Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Funding Opportunity Title

Limited Competition: Shared Instrumentation For Hurricane Sandy Disaster Relief (S10)

Activity Code

S10 Biomedical Research Support Shared Instrumentation Grants

Announcement Type

New

Related Notices

  • July 30, 2014 - Notice of Annual Reporting Requirements and Revised Financial Closeout Requirements for NIH Administrative Supplements Awarded to Recover Losses Due to Hurricane Sandy under the Disaster Relief Appropriations Act. See Notice NOT-OD-14-112.
  • August 28, 2013 - See Notice NOT-OD-13-106. Notice of Special Terms and Conditions for NIH Hurricane Sandy Recovery Awards.
  • August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications.
  • July 3, 2013 - See Companion RFA-OD-13-007. Limited Competition: Extramural Research Facilities Restoration Program: Hurricane Sandy Disaster Relief (C06).

Funding Opportunity Announcement (FOA) Number

RFA-OD-13-006

Companion Funding Opportunity

RFA-OD-13-008, R24 Resource-Related Research Projects

RFA-OD-13-005, R21 Exploratory/Developmental Research Grant Award

RFA-OD-13-199, Administrative Supplement

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.095

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits applications from research institutions damaged as a result of Hurricane Sandy for the purpose of supporting replacement of damaged equipment that was extant before Hurricane Sandy, were being used for biomedical research supported mainly by active NIH-awarded grants, and were destroyed or damaged due to the storm. Benefits of this award are restricted to the FEMA declared major disaster states, which are: Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, West Virginia, and the District of Columbia. 

Key Dates
Posted Date

April 18, 2013

Open Date (Earliest Submission Date)

June 19, 2013

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

July 19, 2013, 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

October/November 2013

Advisory Council Review

January 2014

Earliest Start Date

April 2014

Expiration Date

July 20, 2013

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.

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

In October 2012, Hurricane Sandy devastated parts of the Northeast United States.  The storm affected numerous communities, including the biomedical communities located in this region. NIH is issuing several funding opportunities specifically to help restore and re-build the research and research infrastructure in the biomedical research institutions damaged as a result of Hurricane Sandy.  Benefits of this award are restricted to the FEMA declared major disaster states, which are: Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, West Virginia, and the District of Columbia.  This funding opportunity will be funded through funds received under the Disaster Relief Appropriations Act of 2013 (P.L. 113-2).

In keeping with NIH’s longstanding support of shared instrumentation, this Funding Opportunity Announcement (FOA) solicits applications from research institutions damaged as a result of Hurricane Sandy for the purpose of supporting the replacement of shared instrumentation destroyed or damaged as a result of the hurricane.  Restoration of these instruments will restore investigators' access to sophisticated shared instrumentation needed to continue their NIH-supported research endeavors. NIH expects that recipients of awards from this FOA will be able to purchase and install the instrumentation within one or two years.

Losses may include, but are not limited to, severe damage or total loss of function of expensive sophisticated shared instruments. To meet these special disaster needs, ORIP will support requests, under the S10 mechanism, for replacement of such instruments. The shared instrument requested can range in cost from $100,000 to $2 million. Equipment not being actively used for biomedical research by a group of NIH-funded grantees before Hurricane Sandy will not be considered for replacement.

This is a one-time funding opportunity.  Applicants must describe how they will accommodate the instrument they are requesting in the event that major renovations or re-establishment of resources is required in order to install and operate the equipment. Applications also should describe efforts undertaken since the hurricane to recover and restore the damaged instrument, if any.

Funds provided by the NIH through this FOA 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.

Responsive Applications

Applications must meet the following criteria to be considered responsive:

Non-Responsive Applications

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

Instrumentation Supported

Types of instrumentation supported by this announcement  include, but are not limited to, nuclear magnetic resonance (NMR, MRI) systems, positron emission tomography (PET) scanners, electron and confocal microscopes, mass spectrometers, protein and DNA sequencers, biosensors, X-ray diffractometers, cell sorters, and computer and data storage systems dedicated to biomedical research programs. Applications for "stand alone" computer systems (supercomputers, computer clusters and storage systems) will only be considered if the instrument is solely dedicated to the research needs of a broad community of NIH-supported investigators.

This announcement will not support requests for:

A list of appropriate equipment can be found at http://dpcpsi.nih.gov/orip/diic/instru_fixed_equip_s10.aspx

Applications for synchrotron equipment, with the exception of detectors, are not appropriate for this FOA.

In addition to special eligibility criteria related to Hurricane Sandy Disaster Relief, the requested instrument is to be shared by a group of NIH-supported investigators. For eligibility, a major user group of three or more investigators who are PDs/PIs on active NIH research grants with the following activity codes, P01, R01, U01, R35, R37, DP1 and DP2 must be identified. Once this eligibility requirement has been met, additional users with other types of active NIH research grants (such as but not limited to R00, R03, R21, P30, P41, P50) mechanisms) can be added as major or minor users. NIH training grants and contracts are not eligible. To demonstrate the clear need for the requested instrumentation by NIH grantees, projects supported by NIH research grants should require at least 75 percent of the total instrument usage time.

Major users can be individual researchers, or a group of investigators within the same department or from several departments at the applicant institution. NIH extramural awardees from other nearby institutions may also be included.

If the major user group does not require total usage of the instrument, access to the instrument should be made available to other users upon the advice of the internal advisory committee (see below). These users need not be NIH awardees, but priority should be given to NIH-supported scientists engaged in biomedical/behavioral research.

It is expected that some of the equipment requested will be of a specialized nature and will require a high level of technical expertise to operate the instrument and conduct experiments. Therefore, for the requested instrument to be used effectively and to avoid abuse of the instrument, which frequently occurs in an open access environment, the bulk of the research time may have to be reserved for a few investigators. Alternatively, some types of instruments might be accessed by the research community through collaborations with appropriate investigators. Other types of instruments requested may not be so dedicated; such instruments will serve a broadly diversified biomedical community and should be located within a central core facility.

Each applicant institution must propose a PD/PI who can assume administrative/scientific oversight responsibility for the instrumentation requested. This person need not be an NIH grantee but must be affiliated with the applicant institution. An internal advisory committee must be named to assist the PD/PI in administering the grant and overseeing the usage of the instrument. The committee should include members with diverse expertise. The PD/PI and the advisory committee are responsible for:

The PD/PI also will be responsible for:

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.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon funds received by NIH from the Disaster Relief Appropriations Act and the submission of a sufficient number of meritorious applications.

NIH intends to fund an estimate of 5-7 awards, corresponding to a total of $5 million, for fiscal year 2014. The extent and severity of damages on the research and directly related to Hurricane Sandy will be used in prioritizing funding decisions.

Award Budget

Application budgets are limited to direct costs of commercially-available instruments in the range of $100,000 to $2 million.

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 in response to this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Under the general research support authority of Section 301(a) (3) of the Public Health Service Act, Shared Instrumentation Grant awards are made to public and non-profit domestic institutions only. These institutions include health professional schools, other academic institutions, hospitals, health departments, and research organizations.  Note that Federal institutions, foreign institutions and for-profit institutions are not eligible to apply.  A Federal institution is defined by the NIH as a Cabinet-level department or independent agency of the executive branch of the Federal Government or any component organization of such a department or agency. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

In addition, eligibility is limited to research institutions located in the FEMA declared major disaster states, which are: Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, West Virginia, and the District of Columbia.

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.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

Multiple PDs/PIs are not allowed under the S10 mechanism.   

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 isfor a different instrument.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Major Users

For eligibility, a major user group of three or more investigators who are PDs/PIs on active NIH research grants with the following activity codes, P01, R01, U01, R35, R37, DP1 and DP2 must be identified. Once this eligibility requirement has been met, additional users with other types of active NIH research grants (such as but not limited to R00, R03, R21, P30, P41, P50 mechanisms) can be added as major or minor users. NIH training grants and contracts are not eligible. To demonstrate the clear need for the requested instrumentation, projects supported by NIH research grants should require at least 75 percent of the total usage time.

Major users can be individual researchers, or a group of investigators within the same department or from several departments at the applicant institution. NIH extramural awardees from other nearby institutions may also be included.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download 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, 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.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

For this FOA, there is no overall page limit for the entire Instrumentation Plan. However, there are specified page limitations for each section of the Instrumentation Plan as described below. The sections cannot exceed the page limit including tables, graphs, figures, diagrams, and charts. Although there is no overall page limit, applicants are reminded to be informative yet succinct.

Note: Letters of Support are not included in the page limitations.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Special Application Instructions for this FOA

Below are special instructions for this FOA describing the information that must be included in the required components of the application.

SF424(R&R) Cover

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

Descriptive Title: Enter the generic name of the instrument requested in the title (for example, 600MHz NMR Spectrometer).

Proposed Project: Enter start date of 03/01/2014 and end date of 02/28/2015.

Estimated Project Funding:

Total Federal Funds Requested. Enter the total Federal funds for the requested instrument. This will be the total cost. If the cost of the instrument is more than $2 million, enter $2 million on this line, since this is the maximum award this announcement.

Total Non-Federal Funds. If Total Federal Funds Requested (described immediately above) and Total Federal & Non-Federal Funds (described immediately below) are not the same, enter the difference. Explain how the difference will be paid in the Equipment section on the SF424 (R&R) Other Project Information (described below).

Total Federal & Non-Federal Funds. Enter the total cost of the instrument from the quote.

Estimated Program Income. Enter zero as Program Income does not apply to this FOA.

NOTE: A warning will be generated during submission for any S10 with a budget in excess of $500,000.  This warning can be ignored.

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:

Human Subjects are not involved and Vertebrate Animals are not used. Both should be checked "No".

Project Summary/Abstract: The Project Summary/Abstract is meant to serve as a succinct and accurate description of the proposed work when disassociated from the application. State the application’s broad, long-term objectives and specific aims, making reference to the health relatedness of the project. Describe concisely the research design and methods for achieving the stated goals. This section should be informative to other persons working in the same or related fields and understandable to a scientifically or technically literate reader.

NOTE: The Project Summary/Abstract must be no longer than 30 lines of text.

Project Narrative: Using no more than two or three sentences, describe the relevance of this research to public health. In this section be succinct and use plain language that can be understood by a general, lay audience.

Bibliography & References Cited: Each major user should list only those publications that demonstrate the user's expertise in using the requested instrumentation.

Facilities & Other Resources: Attach a letter from the institution that verifies that the shared instrumentation requested existed and was actively used by the investigator user group prior to the hurricane. The letter should include: 1. Details about the damaged instrument including purchase information, date of installation, physical location of the instrument within the institution, and administrative arrangements for the instrument, such as if it was located within a core facility.  2. To the maximum extent possible, a table of users of the instrument during the year prior to the storm. 3. A description of 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.

Equipment: Describe the instrument requested including manufacturer and model number. The model chosen should be justified by comparing its performance with other available instruments where appropriate. Specific features and any accessories should be justified, both in this section and in the description of research projects. Such accessories must be utilized by at least half of the users. Provide a detailed budget breakdown of the main equipment and accessories requested including tax and import duties, if applicable. An itemized quote, with appropriate discount from a vendor is required. The quote must be scanned and combined in a single attachment with the equipment description as part of this upload. Applications without itemized quote(s) will not be reviewed.  As described above in SF424 Cover form, include an explanation of Total Non-Federal Funds in this section (if applicable). If human or infectious materials, which could create a potential biohazard, are to be analyzed, funds for accessory containment equipment for the instrument may be requested in the budget. In this case, a signed letter from the institutional biosafety committee stating that they have reviewed the proposed containment plan and that the plan adheres to documented biosafety regulations is required in the application, and must be scanned and uploaded in the Other Attachments (described immediately below).

Other Attachments: Provide the following information as a single PDF file with the name “Instrumentation_Plan.pdf.”

Instrumentation Plan (in lieu of Research Plan section). The entire Instrumentation Plan (with the sections described below) must be saved as a single file (named Instrumentation Plan) and attached via Other Attachments. Organize the Instrumentation Plan in the specified order (described below) starting each section with the appropriate section heading (i.e. Justification of Need, Research Projects etc.). Do not include links to websites for further information. Do not include animations.

Letters of Support. Letters of support from institutional officials confirming specific dollar and other support commitments  ( that are described in narrative detail in the section on  Institutional Commitment) and any letters from the biosafety committee (as described in Equipment) should be combined in a single file named Letters of Support and uploaded as a separate attachment via Other Attachments.

SF424(R&R) Senior/Key Person Profile

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

Each applicant institution must propose a PD/PI who can assume administrative/scientific oversight responsibility for the instrumentation requested. This person need not be an NIH grantee but must be affiliated with the applicant institution.

Major users can be individual researchers, or a group of investigators within the same department or from several departments at the applicant institution. NIH extramural awardees from other nearby institutions may also be included.

Include profiles for the Program Director(s)/Principal Investigator(s), the Major Users, and for the technical person(s) responsible for the maintenance and operation of the instrument. For the Major Users, select “Other” under Project Role. Then complete the Other Project Role Category by inserting Major User. For technical person(s), select “Technician” for Project Role field. Follow the instructions in the SF424 (R&R) Application Guide for Additional Senior/Key Person Profile(s) if there are more than 8 major users.

NOTE:  Current and Pending Support. Since Just-in-Time does not apply to the S10 mechanism, this FOA requires current and pending support for the Program Director(s)/Principal Investigator(s), each major user and/or technician at the time of application submission. Follow the format provided in Other Support section of the SF424 (R&R) Application Guide (Part III. Section 1.8. Other Support).

Budget

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

PHS 398 Cover Letter

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.  

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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. 

Awards will be subject to quarterly financial and programmatic reporting requirements. Details for submitting these required reports will be provided in the Terms of Award.

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.

Under the S10 mechanism, funding requests are limited to the purchase cost of the instrument only. Support for technical personnel, service contracts, extended warranties, and supplies are not allowable. Cost sharing towards purchase of the instrument is not required. If the amount of funds requested does not cover the total cost of the instrument, the application should describe the proposed source(s) of funding for the balance of the cost of the instrument. Documentation of the availability of the remainder of funding, signed by an appropriate institutional official, must be presented to ORIP prior to issuance of award.

The program does not provide facilities and administrative (F&A) costs or support for construction or alterations or renovations. Matching funds are not required. However, commitment of an appropriate level of institutional support to ensure the associated sustaining infrastructure is expected and should be described. Grants will be awarded for a period of two years and are not renewable.

Applicants proposing purchase of an instrument that the institution is planning to lease prior to award are urged to consult with their institutional sponsored projects office regarding applicable NIH policy prior to executing the leasing agreement. If the leasing agreement was executed more than one year prior to submission of the application, the applicant must provide strong justification for the requested Federal funds. This justification must demonstrate that the leased instrument is considered state-of-the-art at the time of submission — appropriate award adjustments may be necessary. Execution of a purchase order or agreement, making a down payment or other formal commitment to purchase the equipment prior to award will automatically eliminate an applicant from eligibility for an award.

6. 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.

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 by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in  NOT-OD-13-030.  

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.

Justification of Need

Is the need for the instrument clearly and adequately justified?  Is the equipment essential and appropriate?  Justification of selection of proposed instrument may include but is not limited to comparison with other available instruments of similar function.

Technical Expertise

Does the institution have the technical expertise to make effective use of the requested equipment? How well qualified are the participating investigators or other assigned personnel to operate and maintain the instrument, conduct the projects, and evaluate the research results? How will new users be trained? How will biosafety procedures be implemented?

Research Projects

Will research with the requested instrument advance the knowledge and understanding of the proposed projects? How will the research project of each major user be enhanced?

Administration

Is the plan for the management and maintenance of the requested instrument appropriate? Are there plans for maximizing the effectiveness of the investment in instrumentation? Is the membership of the advisory committee broadly based to oversee the use of the instrument for a wide range of biomedical investigators? How will research time be allocated among the projects? Are the sharing arrangements equitable? If needed, are the policies to manage human subject, animal or biohazardous materials projects adequate?  Is the Financial Plan for long term operation and maintenance of the instrument reasonable?

Institutional Commitment

Is the institutional commitment for continued support of the utilization and maintenance commensurate with the level of sophistication of the requested instrument? Institutional Commitment to the specific financial plan for operation and maintenance of the instrument may include, but is not limited to, support of maintenance contracts, preparation and maintenance of the installation site, contribution to the costs of the operating staff, and any other financial contribution towards the support and acquisition of the instrument.  Is institutional infrastructure (technical support, space, environment and utilities) adequate to support the instrument? Is there an institutional track record for making technology available? Is there appropriate documentation (letters from institutional officials)?

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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

Not Applicable

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 Center for Scientific Review 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:

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

Applications will be assigned 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:

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

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants 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.

Awards will be subject to additional quarterly financial and programmatic reporting requirements.  The NIH will closely monitor all grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

Final Progress Report

Ninety days after the expiration of the grant, a Final Progress Report is required that describes the instrument purchased, and a list of all users and description of the value of the instrument to the investigators and to the institution as a whole. This report is needed by the NIH for informing the public, administrative and Congressional officials about the research resources it supports. The following information must be included in the Final Progress Report:

1. Information about the award and the instrument:
Grant Number: 1S10OD#####-01
Principal Investigator: (Name, Institution, Department, Address)
Funding Period
Name of Instrument (including manufacturer and model)
Total Purchase Cost
Total Award Amount
Other Sources of Funding (if appropriate)

2. Describe the instrument purchased, its usage and its impact on the research community, specifically the NIH funded users. Use a summary table to list the names of the current major users (last, first), the complete NIH grant numbers (e.g. 5R01HL123456-01A1), brief titles of the projects and the percentage of use.

3. Describe the administration, operation, and plans for the maintenance of the instrument.

4. Describe (in language understandable to the lay public) any research accomplishments resulting from the use of the instrumentation. Explain the developments in terms of their contributions to new knowledge and potential for the improvement of human health. Provide a list of publications, if available. Any publications on your final progress report should be consistent with the NIH public access policy (http://publicaccess.nih.gov).

5. Include any other additional information which you would consider useful to the NIH.

The Final Progress Report must be submitted electronically through the Closeout feature in eRA Commons.

Annual Equipment Usage Report

In addition, for the period of four years after the final progress report, annual equipment usage reports must be provided to the NIH. The annual equipment usage reports must include:

1. The equipment usage records, specifically the name of the user; number of hours used per year; and the active supporting NIH grants of the user.

2. Machine downtime and explanation of any remediation plans.

3. Any changes in administrative and technical operation of the equipment from originally described in the application.

4. A list of publications and other research reports depending, in part, on use of the awarded instrument. The publication list should be consistent with the NIH Public Access Policy.

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. 

Awards will be subject to additional quarterly financial and programmatic reporting requirements. 

Details for submission of these quarterly reports will be provided in the terms of award.

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 Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

Scientific/Research Contact(s)

Abraham Levy, PhD
Shared Instrumentation Program
Division of Program Coordination, Planning and Strategic Initiatives
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0777
Email: SIG@mail.nih.gov

Steven Birken, PhD
Shared Instrumentation Program
Division of Program Coordination, Planning and Strategic Initiatives
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0815
Email: birkens@mail.nih.gov

Peer Review Contact(s)

Nuria Assa-Munt
Biological Chemistry & Macromolecular Biophysics IRG
Center for Scientific Review (CSR)
Telephone: 301-451-1323
Email: na116f@nih.gov

Financial/Grants Management Contact(s)

Gabe Hidalgo
Office of Grants Management
National Center for Advancing Translational Sciences
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0844
Email: hidalgoge@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.


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