, the Office of the Inspector General has authority to impose civil monetary penalties for violations (42 C.F.R. Part 1003).  Neither the HHS nor the CDC logo can be used on conference materials under a grant, cooperative agreement, contract or co-sponsorship agreement without the expressed, written consent of either the Project Officer or the Grants Management Officer.  It is the responsibility of the grantee (or recipient of funds under a cooperative agreement) to request consent for the use of the logo in sufficient detail to assure a complete depiction and disclosure of all uses of the Government logos, and to assure that in all cases of the use of Government logos, the written consent of either the Project Officer or the Grants Management Officer has been received.


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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