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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: Recovery Act Limited Competition: High-End Instrumentation Grant Program (S10)

Announcement Type
This is a reissue of PAR-07-383.

Program Announcement (PA) Number: PAR-09-118

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 (4) weeks prior to the grant submission date. See Section IV.

Catalog of Federal Domestic Assistance Number(s)
93.389, 93.701

Key Dates
Release/Posted Date: March 5, 2009
Opening Date: April 6, 2009 (Earliest date an application may be submitted to Grants.gov)
Letters of Intent Receipt Date(s): April 6, 2009
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 Due Date(s): May 6, 2009
Peer Review Date(s): June 2009 and October 2009
Council Review Date(s): October 2009 and January 2010
Earliest Anticipated Start Date(s): December 2009 and April 2010
Additional Information To Be Available Date (Activation Date): Not Applicable
Expiration Date: May 7, 2009

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. Receipt, 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 and Information

Section V. Application Review Information
1. Criteria
2. Review and Selection Process
A. Additional Review Criteria
B. Additional Review Considerations
C. Resource Sharing Plan(s)
3. Anticipated Announcement and Award Dates

Section VI. Award Administration Information
1. Award Notices

2. Administrative and National Policy Requirements
3. Reporting

Section VII. Agency Contacts
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

As part of the American Recovery and Reinvestment Act of 2009 (Recovery Act), Pub. L. No. 111-5, Congress appropriated $1.0B for grants or contracts under section 481A of the Public Health Service Act to construct, repair or renovate existing non-Federal research facilities. In addition, Congress appropriated $300M for shared instrumentation and other capital research equipment. The availability of renovated facilities and the next generation of instruments will speed the translation of basic research to treatments and cures. These purchases and renovations also will stimulate the economy. It is expected that these awards will create or maintain jobs in America.

Four related FOAs have been released in response to the Recovery Act, two for instrumentation and two that allow alterations and repairs.

For shared instruments in the range of $100,000 to $500,000, eligible organizations should apply under PAR-09-028 (http://grants.nih.gov/grants/guide/pa-files/PAR-09-028.html). The funds available in that FOA have been increased using funds from the Recovery Act (NOT-RR-09-008).

For instruments in the range of $600,000 to $8M, eligible organizations should apply using this FOA. The upper limit for requested funds under this FOA has been significantly raised.

To renovate or repair core facilities, eligible organizations should apply using RFA-RR-09-007. Funds requested under that FOA can range from $1M to $10M.

To make major alterations and renovations to existing buildings, add to existing buildings, complete uninhabitable shell space in existing buildings, or construct new facilities, eligible organizations should use RFA-RR-09-008. Major alterations and renovations are defined as those that exceed $500,000. Funds requested under that FOA can range from $2M to $15M.

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 the HEI program in FY 2002 to support expensive, high-end instruments.

Examples of key instruments in this category include, but are not limited to:

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

For the 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, R37, DP1 and DP2.

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 under 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 should 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:

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.

This funding opportunity does not use the Just-in-Time concepts.

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 $160M in FY2010 to fund approximately 40 new awards. The minimum award is $600,000; the maximum award is $8 Million. Since the cost of the instruments will vary, it is anticipated that the size of the award will also vary. The total amount awarded and the number of awards will depend on the funds available for the HEI program.

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 $600,000 per instrument or integrated instrument system. There is no upper limit on the cost of the instrument, but the maximum award is $8,000,000. 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 direct costs only.

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.

Resubmissions. Applicants may submit a resubmission application, but such application must include an Introduction addressing the previous peer review critique (Summary Statement). Beginning with applications intended for the January 25, 2009 official submission due date, all original new applications (i.e., never submitted) and competing renewal applications will be permitted only a single amendment (A1). See http://grants.nih.gov/grants/guide/notice-files/NOT-OD-09-003.html and NOT-OD-09-016 Original new and competing renewal applications that were submitted prior to January 25, 2009 will be permitted two amendments (A1 and A2). For these grandfathered applications, NIH expects that any A2 will be submitted no later than January 7, 2011, and NIH will not accept A2 applications after that date.

Renewals. Renewal (formerly competing continuation or Type 2 ) applications are not permitted.

Revisions. Revision applications will not be accepted.

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 most current version of the NIH Grants Policy Statement].

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, private, 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.

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, R37, DP1 and DP2.

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 $600,000. Applications for routine instruments such as midfield NMR spectrometers and other applications for requests totaling over $600,000 which are the result of an overestimation of price and/or an excessive number of accessories, are not appropriate and will not be reviewed. 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.

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, use the Apply for Grant Electronically button in this FOA or 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 NIH eRA Commons.

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

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

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

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 the 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 301-710-0267, Email: [email protected].

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. Some fields within the SF424 (R&R) application components, 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 has several components. Some components are required, others are optional. The forms package associated with this FOA in Grants.gov/APPLY includes all applicable components, required and optional. A completed application in response to this FOA includes the data in 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

Applicants are advised to follow carefully the instructions given for electronic submission and the use of the SF424 (R&R) form at http://era.nih.gov/ElectronicReceipt/. Below are special instructions for this FOA describing the information that must be included in the required components mentioned above. Incomplete and/or non-compliant applications will not be reviewed.

Please note that the research plan from previous the PAR (PAR-07-383), which included Justification of Need, Technical Expertise, Research Projects, Summary Tables, Institutional Commitment, Administration of the Instrument and Financial Administration, has been renamed Instrumentation Plan and must be uploaded under 11 Other Attachments.

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 12/01/2009 and end date of 11/30/2010.

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 $8,000,000, enter $8,000,000 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.

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

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

7. 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. A brief description of jobs created or maintained along with a statement concerning the environmental impact of the instrument that is being requested should be included in this section.

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

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.

Instrumentation Plan:

Introduction: If you are submitting a 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 Instrumentation Plan 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, rationale 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 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. Because 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. Include a certification that, if awarded, funds can be expended expeditiously, within 18-24 months from the date of award.

E) Administration of the Instrument

Describe the organizational plan for administering the grant. Include how the instrument will be utilized, how requests 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 or 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 additional needed 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 Instrumentation Plan (Section A-F) must be saved as a single file (named Instrumentation Plan) and attached as item 11 Other Attachments. Although there is no overall page limit, applicants are reminded to be informative yet succinct.

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.

12. 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.8. Other Support).

3. Submission Dates and Times

See Section IV.3.A. for details.

3.A. Submission, Review and Anticipated Start Dates
Opening Date: April 6, 2009 (Earliest date an application may be submitted to Grants.gov)
Letter of Intent Receipt Date(s): April 6, 2009
Application Due Date(s): May 6, 2009
Peer Review Date(s): June 2009 and October 2009
Council Review Date(s): October 2009 and April 2010
Earliest Anticipated Start Date(s): December 2009 and April 2010

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 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: [email protected]

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/applicants/apply_for_grants.jsp 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 due date(s). (See Section IV.3.A. for all dates.) If an application is not submitted by the due 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 weekdays (Monday Friday, excluding Federal holidays) to view the application image to determine if any further action is necessary.

Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the IC. Incomplete and non-responsive applications will not be reviewed.

There will be an acknowledgement of receipt of applications from Grants.gov and the Commons. The submitting AOR/SO receives the Grants.gov acknowledgments. The AOR/SO and the PI receive Commons acknowledgments. 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 the 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. However, the NIH will accept a resubmission application, but such application must include an Introduction addressing the critique from the previous review.

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 renewal award if such costs: 1) are necessary to conduct the project, and 2) 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 or renewal 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 NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_Part6.htm.

6. Other Submission Requirements and Information.

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

The NIH requires the PD(s)/PI(s) 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.

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.

Resource Sharing Plan(s)

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.

In awarding grants under the program described in subsection (a) [grants for shared instrumentation], the Director of the National Center for Research Resources shall comply with the peer review requirements in section 492 of the Public Health Service Act (42 U.S.C. 289a). The following shall be considered in the review and selection process: (1) the extent to which an award for the specific instrument involved would meet the scientific needs and enhance the planned research endeavors of the major users by providing an instrument that is unavailable or to which availability is highly limited; (2) with respect to the instrument involved, the availability and commitment of the appropriate technical expertise within the major user group or the applicant institution for use of the instrumentation; (3) the adequacy of the organizational plan for the use of the instrument involved and the internal advisory committee for oversight of the applicant, including sharing arrangements if any; (4) the applicant's commitment for continued support of the utilization and maintenance of the instrument; and (5) the extent to which the specified instrument will be shared and the benefit of the proposed instrument to the overall research community to be served.

As part of the initial merit review, all applications will:

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 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 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? 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)?

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?

Additional Review Criteria.

Resubmission Applications. When reviewing a Resubmission application (formerly called an amended application), the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

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.

Additional Review Considerations.

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

Resource Sharing Plans.

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 or her Summary Statement (written critique) via the NIH eRA Commons.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General.

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.

The terms of the NoA will reference the requirements of the Recovery Act.

In addition to the standard NIH terms of award, all funding provided under the Recovery Act will be subject to the HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009 (ARRA). The full text of these terms approved for NIH awards can be found in the following document: Standard Terms and Conditions for AARA Awards.

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.

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

The funds to support applications received under this FOA have been made available under the Recovery Act. Grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the reporting requirements described in Section 1512 of the Recovery Act, as well as applicable OMB guidance regarding the use of Recovery Act funds.

In addition, grantees must comply with the requirements set forth in the Recovery Act, including, but not limited to, the quarterly reporting requirements of Section 1512 of the Recovery Act as specified in HHS Standard Terms and Conditions for American Recovery and Reinvestment Act of 2009. The full text of these terms approved for NIH awards can be found at the following document: Standard Terms and Conditions for AARA Awards.

Recovery Act-related reporting requirements will be incorporated as a special term of award.

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 (program), peer review, and financial or grants management issues:

1. Scientific/Research Contact(s):

Marjorie A. Tingle, PhD
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) 435-0772
Fax: (301) 480-3659
Email: [email protected]

2. Peer Review Contact(s):

Not Applicable

3. Financial/Grants Management Contact(s):

Ms. Quadira Huff
Office of Grants Management
National Center for Research Resources
6701 Democracy Blvd. Bldg 1, Room 1062
MSC 4874
Bethesda, MD 20892-4874
Telephone: (301) 435-0852
Fax: (301) 480-3777
Email: [email protected]

Section VIII. Other Information


Required Federal Citations

The American Recovery And Reinvestment Act of 2009 (Pub. L. No. 111-5): http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=111_cong_bills&docid=f:h1enr.pdf

Standard Terms and Conditions for Recovery Act Awards: The full text of these terms approved for NIH awards can be found in the following document: http://grants.nih.gov/grants/policy/NIH_HHS_ARRA_Award_Terms.pdf

NIH Public Access Policy Requirement:

In accordance with the NIH Public Access Policy, investigators funded by the NIH must submit or have submitted for them to the National Library of Medicine’s PubMed Central (see http://www.pubmedcentral.nih.gov/), an electronic version of their final, peer-reviewed manuscripts upon acceptance for publication, to be made publicly available no later than 12 months after the official date of publication. The NIH Public Access Policy is available at (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-08-033.html). For more information, see the Public Access webpage at http://publicaccess.nih.gov/.

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 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 FOA is issued under the Recovery Act, Pub. L. No. 111-5.

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. Awards are made under Sections 301, 405 and 497 of the Public Health Service Act, as amended (42 USC 241 and 284) and are subject to 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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