Part I Overview Information

Amendments to this announcement can be found in red.

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

Center 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: Research for Preventing Violence and Violence –Related Injury (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 Health Service Act, as amended.

Announcement Type: New

Instructions for Submission of Electronic Research Applications:

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

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

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

A registration process is necessary before submission, and applicants are 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-CE07-010

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: November 15, 2006
Application Submission Receipt Date: December 15, 2006

Peer Review Date: February, 2007
Council Review Date: June, 2007
Earliest Anticipated Start Date: September 1, 2007

Additional Information to Be Available Date (URL Activation Date): October 30, 2006

Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on October 30, 2006 from 1:30 p.m. to 3 p.m. (Eastern Time). The conference can be accessed by calling: 1-888-399-7388, stating the leader name: MS LADY PATTERSON, and entering the passcode: L PATTERSON.
Expiration Date: December 16, 2006

Due Date for E.O. 12372

Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

NCIPC is soliciting investigator-initiated (R01) research that will expand and advance the understanding of violence, its causes, and prevention strategies. Applications must address one of the research objectives listed in this FOA.
The participating organizations intend to commit a total of $1.8 million to this FOA for payment of applications responsive to this announcement statement.
Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.
Five to six awards will be funded.
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. The total amount awarded and the number of awards will depend upon the activity code, quality, duration, and costs of the applications received.
Budget Period, Project Period, and Award Amounts: The budget period will be for one year and the anticipated project period up to three years. The funding level will not exceed $300,000 total (including direct and indirect costs) per year.
Eligible Organizations: Public nonprofit organizations; private nonprofit organizations; for profit organizations; small, minority, and women-owned businesses; universities; colleges; research institutions; hospitals; community-based organizations; faith-based organizations; federally recognized Indian tribal governments; Indian/Native American tribal government (federally recognized); Indian tribal government (other than federally recognized); Indian/Native American tribally designated organizations; state and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau); and political subdivisions of states (in consultation with states.) 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.
Eligible Project Directors/Principal Investigators (PD/PIs): Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. To be eligible for this FOA, the principal investigator must have conducted violence prevention research and published the findings in a peer-reviewed journal. Principal investigators can submit only one grant application in response to this FOA. Only one application per principal investigator will be funded under this announcement.
See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites: Grants.gov Application Guide SF424 (R&R) - MS Word ; or Grants.gov Application Guide SF424 (R&R) - PDF
For general information on SF424 (R&R) Application and Electronic Submission, see the following Web sites: SF424 (R&R) Application and Electronic Submission Information ;and General Information on Electronic Submission of Grant Applications
HHS/CDC Telecommunications for the hearing impaired is available at the following number: TTY 770-488-2783.

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. Address to 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. HHS/CDC Responsibilities

            3. Collaborative Responsibilities
   3. Reporting

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

4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement

Section I. Funding Opportunity Description

1. Research Objectives

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

For more information, see http://www.healthypeople.gov/

and http://www.whitehouse.gov/omb/mgmt-gpra/.

The purposes of the NCIPC extramural research program are to:

• Build the scientific base for the prevention and control of fatal and nonfatal injuries and related disabilities.

• Encourage 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 more effectively.

• Encourage investigators 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.

For the purpose of this announcement, primary care settings include hospital emergency departments.

Research Objectives

NCIPC is soliciting investigator-initiated research that will help expand and advance our understanding of violence, its causes, and prevention strategies. The following research objectives are the focus of this solicitation:

1. Intervention Evaluation Research:

a) Evaluate the efficacy, effectiveness, and cost effectiveness of primary prevention interventions, programs, and policies to prevent the perpetration of intimate partner violence, child maltreatment and/or suicidal behavior. 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 engaged in the perpetration of intimate partner violence, child maltreatment, or suicidal behavior.

b) Evaluate the efficacy, effectiveness, and cost effectiveness of primary prevention interventions, programs, and policies to prevent the perpetration of sexual violence. 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 engaged in the perpetration of sexual violence. Particular research areas of interest include (but not limited to): assessing the impact of efforts to influence bystanders and peer groups (i.e., efforts to stop sexual violence by influencing the norms among groups/bystanders); approaches that engage men and boys in the prevention of sexual violence; the use of action and asset models to build and support youth to challenge current norms or behaviors that support sexual violence; and the impact of policies or organizational/community level practices that might impact upon or contribute to either decreasing risk factors or increasing protective factors for sexual violence.

c) Evaluate the efficacy, effectiveness, cost effectiveness, and safety of screening and intervention in primary care settings to prevent intimate partner violence and/or sexual violence.

2. Etiologic Research:

Conduct studies to examine the development of intimate partner violence, sexual violence, and/or child maltreatment perpetration. These studies should be designed to provide a better understanding of the developmental pathways and social circumstances that contribute to the perpetration of intimate partner violence, sexual violence, and/or child maltreatment. Such studies should be designed to provide important information on the populations at high-risk for perpetration, the modifiable risk and protective factors, as well as the optimal developmental periods and settings for intervention.

Although not participating in this program announcement, the National Institute of Mental Health (NIMH) shares an interest in this area of research. For specific information on NIMH interests, see PA-04-075 http://grants.nih.gov/grants/guide/pa-files/PA-04-075.html

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

Section II. Award Information

1. Mechanism(s) of Support

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

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

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

2. Funds Available

The participating Centers, Institutes, and Offices (CIO)(s) (NCIPC) intends to commit approximately $1.8 million (direct plus indirect) dollars in FY2007 to fund 5 to 6 applications. The average award amount will be up to $300,000 total (direct plus indirect costs) for the first 12-month budget period. An applicant may request a project period of up to 3 years. An applicant may request up to $300,000 maximum for the first 12-month budget period. The approximate total project period funded amount is $900,000. The anticipated start date for new awards is September, 2007.

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.

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:

Public nonprofit organizations
Private nonprofit organizations
For profit organizations
Small, minority, and women-owned businesses
Universities
Colleges
Research institutions
Hospitals
Community-based organizations
Faith-based organizations
Federally recognized Indian tribal governments
Indian /Native American Tribal Government (Federally Recognized)
Indian/Native American Tribal Government (Other than Federally Recognized)
Indian/Native American Tribally Designated Organizations
State and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau)
Political subdivisions of States (in consultation with States)

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.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for CDC programs.

To be considered responsive to this announcement, the Principal Investigator must provide:

Documented prior experience in conducting violence prevention research as evidenced by at least one first-authored manuscript in violence prevention research published in a peer-reviewed journal.
Demonstrated experience conducting, evaluating, and publishing violence prevention research in peer-reviewed journals.

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 or matching funds are not required.

3. Other-Special Eligibility Criteria

Grant applications must demonstrate an overall match between the applicant's proposed 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 objective 1a (Intervention Evaluation Research). In the “Research Plan” section of their application, the applicant should document that: 1) the intervention is for primary, not secondary prevention, and 2) the target population for the intervention has not already engaged in the perpetration of intimate partner violence, child maltreatment, or suicidal behavior.

The following is the responsiveness criteria if the applicant is addressing research objective 1b (Intervention Evaluation Research). In the “Research Plan” section of their application, the applicant should document that: 1) they are evaluating a primary intervention, program(s) or policy that prevents the perpetration of sexual violence,

2) the target population for the intervention has not already engaged in the perpetration of sexual violence, 3) how the intervention will influence bystanders and peer groups, and 4) develop approaches and models that support high-risk populations to challenge current norms and behaviors that support sexual violence, and will decrease risk factors or increase protective factors.

The following is the responsiveness criteria if the applicant is addressing research objective 1c (Intervention Evaluation Research). In the “Research Plan” section of their application, the applicant should document that: 1) they are evaluating the efficacy, effectiveness, cost effectiveness, and safety of screening and intervention that prevents intimate partner violence and/or sexual violence, and 2) the intervention takes place in a primary care setting.

The following is the responsiveness criteria if the applicant is addressing research objective 2 (Etiologic Research). In the “Research Plan” section of their application, the applicant must document that: 1) the proposed research address developmental pathways and social circumstances that contribute to the perpetration of intimate partner violence, sexual violence, and/or child maltreatment, including identifying developmental periods and settings optimal for intervention, and 2) the design should provide information on populations at high risk for perpetration, identify modifiable risk and protective factors.

The applicant will be expected to have a well-defined partnership with an ongoing violence prevention program as evidenced by a letter of support.
Demonstrated experience on the applicant’s project team in conducting, evaluating, and publishing violence prevention research in peer-reviewed journals.
Effective and well-defined working relationships within the applicant organization and with outside organizations expected to participate in the proposed research as evidenced through letters of support.
The overall match between the proposed research objectives and the program priorities as described under the heading “Research Objectives”.

Principal investigators can submit only one grant application 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 enter 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 at 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 as early as possible.

Applicant institutions/organizations should complete the following actions as soon as possible:

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

Your organization will need to obtain a Data Universal Number System (DUNS) number and register with the Central Contractor Registration (CCR) as part of the Grants.gov registration process.
If your organization does not have a Taxpayer Identification Number (TIN) or Employer Identification Number (EIN), allow for extra time. A valid TIN or EIN is necessary for CCR registration.
The CCR also validates the EIN against Internal Revenue Service records, a step that will take an additional one to two business days.
Direct questions regarding Grants.gov registration to:
Grants.gov Customer Support
Contact Center Phone: 800-518-4726
Business Hours: M-F 7:00 a.m. - 9:00 p.m. Eastern Time
Email support@grants.gov

2) Organizational/Institutional Registration in the eRA Commons

To find out if an organization is already eRA Commons-registered, see the "List of Grantee Organizations Registered in eRA Commons.”

Direct questions regarding the eRA Commons registration to:
eRA Commons Help Desk
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Business hours M-F 7:00 a.m. – 8:00 p.m. Eastern Time
Email commons@od.nih.gov

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

The individual designated as the PD/PI on the application must also be registered in the eRA Commons. It is not necessary for PDs/PIs to register with Grants.gov.
The PD/PI must hold a PD/PI account in the eRA Commons and must be affiliated with the applicant organization. This account cannot have any other role attached to it other than the PD/PI.
This registration/affiliation must be done by the Authorized Organization Representative/Signing Official (AOR/SO) or their designee who is already registered in the eRA Commons.
Both the PD/PI and AOR/SO need separate accounts in the eRA Commons since both hold different roles for authorization and to view the application process.

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

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

1. Request Application Information

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

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

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.)

Do not use the Appendix to circumvent the page limitations of the research plan. In addition to letters of support, the appendix may include the following items: 1) Up to 10 publications, manuscripts (accepted for publication), abstracts, patents, or other printed materials directly relevant to this project. 2) Surveys, questionnaires, data collection instruments, clinical protocols, and informed consent documents. 3) Original glossy photographs or color images of gels, micrographs, etc., provided that a photocopy (may be reduced in size) is also included within the 25-page limit of the research plan.

Abstract (Project Summary and Relevance)

It is especially important that the abstract (Description, SF424 form page 2) of your grant application reflect the project’s focus; the abstract 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 abstract will become public information.

The 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 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:

The project's focus, a justification for the research proposed, and a description of the scientific basis for the research. The focus should be based on recommendations in “Healthy People 2010" (http://www.healthypeople.gov) and the “CDC Injury Research Agenda,” (http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm) and should seek creative approaches that will contribute to a national program for injury control.
Specific, measurable, and time-framed objectives.
A detailed plan describing the methods by which the objectives will be achieved, including their sequence. A comprehensive evaluation plan is an essential component of the application.
A description of the principal investigator's role and responsibilities.
A description of those activities related to, but not supported by, the grant.
A description of the involvement of other entities that will relate to the proposed project, if applicable. It should include commitments of support and a clear statement of their roles.
An explanation of how the research findings will contribute to the national effort to reduce the morbidity, mortality and disability caused by injuries within three to five years from project start-up.

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: November 15, 2006
Application Receipt Date(s): December 15, 2006

Peer Review Date: February, 2007

Council Review Date: June, 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 opportunit

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 mailed, faxed, or emailed 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 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 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.

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 reject it. You will receive notification that you did not meet the submission requirements.

If you have a question about the receipt of your application, 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.

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 or non-responsive applications.

There will be an acknowledgement of receipt of applications from Grants.gov.

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

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

5. Funding Restrictions

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

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

Funds relating to the conduct of research involving human subjects will be restricted until the appropriate assurances and Institutional Review Board approvals are in place.
Reimbursement of pre-award costs is not allowed.
Grant funds will not be made available to support the provision of direct care.
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 the annual monitoring workshop in Atlanta should be included in the applicant’s proposed budget.

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 $400,000, 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.

· 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:

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.
Receive a written critique.
Receive a second level of review by the Science and Program Review Subcommittee (SPRS) of the Secretary’s Advisory Committee for Injury Prevention and Control (ACIPC).
Applications submitted in response to this FOA will compete for available funds with all other eligible applications. The criteria listed in Section V.1. will be considered in making funding decisions.

The goals of HHS/CDC-supported research are to advance the understanding of health promotion and 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 application.

Significance
Approach
Innovation
Investigators
Environment

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.

Significance: Does this study address an important problem? If the applicant achieves the aims of the application, how will it advance scientific knowledge or clinical practice? What will be the effect of these studies on the concepts, methods, technologies, treatments, 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)? Does the principal investigator have a prior history of the principal investigator 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 by of other interested parties as evidenced by letters of support detailing the nature and extent of their 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.

The significance of the proposed activities in relation to the priorities and objectives stated in “Healthy People 2010," the Institute of Medicine report, “Reducing the Burden of Injury,” and the “CDC Injury Research Agenda.”

· 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.

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.

2. A. Additional Review Criteria

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

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

Inclusion of Women and Minorities in Research:

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

Biohazards: If 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.

2. D. Sharing Research Resources

Not applicable.

3. Anticipated Announcement and Award Dates

Grantees will be notified in August or early September of 2007 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.

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 of this document or on the HHS/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 HHS/CDC website, http://www.cdc.gov/od/pgo/funding/forms.htm and at http://grants.nih.gov/grants/funding/2590/2590.htm, no less than 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application.

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

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

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

Adele M. Childress, Ph.D, M.S.P.H
Scientific Program Administrator

National Center for Injury Prevention and Control

Centers for Disease Control and Prevention (CDC)

U.S. Department of Health and Human Services

4770 Buford Hwy, NE, Mailstop K-02
Telephone: (770) 488-4233
FAX: (770) 488-4422
Email: achildress@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) 488-4655

FAX: (770) 488-4422

Email: gxc8@cdc.gov

3. Financial or Grants Management Contacts:

Pamela Render, Grants Management Specialist

Procurement and Grants Office
Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA 30341

Telephone: 770-488-2712

FAX: 770-488-2670

E-mail: plr3@cdc.gov

4. General Questions Contacts:

Technical Information Management Section

CDC Procurement and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA 30341

Telephone: 770-488-2700

Email: PGOTIM@cdc.gov

5. Special Guidelines for Technical Assistance:

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.

Conference Call:

Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on October 30, 2006 from 1:30 p.m. to 3:30 p. m. (Eastern Time). The conference can be accessed by calling: 1-888-399-7388, stating the leader name: MS LADY PATTERSON, and entering the passcode: L PATTERSON.

Participation in this conference call is not mandatory.

At the time of the call, if you have problems accessing the conference call, please call 770-488-1044 for assistance.

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 the Internet at the following address http://www.cdc.gov/od/pgo/funding/ARs.htm.

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

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

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

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

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

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

Paperwork Reduction Act Requirements

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

Smoke-Free Workplace Requirements

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

Healthy People 2010

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

Place small, minority, women-owned business firms on bidders mailing lists.
Solicit these firms whenever they are potential sources of supplies, equipment, construction, or services.
Where feasible, divide total requirements into smaller needs, and set delivery schedules that will encourage participation by these firms.
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 42 CFR Part 93, 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 proselytizing 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 HHS/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 HHS/CDC data sharing agreement will be released as follows:

In a timely manner
Completely, and as accurately as possible
To facilitate the broader community
Developed in accordance with HHS/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.

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

National Historic Preservation Act of 1966

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

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

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

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

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

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

Conference Disclaimer and Use of Logos

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

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

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

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