Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information regarding page limits and the FDA Peer Review Process.

Components of Participating Organizations

Center for Tobacco Products (CTP)

Funding Opportunity Title

The Tobacco Regulation Awareness, Communication, and Education Program (U1A)

Activity Code

U1A Capacity Building for Core Components of Tobacco Prevention and Control Program--Cooperative Agreements

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-12-002

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.058

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) is being issued to announce the availability of an estimated 12-15 cooperative agreements to be awarded under a Limited Competition for the Tobacco Regulation Awareness, Communication, and Education Program.

The purpose of the Tobacco Regulation Awareness, Communication, and Education Program is to assist entities to establish or expand health education and communication programs at the community level congruent with the Tobacco Control Act. 

The Program will advance public health by supporting community-based programs that work to identify and disseminate evidence-based, community-level best practices and improving access to standardized, community-level data. 

Strong applications will seek to educate and communicate to 1) promote the understanding of the consequences of tobacco use through individual and community actions; 2) protect youth from the dangers of tobacco use; and 3) increase cessation among those who use tobacco products.  Funding recipients must implement a comprehensive public education and/or communication program that addresses federal tobacco regulations and the public health goals which flow directly from them, as identified in the applicant’s needs assessment and that will improve health outcomes for members of target population(s).  

Key Dates
Posted Date

March 15, 2012

Open Date (Earliest Submission Date)

March 15, 2012

Letter of Intent Due Date

April 9, 2012

Application Due Date(s)

May 9, 2012 by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

June, 2012

Advisory Council Review

September, 2012

Earliest Start Date(s)

September, 2012

Expiration Date

May 10, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (R&R) Application Guide except where instructed to do otherwise in this FOA. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

AUTHORITY

The Tobacco Regulation Awareness, Communication, and Education Program is authorized by 42 USC 300u-3 of the Public Health Service Act and the Family Smoking Prevention and Tobacco Control Act (PL 111-31).

PROGRAM BACKGROUND

Tobacco use is the foremost preventable cause of premature death in America.  It causes over 400,000 deaths in the United States each year, and approximately 8.6 million Americans have chronic illnesses related to smoking.   A compelling body of evidence illustrates that tobacco products are inherently dangerous and cause cancer, heart disease, and other serious adverse health effects. 

On June 22, 2009, President Obama signed the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), P.L. 111-31, giving the Food and Drug Administration (FDA) regulatory authority over tobacco products. 

The Tobacco Control Act is a Federal law that gives FDA the authority to regulate the manufacturing, labeling, sale, distribution, advertising and promotion of tobacco products. The Tobacco Control Act recognizes that virtually all new users of tobacco products are under 18 – the minimum legal age to purchase these products.  Many new users will become addicted before they are old enough to understand the risks and ultimately will die too young of tobacco-related diseases. Among other central goals, the Tobacco Control Act seeks to prevent and reduce tobacco use by these young people.

Some key FDA activities authorized or required by the Tobacco Control Act include:

Please visit www.fda.gov/tobacco for more information on the Tobacco Control Act and related regulations, guidance, and other educational information.

To implement the new law, Congress directed the creation of the Center for Tobacco Products (CTP) at FDA.  CTP’s mission is to protect Americans from tobacco-related death and disease by regulating the manufacture, distribution, and marketing of tobacco products and by educating the public, especially young people, about tobacco products and the dangers their use poses to themselves and others. 

As noted in FDA’s Strategic Priorities for 2011-2015 (see Food and Drug Administration Strategic Priorities 2011-2015: Responding to the Public Health Challenge of the 21st Century), CTP’s mission focuses on two overarching priorities that support protection of the public’s health: tobacco regulation and communication/public education.   CTP’s long-term public health outcomes include:

CTP seeks to catalyze these outcomes, rooted in the Tobacco Control Act, through regulation, communication, and public education particularly as it pertains to: (1) promoting public understanding of tobacco products and risks associated with tobacco product use (including health and dependency effects, impacts of tobacco product ingredients and additives; and the life threatening health consequence of tobacco use); (2) reducing tobacco use among minors, which would prevent significant numbers of today’s children from becoming regular, daily tobacco product users, saving them from premature death due to tobacco-induced disease, and (3) increasing cessation among current (primary adult) tobacco product users. 

OVERARCHING PROGRAM GOAL

The goal of the Tobacco Regulation Awareness, Communication, and Education Program is to educate Americans about the risks of tobacco products. It seeks to increase capacity at the community level in the areas of health communication and education that address federal tobacco regulations and the public health goals of the Tobacco Control Act.  The Program will help increase knowledge and encourage long term behavior change which will contribute to reductions in the morbidity and mortality associated with tobacco use in the U.S.  

As highlighted above, these efforts are rooted in the Tobacco Control Act and in regulations CTP has and plans to issue.  For these measures, from the restrictions on the use of light, low, and mild descriptors to graphic health warnings, it is important that the public health intent be communicated to the public. This Program will help do that in local communities across the nation, catalyzing and learning from best practices, and complementing CTP’s regulatory and national health education and communication efforts.

Although FDA-centric, this Program involves extensive coordination with related Federal grant and cooperative agreement programs, like those administered by the Centers for Disease Control and Prevention, to create synergy and avoid duplication.

PROGRAM PURPOSE

The purpose of the Tobacco Regulation Awareness, Communication, and Education Program is to assist entities to establish or expand health education and communication programs at the community level congruent with current and future FDA tobacco regulation.

The Program will advance public health by supporting community-based programs that work to identify and disseminate evidence-based, community-level best practices and improving access to standardized, community-level data.

PROGRAM PRIORITIES

The Program’s grant funds would support eligible entities in carrying out their plans to establish or expand health communication and education programs congruent with the Tobacco Control Act.  Strong applications will seek to educate and communicate to:

The public education and/or communication program must include the following activities:

1)    Propose a communication/education project that is evidence-based and relies on:

2)    Demonstrate at least one collaboration between a governmental agency and a community-based partner to identify and implement innovative strategies to help reduce the harms caused by tobacco use and help strengthen and/or sustain new or existing health communication and education infrastructures in the community.

3)    Plan, build, adapt, or expand data collection, management, and reporting protocols for program activities. This data will be used by the funding recipient for program monitoring, continuous program improvements, and accountability.

4)    Evaluate program processes and outcomes, including formative and summative evaluation, to document and disseminate results and outcomes. 

Each applicant must propose to address at least one or more of the following audiences:

Program activities and strategies must be based on a needs assessment, a gap analysis based on what other tobacco control programs are doing, and science-based results and recommendations from published research synthesis and/or meta analyses, such as those outlined in the U.S. Community Guide for Preventive Services (see http://thecommunityguide.org/tobacco/index.html). 

Applicants must propose innovative, evidence-based, and collaborative programs that educate the public, especially young people, about tobacco products and the dangers their use poses to themselves and others. Applicants should tailor their strategies to meet the unique needs of local target audiences by identifying and implementing novel ways for community stakeholders to reach audiences in their communities.  Additionally, applicants must demonstrate how proposed activities are related to CTP’s regulation of tobacco products under the Tobacco Control Act. 

By way of example, project activities could include:

a) Applicants and community stakeholders identifying and implementing novel approaches to improving public health by educating target audiences about FDA's authority to publish a list of harmful and potentially harmful constituents in a format that is understandable and not misleading to the public.  Examples include:

i.  Identifying and implementing novel ways for community stakeholders to take the information published by the FDA for every tobacco product brand and effectively reach youth in their communities with a message about the harmful and potentially harmful constituents in tobacco products to prevent initiation, while working with FDA to ensure the information being made available is understandable and not misleading to the audience.

ii.  Identifying and implementing ways for community stakeholders to involve tobacco influencers such as parents and caregivers in educating youth about the harmful and potentially harmful constituents in tobacco products to impact behavior, while working with FDA to ensure the information being made available is understandable and not misleading to the audience.

b)  Applicants and community stakeholders identifying and implementing novel approaches to provide accurate information to promote awareness to the local community of the risks of smokeless tobacco.  Examples include:

i.  Identifying and implementing novel ways for community stakeholders to utilize required smokeless tobacco warnings, e.g. "Warning: Smokeless tobacco is addictive." and effectively reach youth in their communities about the dangers of using smokeless tobacco to prevent initiation.

Note to Applicants:

Please be familiar with the specific provisions of the Tobacco Control Act and the regulatory activities of FDA.  In addition to demonstrating how the proposed project is related to CTP’s regulation of tobacco products under the Tobacco Control Act, applicants must demonstrate how it will advance the pubic health goals that underlie these FDA activities. Please visit www.fda.gov/tobacco for more information on the Tobacco Control Act and related regulations, guidance, and other educational information. 

Please note that funds may not be used towards tobacco control compliance and enforcement efforts.  Program funds may not be used to duplicate or supplant existing tobacco control, prevention, or cessation efforts, but can enhance existing communication/education efforts relevant to FDA/CTP and the Tobacco Control Act.  Funds may not be used to fund other tobacco control areas such as surveillance, price and tax measures, clean indoor air laws, tobacco control compliance and enforcement efforts, and treatment services like quit lines, nicotine replacement therapy, or any other pharmaceutical or biomedical therapy. 

Section II. Award Information
Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New:  Refers to an application not previously proposed, or one that has not received prior funding. Also known as a Type 1.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA/CTP appropriations, and the submission of a sufficient number of meritorious applications.

FDA/CTP intends to fund approximately 12-15 awards, corresponding to a total of $22,500,000 depending on the availability of funds.

Fiscal Year Funds: 2012

Estimated Current Fiscal Year (FY) Funding: $22,500,000

Estimated Current Fiscal Year Range of Awards:  up to $1,500,000

Maximum Size Award in Current Fiscal Year: $1,500,000

Estimated Number of Awards: 12-15

FDA/CTP anticipates that project costs may escalate in future funding years as project activities transition from an emphasis on project start up in FY 2012 to project implementation in FY 2013, FY 2014, and FY 2015. 

Estimated Future Year Funding:

FY 2013 ($45,000,000)

FY 2014 ($45,000,000)

FY 2015 ($45,000,000)

Estimated Future Year Range of Awards:

FY 2013 (up to $3,000,000)

FY 2014 (up to $3,000,000)

FY 2015 (up to $3,000,000)

Maximum Size Award in Future Years:

FY 2013 ($3,000,000)

FY 2014 ($3,000,000)

FY 2015 ($3,000,000)

Maximum Project Period: Four (4) Years

Award Budget

Awards are contingent upon the availability of funds.  Future year amounts will depend on annual appropriations and performance.

FDA/CTP anticipates that project costs will escalate in future funding years as project activities transition from an emphasis on project start up in FY 2012 to project implementation in FY 2013, FY 2014, and FY 2015.  Applicants should submit a detailed budget breakdown for each budget category listed in the Budget Component form and a detailed budget narrative justification for each year of financial support requested.  The budget should include only costs that are allowable, reasonable, and necessary for carrying out the objectives of the proposed project. 

The total amount of funding available in Fiscal Year 2012 is $22.5 million.  It is estimated that up to 15 cooperative agreements will be awarded, but not exceed $1,500,000 per award in total (direct plus indirect) costs in FY 2012.  The FY 2012 budget period will include an initial 5 month planning period to support project start-up, relationship-building, and capacity-building. 

The estimated total amount of noncompetitive continuation funding in future funding years is as follows:

FY 2013 ($45 million), FY 2014 ($45 million), and FY 2015 ($45 million), depending upon fiscal year appropriations and successful performance.

The estimated future year range of awards is as follows: FY 2013 up to $3,000,000); FY 2014 (up to $3,000,000); FY 2015 (up to $3,000,000).  The maximum size award in future year funding will not exceed $3,000,000 per award in total (direct plus indirect) costs in FY 2013, FY 2014, and FY 2015.  The length of support will depend on the nature of the project.  The budget period in future funding years will be for project implementation as follows: FY 2013 (12 months), FY 2014 (12 months), and FY 2015 (12 months).    

Program funds may not be used for any purpose other than those related to the regulation of tobacco products under the Tobacco Control Act.  These funds may not be used towards tobacco control compliance and enforcement efforts.  Program funds may not duplicate or supplant existing tobacco control, prevention, or cessation efforts, but can enhance existing efforts relevant to FDA/CTP and the Tobacco Control Act.  In addition, funds may not be used to finance other tobacco control areas such as surveillance, price and tax measures, clean indoor air laws, tobacco control compliance and enforcement efforts, and treatment services like quit lines, nicotine replacement therapy, or any other pharmaceutical or biomedical therapy.

Throughout the project period, FDA/CTP’s commitment to continuation of awards will be conditioned on the availability of funds, evidence of satisfactory performance and outcomes by the recipient (as documented in required reports and site visit observations), and the determination that continued funding is in the best interest of the Federal Government.

Funds should be requested for travel to the metropolitan Washington, D.C. area for annual and episodic meetings with program staff (applicants should budget for three meetings per year for principal grantee staff).

In addition, if the cooperative agreement is awarded, funding recipients will be informed if any additional documentation is needed to support their award.  The program office will have continuous interaction with the recipient through site visits, collection of progress reports, and provision of training and technical assistance. There may be other meetings with funding recipients to assist in fulfilling the requirements of the cooperative agreement.

Award Project Period

Maximum project period is four (4) years.

Future year amounts depend on annual appropriations and performance.

FDA grants policies as described in the HHS Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

CTP’s cooperative agreement program is meant to foster partnerships between governmental agencies and community-based organizations to promote the public's health by educating Americans about the goals of FDA tobacco product regulation and the risks of tobacco use.  These efforts are rooted in the Tobacco Control Act and in regulatory activities that CTP has conducted and will conduct.  To best accomplish this goal, non-profit organizations (other than institutions of higher education), governmental agencies, and faith-based or community-based organizations are uniquely positioned to engage partners and build coalitions in unique, efficient and highly effective ways and have the experience to implement evidence-based tobacco prevention and cessation programs aimed at reaching vulnerable target populations. Higher education organizations will have the opportunity to participate in this program as sub-awardees.  A community-based organization is defined as a public or private nonprofit organization of demonstrated effectiveness that:

(1) Is representative of a community or significant segments of a community; and

(2) Provides educational or related services to individuals in the community.

This cooperative agreement program is only available to eligible organizations who demonstrate collaboration between at least one governmental agency and at least one community-based organization.  If a lead applicant is a government agency, it must partner with at least one community-based organization.  If a lead applicant is a community-based organization, it must partner with a governmental agency.  The following organizations/entities are eligible to apply:

This cooperative agreement program is not available to any organization if it or any of its officers or employees, partners, affiliates, agents, contractors, or subcontractors maintains any of the following financial interests or business arrangements:  (a) provides consulting services or other contractual services to a tobacco product manufacturer, distributor, or retailer, as those terms are defined by the Tobacco Control Act (hereinafter "tobacco entity"; (b) serves as an expert witness on behalf of a tobacco entity; (c) conducts research sponsored by or directed by a tobacco entity (either directly or indirectly); (d) sits on a corporate board or advisory board of a tobacco entity; (e) lobbies or testifies on regulatory or legislative matters on behalf of a tobacco entity; (f) names any building, program, or project after a tobacco entity, a tobacco brand, or a tobacco entity employee; or (g) receives funds from a tobacco entity.  The above does not apply where an organization receives funds from a tobacco entity pursuant to a court order or statutory directive and the tobacco entity does not retain any control over the use of such funds.

If awarded a cooperative agreement, the organization and its officers and employees, as well as its partners, affiliates, agents, contractors and subcontractors must refrain from engaging in any of the activities listed in (a) - (g) above during the course of the cooperative agreement program.  By submitting an application, applicants affirm that they meet the eligibility requirements described in this section.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

eRA Commons is the infrastructure utilized by FDA for conducting interactive electronic transactions for the receipt, review, monitoring, and administration of grant awards.   All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 6 weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF 424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is programmatically distinct.

FDA will not accept any application in response to this FOA that is essentially the same as one currently pending review unless the applicant withdraws the pending application. FDA will not accept any application that is essentially the same as one already reviewed.   

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Letter of Intent

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 FDA/CTP staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

1. Descriptive title of proposed public education/communication program
2. Name, address, and telephone number of the applicant
3. Number and title of this funding opportunity

The letter of intent should be sent via electronic mail as a Word or PDF file to CTP-OHCE_CoAg@fda.hhs.gov with “Cooperative Agreement Letter of Intent” in the message subject heading.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Page Limitations

All page limitations described in the SF424 Application Guide must be followed, with the following exceptions or additional requirements:

Responsiveness

To be responsive, an application must be submitted in accordance with the requirements of this notice, including:

1) The application must request support at or below the maximum amount allowable;

2) The application must be from an eligible organization; 

3) The application must contain a memorandum of understanding or equivalent between the eligible applicant, the governmental agency, community-based organization, and other key partners; and

4) The application must propose activities that establish or expand health communication and education programs at the community level that are related to the regulation of tobacco products under the Tobacco Control Act.

Applications found to be non-responsive will receive notice that the application will not be reviewed.

Application Components

The forms package associated with this FOA includes all applicable components, mandatory and optional.  Please note that some components marked optional in the application package are required for application submission. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

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.

A complete application consists of the following components:

Project Abstract

Project Strategy (referred to as the Research Strategy on the SF 424 (R&R)

Bibliography

Memorandum of Understanding or Equivalent

Resumes of Key Personnel and/or position descriptions

Budget Justification

Standard Forms, and

Assurances and Certifications

Standard Form LLL, Disclosure of Lobbying Activities

Instructions for Project Summary/Abstract 

Include the following information in your abstract:

The abstract narrative should not exceed one page and should use language that will be understood by a range of audiences. 

The Project Abstract should be attached to the SF 424 (R&R) Other Project Information Component

Instructions for Project Strategy (referred to as the Research Strategy on the SF 424 R&R)

The Project Strategy (referred to as the Research Strategy on the SF 424 R&R) is where applicants attach their narrative responses to the selection criteria and requirements published in this FOA.  Note that applications will be reviewed according to the specific selection criteria and the requirements specified in this FOA. 

Please limit the Project Strategy to 25 pages, double-spaced, and number the pages consecutively.  Please provide any charts, graphs, citations, or examples in the project strategy.  Refer to Section IV—Application and Submission Information of the FOA for additional application submission requirements and Section I—Funding Opportunity Description for detailed information regarding the requirements for the Tobacco Regulation Awareness, Communication, and Education Program competition.  Applicants must implement a comprehensive public education and/or communication program that relates to federal tobacco regulation and the public health goals that underlie that regulation, as identified in the applicant’s needs assessment and that will improve health outcomes for members of target population(s).  Applicants must demonstrate how proposed activities are related to CTP’s public health regulatory activities under the Tobacco Control Act.

The Project Strategy should be attached to the SF 424 (R&R) Other Project Information Component.

Instructions for Bibliography

Provide a bibliography of any references cited in the Project Strategy. Each reference must include the names of all authors (in the same sequence in which they appear in the publication), the article and journal title, book title, volume number, page numbers, and year of publication. Include only bibliographic citations.

The Bibliography should be attached to the SF 424 (R&R) Other Project Information Component.

Instructions for the Memorandum of Understanding

A Memorandum of Understanding (MOU) or equivalent between the eligible organization, the government agency, at least one community-based organization, and key partners must be included in the application submission.  Key partners should work together based on identified needs and with clearly articulated and mutually defined goals, target populations, roles, and desired results and outcomes. The MOU or equivalent should describe the role each partner will assume, the services or resources each will provide, and the desired results and outcomes.

Instructions for Budget Justification   

Before preparing the budget justification narrative, applicants should review the FOA. 

Provide a detailed budget breakdown for each budget category listed in the SF 424 (R&R) Budget Component form.  If funds are being requested for more than one budget period, you must complete a separate detailed budget for each year of support requested.  Funds may be requested as long as the item and amount are necessary to perform the proposed work and are not precluded by the cost principles or program funding restrictions.  Provide other budget explanations or comments deemed necessary.

The budget justification should be attached to the SF 424 (R&R) Budget Component.

When multiple institutions are involved, one institution must be designated as the lead institution/fiscal agent and funding for other institution(s) must be requested via a subcontract to be administered by the lead institution.  When submitting a detailed budget, the lead institution should submit its budget using the SF 424 (R&R) Budget Component.  All other institutions should have their individual budgets attached separately to the SF 424 (R&R) Sub award Budget Attachments Form.  See Section 4.8 of the SF 424 (R&R) Application Guide for further instruction regarding the use of the sub award budget form.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants across all Federal agencies. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are not allowable.

Program funds may not be used for any purpose other than those related to the regulation of tobacco products under the Tobacco Control Act, as described in this notice.  These funds may not duplicate or supplant existing tobacco control, prevention, or cessation efforts, but can enhance existing efforts relevant to FDA/CTP and the Tobacco Control Act.  In addition, grant funds may not be used to finance other tobacco control areas such as surveillance, price and tax measures, clean indoor air laws, tobacco control compliance and enforcement efforts, and treatment access like quit lines, nicotine replacement therapy, or any other pharmaceutical or biomedical therapy.

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.

Applicants for (and recipients of) Federal grants, cooperative agreements, contracts, and loans are prohibited by 31 U.S.C. 1352, “Limitation on use of appropriated funds to influence certain Federal contracting and financial transactions,” from using appropriated Federal funds to pay any person for influencing or attempting to influence any officer or employee of an agency, a member of Congress, an officer or employee of Congress, or an employee of a member of Congress with respect to the award, extension, continuation, renewal, amendment, or modification of any of these instruments. These requirements are implemented for HHS in 45 CFR Part 93, which also describes types of activities, such as legislative liaison activities and professional and technical services that are not subject to this prohibition.  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

Applicants for HHS grants with total costs expected to exceed $100,000 are required to certify that they have not made, and will not make, such a prohibited payment; will be responsible for reporting the use of non-appropriated funds for such purposes; and will include these requirements in consortium agreements, other sub-awards, and contracts under grants that will exceed $100,000 and will obtain necessary certifications from those consortium participants and contractors.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF 424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the Central Contractor Registration (CCR). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the assigned Grants Management Specialist and responsiveness by a member of the Center for Tobacco Products' staff. Applications that are incomplete and/or nonresponsive will not be forwarded for review..

Section V. Application Review Information

1. Criteria

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

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the topic area(s) involved, in consideration of the following review criteria (as applicable for the project proposed).

Scored Review Criteria

All applications will undergo an objective review process and will be evaluated individually for strengths and weaknesses against the criteria that follow, respectively.  Each proposal will be evaluated and scored in relation to the selection criteria. 

Need and Significance of the Project (25 points)

What is the magnitude or severity of the problems to be addressed by the proposed project in relation to indicators of need and target population to be served?  What is the extent to which the proposed project will identify and address specific gaps or weaknesses in services, infrastructure, or opportunities?  What is the likelihood and extent to which the proposed project will increase capacity at the community level in the areas of health communication and education? What is the extent to which the proposed project involves the development or demonstration of promising or innovative strategies that build on, or are alternatives to, existing strategies? What is the potential to sustain and apply the model of the proposed project or strategies, including, as appropriate, the potential for implementation of the model in a variety of settings?

Quality of the Project Design (30 points)

Has the applicant provided a detailed implementation plan that addresses the goals, objectives, action steps, timeline with milestones, and description of the role of key partners?  Does the applicant describe strategies that are based on the best available evidence?   Does the plan include strategies that will lead to significant improvements in promoting the understanding of tobacco product contents and the consequences of tobacco use; protecting youth from the dangers of tobacco use; and/or increase cessation among those who use tobacco?  How will the applicant use data to manage program implementation, inform decision-making, engage stakeholders, and measure success? Has the applicant provided an evaluation plan that aligns with project goals, objectives, activities, and performance measures? Does the applicant demonstrate an ability to customize and tailor tools and resources to the local level?   What is the extent to which the proposed project will be coordinated with similar or related efforts, and with other appropriate community, State, and Federal resources?

Management Plan (25 points)

Is the management plan adequate to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks? Have MOU’s or equivalent been included for key partners that describe each partner’s financial and/or programmatic commitment; how each partner’s existing vision  and existing activities align with those of the proposed project? What is the governance structure of the proposed project? How extensive is the expertise and experience of the applicant institution and their key personnel in coordinating collaborative endeavors of the size, scope and scientific complexity needed for this Program? Does the organization have experience building coalitions between governmental and community based entities?  What is the potential for continued support of the project after Federal funding ends, including, as appropriate, the demonstrated commitment of appropriate entities to sustain and “scale up” the proposed project?

Key Personnel (20 points)

What is the background, expertise, and administrative experience of key project staff who will direct, manage, and administer the program and/or identify key hires that will be necessary to carry out the program and is it appropriate?  Do key staff have documented success with a similar program?  Does the applicant demonstrate leadership and extensive experience working on complex tobacco prevention and counter-marketing campaigns and initiatives for a governmental entity or a public health organization?  Are proposed program staff able to collaborate effectively within his/her own organization and with individuals at collaborating organizations?  Does the applicant adequately describe the role of all proposed staff and the processes for ensuring that staff meets program and role expectations?  Please note: if awarded, all changes in key program personnel will require prior approval from FDA/CTP.

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Resubmissions

Not applicable.

Renewals

Not applicable.

Revisions

Not applicable.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.

Applications from Foreign Organizations

Not applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed project.

2. Review and Selection Process

All applications will undergo an objective review process.  An objective review panel will evaluate complete and responsive applications according to the criteria listed in the “Objective Review Criteria” section above.  The panel will be comprised of FDA, HHS, and/or other Federal program officials outside of the program office (CTP Office of Health Communication and Education) and will be scored using the pre-determined weight criteria listed in the “Application Review Information” section above.    Funding decisions will be made by the Commissioner of Food and Drugs or her designee. 

Funding decisions may also be made to ensure:

1) Adequate representation of activities related to the regulation of tobacco products under the Tobacco Control Act, including a variety of public education and/or communication programs/campaigns and evidence-based communications strategies. 

2) Balanced geographic and demographic distribution of initiatives nationwide.

3) Balanced representation of the types of organizations awarded.

As set forth in Section III.1, certain financial interests and business relationships render an applicant ineligible.  For eligible applicants that undergo objective review, funding decisions will consider, among other things, whether there are other financial interests or business arrangements with third parties (to include contracts, subcontracts, and grants) that would call into question the ability or motivation of the applicant to objectively and effectively carry out the proposed project.  The Grants Management Specialist may request additional financial information to aid in the evaluation of financial interests and/or business relationships prior to award decision.  Applicants with any financial interests or business arrangements that might call into question the ability or motivation of the applicant to effectively carry out the proposed project should (1) disclose the interest or business arrangement; (2) describe how the interest or business arrangement could actually, or be perceived to, impair the applicant’s ability or motivation to effectively carry out the proposed project; and (3) set forth any steps, plans, or procedures the applicant will take to mitigate the effect of the interest or arrangement on the ability to effectively carry out the proposed project.

The request for and subsequent submission of financial information or mitigation plans does not imply an award decision.

3. Anticipated Announcement and Award Dates

Information regarding the disposition of applications is available in the HHS Grants Policy Statement

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, FDA may request "just-in-time" information from the applicant to reach a final award decision.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.4. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.  Pre-award costs are not allowable for this opportunity.  

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for HHS Grants recipients.

2. Administrative and National Policy Requirements

All FDA grant and cooperative agreement awards will be subject to all policies and requirements that govern the programs of FDA, including provisions of 42 CFR Part 52 45 CFR Parts 74 and 92, and theHHS Grants Policy Statement.

Applicants must adhere to the requirements of this notice.  Special terms and conditions regarding FDA regulatory requirements and adequate progress of the project may be part of the awards notice.   

The following terms and conditions will be incorporated into the award statement and will be provided to the Project Director/Principal Investigator as well as the appropriate institutional official at the time of the award.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services grant administration regulations at 45 CFR parts 74 and 92 and other HHS, PHS, and the FDA grant administration policies. 

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism, in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a collaborative 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 FDA as defined below.

2. A.1. Project Director/Principal Investigator Rights and Responsibilities

The Project Director/Principal Investigator (PD/PI) retains the primary responsibility and dominant role for planning, directing, and executing the proposed project, with FDA/CTP staff being substantially involved as a partner with the PD/PI, as described below.

The PD/PI will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award, as well as ensuring that all staff have sufficient clearance and/or background checks to work on this project.  This individual will work closely with designated officials within the recipient organization and with partner organizations to create and maintain necessary documentation, including both technical and administrative reports; prepare justifications; appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal, regulatory, and organizational requirements.

2. A.2. FDA Responsibilities

An FDA Project Officer (PO) is the official responsible for the programmatic, scientific, and/or technical aspects of assigned applications and cooperative agreements.

The FDA PO will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below. The PO will have substantial involvement in the design, implementation, and evaluation of program activities, and dissemination of program results and outcomes, above and beyond routine grant monitoring.   Substantial involvement by FDA/CTP includes, but is not limited to, the following:

1.    Provide guidance and technical assistance in project planning, implementation, and evaluation. 

2.    FDA/CTP will provide technical assistance and evaluation services to support program activities.

3.    Convene trainings, meetings, web forums, conference calls and site visits with award recipients to facilitate collaboration and information sharing.

4.    Conduct and coordinate program monitoring and evaluation, including development of program-level performance measures and reporting procedures and protocols.

5.    Develop consistent data collection and reporting protocols for program activities.

6.    Identify and disseminate results of promising and effective health education and communication programs and practices.

7.    Provide communication tools, as developed, for potential use in program efforts.  These tools could include research, strategies, creative assets and materials, and media buys. 

8.    Provide final approval of campaign materials and strategies prior to dissemination. 

Monitoring Activities

The program project officer will monitor grantees periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project office/grants management office and the principal investigator. Periodic site visits with officials of the funding recipient organization may also occur. The results of these monitoring activities will be recorded in the official grant file and will be available to the funding recipient upon request consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the project will depend on recommendations from the project officer.  The scope of the recommendation will confirm that: (1) there has been acceptable progress on the project; (2) there is continued compliance with all FDA regulatory requirements; (3) if necessary, there is an indication that corrective action has taken place; and (4) assurance that any replacement of personnel will meet the prior approval of the FDA/CTP program office and grants management officer.

3. Reporting

For continuing cooperative agreements, an annual program progress report is required.  Awardees will be required to submit annual performance reports and financial status reports as required in the HHS Grants Policy Statement.  

A final program progress report must be submitted within 90 days after the expiration of the project period as noted on the Notice of Grant Award.  A final progress report is also required when an award is relinquished, when a recipient changes institutions, or when an award is terminated.  The final program progress report must provide full written documentation of the project, and summaries of achievement of project goals, objectives, and performance measures as described in the grant application.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier sub awards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Sub award Reporting System (FSRS) available at www.fsrs.gov on all sub awards over $25,000. 

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Pre-Application Meeting

FDA/CTP will hold a pre-application meeting for prospective applicants on April 5, 2012 from 1:00 p.m. to 2:30 p.m. (EST) via webinar.  Interested parties are invited to participate in this meeting to discuss the purpose of the Program, application requirements, selection criteria, application content, submission requirements, and reporting requirements.  Interested parties may participate in this meeting either by conference call or via the World Wide Web.

Individuals interested in attending this meeting should register via electronic mail no later than March 30, 2012 with the following information: participant name, organization, and contact information with “PRE-APPLICATION MEETING” in the subject line to CTP-OHCE_CoAg@fda.hhs.gov.  There is no registration fee for participating in this meeting.  For further information contact Tracy Galloway, Center for Tobacco Products, U.S. Food and Drug Administration, 9200 Corporate Boulevard, Rockville, Maryland 20850.  E-mail:  CTP-OHCE_CoAg@fda.hhs.gov.

Application Submission Contacts

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Program Contact(s)

Tracy Galloway
FDA/CTP
Office of Health Communication and Education
9200 Corporate Blvd.
Rockville, MD  20850
Email: CTP-OHCE_CoAg@fda.hhs.gov

Objective Review Contact(s)

Stephanie D. Bogan
Division of Acquisition Support and Grants
Office of Acquisitions & Grants Service
Food and Drug Administration
FHSL Rm 1095, HFA-500
5630 Fishers Lane
Rockville, MD 20857
Email: stephanie.bogan@fda.hhs.gov

Financial/Grants Management Contact(s)

Stephanie D. Bogan
Division of Acquisition Support and Grants
Office of Acquisitions & Grants Service
Food and Drug Administration
FHSL Rm 1095, HFA-500
5630 Fishers Lane
Rockville, MD 20857
Email: stephanie.bogan@fda.hhs.gov

Section VIII. Other Information

All awards will be subject to all policies and requirements that govern discretionary grant programs of the PHS as incorporated in the U.S. Department of Health and Human Services (HHS)  Grants Policy Statement dated January 1, 2007 (http://dhhs.gov/asfr/ogapa/grantinformation/hhsgps107.pdf), including the provisions in 45 CFR Parts 74 and 92.  The regulations issued under Executive Order 12372 do not apply to this program.

All electronic media produced under the terms of resulting grant agreements funded by CTP must be must be Section 508 compliant.  For more information about Section 508 compliant communications visit www.section508.gov.  Applicants should also refer to The Guide to the Section 508 Standard for Electronic and information Technology, which is available at http://www.access-board.gov/sec508/guide/index.htm.

Consistent with the property management requirements of 45 CFR Parts 74.36 and 92.34, FDA/CTP reserves a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use work that was developed for Federal purposes, and to authorize others to do so.

Required Federal Regulations

Human Subjects Protection:
Federal regulations (45 CFR 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).

Access to Research Data through the Freedom of Information Act (FOIA) (NIH Policy Adopted by the FDA):

The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are: (1) first produced in a project that is supported in whole or in part with Federal funds; and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH/DHHS has provided guidance at http://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Required Education on the Protection of Human Subject Participants (NIH Policy Adopted by the FDA)

NIH/DHHS policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Public Access Policy Requirement (NIH Policy Adopted by the FDA)

In accordance with the NIH/DHHS Public Access Policy, investigators funded by the FDA must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/) an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH/DHHS Public Access Policy is available at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html. For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

Standards for Privacy of Individually Identifiable Health Information

The Department of Health and Human Services (HHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information," the "Privacy Rule," on August 14, 2002. The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information and is administered and enforced by the HHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

Sharing Research Data (NIH Policy Adopted by the FDA)

Investigators submitting an application to the FDA seeking $500,000 or more in direct costs in any single year (if applicable) are expected to include a plan for data sharing or state why this is not possible (see http://grants.nih.gov/grants/policy/data_sharing). Investigators should seek guidance from their institutions on issues related to institutional policies and local institutional review board (IRB) rules as well as local, State and Federal laws and regulations, including the Privacy Rule.

Healthy People 2020

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," 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 2020" at http://www.health.gov/healthypeople.

Authority and Regulations

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241), Section 312 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 USC 247b-20),  and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92


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