National Institute of Allergy and Infectious Diseases (NIAID) Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

National Institute of Allergy and Infectious Diseases (NIAID) Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). This funding opportunity supports investigator-initiated clinical trials requiring enhanced oversight, with durations up to 7 years.

While focused on clinical trials, modeling can be a critical component of trial design and analysis in infectious diseases and immunology.

PAR-27-064: NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Allergy and Infectious Diseases ( NIAID ) Funding Opportunity Title NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) U01 Research Project – Cooperative Agreements Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON) Companion Funding Opportunity See Part 2, Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s) Funding Opportunity Purpose This notice of funding opportunity (NOFO) encourages applications for implementation of investigator-initiated, milestone driven clinical trials that need enhanced oversight, and as applicable, include mechanistic studies.

Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities. Support is available for clinical trials up to 5 years, as well as for extended clinical trials of 6- or 7-years. Investigators are encouraged to visit this NIH website for additional information about the overall mission and research areas of NIAID.

Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application. In accordance with NIH standard peer-review processes, the applications will be peer-reviewed, and only meritorious applications will be considered.

Funding Opportunity Goal(s) To assist public and private nonprofit institutions and individuals to establish, expand and improve biomedical research and research training in infectious diseases and related areas; to conduct developmental research, to produce and test research materials.

To assist public, private and commercial institutions to conduct developmental research, to produce and test research materials, to provide research services as required by the agency for programs in infectious diseases, and controlling disease caused by infectious or parasitic agents, allergic and immunologic diseases and related areas.

Projects range from studies of microbial physiology and antigenic structure to collaborative trials of experimental drugs and vaccines, mechanisms of resistance to antibiotics as well as research dealing with epidemiological observations in hospitalized patients or community populations and progress in allergic and immunologic diseases. Because of this dual focus, the program encompasses both basic research and clinical research.

Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

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

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Use Grants. gov Workspace to prepare and submit your application and eRA Commons to track your application.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Notice of Funding Opportunity Description Historically, NIAID has supported both the infrastructure and clinical trial networks through a variety of funding mechanisms.

NIAID recognizes that additional models of clinical research are important to advance its research mission; therefore, NIAID has established this investigator-initiated clinical trial funding opportunity for clinical trials that cannot or will not be conducted through existing NIAID-supported clinical trial networks or infrastructure.

The proposed clinical trial must be ready for implementation, and appropriate documentation must support readiness. The NIAID Clinical Trial Implementation Cooperative Agreement supports implementation of clinical trials that address research areas supporting the mission and goals of NIAID and require enhanced oversight.

NIH defines a clinical trial as: "A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes." For additional details, see NOT-OD-15-015 .

A clinical trial that requires enhanced oversight has one or more of the following attributes: provision of a non-routine intervention, that is, an intervention that would not otherwise be provided for the condition under study in the local facility where the study is being conducted; administration of an unlicensed product; or administration of a licensed product for an unapproved indication.

Any clinical trial that will require a regulatory oversight (such as Investigational New Drug [IND] or Investigational Device Exemption [IDE]) would be considered to require enhanced oversight. NIAID expects all activities and communications regarding all clinical laboratory testing for study participants to comply with U.S. Code of Federal Regulations (see 42 CFR part 493. 2 and 493.

3(b)(2) ).

The NIAID Clinical Trial Implementation Cooperative Agreement will support the conduct, completion, and analysis of the clinical trial, and related activities, for example: training of study personnel recruitment and enrollment of study subjects data collection, clinical data management, and quality control investigational product costs laboratory work and data analyses study management and oversight establishment of committees to manage the complexity of the trial preparation of the final study report; and other related post-trial activities regulatory activities and site monitoring mechanistic studies, if applicable NIAID reserves the right to specify: 1) whether an IND/IDE application should be submitted to the appropriate regulatory agency; 2) the entity (NIAID, primary recipient, etc.) who will hold the IND/IDE; 3) the requirements for the establishment of a Data Safety Monitoring Board (DSMB)/Safety Monitoring Committee (SMC) or the use of an NIAID-sponsored DSMB/SMC; and 4) the use of other NIAID clinical resources such as a Statistical and Clinical Coordinating Center.

Applicants are encouraged to discuss those decisions and requirements with NIAID prior to submission of the application. Extended Performance Period Rationale The scope of the proposed clinical trial and related research activities should determine the project period with the expectation that most trials can be completed within 5 years.

Examples of factors that may require a project period of 6- or 7-years include: nature of condition under study that requires longer follow-up to achieve clinical and mechanistic outcomes number and diversity of study sites number of participants necessary for study completion availability of target population for the study known difficulty with participant recruitment and/or retention complex regulatory requirements specific to the study Applications Not Responsive to This NOFO The following types of applications are not responsive to this NOFO and will not be reviewed: Applications proposing any of the following clinical trial planning tasks: Development of study design Identification of collaborators and enrollment sites Development of the clinical protocol and informed consent Development of the statistical analysis plan Development of the clinical data management plan Development of the Investigator's brochure or equivalent For applications proposing a 6- or 7- year project period: Lack of a study rationale that justifies the need for an extended 6- or 7-year clinical trial Budgeting for a 6- or 7-year clinical trial but lacking a 6- or 7-year milestone plan in the Study Timeline Clinical trials that fall outside the mission and research areas of NIAID Clinical trials that utilize dedicated resources that are part of an existing NIAID-supported clinical trial network without prior program approval Proposing more than one clinical trial in a single application DAIT-focused clinical trials on allergic, transplantation, autoimmune, and immune-mediated diseases lacking mechanistic studies For studies that do not require enhanced oversight, NIAID encourages submission of applications to either NIH Research Project Grant (Parent R01 Clinical Trials Required) PA-25-305 or NIH Research Project Grant (Parent R21 Clinical Trial Required) PA-25-306 .

Applicants are strongly encouraged to contact the Scientific/Research Contact(s) listed in Section VII. Agency Contacts for questions concerning the classification of the proposed clinical trial. Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Award Information 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 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.

Required: Only accepting applications that propose clinical trial(s). Need help determining whether you are doing a clinical trial? Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Application budgets are not limited but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period. The expectation is that most trials will be completed within 5 years, however, the maximum project period is 7 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO. Section III.

Eligibility Information Higher Education Institutions - Includes all types Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Organizations) Foreign Organizations/International Collaborations Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed. NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts.

All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. See NIH Grants Policy Statement 16. 8 Collaborative International Research Awards .

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components , funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

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. Foreign organizations must obtain a NATO Commercial and Government Entity (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.

All PD(s)/PI(s) must be registered with ORCID . The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help .

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. 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 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 ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice , or other notice from NIH Guide for Grants and Contracts ). Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. If mechanistic studies are proposed, describe the appropriate expertise within the biosketch of the individual who will have the general responsibility for the scientific and the technical/laboratory aspects of the proposed work. This person may be the application's PD/PI or a single PD/PI in a multi-PD/PI application.

If a platform trial is proposed, describe the appropriate expertise in statistical design and analysis within the biosketch of the individual that will be responsible for the design of the platform trial. All instructions in the How to Apply- Application Guide must be followed. All applications must request funding needs for the entire trial and data analysis period.

In addition to funds required to support clinical trial conduct, the budget should reflect sufficient funds to support independent study monitoring, medical and data monitoring, clinical site monitoring, regulatory submissions, quality management, safety oversight activities. Costs of study agent and/or product, labeling, distribution should also be delineated, if applicable.

If parts of the costs of the trial are to be borne by sources other than NIH, these contributions must be presented in detail along with supporting letters signed by individuals who have the authority to make fiduciary commitments on behalf of the institution.

These outsource costs do not constitute cost sharing as defined in the current NIH Grants Policy Statement and should not be presented either as part of the requested budget or as Estimated Project Funding. NIAID reserves the right to independently procure drug for the study if that offers cost or other advantages to the clinical trial.

Further information concerning budget preparation may be obtained from the Financial/Grants Management Contact(s) listed in Section VII. Agency Contacts. All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply - Application Guide must be followed. All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: Each application may propose a single clinical trial that may include more than one intervention.

A single platform trial that allows for simultaneous comparison of multiple intervention groups against a single control group or a trial that includes more than one sequential stage is permitted. All clinical trial planning activities must be completed prior to the time of application submission and investigators must be ready to implement the proposed trial at the time of award.

As applicable, mechanistic studies will be supported as part of the proposed clinical trial. DAIT-focused clinical trials on allergic, autoimmune, and immune-mediated diseases or transplantation must include mechanistic studies. Prior to initiation, protocols and consent forms may be subject to review by NIAID.

Investigators are strongly encouraged to contact the Scientific/Research Contact(s) listed in Section VII. Agency Contacts for more information regarding division-specific clinical protocol templates. Specific Aims: Specify the primary and major secondary outcomes and endpoints to be measured.

Provide a clear explanation of the importance of various outcome measures and endpoints and their relevance to the hypothesis being tested.

Research Strategy: Within the Research Strategy describe the following: Studies that led to the proposed clinical trial and information or data from preliminary studies which address the need for and the feasibility of the trial Significance of the clinical and mechanistic (if applicable) problem(s) being studied How the trial will test the proposed hypothesis(es), and the potential impact of the results of the trial A clear rationale for the need of a 6- or 7-year project period that is linked to the clinical trial's specific aims and delineated milestones, if applicable Potential biases or challenges in the protocol and how they will be addressed Plans for appropriate oversight over the conduct of the trial, including at a minimum the appropriate clinical monitoring independent of the study team, safety monitoring, regulatory compliance plan and approval timelines, and quality management (limit to new details not provided in the Data and Safety Monitoring Plan in Section 3.

3 of the PHS Human Subjects and Clinical Trials Information section) Demonstrated consideration of ethical issues involving the disease/condition under study Activities related to the conduct, completion, and analysis, including statistical approach, of the clinical trial Anticipated impediments that could require a revision in the timeline and alternative approaches Applications proposing a platform trial must include details about the interventions to be included and contain sufficient detail to assess the totality of planned interventions Letters of Support: Provide letters of support to document access to or commitment of critical resources, including consortium and/or site participants, cores, laboratories, pharmacies, data management resources, or other collaborators, including sharing of NIH resources, in the case of intramural collaborators.

Intramural scientist collaborators are referred to their intramural division contacts for additional guidance on Intramural Scientist Collaboration on Extramural Funded Grants.

If co-funding or in-kind support is planned from any source (non-NIH sources or NIH sources), letter(s) of commitment (e.g., type, amount, and source of support), signed by a business official, on organization letterhead, must be included in the Letters of Support section. 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 .

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions: A Data Management and Sharing Plan (DMS Plan) is required for any NIH-funded or conducted research that will generate scientific data. Applicants must submit the DMS Plan at the time of application using the NIH DMS Plan Format Page . The DMS Plan must address the elements in the structured format.

Where the DMS Plan Format Page requires a "Yes or No" response, no additional narrative is allowed. Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide .

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix. The following modifications apply: Include the informed consent form(s) and, if applicable, assent form(s). Complete Clinical Protocol: include a complete protocol as part of the Appendix.

Investigators should contact the relevant Scientific/Research Contact(s) listed in Section VII. Agency Contacts to obtain the NIAID Division-specific protocol template for their application. Investigators are urged to address all protocol template elements in a succinct manner.

Applications that lack the Complete Clinical Protocol are incomplete and will not be reviewed. Provide the informed consent forms, assent forms and the Complete Clinical Trial Protocol combined in a single PDF file in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the 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 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.

Section 2 - Study Population Characteristics Detailed protocol-specific milestones for major project stages and/or activities and completion of the clinical trial. A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity. Discuss the feasibility and appropriateness of achieving and completing milestones on time.

Include alternative approaches and contingency plans should there be delays and/or impediments in attaining milestones. Milestones will be negotiated at the time of award, as appropriate Include a Gantt chart to describe the timeline for all milestones.

A timeline for the following general milestones, as applicable Timing of enrollment of 25%, 50%, 75% and 100% of the projected recruitment for all study subjects, including a plan for initial site activation and expected timing of screening/enrollment of first participant Timing of completion of data collection Timing of completion of primary endpoint and secondary endpoint data analyses Completion of clinical study report Completion of regulatory approvals Submission of initial manuscript Additional milestones, as applicable, such as personnel training completion, communication and/or submission to U.S. Food and Drug Administration (FDA) or FDA equivalent, DSMB reporting, completion of biospecimen analyses, etc. These milestones will be negotiated at the time of the award, as appropriate For clinical trials requesting an extended project period of 6- or 7-years, include a 6- or 7-year milestone plan Section 3 - Protection and Monitoring Plans 3.

3 Data and Safety Monitoring Plan The Data and Safety Monitoring (DSM) Plan must address the following areas: Where the monitoring will occur How site(s)/center(s), and participating facilities (labs, pharmacies) will be monitored Appropriate oversight for conduct of the trial, including at a minimum the appropriate clinical monitoring independent of the study team, safety monitoring, regulatory submissions and compliance and quality management A clinical data management plan describing: (1) database system to be employed, (2) compliance with federal regulations, (3) security and emergency back-up, and (4) quality control of data from clinical sites and laboratories, as appropriate Applications that lack the DSM Plan are incomplete and will not be peer reviewed.

3.

5 Overall Structure of the Study Team This section must include: A description of the study organization and administration, including, but not limited to: a description of committee structures needed to manage the complexity of the trial; the role of any internal or external advisory committees; the oversight, responsibilities, and coordination of any sites or cores proposed; and the role of any subawards or service providers for personnel or facilities.

Note: If proposing an external advisory committee, then please do not contact potential members prior to award nor propose their names in the application. Section 4 - Protocol Synopsis 4. 5 Will the study use an FDA-regulated intervention?

4. 5. a If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status If FDA staff have determined that IND/IDE approval is not required, include a copy of the FDA letter/email stating no IND/IDE is required and the date of the decision.

Section 5 - Other Clinical Trial-related Attachments 5.

1 Other Clinical Trial-related Attachments The following additional documents should be included as attachments: Identification and qualifications of clinical trial site(s), pharmacies, and laboratories Copies of data collection forms, questionnaires, or other relevant materials, including the Table of Contents of the Manual of Operations (MOPs) and a comprehensive Laboratory Plan A plan to implement and monitor Good Clinical Practices (GCP) (see NOT-OD-16-148 ), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), as appropriate.

Documentation of availability of study agent(s), as well as plans and support for acquisition, distribution, and administration of study agent(s), including the Investigator's Brochure or equivalent for the study products(s), if applicable Documentation of any communications with regulatory authorities, if applicable If any of these documents requested in Section 5 are not available at the time of submission, substitute a justification for their omission.

The Study Timeline included as part of the application should address when these materials will be available, if applicable. 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 All instructions in the How to Apply- Application Guide must be followed. Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement , and procedures for foreign organizations described throughout the How to Apply- Application Guide. 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). 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