Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Center for Research Resources (NCRR)

Funding Opportunity Title

Limited Competition: Competitive Revision for Technology Development within Biomedical Technology Research Centers (P41)

Activity Code

P41 Biotechnology Resource Grants

Announcement Type

New

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-12-046

Companion FOA

 None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.389

FOA Purpose

The National Center for Research Resources (NCRR) invites awarded (P41) Biomedical Technology Research Centers (BTRCs) to compete for funds for technology development that extends beyond the scope of and is synergistic with technology development currently funded through their parent grant (current parent grant Funding Opportunity Announcement PAR-10-225)

 
Key Dates
Posted Date

November 30, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

January 31, 2012

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

March 2012

Advisory Council Review

May 2012

Earliest Start Date(s)

July 2012

Expiration Date

February 1, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 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. While some links are provided, 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 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 Center for Research Resources (NCRR) uses the P41 mechanism to support Biomedical Technology Research Centers (BTRCs) in a variety of areas of biomedical science. BTRCs create critical, often unique, technologies and methods at the forefront of their respective fields, and apply them to a broad range of basic, translational, and clinical research. This competitive revision allows for emerging needs of the scientific community to be met through development of new technology projects which were not identifiable at the time of the initial parent grant application.

A technology development project may focus on advancement of a single technology or the integration of technologies to create a new approach to a problem in a scientific area (e.g., proteomics, data visualization). As in a full application for a BTRC, the technology development project proposed here should be at the cutting edge of the technological field, with a goal of increasing its utility in biomedical research. This project may involve development of new or significant modification of existing instruments and associated control and data analysis systems, development of new computer algorithms and related software, new physical or chemical methods to prepare samples for analysis, or development of innovative applications through the integration of existing technologies.

Technology development projects are most effective when they respond to the needs of the biomedical research community. To encourage synergistic interaction, one or more Driving Biomedical Projects (DBPs) serving as test-beds for technology development must be included in the application. The DBP(s) should be collaborative in nature, with Center personnel working jointly with investigators outside the Center who have expertise in a particular biomedical discipline. The DBP(s) should be selected on the basis of both the potential for significant biomedical impact and the appropriateness as a test-bed for new technology. The selected DBP(s) should present substantial technical challenges that make it(them) difficult to solve with current approaches. The project(s) should present the opportunity for an iterative push-pull relationship to develop between proposed technology development and the DBP(s), advancing both the technology and the biomedical research project(s). Such efforts are expected to lead to joint publications, and in some cases, patents.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

Revision

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.

The NCRR intends to commit up to $3 million in total costs per year beginning in FY2012. NCRR intends to fund up to 10 awards under this Announcement.

Award Budget

Direct costs other than equipment are limited to $250,000 per year. Requested equipment costs should be aligned with the proposed technology development.  The budget of the requested revision must reflect aims and goals that can be accomplished within the project period.

Award Project Period

Applicants may request funding for up to three years, not to exceed the time remaining in the project period or project end date of the parent grant. The scope of the requested revision must reflect aims and goals that can be accomplished within the project period.

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

Governments

Other

This announcement is for revision applications for technology development within NCRR Biomedical Technology Research Centers (BTRCs). Applicant organizations must be current recipients of an NCRR-issued P41 BTRC award with a project end date on or after June 30, 2013.

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 not allowed.

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Director(s)/Principal Investigator(s )(PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

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.

All revision applications must have the same PD(s)/PI(s) and project title as the currently funded parent grant.

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 in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 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.

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application must be sent to:

Mohan Viswanathan, Ph.D.
Deputy Director
Office of Review
National Center for Research Resources
National Institutes of Health
6701 Democracy Blvd, MSC 4874, Room 1084
Bethesda MD 20892-4874
Courier service zip code 20817
301-435-0829 (Direct line)
301-435-0811 (Office of Review)
301-480-3660 (Fax)
Email: viswanathanm@ncrr.nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and must be followed, with the following exceptions:

·         For the Research Strategy section, do not exceed 12 pages.

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

The Research Strategy section should describe the proposed technology development project and should address, within the outline provided in the PHS Form 398 instructions, the background and rationale for the project, its significance, specific aims, and methods. The facilities available to conduct the project should also be described. The investigator(s) should be listed and their roles described. One or more related Driving Biomedical Projects (DBPs) should be listed for the proposed technology development project. The application should describe the relationship between the proposed technology development and the existing Technology Reserch and Development (TR&D) projects in the parent award, which is expected to be synergistic. The description of the proposed technology development should also show support of the overall goals of the BTRC. An element of high risk (and potentially high payoff) may be present in the proposed technology development project and is appropriate. Investigators should, however, present alternative approaches to solving technological problems in the event that their main conceptual thrust should prove unfeasible.

The technology development project should not focus on data collection. However, in some cases, modest sub-projects designed to generate data for use in technology development or testing may be included as a part of a technology development project. Such projects should be included only when data to test tools, devices, or software are not available elsewhere. These small data collection components cannot substitute for DBPs.

The driving relationship between the proposed technology development project and the DBP(s) must be delineated explicitly. The DBP(s) may be selected from ongoing projects already active in the BTRC, or may be newly identified projects. In either case, the DBP(s) should stem from biomedical research projects that have already been peer-reviewed and funded and will be evaluated solely on the basis of how the projects advance and stimulate BTRC technological development. No support may be requested in the application for DBP activities conducted outside of the BTRC in the collaborating laboratories. Support for Center staff conducting DBP-related work can be requested. Purely technical collaborations focused on advancing some aspect of technology development can also be included within this project.

Because BTRCs must demonstrate a national scope and impact, applicants are encouraged to develop collaborative DBP(s) outside their home institution. However, it is understood that in many instances there are significant technical and logistical obstacles associated with distant collaborations (e.g., access to patient populations, the need for repeated ready access to biological materials). If the proposed DBP(s) is(are) local, the applicant should provide justification and rationale with respect to the overall mission to achieve a national impact.

In this application, only one DBP need be presented in detail. The detailed DBP description should include the following information:

(1) Name of the collaborating investigator (This may or may not be the PD(s)/PI(s) named on the funding award of the DBP.)

(2) Institution of the collaborating investigator

(3) Title of the DBP

(4) Names of the BTRC personnel involved with the project

(5) DBP Funding, including

(6) Significance: Address the importance as an impetus for technology development of the biomedical research problem that will form the basis of the DBP; challenges inherent in this research problem that will drive technology development; appropriateness of the DBP as a test-bed for the proposed technology development project.

(7) Innovation: Describe the innovations and technological advances that will result from the DBP interaction with the proposed technology development and their implications beyond this project.

(8) Approach: Describe methods and procedures to be used, emphasizing the relationship between the DBP and BTRC personnel and technologies, rationale for the proposed approach to the problem and impact of the expertise of the BTRC investigators and technology on the project.

If more than one DBP will be associated with the proposed technology, you may include only items (1) through (5) above for the the additional DBPs, in tabular form.

The Research Strategy limit of 12 pages or less includes both the technology development project and the associated DBP subsections.

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 PHS398 Application Guide.

Appendix

No appendix materials are allowed.  If appendix materials are included, the application will not be reviewed. 

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

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 postmarked on or before the due date in Part I. Overview Information.

All revision applications submitted to this funding opportunity announcement must:

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

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS398 Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Overall Impact

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored 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.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?   

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?  

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?   

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? 

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?   

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?        

Additional Review Criteria

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/priority score, but will not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

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

Not Applicable

Renewals

Not Applicable.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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/priority score.   

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).

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 NCRR,  in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments 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 and will compete for available funds with all other recommended applications . 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:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD(s)/PI(s) 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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

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 grantee’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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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 Non-Competing Continuation Grant Progress Report (PHS 2590) annually 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

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

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Mary Ann Wu, Ph.D.
Division of Biomedical Technology
National Center for Research Resources
National Institutes of Health
One Democracy Plaza, MSC 4874, Room 957
6701 Democracy Blvd.
Bethesda MD 20892-4874
301-435-0787 (Direct line)
301-435-0755 (Div. Biomedical Technology)
301-480-3659 (Fax)
Email: maryann.wu@nih.gov

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

Judy Musgrave
Division of Grants Management
National Center for Research Resources
National Institutes of Health
One Democracy Plaza, MSC 4874, Room 1048
6701 Democracy Boulevard
Bethesda, MD 20892
Telephone: (301) 435-0841
FAX: (301) 480-3777
Email: musgravj@mail.nih.gov

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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