Department of Health and Human Services
Part 1. Overview Information
Participating Organization(s)

U.S. Food and Drug Administration  (FDA)

The policies, guidelines, terms, and conditions stated in this announcement may differ from those used by the NIH.  Where this Funding Opportunity Announcement (FOA) provides specific written guidance that may differ from the general guidance provided in the grant application form, please follow the instructions given in this FOA.

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

Components of Participating Organizations

Center for Drug Evaluation and Research (CDER)

Funding Opportunity Title

Therapeutic Areas for Data Standards Development (U01)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

New

Related Notices

  • NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015)
  • Funding Opportunity Announcement (FOA) Number

    RFA-FD-16-020

    Companion Funding Opportunity

    None

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

    93.103  

    Funding Opportunity Purpose

    Establishing common study data standards will provide new opportunities to transform the vast and continually increasing amount of clinical study data received into useful information to speed the delivery of new therapies to patients.  Standardized data elements, terminologies, and data structures enable automation of important analyses of clinical study data to support more efficient and effective regulatory decision-making. In 2011, in response to an urgent need to further standardize study data terminologies and concepts for efficacy analysis, FDA’s Center for Drug Evaluation and Research (CDER) compiled a prioritized list of disease and therapeutic areas (TAs) for which additional data standardization was needed, and made the list available on the FDA website. 

    The primary objective of this funding opportunity is to support projects leading to the development of specifications for TAs which capture how to structure commonly collected data and outcome measurements in disease clinical trials.

    Key Dates
    Posted Date

    March 25, 2016

    Open Date (Earliest Submission Date)

    April 04, 2016

    Letter of Intent Due Date(s)

    Not Applicable 

    Application Due Date(s)

    June 03, 2016, by 11:59 PM Eastern Time.

    Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

    Applicants should be aware that on-time submission means that an application is submitted error free (of both Grants.gov and eRA Commons errors) by 11:59 PM Eastern Time on the application due date. 

    Late applications will not be accepted for this FOA.

    AIDS Application Due Date(s)

    Not Applicable

    Scientific Merit Review

    July 2016 

    Advisory Council Review

    Not Applicable

    Earliest Start Date

    September 2016

    Expiration Date

    June 04, 2016

    Due Dates for E.O. 12372

    Not Applicable

    Required Application Instructions

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

    Note:  The electronic application forms for this funding opportunity announcement will be posted soon. Please check back later to download the application forms.

    Table of Contents

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

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

    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description

    Background

    The FDA/Center for Drug Evaluation and Research (CDER) receives a vast and growing amount of data in a variety of regulatory submissions from a multitude of sources and in a variety of formats. This wealth of data holds great potential to advance CDER’s regulatory and scientific work, but the present lack of standardized data creates significant challenges to realizing that potential.  The volume and complexity of drug-related information submitted to CDER for regulatory review is creating significant challenges to the Center’s ability to efficiently and effectively perform its critical public health mission.

    The lack of standardized data affects CDER’s review processes by curtailing a reviewer’s ability to perform integral tasks such as rapid acquisition, analysis, storage and reporting of regulatory data. Improved data quality, accessibility and predictability will give reviewers more time to carry out complex analyses, ask in-depth questions and address late-emerging issues. Standardized data will allow reviewers to increase review consistency and perform evaluations across the drug lifecycle. This will enhance the Center’s performance across key drug regulatory functions and ongoing business operations, including pre-market review, post-market safety, oversight of drug quality, and oversight of drug promotion.

    In addition to being beneficial to CDER, standardized efficacy data benefit external stakeholders including industry and those dealing with clinical data (e.g., clinical research organizations, medical and academic institutions) as well.  These benefits include enabling efficiencies in data management and analysis, facilitating traceability of data and combining of data from different sources. Enabling more consistent data collection in clinical studies could lead to more efficient studies with better quality data which ultimately leads to improved knowledge about safety and efficacy of a drug product.  In response to the need to further standardize study data terminologies and concepts for efficacy analysis, CDER maintains a list of prioritized disease and therapeutic areas (TAs) for which additional data standardization was needed, and made the list available on the FDA Priority Therapeutic Areas for Development website.

    In accordance with the Office of Management and Budget (OMB) Circular A-119, the FDA will: use voluntary, consensus-based standards development processes in place of government unique standards unless such standards are inconsistent with law or otherwise impractical; advocate to align these standards with existing health information technology initiatives, laws, regulations, and mandates; and promote coordination with other standards currently in use. The projects selected under this funding opportunity must adhere to these principles.

    Purpose/Objective

    CDER is supporting projects leading to the development of non-proprietary, consensus-based, TA specifications to be used in conjunction with existing standards for use in regulatory submissions for human drugs and biologics, while striving for interoperability between clinical research and healthcare standards. 

    See Section VIII. Other Information for award authorities and regulations.
    Section II. Award Information
    Funding Instrument

    Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, FDA scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

    Application Types Allowed

    New

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

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon FDA appropriations and the submission of a sufficient number of meritorious applications. Future year amounts will depend on annual appropriations, availability of funding and awardee performance.

    FDA/CDER intends to fund up to $675,000, for fiscal year 2016 in support of this grant program.

    It is anticipated that up to three (3) awards will be made, not to exceed $225,000 in total costs (direct plus indirect), per award for fiscal year 2016.

    Award Budget

    Application budgets need to reflect the actual needs of the proposed project and should not exceed the following in total costs (direct and indirect):

    YR 01: $225,000
    YR 02: $100,000

    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is two (2) years.

    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.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Higher Education Institutions

    • Public/State Controlled Institutions of Higher Education
    • Private Institutions of Higher Education

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

      • Hispanic-serving Institutions
      • Historically Black Colleges and Universities (HBCUs)
      • Tribally Controlled Colleges and Universities (TCCUs)
      • Alaska Native and Native Hawaiian Serving Institutions
      • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

    Nonprofits Other Than Institutions of Higher Education

    • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
    • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

    For-Profit Organizations

    • Small Businesses
    • For-Profit Organizations (Other than Small Businesses)
    Foreign Institutions

    Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
    Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
    Foreign components, as defined in the HHS Grants Policy Statement, are not allowed.

    Required Registrations

    Applicant Organizations

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

    • 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.
    • 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.

    Eligible Individuals (Program Director/Principal Investigator)

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

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

    The FDA will not accept duplicate or highly overlapping applications under review at the same time.  This means that the FDA will not accept:

    • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
    • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
    Section IV. Application and Submission Information
    1. Requesting an Application Package

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

    2. Content and Form of Application Submission

    It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, 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.

    Page Limitations

    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.
    Instructions for Application Submission

    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.

    SF424(R&R) Cover

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

    SF424(R&R) Project/Performance Site Locations

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

    SF424(R&R) Other Project Information

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

    SF424(R&R) Senior/Key Person Profile

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

    R&R Budget

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

    • 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 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.
    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

    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, with the following modification:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

    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.

    PHS Inclusion Enrollment Report

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

    PHS Assignment Request Form

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

    3. Unique Entity Identifier and System for Award Management (SAM)

    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

    4. Submission Dates and Times

    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.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

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

    7. Other Submission Requirements and Information

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

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

    For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.  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 in FDA. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

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

    Section V. Application Review Information
    1. Criteria

    Only the review criteria described below will be considered in the review process.

    Scored Review Criteria

    Reviewers will consider each of the review criteria below in the determination of scientific merit.

    Significance (10 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? Does the PI have relevant experience for the project?        

    Approach (30 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? Does the project outline an approach to how stakeholders will be included? 

    Outcomes and Project Plan (10 Points)

    Does the application explain the planned outcomes?  Is the proposed project schedule reasonable?      

    Prior Experience (30 Points)

    Does the application highlight how previous work done and knowledge gained is relevant to the project being proposed?

    Additional Review Criteria

    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.   

    Protections for Human Subjects

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

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

    Inclusion of Women, Minorities, and Children 

    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.

    Vertebrate Animals

    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.

    Biohazards

    Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

    Resubmissions

    Not Applicable

    Renewals

    Not Applicable  

    Revisions

    Not Applicable

    Select Agent Research

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

    Resource Sharing Plans

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

    Authentication of Key Biological and/or Chemical Resources:

    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.

    Budget and Period of Support

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

    2. Review and Selection Process

    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:

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

    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.

    Section VI. Award Administration Information
    1. Award Notices

    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.

    2. Administrative and National Policy Requirements

    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.

    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 CDER 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 Parts75Part 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, in which substantial FDA programmatic involvement with the awardee is anticipated during the performance of the activities.

    Under the cooperative agreement, the 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 of activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardee for the project, although specific tasks and activities may be shared among the awardee and the FDA as defined below:

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

    b.  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 DHHS, PHS, and FDA polices.

    c.  An agency program official/Project Officer (PO) or a Center program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. FDA staffs have substantial programmatic involvement that is above and beyond the normal stewardship role in award as described below:

    Principal Investigator(s) (PI)/Program Director (PD) responsibility

    The Principal Investigator (PI)/Program Director (PD) will have responsibility for the scientific, technical, and programmatic aspects of the grant, and for the 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, and ensuring that all staff has 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 prepare justifications, appropriately acknowledge Federal support in publications, announcements, news programs, and other media; and ensure compliance with other Federal and organizational requirements.

    The awardee is responsible for submitting interim progress reports (e.g. at specified intervals), when requested, to the PO and the Grants Management Officer (GMO)/Specialist (GMS), listed as a contact on the Notice of Grant Award (NGA/NoA) including summary data on progress and expenses to date.

    The awardee is encouraged to publish and publicly release and disseminate results, data and other products of the study, concordant with the study protocol and governance and the approved plan for making data and materials available to the scientific community, or as required by any federal regulation or statute.

    Publications or oral presentations of work performed under this Cooperative Agreement will require appropriate acknowledgement of FDA support.  Timely publication of major findings is encouraged.

    The awardee is responsible for obtaining prior approval for the development and design of FDA projects prior to execution. See additional prior approval requirements in the HHS Grants Policy Statement http://www.hhs.gov/asfr/ogapa/aboutog/hhsgps107.pdf

    The awardee will schedule a monthly grant status meeting with FDA and provide a meeting summary including action items for the monthly status conversation or any scheduled meeting with FDA.

    FDA Responsibilities

    The PO will monitor grantees periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the PO/GMO/ GMS and the PI. Periodic site visits with officials of the grantee organization may also occur.

    A PO with scientific/technical expertise and other members of the FDA staff will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

    • The responsibilities of the PO include involvement during conduct of the activity, through technical assistance, advice, coordination, and/or other assistance activities.
    • As appropriate, the PO will participate in the definition of objectives and approaches, and in planning, conducting, analyzing, and publishing results, interpretations, and conclusions of their studies.  However, the dominant role and prime responsibility for the activity reside with the awardees(s) for the project.
    • The PO will be responsible for the administration and general scientific and programmatic stewardship of the award and have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.
    • The FDA, through the PO, will have access to data generated under this Cooperative Agreement and may periodically review the data and progress reports.  The PO may use information obtained from the data for the preparation of internal reports on the activities of the study.  However, awardees will retain custody of and have primary rights to all data developed under these awards or as stated in the terms and conditions of award.
    • Retain the right to have prior approval on the appointment of all key personnel substantially supported by the grant.
    • Be directly involved in the guidance and development of the program and the collaborative structure of for the program.
    • Participate with the grantee in determining and carrying out the methodological approaches to be used.  Collaboration will also include data analysis, interpretation of findings and where appropriate, co-authorship of publications.
    • Arrange to have professional scientific and administrative/clerical personnel working in collaboration with the grantee as required.
    • The FDA agency program official will have primary responsibility for finalizing standard procedures, and measures common to all funded projects.

    Collaborative Responsibilities

    The grantee organization must comply with all special terms and conditions of the grant, including those which state that future funding of the study will depend on recommendations from the PO.

    During performance of the award, the PO, with assistance from other scientific program staff, designated 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.  It is anticipated that decisions in all activities will be reached by consensus between the PD/PI and the PO, and that the FDA programmatic staff will be given the opportunity to offer input into this process.  The PO will facilitate liaison activity for partnerships, and provide assistance with access to FDA supported resources and services.

    SPECIAL TERMS AND CONDITIONS:

    Dispute Resolution Process

    Any disagreements that may arise in technical or programmatic matters (within the scope of the award) between award recipients and the FDA may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened comprised of (1) a designee of the Steering Committee (if a Steering Committee is not active, a designee of the recipient organization) chosen without FDA staff voting, one FDA designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardees’ 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.

    REPORTING REQUIREMENTS:

    Periodic program monitoring will be conducted on an ongoing basis which may be in the form of telephone conversations between the Principal Investigator and the Project Officer/Grants Management Officer/Grants Management Specialist as well as the review of written reports.

    1. Mid-year and Annual progress reports will be required. A Mid-year Progress Report will be due 14 days following the close of the 6 month from date of award. The Annual Progress Report will be due as part of the Research Performance Progress Report (RPPR).

    Recipients must relate financial information to performance data and compare costs against budgeted amounts. The report should capture unobligated balance.  Travel costs that quarter as well as planned travel must be included.  FDA will accept estimates based on available documentation.

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

    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 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.

    3. Closeout Requirements (when applicable): A Final Program Progress Activity Report, Final Federal Financial Report SF-425, Final Invention Statement HHS-568 (if applicable), and Statement of Disposition of Equipment (if applicable) must be submitted within 90 days after the expiration date of the project period. All forms can be found at: http://grants.nih.gov/grants/forms.htm.

    4. The recipient will conduct, when appropriate, an annual Single Audit as required by OMB Circular A-133. This audit must be submitted to the Federal Audit Clearinghouse at the Bureau of the Census within 9 months of the close of their fiscal year. If you need information on your organization’s obligations under the Single Audit Act, please visit the following website: http://harvester.census.gov/sac/. Valuable information is included under the ‘Frequently Asked Questions’ section of that website.

    5. The grantee will be responsible for recording and disseminating all official meeting minutes under this project.

    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 a grantee questions regarding the need or requirement for prior approval for an activity or cost, the grantee is to contact the assigned Grants Management Specialist prior to expenditure of funds for clarification. Below are activities that require prior approval from FDA/CDER:

    1. CHANGE IN SCOPE OR OBJECTIVES

    2. CHANGE IN KEY PERSONNEL

    3. CHANGE IN GRANTEE ORGANIZATION

    4. CHANGE IN KEY PARTNER ORGANIZATION(S)

    5. ANY DEVIATION FROM TERMS AND CONDITIONS OF THE AWARD

    6. CARRYOVER OF UNOBLIGATED BALANCES

    7. NO COST EXTENSIONS

    8. SIGNIFICANT REBUDGETING

    PUBLICATIONS, EDUCATIONAL MATERIALS AND PRESS STATEMENTS

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

    The grantee agrees that, prior to submission of a manuscript with FDA co-author (s) describing the results for publication, the grantee shall forward to the FDA a copy of the manuscript to be submitted and shall allow the FDA 30 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/PDUFA funds to support the grant, a courtesy  review of the publication is appreciated to ensure that any potential language that might reference, imply, or infer any FDA endorsement of regulatory and/or policy changes related to the project is not stated.

    At this time the grantee shall be free to submit the manuscript and publish results in any manner consistent with academic standards. The FDA will have the right to request deletion of any trade secret, proprietary, or confidential information, and any inference to FDA endorsement of regulatory and/or policy changes related to the project.

    CONFERENCES AND TRAVEL

    Before a grantee expends any grant funds on newly proposed conference attendance and/or travel that was never previously proposed in the original application submission or subsequent progress reports, they must obtain prior approval from FDA/CDER. A prior approval request for conference attendance and/or travel must be submitted in writing to the Grants Management Specialist and must include the following information:

    A.         Title/Topic of Conference

    B.         Purpose of Conference

    C.         Explanation of how the Conference directly supports the CDER goals and objectives

    D.         Dates of Conference

    E.         Location of Conference

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

    ALL THE ABOVE REQUIREMENTS MUST BE SENT VIA E-MAIL TO:

    Eric Bozoian

    Grants Management Specialist

    Food and Drug Administration

    Email: Eric.Bozoian@fda.hhs.gov

    ACKNOWLEDGEMENT OF FEDERAL SUPPORT:

    When issuing statements, press releases, publications and other documents describing projects or programs funded in whole or in part with Federal money, all awardees receiving Federal funds, including and not limited to State and local governments and recipients of Federal research grants, shall clearly state:

    *Funding for this statement, publication, press release, etc. was made possible, in part, by the Food and Drug Administration through grant (insert grant number). Views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.*

    PROGRAM INCOME:

    1.   The grantee is required to report any Program Income generated during the Project Period of this grant. Except for royalty income generated from patents and inventions, the amount and disposition of Program Income must be identified on lines 10 (l), (m), (n), and (o) of the grantee’s Federal Financial Report (FFR) SF-425.

    2. Examples of Program Income include (and not limited to): fees for services performed during the grant or sub-grant period, proceeds from sale of tangible personal or real property, usage or rental fees, patent or copyright royalties, and proceeds from the sale of products and technology developed under the grant.

    3. Any Program Income generated during the Project Period of this grant by the grantee or sub-grantee is subject to the Addition Alternative for Program Income and, therefore, must only be used to further the goals of the project for which this grant was awarded.

    EQUIPMENT AND PRODUCTS:

    To the greatest extent practicable, all equipment and products purchased with FDA funds should be American-made.

    PAYMENT MANAGEMENT SYSTEM (PMS):

    The Payment Management System is administered by the Program Support Center (PSC), DHHS, and payments for FDA grant awards are made through the Division of Payment Management. Applicant organizations are assigned a 12-digit Entity Identification Number for payment and accounting purposes. That number is an expansion of the 9-digit Employer Identification Number assigned to an organization by the Internal Revenue Service.

    Included are the following Links & Instructions for drawing down funds, reporting expenditures, required forms, and the help desk info:

    Homepage: http://www.dpm.psc.gov/Default.aspx

    Grant Recipient Information: http://www.dpm.psc.gov/grant_recipient/grant_recipient.aspx?explorer.event=true

    Grant Recipient Forms: http://www.dpm.psc.gov/grant_recipient/grantee_forms.aspx?explorer.event=true

    PMS Help Desk: http://www.dpm.psc.gov/help/help.aspx?explorer.event=true

    The ONE-DHHS Help Desk for PMS Support is now available Monday Friday from 7 a.m. to 9 p.m. EST (except Federal Holidays). Phone (877) 614-5533; Email PMSSupport@psc.gov

    3. Reporting

    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. 

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA 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 CenterTelephone: 800-518-4726
    Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Fatima Frye
    Center for Drug Evaluation and Research (CDER)
    Telephone: 301-796-4863
    Email: fatima.frye@fda.hhs.gov

    Jenise Gillespie-Pedersen
    Center for Drug Evaluation and Research (CDER)
    Telephone: 301-796-4211
    Email: jenise.gillespie-pedersen@fda.hhs.gov

    Objective Review Contact(s)

    Eric Bozoian
    Office of Acquisition & Grants Services (OAGS)
    Food and Drug Administration (FDA)
    5630 Fishers Lane
    Rockville, MD 20857
    Telephone: 240-402-7623
    Email: Eric.Bozoian@fda.hhs.gov

    Financial/Grants Management Contact(s)

    Eric Bozoian
    Office of Acquisition & Grants Services (OAGS)
    Food and Drug Administration (FDA)
    5630 Fishers Lane
    Rockville, MD 20857
    Telephone: 240-402-7623
    Email: Eric.Bozoian@fda.hhs.gov

    Section VIII. Other Information

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

    Authority and Regulations

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

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