Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

U.S. Food and Drug Administration (FDA)

NOTE:  The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

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

Components of Participating Organizations

Center for Tobacco Products (CTP)

Funding Opportunity Title

Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Products (UC2) Clinical Trials Not Allowed

Activity Code

UC2 High Impact Research and Research Infrastructure Cooperative Agreement Programs

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-FD-21-003

Companion Funding Opportunity

None

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

93.103

Funding Opportunity Purpose

FDA's CTP is seeking to develop a smoking machine adaptor for use with electronic nicotine delivery system (ENDS), cigars, and heated tobacco products that will require significant collaboration and research efforts with outside organizations.  The selected organization(s) will develop a single universal adaptor, or standardized family of adaptors, for the attachment of ENDS, cigars, and heated tobacco products to existing smoking machines originally designed for use with cigarettes and make available to tobacco stakeholders, contract and government laboratories, and academic institutions.

Key Dates

 

Posted Date

April 13, 2020

Open Date (Earliest Submission Date)

April 13, 2020

Letter of Intent Due Date(s)

May 8, 2020

Application Due Date(s)

July 10, 2020 by 11:59 PM Eastern Time.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. 

Late applications will not be accepted for this FOA

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

August 2020

Advisory Council Review

Not Applicable

Earliest Start Date

November 2020

Expiration Date

July 11, 2020

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) 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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. 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

    FDA's CTP is seeking to develop a smoking machine adaptor for use with electronic nicotine delivery system (ENDS), cigars, and heated tobacco products that will require significant collaboration and research efforts with outside organizations.  The selected organization(s) will develop a single universal adaptor, or standardized family of adaptors, for the attachment of ENDS, cigars, and heated tobacco products to existing smoking machines originally designed for use with cigarettes; make available to tobacco product science stakeholders a smoking machine adaptor for ENDS, cigars, and heated tobacco products possessing both high repeatability and reproducibility, coupled with continuous design improvement, and stakeholder support; coordinate and administer a comparison study testing repeatability and device validation between the smoking machine adaptor(s) to be developed by this project and those smoking machine adaptors currently available; and provide to tobacco product stakeholders continued smoking machine adaptor product support and improvement for ongoing research.

    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 Americans 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.

    On May 10, 2016, FDA issued a final rule deeming all products that meet the statutory definition of a tobacco product, except accessories of deemed tobacco products, to be subject to FDA’s tobacco product authority. This included electronic nicotine delivery systems (ENDS), cigars, waterpipe (hookah) tobacco, pipe tobacco, nicotine gels, and dissolvables that were not already subject to the FD&C Act (81 FR 28974 at 28976 (May 10, 2016)).  It has come to CTP's attention that manufacturers, researchers, and other stakeholders seeking to study and quantify both aerosol and smoke physical properties and harmful and potentially harmful constituents (HPHC) levels produced by cigars, ENDS, and heated tobacco products lack standardized adaptor mechanisms for attachment of the tobacco products to currently marketed smoking machines. 

    The current lack of standard smoking machine adaptors for these tobacco products is due to several limitations.  First, the adaptor is specifically designed for either an individual tobacco product, or a small family of tobacco products, and therefore cannot be implemented across tobacco products.  This limitation is most applicable to ENDS as they possess the most variation in both mouthpiece geometry and materials, but the limitation can also be seen for little cigars, since they also have varying geometries.  Second, adaptors as currently designed, allow for a high variability in results between identical test runs.    Third, current adaptors were developed by tobacco manufacturers and independent test labs and are optimized for specific products only.  These custom adaptors are proprietary, not available to third-party researchers, and are not typically applicable across multiple tobacco products within the same tobacco product category.

    Standardized adaptors will have multiple public health benefits due to better data on products that are either being marketed or that are being developed to be marketed to the public.  A standardized adaptor would allow for data acquisition from an increased number of tobacco products within deemed categories.  A standardized adaptor product that has undergone a thorough iterative design validation process will eliminate a major source of measurement uncertainty and will lead to improved measurement accuracy.  An additional benefit of a standardized smoking machine adaptor is that it may aid manufacturers in developing and demonstrating modified risk tobacco products (MRTPs).    High-quality data will aid manufacturers in developing modified risk products and supporting their claims.  Similarly, a standardized smoking machine adaptor may aid manufacturers in the development of new tobacco products that are appropriate for the protection of the public health.  A well-validated standardized smoking machine adaptor needs to be developed to ensure accurate, high quality data are being used by stakeholders in their efforts to quantify, improve and protect the public from tobacco-related death and disease.  A well-validated standardized smoking machine adaptor for nonclinical evaluations will allow academic institutions, public advocacy groups, tobacco product manufacturers, and independent contract testing laboratories ensure that high quality data is gathered.  This scientific information may help inform the public about the risks and potential risks associated with tobacco use. 

    Overarching Program Goal

    The goal of the smoking machine adaptor design project for ENDS, cigars, and heated tobacco products is to assist tobacco stakeholders, such as tobacco product manufacturers, universities, and other laboratory testing facilities, in the development of a standardized and validated adaptor, or family of adaptors, for currently marketed smoking machines.  A validated and standardize smoking machine adaptor system will improve the quality of collected experimental data from cigars, ENDS, and heated tobacco products.  Additionally, the Awardee should be responsible for continued device support, manufacture, development, and sale (i.e., all ongoing business activities) upon conclusion of CTP sponsorship of the design project.

    Program Purpose

    The purpose of the smoking machine adaptor design program is to develop a standardized and validated adaptor, or family of adaptors, to assure the accuracy and reliability of scientific data obtained from the study of the physical and chemical properties ENDS, cigars, and heated tobacco products.  The program will provide a public benefit by ensuring that stakeholders have accurate scientific data and reduce measurement variability to help fill current scientific gaps regarding the chemical and physical properties of ENDS, cigars, and heated tobacco products, which will improve information regarding the harms associated with tobacco use. 

    Smoking machine adaptors could be used by tobacco product manufacturers, academic researchers, and contract and government laboratories for the following purposes:

    • Basic scientific research    
    • Proficiency testing
    • Instrument calibration
    • Quality control
    • Employee training and certification
    • Analytical method validation
    Program Priorities    

    The applicant is responsible for developing a smoking machine adaptor device.  FDA will be involved in the cooperative agreement by providing advice and guidance on key aspects.  The program is divided into four phases, which will be conducted over 60 months (5 years):

    Phase I:  Feasibility study

    Phase II: Design, prototyping, and pilot testing

    Phase III:  Adaptor validation and comparison study

    Phase IV:  Stakeholder support

    PHASE I (Feasibility Study)

    Phase I will focus on project feasibility, market research, and an assessment of currently existing adaptor and smoking machine technologies for ENDS, cigars, and heated tobacco products.  The objective of Phase I is to establish the technical merit, feasibility, and commercial potential of the proposed development effort.

    Baseline Research

    Deemed tobacco categories:  The Grantee should determine tobacco products with the greatest market share in each deemed tobacco product category (ENDS, cigars, and heated tobacco products).  Key tobacco products in each tobacco product subcategory should be identified as well, dependent on product tip geometry (shape, size, and dimensions) and properties.  For example, cigars with a combination of filtered or non-filtered, leaf or sheet-wrapped, and with and without tip, should be evaluated and reported.  Exact tobacco product subcategory classing, for the purposes of this project, will be dependent on Grantee’s evaluation to be provided in the final feasibility analysis report.  

    Smoking machines:  The Grantee should determine the most appropriate smoking machine to target for adaptor development considering availability, current market share, product quality, and other factors to be determined by the Grantee, with a focus on ease of acquisition and use by a majority of stakeholder groups (e.g., tobacco product manufacturer, academic institutions, non-profits, and others).

    Existing adaptors:  The Grantee should determine currently available smoking machine adaptors for each deemed tobacco product category (ENDS, cigars, and heated tobacco products), and if applicable, each tobacco product subcategory. 

    Feasibility Analysis Report:  The Grantee should provide a detailed project feasibility analysis report to include factors from the Baseline Research.  The feasibility of the adaptor design project should be outlined in terms of cost and marketability.  A comprehensive breakdown of current adaptor options should be provided which includes an evaluation (legal, engineering, marketing, safety, and other grantee defined variables) of current available products compared to the development of a new adaptor system.  The report should include an evaluation and correlation of market share tobacco products with selected smoking machines to provide the projected minimum number of adaptors to ensure maximum market coverage. In addition, the feasibility analysis should consider the following primary design parameters and any other parameters the Grantee determines to be necessary: 

    1) Minimization of aerosol aging (residence time, mechanical agitation, impaction, diffusion)

    2) Device-adaptor seal quality

    3) The selected construction materials’ electrical properties

    4) Device-adaptor-smoking machine relative positioning, and variability [required functionality]

    5) Number and complexity of components

    6) Ability to collect total particulate matter (TPM) [required functionality]

    7) Ease of reuse (sterilization, seal or filter pad replacement)

    8) Cost and ease of manufacture

    9) Ability to comply with commonly used ENDS, cigar, and heated tobacco product testing standards

    PHASE II (Design, Prototyping, and Pilot Testing)

    Overall, Phase II will focus on the design, fabrication, system integration, and initial pilot testing of the adaptor systems components and overall completed system.  Multiple design solutions (no less than two) with varying device numbers, degrees of complexity and interchangeability are expected.  Grantee should include a full list of currently owned equipment, software, supplies, and other design tools available for this project, as well as equipment, software, supplies and design tools that would need to be purchased.  The list should include, but not be limited to, items such as smoking machines, prototyping equipment, computers, data acquisition systems, filter pads, aerosol and smoke characterization equipment (mass, count, and chemical), tubing, lab supplies, safety equipment, tobacco products, flow meters, and available dedicated laboratory space.  Primary design consideration should include those outlined in Phase I Feasibility Analysis Report. 

    The Grantee should design and construct no less than two smoking machine adaptor system prototypes (i.e., two separate adaptor systems which may each consist of multiple adaptors therein) with comparison of their design feasibility, and commercial potential in relation to Phase I feasibility analysis report results.  The Grantee should provide the following as well as other information the Grantee determines to be necessary:

    1) Submit computer aided design (CAD) models, both individual component, and assembly via electronic means in mutually agreed upon file format (to be determined at Initial Project Briefing) for FDA’s review.  CAD models should include fully dimensioned components and assemblies as well as manufacturer ready technical drawing and materials tables with properties.  The Grantee should submit no less than two design options with detailed explanations of compliance with the key design consideration outlined in Phase I.  The FDA will consider that the differentiation between the two prototype adaptor system options may be due to variation in materials, but FDA would prefer complete competing designs.

    2) The Grantee should provide no less than two prototype adaptor systems, preferably differentiated in their means of mechanical operation.  The means of manufacture (e.g., 3D printing, injection molding) and the number of prototypes needed for testing will be determined following the design selection review between the Grantee and FDA.  The prototype adaptor systems constructed, and subsequently sent to the FDA for review, should be fully assembled and test ready.

    Following prototype design selection and prior to pilot testing, the FDA project officer, and other FDA personnel will conduct a site visit of the Grantee’s testing laboratory.

    The Grantee should purchase tobacco products to be tested with the prototype adaptor systems developed as well as purchase at least two commercial adaptors for comparison testing.  The Grantee should submit a list of tobacco products prior to purchase for FDA review and approval.  The type of tobacco products purchased should be based on the results of the Phase I Feasibility Analysis Report.  Total number of purchased ENDS, cigars, heated tobacco products and associated tobacco product consumables, should be sufficient to provide final data on 10 testing replicates.  All purchased ENDS and heated tobacco product devices should be tobacco flavored, and all purchased cigars should be free of characterizing flavors (e.g., mint, menthol, berry, mango) and comply with FDA regulatory enforcement discretion guidance “Modifications to Compliance Policy for Certain Deemed Tobacco Products” published March 2019 or subsequent guidance published thereafter which supersedes the March 2019 guidance.  Online purchases are acceptable.  Purchasing requirements are as follows:

    1) The Grantee should provide FDA with copies of all receipts from the tobacco product purchases for verification of the location where the samples were purchased.

    2) The Grantee should provide FDA with the lot number, bar code/UPC number, and expiration date of the tobacco product (as applicable).

    The Grantee should immediately contact the FDA project officer for guidance if there is not enough tobacco product available for purchase from the same company. 

    The Grantee should conduct pilot testing to determine which of the prototype designs possess superior repeatability, precision and accuracy for each of the tobacco product types, and tobacco product type subcategories, as defined in the Feasibility analysis Report of Phase I.  Additionally, pilot testing will be conducted on currently available adaptor devices for comparison to the prototype designs.  There should be a minimum of 10 replicates tested for each tobacco product category, subcategory, and/or purchased device.  At a minimum, testing should be done as follows and any other pertinent testing the Grantee determines to be necessary:

    1) Pilot testing should be conducted according to CRM 64, CRM 81 and ISO 20768-2018 as their respective scopes apply and consist solely of total particulate matter (TPM) mass measurements, collected on Cambridge filter pads, for all tobacco products.

    2) Aerosol or smoke generation and collection testing protocols should be established as the project progresses and will be dependent on best practices and the current state of the science (SOS) in the field and physical design constraints of the selected tobacco products. 

    The Grantee should submit a report with details about the experimental set up, testing procedure used, the TPM for each test run, the mean, standard deviation, and percent relative standard deviation (%RSD).

    PHASE III (Adaptor Validation and Comparison Study)

    Phase III will focus on quantifying the effects of the adaptor system on smoke and aerosol and functionality of the adaptors. Additionally, the Grantee should undertake the development and validation of a standardized testing method for ENDS, cigars, and heated tobacco products where such methods are currently incomplete or do not exist.  The Grantee should provide a comparison of the selected designs to top competitive smoking machine adaptors in the same tobacco product class, as well as a comparison between results with and without the selected adaptor designs.  The applied testing method should quantify the levels of total particulate matter (TPM) and the aerosol mass and count distributions as a function of particle size. 

    The Grantee should develop laboratory protocol and experimental plan for FDA review and approval.  The laboratory protocol and experimental plan should consist of the following, at a minimum, as well as other pertinent information the Grantee determines is necessary:

    1)  Identify projected timeline, detail proposed experimental setup and the means of assembling the necessary resources for conducting the tests (i.e., a purchase and acquisition plan for representative tobacco products, smoking machine, aerosol characterization apparatus, and other needed items). 

    2)  Provide a detailed experimental setup with testing plan. 

    3)  Provide testing method and validation plan for each tobacco product type.  The methods must be determined to be fit for their purpose, which includes consideration of the following method characteristics: accuracy, precision, robustness, limit of detection, limit of quantification, range and specificity. 

    4)  The Grantee should review currently existing testing method for cigars, ENDS, and heated tobacco products (e.g., CRM 64, CRM 81 and ISO 20768-2018) and determine their applicability while working with FDA to determine the best approach.  The exact testing method employed for all tests may be a currently existing method, a modified testing method, or a wholly new testing method dependent on FDA and Grantee discussions.

    The Grantee has the discretion to perform multiple tasks at one time for efficiency.  The Lab Protocol and Experimental Plan should be submitted within a few weeks after the start of Phase III.

    The Grantee should purchase enough ENDS, cigars, heated tobacco products, and associated consumables from the same batch or lot (where possible) to perform all analyses of the physical characterization of the generated smoke and aerosols.  The type of tobacco products purchased should be in accordance with the results of the Phase I Feasibility Analysis Report.  The total number of purchased ENDS, cigars, heated tobacco products, and associated consumables should be sufficient to complete the requirements with reasonable excess.  The Grantee should submit a list of tobacco products prior to purchase for FDA review and approval.  If products do not bear a batch or lot number, the Grantee should purchase consumables at the same time and from the same vendor.  All purchased ENDS and heated tobacco products should be tobacco flavored, and all purchased cigars should be free of characterizing flavors (e.g., mint, menthol, berry, mango) and in compliance with FDA regulatory enforcement discretion guidance “Modifications to Compliance Policy for Certain Deemed Tobacco Products” published March 2019.  Online purchases are acceptable.  Purchasing requirements are as follows:

    1)  The Grantee should provide FDA with copies of all receipts from the tobacco product purchases for verification of the location where the samples were purchased.

    2)  The Grantee should provide FDA with the lot number, bar code/UPC number, and expiration date of the tobacco product (as applicable) in a separate document.

    The Grantee should immediately contact the FDA Project Officer for guidance if there is not enough tobacco product available for purchase from the same company.

    The Grantee should perform tests on product acquired.  Prior to beginning experimental test runs the Grantee should take reasonable steps to measure and ensure consistency in the nicotine, propylene glycol (PG), and vegetable glycerin (VG) concentrations of ENDS e-liquids and report these results to FDA. 

    The Grantee should provide a Phase III report after the completion of Phase III for FDA approval.  The report should present the background, objectives, methods, results of the analyses, summary of the findings, and conclusions of the project.  Proposed final validated methods for each tobacco product aerosol/smoke generation and collection using the smoking machine adaptor should be outlined in detail. The Phase III report should contain all raw data, testing parameters, instrument settings (to include all final settings and all developmental settings with a description of outcomes), validation data, and identification and quantification of parameters requested in this project. 

    PHASE IV (Continued Stakeholder Support)

    Phase IV will focus on the Grantee's final product strategy plan and continued product improvement, validation, marketing, and the production and distribution of the product into the market.  The Grantee should include a detailed strategy to develop manufacturing, testing, and quality assurance processes applicable to volume commercialization.  Stakeholder support mechanisms, such as web interfaces, and proposed staffing allocations should be highlighted.  Such plans should include a detailed technology-to-market plan covering transition strategy, intellectual property strategy, manufacturing plan and initial strategy plan.  This may include the licensing of adaptor manufacture, quality control procedures, sale, and distribution (i.e., all practical measures for scaled implementation) to a separate vendor by the awardee; in such case a full explanation of licensing scope and draft contracting language should be provided for evaluation.

    The Grantee should submit a draft strategy plan to be reviewed by the FDA and later discussed with the Grantee and FDA personnel connected directly with the project.  After FDA’s review of the draft strategy plan, a list of recommended changes will be submitted to the Grantee.

    The Grantee should submit a final strategy plan to include approved FDA draft after receipt of the FDA’s comments.

    See Section VIII. Other Information for award authorities and regulations.

    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. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New
    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial?

    Not Allowed: Only accepting applications that do not propose clinical trials

    Need help determining whether you are doing a clinical trial?

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Award(s) will provide one (1) year of support and include future recommended support for four (4) additional year(s) contingent upon annual appropriations, availability of funding and satisfactory awardee performance.

    FDA/CTP intends to fund up to $2,000,000, for fiscal year 2021 in support of this grant program.

    It is anticipated that up to one award will be made, not to exceed $2,000,000 in total costs (direct plus indirect), per award.  FDA anticipates the possibility of four (4) additional years of support up to $3,000,000. The FY 2021 budget period will include an initial start-up phase to support activities associated with the acquisition and storage of the smoking adaptors.  FDA/CTP anticipates that project costs will significantly decrease in future funding years as project activities transition from an emphasis on project start up in FY 2021 to project implementation in FY 2022, FY 2023, FY 2024, and FY 2025.

    Award Budget

    Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

    YR 01: $2,000,000

    YR 02: $1,000,000

    YR 03: $1,000,000

    YR 04: $500,000

    YR 05: $500,000

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

    Funds should be requested for travel to the metropolitan Washington, D.C. area for an initial kick off meeting in Year 1 with program staff (the applicant should budget for one meeting with principal grantee staff).

    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is Five (5) years.

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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:

    o   Hispanic-serving Institutions

    o   Historically Black Colleges and Universities (HBCUs)

    o   Tribally Controlled Colleges and Universities (TCCUs)

    o   Alaska Native and Native Hawaiian Serving Institutions

    o   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)
    • 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
    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

    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.

    • 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)– 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.
    • o   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 to register in eRA Commons.  Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. 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.

    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(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.

    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 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.
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Research (R) 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.

    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 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), email 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 Word or PDF file to Rene Vasquez at Rene.Vasquez@fda.hhs.gov with “RFA-FD-21-003 Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Products Letter of Intent” and the Institution's Name in the message subject heading to:

    Rene Vasquez
    Telephone: 301-796-3546
    Email: Rene.Vasquez@fda.hhs.gov

    A technical session will be held for prospective applicants in May 2020.  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. 

    Page Limitations

    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 is limited to 30 pages.

    Instructions for Application Submission

    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.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R Budget

    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'.
    • 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 a kick off meeting in Project Year 1 with FDA program staff and principal grantee staff.
    • 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.
    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    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:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

    Appendix:

    Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

    PHS Human Subjects and Clinical Trials Information

    When involving human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

    Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

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

    PHS Assignment Request Form

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

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. 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 and time.  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.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. 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 allowable only as described in the HHS Grants Policy Statement.

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

    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

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

    7. Other Submission Requirements and Information

    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 How to Apply – Application Guide. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    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.

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

    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 smoking machine adaptor for ENDS, cigars, and heated tobacco products that is related to the regulation of tobacco products under the Tobacco Control Act.

    Post Submission Materials

    Post-submission materials are those submitted after submission of the grant application but prior to objective review. They are not intended to correct oversights or errors discovered after submission of the application. FDA accepts limited information between the time of initial submission of the application and the time of objective review.  Applicants must contact the assigned Grants Management Specialist to receive approval, prior to submitting any post submission materials. Acceptance and/or rejection of any post submission materials is at the sole discretion of the FDA. Any inquiries regarding post submission materials should be directed to the assigned Grants Management Specialist.

    Section V. Application Review Information
    1. Criteria

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

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. 

    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 smoking machine adaptor 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 Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Products?  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 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 smoking machine adaptor in a timely manner?

    Additional Review Considerations

    As applicable for the project proposed, reviewers will evaluate the following additional items but will not give separate scores for these items, and should not consider them in providing an overall score.

    Protections for Human Subjects

    For research that involves human subjects but does not involve one of the  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 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 Guidelines for the Review of Human Subjects.

    Inclusion of Women, Minorities, and Individuals Across the Lifespan 

    When the proposed project involves human subjects and/or FDA-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    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.

    Resubmissions

    Not Applicable.

    Renewals

    Not Applicable.  

    Revisions

    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)  Genomic Data Sharing Plan (GDS).

    Authentication of Key Biological and/or Chemical Resources:

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    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 research.

    2. Review and Selection Process

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

    As part of the objective review, all applications:

    • Will receive a written critique.

    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 program priorities.
    3. Anticipated Announcement and Award Dates

    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.

    Section VI. Award Administration Information
    1. Award Notices

    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, this FOA, and Notice of Award. 

    2. Administrative and National Policy Requirements

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

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency.  The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS.  Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

    HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.  For additional guidance regarding how the provisions apply to FDA grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

    Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), FDA awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.”  This provision will apply to all FDA grants and cooperative agreements.

    FDA considers the sharing of research resources developed through FDA-sponsored research an important means to enhance the value and further the advancement of research. When research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community.

    Upon acceptance for publication, scientific researchers must submit the author’s final manuscript of the peer-reviewed scientific publication resulting from research supported in whole or in part with FDA funds to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines the author's final manuscript as the final version accepted for journal publication, which includes all modifications from the publishing peer review process. The PMC archive is the designated repository for these manuscripts for use by the public, health care providers, educators, scientists, and FDA. Please see the FDA Public Access Policy.

    Certificates of Confidentiality – 42 U.S.C. 241(d)

    Awardees are responsible for complying with all requirements to protect the confidentiality of identifiable, sensitive information that is collected or used in biomedical, behavioral, clinical, or other research (including research on mental health and research on the use and effect of alcohol and other psychoactive drugs) funded wholly or in part by the Federal Government.  See 42 U.S.C. 241(d).  All research funded by FDA, in whole or in part, that is within the scope of these requirements is deemed to be issued a “Certificate of Confidentiality” through these Terms and Conditions.   Certificates issued in this manner will not be issued as a separate document. 

    Awardees are expected to ensure that any investigator or institution not funded by FDA who receives a copy of identifiable, sensitive information protected by these requirements, understand they are also subject to the requirements of 42 U.S.C. 241(d).  Awardees are also responsible for ensuring that any subrecipient that receives funds to carry out part of the FDA award involving a copy of identifiable, sensitive information protected by these requirements understand they are also subject to subsection 42 U.S.C. 241(d).

    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 Notice of Grant Award.  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 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.

    Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Products Special Terms and Conditions

    The purpose of the smoking machine adaptor design project for ENDS, cigars, and heated tobacco products is to develop a standardized and validated adaptor, or family of adaptors, to assure the accuracy and reliability of scientific data obtained from the study of the physical and chemical properties ENDS, cigars, and heated tobacco products.  The program will provide a public benefit by ensuring that stakeholders have accurate scientific data and reduce measurement variability to help fill current scientific gaps regarding the chemical and physical properties of ENDS, cigars, and heated 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-21-003 entitled Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Products (UC2).

    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 budget period:

    A. A Mid-Year Progress Report is to be submitted 14 days following the end of the first 6 months of the budget period. This report should provide the following reporting elements:

    a)     Overall progress on the activities of the Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Products.

    b)     Projected timeline for uncompleted grant activities (expected accomplishments/milestones by the end of the current budget period of the grant).

    c)     Pending issues/concerns.

    d)     Estimated unobligated balance: funds expended and funds remaining on this project as of report submission date.    

    B. The Annual Progress Report will be due as part of the Research Performance Progress Report (RPPR) and is due no later than 60 days prior to the start date of the next budget period start date.

    2. Grants with Multiple Years: In order to receive future funding, the grantee is required to submit the Research Performance Progress Report (RPPR). 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:

    A. General progress on the activities of the Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Products to include the project status in relation to established timeline.

    B. Projected timeline for uncompleted grant projects and or activities (expected accomplishments/milestones by the end of the current budget period of the grant).

    C. Pending issues/concerns.

    D. Estimated unobligated balance: funds expended and funds remaining on this project as of report submission date.

    3. Financial Reporting:

    A. Cash Transaction Reports

    The Federal Financial Report (FFR) has a dedicated section to report Federal cash receipts and disbursements. For recipients this information must be submitted quarterly directly to the Payment Management System (PMS) using the web-based tool. Quarterly reports are due 30 days following the end of each calendar quarter. The reporting period for this report continues to be based on the calendar quarter. Questions concerning the requirements for this quarterly financial report should be directed to the PMS.

    B. Financial Expenditure Reports

    A Mid-Year FFR is due along with the Mid-Year Progress Report.

    A required Federal Financial Report (FFR) must be submitted annually. FDA now requires all annual financial expenditure reports to be submitted electronically using the Federal Financial Report (FFR) system located in the eRA Commons. This includes all initial FFRs being prepared for submission and any revised FSR/FFRs being submitted or re-submitted to FDA. Paper expenditure/FFR reports will not accepted.

    Annual FFRs must be submitted for each budget period no later than 90 days after the end of the calendar quarter in which the budget period ended. The reporting period for an annual FFR will be that of the budget period for the particular grant; however, the actual submission date is based on the calendar quarter. Failure to submit timely reports may affect future funding.

    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. A non-Federal entity that expends $750,000 or more during the non-Federal entity's fiscal year in Federal awards must have a single or program-specific audit conducted for that year in accordance with the provisions of 45 CFR 75, Subpart F-Audit Requirements.  Audits must be completed and submitted electronically to the Federal Audit Clearinghouse (FAC) within 30 days after receipt of the auditor's report(s), or 9 months after the end of the audit period, i.e., the end of the organization's fiscal year, whichever is earlier. If you need information on your organization’s obligations, 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

    The grantee and its employees should have the right, consistent with academic standards, to publish the results of research performed under this Agreement, provided such publication does not disclose proprietary trade secrets or confidential information of the FDA and does not reference, imply or infer any FDA endorsement of regulatory and/or policy changes related to the project.

    The grantee agrees that, prior to submission of a manuscript with FDA co-author(s) describing the results for publication, the grantee should forward to the FDA a copy of the manuscript to be submitted and should allow the FDA 30 business days to review for any potential language that might reference, imply or infer any FDA endorsement of regulatory and/or policy changes related to the project. For publications without an FDA co-author but using FDA/Tobacco User Fee funds to support the grant, a courtesy review of the publication is necessary to ensure that any potential language that might reference, imply, or infer any FDA endorsement of regulatory and/or policy changes related to the project is not stated.

    At this time the grantee should be free to submit the manuscript and publish results in any manner consistent with academic standards. The FDA will have the right to request deletion of any trade secret, proprietary, or confidential information, and any inference to FDA endorsement of regulatory and/or policy changes related to the project.

    2. CONFERENCES AND TRAVEL

    Before a grantee expends any grant funds on newly proposed conference attendance and/or travel that was never previously proposed in the original application submission or subsequent progress reports, 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 Officer and must include the following information:

    A.  Title/Topic of Conference

    B.  Purpose of Conference

    C.  Explanation of how the Conference directly supports the STRP 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. DISTRIBUTION OF SMOKING MACHINE ADAPTOR

    The grantee, its employees, and designees must submit a written request to the Program Officer before distributing the smoking machine adaptor to any organization or individual outside the grantee organization. The written request must include the following information:

    A. The specific smoking machine adaptor design being used for distribution purpose

    B. Any other information to be included along with the product during distribution

    C. Description of process used by customers to order product

    D. Description of system used to track customer orders, including inventory of customers and order history

    The grantee, its employees, and designees should not distribute the smoking machine adaptor until receiving written approval from the Program Officer.

    All distributions of smoking machine adaptor developed under this program must accord with all applicable laws.

    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.

    2.  Examples of Program Income include (and not limited to): 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.

    4. Program Income retained after the project performance period must only be used to sustain and support the needs of the public through the tobacco product reference material program.

    FUNDING RESTRICTIONS:

    The following highlights allowable and unallowable activities/costs under the Smoking Machine Adaptor Design Project for ENDS, Cigars, and Heated Tobacco Products.  The grantee should contact the assigned Grants Management Specialist if clarification is needed regarding 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-21-003.

    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-21-003.

    The grantee must ensure that during the design process the smoking machine adaptor will only be used for research purposes and not be resold.

    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

    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, should clearly indicate:

    *Funding for this statement, publication, press release, etc. was made possible, in part, by the Food and Drug Administration through grant [FAIN] 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.*

    FINANCIAL CONFLICT OF INTEREST:

    Recipients and investigators must comply with the requirements of 42 CFR Part 50, Subpart F, "Promoting Objectivity in Research" for which PHS funding is sought. That subpart promotes objectivity in research by establishing standards to ensure that the design, conduct, and reporting of research funded under PHS grants or cooperative agreements will not be biased by any conflicting financial interest of an investigator. These requirements do not apply to Phase I of the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs. Under those requirements the organization must do the following:

    • Have a written and enforced administrative process to identify and manage, reduce, or eliminate conflicting financial interests with respect to research projects for which PHS funding is sought
    • Before spending any PHS funds awarded under a new award, inform the GMO of the existence of any conflicting financial interests it identified of the type covered by 42 CFR 50.605 and assure that the interest been managed, reduced, or eliminated in accordance with the regulations
    • Continue to make similar reports on subsequently identified conflicts within 60 days of identifying them
    • Make additional information available to the OPDIV, upon request, as to how it handled conflicting interests in accordance with the regulations.  As described in the regulations, examples of how financial conflicts of interest might be addressed include the following:

    •          Public disclosure of significant financial interests

    •          Monitoring of research by independent reviewers

    •          Modification of the research plan

    •          Disqualification from participation in all or a portion of the research funded by PHS

    •          Divestiture of significant financial interests

    •          Severance of relationships that create actual or potential conflicts. Recipients also

    must ensure that subawards in the form of consortium agreements address whether the consortium participant's employees will be subject to the financial conflict of   interest requirements of the consortium participant or to those of the recipient.

    Some IRBs also consider investigator financial conflict of interest in their deliberations, although they are not required to do so. If an IRB considers the impact of potential financial (or other) conflicts of interest on the research and the protection of human subjects, it should refer to the organization's policies and procedures for identifying and monitoring conflicts of interest. Following are some strategies used by IRBs:

    • Make IRB members aware of the organization's conflict of interest policies and procedures
    • Include a statement in the informed consent form that all investigators comply with the organizational guidelines
    • Ask investigators to complete a short questionnaire about whether they—or any person responsible for the design, conduct, or reporting of research—have an economic interest in or act as an officer or a director of any outside entity whose financial interest could reasonably appear to be affected by the research
    • Instruct IRB members during their orientation on how to identify and respond to a perceived financial, academic, or other conflict of interest.  Suggestions for recipients to consider when implementing the requirements of this regulation are available in an NIH publication, Financial Conflict of Interest–Objectivity in Research: Institutional Policy Review, available on the NIH Web site at http://grants.nih.gov/grants/policy/coi/nih_review.htm.
    3. Reporting

    When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the Notice of Award.

    A Mid-Year Progress Report is to be submitted 14 days following the end of the first 6 months of the budget period.  A Mid-Year FFR is due along with the Mid-Year Progress Report.

    A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the terms and conditions of award and 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. 

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Christi Wakefield
    Center for Tobacco Products (CTP)
    Food and Drug Administration
    Email: Christi.Wakefield@fda.hhs.gov

    Objective Review Contact(s)

    Rene Vasquez
    Office of Acquisitions & Grants Services (OAGS)
    Food and Drug Administration
    Email: Rene.Vasquez@fda.hhs.gov

     
    Financial/Grants Management Contact(s)

    Rene Vasquez
    Office of Acquisitions & Grants Services (OAGS)
    Food and Drug Administration
    Email: Rene.Vasquez@fda.hhs.gov

    Section VIII. Other Information

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

    Authority and Regulations

    Awards are made under the authorization of Section 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 and Section 919(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 387s(c))).

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