Centers for Disease Control and Prevention (CDC), (http://www.cdc.gov); National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), (http://www.cdc.gov/nccdphp)

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

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.

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).

Key Dates

Release/Posted Date: September 13, 2006

Letter of Intent Receipt Date: October 3, 2006
Application Submission Receipt Date: November 3, 2006
Peer Review Date(s): December 2006
Council Review Date(s): January 2007

Earliest Anticipated Start Date: February 1, 2007

Expiration Date: 11/04/2006

Executive Order 12372 does not apply to this program.

Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
   1. Research Objectives

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

Section III. Eligibility Information
   1. Eligible Applicants
       A. Eligible Institutions
       B. Eligible Individuals
   2.Cost Sharing or Matching
   3.Other - Special Eligibility Criteria

Section IV. Application and Submission Information
   1. Request Application Information
   2. Content and Form of Application Submission
   3. Submission Dates and Times
       A. Receipt and Review and Anticipated Start Dates
           1. Letter of Intent
       B. Submitting an Application to CDC
       C. Application Processing
   4. Intergovernmental Review
   5. Funding Restrictions
   6. Other Submission Requirements

Section V. Application Review Information
   1. Criteria
   2. Review and Selection Process
       A. Additional Review Criteria
       B. Additional Review Considerations
       C. Sharing Research Data
       D. Sharing Research Resources
   3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
   1. Award Notices
   2. Administrative and National Policy Requirements
       A. Cooperative Agreement

            1. Recipient Rights and Responsibilities
           2. 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

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.

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 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 the spring 2007 data collection cycle 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.

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 www.cdc.gov/tobacco/Indicators/KeyIndicators.htm 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 will be 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.

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.

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.

The administration of the proposed revised YTS must occur at the same time as the 2007 state YTS. 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 June 1, 2007 with the final report submitted by September 30, 2007. 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.

This funding opportunity will use the U1A activity code.

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

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.

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

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.

Cost sharing, matching funds, or cost participation are not required under this announcement.
The most current PHS Grants Policy Statement is available at: http://www.hhs.gov/grantsnet/gps/

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.

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

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

CDC strongly encourages all applicants to register in Electronic Research Administration (eRA Commons) as soon as possible. Although an eRA Commons account is not mandatory at this time, future FOAs may require your participation in eRA Commons to complete an electronic application submission through Grants.gov. Important information on registration can be obtained at the following:

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

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

1) Organizational/Institutional Registration in Grants.gov/Get Started

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.

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.

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:

SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person

PHS398 Cover Page Supplement
PHS398 Research Plan
PHS398 Checklist

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.)

See Section IV.3.A for details.

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

NCCDPHP, Office of Extramural Research
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

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.

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 – DP07-001

CDC, Procurements and Grants Office

U.S. Department of Health and Human Services

2920 Brandywine Road

Atlanta, GA 30341

Phone: (770) 488-2700

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.

Executive Order 12372 does not apply to this program.

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:

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

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.

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

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

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

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:

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 spring 2007 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 spring of 2007, producing a preliminary report by June 1, 2007 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 in the spring of 2007? Does the applicant show documented proof of access to the 2007 YTS data in the state?

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.

HHS/CDC expects to make this award on or about January 31, 2007.

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.

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.

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.

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

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 June 1, 2007 and the final report submitted by September 30, 2007.

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.

Brenda Colley Gilbert, PhD, MSPH
Office of Extramural Research, NCCDPHP

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 Administrator

Office of Extramural Research, NCCDPHP

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: oer@cdc.gov

3. Financial or Grants Management Contacts:

Annie Harrison-Camacho, 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, MS E-09

2920 Brandywine Road

Atlanta, GA 30341
Telephone: (770) 488-2735
Email: adharrisoncamacho@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

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.

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:

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.

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).

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.

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.

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.

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.

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:

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.

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.

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:

April 16, 2003, http://www.cdc.gov/od/foia/policies/sharing.htm, and in full compliance with the 1996 Health Insurance Portability and Accountability Act (HIPPA), (where applicable), The Office of Management and Budget Circular A110, (2000) revised 2003, www.whitehouse.gov/omb/query.html?

col=omb&qt=Releasing+and+Sharing+of+Data and Freedom of Information Act (FOIA) www.4.law.cornell.edu/uscode/5/5/552/html.

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

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:

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.