Part I Overview Information


United States Department of Health and Human Services (HHS) 

Issuing Organization

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

Participating Organizations

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


Components of Participating Organizations

National Center on Birth Defects and Developmental Disabilities (NCBDDD/CDC), at http://www.cdc.gov/ncbddd 

Title: Prevention of Health Risk Behaviors among Youth with Attention-Deficit/Hyperactivity Disorder (U01)

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement might differ from those used by the HHS National Institutes of Health (NIH).  If written guidance for completing this application is not available on the CDC website, then CDC will direct applicants elsewhere for that information. 

Authority: This program is authorized under Sections 301 and 317C of the Public Health Service Act, (42 U.S.C. Sections 241 and 247(b) 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)

A registration process is necessary before submission, and applicants are strongly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Two steps are required for on time submission:

1) 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.)

2) Applicants must complete a verification step in the Electronic Research Administration (eRA Commons) within two business days of notification. Note: Since email can be unreliable, it is the responsibility of the applicant to periodically check on their application status in the eRA Commons.

Funding Opportunity Announcement (FOA) Number:

RFA-DD-O9-003

Catalog of Federal Domestic Assistance Number(s): 93.184   Disabilities Prevention
 

Key Dates
Release/Posted Date:

Letter of Intent Receipt Date:
March 09, 2009
Application Submission Receipt Date:
April 09, 2009
Peer Review Date:
May, 2009
Secondary Review Committee (SRC) Date:  J
une, 2009

Earliest Anticipated Start Date: September 30, 2009

Expiration Date: April 10, 2009

 

Due Date for E.O. 12372

Executive Order 12372 does not apply to this program.

 

Additional Overview Content


Executive Summary
 

·          Purpose: This FOA solicits proposals in the form of cooperative agreements to conduct research on health risk behaviors among children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).  Grantees will identify, implement, and evaluate interventions aimed at preventing or reducing health risk behaviors in youth with ADHD that are based on evidence-based theory or generalized from previous research. 

·          FY08 Conference Report (110) language commends CDC’s work regarding Attention Deficit-Hyperactivity Disorder to support activities designed to provide information, support services and health professional education regarding ADHD.

·          Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

·          Anticipated number of awards: anticipated number of awards to be issued under this FOA:  Up to two

·          Budget Period, Project Period, and Award Amounts:  The average award amount will be $200,000 in total costs (direct and indirect) for the first 12 month budget period.  The total project period will be three years.

·          Eligible Organizations: Public nonprofit organizations; private nonprofit organizations; for profit organizations; small, minority, and women-owned businesses; universities; colleges; research institutions; hospitals; community-based organizations; faith-based organizations; federally recognized or state-recognized American Indian/Alaska Native tribal governments; American Indian/Alaska Native tribally designated organizations; Alaska Native health corporations; urban Indian health organizations; tribal epidemiology centers; state and local governments or their Bona Fide Agents (this includes the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, the Commonwealth of the Northern Marianna Islands, American Samoa, Guam, the Federated States of Micronesia, the Republic of the Marshall Islands, and the Republic of Palau); and political subdivisions of states (in consultation with states.)   A Bona Fide Agent is an agency/organization identified by the state as eligible to submit an application under the state eligibility in lieu of a state application.  If you are applying as a bona fide agent of a state or local government, you must provide required documentation 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.

·          Application Materials: See Section IV.1 for application materials. The SF424 (R&R) Application Guide for this FOA is located at these Web sites:  http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General.doc (MS Word); http://grants1.nih.gov/grants/funding/424/SF424_RR_Guide_General.pdf (PDF).

·          General Information: For general information on SF424 (R&R) Application and Electronic Submission, see these the following Web sites: SF424 (R&R) Application and Electronic Submission Information: http://grants.nih.gov/grants/funding/424/index.htm; General information on Electronic Submission of Grant Applications: http://era.nih.gov/ElectronicReceipt/.

·          HHS/CDC Telecommunications for the hearing impaired is available at the following number: TTY 770-488-2783. 

Funding Opportunity Announcement Glossary: FOA Glossary Terminology

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
    1. Research Objectives

Section II. Award Information
    1. Mechanism(s) of Support
    2. Funds Available

Section III. Eligibility Information
    1. Eligible Applicants
        A. Eligible Institutions
        
    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. HHS/CDC Responsibilities
            3. Collaborative Responsibilities

    3. Reporting

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

    4. General Questions Contact(s)

Section VIII. Other Information - Required Federal Citations


Part II - Full Text of Announcement


 

Section I. Funding Opportunity Description


1. Research Objectives  

The National Center on Birth Defects and Developmental Disabilities (NCBDDD) 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 funding opportunity announcement (FOA) addresses the “Healthy People 2010” priority areas of Maternal, Infant, and Child Health and Mental Health and Mental Disorders.  It is in alignment with the NCBDDD performance goal to improve health and optimal development of all at risk children and all people with disabilities or potentially disabling conditions.  For more information: www.healthypeople.gov and http://intra-apps.cdc.gov/fmo/.  

Nature of Research Opportunity

This FOA solicits proposals in the form of cooperative agreements to conduct research that will prevent or reduce health risk behaviors among children and adolescents under the age of 18 with Attention-Deficit/Hyperactivity Disorder (ADHD).  Grantees will identify, implement, and evaluate interventions aimed at preventing or reducing health risk behaviors in youth with ADHD that are based on evidence-based theory or generalized from previous research.   

Background

Children diagnosed with ADHD have been documented at higher risk for a variety of health risk behaviors, including accidents and injuries, violence and aggression, and substance abuse. The public health burden and long term risk based on such health risk behaviors is well documented. There is some evidence that treatment for symptoms of ADHD have also resulted in decreased health risk behaviors, but evidence for effective treatment directly targeting health risk behavior in youth with ADHD is limited. It is not clear based on available evidence to what extent prevention programs aimed at reducing health risk behavior in normative youth would also benefit children diagnosed with ADHD.  

Scientific Knowledge to be Achieved through this FOA

It is anticipated that findings from this research will identify interventions that will prevent or reduce health risk behaviors in youth with ADHD.  Results from this study will be used to provide data that will help guide state and national policies and guide services for children and adolescents with ADHD and their families. The data may also be used to develop (or, employ previously developed) interventions to lessen the areas of greatest impact.    

Research Objectives and Experimental Approach

The objective of this program is to improve quality of life for children and adolescents with ADHD and their families by developing interventions that will prevent or reduce health risk behaviors in youth with ADHD.  Grantees will design and implement at least one intervention that is evidence-based or generalized from previous research to reduce or prevent health risk behaviors in youth with ADHD.  Grantees will also evaluate the effectiveness of the intervention in meeting the objectives of this program.   

The study population is children and adolescents under the age of 18 who meet current diagnostic criteria for ADHD (as seen in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]) and their families.  The study should include a comparison group of children and adolescents without ADHD as defined by the applicant.  The actual sample size will depend on the outcomes, hypotheses, and the power analysis.   

Grantees will be responsible for study design, recruitment, and data collection, analysis, and presentation.  Applicant’s should propose the use of either 1) a new intervention informed by evidence-based theory, or 2) an existing intervention that has been evaluated and has been associated with decreased incidence of health risk behaviors in pediatric populations.  Previously developed interventions may be adapted to fit the applicant’s research setting.  The research study should engage community partners and appropriate stakeholders, i.e. schools, school districts, pediatric practices, clinics, local officials, professionals, or local organizations. 

As part of their research project, grantees will 1) collect baseline and demographic information on the study families; 2) identify the presence of a select group of comorbid conditions at baseline through survey or chart review; 3) identify the health risk behaviors that will be targeted; and 4) develop, implement, and evaluate the intervention.  The applicant must provide evidence that the selected intervention will be suitable for the target population.  

The grantee will be responsible for developing, managing and documenting the study database.  Data management procedures will be designed and implemented to assure the timely availability of high quality data by controlling for both the loss of data and the introduction of error.  Activities will include the design and oversight of the collection, editing, and computer entry of all study data.  

Grantees will be responsible for on-site activities, such as selection and enrollment of study subjects, implementation of the study protocol, quality assurance procedures, data management and timely submission of computerized, de-identified data to a central repository for inclusion in the data set.  If two sites are funded, it is anticipated that a collaborative survey protocol will be developed and agreed upon in the first year of the grant award.  It is important that wherever possible, identical case ascertainment methods are used and that investigator-initiated special survey questions or modules are jointly agreed to by the grantees and implemented at both sites.  Grantees will work together on cross-site training and reliability measures.

 

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

Section II. Award Information


1. Mechanism of Support 

This funding opportunity will use the UO1 activity code.  The HHS/CDC U01 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, and with HHS/CDC staff is substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.

2. Funds Available

NCBDDD intends to commit $400,000 in total costs (direct and indirect) in FY2009 to fund 1-2 applications. The average award amount will be approximately $200,000 for the first 12 month budget period to support direct and indirect costs.  An applicant may request a project period of up to three years. An applicant may request up to $200,000 for the first 12 month budget period. The approximate total project period funded amount is Approximate $1.5M. The anticipated start date for new awards is September 30, 2009.  

If an applicant requests a funding amount greater than the ceiling of the award range, HHS/CDC will consider the application non-responsive, and it will not enter into the review process. HHS/CDC will notify the applicant that the application did not meet the submission requirements. 

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

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.  

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.

2. Cost Sharing or Matching

This program does not require cost sharing as defined in the current HHS Grants Policy Statement.


The most current HHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc
 

 

3. Other-Special Eligibility Criteria 

Eligible applicants must meet the following criteria: 

·          Access to a population of children and adolescents under the age of 18 with ADHD.  Documentation must be provided in the form of a thorough description of the multiple sources (i.e., clinical practices, school systems, parent groups) from which the study participants will be recruited.

·          Letters of Support from each source must be included with the application.   

If your application is incomplete or non-responsive to the special requirements listed in this section, it will not enter into the review process.


Note: Title 2 of the United States Code Section 1611 states that an organization described in Section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant, or loan.

 

Section IV. Application and Submission Information


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

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

·          Grants.gov Get Registered,http://www.grants.gov/applicants/get_registered.jsp

·          eRA Commons Prepare to Apply, http://era.nih.gov/ElectronicReceipt/preparing.htm

IMPORTANT: both the applicant organization, as well as, the PD/PI must register in eRA Commons for an application to be accepted electronically. The Credentials Log-In, referenced in Section IV. 2. Content and Form of Application Submission, is obtained through Step #3 in the required actions below.

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

The following three steps are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov Get Registered,  http://www.grants.gov/applicants/get_registered.jsp

2) Organizational/Institutional Registration in the eRA Commons Prepare to Apply,  http://era.nih.gov/ElectronicReceipt/preparing.htm

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.

For 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. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by HHS/CDC (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Tips and Tools for Navigating Electronic Submission” on the front page of “Electronic Submission of Grant Applications.”

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 Sub award Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the CDC U01 (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:
March 09, 2009

Application Submission Receipt Date: April 09, 2009

Peer Review Date: May, 2009

Secondary Review Committee: June, 2009

Earliest Anticipated Start Date: September 30, 2009

 

3.A.1. Letter of Intent
 

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

·          Descriptive title of proposed research

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

·          Names of other key personnel

·          Participating institutions

·          Number and title of this funding opportunity 

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows CDC Program staff to estimate the potential review workload and plan the review.  The letter of intent is to be sent by the date listed in Section IV. 3.A 

The letter of intent should be sent to:

Phaeydra Brown

Extramural Research Program Office

Coordinating Center for Health Promotion

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

Koger Center – Williams Building, Rm. 5517 – (MS K-92)

2877 Brandywine Road

Atlanta, GA   30341

Fax: 770-488-8046

Email: pxb4@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 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.  The applicants’ Authorized Organization Representative (AOR) will receive an e-mail notice of receipt from eRA Commons and Grants.gov when HHS/CDC receives the application.  All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Standard Time on the deadline date.  

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

Technical Information Management Section – DD09-003

CDC, Procurements and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA  30341

Phone:  770-488-2700 EST


3.C. Application Processing

HHS/CDC must receive applications on or before 5:00 P.M. Eastern Standard Time on the application submission date 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.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

·          If everything is acceptable, no further action is necessary. The application will automatically move forward for processing by the CDC, PGO, Technical Information Management Section, after two business days.

·          Prior to the submission deadline, the AOR/SO can “Reject” the assembled application and submit a changed/corrected application within the two day viewing window. This option should be used if the AOR/SO determines that warnings should be addressed. Reminder: warnings do not stop further application processing. If an application submission results in warnings (but no errors) it will automatically move forward after two business days if no action is taken.  Please remember that some warnings may not be applicable or may need to be addressed after application submission.

·          If the two day window falls after the submission deadline, the AOR/SO will have the option to “Reject” the application if, due to an eRA Commons or Grants.gov system issue, the application does not correctly reflect the submitted application package (e.g., some part of the application was lost or didn’t transfer correctly during the submission process). The AOR/SO should first contact the eRA Commons Helpdesk to confirm the system error, document the issue, and determine the best course of action. HHS/CDC will not penalize the applicant for an eRA Commons or Grants.gov system issue.

·          If the AOR/SO chooses to “Reject” the image after the submission deadline for a reason other than an eRA Commons or Grants.gov system failure, a changed/corrected application still can be submitted but it will be subject to the CDC late policy guidelines and may not be accepted. The reason for this delay should be explained in the cover letter attachment and must refer only to Commons errors and/or technical errors.

·          Both the AOR/SO and PD/PI will receive e-mail notifications when the application is rejected or the application automatically moves forward in the process after two days.

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

 

There will be an acknowledgement of receipt of applications from Grants.gov and the eRA Commons

4. Intergovernmental Review

Executive Order 12372 does not apply to this program.

 

5. Funding Restrictions

 

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

 

Additional guidance can be found at HHS Grants Policy Statement.

 

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

 

·          Funds relating to the conduct of research involving human subjects will be restricted until the appropriate assurances and Institutional Review Board (IRB) approvals are in place.

·          Reimbursement of pre-award costs is not allowed.


6. Other Submission Requirements

 

Applicants’ research plan should address activities they will conduct over the three year project period.  Research plans should include the following:

 

·          Rationale for the study that provides a clear, concise understanding of the issues, challenges, and complexities of conducting a research study on children and adolescents with ADHD.

·          Qualifications of key personnel, including experience in prevention research and similar intervention studies, working with populations of youth with ADHD, data management, and statistical analysis.

·          Organizational chart describing personnel responsibilities and activities.

·          Short and long-term goals and objectives that are consistent with the stated goals and purpose of the FOA.

·          Timeline of project activities.

·          Description of the community, including size and demographic characteristics, from which cases of ADHD as well as an appropriate comparison group or groups will be recruited.  The community should have clear geographic boundaries and multiple data sources to recruit participants as specifically necessary for the proposed study.  For instance, clinical practices, school systems, local officials, parent groups, or others for the purpose of case ascertainment and assessment, where appropriate.  Letters of support much be included from each source.

·          Plans for engaging community partners in the study, including establishing or enhancing collaborative relationships with appropriate stakeholders, i.e. schools, school districts, pediatric practices, clinics, local officials, professionals, or local organizations.

·          Training plan for project staff on participant selection methods, assessment, and intervention delivery.

·          Dissemination plan for study results. 

In the research project design and methodology, applicants should describe the methods they will use to recruit and retain sufficient sample size with statistical power to investigate the effectiveness of the intervention.  Applicants should include: 

·          Details on the specific methods through which study participants will be recruited and retained.  Study participants must meet current diagnostic criteria for ADHD as seen in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV). Specifically, require satisfaction of symptom, setting, duration, and impairment criteria. Where possible, require at least two sources of data into the case identification process (e.g. gather data from parents, teachers, and/or the ADHD child); and if possible, replicate case ascertainment methods from existing literature that meet the preceding criteria and fit the selected study setting (e.g., school, pediatric practice, psychiatric practice, etc.).    

·          Details on the specific methods through which an appropriate comparison group or groups without ADHD will be identified. 

·          Plans for the development and implementation of an instrument or instruments to collect baseline and demographic information on the study families (i.e., socio-economic factors, access to care, medical and treatment history, health care satisfaction, parental factors [e.g., prenatal smoking and alcohol use, mental health history], and other potential factors related to ADHD, comorbid conditions, and health risk behaviors in youth with ADHD.  The instrument should collect relevant factors that may moderate or mediate the impact of the selected intervention.

·          Plans to identify the presence of a select group of comorbid conditions at baseline through survey or chart review.  Where appropriate, diagnostic rating scales using the DSM-IV symptom criteria in its entirety must be used to determine the presence of the following comorbid conditions: learning disorders; oppositional-defiant disorder; conduct disorder; depression; anxiety; and tic disorders. Other comorbid conditions may be investigated based on the interest and capabilities of the applicant organization; however, the preceding conditions noted must be assessed and proposed methods described fully in the application.

·          Plans to conduct a baseline assessment of health risk behaviors among study participants.  The assessment should include documentation of baseline health risk behaviors appropriate to the age of the sample including unintentional injury (i.e., due to poisoning, bicycle injuries, serious injuries in pedestrian situations, fighting/bullying, automobile accidents or driving errors, bicycle or sports related injuries, pedestrian-vehicle incidents); dietary behavior; physical activity; drug use and frequency (including huffing, sniffing, or other substance use); alcohol use and frequency; sexual activity (e.g., protected or unprotected sexual contact, number of partners, pregnancy if female and paternity if male); self-injurious behaviors (i.e., suicide attempts, cutting or self-mutilating behaviors, etc.); and criminality.  Emergency room or emergency medical care utilization must also be assessed for reason care was needed and the frequency of care in a specified time frame (e.g., the last 6 months, the last year, or lifetime).

·          Description of quality assurance procedures that will ensure that study protocols are followed and data are not compromised.

 

Applicant initiated questions or modules should be proposed and clearly described in the methods section of the application.  Justification for the proposed additions should be provided and supported by current literature in ADHD. 

Following baseline assessment of demographic and health risk behaviors, the applicant should clearly describe the selected intervention.   The proposed intervention should be 1) a new intervention informed by evidence-based theory, or 2) an existing intervention that has been evaluated and has been associated with decreased incidence of health risk behaviors in pediatric populations.  Applicants should include the following:   

·          Justification for which health risk behaviors will be targeted and its appropriateness for the study sample and behaviors.

·          Description of the manner in which the intervention will be delivered to the study participants and how data on relevant process-related variables and factors that may be associated with intervention effectiveness will be collected.

·          Description of statistical analyses to test the effectiveness of the intervention will be conducted.  Consider and incorporate the design and administration of the intervention when performing proposed statistical analyses.

 

Following the administration of the intervention, a complete post-intervention evaluation of intervention effectiveness should be conducted.  In the evaluation plan, applicants should: 

·          Describe a post-intervention survey of baseline factors that includes demographic and socio-economic factors, access to care, medical and treatment history, health care satisfaction, and health risk behaviors.

·          Describe how the methodological design of the study is incorporated and considered in the design of the statistical evaluation of intervention effectiveness.

·          Describe the methods that will be used to evaluate the completeness of coverage for the intervention and assessment aspects of the study.

·          Describe how they will monitor the reliability, progress, timeliness, and completeness of the objectives and activities of the project. 

Applicants should describe and indicate the availability of facilities and equipment necessary to carry out the proposed research.

 

The HHS/CDC requires the PD/PI to fill in his/her eRA Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.

 

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

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

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

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

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

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

 

Please note the following restriction on appendix attachments: The Research Plan Appendix attachments are limited to 10 attachments. Appendices are uploaded as attachments in the PHS 398 Research Plan form, in field #18, within the electronic application package. An applicant will receive an error message if the number of appendix attachments exceeds 10, which will result in an unsuccessful submission of the application. You may include more than one publication, or other allowable appendix material, within one attachment; however, do not let your attachments exceed 10.”

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

Plan for Sharing Research Data

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 they will provide, 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 (see the HHS Grants Policy Statement http://www.hhs.gov/grantsnet/docs/HHSGPS_107.doc.)  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.

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

·         Availability of funds

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

·         Ability to identify a setting with clear geographic boundaries from which to select cases of ADHD, as well as an appropriate comparison group or groups

·         Applicant is required to clearly detail the specific methods through which participants will be recruited, including the applicants ability to recruit a racial/ethnic diverse study population to allow for comparisons in testing the effectiveness of the intervention.

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 CCHP in accordance with the review criteria stated below.

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

·          Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score

·          Receive a written critique; and

·          Receive a second level of review by HHS/CDC CCHP  

Applications submitted in response to this FOA will compete for available funds with all other eligible applications. The criteria listed in Section V.1. will be considered in making funding decisions. 

The goals of HHS/CDC-supported research are to advance the understanding of health promotion and 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 and weighted, as appropriate for each applications.   

·          Significance

·          Approach

·          Innovation

·          Investigators

·          Environment 

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

Significance: Does this study address an important problem? If the applicant achieves the aims of the application, how will it advance scientific knowledge or clinical practice? What will be the effect of these studies on the concepts, methods, technologies, treatments, or preventative interventions that drive this field?
 

Does the applicant show a clear, concise understanding of ADHD in children and youth?  Is there understanding of issues, challenges, complexity and barriers associated with case ascertainment for ADHD and developing and implementing a study to describe the impact of ADHD?   


Approach: Are the conceptual or clinical framework, design, methods, and analyses adequately developed, well integrated, well reasoned, and appropriate to the aims of the project? Does the applicant acknowledge potential problem areas and consider alternative tactics?
 

Does the applicant clearly describe short and long-term goals and objectives in a realistic manner and are they consistent with the stated goals and purpose of the announcement and proposed program methodology?  Can the applicant recruit and retain a sufficient sample size with statistical power to investigate the effectiveness of intervention?   Does the applicant identify possible collaborative relationships with existing ADHD research programs that may enhance future research activities?  Do the proposed investigator-initiated survey questions or modules, including specific questions or types of questions, existing scales, instruments, or inventories, and why these additions are relevant and important to the intent of this announcement?


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?  

Does the applicant demonstrate capability to conduct collaborative research?  Do the plans for recruitment and outreach for study participants include establishing partnerships with the community(ies) and recognition of mutual benefits?


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 application include a plan to train staff on case ascertainment as appropriate?

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

Does the applicant identify and define the community for the proposed research, including size and demographic characteristics?  


2.A. Additional Review Criteria

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

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

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

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. Is the number of person months listed for the effort of the PD/PI appropriate for the work proposed?  Is each budget category realistic and justified in terms of the aims and methods?  The evaluation of the budget should not affect the priority score.

2.C. Sharing Research Data
 

Data Sharing Plan: HHS/CDC will assess the reasonableness of the data sharing plan. However, reviewers will not factor the proposed data sharing plan into the determination of scientific merit or the priority score. The presence of a data sharing plan will be part of the terms and conditions of the award. The funding organization will be responsible for monitoring the data sharing policy.  

2.D. Sharing Research Resources

HHS policy requires that recipients of grant awards make unique research resources readily available for research purposes to qualified individuals within the scientific community after publication.  Please see http://grants.nih.gov/grants/policy/gps/8postnew.htm#phs. Investigators responding to this funding opportunity should include a plan on sharing research resources.
 

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

The adequacy of the resources sharing plan will be considered by 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 (HHS/PHS 2590 http://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting


3. Anticipated Announcement and Award Dates
 

It is anticipated that awards will be announced August 2009. 
 

 

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the applicant organization will receive a written critique called a “Summary Statement.”  The applicant organization and the PD/PI will be able to access the Summary Statement via the eRA Commons.

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization.  The NoA signed by the Grants Management Officer (GMO) is the authorizing document.  HHS/CDC will mail and/or e-mail this document to the recipient fiscal officer identified in the application. 

 

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


2. Administrative and National Policy Requirements

The Code of Federal Regulations 45 CFR Part 74 and Part 92 have details about  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 Section VIII. Other Information of this document or on the HHS/CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.
 

The following terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a courteous 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/CDC grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement U01 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 may share specific tasks and activities, as defined above.

2.A.1. Recipient Rights and Responsibilities

The Recipient will have the primary responsibility for the following: 

1.      Providing oversight of the management and administrative aspects of the project, including maintaining an adequate staffing plan to support project activities.

2.      Developing and implementing all scientific aspects of the study protocol, including participant recruitment, data collection and follow-up, quality control, data analyses and interpretation. 

3.      Preparing and coordinating the submission of the study protocol to the designated IRB(s) and ensure that the protocol(s) is (are) conducted in compliance with the terms and conditions of the IRB approval.

4.      The information collected will be private and sensitive in nature.  The PI will be responsible for obtaining informed consent/assent, seeking a Certificate of Confidentiality (NIH) and will only deliver de-identifiable data to CDC.

5.      Collecting consent/assent from study participants before any identifiable information is collected.

6.      Publishing results of the research in a peer-reviewed journal.   

Each project will be responsible independently for on-site activities, such as selection and enrollment of study subjects, implementation of the study protocol, quality assurance procedures, data management, and timely submission of computerized, de-identified data to a central repository for inclusion in a pooled data set.  Sites will work together on cross-site training and reliability measures. 

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/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.  CDC substantial involvement of activities include: 

Data Collection and Evaluation           

1.      Participating in the development and planning of the survey instruments. CDC will provide final approval of survey instruments.

2.      Providing current information on methods including technical information on ADHD, selected comorbid conditions, and health risk behaviors.

3.      Assisting in the development of quality assurance procedures.

4.      Participate in the development of an evaluation plan for the completeness and validity of data from the assessments.

5.      Providing technical consultation regarding data analyses as requested. 

The CDC will provide leadership and collaborative guidance to the grantees for the following purposes: (1) enhance the potential for using congruent methodologies (to the extent possible) for identifying ADHD cases, identifying cases of selected comorbid conditions, and assessing health risk behaviors in these populations and (2) enhance communication and collaboration among ADHD researchers and the CDC.  These formal collaborations will combine the expertise and resources of the investigators at each site to achieve integrated and effective intervention efforts in the study of health risk behaviors within a sample of youth with ADHD and related disorders.   

CDC Scientific Program Administrator (SPA)

The CDC, ERPO/CoCHP will appoint an SPA, apart from the NCBDDD Scientific Collaborator , who will: 

·          Serve as the Program Official for the funded research institutions;

·          Carry out continuous review of all activities to ensure objectives are being met;

·          Participate in conference calls for the purposes of assessing overall progress and for program evaluation purposes;

·          Provide scientific consultation and technical assistance in the conduct of the project as requested, and;

·          Conduct site visits to recipient institutions to determine the adequacy of the research and to monitor performance against approved project objectives. 

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
 

Critical issues for understanding the relationship between ADHD and health risk behaviors will be better defined through the discussions and deliberations of all participants.  If two sites are funded, it is anticipated that a collaborative survey protocol will be developed and agreed upon in the first year of the grant award.  It is important that wherever possible, identical case ascertainment methods are used and that investigator-initiated special survey questions or modules are jointly agreed to by the new projects and implemented at both sites.  A cross-site operations manual, data entry procedures, data sharing procedures and approved publication plan may be developed for use by the project sites.  Periodic meetings may be held to facilitate collaboration. 

Each full member will have one vote. Awardee members of the Coordinating Committee (including a CDC member) should accept and implement policies approved by the Committee.

3. Reporting

Recipient Organization must provide HHS/CDC with one signed original, and one hard copy 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. 

Also as an alternative for sending reports to HHS/CDC, recipient organizations may send electronic reports in the following format; PDF file, via email, or by mailing a CD to the Grants Management Specialist listed in the “Agency Contacts” Section of this FOA.  

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

Although the financial plans of the HHS/CDC CIO(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds, evidence of satisfactory progress by the recipient (as documented in required reports) and the determination that continued funding is in the best interest of the Federal government.

 

Section VII. Agency Contacts


HHS/CDC encourages your inquiries concerning this FOA and welcomes the opportunity to answer questions from potential applicants. Inquiries can fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Brenda Colley Gilbert, PH.D., MSPH

Extramural Research Program Office

Coordinating Center for Health Promotion

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

Koger Center – Williams Building, (MS K-92)

2877 Brandywine Road

Atlanta, GA  30341

Telephone:  770-488-8390


 

2. Peer Review Contacts:

Brenda Colley Gilbert, PH.D., MSPH

Extramural Research Program Office

Coordinating Center for Health Promotion

Centers for Disease Control and Prevention

U.S. Department of Health and Human Services

Koger Center – Williams Building, (MS K-92)

2877 Brandywine Road

Atlanta, GA  30341

Telephone:  770-488-8390

Email: ero@cdc.gov



3. Financial or Grants Management Contacts:

Veronica Davis

Grants Management Specialist

Procurement and Grants Office

Center for Disease Control and Prevention

U.S. Department of Health and Human Services

Koger Center – Colgate Building

2920 Brandywine Road, Mailstop E-09

Atlanta, GA  30341

Telephone: (770) 488-2743

Email: vad4@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

 

Section VIII. Other Information


Required Federal Citations
 

Human Subjects Protection

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

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

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

Inclusion of Persons Under the Age of 21 in Research

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

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

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

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

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 www.healthypeople.gov

 

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.

 

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.


Security Clearance Requirement

All individuals who will be performing work under a grant or cooperative agreement in a HHS/CDC-owned or leased facility (on-site facility) must receive a favorable security clearance, and meet all security requirements. This means that all awardees employees, fellows, visiting researchers, interns, etc., no matter the duration of their stay at HHS/CDC must undergo a security clearance process.

 

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:

a.      In a timely manner.

b.      Completely, and as accurately as possible.

c.       To facilitate the broader community.

d.      Developed in accordance with CDC policy on Releasing and Sharing Data.

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

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

National Historic Preservation Act of 1966 (Public Law 89-665, 80 Stat. 915)

 

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

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

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

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

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

Conference Disclaimer and Use of Logos

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

 

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

 

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

 

 


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

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

CDC Forms Web Page: http://www.cdc.gov/od/pgo/funding/grants/app_and_forms.shtm