Department of Health and Human Services


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 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)

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

March 2014, July 2014, February 2015, July 2015, February 2016, July 2016

Advisory Council Review

Not Applicable

Earliest Start Date

Not Applicable

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.


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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

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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.

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:

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”:

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Are Human Subjects Involved: Select "No" even if human subjects will be involved in the project,

Are Vertebrate Animals Used: Select "No" even if vertebrate animals will be involved in the project,

Other Attachments: Do not submit other attachments.

SF424(R&R) Senior/Key Person Profile

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

Biographical Sketches: Do not include biosketches for collaborating investigators who will not be included in the Resource (e.g. DBP investigators).

R&R Budget

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

Budget forms are not included as part of the pre-application package.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims:  The Specific Aims attachment is not required for this X02 and should not be included. Applicants submitting X02 pre-applications without a Specific Aims attachment will receive a warning message but the pre-application will proceed through the electronic submission process. Disregard the warning message.

Research Strategy: The Research Strategy section must address each of the five components of a BTRR. Those components are: Technology Research and Development, Driving Biomedical Projects, Collaboration and Service, Training, and Dissemination. A full description of all of these components can be found in the associated Funding Opportunity Announcement for a full BTRR application, PAR-14-021. That full announcement should be read in conjunction with this one.

In the Technology Research and Development (TR&D) sub-section of the application, describe each of the projects that will be proposed in the full BTRR application, and their synergistic relationship. A BTRR is expected to have at least three TR&D projects.

In the Driving Biomedical Projects (DBPs) sub-section, one or more DBPs and the nature of their synergy with TR&Ds must be described for each (TR&D) project. It is possible that a DBP could drive more than one TR&D project.

A concise but well considered summary of plans for the remaining three components, Collaboration and Service, Training, and Dissemination must be presented. Plans to make the facilities and expertise of the BTRR available to outside users must be described in the Collaboration and Service sub-section. Training and Dissemination are essential components of a BTRR. These topics should be addressed in sufficient detail to articulate a commitment to specific approaches and plans.

It is essential that a BTRR function as a well-integrated multidisciplinary team, rather than a collection of separate laboratories or projects linked by a common thematic interest. It is expected that the PD(s)/PI(s) will provide leadership and direction to the key components of the Resource. This includes directing and coordinating the TR&D project leaders, overseeing the progress and turnover of DBPs, and ensuring proper access to Resource resources through Collaboration and Service, Training and Dissemination activities. PD/PI(s) are expected to be fully engaged in all of these activities.

If multiple PD(s)/PI(s) are proposed, the application must describe in detail the structural and procedural elements that will ensure this integration and prevent balkanization of the Resource. Funds and personnel effort should not simply be divided among PD(s)/PI(s) who pursue their respective aims independently. It should not be presumed that the best way to organize Resource projects is along organizational boundaries, or the boundaries between the research activities of the individual PD(s)/PI(s). The organizational structure of the Resource, particularly the TR&D projects, should be carefully justified. All PD(s)/PI(s) are expected to commit adequate levels of effort to provide the leadership commensurate with that role.

Be sure to provide enough information in the Research Strategy narrative to allow reviewers to assess whether or not the proposed research is appropriate for the BTRR program. They will also need to assess the quality of the proposed effort, the likely impact, and the timeliness of the application. See Section V. Application Review Information.

Protection of Human Subjects:  Even if human subjects will be involved in the project, no human subjects section should be included in the X02 pre-application.

Vertebrate Animals:  Even if vertebrate animals will be involved in the project, no vertebrate animal section should be included in the X02 pre-application.

Letters of Support: In the X02 pre-application, do not provide letters of support.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the SF424 (R&R) Application Guide, with the following modification:

Appendix:  Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. NIGMS does not accept appendix material submitted with the pre-application.

Planned Enrollment Report

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide. 

PHS 398 Cumulative Inclusion Enrollment Report

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide. 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

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

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

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

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

6. Other Submission Requirements and Information

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

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

Post Submission Materials

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

Section V. Application Review Information


1. Criteria

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

Pre-applications that are complete will be evaluated for scientific, technical, and programmatic merit by an appropriate peer review group convened by NIGMS using the review criteria stated below.

1. Is the proposed effort appropriate for a P41 Biomedical Technology Research Resource (BTRR)? Are the TR&D projects complementary? Are they relevant to the overall theme of the Resource?

2. Will the proposed DBPs be appropriate test beds that drive development of the nascent technologies? Are the technology needs of the proposed DBPs representative of the broad research community?

3. Are the dissemination and training components integral to the proposed effort? Will the broader research community have access to the Resource's technology and expertise?

4. What will be the likely impact of the technology development on the broader research community? Will the technologies result in new approaches to biomedical research problems?

5. Is the technology development timely? Is the time right to focus a substantial effort in developing technology in the area proposed? Are the needs apparent?

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NIGMS 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:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. The following will be considered in making decisions about notifying applicants of the opportunity to submit a P41 BTRR application:

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information


1. Award Notices

Applicants will be notified in a timely fashion of the opportunity to submit a full application for a Biomedical Technology Research Resource..

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

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

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

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

Scientific/Research Contact(s)

Douglas M. Sheeley, Sc.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-6446
Email: sheeleyd@mail.nih.gov

Peer Review Contact(s)

Helen R. Sunshine, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-2881
Email: sunshinh@mail.nih.gov

Financial/Grants Management Contact(s)

Not Applicable

Section VIII. Other Information

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

Authority and Regulations

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


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