Part I Overview Information


United States Department of Health and Human Services (HHS)

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

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

Title: Dissemination Research on Fall Prevention: “Stepping On” in a U.S. Community Setting (U49)

Note: The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.

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. 280b(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: RFA-CE-07-007

Catalog of Federal Domestic Assistance Number(s):
93.136

Key Dates
Release/Posted Date: November 6, 2006
Letter of Intent Receipt Date: January 23, 2007
Application Submission Receipt Date: February 23, 2007
Peer Review Date(s): May 2007
Council Review Date(s): July 2007
Earliest Anticipated Start Date: September 1, 2007
Additional Information to Be Available Date (URL Activation Date):  December 5, 2006
Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on December 5, 2006 from 1:00 p.m.to 2:30 p.m. (Eastern Time). The conference can be accessed by calling 1-888-552-9191 and saying the access code LPATTERSON. 
Expiration Date: February 24, 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)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

The 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 RFA addresses “Healthy People 2010” priority area(s) of injury and violence prevention and is in alignment with NCIPC performance goal(s) to increase the capacity of injury prevention and control programs to address the prevention of injuries and violence.  For more information, see www.healthypeople.gov  and www.whitehouse.gov/omb/mgmt-gpra/.

Background: 

The problem of fall-related injuries among persons aged 65 and older is enormous—accounting for 13,700 deaths and over 1.8 million non-fatal emergency department-treated injuries in 2003. (1)  With a rapidly increasing older adult population, it is essential to address the problem of older adult falls.  Research has shown that most effective interventions address multiple risk factors (2-3) and a number of randomized controlled studies have documented interventions that are effective in research settings. 

There remains, however, a paucity of effective programs available for dissemination at the community level.  Research is needed to translate science-based effective fall prevention interventions into programs for the community.  This includes research to develop program guides and packages for use by community organizations and to identify the best formats and channels for delivering programs to ensure that older adults adopt them.

“Stepping On” is a multi-component intervention that has been rigorously evaluated in a randomized trial in Australia and shown to reduce falls 31% among community-dwelling seniors. (4)  Participants who received the intervention had one-third fewer falls compared to those who were not in the program. The program was especially effective among men.  Falls among male program participants were reduced by two-thirds.

An occupational therapist facilitated the program and conducted home visits. A team of content experts presented on key content areas.  The program took place over a 7-week period and a follow-up home visit took place within 6 weeks of the final session. Each session covered a different aspect of reducing risk of falling.(4)

The “Stepping On” manual (5) describes how to prepare, plan and run the multi-faceted program in Australia. The manual includes the following:

• A step by step guide to running the seven week (2hrs/week) group program.

• Essential background information for understanding the conceptual underpinning of the program and the group process.

• Valuable content information for all the key falls prevention areas that can be used to upskill local experts participating in the program.

• A guide to useful resources.

• Handouts for group participants.

• Ideas on recruitment and evaluation

The purpose of this funding is to support research on translating “Stepping On”, an effective fall prevention program tested in Australia, into a U.S. community program; testing implementation of the program in a community setting; and conducting dissemination evaluation research focusing on participants’ outcomes, reach, uptake (adoption), feasibility, fidelity, and acceptability.

This program addresses the “Healthy People 2010” focus area of Injury and Violence Prevention.  Specifically, it addresses Objective 15-27, to reduce deaths from falls, and Objective 15-28, to reduce hip fractures among people age 65 and older. 

Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for (NCIPC):

1.         Increase the capacity of injury prevention and control programs to address the prevention of injuries and violence.

2.         Conduct a targeted program of research to reduce injury-related death and disability.

Outcomes also should be in alignment with the NCIPC Research Agenda priority areas to disseminate effective interventions to reduce injuries at home and in the community and to reduce older adult falls and fall-related injuries.  Specifically, “Evaluate strategies for widespread dissemination and implementation of effective interventions to reduce injuries at home and in the community.” (NCIPC Research Agenda, p.19); “Research has demonstrated that many interventions at home and in the community work....  Encouraging widespread adoption of these efficacious interventions calls for dissemination research.... Demonstration programs should be developed and evaluated to determine the effectiveness of various persuasive communications techniques, audience segmentation, tailored messaging, and collaboration models to speed diffusion and widen adoption.” (NCIPC Research Agenda, p.19)  “[Pertaining to older adult falls:] Research is needed to develop and evaluate approaches to implementing and disseminating effective fall prevention programs in the community....  This includes research to identify the best formats and channels for delivering interventions to ensure that older adults adopt them.” (NCIPC Research Agenda, p.22) Available from: URL: http://www.cdc.gov/ncipc/pub-res/research_agenda/agenda.htm.  

Examples of translational research used to develop programs in topic areas such as HIV/AIDS have been presented in the scientific literature (6-7) and more information about dissemination/translation research is available at: http://www.cdc.gov/ncipc/res-opps/Dissemination_Research_FAQ_Apr06.htm http://cancercontrol.cancer.gov/d4d/about.html   http://www.nimh.nih.gov/publicat/nimhbridge.pdf
http://www.nimh.nih.gov/publicat/nimhtranslating.pdf  http://cancercontrol.cancer.gov/d4d/info.html#conferences
http://www.ahcpr.gov/clinic/epcsums/canconsum.htm http://www.drugabuse.gov/about/organization/nacda/HSRReport.pdf

Research Objectives:

1. To translate “Stepping On”, an effective fall prevention intervention for older adults, into a program that can be implemented in U.S. community settings (while retaining key elements that made the original research effective).  Translating the intervention into a program will require using focus groups to assess the fit and acceptance of the program for U.S. seniors; appropriately modifying the manual, training materials, handouts, and took kit materials; and recruiting organizations for testing.

2. To implement the “Stepping On” program in a community setting;

3. To evaluate the results of the implementation with particular emphasis on dissemination research questions of reach, uptake (adoption), feasibility, and implementation fidelity and acceptability; as well as participants’ functional outcomes through measurement of appropriate variable(s). Fidelity of implementation and participants’ compliance with the intervention program requirements also must be assessed during the course of the program.

4. To refine the program and recruit a second organization and implement the revised program;

5. To produce a final package that can be broadly disseminated and used nationwide. (Note: actual broad dissemination (nationwide use) is not a part of this Announcement). 

6. To conduct dissemination and translation research on turning this intervention into a program that can be implemented in community settings.  In this funding announcement, dissemination research refers to research on the dissemination of an effective innovation (i.e., intervention) to prevent or control unintentional fall injuries. In this context, NCIPC’s goal for dissemination research is to better understand how, when, by whom, and under what circumstances effective innovations are spread and used by agencies, organizations, and frontline workers who conduct injury prevention or control in communities.  The research portion of this funding mechanism is NOT intended to support dissemination activities alone. A research component is needed to examine strategies for improved spread and use.(8-10)  Applicants would need to propose a research question about the spread or use of the intervention that would advance the state of the knowledge for the dissemination or implementation of effective innovations. The major focus of dissemination research is on discovering the best ways to spread or use an innovation, not on discovering the effectiveness of the innovation.    

Research questions to be addressed include:

a)         Reach – Who are you most interested in reaching and how many persons from this target audience will be reached?

b)         Uptake (adoption) – Do organizations and individuals who learn of the program consider using it, actually use it, and use it fully?  What barriers and facilitators to use can be identified? Who has the most potential for implementing effective innovations to prevent or control unintentional fall injuries?

c)         Feasibility – How much time, money, staff, space and other resources are needed vs. what is available?

d)         Fidelity – Are the key components that made the intervention effective maintained when the program is implemented?

e)         Acceptability – How acceptable is the intervention to those it will impact; e.g., are cultural norms taken into account?  Is the program acceptable at organizational and individual levels?

f)          Adaptability – Can the intervention vary, as needed, depending on the audience?

g)         Participants’ outcomes– Using simplified pre-post assessments based upon the original research (e.g., functional measures of mobility, balance, and falls self-efficacy), does the program continue to show effectiveness in fall prevention?

This Announcement does not include dissemination of exercise programs to nursing home residents or frail, home-bound older adults where medical screening and follow up, or medical monitoring, is required. 

Applicants will need to identify the key elements that made the original intervention effective.  In the absence of a component analysis which is rare in behavioral studies, the applicant will need to derive these key elements based on publications, notes, and judgment.  They will likely need to consult with others, consider the underlying theoretical models used in the intervention design, and examine results obtained in the original study.  Applicants other than the original investigators will need to demonstrate the ability to carry out these processes. 

Applicants will likely need to consider the following questions:

What is the existing individual, organizational, or community capacity to implement effective innovations? When lacking, how can capacity be enhanced? How should capacity be measured? How do organizational, political, and social processes affect the dissemination of effective innovations to prevent or control unintentional fall injuries?

Where do intended users seek out information on effective innovations or on programmatic decision making? What format should scientific translation take? What formats or outlets are most accessible and most useful to the intended audience?

What types of training, technical assistance, and coaching effectively support implementation in specific practice settings?

What factors influence the long-term implementation of effective innovations?

Activities

A series of activities will take place over the four years of the Cooperative Agreement:

Year One: Planning and Material Development

•           Identify key elements that made the “Stepping On” intervention effective;

•           Establish an ad hoc expert group to guide and support development of a draft fall prevention program package;

•           Modify the program by translating the key elements into a community-based exercise program;

•           Develop materials for recruitment of organizations and individuals;

•           Develop materials for training providers of the exercise program, including criteria-based performance standards;

•           Create the draft program package of the manual, training manual, handouts, and tool kit materials;

•           Develop a research protocol and submit for Institutional Review Board (IRB) review by all cooperating institutions engaged in the research study;

•           Develop evaluation instruments/tools to assess reach, uptake (adoption), feasibility, fidelity, acceptability and participant outcomes;

•           Prepare for and attend annual progress meeting with HHS/CDC staff (include travel costs in budget). 

Year Two: Development continued.

•           Recruit one community-based organization for focus group testing;

•           Conduct focus group testing;

•           Revise all materials based upon focus group findings;

•           Test dissemination evaluation instruments/tools with focus group materials;

•           Conduct a pilot study: 

•           Recruit older adults into the program;

•           Train personnel;

•           Implement the program in one community setting.  Provide the program to a small number of older adults (less than eight), for a predetermined period depending on the program design;

•           Employ evaluation instruments/tools to collect data required to address the dissemination research questions previously listed;

•           Prepare for and attend annual progress meeting with HHS/CDC staff (include travel costs in budget). 

Year Three: Implementation

•           Make minor revisions to the provider materials as needed and repeat implementation in same setting two to three times;

•           Revise all materials;

•           Recruit older adults into the program in a new setting, train personnel, and implement the program following guidance above;

•           In all instances, employ the evaluation instruments/tools to collect data required to address research questions previously listed;

•           Prepare for and attend annual progress meeting with HHS/CDC staff (include travel costs in budget). 

Year Four: Evaluation

•           Evaluate the dissemination/translation process using data collected during Years Two and Three (analyze participant outcomes, reach, uptake (adoption), feasibility, implementation fidelity, and acceptability);

•           Use findings to revise and refine the program package;

•           Incorporate dissemination research results to produce a final program package that will enable the program to be broadly disseminated in various community settings nationwide;

•           Prepare a paper for publication in a peer review practice journal;

•           Prepare for and attend annual progress meeting with HHS/CDC staff (include travel costs in budget).  Provide HHS/CDC staff with a copy of the final program package.

References:

1. Centers for Disease Control and Prevention (CDC). Web-based Injury Statistics Query and Reporting System (WISQARS) [Online]. (2004).  National Center for Injury Prevention and Control (NCIPC)and, CDC (producer). Available from: http://www.cdc.gov/ncipc/wisqars. [Cited 26 July 2004].

2. Tinetti ME, Baker DI, AcAvay G, et al.  A multifactorial intervention to reduce the risk of falling among elderly people living in the community.  N Engl J Med 1994;331:821-827.

3. Gillespie LD, Gillespie WJ, Robertson MC et al. Interventions for preventing falls in elderly people.  (Cochrane Review).  The Cochrane Library, Issue 2.  Chichester, UK:  John Wiley & Sons, Ltd, 2004.

4. Clemson L, Cumming RG, Kendig H et al. The effectiveness of a community-based program for reducing the incidence of falls in the elderly: A randomized trial. JAGS 2004;52:1487-94.

5Stepping On, building confidence and reducing falls: A community-based program for older people, available at: http://www.therapybookshop.com.

6. Kraft JM. Mezoff JS. Sogolow ED. Neumann MS. Thomas PA. A technology transfer model for effective HIV/AIDS interventions: science and practice. AIDS Education & Prevention. 12(5 Suppl):7-20, 2000.

7. Sogolow ED. Kay LS. Doll LS. Neumann MS. Mezoff JS. Eke AN. Semaan S. Anderson JR. Strengthening HIV prevention: application of a research-to-practice framework. AIDS Education & Prevention. 12(5 Suppl):21-32, 2000.

8. Sogolow, E S, Sleet, DA,  Saul, J   Dissemination, Implementation and Widespread Use of Injury Prevention Interventions.    In Doll, L, Bonzo, S, Mercy, J, Sleet, D (Eds).  Handbook of Injury and Violence Prevention.  New York:   Springer, 2006.

9. Bulletin of the World Health Organization, 2006:84 (Special theme issue on Knowledge Translation in Global Health)

10. Maibach, EW, Van Duyn, AS, Bloodgood, B.  A marketing perspective on disseminating evidence-based approaches to disease prevention and health promotion.  Preventing Chronic Disease.  Vol 3< No. 3, 1-11, July, 2006. 

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 cooperative agreement assistance mechanism and will use the U49 activity code.

The HHS/CDC U49 is a cooperative agreement assistance instrument. Under the cooperative agreement assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with HHS/CDC staff substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.

2. Funds Available

The participating Centers, Institutes, and Offices (CIOs) (NCIPC) intend to commit approximately $340,000 (includes direct and indirect costs) in FY2007 to fund one application. The average award amount will be $340,000 which includes direct and indirect costs for the first 12-month budget period. An applicant may request a project period of up to four years. An applicant may request up to $340,000 for the first 12-month budget period. The approximate total project period funded amount is $1,360,000. The anticipated start date for new awards is September 1, 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.

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

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

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.

Principal Investigator qualifications are as follows:

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

The PI must demonstrate that he or she has the authority to carry out this research.  For example, if the PI is affiliated with a university, he or she must be a faculty member and not a visiting scientist. The applicant must provide evidence such as publications from peer reviewed journals (in the appendix of the application) of either prior experience or collaborative work in at least one of the following:

a.         Designing and conducting original intervention research;

b.         Conducting translation/dissemination research.

If the applicant is not strong in both areas, the applicant must demonstrate enhanced capacity to perform the translation and dissemination research by including documentation of potential consultants or collaborators who have the relevant expertise.

The applicant must provide documentation of collaborating experts (e.g., administrators of senior centers, technical experts, and community-based seniors) describing the areas of expertise and indicating willingness to collaborate and areas of potential collaboration.   

2. Cost Sharing or Matching

None.

3. Other-Special Eligibility Criteria

Special Requirements:

Late applications will be considered non-responsive.  See section “IV.3. Submission Dates and Times” for more information on deadlines.

Applicants that do not intend to translate the “Stepping-On” program as described, and propose an alternative fall prevention program will be considered non-responsive and will not be entered into the review process.

If program participants are not independent, U.S. community dwelling older adults, applications will be considered non-responsive and will not be entered into the review process.  For example, the applicant should not propose to disseminate via health care providers to older adults who reside in assisted living or nursing homes. 

Principal investigators are encouraged to submit only one proposal in response to this program announcement. 

The applicant must provide evidence, such as publications from peer reviewed journals in the appendix, which demonstrate expertise in intervention research and translation/dissemination research.  If the applicant is not strong in both areas, the applicant must demonstrate enhanced capacity to perform research activities by including documentation of potential consultants or collaborators who have the relevant other area of expertise. 

Applicant must provide documentation of collaborating experts (e.g., administrators of senior centers, technical experts, and community-based seniors) describing the areas of expertise and indicating willingness to collaborate and areas of potential collaboration.  

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:

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:

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.

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

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

2. Content and Form of Application Submission

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

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

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
Research & Related Subaward Budget Attachment(s) Form

Optional Components:
PHS398 Cover Letter File

Note: While both budget components are included in the SF424 (R&R) forms package, the HHS/CDC U49 (activity code) uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)

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 23, 2007
Application Submission Receipt Date(s): February 23, 2007
Peer Review Date: May 2007
Council Review Date: July 2007
Earliest Anticipated Start Date: September 1, 2007

3.A.1. Letter of Intent

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

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

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

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

NCIPC Extramural Resources Team
CDC, National Center for Injury Prevention and Control
Address for Express Mail or Delivery Service:

2945 Flowers Rd.
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 SF424 R&R instructions, follow the instructions in this announcement.

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov.  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 discard it. You will receive notification that you did not meet the submission requirements.

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

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.

Restrictions, which must be taken into account while writing your budget, are as follows:

6. Other Submission Requirements

Awardees, upon acceptance of Notice of Award (NoA), must agree to the "Cooperative Agreement Terms and Conditions of Award" in Section VI.  "Award Administration Information.”

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.

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

For cooperative agreements, awardees must agree to Section VI.2.A., "Cooperative Agreement.

Plan for Sharing Research Data

The precise content of the data-sharing plan will vary, depending on the data being collected and how the investigator is planning to share the data. Applicants should describe briefly the expected schedule for data sharing, the format of the final dataset, the documentation to be provided, whether or not any analytic tools also will be provided, whether or not a data-sharing agreement will be required and, if so, a brief description of such an agreement (including the criteria for deciding who can receive the data and whether or not the awardee will place any conditions on their use), and the mode of data sharing (e.g., under their own auspices by mailing a disk or posting data on their institutional or personal website, through a data archive or enclave). References to data sharing may also be appropriate in other sections of the application.

All applicants must include a plan for sharing research data in their application. The data sharing policy is available at http://www.cdc.gov/od/pgo/funding/ARs.htm under Additional Requirements 25, Release and Sharing of Data. All investigators responding to this funding opportunity should include a description of how final research data will be shared, or explain why data sharing is not possible.

The reasonableness of the data sharing plan or the rationale for not sharing research data will be assessed by the reviewers. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score.

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 $340,000, a data sharing plan is not required.

Sharing Research Resources

HHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (Grants Policy Statement http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.)  Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

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

Section V. Application Review Information


1. Criteria

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

The following will be considered in making funding decisions:

2. Review and Selection Process

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

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

Key elements of a successful application must include the ability to:

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

Note that an application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but is essential to move a field forward.
 
Significance: Does this study address an important problem? If the 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? Will study advance scientific knowledge of how to disseminate the “Stepping-On” fall prevention program?

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?  To what extent do the applicant’s work plan and timetable include development of program package materials, specification of relevant experts and agreements with them, recruitment of organizations, staffing including trainer, training for providers, program delivers, and dissemination research design and implementation.

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)? Are the investigators well versed in dissemination research?

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

2.A. Additional Review Criteria

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

To what extent have the applicants and proposed collaborators documented:

            a. Their history and current capacity to provide a leadership function in conducting translation/dissemination research?

            b. A willingness to partner with HHS/CDC so that the Applicant Activities and HHS/CDC Activities are undertaken in a collaborative fashion as intended for Cooperative Agreement recipients.  This would include a willingness to attend and participate in technical assistance and planning meetings and related travel to Atlanta coordinated by HHS/CDC for all Cooperative Agreement recipients.

            c. Their organizational capacity to realize the objectives of the Cooperative Agreement.

            d. Their management operation, structure, and or organization.  An organizational chart of the applicant’s organization should be included as an Appendix.  Additionally, the applicant should include within their management plan the specific role and mechanisms to be established to ensure effective coordination, communication and shared decision-making among the involved agencies/organizations.

            e. A staffing plan for the project, noting existing staff as well as additional staffing needs.  The responsibilities of individual staff members including the level of effort and allocation of time for each project activity by staff position should be included.  If relevant, the specific staff positions within other involved agencies, both in-kind and funded, should be described.

            f. Curricula Vitae for the PI and co-PIs (if any), and CVs, resumes, and/or biosketches for current, proposed, and in-kind staff, and position descriptions for all proposed positions to be funded under this cooperative agreement should be included as an Appendix.  This should include the use of consultants, as appropriate.

            g. Ability to demonstrate the willingness of collaborating agencies (e.g., administrators of senior centers, community-based senior organizations) to partner in the project.

Application Review

Once an application is determined eligible, 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:

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:

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

Inclusion of Women and Minorities in Research:

Does the application adequately address the 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). 

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: 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 $340,000, a data sharing plan is not required.

2.D. Sharing Research Resources

HHS policy requires that grant award recipients make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication (Grants Policy Statement http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs.)  Investigators responding to this funding opportunity should include a plan for sharing research resources addressing how unique research resources will be shared or explain why sharing is not possible.

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

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.  This document will be mailed and/or emailed to the recipient fiscal officer and PD/PI identified in the application. 

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

2. Administrative and National Policy Requirements

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

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

2.A. Cooperative Agreement

The following terms of award are in addition to, and not in lieu of, otherwise applicable Office of Management and Budget (OMB) administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS/PHS, and HHS/CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, U49, an "assistance" instrument (rather than an "acquisition" instrument), in which substantial HHS/CDC programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the HHS/CDC purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the CDC as defined above.

2.A.1. Recipient Rights and Responsibilities

The Recipient will have the primary responsibility for the following:

Recipient Organization will retain custody of and have primary rights to the information, data and software developed under this award, subject to U.S. Government rights of access consistent with current HHS, HHS/PHS, and applicable HHS/CDC policies.

2.A.2. HHS/CDC Responsibilities

An HHS/CDC Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

HHS/CDC Activities for this program are as follows:

1.         Provide up-to-date scientific information, technical assistance, and guidance in the design and conduct of the research when and where needed or requested.

2.         Provide to awardees:

a) scientific information and guidance in translation and dissemination research design, data collection methods, and data quality assurance when requested;

b) if necessary, technical assistance in developing data collection instruments and methods for data management;

c) if necessary, guidance in developing a research protocol for annual Institutional Review Board (IRB) review and approval for use by all cooperating institutions participating in the research study; and

d) technical assistance and guidance in analysis and dissemination of results including the preparation of manuscripts when required.

3.         The appropriate IRB will review the protocol initially and on at least an annual basis until the research study, including analyses, is completed and will assist in ensuring human subjects assurances are in place as needed.

4.         Monitor and evaluate the scientific and operational accomplishments of the project.  This may be accomplished through periodic site visits, telephone calls, electronic communication, and bi-annual report.  Provide a review of the final program package developed by the applicant.

5.         Convene meetings of recipient for the exchange of information related to:

a) Scientific information and guidance in translation and dissemination research design, data collection methods, and data quality assurance.

b) Technical assistance with methods          

c) Guidance in developing for use; and

d) Technical assistance and guidance in analysis and dissemination of results including the preparation of manuscripts.

Additionally, an HHS/CDC agency program official or CIO program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the NoA.

2.A.3. Collaborative Responsibilities

Each full member will have one vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

3. Reporting

Recipient Organization must provide HHS/CDC with an original, plus two hard copies of the final program package, no more than 90 days after the end of the project period.

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:

Karin A. Mack, Ph.D.
Behavioral Scientist
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-63
Atlanta, GA  30341
Telephone: (770) 488-4389
FAX: 770-488-1317
Email: kmack@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 & Assistance Branch IV
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services
Colgate Building, Room 3225, Mailstop K-70
2920 Brandywine Road
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:

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 December 5, 2006 from 1:00 p.m. to 2:30 p.m. (Eastern Time). The conference can be accessed by calling 1-888-552-9191 and saying the access code LPATTERSON. 

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

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

HHS/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 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:

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

Research Integrity

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

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

For example:

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

Compliance with Executive Order 13279

Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations.  All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS.  If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance.  A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above.  A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols.  In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its 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 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, http://www.whitehouse.gov/omb/circulars/a110/a110.html and Freedom of Information Act (FOIA) http://www.hhs.gov/foia.

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 $340,000, a data sharing plan is not required.

Conference Disclaimer and Use of Logos

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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