Part 1. Overview Information

Key Dates

Dates in bold italics in the following table were modified per issuance of NOT-OD-21-136.

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The purpose of this funding opportunity is to continue the Shared Instrumentation Grant (SIG) Program administered by ORIP. The objective of the Program is to make available to institutions high-priced research instruments that can only be justified on a shared-use basis and that are needed for NIH-supported projects in basic, translational, or clinical biomedical and bio-behavioral research. The SIG Program provides funds to purchase or upgrade a single item of expensive, state-of-the-art, specialized, commercially available instrument or an integrated instrumentation system. An integrated instrumentation system is one in which the components, when used in conjunction with one another, perform a function that no single component can provide. The components must be dedicated to the system and not used independently.

Types of supported instruments include, but are not limited to: X-ray diffractometers, mass spectrometers, nuclear magnetic resonance (NMR) spectrometers, DNA and protein sequencers, biosensors, electron and light microscopes, cell sorters, and biomedical imagers. Applications for standalone computer systems (supercomputers, computer clusters and data storage systems) will only be considered if the system is solely dedicated to biomedical research.

All instruments, integrated systems, and computer systems must be dedicated to research only.

Foreign-made instruments are allowed.

The SIG Program will not support requests for:

• An instrument with a base cost of less than $50,000;
• Multiple instruments bundled together;
• Purely instructional equipment;
• Instruments used for clinical (billable) care;
• Instruments that are not commercially available and do not have a manufacturer warranty
• Institutional administrative management systems, clinical management systems;
• Software, unless it is integrated in the operation of the instrument and/or necessary for generation of high-quality experimental data from the instrument;
• Multiple stand-alone workstations for data processing, software licenses, and duplicate software items;
• General purpose equipment (such as standard machine shop equipment), instruments to furnish a research facility (such as autoclaves, hoods, equipment to upgrade animal facilities), equipment for routine sustaining infrastructure (such as standard computer networks or data storage systems);
• Disposable devices, office furniture, and supplies;
• Alteration or renovation of space to house the instruments.

Applicants are advised to discuss with the SIG Scientific/Research Contact (See Section VII) any questions about appropriate types of equipment, eligibility, and Program requirements, prior to submitting an application for an integrated instrumentation system.

In order to promote cost effectiveness, to encourage optimal sharing among individual investigators, research groups and departments, and to foster a collaborative multidisciplinary environment, the instrument should be integrated in a core facility or another shared resource, whenever possible.

Each applicant institution must propose a Program Director/Principal Investigator (PD/PI) who can assume administrative and scientific oversight responsibility for the requested instrumentation. See Section III.1 for qualifications for the PD/PI. The PD/PI also will be responsible for:

• Requesting no-cost extensions of the project period, if needed;
• Preparing (and working with the institution to submit) a Final Research Performance Progress Report (Final RPPR) at the end of the project period. See Section VI.3 for the content of a Final RPPR;
• Submitting Annual Usage Reports (AURs) of the instrument to the NIH for a period of four years after the project end date, see Section VI.3.

An Advisory Committee must be named to assist the PD/PI in administering the grant and overseeing the usage of the instrument. For details on the composition of the Advisory Committee, see Section IV.2 under "Administration." The PD/PI and the Advisory Committee are responsible for the development of guidelines for:

• Maximum utilization of the instrument, including time allocation;
• A detailed plan for the day-to-day management and safe operation of the instrument;
• A plan to ensure that access to the instrument is limited to users whose projects have received approval from the Institutional Review Board, the Institutional Animal Care and Use Committee or a biosafety committee, as applicable;
• A financial plan for the long-term operation and maintenance of the instrument during the post-award period;
• A relocation of the instrument within or outside the institution or change(s) of ownership, if such changes are necessary;
• Recommending a new PD/PI, if such a need arises.

The PD/PI and the Advisory Committee should convene meetings and issue annual reports on the instrument status, including their recommendations for the instrument operations.

NIGMS is interested in co-funding S10 applications that include research projects aligned with the mission of NIGMS. NIGMS-supported research may utilize specific cells or organ systems if they serve as models for understanding general systemic principles. NIGMS also supports research in specific clinical areas that affect multiple organ systems.

In parallel, NIGMS is especially interested in promoting participation of Institutional Development Award (IDeA) states and programs in the S10 Program. The IDeA program will provide co-funding for scientifically meritorious applications from IDeA states and encourages sharing and collaboration among institutions, programs, and states.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Federal Governments

• U.S. Territory or Possession

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations

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

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

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

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

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

The PD/PI should document (in the biographical sketch) technical expertise directly related to the type of the requested instrument. The PD/PI does not need to have an NIH research grant or any other research support but is expected to be an expert on the requested instrument. The PD/PI may be a core director, tenured, or non-tenured faculty member of the applicant organization. The PD/PI must be affiliated with the applicant organization and must be registered on eRA Commons.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

There is no restriction on the number of applications an institution can submit to the SIG and/or High-End Instrumentation (HEI) Programs each year, provided the applications request different types of equipment. However, only one application to the Basic Instrumentation Grant (BIG) Program is allowed per receipt date. Concurrent SIG, HEI or BIG applications for the same instrument (or the same type of instrument with added special accessories for example, to meet the HEI budget requirement) are not allowed unless documentation from a high-level institutional official is provided, stating that this is not an unintended duplication, but part of a campus-wide instrumentation plan. Applicants are advised to discuss with the SIG Scientific/Research Contact (Section VII) potential duplicates before submitting two applications for the same type of instrument.

A single application requesting more than one type of instrument (for example, a mass spectrometer and a confocal microscope) is not appropriate for this FOA and will not be considered.

Major User Group

Three Major Users who have substantial need for the instrument must be identified. Each of these Major Users must be a PD/PI on a distinct active NIH research award (i.e., a grant or a cooperative agreement) in an area of basic, translational, or clinical research. The requirement is one award per investigator, with more awards per investigator allowed. An award given to multi-PDs/PIs is counted only once towards the fulfillment of this requirement. NIH training or fellowship grants (i.e., T and F mechanisms), other non-research and SBIR/STTR grants, Other Transaction (OT) awards, and contracts cannot be counted towards the fulfillment of this requirement. Once the eligibility requirement of three Major Users with distinct NIH-funded research projects has been met, additional users with active research awards from NIH or other sources may be added as Major or Minor Users. Investigators with funding from sources such as other Federal agencies (e.g., NSF, DoE, DoD), private foundations, or academic institutions, can be added as Major Users, provided they are engaged in basic, translational or clinical research and can demonstrate a substantial need for the instrument. Major Users can be researchers from the same department or from several departments, divisions or schools at the applicant institution, or from nearby or regional institutions. In certain circumstances, as technology dictates, Major Users may come from distant institutions, but they must demonstrate the need for the instruments and describe plans for regular access to the instrument.

To demonstrate the clear need for the requested instrument, the projects supported by NIH research awards (i.e., grants or cooperative agreements) should together use the instrument at the 75 percent level of the Accessible User Time (AUT), or higher see Section Other Project Information for the definition of AUT. Major Users supported by NIH grants should collectively use the instrument at the 35 percent level of the AUT, or higher.

The Major User group must meet the eligibility requirement at the time of submission. In addition, if/when the application is considered for funding, the SIG Program Staff will check that the Major User group eligibility requirement is also met at the time of award.

Quote

An itemized quote from the vendor with appropriate academic discounts and warranty terms is required and must be included in the application.

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

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

For this FOA, there is no overall page limit for the entire Instrumentation Plan. However, there are specified page limits for each section of the Instrumentation Plan as described below. All tables, graphs, figures, diagrams, and charts must be included within the page limits for these sections. The applicants should make every effort to be succinct. It is expected that the length of the Plan's narrative will depend on the type of the requested instrument and the number of users. To be successful, an application does not have to reach the page limits described here.

• Introduction to Resubmission (if applicable): 3 pages
• Justification of Need: 9 pages in total
• Technical Expertise: 3 pages in total
• Research Projects section must not exceed 30 pages in total. This section can be structured in subsections Research Projects of Major Users and Research Projects of Minor Users or subsections Specific Research Topics. The limit is 4 pages per each Major User's project; however, three or fewer pages are strongly recommended. The Research Projects of Minor Users subsection is limited to 4 pages in total.
• Summary Table(s): 6 pages in total
• Administration (Organizational / Management Plan): 6 pages in total
• Institutional Commitment: 3 pages in total
• Overall Benefit: 3 pages in total

Note: Letters of Support and Bibliography & References Cited Section are not included in the page limitations.

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

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

Descriptive Title: Enter the generic name of the instrument requested in the title (for example, 600MHz NMR Spectrometer or High-Throughput DNA Sequencer ).

Proposed Project: Enter start date 02/01/2022 and end date 01/31/2023.

Estimated Project Funding:

Total Federal Funds Requested: Enter the total Federal funds for the requested instrument. This entry cannot exceed $600,000 which is the maximum award under the SIG Program. If the cost of the instrument is more than $600,000 enter $600,000 (or any lower amount of the requested Federal Funds).

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

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

Program Income: Enter zero as this does not apply to the SIG Program.

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

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

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

Project Summary/Abstract: The Project Summary/Abstract should contain a succinct and accurate description of the requested instrument and an explanation of the need for the instrument to advance research projects of the Users. The application's broad, long-term objectives should be stated, concisely describing how access to the instrument will enhance the health-related goals of the research projects. This section should be informative to other persons working in the same or related fields and understandable to a scientifically or technically literate reader.

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

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

Bibliography & References Cited: List only publications that demonstrate the researchers' expertise in operation and usage of the requested instrument or are relevant to research projects, which will be supported by the instrument. References of the Research Projects Section may appear in this section or may be listed at the end of individual research subsections.

Facilities & Other Resources: Not Applicable. Do not include an attachment here.

Equipment: Describe the requested instrument by stating its manufacturer, model number, specific features, and accessories. Provide a detailed budget breakdown of the main instrument and requested accessories, including tax and import duties, if applicable. An itemized quote from the vendor, with appropriate discounts and warranty terms, is required. The quote must be scanned and combined in a single attachment with the equipment description as part of this upload. As described above in SF424 Cover form, include an explanation of Total Non-Federal Funds in this section (if applicable).

Applications without a quote will be deemed incomplete and returned to the applicant without review.

If human, animal, 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.

Do not describe the need for the instrument or accessories in this section; such narrative should be a part of the Justification of Need section of the Instrumentation Plan.

Other Attachments:

I) Instrumentation Plan (in lieu of Research Plan section).

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

• Introduction: Only in the case of a resubmission, include an Introduction describing the changes that have been made in response to comments in the previous review.

• Justification of Need: Name the requested instrument. Compare performance of the requested model with other similar instruments available on the market. Justify the need for specific features and special accessories of the requested instrument. Each such accessory must be utilized by at least three Major Users.

If the requested instrument is under a lease agreement, demonstrate that the instrument is considered state-of-the-art at the time of the application submission (see details in Section IV. 6. Funding Restrictions)

Justify the need for software. All software supported by this program must be integrated in the operation of the instrument or be necessary for the generation of high-quality data from the instrument. Depending on the needs of research projects, different configurations of such software may be needed to ensure productive scientific use of the instrument. If such additional software modules are requested (e.g., software configuration for the acquisition of metabolomics data, microscope image acquisition and control modules, tools for MRS/MRI functionalities), they must be essential for the advancement of research projects of least 3 Major Users. As noted previously, stand-alone workstation, duplicate software items, and software licenses are not allowed.

Explain why the chosen model and its manufacturer are the most suitable for your user group. Preliminary data are not required, though if feasible, can be included to justify the choice of the instrument. Especially, if access to a demo instrument is practical, preliminary data are encouraged. Provide an inventory of similar instruments existing at your institution, neighboring research institutions, or otherwise accessible; describe why each similar instrument is unavailable or inappropriate for the proposed research. If similar instruments are listed as "unavailable," add a letter to the Letters of Support section from the instrument manager explaining why the instrument is not available to your user group. Include specific documentation on the current usage and downtime of each of these existing instruments in annual hours and a realistic estimate of the projected usage for the requested instrument. You may use tables to clarify the presentation. Tables included within this section will count towards the specified page limit.

Define and justify the Accessible User Time (AUT) for the requested instrument. The AUT is the number of annual hours the instrument can be practically used for biomedical research. AUT hours may be limited by the times an instrument operator is available (if an operator is required), site or building access schedules, scheduled maintenance, start-up and standardization, and any other factors that take time away from the use of the instrument for biomedical research. More importantly, AUT will be limited by the type of the technology requested; some instruments can be and are typically operated 24/7 while other technologies can be used only during regular hours. Therefore, justify the AUT based on the type of the technology requested and an individual managerial plan at your institution to make clear that the AUT corresponds to expected practical full-time use of the instrument at your institution.

• Technical Expertise: Describe the technical expertise of individuals who will set up and run the instrument. Specify who will ensure that the instrument is safely operated and appropriately maintained. State who will train new users. If the instrument requires complex sample preparation or consultation for experimental designs, describe the expert individuals who will serve in that capacity. Address technical support for data collection, management, and analysis.

• Research Projects: In this section, describe the benefit of the requested instrument to enhance Users research projects. First, describe the research projects of Major Users. You can organize this section into subsections Research Projects of Major Users or Specific Research Topics . The latter format may be especially useful to avoid redundancies in the presentation of research projects if several Major Users pursue research topics which follow similar protocols and scientific benefits of the new instrument for their projects are comparable. All Major Users must have substantial need for the requested instrument. Detailed eligibility requirements for Major Users are described in Section III.3.

Since the research projects have been previously peer reviewed, describe their details only as necessary to explain how the requested instrument will advance the projects research objectives. Do not simply copy the Specific Aims section from a funded application. Present sufficient technical details about types of samples or specific experimental protocols to be employed to allow evaluation of whether the instrument is appropriate, would be effectively utilized, and would provide advantages over other methods and other similar existing or new instruments. In particular, explain the need for special features and accessories of the requested instrument by describing the specific studies that will utilize these options as at least three Major Users must need any of these special options. Similarly, if special software modules are requested, justify how they will advance the research projects of at least 3 Major Users. Preliminary data are not required, but if available, they may be used to illustrate the benefit of the requested instrument to the research projects. Describe how generated data will be handled and analyzed so that benefits of the entire experimental set-up can be evaluated. Summarize benefits that the requested instrument will provide towards answering specific scientific questions. Be succinct and clear.

If you choose to structure this Research Project section by including the Research Projects of Major Users subsections, limit the text to no more than 4 pages per each Major User's project. In the beginning of each Major User's Project narrative, list the PI’s name and grant information (number, title, project start and end dates). Specify the anticipated usage in annual hours for each project.

If you choose to group Research Projects in subsections Specific Research Topics, list Major Users, their funded grants that you describe therein, and their cumulative usage as measured annual usage hours, in the beginning of each subsection.

In cases of certain technologies (such as computer systems or X-ray detectors), a large number of users, exceeding what is necessary to make a strong case for the need of the instrument, may be expected. Keep in mind that the sole number of users is not a compelling factor to justify scientific needs for the requested instrument.

If there are Minor Users and other users, include an up to 4-page long section entitled Minor Users Projects. Describe the need of the requested instrument to advance projects from Minor Users and the user community at your institution (e.g., unfunded users who have significant need for the instrument to develop their research programs or users whose expected needs are at the level of 1% or less of the expected usage time). Include a sum of the anticipated usage in annual hours for all Minor/Other Users.

You should focus the Research Projects section on detailed explanation of how the requested instrument will advance research projects. Research projects may be drawn from a broad array of topics in basic, translational, or clinical research; in particular, research projects on the advancements of technologies for the benefit of biomedical research may be included.

• Summary Tables: At the beginning of this section, please re-state the Accessible Usage Time (AUT) in annual hours, as introduced in the Justification of Need Section.

Next, insert the following summary tables - a) Research Projects of Major Users and b) Research Projects of Minor Users. The tables should have the following columns: User's name, grant number (for NIH awards list the grant numbers such as R01IC123456), brief title of the project, grant start and end dates, and estimated usage in annual hours. If there are multiple Users funded by the same grant, list a total of their estimated usage in annual hours for projects supported by that grant. If applicable, include in this section a separate table to indicate the users' needs for any requested accessory. Do not list users whose annual usage is at the level of 1% or less of AUT.

Following the tables, state

(i) a total estimated usage time by Users projects in annual hours,

(ii) the percentage of the estimated usage time devoted to Major Users NIH-funded projects, and

(iii) the percentage of the estimated usage time devoted to NIH-funded projects.

Major Users with NIH research funding should use the instrument at the level of at least 35% of the AUT; NIH-funded users (Major and Minor) should use the instrument at the level of 75% of the AUT.

Provide an estimated usage time and AUT for the requested instrument, considering that both the AUT (related to the administration of the instrument) and the expected usage (depending on actual need for the instrument) may be significantly different for different types of instruments and at different institutions.

• Administration (Organizational/Management Plan): Describe the organizational plan to administer the grant. Describe where the instrument will be located, how it will be utilized, how requests to use the instrument will be made, how time will be allocated among Major and Minor Users, how other projects and new users will be enlisted. Describe how users will be trained in experimental design, instrument operation and data analysis. Describe typical day-by-day management of the instrument. If the plans are to install the instrument in a setting other than a core or a shared resource facility, describe the procedures that will implement and assure broad access to the instrument and its use on a shared basis.

List the names and titles of the members of the local Advisory Committee. The membership of this Committee should be broad to balance interests of different users and should include members without conflicts of interest (non-users of the requested instrument) who can resolve disputes, if they arise. The membership of this Committee should include at least one senior institutional official (e.g., Provost for Research, Dean of School, Department Chair) who will represent the financial commitment of the institution. It is recommended that the Advisory Committee includes at least 4 members. Major and other active Users (such as Minor Users) of the instrument may be members, but none may Chair the Advisory Committee. The PD/PI cannot be a voting member of the Advisory Committee.

The PD/PI and the Advisory Committee should convene meetings and prepare annual reports on the instrument status. The reports will become part of the Final Research Performance Progress Report (Final RPPR) and the Annual Usage Reports (see Section VI.3).

Provide a plan about how the Users will be instructed and reminded about citing the S10 award in their publications and how their compliance will be verified.

Describe a plan for managing access to the instrument if users' projects involve human subjects, vertebrate animals or biohazards such as infectious materials.

Financial Plan: Submit a specific financial plan for the long-term operation and maintenance of the instrument as such costs are not supported by the S10 Program. Explain how various operational costs will be met; specifically, costs associated with routine operation and maintenance of the instrument, and costs for support personnel. Enumerate the sources of income such as charge back fee structure, grants, or institutional support. The financial plan must include a table for year one of operation with approximate dollars for anticipated expenditures and anticipated income, showing how these estimates were derived. For year one, specific dollar amounts are required; for years 2 5, approximate amounts are sufficient.

Typically, during year one, the maintenance costs are fully covered by a one-year manufacturer warranty. In subsequent years, costs of maintenance must be considered in the financial plan.

Include a description of projected changes of the financial plan over the subsequent four years.

Operation: Include salary support of expert personnel that will operate the instrument and oversee routine care and procedures for standardization.

Maintenance: May include a service contract, or funds for parts and local technical personnel who will maintain the instrument (if such personnel are qualified to do so).

Supplies: Include necessary supplies for operating the instrument such as chemicals, cryogenics, and other expendable items.

Software: Include costs for updates/maintenance of software licenses needed for the proper operation of the instrument or additional software for data analysis

Anticipated Income: Enumerate the sources of income, such as any charge back fee structure, grants, or institutional support.

• Institutional Commitment: Describe the institutional infrastructure available to support the instrumentation, including space to house the instrument and a site for sample preparation, if applicable. Confirm the institutional support toward the maintenance and operation of the instrument. In particular, confirm that the institution will commit to provide backup for the financial plan for five years from the installation date of the instrument or for its effective lifetime. Describe institutional support for personnel. The timeline of institutional support should be consistent with the expected usable lifetime of the requested type of instrument.
• Overall Benefit: Explain how the instrument will impact NIH-funded research and contribute to the institution's long-range biomedical research goals.

II) Letters of Support

All letters of support should be combined in a single file named "Letters of Support" and uploaded as a separate attachment via Other Attachments. This combined file should include, as applicable:

• Letters from institutional officials;

• Institutional back-up for the proposed financial plan;

• Letters about inventory of instruments at the institution which are unavailable to the PD/PI (as noted in the Justification of Need Section).
• The institution (i.e., the entity with the same DUNS number as the applicant’s institution) must also provide a table that includes information about performance of all previous S10-awarded instruments within the past five years; that is, FY 2016 - 2020. (If there have been no awards, please state so.) The table should have the following columns:

1) S10 Grant Number;

2) Year of Award;

3) Installation Date of the Instrument;

4) PD/PI's Name;

5) Generic Name of Instrument;

6) Instrument Status: (Active (instrument in use), Pending (order placed, but instrument not delivered, instrument received but not installed or not calibrated for general use), Upgraded (or replaced), Not Available (sold, decommissioned, transferred)); (If the instrument is currently non-functional, provide a succinct explanation of the instrument status immediately following this table.)

7) Actual Usage Time (actual total time in hours per year the instrument was used for research; if the instrument has been installed less than a year ago, the hours can be extrapolated for an estimate of hours per full year)

8) Maintenance Agreement Active (Warranty in place), In-House (or Self-Insured), None (Fee for Service, Pending), Not Available (no longer supported by manufacturer); and

9) Publications: Enter the number of research publications citing the S10 award or have been linked with the S10 award in My NCBI. The number of reported publications should be verified in the NIH RePORTER. If there are no publications for any of the previously awarded S10-awarded instruments provide an explanation immediately following this table.

• Letter from Biosafety Official. If human, animal, or infectious materials, which could create a potential biohazard, are to be analyzed, a signed letter from the institutional biosafety officer stating the proposed containment plan was reviewed and adheres to documented biosafety regulations. If relevant, this letter is required in the application.

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

Include the profile of the PD/PI, Major Users, Minor Users, and technical personnel, as applicable.

This FOA requires the attachment of Current & Pending Support for the PD/PI at the time of application submission. If PD/PI has no research grant or any other research support, state None in the form.

R&R Budget

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

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

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

Not applicable

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix materials are not allowed for this FOA.

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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

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

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

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

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 not allowable.

Under the S10 mechanism, funding requests are limited to the purchase cost of the instrument only. Support for technical personnel, service contracts, extended warranties, software (except as defined in Part 2, Section I), and supplies are not allowable. Cost sharing towards purchase of the instrument is not required and any institutional funds contributed to the costs of the purchase of the instrument are voluntary. 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 and document their availability in a letter signed by an appropriate institutional official. Note that any voluntarily committed cost will be noted in the Notice of the Award and the institution will be held to the commitment and reporting requirements.

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

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

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

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

No animations/videos are allowed.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall benefit score to reflect their assessment of the likelihood that the requested instrument will exert a sustained, powerful influence on the conduct of research projects and their scientific outcomes, in consideration of the following review criteria

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

Justification of Need Is the need for the instrument clearly and adequately justified? Is the equipment essential and appropriate? Are all specific features, special accessories, and the software configuration of the requested instrument well justified, in particular, by their need by Major Users? Is Accessible User Time (AUT) well defined and explained? Is AUT reasonable for the requested technology/instrument type? Is AUT reasonable in the context of the managerial plan? Justification of selection of the proposed instrument may include, but is not limited to, comparison with other commercially available instruments of similar function.

Technical Expertise Does the institution have the technical expertise to make effective use of the requested equipment? How well-qualified are the participating investigators or other assigned personnel to operate and maintain the instrument, conduct the projects, and evaluate the research results, including analysis and interpretation of data? Are the plans for new users training well developed? Are the proposed biosafety procedures well described and appropriate?

Research Projects Will research with the requested instrument advance the knowledge and understanding of the proposed projects? How will the research projects of individual Users be enhanced? Do Users adequately justify the requested instrument and accessories for the needs of their specific projects? If accessories are requested for the instrument, do at least three Major Users require each of the accessories for their research projects?

Administration Is the plan for the management and maintenance of the requested instrument appropriate? Are the plans for the use of the instrument on a shared basis well-documented? Are the plans for time allocation of the instrument to different projects well developed? Are the sharing arrangements equitable? If needed, are the policies to manage projects which have human subjects, animals, or biohazards adequate? Is the membership of the Advisory Committee broadly based to oversee the use of the instrument for the appropriate range of biomedical investigators, to balance interests of different users, and to resolve disputes, if they arise? Is the financial plan for the instrument for five years or the expected lifetime of the instrument reasonable and secured, balancing anticipated expenditures and anticipated income? Is the expected usable lifetime of the instrument reasonable? Are adequate plans in place to document use and scientific benefits of the instrument by citations and acknowledgments of the S10 grant in the scientific publications?

Institutional Commitment Does the institutional commitment letter provide support in the event of a shortfall of income? Is the institutional commitment to back-up the financial plan provided for a time period consistent with the expected effective lifetime of the requested instrument? Is the management of awarded S10 instruments adequate (based on the data in the table of Previously Awarded S10 Instruments in the institutional Letter of Support)? Does the Institution provide adequate infrastructure support for the requested instrument including space to house the instrument and site for sample preparation, if needed?

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

Protections for Human Subjects

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any concerns to the attention of the Scientific Review Officer..

Biohazards

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

Resubmissions

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

Renewals

Not applicable

Revisions

Not applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Not applicable

Resource Sharing Plans

Not applicable

Budget and Period of Support

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

2. Review and Selection Process

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

As part of the scientific peer review, all applications will receive a written critique.

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

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities
• Program balances among various types of supported instruments and geographical distribution of awards.

3. Anticipated Announcement and Award Dates

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

Section VI. Award Administration Information

1. Award Notices

Applicants should ignore eRA Commons system-generated just-in-time (JIT) requests which are typically sent soon after peer review. If an application is considered for funding, ORIP SIG Program staff will send PD/PI special instructions on how to submit a JIT update, from the e-mail address [email protected]. Once an application is selected for funding, the grants management officer may request additional information..

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

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

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

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment. Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws. Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions. Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

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

Not Applicable

3. Reporting

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

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

At the expiration of the grant, a Final Research Performance Progress Report (Final RPPR) is required that describes the purchased instrument, 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 following information about the award and the instrument must be included in the SIG Final RPPR:

1) Grant Number: 1S10OD#####-01

2) Principal Investigator: (Name, Institution, Department, Address)

3) Funding Period

4) Name of Instrument (including manufacturer and model)

5) Total Purchase Cost

6) Total SIG Award Amount

7) Other Sources of Funding (if appropriate)

8) Instrument Installation Date

9) List of users, their funding and hours of use

10) List of publications, if available. This publication list should be consistent with the NIH Public Access Policy.

11) A narrative describing the impact of the instrument on the research community, specific research accomplishments, and administration and operation of the instrument.

12) A report from the Advisory Committee.

The SIG Final RPPR must be submitted electronically through the Closeout module in eRA Commons. For facilitation of Final RPPR preparation, the SIG Scientific Research/Contact staff will contact grantees prior to the due date for report and provide specific instructions.

Annual Instrument Usage Report

In addition, for the period of four years after the Final RPPR, on the anniversaries of the expiration of the award, Annual Instrument Usage Reports (AURs) must be provided to the NIH. These reports will include analogous information requested in S10 Final RPPR (as listed above in Final Research Performance Progress Report section) about the usage and operation of the instrument, with an attached report from the Advisory Committee, description of research which benefited from the instrument, and a summary of research outcomes as documented by publications.

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

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Alena Horska, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0772
Email: [email protected]v

Christina Liu, PhD PE
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
E-mail: [email protected]

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Karen Brummett
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-827-8024
Email: [email protected]

Section VIII. Other Information

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

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