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.

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

FDA's Center for Tobacco Products (CTP) is seeking to develop a cigar tobacco reference products program that will require significant collaboration and research efforts with outside organizations. The selected organization(s) will develop tobacco reference products representing cigars to be used for nonclinical investigational purposes by tobacco manufacturers, contract and government laboratories, and academic institutions. The selected organization(s) will collaborate with these stakeholders, including FDA, in developing the cigar tobacco reference products.

The Cigar 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).

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 August 8, 2016, FDA issued a final rule extending the Agency's tobacco product authorities to all other categories of tobacco products. Based on this August 8, 2016 final rule, cigars meet the statutory definition of tobacco products regulated by FDA.

Cigars vary significantly in size, ranging from greater than 1 gram per unit to 20 grams per unit. CTP is aware of the lack of high-quality, well characterized cigar tobacco reference products available for manufacturers, researchers, and other stakeholders interested in measuring the chemical and physical properties related to various cigars. The development of cigar tobacco reference products would result in products with known chemical and physical composition and well characterized physical and chemical properties. These cigar tobacco reference products would also include a certificate of analysis listing the measured values and the uncertainties associated with those measurements. The proposed reference cigar products would closely resemble marketed products (i.e., cigars) in physical and chemical composition and are expected to have similar analytical challenges to commercially marketed cigars. Developing certified cigar tobacco reference products 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. Because these proposed cigar reference products would have known physical and chemical composition, commercially marketed products can be evaluated by manufacturers, researchers, and other stakeholders and compared to the cigar reference products leading to a reduction of uncertainty in measurements and resulting in improved accuracy of analytical measurements.

Tobacco reference products for cigarettes have been developed (e.g. 1R6F research cigarettes) and smokeless tobacco reference products are underway. Lack of suitable test methods to study the properties of cigars due to varying circumferences, weights, lengths, densities, and pressure drops has inhibited research of cigar tobacco reference products. In the absence of a research cigar, tobacco manufacturers, contract laboratories, government laboratories, and academic institutions use internal standards such as heptadecane, or quinaldine [[1]] and/or may use the cigarette tobacco reference product when performing cigar studies. Cigar and cigarettes differ in the physical composition of tobacco (e.g. leaf sizes, tobacco quantities) and tobacco additives (e.g. added humectants and flavors). Levels of harmful and potentially harmful constituents (HPHCs) in cigar tobacco products differ from cigarette tobacco products. [[2]] Repeatability and reproducibility of the chemical constitution of mainstream smoke from burning cigars is challenging due to the different cigar sizes and types. For example, the appropriate puff volume of larger cigars is difficult to determine because they often need to be relit, and the various cigar sizes and dimension impact repeatability and reproducibility of cigar burn rates, constant air velocities, and burn cones. [[3]] The Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA) have developed CORESTA Recommended Methods (CRM) for cigar testing (i.e., CRM 46, 47, 64 68) including smoking machine test conditions allowing for a more systematic evaluation of the chemical (tar, nicotine, and carbon monoxide) and physical properties of different types of cigars.[[4]] HPHCs in cigar tobacco products are of interest to researchers and the public health community, as well as FDA.

Well-characterized reference cigar products need to be developed that are representative of common cigars in the US 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. Cigar types are determined by the manufacture process (i.e., machine made, or hand rolled) and by the product dimensions (i.e., little cigars [brown cigarettes or little filtered cigars], small cigars [cigarillos], large cigars [processed leaf filler, non-premium], and premium cigars [whole leaf filler]). Multiple reference cigar tobacco products will be necessary to appropriately represent the various cigars available on the market. The cigar reference products developed would represent machine-made, sheet-wrapped cigars: filtered or unfiltered cigar products with dimensions and characteristics of little cigars (brown cigarettes), small cigars (cigarillos), and large cigars (processed leaf filler, non-premium). Cigar reference products would be thoroughly analyzed to ensure high-quality HPHC data is available for the three different cigar types. By having well characterized cigar tobacco reference products for nonclinical 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.

The goal of the Cigar Tobacco Reference Products Program is to develop well-characterized cigar tobacco reference products to ensure 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 three cigar tobacco reference productst will enable an accurate and thorough scientific characterization of various cigar tobacco products available on the market today. The value of having a well-characterized cigar tobacco reference product will benefit the public and other stakeholders as accurate scientific evidence will 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.

The purpose of the Cigar Tobacco Reference Products Program is to develop cigar tobacco reference products to assure the accuracy and reliability of scientific data obtained from the study of the physical and chemical properties of cigars. The cigar tobacco reference products will be representative of marketed cigar 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 cigar tobacco products, which will improve information regarding the harms associated with tobacco use.

Cigar tobacco reference products could be used by tobacco product manufacturers, academic researchers, and contract and government laboratories 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 tobacco chemicals 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 chemical.

Laboratories could also use the cigar tobacco reference products as control samples during instrument calibration, method validations 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), the instrument needs to be recalibrated to confirm that the instrument is working properly and to confirm optimum instrument performance before being introduced back into routine laboratory use. In utilizing the cigar tobacco reference product 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 cigar 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

The applicant is responsible for developing cigar tobacco reference products. A high-quality reference product is one that is manufactured and stored under tightly controlled conditions and thoroughly characterized (chemically and physically). A certificate of analysis listing the measured values of 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 key aspects. A tobacco reference program should include the following:

1. Obtain reference product(s): Produce machine made, sheet-wrapped cigars: filtered or unfiltered cigar products with dimensions and characteristics of little cigars (brown cigarettes), small cigars (cigarillos), and large cigars (processed leaf filler, non-premium cigars). Product(s) should be manufactured in one batch (i.e., one manufacturing run) using identical specifications per each product type (e.g., little cigar, cigarillo, and large cigar). The reference tobacco product(s) should be acquired 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. In obtaining the reference products, the applicant must comply with all applicable laws.

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

a) Tobacco blend

b) HPHCs in smoke shall be determined according to smoking regimen described in CORESTA methods CRM 64 68 (Acetaldehyde; Acrolein; Acrylonitrile; 4-Aminobiphenyl; 1-Aminonaphthalene; 2-Aminonaphthalene; Ammonia; Benzene; Benzo[a]pyrene; 1,3-Butadiene; Carbon monoxide; Crotonaldehyde; Formaldehyde; Isoprene; Total nicotine; NNK (4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone); NNN (N-nitrosonornicotine); Toluene) using a cigar smoking machine (e.g., Borgwaldt LM4C / LM5C Linear smoking machine or similar containing variable adaptors)

c) HPHCs in tobacco filler, binder, and wrapper (Ammonia; Arsenic; Cadmium; Total nicotine; NNN; NNK)

d) Tar (nicotine-free dry particulate matter)

e) Cigar circumference

f) Cigar length

g) Cigar nominal diameter

h) Filter and tobacco rod density (as applicable)

i) Filter length (as applicable)

j) Filter pressure drop (as applicable)

k) Filter ventilation amount (as applicable)

l) Air permeability

m) Mass of the tobacco total cigar, filler, binder, and wrapper

n) Moisture content of the tobacco filler, binder, and wrapper

o) pH of the tobacco filler, binder, and wrapper

p) Tobacco rod length (if filtered)

q) Cigar butt length (as applicable)

r) Cigar wrapper and binder porosity (as applicable)

s) Product stability testing (periodic characterization of the chemical and physical properties during the proposed storage life of the product)

t) Water activity

u) Filter material (as applicable)

v) Tobacco cut size

w) Total Aerobic Microbial counts (TAMC), Total Yeast and Mold counts (TYMC), Nitrate and nitrite content in the cigar wrapper, filler and binder.

3. Storage: Determine and provide optimal storage conditions for cigar 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 chemical and physical properties, including uncertainties associated with the measurements, found in the cigar 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. Proficiency testing ( round-robin comparison study): Coordinate and administer an inter-laboratory comparison study using the reference product. This should include the following:

a) Identify 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.

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

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

• 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.
• 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.

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.

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.

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.

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-20-002 Cigar TRP 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 July 2019. 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'.
• 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.

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:

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:

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

When involving FDA-defined 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.

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

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

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.

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.

Special arrangement 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 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 cigar tobacco reference product program that is related to the regulation of tobacco products under the Tobacco Control Act.

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.

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, 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 cigar 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 cigar tobacco 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 evaluate the following additional items but will not give separate scores for these items, and should not consider them in providing an overall score.

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.

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.

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 Data Sharing Plan (GDS).

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.

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) 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.

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.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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.

HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. 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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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.

The purpose of the Cigar Tobacco Reference Products Program (Cigar TRP) is to develop cigar tobacco reference products to assure the accuracy and reliability of scientific data obtained from the study of the physical and chemical properties of cigars. The cigar tobacco reference products will be representative of marketed cigar 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 cigar 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-20-002 entitled the Cigar Tobacco Reference Products Program (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 Cigar TRP project.

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 Cigar TRP 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 shall 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 shall forward to the FDA a copy of the manuscript to be submitted and shall 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 shall 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 REFERENCE PRODUCTS

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

A. Name of the reference product being used for distribution purpose

B. Illustration of product packaging and labeling

C. Certificate of analysis and any other information to be included along with the product during distribution

D. All analytical testing information supporting the certificate of analysis

E. Description of process used by customers to order product

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

The grantee, its employees, and designees shall not distribute the reference products until receiving written approval from the Program Officer.

All distributions of cigar tobacco reference products 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 Cigar TRP Program. The grantee should contact the assigned Grants Management Specialist if clarification is needed regarding Cigar TRP Program allowable activities or costs prior to the expenditure of funds.

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:

The grantee must ensure that the cigar tobacco reference products 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

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-20-002 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.

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 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.

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

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

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

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

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