Part I Overview Information


United States Department of Health and Human Services (HHS)

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

Components of Participating Organizations
Coordinating Center for Health Promotion (CoCHP); National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), (http://www.cdc.gov/nccdphp); Office on Smoking and Health (OSH), (http://www.cdc.gov/tobacco/)
 
Title:  Assessment of Proposed Revisions to the Youth Tobacco Survey:  Impact on Measures of Youth Tobacco Use (U1A)    

The policies, guidelines, terms, and conditions of the HHS Centers for Disease Control and Prevention (CDC) stated in this announcement may 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 applicants will be directed elsewhere for that information. 

Authority:  Section 317(k)(2) of the Public Health Service Act (PHS Act), 42 U.S.C. 247b(k)(2); Section 301(a) of the PHS Act, 42 U.S.C. 241(a).

Announcement Type:  
New

Instructions for Submission of Electronic Research Applications:

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

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

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

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-DP-07-003

Catalog of Federal Domestic Assistance Number(s):
93.068

Key Dates
Release/Posted Date:  March 15, 2007
Letter of Intent Receipt Date:  April 11, 2007    
Application Submission Receipt Date:  May 11, 2007
Peer Review Date:  June 2007
Secondary Review Date:  July 2007
Earliest Anticipated Start Date:  August 15, 2007
Expiration Date: May 12, 2007

Due Date for E.O. 12372

Executive Order 12372 does not apply to this program.

Additional Overview Content

Executive Summary

Funding Opportunity Announcement Glossary: FOA Glossary Terminology

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
    1. Research Objectives

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

Section III. Eligibility Information
    1. Eligible Applicants
        A. Eligible Institutions
        B. Eligible Investigators
    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 for Chronic Disease Prevention and Health Promotion (NCCDPHP) 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 tobacco use and is in alignment with NCCDPHP’s performance goal to reduce cigarette smoking among youth.  For more information, see www.health.gov/healthypeople and www.whitehouse.gov/omb/mgmt-gpra/.

This FOA specifically supports the “Healthy People 2010” goal to reduce illness, disability, and death related to tobacco use and exposure to secondhand smoke, and contributes toward the achievement of the following objectives:  1) to reduce tobacco use by adolescents, 2) to increase the average age of first use of tobacco products by adolescents and young adults, and 3) to increase adolescents’ disapproval of smoking.

Nature of the Research Opportunity

This FOA solicits applications in the form of cooperative agreements to conduct research that will enhance the evaluation and surveillance capabilities of the state Youth Tobacco Survey (YTS).  The YTS is used by states to evaluate the effectiveness of state tobacco control interventions and track tobacco use, attitudes and related behaviors among youth in middle schools and high schools.  Recently, the CDC Youth Tobacco Survey (CDC YTS) Workgroup proposed revisions to several outcome measures on the state YTS to improve their readability, applicability and capacity in measuring specific indices from the 2005 publication Key Outcome Indicators for Evaluating Comprehensive Tobacco Control Programs.  The CDC YTS Workgroup adopted a two-phase process to revise the state YTS that involves the incorporation of key indicators into the survey and revisions to existing questions.

This FOA will support the administration of a split-sample or split-ballot of the YTS to be conducted by states in either the fall 2007 or spring 2008 data collection cycles to assess whether current estimates of performance (e.g., prevalence of current tobacco use, ever use, cessation) will be affected by changes in the wording and format of the proposed revised questions.  If differences in the performance estimates are observed between the original state YTS questions and the proposed YTS questions, this research will provide information on the effect of these question changes on the outcome measures and assess the direction and magnitude of the differences in the measures.  The results of this research may be used to provide guidance to states on using the YTS to evaluate programs and monitor trends in youth tobacco use.

The research funded through this FOA constitutes an essential step in the thorough revision of the indicators used by the YTS to measure state’s progress as part of the National Tobacco Control Program (NTCP) in meeting goals to reduce initiation and increase cessation among youth.  This research is critical to aligning the state YTS survey measures with the Key Outcome Indicators for Evaluating Comprehensive Tobacco Control Programs and will represent the most up-to-date and expert opinion on key evaluation measures for youth tobacco control. 

Background

After reaching financial settlements with the tobacco industry, the states of Florida, Mississippi, and Texas conducted the first Youth Tobacco Surveys in the spring of 1998.  Technical assistance was requested from the CDC Office on Smoking and Health (OSH) to aid in the collection of baseline data with respect to youth tobacco use.  In November 1998, OSH conducted the first YTS workshop for states to develop a core questionnaire and review procedures for sampling, analysis and reporting of data.   As part of the workshop, states developed a core YTS questionnaire consisting of 54 tobacco-specific questions and a set of optional questions that could be added to meet the individual evaluation and surveillance needs of each state.  During the spring of 1999, nine states conducted state-specific Youth Tobacco Surveys: Arkansas, Florida, Georgia, Kansas, Mississippi, Missouri, Oklahoma, Tennessee, and Texas.

The second YTS workshop was held in September 1999.  Once again, core questions, sampling, analysis, and data reporting procedures were reviewed.  State representatives updated the core YTS questionnaire to include 64 tobacco-specific questions and revised the set of optional questions that could be added to meet the individual evaluation and surveillance needs of each state.  Four states conducted state-specific Youth Tobacco Surveys in the fall of 1999, 22 during spring of 2000, 8 during fall of 2000, and 11 during the spring of 2001.  Since that time, approximately 20 states, on average, have participated each year.

Over the past two years, the CDC YTS Workgroup has applied a two-phase process to revise the state YTS format and questions and align them with the key outcome indicators for tobacco control evaluation from the Key Outcome Indicators for Evaluating Comprehensive Tobacco Control Programs.  Published in May 2005 the Key Outcome Indicators for Evaluating Comprehensive Tobacco Control Programs (PDF - 3.28 MB) was developed to help state and territorial health departments plan and evaluate state tobacco control programs.  It describes, in detail, 120 indicators that have been scientifically linked to tobacco control program outcomes.  Bringing the current state YTS questionnaire into agreement with the recommendations of this publication is critical to achieving best practices for tobacco control in the NTCP and meeting national health objectives for decreasing tobacco use among youth.

In Phase I, modifications were made to the questionnaire that did not involve changing question wording.  State YTS core survey questions (i.e., questions that can apply to all states) were scrutinized to ensure that all key indicators relevant to youth tobacco use were included.  Core questions that did not relate to a key indicator became supplementary questions, thus reducing the number of core items from 64 to 41.  The 23 questions that were previously in the core, but were not measuring key indicators, were included in the revised questionnaire, but were labeled “supplementary”.  In addition, seven questions that did not reference key indicators, but had been used often by states in the past, were included in the questionnaire as supplementary questions. 

New questions that measure important aspects of tobacco control programs that can be found in Key Outcome Indicators for Evaluating Comprehensive Tobacco Control Programs were added to the questionnaire.  Nine of these new questions were placed among the core items for a total of 50 core questions. The revised core and supplementary items were arranged in a logical order for use by the states.  The revised final questionnaire with the changes from Phase I contains 81 items that states can use in their YTS surveys.  Phase I was completed in the summer of 2006 and the revised questionnaire was used by states for the first time in the fall of 2006.

In Phase II of the state YTS revision, the CDC YTS Workgroup focused on question wording.  After extensive review, input from states and partners, and consultation with experts on questionnaire design, the workgroup proposed revisions to the questions that measure prevalence of current and past tobacco use, interest and experience with cessation, and exposure to secondhand smoke, among others, to improve the measurement of these key indicators for tobacco control.  The proposed questions were cognitively tested to ensure that middle school and high school students interpreted the items correctly, resulting in further revisions to the wording of the state YTS questions. 

The intent of this FOA is to assess whether the question wording changes from Phase II of the proposed revision of the state YTS affect responses to key questions, and consequently to any estimates that are made using these questions.  It will support the administration of a split-sample (split-ballot) survey of sufficient size to provide reliable estimates, determine whether there are significant differences in the estimates derived from the original state YTS survey questions compared to the proposed state YTS survey questions, and quantify the direction and magnitude of any identified differences.  Creative suggestions and possible solutions for state-based surveillance and evaluation activities will be proposed for addressing any differences that result from changes in question wording.  It is anticipated that study findings will be showcased at a special session of a national tobacco control meeting.

Scientific Knowledge to be Achieved

The research supported by this FOA will increase our knowledge of appropriate and effective measures for evaluation and surveillance, and prevention and control strategies for reducing tobacco use among youth in the United States.  It is anticipated that estimates of the impact of the proposed revision of the YTS questions will provide states with improved data and increase their ability to measure youth tobacco use and evaluate the effectiveness of state-level tobacco control programs. 

Research Objectives and Experimental Approach

The research objective of this FOA is to improve the measurement of tobacco use and cessation in the state YTS.  Using a split sample (split-ballot) survey, this project will compare the estimates resulting from the proposed revised state YTS questions (e.g., prevalence of current use, ever use, cessation of tobacco use in youth) to those from the original 2006 state YTS and examine the effect of the proposed question changes. 

In split sample tests two or more versions of a question are administered to a random selection of individuals, using the same procedures for selection and administration.  Predetermined sample size calculations are carried out in order to determine that the sample sizes are adequate for assessing the differences of interest.  State-level estimates for selected YTS variables will be determined using the proposed revised state YTS questions and comparing those estimates with ones made using the original 2006 state survey questions, conducted using the same sampling frame, sampling strategy, methods, and data collection procedures at the same time.  Changes in question wording between the two survey versions will be examined to identify the direction and magnitude of the differences in their ability to measure prevalence, interest in, and experience with state-level tobacco use.

Awardees may administer the proposed revised YTS in either the fall 2007 or spring 2008 state YTS administration cycle.  It is essential that the two state surveys be conducted simultaneously and in the same manner utilizing the established YTS protocol for states.  Following is a brief description of the state YTS protocol:

Sampling:  The state YTS uses a two-stage sample design for 1) the selection of schools, and 2) the selection of classes and students within the schools.  Eligible schools include middle schools, junior high and high schools (or any school that consists of students in grades 6-12).  Each student must have an equal probability of selection.

Response Rates: School, Student, and Overall.  All three of these response rates must be reported for the sample completing the original questionnaire and for the sample completing the proposed revised questionnaire.

Weighting: The following three criteria are used in determining whether a data set can be weighted; the sampling method, selection probabilities are known for each student, and the overall response rate is at least 60%.

Protocol:  The state YTS has specific guidelines for contacting schools, obtaining parental permission, and classroom administration.  There are clear instructions for the roles of the various personnel in the schools and classrooms. 

Analyzing the Data:   Analysis of the standard state YTS data consists of two phases.  Questionnaires are sent to CDC for processing.  The weighted data is then analyzed and estimates made.  In the calculation of standard YTS sampling errors, it will be necessary to include the stratum, primary sampling units, and final sampling weight, all of which are provided by CDC.

The full state YTS protocol can be accessed at:  http://www.cdc.gov/tobacco/yts.htm   

A preliminary report of the results of this research must be submitted by January 4, 2008 for the fall cycle or by June 2, 2008 for the spring cycle.  It is anticipated that CDC will use the findings from this research to provide guidelines to states for interpreting the proposed revised measures of the state YTS to improve their ability to monitor trends in youth tobacco use and evaluate tobacco-control programs.   

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

Section II. Award Information


1. Mechanism(s) of Support

This funding opportunity will use the U1A activity code.  The HHS/CDC U1A is a cooperative agreement assistance instrument.  Under the cooperative agreement assistance instrument, the Recipient Organization retains the primary responsibility and dominant role for planning, directing, and executing the proposed project with HHS/CDC staff substantially involved as a partner with the Recipient Organization, as described in Section VI.2.A., "Cooperative Agreement”.

2. Funds Available

The participating Center, Institutes and Office (CIO), NCCDPHP, intends to commit approximately $200,000 (direct and indirect costs) in FY2007 to fund two cooperative agreements.  An applicant may request up to $100,000 in total costs, direct and indirect, for the 12 month budget period.  The total project period for awards funded under this FOA is 12 months. The anticipated start date for new awards is August 15, 2007.

All estimated funding amounts are subject to availability of funds.

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

Although the financial plans of the CIO are to provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds. 

Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

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

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

1.B. Eligible Investigators

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support.

The PD/PI or project lead must have experience leading teams in school-based survey data collection and analysis of large datasets related to youth tobacco use.  Evidence of such experience should be provided in the curriculum vitae and publications within the last five years. 

2. Cost Sharing or Matching

Cost sharing or matching funds are not required for this program.

The most current HHS Grants Policy Statement is available at: http://www.cdc.gov/od/pgo/funding/HHS_GPS_Oct_2006.doc

3. Other-Special Eligibility Criteria

The following criteria will be used to determine the applicant ’s eligibility:

•     The project team must have experience in school-based survey data collection, and in the synthesis, analysis, and dissemination of data related to youth tobacco use.  Evidence of such experience should be provided in the form of publications and/or reports within the last five years on:  1) the prevalence of tobacco use among youth; and 2) the knowledge, attitudes, and behaviors associated with tobacco use among youth;

•     The project team must have access to all of the study information necessary to conduct the research.  The team must provide Letters of Support assuring access to data from either the fall 2007 or spring 2008 state YTS;

•     The project team must have access to the schools and the study populations necessary to conduct the state YTS survey that incorporates the proposed revised questions.  Evidence should be provided in the form of Letters of Support assuring access to the schools in which the surveys will be conducted.

•     Evidence of capacity and infrastructure to coordinate the research/surveillance and evaluation of state school-based surveys in tobacco use.  Applicants must provide evidence in the form of summaries of existing data collected in the last five years showing the prevalence of tobacco use among youth and associated knowledge, attitudes, and behaviors by age, sex, and race/ethnicity; and

•     Evidence of the project team’s experience within the past five years in collaborating with other partners (e.g. schools, states, education agencies, etc.) on evaluation and surveillance related to tobacco use in a study that included:  1) a common protocol; 2) the development of methods and procedures; 3) design of instruments; 4) the collection, analyses, and interpretation of data; and 5) the dissemination of results.  Applicants should provide evidence of previous collaborations with other institutional partners in the form of publications or reports.

Eligible institutions may submit only one application under this announcement.

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

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

Section IV. Application and Submission Information


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

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

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

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

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

2) Organizational/Institutional Registration in the eRA Commons

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

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

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

1. Request Application Information

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

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

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 Subaward Budget Attachment(s) Form

Note: While both budget components are included in the SF424 (R&R) forms package, the CDC U1A activity code uses ONLY the detailed Research & Related Budget. (Do not use the PHS 398 Modular Budget.)

3. Submission Dates and Times

3.A. Submission, Review and Anticipated Start Dates
Letter of Intent Receipt Date:  April 11, 2007  
Application Submission Receipt Date:  May 11, 2007  
Peer Review Date:  June 2007  
Council Review Date:  July 2007  
Earliest Anticipated Start Date:  August 15, 2007

3.A.1. Letter of Intent

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

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

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

The letter of intent should be sent to:

Brenda Colley Gilbert, PhD, MSPH
Office of Extramural Research
National Center for Chronic Disease Prevention and 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
FAX:   (770) 488-8046
Email: bjc4@cdc.gov

3.B. Submitting an Application to CDC

If the instructions in this announcement differ in any way from the 424 R&R instructions, follow the instructions in this announcement.

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. If submittal of the application is done electronically through Grants.gov (http://www.grants.gov), the application will be electronically time/date stamped by Grants.gov.  Applicants will receive an e-mail notice of receipt from Grants.gov when HHS/CDC receives the application. 

All requested information must be received in the HHS/CDC Procurement and Grants Office by 5:00 p.m. Eastern Standard Time on the deadline date. If an applicant submits materials by the United States Postal Service or commercial delivery service, you must ensure that the carrier will be able to guarantee delivery by the closing date and time.  If HHS/CDC receives your submission after closing because of : (1) carrier error, when the carrier accepted the package with a guarantee for delivery by the closing date and time; or (2) significant weather delays or natural disasters, you have the opportunity to submit documentation of the carrier’s guarantee.  If the documentation verifies a carrier problem, HHS/CDC will consider the submission as having been received by the deadline. 

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

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

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

Technical Information Management Section – DP07-003

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

3.C. Application Processing

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

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.

Upon receipt, applications will be evaluated for completeness and responsiveness by NCCDPHP 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.

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

6. Other Submission Requirements

The following other submission requirements should be included in the application:

1.   A description of the plan to test the changes in question wording and the methods that will be used to achieve a valid comparison of the proposed revised state YTS questions and the original 2006 questions and how CDC’s technical support on split-sample methodology will be incorporated into project plans.  The plan must adhere to the requirements stated in this announcement. 

2.   A description of the study population and a justification of the sample size.

3.   A description of the sample selection criteria that will be provided to CDC for sample selection.

4.   A description of potential limitations of the proposed methods and how they will be addressed in the data collection, analysis and interpretation of the findings.

5.   A description of the split-sample (split-ballot) data that will be examined to determine the impact of the proposed revised question wording on the survey estimates. 

6.   A description of the detailed analysis that will identify the direction and magnitude of the changes to key indicators for measures of prevalence of current and past tobacco use, interest and experience with cessation, exposure to secondhand smoke, etc.

7.   A proposed timeline of activities over the 12 month project period.  The timeline must adhere to the CDC reporting requirements stated in this announcement.

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

If you are requesting indirect costs in your budget, you must include a copy of your indirect cost rate agreement.  If your indirect cost rate is a provisional rate, the agreement should be less than 12 months of age.  If submitting electronically, use a PDF version of the agreement, attach it in Grants.gov under “Other Attachments”, and title it appropriately. 

Applicants’ research plan should address activities they will conduct over the entire project period.

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:  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.

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 PHS398 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.

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

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.cdc.gov/od/pgo/funding/HHS_GPS_Oct_2006.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.

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 NCCDPHP in accordance with the review criteria stated below.

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

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

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?

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 provide documentation on what criteria will be provided to CDC for sample selection?  Does the applicant provide documentation on access to the sample for data collection in conjunction with the fall 2007 or spring 2008 state YTS data collection?  Does the applicant demonstrate and provide detailed calculations of how to meet the standards in state YTS response rates?  Does the applicant provide a detailed analysis plan that will determine the direction and magnitude of any potential differences in estimates between the proposed revised YTS questions the original 2006 state YTS questions?  Is the timeline sufficient to meet the goal of the FOA to collect data in the fall 2007 or spring 2008, producing a preliminary report by January 4, 2008 (fall cycle) or June 2, 2008 (spring cycle), and completing the project within the 12 month project period?  Does the applicant provide clear descriptions of the limitations of the methods that are being proposed and the justification and explanation of how they will be addressed in the data collection, analysis and interpretation of the findings?  Does the applicant provide explanations on the completeness and relevance of the information that will be examined in order to determine the impact of the proposed revised question wording on the survey estimates?  Does the applicant provide justification for the adequacy of the proposed sample size to meet the 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 project team have statistical expertise in survey data collection methods (e.g. survey estimation, sampling, statistical analysis, and survey development)?  Does the project team have experience in conducting the state YTS or similar school-based surveys?  Does the project team demonstrate experience in survey estimation, survey development, and split-sample or split-ballot administration and analysis?   

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 show documented proof of access to the YTS population in the state for either the fall 2007 or the spring 2008 administration?  Does the applicant show documented proof of access to the fall 2007 or spring 2008 YTS data in the state?

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.

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

HHS/CDC expects to announce awards in August 2007.

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 in Section VIII. Other Information of this document or on the HHS/CDC website at the following Internet address: http://www.cdc.gov/od/pgo/funding/ARs.htm. These will be incorporated into the NoA by reference.
 

The following terms and conditions will be incorporated into the NoA and will be provided to the appropriate institutional official and a 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 U1A 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.   Coordinating and conducting data collection, quality control, data analysis and interpretation, including analyzing the information from the proposed revised YTS state questions and comparing the results to the original state YTS survey questions.

2.   Promoting and facilitating a collaborative environment with the study schools.

3.  Establishing and maintaining relationships with the survey group that conducts the YTS in the state.

4.  Conducting the survey according to the state YTS protocol provided by CDC to the states and providing on-going information to CDC on any changes or modifications.

5.  Communicating with CDC on a regular basis about the progress of the research (information on the sample, protocol, design, methods, data analysis, etc.), providing statistical reports, and communicating with other investigators.

6.   Assuring and maintaining confidentiality of all relevant data.

7.   Obtaining IRB approval for the project.

8.   Proposing innovative strategies and solutions for state-based surveillance and evaluation programs in addressing any observed differences in key estimates between the original and revised YTS surveys.

9.   Producing a preliminary report of the results by January 4, 2008 for a fall 2007 sample or June 2, 2008 for a spring 2008 sample.

10. Preparing materials for publications and presentations on the findings of the research.

11. Participate in a special session on study findings at a national tobacco control conference. 

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, and applicable HHS/CDC policies.

2.A.2. HHS/CDC Responsibilities

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

1.      Supporting the grantee by providing scientific and public health consultation and assistance in the development of the activities of the project.

2.      Providing technical assistance directly or through a designated representative on split sample methodology and study design.

3.      Providing technical assistance on the use of the revised YTS questions in the state-specific questionnaire.

4.      Ensuring adherence of human subjects requirements and approval of study protocol by appropriate local IRBs.

5.      Assisting in facilitating communication among study investigators/project teams.

6.      Selecting and providing the YTS state sample to the grantee using their specifications.

7.      Providing a weighted data set in a timely fashion following receipt of the data sheets from the grantee.

8.      Providing written guidelines to the states who will be conducting the state YTS on the impact of the revisions to questions on survey estimates.

9.      Providing technical assistance in developing, writing, and publishing scientific manuscripts and reports.

10.  Assisting in the development and implementation of a special session on study findings at a national tobacco control conference.

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

The Recipient and HHS/CDC will have joint responsibility for the following:

  1. Reporting the findings and recommendations from this research project through presentations, technical reports, and manuscripts for peer-reviewed publications.
  2. Disseminating the findings and recommendations from this research to the states for conducting and analyzing future Youth Tobacco Surveys.

3. Reporting

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

1.   A preliminary report of the results of the research by January 4, 2008 for the fall 2007 YTS cycle or by June 2, 2008 for the spring 2008 YTS cycle. 

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

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

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

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, PhD, MSPH
Office of Extramural Research, NCCDPHP
National Center for Chronic Disease Prevention and 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: bjc4@cdc.gov

2. Peer Review Contacts:

Scientific Review Service
Office of Public Health Research
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services
1600 Clifton Road NE, MS D-72
Atlanta, GA  30333
Telephone: (404) 639-4621
Email: cmj3@cdc.gov

3. Financial or Grants Management Contacts:

Lucy Picciolo, Grants Management Specialist
Procurement and Grants Office
Centers for Disease Control and Prevention
U.S. Department of Health and Human Services
Koger Center-Colgate Building,
Room 3000, MS E-09
2920 Brandywine Road
Atlanta, GA  30341
Telephone: (770) 488-2777
Email: LPicciolo@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.

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

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

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

1.           A description of the population to be served.

2.           A summary of the services to be provided.

3.           A description of the coordination plans with the appropriate state and/or local health agencies.

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

Paperwork Reduction Act Requirements

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

Smoke-Free Workplace Requirements

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

Healthy People 2010

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Lobbying Restrictions

Applicants should be aware of restrictions on the use of HHS funds for lobbying of Federal or State legislative bodies. Under the provisions of 31 U.S.C. Section 1352, recipients (and their sub-tier contractors) are prohibited from using appropriated Federal funds (other than profits from a Federal contract) for lobbying congress or any Federal agency in connection with the award of a particular contract, grant, cooperative agreement, or loan. This includes grants/cooperative agreements that, in whole or in part, involve conferences for which Federal funds cannot be used directly or indirectly to encourage participants to lobby or to instruct participants on how to lobby.

In addition no part of HHS/CDC appropriated funds, shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support or defeat legislation pending before the Congress or any State or local legislature, except in presentation to the Congress or any State or local legislature itself. No part of the appropriated funds shall be used to pay the salary or expenses of any grant or contract recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress or any State or local legislature.

Any activity designed to influence action in regard to a particular piece of pending legislation would be considered "lobbying." That is lobbying for or against pending legislation, as well as indirect or "grass roots" lobbying efforts by award recipients that are directed at inducing members of the public to contact their elected representatives at the Federal or State levels to urge support of, or opposition to, pending legislative proposals is prohibited. As a matter of policy, HHS/CDC extends the prohibitions to lobbying with respect to local legislation and local legislative bodies.

The provisions are not intended to prohibit all interaction with the legislative branch, or to prohibit educational efforts pertaining to public health. Clearly there are circumstances when it is advisable and permissible to provide information to the legislative branch in order to foster implementation of prevention strategies to promote public health. However, it would not be permissible to influence, directly or indirectly, a specific piece of pending legislation

It remains permissible to use HHS/CDC funds to engage in activity to enhance prevention; collect and analyze data; publish and disseminate results of research and surveillance data; implement prevention strategies; conduct community outreach services; provide leadership and training, and foster safe and healthful environments.

Recipients of HHS/CDC grants and cooperative agreements need to be careful to prevent 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.

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 (HHS) regulations in Title 42 Part 93, Subparts A-E, entitled PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT.

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

For example:

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

Compliance with Executive Order 13279

Faith-based organization are eligible to receive federal financial assistance, and their applications are evaluated in the same manner and using the same criteria as those for non-faith-based organizations in accordance with Executive Order 13279, Equal Protection of the Laws for Faith-Based and Community Organizations.  All applicants should, however, be aware of restrictions on the use of direct financial assistance from the Department of Health and Human Services (DHHS) for inherently religious activities. Under the provisions of Title 45, Parts 74, 87, 92 and 96, organizations that receive direct financial assistance from DHHS under any DHHS program may not engage in inherently religious activities, such as worship, religious instruction, or proselytization as a part of the programs or services funded with direct financial assistance from DHHS.  If an organization engages in such activities, it must offer them separately, in time or location, from the programs or services funded with direct DHHS assistance, and participation must be voluntary for the beneficiaries of the programs or services funded with such assistance.  A religious organization that participates in the DHHS funded programs or services will retain its independence from Federal, State, and local governments, and may continue to carry out its mission, including the definition, practice, and expression of its religious beliefs, provided that it does not use direct financial assistance from DHHS to support inherently religious activities such as those activities described above.  A faith-based organization may, however, use space in its facilities to provide programs or services funded with financial assistance from DHHS without removing religious art, icons, scriptures, or other religious symbols.  In addition, a religious organization that receives financial assistance from DHHS retains its authority over its internal governance, and it may retain religious terms in its organization=s name, select its board members on a religious basis, and include religious references in its organization=s mission statements and other governing documents in accordance with all program requirements, statutes, and other applicable requirements governing the conduct of DHHS funded activities.  For further guidance on the use of DHHS direct financial assistance see Title 45, Code of Federal Regulations, Part 87, Equal Treatment for Faith-Based Organizations, and visit the internet site: http://www.whitehouse.gov/government/fbci/

Health Insurance Portability and Accountability Act Requirements

Recipients of this grant award should note that pursuant to the Standards for Privacy of Individually Identifiable Health Information promulgated under the Health Insurance Portability and Accountability Act (HIPAA) (45 CFR Parts 160 and 164) covered entities may disclose protected health information to public health authorities authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions.  The definition of a public health authority includes a person or entity acting under a grant of authority from or contract with such public agency.  HHS/CDC considers this project a public health activity consistent with the Standards for Privacy of Individually Identifiable Health Information and HHS/CDC will provide successful recipients a specific grant of public health authority for the purposes of this project.

Release and Sharing of Data

The Data Release Plan is the Grantee's assurance that the dissemination of any and all data collected under the HHS/CDC data sharing agreement will be released as follows:

  1. In a timely manner.
  2. Completely, and as accurately as possible.
  3. To facilitate the broader community.
  4. Developed in accordance with 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)

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. 

Conference Disclaimer and Use of Logos

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

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

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


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices


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