Department of Health and Human Services


Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

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

Components of Participating Organizations

Center for Tobacco Products (CTP)

Funding Opportunity Title

Cigarette Tobacco Reference Products Program (UC2)

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-14-001

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.103

Funding Opportunity Purpose

FDA's CTP is seeking to develop a cigarette 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 American blended cigarettes to be used for investigational non-clinical purposes by tobacco manufacturers, contract and government laboratories, and academic institutions.

Key Dates
Posted Date

September 26, 2013

Open Date (Earliest Submission Date)

October 1, 2013

Letter of Intent Due Date(s)

October 15, 2013 by 11:59 PM Eastern Time

Application Due Date(s)

November 15, 2013  by 11:59 PM Eastern Time

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 p.m. Eastern Time on the application due date.  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.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

January 2014

Advisory Council Review

Not Applicable

Earliest Start Date

March 2014

Expiration Date

November 16, 2013

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.  Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV.  When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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 Center for Tobacco Products (CTP) is seeking to develop a cigarette 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 American blended cigarettes to be used for non-clinical 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 tobacco reference products.

Authority

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

Program Background

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

Cigarettes are among the tobacco products regulated by CTP.  It has come to CTP's attention that manufacturers, researchers, and other stakeholders seeking to study and measure properties related to cigarettes lack a high-quality cigarette tobacco reference product.  A reference product is a product whose properties (both chemical and physical) have been thoroughly characterized.  A certificate of analysis listing the measured values and the uncertainties associated with those measurements is distributed with the reference product.  Since the reference product physically and chemically resembles the marketed product (i.e., a cigarette), the reference product provides analytical challenges similar to those encountered by the analyst.  By providing a cigarette reference product with known composition, a major source of measurement uncertainty is eliminated, leading to improved measurement accuracy.    

Currently, a few tobacco reference products exist for cigarettes and various smokeless products which have been distributed and used by various entities including tobacco manufacturers, contract laboratories, government laboratories, and academic institutions.  In the United States, tobacco reference products have been exclusively developed and distributed by academic institutions, whereas in Europe, tobacco reference materials have been developed and distributed by CORESTA (Cooperation Center for Scientific Research Relative to Tobacco). 

The reference cigarette products containing American tobacco blends that are currently available to the public have not been sufficiently characterized to ensure that high-quality data is available for a variety of different cigarette characteristics.  For example, the smoking analysis measurements for currently available reference cigarettes are limited to tar, nicotine, and carbon dioxide.  These products have not been certified for additional harmful and potentially harmful constituents (HPHCs).  Levels of HPHCs in cigarettes are of particular interest to researchers and the public health community, as well as FDA. 

Another benefit of a cigarette tobacco reference product is that it may aid manufacturers in developing and demonstrating modified risk tobacco products.  Manufacturers who wish to market tobacco products with claims of reduced exposure or harm compared to currently marketed products must submit a modified risk tobacco product application (MRTPA) to FDA pursuant to section 911 of the FD&C Act.  High-quality data will aid manufacturers in making the necessary showing.  Similarly, another benefit is that a cigarette tobacco reference product may aid manufacturers in the development of new tobacco products that are appropriate for the protection of the public health.  A well-characterized cigarette tobacco reference product, similar to cigarettes commercially marketed in the United States, needs to be developed to ensure accurate, high quality data are being used by stakeholders in their efforts to improve and protect the public from tobacco related death and disease.    By having a well characterized cigarette tobacco reference product for non-clinical evaluations, various organizations such as academic institutions, public advocacy groups, tobacco product manufacturers, and independent contract testing laboratories can ensure that high quality data is gathered, and this scientific information can, for example, be communicated to the public about the risks and potential risks associated with tobacco use. 

Overarching Program Goal

The goal of the Cigarette Tobacco Reference Products Program is to develop a cigarette tobacco reference product to ensure the accuracy of scientific data stakeholders will use in their efforts to  protect the public from tobacco related disease and death. The development of a cigarette tobacco reference product will enable an accurate and thorough scientific characterization of cigarette tobacco products.  The value of having a well-characterized cigarette 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.

Program Purpose

The purpose of the Cigarette Tobacco Reference Products Program is to develop cigarette tobacco reference products that closely resemble marketed cigarette tobacco products.  The program will provide a public benefit by ensuring that stakeholders have accurate scientific data to help fill current scientific gaps regarding the chemical and physical properties of tobacco products, which will improve information regarding the harms associated with tobacco use. 

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

•   Proficiency testing,

•   Instrument calibration,

•   Employee training,

•   Method validation, and

•   Investigational purposes.

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

Laboratories could also use the reference products as control samples during instrument calibration.  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 before being introduced back into routine use in the laboratory.  In utilizing the cigarette tobacco reference product in this manner, further confidence of the chemical composition of the tobacco product is established.   

The development of a cigarette tobacco reference product along with its utility and performance in a laboratory setting will facilitate high quality data, enable researchers to use this product as a control to fill tobacco science gaps, and access laboratory performance standards in order to protect the general public from tobacco related diseases and harms.    

Program Priorities    

The applicant is responsible for developing a cigarette tobacco reference product.  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 these aspects.  A tobacco reference program should include the following:

1.  Obtain reference product:  Obtain cigarettes representative of an American blended cigarette.  Product should be manufactured in one batch (i.e., one manufacturing run).  The reference tobacco product should be acquired to allow for distribution over multiple years.  In obtaining the reference products, the applicant must comply with all applicable laws.

2.  Characterization (physical and chemical properties):  A well designed cigarette tobacco reference product 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 cigarette tobacco reference product should accompany the product. 

a)   Tobacco blend

b)   HPHCs in smoke under ISO and Canadian Intense smoking regimens (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)

c)   HPHCs in tobacco filler (Ammonia; Arsenic; Cadmium; Total nicotine; NNN; NNK)

d)   Tar (nicotine-free dry particulate matter)

e)   Cigarette circumference

f)    Cigarette draw resistance

g)   Cigarette length

h)   Cigarette mass

i)    Cigarette nominal diameter

j)    Filter density

k)   Filter length

l)    Filter pressure drop

m)  Filter ventilation amount

n)   Air permeability

o)   Tobacco filler mass

p)   Tobacco filler moisture content

q)   Tobacco filler pH

r)    Tobacco rod length

3.  Storage:  Determine and provide optimal storage conditions for tobacco reference products (e.g. temperature, humidity, reference product packaging). 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 cigarette 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:  Coordinate and administer an inter-laboratory comparison study using the reference product.  Ideally, 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. 

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 program staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

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

Funds Available and Anticipated Number of Awards

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

FDA intends to commit up to $6,700,000 in FY 2014.  Future year amounts will depend on annual appropriations, availability of funding and awardee performance.

This is a multi-year cooperative agreement.  It is anticipated that up to one (1) award will be made, not to exceed $6,700,000 (total costs including indirect costs) per award.  FDA anticipates the possibility of four (4) additional years of support up to $2,800,000 of funding contingent upon successful performance and availability of funding. The FY 2014 budget period will include an initial start-up phase to support activities associated with the acquisition and storage of the cigarette reference product.  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 2014 to project implementation in FY 2015, FY 2016, FY 2017, and FY 2018.

Fiscal Year (FY) 2014 Funds:

Estimated FY 2014 Funding: $6,700,000

Maximum Size Award in FY 2014: $6,700,000

Estimated Number of Awards: 1

Estimated Future Year Funding:

FY 2015: $1,000,000

FY 2016: $700,000

FY 2017: $600,000

FY 2018: $500,000

Maximum Size Award in Future Years:

FY 2015: $1,000,000

FY 2016: $700,000

FY 2017: $600,000

FY 2018: $500,000

Maximum Project Period: Five (5) years

Award Budget

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 annual meetings with program staff (the applicant

should budget for one meeting per year for 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.

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

Section III. Eligibility Information


1. Eligible Applicants


Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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.

For additional guidance on how to apply electronically please go to: http://grants.nih.gov/grants/ElectronicReceipt/index.htm

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account.  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

FDA will not accept any application that is essentially the same as one already reviewed within the past twelve months (as described in the HHS Grants Policy Statement), except for submission:

Section IV. Application and Submission Information


1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

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

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows FDA/CTP staff to estimate the potential review workload and plan the review.

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

The letter of intent should be sent via electronic mail as a Word or PDF file to Lisa Ko at Lisa.Ko@fda.hhs.gov with “RFA-FD-14-001 TRP Letter of Intent” and the Institution's Name in the message subject heading.

A technical session will be held for prospective applicants in October 2013.  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 must be followed, with the following exceptions or additional requirements:

Responsiveness

To be responsive, an application must be submitted in accordance with the requirements of this notice, 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 cigarette tobacco reference product program that is related to the regulation of tobacco products under the Tobacco Control Act.

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

 
Required and Optional Components

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

SF424(R&R) Cover (Required)

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

SF424(R&R) Project/Performance Site Locations (Required)

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

SF424(R&R) Other Project Information (Required)

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

SF424(R&R) Senior/Key Person Profile (Required)

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:

PHS 398 Cover Letter (Optional)

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

PHS 398 Cover Page Supplement (Required)

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

PHS 398 Research Plan (Required)

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

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

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide,

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

3. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems.  Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, FDA’s electronic system for grants administration.  eRA Commons and Grants.gov systems check the application against many of the application instructions upon submission.  Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.  Late applications will not be accepted for this announcement.  

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

Pre-award costs are allowable only as described in the HHS Grants Policy Statement.

Program funds may not be used for any purpose other than those directly tied to the regulation of tobacco products under the Tobacco Control Act. 

Special 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.

6. 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 Applying Electronically.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package.  Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to FDA.  See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management.  Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the assigned Grants Management Specialist and responsiveness by components of participating organizations, FDA.  Applications that are incomplete and/or nonresponsive will not be reviewed.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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 cigarette 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 cigarette 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?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, but will not give separate scores for these items.

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children.  For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia.  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

Additional Review Considerations

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.  A detailed budget of the cigarette tobacco reference product project will need to be supplied and justified by the applicant.  This budget should include as applicable costs associated with cigarette product acquisition, facility renovations (i.e. storage), salaries, maintenance of program, and proficiency testing.

2. Review and Selection Process

Applications determined to be complete and responsive will undergo an objective review process.  An objective review panel will evaluate complete and responsive applications, using the stated review criteria.

As part of the objective review, all applications:

Applicants are strongly encouraged to contact FDA to resolve any questions about criteria before submitting the application.  Please direct all questions of a technical or scientific nature to the CTP Program contact and all questions of an administrative or financial nature to the grants management staff.

The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the review of the application is completed, the PD/PI will be provided his or her Summary Statement. 

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

Section VI. Award Administration Information


1. Award Notices

If the application is under consideration for funding, FDA will request "just-in-time" information from the applicant as described in the HHS Grants Policy Statement.

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 the DUNS, SAM Registration, and Transparency Act requirements as noted in the HHS Grants Policy Statement.

2. Administrative and National Policy Requirements

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

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

Cooperative Agreement Terms and Conditions of Award

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

a.  Project Director/Principal Investigator Rights and Responsibilities

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

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

b.  FDA Responsibilities

An FDA Project Officer (PO) will be assigned and named in the NoA.  The FDA PO is the official responsible for the programmatic, scientific, and/or technical aspects of assigned applications and cooperative agreements.  The FDA PO will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards as described below.

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

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.

3. Reporting

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY 2011 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.  See the HHS Grants Policy Statement for additional information on this reporting requirement. 

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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

Program Contact(s)

Stephanie Durkin
Office of Science, Center for Tobacco Products
U.S. Food & Drug Administration
9200 Corporate Boulevard
Rockville, MD  20850
Email: Stephanie.Durkin@fda.hhs.gov

Objective Review Contact(s)

Lisa Ko
Office of Acquisitions & Grants Service
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20857
Email: Lisa.Ko@fda.hhs.gov

Financial/Grants Management Contact(s)

Lisa Ko
Office of Acquisitions & Grants Service
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20857
Email: Lisa.Ko@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, including the provisions in 45 CFR Parts 74 and 92.  The regulations issued under Executive Order 12372 do not apply to this program.

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

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

Authority and Regulations

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

Required Federal Regulations

Human Subjects Protection:

Federal regulations (45 CFR 46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). 

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

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

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

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

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

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

Standards for Privacy of Individually Identifiable Health Information:

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

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

Sharing Research Data (NIH Policy Adopted by the FDA):

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

Healthy People 2020:

The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2020," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas.  Potential applicants may obtain a copy of "Healthy People 2020" at http://www.health.gov/healthypeople.

Smoke-Free Workplace:

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

Authority and Regulations:

This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov No. 93.103, and is not subject to the intergovernmental review requirements of Executive Order 12372. Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241), Section 312 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (42 USC 247b-20), and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.  All awards are subject to the terms and conditions, cost principles, and other considerations described in the HHS Grants Policy Statement.


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