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

Coordinating Center for Health Promotion (CCPH) at http://www.cdc.gov/about organization/cchp.htm, National Center on Birth Defects and Developmental Disabilities (NCBDDD/CDC) http://www.cdc.gov/ncbddd 

Title:  Impact of Tic Disorders, including Tourette Syndrome, in Youth, on Individuals, Families and Communities (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 317(C) of the Public Health Service Act [42 U.S.C. Section 241.]  

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 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-O9-004

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

Key Dates
Release/Posted Date:
February 09, 2009

Letter of Intent Receipt Date: March 09, 2009

Application Submission Receipt Date: April 09, 2009

Peer Review Date: May, 2009

Secondary Review Committee Date: June, 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 investigate the impact of Tic Disorders, including Tourette Syndrome, on children and adolescents, families, and communities.  Data will be collected and analyzed to assess the impact of tic symptom severity and morbidity, as well as the presence and impact of co-occurring psychiatric disorders (including attention-deficit hyperactivity disorder), on youth and their families.  

·          FY08 Conference Report (110) language commends CDC’s work regarding Tourette Syndrome and supports the continuation of funding to implement public health education and research program to expand the scientific knowledge base on prevalence, risk factors and co-morbidities of Tourette Syndrome.  

·          Anticipated number of awards: Up to two.  Awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications.

·          Budget Period, Project Period, and Award Amounts:  It is expected that the average award 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.

·          Number of applications: Only one application from each organization may be submitted for this announcement. 

·          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 FOA addresses “Healthy People 2010” priority area of disability and secondary conditions and is in alignment with NCBDDD’s 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 see, www.healthypeople.gov and http://intra-apps.cdc.gov/fmo/

Nature of the Research Opportunity

This FOA solicits proposals in the form of cooperative agreements to conduct research on tic disorders and the impact of the disorder on children and adolescents, their families, and communities.  Grantees will collect and analyze data to assess the impact of tic symptom severity and morbidity, co-occurring psychiatric disorders and overall morbidity, and tic disorders with subtle neurocognitive deficits on youth and their families.  Areas of impact will include one or more of the following:  degree of cost, disability, disparity in diagnosis, treatment and/or access to care, quality of life, adequacy of insurance coverage for treatment of symptoms associated with tic disorders, satisfaction with services, impact on family functioning, school functioning, teacher-child relationships, peer relationships, peer victimization, typical treatments for Tourette Syndrome, the distribution of services (coordination of care) and presence and impact of explosive and disruptive behavior (“rage attacks”). 

Background

There is limited data available on the impact of tic disorders including Tourette Syndrome on individuals and their families. Specifically, there is limited information available describing the quality of life of children with tic disorders, and the impact of tic disorders on various aspects of family functioning, and a scarcity of information on disparities in knowledge, diagnosis and treatment of tic disorders, health care needs and service use among these children, and the economic impact of tic disorders.   

Research is needed to gain a better understanding of the public health burden of the condition and the specific challenges faced by youth with tic disorders and their families.  Because of the high rate of co-occurring conditions in children with tic disorders, including attention-deficit hyperactivity disorder (ADHD), defining burden will likely be complicated by the presence of different conditions, as well as the severity of tic symptoms.  

Scientific Knowledge to be Achieved through this Funding Opportunity Announcement

Rigorous methodology using appropriate samples is needed to define the impact of tic disorders, including Tourette Syndrome, on children and adolescents with the condition, their families, and communities.  Findings from this research will 1) provide accurate data on the impact of tic disorders on youth with the condition and their families, 2) provide a better understanding of the specific challenges faced by individuals with tic disorder, and 3) provide data that will aide in the development of programs and interventions that will improve quality of life for individuals with tic disorders and their families.  It is anticipated that data on measures of impact can also be used to help guide local, state and national policies and to guide services for children and adolescents with tic disorder and their families or caregivers.  

Research Objectives and Experimental Approaches:

The research objective of this program is to improve the lives of youth with tic disorders, including Tourette Syndrome, and their families by using the knowledge gained from this research to guide the development of interventions and community services.  Grantees funded under this FOA will identify a study population of youth under 18 years of age with tic disorders, assess the presence of co-occurring conditions, and evaluate and describe at least one, but preferably multiple, area(s) of impact with regard to symptom severity, presence of comorbid conditions, and demographic characteristics. 

Proposed research activities should be based on an understanding of issues, challenges, complexity and barriers associated with developing and implementing a study to describe the impact of tic disorders.  The study population should include families with a child under the age of 18 with a tic disorder, including a sample of children with Tourette Syndrome (as seen in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)), ADHD, and control families, as defined by the applicant.  The actual sample size will depend on the outcomes, hypotheses, and the power analysis. 

In their proposal, applicants should describe the epidemiological methods that will be used to address the specific objectives defined in their study.  Proposals should describe the study design that will be used to measure the impact of tic disorders relative to controls.  Data collection may include the use of surveys (paper, phone, in-person), interviews, medical chart review, review of insurance claims or other methods.   

The study population should be ethnically and racially diverse and should be assessed for the presence of co-occurring conditions, including ADHD, Obsessive Compulsive Disorder (or Obsessive Compulsive Behaviors), Depression and Anxiety Disorders, and Learning Disorders.  Data collected from the study population should document the impact of the disorder and comorbid conditions on at least one of the following: degree of cost, disability, disparity in diagnosis, treatment and or access to care, quality of life, adequacy of insurance coverage for treatment of symptoms associated with tic disorders, satisfaction with services, impact on family functioning, school functioning, teacher-child relationships, peer relationships, peer victimization, typical treatments for Tourette Syndrome, the distribution of services (coordination of care) and presence and impact of explosive and disruptive behavior (“rage attacks”). 

Grantees will be responsible for developing, managing and documenting a study database.  Data management procedures should 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 should include the design and oversight of the collection, editing, and computer entry of all study data.  

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 U01 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

The participating Centers, Institutes and Offices (CIO), NCBDDDD, intends to commit approximately $400,000 in total costs (direct and indirect) in FY2009 to fund up to 2 applications.  The average award amount will be up to $200,000 in total costs for the first 12-month budget period.  An applicant may request a project period of up to three years. The approximate total project period funded amount is $1.0M. The anticipated start date for new awards is September 30, 2009.  

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. 

Facilities and Administrative 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 tic disorders.

-          Population will include at least 100-200 youth with tic disorders, including a sample of youth with Tourette Syndrome and ADHD. 

-          Documentation must be provided in the form of a thorough description of the population from which the study participants will be recruited.  

-          If multiple sources are necessary to obtain study participants (i.e., school systems, parent groups, or others for the purpose of case ascertainment), 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 Date: 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, Room 5517 - (Mailstop 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 424 R&R instructions, follow the instructions in this announcement.

 

To submit an application in response to this FOA, applicants should access this FOA via 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, and HHS/CDC will discard it. You will receive notification that you did not meet the submission requirements. 


3.C. Application Processing

HHS/CDC must receive applications on or before 5:00 P.M. Eastern Standard Time on the application submission date(s) described above (Section IV.3.A.). If HHS/CDC receives an application after that submission date and time, the application may be delayed in the review process or not reviewed.

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 the Coordinating Center for Health Promotion 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 entire three year project period.  Applicant should clearly describe the study design, recruitment methods, data collection, analysis, presentation of the data, and a timeline of activities.  In their proposal, applicants should include information on the following: 

  1. A staffing plan that includes a description of the research team’s qualifications and experience in relevant methods, survey design, data management and analysis, and knowledge of tic disorders and other related disorders.  An organizational chart should be included in the application.
  2. A clear description of the proposed research study, including rationale, short and long-term goals and objectives, and a project timeline.  The research plan should clearly state the measures of impact selected for the study.  Measures of impact should include at least one of the following:   degree of cost, disability, disparity in diagnosis, treatment and or access to care, quality of life, adequacy of insurance coverage for treatment of symptoms associated with tic disorders, satisfaction with services, impact on family functioning, school functioning, teacher-child relationships, peer relationships, peer victimization, typical treatments for Tourette Syndrome, the distribution of services (coordination of care) and presence and impact of explosive and disruptive behavior (“rage attacks”).
  3. A description of the community and demographic characteristics from which cases of tic disorders, including Tourette Syndrome and ADHD will be selected as well as an appropriate comparison group or groups.  The population must be ethnically and racially diverse.  The setting must be specifically defined and characteristics of the setting must be described in the application.  If multiple sources are necessary to obtain study participants (i.e., school systems, parent groups, or others for the purpose of case ascertainment), Letters of support from each source must be included with the application.
  4. A description of how the sample population, at least 100-200 children and adolescents aged 18 and under with tic disorders, will be identified.  Youth (cases) must meet current diagnostic criteria for tic disorders, and include a sample of youth with Tourette Syndrome, as seen in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV).  The specific tic disorder should be specified, including the severity of symptoms related to the disorder.
  5. Identification and recruitment of an appropriate sample of control youth and a clearly documented mechanism and methods through which these comparison families will be recruited.
  6. Complete power analyses to determine an appropriate sample size and a description of the expected participation rate.
  7. A description of the methods that will be used to collect and analyze study data.  Data collection may include the use of surveys (paper, phone, in-person), interviews, medical chart review, review of insurance claims or other methods.  The survey should include the following demographic information:  age, sex, race, ethnicity, income, insurance coverage, parental mental health.  Other factors may include family history of tic disorders (or co-occurring conditions), age of tic symptom onset, family history of tic disorders and other mental disorders, and appropriate genetic or biological measures.
  8. A description of how the presence of co-occurring conditions will be identified in the study population.  Co-occurring conditions include ADHD, Obsessive Compulsive Disorder (or Obsessive Compulsive Behaviors), Depression and Anxiety Disorders, and Learning Disorders.  Co-occurring conditions should be assessed using current diagnostic criteria and functional impairment should be established for case identification.  Where appropriate, diagnostic rating scales using the DSM IV symptom criteria in its entirety must be used.
  9. A description of possible collaborative relationships with other institutions or relevant stakeholders that may enhance the study and future research activities.
  10. A plan to train staff on case ascertainment and study methodology.
  11. A description of quality assurance procedures and a specific evaluation plan for the completeness and validity of data from the survey.
  12. A description of a plan to disseminate study findings.

 

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”.

 

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

·         Population criteria; access to a population that is ethnically and racially diverse that meets the study criteria

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/CCPH.   

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 understanding of issues, challenges, complexity and barriers associated with developing and implementing a study to describe the impact of Tic disorders, including Tourette Syndrome, case ascertainment for the tic disorders and does the application state a clear need for a study of the impact of Tic disorders? Does the applicant show access to an appropriate population for recruitment for an adequate sized sample? Does the research proposal address multiple areas of impact?

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? Are the objectives consistent with the stated goals and purpose of the announcement and proposed program methodology? Does the applicant identify and define the community for the proposed research to include size and demographic characteristics?  Is the proposed population ethically and racially diverse?  Will the population from which the study population will be recruited provide a large enough sample size for adequate study power?  Is the proposed timeline adequate to meet research objectives? 

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

Does the applicant demonstrate capacity to conduct the proposed research?  Does the applicant propose appropriate data collection methods (i.e., investigator-initiated survey questions or modules, including specific questions or types of questions, existing scales or inventories) and describe why these additions are relevant and important to the intent of this project?

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?

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 September 30, 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 and collecting consent/assent from study participants before any identifiable information is collected, seeking a Certificate of Confidentiality. Only de-identifiable data will be delivered to CDC.

5.      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.   

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 includes: 

1.      Assisting and overseeing the development or choice of surveys to assess application questions.  The specific measurement protocol will be drafted in collaboration with CDC and finalized only upon approval of CDC.

2.      Providing current information pertaining to survey methods, including technical information on tic disorders, selected co-occurring conditions, and available information on impact of tic disorders

3.      Assisting with the development of quality assurance procedures. 

4.      Collaborating on development of an evaluation plan to assure completeness and validity of survey data.

5.      Coordinating cross-site training and maintaining documentation on reliability of study assessments.

6.      Providing technical consultation regarding data analysis as requested. 

 

CDC Scientific Program Administrator (SPA) 

The CDC, ERPO/CCPH 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
 

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.  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. 

CDC and grantees will: 

1.      Establish and provide leadership for collaborative activities and processes;

2.      Communicate/coordinate collaborative activities to improve the overall quality of the studies and ensure data quality; and

3.      Develop cross-site operations manual, data entry procedures, data sharing procedures and approved publication plan.

4.      Grantees 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.  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 project.   


E
ach 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 he 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, Mailstop 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, Mailstop K-92

2877 Brandywine Road

Atlanta, GA  30341

Telephone: 770-488-8390

Fax: 770-488-8046

 

3. Financial or Grants Management Contacts:

Tracey Sims

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, Room 3000

2920 Brandywine Road, Mailstop E-09

Atlanta, GA  30341

Telephone: (770) 488-2739

Fax: (770) 488-2777

Email: atu9@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. 

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.htm 

Indian tribes must request tribal government review of their applications.

 

Specs 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:

Tracey M. Sims, Grants Management Specialist
Procurement and Grants Office
Announcement Number DD09-004
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 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.

 

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.


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: 

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.

 

 


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