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

AUTHORITY

This Program is authorized under Section 301 of the Public Health Service Act as amended (42 USC 241), under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75, and consistent with the Family Smoking Prevention and Tobacco Control Act (PL 111-31).

BACKGROUND

Tobacco use is the foremost preventable cause of premature death in America. Each year, at least 480,000 people in the United States die prematurely from diseases caused by cigarette smoking or secondhand exposure. Furthermore, tobacco use causes nearly six million deaths per year worldwide. A compelling body of evidence illustrates that tobacco products can cause cancer, heart disease, or other serious adverse health effects.

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), P.L. 111-31, gives the Food and Drug Administration (FDA) regulatory authority to regulate the manufacturing, labeling, sale, distribution, advertising and promotion of tobacco products. The FDA Center for Tobacco Products (CTP) oversees the implementation of the Tobacco Control Act. CTP’s mission is to protect Americans from tobacco-related death and disease by regulating the manufacture, distribution, and marketing of tobacco products and by educating the public, especially young people, about tobacco products and the dangers their use poses to themselves and others.

With passage of the Tobacco Control Act in 2009, FDA began regulating cigarettes, cigarette tobacco, smokeless tobacco, and roll-your-own tobacco. Since August 2016, FDA’s regulatory authority covers all tobacco products, including e-cigarettes which are also called electronic cigarettes or electronic nicotine delivery systems (ENDS) all cigars, hookah (also called waterpipe tobacco), pipe tobacco, nicotine gels, and dissolvables, that did not previously fall under the FDA’s authority. Accessories of deemed products are excluded. On March 15, 2022, President Biden signed H.R. 2471 the Consolidated Appropriations Act, 2022. A provision of H.R. 2471 amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to include specific language that makes clear the FDA can regulate tobacco products containing nicotine from any source, which includes synthetic nicotine.

FDA's unique position as a regulatory agency allows for a framework of decision-making based on and within the limits of both the science and the law. Although a vast and sound science base already exists for many areas of the Tobacco Control Act, new research will build upon that robust base of scientific evidence. The global tobacco control community is also actively working to bridge the knowledge gap pertaining to existing and novel tobacco products and complex regulatory approaches to decreasing tobacco product use and harms. CTP relies on the most current science to make regulatory decisions on tobacco products. Scientific research is critical to our mission of reducing the death and disease resulting from tobacco use.

CTP uses a comprehensive approach as the best way to end the negative health effects of tobacco use. This includes defining policy, issuing regulations, conducting research, educating Americans on regulated tobacco products, and making decisions on whether new products and claims can be marketed including reviewing and evaluating applications and claims before the products are allowed on the market.

This cohesive, comprehensive approach can help us reach our goals of

• preventing people from starting to use tobacco products;
• encouraging current tobacco users to quit; and
• reducing the harm caused by tobacco use.

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

OVERARCHING PROGRAM GOAL

The goal of the Building Research Capacity in Global Tobacco Product Regulation Program is to advance and expand research in support of tobacco product regulation, in order to reduce the morbidity and mortality associated with tobacco use both within the United States and internationally.

The World Health Organization (WHO), in particular the WHO No Tobacco Unit (Tobacco Free Initiative (TFI)), will conduct and coordinate data collection, expert insights and analysis, and other research to support tobacco product regulation. WHO's activities provide a universal public health benefit by identifying and analyzing tobacco regulatory challenges, identifying science-based tools to combat such challenges, and enhancing regulatory capabilities of governments to implement successful tobacco product regulation and decrease the global use of tobacco products. These activities will provide a significant domestic benefit, as the scientific, policy and legal research gathered will contribute to FDA’s own tobacco product regulation efforts aimed at decreasing domestic tobacco-related death and disease, and the American public will gain new information about tobacco products and the dangers their use poses.

As highlighted above, CTP continues to take steps to implement the Tobacco Control Act. It is beneficial for FDA to learn from other regulatory agencies -- both their successes as well as challenges faced -- and consider the vast research available globally to inform FDA’s decisions. As CTP considers the issuance of regulations setting out tobacco product standards and tobacco product sales and distribution restrictions, and reviews applications for new tobacco products and modified risk tobacco products, among other activities, it is important to consider global trends, scientific literature, and the support/scientific information/research or evaluation opportunities in other countries relevant tobacco experience. Since CTP has authority to regulate all tobacco products, including novel products that may not be on the U.S. market yet but excluding accessories, it is particularly important to learn from other regulators and researchers with relevant experience. The Building Research Capacity in Global Tobacco Product Regulation Program will help support a global network of tobacco product regulators that will enable robust information sharing and health research collection globally, thereby catalyzing the use of best practices, and complementing CTP’s regulatory efforts.

Protecting the public health requires multidimensional programs that address both immediate threats as well as their systemic causes. Using this public health approach, CTP can successfully deter youth from ever using tobacco products while encouraging current consumers to quit.

PROGRAM PURPOSE

The purpose of the Building Research Capacity in Global Tobacco Product Regulation Program is to identify, support, develop, conduct, and coordinate research efforts relating to tobacco control laws and rules in foreign countries that will directly inform and support FDA’s exercise of its authority to regulate the manufacture, distribution, marketing and sale of tobacco products in the United States. The program will advance CTP’s mission by utilizing the WHO’s Member States expertise and extensive international contacts in global tobacco control, as well as take advantage of WHO’s own programmatic expertise, to inform and support adequate manufacture, distribution and market regulations of tobacco products for the protection of public health in the United States.

PROGRAM OBJECTIVE

The objective of this cooperative agreement is to enhance collaboration between CTP and WHO and rely on WHO's extensive international contacts and proven experience conducting, analyzing, and evaluating global tobacco-related research to directly inform and support FDA’s exercise of its authority to regulate the manufacture, distribution, marketing and sale of tobacco products in the US.

PROGRAM PRIORITIES

The Program’s grant funds will support WHO in expanding the research foundation for tobacco product regulation, and thus support the FDA s implementation of the Tobacco Control Act. A strong application will seek to increase comprehensive data collection, expert insight and analysis, and other research related to scientific, legal and policy information that can contribute to successful domestic regulation and policies that will protect Americans from tobacco-related death and disease and promote public understanding of tobacco risks.

At a minimum, the application Research Plan must include:

• A Program Plan, relying on WHO’s long history of coordinating international collaborative projects in support of tobacco control development and its established international contacts, that supports FDA approaches to reducing tobacco use, harm and addiction;
• Activities that identify, support, develop, conduct and coordinate multilateral research efforts in the areas of science, law, policy and public health communications/education that advance the FDA's regulation of the manufacturing, marketing and distribution of tobacco products as found in the Tobacco Control Act;
• Activities that continue to plan, build, adapt, or expand data collection/information sharing mechanisms, management, and reporting protocols necessary to facilitate Program information exchanges, analysis and other research;
• Details describing how the applicant will evaluate program activities, processes and outcomes, including summation evaluation, to document and disseminate results and outcomes.

The applicant must propose science-based activities that advance the international tobacco product regulation research foundation in order to reduce tobacco-related death and disease both in the United States and around the world. The applicant should track both short-term and long-term goals and demonstrate how the proposed activities are related to CTP s regulation of tobacco products under the Tobacco Control Act.

By way of example, project activities could include:

• Develop a plan to increase WHO’s capacity to facilitate global tobacco-related research and address novel tobacco products;
• Create and maintain existing global data information systems to support the Program research goals and allow for efficient and timely information sharing with FDA and other partners;
• Continue to coordinate and mobilize the Global Tobacco Regulators Forum for the purpose of sharing global tobacco regulation experience and expertise;
• Analyze tobacco-related research and produce technical papers on various issues of relevance to tobacco product regulation, e.g., the science of novel products, the environmental impact of tobacco products, illicit trade in tobacco products, tobacco product addiction, the science of nicotine, regulation of tobacco products that contain synthetic nicotine or nicotine otherwise not derived from tobacco; and/or
• Share knowledge and resources regarding the use of sensory methods to assess the presence of characterizing flavors in tobacco products.

The applicant must be familiar with the specific provisions of the Tobacco Control Act and the regulatory activities of FDA CTP. In addition to demonstrating how the proposed project is related to CTP s regulation of tobacco products under the Tobacco Control Act, the applicant must demonstrate how it will advance the public health goals that underlie such regulation.

See Section IV. Application and Submission Information, Subsection 2. Content and Form of Application Submission for further instructions regarding PHS 398 Research Plan.

 

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.

The following organization is eligible to apply:

• The World Health Organization (WHO)

As FDA seeks to proactively work with other countries and identify research and evaluation opportunities that will impact FDA’s ability to successfully implement the Tobacco Control Act, further collaboration with WHO is anticipated. With the financial support from the U.S. FDA, WHO is uniquely qualified to undertake these activities, given its mandate, wide access to data, participation of member states, and access to worldwide regulatory expertise.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are 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 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.

• 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.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; 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 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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women 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.

Only 1 application per institution (normally identified by having a unique UEI number or NIH IPF number) is allowed.

The FDA will not accept any application that is essentially the same as one already reviewed within the past twelve months, except for submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

 

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.

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, with the following additional requirements:

• Project summary/abstract that includes a summary of the proposed activities and a statement of objectives suitable for dissemination to the public. It should be a self-contained description of the project and should contain a statement of objectives and methods to be employed. It should be informative to other persons working in the same or related fields and insofar as possible understandable to a scientifically or technically literate lay reader. This Summary must not include any proprietary information.

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.
• Applicant 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.
• If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
• If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed. MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and subaward and subcontracts up to the first $25,000 of each subaward or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.
• Indirect/F&A costs under grants to foreign and international organizations will be funded at a fixed rate of 8 percent of modified total direct costs (MTDC), exclusive of tuition and related fees, direct expenditures for equipment, and subawards in excess of $25,000. (With the exception of the American University of Beirut and the World Health Organization, which are eligible for full F&A cost reimbursement). Awards to domestic organizations with a foreign or international consortium participant may include 8 percent of MTDC, exclusive of tuition and related fees, direct expenditures for equipment, and subawards 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 requirements:

The Research Strategy Section should include:

• Current Capacity - Give general information about the challenges to tobacco product regulation today; describe the applicant's success in coordinating multilateral projects and building linkages among international regulators; explain how the applicant is uniquely qualified to meet program objective.
• Strategy - Explain the overall approach to achieving the stated goals of the program, including the applicant's specific aims for the project. Explain how the proposed activities build from and continue the applicant's past efforts to identify, support, develop, conduct, and coordinate research efforts relating to tobacco product regulation and tobacco control laws. Detail how the work will benefit CTP.
• Operational Plan - Propose specific activities. For each, detail the scope of work, deliverable due dates, intended outcomes and management/organization plans. At a minimum, the operational plan must include the following:
• Monitor the global tobacco regulatory landscape and track regulations of specific interest to CTP.
• Serve as the Secretariat of the Global Tobacco Regulators Forum (GTRF) and the GTRF Steering Committee. Convene an annual GTRF meeting during Program Year 1.
• Coordinate the GTRF’s efforts to narrow the gaps in tobacco product regulatory science.
• Lead the GTRF’s efforts to work in concert and support the other WHO multilateral groups.
• Maintain an EZ Collaboration website and/or a time-limited community of practice for GTRF members, develop concrete processes to encourage multilateral use.
• Facilitate multilateral collaborations in the areas focused on unique policy opportunities for regulators interested in addressing the addictiveness, attractiveness, and/or toxicity of tobacco products.
• Further develop a mechanism/process to connect regulators that might share similar research interests and/or needs; monitor the global landscape and make connections to encourage research collaborations and the sharing of science and experience.
• Performance Measures - Describe a plan for measuring the overall project as well as the specific Year 1 activities proposed. Include proposed metrics, interim milestones, and approach to evaluating the success, impact and added value of each activity and sub-activity.

 

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 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.

Foreign (non-U.S.) institutions must follow policies described in the HHS Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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 and 45 CFR 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

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

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

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.

These funds may not duplicate or supplant existing tobacco control, prevention, or cessation efforts, and cannot duplicate existing WHO plans/efforts, but can enhance existing efforts relevant to FDA/CTP and the Tobacco Control Act. The program funds may not be used to fund work that is duplicative of WHO’s mandates outside this particular program.

FDA must confirm in advance the relevance of funding conference and travel costs to the goals of the program. The program funds may not be used to pay for any

travel that WHO personnel would have incurred if the grant had not been awarded.

1. Allowable Activities/Costs:

Allowable activities must support CTP activities pursuant to its authorities under the Tobacco Control Act to regulate tobacco products and their manufacture, distribution, and sale in the United States.

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

d. Costs for research that is not beneficial to the United States

e. Costs for WHO activities or other programs that were already underway or planned prior to the award of this grant

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 form. 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 unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

 

See more tips for avoiding common errors.

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

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/technical merit.

(a) The extent to which the applicant describes the magnitude or severity of the challenges of tobacco product regulation in the United States and globally.

(a) The extent to which the applicant demonstrates success in leading and coordinating multilateral activities, projects, and collaborative efforts among international tobacco regulators.

(b) The extent to which the applicant documents strong partnerships and collaborations with tobacco regulators, including any involvement it has with existing tobacco control networks.

(c) The extent to which the applicant describes its experience in program development, coordination and evaluation, systems evaluation, and the development of performance metrics and standards.

(a) The extent to which the applicant provides clear goals, objectives, and intended outcomes that align with an operational plan for conducting and promoting the coordination of tobacco product regulatory research, creating a mechanism and technical support for the timely sharing of information among regulators, coordinating regional and multilateral regulator meetings, and building upon an international network of regulators.

(b) The extent to which the applicant describes how each of the proposed activities and sub-activities will address the overall purpose of this grant to increase international tobacco regulatory collaboration and information sharing to inform domestic decisions.

(a) The extent to which the management plan is adequate to achieve the objectives of the proposed project on time and within budget, including clearly defined responsibilities, timelines, and milestones for accomplishing project tasks.

(b) The extent to which the background, expertise, and administrative experience of key project staff who will direct, manage, and administer the program are qualified, necessary, and appropriate to carry out the program.

(c) The extent to which the applicant describes expected organizational, fiscal, administrative, and programmatic challenges or limitations associated with their proposed activities and strategies to overcome these challenges or limitations.

(a) The extent to which the applicant proposes clear plans to monitor progress and outcomes of proposed activities and implementation.

(b) The extent to which applicant provides an evaluation plan that aligns with project goals, objectives, activities, and performance measures.

(c) The extent to which the applicant describes how it will collect, analyze, and use data for monitoring progress, decision-making, continuous improvement, and accountability, including whether the applicant has a plan to build, adapt, or expand a data system that integrates information from multiple sources in order to measure and report on progress.

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.

When the proposed project involves human subjects and/or 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.

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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 recipient’s business official.

Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions and in the Notice of Award. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

Institutional Review Board or Independent Ethics Committee Approval: For projects that involve Human Subjects and/or Clinical Trials Research, Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in FDA-funded studies, the recipient must provide FDA copies of documents related to all major changes in the status of ongoing protocols.

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

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA)from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some

circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and

pregnancy). This includes ensuring programs are accessible to persons with limited English

proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on

complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/forproviders/provider-obligations/index.html and https://www.hhs.gov/civil-rights/forindividuals/nondiscrimination/index.html.

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about FDA's commitment to supporting a safe and respectful work environment, and what FDA's expectations are for institutions and the individuals supported on FDA-funded awards, please see https://www.fda.gov/science-research/about-science-research-fda/fda-sexual-harassment-policy-concerning-extramural-research.
• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/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. 

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 and 2 CFR’s 200.206 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.

Termination provisions in 2 CFR 200.340 (a) (1-4) are applicable to awards issued under this Notice of Funding Opportunity.

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

Reporting Requirements:

All FDA grants require both Financial and Performance reporting.

Financial Reporting:

A. Financial Expenditure Reports

A required Federal Financial Report (FFR) must be submitted annually. All annual FFRs must be submitted electronically using the Payment Management System (PMS). This includes all initial FFRs being prepared for submission and any revised 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. If a grant is under expanded authorities, the grantee must indicate the carryover amount in Section 12. Remarks of the annual FFR.

Performance Progress Reporting:

When multiple years (more than one budget period) are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually as required in the Notice of Award. Annual RPPRs must be submitted using the RPPR module in eRA Commons. The annual RPPR must include a detailed budget. Annual RPPRs are due no later than 60 days prior to the start of the next budget period.

Failure to submit timely reports may affect future funding. Additional Financial and Performance Progress reports may be required for this award. Any additional reporting requirements will be listed under Section IV Special Terms and Condition of the Notice of Award.

Salary Caps:

None of the funds in this award shall be used to pay the salary of an individual at a rate in excess

of the current Executive Level II of the Federal Executive Pay Scale.

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).

Acknowledgment of Federal Support:

When issuing statements, press releases, publications, requests for proposal, bid solicitations and other documents --such as tool-kits, resource guides, websites, and presentations (hereafter statements )--describing the projects or programs funded in whole or in part with FDA federal funds, the recipient must clearly state:

1. the percentage and dollar amount of the total costs of the program or project funded with federal money; and,

2. the percentage and dollar amount of the total costs of the project or program funded by non-governmental sources.

When issuing statements resulting from activities supported by FDA financial assistance, the recipient entity must include an acknowledgement of federal assistance using one of the following statements.

If the FDA Grant or Cooperative Agreement is NOT funded with other non-governmental sources:

This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with 100 percent funded by FDA]/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

If the FDA Grant or Cooperative Agreement IS partially funded with other nongovernmental sources:

This [project/publication/program/website, etc.] [is/was] supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award [FAIN] totaling $XX with XX percentage funded by FDA/HHS and $XX amount and XX percentage funded by non-government source(s). The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.

The federal award total must reflect total costs (direct and indirect) for all authorized funds (including supplements and carryover) for the total competitive segment up to the time of the public statement. Any amendments by the recipient to the acknowledgement statement must be coordinated with FDA. If the recipient plans to issue a press release concerning the outcome of activities supported by FDA financial assistance, it should notify FDA in advance to allow for coordination.

Additional prior approval requirements pertaining to Acknowledgement of Federal Support, publications, press statements, etc. may be required, and if applicable, will be listed under Section IV Special Terms and Condition of the Notice of Award.

Prior Approval:

All prior approval requests must be submitted using the Prior Approval module in eRA Commons. 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.

For grant awards not covered under Expanded Authorities, Carryover and No Cost Extension (NCE) requests will require prior approval. All Carryover and NCE requests should be submitted using the Prior Approval module in eRA Commons. ****Please review the section on Expanded Authorities to determine if this award is covered/not covered under Expanded Authorities and whether prior approval is needed for carryover and no cost extension requests.****

The following activities require prior approval from FDA on all awards:

1. Change in Grantee Organization

2. Significant Rebudgeting

3. Change in Scope or Objectives

4. Deviation from Terms and Conditions of Award

5. Change in Key Personnel which includes replacement of the PD/PI or other key personnel as specified on the NoA.

6. Disengagement from the project for more than three months, or a 25 percent reduction in time devoted to the project, by the approved PD/PI. No individual may be committed to more than 100% professional time and effort. In the event that an individual's commitment exceeds 100%, the grantee must make adjustments to reduce effort. For FDA-sponsored projects, significant reductions in effort (i.e., in excess of 25% of the originally proposed level of effort) for the PD/PI and key personnel named on named on this Notice of Award must receive written prior approval from FDA.

Additional prior approval requirements may be required for this award, and if applicable, will be listed under Section IV Special Terms and Condition of the Notice of Award.

Audits and Monitoring:

Audit Requirements:

1. Recipients of Federal funds are subject to annual audit requirements as specified in 45 CFR 75.501 (https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=8040c4036b962cc9d75c3638dedce240&ty=HTML&h=L&r=PART&n=pt45.1.75#se45.1.75_1501). Grantees should refer to this regulation for the current annual Federal fund expenditure threshold level which requires audit.

2. Foreign recipients are subject to the same audit requirements as for-profit organizations (specified in 45 CFR 75.501(h) through 75.501(k).

3. For-profit and foreign entities can email their audit reports to AuditResolution@hhs.gov or mail them to the following address:

U.S. Department of Health and Human Services

Audit Resolution Division, Room 549D

Attention: Robin Aldridge, Director

200 Independence Avenue, SW

Washington, DC 20201

Monitoring:

Recipients are responsible for managing the day-to-day operations of grant-supported activities using their established controls and policies, as long as they are consistent with Federal, DHHS and FDA requirements. However, to fulfill their role in regard to the stewardship of Federal funds, FDA monitors our grants to identify potential problems and areas where technical assistance might be necessary. This active monitoring is accomplished through review of reports and correspondence from the recipient, audit reports, site visits, and other information available to FDA.

1. Desk review: FDA grants monitoring specialists will periodically reach out to recipients to request information for the completion of desk reviews. Requested information may include:

• Policies and procedures
• List of grant expenditures
• Accounting records
• Supporting documents (e.g., invoices, receipts, paystubs, timesheets, contracts, etc.)
• Financial statements
• Audit reports
• Other related documentation

2. Site visits: FDA will conduct site visits when necessary and will notify the recipient with reasonable advance notice of any such visit(s).

3. Foreign entities: All Foreign entities are subject to the same monitoring requirements as domestic entities. Foreign entities covered under immunity Executive Orders will provide supporting documents for monitoring requirements unless such an action is a violation of the Executive Orders. Recipients may discuss with the FDA to come up with an alternate approach to satisfy the award monitoring requirements.

All recipients will make reasonable efforts to resolve issues found, including audit findings. Successful resolutions to issues are important as they are part of the grant performance review. All recipients are responsible for submitting all requested information in an expeditious manner. Failure to submit timely reports and/or respond to inquiries from FDA may affect future funding or enforcement actions, including withholding, or conversion to a reimbursement payment method.

Financial Conflict of Interest (FCOI):

This award is subject to the Financial Conflict of Interest (FCOI) regulation at 42 CFR Part 50 Subpart F.

Closeout Requirements (when applicable):

A Final Research Performance Progress Report (FRPPR), Final Invention Statement HHS-568 (if applicable), Tangible Personal Property Report SF-428 (if applicable), and Statement of Disposition of Equipment (if applicable) must be submitted within 120 days after the expiration date of the project period. All closeout documents must be submitted electronically in eRA Commons.

The Final Federal Financial Report (FFR SF-425) must be submitted in PMS and indicate the exact balance of unobligated funds and may not reflect unliquidated obligations. There must be no discrepancies between the Final FFR expenditure data and FFR cash transaction data in the Payment Management System (PMS). The expended funds reported on the Final FFR must exactly match the disbursements and the charge advances in PMS. It is the recipient's responsibility to reconcile reports submitted to PMS and to the FDA.

Program Income:

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.

Examples of Program Income include (but are 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.

Any Program Income generated during the Project Period of this grant by the grantee or sub-grantee will be treated as identified below.

Treatment of Program Income:

Prohibition on certain telecommunications and video surveillance services or equipment:

(a) As described in CFR 200.216, recipients and subrecipients are prohibited to obligate or spend grant funds (to include direct and indirect expenditures as well as cost share and program) to:

(1) Procure or obtain,

(2) Extend or renew a contract to procure or obtain; or

(3) Enter into contract (or extend or renew contract) to procure or obtain equipment, services, or systems that use covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. As described in Pub. L. 115-232, section 889, covered telecommunications equipment is telecommunications equipment produced by Huawei Technologies Company or ZTE Corporation (or any subsidiary or affiliate of such entities).

i. For the purpose of public safety, security of government facilities, physical security surveillance of critical infrastructure, and other national security purposes, video surveillance and telecommunications equipment produced by Hytera Communications Corporation, Hangzhou Hikvision Digital Technology Company, or Dahua Technology Company (or any subsidiary or affiliate of such entities).

ii. Telecommunications or video surveillance services provided by such entities or using such equipment.

iii. Telecommunications or video surveillance equipment or services produced or provided by an entity that the Secretary of Defense, in consultation with the Director of the National Intelligence or the Director of the Federal Bureau of Investigation, reasonably believes to be an entity owned or controlled by, or otherwise, connected to the government of a covered foreign country.

Other:

This award is subject to the requirements of 2 CFR Part 25 for institutions to maintain an active registration in the System of Award Management (SAM). Should a consortium/subaward be issued under this award, a requirement for active registration in SAM must be included.

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 with cumulative total value greater than $10,000,000 must report and maintain information 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 the Federal Awardee Performance and Integrity Information System (FAPIIS)). Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75.

You must administer your project in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes taking reasonable steps to provide meaningful access to persons with limited English proficiency and providing programs that are accessible to and usable by persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/providerobligations/index.html and https://www.hhs.gov/civil-rights/forindividuals/nondiscrimination/index.html.

• You must take reasonable steps to ensure that your project provides meaningful access to persons with limited English proficiency. For guidance on meeting your legal obligation to take reasonable steps to ensure meaningful access to your programs or activities by limited English proficient individuals, see https://www.hhs.gov/civilrights/for-individuals/special-topics/limited-english-proficiency/fact-sheetguidance/index.html and https://www.lep.gov.
• For information on your specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and taking appropriate steps to provide effective communication, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sexdiscrimination/index.html .
• For guidance on administering your project in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws, see https://www.hhs.gov/conscience/conscienceprotections/index.html and https://www.hhs.gov/conscience/religiousfreedom/index.html.

Dispute Resolution Process

Any dispute between FDA and the recipient arising out of the interpretation or execution of this award shall be settled by mutual consultations between the Parties, and shall be governed by general principles of law, to the exclusion of any single national system of law.

Intellectual Property Rights

All intellectual property rights, including copyright, in work performed and outputs produced under projects pursuant to this Arrangement will be vested in WHO, including, without any limitations, the right to use, publish, translate, sell and distribute, distribute, privately or publicly, any item or part thereof. WHO supports the principle of open access publishing and undertakes to ensure the immediate and maximum dissemination of information and publications produced under projects

pursuant to this Arrangement. FDA will have the right to use and distribute any item or part thereof for public and non-commercial purposes, provided that such use is compliant with the terms and conditions applicable to peer-reviewed publications and other such products referred to in Progress Reports section of this Special Programmatic Terms and Conditions. Information and publications emanating from specific projects that involve third party intellectual or financial contributions may be

subject to separate publishing agreements. Neither WHO nor FDA will use the emblem or logos of the other Party without that Party’s prior written consent.

Cost Principals

Facilities and Administrative (F&A) Costs: Full F&A costs will not be allowed, except where for the World Health Organization and necessary to support tobacco regulation activities. However, FDA provides limited F&A costs (8 percent of total direct costs less only equipment) to foreign institutions and international organizations to support the costs of compliance with FDA requirements. Some examples of FDA compliance requirements are the protection of human subjects (including the required education in the protection of human research participants), animal welfare, and invention reporting, other post-award reporting requirements, financial conflict of interest and research misconduct. Note, these are just a few representative examples of compliance requirement; this list is not all inclusive. FDA will not support the acquisition of, or provide for depreciation on, any capital expenditures, or support the normal, general operations of foreign and international organizations. These expenses should not be requested as a Direct

Cost budget expense. Note the reference to capital expenditures for the purposes of allowable F&A costs do not include purchases of equipment. Equipment is still allowable as a direct cost. Since the F&A costs are intended for compliance costs only, other items normally considered an F&A cost can be requested as a direct cost, e.g. rent.

Within the total budget, 7 (seven) percent of the total direct costs may be spent on administrative costs incurred by WHO.

Data Sharing

In addition to sharing data and research resources with the research community, upon request of the FDA, the recipient also must provide a copy of documents or a sample of any material developed under an HHS grant award as long as such material is cleared for public distribution. The recipient may charge a nominal fee to cover shipping costs for providing this material.

Program Income

1. Income earned from these charges must be treated as program income.

2. 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.

3. Examples of Program Income include (but are 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.

4. 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.

Audit and Records

1. The recipient agrees to furnish the U.S. Government (USG) with a final report on activities carried out under the award, including accounting for award funds in sufficient detail to enable USFDA to liquidate the award. The report must be submitted to the address specified in the award.

2. It is understood that financial records, including documentation to support entries on accounting records and to substantiate charges against the award, will be maintained in accordance with the recipient’s usual accounting procedures, which must follow generally accepted accounting practices. The recipient must maintain such financial records for at least three years after the recipient’s final disbursement of funds under the award.

3. The recipient confirms that the award account will be audited applying established procedures under appropriate provisions of the financial regulations and rules of the World Health Organization of the United Nations. The recipient agrees to make available these audit reports to the USG and other related Information as agreed upon by the parties. In exceptional circumstances, at USFDA's request, WHO shall request its Finance Committee to request its External Auditor to perform a special

examination of the accounts, records, and statements of a project covered by the award, of such scope as WHO, in consultation with USFDA, shall specify, provided that the costs of such special examination are covered by USFDA or the project itself.

Allowable Costs

1. Without prejudice to the privileges and immunities enjoyed by WHO, the recipient will be reimbursed for costs incurred in carrying out the purposes of this award, which are reasonable, allocable, and allowable.

(a) Reasonable means those costs that do not exceed those that would ordinarily be incurred by a prudent person in the conduct of normal business.

(b) Allocable means those costs that are reasonable and allocable, and that conform to any limitations set forth in this award.

(c) Allowable means those costs that are reasonable and allocable, and that conform to any limitations set forth in this award.

2. The recipient is encouraged to obtain the FDA PO s written determination as to whether the cost will be allowable before incurring a questionable or unique cost.

Funding Restrictions

Program funds may not be used for any purpose other than to support CTP’s activities pursuant to its statutory authorities to regulate tobacco products and their manufacture, distribution, marketing and sale in the United States, as described in RFA-FD-23-003. These funds may not duplicate or supplant existing tobacco control, prevention, or cessation efforts, and cannot duplicate existing WHO plans/efforts, but can enhance existing efforts relevant to FDA/CTP and the Tobacco Control Act.

1. Allowable Activities/Costs:

Allowable activities must support CTP activities pursuant to its authorities under the Tobacco Control Act to regulate tobacco products and their manufacture, distribution, and sale in the United States, as described in RFA-FD-23-003.

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

d. Costs for research that is not beneficial to the United States

e. Costs for WHO activities or other programs that were already underway or planned prior to the award of this grant

Financial Conflict of Interest

Recipients and investigators must comply with the requirements of 42 CFR Part 50, Subpart F, Responsibility of Applicants for 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. Under these requirements the organization must do the following:

1. 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

2. Before spending any PHS funds awarded under a new award, inform the GMS 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

3. Continue to make similar reports on subsequently identified conflicts within 60 days of identifying them

4. 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:

a. Public disclosure of significant financial interests

b. Monitoring of research by independent reviewers

c. Modification of the research plan

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

e. Divestiture of significant financial interests

f. 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.

Budget Control

Recipients must be able to compare actual expenditures or outlays with the approved budget.

Cash Management

Recipients must have procedures for minimizing the time elapsing between the transfer of any advance payments of funds under the award and disbursement of the funds for direct program costs and the proportionate share of any allowable indirect or facilities and administrative costs. Recipients must ensure that the timing and amount of any payments to sub-recipients under the award conform to this standard.

Refunds

1. If the recipient earns interest on Federal advances before expending the funds for program purposes, the recipient must remit the interest annually to FDA through the same way as paid. Interest amounts up to $250 per year may be retained by the recipient for administrative expenses.

2. Funds obligated by FDA but not disbursed to the recipient before the award expires or is terminated will revert to FDA, except for funds committed by the recipient to a legally binding transaction applicable to this award.

3. If, at any time during the life of the award, or as a result of final audit, it is determined that FDA funds provided under this award have been expended for purposes not in accordance with the terms of this award, the recipient must refund such amount to FDA.

Post-Award Monitoring

1. Initial Post-Award Teleconference:

a. An initial post-award teleconference will be held within thirty (30) days of award to ensure an understanding of roles and responsibilities, adherence to applicable federal statutes and regulations, grant administration requirements, grant milestones and due dates.

2. Regular WHO/FDA Grant Monitoring Meetings:

Monthly teleconferences will be held to:

a. Track interim and major Activity milestones

b. Discuss impact and measurable value added of ongoing and completed Activity work

c. Evaluate WHO’s ongoing internal controls

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. Publication, Educational Materials, and Press Statements

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

a. The grantee must include the publication(s) and/or educational material(s) and/or press statements as activities within their strategic plan.

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

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

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

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

2. Conferences and Travel

Prior approval from FDA/CTP is required for the grantee and any sub-awardees to use grant funds to sponsor, support or attend any meetings/conferences. Prior approval from FDA/CTP is required for all travel by the grantee, any sub-awardees, and any third-party that the grantee wishes to sponsor (including all foreign nationals). Grant funds cannot be used to cover costs of participant meeting attendance for participants that do not require funding assistance. Grant funds cannot be used to pay for any travel that WHO personnel would have incurred if the grant had not been awarded. All travel must be limited to attending meetings and conferences that will directly benefit the goals of the program. Efforts must be made to hold grant-created meetings using remote participation technologies and/or scheduled in conjunction with other international meetings to minimize related travel costs. No grant funds are to be expended for these purposes by the grantee in advance of

receiving written approval from FDA/CTP.

a. A prior approval request for conference attendance and/or travel must be submitted in writing to the FDA/CTP Project Officer no later than 60 days prior to the conference date and must include the following information:

i. Title/Topic of Conference

ii. List of Conference Attendees

iii. Purpose of Conference

iv. Explanation of how the Conference directly supports the Global Tobacco Program goals and objectives, falls within the scope of CTP s authorities set forth in the

Tobacco Control Act, and benefits the protection of the public health in the United States

v. Dates of Conference

vi. Location of Conference

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

3. Additional activities that require prior approval include:

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

 

Performance Progress Reporting

1. Two (2) Progress Reports are required on grant activities in the 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. Specific reporting elements will be provided to the grantee 60 days prior to the report due date, including but not limited to:

i. Performance measures/milestones for each calendar quarter, including objectives, measures, and targets.

ii. Overall progress on all Year 1 Activities.

iii. Updates to any Activity deliverable due dates; finalize deliverable timelines.

iv. A list of any publications or conference presentations made.

v. A list of any third party participants and other collaborating organizations.

vi. Pending issues/concerns; any expected changes.

vii. Estimated unobligated balance; funds expected and funds remaining on this project as of report submission date. Recipients must be able to compare actual expenditures or outlays with the approved budget.

Reporting for Grants with Multiple Years:

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR).

a. An 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.

Information regarding submitting the RPPR is available at https://era.nih.gov/erahelp/commons/default.htm#cshid=1020

(https://era.nih.gov/erahelp/commons/default.htm#cshid=1020)

b. 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:

i. General progress on the activities of the Global Tobacco project to include the project status in relation to established timeline

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

iii. Pending issues/concerns

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

v. Detailed budget breakdown of actual expenditures during current budget performance period

vi. Detailed budget request and narrative justification for upcoming budget performance period that aligns with proposed next year activities

Financial Reporting

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

Sub recipient reporting

Each recipient is to determine their specific sub-recipient reporting requirements. Recipients are responsible for managing and monitoring each project, program, subaward, function or activity supported by the award. Recipients must monitor sub-awards to ensure that sub-recipients have met the audit requirements as delineated in award.

Sub-recipient Monitoring

Recipients are responsible for monitoring sub-recipient activities and provide for their training needs, tracking progress toward objectives, and identifying challenges during the project period.

Procurement

All procurements shall be made in accordance with WHO regulations, which shall conform to generally accepted principles of good procurement practice, and which shall include safeguards against corrupt and illegal practice. WHO shall include in the solicitations for equipment and services an assessment of potential sources of supply in the recipient country and other relevant developing countries. No offer, gift, consideration, payment or benefit of any kind, which would or could be construed as an illegal or corrupt practice may be accepted, either directly or indirectly, as an inducement or reward for the award or execution of procurement contracts. To this end, WHO shall ensure that it applies and enforces its relevant rules regarding corrupt and illegal practices.

Federal Point of Contact Information

1. Direct inquiries regarding fiscal and/or administrative matters to the grants management specialist listed. Grants Management Officer: Rene Vasquez; Email: rene.vasquez@fda.hhs.gov

2. Direct inquiries regarding scientific programmatic issues to the official listed. Program Official: Eshael Johnson; Email: eshael.johnson@fda.hhs.gov

3. All formal correspondence reports regarding the grant should be signed by an authorized institutional official and the Principal Investigator and should be sent to the attention of the grants management specialist/officer, with a copy to the Project Officer via scanned electronic copy.

Modification and Termination

1. FDA and WHO shall promptly inform each other of any event or situation which might affect the implementation of the Project and which may necessitate a modification or alteration of the scope, implementation, the agreed budget or other aspects of the award. In case any change occurs in the schedule or implementation of the project, WHO shall promptly inform the FDA Project Officer (PO).

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

3. FDA may at any time, by providing upon three-month written notice given to WHO, terminate this award if major deviations from mutually approved plans and budgets occur or if reasonable doubt arises with regard to the proper use of funds under this award; if the project’s main objectives are endangered; if reports, information or records are not delivered as agreed and as set forth in Article 24 and 25; or if any circumstances occur which, in the opinion of FDA, impair significantly on the value of the project. FDA and WHO will consult on measures to resolve the problem and possible courses of action. In such an event, FDA may also modify or terminate its financial contribution to any project under this award. Before taking such a decision, FDA shall consult with WHO to rectify the shortfalls and take corrective actions in line with project. In the event of termination, the obligations already assumed by either Party shall remain in force to the extent necessary to permit orderly withdrawal of

personnel, funds and assets, the settlement of accounts between the Parties and the settlement of any liability incurred by WHO for the activities covered by this award. WHO shall promptly remit any remaining funds after the settlement of accounts between the Parties to FDA.

Nothing in this Notice of Grant or in any document relating thereto, shall be construed as constituting a waiver of privileges or immunities of WHO, or as its acceptance of the jurisdiction of the courts of any country over disputes arising out of this Agreement.

The present Notice of Grant and any document or arrangement relating thereto shall be governed by general principles of law, to the exclusion of any single national system of law. Such general principles of law shall include the UNIDROIT General Principles of International Commercial Contracts 2010.

Organizations that believe they will be unable to comply with these requirements should promptly contact the Grant Management Specialist (GMS) to discuss the circumstances, obtain information that might enable compliance, and reach an understanding in advance of an award.

Cooperative Agreement Terms and Conditions of Award

Cooperative Agreement: The administrative and funding mechanism used for this program is cooperative agreement, an "assistance" mechanism in which substantial FDA programmatic involvement with the recipients is anticipated during the performance of the activities.

Under the cooperative agreement, FDA's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project, although specific tasks and activities may be shared among the recipients and FDA as defined below.

All recipients are required to participate in a cooperative manner with FDA.

Principal Investigator(s) (PI)/Program Director (PD) will have primary responsibility for the following:

The Principal Investigator (PI)/Program Director (PD) will have responsibility for the scientific, technical, and programmatic aspects of the grant and for day-to-day management of the project or program. The PD/PI(s) will maintain general oversight for ensuring compliance with the financial and administrative aspects of the award. This individual will work closely with designated officials within the recipient organization to prepare justifications; appropriately acknowledge Federal support in

publications, announcements, news programs, and other media; and ensure compliance with other organizational requirements.

The recipient is responsible for submitting interim progress reports (e.g. at specified intervals), when requested, to the FDA Project Officer (PO) and the Grants Management Specialist (listed as contacts on the Notice of Grant Award) including summary data on progress to date. The recipient is responsible for obtaining approval for the development and design of FDA projects prior to execution.

The FDA, through the PO, will have access to methodologies and training tools, as well as report cleared for public dissemination, generated under this Cooperative Agreement and may periodically review these as well as progress reports two times a year. The FDA PO may use information obtained from these for the preparation of internal reports on the activities of the award.

An FDA Project Officer (PO) with scientific/technical expertise and other members of the FDA staff will be closely associated with the implementation of the activities funded under this award, as described below:

The responsibilities of the PO include consultation during conduct of the activity, including on methodological approaches.

FDA program staff will arrange to have professional scientific and administrative personnel working in collaboration with the recipient as agreed with the Principal Investigator/Program Director.

As relevant, the PD/PIs in collaboration with PO will work collaboratively in evaluating the most appropriate research topics, methods, data quality control strategies, safety issues, study design and implementation, data analysis and interpretation, publication and dissemination of study results. Projects require FDA approval prior to implementation/initiation.

During performance of the award, the PO, with assistance from other scientific program staff, designated by FDA based on their relevant expertise, may provide appropriate assistance, advice and guidance. The role of the PO will be to facilitate and not to direct the activities. As appropriate, the FDA will work collaboratively with WHO to identify and coordinate training, professional development and training-related scientific exchange opportunities.

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

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. FDA FOAs outline intended goals and objectives. Post award, FDA will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR 75.301 and 2 CFR 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition 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

Eshael Johnson
Center for Tobacco Products (CTP)
Food and Drug Administration
Email: eshael.johnson@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, Notice of Award and 45 CFR Part 75, currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions .

 

Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200, and are consistent with the Family Smoking Prevention and Tobacco Control Act (PL 111-31).