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

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

A. Background

FDA's Office of Counterterrorism and Emerging Threats (OCET) is a leader and active participant in the public health community and with the military defense community, helping to advance the development, evaluation, and approval of medical countermeasures to be used against threats involving chemical, biological, radiological, or nuclear (CBRN) agents. In 2010, FDA launched its Medical Countermeasures initiative (MCMi) in response to a report by the Secretary of the Department of Health and Human Services to assess the our nation's emergency readiness improve our nation's capacity to respond faster and more effectively to CBRN and emerging infectious disease threats--such as pandemic influenza, Zika Virus, and Ebola. OCET was tasked with leading the implementation of the MCMi. OCET's activities are informed by the knowledge that protecting the civilian public and the warfighter against CBRN agents is a national security priority. A significant area of engagement for OCET is its support of innovative science to advance CBRN countermeasure development with the goal of improving access to safe and effective medical countermeasures, should the need arise. These efforts are central to strengthening national preparedness and security.

The "Animal Rule' (21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products) permits animal models to be used to test the effectiveness of a product when testing in humans is neither possible nor feasible. Under the "Animal Rule,' FDA recommends that pivotal efficacy studies be conducted in accordance with Good Laboratory Practice (GLP) regulations (21 CFR parts 58). Biological threats, such as Ebola virus, Marburg virus, Variola virus, or Lassa fever virus, for which medical countermeasures are needed, require testing in high and maximum biosecurity level (BSL-4) laboratories. These laboratory environments pose daunting challenges to a researcher's ability to meet the standards of GLP regulations. There has been tremendous progress in the development of candidate interventions over the last decade. However, to date there is not a single facility that is capable of performing pivotal studies under GLP at BSL-4. To break the current choke point in the development process for interventions against agents requiring maximum containment, it will be critical for laboratories with BSL-4 capacity to receive the training and develop the capability necessary to routinely perform pivotal studies in accordance with GLP.

OCET seeks to support an effort to design a robust, collaborative, and educational program using problem-based learning techniques designed to bring researchers and regulators together to educate each other on the challenges related to these issues and to identify solutions that are acceptable from both scientific and regulatory perspectives.

1. GLP Natural History Studies in BSL-4 Laboratories

Natural history studies are performed to establish the dose of the disease agent, the route of exposure, and to study the pathogenicity of the disease agent in the animal model. Results of these studies help determine which animal model best describes the disease in humans. Examples of challenges in meeting GLP standards include appropriate data recording, record keeping, inspections, and equipment validation. Training on the development of strategies to meet GLP standards in high and maximum biocontainment laboratories can be realized when everyone has a common understanding of the challenges and standards. In such a case, the scientific validity and regulatory acceptance of a study can be ensured early on, reducing the need for repeat studies, thereby reducing the numbers of animals needed to address the scientific and regulatory objectives. Once the natural history of the disease in the animal model has been established, it can be used to test the efficacy of antibiotics, vaccine, or other therapies as described in the "Animal Rule.'

2. GLP Animal Efficacy Studies in BSL-4 Laboratories

Animal efficacy studies are performed in accordance with the "Animal Rule' to test the effectiveness of a medical countermeasure against a specific threat agent in an animal model that best models the disease in humans. Results from these studies also help determine the dose of the medical countermeasure that will be effective in humans.

To date, three countermeasure products have been FDA approved using "Animal Rule'-type studies in support of efficacy.

3. Good Clinical Practices to maintain data quality in maximum containment infectious disease settings

Following successful conclusion of the training program (2012-2017), FDA identified a need to sustain best practices following conclusion of laboratory studies, specifically during clinical trials undertaken in maximum containment environments (i.e. "clinical sites") or high consequence pathogen environments. To that end, challenges of maintaining data quality at clinical sites, and best practices for mitigating risks to data quality (such as appropriate data recording, record keeping, onsite training, and validation techniques) are necessary in order to maintain the continuum of good practice from laboratory studies through completion of MCM response/clinical trials onsite.

B. Research Objectives

1. The Role of the University of Texas Medical Branch, Galveston National Laboratory

The University of Texas Medical Branch, Galveston National Laboratory (UTMB-GNL) is globally renowned for educational excellence in the sciences, medicine and research, as well as for its Laboratory Biosafety Training Program (LBTP). The LBTP courses are designed to provide training for laboratorians working at BSL-2 through BSL-4 levels. UTMB's Institutional Office of Regulated Nonclinical Studies (ORNcS) provides oversight for regulated studies and regulatory operations. In addition to the LBTP courses, the ORNcS offers an extensive, high-quality GLP training program to support faculty and staff at UTMB that are conducting nonclinical studies to support product licensure, including nonclinical studies conducted in BSL-3 and BSL-4 laboratories. ORNcS and OCET concur that an educational gap exists regarding the performance challenges of conducting GLP compliant studies in (A)BSL3/4 environments. Both have identified the need for an educational opportunity designed to better link GLP regulatory standards with BSL-4 laboratory work to increase the efficiency of FDA data review and subsequently facilitate approval of medical countermeasures.

2. Project Description

This project represents a collaborative effort between OCET, BARDA the UTMB-GNL, and UTMB ORNcS to support scientific and regulatory collaboration and enhance regulatory science to advance the development of safe and effective antibiotics, vaccines, and other medical countermeasures for use by civilian and military personnel in response to CBRN threat agents. The goal is to develop training strategies for scientists to foster a thorough understanding of the challenges and establish collaborative classroom environments to find solutions for overcoming hurdles. A common understanding of the challenges and requirements can lead to scientific validity and early regulatory acceptance of a study, reducing the need for repeat studies, thereby reducing the numbers of animals needed to address the scientific and regulatory objectives. Empowered with knowledge of how to successfully meet GLP standards in high and maximum biocontainment, scientists working in this environment and FDA staff who will be evaluating applications will be better able to link GLP regulatory standards with BSL-4 laboratory work, thus increasing the quality of the data and the efficiency of data review, subsequently facilitating approval of medical countermeasures. Additionally, researchers and clinicians will gain understanding of the importance of good clinical practices (GCP) in moving beyond laboratory studies in order to continually maintain data quality in clinical sites. This project will also lead to improved technical cooperation between FDA and the regulated institutions conducting GLP research in maximum biocontainment. The project has the following goals:

a. Mutual understanding. Progress in the development of animal models for efficacy testing of medical countermeasures has been very slow as developers struggle to design and conduct studies that meet scientific objectives and regulatory requirements for approval. Progress is further slowed as developers are sometimes at a loss with regard to how to satisfy GLP standards when conducting studies in maximum biocontainment conditions. Currently, FDA's Basic Bioresearch

Monitoring training program used to train field inspectors who inspect laboratories for GLP compliance lacks specific guidance for inspection of BSL-3 or BSL-4 laboratories that conduct GLP studies. Furthermore, recent implementation of training to address GLP requirements in high containment have consequently highlighted the need for additional continuity of good practices, specifically the importance of maintaining good clinical practices (GCP) at clinical sites responding to a public health event that requires maximum biocontainment. OCET and ORNcS believe one way to foster progress on these issues is by gathering researchers and regulators together in a nonthreatening educational environment to identify the challenges and needs, then work together to find solutions.

b. Develop collaborations. The training opportunity will bring together the community of researchers involved in conducting research in high and maximum biocontainment laboratories, who are also interested in conducting "animal rule' studies and animal qualification studies to support medical countermeasure development and approval. In some cases, similar research is being conducted in different laboratories for the same medical countermeasure need.

Participants will be encouraged to share experiences and join in collaborations to prevent duplication of research and avoid repetition of failed efforts and otherwise join in support of each other to attain shared goals and facilitate countermeasure development and approval.

3. Continuing Education--Areas of Focus

a. GLP in high and maximum containment.--This portion of the training will be a joint UTMB/FDA effort, with UTMB providing the course foundation and FDA offering the field inspector perspective.

Lecture examples would include a GLP Refresher, Good Documentation practices, Internal GLP Audits, Equipment Validation and Calibration, and Effective SOPs. Lectures could be followed with practical exercises pointing out specific challenges in meeting GLP standards that have been encountered in BSL-3 and BSL-4 studies conducted at UTMB.

b. GCP in maximum containment clinical sites.--this portion of the training will provide insights from clinicians and researchers working in response to a public health emergency (e.g. Ebola, Zika) moving beyond laboratory research and into patient care at clinical sites. Given the characteristics of emerging diseases (i.e. the impacts to infected patients, the potential risk to responders, potential spread to uninfected populations, and logistical limitations), the ability to maintain data quality in a maximum containment clinical site features significant challenges and risks. This portion of the course will provide insights and experiences from clinicians involved in prior emergency responses, and give insight into methodologies to both respond effectively to the emergency, while adapting and using the principles of GLP to ensure effective data is generated to mitigate further spread, and aid preparedness in the future.

c. The "Animal Rule.'--FDA will provide an overview of the regulations for approval of new drugs and biologics based on evidence of effectiveness from studies in animals, including lecture and training for the updated "Animal Rule", in accordance with the October 2015 guidance document entitled "Product Development Under the Animal Rule, Guidance for Industry". This training will also provide guidance for the animal model qualification process.

d. Animal welfare.--This portion of the training will review animal welfare laws, policies guidelines and requirements, including lectures and discussions on the role of the veterinarian, determination of humane endpoints, and use of supportive care measures in BSL-4 studies.

e. Telemetry.--Use of telemetry for remote monitoring of routine clinical parameters, such as body temperature, heart rate, respiration rate, and blood pressure is a helpful and sometimes an essential tool for conducting studies in BSL-4 laboratories. An entire half-day will be devoted to teaching what is available and how to implement telemetry techniques into BSL-4 studies.

4. Dissemination of Successful Enhancements to the Regulatory Science and Regulation of Animal Rule Studies for Medical Countermeasure Development

UTMB and OCET will collaborate to incorporate any new FDA guidance and educational tools into the training program as new measures are developed (e.g., drug development tool guidance, updates to GLPs).

C. Eligibility Information

As work in regulatory science for medical countermeasure development progresses, OCET and UTMB anticipate additional collaboration through seminars and training programs, particularly in the areas of GLP in maximum and high biocontainment laboratories, training FDA field inspectors how to effectively conduct GLP inspections in a high or maximum biocontainment laboratories, and training laboratorians and regulators in how to work in high or maximum biocontainment laboratories. By incorporating GLP in the training program, laboratorians are enabled to maintain data quality despite the challenges of working in high biocontainment laboratory environments. With the financial and scientific support from FDA, UTMB is uniquely qualified to undertake these activities, given its mandate as an educational and scientific institution, its high visibility as a pioneer in implementing GLP in maximum and high biocontainment laboratories, and its access to worldwide scientific and regulatory expertise. UTMB has demonstrated a GLP reporting structure and large animal in vivo GLP BSL-4 expertise. In addition, the FDA/UTMB training program will be accessible to researchers at all other university, government, and private organizations.

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

University of Texas Medical Branch (UTMB)

Applicant Organizations

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

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

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for FDA support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

Buttons to access the online ASSIST system or to download application forms 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 instructions in the Research Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

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

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

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

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

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

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

• Applications requesting multiple years of support must complete and submit a separate detailed budget breakdown and narrative justification for each year of financial support requested.
• If an applicant is requesting indirect costs as part of their budget, a copy of the most recent Federal indirect cost rate or F&A agreement must be provided as part of the application submission. This agreement should be attached to the RESEARCH & RELATED Other Project Information Component as line #12 'Other Attachments'.
• If the applicant organization has never established an indirect cost rate and/or does not have a negotiated Federal indirect cost rate agreement, a de minimis indirect cost rate of 10 percent (10%) of modified total direct costs (MTDC) will be allowed. MTDC means all direct salaries and wages, applicable fringe benefits, materials and supplies, services, travel, and sub award and subcontracts up to the first $25,000 of each sub award or subcontract. MTDC excludes equipment, capital expenditures, charges for patient care, rental costs, tuition remission, scholarships and fellowships, participant support costs and the portion of each subaward and subcontract in excess of $25,000.

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

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

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

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

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
• Generally, Resource Sharing Plans are expected, but they are not applicable for this FOA.

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

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

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

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

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

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

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

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

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

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

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

See more tips for avoiding common errors.

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.

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

Only the review criteria described below will be considered in the review process. As part of the FDA Mission, all applications submitted to the FDA are evaluated for programmatic, scientific, and technical merit through the FDA Review Process.

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judge likely to have major communications impact. For example, a project that by its nature is not innovative may still have a major impact on public health.

Significance (40 Points)

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Investigator(s) (20 Points)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Approach (20 Points)

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or FDA-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Innovation (10 Points)

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Environment (10 Points)

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

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

When the proposed project involves human subjects and/or FDA-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children 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.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous Objective Review Committee and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period.

Not Applicable

Not Applicable.

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

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

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

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

Applications will be evaluated for scientific and technical merit by an Objective Review Committee in FDA OCET, at the FDA campus in White Oak, Maryland. FDA OCET reserves the right to recruit additional government personnel to serve as reviewers and/or subject matter expertise as necessary. The review will use the stated review criteria.

As part of the objective review, all applications:

• Will receive a written critique.

Appeals of objective review will not be accepted for applications submitted in response to this FOA.

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

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

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

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

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

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

In accordance with Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), codified as amended at 41 U.S.C. 2313, Federal award making officials are required to review and consider information about an applicant in the designated integrity and performance system (currently the Federal Awardee Performance and Integrity Information System 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.

HHS provides general guidance to recipients of Federal Financial Assistance FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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.

Peer-reviewed articles resulting from research supported in whole or in part with FDA funds must be submitted to the NIH National Library of Medicine's (NLM) PubMed Central (PMC). FDA defines peer reviewed articles as an article describing original scientific research findings published in a scholarly scientific journal that has been peer reviewed prior to publication. The PMC archive is the designated repository for these articles for use by the public, health care providers, educators, scientists, and FDA. Please see the FDA Public Access Policy.

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

Cooperative Agreement Terms and Conditions of Award

2.A. Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 45 CFR Part 75, and other HHS PHS, and FDA grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an assistance instrument (rather than an acquisition instrument), in which substantial FDA programmatic involvement with the awardees 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 award 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 awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and FDA as defined below.

2.A.1. Principal Investigator Rights and Responsibilities

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

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and FDA policies.

Additionally PD/PIs will:

1. Participate in site visits or attend meetings as requested by the FDA. A portion of the budget should be reserved for such travel.

2. FDA may also request data be made available through speaking engagements and publications, presentations at scientific symposia and seminars, while making sure that confidentiality and privacy of the data is protected.

3. The awardees will provide FDA any data obtained from investigations if requested by FDA.

4. Any publication or oral presentation of the results of Vet-LIRN testing must undergo FDA Office of Research and Center review and approval process. This process can take 30-90 days.

2. A.2. FDA Responsibilities

An FDA Project Officer (PO) will have substantial programmatic involvement as described below. The PO is the official responsible for the programmatic, scientific, and/or technical aspects of assigned applications and grants. The PO’s responsibilities include, but are not limited to, post-award monitoring of project/program performance, including review of progress reports and making site visits; and other activities complementary to those of the Grants Management Officer (GMO). The PO and the GMO work as a team in many of these activities.

Additionally, an agency program official will be responsible for the scientific and programmatic stewardship of the award and will be named in the award notice.

FDA will provide technical monitoring and/or direction of the work, including monitoring of data analysis, interpretation of analytical findings and their significance.

FDA will assist and approve (as deemed appropriate) the substance of publications, co-authorship of publications and data release.

Financial Reporting:

A. Cash Transaction Reports

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

B. Financial Expenditure Reports

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

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

Performance Progress Reporting:

1. Annual progress reports are required. The Annual Progress Report will be due as part of the Research Performance Progress Report (RPPR).

2. Grants with Multiple Years: When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR).

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

FAILURE TO COMPLY WITH THE ABOVE STATED TERMS AND CONDITIONS COULD RESULT IN THE SUSPENSION OR TERMINATION OF THIS COOPERATIVE AGREEMENT.

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, unless otherwise directed.

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable FDA grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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 submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

Estella Jones
FDA Office of the Chief Scientist, Office of Counterterrorism and Emerging Threats
Telephone: 301-796-0742
Email: [email protected]

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402
Email: [email protected]

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: [email protected]

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

Awards are made under the authorization of Section 301 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.