Model: christinemahler/aie5-midterm
Author: christinemahler
Pipeline: sentence-similarity
Library: sentence-transformers
Tags: sentence-transformers, safetensors, bert, sentence-similarity, feature-extraction, generated_from_trainer, dataset_size:216, loss:MatryoshkaLoss, loss:MultipleNegativesRankingLoss, arxiv:1908.10084, arxiv:2205.13147, arxiv:1705.00652, base_model:Snowflake/snowflake-arctic-embed-l, base_model:finetune:Snowflake/snowflake-arctic-embed-l, model-index, text-embeddings-inference, endpoints_compatible, region:us
Base models (finetune): id: Snowflake/snowflake-arctic-embed-l
Card metadata: tags: sentence-transformers, sentence-similarity, feature-extraction, generated_from_trainer, dataset_size:216, loss:MatryoshkaLoss, loss:MultipleNegativesRankingLoss
base_model: Snowflake/snowflake-arctic-embed-l
widget: source_sentence: Are foreign organizations eligible to apply for the intervention research grant mentioned in the context?
sentences: PAR-25-379: Intervention Research to Improve Native American Health (R01 Clinical Trial Optional) 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 Organizations
    
 
 
    Non-domestic (non-U.S.) Entities (Foreign Organizations)
     
     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 How to Apply-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, please reference the
     
     NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications
     
    .
    
 
 
 
      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 their 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
     
    and Notice of NIH's Interest in Diversity,
     
     NOT-OD-20-031
     
    .
    
 
    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 How to Apply- Application Guide.
    
 
 
 
    Foreign components, as
     
     defined in the
      
      NIH Grants Policy Statement
      
 
    ,
     
     are
     
    allowed only when the ancestral catchment area(s) of tribe(s) cross(es) U.S. national boundary.
    
 
 
 
    2. Cost Sharing
    
 
    This NOFO does not require cost sharing as defined in the
     
     NIH Grants Policy Statement Section 1.2 Definition of Terms
     
    .
    
 
 
 
    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
     
     NIH Grants Policy Statement Section 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
      
      NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications
      
     )., RFA-HL-26-010: Limited Competition: Data Analysis and Sharing Center (DASC) for the MACS/WIHS Combined Cohort Study (MWCCS) (U01 Clinical Trials Not Allowed) Section II. Award Information
    
 
 
   Funding Instrument
    
    Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH 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 NOFO.
    
 
 
   Application Types Allowed
   New
    
   Renewal
    
 
 
 
    The
     
     OER Glossary
     
    and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
    
 
 
   Clinical Trial?
    
    Not Allowed: Only accepting applications that do not propose clinical trials.
    
 
 
 
 
     Need help determining whether you are doing a clinical trial?
     
 
 
 
   Funds Available and Anticipated Number of Awards
    
    The following NIH components intend to commit an estimated total of $3 million to fund a single award in FY 2026:
    
 
    NHLBI, $0.97 million
    
 
    NIAID, $0.30 million
    
 
    NIMH, $0.30 million
    
 
    NCI, $0.75 million
    
 
    NIA, $0.19 million
    
 
    NIDA, $0.15 million
    
 
    NICHD, $0.13 million
    
 
    NIDCR, $0.07 million
    
 
    NIMHD, $0.04 million
    
 
    NIAAA, $0.03 million
    
 
    NINR, $0.03 million
    
 
    ORWH, $0.03 million
    
 
    NIDCD, $0.02 million
    
 
 
   Award Budget
    
    Application budgets may not exceed direct costs of $2 million per year in Fiscal Years 2026 through 2031.
    
 
 
   Award Project Period
    
    6 years
    
 This variable defines that we need to start a new row.  
 
 
 
    NIH grants policies as described in the
     
     NIH Grants Policy Statement
     
    will apply to the applications submitted and awards made from this NOFO., PAR-25-378: Intervention Research to Improve Native American Health (R34 Clinical Trial Optional) Part 2. Full Text of Announcement, source_sentence: What are the sections of the Public Health Service Act under which the awards for the intervention research are made?
sentences: PAR-25-379: Intervention Research to Improve Native American Health (R01 Clinical Trial Optional) 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 2 CFR Part 200.
    
  end row  
 
 
 
 
    Weekly TOC for this Announcement
    
 
 
    NIH Funding Opportunities and Notices
    
 
 
 
 
 
 
 
 
 
 
 
 
  Department of Health
   
  and Human Services (HHS)
   
 
 
 
   NIH... Turning Discovery Into Health
    
    ®, RFA-DK-26-007: Collaborative Research Using Biosamples and/or Data from Type 1 Diabetes Clinical Studies (R01 - Clinical Trial Not Allowed) Part 1. Overview Information
    
 
 
   Participating Organization(s)
    
    National Institutes of Health (
     
     NIH
     
    )
    
 
 
   Components of Participating Organizations
    
    National Institute of Diabetes and Digestive and Kidney Diseases (
     
     NIDDK
     
    )
     
 
     Office of The Director, National Institutes of Health (
      
      OD
      
     )
     
 
 
   Funding Opportunity Title
    
    Collaborative Research Using Biosamples and/or Data from Type 1 Diabetes Clinical Studies (R01 - Clinical Trial Not Allowed)
    
 
 
   Activity Code
    
 
     R01
     
    Research Project Grant
    
 
 
   Announcement Type
   Reissue of
    
    RFA-DK-22-021
    
 
 
 
   Related Notices
    
 
 
      April 4, 2024
      
     - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice
      
      NOT-OD-24-084
      
     .
     
 
 
      August 31, 2022
      
     - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice
      
      NOT-OD-22-198
      
     .
     
 
 
      August 5, 2022
      
     - Implementation Details for the NIH Data Management and Sharing Policy. See Notice
      
      NOT-OD-22-189
      
     .
     
 
 
 
   Funding Opportunity Number (FON)
    
    RFA-DK-26-007
    
 
 
   Companion Funding Opportunity
   None
    
 
   Number of Applications
    
    See
     
     Section III. 3. Additional Information on Eligibility
     
    .
    
 
 
   Assistance Listing Number(s)
   93.847
    
 
   Funding Opportunity Purpose
    
    This Notice of Funding Opportunity (NOFO) invites applications for studies of type 1 diabetes etiology and pathogenesis using data and samples from clinical trials and studies. This opportunity is intended to fund investigative teams collaborating to answer important questions about disease mechanisms leading to improved delay and durable prevention of type 1 diabetes. This NOFO is associated with the Special Diabetes Program (
     
     https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/type-1-diabetes-special-statutory-funding-program/about-special-diabetes-program
     
    ) which funds research on the prevention, treatment, and cure of type 1 diabetes and its complications, including unique, innovative, and collaborative research consortia and clinical trials networks.
    
 
 
 
 
 
 
   Funding Opportunity Goal(s)
    
    To promote extramural basic and clinical biomedical research that improves the understanding of the mechanisms underlying disease and leads to improved preventions, diagnosis, and treatment of diabetes, digestive, and kidney diseases. Programmatic areas within the National Institute of Diabetes and Digestive and Kidney Diseases include diabetes, digestive, endocrine, hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic diseases.
    
 This variable defines that we need to start a new row., RFA-HL-26-010: Limited Competition: Data Analysis and Sharing Center (DASC) for the MACS/WIHS Combined Cohort Study (MWCCS) (U01 Clinical Trials Not Allowed) Section VI. Award Administration Information
    
 
 
 
    1. Award Notices
    
 
    A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.
    
 
    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.
    
 
    Recipients must comply with any funding restrictions described in
     
     Section IV.6. Funding Restrictions
     
    . Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the
     
     NIH Grants Policy Statement Section 5. The Notice of Award
     
    and NIH Grants & Funding website, see
     
     Award Process.
     
 
 
 
 
    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
    
 
    The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
    
 
 
     The rules listed at
      
      2 CFR Part 200
      
     , Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
     
 
     All NIH grant and cooperative agreement awards include the
      
      NIH Grants Policy Statement
      
     as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the
      
      NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General
      
     and
      
      Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities
      
     .
     
 
     If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (
      
      HHS-690
      
     ). To learn more, see the
      
      Laws and Regulations Enforced by the HHS Office for Civil Rights website
      
     .
      
 
       HHS recognizes that NIH 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 NOFO.
       
 
 
 
 
    All federal statutes and regulations relevant to federal financial assistance, including those highlighted in
     
     NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
     
 
 
    Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See
     
     2 CFR Part 200.340 Termination
     
    and
     
     NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support
     
    .
    
 
    Successful recipients under this NOFO agree that:
    
 
    Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit
     
     https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B
     
    to learn more.
    
 
    Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit
     
     https://www.healthit.gov/topic/certification-ehrs/certification-health-it
     
    to learn more.
    
 
    Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
    
 
    Successful recipients under this NOFO agree that:
    
 
    When recipients, subrecipients, or third-party entities have:
    
 
 
     ongoing and consistent access to HHS owned or operated information or operational technology systems; and
     
 
     receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.
     
 
 
    Recipients shall develop plans and procedures, modeled after the
     
     NIST Cybersecurity framework
     
    , to protect HHS systems and data. Please refer to
     
     NIH Post-Award Monitoring and Reporting
     
    for additional information.
    
 
 
   Cooperative Agreement Terms and Conditions of Award
    
    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
    
 
    The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.
    
 
 
     Each U01 CRS project, the U01 (DASC, and the U01 LACC will receive a separate award, and the mPIs of each respective award will have control over their project's operating budget.
     
 
     All recipients will be required to attend annual cohort meetings and participate in the cooperative nature of the cohort.
     
 
 
 
     The Clinical Research Sites will have primary responsibility for:
     
 
 
 
     The CRS mPI(s) will be responsible for the scientific and technical direction of the project and agree to abide by cohort policies and guidance. This includes accepting the actions and recommendations approved by the Steering Committee, the Executive Committee, and the Observational Study Monitoring Board. In addition, each CRS mPI must agree to accept participation of and close coordination and cooperation with the following stakeholders: NIH Program Staff, the LACC, and the DASC in those aspects of management of the project as described below.
     
 
     Specific responsibilities of the CRS include but are not limited to:
      
 
       Collaboratively defining objectives and approaches of specific research protocols
       
 
       Providing leadership in protocol development for specific research protocol(s), and/or serving as an expert Reading Center or Laboratory for specific research protocol(s) as needed
       
 
       Participating fully in required activities and responsibilities of the MWCCS Executive Committee
       
 
       Accepting and implementing the policies approved by the MWCCS Executive Committee consistent with applicable grant regulations
       
 
       Monitoring CRS staff and investigator adherence to clinical and laboratory protocols
       
 
       Obtaining all requisite study and protocol IRB approvals
       
 
       Scheduling participant clinic visits, capturing study-specified outcomes, and completion of study visit components including consent, questionnaires, in-person examinations, and collection of biospecimens
       
 
       Tracking retention and follow-up of participants at the CRS and making these data available to the LACC and the DASC on a monthly basis
       
 
       Close monitoring of participant safety and unexpected adverse outcomes
       
 
       Collaborating closely with the LACC and the DASC to establish and implement quality assurance and control processes in all study activities, including data analyses led by the CRS
       
 
       Participating in all relevant staff trainings and ongoing evaluation of CRS personnel interview skills, HIV counseling, and examination techniques
       
 
       Implementing training, ongoing evaluation, and quality control for all CRS laboratory staff and procedures for handling and testing of participant specimens, including web-based tracking of delivery to central repository
       
 
       Implementation and maintenance of strict data security procedures for the collection, storage, analysis, and archiving of participants' personal health information
       
 
       Taking rapid corrective actions for all supported activities when deficits or problems are identified
       
 
       Cooperating fully with the LACC, the DASC, and NIH programmatic, technical, and administrative staff
       
 
       Providing research opportunities and mentorship to early career investigators, including those at the pre-doctoral, post-doctoral, and early independent career stages
       
 
       Developing and supporting collaborations with external investigators, as appropriate
       
 
       All other specific required activities described in RFA HL-26-009 but not listed here
       
 
 
 
     Recipients will retain custody of, and have primary rights to, the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies. However, recipients will implement the approved Data Management and Sharing Plan (see Submitting an Application), which will be incorporated as an additional term of award and will be expected to share (make available) these data both within the consortium and with the scientific community. Recipients should comply with their institutional intellectual property policies and practices as approved in the award.
     
 
 
 
     The Leadership and Coordination Center will have primary responsibility for:
     
 
 
 
     Clinical and scientific guidance and oversight of the MWCCS as a whole, including scientific leadership, scientific working group support, operational working group support, training pertaining to the clinical protocol and participant interactions, operational accountability, community and participant engagement, and promotion of the cohort to external stakeholders
     
 
     Establishing and maintaining congenial, respectful, and productive working relationships with each of the CRS, the DASC, the NCAB, and NIH Program Staff
     
 
     Collaborating closely with the mPIs of the DASC to ensure clear delineation of responsibilities, frequent communications, and smooth central functioning of various aspects of cohort management and support of the CRS for both cohort operational specific aims and scientific investigational aims
     
 
     Serving as permanent co-chair(s) of the MWCCS Executive Committee, with an additional co-chair elected or selected by the CRS mPIs, in order to facilitate leadership continuity over time, accountability, and timely communications
     
 
     Developing and leading a consensus process for finalizing and implementing the Joint Unified Modular Protocol (JUMP)
     
 
     Collecting and tracking study and protocol approvals, including IRB approvals, ancillary studies, and renewals
     
 
     Providing clinical, scientific, and operational leadership, accountability, and technical assistance to the cohort-wide efforts to ascertain and adjudicate significant clinical events and outcomes for all ever-enrolled participants (e.g. major adverse cardiovascular events (MACE), incident cancers, HIV/AIDS-related comorbidities, hospitalizations, deaths), as allowable per participant consents
     
 
     Coordinating, facilitating, and monitoring clinical review committees' efforts to adjudicate all significant clinical events in a timely fashion
     
 
     Actively participating in specific scientific investigations when appropriate
     
 
     Working collaboratively with investigators proposing ancillary study components
     
 
     Providing summary tracking of submitted site-specific and MACS/WIHS-wide concept sheets
     
 
     Establishing a process for annual strategic planning of scientific and management priorities to ensure that resources are allocated to meet local and cohort-wide aims
     
 
     Arranging, conducting, and distributing documentation for regular conference calls for Scientific Work Groups (SWG), Executive Committee (EC) and other committees, and annual meetings of cohort investigators
     
 
     Ensure high-fidelity adherence and quality outcomes for all clinical and laboratory protocols, via development of enhanced resources for staff training, guidelines for credentialing, regular monitoring and oversight for quality control purposes, and additional approaches as proposed by the LACC mPIs
     
 
     Coordinating implementation of new or modified protocols approved by the Executive Committee
     
 
     Consult and coordinate with the DASC on all areas of protocol implementation, tracking, quality control, and data collection which involve overlapping areas of responsibility (e.g. the overlap between clinical techniques and collection of clinical data). Providing teaching and training to cohort personnel at the CRSs to assure that the questionnaires continue to be administered in a uniform, standardized fashion
     
 
     Providing a forum for posting, circulating and consolidating input on draft manuscripts to co-authors, NIH co-funding ICO Project Scientists and Program Officers
     
 
     Planning and hosting an annual symposium or workshop to inform the broader research community about scientific progress of the MWCCS and provide an opportunity for development of collaborations with outside investigators
     
 
     All other specific required activities described in RFA HL-26-011 but not listed here
     
 
 
 
     The Data Analysis and Sharing Center will have primary responsibility for:
     
 
 
 
     Modernizing and maintaining all data collection systems for the MWCCS, with continual quality-improvement updates to facilitate CRS data collection activities.
     
 
     Preparing and updating operations manuals, data collection forms, coordinating the revision of existing questionnaires and development and testing of new questionnaires for use in the cohort, including the standardization of procedures for data collection
     
 
     Implementing uniform methods to capture participant data on vital and health status, risk factors, and other personal information
     
 
     Developing data linkages with health information exchanges, clinics, and medical centers to ascertain events of clinical significance, ideally through automated data collection.
     
 
     Performing centralized data analyses to support MWCCS scientific investigations
     
 
     Developing innovative approaches to statistical analysis of prospective observational cohort data
     
 
     Tracking recruitment and retention of participants at each CRS and making these figures available to the Executive Committee (EC) and representatives of co-funding institutes in annual progress reports
     
 
     Collecting, editing, cleaning, and storing data collected from CRSs; providing centralized storage, security, processing and retrieval of cohort data; providing quality control of the data management system and addressing evolving data needs of the cohort study
     
 
     Preparing a final annotated dataset for delivery to NIH or an NIH designated repository of the complete cohort dataset (all data included in the cohort dataset)
     
 
     Performing data audit site visits on a routine basis at a minimum of once every three years
     
 
     Collaborate with the biorepository to ensure accurate inventory of specimens in the repository; train and provide updates on the web-based tracking system; manage requests for specimens from investigators; prioritize requests for samples; facilitate timely delivery of samples to investigators
     
 
     Releasing clinical and GWAS data to the scientific community in a timely manner, consistent with NIH and NHLBI policies
     
 
     Producing an annual study progress report to be distributed at the annual EC meeting in collaboration with the LACC.
     
 
     Maintaining the system for tracking cohort research and providing study progress reports at the semi-annual investigator meeting
     
 
     Maintaining an ongoing, up-to-date web-based searchable list of all MWCCS publications, manuscripts in progress and presentations using cohort data
     
 
     Maintaining internal and public websites, posting study documents on internal website
     
 
     All other specific required activities described in RFA HL-26-010 but not listed here
     
 
 
 
     NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
     
 
 
    The NHLBI Project Collaborator will have substantial involvement in the conduct of this activity through technical assistance, advice, and coordination above and beyond normal program stewardship for grants. In addition to the NHLBI Project Collaborator, other NHLBI Program Officials and Grants Management Officers will oversee the normal program stewardship of the cooperative agreements. Final decision-making authority on matters of budgetary and funding actions, grants management actions, and management of intellectual property will reside with Senior Institute management, separate organizational components, and/or oversight committees. Other NHLBI staff members such as direct line supervisor or other Senior NHLBI Program management staff may serve as agency Program Officials as needed with responsibility for the normal scientific and programmatic stewardship of the award.
    
 
    In addition, each co-sponsoring institute will nominate at least one Project Collaborator, Scientist, or Program Officer to provide scientific oversight, technical assistance, and coordination aligned with their institute’s scientific priorities for the MWCCS. NIH Program Staff activities will include but may not be limited to:
    
 
 
     Participating in the NIH Scientific Oversight Committee (N-SOC) which will be comprised of representatives from all MWCCS co-funding ICOs, the Office of AIDS Research (OAR), and other NIH stakeholders as appropriate
     
 
     Participating in study leadership via voting membership in the MWCCS Executive Committee, close and regular consultations with the LACC and the DASC, and regular communication with NIH stakeholders in the MWCCS
     
 
     Reviewing all relevant study protocols and data
     
 
     Monitoring study progress, results and quality assurance across all sites
     
 
     Participating in selected Scientific Working Groups and Operational Working Groups as appropriate
     
 
     Providing technical assistance and advice to the recipients as appropriate
     
 
     Providing mentoring and counseling to MWCCS investigators, including trainees and early stage investigators, as appropriate and needed
     
 
     Assisting with the development of research protocols
     
 
     Ensuring disclosure of conflicts of interest and adherence to NIH policies
     
 
     Facilitating collaborations between the recipients and other NIH-sponsored programs investigators, or organizations that may contribute to the study's goals
     
 
     Assisting in the interaction between the recipients and investigators at other institutions, as appropriate for the cohort
     
 
     Promoting collaborative research efforts that involve interactions with other NIH-supported projects, programs, and centers and helping with the coordination of such efforts
     
 
 
 
     Areas of Joint Responsibility include, but may not be limited to:
     
 
 
 
     MWCCS Executive Committee
     
 
 
    The EC is the primary decision-making body for this multi-site collaborative research study. All MWCCS stakeholders will have representation on the EC and participate in sharing decision-making on all topics of broad important to cohort operations. One or more of the LACC mPIs will serve as permanent EC Chair, with an additional EC Chair chosen by the CRS mPIs.
    
 
    As an explicit condition of their NIH cooperative agreement awards, all recipients must agree to both actively participate in the EC and to collegially abide by its decisions and policies pertaining to all aspects of study operations.
    
 
    Specific areas of responsibility for EC members include but may not be limited to:
    
 
 
     Protection of participant safety via regular monitoring and responsive corrective action when needed
     
 
     Promotion of scientific integrity, validity, and excellence in all areas of study operations and scientific investigations
     
 
     Facilitation of rapid and regular data sharing with the broader scientific community to increase the pace, significance, and impact of MWCCS HIV populomics research.
     
 
     Participation in regular EC video calls, annual cohort meetings, and ad-hoc trainings, research meetings, and other gatherings as needed
     
 
     Assistance to and support of the NCAB
     
 
     Substantive contributions to, and participation in, Scientific Working Groups and Operational Working Groups as appropriate for individual areas of expertise.
     
 
     Cooperation and collaboration with the LACC and the DASC on relevant areas of study operations and scientific investigations
     
 
 
 
     MWCCS Steering Committee
     
 
 
    The SC is a subset of the EC which meets more frequently than the full EC and advises the EC on important operational and scientific issues. All MWCCS stakeholders (CRS mPIs, CRS Project Directors, LACC mPIs, DASC mPIs, NIH Program Staff, NCAB members) should have at least one representative on the SC. The EC Co-Chairs will also serve as SC Co-Chairs.
    
 
 
     Scientific Work Groups
     
 
 
    SWGs are comprised of subject-matter scientific experts from the CRS, the LACC, the DASC, and NIH who collaborate on new and continuing scientific investigations which will result in public presentations and peer-reviewed publications. SWGs should also include and provide mentorship opportunities for early-stage investigators, including pre-doctoral and post-doctoral trainees. The LACC will provide scientific leadership and coordination of operations (e.g. scheduling of meetings, maintenance of records, facilitation of communications), while the DASC will monitor SWG productivity and outputs via monitoring of agreed-upon productivity metrics and regular reporting to the EC. The number and topic areas of the SWG will be determined by the MWCCS investigators (LACC and EC); however NIH expects that these topic areas will be well-aligned with the NIH scientific priority areas detailed in Section 1 of this NOFO. Furthermore, NIH expects that there will be no gaps in coverage – in other words there should be no NIH priority area which is not covered by at least one SWG.
    
 
 
     Operational Work Groups
     
 
 
    OWGs have the purpose of bringing together scientific and methodological experts from among MWCCS investigators and staff, as well as NIH staff as appropriate, to consider and advise the LACC, the DASC, and the EC on topics of significance to cohort operations. For example, a Laboratory Measures Working Group might have the mandate of reviewing and ensuring quality and high-fidelity adherence to study protocol in the collection, processing, storage, and analysis of participant biospecimens. The number and topic areas of the OWGs will be proposed by the LACC and the DASC and agreed to by the EC. Coordination, administrative support, and monitoring of the OWGs will be the responsibility of either the LACC or the DASC, depending on the specific topic area.
    
 
 
     National Community Advisory Board
     
 
 
    MWCCS investigators and staff from the CRS, LACC, and DASC and NIH staff will collaborate to support the NCAB, its members, and its planned activities as requested by NCAB leadership. The LACC will provide leadership and coordination for cohort support of the NCAB, including centralized administration and payment of stipends and travel reimbursements to NCAB members for required annual national meetings.
    
 
 
     Observational Study Monitoring Board
     
 
 
    The OSMB is an independent board of scientific, clinical care, and bioethics experts who monitor MWCCS progress and advise the Director of NHLBI on matters of study performance, participant safety, return of clinical results, informed consent, participant burden, and overall study success. All MWCCS stakeholders collaborate to support the OSMB through provision of any requested data or information about study operations and scientific investigations, including making presentations and/or preparing topic-specific reports as requested by the OSMB members.
    
 
 
     Violations of Terms and Conditions of Cooperative Agreement Awards
     
 
 
    The NHLBI and NIH reserve the right to withhold funding or curtail the study if any of the following occur:
    
 
 
     Human participant ethical issues that may dictate a premature end of the award
     
 
     Substantial shortfall in participant recruitment, follow-up, data reporting, data sharing, or quality control
     
 
     Failure to develop or implement a mutually agreeable protocol
     
 
     Major breach of the protocol or substantive changes in the agreed-upon protocol, methodologies, and/or tools with which the NHLBI/NIH cannot concur
     
 
 
 
     Dispute Resolution:
     
 
 
    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.
    
 
 
   3. Data Management and Sharing
    
    Consistent with the 2023 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 Section 8.4.1 Reporting.
     
    To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see
     
     Post-Award Monitoring and Reporting
     
    .
    
 
 
 
    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 Section 8.6 Closeout
     
    . NIH NOFOs 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 2 CFR Part 200.301., source_sentence: What is the maximum allowable direct costs for application budgets per year for the award period from Fiscal Years 2026 through 2031?
sentences: RFA-HL-26-011: Leadership and Coordination Center (LACC) for the MACS/WIHS Combined Cohort Study (MWCCS) (U01 Clinical Trials Not Allowed) Section II. Award Information
    
 
 
   Funding Instrument
    
    Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH 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 NOFO.
    
 
 
   Application Types Allowed
   New
    
 
 
 
    The
     
     OER Glossary
     
    and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
    
 
 
   Clinical Trial?
    
    Not Allowed: Only accepting applications that do not propose clinical trials.
    
 
 
 
 
     Need help determining whether you are doing a clinical trial?
     
 
 
 
   Funds Available and Anticipated Number of Awards
    
    The following NIH components intend to commit an estimated total of $3 million to fund a single award in FY 2026:
    
 
    NHLBI, $1.37 million
    
 
    NIAID, $0.30 million
    
 
    NIMH, $0.30 million
    
 
    NCI, $0.35 million
    
 
    NIA, $0.19 million
    
 
    NIDA, $0.15 million
    
 
    NICHD, $0.13 million
    
 
    NIDCR, $0.07 million
    
 
    NIMHD, $0.04 million
    
 
    NIAAA, $0.03 million
    
 
    NINR, $0.03 million
    
 
    ORWH, $0.03 million
    
 
    NIDCD, $0.02 million
    
 
 
   Award Budget
    
    Application budgets may not exceed direct costs of $2 million per year in Fiscal Years 2026 through 2031.
    
 
 
   Award Project Period
    
    6 years
    
 This variable defines that we need to start a new row.  
 
 
 
    NIH grants policies as described in the
     
     NIH Grants Policy Statement
     
    will apply to the applications submitted and awards made from this NOFO., PAR-25-379: Intervention Research to Improve Native American Health (R01 Clinical Trial Optional) 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 Organizations
    
 
 
    Non-domestic (non-U.S.) Entities (Foreign Organizations)
     
     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 How to Apply-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, please reference the
     
     NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications
     
    .
    
 
 
 
      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 their 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
     
    and Notice of NIH's Interest in Diversity,
     
     NOT-OD-20-031
     
    .
    
 
    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 How to Apply- Application Guide.
    
 
 
 
    Foreign components, as
     
     defined in the
      
      NIH Grants Policy Statement
      
 
    ,
     
     are
     
    allowed only when the ancestral catchment area(s) of tribe(s) cross(es) U.S. national boundary.
    
 
 
 
    2. Cost Sharing
    
 
    This NOFO does not require cost sharing as defined in the
     
     NIH Grants Policy Statement Section 1.2 Definition of Terms
     
    .
    
 
 
 
    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
     
     NIH Grants Policy Statement Section 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
      
      NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications
      
     )., Department of Health and Human Services, source_sentence: What is the purpose of the Notice of Award (NoA) in the context of NIH funding?
sentences: RFA-HL-26-011: Leadership and Coordination Center (LACC) for the MACS/WIHS Combined Cohort Study (MWCCS) (U01 Clinical Trials Not Allowed) 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 Governments
    
 
 
     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 Organizations
    
 
 
    Non-domestic (non-U.S.) Entities (Foreign Organizations)
     
     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 not
     
    allowed.
    
 
 
   Required Registrations
    
 
     Applicant Organizations
     
 
 
    Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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, please reference the
     
     NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications
     
    for additional information.
    
 
 
 
      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 registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
     
 
 
      Grants.gov
      
     – Applicants must have an active SAM registration in order to complete the Grants.gov registration.
     
 
 
 
     Program Directors/Principal Investigators (PD(s)/PI(s))
     
 
 
    All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
    
 
 
   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 their organization to develop an application for 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 How to Apply-Application Guide.
    
 
 
 
    A multiple PI (mPI) leadership structure is required. The LACC mPI team should include individuals with demonstrated deep knowledge of, and familiarity with, the MWCCS. In addition, the team should include at least one clinician with experience in clinical care of patients living with HIV and/or relevant comorbidities, as well as one or more individuals with epidemiologic cohort study leadership experience.Individuals may not apply to be an mPI of both the LACC and Data Analysis and Sharing Center (DASC) (
     
     RFA-HL-26-010
     
    ). Applications without an mPI leadership structure will be considered incomplete and will not proceed to peer review.
    
 
 
 
    2. Cost Sharing
    
 
    This NOFO does not require cost sharing as defined in the
     
     NIH Grants Policy Statement Section 1.2 Definition of Terms
     
    .
    
 
 
 
    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
     
     NIH Grants Policy Statement Section 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
      
      NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications
      
     )., RFA-HL-26-011: Leadership and Coordination Center (LACC) for the MACS/WIHS Combined Cohort Study (MWCCS) (U01 Clinical Trials Not Allowed) Part 2. Full Text of Announcement, RFA-AI-24-079: Asthma and Allergic Diseases Cooperative Research Centers (U19 Clinical Trial Optional) Section VI. Award Administration Information
    
 
 
 
    1. Award Notices
    
 
    A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.
    
 
    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.
    
 
    Recipients must comply with any funding restrictions described in
     
     Section IV.6. Funding Restrictions
     
    . Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the
     
     NIH Grants Policy Statement Section 5. The Notice of Award
     
    and NIH Grants & Funding website, see
     
     Award Process.
     
 
 
 
 
    Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
    
 
    ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (
     
     https://register.clinicaltrials.gov
     
    ). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see
     
     https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
     
 
 
    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all 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.
    
 
    Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
    
 
    Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
    
 
 
 
    Prior Approval of Pilot Projects
    
 
    Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.
    
 
 
     The recipient institution will comply with the NIH
      
      Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval
      
     .
     
 
     The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with
      
      NIH DSMP policies
      
     .
     
 
 
 
 
    2. Administrative and National Policy Requirements
    
 
    The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
    
 
 
     The rules listed at
      
      2 CFR Part 200
      
     , Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
     
 
     All NIH grant and cooperative agreement awards include the
      
      NIH Grants Policy Statement
      
     as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the
      
      NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General
      
     and
      
      Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities
      
     .
     
 
     If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (
      
      HHS-690
      
     ). To learn more, see the
      
      Laws and Regulations Enforced by the HHS Office for Civil Rights website
      
     .
      
 
       HHS recognizes that NIH 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 NOFO.
       
 
 
 
 
    All federal statutes and regulations relevant to federal financial assistance, including those highlighted in
     
     NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
     
 
 
    Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See
     
     2 CFR Part 200.340 Termination
     
    and
     
     NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support
     
    .
    
 
    Successful recipients under this NOFO agree that:
    
 
    Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit
     
     https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B
     
    to learn more.
    
 
    Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit
     
     https://www.healthit.gov/topic/certification-ehrs/certification-health-it
     
    to learn more.
    
 
    Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
    
 
    Successful recipients under this NOFO agree that:
    
 
    When recipients, subrecipients, or third-party entities have:
    
 
 
     ongoing and consistent access to HHS owned or operated information or operational technology systems; and
     
 
     receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.
     
 
 
    Recipients shall develop plans and procedures, modeled after the
     
     NIST Cybersecurity framework
     
    , to protect HHS systems and data. Please refer to
     
     NIH Post-Award Monitoring and Reporting
     
    for additional information.
    
 
 
   Cooperative Agreement Terms and Conditions of Award
    
    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
    
 
    The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.
    
 
 
     The PD(s)/PI(s) will have the primary responsibility for:
     
 
 
 
     Determining and coordinating the scientific and administrative activities of the approved projects;
     
 
     Setting project goals and timelines;
     
 
     Serving on the AADCRC Steering Committee and participating in all Steering Committee activities;
     
 
     Accepting and implementing common guidelines approved by the Steering Committee;
     
 
     For clinical trials and other human subject research, implementing current Good Clinical Practice guidelines and complying with the
      
      NIAID Clinical Terms of Award
      
     ;
     
 
     For clinical trials in which the PD(s)/PI(s) is the IND/IDE Sponsor, having responsibilty for the development, assembly, and submission of all required regulatory documents, providing NIAID all required information in accordance to NIH clinical research guidance. This includes, but is not limited to, all communications with the FDA (or other regulatory authority) and the Institutional Review Board (IRB). If NIAID is the IND/IDE Sponsor, providing access to all necessary data and documentation to NIAID to fulfill its role.
     
 
     Sharing reagents and resources with other investigators funded under this NOFO as appropriate, including any scientists added via IOF support;
     
 
     Making data available for external checking against the original source documentation;
     
 
     Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
     
 
 
 
     NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
     
 
 
 
     NIAID may assign one or more Project Scientist(s) to the AADCRC program. The Project Scientist(s) will:
      
 
       Provide guidance and support in the design of research activities;
       
 
       Provide guidance and support in the execution of studies;
       
 
       Contribute to the analysis and publication of data;
       
 
       Advise in the selection of sources or resources;
       
 
       Advise in management and technical performance;
       
 
       In AADCRC centers that include clinical trials, and in some cases clinical studies, the NIAID-assigned Project Scientist will be a Medical Officer;
       
 
       Assist in planning of the meetings and teleconferences of the Steering Committee and subcommittees, and ensure coordination of Steering Committee activities and implementation of its recommendations, decisions, and policies.
       
 
       All NIAID staff will be non-voting members of the Steering Committee.
       
 
 
 
 
 
     Clinical Research Oversight
     
 
 
 
 
      Protocol Development, Review and Approval:
      
     The NIAID Project Scientist will participate in the development, review and approval of all clinical research protocols supported by this NOFO.
     
 
     In some cases, the NIAID-assigned Project Scientist will be a physician who may also assume the role of Medical Monitor of a clinical study or trial.
     
 
 
      IND/IDE:
      
     NIAID retains the right to have NIAID serve as the IND/IDE sponsor for trials involving the use of investigational products.
     
 
 
      Monitoring Boards and Safety Reporting:
      
     NIAID Project Scientists will facilitate and provide oversight of the review and reporting of data to DAIT monitoring committees and Data Safety and Monitoring Boards.
     
 
 
      Study Termination:
      
     NIAID reserves the right to terminate or curtail a clinical study or clinical trial for any of the following reasons:
      
 
       risk to subject safety;
       
 
       the scientific question is no longer relevant, or the objectives will not be met;
       
 
       failure to comply with Good Clinical Practices, Federal Regulations, or Terms and Conditions of Award;
       
 
       occurrence of unforeseen drug safety issues or data from preclinical studies indicate a presence of unanticipated toxicity;
       
 
       risks that cannot be adequately quantified;
       
 
       failure to remedy deficiencies identified through site monitoring;
       
 
       substandard data; inadequate progress in fulfilling the research agenda;
       
 
       slow accrual; or
       
 
       reaching a major study endpoint substantially before schedule with persuasive statistical significance.
       
 
 
 
 
      Access to Data:
      
     The NIAID Project Scientist or designee will have access to all data generated under this cooperative agreement and may review the data as recorded on the case report forms or in a database. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study.
     
 
     Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
     
 
 
 
     Areas of Joint Responsibility include:
     
 
 
 
     Establishing a Steering Committee consisting of the PD(s)/PI(s) of each AADCRC and NIH Project Scientists from NIAID. The NIH Program Officer will be an optional attendee. The Steering Committee’s responsibilities include facilitating collaborative projects, organizing the yearly IOF competition (establishing goals, guidelines and evaluation criteria, evaluating proposed projects, and proposing funding plans), setting the agenda for an annual face-to-face AADCRC scientific meeting, establishing an AADCRC policy to promote resource sharing among AADCRCs and outside collaborators, and proposing AADCRC-centered sessions for national and international scientific meetings.
     
 
 
    Each AADCRC Center will have one voting member on the Steering Committee; in the case of multi-PI centers, all PIs/PDs will be Steering Committee members, but must share one vote. NIAID Project Scientists and the NIH Program Officer will be non-voting members of the Steering Committee and participate in all Steering Committee activities. A chair will be elected by the majority of vote among the voting members of the Steering Committee. The Steering Committee will make decisions by majority vote. The Steering Committee will meet by teleconference twice a year and at a face-to-face meeting once a year.
    
 
 
     Collaboratively facilitating the conduct, progress and monitoring of the studies supported by the award.
     
 
     Fostering collaborations between AADCRCs.
     
 
 
 
     Dispute Resolution:
     
 
 
    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.
    
 
 
 
    3. Data Management and Sharing
    
 
    Consistent with the 2023 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 Section 8.4.1 Reporting
      
     . To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see
      
      Post-Award Monitoring and Reporting
      
     .
     
 
 
 
 
    Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.
    
 
 
 
    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 Section 8.6 Closeout
     
    . NIH NOFOs 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 2 CFR Part 200.301., source_sentence: What are the responsibilities of the PD(s)/PI(s) in managing the activities of the approved projects under the cooperative agreement?
sentences: RFA-DK-26-007: Collaborative Research Using Biosamples and/or Data from Type 1 Diabetes Clinical Studies (R01 - Clinical Trial Not Allowed) Part 1. Overview Information
    
 
 
   Participating Organization(s)
    
    National Institutes of Health (
     
     NIH
     
    )
    
 
 
   Components of Participating Organizations
    
    National Institute of Diabetes and Digestive and Kidney Diseases (
     
     NIDDK
     
    )
     
 
     Office of The Director, National Institutes of Health (
      
      OD
      
     )
     
 
 
   Funding Opportunity Title
    
    Collaborative Research Using Biosamples and/or Data from Type 1 Diabetes Clinical Studies (R01 - Clinical Trial Not Allowed)
    
 
 
   Activity Code
    
 
     R01
     
    Research Project Grant
    
 
 
   Announcement Type
   Reissue of
    
    RFA-DK-22-021
    
 
 
 
   Related Notices
    
 
 
      April 4, 2024
      
     - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice
      
      NOT-OD-24-084
      
     .
     
 
 
      August 31, 2022
      
     - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice
      
      NOT-OD-22-198
      
     .
     
 
 
      August 5, 2022
      
     - Implementation Details for the NIH Data Management and Sharing Policy. See Notice
      
      NOT-OD-22-189
      
     .
     
 
 
 
   Funding Opportunity Number (FON)
    
    RFA-DK-26-007
    
 
 
   Companion Funding Opportunity
   None
    
 
   Number of Applications
    
    See
     
     Section III. 3. Additional Information on Eligibility
     
    .
    
 
 
   Assistance Listing Number(s)
   93.847
    
 
   Funding Opportunity Purpose
    
    This Notice of Funding Opportunity (NOFO) invites applications for studies of type 1 diabetes etiology and pathogenesis using data and samples from clinical trials and studies. This opportunity is intended to fund investigative teams collaborating to answer important questions about disease mechanisms leading to improved delay and durable prevention of type 1 diabetes. This NOFO is associated with the Special Diabetes Program (
     
     https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/type-1-diabetes-special-statutory-funding-program/about-special-diabetes-program
     
    ) which funds research on the prevention, treatment, and cure of type 1 diabetes and its complications, including unique, innovative, and collaborative research consortia and clinical trials networks.
    
 
 
 
 
 
 
   Funding Opportunity Goal(s)
    
    To promote extramural basic and clinical biomedical research that improves the understanding of the mechanisms underlying disease and leads to improved preventions, diagnosis, and treatment of diabetes, digestive, and kidney diseases. Programmatic areas within the National Institute of Diabetes and Digestive and Kidney Diseases include diabetes, digestive, endocrine, hematologic, liver, metabolic, nephrologic, nutrition, obesity, and urologic diseases.
    
 This variable defines that we need to start a new row., RFA-AI-24-079: Asthma and Allergic Diseases Cooperative Research Centers (U19 Clinical Trial Optional) Section VI. Award Administration Information
    
 
 
 
    1. Award Notices
    
 
    A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.
    
 
    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.
    
 
    Recipients must comply with any funding restrictions described in
     
     Section IV.6. Funding Restrictions
     
    . Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the
     
     NIH Grants Policy Statement Section 5. The Notice of Award
     
    and NIH Grants & Funding website, see
     
     Award Process.
     
 
 
 
 
    Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
    
 
    ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (
     
     https://register.clinicaltrials.gov
     
    ). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see
     
     https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
     
 
 
    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all 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.
    
 
    Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
    
 
    Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
    
 
 
 
    Prior Approval of Pilot Projects
    
 
    Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.
    
 
 
     The recipient institution will comply with the NIH
      
      Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval
      
     .
     
 
     The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with
      
      NIH DSMP policies
      
     .
     
 
 
 
 
    2. Administrative and National Policy Requirements
    
 
    The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
    
 
 
     The rules listed at
      
      2 CFR Part 200
      
     , Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
     
 
     All NIH grant and cooperative agreement awards include the
      
      NIH Grants Policy Statement
      
     as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the
      
      NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General
      
     and
      
      Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities
      
     .
     
 
     If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (
      
      HHS-690
      
     ). To learn more, see the
      
      Laws and Regulations Enforced by the HHS Office for Civil Rights website
      
     .
      
 
       HHS recognizes that NIH 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 NOFO.
       
 
 
 
 
    All federal statutes and regulations relevant to federal financial assistance, including those highlighted in
     
     NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
     
 
 
    Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See
     
     2 CFR Part 200.340 Termination
     
    and
     
     NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support
     
    .
    
 
    Successful recipients under this NOFO agree that:
    
 
    Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit
     
     https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B
     
    to learn more.
    
 
    Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit
     
     https://www.healthit.gov/topic/certification-ehrs/certification-health-it
     
    to learn more.
    
 
    Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
    
 
    Successful recipients under this NOFO agree that:
    
 
    When recipients, subrecipients, or third-party entities have:
    
 
 
     ongoing and consistent access to HHS owned or operated information or operational technology systems; and
     
 
     receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.
     
 
 
    Recipients shall develop plans and procedures, modeled after the
     
     NIST Cybersecurity framework
     
    , to protect HHS systems and data. Please refer to
     
     NIH Post-Award Monitoring and Reporting
     
    for additional information.
    
 
 
   Cooperative Agreement Terms and Conditions of Award
    
    The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
    
 
    The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.
    
 
 
     The PD(s)/PI(s) will have the primary responsibility for:
     
 
 
 
     Determining and coordinating the scientific and administrative activities of the approved projects;
     
 
     Setting project goals and timelines;
     
 
     Serving on the AADCRC Steering Committee and participating in all Steering Committee activities;
     
 
     Accepting and implementing common guidelines approved by the Steering Committee;
     
 
     For clinical trials and other human subject research, implementing current Good Clinical Practice guidelines and complying with the
      
      NIAID Clinical Terms of Award
      
     ;
     
 
     For clinical trials in which the PD(s)/PI(s) is the IND/IDE Sponsor, having responsibilty for the development, assembly, and submission of all required regulatory documents, providing NIAID all required information in accordance to NIH clinical research guidance. This includes, but is not limited to, all communications with the FDA (or other regulatory authority) and the Institutional Review Board (IRB). If NIAID is the IND/IDE Sponsor, providing access to all necessary data and documentation to NIAID to fulfill its role.
     
 
     Sharing reagents and resources with other investigators funded under this NOFO as appropriate, including any scientists added via IOF support;
     
 
     Making data available for external checking against the original source documentation;
     
 
     Recipients will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
     
 
 
 
     NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
     
 
 
 
     NIAID may assign one or more Project Scientist(s) to the AADCRC program. The Project Scientist(s) will:
      
 
       Provide guidance and support in the design of research activities;
       
 
       Provide guidance and support in the execution of studies;
       
 
       Contribute to the analysis and publication of data;
       
 
       Advise in the selection of sources or resources;
       
 
       Advise in management and technical performance;
       
 
       In AADCRC centers that include clinical trials, and in some cases clinical studies, the NIAID-assigned Project Scientist will be a Medical Officer;
       
 
       Assist in planning of the meetings and teleconferences of the Steering Committee and subcommittees, and ensure coordination of Steering Committee activities and implementation of its recommendations, decisions, and policies.
       
 
       All NIAID staff will be non-voting members of the Steering Committee.
       
 
 
 
 
 
     Clinical Research Oversight
     
 
 
 
 
      Protocol Development, Review and Approval:
      
     The NIAID Project Scientist will participate in the development, review and approval of all clinical research protocols supported by this NOFO.
     
 
     In some cases, the NIAID-assigned Project Scientist will be a physician who may also assume the role of Medical Monitor of a clinical study or trial.
     
 
 
      IND/IDE:
      
     NIAID retains the right to have NIAID serve as the IND/IDE sponsor for trials involving the use of investigational products.
     
 
 
      Monitoring Boards and Safety Reporting:
      
     NIAID Project Scientists will facilitate and provide oversight of the review and reporting of data to DAIT monitoring committees and Data Safety and Monitoring Boards.
     
 
 
      Study Termination:
      
     NIAID reserves the right to terminate or curtail a clinical study or clinical trial for any of the following reasons:
      
 
       risk to subject safety;
       
 
       the scientific question is no longer relevant, or the objectives will not be met;
       
 
       failure to comply with Good Clinical Practices, Federal Regulations, or Terms and Conditions of Award;
       
 
       occurrence of unforeseen drug safety issues or data from preclinical studies indicate a presence of unanticipated toxicity;
       
 
       risks that cannot be adequately quantified;
       
 
       failure to remedy deficiencies identified through site monitoring;
       
 
       substandard data; inadequate progress in fulfilling the research agenda;
       
 
       slow accrual; or
       
 
       reaching a major study endpoint substantially before schedule with persuasive statistical significance.
       
 
 
 
 
      Access to Data:
      
     The NIAID Project Scientist or designee will have access to all data generated under this cooperative agreement and may review the data as recorded on the case report forms or in a database. NIAID staff may use information obtained from the data for the preparation of internal reports on the activities of the study.
     
 
     Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
     
 
 
 
     Areas of Joint Responsibility include:
     
 
 
 
     Establishing a Steering Committee consisting of the PD(s)/PI(s) of each AADCRC and NIH Project Scientists from NIAID. The NIH Program Officer will be an optional attendee. The Steering Committee’s responsibilities include facilitating collaborative projects, organizing the yearly IOF competition (establishing goals, guidelines and evaluation criteria, evaluating proposed projects, and proposing funding plans), setting the agenda for an annual face-to-face AADCRC scientific meeting, establishing an AADCRC policy to promote resource sharing among AADCRCs and outside collaborators, and proposing AADCRC-centered sessions for national and international scientific meetings.
     
 
 
    Each AADCRC Center will have one voting member on the Steering Committee; in the case of multi-PI centers, all PIs/PDs will be Steering Committee members, but must share one vote. NIAID Project Scientists and the NIH Program Officer will be non-voting members of the Steering Committee and participate in all Steering Committee activities. A chair will be elected by the majority of vote among the voting members of the Steering Committee. The Steering Committee will make decisions by majority vote. The Steering Committee will meet by teleconference twice a year and at a face-to-face meeting once a year.
    
 
 
     Collaboratively facilitating the conduct, progress and monitoring of the studies supported by the award.
     
 
     Fostering collaborations between AADCRCs.
     
 
 
 
     Dispute Resolution:
     
 
 
    Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the Steering Committee chosen without NIH staff voting, one NIH 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.
    
 
 
 
    3. Data Management and Sharing
    
 
    Consistent with the 2023 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 Section 8.4.1 Reporting
      
     . To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see
      
      Post-Award Monitoring and Reporting
      
     .
     
 
 
 
 
    Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.
    
 
 
 
    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 Section 8.6 Closeout
     
    . NIH NOFOs 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 2 CFR Part 200.301., RFA-AI-24-079: Asthma and Allergic Diseases Cooperative Research Centers (U19 Clinical Trial Optional) Section IV. Application and Submission Information
    
 
 
 
    1. Requesting an Application Package
    
 
    The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.
    
 
 
 
    2. Content and Form of Application Submission
    
 
    It is critical that applicants follow the Multi-Project (M) Instructions in the
     
     How to Apply - Application Guide
     
    , except where instructed in this notice of funding opportunity to do otherwise and where instructions in the
     
     How to Apply - Application Guide
     
    are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the
     
     How to Apply - 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:
    
 
    Poonam Tewary, PhD
     
    Telephone: 240-532-9777
     
    Email:
     
 
      [email protected]
      
 
 
 
 
 
 
    Page Limitations
    
 
    All page limitations described in the
     
     How to Apply- Application Guide
     
    and the
     
     Table of Page Limits
     
    must be followed.
    
 
 
 
 
 
 
       Component
       
 
       Component Type for Submission
       
 
       Page Limit
       
 
       Required/Optional
       
 
       Minimum
       
 
       Maximum
       
 
 
 
 
 
       Overall
       
 
       Overall
       
 
       12
       
 
       Required
       
 
       1
       
 
       1
       
 
 
 
       Admin Core
       
 
       Admin Core
       
 
       6
       
 
       Required
       
 
       1
       
 
       1
       
 
 
 
       Data Stewardship Core
       
 
       Data Core
       
 
       6
       
 
       Required
       
 
       1
       
 
       1
       
 
 
 
       Clinical Core
       
 
       Clinical Core
       
 
       6
       
 
       Optional
       
 
       0
       
 
       1
       
 
 
 
       Scientific Core
       
 
       Scientific Core
       
 
       6
       
 
       Optional
       
 
       0
       
 
       2
       
 
 
 
       Research Project
       
 
       Project
       
 
       12
       
 
       Required
       
 
       2
       
 
       NA
       
 
 
 
 
 
 
    Instructions for the Submission of Multi-Component Applications
    
 
 
 
    The following section supplements the instructions found in
     
     How to Apply- Application Guide
     
    and should be used for preparing a multi-component application.
    
 
 
 
    The application should consist of the following components:
    
 
    Overall: required, 1
    
 
 
     Administrative Core: required, 1
     
 
     Data Stewardship Core: required: 1, the Data Stewardship Core must support all Research Projects, and will support other Scientific/Clinical Core(s), as needed
     
 
     Clinical Core: optional, maximum 1, the Clinical Core must support at least two Research Projects
     
 
     Scientific Core: optional, maximum 2, each Scientific Core must support at least two Research Projects
     
 
     Research Projects: required, minimum 2, no maximum
     
 
 
 
 
    Overall Component
    
 
    When preparing the application, use Component Type ‘Overall’.
    
 
    All instructions in the
     
     How to Apply - Application Guide
     
    must be followed, with the following additional instructions, as noted.
    
 
 
 
    SF424(R&R) Cover (Overall)
    
 
    Complete entire form.
    
 
 
 
    PHS 398 Cover Page Supplement (Overall)
    
 
    Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
    
 
 
 
    Research & Related Other Project Information (Overall)
    
 
    Follow standard instructions.
    
 
 
 
    Project/Performance Site Locations (Overall)
    
 
    Enter primary site only.
    
 
 
 
 
     A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
     
 
 
 
 
    Research and Related Senior/Key Person Profile (Overall)
    
 
    Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.
    
 
 
 
 
     A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
     
 
 
 
 
    Budget (Overall)
    
 
    The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
    
 
 
 
 
     A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
     
 
 
 
 
    PHS 398 Research Plan (Overall)
    
 
 
 
 
     Specific Aims:
     
    List in priority order, the broad, long-range objectives and goals of the proposed Center. Concisely describe the hypothesis or hypotheses to be tested.
    
 
 
 
 
     Research Strategy:
     
    Describe the focus of the research Center. This narrative section should summarize the overall research strategy for the multi-component application. The multi-component application should be viewed as a confederation of interrelated Research Projects, each capable of standing on its own scientific merit, but complementary to one another. This is an important section, for it provides the group of investigators an opportunity to give conceptual wholeness to the overall Center by giving a statement of the general problem area and by laying out a broad strategy for attacking the problem. As the strategy develops, each Research Project and Core should be cited briefly as to its place in the overall scheme. To help achieve the NOFO’s objective, it is recommended, but not required, to draft the applications along the lines of either of the two models: the Pathway Focus (Model A) or Clinical Intervention/Observation Focus (Model B) as described under Part 2, Section I.
    
 
    To highlight Center synergy, describe how the individual components will be coordinated and work together to address the overall goals and aims of the Center. Include a schematic overview of the interactions and collaborations among the components and indicate collaborations among members and relevant publications co-authored by members of the Center. Center synergy may also be addressed in other sections of the application, as appropriate. Discuss the role of all Research Projects and Cores in the Overall Research Strategy of the application. Describe how the integration of the individual Research Projects into a single Center benefits the objectives more than pursuing each project independently. For renewal applications, describe the impact that the Center’s prior accomplishments have had on the field of asthma and/or allergic disease.
    
 
    For individual Research Projects and Cores that will be continued as part of a renewal application, additional details of progress made during the prior funding period should be provided in the Research Strategy within each Research Project and/or Core.
    
 
 
 
 
 
 
 
 
     Resource Sharing Plan
     
    :
     
    Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the
     
     How to Apply - Application Guide
     
    .
    
 
 
 
 
     Other Plan(s):
     
 
 
    All instructions in the
     
     How to Apply- 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.
     
 
     Recipients are encouraged to deposit data into the
      
      ImmPort database
      
     .
     
 
 
 
 
 
     Appendix:
     
 
 
    Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in
     
     How to Apply- Application Guide
     
    ; any instructions provided here are in addition to the
     
     How to Apply - Application Guide
     
    instructions.
    
 
 
 
    PHS Human Subjects and Clinical Trials Information (Overall)
    
 
    When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the
     
     How to Apply - 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, there must be at least one human subjects study record using the
     
     Study Record: PHS Human Subjects and Clinical Trials Information
     
    form or a
     
     Delayed Onset Study
     
    record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.
    
 
 
     Study Record: PHS Human Subjects and Clinical Trials Information
     
 
 
    All instructions in the
     
     How to Apply - 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
     
     How to Apply- Application Guide
     
    must be followed.
    
 
 
 
    PHS Assignment Request Form (Overall)
    
 
    All instructions in the
     
     How to Apply- Application Guide
     
    must be followed.
    
 
 
 
 
     Administrative Core
     
 
 
    When preparing your application, use Component Type ‘Admin Core.’
    
 
    All instructions in the
     
     How to Apply- Application Guide
     
    must be followed, with the following additional instructions, as noted.
    
 
 
     SF424 (R&R) Cover (Administrative Core)
     
 
 
    Complete only the following fields:
    
 
 
     Applicant Information
     
 
     Type of Applicant (optional)
     
 
     Descriptive Title of Applicant’s Project
     
 
     Proposed Project Start/Ending Dates
     
 
 
 
     PHS 398 Cover Page Supplement (Administrative Core)
     
 
 
    Enter Human Embryonic Stem Cells in each relevant component.
    
 
 
     Research & Related Other Project Information (Administrative Core)
     
 
 
 
     Human Subjects:
     
    Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.
    
 
 
     Vertebrate Animals:
     
    Answer only the ‘Are Vertebrate Animals Used?’ question.
    
 
 
     Project Narrative:
     
    Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
    
 
 
     Project/Performance Site Location(s) (Administrative Core)
     
 
 
    List all performance sites that apply to the specific component.
    
 
 
     Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
     
 
 
 
     Research & Related Senior/Key Person Profile (Administrative Core)
     
 
 
 
     In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
     
 
     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
     
 
     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
     
 
     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
     
 
     For institutions/organizations proposing a single PD/PI, the PD/PI will serve as the Administrative Core Lead. For institutions/organizations proposing multiple PD(s)/PI(s), the Contact PD/PI must serve as the Administrative Core Lead.
     
 
 
 
     Budget (Administrative Core)
     
 
 
    Budget forms appropriate for the specific component will be included in the application package.
    
 
    In the budget, include funding for the overall administrative efforts, administrative services, expenses for publications demonstrating collaborative efforts, and communication expenses.
    
 
 
     Infrastructure and Opportunity Fund (IOF)
     
    : Propose funds for the IOF within the Administrative Core component; the IOF budget is not expected to exceed $350K in direct costs. This will be awarded to one recipient organization that will be selected by NIAID post-award to manage the fund. Include IOF costs as a single line item in the Other Direct Costs Category of the Administrative Core Budget. A part of the IOF budget, direct costs proposed for an IOF administrator may be requested in the Personnel category for a maximum of 0.5 person months and must comply with NIH grants policy. F&A Costs will be applied in accordance with NIH grants policy.
    
 
    Include travel funds for the PD(s)/PI(s) and subproject PD(s)/PI(s) to attend an annual AADCRC Scientific and Steering Committee meeting. The two-day meeting will be held each year in or near Rockville, Maryland.
    
 
 
     Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
     
 
 
 
     PHS 398 Research Plan (Administrative Core)
     
 
 
 
     Specific Aims:
     
    List in priority order the proposed activities and services of the Administrative Core. Describe the work to be completed to address issues of Center coordination, communication, management, and administering the IOF. Testing of scientific hypotheses should not be proposed within a Core.
    
 
 
     Research Strategy:
     
    A fully developed and well-described Administrative Core plan is required.
    
 
    Describe and justify the operational plan and organizational structure of the proposed multi-component application. Include plans on how the PD(s)/PI(s) will interact and coordinate with Project/Core Leaders to identify and resolve problems and establish a strong collaborative environment for the Center. Provide an administrative plan that includes a discussion of the structure and roles of administrative staff, including the functions to be performed; how fiscal and other resources will be prioritized, allocated, and managed; how communications, group meetings, and teleconferences will be facilitated; how conflict resolution will be attained; and how research related travel and training will be managed. Describe how the Core’s administrative, management, and leadership capabilities provide for: internal quality control of on-going research, management of day-to-day program activities, management of contractual agreements, fair communication and cooperation among program leaders and/or program investigators, and development of scientific meetings, as applicable. Present a leadership succession plan.
    
 
    Provide a plan to administer the AADCRC Infrastructure and Opportunity Fund (IOF), including fund disbursement, administration, and reports. Within the plan, address the following: establishing an administrative structure to manage the IOF; disbursing and tracking IOF funds under the direction of the Steering Committee; implementing plans for interacting with the institutions that will receive IOF funds, including establishing consortium agreements when applicable; and establishing procedures, formats, and timelines for reporting on the status of IOF projects and expenditures to the NIAID and the AADCRC Steering Committee.
    
 
 
     External Advisory Group (optional)
     
    : If an EAG is proposed for an individual Center, then describe the expertise and responsibilities of the potential members. Discuss how the individual Center Research Projects will be supported by the EAG.
     
 
    For a new application,
     
     do not
     
    contact or name potential members in the application
     
     .
     
    For a renewal application with an EAG already established, provide the names only of current EAG members in the application.
    
 
 
     Resource Sharing Plan:
     
    Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the
     
     How to Apply - Application Guide
     
    .
    
 
 
     Appendix:
     
 
 
    Only limited items are allowed in the Appendix. Follow all instructions for the
     
     How to Apply - Application Guide
     
    ; any instructions provided here are in addition to those in the
     
     How to Apply - Application Guide
     
    instructions.
    
 
 
     PHS Human Subjects and Clinical Trials Information (Administrative Core)
     
 
 
    When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the
     
     How to Apply - 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 a
     
     Delayed Onset Study
     
    record.
    
 
 
     Study Record: PHS Human Subjects and Clinical Trials Information
     
 
 
    All instructions in the
     
     How to Apply - 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
     
     How to Apply - Application Guide
     
    must be followed.
    
 
 
     Data Stewardship Core
     
 
 
    When preparing your application, use Component Type ‘Data Core.’
    
 
    All instructions in the
     
     How to Apply - Application Guide
     
    must be followed, with the following additional instructions, as noted.
    
 
 
     SF424 (R&R) Cover (Data Stewardship Core)
     
 
 
    Complete only the following fields:
    
 
 
     Applicant Information
     
 
     Type of Applicant (optional)
     
 
     Descriptive Title of Applicant’s Project
     
 
     Proposed Project Start/Ending Dates
     
 
 
 
     PHS 398 Cover Page Supplement (Data Stewardship Core)
     
 
 
    Enter Human Embryonic Stem Cells in each relevant component.
    
 
 
     Research & Related Other Project Information (Data Stewardship Core)
     
 
 
 
     Human Subjects:
     
    Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.
    
 
 
     Vertebrate Animals:
     
    Answer only the ‘Are Vertebrate Animals Used?’ question.
    
 
 
     Project Narrative:
     
    Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
    
 
 
     Facilities & Other Resources:
     
    Describe the facilities provided by the Core, as applied to procedures and techniques provided, as well as quality control.
    
 
 
     Project/Performance Site Location(s) (Data Stewardship Core)
     
 
 
    List all performance sites that apply to the specific component.
    
 
 
     Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
     
 
 
 
     Research & Related Senior/Key Person Profile (Data Stewardship Core)
     
 
 
 
     In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
     
 
     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
     
 
     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
     
 
     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
     
 
 
 
     Budget (Data Stewardship Core)
     
 
 
    Budget forms appropriate for the specific component will be included in the application package.
    
 
    Request funds to support central data management (database establishment, data management and cleaning, data storage, database security) for the entire awarded U19 Cooperative Agreement to all researchers within the applicant group.
    
 
    In case the statistical design and analysis of data for at least two Research Projects is to be conducted by this Core, request funds to support appropriate biostatistical personnel and equipment use effort.
    
 
    Request funds to support the required timely submission of data, meta-data and data analyses to the ImmPort database or other public databases as appropriate.
    
 
    The percentage of total funds that will be required to support each component Research Project or Core that will utilize the Data Stewardship Core should also be presented. This information should be included in the Core’s budget justification for Year 1.
    
 
    For all clinical trials, NIAID will provide a Data and Safety Monitoring Board (DSMB). Therefore, the applicant does not need to include or budget for DSMB expenses.
    
 
 
     Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
     
 
 
 
     PHS 398 Research Plan (Data Stewardship Core)
     
 
 
 
     Specific Aims:
     
    List in priority order the broad, long-range activities and services of the proposed Core. In addition, state the Core’s relationship to the Center’s goals and how the Core relates to all the activities of individual Research Projects in the application. Testing of scientific hypotheses should not be proposed within a Core.
    
 
 
     Research Strategy:
     
 
 
    Describe and justify the overall function of the required Data Stewardship Core. Describe how the services of this Core (including procedures, techniques and quality control) will support all proposed Research Projects and Scientific and/or Clinical Cores, and advance the outcomes from the proposed research Center.
    
 
    Describe how the Data Stewardship Core will facilitate the harmonization of data collection and analysis services across all Research Projects and Scientific/Clinical Cores, as needed.
    Discuss how the Core will support data management by providing appropriate team expertise.  Describe the plans for development of harmonized protocols, including selection and use of common data elements, if applicable. Explain the processes, procedures, methods and plans to provide bioinformatics infrastructure support for Center-wide database establishment, data cleaning and tracking, information management, curation, data monitoring, data storage and quality control. Outline how the Core will promote the exchange of information among all recipients of this NOFO.
    
 
    If the Data Stewardship Core will support the statistical design and data analyses for Research Projects and/or a Clinical or Scientific Core, provide general descriptions of statistical approaches to be used. However, specific statistical analyses addressing scientific hypotheses should be described within each of the Research Projects or within the Clinical or Scientific Core, whichever is applicable.
    
 
    Note that information requested here for this Core should not duplicate the information provided in the Data Management and Sharing Plan. Place information regarding plans to comply with the NIH Data Management and Sharing Policy in the Data Management and Sharing Plan attachment in the “Other Plan(s)” section of the Overall component.
    
 
 
     Note
     
    : Specific details for clinical trials and studies will be captured using the PHS Human Subjects and Clinical Trials Information Form. Do not duplicate information requested under the PHS Human Subjects and Clinical Trials Information Forms.
    
 
 
     Resource Sharing Plan:
     
    Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the
     
     How to Apply - Application Guide
     
    .
    
 
 
     Appendix:
     
 
 
    Only limited items are allowed in the Appendix. Follow all instructions for the
     
     How to Apply- Application Guide
     
    ; any instructions provided here are in addition to those in the
     
     How to Apply- Application Guide
     
    instructions.
    
 
 
     PHS Human Subjects and Clinical Trials Information (Data Stewardship Core)
     
 
 
    When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the
     
     How to Apply- 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 a
     
     Delayed Onset Study
     
    record.
    
 
 
     Study Record: PHS Human Subjects and Clinical Trials Information
     
 
 
    All instructions in the
     
     How to Apply- 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
     
     How to Apply- Application Guide
     
    must be followed.
    
 
 
     Clinical Core
     
 
 
    When preparing your application, use Component Type ‘Clinical Core.’
    
 
    All instructions in the
     
     How to Apply- Application Guide
     
    must be followed, with the following additional instructions, as noted.
    
 
 
     SF424 (R&R) Cover (Clinical Core)
     
 
 
    Complete only the following fields:
    
 
 
     Applicant Information
     
 
     Type of Applicant (optional)
     
 
     Descriptive Title of Applicant’s Project
     
 
     Proposed Project Start/Ending Dates
     
 
 
 
     PHS 398 Cover Page Supplement (Clinical Core)
     
 
 
    Enter Human Embryonic Stem Cells in each relevant component.
    
 
 
     Research & Related Other Project Information (Clinical Core)
     
 
 
 
     Human Subjects:
     
    Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.
    
 
 
     Vertebrate Animals:
     
    Answer only the ‘Are Vertebrate Animals Used?’ question.
    
 
 
     Project Narrative:
     
    Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
    
 
 
     Facilities & Other Resources:
     
    Describe the facilities provided by the Core, as applied to procedures and techniques provided, as well as quality control.
    
 
 
     Project/Performance Site Location(s) (Clinical Core)
     
 
 
    List all performance sites that apply to the specific component.
    
 
 
     Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
     
 
 
 
     Research & Related Senior/Key Person Profile (Clinical Core)
     
 
 
 
     In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
     
 
     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
     
 
     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
     
 
     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
     
 
     Within the biosketches, highlight the expertise of the Clinical Core Lead to guide and/or assist in the development and preparation of documentation required for clinical research, as well as experience with regulatory activities, including IND/IDE submissions (if applicable), recruitment and retention of study participants, medical monitoring, and safety oversight and reporting.
     
 
 
 
     Budget (Clinical Core)
     
 
 
    Budget forms appropriate for the specific component will be included in the application package.
    
 
    For Year 1, outline the percentage of total funds that will be required to support each component Research Project that will utilize the Clinical Core
    
 
    If a clinical trial is proposed, include costs for a medical monitor.
    
 
    For all clinical trials, NIAID will provide a Data and Safety Monitoring Board (DSMB). Therefore, do not include or budget for DSMB expenses.
    
 
 
     Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
     
 
 
 
     PHS 398 Research Plan (Clinical Core)
     
 
 
 
     Specific Aims:
     
    List in priority order the broad, long-range activities and services of the proposed Clinical Core. In addition, state the Core’s relationship to the Center’s goals and how the Core relates to two or more individual Research Projects in the application. Testing of scientific hypotheses should not be proposed within a Core.
    
 
 
     Research Strategy:
     
 
 
    Describe how the Clinical Core will support at least one of two purposes: 1) recruit and characterize human subjects and collect appropriate biosamples in support of at least two Research Project(s), and/or 2) conduct one or more single-site pilot clinical trials or clinical studies in support of at least two Research Projects.
    
 
 
     Describe how the proposed Clinical Core activities will contribute to meeting the Center’s goals and objectives and explain why the Core resources are not otherwise available.
     
 
     Describe how resource utilization will be allocated and/or prioritized, if applicable, to support the Center. Indicate the specific projects to be supported by the Clinical Core.
     
 
     Describe the services provided by the Core (including procedures, techniques, and quality control).
     
 
 
    If the Clinical Core proposes single site pilot clinical trials and/or studies designed only to collect and provide samples for two or more Research Projects, describe the following aspects of the proposed trial(s)/study(ies):
    
 
 
     Discuss the rationale and process for the selection, recruitment and retention of the participant population, choice of intervention (if applicable), choice of study sites, duration, plans for trial management and schedule of events.
     
 
     Discuss the trial/study's feasibility, difficulties that may be encountered, and offer alternative approaches to be implemented, if needed, include general concepts for sample size determinations and statistical methodologies, but, particularly for pilot clinical trials, provide study-specific details in the PHS Human Subjects and Clinical Trial Information Forms.
     
 
 
 
     Note:
     
    If a clinical trial/study is included in a Research Project (and not as a Clinical Core), then the above information should appear as part of that Research Project.
    
 
 
     Note:
     
    Specific details for trials and studies will be captured using the PHS Human Subjects and Clinical Trials Information Form. Do not duplicate information requested under the PHS Human Subjects and Clinical Trials Information Forms.
    
 
 
     Resource Sharing Plan:
     
    Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the
     
     How to Apply- Application Guide
     
    .
    
 
 
     Appendix:
     
 
 
    Only limited items are allowed in the Appendix. Follow all instructions for the
     
     How to Apply- Application Guide
     
    ; any instructions provided here are in addition to those in the
     
     How to Apply- Application Guide
     
    instructions.
    
 
 
     PHS Human Subjects and Clinical Trials Information (Clinical Core)
     
 
 
    When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the
     
     How to Apply- 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 a
     
     Delayed Onset Study
     
    record.
    
 
 
     Study Record: PHS Human Subjects and Clinical Trials Information
     
 
 
    All instructions in the
     
     How to Apply- 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
     
     How to Apply- Application Guide
     
    must be followed.
    
 
 
     Scientific Core
     
 
 
    When preparing your application, use Component Type ‘Scientific Core.’
    
 
    All instructions in the
     
     How to Apply- Application Guide
     
    must be followed, with the following additional instructions, as noted.
    
 
 
     SF424 (R&R) Cover (Scientific Core)
     
 
 
    Complete only the following fields:
    
 
 
     Applicant Information
     
 
     Type of Applicant (optional)
     
 
     Descriptive Title of Applicant’s Project
     
 
     Proposed Project Start/Ending Dates
     
 
 
 
     PHS 398 Cover Page Supplement (Scientific Core)
     
 
 
    Enter Human Embryonic Stem Cells in each relevant component.
    
 
 
     Research & Related Other Project Information (Scientific Core)
     
 
 
 
     Human Subjects:
     
    Answer only the ‘Are Human Subjects Involved?’ and ‘Is the Project Exempt from Federal regulations?’ questions.
    
 
 
     Vertebrate Animals:
     
    Answer only the ‘Are Vertebrate Animals Used?’ question.
    
 
 
     Project Narrative:
     
    Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
    
 
 
     Facilities & Other Resources:
     
    Describe the facilities provided by the Core, as applied to procedures and techniques provided, as well as quality control.
    
 
 
     Project/Performance Site Location(s) (Scientific Core)
     
 
 
    List all performance sites that apply to the specific component.
    
 
 
     Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
     
 
 
 
     Research & Related Senior/Key Person Profile (Scientific Core)
     
 
 
 
     In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
     
 
     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
     
 
     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
     
 
     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
     
 
 
 
     Budget (Scientific Core)
     
 
 
    Budget forms appropriate for the specific component will be included in the application package.
    
 
    For Year 1, outline the percentage of total funds that will be required to support each component Research Project that will utilize the Scientific Core.
    
 
 
     Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
     
 
 
 
     PHS 398 Research Plan (Scientific Core)
     
 
 
 
     Specific Aims:
     
 
 
 
     Discuss the Core’s relationship to the Center’s goals and how the Core relates to two or more individual Research Projects in the application. Testing of scientific hypotheses should not be proposed within a Core.
     
 
 
 
     Research Strategy:
     
 
 
 
     Describe how the proposed Scientific Core activities (including procedures, techniques and quality control) will contribute to meeting the Center’s goals and objectives and explain why the Core resources are not otherwise available.
     
 
     Describe how resource utilization will be allocated and/or prioritized, if applicable, to support the Center.
     
 
 
    Indicate the specific Research Projects to be supported by the Scientific Core. Describe the interactions of the Core with each of the Research Projects.
    
 
 
     Resource Sharing Plan:
     
    Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the
     
     How to Apply- Application Guide
     
    .
    
 
 
     Appendix:
     
 
 
    Only limited items are allowed in the Appendix. Follow all instructions for the
     
     How to Apply- Application Guide
     
    ; any instructions provided here are in addition to those in the
     
     How to Apply- Application Guide
     
    instructions.
    
 
 
     PHS Human Subjects and Clinical Trials Information (Scientific Core)
     
 
 
    When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the
     
     How to Apply- 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 a
     
     Delayed Onset Study
     
    record.
    
 
 
     Study Record: PHS Human Subjects and Clinical Trials Information
     
 
 
    All instructions in the
     
     How to Apply- 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
     
     How to Apply- Application Guide
     
    must be followed.
    
 
 
     Research Project
     
 
 
    When preparing your application, use Component Type ‘Project.’
    
 
    All instructions in the
     
     How to Apply- Application Guide
     
    must be followed, with the following additional instructions, as noted.
    
 
 
     SF424 (R&R) Cover (Research Project)
     
 
 
    Complete only the following fields:
    
 
 
     Applicant Information
     
 
     Type of Applicant (optional)
     
 
     Descriptive Title of Applicant’s Project
     
 
     Proposed Project Start/Ending Dates
     
 
 
 
     PHS 398 Cover Page Supplement (Research Project)
     
 
 
    Enter Human Embryonic Stem Cells in each relevant component.
    
 
 
     Research & Related Other Project Information (Research Project)
     
 
 
 
     Human Subjects:
     
    Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.
    
 
 
     Vertebrate Animals:
     
    Answer only the ‘Are Vertebrate Animals Used?’ question.
    
 
 
     Project Narrative:
     
    Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
    
 
 
     Project/Performance Site Location(s) (Research Project)
     
 
 
    List all performance sites that apply to the specific component.
    
 
 
     Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
     
 
 
 
     Research & Related Senior/Key Person Profile (Research Project)
     
 
 
 
     In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
     
 
     In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
     
 
     Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
     
 
     If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
     
 
     Within the biosketches, highlight the experience and expertise of the Research Project Lead and key personnel in regulatory activities, including IND/IDE submissions, safety oversight and reporting.
     
 
 
 
     Budget (Research Project)
     
 
 
    Budget forms appropriate for the specific component will be included in the application package.
    
 
    In single PD/PI applications, the PD/PI must also lead at least one Research Project and is required to commit an overall minimum of 2 person months in AADCRC activities. In multi-PD/PI applications, every PD/PI must lead a Research Project or Core, with at least one of the PD(s)/PI(s) leading a Research Project and committing an overall minimum of 2 person months to AADCRC activities.
    
 
    Include costs to support statistical design/support, data collection and analysis if those are not included in one of the Cores.
    
 
    If the Research Project involves a pilot clinical trial or a clinical observational study:
    
 
 
     Include costs for clinical site monitoring, medical monitoring, project management, and quality assurance of the proposed pilot clinical trials or observational clinical studies in the application budget. Alternatively, these costs can be incorporated into the budget of a Clinical Core, provided that specific cross-references are made to clarify how these necessary functions will be supported.
     
 
 
    Note: For all clinical trials, NIAID will provide a Data and Safety Monitoring Board (DSMB). Therefore, do not include or budget for DSMB expenses.
    
 
 
     Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
     
 
 
 
     PHS 398 Research Plan (Research Project)
     
 
 
 
     Specific Aims:
     
 
 
 
     List, in priority order, the objectives and goals of the proposed project.
     
 
     Concisely describe the hypothesis or hypotheses to be tested. In addition, state the individual Research Project's relationship to the Center’s goals and how it relates to other projects or Cores.
     
 
 
 
     Research Strategy:
     
 
 
 
     Describe how the proposed research will contribute to meeting the Center’s goals and objectives and indicate the project's relevance to the primary theme of the application.
     
 
     Explain the rationale for selecting the methods to accomplish the specific aims of the Research Project.
     
 
     Provide a detailed timeline for the study supporting completion within the funding period.
     
 
 
 
     Clinical Trials
     
 
 
    The Approach section of a pilot clinical trial project should address the following aspects of the proposed trial(s):
    
 
 
     Discuss the rationale for the proposed approach for the problems being studied.
     
 
     Describe the design of the proposed trial, include rationale for the selection of the participant population, choice of intervention (if applicable), duration, and schedule of events.
     
 
     Discuss each trial’s feasibility.
     
 
     Include a plan for the management of the pilot clinical trial that offers description of personnel involved in 1) conducting the trial, and 2) data entry and interactions with the activities of the Data Stewardship Core.
     
 
     Include general concepts for sample size determinations and statistical methodologies, but provide trial-specific details in the PHS Human Subjects and Clinical Trial Information Forms.
     
 
 
    Note: Specific details for each trial will be captured using the PHS Human Subjects and Clinical Trials Information Forms. Do not duplicate information requested under the PHS Human Subjects and Clinical Trials Information Forms.
    
 
 
     Clinical studies
     
 
 
    For applications proposing one or more clinical studies (observational studies with no interventions and involving only minimal risk procedures or cross-sectional studies), the Approach section of the clinical study project should address the following aspects of the study:
    
 
 
     Describe the design of the proposed study, include rationale for the selection of the participant population, choice of outcomes, duration, and schedule of events.
     
 
     Discuss each study's feasibility. Include a plan for the management of the clinical study that offers description of personnel involved in conducting the study, personnel involved in data entry, and the personnel involved in statistical analysis. Describe the interactions between these teams and the Data Stewardship Core.
     
 
     Include general concepts for sample size determinations and statistical methodologies, but provide study-specific details in the PHS Human Subjects Information Forms.
     
 
     Describe the timeline for protocol development, the plan for study implementation, the plan for evaluation of proposed study site(s), and plans for management and analysis of study data.
     
 
     For observational or cross-sectional clinical studies, describe the data analyses and statistical approach for the proposed study design and methods used to assign participants.
     
 
 
    Note: Specific details for each study will be captured using the PHS Human Subjects Information Form. Do not duplicate information requested under the PHS Human Subjects Information Forms.
    
 
 
     Projects obtaining human samples from non-AADCRC-supported clinical studies or trials:
     
 
 
    For projects that plan to obtain human samples derived from clinical studies or clinical trials that are planned, ongoing, or completed and are or have been sponsored by sources other than the AADCRC, the information in the Approach section should include the following:
    
 
 
     Study title
     
 
     Study objectives (primary and secondary)
     
 
     Study population(s) with clear description of clinical phenotypes
     
 
     Key design features, including primary and secondary endpoints, comparison/control groups
     
 
     Sample size calculations and statistical analysis plans as they pertain to the questions posed by the AADCRC study that will utilize the parent study/trial samples
     
 
     Study duration and timeline (if a planned or an ongoing study)
     
 
 
 
     Non-clinical research
     
 
 
 
     Describe the research design conceptual procedures and analyses to be used to accomplish the specific aims of the project.
     
 
     In the rare instances where animal models are proposed, justify the models and describe how the findings could be translated into human research and how they associate with the proposed clinical project(s).
     
 
     Provide a tentative timetable for the project.
     
 
     If animal studies are included, describe the relevance of the proposed animal model(s) to human asthma and/or allergic diseases. Describe the scientific potential for findings in animals to translate to human disease and appropriately justify the use of animal models if similar data could be obtained from human studies.
     
 
 
 
     Letters of Support:
     
    For Projects obtaining human samples from non-AADCRC-supported clinical studies or trials, include documentation of the ability to acquire human samples, including written agreements between the PD(s)/PI(s), the applicant institution, the clinical study/trial sponsor(s), including drug companies, if applicable, and the IND/IDE sponsor (if not one of the above) to be used in the studies proposed by the application is required. A statement is required that the subjects from whom samples were obtained from the parent clinical study/trial not supported by the proposed AADCRC project have given informed consent/assent and the material they have provided can be used by the AADCRC project.
    
 
 
     Resource Sharing Plan:
     
    Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the
     
     How to Apply- Application Guide
     
    .
    
 
 
     Appendix:
     
 
 
    Only limited items are allowed in the Appendix. Follow all instructions for the
     
     How to Apply- Application Guide
     
    ; any instructions provided here are in addition to those in the
     
     How to Apply- Application Guide
     
    instructions.
    
 
 
     PHS Human Subjects and Clinical Trials Information (Research Project)
     
 
 
    When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the
     
     How to Apply- 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 a
     
     Delayed Onset Study
     
    record.
    
 
 
     Study Record: PHS Human Subjects and Clinical Trials Information
     
 
 
    All instructions in the
     
     How to Apply- Application Guide
     
    must be followed with the following additional instructions:
    
 
 
     Section 2 - Study Population Characteristics
     
 
 
 
     2.5 - Recruitment and Retention Plan
     
 
 
    Describe actions to be taken to address problems with recruitment of study participants.
    
 
 
     Section 4 - Protocol Synopsis
     
 
 
 
     4.1 Study Design
     
 
 
 
     4.1.a Detailed Description
     
 
 
    For multi-visit studies, provide a description of the study design including the procedures and activities that can occur at each visit (schedule of events).
    
 
 
     Section 5 - Other Clinical Trial-related Attachments
     
 
 
 
     5.1 Other Clinical Trial-related Attachments
     
 
 
    Describe the plan to obtain required investigational agent(s).
    
 
    IND applications required by the FDA for any investigational agents should be obtained by applicants prior to submission of applications. Provide the IND documents with other clinical trial related attachments.
    
 
 
     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
     
     How to Apply- Application Guide
     
    must be followed.
    
 
 
 
    3. Unique Entity Identifier and System for Award Management (SAM)
    
 
    See Part 2. 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. 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) using ASSIST or other electronic submission systems. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications
     
    .
    
 
 
     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
     
     How to Apply- 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
     
 
     Section 7.9.1 Selected Items of Cost.
     
 
 
 
 
    7. Other Submission Requirements and Information
    
 
    Applications must be submitted electronically following the instructions described in the
     
     How to Apply - Application Guide
     
    . Paper applications will not be accepted.
    
 
    For information on how applications will be automatically assembled for review and funding consideration after submission, refer to:
     
     http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf
     
    .
    
 
 
     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) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form
     
     .
     
    Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
    
 
    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
     
     How to Apply - 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 the National Institute of Allergy and Infectious Diseases, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
    
 
 
   Mandatory Disclosure
    
    Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures,
     
     2 CFR 200.113
     
    and
     
     NIH Grants Policy Statement Section 4.1.35
     
    .
    
 
    Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the
     
     HHS Office of Inspector Grant Self Disclosure Program
     
    at
     
 
      [email protected]
      
 
    .
    
 
 
 
    Post Submission Materials
    
 
    Applicants are required to follow the instructions for post-submission materials, as described in
     
     the policy
     
    .
pipeline_tag: sentence-similarity
library_name: sentence-transformers
metrics: cosine_accuracy@1, cosine_accuracy@3, cosine_accuracy@5, cosine_accuracy@10, cosine_precision@1, cosine_precision@3, cosine_precision@5, cosine_precision@10, cosine_recall@1, cosine_recall@3, cosine_recall@5, cosine_recall@10, cosine_ndcg@10, cosine_mrr@10, cosine_map@100
model-index: name: SentenceTransformer based on Snowflake/snowflake-arctic-embed-l
results: task: type: information-retrieval
name: Information Retrieval
dataset: name: Unknown
type: unknown
metrics: type: cosine_accuracy@1
value: 0.9166666666666666
name: Cosine Accuracy@1
verified: no, type: cosine_accuracy@3
value: 1
name: Cosine Accuracy@3
verified: no, type: cosine_accuracy@5
value: 1
name: Cosine Accuracy@5
verified: no, type: cosine_accuracy@10
value: 1
name: Cosine Accuracy@10
verified: no, type: cosine_precision@1
value: 0.9166666666666666
name: Cosine Precision@1
verified: no, type: cosine_precision@3
value: 0.3333333333333333
name: Cosine Precision@3
verified: no, type: cosine_precision@5
value: 0.20000000000000004
name: Cosine Precision@5
verified: no, type: cosine_precision@10
value: 0.10000000000000002
name: Cosine Precision@10
verified: no, type: cosine_recall@1
value: 0.9166666666666666
name: Cosine Recall@1
verified: no, type: cosine_recall@3
value: 1
name: Cosine Recall@3
verified: no, type: cosine_recall@5
value: 1
name: Cosine Recall@5
verified: no, type: cosine_recall@10
value: 1
name: Cosine Recall@10
verified: no, type: cosine_ndcg@10
value: 0.9692441461309548
name: Cosine Ndcg@10
verified: no, type: cosine_mrr@10
value: 0.9583333333333334
name: Cosine Mrr@10
verified: no, type: cosine_map@100
value: 0.9583333333333334
name: Cosine Map@100
verified: no
Likes: 0 | All-time downloads: 109
Created: 2025-02-23 06:10:19