Part I Overview Information


Department of Health and Human Services

Participating Organizations
National Institutes of Health (NIH) (http://www.nih.gov)

Components of Participating Organizations
National Center for Research Resources (NCRR) (http://www.ncrr.nih.gov/)

Title:  High-End Instrumentation Grant Program (S10)

Announcement Type
This is a reissue of PAR-05-124, which was previously released June 17, 2005

Update: The following update relating to this announcement has been issued:

NOTICE: Applications submitted in response to this Funding Opportunity Announcement (FOA) for Federal assistance must be submitted electronically through Grants.gov (http://www.grants.gov) using the SF424 Research and Related (R&R) forms and the SF424 (R&R) Application Guide. 

APPLICATIONS MAY NOT BE SUBMITTED IN PAPER FORMAT.

This FOA must be read in conjunction with the application guidelines included with this announcement in Grants.gov/Apply for Grants (hereafter called Grants.gov/Apply).

A registration process is necessary before submission and applicants are highly encouraged to start the process at least four weeks prior to the grant submission date. See Section IV.

Program Announcement (PA) Number: PAR-07-383

Catalog of Federal Domestic Assistance Number(s)
93.389

Key Dates
Release/Posted Date: June 13, 2007
Opening Date:  August 17, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): August 17, 2007
NOTE: On time submission requires that applications be successfully submitted to Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization). 
Application Submission/Receipt Date(s):  September 17, 2007
Peer Review Date(s): February - March 
Council Review Date: May 2008
Earliest Anticipated Start Date: July 1, 2008
Additional Information To Be Available Date: Not Applicable
Expiration Date: September 18, 2007

Due Dates for E.O. 12372

Not Applicable

Additional Overview Content

Executive Summary

Table of Contents


Part I Overview Information

Part II Full Text of Announcement

Section I. Funding Opportunity Description
1. Research Objectives

Section II. Award Information
1. Mechanism of Support
2. Funds Available

Section III. Eligibility Information
1. Eligible Applicants

    A. Eligible Institutions
    B. Eligible Individuals
2. Cost Sharing or Matching
3. Other - Special Eligibility Criteria

Section IV. Application and Submission Information
1. Request Application Information
2. Content and Form of Application Submission
3. Submission Dates and Times
    A. Submission, Review, and Anticipated Start Dates
         1. Letter of Intent
    B. Submitting an Application Electronically to the NIH
    C. Application Processing
4. Intergovernmental Review
5. Funding Restrictions
6. Other Submission Requirements

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
    A. Additional Review Criteria
    B. Additional Review Considerations
    C. Sharing Research Data
    D. Sharing Research Resources
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices
2. Administrative and National Policy Requirements
    A. Cooperative Agreement Terms and Conditions of Award
3. Reporting

Section VII. Agency Contact(s)
1. Scientific/Research Contact(s)

2. Peer Review Contact(s)
3. Financial/Grants Management Contact(s)

Section VIII. Other Information - Required Federal Citations

Part II - Full Text of Announcement


Section I. Funding Opportunity Description


1. Research Objectives

With advances in technological development, biomedical scientists require ever more powerful tools for their research. As new instruments with enhanced performance become available, their importance for research increases along with the costs. Although the Shared Instrumentation Grant Program (SIG) provides a cost-effective mechanism for groups of NIH supported investigators to obtain commercially available equipment costing between $100,000 and $500,000, there is a continuing need for an NIH program that provides expensive, high-end instruments to the broad community of basic and clinical scientists. To meet the demands of the community, the NCRR initiated this HEI program in FY 2002 to support expensive, high-end instruments.

Examples of key instruments in this category include but are not limited to: Biomedical Imagers: The boundaries of imaging technology have been extended to acquire functional, biochemical and physiological information intact on biological systems including humans. This has led to an increased demand for multinuclear spectroscopy and functional magnetic resonance and PET imaging instruments. Nuclear Magnetic Resonance Spectrometers: There is a significant demand for increased sensitivity and resolution of high-field NMR spectrometers to determine three-dimensional structures of large proteins and protein complexes in extremely small samples. This need is magnified by the extended run time for data collection at lower fields, which limits access to these instruments. Mass Spectrometers: Instruments that combine electrospray ionization with Fourier transform ion cyclotron resonance (FTICR) mass spectrometry are now available. The FTICR methods provide very high resolution and accurate molecular weight measurement to study large biopolymers and their interactions. Electron Microscopes: The frontier of cell biology now focuses on elucidating the nature and function of cell organelles and the role of complex protein machines. Such studies require intermediate voltage electron microscopes with field emission illumination for high resolution imaging of single molecules. Such microscopes are also needed to perform computer reconstruction at the subnanometer scale for macromolecular assemblies that are too large and complex to study by x-ray crystallography and NMR spectroscopy. Supercomputers: Computational biologists require computers or clusters of computers with high-performance visualization hardware, parallel architectures, and large data storage and transfer capabilities at increased speed. Applications for general use computer networks will not be accepted. Applications for synchrotron equipment, with the exception of detectors, will not be accepted.

For purpose of eligibility, a major user group of three or more investigators must be identified. A minimum of three major users must be Principal Investigators on NIH peer reviewed research grants at the time of the application and award. For purposes of this program, research grants are defined as those grants awarded with the following activity codes: P01, R01, U01, R35, and R37.

The application should also show a clear need for the instrumentation by projects supported by multiple NIH peer reviewed research grants (including, but not limited to those listed above) and demonstrate that these projects will require at least 75 percent of the total usage of the instrument. 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.

It is expected that most of the equipment requested in the HEI Program 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 instrumentation, 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 type of instruments might be accessed by the research community through collaborations with appropriate investigators. Other types of instruments requested may not be as dedicated and will serve a broadly diversified biomedical community. In any case, priority for instrument use should be given to NIH-supported scientists engaged in biomedical/behavioral research.

Each applicant institution must propose a Principal Investigator 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 and registered on the eRA Commons. Multiple Principal Investigators are not allowed under the S10 mechanism. An internal advisory committee must be named to assist the Principal Investigator in administering the grant and overseeing the responsibility for the instrument.  The membership of this committee should be broadly based and include members without conflicts of interest who can resolve disputes if they arise.  The Principal Investigator and the advisory committee are responsible for the development of guidelines for:

The Principal Investigator also will be responsible for:

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

Section II. Award Information


1. Mechanism of Support

This funding opportunity will use the S10 (HEI) award mechanism. As an applicant, you will be solely responsible for planning, directing, and executing the proposed project. HEI provides support for expensive state-of-the-art instrumentation utilized in both basic and clinical research. Applications are limited to instruments that cost at least $750,000 per instrument or integrated instrument system. Since the nature and scope of the instruments that may be requested will vary, it is anticipated that the size of an award will vary also. There is no upper limit on the cost of the instrument, but the maximum award is $2,000,000. 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 NCRR prior to issuance of award. Awards will be made for the direct costs only. The program does not provide facilities and administrative (F &A) costs or support for construction or alterations and renovations. Matching funds are not required. However, commitment of an appropriate level of institutional support to insure the associated infrastructure is expected (building alterations, or renovations, post-award service contracts and technical personnel). Grants will be awarded for a period of one year and are not renewable. Supplemental applications will not be accepted.

This funding opportunity does not use the Just-In-Time concepts. It also uses the non-modular format (see Section IV.6. Other Submission Requirements).

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 HEI application, the applicant must provide strong justification for the requested Federal funds. Further, the instrument must be considered state-of-the-art at the time of submission of the HEI application. 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 must be in compliance with NIH policy regarding pre-award cost authority [see NIH Grants Policy Statement (Rev.12/03), Allow ability of Costs/Activities, Prewar (Regalement) Costs, page 94]. Non-compliance with this policy automatically eliminates an applicant from eligibility for an award.

2. Funds Available

Although the financial plans of the NCRR provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

The NCRR intends to commit approximately $20 million in FY2008 to fund approximately 10-15 new awards. The minimum award is $750,000; the maximum award is $2 Million. Since the cost of the various instruments will vary, it is anticipated that the size of the award also will vary. The total amount awarded and the number of awards will depend on the funds available for the HEI program. Awards are for one year only. The anticipated start date is July 1, 2008.


Section III. Eligibility Information


1. Eligible Applicants

1.A. Eligible Institutions

You may submit an application(s) if your institution/organization has any of the following characteristics:

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.

To be eligible to apply, three or more NIH funded investigators (Principal Investigators of active P01, R01, U01, R35 or R37 research grants) who will be users of the requested instrument must be identified.

1.B. Eligible Individuals

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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.

2. Cost Sharing or Matching

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

3. Other-Special Eligibility Criteria

For purpose of eligibility, a major user group of three or more investigators must be identified. A minimum of three major users must be Principal Investigators on NIH peer reviewed research grants at the time of the application and award. For purposes of this program, research grants are defined as those grants awarded with the following activity codes: P01, R01, U01, R35, and R37.

Although the focus of the HEI Program is on a new generation of instruments that cost over $1,000,000 the floor for the program has been set at $750,000. Applications for routine instruments such as mid-field NMR spectrometers and other applications for requests totaling over $750,000 which are the result of an overestimation of price and/or an excessive number of accessories, will be returned as not being responsive. Identical or very similar applications may not be submitted to the SIG Program and the HEI Program. However, a revised application based on a previously reviewed SIG submission may be submitted to the HEI Program. In order to submit a revised application, the investigator must have received the summary statement from the previous review and must address the criticisms raised in the Introduction. An institution may submit more than one application, but the instruments requested should be substantially different. It is anticipated that only a few grants will be awarded in a given technological area.

Section IV. Application and Submission Information


To download a SF424 (R&R) Application Package and SF424 (R&R) Application Guide for completing the SF424 (R&R) forms for this FOA, link to http://www.grants.gov/Apply/ and follow the directions provided on that Web site.

A one-time registration is required for institutions/organizations at both:

PDs/PIs should work with their institutions/organizations to make sure they are registered in the eRA Commons.

Several additional separate actions are required before an applicant institution/organization can submit an electronic application, as follows:

1) Organizational/Institutional Registration in Grants.gov/Get Started

2) Organizational/Institutional Registration in the eRA Commons

3) Project Director/Principal Investigator (PD/PI) Registration in the NIH eRA Commons: Refer to the NIH eRA Commons System (COM) Users Guide.

Both the PD/PI(s) and AOR/SO need separate accounts in the NIH eRA Commons since both are authorized to view the application image.

Note that if a PD/PI is also an NIH peer-reviewer with an Individual DUNS and CCR registration, that particular DUNS number and CCR registration are for the individual reviewer only. These are different than any DUNS number and CCR registration used by an applicant organization. Individual DUNS and CCR registration should be used only for the purposes of personal reimbursement and should not be used on any grant applications submitted to the Federal Government.

Several of the steps of the registration process could take four weeks or more. Therefore, applicants should immediately check with their business official to determine whether their organization/institution is already registered in both Grants.gov and the Commons. The NIH will accept electronic applications only from organizations that have completed all necessary registrations.

1. Request Application Information

Applicants must download the SF424 (R&R) application forms and SF424 (R&R) Application Guide for this FOA through Grants.gov/Apply.

Note: Only the forms package directly attached to a specific FOA can be used. You will not be able to use any other SF424 (R&R) forms (e.g., sample forms, forms from another FOA), although some of the "Attachment" files may be useable for more than one FOA.

For further assistance, contact GrantsInfo: Telephone 301-435-0714, Email: GrantsInfo@nih.gov.

Telecommunications for the hearing impaired: TTY 301-451-5936.

2. Content and Form of Application Submission

Prepare all applications using the SF424 (R&R) application forms and in accordance with the SF424 (R&R) Application Guide for this FOA through Grants.gov/APPLY.

The SF424 (R&R) Application Guide is critical to submitting a complete and accurate application to NIH. There are fields within the SF424 (R&R) application components that, although not marked as mandatory, are required by NIH (e.g., the “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component must contain the PD/PI’s assigned eRA Commons User ID). Agency-specific instructions for such fields are clearly identified in the Application Guide. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

The SF424 (R&R) application is comprised of data arranged in separate components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY will include all applicable components, required and optional. A completed application in response to this FOA will include the following components:

Required Components:
SF424 (R&R) (Cover component)
Research & Related Project/Performance Site Locations
Research & Related Other Project Information
Research & Related Senior/Key Person
PHS398 Cover Page Supplement
PHS398 Checklist 

Optional Components:
PHS398 Cover Letter File

SPECIAL INSTRUCTIONS  

SF424 (R&R) Cover Component

11. Descriptive Title of the Applicant’s Project.  Enter the type of instrument requested.

13.  Proposed Project. Enter start date of 07/01/2008 and end date of 03/31/2009.

16. Estimated Project Funding.  Enter the total Federal funds for the requested instrument in line a.  This will be the total cost since the award period for the HEI program is one year.  If the cost of the instrument is more than $2,000,000, enter $2,000,000 on this line, since this is the maximum award under the HEI program.  In line b, enter the total cost of the instrument from the quote.  If lines a and b are not the same, explain the difference in section 10 Equipment in the Other Project Information component (see below).  Enter zero for line c.

SF424 Research & Related Other Project Information

1. Are Human Subjects Involved?  Check no. 

2.  Are Vertebrate Animals Used?  Check no. 

6. Project Summary/Abstract.  The Project Summary/Abstract and Relevance components must be combined as one single document and attached in line 6.

The first and major component of the Project Summary/Abstract is a Project Summary.  It is meant to serve as a succinct and accurate description of the proposed work when separated 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, insofar as possible, should be understandable to a scientifically or technically literate reader. 

The second component of the Project Summary/Abstract is Relevance.  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.

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

7. Project Narrative.  If you are submitting an resubmission (Cover Page Item 8) then you should include an Introduction describing the changes that have been made in response to comments in the previous review.  This Introduction may not exceed three pages. 

Divide the Project Narrative into the following sections that follow the review criteria.

A) Justification of Need

Describe the instrument requested. Inventory similar instruments existing at the applicant institution, neighboring research institutions, or otherwise accessible; describe why they are unavailable or inappropriate for the proposed research. For a new generation instrument present the design concept, rational and development methods in sufficient detail to allow evaluation of its technical feasibility. Provide a clear justification why new or updated equipment, including accessories, are needed. Include specific documentation on the current usage and downtime of existing instruments and a realistic estimate of the projected usage for the requested instrument.  Such documentation should be expressed as hours of use, setup time, etc., per day or week, not simply as percentage of available time. Be specific and quantitative.

B) Technical Expertise

Describe the technical expertise present at the institution to set up, run and maintain the instrument. Specify who will operate the instrument, train new users, and ensure that it is operated safely and appropriately maintained. Are there any collaborations between disciplinary and interdisciplinary scientists for developing the technical aspects of the instrumentation? Outline the roles of the technical staff in training new users and in facilitating the adoption of these state-of-the-art techniques in the users' research programs.

C) Research Projects

Give a brief description of the major users projects. Since the projects have been previously peer reviewed, the project descriptions should be concise and focus on the benefit of the instrument to the research objectives of each user. Sufficient technical detail (preliminary data and/or supplemental information) should be included within the research plan to evaluate whether the instrument is appropriate, would be effectively employed, and would provide advantages over other methods. The need for special features and accessories must be justified. Individual projects that require a specific option or upgrade (e.g., a UV laser) should describe the specific studies that utilize this option. If possible, each user should highlight those publications that demonstrate the user's expertise in using the requested instrumentation. If the number of projects is large and broadly diversified, select out a smaller representative group.  For minor users, only include a very brief (one-paragraph) summary of the research related to the need for the instruments. Although there is no overall page limitation, the research projects should be informative and succinct (recommend three pages or less per major user).

Summary Table(s)

Use a table to list the names of the users from section C, brief titles of the projects, the NIH grant numbers and the estimated percentage of use. Make a separate table to indicate the users needs for the requested accessories.

D) Institutional Commitment

Explain how the requested instrumentation will contribute to the institution's biomedical research goals. Describe the institutional infrastructure (space, environment and utilities) available to support the instrumentation. Indicate if the institution has any history of making technology available and for keeping instruments in top operating condition.

E) Administration of the Instrument

Describe the organizational plan for administering the grant. Include how the instrument will be utilized, how request are made, how time will be allocated to competing research projects and how schedules are posted. Describe a plan for managing access to the instrument if users projects involve human subjects, animals or human of infectious materials. How will the results obtained be disseminated broadly to enhance scientific understanding? What are the plans for attracting new users? Include the names and titles of members of the advisory committee to oversee its use. Describe the role and responsibility of the advisory committee(s) in developing policies and procedures to assure equitable use of the instrument time and their meeting schedules.

F) Financial Administration

Provide a financial plan for long-term operation of the instrument. Specify how and by whom the requested instrumentation will be operated and maintained. Pertinent data on user charges, salaries of technical support personnel, maintenance contracts, instrument upgrades, shop charges and other expenses, should be included. Specify the plans for fully funding the instrument. Specify the sources and amounts of cost sharing funds (private, state or institutional funds) and a projection of when they will be available. Give a time frame or prospects for delivery of the instrument. Provide documentation (separate letters signed by appropriate institutional officials) specifically describing the institutional commitment (in dollars) in support of the instrument.  Those letters must be scanned and uploaded in the Other Attachments section (line 11).

The entire Project Narrative (Section A-G) must be saved as a single file and attached as item 7 in the Other Project Information component.  Although there is no overall page limit, applicants are reminded to be informative yet succinct.

9. Facilities & Other Resources.  Not applicable.  Do not include an attachment here.

10.  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. Provide a detailed budget breakdown of the main equipment and accessories requested including tax and import duties, if applicable. An itemized quote from a vendor should be included.  The quote must be scanned and combined in a single attachment with the equipment description as part of the item 10 upload. 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. This letter must be scanned and uploaded in the Other Attachments section (line 11).

11.  Other Attachments.  Both letters from appropriate institutional officials (mentioned in F Financial Administration) and letters from the biosafety committee (line 10), if needed, should be attached here.   After the application has been submitted, the assigned SRA must be contacted concerning submission of supplemental information.

Senior/Key Person Profile(s) Component

Include profiles for the Principal Investigator, 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 Application Guide for Additional Senior/Key Person Profile(s) if there are more than 8 major users.

11.  Current and Pending Support.  This FOA requires current and pending support for the Principal Investigator, each major user and/or technician at the time of application submission.   Follow the format provided in Other Support section of the Application Guide (Part III. Section I.H. Other Support).

PHS398 Cover Page Supplement

2. Human Subjects.  Check no to both the Clinical Trial and Agency-Defined Phase III Clinical Trial questions.

4. Human Embryonic Stem Cells.  Check no. 

3. Submission Dates and Times

See Section IV.3.A for details.

3.A. Submission, Review, and Anticipated Start Dates
Opening Date: August 17, 2007 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date: August 17, 2007
Application Submission/Receipt Date: September 17, 2007
Peer Review Date(s): February – March  
Council Review Date: May 2008
Earliest Anticipated Start Date: July 1, 2008

3.A.1. Letter of Intent

Prospective applicants are asked to submit a letter of intent that includes the following information:

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.

The letter of intent is to be sent by the date listed in Section IV.3.A.

The letter of intent should be sent to:

Marjorie A. Tingle, Ph.D.
High End Instrumentation Grant Program
National Center for Research Resources
6701 Democracy Blvd, Bldg 1, Room 958
MSC 4874
Bethesda, MD 20892-4874 (courier service 20817)
Telephone:  (301) 301-435-0772
Fax:  (301) 480-3659
Email: HEI@mail.nih.gov

3.B. Submitting an Application Electronically to the NIH

To submit an application in response to this FOA, applicants should access this FOA via http://www.grants.gov/Apply and follow steps 1-4. Note:  Applications must only be submitted electronically.  PAPER APPLICATIONS WILL NOT BE ACCEPTED. 

3.C. Application Processing

Applications may be submitted on or after the opening date and must be successfully received by Grants.gov no later than 5:00 p.m. local time (of the applicant institution/organization) on the application submission/receipt date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the receipt date(s) and time, the application may be delayed in the review process or not reviewed.

Once an application package has been successfully submitted through Grants.gov, any errors have been addressed, and the assembled application has been created in the eRA Commons, the PD/PI and the Authorized Organization Representative/Signing Official (AOR/SO) have two business days to view the application image.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Incomplete applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. Information related to the assignment of an application to a Scientific Review Group is also in the Commons. 

Note: Since email can be unreliable, it is the responsibility of the applicant to check periodically on their application status in the Commons.

The NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial merit review unless the applicant withdraws the pending application. The NIH will not accept any application that is essentially the same as one already reviewed. This does not preclude the submission of an application already reviewed with substantial changes, but such application must include an “Introduction” addressing the previous critique. Note such an application is considered a "resubmission" for the SF424 (R&R).

4. Intergovernmental Review

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. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing renewal award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See the NIH Grants Policy Statement.

6. Other Submission Requirements

PD/PI Credential (e.g., Agency Login)

The NIH requires the PD/PI to fill in his/her Commons User ID in the “PROFILE – Project Director/Principal Investigator” section, “Credential” log-in field of the “Research & Related Senior/Key Person Profile” component. The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Registration FAQs – Important Tips -- Electronic Submission of Grant Applications.”

Organizational DUNS

The applicant organization must include its DUNS number in its Organization Profile in the eRA Commons. This DUNS number must match the DUNS number provided at CCR registration with Grants.gov. For additional information, see “Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.”

Warning: Please be sure that you observe the direct cost, project period, and page number limitations specified above for this FOA. Application processing may be delayed or the application may be rejected if it does not comply with these requirements.

Appendix Materials

NIH has published new limitations on grant application appendix materials to encourage applications to be as concise as possible while containing the information needed for expert scientific review. See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-018.html.

Applicants must follow the specific instructions on Appendix materials as described in the SF424 (R&R) Application Guide (See http://grants.nih.gov/grants/funding/424/index.htm).

Do not use the Appendix to circumvent the page limitations of the Research Plan component. An application that does not observe the required page limitations may be delayed in the review process.

Note: While each section of the PHS398 Research Plan component needs to be uploaded separately as a PDF attachment, applicants are encouraged to construct the Research Plan component as a single document, separating sections into distinct PDF attachments just before uploading the files. This approach will enable applicants to monitor better formatting requirements such as page limits. All attachments must be provided to NIH in PDF format, filenames must be included with no spaces or special characters, and a .pdf extension must be used.

Plan for Sharing Research Data

Not applicable.

Sharing Research Resources

Not applicable.

Section V. Application Review Information


1. Criteria 

Only the review criteria described below will be considered in the review process.

2. Review and Selection Process

 Applications that are complete will be evaluated for scientific and technical merit by specially convened initial review groups of the CSR in accordance with the review criteria stated below. As part of the initial merit review, all applications will:

In making funding decisions, the NCRR will give consideration to the following:

Review Criteria:

The review committee will consider the following criteria:

Justification of Need:

Is the need for the instrument clearly and adequately justified? Is the equipment essential and appropriate? Will the instrument requested have a significant impact on biomedical/behavioral research and contribute to the advancement of human health?

Technical Expertise:

Does the institution have the high-level technical expertise and access to the necessary infrastructure to make effective use of the requested equipment? How well qualified are the participating investigators to operate and maintain the instrument, conduct the projects, and evaluate the research results? How will new users be trained? Are there collaborations in place between disciplinary and interdisciplinary scientists? How will biosafety procedures be implemented?

Research Projects:

Will research with the requested instrument advance the knowledge and understanding of the proposed projects? How would the research project of each major user be enhanced? Will the results be disseminated broadly to enhance scientific and technological understanding? Are there appropriate plans in place for record keeping and bioinformatics?

Institutional Commitment:

What is the evidence of institutional commitment to support the instrument? Is institutional infrastructure (technical support, space, environment and utilities) available to support the instrument? Is there an institutional track record for making technology available?

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 there an advisory committee for oversight of the instrument including sharing arrangements? 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?

Financial Plan:

Is the financial plan for fully funding the purchase and long-term operation and maintenance of the instrument reasonable? Is there appropriate documentation (letters from institutional officials)?

2.A. Additional Review Criteria:

Resubmission Applications (formerly “revised/amended” applications): Are the responses to comments from the previous scientific review group adequate?  Are the improvements in the resubmission application appropriate?

2.B. Additional Review Considerations

Budget and Period of Support: The reasonableness of the proposed budget and the appropriateness of the requested period of support in relation to the proposed research may be assessed by the reviewers. The priority score should not be affected by the evaluation of the budget.

2.C. Sharing Research Data

Not applicable.

2.D. Sharing Research Resources

Not applicable.

3. Anticipated Announcement and Award Dates

Not applicable.

Section VI. Award Administration Information


1. Award Notices

After the peer review of the application is completed, the PD/PI will be able to access his/her Summary Statement (written critique) via the NIH eRA Commons.

Just-in-time information will not be requested for S10 applications.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official.

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. See Section IV.5., “Funding Restrictions.”       


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.

3. Reporting

Ninety days following the end of the project period, 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.   The Final Progress Report instructions are available at http://www.ncrr.nih.gov/biotech/btforms.asp.

Section VII. Agency Contacts


We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

1. Scientific/Research Contacts:

Marjorie A. Tingle, Ph.D.
High End Instrumentation Grant Program
National Center for Research Resources
6701 Democracy Blvd, Bldg 1, Room 958
MSC 4874
Bethesda, MD 20892-4874 (courier service 20817)
Telephone:  (301) 301-435-0772
Fax:  (301) 480-3659
Email: HEI@mail.nih.gov

2. Peer Review Contacts:

Not applicable.

3. Financial or Grants Management Contacts:

Ms. Jenelle D. Wiggins
Office of Grants Management
National Center for Research Resources
6701 Democracy Blvd. Bldg 1, Room 1038
MSC 4874
Bethesda, MD 20892-4874 (courier service 20817)
Telephone: (301) 435-0843
Fax: (301) 480-3777
Email:  JWiggins@mail.nih.gov

Section VIII. Other Information


Required Federal Citations

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

For more information about the Policy or the submission process, please visit the NIH Public Access Policy Web site at http://publicaccess.nih.gov/ and view the Policy or other Resources and Tools, including the Authors' Manual.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. For publications listed in the appendix and/or Progress report, Internet addresses (URLs) or PubMed Central (PMC) submission identification numbers must be used for publicly accessible on-line journal articles.  Publicly accessible on-line journal articles or PMC articles/manuscripts accepted for publication that are directly relevant to the project may be included only as URLs or PMC submission identification numbers accompanying the full reference in either the Bibliography & References Cited section, the Progress Report Publication List section, or the Biographical Sketch section of the NIH grant application. A URL or PMC submission identification number citation may be repeated in each of these sections as appropriate. There is no limit to the number of URLs or PMC submission identification numbers that can be cited.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This FOA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.


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