Expired PAR-14-023: Pre-application for a Biomedical Technology Research Center (X02)

Part 1. Overview Information

Participating Organization(s)	National Institutes of Health (NIH)
Components of Participating Organizations	National Institute of General Medical Sciences (NIGMS)
Funding Opportunity Title	Pre-application for a Biomedical Technology Research Resource (X02)
Activity Code	X02 Pre-application
Announcement Type	Reissue of PAR-10-224
Related Notices	June 14, 2017 - This PAR has been reissued as PAR-17-315. June 15, 2016 - Notice of Research Strategy Page Limit for PAR-14-023. See Notice NOT-GM-16-110. NOT-OD-16-004 - NIH & AHRQ Announce Upcoming Changes to Policies, Instructions and Forms for 2016 Grant Applications (November 18, 2015) NOT-OD-16-006 - Simplification of the Vertebrate Animals Section of NIH Grant Applications and Contract Proposals (November 18, 2015) April 24, 2015 - Change in Application Due Dates for PAR-14-023. See Notice NOT-GM-15-115. June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. January 31, 2014 - NIH and AHRQ Extend Due Dates for Applications Due Jan 31-Feb 3 to Feb 4. See Notice NOT-OD-14-047.
Funding Opportunity Announcement (FOA) Number	PAR-14-023
Companion Funding Opportunity	PAR-14-021, P41 Biotechnology Resource Grant
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.859
Funding Opportunity Purpose	This announcement encourages pre-applications for the creation of national Biomedical Technology Research Resources (BTRRs). These Resources develop new or improved technology driven by the needs of basic, translational, and clinical researchers. The BTRRs are charged to make their technologies available the biomedical research community, to train members of this community in the use of the technologies, and to disseminate both the technologies and the Resource’s experimental results broadly. A detailed description of the required components of a BTRR can be found in PAR-14-021. A pre-application is a helpful first step toward submitting a full BTRR application for a new Resource, because the Resources and corresponding full applications are very complex. A pre-application can help applicants focus and refine their ideas and determine whether a BTRR is the appropriate means to support the work they have in mind, but is not required. Existing Resources are not required to submit a pre-application prior to submitting a competitive renewal. No awards will be made under this announcement.

Key Dates

Posted Date	December 10, 2013
Open Date (Earliest Submission Date)	January 3, 2014
Letter of Intent Due Date(s)	Not Applicable
Application Due Date(s)	New Dates July 15, 2015; March 15, 2016; July 15, 2016, by 5:00 PM local time of applicant organization per issuance of NOT-GM-15-115. Extended to February 4, 2014 per NOT-OD-14-047 (previously February 3, 2014), May 15, 2014, December 16, 2014, May 15, 2015, December 16, 2015, May 16, 2016, by 5:00 PM local time of applicant organization. Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	New Dates October 2015, June 2016, October 2016 per issuance of NOT-GM-15-115. ~~March 2014, July 2014, February 2015, July 2015, February 2016, July 2016~~
Advisory Council Review	Not Applicable
Earliest Start Date	Not Applicable
Expiration Date	New Date July 16, 2016 per issuance of NOT-GM-15-115. (Original Expiration Date: May 17, 2016)
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

The National Institute of General Medical Sciences (NIGMS) uses the P41 mechanism to support Biomedical Technology Research Resources (BTRRs) in a variety of areas of biomedical science. (BTRR and Resource are used as synonyms throughout this text.) BTRR research teams create critical, often unique, technologies at the forefront of their fields. The Resources are structured to foster collaborations with biomedical researchers to apply the technologies to a broad range of basic, translational, and clinical research. Resources also promote the broadest possible use of those technologies through training and dissemination activities. Details concerning current BTRRs can be found at http://www.nigms.nih.gov/About/Overview/BBCB/BiomedicalTechnology/BiomedicalTechnologyResearchCenters.htm. New applicants are strongly encouraged to submit a pre-application in response to this announcement. The pre-application process provides feedback regarding appropriateness for this program and competitiveness of a potential application.

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) has a similar program that supports Biomedical Technology Resource Resources. Details about that program can be found at http://www.nibib.nih.gov/Research/ResourceCenters. Applicants who are interested in submitting an application to the NIBIB program should refer to PAR-13-376.

BTRR applications are complex, typically requiring a significant investment of time to prepare and review. This pre-application process for new NIGMS BTRRs is meant to minimize the burden on both the applicant and reviewer communities. All applicants will receive a written critique addressing the Review Criteria listed in this PAR. The critique will help the applicant understand more clearly whether a full application for a BTRR is appropriate for the work they propose. Before preparing a full application, applicants will also generally find it helpful to speak with program staff to discuss the critique of their X02 pre-application. At any point in this process, applicants should contact program staff listed in Section VII Agency Contacts below.

BTRRs may be developed in a specific technological area. For example, a Resource might focus on instrumentation and methods development for a specific instrument type. In contrast, a Resource may integrate multiple technologies to create transformative approaches to a class of research problems. The research tools developed in a BTRR may include instruments and other specialized devices, software, reagents, and methods. The main focus of the program over the past fifty years has been the invention, development, and adaptation of technologies rooted in the physical and mathematical sciences, such as major instrument platforms or data visualization and analysis software. This should not be interpreted to exclude other areas. An important feature of a BTRR is the assembly of a critical mass of both technological and intellectual resources with the intent of developing and exploiting advances in technology and methods for biomedical research.

These Resources create tools that can substantially improve present approaches to a wide variety of problems in the biomedical sciences. A successful BTRR will drive a virtuous cycle in which technological advances facilitate biomedical inquiry, leading to new questions which in turn motivate further technical innovation. This is accomplished through a synergistic interaction of technical and biomedical expertise, both within the Resources and through intensive collaborations with other leading laboratories. Ideally, these Resources identify opportunities for transformative technological advances that open new lines of biomedical inquiry. They also should be uniquely positioned to recognize biomedical research problems that are solvable by the creation of new tools. This intense synergy between technology development and community-driven biomedical problem-solving defines the Resources as fundamentally different in character from laboratories engaged in research projects that may have more narrowly defined goals.

A BTRR is expected to serve as a resource for the biomedical research community and must have a national impact. Each Resource has three critical components that set it apart from other NIH research Resources. A BTRR must provide (a) service and (b) training to outside investigators and must (c) disseminate the technology and methods it has developed. These efforts require the commitment of significant financial and personnel resources to activities outside of their primary research focus. Providing other investigators with ready access to Resource tools and expertise has a substantial impact on the administration and daily operation of the laboratory. Substantive, ongoing efforts to disseminate technologies and train non-specialists in their use require a fundamentally outward-looking philosophy, as well as enthusiasm for engaging the research community. The goal of these efforts is, so far as is possible, to export the technology and expertise of the Resource into the community, achieving a broader impact on biomedical research than would be possible through the projects in which the Resource can participate directly. Industrial partnerships are welcome when appropriate. Ultimately, the service, training, and dissemination components of the Resource should aim for the widespread and routine application of the technologies being actively disseminated.

Section II. Award Information

Funding Instrument	Other: A mechanism that is not a grant or cooperative agreement. Examples include access to research resources or pre-applications
Application Types Allowed	New The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	No awards will be made in response to this announcement. Authors of pre-applications under this announcement that are found meritorious and programmatically relevant will be notified of the opportunity to submit a full application for a new Biomedical Technology Research Resource.
Award Budget	Not Applicable
Award Project Period	Not Applicable

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

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)

For-Profit Organizations

Small Businesses
For-Profit Organizations (Other than Small Businesses)

Governments

State Governments
County Governments
City or Township Governments
Special District Governments
Indian/Native American Tribal Governments (Federally Recognized)
Indian/Native American Tribal Governments (Other than Federally Recognized)
Eligible Agencies of the Federal Government
U.S. Territory or Possession

Other

Independent School Districts
Public Housing Authorities/Indian Housing Authorities
Native American Tribal Organizations (other than Federally recognized tribal governments)
Faith-based or Community-based Organizations
Regional Organizations

Foreign Institutions

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

PDs/PIs must possess the skills, knowledge and resources required to provide leadership to all key components of the Resource, not only to individual select activities.

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.

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

To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
Of an application with a changed grant activity code.

Section IV. Application and Submission Information

1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

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

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Page Limitations

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

Required and Optional Components

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

Instructions for Application Submission

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

SF424(R&R) Cover

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

Type of Submission: Indicate Pre-application as the type of submission.

Proposed Project Start and End Date: The start date should be the date that full BTRR application will be submitted. The standard due dates for P Series mechanisms can be found at http://grants.nih.gov/grants/funding/submissionschedule.htm. The ending date should be one year after the start date.

Estimated Project Funding: Enter zero for all Estimated Project Funding fields. The following fields in the Estimated Project Funding section of the SF424 R&R Cover page must be filled in as zero :

The total Federal Funds Requested
The Total Federal and non-Federal Funds
The Total Estimated Program Income

Pre-application: Do not add any attachments here even though the X02 is a pre-application mechanism.

SF424(R&R) Project/Performance Site Locations