Part I Overview Information


United States Department of Health and Human Services (HHS)

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

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

Title:  The Impact of Traumatic Brain Injury Among Incarcerated Persons (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 Sections 301 and 393A of the Public Health Service Act [42 U.S.C. Sections 241 and 280b-1b], as amended.  

Announcement Type:
New
 

Instructions for Submission of Electronic Research Applications:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance 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.)

CDC encourages all applicants to register in the Electronic Research Administration (eRA Commons) as soon as possible. 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.

Funding Opportunity Announcement (FOA) Number: RFA-CE-07-008

Catalog of Federal Domestic Assistance Number(s):
93.136

Key Dates
Release/Posted Date: November 9, 2006
Letter of Intent Receipt Date: January 29, 2007
Application Submission Receipt Date: February 28, 2007
Peer Review Date:  May 2007
Council Review Date: July 2007
Earliest Anticipated Start Date: September 30, 2007
Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on January 10, 2007 from 2:00 p.m. to 3:30 p.m. (Eastern Time). The conference can be accessed by calling 1-866-687-1450 and entering pass code 9247007. The leader is Dr. Jean A. Langlois.
Expiration Date: March 1, 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. Sending an Application
        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 Terms and Conditions of Award
            1. Principal Investigator 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 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 disability.   For more information, see www.health.gov/healthypeople  and www.whitehouse.gov/omb/mgmt-gpra/.

The purpose of this solicitation is to announce the availability of fiscal year (FY) 2007 funds to support one cooperative agreement to study the potential impact on community reintegration and recidivism of traumatic brain injury (TBI) and related problems among adults in state or federal prisons.  The proposed study will investigate the interrelationships among a history of TBI, substance abuse, and violent or aggressive behavior problems to inform programs to improve the health of incarcerated persons, reduce recidivism, and increase their potential for successful reintegration into the community.  This program addresses the “Healthy People 2010” focus area(s) of Injury and Violence Prevention.  Measurable outcomes of the program will be in alignment with one (or more) of the following performance goal(s) for the National Center for Injury Prevention and Control: Conduct a targeted program of research to reduce injury-related death and disability.

Background

Approximately 2.2 million people currently reside in US prisons and jails (DOJ 2006).  

Although women account for about 8 percent of those incarcerated (DOJ 2006), from 1990 to 2000, the number of women in prisons and jails more than doubled (DOJ 2006).  Ensuring the successful community re-integration of prisoners is of concern since approximately 95% of persons incarcerated in jail or prison will be released at some point. (Commission Report, 2006)

TBI among prisoners

Prevalence of a history of TBI

The impact of TBI in the prison setting has not been well-recognized but is potentially quite great.  Previous studies suggest that a history of TBI is highly prevalent among inmates, including women, occurring among an estimated 25-87 percent of the prison population (Morell, Merbitz, Jain, et al., 1998; Slaughter, Fann, Ehde, 2003).  In contrast, it is estimated that 8.5 percent of non-incarcerated adults report a history of TBI (Silver, Kramer, Greenwald and Weissman, 2001).  These data suggest that the prevalence of a TBI history may be as high as 10 times that of the general population.  However, previous studies are limited because they were conducted in single facilities and thus the findings are not population-based.  According to the Children’s Health Act of 2000 and recently introduced legislation which guide CDC’s TBI activities, more accurate estimates of the prevalence of TBI among prisoners are needed to inform public health efforts to improve the lives of prisoners with TBI, their families, and other members of the community.  Thus, a more detailed study of a representative sample of prisoners in multiple institutions within a state or federal prison system is needed to obtain a population-based estimate for an individual state or for the U.S.  

TBI-related secondary conditions

Traumatic brain injury among prisoners is of particular concern because it often results in cognitive, social, emotional, and behavioral problems, including aggressive behavior (NIH Consensus Conference, 1999), and secondary conditions such as substance abuse that can greatly affect their ability to function both while they are in prison and after they return to the community.  Knowledge that these problems are related to TBI as opposed to other etiologies would help inform the implementation of TBI-specific interventions, resulting in more effective management and rehabilitation and ensuring greater potential for successful community reintegration.

Individuals with a history of TBI are significantly more likely to have problems with alcohol or substance abuse (SA) compared with persons without TBI (Silver et al., 2001; Moore, Greer and Li, 1994).  However, the relationship between TBI and substance abuse problems among prisoners has not been well-studied.  The limited literature to date suggests that cognitive problems associated with a past history of TBI may affect inmates’ potential to succeed in rehabilitation (Valliant, Freeston, Pottier, Kosmyna, 2003; Corrigan, 1995), including substance abuse treatment. (SAMHSA, 1998).  Screening for TBI among prisoners with SA problems has been recommended as a means of informing more effective treatment (SAMHSA, 1998).

Traumatic Brain Injury can result in irritability or aggressiveness, including explosive outbursts that can be set off by minimal provocation or occur without warning (Silver, Yudofsky, and Anderson, 2005).  Some reports suggest that the frequency of aggressive behavior and threats of violence, and the severity of temper outbursts, may increase with time post-injury (Hall, Karzmark, and Stevens et al., 1994; Brooks, Campsie, and Symington, et al., 1986).  Among male prisoners, a history of TBI is strongly associated with perpetration of domestic violence (Cohen et al., 1999), and female prisoners who are convicted of a violent crime are more likely to have had a pre-crime TBI and/or some other form of physical abuse (Brewer-Smyth, 2004)  In the prison setting, such aggression and other behavioral disturbances can lead to further injury for the prisoner or others (DOJ 2001; Maryland Police, 2001) and affect corrections center management (Schofield, Butler, Hollis, Smith, Lee, and Kelso, 2006; Merbitz, Jain, Good, and Jain, 1995).  Aggressive or violent behavior is also associated with an increased likelihood of recidivism (Coid, 2005).  Thus screening for TBI within the prison setting has been recommended to help inform improved inmate safety and management (Schofield et al. 2006).  Persons with TBI-related aggression might also be taught behavioral and cognitive strategies to inhibit aggressive behaviors (Cohen et al., 1999), although to our knowledge this has not been demonstrated in a prison population.

Although few studies have investigated the topic, homelessness has been found to be associated with both imprisonment (Kushel, Hahn, Evans, et al., 2005) and with a history of head injury (Bremner, Duke, Helson, et al., 1996).  The association between homelessness and imprisonment appears to be complex because of shared causal pathways in both directions (Kushel, et al., 2005), but the role of head injury (or TBI) as a risk factor has not been well described.  Inclusion of homelessness in studies of TBI and incarceration could provide additional insights about these relationships.

Identifying a history of TBI

Screening for TBI in prisons has been recommended as a means of informing more effective substance abuse treatment (SAMHSA, 1998) and inmate management (Schofield et al. 2006; Kaufman, 2005) within corrections facilities.  Anecdotal reports suggest that although some prison intake interviews ask about history of head injury or TBI, valid and reliable measures for TBI screening have not routinely been used in the prison setting (John Corrigan, personal communication, July 2006).  The Brain Injury Screening questionnaire (BISQ) is a validated measure for assessing history of TBI (Gordon, Haddad, Brown, Hibbard, Sliwinski, 2000) that was used in one unpublished study of TBI in a prison population (Armstrong, 2006).  With HHS/CDC funding, two additional unpublished TBI screening measures are currently being evaluated to determine their potential for use in identifying a history of TBI among incarcerated populations.

Need for research on TBI in prisons

Research is needed to elucidate the interrelationships among a history of TBI and characteristics of the injury (e.g., severity), substance abuse, and violence and to demonstrate the usefulness of implementing valid, reliable, and efficient screening methods to identify persons with a history of TBI and related problems within the corrections setting.  Although the interrrelationships among SA, aggression, and criminal behavior have been investigated among nonincarcerated persons with TBI (Kreutzer, Marwitz, and Witol, 1995), to our knowledge, no previous studies have examined these issues among prisoners.  Multi-institution population-based estimates of the prevalence of a history of TBI and related problems are also needed to better quantify the potential public health impact of routine screening for TBI within the correctional setting.  

Research Objectives

In a representative sample of incarcerated adults:

Design

Research funded under this announcement is expected to adhere to high scientific standards, and to incorporate the following elements:

Note that the research must be conducted

a)  within federal or state prisons (excludes jails), and

b) among individuals aged 18 years or older.

References:

Armstrong CL.  Mild traumatic brain injury and violent criminality.  Thesis, Walla Walla College, May 2006.

Bremner AJ, Duke PJ, Helson HE, et al.  Cognitive function and duration of rooflessness in entrants to a hostel for homeless men.  British Journal of Psychiatry 1996;169:434-439.

Brewer Smyth K, Burgess AW, Shults J. Physical and sexual abuse, salivary cortical, and neurologic correlates of violent criminal behavior in female prison inmates. Biological Psychiatry. 2004;55:21-31.

Brooks N, Symington C., Beattie A., et al.  The five year outcome of severe blunt head injury: a relative’s view. Journal of Neurology, Neurosurgery, and Psychiatry. 1986;49:764-770.

Cohen RA, Rosenbaum A, Kane RL, Warnken WJ, Benjamin S.  Neuropsychological correlates of domestic violence.  Violence and Victims 1999;14:397-411.

Coid J. Correctional populations: criminal careers and recidivism.  Oldham JM, Skodol AE, Bender DS, Eds. Textbook of Personality Disorders. Washington, DC: American Psychiatric Publishing; 2005: 579-606.

Commission on Safety and Abuse in America’s Prisons.  Gibbons JJ , Katzenbach NB, co-chairs. Confronting confinement [online]. 2006 [cited 2006 June 8].  Available from: URL: http://www.prisoncommission.org

Corrigan, JD. Substance abuse as a mediating factor in outcome from traumatic brain injury. Archives of Physical Medicine and Rehabilitation 1995;76:302-309.

Gordon, W. A., Haddad, L., Brown, M., Hibbard, M. R., Sliwinski, M. The sensitivity and specificity of self-reported symptoms in individuals with traumatic brain injury. Brain Injury, 2000;14:31.

Hall K, Karzmark P, Stevens M, et al. Family stressors in traumatic brain injury a two-year follow-up. Archives of Physical Medicine and Rehabilitation. 1994;75:876-884.

Kaufman CW. Handbook for Correction Officers and Other Institutional Staff to Identify and Manage Inmates With Traumatic Brain Injuries. Dissertation. Carlos Albizu University. Ann Arbor, MI: University Microfilms, 2005.

Kreutzer JS, Marwitz JH, Witol AD. Interrelationships between crime, substance abuse, and aggressive behaviours among persons with traumatic brain injury. Brain Injury. 1995;9:757-768.

Kushel MB, Hahn JA, Evans JL, et al. Revolving doors: imprisonment among the homeless and marginally housed population.  American Journal of Public Health 2005;95:1747-1752.

Maryland Police and Correctional Training Commissions. Police interaction with individuals with brain injury: Student workbook [online]. 2001 [cited 2006 February 21]. Available from: URL: http://www.tbitac.nashia.org/tbics/download/mdpolice.pd.

Merbitz C, Jain S, Good GL, Jain A. Reported head injury and disciplinary rule infractions in prison. Journal of Offender Rehabilitation. 1995;22:11-19.

Moore D, Greer BG, Li L.  Alcohol and other substance use/abuse among people with disabilities.  In Dunn DS (ed).  Psychosocial perspectives on disability [Special Issue]. Journal of Social Behavior and Personality 1994;9:369-382.

Morrell RF, Merbitz CT, Jain S, et al. Traumatic brain injury in prisoners. Journal of Offender   Rehabilitation. 1998;27:1-8.

Schofield, PS, Butler TG, Hollis SJ, Smith NE, Lee SJ, Kelso WM.  Traumatic brain injury among Australian prisoners:  rates, recurrence, and sequelae.  Brain Injury 2006; 20:499-506. 

Silver JM, Kramer R, Greenwald S, Weissman M. The association between head injuries and psychiatric disorders:  findings from the New Haven NIMH Epidemiologic Catchment Area study. Brain Injury. 2001;15(11):935-945.

Silver JM, Yudofsky SC, Anderson KE. Aggressive disorders. Silver JM, McAllister TW,Yudofsky SC, Editors. Textbook of Traumatic Brain Injury. 2nd ed. Washington, D.C.: American Psychiatric Publishing, Inc.; 2005:259-277.

Slaughter B, Fann JR, Ehde D. Traumatic brain injury in a county jail population: prevalence, neuropsychological functioning and psychiatric disorders. Brain Injury. 2003;17:731-41.

U.S. Code of Federal Regulations. Permitted research involving prisoners. (codified at 45 CFR §46.306).

U.S. Dept. of Health and Human Services. National Institutes of Health. (NIH)

Report of the NIH consensus development conference on the rehabilitation of persons with traumatic brain injury, October 26-28, 1998. Ragnarsson KT, editor.

Washington (DC): Department of health and Human Services, Public Health Service, National Institutes of Health; 1999.

U.S. Dept. of Health and Human Services. Substance Abuse and Mental Health Services Administration. (SAMHSA).  Substance Use Disorder Treatment For People With Physical and Cognitive Disabilities: Treatment Improvement Protocol (TIP) Series 29; DHHS Publication No. (SMA) 98-3249; Rockville, MD; U.S. Department of Health and Human Services, 1998 [cited 2006 August 3]. Available from:  http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat5.chapter.5248

U.S. Dept. of Health and Human Services. Substance Abuse and Mental Health Services Administration. (SAMHSA).  Put Prevention into Practice.  Treatment Improvement Protocol (TIP) Series 44; DHHS Publication No. (SMA) 98-3249; Rockville, MD; U.S. Department of Health and Human Services, 1998 [cited 2006 August 3]. Available from:   http://www.ncbi.nlm.nih.gov/books/bv.fcgi?rid=hstat5.chapter.8004

U.S. Dept. of Justice. Office of Justice Programs. Bureau of Justice Statistics. Medical Problems of Inmates, 1997.  Maruschak LM, Beck AJ (Eds.) Bureau of Justice Statistics Special Report. No (NCJ) 181644. Washington, D.C.; U.S. Department of Justice, 2001 [cited 2006 August 3]. Available from: http://www.ojp.usdoj.gov/bjs/pub/pdf/mpi97.pd

U.S. Dept. of Justice. Office of Justice Programs. Bureau of Justice Statistics. Prison and Jail Inmates at Midyear 2005.  Harrison PM, Beck AJ (Eds.) Bureau of Justice Statistics Special Report. No. (NCJ) 213133. Washington, D.C.; U.S. Department of Justice, 2006 [cited 2006 August 3]. Available from: http://www.ojp.usdoj.gov/bjs/pub/pdf/pjim05.pd

Valliant PM, Freeston A, Pottier D, Kosmyna R. Personality and executive functioning as risk factors in recidivist. Psychological Reports. 2003;92:299-306.

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the U49 activity code, Cooperative Agreement for Injury Control Research and Demonstration Projects and Injury Prevention Research Centers.

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

NCIPC intends to commit approximately $500,000 (both direct and indirect costs) dollars in FY2007 to fund one application. The average award amount will be $500,000 (both direct and indirect costs) and is for the first 12-month budget period. An applicant may request a project period of up to 4 years. An applicant may request up to $500,000 for the first 12-month budget period. The approximate total project period funded amount is $2,000,000 (both direct and indirect costs), with a maximum of $500,000 (both indirect and direct costs) per year. The anticipated start date for new awards is September 30, 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.

Although the financial plans of the CIO (s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

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:

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.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

Participation of persons under the age of 21

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:

CDC strongly encourages all applicants to register in Electronic Research Administration (eRA Commons) as soon as possible. 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 register can be obtained at the following:

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

Several additional actions an applicant institution/organization should complete before submitting an electronic application, are as follows:

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.  Application forms can be mailed to you.  For this, or further assistance, contact PGO TIMS: Telephone (770) 488-2700, Email: PGOTIM@cdc.gov.

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

2. Content and Form of Application Submission

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

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

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

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

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

Note: While both budget components are included in the SF424 (R&R) forms package, the 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 29, 2007
Application Submission Receipt Date: February 28, 2007
Peer Review Date:  May 2007
Council Review Date: July 2007
Earliest Anticipated Start Date: September 30, 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 CIO staff to estimate the potential review workload and plan the review.

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

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

NCIPC Extramural Resources Team
CDC, National Center for Injury Prevention and Control
Address for Express Mail or Delivery Service:
2945 Flowers Rd.
Yale Building, Room 2054
Atlanta, GA  30341

Address for U.S. Postal Service Mail:

4770 Buford Hwy., NE, Mailstop K-62
Atlanta, GA 30341
Telephone: (770) 488-4037
FAX: (770) 488-1662
Email: CIPERT@cdc.gov

3.B. Submitting an Application to CDC

If the instructions in this announcement differ in any way from the 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. If an applicant submits materials by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time.  If HHS/CDC receives your submission after closing because of : (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time, or (2) significant weather delays or natural disasters, you have the opportunity to submit documentation of the carrier’s guarantee.  If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline. 

This announcement is the definitive guide on Letter Of Intent (LOI) and application content, submission address, and deadline.  It supersedes information provided in the application instructions.  If your application does not meet the deadline described in Section IV.3.A, it will not be eligible for review, and HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements.

Otherwise, HHS/CDC will not notify you upon receipt of your paper submission.  If you have a question about the receipt of your application, first contact your courier.  If you still have a question, contact the PGO-TIMS staff at: 770-488-2700.  Before calling, please wait two to three days after the submission deadline.  This will allow time for HHS/CDC to process and log submissions.

If submitting a paper application, it must be prepared using the 424 R&R instructions for preparing a research grant application. Submit a signed, typewritten original of the application and all appendices, including the checklist, and three signed photocopy(s) to the following address:

Technical Information Management Section – CDC-RFA-CE07-008

CDC, Procurements and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Road
Atlanta, GA  30341
Phone:  770-488-2700

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/CDC 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.

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 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 five 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 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.

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 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://www.cdc.gov/od/pgo/forminfo.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.

2. Review and Selection Process

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

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

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

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? Is the selection of a research design justified, and is the research design appropriate to answer the research questions?  Are descriptions of sampling methods, sample size and power estimates, and data collection methods well-described and justified?  Does the data analytic plan appropriately consider the level of data collection and the longitudinal design of the study?

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 investigator have relevant knowledge and experience to conduct the 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? If collaborations are being proposed, are the partners and their skills and expertise well described? Can proposed collaborations reasonably be expected to improve the quality of the research?   

2.A. Additional Review Criteria

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

Application Review

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 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).  . 

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.  

Program staff will be responsible for the administrative review of the plan for sharing research data.

2.D. Sharing Research Resources

Not Applicable

3. Anticipated Announcement and Award Dates

Applicants will be notified in August or early September of 2007 by CDC’s Procurement and Grants Office (PGO) if their applications were funded.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the applicant organization will receive a written critique called a “Summary Statement.” 

HHS/CDC will contact those applicants under consideration for funding for additional information.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.  The NoA signed by the Grants Management Officer (GMO) is the authorizing document.  This document will be mailed and/or emailed to the recipient fiscal officer 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 of this document or on the CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.

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

2.A. Cooperative Agreement

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 HHS/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:

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

Not Applicable.

3. Reporting

Recipient Organization must provide HHS/CDC with an original, plus two hard copies of the following reports:

1.      Non-Competing Grant Progress Report, (use form PHS 2590, posted on the HHSCDC website, http://www.cdc.gov/od/pgo/funding/forms.htm and at  http://grants.nih.gov/grants/funding/2590/2590.htm, no less than 120 days prior to the end of the current budget period. The progress report will serve as the non-competing continuation application.

2.      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:

Jean A. Langlois, ScD., MPH
National Center for Injury Prevention and Control

Centers for Disease Control and Prevention (CDC)
U.S. Department of Health and Human Services
4770 Buford Hwy, NE, Mailstop F-41
Telephone: (770) 488-1478
FAX:  (770) 488-4338
Email:  jal7@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:

Lisa Williams, Grants Management Specialist
CDC Procurement and Grants Office
U.S. Department of Health and Human Services
2920 Brandywine Rd., MS-K70
Atlanta, GA  30341
Telephone: (770) 488-2743
FAX: (770) 488- 2987
Email: lrw3@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, MS-K70
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

Technical assistance will be available for potential applicants during one conference call. The call for eligible applicants will be held on January 10, 2007 from 2:00 p.m. to 4:00 p.m. (Eastern Time). The conference can be accessed by calling 1-866-687-1450 and entering pass code 9247007. The leader is Dr. Jean A. Langlois.

Section VIII. Other Information


Required Federal Citations

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).   Additional HHS/CDC Requirements under AR-1 Human Subjects Requirements can be found on http://www.cdc.gov/od/pgo/funding/ARs.htm.

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 HHS/CDC is that persons under the age of 21 must be included in all human subjects research that is conducted or supported by HHS/CDC, unless there are scientific and ethical reasons not to include them. This policy applies to all HHS/CDC-conducted or HHS/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 HHS/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 HHS/CDC-conducted or HHS/CDC-supported research activities in foreign countries (including collaborative activities) is the same as that for research conducted in the United States.

Patient Care

Ensure that all STD or HIV infected patients enrolled in the proposed project will be linked to an appropriate local care system that can address their specific needs, such as medical care, counseling, social services, and therapy.

Executive Order 12372 Review

Applications are subject to Intergovernmental Review of Federal Programs, as governed by Executive Order (E.O.) 12372. The order sets up a system for State and local governmental review of proposed Federal assistance applications. Applicants should contact their State single point of contact (SPOC) as early as possible to alert the SPOC to prospective applications and to receive instructions on the State process. For proposed projects serving more than one State, the applicant is advised to contact the SPOC for each State affected.

Click on the following link to get the current SPOC list http://www.whitehouse.gov/omb/grants/spoc.html

Indian tribes must request tribal government review of their applications.

SPOCs or tribal governments that have recommendations about an application submitted to HHS/CDC should send them, in a document bearing the program announcement number, no more than 60 days after the application deadline date, to:

Lisa Williams, Grants Management Specialist
Procurement and Grants Office
Announcement Number CDC-RFA-CE07-008
Centers for Disease Control and Prevention (CDC)
2920 Brandywine Road
Atlanta, Georgia 30341-4146

HHS/CDC does not guarantee to accept or justify its non-acceptance of recommendations that are received more than 60 days after the application deadline.

Public Health System Reporting Requirements

This program is subject to the Public Health System Reporting Requirements. Under these requirements, all community-based non-governmental organizations submitting health services applications must prepare and submit the items identified below to the head of the appropriate State and/or local health agency(s) in the program area(s) that may be impacted by the proposed project no later than the application deadline date of the Federal application. The appropriate State and/or local health agency is determined by the applicant. The following information must be provided:

A. A copy of the face page of the application (SF 424).

B. A summary of the project that should be titled "Public Health System Impact Statement" (PHSIS), not exceed one page, and include the following:

  1. A description of the population to be served.
  2. A summary of the services to be provided.
  3. A description of the coordination plans with the appropriate state and/or local health agencies.

If the State and/or local health official should desire a copy of the entire application, it may be obtained from the State Single Point of Contact (SPOC) or directly from the applicant.

Paperwork Reduction Act Requirements

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

Smoke-Free Workplace Requirements

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 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 HHS/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 HHS/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.

Third Party Agreements – HHS/ATSDR

Applicant must justify the need to use a contractor. If contractors are proposed, the following must be provided: (1) name of contractor, (2) method of selection, (3) period of performance, (4) detailed budget, (5) justification for use of contractor, and (6) assurance of non-conflict of interest.

Project activities which are approved for contracting pursuant to the prior approval provisions shall be formalized in a written agreement that clearly establishes the relationship between the recipient and the third party.

The written agreement shall, at a minimum:

1. State or incorporate by reference all applicable requirements imposed on the contractors under the terms of the grant and/or cooperative agreement, including requirements concerning technical review (ATSDR selected reviewers), ownership of data, and the arrangement for copyright when publications, data, or other copyrightable works are developed under or in the course of work under a PHS grant-supported project or activity.

2. State that any copyrighted or copyrightable works shall be subject to a royalty-free, nonexclusive, and irrevocable license to the government to reproduce, publish, or otherwise use them, and to authorize others to do so for Federal government purposes.

3. State that whenever any work subject to this copyright policy may be developed in the course of a grant by a contractor under a grant, the written agreement (contract) must require the contractor to comply with these requirements and can in no way diminish the government's right in that work.

4. State the activities to be performed, the time schedule for those activities, the policies and procedures to be followed in carrying out the agreement, and the maximum amount of money for which the grantee may become liable to the third party under the agreement.

5. State non-conflict of interest concerning activities conducted for HHS/ATSDR and site-remediation activities for other parties.

The written agreement required shall not relieve the recipient of any part of its responsibility or accountability to PHS under the cooperative agreement. The agreement shall, therefore, retain sufficient rights and control to the recipient to enable it to fulfill this responsibility and accountability.

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 HHS/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 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

{Mandatory for all grants and cooperative agreements.}

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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