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

For Renewals, the committee will consider the progress made within the last two (2) years and any CERSI activities of significance provided by the applicant that occurred more than two (2) years ago.

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 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:

• Capabilities provided by the overall CERSI program
• Scientific and technical merit of the proposed projects as determined by objective review.
• Availability of funds.
• Relevance of the proposed projects to FDA's unmet regulatory science priorities (see Part 2, Section I.A).
• Past Performance of the CERSI

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

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

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

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

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

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

HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see 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.

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 judgment about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants." This provision will apply to all FDA grants and cooperative agreements.

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

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

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

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 (DHHS) 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" mechanism (rather than an "acquisition" mechanism), in which substantial FDA programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, 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. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the program as a whole, although specific tasks and activities may be shared among the awardees and FDA as defined below.

Awardee Responsibilities

The PD(s)/PI(s) (awardee) will have the primary responsibility for the scientific, technical, and programmatic aspects of the grant and for day-to-day management of the program (i.e., FDA-CERSI collaborative regulatory science research projects and any regulatory science training activities). The PD/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 has appropriate clearance (e.g., appropriate Institutional Review Board (IRB) training for human subject related research) and/or background checks to work on this program. This individual will work closely with designated officials within the recipient organization to appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.

The awardee will be required to participate in a cooperative manner with FDA:

The FDA/OCS/ORSI Program Office will be responsible for the normal scientific and programmatic stewardship of the award and an individual from this office will be named in the award notice.

--The awardee is responsible for obtaining approval from the FDA/OCS/ORSI Program Office for the development and design of certain projects (i.e., all FDA-CERSI collaborative research projects, CERSI workshops, lectures, fellowships at FDA and any other regulatory science training for which FDA cooperative agreement funds are to be used) prior to execution. The awardee is also responsible for obtaining approval for any scientific exchanges between the CERSI and FDA; the FDA/OCS/ORSI Program Office will provide funds separate from the cooperative agreement for travel of FDA personnel to the CERSI.

--The awardee is responsible for preparing materials for meetings involving participants from FDA. Some meetings occur at FDA while others are conducted via teleconference;

--The awardee is responsible for maintaining a Web site containing information on the CERSI program, including FDA-CERSI collaborative research projects and publications and any regulatory science training activities;

--The awardee is responsible for submitting mid-year and annual progress reports, when requested, to the FDA/OCS/ORSI Program Office. See Part II, Section VI.3 on Reporting for information on content for these reports;

Data Access/Data Sharing/Resource Sharing/Data Rights

-- The awardee is responsible for timely publication and public release and dissemination of results, Data (under this cooperative agreement, Data is as defined in the HHS Grants Policy Statement to mean recorded information, regardless of the form or media on which it may be recorded, and includes writings, films, sound recordings, pictorial reproductions, drawings, designs or other graphic representations, procedural manuals, forms, diagrams, work flow charts, equipment descriptions, data files, data processing or computer programs (software), statistical records, and other research data) and other products of the study, concordant with an approved plan for making Data and materials available to the scientific community and FDA. Awardee is requested to provide materials (such as abstracts, manuscripts and reviews (co)authored by members of the grant and supported in part or in total under this cooperative agreement) for public disclosure to FDA/OCS/ORSI Program Office prior to disclosure or submission for publication so that the Agency can review the material (within an agreed upon timeframe between FDA and the awardee).

-- Publications or oral presentations of work performed under this cooperative agreement will require appropriate acknowledgement of FDA support. Awardees should use the following language for these acknowledgements: "This work was supported [in part] by a Center of Excellence in Regulatory Science and Innovation (CERSI) grant to [insert name of institution(s)] from the US Food & Drug Administration (insert grant number). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS or FDA."

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;

--Awardees will retain custody of and have primary rights to the Data developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and FDA policies. Any publications, Data or other copyrightable works developed under this grant may be copyrighted without prior FDA approval. In all cases, whether FDA funded all or part of the project or program resulting in the Data or other copyrightable work, FDA must be given a royalty-free, nonexclusive, and irrevocable license for the Federal government to reproduce, publish, or otherwise use the material and to authorize others to do so for Federal purposes.

FDA Responsibilities

FDA will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

The responsibilities of the FDA/OCS/ORSI Program Office and other FDA subject matter expert program staff with relevant scientific expertise (FDA SMEs) during conduct of the FDA-CERSI collaborative research projects is above and beyond normal program stewardship for grants. The FDA/OCS/ORSI Program Office provides FDA oversight for the collaborative research projects and the FDA SMEs provide technical assistance, advice, and/or other assistance activities. As appropriate, the FDA SMEs may participate in the definition of specific aims and approaches, and in planning, conducting, analyzing, and publishing results, interpretations, and conclusions of FDA-CERSI collaborative research studies. However, the dominant role and prime responsibility for the activity reside with the awardees(s) for the project as a whole, but not necessarily for each task.

The FDA/OCS/ORSI Program Office, with assistance of FDA SMEs, will be involved in the programmatic coordination and management of any FDA-CERSI collaborative workshops and lectures and any fellowships at FDA. CERSI workshops conducted under this cooperative agreement are not permitted to provide consensus recommendations from the workshop to FDA in accordance with the Federal Advisory Committee Act (FACA) or otherwise provide consensus recommendations to others (e.g., the public) in accordance with Good Guidance Practice (GGP) regulations at 21 CFR 10.115, in particular 21 CFR 10.115(e).

FDA and Awardee Joint Responsibilities

As relevant, the PDs/PIs (awardee) and FDA SMEs (with oversight of the FDA/OCS/ORSI Program Office) will work collaboratively in evaluating the most appropriate research methods, data quality control strategies, safety issues, study design and implementation, data analysis and interpretation, publication and dissemination of study results. Projects will require FDA/OCS/ORSI Program Office approval prior to implementation/ initiation.

During performance of the award, the FDA/OCS/ORSI Program Office, in consultation with FDA SMEs, may provide appropriate assistance, advice and guidance. The role of the FDA/OCS/ORSI Program Office will be to facilitate and not to direct the activities. It is anticipated that decisions for FDA-CERSI collaborative research projects and any FDA-CERSI collaborative workshops and lectures will be reached by consensus between the PDs/PIs and the FDA/OCS/ORSI Program Office and that FDA SMEs will be given the opportunity to offer input into this process. The FDA/OCS/ORSI Program Office will facilitate liaison activity for partnerships, and provide assistance with access to FDA supported resources and services.

Dispute Resolution Process

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the FDA may be brought to a dispute resolution panel composed of three members not involved in the study. One member will be designated by the PDs/PIs, another will be designated by FDA and the third member, who will have expertise in the relevant area of experience, will be chosen by the other two members.

This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

Non-Federal Funds

The awardee may accept funds from any entity, including an FDA-regulated entity or non-profit organization (participant), to support grant activities such as research projects, training programs, workshops or seminars, so long as federal and non-federal funds are managed in accordance with the HHS Grants Policy Statement and the awardee complies with the terms and conditions in the Notice of Grant Award, including the special terms and conditions described in this section:

I. Assurances to Prevent Conflicts of Interest, and Special Access to, or Undue Influence on FDA, or Their Appearance

• FDA will not be involved in soliciting funds from outside entities for the grant;
• FDA staff will abide by federal ethics rules regarding acceptance of gifts, honoraria, travel reimbursement and prospective employment (see 5 C.F.R. 2635 (2015));
• In accordance with the HHS Grants Policy Statement, all awardees must acknowledge federal funding when issuing statements, press releases, requests for proposals, bid invitations, and other documents describing projects or programs funded in whole or in part with federal funds (see HHS Grants Policy Statement, at II-23);
• An awardee may not promote itself as having special access to or undue influence on FDA or as having FDA endorsement of the organization, an activity, or a product; however, FDA may co-sponsor events with outside non-federal entities (see HHS Co-Sponsorship Guidance, August 8, 2002). FDA retains the authority to take remedial actions against any awardee or participant determined by the agency not to be in compliance with this requirement;
• Collaboration activities that include members of FDA-regulated industry, academia, and/or public interest groups will be based on sound scientific evidence and designed to be protective of public health;
• Costs for meetings must be kept reasonably low. Except where FDA funds are being used to support an activity, FDA will not itself review the relationship of the fees to the costs of the collaboration or whether meeting costs are reasonable in advance of the meeting. If, however, adherence to this assurance is questioned, FDA may take steps to evaluate the relationship of costs and fees to determine whether this assurance has not been adhered to and what action the agency may take in response;
• Any solicitation by an awardee for outside funding and all funding agreements between the awardee and participants will include a statement that: (a) the contributions will be reasonably related to the costs of the collaboration; (b) the contributions will not result in undue influence on FDA regulatory decisions; (c) the contributions will not result in an endorsement of the participant or any of its products or activities by FDA; (d) the contributions will not provide access to non-public product specific information from FDA; (e) the contribution may be publicly acknowledged by the participant, but the participant may not promote itself as having a relationship with FDA; and (f) the participant understands that FDA staff will abide by federal ethics rules regarding acceptance of gifts, honoraria, travel reimbursement and prospective employment. In particular, any FDA employee who commences employment discussions or otherwise seeks employment with a participant will immediately recuse themselves from official participation in any collaboration involving that participant and from all other particular government matters affecting the financial interests of that participant.

II. Transparency/Equal Access:

• The awardee must publicize major grant activities with non-federal entity(ies), including summaries of on-going research projects to the extent that publication of the work product and protection of intellectual property would not be compromised, training programs, workshops, scientific exchanges and seminars on a publicly accessible website. The awardee must also publicize on this website a list of the non-federal entities with which it collaborates;
• The awardee must develop procedures by which any interested party may have the opportunity to provide their views and feedback on grant activities with non-federal entities, without the payment of fees;
• As with all federally-supported research, the awardee is encouraged to publish or otherwise make publicly available all results, data, and other work-product from the grant activities with non-federal entities, consistent with relevant confidentiality laws and agreements. After the work-product is published, the awardee is encouraged to provide access to the work-product, or a citation to a publication regarding the work-product, on the same website where the awardee has publicized its grant activities.

III. External Advisory Board

The awardee may choose to create an external body of experts to advise them on its grant program

(e.g., recommendations for research agenda, training programs, workshops or seminars).

• Any external advisory board must be created and established by the awardee;
• Any external advisory board must function to provide recommendations on the grant program to the awardee, and not to FDA;
• FDA must not be a part of the external advisory board, but may attend meetings of the external advisory board on an as needed basis;
• Organizations may, but are not required to, provide funds to the awardee to participate on the external advisory board. In choosing members of the external advisory board, the awardee may not take into account the willingness of the potential members or their employers to provide funds to underwrite grant activities.

Food and/or Meals

Grant funds may not be used for any 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). This does not apply to per diem (for subsistence) that is necessary when travel is required and approved in support of the cooperative agreement.

Non-federal funds obtained from registration fees and sponsors can be used to purchase food for a workshop, conference or training event under the cooperative agreement as long as:

1. The meal-related portion of registration fees are not collected from federal government staff, including individuals that are paid by the federal government (e.g., contractors, ORISE fellows)

2. The non-federal funds are held in a separate account and not co-mingled with the grant funds

3. The food is part of the event (e.g., catered meals) and not purchased individually for attendees.

In accordance with the Standards of Ethical Conduct for Employees in the Executive Branch, HHS Supplemental Standards of Conduct, the criminal conflict of interest statutes (18 U.S.C. 201-209), and the Foreign Gifts and Decorations Act, a federal employee is allowed to accept a gift valued at $20 or less on a single occasion, provided that the total value of gifts from the same source is not more than $50 in a calendar year. Under this cooperative agreement, food provided to federal government staff attending a workshop, conference or training event would be considered a gift.

Terms and Conditions of Award for Collaborative Research Projects Funded by the Center for Tobacco Products (CTP)

Collaborative research projects funded by CTP are subject to the terms and conditions of this cooperative agreement. In addition, terms and conditions, as follows, also apply to these CTP-funded collaborative research projects.

ACTIVITIES THAT REQUIRE PRIOR APPROVAL FROM FDA/CTP:

1. PUBLICATIONS, EDUCATIONAL MATERIALS AND PRESS STATEMENTS

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

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

The grantee shall otherwise be free to submit the manuscript and publish results in any manner consistent with academic standards.

2. CONFERENCES AND TRAVEL

Before a grantee expends any grant funds on newly proposed conference attendance and/or travel that was not previously proposed in the original application submission or subsequent progress reports, they must obtain prior approval from FDA/CTP. A prior approval request for conference attendance and/or travel must be submitted in writing to the Program Officer and must include the following information:

A. Title/Topic of Conference

B. Purpose of Conference

C. Explanation of how the Conference directly supports the grant's goals and objectives

D. Dates of Conference

E. Location of Conference

F. Detailed breakdown on costs associated with Conference attendance/travel, to include the name of the attendee

3. ADDITIONAL ACTIVITIES THAT REQUIRE PRIOR APPROVAL

The following activities also require prior approval by FDA before being implemented by the grantee, its employees, or designee:

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 the terms and conditions of the award

Carryover of unobligated balances

No cost extensions

Any deviation from the approved budget

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-18-011.

CONFLICT OF INTEREST:

Financial Conflict of Interest

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

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

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

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

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

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

FDA Evaluation for Non-competing Renewal

Once an award is granted, each year the applicant must submit a Research Performance Progress Report (RPPR) requesting funding for the following year. In considering requests for non-competing renewal of the award, FDA will review the progress of the CERSI program taking into account: 1) overall management and accomplishments of the CERSI program, 2) interactions with FDA, 3) achievement of FDA-CERSI collaborative research project milestones and deliverables, and 4) impact of FDA-CERSI collaborative research projects on FDA.

In addition to the RPPR, awardees are required to submit mid-year and annual progress reports and financial reports for each year of the cooperative agreement. All of these reports should be documented in an agreed upon format between FDA and the CERSI.

• Regarding the progress reports: the mid-year report should describe progress made during the previous 6 months of the cooperative agreement related to overall management of the core CERSI program infrastructure, FDA-CERSI collaborative research projects and any regulatory science training, while the annual report should describe progress made during the entire past year. These reports should include all FDA-CERSI collaborative research projects, in process and final, accomplishments in all other aspects of CERSI work, issues and concerns encountered, and solutions used to resolve issues. In addition to providing summary information on FDA-CERSI collaborative research projects in progress reports, a separate status report should be provided for each project. These reports should also include a table of grant funds provided and expenditures/remaining funds broken down by categories (e.g., core CERSI program infrastructure, collaborative research projects, regulatory science training, travel, indirect costs). Progress reports beyond the first year of award of a cooperative agreement should include a cumulative accomplishments table listing all the previous achievements of the CERSI program.
• When a research project is ready for communication to the public (e.g., FDA Internet site, FDA blogs), provide a brief description of the project and its current status using Plain Language Principles.

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 HHS Grants Policy Statement.

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

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons 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: support@grants.gov

Audrey Thomas
Office of the Commissioner
Office of the Chief Scientist
Telephone: 301-796-3520
Email: audrey.thomas@fda.hhs.gov

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: Shashi.Malhotra@fda.hhs.gov

Shashi Malhotra
Office of Acquisitions & Grants Services (OAGS)
Food and Drug Administration
Telephone: 240-402-7592
Email: Shashi.Malhotra@fda.hhs.gov

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

Awards are made under the authorization of Section 301 and 405 of the Public Health Service Act as amended (42 USC 241) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.