Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)

Funding Opportunity Title

Developing and Improving Institutional Animal Resources (G20)

Activity Code

G20 Grants for Repair, Renovation and Modernization of Existing Research Facilities

Announcement Type

This is a reissue of RFA-RR-10-011.

Related Notices

  • May 2,2013 - This RFA has been reissued as PAR-13-219.

Funding Opportunity Announcement (FOA) Number

RFA-OD-12-008

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed. See Section III. 3. Additional Information on Eligibility.

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

93.351

Funding Opportunity Purpose

This FOA issued by the Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP), Office of the Director, National Institutes of Health, solicits applications from biomedical research institutions that propose to renovate, repair, or improve individual animal resources. The major objective of this program is to upgrade animal facilities to support the conduct of biomedical and/or behavioral research.  Support can be requested to alter and renovate (A&R) the animal facilities, as well as to improve the animal care equipment in the facility. It is expected that all award funds will be expended expeditiously and that applicants will consider the use of sustainable design technologies and design approaches.  

Key Dates
Posted Date

June 8, 2012

Open Date (Earliest Submission Date)

July 7, 2012

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

August 7, 2012 , by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

October 2012

Advisory Council Review

January 2013

Earliest Start Date(s)

March 2013

Expiration Date

August 8, 2012

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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

Research Objectives

The Office of Research Infrastructure Programs (ORIP) encourages the submission of animal resource improvement grant applications from biomedical research institutions that have one or more active  biomedical or behavioral research grants. The major objective of this program is to upgrade animal facilities to support the conduct of biomedical and/or behavioral research. A related objective is to assist institutions in complying with the United States Department of Agriculture (USDA) Animal Welfare Act and the Department of Health & Human Services (DHHS) policies related to the care and use of laboratory animals. Support is limited to alterations and renovations (A&R) to improve laboratory animal facilities, and the purchase of major equipment items for animal resources, diagnostic laboratories, transgenic animal resources, or similar associated activities.

Animal resource improvement grants are awarded to assist biomedical research institutions in upgrading animal facilities and developing administratively centralized and uniformly effective programs of research animal care in support of biomedical and/or behavioral research.

No facilities and administrative (F&A) costs or continuation costs will be awarded.  The NIH reserves the right to conduct site visits when deemed essential. This may include site visits during the application evaluation process and/or not only during the renovation but also at the completion of the project.

Section II. Award Information
Funding Instrument

Grant

Application Types Allowed

New

The OER Glossary and the SF 424 (R&R) 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.

NIH intends to fund an estimate of 12-14 awards, corresponding to a total of $6M, for fiscal year 2013.

Award Budget

Budgets for direct costs must be for $500,000 or less.  The budget may include a request for animal care equipment, for alteration and renovation funds, or both.  

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size of each award will also vary. Although the financial plans of ORIP provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Award Project Period

The requested project period for an award could be up to one year.  Requests for no-cost extensions will be considered.  

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

Only biomedical research institutions that have one or more active biomedical or behavioral research  award(s) may apply.

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 SF 424 (R&R) 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 least 4-6 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.

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 SF 424 (R&R) Application Guide.

In addition to the PD(s)/PI(s), applicants must include biographical sketches for a Facilities Person (name and function on the project) and veterinarians.  Do not include biographical sketches of investigators.   

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 not submit more than one application.

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. 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.

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory 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.

All application instructions outlined in the SF424 (R&R) Application Guide are to be followed, incorporating "Just-in-Time" information concepts, and with the following additional requirements:

SF424(R&R) Cover Component

Applicants  MUST provide an entry for the “Total Federal Funds Requested”,  “Total Federal and Non-Federal Funds”, and “Estimated Program Income’ on the SF424 RR Cover page.

SF424(R&R) Senior/Key Person Profile Expanded Component

Include information about the PD(s)/PI(s), the Animal Facility Director, the Project Manager, and any other key persons in this component.  G20 applications must specify a Facilities Person in the R&R Senior/Key Person Profile component.  Please provide the information for this person after the PD/PI on the Senior/Key Person page.  Specify a project role of ‘Other’ or ‘Other Professional’, and an Other Project Role Category of ‘Facilities Person/Project Manager’.  .”  The Facilities Person will communicate directly with NIH architects and engineers. He/she is familiar with systems of biomedical research buildings and many times is an architect, engineer or the construction project person.  

Budget Information for Construction Programs (SF424C)

The Budget Information for Construction Programs (SF424C) must be used to attach an overall application budget page for the total requested funds.

SF424(R&R) Other Project Information Component

PROJECT NARRATIVE (assemble in order shown below): The entire Project Narrative (including the Specific Aims, Background, and Renovation and/or Equipment Plans sections) is limited to 13 pages. Line drawings and tables do not count towards this limit.  Upload this information using the Project Narrative Attachment in the Other Project Information Component.

SPECIFIC AIMS: This section must not exceed one page and should summarize any request for alterations and renovation (A&R) including the associated square footage.

BACKGROUND: The Background and Significance section should not exceed two pages. This section must:

(1) Identify the animal facilities for which funds are requested and provide information about the usage of these facilities.  This is best done in a table or in a bulleted list.

(2) Describe the overall management of animal facilities at the institution, and discuss how this project fits into that overall vision. 

(3) Describe past institutional support of this animal facility.  This might include support for technicians, equipment purchased by the institution, support for animal facility director, and previous A&R supported by the institution.

(4) Animal Program Data - Provide a brief description of all on-campus and off-campus animal facilities, including sites where experimental surgery is performed. Indicate who manages each facility. Indicate the average daily census (by species) for each facility.  Indicate whether the institution is accredited by the American Association for Accreditation of Laboratory Animal Care (AAALAC), and if not, describe plans for obtaining accreditation. It is not mandatory that the applicant’s institution be AAALAC accredited to apply to this FOA. If equipment is requested for surgical or diagnostic facilities, the caseload, species, types and numbers of surgeries or diagnostic tests must be documented.

(5) Applicant must describe how biohazards are handled in the animal facility.

(6) Explain what extent the proposed change in the research environment facilitates the applicant institution’s ability to conduct, expand, improve, or maintain biomedical and/or behavioral research as well as its effect on other relevant research programs and facilities in the geographic area and nationwide.   

RENOVATION AND/OR EQUIPMENT PLANS: The Renovation/Equipment Plan can be up to 10 pages (or more) as long as the number of pages in the Specific Aims, Background, and Renovation/Equipment totals no more than 12 pages.  The Renovation/Equipment Plan includes the following subsections: Significance and Need, Project Management and Institutional Commitment, Design Considerations, Equipment and Project Timeline.  The page limits in this section do NOT include the requested tables or line drawings.

SIGNIFICANCE AND NEED

Tables: Grant Support

Include two tables containing (1) active and (2) pending grants (from the NIH and other sources) that will be affected by the renovation.  These tables do not count toward the 12 page limit. These tables should have the following columns: 

Need for the Renovation

PROJECT MANAGEMENT AND APPROACH

Project Administrative Structure and Oversight

Timeline

Provide a project timeline for the proposed alteration and renovation

Table: Spaces affected by Alterations and Renovation (A&R)

If requested, list in tabular format the size (dimensions) and square footage of each component (e.g., room, alcove, cubicle, laboratory etc.) that will be directly affected by the renovation project. This table will not count against the 12 page project narrative limit.

Mechanical, Electrical, Plumbing (MEP) and Utilities per Renovated Component

Provide information about the mechanical, electrical, plumbing (MEP) systems and utilities for each component.  Include information about the

Architectural Criteria

Provide information including but not limited to

Provide sufficient information to allow the evaluation of plans for BSL-3/ABSL-3 animal facility design documents.

Line Drawings (REQUIRED)

The line drawings do not count toward the 12 page limits and must be included for all applications submitted in response to this FOA.

General guidance for Floor Plans

Equipment

List and justify all equipment. Equipment should be relevant to the function of the animal facility.  Information such as the manufacturer, model number, size, capacity, total cost, and location in the facility should be included.  Quotes for equipment should be provided in the Other Attachments section below.

Sustainable Design

To the maximum extent feasible, sustainable design practices shall be considered in the design requirements for facilities funded through extramural construction/renovation grants.  Grantees are encouraged to implement the primary elements of sustainable design in federally funded facilities.  Sustainability is the outcome of an integrated process of facility development and operation incorporating a balance of life-cycle cost, environmental impact and occupant health and safety, security, and productivity.  The following primary elements of sustainable design shall be considered in all projects, as applicable.

1. Integrated design.

2. Commissioning.

3. Optimization of energy performance.

4. Energy efficiency.

5. Measurement and verification.

6. Protection and conservation of water.

7. Indoor water.

8. Outdoor water.

9. Enhancement of indoor environmental quality.

10. Ventilation and thermal comfort.

11. Moisture control.

12. Day lighting.

13. Low-emitting materials.

14. Protection of indoor air quality during renovation.

15. Reducing the environmental impact of materials.

16. Maximizing recycled and bio-based content.

17. Construction waste reuse and recycling. 

18. Minimizing use of ozone depleting compounds.

Sustainable Design References 

Department of Health and Human Services. HHS Policy for Sustainable and High Performance Buildings. December 2010. http://www.hhs.gov/about/2010plan.html

Department of Health and Human Services. HHS Real Property Asset Management Plan. http://www.hhs.gov/asa/ofmp/about/real_property_asset_mgmt_plan.pdf

Executive Order 13101: Greening the Government through Waste Prevention, Recycling, and Federal Acquisition http://www.epa.gov/epp/pubs/13101.pdf

Executive Order 13123: Greening the Government through Efficient Energy Management. http://www1.eere.energy.gov/femp/pdfs/eoguidancedoc.pdf

Executive Order 13134: Developing and Promoting Biobased Products and Bioenergy.  http://ceq.hss.doe.gov/nepa/regs/eos/eo13134.html

Executive Order 13148: Greening the Government through Leadership in Environmental Management. http://ceq.hss.doe.gov/nepa/regs/eos/eo13148.html

OMB Circular A-11, Section 55-Energy and Transportation Efficiency Management.
http://www.whitehouse.gov/omb/circulars/a11/current_year/s300.pdf#search=%22 OMB%20Circular%20A-11%20Part%207%22

OMB Circular A-11, Part 7 (Section 300), Planning, Budgeting, Acquisition, and Management of Capital Assets.
http://www.whitehouse.gov/omb/circulars/a11/current_year/s300.pdf#search=%22 OMB%20Circular%20A-11%20Part%207%22

The Federal Leadership in High Performance and Sustainable Buildings, Memorandum of Understanding. http://www.energystar.gov/ia/business/Guiding_Principles.pdf

Green Building Initiative Green Globes System. http://www.thegbi.org

US Green Building Council. http://www.usgbc.org

Whole Building Design Guide http://www.wbdg.org

See Section VIII, Other Information - Required Federal Citations, for policies related to this announcement.

OTHER ATTACHMENTS

In the Other Attachments section, include the following, each as a separate attachment. NOTE: Each attachment must be given a file name using the headings below (e.g., budget_justification_form.)

(1) Budget Justification, List of fixed and movable Equipment and Vendor Quotes:  The next attachment should be all vendor quotes, list of equipment and the budget justification. List and justify each piece of equipment.  These quotes may include delivery costs, but should not contain service contract costs.

(2) In a separate brief attachment, applicants must include information about the Institutional Occupational Health Program as it pertains to animal care staff.

(3) Applicants must include the Institutional Animal Care and Use Committee (IACUC) and if accredited, the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) summary reports, and/or sections of these reports that describe deficiencies of the facility and the animal care program. 

NOTE:

The environmental analysis form (http://dpcpsi.nih.gov/orip/documents/environmental_analysis_form_3-2009.pdf)

is not required at the time of the application. Instead this information will be requested later in the review cycle as part of the Just-in-Time process (NOT-OD-10-120).  

The following documents are likely to be useful when responding to this FOA.

NIH Grants Policy Statement http://grants.nih.gov/grants/policy/nihgps_2010/nihgps_ch10.htm#construction_grants .

NIH Design Requirements Manual   http://orf.od.nih.gov/PoliciesAndGuidelines/BiomedicalandAnimalResearchFacilitiesDesignPoliciesandGuidelines/DesignRequirementsManualPDF.htm

Biosafety in Microbiological and Biomedical Laboratories, CDC/NIH, 5th Edition, http://www.cdc.gov/biosafety/publications/bmbl5/index.htm.  Appendix A is particularly useful.

Information about the Select Agent Rule and related matters. http://www.selectagents.gov/

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 modifications:

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, with the following modifications:

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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 SF 424 (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 SF 424(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.

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 Central Contractor Registration (CCR). 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 and responsiveness by the National Center for Advancing Translational Sciences (NCATS) http://ncats.nih.gov/ review staff working on behalf of ORIP. Applications that are incomplete and/or nonresponsive will not be reviewed.     

Post Submission Materials

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

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? What is the need for the project or for additional space? Is there sufficient justification for improving this facility?  To what extent will the proposed change in the research environment facilitate the applicant institution’s ability to conduct, expand, improve, or maintain biomedical and/or behavioral research as well as its effect on other relevant research programs and facilities in the geographic area and nationwide?   

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/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Do the PD(s)/PI(s) have the appropriate experience and background suited to the proposed project? Is the Facility Person/Project Manager identified for the project? Does the Facility Person/Project Manager have the skills necessary to complete the project on time and within budget?

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? How does the application implement sustainable design principles described above in Section IV under Project Management and Approach/Sustainable Design? What innovative strategies are used in the design? How does the proposed A&R increase efficiency in the use of energy, water, or materials to reduce adverse impacts on the environment?

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? Are potential problems, alternative strategies, and benchmarks for success presented? Does the plan indicate the proposed renovation area in the building, including associated room adjacencies, traffic patterns for the movement of people, animals, and materials (clean and dirty) through the facility, and relative location of needed ancillary areas (e.g., changing rooms for animal facilities)?  Are the total net and gross square feet of space to be renovated provided?  Are the proposed timeline and sequence of construction reasonable?

Engineering Criteria:  Do the engineering criteria include information about the mechanical, electrical, plumbing systems, and utilities in the renovation?  Are the number of air changes per hour, electrical power, light levels, hot and cold water, and steam appropriate for the project?

Architectural Criteria:  Are the architectural criteria such as the width of corridors and doors and surface finishes appropriate for the project?

Line Drawings: Is the function of the space indicated?  Do the line drawings indicate the size dimensions, function, and net and gross square feet for each component?   Are the line drawings at a scale adequate to explain the project?  Do the plans indicate the changes to be made to the space? Are the line drawings drawn to scale to indicate adjacencies and operational relationships of equipment?  Is the location of major equipment, fume hoods, sinks, showers, and other major items indicated in the drawings?  Are areas to be demolished indicated?

Are changes or additions to existing mechanical and electrical systems clearly described and adequate to the project?   Are requests for equipment justified?  Will the requested equipment remedy identified deficiencies or fill gaps in the animal facility?  

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? Is the institution committed to using the renovated space for biomedical or behavioral research? Does the institution have a history of adequate support for this facility? Has the institution provided evidence of future commitments to this animal facility?   

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.

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

Not Applicable.

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

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 NCATS review staff on behalf of ORIP, 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:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA..

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 Council of Councils. 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/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

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 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

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading or navigating forms)
Contact Center Phone: 800-518-4726
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

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)

Elisabeth Koss, Ph.D.
Program Officer
Office of Research Infrastructure Programs/DPCPSI/OD
National Institutes of Health/DHHS
Democracy One, Room 1006 
6701 Democracy Boulevard
Bethesda, MD 20892-4874 
Telephone: (301) 451-7818
Email: kosse@mail.nih.gov  

Direct inquiries regarding technical programmatic issues (engineering and architectural) to:

Marlene E. Jefferson, AIA
Senior Architect
Office of Research Infrastructure Programs/DPCPSI/OD
National Institutes of Health/DHHS
6701 Democracy Blvd., Suite 1004
Bethesda, MD 20892-4874
Telephone: (301) 594-6140
Email: jeffersm@mail.nih.gov

Peer Review Contact(s)

Barbara J. Nelson, Ph.D.
Scientific Review Officer
National Center for Advancing Translational Sciences
Office of Scientific Review
6701 Democracy Blvd., Suite 1080
Bethesda, Maryland 20892-4874
Telephone: 301-435-0806
Email: nelsonbj@mail.nih.gov

Financial/Grants Management Contact(s)

Shannon Oden
Office of Grants Management
National Center for Advancing Translational Sciences, NIH, DHHS
Office of Research Infrastructure Programs/DPCPSI/OD
One Democracy Plaza
6701 Democracy Blvd
Bethesda, MD 20892 (20817 for express delivery)
Office: (301) 594-3028
Fax: (301) 480-3777
Email: Odens@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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NIH Funding Opportunities and Notices



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