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 Grant (R01)

Activity Code

R01 Research Project Grant  

Announcement Type

Reissue of PAR-13-149

Related Notices
Funding Opportunity Announcement (FOA) Number

PAR-16-269

Companion Funding Opportunity

PAR-16-270U01 Research Project Cooperative Agreement
PAR-16-272R34 Clinical Trial Planning Grant Program

PAR-16-271, U44 Small Business Innovation Research (SBIR) Cooperative Agreement

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

93.855, 93.856

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications for implementation of investigator-initiated, non-high-risk clinical trials.  The trials should be hypothesis-driven, related to the research mission of the NIAID and considered a high priority by the Institute.  Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID (https://www.niaid.nih.gov/research/role). Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation (R01) Grant application. 

Key Dates

 

Posted Date

May 18, 2016

Open Date (Earliest Submission Date)

August 13, 2016

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

September 13, 2016; January 13, 2017; May 12, 2017; September 13, 2017 January 12, 2018; May 14, 2018; September 13, 2018; January 14, 2019; May 13, 2019, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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.

AIDS Application Due Date(s)

September 13, 2016; January 13, 2017; May 12, 2017; September 13, 2017 January 12, 2018; May 14, 2018; September 13, 2018; January 14, 2019; May 13, 2019, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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.

Scientific Merit Review

Non-AIDS Applications: February 2017; June 2017; October 2017; February 2018; June 2018; October 2018; February 2019; June 2019; October 2019

AIDS Applications:  December 2016; April 2017; August 2017; December 2017; April 2018; August 2018; December 2018; April 2019; August 2019

Advisory Council Review

Non AIDS Applications:  May 2017; October, 2017; January 2018; May 2018; October 2018; January 2019; May 2019; October 2019; January 2020;

AIDS Applications:  January 2017; May 2017; October, 2017; January 2018; May 2018; October 2018; January 2019; May 2019; October 2019

Earliest Start Date

Non-AIDS Applications:  July 2017; December 2017; March 2018; July 2018; December 2018; March 2019; July 2019; December 2019; March 2020

AIDS Applications:  March 2017; July 2017; December 2017; March 2018; July 2018; December 2018; March 2019; July 2019; December 2019

Expiration Date

May 14, 2019

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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

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

  3. Go to Grants.gov to download an application package to complete the application forms offline or create a Workspace to complete the forms online; submit your application to Grants.gov; and track your application in eRA Commons.
Learn more about the various submission options.

Table of Contents

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

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


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

This Funding Opportunity Announcement (FOA) encourages applications for implementation of investigator-initiated, non-high-risk clinical trials.

A clinical trial is defined by NIH 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." - See more at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html

In addition any research study that will require a regulatory oversight (such as IND or IDE) will be in the scope of this FOA.

The proposed trial should be hypothesis-driven, related to the research mission of the NIAID, and address a research area considered a high priority by the Institute. For HIV-related clinical trials, NIAID encourages projects that integrate biomedical and behavioral interventions; studies that explore pathogenesis of HIV infection within the trial are also encouraged. 

This FOA will utilize the NIH R01 research project grant mechanism, and coincide with three related FOAs, PAR-16-272PAR-16-270 and PAR-16-271 that invite applications for NIAID Clinical Trial Planning (R34) Grants, which support planning activities for investigator-initiated clinical trials, NIAID Clinical Trial Implementation (U01) Cooperative Agreement, which support implementation of  high-risk clinical trials, and NIAID SBIR Phase II Implementation Cooperative Agreement (U44), which supports small business concerns for hypothesis-driven, milestone-driven clinical trials, respectively.

Background

Over the past three years, NIAID committed over $4 billion to clinical research, of which $2 billion was devoted to clinical trials. Clinical trials are one research strategy NIAID uses to improve the understanding of the clinical mechanisms of infectious, immunologic, and allergic diseases or to improve prevention, diagnosis, and treatment. For additional information about the mission, strategic plan, and research interests of the NIAID, applicants are encouraged to consult the NIAID web site https://www.niaid.nih.gov/research/role.

Clinical Trial Infrastructure

Historically, NIAID has supported a wide variety of clinical research activities through a clinical trial infrastructure funded through cooperative agreements, solicited under NIAID Funding Opportunity Announcements (FOAs), and contracts, solicited under NIAID Requests for Proposals (RFPs). This infrastructure focuses on high-priority disease research areas. Examples include the HIV/AIDS Clinical Trial Networks supported by the Division of AIDS (https://www.niaid.nih.gov/research/hivaids-clinical-trials-networks), the Division of Microbiology and Infectious Diseases Clinical Trials Programs and Networks (https://www.niaid.nih.gov/research/networks?keyword=&division=12 ), and the Immune Tolerance Network supported by the Division of Allergy, Immunology and Transplantation (http://www.immunetolerance.org/). NIAID’s clinical research infrastructure includes coordinating centers, statistical units, data centers, central laboratories, clinical centers, and other specialized resources. For additional information on DMID supported clinical trials refer to the DMID Good Clinical Practice Resource Guide    (https://www.dmidcroms.com/Shared%20Documents/Good%20Clinical%20Practice%20Resource%20Guide.pdf).  For additional information on DAIDs supported clinical trials refer to the Division of AIDS (DAIDS) Clinical Research Policies and Standard Procedures Documents:  https://www.niaid.nih.gov/research/daids-clinical-research-policies-standard-procedures .  For additional information on DAIT Clinical Research Policies and Documents: https://www.niaid.nih.gov/research/dait-clinical-research-policies-and-standards .

Investigator-Initiated Clinical Trials

Although clinical research infrastructure is crucial to furthering the Institute’s research, NIAID recognizes that additional models of clinical research may be important to advancing its research mission; therefore, NIAID has established the investigator-initiated clinical trial program for clinical trials that cannot or will not be conducted through existing NIAID-supported clinical trial infrastructure. This program consists of support for the NIAID Clinical Trial Planning (R34) Grant, the NIAID Clinical Trial Implementation (R01) Grant and the NIAID Clinical Trial Implementation (U01) Cooperative Agreement.  The NIAID Clinical Trial Implementation (R01) Grant (PAR-16-269) is designed to support non-high-risk clinical trials, while the NIAID Clinical Trial Implementation (U01) Cooperative Agreement (PAR-16-270) is designed to support high-risk clinical trials, as defined by NIAID below and in the associated policy statement (see NOT-AI-10-024). The NIAID Clinical Trial Planning Grant (R34) is available to support planning activities associated with either high- or non-high-risk clinical trials. However, the NIAID Clinical Trial Planning (R34) Grant (PAR-16-272) is not a prerequisite for either NIAID implementation award. If a clinical trial is ready for implementation, and readiness is adequately supported by appropriate documentation, the R01 or U01 application may be submitted to the appropriate FOA.

For additional information about NIAID’s investigator-initiated clinical trial program, see https://www.niaid.nih.gov/grants-contracts/investigator-initiated-clinical-trial-resources

Scope

The NIAID Clinical Trial Implementation Grant supports implementation of non-high-risk clinical trials that address research areas that are well matched with the mission and goals of NIAID. 

A high-risk clinical trial is defined by the NIAID as having one or more of the following attributes:

  • provision of a non-routine intervention, that is, an intervention or non-routine use of 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.

A non-high-risk trial would not have any of the attributes listed above; for example, it would involve provision of a routine intervention and administration of a licensed product for an approved indication. Applicants are strongly encouraged to contact NIAID staff listed in Section VII. Agency Contacts for questions concerning the classification of the proposed clinical trial.

Activities and communications regarding all clinical laboratory testing for study participants must comply with US federal regulations [see 42 CFR part 493.2 and 493.3(b)(2)].

For the purposes of this FOA, implementation support is defined as support for activities related to the conduct of the clinical trial, including, but not limited to:

  • training of study personnel;
  • enrollment and recruitment of study subjects;
  • data collection, management and quality control;
  • laboratory work and data analyses;
  • study management and oversight;
  • establishment of committees to manage the complexity of the trial; and
  • preparation of the final study report; and other related post-enrollment activities
  • Regulatory activities and site monitoring.
  • Clinical Trial Insurance costs

Each NIAID Clinical Trial Implementation award will support the implementation of a single clinical trial that may include more than one intervention. Applications that include more than one clinical trial will not be supported by this FOA.  

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.

NIAID reserves the right to specify: 1) whether an IND (Investigational New Drug)/IDE (Investigational Device Exemption) application should be submitted to an appropriate regulatory agency; 2) the entity (NIAID, primary awardee, etc.) who will hold the IND/IDE; and 3) the requirements for the establishment of a DSMB (Data Safety Monitoring Board)/SMC (Safety Monitoring Committee).  Applicants are encouraged to discuss those decisions and requirements with NIAID prior to submission of the application.

Mechanistic studies should be part of the application for all clinical trials sponsored by DAIT.  DAIT will not fund applications without the inclusion of mechanistic studies.  

Investigators are referred to NIAID’s Clinical Research Toolkit website (https://www.niaid.nih.gov/research/trans-niaid-clinical-research-toolkit) for protocol templates and guidance, clinical research resources, and links to program divisions. Investigators are strongly encouraged to contact NIAID’s program divisions (Agency Contacts) for information regarding division-specific clinical research policies and procedures as well as review the Division specific research polices and start procedure documents for protocol templates and guidance and requirement for clinical trials.  Prior to initiation, protocols and consent forms may be subject to review by the NIAID Division.

Milestones

Delineation of milestones is a key characteristic of the NIAID Clinical Trial Implementation Grant. A milestone is defined as a scheduled event in the project timeline, signifying the completion of a major project stage or activity.

The milestones will undergo peer review and will be incorporated into the terms of award.

 
Exclusions

NIAID R01 clinical trial implementation grants will NOT support clinical trial planning tasks such as:

  • 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 data management plan
  • Development of the Investigator’s brochure or equivalent

Applications that propose to conduct planning activities will not be reviewed. Investigators seeking support for the planning and design of clinical trials should refer to the NIAID Clinical Trial Planning (R34) Grant FOA (PAR-16-272).

NIAID R01 clinical trial implementation grants will NOT support high-risk clinical trials. Investigators seeking support for high-risk clinical trials should refer to the NIAID Clinical Trial Implementation Cooperative Agreement (U01) Grant FOA (PAR-16-270).

NIAID R01 clinical trial research project grants will NOT provide support for clinical trials that fall outside the mission and high-priority research areas of the NIAID and will not support more than one clinical trial in a single application.

For more information, please see the Investigator-Initiated Clinical Trial Questions and Answers at: https://www.niaid.nih.gov/grants-contracts/investigator-initiated-clinical-trials-faqs

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

Section II. Award Information

 

Funding Instrument

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

Application Types Allowed

New
Resubmission
Revision

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

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The scope of the proposed project should determine the project period. The maximum period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Higher Education Institutions

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

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

o    Hispanic-serving Institutions

o    Historically Black Colleges and Universities (HBCUs)

o    Tribally Controlled Colleges and Universities (TCCUs)

o    Alaska Native and Native Hawaiian Serving Institutions

o    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)

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)
  • 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
  • Non-domestic (non-U.S.) Entities (Foreign Institutions)
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) 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.

Required Registrations

Applicant Organizations

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

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • 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. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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 NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

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:

Priti Mehrotra, M.Sc., Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5066
Email: pm158b@nih.gov

Page Limitations

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments: The following items must be included as attachments.

Clinical Protocol Synopsis

The filename "Clinical Protocol Synopsis.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers. Do not duplicate information provided in the Research Strategy.

The clinical protocol synopsis must include the following information:

  • Title
  • Participating Sites(s)
  • Hypothesis
  • Primary objectives
  • Intervention(s) including justification for dose / schedule selected
  • Study Design, including schema showing schedule of interventions, procedures and evaluations
  • Study population, including sample size and subject inclusion/exclusion criteria
  • Primary endpoints
  • Rationale, including justification for the selection endpoints and interventions(s)

Applications that lack the Clinical Protocol Synopsis are incomplete and will not be peer reviewed.

Statistical Analysis Plan

The filename "Statistical Analysis Plan.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers.

This plan is critical to knowing whether applicants have selected the correct cohort size based on proper power calculations and/or are using the most appropriate methods to analyze the resulting data and make correct conclusions at the end of the study. The ability to make conclusions of primary outcomes other than safety will be particularly important in small studies. This is the plan is to clarify how the statistical analysis will be designed, as well as  clarify the underlying assumptions (and data) used to link these calculations to the endpoints and to the hypothesis(es) being tested. This should not discuss statistical methods, including sample size and power calculations, or other information in the Research Strategy attachment.

Applications that lack the Statistical Analysis Plan are incomplete and will not be peer reviewed.

Milestone Plan

The filename "Milestone Plan.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers.

Applications must include a series of milestones for completion of the clinical trial and provide contingency plans should there be delays in attaining them. The milestones will undergo peer review and will be incorporated into the terms of award.

Applicants are required to provide detailed project performance and timeline objectives in a section entitled “Milestone Plan”. This section must include:

  • A timeline for the following general milestones, as applicable;
  • Completion of regulatory approvals;
  • Enrollment of the first subject;
  • Enrollment of 25%, 50%, 75% and 100% of the projected recruitment time period for all study subjects, including women, minorities and children (as appropriate);
  • Completion of data collection time period;
  • Completion of primary endpoint and secondary endpoint data analyses time period;
  • Completion of final study report; and
  • Detailed protocol-specific performance milestones and timeline; these milestones will be negotiated at the time of the award, if appropriate.

Applications that lack the Milestone Plan are incomplete and will not be reviewed.

Complete Clinical Protocol

The filename "Complete Clinical Protocol.pdf" should be used and will be reflected in the final image bookmarking for easy access for reviewers.

The complete Clinical Protocol must be included immediately after the Milestone Plan.

Investigators are referred to the Trans-NIAID Clinical Research Toolkit website for clinical protocol guidance and templates (https://www.niaid.nih.gov/research/trans-niaid-clinical-research-toolkit ). Investigators are urged to be succinct.

Applications that lack the Complete Clinical Protocol are incomplete and will not be reviewed.

The following additional documents must be included as attachments:

  • the informed consent form(s) and, if applicable, assent form(s)
  • identification and qualifications of clinical trial site(s), pharmacies and laboratories
  • copies of data collection forms, questionnaires or other relevant materials
  • the Investigator’s Brochure or equivalent for the study products(s)
  • the Table of Contents of the Manual of  Operations
  • a comprehensive Laboratory Plan
  • plans and support for acquisition and administration of study agent(s); Documentation of availability of study agent should be in Letters of Support
  • documentation of co-funding of clinical trials from partners, if applicable
SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.  When mechanistic studies are proposed, the application should identify an individual who will have the general responsibility for the scientific and the technical/laboratory aspects of the proposed work.  This individual may be the application's PD/PI or one of the PD/PIs in a multi-PD/PI application.

R&R or Modular Budget

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

Because all applications must include detailed scientific and operational plans, funding needs for the entire trial and data analysis period must also be included.  In addition to funds required to support clinical trial conduct, the budget should reflect sufficient funds to support independent study monitoring, regulatory submissions, quality management, safety oversight activities and Clinical Trial insurance, as appropriate. Costs of study drug/product, labeling, distribution should also be delineated if applicable. Investigators must submit a complete, justified, individual budget for each year of support requested. All costs requested and all changes in budgets after the first year should be clearly identified and justified. 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 (see Letters of Support in the PHS 398 Research Plan below). 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.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: The goals of the trial and the expected outcome(s) should be concisely stated in the Specific Aims section. The specific objectives of the trial must be clearly and concisely presented, including a specification of the primary and major secondary endpoints to be measured. There should be a clear explanation of the importance of various endpoints.

Research Strategy: The following three sections comprise the Research Strategy: Significance, Innovation, and Approach. The Research Strategy must include:

  • An overview of the state of the science, a discussion of the significance of the clinical and mechanistic (if applicable) problem(s) being studied, the need for the trial, and the potential impact of the results of the trial, as well as how the trial will test the hypothesis(es) proposed and have clear primary and secondary endpoints
  • a concise description of the overall strategy, methodology and analyses to be used to accomplish the goals and specific aims of the trial;
  •  
  • a discussion of potential biases or challenges in the protocol and how they will be addressed;
  • statistical methods that are appropriate for the study design, including sample size and power calculations (this should not duplicate the  specific topics discussed in  the Statistical Analysis Plan);
  • a discussion of 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; and
  • 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 sub-contractors or service providers for personnel or facilities.
  • A description of the plans to implement and monitor Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), as appropriate.
  • The appropriate oversight over the conduct of the trial, including at a minimum the appropriate clinical monitoring, safety monitoring, regulatory submissions and quality management (this is in addition to what is in the Data Safety Monitoring Plan).
  • Explanation why the study population is an appropriate group to study the research question(s) posed, subject eligibility, inclusion and exclusion criteria, and a feasible recruitment and enrollment plan must also be included; plans for recruitment and ensuring availability of study participants, including plans for recruitment and retention of children, women, and minorities, if these are included in the study; indicate plans for recruitment outreach and follow-up procedures;
  • The process to be used for obtaining informed consent and, if applicable, assent;
  • Plans for acquisition and handling of study agent(s), if applicable;
  • Demonstrated consideration of ethical issues involving the disease/condition under study.
  • Any anticipated impediments that could require a revision in the timeline must be identified and accompanied by a discussion of alternative approaches
  • Data Safety Monitoring Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: The DSM Plan must address the following areas:

  • Where the monitoring will occur;
  • How the reportable events will be managed and reported; and
  • How site(s)/center(s), and participating facilities (labs, pharmacies) will be monitored.

Applications that lack the DSM Plan are incomplete and will not be peer reviewed.

Letters of Support: Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium/site participants, cores, laboratories, pharmacies and other collaborators, including cost-sharing by NIH resources, in the case of intramural collaborators. Investigators are referred to https://www.niaid.nih.gov/research/intramural-collaboration-extramural-funded 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) outlining details of the commitment (e.g. type, amount and source of support), signed by a business official on organization letterhead, and 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 SF424 (R&R) Application Guide, with the following modification:

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

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

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

PHS Assignment Request Form

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

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

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

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

See more tips for avoiding common errors.

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

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 10 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or more in Direct Costs as described in the SF424 (R&R) Application Guide.

Prior Consultation with NIAID

Consultation with NIAID staff at least 10 weeks prior to the application due date is strongly encouraged for submission of the NIAID Clinical Trial Implementation Grant application, including new and resubmission applications. If requested, NIAID staff will consider whether the proposed clinical trial meets the goals and mission of the Institute, whether it addresses one or more high priority research areas, and whether it is appropriate to conduct  as an investigator-initiated clinical trial. Prior consultation with NIAID staff is required a minimum of 10 weeks prior to the application due date if the budget is equal to or greater than $500,000 direct costs per year for any year of the proposed trial. NIAID staff will not evaluate the technical and scientific merit of the proposed trial; technical and scientific merit will be determined during peer review using the review criteria indicated in this FOA. NIAID staff members are also available to work with potential applicants to determine the risk level of the proposed trial and delineate all documentation that will be needed at the time of application submission. During the consultation phase, if the proposed trial does not meet NIAID’s programmatic needs or is not appropriate as an investigator-initiated clinical trial, applicants will be strongly encouraged to consider other Funding Opportunities. NIAID reserves the right to provide support for clinical trials through other available mechanisms supported by NIAID. If NIAID ascertains that substantial additional planning may be necessary, or that substantial staff involvement may not be necessary, the applicant will be encouraged to consider funding under the Clinical Trial Planning Grant (R34) (PAR-16-272) or the Clinical Trial Implementation Cooperative Agreement (U01) FOA (PAR-16-270), respectively.

A letter that summarizes the discussion during prior consultation may be obtained from the appropriate NIAID Division Director and attached as in the Cover Letter attachment field on the SF424(R&R) Cover form. 

Post Submission Materials

Applicants are required to follow our Post Submission Application Materials policy.

Section V. Application Review Information
1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

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

Scored Review Criteria

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Is the need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, information in the literature or knowledge of biological mechanisms? Is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?

Investigator(s)

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

Evaluate the proposed leadership for the project. Do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics?

Innovation

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

Approach

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

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

Does the application adequately address the following, if applicable?

Study Design

Is the study design appropriate to address primary and secondary outcome variable(s) that will be clear, informative and relevant to the clinical, mechanistic if applicable, and statistical hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical research? Is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the sample size, proposed intervention arms/dose, and duration of the trial, appropriate and well justified? Is the eligible population available?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate, as applicable to ensure collection of data? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity? Are the plans to standardize, quality control of, and monitor adherence to, the clinical protocol and data collection or distribution guidelines appropriate? Are the project milestones and timeline feasible and appropriate for the timely completion of the trial?

Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable? Does the application adequately address Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing Practices (GMP) compliance?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award? Is the clinical monitoring plan adequate?

Environment

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

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites, is there evidence of the ability of the individual site to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure? Are the entities that would provide safety oversight, clinical monitoring and quality monitoring adequate?   

Additional Review Criteria

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

Select Agent Research

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

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Institute of Allergy and Infectious Diseases  in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Allergy and Infectious Disease Council.

The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.
  • Sufficiency of proposed budget to support the proposed research.
3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information
1. Award Notices

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

Such "just-in-time" information may include Complete Manual of Operations; IRB or Ethical Committee approval of the final protocol and the informed consent form (and assent form if applicable); Other necessary approvals (e.g., Institutional biosafety committee) of the final protocol, as applicable.

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Scientific/Research Contact(s)

Ellen Goldmuntz, M.D., Ph.D. 
Division of Allergy, Immunology and Transplantation (DAIT)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3502
Email: egoldmuntz@niaid.nih.gov  

Martin Gutierrez
Division of Acquired Immunodeficiency Syndrome (DAIDS)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-292-4844
Email: mgutierrez@niaid.nih.gov  

Shy Shorer, M.D.
Division of Microbiology and Infectious Diseases (DMID)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3371
Email: ss932c@nih.gov

Peer Review Contact(s)

Priti Mehrotra, Ph.D. 
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5066
Email: pm158b@nih.gov

Financial/Grants Management Contact(s)

Laura Pone
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2951
Email: laura.pone@nih.gov  

Section VIII. Other Information

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

Authority and Regulations

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

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