Part I Overview Information

 

United States Department of Health and Human Services (HHS)

 

Issuing Organization

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


 Participating Organizations

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


Components of Participating Organizations

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

 

Title: Grants for Traumatic Injury Biomechanics Research (R01)


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 Service Act, as amended.

 

Announcement Type: New

Instructions for Submission of Electronic Research Applications:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance may 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 highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Required for on time submission:

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.)

 

Note: CDC also encourages all applicants to register in the Electronic Research Administration (eRA Commons). Although an eRA Commons account is not mandatory for applications in response to this FOA, future FOAs may require your participation in eRA Commons to complete an electronic application submission through Grants.gov. Please visit: NIH eRA Commons to learn more about the features of eRA Commons and begin your registration process as early as possible.

Funding Opportunity Announcement (FOA) Number: CDC- RFA-CE07-006

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

 

Key Dates


Release/Posted Date:

Letter of Intent Receipt Date: January 19, 2007

Application Submission Receipt Date: February 21, 2007

Peer Review Date: May, 2007

Council Review Date: July, 2007

Earliest Anticipated Start Date: September, 2007

Additional Information To Be Available Date: November 14, 2006

Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on November 14, 2006 from 1:30 p.m. to 3:30 p.m. (Eastern Time). The conference call can be accessed by calling 1-866-662-4806, entering the passcode: 5488061, and stating the leader name: Lady Patterson.

Expiration Date: February 22, 2007


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
        B. Eligible Individuals
    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)

    5. Special Guidelines for Technical Assistance

  
Section VIII. Other Information - Required Federal Citations


 Part II - Full Text of Announcement

 

Section I. Funding Opportunity Description

 

1. Research Objectives

 

The National Center for Injury Prevention and Control (NCIPC) of CDC within HHS is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010" and to measuring program performance as stipulated by the Government Performance and Review Act (GPRA). This FOA addresses “Healthy People 2010” priority area(s) of injury and violence prevention and control and is in alignment with NCIPC performance goal(s) to conduct a targeted program of research to reduce injury related disability.

 

For more information, see www.health.gov/healthypeople  and www.whitehouse.gov/omb/mgmt-gpra/.

 

The purposes of the NCIPC extramural research program are to:

 

 

Research Objectives

 

NCIPC is soliciting investigator-initiated research that will help expand and advance our understanding of non-occupational injuries and how to minimize the consequences of injuries when they do occur. The following research themes are the focus of this solicitation: (Applications that fail to address one of these research objectives will be considered non-responsive.)

 

1.  Use biomechanics research and the knowledge of injury tolerance and injury mechanisms to develop and/or evaluate interventions that address the following specific injury prevention and control problems. An intervention can be broadly defined as a specific action, policy, device or strategy designed to address injury prevention and control:

  a. Falls that occur among children or older adults.

  b. Sports, recreation, and exercise-related injuries (e.g. playground and other play

       environments, safety gear).

  c. Motorcycling, bicycling and pedestrian injuries (e.g. improved helmets or

       environments).

  d. Injuries to child or older adult occupants of motor vehicles.

 

2.  Define the human tolerance limits for injury in children (0 to 18 years old) and/or older adults (greater than 65 years old), especially determining the differences in human tolerance by age and gender and the biomechanics and injury tolerances of tissue, bone, and other human structures as a prerequisite for developing interventions.

 

3.  Advance the biomechanical understanding of traumatic injury in children (0 to 18 years old) and/or older adults (greater than 65 years old) including: development of biofidelic models to elucidate injury physiology, impact injury mechanisms research, and quantification of injury-related biomechanical responses for critical areas of the human body (e.g. brain and vertebral injury with spinal cord involvement).    

 

NCIPC has particular interest in research objective 1 and will give special priority to this objective in the secondary review phase.

 

Injury is defined as physical damage to an individual that occurs over a short period of time as a result of acute exposure to one of the forms of physical energy in the environment, to chemical agents, or the acute lack of oxygen. Excluded from this definition of injury are cumulative trauma disorders, musculoskeletal disorders of the back not caused by acute trauma, effects of repeated exposure to chemical or physical agents, and injuries occurring as a result of medical procedures. The major categories of injury are intentional, unintentional, and occupational. Research involving occupational injuries will not be considered for this announcement. Intentional injuries result from interpersonal or self-inflicted violence, and include homicide, assaults, suicide and suicide attempts, child abuse and neglect (includes child sexual abuse), intimate partner violence, elder abuse, and sexual assault. Unintentional injuries include those that result from motor vehicle collisions, falls, fires, poisonings, drownings, recreational, and sports-related activities. Occupational injuries occur at the worksite and include unintentional trauma (for example, work-related motor—vehicle injuries, drownings, and electrocutions), and intentional injuries in the workplace.

 

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 grant activity code.

2. Funds Available

The participating Centers, Institutes and Offices (CIO)(s) NCIPC intends to commit approximately $1,000,000 (including both direct and indirect costs) in FY2007 to fund three applications. The average award amount will be between $250,000 and $300,000 (including both direct and indirect costs). An applicant may request a project period of up to three years. An applicant may request up to $300,000 (including both direct and indirect costs) for the first 12-month budget period. The approximate total project period funded amount is $900,000 (including both direct and indirect costs), with a maximum of $300,000 per year. The anticipated start date for new awards is September, 2007.

Note: All Facilities and Administrative (F&A) costs, including those requested by consortium participants count as part of the $300,000 first year maximum and the three year $900,000 maximum.

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.

 

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.

 

Although the financial plans of NCIPC 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.

 

This FOA is a one-time solicitation.

 

Consideration will also be given to current NCIPC R01 biomechanics grantees who submit a competitive supplement application requesting one year of funding to enhance or expand existing projects, or to conduct one-year pilot studies.  These awards will not exceed $150,000, including both direct and indirect costs. Supplemental awards will be made for the budget period to coincide with the actual budget period of the grant and are based on the availability of funds. The competitive supplement application must address one of the research objectives listed in this FOA.

 

Continued Funding

 

Continuation awards made after FY 2007, but within the project period, will be made on the basis of the availability of funds and the following criteria:

·         The accomplishments reflected in the progress report of the continuation application indicate that the applicant is meeting previously stated objectives or milestones contained in the project’s annual work plan and satisfactory progress is being demonstrated through presentations at work-in-progress monitoring workshops (travel expenses for this annual one-day meeting should be included in the applicant’s proposed budget).

·         The objectives for the new budget period are realistic, specific, and measurable.

·         The methods described will clearly lead to achievement of these objectives.

·         The evaluation plan will allow management to monitor whether the methods are effective.

The budget request is clearly explained, adequately justified, reasonable and consistent with the intended use of grant funds.


 Section III. Eligibility Information

 

1. Eligible Applicants

1.A. Eligible Institutions

 

You may submit an application(s) 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. 


1.B. Eligible Investigators


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

 

To be considered responsive to this FOA, the Principal Investigator must have conducted biomechanical injury prevention and/or control research and published the findings in a peer-reviewed journal.  This must be documented by listing the relevant publication(s) under section B “Selected peer-reviewed publications” of the Principal Investigator’s Biographical Sketch page in the application. Applications from Principal Investigators who do not meet these requirements will be considered non-responsive and will not be reviewed.

 

2. Cost Sharing or Matching

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

 

3. Other-Special Eligibility Criteria

 Grant applications must demonstrate an overall match between the applicant's proposed project theme and research objectives and the program priorities as described under the heading, “Research Objectives.”

 The following is the responsiveness criteria if the applicant is addressing research priority 1 (Development and/or evaluation of interventions).  In the “Research Plan” section of their application the applicant must document that; 1) the proposed research uses biomechanical principles to develop and/or evaluate a intervention, 2) the intervention to be developed and/or evaluated focuses on child or adult falls, sports, recreation, or exercise-related injuries, motorcycling, bicycling or pedestrian injuries, or child or older adult motor vehicle injuries.

The following is the responsiveness criteria if the applicant is addressing research priority 2 (Human injury tolerance limits in children or older adults).  In the “Research Plan” section of their application the applicant must document that the proposed research addresses the injury tolerances of tissue, bone, and/or other human structures as they relate to either children (0 to 18 years old) or older adults (greater than 65 years old).

 

The following is the responsiveness criteria if the applicant is addressing research priority 3 (Understanding traumatic injury in children or older adults).  In the “Research Plan” section of their application the applicant must document that; 1) the proposed research advances the biomechanical understanding of traumatic injury in humans, 2) the focus of the research is either children (0 to 18 years old) or older adults (greater than 65 years old).

 

Evidence that the principal investigator has conducted biomechanical injury prevention and/or control research and published the findings in a peer-reviewed journal must be documented by listing the relevant publication(s) under section B “Selected peer-reviewed publications” 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 all relevant participating organizations. Place these letters in the appendix of your application.

 

Principal Investigators are encouraged to submit only one grant application in response to this FOA.  With few exceptions, 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

To download a SF424 (R&R) Application Package and SF424 (R&R) Application Instructions for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

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

·         Grants.gov, http://www.grants.gov/GetStarted

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

·         eRA Commons Registration, Electronic Submission of Grant Applications

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

Several additional actions are required before an applicant institution/organization can submit an electronic application:

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

2) Organizational/Institutional Registration in the eRA Commons

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 on-line, you may contact the CDC Procurement and Grants Office Technical Information Management Section (PGO-TIM) staff. For this, or further assistance, contact PGO TIMS: Telephone (770) 488-2700, Email: PGOTIM@cdc.gov.

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

2. Content and Form of Application Submission

 

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

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to HHS/CDC.

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

Required Components:

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

Optional Components:

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

Note: While both budget components are included in the SF424 (R&R) forms package, the CDC R01 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)

 Project Summary/Abstract

 It is especially important that the project summary/abstract of your grant application reflects the project’s focus, because it will be used to help determine the responsiveness of the application.  The following instructions supersede those provide in the SF424 instructions.  If your application is funded, your project summary/abstract will become public information.

 The project summary/abstract should contain the following sections:

 •           Importance                  (One or two sentences explaining the importance of the

                                                   study question)

•           Objectives                   (Include specific aims and hypotheses)

•           Study Design

•           Setting

•           Participants                 (Include the number of participants and how they will be                                                           selected)

•           Interventions                (Explain the essential features of any interventions)

•           Outcome Measures

 

The language of the project summary/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

 Research Plan

 You must include a research plan in your application. The research plan should address activities to be conducted over the entire project period. The research plan should include the following information:

 

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 19, 2007

Application Submission Receipt Date(s): February 21, 2007
Peer Review Date: May, 2007
Council Review Date: July, 2007
Earliest Anticipated Start Date: September, 2007


3.A.1. Letter of Intent

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

·         Descriptive title of proposed research.

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

·         Names of other key personnel.

·         Participating institutions.

·         Number and title of this funding opportunity

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

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

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

 NCIPC Extramural Resources Team

CDC, National Center for Injury Prevention and Control

Address for Express Mail or Delivery Service:

2945 Flowers Rd.

Yale Building, Room 2054

Atlanta, GA  30341

Address for U.S. Postal Service Mail:

4770 Buford Hwy., NE, Mailstop K-62

Atlanta, GA 30341

Telephone: (770) 488-4037
FAX: (770) 488-1662
Email: CIPERT@cdc.gov

 3.B. Submitting an Application to CDC

 

If the instructions in this announcement differ in any way from the 424 R&R instructions, follow the instructions in this announcement.

 

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov.  Applicants will receive an e-mail notice of receipt from 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-CE07-006

CDC, Procurements and Grants Office

2920 Brandywine Road

Atlanta, GA  30341

 

Note: If you are submitting a paper application, 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 Standard Time on the application submission date(s) described above (Section IV.3.A.). If HHS/CDC receives an application after that submission date and time, the application may be delayed in the review process or not reviewed.

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

 Upon receipt, applications will be evaluated for completeness and responsiveness by NCIPC and HHS/CDC Procurement and Grants Office (PGO). HHS/CDC will not review incomplete and non-responsive applications.

 For electronic submissions, there will be an acknowledgement of receipt of applications from Grants.gov. 

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

 5. Funding Restrictions


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

 

Additional guidance can be found at HHS/NIH Grants Policy Statement.

 

Restrictions, which must be taken into account while writing your budget, 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.

 Research Plan Component Sections

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

 

The following materials may be included in the Appendix:

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

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

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

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

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

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

Do not to 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

All applicants must include a plan for sharing research data in their application. The HHS/CDC 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.
 

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 $300,000, a data sharing plan is not required.

 Sharing Research Resources

 Not applicable.

 Section V. Application Review Information

 1. Criteria

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


 The following will be considered in making funding decisions:

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

·         Availability of funds

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

2. Review and Selection Process

Applications that are complete and responsive to the 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 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 and weighted, as appropriate for each applications. 

 

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


Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?  Does the project include plans to measure progress toward achieving the stated objectives?  Is there an appropriate work plan included?

 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)? Is there a prior history by the principal investigator of conducting violence prevention research?

Environment: Does the scientific environment in which the applicant will do the work 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 of other interested parties as evidenced by letters of support detailing the nature and extent of the involvement?

 Application Review

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

 The secondary review will be conducted by the Science and Program Review Subcommittee (SPRS) of the Advisory Committee for Injury Prevention and Control (ACIPC).  The ACIPC Federal agency experts will be invited to attend the secondary review and will receive modified briefing books (i.e., abstracts, strengths and weaknesses from summary statements, and project officer’s briefing materials).  ACIPC Federal agency experts will be encouraged to participate in deliberations when applications address overlapping areas of research interest, so that unwarranted duplication in federally-funded research can be avoided and special subject area expertise can be shared.  The NCIPC Division Associate Directors for Science (ADS) or their designees will attend the secondary review in a similar capacity as the ACIPC Federal agency experts to assure that research priorities of the announcement are understood and to provide background regarding current research activities.  Only SPRS members will vote on funding recommendations, and their recommendations will be carried to the entire ACIPC for voting by the ACIPC members in closed session.  If any further review is needed by the ACIPC, regarding the recommendations of the SPRS, the factors considered will be the same as those considered by the SPRS.

 

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

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

·         The relevance and balance of proposed research relative to the NCIPC programs and priorities.

·         Budgetary considerations.

All awards will be determined by the Director of the NCIPC based on priority scores assigned to applications by the primary review committee IRG, recommendations by the secondary review committee of the Science and Program Review Subcommittee of the ACIPC, consultation with NCIPC senior staff, and the availability of 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: 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)] 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 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.

 Note.  A data sharing plan is required by NCIPC only for applications requesting total (direct and indirect) costs of $500,000 or more per year.  Because the ceiling for this FOA is $300,000, 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 September of 2007 by CDC’s Procurement and Grants Office (PGO) if their applications were funded.

 

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”. 

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.  This document will be mailed and/or emailed 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 of this document or on the CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.

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

 2.A. Cooperative Agreement

Not Applicable

 
 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 HHSCDC 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.      Yearly outcome report summarizing the results, including publications, and impact resulting from the research.  An outcome report form will be sent by NCIPC to the grantees. The outcome report will be due at the same time as the Interim/Grant Progress Report.

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

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

5.      At the completion of the project, the grant recipient will submit a final yearly outcome 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 NoA.

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, Ph.D
Project Officer

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 K-02

Atlanta, GA  30341

Telephone: (770) 488-1508
FAX: (770) 488-4422
Email: wsmutz@cdc.gov

2. Peer Review Contacts:

 Gwendolyn Cattledge, Ph.D.

Scientific Review Administrator

National Center for Injury Prevention and Control

Centers for Disease Control and Prevention (CDC)

U.S. Department of Health and Human Services

4770 Buford Hwy, NE, Mailstop K-02

Atlanta, GA  30341

Telephone: (770) 488-1430

FAX: (770) 488-4422

Email: gxc8@cdc.gov


3. Financial or Grants Management Contacts:

 

Gary Teague, MBA, CPA

Grants Management Officer

Procurement and Grants Office

Acquisition and Assistance Branch IV

Centers for Disease Control and Prevention (CDC)

U.S. Department of Health and Human Services

2920 Brandywine Road, Room 3225, Mailstop K-70

Atlanta, GA  30341

Telephone: (770) 488-1981

FAX:  (770) 488-2670

Email: GTeague@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:

 

Conference Call: Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on November 14, 2006 from 1:30 p.m. to 3:30 p.m. (Eastern Time). The conference call can be accessed by calling 1-866-662-4806, entering the passcode: 5488061, and stating the leader name: Lady Patterson.

 

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 (45CFR46) 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 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).

 

Smoke-Free Workplace Requirements

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

 

Healthy People 2010

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

 

Lobbying Restrictions

Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

 

In addition no part of CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

 

Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.

 

The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation

 

It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.

 

Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent CDC funds from being used to influence or promote pending legislation. With respect to conferences, public events, publications, and "grassroots" activities that relate to specific legislation, recipients of HHS/CDC funds should give close attention to isolating and separating the appropriate use of HHS/CDC funds from non-CDC funds. HHS/CDC also cautions recipients of HHS/CDC funds to be careful not to give the appearance that HHS/CDC funds are being used to carry out activities in a manner that is prohibited under Federal law.

 

Prohibition on Use of CDC Funds for Certain Gun Control Activities

The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act specifies that: "None of the funds made available for injury prevention and control at the Centers for Disease Control and Prevention may be used to advocate or promote gun control."

 

Anti-Lobbying Act requirements prohibit lobbying Congress with appropriated Federal monies. Specifically, this Act prohibits the use of Federal funds for direct or indirect communications intended or designed to influence a member of Congress with regard to specific Federal legislation. This prohibition includes the funding and assistance of public grassroots campaigns intended or designed to influence members of Congress with regard to specific legislation or appropriation by Congress.

 

In addition to the restrictions in the Anti-Lobbying Act, HHS/CDC interprets the language in the HHS/CDC's Appropriations Act to mean that HHS/CDC's funds may not be spent on political action or other activities designed to affect the passage of specific Federal, State, or local legislation intended to restrict or control the purchase or use of firearms.

 

Accounting System Requirements

The services of a certified public accountant licensed by the State Board of Accountancy or the equivalent must be retained throughout the project as a part of the recipient's staff or as a consultant to the recipient's accounting personnel. These services may include the design, implementation, and maintenance of an accounting system that will record receipts and expenditures of Federal funds in accordance with accounting principles, Federal regulations, and terms of the cooperative agreement or grant.

 

Capability Assessment

It may be necessary to conduct an on-site evaluation of some applicant organization's financial management capabilities prior to or immediately following the award of the grant or cooperative agreement. Independent audit statements from a Certified Public Accountant (CPA) for the preceding two fiscal years may also be required.


Proof of Non-profit Status

Proof of nonprofit status must be submitted by private nonprofit organizations with the application. Any of the following is acceptable evidence of nonprofit status: (a) a reference to the applicant organization's listing in the Internal Revenue Service's (IRS) most recent list of tax-exempt organizations described in section 501(c)(3) of the IRS Code; (b) a copy of a currently valid IRS tax exemption certificate; (c) a statement from a State taxing body, State Attorney General, or other appropriate State Official certifying that the applicant organization has a nonprofit status and that none of the net earnings accrue to any private shareholders or individuals; (d) a certified copy of the organization's certificate of incorporation or similar document that clearly establishes nonprofit status; (e) any of the above proof for a State or national parent organization and a statement signed by the parent organization that the applicant organization is a local nonprofit affiliate.


Small, Minority, And Women-owned Business

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

  1. Place small, minority, women-owned business firms on bidders’ mailing lists.

  2. Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.

  3. Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.

  4. Use the assistance of the Minority Business Development Agency of the Department of Commerce, the Office of Small and Disadvantaged Business Utilization, DHHS, and similar state and local offices.

 

Research Integrity

The signature of the institution official on the face page of the application submitted under this Funding Opportunity Announcement is certifying compliance with the Department of Health and Human Services (DHHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

 

The regulation places requirements on institutions receiving or applying for funds under the PHS Act that are monitored by the DHHS Office of Research Integrity's (ORI) (http://ori.hhs.gov./policies/statutes.shtml).

 

For example:

Section 93.301 Institutional assurances.(a) General policy. An institution with PHS supported biomedical or behavioral research, research training or activities related to that research or research training must provide PHS with an assurance of compliance with this part, satisfactory to the Secretary. PHS funding components may authorize [[Page 28389]] funds for biomedical and behavioral research, research training, or activities related to that research or research training only to institutions that have approved assurances and required renewals on file with ORI. (b) Institutional Assurance. The responsible institutional official must assure on behalf of the institution that the institution-- (1) Has written policies and procedures in compliance with this part for inquiring into and investigating allegations of research misconduct; and (2) Complies with its own policies and procedures and the requirements of this part.

 

Compliance with Executive Order 13279

Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations.  All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS.  If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance.  A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above.  A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols.  In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization’s name, select its board members on a religious basis, and include religious references in its organization’s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities.  For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site:

http://www.whitehouse.gov/government/fbci/

 

Health Insurance Portability and Accountability Act Requirements

Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions.  The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency.  HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

 

Release and Sharing of Data

 

The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the CDC data sharing agreement will be released as follows:

  1. In a timely manner

  2. Completely, and as accurately as possible

  3. To facilitate the broader community

  4. Developed in accordance with CDC policy on Releasing and Sharing Data, April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) www.4.law.cornell.edu/uscode/5/5/552/html.

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 $300,000, 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 sub grant or a contract the recipient must include the following statement on conference materials, including promotional materials, agenda, and internet sites:

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

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

 

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

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

CDC Forms Web Page: http://www.cdc.gov/od/pgo/forminfo.htm