Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

U.S. Food and Drug Administration (FDA)

Components of Participating Organizations

National Institute of Dental and Craniofacial Research (NIDCR)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Institute of Neurological Disorders and Stroke (NINDS)

National Center for Complementary and Integrative Health (NCCIH)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Office of Behavioral and Social Sciences Research (OBSSR)

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Planning for the TMD Collaborative for IMproving PAtient-Centered Translational Research (TMD IMPACT) (R34 Clinical Trial Not Allowed)
Activity Code

R34 Planning Grant

Announcement Type
New
Related Notices

NOT-OD-22-195 New NIH "FORMS-H" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2023

NOT-OD-22-189 Implementation Details for the NIH Data Management and Sharing Policy

NOT-OD-22-198 Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023

NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available

Funding Opportunity Announcement (FOA) Number
RFA-DE-23-014
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.121, 93.853, 93.286, 93.103, 93.313, 93.213, 93.846
Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) invites Planning Grant applications that conceptualize the design and implementation of a future national, interdisciplinary, patient-centered research collaborative that will advance Temporomandibular Disorders (TMDs) basic and clinical research, research training, and translation to evidence-based treatments and improved clinical care. The planning grants are intended to enable institutions to develop partnerships, infrastructure, and capabilities needed to address the major goals of a future Collaborative and develop a Collaborative-wide research framework and strategies to support coordination among studies, research projects, and sites, and thereby enhance competitiveness for future participation in TMD Collaborative for Improving Patient-Centered Translational Research (TMD IMPACT).

The planning grant will not be a prerequisite for submission of a TMD IMPACT application.

Key Dates

Posted Date
January 11, 2023
Open Date (Earliest Submission Date)
March 14, 2023
Letter of Intent Due Date(s)

March 14, 2023

Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
April 14, 2023 Not Applicable Not Applicable July 2023 October 2023 December 2023

All applications are due by 5:00 PM local time of applicant organization. 

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.

Expiration Date
April 15, 2023
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This Funding Opportunity Announcement (FOA) invites Planning Grant applications that conceptualize the design and implementation of a future national, interdisciplinary, patient-centered research collaborative that will advance Temporomandibular Disorders (TMDs) basic and clinical research, research training, and translation to evidence-based treatments and improved clinical care. These planning grants are intended to enable institutions to develop the necessary partnerships, infrastructure, and capabilities needed to address the major goals of the future Collaborative. This includes development of a Collaborative-wide research framework and strategies that support coordination among studies, research projects, and sites, thereby enhancing competitiveness for future participation in TMD Collaborative for Improving Patient-Centered Translational Research (TMD IMPACT).

The planning grant will not be a prerequisite for submission of a TMD IMPACT application.

Background

Temporomandibular Disorders (TMDs) are a set of more than 30 heterogeneous health disorders associated with the temporomandibular joint (TMJ), muscles of mastication, and surrounding tissues. The TMJ’s skeletal and connective tissues originate from the neural crest during early development, rather than from the mesoderm, indicating different genetic drivers and pathways than in other joints. TMDs are pain conditions with multifactorial components that range from acute to chronic, and from mild to severe, compromising quality of life for many individuals. They affect between 5-10% of the U.S. population with an annual incidence rate that is greater in females compared to males (~2:1) and often lack correlation between overt signs of injury and pain intensity ratings. TMDs may present with other systemic and comorbid medical conditions. There is chronic overlapping or frequent co-occurrence between TMD and chronic pain conditions (COPCs) such as fibromyalgia, back pain, headache, and irritable bowel syndrome—indicating changes in central processes. The heterogeneous etiologies and clinical presentations of TMDs make accurate, clinically relevant and mechanistically based phenotyping difficult.

Studies indicate that TMDs are multifactorial conditions influenced by genetics, sex and gender, environmental and psychological factors; however, significant gaps remain in our understanding of peripheral and central adaptation mechanisms, and psychosocial influences, that drive chronic pain development or resolution of TMD pain. While our mechanistic understanding of TMDs has been advanced through human and animal studies, progress has been hampered by limited emphasis on changes in affected human target tissues and few integrated analyses combining findings in multiple cells and tissues. The absence of a firm mechanistic understanding of TMDs has precluded stratification of patients into clinically meaningful and mechanistically based subgroups and hampered identification and validation of clear etiological targets for development of effective evidence-based treatments or their clinical endpoints.

TMDs have long confounded medical and dental health care providers, often resulting in misdiagnosis and delayed or ineffective treatment. There is a clear need to accelerate research and treatment breakthroughs on TMDs; and the complexity of this set of conditions calls for a coordinated, integrated, interdisciplinary and multi-level approach to address TMD comprehensively from the whole-person perspective.

Future TMD IMPACT Collaborative

The key objectives of the future TMD IMPACT are to: 1) support robust and rigorous TMD basic research that leads to clinically relevant insights and mechanistic understanding; 2) develop translational programs and support clinical research to improve diagnosis, prevention, and treatment of the various TMDs to ultimately improve standard of care; 3) strengthen population-based research on the public health burden and costs of TMDs to improve prevention and management of TMDs, and health services and implementation research to improve quality and access to care; and 4) train the next generation of interdisciplinary TMD researchers that represent diversity of backgrounds, career stages, and disciplines.

The research framework of the future TMD IMPACT Collaborative is anticipated to be broad and interdisciplinary. Research priorities of the future TMD IMPACT Collaborative that may be of interest to the participating NIH Institutes, Centers, and Offices include (not all-inclusive):

  • Stratification of patients into clinically meaningful and mechanistically based subgroups, and identification and validation of etiological targets for diagnosis, treatments, or their clinical endpoints, including any sex and/or gender differences.
  • Research focused on discerning mechanisms of molecular pathogenesis, disease progression, or resilience that correlate with stratification approaches and TMD clinical heterogeneity; as well as mechanisms that sustain or promote endogenous resolution of chronic TMD pain and/or prevent the transition from acute to chronic pain.
  • Development of minimally invasive treatments and therapies (e.g., force-based manipulations, dry needling, thermotherapies, and local chemical injections) and/or strengthening their evidence-base; and symptom management using biobehavioral approaches.
  • Systems biology, whole-organ, and whole-person approaches that include biopsychosocial mechanisms and consider mental health comorbidities, affective influences on pain, and chronic overlapping pain conditions (e.g., headache, mixed musculoskeletal or myofascial pain).
  • Innovative approaches to understand how sex as a biological variable impacts the annual U.S. incidence rate, which is greater in females compared to males (~2:1).
  • Biomechanical, tissue engineering, and regeneration studies.
  • Adaptation and utilization or development of new tools, devices, and technologies to facilitate access to the TMJ and the unique orofacial physiology, advance current standards of detection and measurement, and for therapeutic applications.
  • Computational methods (e.g., statistical modeling, artificial intelligence, etc.) to leverage large datasets for purposes such as integration of data from various animal models, distinguishing disease subtypes, developing individualized clinical decision support, and predicting patient responses.
  • Strengthening the evidence-base for existing pharmacological and non-pharmacological treatments, including mechanistic studies, efficacy trials, pragmatic trials, and comparative effectiveness trials.
  • Rigorous target validation in the TMJ and/or associated tissues for small molecule, monoclonal antibody, or biologics therapeutic development.

The structure of the TMD IMPACT Collaborative will be designed by the NIH and informed by the opportunities, priorities, and issues identified during the implementation of the planning phase. NIH anticipates sharing the proposed structure with the community prior to issuing any future open solicitations for the Collaborative.

Research Objectives of this Planning Grant FOA

The Planning Grants under this FOA are intended to enable institutions to develop the necessary partnerships, infrastructure, and capabilities needed to address the major goals of the future TMD IMPACT Collaborative, described above. Applicants must: 1) propose a design for the future Collaborative that includes details on overall structure as well as the applicant's functional and structural fit in the larger Collaborative; 2) include an implementation plan that details the strategy for addressing the major goals of the future Collaborative; and 3) delineate a timeline driven set of goals and activities to be accomplished under the Planning Grant that will substantively enhance the applicant's capacity to participate in the future Collaborative and advance its goals.

The interdisciplinary nature of the overall strategy and in the approaches that will be implemented in the future Collaborative should be evident throughout the Research Strategy and Implementation Plan. Interdisciplinary expertise and approaches are essential to meeting the challenges presented by multi-faceted, complex disorders such as TMDs, especially in the context of comorbidities and chronic overlapping pain conditions. Systems biology and whole-joint or whole-person approaches that address sex as a biological variable are also interdisciplinary in nature. In addition, neurotherapeutic targets or molecular pathways investigated in other musculoskeletal pain conditions may inform TMD research; and similarly, approaches or discoveries in TMD research may further our mechanistic understanding and subsequent treatments of other chronic pain conditions.

The implementation plan must include details of proposed governance and data harmonization within the future Collaborative, as well as coordination and data interoperability with other sites, consortia, or resources. The implementation plan must also include a description of how research priorities will be determined or how individual projects, studies, or trials will be selected once the Collaborative is launched. Translation to clinical studies or clinical relevance must be considered in the research projects that are proposed or in the description of how research priorities will be determined. Furthermore, an iterative process for determining the prioritization of research is recommended based on the changing research and treatment landscape, relevant scientific expertise or ability to secure needed expertise, involvement of Federal partners and stakeholders, and potential to advance the research enterprise.

Partnerships and/or plans to leverage and coordinate among existing intra- and inter-institutional, or inter-professional infrastructure to achieve the ambitious goals of TMD IMPACT are encouraged and should be included in the implementation plan as applicable. Examples of relevant infrastructure include (not all-inclusive) the Dental, Oral and Craniofacial Tissue Regeneration Consortium (DOCTR-C); NIH Helping to End Addiction Long-term (HEAL) Restoring Joint Health and Function to Reduce Pain (RE-JOIN) Consortium; NIH HEAL Back Pain Consortium (BACPAC); National Dental Practice-Based Research Network (PBRN); and NCCIH's Force-Based Manipulation U24 Research Networks. This is intended to avoid duplication of efforts and to enhance, complement, or build on the discoveries and foundational outcomes or resources of ongoing or prior initiatives.

Scope

A description of activities to be accomplished during this Planning Grant as well as a timeline for these activities are also required. These Planning Grant activities should support the submission of a competitive application for the future TMD IMPACT program. Planning Grant activities may include (not all inclusive):

  • Establishment of an interdisciplinary research team, including identification and support of collaborators.
  • Development of interdisciplinary curricula and other preparation for the establishment of an interdisciplinary program for research training, career development, or research education.
  • Demonstration of clinical research readiness through study document preparation as applicable; IRB (and IACUC) approvals as applicable.
  • Development of a detailed strategy to align with FDA standards, regulations, and procedures for translational research, device development, investigational new drug development, or FDA-approved clinical trial as applicable; early engagement with the FDA on medical product pre-submission processes.
  • Landscape analysis of relevant existing resources, databases, registries, repositories, programs, and consortia.
  • Engagement with stakeholders such as scientific or professional associations and patients and patient-advocates for outreach and dissemination, better translation to policy and patient care, and to inform the research agenda.
  • Collaboration with stakeholders in the development of a TMD Coordinated Patient Registry Network.
  • Finalization of MOUs or other agreements with partners for access to data; or to leverage and collaborate with existing networks and consortia such as the HEAL RE-JOIN consortium, HEAL Myofascial Biomarker program, or NCCIH's Force-Based Manipulation U24 Research Networks.
  • Refinement and finalization of design, processes, organization, and coordination.
  • Development of the statistical analysis plan and the data sharing and management plan, including plans for data harmonization within the future TMD IMPACT, as well as coordination and data interoperability with other sites, consortia, or resources.

Applications not responsive to the FOA will not be reviewed and include the following:

  • Clinical trials
  • Missing TMD IMPACT design proposal and implementation plan
  • Interdisciplinary expertise and approach are not specified
  • Missing approach for setting research priorities for individual projects, studies, or trials
  • Missing Planning Grant goals, activities, and timeline

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Funds Available and Anticipated Number of Awards

Issuing IC and partner components intend to commit an estimated total of $2M to fund 6-7 awards.

Award Budget

Application budgets are limited to $200,000 Direct Cost and must reflect the actual needs of the proposed project. A detailed budget is required.

Award Project Period

The maximum project period is 1 year.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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 NIH 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)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

  • Eligible Agencies of the Federal Government
  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
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 NIH Grants Policy Statement, are 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • System for Award Management (SAM)– Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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 NIH 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 NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH 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.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

Letter of Intent

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

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

  • Descriptive title of proposed activity
  • Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
  • Names of other key personnel
  • Participating institution(s)
  • Number and title of this funding opportunity

The letter of intent should be sent to:

Yasaman Shirazi, PhD
Telephone: 301-594-5593
Fax: 301-480-8303
Email: yasaman.shirazi@nih.gov

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

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.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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 or Modular Budget

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

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, with the following additional instructions:

Research Strategy:

The Research Strategy must include:

  1. The proposed design for the future TMD IMPACT that includes details on overall structure as well as the applicant's functional and structural fit in the larger Collaborative.
  2. The delineation of goals or sub-goals of the TMD IMPACT Collaborative that the applicant currently has the capacity/resources/expertise to implement.
  3. A description of goals and activities proposed for this Planning Grant that will support the submission of a competitive application for the future TMD IMPACT program.
  4. A detailed timeline of activities to be achieved.
  5. An implementation plan that includes details of governance and data harmonization within the future TMD IMPACT, as well as coordination and data interoperability with other sites, consortia, or resources.
  6. An implementation plan that includes a description of how research priorities will be determined once the Collaborative is launched. Translation to clinical studies or clinical relevance must be considered in the research projects that are proposed or in the description of how research priorities will be determined.
  7. The interdisciplinary nature of the research team, including identification and role of collaborators, as well as in the interdisciplinary nature of approaches to be implemented.

In addition, the following elements are encouraged:

  • Plan for development of interdisciplinary curricula and establishing an interdisciplinary program should one of the objectives to be addressed include research training, career development, or research education.
  • A detailed plan for the consideration, collection, characterization, and communication of sex and gender-based data.
  • Demonstrate clinical readiness of the study team through study document preparation, as applicable.

Letters of Support:

Letters of support from research collaborators, clinical collaborators, patient organizations, or other groups with whom the investigators propose to collaborate with are recommended.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

  • All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.
Appendix:

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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, NIH’s electronic system for grants administration. NIH 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. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

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

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

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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. 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 fieldof the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NIDCR Referral Office by email at yasaman.shirazi@nih.gov when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applications Involving the NIH Intramural Research Program

NIH Intramural scientists may participate in a planning grant as collaborators. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). These costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, appropriate funding will be provided by the NIH Intramural Program. NIH intramural scientists will participate in this program as collaborators, in accordance to the established policies included in the NIH Grants Policy Statement, and appropriate cost principles. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

For this particular announcement, note the following:

Although applicants must propose a design for the future TMD IMPACT that includes details on overall structure as well as the applicant's functional and structural fit in the larger Collaborative, the structure of the future TMD IMPACT Collaborative will be designed by the NIH and informed by the opportunities, priorities, and issues identified during the implementation of the planning phase. NIH anticipates sharing the proposed structure with the community prior to issuing any future open solicitations for the Collaborative.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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)

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

Innovation

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

Approach

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

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

Specific for this FOA:

  • Is there a proposed design for the future TMD IMPACT that includes details on overall structure as well as the applicant’s functional and structural fit in the larger Collaborative? Does this proposed design include a delineation of goals or sub-goals of the future TMD IMPACT Collaborative that the applicant can currently implement, and a description of activities for this Planning Grant that will enable the applicant to comprehensively address the goals of the future Collaborative? Are the activities and timeline proposed achievable during the Planning Grant and likely to prepare the applicant to meet the goals of the future TMD IMPACT program?
  • If the implementation plan includes the development of a research training, career development, or research education program, are the curricula and other training aspects interdisciplinary in nature, and is the program likely to produce interdisciplinary investigators who are well prepared to advance TMD research, prevention, and/or interventions in innovative ways?
  • Is there evidence that translation to clinical studies or clinical relevance is considered in the research projects that are proposed or in the description of how research priorities will be determined?
  • If clinical research is proposed in the design of the future TMD IMPACT Collaborative, is the readiness of the study team as demonstrated in plans for study document preparation evident?
  • To what extent does the application describe plans for data harmonization within the future TMD IMPACT, as well as coordination and data interoperability with other sites, consortia, or resources?

Environment

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

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

Additional Review Considerations

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

Not applicable.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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) appropriate Scientific Review Group(s) convened by NIDCR, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Dental and Craniofacial Research Council. The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients 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 on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

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

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

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.

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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-637-3015

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Melissa Ghim, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-529-6570
Email:melissa.ghim@nih.gov

Danica Marinac-Dabic, MD, PhD, MMSc, FISPE
Associate Director, Office of Clinical Evidence and Analysis 
US Food and Drug Administration (FDA)  
Center for Devices and Radiological Health (CDRH) 
Telephone: (301)796-6689
Email: danica.marinac-dabic@fda.hhs.gov
 

 

 

Karen Wylie
Office of Research on Women's Health (ORWH)
Telephone: 240-529-8680
Email: karen.wylie@nih.gov

Michael L. Oshinsky, PhD 
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: michael.oshinsky@nih.gov

Inna Belfer, MD, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-435-1573
Email: inna.belfer@nih.gov

Aron Marquitz, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: none
E-mail: marquitzar@mail.nih.gov

Guoying Liu
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: (301) 594-5220
E-mail: liug@mail.nih.gov

Peer Review Contact(s)

Yasaman Shirazi, PhD
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-5593
Email:yasaman.shirazi@nih.gov

Financial/Grants Management Contact(s)

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email:rutbergd@mail.nih.gov

Kiara Farmer
Grants Management Specialist
Office of Acquisitions & Grants Services (OAGS)
U.S. Food and Drug Administration (FDA)
Telephone: (240)402-3099
Email: Kiara.Farmer@fda.hhs.gov 

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov

Katie Ellis
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-451-4791
E-mail: kellis@mail.nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.

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