Amendments to this announcement were made on 05/19/08. The amendments can be found in red.
Part I Overview Information
United States Department of Health and Human Services (HHS)
Issuing Organization
National Center for Injury Prevention and Control, Centers for Disease Control and Prevention (NCIPC/CDC) at http://www.cdc.gov/ncipc/
Title:
Grants for Injury Control Research Centers (R49)
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: This program is authorized under Section 301 (a) [42 U.S.C. 241(a)] of the Public Health Service Act, and Section 391 (a)[42 U.S.C. 280 b(a)] of the Public Health Service Act, as amended
Announcement Type: New
Instructions for Submission of Research Applications:
Due to the complexity of the information requested, applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance can not be submitted electronically through Grants.gov (http://www.grants.gov). Applications must be submitted in paper format using the PHS 398 form. The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance, contact Grants Info, Telephone (301) 435-0714, E-mail GrantsInfo@nih.gov.
HHS/CDC Telecommunications for the hearing impaired: TTY 770-488-2783.
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.
Funding Opportunity Announcement (FOA) Number: RFA CE-09-001
Catalog of Federal Domestic Assistance Number(s): 93.136, Injury Prevention and Control Research and State and Community Based Programs
Key Dates
Release/Posted Date:
Letter of Intent Receipt
Date: August 1, 2008
Application Submission Receipt Date(s): September
2,
2008
Peer Review Date(s): October 2008 - January 2009
Council Review Date(s): March - April 2009
Earliest Anticipated Start Date(s): July 31, 2009
Additional Information to Be Available Date: April 17, 2008
Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on April 17, 2008 from 1:30 p.m. to 3:30 p.m. (Eastern Time). The conference call can be accessed by calling 1-866-704-7564 and entering the passcode: 1314492.
Expiration Date: September 3, 2008
Due Date for E.O. 12372
Executive Order 12372 does not apply to this program.
Additional Overview Content
Executive Summary
Funding Opportunity Announcement Glossary: FOA Glossary Terminology
Table of Contents
Part I Overview Information
Part II Full Text of Announcement
Section I. Funding Opportunity Description
1. Research Objectives
Section II. Award Information
1. Mechanism(s) of Support
2. Funds Available
Section III. Eligibility Information
1. Eligible Applicants
A. Eligible Institutions
2. Cost Sharing or Matching
3. Other - Special
Eligibility Criteria
Section IV. Application and Submission Information
1. Request Application
Information
2. Content and Form of
Application Submission
3. Submission Dates and Times
A. Receipt and Review and
Anticipated Start Dates
1. Letter of Intent
B. Submitting an
Application to CDC
C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission
Requirements
Section V. Application Review Information
1. Criteria
2. Review and Selection
Process
A. Additional Review
Criteria
B. Additional Review
Considerations
C. Sharing Research Data
D. Sharing Research
Resources
3. Anticipated Announcement
and Award Dates
Section VI. Award Administration Information
1. Award Notices
2. Administrative and
National Policy Requirements
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 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 of injury and violence prevention and is in alignment with NCIPC’s performance goal to conduct a targeted program of research to reduce injury-related death and disability. For more information, see www.healthypeople.gov and http://intra-apps.cdc.gov/fmo/.
Purpose
The purposes of this announcement are to:
• Solicit applications from new or existing injury centers to conduct injury and/or violence prevention research and to train the next generation of injury and/or violence prevention professionals.
• Build the scientific base for the prevention and control of fatal and nonfatal injuries, violence, and related disabilities.
• Integrate, in the context of a national program, professionals from a wide spectrum of disciplines of epidemiology, behavioral and social sciences, medicine, biostatistics, public health, health economics, law, criminal justice, and engineering to perform research in order to prevent and control injuries and/or violence more effectively.
• Encourage applicants to propose research that involves intervention development and testing as well as research on methods to enhance the adoption and maintenance of effective intervention strategies among individuals, organizations, or communities.
Applications should address violence and injury reduction through research, education and training, community outreach, and the development and implementation of prevention/intervention programs that address pertinent injury and/or violence prevention and control problems in the community, state, and region where the center will be located.
Background
An injury control research center is not just a collection of research projects. It should be multidisciplinary/interdisciplinary organizations that address training and research in a cross cutting and integrated manner that will impact the field of injury and/or violence prevention and control research. Centers should strive to strengthen the injury and/or violence prevention infrastructure by integrating resources at the state, local and national levels. Centers activities should also be designed to integrate research, education, and prevention projects that address unique problems of injury and/or violence prevention in the geographic region served as well as nationally.
Research Objectives:
An injury control research center is expected to have the following components that together address the objectives of this announcement:
1. Core Activities
• Administrative Core
• Education and Outreach Core
2. Defined Research Projects
• Large Research Projects
• Small Research Projects
1. Administrative Core.
Core activities include administration, management, general support services (e.g., statistical, library, media relations, and advocacy) as well as activities associated with research development to integrate professionals from a wide spectrum of disciplines to perform research in order to prevent and control injuries and/or violence more effectively.
The administrative core must have strong leaders committed to the program, who are capable of providing scientific leadership for the administration and integration of the program. Assessment of the ability of the program’s principal investigator to lead a highly integrated program of research, prevention, intervention development and evaluation, and translation projects will be a significant consideration in the evaluation of the application.
The administrative core supports the administrative infrastructure for the entire center and should not be duplicated within any other components.
Other activities for this core include:
A. Appropriate and adequate organization and facilities for activities such as seminars, workshops, reference collection and computer support, etc.
B. Seed Projects. Support of feasibility/pilot projects in the research, prevention/intervention and translation. These projects are intended to lead to the development of new and creative research, prevention/intervention and education/translation projects, and are considered an important part of the center. Seed projects have budgets of less than $25,000 and a duration of one year or less.
2. Education and Outreach Core.
This core should include the development, implementation and evaluation of model education and intervention programs designed to prevent and control injuries and/or violence within the center’s region.
The education core should focus on injury and/or violence prevention training and research training. This training will help insure that there exists an adequate supply of qualified professionals to carry out the goals and purposes of NCIPC. The educational core is multidisciplinary/interdisciplinary in nature and should address training and research training in a cross cutting and integrated manner, and should result in cross-fertilization among the various disciplines that impact injury and/or violence prevention practice and research. The educational core should provide interdisciplinary graduate training and continuing education in the core disciplines (epidemiology, behavioral and social sciences, medicine, biostatistics, public health, health economics, law, criminal justice, and engineering) of injury and/or violence prevention research.
Outreach core activities should include collaboration, and technical assistance with institutions, businesses, community groups or agencies located within the center’s geographic region. Programs should address area needs and implement innovative strategies for meeting those needs with a focus on impacting the practitioner environment. Partnerships and collaborative relationships are encouraged. Centers should include plans to develop linkages and communication with other governmental and non-governmental bodies involved in injury and/or violence prevention and control.
A priority for the outreach core is for activities that will have a measurable impact on the environment of injury and/or violence prevention practitioners. Outreach activities that facilitate the translation of research and training products into the practitioner environment are highly encouraged.
Social marketing projects and other approaches that target important topics in injury and/or violence prevention and control at the community, regional, state, or national level are also appropriate.
3. Large Research Projects.
Large research projects focus on improving our understanding of injury and/or violence issues. They may be lab or field projects that provide the basis for creation or improvement of interventions. These projects are similar in size and scope to a R01 (investigator-initiated) grant proposal (annual budgets exceeding $150,000/year and durations of between three and five years). These projects typically will test hypotheses and employ more sophisticated methodologies and/or larger sample sizes than small studies. Large research projects should target priority topics, be part of multidisciplinary efforts to address important problems, and avoid fragmentary efforts.
One of the requirements of this FOA is that each application must have a minimum of one large research project approved by the Initial Review Group (IRG) in order for the application to be recommended for further consideration. To give each applicant a better chance of meeting this requirement, two large projects may be submitted. Both large projects will be peer reviewed and scored. However, only one large research project per applicant will be funded. The budget for the second large project will not be counted against the maximum limit of $905,500. Only the top scoring large research project will be used when calculating the overall score of the application.
4. Small Research Projects.
Small projects ($25,000-150,000/year for one to three years duration) are smaller in size and scope than large projects. These projects may be expansions of seed projects either further developing methods or hypotheses. Small projects can be stand-alone investigations sufficient to yield results worthy of publication in a peer-reviewed journal and/or a technical report for a legislative body, governmental agency, or injury control program or in preparation for a larger investigation. They may also be done in anticipation of leading to a larger study or the submission of a federal RO1 level grant application.
Additional Research Project Information
At least one of the large or small research projects must address translation research.
At least one of the large or small research projects must address primary injury and/or violence prevention research.
Note: If the translation or the primary prevention research project is the worse scoring of the two large projects, this will not eliminate the application from further consideration for funding.
Collaborations with foreign institutions are allowed if they provide injury prevention and control information relevant to important injury prevention and control problems in the United States.
Primary prevention in injury control the sum total of efforts intended to prevent the occurrence of an event with injury-producing potential. It focuses on environmental or behavioral changes that are aimed at entire populations. These interventions, programs or policies can be targeted universally or at selected or high-risk populations, but cannot be targeted at individuals who have already been injured, or in the case of violence, already engaged in the perpetration or been the victim of violence. Anti-drunk-driving legislation and its associated enforcement is an example of primary prevention and is intended to keep a motor vehicle crash caused by an intoxicated driver from ever occurring.
For the large and small research projects of this announcement, NCIPC is soliciting investigator-initiated research that will help expand and advance our understanding of fatal and nonfatal injuries and/or violence, and their related disabilities, their causes, and prevention strategies. Relevant research objectives include the following:
1. Translation Research:
The purpose of translation research is to accelerate the translation of research findings into public health practice through implementation, dissemination, and diffusion research. For the purpose of this FOA, the following terminology is defined:
• 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., seamlessly integrated into established practice and policy). In the context of this RFA, translation research does not encompass pure biomedical or formative basic science research (e.g., discovery of a new gene, metabolic pathway or etiology research). It also does not include the conduct of an initial or replication intervention efficacy or effectiveness trial. Translation Research is comprised of many complex components which include specialized fields of study. Specifically, translation research is comprised of dissemination research, implementation research and diffusion research.
• Dissemination Research is the systematic study of how the targeted distribution of information and intervention materials to a specific public health audience can be successfully executed so that increased spread of knowledge about the evidence-based public health interventions achieves greater use and impact of the intervention.
• Implementation research is the systematic study of how a specific set of activities and designed strategies are used to successfully integrate an evidence-based public health intervention within specific settings (e.g., primary care clinic, community center, school).
• Diffusion research is the systematic study of the factors necessary for successful adoption by stakeholders and the targeted population of an evidence-based intervention which results in widespread use (e.g., state or national level) and specifically includes the uptake of new practices or the penetration of broad scale recommendations through dissemination and implementation efforts, marketing, laws and regulations, systems-research and policies.
2. Intervention Evaluation Research:
Evaluate the efficacy, effectiveness, and cost effectiveness of primary prevention or control interventions, programs, and policies to prevent injuries and/or violence and related disabilities.
Rigorous evaluations are needed to determine the effectiveness of interventions, programs, and policies addressing the prevention or control of injuries and/or violence. Experimental designs are strongly encouraged. However, NCIPC will consider other evaluation designs, if justified, as required by the needs and constraints in a particular setting.
For effective interventions, it is possible to do cost-effectiveness studies. To be comparable to other cost effectiveness studies, the studies should follow the guidelines in the following references:
Gold MR, Siegel JE, Russell LB, Weinstein MC. Cost-effectiveness in Health and Medicine. New York: Oxford University Press, 1996.
Haddix AC, Teutsch SM, Corso, PS. Prevention Effectiveness: A Guide to Decision Analysis and Economic Evaluation. Second Edition. New York: Oxford University Press, 2003.
For randomized trials, applicants are encouraged to clearly state how study subjects, whether individuals or groups, were selected, randomized, and followed through the trial. One relevant useful guidance document is Moher D, Schulz KF, Altman D. The CONSORT Statement, JAMA 2001;285:1987-2001.
3. Developmental Research:
Developmental research supports the design and preliminary testing of potential strategies to prevent and control injuries and/or violence. Included are risk-factor research and pilot and feasibility studies that measure how interventions affect key variables in the causal chain.
4. Foundational Research:
Foundational research covers the basic studies and public health surveillance approaches that define and quantify the extent of an injury or violence problem. These activities establish the causes of injuries, create causal models for injury and/or violence prevention, and provide a foundation for developing theory-based interventions.
Detailed budget and justification are required for each component/research activity.
See
Section VIII, Other Information - Required Federal Citations,
for policies related to this announcement.
Section II. Award Information
1. Mechanism(s) of Support
This funding opportunity will use the R49 activity code.
2. Funds Available
The participating Centers, Institutes, and Offices (CIOs) (NCIPC) intend to commit approximately $5,400,000 in FY2009 to fund six applications. The average award amount will be $905,500. An applicant may request a project period of up to five years. An applicant may request up to $905,500 for the first 12-month budget period. An applicant may include of the description of a second large project in their application (three to five years in duration with a maximum budget of $250,000/ year). The budget for the second large project will not be counted against the maximum of limit of $905,500. However if the applicant is successful in being selected for funding; only one of the two large projects will be funded. The approximate total project period funded amount is $4,527,500 (including both direct and indirect costs), with a maximum of $905,500 per year. The anticipated start date for new awards is July 31, 2009.
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.
Use of Funds:
Center funding is to be designated for two types of activities; core activities and defined research projects.
Core activities includes administration, management, general support services (e.g., statistical, library, media relations, and advocacy) as well as activities associated with research development, technical assistance, and education (e.g., training activities, collaborative and technical assistance activities with other groups, and seed projects).
Defined research projects constitute the second type of activity. These include large and small research projects.
Core activities (administrative and education and outreach) and defined research projects (large and small projects) must each constitute between 25 percent and 75 percent of the operating budget of the center. These activities should be balanced in such a way that the center demonstrates productivity in research as well as teaching and service. Applicants with less demonstrated expertise in research may devote a larger percentage of funds to defined research projects in order to establish their capability as research centers of excellence.
Grant funds will not be made available to support the provision of direct care. Studies may be supported which evaluate methods of acute care and rehabilitation for potential reductions in injury effects and costs. Studies may be supported which identify the effect on injury outcomes and cost of systems for pre-hospital, hospital, and rehabilitative care and independent living.
Tuition remission and other forms of compensations paid as, or in lieu of, wages to students (including fellows and trainees) under research grants are allowable, provided the following conditions are met:
Eligible applicants may enter into contracts, including consortia agreements (as set forth in the PHS Grants Policy Statement, dated October 1, 2006 http://grants.nih.gov/grants/policy/policy.htm#gps), as necessary to meet the requirements of the program and strengthen the overall application.
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.
For this FOA, applicants from all ten Department of Health and Human Services (DHHS) regions are eligible to apply.
Note: ICRC grant awards are made to the applicant institution/organization, not the Principal Investigator.
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
Each applicant institution can submit only one grant application with the same principal investigator in response to this FOA. Only one application per principal investigator will be funded under this announcement.
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
1.
Request Application Information
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance, contact Grants Info, Telephone (301) 435-0714, E-mail GrantsInfo@nih.gov.
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
Applications must be prepared using the most current PHS 398 research grant application instructions and forms.
Due to the complexity of the information requested, applications submitted in response to this (FOA) must be submitted in paper format.
Applications must have a Dun & Bradstreet (D&B) Data Universal Numbering System number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/ The D&B number should be entered on line 11 of the face page of the PHS 398 form.
The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the Yes box must be checked.
Required Components:
Face Page
Abstract
Table of Content
List of all key research personnel and critical core staff and the percent effort to be devoted to activities described in the proposed program project
Detailed Budgets
Administrative core
Education and outreach core
Each large research project
Each small research project
Description of Resources and Environment.
Research Plan
Administrative core
Education and outreach core
Each large research project
Each small research project
Detailed Descriptions of Large and Small Research Projects
Optional
Components:
PHS398 Cover Letter File
Research & Related Subaward
Budget Attachment(s) Form
Abstract
It is important that the abstract (Description, PHS 398 form page 2) of your grant application reflects the overall application’s (both core and research) focus. Note: If your application is funded, your abstract will become public information.
The language of the abstract must be simple and easy to understand for a broad audience. For more information on how to write an abstract please see the “Structured Abstracts” section at: http://jama.ama-assn.org/ifora_current.dtl
Detailed Budgets
Provide a detailed budget (direct and indirect costs) and justification for the overall application for the initial budget period and for entire proposed project period. The budget should reflect the composite figures for the grant.
Separate budgets (direct and indirect costs) and justifications should be provided for the following categories of activities:
a. Administrative Core activities, including management and administrative functions,
b. Education and Outreach Core
c. Research Studies:
(1) Larger projects with annual budgets exceeding $150,000/year (total of direct and indirect costs) and lasting between three and five years.
(2) Small projects of $25,000-150,000/year (total of direct and indirect costs) for one to three years duration.
Detailed budgetary support including all sub-recipients must be provided in the form, format, and to the level of detail as indicated in the CDC Budget Guidelines. These can be located at: http://www.cdc.gov/od/pgo/funding/budgetguide.htm
An applicant organization has the option of having specific salary and fringe benefit amounts for individuals omitted from the copies of the application which are made available to outside reviewing groups. To exercise this option: on the original and two copies of the application, the applicant must use asterisks to indicate those individuals for whom salaries and fringe benefits are not shown; however, the subtotals must still be shown. In addition, the applicant must submit an additional copy of page four of Form PHS-398, completed in full, with the asterisks replaced by the salaries and fringe benefits. This budget page will be reserved for internal staff use only.
Eligible applicants may enter into contracts, including consortia agreements, as necessary to meet the requirements of the program and strengthen the overall application.
Travel expenses for two, one day work-in-progress monitoring workshops (to be held in Atlanta) should be included in the applicant’s proposed budget.
Charge back of customs and import fees are not allowed for collaborating foreign organizations
Administrative (indirect) costs cannot be requested by collaborating foreign organizations.
Note: This funding opportunity uses the non-modular budget format described in the PHS 398 application instructions. (Do not use the PHS 398 Modular Budget.)
Research Plan
The applicants are to develop a range of research and other non-research activities that are designed to advance the field of injury and/or violence prevention and control through development of new scientific or surveillance methods, creation of new knowledge, and translation of knowledge into training, program and policy development and evaluation activities or other applications that will ultimately reduce injuries and violence or their effects. ICRC applications should articulate how the activities of their program are integrated with each other.
A research plan for the center should be included, in accordance with NCIPC’s performance goal (as stated in Section I. Funding Opportunity Description, 1. Research Objectives) including hypothesis, expected outcome, value to the field, and measurable and time-framed objectives consistent with the activities for each project within the proposed grant. The focus of the research should be based on recommendations in “Healthy People 2010” (http://www.healthypeople.gov), the “CDC Injury Research Agenda” (http://www.cdc.gov/ncipc/pub-res/research_agenda.htm), and the “Acute Injury Care Research Agenda” (http://www.cdc.gov/ncipc/didop/ACRAgenda.pdf).
Include a description of the core faculty and their roles in implementing and evaluating the proposed programs. The applicant should clearly specify how disciplines will be integrated to achieve the ICRC’s objectives.
Include a description of the administrative core.
As part of the administrative core, a process for supporting feasibility/pilot/seed projects to address promising new ideas or identified eminent research needs in the prevention/intervention of injuries should be included. These projects should address one of the NCIPC’s research priority areas related to violence, unintentional injury, and/or acute care. Provide in the description of the administrative core the process for announcing the availability of feasibility/pilot/seed project funding, a mechanism for merit/peer review of proposals including the make-up of the panel (internal or external members), mechanism for determining meritorious applications and the selection of awards, maximum award amount including direct and indirect costs, description of award administration, and a clear description of the procedures to be used to select subsequent funding in out-years. Proposals for seed money should include a description of the research objective and significance, research design and analysis, expected results, timelines and plans for translation/dissemination. Also describe the mechanism that will be used to maintain a record of the entire process for the feasibility/pilot/seed project award process. This record must be available to reviewers in the event of a site visit for competing renewals.
Include a description of the training and outreach core.
Include a short description of each large and small project. The short description of each project should be included in the 75 page research plan while the detailed description of each large and small project should be included as an appendix. In the 75 page research plan section of the application, include the following for each large and small research project:
(a.) Title of Project
(b.) Project Director/Lead Investigator
(c.) Participating Institution(s)
(d.) Categorization as to which NCIPC research agenda priority area the project addresses. Also, a brief description on how it addresses that priority area. If a priority area is not addressed, provide an explanation of why it is important.
(e.) Categorization as Violence Prevention, Unintentional Injury Prevention, Acute Care, Rehabilitation, or Biomechanics
(f.) Categorization as translation, dissemination, intervention/evaluation or developmental research
(g.) Categorization as Large Research Project or Small Research Project
(h.) Categorization as New or Ongoing Project
(i.) Total Cost/Year (total of direct and indirect costs)
(j.) Research Training: Names, Degrees of Persons Trained or in Training
(k.) Key Words
(l.) Brief Summary (Abstract) of Project including Intended Application of Findings
Include charts showing the proposed organizational structure of the ICRC and its relationship to the broader institution of which it is a part and, where applicable, to affiliate institutions or collaborating organizations. These charts should clearly detail the lines of authority as they relate to the center, both structurally and operationally. ICRC Directors should report to an appropriate organizational level (e.g. Dean of a school, Vice-President of a University, or Commissioner of Health), demonstrating strong institution-wide support of ICRC activities and ensuring oversight of the process of interdisciplinary activity.
Include documentation of the public health agencies and other public and private sector entities to be involved in the proposed program, including letters that detail commitments of support and a clear statement of the role, activities, and participating personnel of each agency or entity.
Detailed Descriptions of Large and Small Research Projects
A detailed description for each large and small project should be included as a separate appendix. The detailed description for the large research projects require a summary level similar to that required for an investigator-initiated NIH an RO1 grant application. These projects typically will test hypotheses and employ more sophisticated methodologies and/or larger sample sizes than small studies. Each applicant may submit a maximum of two large research projects. Only the top scoring large research project will be used when calculating the overall peer review score.
The detailed description for each small research project requires a ten to fifteen page summary describing the accomplishment of all the steps, including a description of the significance of the project, the development and testing of methods and instruments, and the collection of preliminary data needed to take an innovative approach and develop it to the level of a larger investigation. These projects might be expansions of seed projects, either further developing methods or hypotheses in preparation for a larger investigation leading to the submission of an RO1 level (investigator-initiated) proposal, or might be stand-alone investigations sufficient to yield results worthy of publication in a peer-reviewed journal and/or a technical report for a legislative body, governmental agency, or injury control program.
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: August 1, 2008
Application Submission Receipt Date(s): September
2,
2008
Peer Review Date: October 2008 - January 2009
Council Review Date: April – March - April, 2009
Earliest Anticipated Start Date: July 31, 2009
3.A.1. Letter of Intent
Prospective applicants are asked to submit a letter of intent that includes the following information:
· Descriptive title of proposed research.
· Name, address, and telephone number of the Principal Investigator.
· Names of other key personnel.
· Participating institutions.
· Number and title of this funding opportunity
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate the potential review workload and plan the review.
The letter of intent is to be sent by the date listed in Section IV.3.A
The letter of intent should be sent by mail, fax or email to:
NCIPC Extramural Resources Team
CDC, National Center for Injury Prevention and Control
4770 Buford Hwy. NE, Mailstop F-63
Atlanta, GA 30341
FAX: (770) 488-1662
Email:
CIPERT@cdc.gov
Telephone: (770) 488-4037
3.B. Submitting an Application to CDC
If the instructions in this announcement differ in any way from the PHS 398 instructions, follow the instructions in this announcement.
The PHS 398 application instructions are available at http://grants.nih.gov/grants/funding/phs398/phs398.html in an interactive format. Applicants must use the currently approved version of the PHS 398. For further assistance, contact Grants Info, Telephone (301) 435-0714, E-mail GrantsInfo@nih.gov.
Due to the complexity of the information requested, applications must be submitted in paper format.
All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Daylight 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.
A paper application is required. It must be prepared using the PHS 398 instructions for preparing a research grant application. The application must adhere to the font and formatting requirements of the PHS 398 instructions. Submit a signed, typewritten original of the application and all appendices, including the checklist, and two signed photocopy(s) to the following address:
Technical Information Management Section – RFA CE09-001
CDC, Procurements and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA 30341
Phone: 770-488-2700 EDT
Note: Make sure that the application is sent to CDC in Atlanta, GA and not to NIH in Bethesda, MD. Applications sent to NIH in Bethesda, MD will not be reviewed.
3.C. Application Processing
HHS/CDC must receive applications
on or before 5:00 P.M. Eastern
Daylight 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.
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 no
acknowledgement of
receipt of applications from Grants.gov and the eRA
Commons.
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.
4. Intergovernmental Review
Executive Order 12372 does not apply to this program.
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.
http://www.hhs.gov/grantsnet/adminis/gpd/
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.
Applicants’ research plan(s) should address activities they will conduct over the entire project period.
Research Plan Component Sections
The research plan section of your application must not exceed 75 pages. If your research plan exceeds the page limitation, your application may be considered unresponsive and ineligible for review.
Appendices
The following materials may be included in the Appendices:
· Publications in press: Include only a publication list with a link to the publicly available on-line journal article or the NIH Pub Med Central (PMC) submission identification number. Do not include the entire article.
· Manuscripts accepted for publication but not yet published:
· Manuscripts published but a publicly available online journal link is not available:
Do not use the Appendix to circumvent the page limitations of the Research Plan component. The purpose of appendices is for items that are either too large to fit into the main body of the application or would detract from the flow of the application narrative. Remember anything listed in an appendix should be referenced in the main body of the application.
Plan for Sharing Research Data
Not applicable. Only proposals submitted to NCIPC for individual research projects of $500,000 or more in total (direct and indirect) costs per year require the applicant to include a data-sharing plan. Because this is not an individual research project a data sharing plan is not required.
Sharing Research Resources
Not applicable.
Section V. Application Review Information
1. Criteria
Only the review criteria described below will be considered
in the review process.
The following will be considered in making funding
decisions:
2.
Review and Selection Process
Upon receipt at CDC, each application will be reviewed to insure that it addresses the following items:
• The Director must report to an appropriate institutional official, e.g., Dean of a school, Vice-President of a University, or Commissioner of Health. This must be documented by providing a letter from the institutional official or by providing an organization chart .
• The director must have no less than thirty percent effort devoted solely to this project.
• The director must have conducted injury and/or violence prevention research and published the findings in a peer-reviewed journal. This must be documented by listing the relevant publication(s) under the “Selected peer-reviewed publications” section of the principal investigator’s Biographical Sketch page in the application.
• Applications must demonstrate effective and well defined working relationships within the performing organization and with outside entities which will ensure implementation of the proposed activities, as evidenced by letters of support from the relevant participating organizations. Place these letters in the appendix of the application.
Applications that do not address the items listed above will not be entered into the peer review process.
Peer Review
Applications that are complete
and responsive to the FOA 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, reviewers will be asked to 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.
The primary review will be a peer review conducted by NCIPC’s IRG. The 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 overall score of the application will be a composite of the priority scores assigned to the different parts of the application by the IRG during peer review. The scoring will be weighted as follows; administrative core = 25%, training and outreach core = 25%, highest scoring large project = 25%, and small projects = 25%,
Factors to be considered during the detailed review include:
REVIEW CRITERIA FOR THE OVERALL APPLICATION
Significance: What is the potential impact of the center in addressing local, regional, and national health needs related to injury and/or violence prevention and control? Does the creation or continuation of a particular center push forward the field of injury and/or violence prevention and control, and is it a driving resource to the region?
Approach: Have the investigators adequately established the feasibility of meeting the proposed goals of the application? Are the key stakeholders involved? Do the proposed center activities adequately address the distinct characteristics, specific populations, and needs of the geographic region in which the center resides? Is the scope of the center activities multidisciplinary? Are there appropriate administrative arrangements and facilities to stimulate collaboration among constituent projects and personnel? Are there adequate connections among the proposed research, intervention, and education projects, involving topical and collaborative relationships, to build a synergistic overall program? Is the proposed center more than the sum of its parts, not just a collection of research projects? What are the long term goals of the center? Are they appropriate?
Innovation: What is the degree of innovation of the proposed center activities? To what extent are novel administrative models, research methods, research topics, or potentially synergistic project relationships proposed that may enhance the potential of the field of injury and/or violence prevention and control?
Investigators: Are the investigators appropriately trained and well suited to carry out this work? Are the core investigators adequately qualified to plan and conduct research and administer a national center for injury prevention and control? Does the center director have adequate leadership ability, scientific stature, and commitment of time to adequately manage such a center? Does the center director report to an appropriate institutional official, e.g., Dean of a school, Vice-President of a University, or Commissioner of Health? Has the center director committed at least thirty percent effort devoted solely to this project? Has the center director conducted injury and/or violence prevention research and published the findings in a peer-reviewed journal? Has the applicant team demonstrated expertise and experience in conducting and publishing primary prevention injury and/or violence research? Is there evidence of involvement of specialists or experts in medicine, biomechanics and other engineering, epidemiology, law and criminal justice, behavioral and social sciences, biostatistics, and public health in the proposed research? Does the applicant team have experience in disseminating injury control research findings, translating them into interventions (i.e., programs or policies), and evaluating their effectiveness?
Environment: Does the scientific and institutional 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 strong Institutional commitment to the proposed center? Is there document evidence of ongoing injury control-related research projects and activities currently supported by other sources of funding? Does the proposed center have established curricula and graduate training programs in disciplines relevant to injury prevention and control?
Adequacy of an Interdisciplinary Coordination Plan: Does the applicant describe an appropriate plan for ensuring and enhancing interdisciplinary coordination among the research, intervention, and education projects? Does the applicant provide evidence of past success in interdisciplinary coordination?
ADDITIONAL REVIEW CRITERIA FOR THE ADMINISTRATIVE CORE
Adequacy of the Administrative Core: Are there adequate overall plans for administration and management of the ICRC to support all facets of the operation of the center? Is the center director adequately supported and is there adequate management depth to provide long-term continuity of center leadership? Does the administrative structure facilitate communication among the center leaders and the program directors? Are the plans for day-to-day management, allocation of funds and cooperative arrangements designed to effectively achieve the goals of an ICRC?
Advancing the Injury Field: In addition to conducting defined research projects, ICRCs are expected to devote substantial attention to advancing the field through other activities that are designed to improve research capabilities and translate research into practice. Examples of activities include: consultation and technical assistance that are responsive to local, regional, State, national, or international priorities; professional training for researchers and practitioners; program development; and evaluation endeavors. The degree of effort devoted to these aspects of the ICRCs program should be clearly stated in the justification and the budget. The degree of effort may be varied and should reflect the specific focus and goals of the ICRC.
Adequacy of Seed Research Projects Program: Are the goals for the program well described? Is the plan to conduct the seed research projects program adequate? This includes the adequacy of procedures for reviewing and funding projects, the scientific review mechanism, and program quality assurance. Does the applicant encourage participation by other investigators interested in injury and/or violence prevention and control either within the institution or regional institutions? Is there a mechanism for tracking the results of each Pilot/Small Project study (abstract, RO1 submission, dissertation, etc.)?
ADDITIONAL REVIEW CRITERIA FOR THE TRAINING AND OUTREACH PROGRAMS
Significance: What is the potential impact of the program in meeting the local, regional and national needs for injury and/or violence prevention? What is the potential of the outreach component to implement effective interventions and to train injury and/or violence prevention professionals?
Approach: Is the curriculum content and design, the formal training objectives, and the plans to meet the professional needs adequate to meet the training objectives of the center? Is the course content adequate to achieve the proposed degree? Are the courses, course sequence, time devoted to lecture, laboratory, and field experience, and the nature of specific field and clinical experiences including their relationships with didactic programs consistent with a high quality, innovative program? How well does this program integrate with and complement other academic programs in the parent institution? Is there adequate consideration of requirements for information dissemination and special training needs that may be peculiar to the region?
Innovation: Does the academic program involve new and innovative approaches to training and education relevant to the injury and/or violence prevention and control field?
Training Staff: The qualifications of the director and faculty in delivering academic and/or short course training in the proposed field. For doctoral and post-doctoral training programs, the accomplishments of the teaching staff and mentors as research investigators in injury and/or violence prevention and control as evidenced by peer-reviewed publications and research grant support.
Environment: Quality, sufficiency, and multidisciplinary character of the training and research environment, evidence of an Institutional commitment to the program goals, the relationship of this program to the broader ICRC program, and a record of success in obtaining outside support to supplement the academic program such as other federal grants, support from states and other public agencies, and support from the private sector.
Adequacy of the Outreach Plan: Does the program adequately describe activities that will impact the practitioner, or other agencies and institutions located within the center’s geographic area? Does the program facilitate the translation of injury and/or violence prevention findings into practice? Are appropriate injury prevention constituents engaged in the program? Will the proposed activities have an impact on the practitioner or ability to affect injury prevention and control?
ADDITIONAL REVIEW CRITERIA FOR THE LARGE AND SMALL RESEARCH PROJECTS
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 project include plans to measure progress
toward achieving the stated objectives? Is there an
appropriate work plan included? 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?
Is
there an appropriate degree of commitment and cooperation by
other interested parties as evidenced by letters of support
detailing the nature and extent of their involvement?
At least one of the large or small research projects must address translation research.
At least one of the large or small research projects must address primary injury and/or violence prevention research.
All large and small research projects (including new research projects proposed during the five-year funding cycle), in accordance with NCIPC’s performance goal are subject to peer review.
The budget request is clearly explained, adequately justified, reasonable and consistent with the intended use of grant funds.
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:
Dissemination: What plans have been articulated for disseminating findings?
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 E on Human Subjects in the PHS Form 398). 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.
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 F of the PHS Form 398 research grant application instructions will be assessed. Additional CDC Requirements under AR-3 Animal Subjects Requirements can be found on 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
Not applicable. Only proposals submitted to NCIPC for individual research projects of $500,000 or more in total (direct and indirect) costs per year require the applicant to include a data-sharing plan. Because this is not an individual research project a data sharing plan is not required.
2.D. Sharing Research Resources
Not applicable.
3. Anticipated Announcement
and Award Dates
Grantees will be notified in July 2009 by HHS/CDC’s
Procurement and Grants Office (PGO) if their applications
were selected for funding.
Section VI. Award Administration Information
1.
Award Notices
After the peer review of the
application is completed, the applicant organization will
receive a written critique called a “Summary Statement.”
The applicant organization and the PD/PI will be able to
access the Summary Statement via the eRA Commons.
HHS/CDC will contact those
applicants under consideration for funding for additional
information.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the Grants Management Officer (GMO) is the authorizing document. HHS/CDC will mail and/or e-mail this document to the recipient fiscal officer identified in the application.
Selection of the application for award is not an authorization to begin performance. Any cost incurred before receipt of the NoA is at the recipient’s risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See also Section IV.5. Funding Restrictions.
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. Interim 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.
Final financial report, no more than 90 days after the end of the project period.
3. At the completion of the project, the grant recipient will submit a final report and a summary of the research written in non-scientific [laymen’s] terms. The summary should be concise and include a statement of progress toward the achievement of the originally stated goals, a list of the results considered significant (whether positive or negative), and the implication of the results for injury prevention programs, policies, environmental changes, etc. The grant recipient will also include a description of the dissemination plan for research findings. This plan will include publications in peer-reviewed journals and ways in which research findings will be made available to stakeholders outside of academia (e.g., state injury prevention program staff, community groups, public health injury prevention practitioners, and others). CDC will place the summary report and each grant recipient’s final report with the National Technical Information Service (NTIS) to further the agency’s efforts to make the information more available and accessible to the public.
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:
Paul Smutz, PhD,
Scientific Review Administrator
National Center for Injury Prevention and Control
Centers for Disease Control and Prevention (CDC)
U.S. Department of Health and Human Services
4770 Buford Hwy, NE, Mailstop F-62
Atlanta, GA 30341
Telephone: (770) 488-1508
FAX: (770) 488-1665
Email: wsmutz@cdc.gov
2. Peer Review Contacts:
J Felix Rogers, PhD, MPH
Scientific Review Administrator
National Center for Injury Prevention and Control
Centers for Disease Control and Prevention (CDC)
U.S. Department of Health and Human Services
4770 Buford Hwy, NE, Mailstop F-62
Atlanta, GA 30341
Telephone: (770) 488-4334
FAX: (770) 488-1665
Email: fxr3@cdc.gov
3. Financial or Grants
Management Contacts:
Tracey Coleman
Grants Management Specialist
Procurement and Grants Office
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services
2920 Brandywine Road, MS-K-70
Atlanta, GA 30341
Telephone: (770) 488-2074
FAX: (770) 488-2670
Email:
apf4@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 April 17, 2008 from 1:30 p.m. to 3:30 p.m. (Eastern Time). The conference call can be accessed by calling 1-866-704-7564 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.
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).
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 FOA is related to one or more
of the priority areas. Potential applicants may obtain a
copy of "Healthy People 2010" at
www.healthypeople.gov.
Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.
In addition no part of CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.
Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.
The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation
It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.
Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.
Prohibition on Use of CDC Funds for Certain Gun Control Activities
The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."
Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.
In addition to the restrictions in the Anti-Lobbying Act, HHS/CDC interprets the language in the HHS/CDC's Appropriations Act to mean that HHS/CDC's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.
Accounting System Requirements
The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.
Capability Assessment
It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.
Proof of Non-profit Status
Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.
Small, Minority, And
Women-owned Business
It is a national policy to place a fair share of purchases with small, minority and women-owned business firms. The Department of Health and Human Services is strongly committed to the objective of this policy and encourages all recipients of its grants and cooperative agreements to take affirmative steps to ensure such fairness. In particular, recipients should:
Research Integrity
The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.
The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity (ORI) (http://ori.hhs.gov./policies/statutes.shtml).
For example:
Section 93.301 Institutional assurances. (a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.
Compliance with Executive Order 13279
Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations. All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS. If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance. A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above. A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols. In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization=s name, select its board members on a religious basis, and include religious references in its organization=s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities. For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site:
http://www.whitehouse.gov/government/fbci/
Health Insurance Portability and Accountability Act Requirements
Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions. The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency. HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.
Release and Sharing of Data
The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the CDC data sharing agreement will be released as follows:
When required (see note below) applications must include a copy of the applicant's Data Release Plan. Applicants should provide CDC with appropriate documentation on the reliability of the data. Applications submitted without the required Plan may be ineligible for award. Award will be made when reviewing officials have approved an acceptable Plan. The successful applicant and the Program Manager will determine the documentation format. HHS/CDC recommends data is released in the form closest to micro data and one that will preserve confidentiality.
Note: Only proposals submitted to NCIPC for individual research projects of $500,000 or more in total (direct and indirect) costs per year require the applicant to include a data-sharing plan. Because the ceiling for this FOA is below $500,000, a data sharing plan is not required.
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, and 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.
CDC Home Page: http://www.cdc.gov
CDC Funding Web Page: http://www.cdc.gov/od/pgo/funding/FOAs.htm
CDC Forms Web Page:
http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm