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):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
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.
Executive Order 12372 does not apply to this program.
All HHS/CDC awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.
Restrictions, which applicants must take into account while writing their budgets, are as follows:
6. Other Submission
Requirements
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
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.
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 s