Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). 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.

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

AUTHORITY: The Smokeless Tobacco Reference Product Program is authorized by 42 U.S.C. 241(a) and the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31).

PROGRAM BACKGROUND

On June 22, 2009, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), P.L. 111-31, which amended the Food, Drug, and Cosmetic Act (FD&C Act) and gave FDA broad authority to regulate the manufacture, marketing, and distribution of tobacco products. To implement the new law, Congress directed the creation of the Center for Tobacco Products (CTP) within FDA. The law included a public health mandate requiring FDA to regulate tobacco products according to their overall effect on population health. CTP’s mission is to protect the American public from tobacco-related death and disease by regulating tobacco products and by educating the public, especially young people, about tobacco products and the dangers their use poses to themselves and others.

Smokeless tobacco products are among the tobacco products regulated by CTP. CTP recognizes that, at present, high-quality, well characterized smokeless tobacco reference products are unavailable to manufacturers, researchers, and other stakeholders seeking to study and measure physical and chemical properties related to smokeless tobacco products. A reference product is a product of known composition whose physical and chemical properties are thoroughly characterized using the highest standards of measurement procedures. A certificate of analysis listing the measured values and the expanded uncertainties associated with those measurements is distributed along with the reference product. A smokeless tobacco reference product is a product that closely mimics the physical and chemical properties of the commercially marketed smokeless tobacco product and provides similar analytical challenges. Providing a certified smokeless tobacco reference product with known ingredient composition and chemical constituent levels for use in tobacco product analysis reduces measurement uncertainty, improves measurement reliability, and permits comparability of test results across time and space.

A variety of tobacco reference products representing a few subcategories of smokeless tobacco products are distributed and used by various entities including tobacco manufacturers, contract laboratories, government laboratories, and academic institutions to assure the accuracy of test measurements. In the United States, smokeless tobacco reference products are developed by CORESTA (Cooperation Center for Scientific Research Relative to Tobacco) and distributed by academic institutions. The smokeless tobacco reference products developed by CORESTA have not been sufficiently characterized to ensure that high-quality and reliable data is available for harmful and potentially harmful constituents (HPHCs) typically found in these products. For example, the chemical analysis measurements for currently available smokeless reference products are based on an insufficient number of replicates used to determine the range of concentrations for some HPHCs. In addition, no inter-laboratory comparison was performed for some HPHCs, so reproducibility and repeatability of the reported values cannot be determined for those HPHCs and no free nicotine values are provided for these products. Levels of HPHCs in smokeless tobacco products are of particular interest to researchers and the public health community, as well as FDA.

Well-characterized smokeless tobacco reference products, similar to smokeless tobacco products commercially marketed in the United States, need to be developed to ensure accurate, high quality data are being used by stakeholders in their efforts to improve and protect the public from tobacco related death and disease. By having well-characterized smokeless tobacco reference products for non-clinical evaluations, various organizations such as academic institutions, public advocacy groups, tobacco product manufacturers, and independent contract testing laboratories can ensure that high quality data is gathered, and this scientific information can, for example, be communicated to the public about the risks and potential risks associated with tobacco use.

OVERARCHING PROGRAM GOAL

The goal of the Smokeless Tobacco Reference Product Program is to develop well-characterized smokeless tobacco reference products to assure the accuracy and reliability of scientific data that stakeholders will use in their efforts to protect the public from tobacco related disease and death. The development of smokeless tobacco reference products will enable an accurate and reliable physical and chemical characterization of smokeless tobacco products. Having well-characterized smokeless tobacco reference products will benefit the public and other stakeholders as accurate scientific evidence will help fill scientific gaps regarding the chemical and physical properties of tobacco products, which will improve information regarding the harms associated with tobacco use.

PROGRAM PURPOSE

The purpose of the Smokeless Tobacco Reference Products Program is to develop smokeless tobacco reference products, which have physical and chemical properties that closely resemble commercial smokeless tobacco products. The program will provide a public benefit by ensuring that decision making by stakeholders is based on accurate scientific data; reduce measurement variability and will help fill scientific gaps regarding the chemical and physical properties of tobacco products. The program will improve information regarding the harms associated with tobacco use.

Smokeless tobacco reference products could be used by tobacco product manufacturers, contract and government laboratories, and academic researchers for the following purposes:

• Proficiency testing
• Instrument calibration
• Quality control
• Employee training and certification
• Analytical method validation
• Investigational purposes

Laboratories may use the reference products for proficiency testing to demonstrate that they are capable of accurately measuring the constituents of interest. For example, if a laboratory wanted to demonstrate proficiency in measuring nicotine, the laboratory would measure the amount of nicotine in the reference product and compare the result to the amount of nicotine listed on the certificate of analysis. If the measured value equals the certificate value, then the laboratory has demonstrated that it is capable of accurately measuring this constituent.

Laboratories can use the smokeless tobacco reference products as control samples during instrument and method revalidation and sample analysis. After an instrument has been manipulated (e.g., undergone repairs and/or maintenance, moved to a different location in the lab, used for a different testing method), revalidation of the instrument is required to confirm optimum instrument performance before it is reintroduced into routine use for sample analysis. In utilizing smokeless tobacco reference products in this manner, further confidence of the chemical composition of the tobacco product is established.

The Program will advance the mission of the FDA Center for Tobacco Products by providing researchers with high-quality smokeless tobacco reference products as an analytical tool to:

• Reduce measurement variability of tobacco constituents
• Eliminate uncertainty of test results
• Assure accuracy and quality of scientific data
• Enable research translation to fill tobacco science gaps
• Establish laboratory performance standards to protect the general public from tobacco related diseases and harms

PROGRAM PRIORITIES

The Program’s grant funds would support eligible entities in carrying out their plans to developing smokeless tobacco reference products. A high-quality reference product is one that is manufactured and stored under tightly controlled conditions and is thoroughly characterized (chemically and physically). A certificate of analysis listing the measured values and expanded uncertainties for constituents contained in the reference products should be distributed with the reference products.

FDA will be involved in the cooperative agreement by providing advice and guidance on these aspects. A tobacco reference program should include the following:

1. Obtain reference products: Obtain smokeless tobacco products representative of loose moist snuff, pouched snus, and, if possible, loose leaf chewing tobacco. Each smokeless tobacco reference product should be manufactured in one batch (i.e., one manufacturing run). The reference tobacco products should be produced in sufficient quantities to allow for distribution over multiple years. The quantity of each reference tobacco product should be based on anticipated use each year, such that the quantities of each reference tobacco product varies. The applicant must comply with all applicable laws in obtaining the reference products.

2. Characterization (physical and chemical properties): Well-designed smokeless tobacco reference products would be characterized for at least the properties listed below. A certificate of analysis listing these measurements, including expanded uncertainties associated with the measurements, found in the smokeless tobacco reference product should accompany the product.

a) Tobacco blend

b) HPHCs (Acetaldehyde; Arsenic; Benzo[a]pyrene; Cadmium; Crotonaldehyde; Formaldehyde;

Total nicotine; Free nicotine; NNK (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone); NNN (N

nitrosonornicotine))

c) Moisture content/water activity

d) pH

e) Microbial content

f) Tobacco cut size

g) Portion mass (pouched snus only)

h) Portion length (pouched snus only)

i) Portion width (pouched snus only)

j) Portion thickness (pouched snus only)

k) Paper basis weight (pouched snus only)

l) Paper porosity (pouched snus only)

m) The use of chemical additives (i.e. preservatives, metabolic inhibitors, humectants) and

processes (i.e. pasteurization) to control microbial activity.

n) Product stability testing (periodic characterization of the chemical and physical properties

during the proposed storage life of the product)

3. Storage: Determine and develop optimal storage conditions for tobacco reference products (e.g., temperature, humidity, reference product packaging, and expiration) to minimize deviations from the original characteristics. If justified and necessary, renovations will be allowed to meet determined optimal storage conditions.

4. Distribution: Fulfill and ship tobacco reference product orders to customers in a timely manner (preferably within 7-10 business days of order receipt). Determine the best shipping method using appropriate packing materials based on the determined optimal storage conditions (e.g., dry ice, shipping method, and speed). Every effort should be made to minimize the time the tobacco reference product is not kept under optimal storage conditions. A certificate of analysis listing measurements of physical properties and chemical constituents, including expanded uncertainties associated with the measurements, found in the smokeless tobacco reference product should accompany the product. Distributions must accord with all applicable laws. In addition, the applicant must ensure that the tobacco reference product will only be used for research purposes and not be resold or consumed by humans.

5. Interlaboratory round-robin comparison study: Coordinate and administer an inter-laboratory comparison study using the reference products. Ideally, this should include the following:

a) Identification of interested laboratories

b) Distribute samples for analysis

c) Instruct participants on their responsibilities, expectations, and provide guidance

d) Collect, compile, and analyze data (including statistical analyses)

e) Summarize and distribute the results

Please note that applicants must comply with all applicable provisions of the FD&C Act and all other regulatory authorities of the FDA. Visit www.fda.gov/tobacco for more information on the FD&C Act and related regulations, guidance, and other educational information.

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

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for FDA support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission. Late applications will not be accepted for this FOA.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) 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 SF424 (R&R) Application Guide.

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

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

The FDA will not accept duplicate or highly overlapping applications under review at the same time. This means that the FDA will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

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.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

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 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:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent via electronic mail as a PDF file to Lisa Ko at Lisa.Ko@fda.hhs.gov with RFA-FD-15-026 STRP Letter of Intent and the Institution's Name in the message subject heading.

A technical session will be held for prospective applicants in June/July 2015. The conference call information will be provided to prospective applicants that submit a letter of intent. The technical session will provide an overview of the submission requirements and allow prospective applicants an opportunity to ask questions regarding the application process. Participation in the technical session is optional, but strongly encouraged.

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

• For this specific FOA, the Research Strategy section is limited to 30 pages.

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
• If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
• If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed. MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs, and the portion of each subaward and subcontract in excess of $25,000.
• Special arrangement and alteration of facilities costs incurred specifically for the project are allowable with the prior approval of FDA/CTP. Applications requesting funds for rearrangement or alteration of facilities should provide a narrative justification and detailed budget breakdown for such costs.
• Funds should be requested for travel to the metropolitan Washington, D.C. area for annual meetings with program staff (the applicant should budget for one meeting per year for principal grantee staff).

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

• The Research Strategy must include narrative responses to the selection criteria and requirements published in this FOA. Note that applications will be reviewed according to the specific selection criteria in Section V and the requirements specified in Section I (Program Priorities) of this FOA.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to 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, FDA’s electronic system for grants administration. eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Late applications will not be accepted for this FOA.

Applicants are responsible for viewing their application before the due date 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.

This initiative is not subject to intergovernmental review.

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 allowable only as described in the HHS Grants Policy Statement.

Program funds may not be used for any purpose other than those directly tied to the regulation of tobacco products under the Tobacco Control Act. Special arrangements and alteration of facilities costs incurred specifically for the project are allowable with the prior approval of FDA/CTP.

Additional funding restrictions may be part of the Notice of Award.

Applications must be submitted electronically following the instructions described in the SF424 (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 SF424(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. See Section III of this FOA for information on registration requirements.

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 System for Award Management. 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 and compliance with application instructions by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA.

Responsiveness

To be responsive, an application must be submitted in accordance with the requirements of this notice, and meet the following criteria:

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 propose science-based activities that advance development of a smokeless tobacco reference product program that is related to the regulation of tobacco products under the Tobacco Control Act.

Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

Reviewers will consider each of the review criteria below in the determination of scientific merit.

Significance (10 points)

Will successful completion of the objectives of the project improve the quality of data used to assess the health risks associated with new tobacco products? How does the quality of the proposed smokeless tobacco reference product compare to currently available product(s)?

Investigator(s) (25 points)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? Do they have complementary and integrated expertise? Are their leadership approach, governance and organizational structure appropriate for the project?

Approach (30 points)

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific goals of the smokeless tobacco product reference program? Are potential problems, alternative strategies, and benchmarks for success presented? Will the organization be able to sustain long term success (5, 10, 15, 20 years projections) and continue to support the needs of the public through the tobacco product reference material program by being self-sufficient and self-governed?

Environment (25 points)

Will the scientific work environment contribute to the probability of success? Are the laboratories, storage facilities, equipment, and other physical resources available to the investigators adequate for the completion of this project? Have they presented a plan to overcome any deficiencies?

Time (10 points)

Has a reasonable timeline been presented? Has the applicant demonstrated or presented a logical and achievable process to fulfill orders and distribute the tobacco reference product in a timely manner?

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 score.

Not Applicable

Not Applicable

Not Applicable

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Not Applicable

Not Applicable

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).

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) Genomic Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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

Applications will be evaluated for scientific and technical merit by an Objective Review Committee, using the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

Applicants are strongly encouraged to contact FDA to resolve any questions about criteria before submitting the application. Please direct all questions of a technical or scientific nature to the CTP Program contact and all questions of an administrative or financial nature to the grants management staff. Appeals of objective review will not be accepted for applications submitted in response to this FOA.

Applications will compete for available funds with all other recommended applications submitted in response to this FOA. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by objective review.
• Availability of funds.
• Relevance of the proposed project to the program goals, purpose and priorities.

Successful applicants will be notified of additional information that may be required or other actions leading to an award. The decision not to award a grant, or to award a grant at a particular funding level, is discretionary and is not subject to appeal to any FDA or HHS official or board.

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’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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.

Any application awarded in response to this FOA will be subject to terms and conditions found in the HHS Grants Policy Statement.

All FDA grant and cooperative agreement awards include the HHS Grants Policy Statement as part of the NoA.

Additional terms and conditions regarding FDA regulatory and CTP programmatic requirements may be part of the Notice of Award.

Cooperative Agreement Terms and Conditions of Award

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an acquisition" mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the FDA's objective is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role of activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardee for the project as a whole, although specific tasks and activities may be shared between the awardee and the FDA as defined below.

a. 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.

b. FDA Responsibilities

An FDA Project Officer (PO) will be assigned and named in the NoA. The FDA 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:

• Provide guidance, direction and technical assistance in project planning, implementation, and evaluation.
• Provide subject matter expertise and programmatic assistance to support program activities.
• Convene meetings, conference calls and site visits with grantee to facilitate collaboration and information sharing.
• Working collaboratively with the grantee, participate in system design and development, including consistent terminology, standards for data collection and analyses, and the implementation of a data collection/information sharing mechanism.
• Retain the right to have prior approval on the appointment of all key personnel substantially supported by the grant.

Monitoring Activities

The FDA project officer will monitor grantees periodically. The monitoring may be in the form of, but not limited to, telephone conversations, e-mails, or written correspondence between the project program 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.

The purpose of the Smokeless Tobacco Reference Products (STRP) Program is to develop smokeless tobacco reference products that closely resemble marketed smokeless tobacco products. The program will inform and support the Center for Tobacco Product’s (CTP) activities pursuant to its statutory authorities set forth in the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) as well as provide a public benefit by ensuring that stakeholders have accurate scientific data to help fill current scientific gaps regarding the chemical and physical properties of tobacco products, which will improve information regarding the harms associated with tobacco use.

This award is subject to the Terms and Conditions as specified in the Request for Applications RFA-FD-15-026 entitled, the Smokeless Tobacco Reference Products Program (UC2) available at: TBD

REPORTING REQUIREMENTS:

Periodic program monitoring will be conducted by FDA on an ongoing basis which may include telephone conversations between the Principal Investigator and the Project Officer/Grants Management Officer/Grants Management Specialist, site visits and the review of written reports.

1. Two (2) Progress Reports are required on grant activities in the first budget period:

A. A Mid-Year Progress Report is to be submitted at the end of the first 6 months of the initial budget period. This report should provide the following reporting elements:

• Overall progress on the activities of the STRP project.
• Projected timeline for uncompleted grant activities (expected accomplishments/milestones by the end of the current budget period of the grant).
• Pending issues/concerns.
• Estimated unobligated balance: funds expended and funds remaining on this project as of report submission date.

B. An Annual Progress Activity Report is due no later than 60 days prior to the start date of the second budget period start date. This Report is to be incorporated into the PHS 2590 form. Please see #2 below on the requirements of the Annual Progress Activity Report and the PHS 2590 form.

2. Grants with Multiple Years: In order to receive future funding, the grantee is required to submit the PHS 2590 Continuation - Progress Report for a Public Health Service Grant each future budget period year.

The PHS 2590 Form is available at: http://grants.nih.gov/grants/forms.htm

The PHS 2590 Form must be submitted at least 60 days prior to the next budget period start date and to ensure your submission is a complete package, please include the following:

Form Page 1 (Face page)
Form Page 2 (Detailed budget)
Form Page 3 (Budget Justification)

Form Page 5 (Progress Report Summary): Page 5 of the PHS-2590 is the section in which you would actually incorporate your Annual Progress Report information/data. This page does have a character limit, so if you find that you do not have enough space to report on a full performance period's worth of work, you may attach a separate report to cover this information. If you do use a separate document for reporting purposes, please state so on page 5 of the PHS-2590 form (i.e. "Please see attached report"). This report should cover all activities/work that took place during the current budget performance period noted in your Notice of Grant Award (NGA) and at a minimum include the following information:

• General progress on the activities of the CTRP to include the project status in relation to established timeline.
• Projected timeline for uncompleted grant projects and or activities (expected accomplishments/milestones by the end of the current budget period of the grant).
• Pending issues/concerns.
• Estimated unobligated balance: funds expended and funds remaining on this project as of report submission date.

Form page 6 (Checklist Page) To be completed if there is a change in performance site(s) that will affect facilities and administrative costs, if program income is anticipated and/or if indirect costs are being requested in the budget.

Form page 7 (Key personnel Report)

3. A required Federal Financial Report (FFR) using Form (SF-425) should be submitted biannually and is available at: http://grants.nih.gov/grants/forms.htm. A Mid-Year FFR is due along with the Mid-Year Progress Report. An annual FFR is due no later than 90 days after the current budget period end date. A final FFR shall be submitted at the completion of the award agreement. Final FFRs shall be submitted no later than 90 days after the project or grant period end date.

4. Closeout Requirements (when applicable): A Final Program Progress Activity Report, Final Federal Financial Report SF-425, Final Invention Statement HHS-568 (if applicable), Tangible Personal Property Report SF-428, and Statement of Disposition of Equipment (if applicable) must be submitted within 90 days after the expiration date of the project period. All forms can be found at: http://grants.nih.gov/grants/forms.htm.

5. The recipient will conduct, when appropriate, an annual Single Audit as required by OMB Circular A-133. This audit must be submitted to the Federal Audit Clearinghouse at the Bureau of the Census within 9 months of the close of their fiscal year. If you need information on your organization’s obligations under the Single Audit Act, please visit the following website:

http://harvester.census.gov/sac/. Valuable information is included under the Frequently Asked Questions section of that website.

PRIOR APPROVAL:

All requests that require prior approval must include the award number and bear the signature of an authorized official of the grantee business office as well as that of the PI/PD. Any requests involving budgetary issues must include a new proposed budget and a narrative justification of the requested changes. If there are any questions regarding the need or requirement for prior approval for any activity or cost, the grantee is to contact the assigned Grants Management Specialist prior to expenditure of funds. Below are activities that require prior approval from FDA/CTP:

1. PUBLICATIONS, EDUCATIONAL MATERIALS AND PRESS STATEMENTS

Prior to creating and disseminating any publications and/or educational materials, the grantees must receive written approval of both concept and content of the materials from FDA/CTP. The following steps must be completed:

A. Prior to development, the grantee shall submit a detailed outline of the publication(s) and/or educational material for concept clearance.

B. FDA/CTP will review the submission and either approve, disapprove, or disapprove with FDA/CTP required revisions. The outline must be revised and resubmitted until written approval is received. Materials may not be developed without this written approval. CTP must ensure that all materials fall within the scope of CTP’s authorities set forth in the Tobacco Control Act and benefit the protection of the public health in the United States.

C. Once written approval is received and publication(s) and/or educational materials are created, the grantee must submit the material to the FDA/CTP Project Officer for final content clearance. The grantee must receive written approval prior to the production and dissemination of publication(s) and/or educational materials.

D. The grantee must provide final versions of all approved materials to FDA/CTP.

2. CONFERENCES AND TRAVEL

Before a grantee expends any grant funds on conference attendance and/or travel, they must obtain prior approval from FDA/CTP. A prior approval request for conference attendance and/or travel must be submitted in writing to the Program Official and must include the following information:

A. Title/Topic of Conference

B. Purpose of Conference

C. Explanation of how the Conference directly supports the CTRP goals and objectives

D. Dates of Conference

E. Location of Conference

F. Detailed breakdown on costs associated with Conference attendance/travel

3. ALTERATION OF FACILITIES

Special arrangement and alteration of facilities costs incurred specifically for the project are allowable with the prior approval of FDA/CTP.

4. ADDITONAL ACTIVITIES THAT REQUIRE PRIOR APPROVAL INCLUDE:

• CHANGE IN SCOPE OR OBJECTIVES
• CHANGE IN KEY PERSONNEL
• CHANGE IN GRANTEE ORGANIZATION
• CHANGE IN KEY PARTNER ORGANIZATION(S)
• CREATION AND DISTRIBUTION OF PROMOTIONAL ITEMS
• ANY DEVIATION FROM TERMS AND CONDITIONS OF THE AWARD
• CARRYOVER OF UNOBLIGATED BALANCES
• NO COST EXTENSIONS
• SIGNIFICANT REBUDGETING OF 10% OR MORE OF THE TOTAL FUNDS AUTHORIZED UNDER THE CURRENT YEAR’s AWARD

ALL THE ABOVE REQUIREMENTS MUST BE SENT VIA E-MAIL TO:

Lisa Ko
Grants Management Specialist
Lisa.Ko@fda.hhs.gov

AND

Kenneth Taylor
Project Officer
Office of Science
Center for Tobacco Products
Kenneth.Taylor@fda.hhs.gov

FUNDING RESTRICTIONS:

The following highlights allowable and unallowable activities/costs under the STRP Program. The grantee should contact the assigned Grants Management Specialist if clarification is needed regarding STRP Program allowable activities or costs prior to the expenditure of funds.

Program funds may not be used for any purpose other than to support CTP’s activities pursuant to its statutory authorities to regulate tobacco products and their manufacture, distribution, marketing and sale in the United States, as described in RFA-FD-15-026.

The grantee 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.

1. ALLOWABLE ACTIVITIES/COSTS:

Allowable activities must support CTP activities pursuant to its authorities under the Tobacco Control Act to regulate tobacco products and their manufacture, distribution, and sale in the United States, as described in RFA-FD-15-026.

The grantee must ensure that the tobacco reference product will only be used for research purposes and not be resold or consumed by humans.

2. UNALLOWABLE ACTIVITIES/COSTS:

A. Food and/or Meals: All food, meals or light refreshments, regardless if certain meals are an integral and necessary part of a meeting (i.e., a working lunch where business is transacted), are not allowable and grant funds may not be used for such costs.

B. Lobbying

C. Advocacy

DISTRIBUTION OF SMOKELESS TOBACCO REFERENCE PRODUCTS:

All distributions of smokeless tobacco reference products developed under this program must accord with all applicable laws.

ACKNOWLEDGEMENT OF FEDERAL SUPPORT:

When issuing statements, press releases, publications and other documents describing projects or programs funded in whole or in part with Federal money, all awardees receiving Federal funds, including and not limited to state and local governments and recipients of Federal research grants, shall clearly indicate:

*Funding for this statement, publication, press release, etc., was made possible, in part, by the Food and Drug Administration through grant RFA-FD-15-026. The views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.*

PROGRAM INCOME:

1. The grantee is required to report any Program Income generated during the Project Period of this grant. Except for royalty income generated from patents and inventions, the amount and disposition of Program Income must be identified on lines 10 (l), (m), (n), and (o) of the grantee s Federal Financial Report (FFR) SF-425 http://www.whitehouse.gov/sites/default/files/omb/assets/grants_forms/SF-425.pdf.

2. Examples of Program Income include, but are not limited to, the following types of income related to the grant project: fees for services performed during the grant or sub-grant period , proceeds from sale of tangible personal or real property, usage or rental fees, patent or copyright royalties, and proceeds from the sale of products and technology developed under the grant.

3. Any Program Income generated during the Project Period of this grant by the grantee or sub-grantee is subject to the Addition Alternative for Program Income and, therefore, must only be used to further the goals of the project for which this grant was awarded.

EQUIPMENT AND PRODUCTS:

To the greatest extent practicable, all equipment and products purchased with FDA funds should be American-made.

PAYMENT MANAGEMENT SYSTEM (PMS):

The Payment Management System is administered by the Program Support Center (PSC), DHHS, and payments for FDA grant awards are made through the Division of Payment Management. Applicant organizations are assigned a 12-digit Entity Identification Number for payment and accounting purposes. That number is an expansion of the 9-digit Employer Identification Number assigned to an organization by the Internal Revenue Service.

Included are the following Links & Instructions for drawing down funds, reporting expenditures, required forms, and the help desk info:

Homepage: http://www.dpm.psc.gov/Default.aspx

Grant Recipient Information: http://www.dpm.psc.gov/grant_recipient/grant_recipient.aspx?explorer.event=true

Grant Recipient Forms: http://www.dpm.psc.gov/grant_recipient/grantee_forms.aspx?explorer.event=true

PMS Help Desk: http://www.dpm.psc.gov/help/help.aspx?explorer.event=true

The ONE-DHHS Help Desk for PMS Support is now available Monday Friday from 7 a.m. to 9 p.m. EST (except Federal Holidays). Phone (877) 614-5533; Email PMSSupport@psc.gov

FDA/CTP CONTACT INFORMATION:

Grants Management Contact:

Lisa Ko
Grants Management Specialist
Food and Drug Administration, MSC HFA-500
5630 Fishers Lane, Rockville, MD 20857
Phone: 240-402-7592
Email: Lisa.Ko@fda.hhs.gov

Programmatic Contact:

Kenneth Taylor
Project Officer
Office of Science
Email: kenneth.taylor@fda.hhs.gov

Failure to comply with the above stated Program Terms and Conditions could result in the suspension or termination of this grant project.

THE EXPANDED AUTHORITIES DO NOT APPLY TO THIS GRANT

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the HHS Grants Policy Statement.

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 subawards 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 Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.

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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

Kenneth Taylor
Center for Tobacco Products (CTP)
Email: Kenneth.Taylor@fda.hhs.gov

Lisa Ko
Office of Acquisition & Grants Services (OAGS)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20857
Telephone: 240-402-7592
Email: Lisa.Ko@fda.hhs.gov

Lisa Ko
Office of Acquisition & Grants Services (OAGS)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20857
Telephone: 240-402-7592
Email: Lisa.Ko@fda.hhs.gov

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

Awards are made under the authorization of Sections 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75. The regulations issued under Executive Order 12372 do not apply to this program. All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement

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 75.322, FDA/CTP reserves a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use work that was developed, or for which ownership was required, under a Federal award for Federal purposes, and to authorize others to do so.

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 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.

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/noticefiles/ 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/noticefiles/ 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.

Smoke-Free Workplace:

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.