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

National Institutes of Health (NIH)

Components of Participating Organizations

National Cancer Institute (NCI)
National Eye Institute (NEI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Complementary and Integrative Health (NCCIH)

Funding Opportunity Title

Limited Competition:  Restoring Research Resources Lost or Damaged Due to Hurricanes Harvey, Irma, and Maria (R24 Clinical Trial Optional)

Activity Code

R24 Resource-Related Research Projects

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

RFA-OD-18-102

Companion Funding Opportunity

None

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

93.663 Extramural Research Restoration Program: Hurricanes Harvey, Maria, and Irma – non-construction; 93.213; 93.393; 93.394; 93.395; 93.399; 93.396; 93.867; 93.172; 93.866; 93.273; 93.855; 93.846; 93.286; 93.865; 93.279; 93.173; 93.121; 93.113; 93.859; 93.242; 93.307; 93.853

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to provide support to help restore research resources, including animal colonies and related materials and equipment, that were lost or damaged due to Hurricanes Harvey, Irma, and Maria. Benefits of this award are restricted to the counties that FEMA declared a major disaster area in the following states and territories:  Georgia, Florida, Louisiana, South Carolina, Texas, US Virgin Islands, and Puerto Rico.

Applications submitted in response to this announcement will be considered for funding only with funds received under the Bipartisan Budget Act of 2018 P.L. 115-123. Funds will be provided in a single award with a 24-month budget and project period. No-cost extensions will not be available. Support will be considered for replacement only of those animals and other materials that were extant before Hurricanes Harvey, Irma, and Maria and were being used in connection with funded grant support or otherwise being used actively but were lost due to the hurricane(s).

These funds cannot duplicate nor overlap with reimbursement provided by the Federal Emergency Management Agency (FEMA), under a contract for insurance, or by self-insurance.    

Key Dates
Posted Date

October 29, 2018

Open Date (Earliest Submission Date)

November 14, 2018

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

December 14, 2018, 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.

AIDS Application Due Date(s)

Not applicable

Scientific Merit Review

February/ March 2019

Advisory Council Review

May 2019

Earliest Start Date

July 2019

Expiration Date

December 15, 2018

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from 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. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. 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

    Purpose

    The purpose of this funding opportunity announcement (FOA) is to restore Research Resources, including animal colonies and related materials and equipment, that were severely damaged in some Institutions impacted by Hurricanes Harvey, Irma, and Maria and with NIH grants active at the time of the storms.  Benefits of this award are restricted to the counties that FEMA declared a major disaster area in the following states and territories:  Georgia, Florida, Louisiana, South Carolina, Texas, US Virgin Islands, and Puerto Rico.

    Applications submitted in response to this announcement will be considered for funding only with funds received under the Bipartisan Budget Act of 2018, P.L. 115-123.  Funds provided by NIH through these supplements cannot duplicate nor overlap with reimbursement provided by FEMA, under a contract for insurance, or by self-insurance.

    Funds will be provided in a single award with a 24-month budget and project period.  No-cost extensions will not be available. Therefore, the applicant must assure that the scope of work proposed and outlays of awarded funds can be completed within this 24-month period.

    Losses may have included animals (e.g., genetically modified variants, wild strains); cryopreserved germ plasm and cell lines; reagents; equipment related to maintenance of animal records; equipment directly related to animal-based experiments or cryopreservation such as freezers, surgical apparatus, etc.; and materials of human origin such as cell lines and tissues.  Other losses also may have been incurred.  This FOA provides support to restore these types of losses, including, but not limited to:

    • Specific strains of animals, including both wild type and genetically modified or mutant strains.  Applicants are encouraged to obtain replacement animals by the least expensive means possible, for example, as living animals from national repositories or companies.  Applicants may also replace animal stocks by obtaining germ plasm or embryos, when appropriate, and re-deriving living stocks in their own facilities.  In some cases, mutant animals or cryopreserved germ plasm may have been stored in secondary locations.  Support will be provided for purchasing, shipping and handling of materials from these remote locations (for example a national resource facility or a secondary or back-up storage facility).
    • In cases of unique variants that are not available from repositories or companies, derivation of live animals that may have been cryopreserved as germ plasm or embryos at a remote location or that are recoverable from the damaged facility.  Rederivation can be accomplished through an outside service or in the laboratory that was affected by the storm.  Applicants should use the most cost-effective means of rederiving animals.
    • Testing of animals or cryopreserved material for quality control purposes, for example, for the presence of specific genetic modifications or pathogens.
    • Cryopreserved animal germ plasm or animal cell lines.  Support will be provided for generating the quantities of these materials that were present before Hurricane Harvey, Maria, and/or Irma.
    • Reagents required for animal-based purchasing, importation, testing (genetic background and infectious status), and maintenance of germ plasm or cell lines.
    • Equipment related to the following:  a) animal records systems; b) cryopreservation (e.g., freezers); c) preparation of animals for experimental protocols (e.g., surgical apparatus); d) embryo transfer; e) necropsies, f) others, as appropriate.
    • Human cell lines, tissues and records systems related to ongoing experiments.

    Applications requesting the following will be deemed non-responsive and will not be  supported by this FOA:

    • Research resources such as specific strains of animals that can be obtained or rederived using funding from a supplement to an active grant funded by one of the NIH Institutes and Centers.  These should be requested in response to (PA-18-936
    • Construction or renovation of animal facilities, including caging, cage washers, autoclave, etc.
    • Computers or other equipment related to information technology that are not directly related to use or maintenance of animal records systems or systems involved in record keeping related to human cells or tissues.
    • Animals, reagents or equipment that were not extant at the facility before Hurricane Harvey, Maria, and/or Irma.
    • Animals, reagents or equipment that were not being used in connection with a funded grant or were not being used actively before Hurricane Harvey, Maria, and/or Irma.

    Responsive Applications

    Applications must meet the following criteria to be considered responsive to this FOA:

    • Applicant institution was damaged as a result of Hurricane Harvey, Maria, and/or Irma defined as, and limited to, the counties that FEMA declared a major disaster area in the following states and territories: Georgia, Florida, Louisiana, South Carolina, Texas, US Virgin Islands, and Puerto Rico.
    • A letter from the institution is included in the application that verifies that animals (e.g., genetically modified variants, wild strains); cryopreserved germ plasm and cell lines; reagents; equipment related to maintenance of animal records; equipment directly related to animal-based experiments or cryopreservation such as freezers, surgical apparatus, etc.; and/or materials of human origin such as cell lines and tissues existed prior to the hurricane and includes a description of the extent of the damage, destruction or loss resulting from the hurricane. Also, the letter must confirm that the application does not request any funding that overlaps with FEMA, under a contract for insurance or self-insurance payments. The letter must be signed by an institutional Signing Official. 

    Non-Responsive Applications

    Applications meeting any of the following criteria will be considered non-responsive and will not proceed to peer review:

    • Applicant institution does not meet the definition of an institution impacted by Hurricane Harvey, Maria and/or Irma.
    • A letter of support from the institution was: (a) NOT included in the application, (b) did not verify that animals (e.g., genetically modified variants, wild strains); cryopreserved germ plasm and cell lines; reagents; equipment related to maintenance of animal records; equipment directly related to animal-based experiments or cryopreservation such as freezers, surgical apparatus, etc.; and/or materials of human origin such as cell lines and tissues existed prior to the hurricane, (c) did not describe the extent of damage, destruction or loss, or (d) did not include a statement that the application does not request any funding that overlaps with FEMA, under a contract for insurance or self-insurance payments. 

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

    Section II. Award Information
    Funding Instrument

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

    Application Types Allowed

    New

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

    Clinical Trial?

    Optional: Accepting applications that either propose or do not 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 funds received from the Bipartisan Budget Act of 2018 and the submission of a sufficient number of meritorious applications.

    The NIH intends to commit up to approximately $20 million; awards will be made in FY 2019. The extent of losses and severity of damages on the research and directly related to Hurricanes Harvey, Irma, and/or Maria, will be used in prioritizing funding decisions.

    Award Budget

    Application budgets are not limited but need to reflect the actual needs of the proposed project. Award funds shall be expended within 24 months of the Initial Issue Date listed on the Notice of Award.

    Award Project Period

    The total project period may not exceed 2 years. Funds will be provided in a single award with a 24-month budget and project period.  No-cost extensions will not be available. Therefore, the applicant must assure that the scope of work proposed, and outlays of awarded funds can be completed within this 24-month period.    

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

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    Eligibility is limited to research institutions located in counties that FEMA declared a major disaster area in the following states and territories: Georgia, Florida, Louisiana, South Carolina, Texas, Puerto Rico, and US Virgin Islands.

    Foreign Institutions

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

    Required Registrations

    Applicant Organizations

    Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. 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

    Buttons to access the online ASSIST system or to download application forms are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    2. Content and Form of Application Submission

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

    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:

    Larry Pinkus, Ph.D.
    Telephone: 301-435-1214
    Email: pinkusl@csr.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. with the following additional instructions:

    Provide a letter from the institution that verifies that animals (e.g., genetically modified variants, wild strains); cryopreserved germ plasm and cell lines; reagents; equipment related to maintenance of animal records; equipment directly related to animal-based experiments or cryopreservation such as freezers, surgical apparatus, etc.; and/or materials of human origin such as cell lines and tissues existed prior to the hurricane and that describes the extent of the damage, destruction or loss resulting from the hurricane. The letter must confirm that the application does not request any funding that overlaps with FEMA, under a contract for insurance, or self insurance payments. The letter must be signed by an institutional Signing Official.  

    SF424(R&R) Senior/Key Person Profile

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

    R&R Budget

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

    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:
    • A concise description of the resource-related activities that were being performed prior to the hurricane, including the number of animals, cell lines and human tissues used under active sponsored research.
    • A narrative indicating the damage that occurred as a result of Hurricane Harvey, Irma, and/or Maria and the present state of facilities that can be used for animal housing, procedures involving animals and human cell lines and tissues. If facilities must be rebuilt or repaired, the applicant must discuss plans for these repairs and how the schedule will impact the ability to perform the functions, house the animals, etc., that are requested in the application.
    • A rationale for each component of the application, including a justification for each particular strategy (e.g., if a specific strain of animal is proposed to be rederived rather than purchased).
    • A plan for sustaining the animal colony/activities beyond the two year limit of funding provided by this FOA.  The plan should include a discussion of funding strategies that were in place before the Hurricane and any necessary modifications.  A plan that simply proposes the request of further funding from NIH will not be considered to be adequate. 
    • Discussion of the status of vertebrate animal research, including availability of research organisms and status of IACUC approval of facilities and research protocols.
    • If restoration of human materials such as cell lines or tissues is proposed, a discussion of the status of human subjects approvals and how additional approvals will be obtained, if needed.
    • The following documents must be submitted with each request for approval of minor A&R costs (See Sec. 1.2,  Definition of Terms, of the NIH Grant Policy Statement) greater than $300,000, but not more than $500,000 (whether proposed in the application or as a post-award rebudgeting request):
    • Single-line drawing of the existing space and proposed alterations.
    • Narrative description of the proposed functional utilization of the space and equipment requirements prepared by the program and administrative managers who will use and be responsible for the working space and, when appropriate, with input from architectural and engineering advisors. Final drawings and specifications will be based on this description. The description must include a detailed explanation of the need, character, and extent of the functions to be housed in the space proposed for A&R, using the following headings, as appropriate:
    • General information
    • Description of the functions to be performed in the space
    • Space schedule (detailed description of floor space)
    • List of fixed equipment proposed for the facility
    • Cost estimate (see sample format in Exhibit 8)
    • Special design problems
    • Description of the existing and proposed utility systems for the modified space
    • Description of plans to provide accessibility for the physically handicapped
    • Provisions for meeting the requirements of the Life Safety Code
    • Length of the property lease if the space is rented
    • Other information required by program legislation or regulations.
    • When the proposed alteration is to occur in a building that is under construction or in an incomplete structure, the following documentation also must be provided:
    • Detailed justification for the need to perform the work before the building is completed
    • Cost comparison between doing the work before and after the building is completed
    • Description of other specific benefits to be gained by doing the work before the building is completed.

    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:

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

    Include a table showing the numbers of animals, cell lines, tissues, equipment, reagents, etc. that were extant before Hurricanes Harvey, Irma, and/or Maria, were being used in connection with an active NIH grant or otherwise being used actively and were lost as a result of the storm. Indicate which of these are being requested to be replaced by the proposed funding.

    PHS Human Subjects and Clinical Trials Information

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

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

    Study Record: PHS Human Subjects and Clinical Trials Information

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

    Delayed Onset Study

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

    PHS Assignment Request Form

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

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

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

    4. Submission Dates and Times

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

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

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

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

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

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

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

    Funds will be awarded in a single action using a 24-month budget and project period.  Awarded funds shall be expended within 24-months of the Initial Issue Date listed on the Notice of Award.  No-cost extensions will not be available.

    Funds will be restricted so that they cannot duplicate costs reimbursed by FEMA, under a contract for insurance or self-insurance.  If during the period of the award a claim is paid which provides such duplication, the grantee will be required to pay back the funds to the NIH.

    Funds are only awarded for response, recovery, and other expenses directly related to the consequences of Hurricane Harvey, Irma, and/or Maria.  Any other expenses/charges are strictly unallowable. Carryover of unobligated balances is not allowed for any awards made in response to this FOA.

    Minor alteration and renovation (A&R) up to $500,000 is allowable.  See Sec. 10.8.2,  Alteration and Renovation Projects Under Non-construction Grants, of the NIH Grant Policy Statement.  Note: Eligible applicants with minor A&R costs less than $150,000 should apply to (PA-18-936). 

    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 responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the 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.

    In addition, for applications involving clinical trials:

    A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs.  Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

    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 proposed project address the needs of the research resource that it will serve? Is the scope of the activities proposed for the project appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research resource? Will the proposed activities restore the losses related to research resources incurred because of the effects of Hurricanes Harvey, Irma, and/or Maria? 

    In addition, for applications involving clinical trials

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, 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?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

    Investigator(s)

    Are the PD(s)/PI(s), and other personnel well suited to their roles in the project? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the project Does the applicant have experience overseeing selection and management of subawards, if needed?   

    In addition, for applications involving clinical trials

    With regard to 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? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

    Innovation

    Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research resource? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed?   

    In addition, for applications involving clinical trials

    Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

    Approach

    Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research resource? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are an appropriate plan for work-flow and a well-established timeline proposed? 

    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?

    Can the proposed activities, such as rederivation of animal strains or restoration of human samples, be performed using currently available facilities and/or renovated facilities during the two year duration of support? Are the methods used to restore animal colonies and/or rederive specific strains of animal the most appropriate ones for the purposes proposed?  Are the proposed methods for rederivation the most cost effective means of recovering animals and reestablishing colonies and resources?  Do the proposed activities relate only to research resources or equipment that were extant before the Hurricane(s)? Are all computers and computer-related equipment related to use and maintenance of the animal records system or involved with record keeping related to human samples? Do the applicants propose an adequate and viable plan for sustaining the animal colonies and animal-based activities beyond the funding requested under this announcement?  Are appropriate research animals available for the proposed activities?  Are appropriate methods proposed for recovery of human samples?  Is the plan for long-term sustained support of the animal resources fitting for continued maintenance of the investment to establishing the animal colonies with the funds provided under this project? 

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, 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 study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? 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, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? 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?

    Environment

    Will the institutional environment in which the resource will operate contribute to the probability of success in facilitating the research program it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the resource proposed? Will the resource benefit from unique features of the institutional environment, infrastructure, or personnel?  Are resources available within the scientific environment to support electronic information handling?

    In addition, for applications involving clinical trials

    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 multi-sites/centers, is there evidence of the ability of the individual site or center 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?

    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.

    Study Timeline

    Specific to applications involving clinical trials

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

    Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

    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

    Not Applicable.

    Renewals

    Not Applicable.

    Revisions

    Not Applicable.

    Additional Review Considerations

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

    Applications from Foreign Organizations

    Not Applicable

    Select Agent Research

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

    Resource Sharing Plans

    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 resources 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 CSR, 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.

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

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

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

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

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

    Section VI. Award Administration Information
    1. Award Notices

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

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

    Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA. 

    ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ 

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.  Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

    Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE). 

    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; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

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

    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.

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

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

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten on-time submission, and post-submission issues)

    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    General Grants Information (Questions regarding application processes and NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

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

    Scientific/Research Contact(s)

    Craig Hopp, Ph.D.
    National Center for Complementary and Integrative Health (NCCIH)
    Telephone: 301-496-5825
    Email: hoppdc@mail.nih.gov

    Stephen White, Ph.D.
    National Cancer Institute (NCI)
    Telephone: 240-276-5941
    Email: whitesl@mail.nih.gov

    Cheri Wiggs, Ph.D.
    National Eye Institute (NEI)
    Telephone: 301-451-2020
    Email: cheri.wiggs@nih.gov

    Bettie Graham, Ph.D.
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-496-7531
    Email: graphambj@exchange.nih.gov

    Robin Barr, Ph.D.
    National Institute on Aging (NIA)
    Telephone: 301-496-9322
    Email: barrr@nia.nih.gov

    Kathy Jung, Ph.D.
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone: 301-443-8744
    Email: jungma@mail.nih.gov

    Andrea Wurster, Ph.D.
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-5062
    Email: andrea.wurster@nih.gov

    Gayle Lester, Ph.D.
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    Telephone: 301-594-3511
    Email: lester1@mail.nih.gov

    Ashley Storm
    National Institute of Biomedical Imaging and Bioengineering (NIBIB)
    Telephone: 301-451-7191
    Email: ashley.storm@nih.gov

    NICHD Referral Officer
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Email: NICHDReferral@mail.nih.gov

    Tracy Waldeck, Ph.D.
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-827-5844
    Email: tracy.waldeck@nih.gov

    Janet Cyr, Ph.D.
    National Institute on Deafness and Other Communication Disorders (NIDCD)
    Telephone: 301-402-3458
    Email: cyrj@nidcd.nih.gov

    Michelle Cortes, Ph.D.
    National Institute of Dental and Craniofacial Research (NIDCR)
    Telephone: 301-827-4656
    Email: michelle.cortes@nih.gov

    Patrick Mastin. Ph.D.
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3285
    Email: mastin@niehs.nih.gov

    Luis Cubano, Ph.D.
    National Institute of General Medical Sciences (NIGMS)
    Telephone: 301-594-3900
    Email: luis.cabano@nih.gov

    Meena Hiremath. Ph.D., P.M.P.
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-3367
    Email: meenaxi.hiremath@nih.gov

    Jennifer Alvidrez, Ph.D.
    National Institute on Minority Health and Health Disparities (NIMHD)
    Telephone: 301-594-9567
    Email: jennifer.alvidrez@nih.gov

    Michelle Jones-London, Ph.D.
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-451-7966
    Email: jonesmiche@ninds.nih.gov

    Peer Review Contact(s)

    Larry Pinkus, Ph.D.
    Center of Scientific Review (CSR)
    Telephone: 301-435-1214
    Email: pinkusl@csr.nih.gov

    Financial/Grants Management Contact(s)

    Shelley Carow
    National Center for Complementary and Integrative Health (NCCIH)
    Telephone: 301-594-3788
    Email: carows@mail.nih.gov

    Crystal Wolfrey
    National Cancer Institute (NCI)
    Telephone: 240-276-6277
    Email: wolfreyc@mail.nih.gov

    Karen Robinson-Smith
    National Eye Institute (NEI)
    Telephone: 301-451-2020
    Email: karen.robinson.smith.@nei.nih.gov

    Deanna Ingersoll
    National Human Genome Research Institute (NHGRI)
    Telephone: 301-435-7858
    Email: deanna.ingersoll@nih.gov

    Robin Laney
    National Institute on Aging (NIA)
    Telephone: 301-496-1472
    Email: laneyr@mail.nih.gov

    Judy Fox
    National Institute on Alcohol Abuse and Alcoholism (NIAAA)
    Telephone: 301-443-4704
    Email: jfox@mail.nih.gov

    Gregory Smith
    National Institute of Allergy and Infectious Diseases (NIAID)
    Telephone: 240-669-2993
    Email: gsmith@niaid.nih.gov

    Andrew Jones
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
    Telephone: 301-435-0610
    Email: jonesan@mail.nih.gov

    Kwesi Wright
    National Institute of Biomedical Imaging and Bioengineering (NIBIB)
    Telephone: 301-451-4789
    Email: wrightnk@mail.nih.gov

    Bryan S. Clark
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Telephone: 301-435-6975
    Email: bryan.clark@mail.nih.gov

    Pamela Fleming
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-480-1159
    Email: pfleming@nida.nih.gov

    Christopher Myers
    National Institute on Deafness and Other Communication Disorders (NIDCD)
    Telephone: 301-435-0713
    Email: myersc@nidcd.nih.gov

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

    Lisa Edwards
    National Institute of Environmental Health Sciences (NIEHS)
    Telephone: 984-287-3258
    Email: archer@niehs.nih.gov

    Christy Leake
    National Institute of General Medical Sciences (NIGMS)
    Telephone: 301-594-7706
    Email: christy.leake@nih.gov

    Rebecca Claycamp
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-2811
    Email: rclaycam@mail.nih.gov

    Priscilla Grant
    National Institute on Minority Health and Health Disparities (NIMHD)
    Telephone: 301-594-8412
    Email: grantp@mail.nih.gov

    Tijuanna Decoster, Ph.D.
    National Institute of Neurological Disorders and Stroke (NINDS)
    Telephone: 301-496-9231
    Email: tijuanna.decoster@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); the Bipartisan Budget Act of 2018 (P.L 115-123); and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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