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	Limited Competition: Restoring Research Resources Lost Due to Hurricane Sandy (R24)
Activity Code	R24 Resource-Related Research Projects
Announcement Type	New
Related Notices	July 30, 2014 - Notice of Annual Reporting Requirements and Revised Financial Closeout Requirements for NIH Administrative Supplements Awarded to Recover Losses Due to Hurricane Sandy under the Disaster Relief Appropriations Act. See Notice NOT-OD-14-112. August 28, 2013 - See Notice NOT-OD-13-106. Notice of Special Terms and Conditions for NIH Hurricane Sandy Recovery Awards. July 11, 2013 - See Notice NOT-OD-13-087. Notice of Change to Page Limits and Application Due Date. July 3, 2013 - See Companion RFA-OD-13-007. Limited Competition: Extramural Research Facilities Restoration Program: Hurricane Sandy Disaster Relief (C06).
Funding Opportunity Announcement (FOA) Number	RFA-OD-13-008
Companion Funding Opportunity	RFA-OD-13-005, R21 Exploratory/Developmental Research Grant Award RFA-OD-13-006, S10 Biomedical Research Support Shared Instrumentation Grants RFA-OD-13-199, Administrative Supplement
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.095
Funding Opportunity Purpose	The purpose of this funding opportunity announcement (FOA) is to provide support to help restore research resources, including animal colonies and related materials and equipment, that were lost due to Hurricane Sandy. Benefits of this award are restricted to the FEMA declared major disaster states, which are: Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, West Virginia, and the District of Columbia. Applications submitted in response to this announcement will be considered for funding only with funds received under the Disaster Relief Appropriations Act of 2013, P.L. 113-2. Funds will be provided in a single award with a 24-month budget and project period. No-cost exensions will not be available. Support will be considered for replacement only of those animals and other materials that were extant before Hurricane Sandy and were being used in connection with funded grant support or otherwise being used actively, but were lost due to the storm. These funds cannot duplicate nor overlap with reimbursement provided by the Federal Emergency Management Agency (FEMA), under a contract for insurance, or by self-insurance.

Posted Date	April 18, 2013
Letter of Intent Due Date(s)	June 19, 2013
Application Due Date(s)	(Extended to July 31, 2013 per NOT-OD-13-087), Originally July 19, 2013
AIDS Application Due Date(s)	Not Applicable
Scientific Merit Review	October/November 2013
Advisory Council Review	January 2014
Earliest Start Date	April 2014
Expiration Date	(Extended to August 1, 2013 per NOT-OD-13-087), Originally July 20, 2013
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS 398 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.

Looking ahead: NIH is committed to transitioning all grant programs to electronic submission using the SF424 Research and Related (R&R) format and is currently investigating solutions that will accommodate NIH’s multi-project programs. NIH will announce plans to transition the remaining programs in the NIH Guide to Grants and Contracts and on NIH’s Applying Electronically website.

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

The purpose of this funding opportunity announcement (FOA) is to restore Research Resources, including animal colonies, that were severely damaged in some Institutions impacted by Hurricane Sandy and with NIH grants active at the time of the storm. Benefits of this award are restricted to the FEMA declared major disaster states, which are: Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, West Virginia, and the District of Columbia. Applications submitted in response to this announcement will be considered for funding only with funds received under the Disaster Relief Appropriations Act of 2013, P.L. 113-2. Funds provided by NIH through these supplements cannot duplicate nor overlap with reimbursement provided by FEMA, under a contract for insurance, or by self-insurance.

Funds will be provided in a single award with a 24-month budget and project period. No-cost extensions will not be available. Therefore the applicant must assure that the scope of work proposed and outlays of awarded funds can be completed within this 24-month period.

Losses may have included animals (e.g., genetically modified variants, wild strains); cryopreserved germ plasm and cell lines; reagents; equipment related to maintenance of animal records; equipment directly related to animal-based experiments or cryopreservation such as freezers, surgical apparatus, etc.; and materials of human origin such as cell lines and tissues. Other losses also may have been incurred. This FOA provides support to restore these types of losses, including, but not limited to:

• Specific strains of animals, including both wild type and genetically modified or mutant strains. Applicants are encouraged to obtain replacement animals by the least expensive means possible, for example, as living animals from national repositories or companies. Applicants may also replace animal stocks by obtaining germ plasm or embryos, when appropriate, and re-deriving living stocks in their own facilities. In some cases, mutant animals or cryopreserved germ plasm may have been stored in secondary locations. Support will be provided for purchasing, shipping and handling of materials from these remote locations (for example a national resource facility or a secondary or back-up storage facility).
• In cases of unique variants that are not available from repositories or companies, derivation of live animals that may have been cryopreserved as germ plasm or embryos at a remote location or that are recoverable from the damaged facility. Rederivation can be accomplished through an outside service or in the laboratory that was affected by the storm. Applicants should use the most cost effective means of rederiving animals.
• Testing of animals or cryopreserved material for quality control purposes, for example, for the presence of specific genetic modifications or pathogens.
• Cryopreserved animal germ plasm or animal cell lines. Support will be provided for generating the quantities of these materials that were present before Hurricane Sandy.
• Reagents required for animal-based purchasing, importation, testing (genetic background and infectious status), and maintenance of germ plasm or cell lines.
• Equipment related to the following: a) animal records systems; b) cryopreservation (e.g., freezers); c) preparation of animals for experimental protocols (e.g., surgical apparatus); d) embryo transfer; e) necropsies, f) others, as appropriate.
• Human cell lines, tissues and records systems related to ongoing experiments.

The following will not be supported by this FOA:

• Research resources such as specific strains of animals that can be obtained or rederived using funding from a supplement to an active grant funded by one of the NIH Institutes and Centers. These should be requested in response to RFA-OD-13-199. Equipment costing more than $100,000. Replacement of equipment costing more than $100,000 can be requested under RFA-OD-13-006.
• Construction or renovation of animal facilities, including caging, cage washers, autoclave, etc.
• Computers or other equipment related to information technology that are not directly related to use or maintenance of animal records systems or systems involved in record keeping related to human cells or tissues.
• Animals, reagents or equipment that were not extant at the facility before Hurricane Sandy.
• Animals, reagents or equipment that were not being used in connection with a funded grant or were not being used actively before Hurricane Sandy.

Applications must meet the following criteria to be considered responsive to this FOA:

• Applicant institution was damaged as a result of Hurricane Sandy defined as, and limited to, the FEMA declared major disaster states, which are: Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, West Virginia, and the District of Columbia.
  
  
• A letter from the institution is included in the application that verifies that animals (e.g., genetically modified variants, wild strains); cryopreserved germ plasm and cell lines; reagents; equipment related to maintenance of animal records; equipment directly related to animal-based experiments or cryopreservation such as freezers, surgical apparatus, etc.; and materials of human origin such as cell lines and tissues existed prior to the hurricane and includes a description of the extent of the damage, destruction or loss resulting from the hurricane. Also, the letter must confirm that the application does not request any funding that overlaps with FEMA, under a contract for insurance or self insurance payments. The letter must be signed by an institutional Signing Official.

Applications meeting any of the following criteria will be considered non-responsive and will not proceed to peer review:

• Applicant institution does not meet the definition of an institution impacted by Hurricane Sandy.
  
  
• A letter of support from the institution was: (a) NOT included in the application, (b) did not verify that animals (e.g., genetically modified variants, wild strains); cryopreserved germ plasm and cell lines; reagents; equipment related to maintenance of animal records; equipment directly related to animal-based experiments or cryopreservation such as freezers, surgical apparatus, etc.; and materials of human origin such as cell lines and tissues existed prior to the hurricane, (c) did not describe the extent of damage, destruction or loss, or (d) did not include a statement that the application does not request any funding that overlaps with FEMA, under a contract for insurance or self insurance payments.

Funding Instrument	Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Application Types Allowed	New The OER Glossary and the PHS 398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon funds received by NIH from the Disaster Relief Appropriations Act and the submission of a sufficient number of meritorious applications. The NIH intends to commit up to approximately $9.5 million to fund 2-10 applications; awards will be made in FY 2014. The extent of loses and severity of damages on the research and directly related to Hurricane Sandy will be used in prioritizing funding decisions.
Award Budget	Application budgets are not limited, but need to reflect the actual needs of the proposed project. Award funds shall be expended within 24 months of the Initial Issue Date listed on the Notice of Award.
Award Project Period	The total project period may not exceed 2 years. Funds will be provided in a single award with a 24-month budget and project period. No-cost extensions will not be available. Therefore the applicant must assure that the scope of work proposed and outlays of awarded funds can be completed within this 24-month 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.

Eligibility is limited to research institutions located in the FEMA declared major disaster states, which are: Connecticut, Delaware, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, Virginia, West Virginia, and the District of Columbia.

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

Applicant organizations must complete the following registrations as described in the PHS 398 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.

• System for Award Management (SAM) must maintain an active entity registration (formerly CCR registration), to be renewed at least annually. Use the Sam.gov Manage Entity function to manage your entity registrations. See the Grants Registration User Guide at SAM.gov for additional information.
• eRA Commons

All Program Directors/Principal Investigators (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 6 weeks prior to the application due date.

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 PHS 398 Application Guide.

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

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

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

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

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

It is critical that applicants follow the instructions in the PHS 398 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.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Oleg Mirochnitchenko, Ph.D.
6701 Democracy Blvd, Room 943
Bethesda, MD 20892
Telephone: 301-435-0744
Email: [email protected]

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 five 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)

All page limitations described in the PHS 398 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the PHS398 Application Guide, and should be used for preparing the R24 application.

Face Page

All instructions in the PHS 398 Application Guide must be followed.

Description, Project/Performance Sites, Senior/Key Personnel, Other Significant Contributors, Human Embryonic Stem Cells

All instructions in the PHS 398 Application Guide must be followed.

Table of Contents

All instructions in the PHS 398 Application Guide must be followed.

Detailed Budget for Initial Budget Period

All instructions in the PHS 398 Application Guide must be followed.

Budget for Entire Proposed Period of Support

All instructions in the PHS 398 Application Guide must be followed.

Biographical Sketch

All instructions in the PHS 398 Application Guide must be followed.

Resources

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Provide a letter from the institution that verifies that animals (e.g., genetically modified variants, wild strains); cryopreserved germ plasm and cell lines; reagents; equipment related to maintenance of animal records; equipment directly related to animal-based experiments or cryopreservation such as freezers, surgical apparatus, etc.; and materials of human origin such as cell lines and tissuesexisted prior to the hurricane and that describes the extent of the damage, destruction or loss resulting from the hurricane. The letter must confirm that the application does not request any funding that overlaps with FEMA, under a contract for insurance, or self insurance payments. The letter must be signed by an institutional Signing Official.

Research Plan

All instructions in the PHS 398 Application Guide must be followed, with the following additional instructions:

Research Strategy: Provide the following information.

• A concise description of the resource-related activities that were being performed prior to the hurricane, including the number of animals,cell lines and human tissues used under active sponsored research.
• A narrative indicating the damage that occurred as a result of Hurricane Sandy and the present state of facilities that can be used for animal housing, procedures involving animals and human cell lines and tissues. If facilities must be rebuilt or repaired, the applicant must discuss plans for these repairs and how the schedule will impact the ability to perform the functions, house the animals, etc., that are requested in the application.
• A rationale for each component of the application, including a justification for each particular strategy (e.g., if a specific strain of animal is proposed to be rederived rather than purchased).
• A plan for sustaining the animal colony/activities beyond the two year limit of funding provided by this FOA. The plan should include a discussion of funding strategies that were in place before the Hurricane and any necessary modifications. A plan that simply proposes the request of further funding from NIH will not be considered to be adequate.
• A statement that support for any proposed animals, equipment or other materials cannot be provided by the Federal Emergency Management Agency (FEMA), under a contract for insurance, self-insurance, or other source, in a timely manner.
• Discussion of the status of vertebrate animal research, including availability of research organisms and status of IACUC approval of facilities and research protocols.
• If restoration of human materials such as cell lines or tissues is proposed, a discussion of the status of human subjects approvals and how additional approvals will be obtained, if needed.

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 PHS 398 Application Guide, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS 398 Application Guide, with the following additional instructions:

• Include a table showing the numbers of animals, cell lines, tissues, equipment, reagents, etc. that were extant before Hurricane Sandy, were being used in connection with an active grant or otherwise being used actively and were lost as a result of the storm. Indicate which of these are being requested to be replaced by the proposed funding.

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 PHS 398 Application Guide.

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

This initiative is not subject to intergovernmental review.

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

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

Funds will be awarded in a single action using a 24-month budget and project period. Awarded funds shall be expended within 24-months of the Initial Issue Date listed on the Notice of Award. No-cost extensions will not be available.

Awards will be subject to quarterly financial and programmatic reporting requirements. Details for submitting these required reports will be provided in the Terms of Award.

Funds will be restricted so that they cannot duplicate costs reimbursed by FEMA, under a contract for insurance or self insurance. If during the period of the award a claim is paid which provides such duplication, the grantee will be required to pay back the funds to the NIH.

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.

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

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.

Reviewers will provide an overall impact 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).

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? Will the proposed activities restore the losses related to research resources incurred because of the effects of Hurricane Sandy?

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?

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? Can the proposed activities, such as rederivation of animal strains or restoration of human samples, be performed using currently available facilities and/or renovated facilities during the two year duration of support? Are the methods used to restore animal colonies and/or rederive specific strains of animal the most appropriate ones for the purposes proposed? Are the proposed methods for rederivation the most cost effective means of recovering animals and reestablishing colonies and resources? Do the proposed activities relate only to research resources or equipment that were extant before Hurricane Sandy? Are all computers and computer-related equipment related to use and maintenance of the animal records system or involved with record keeping related to human samples? Do the applicants propose an adequate and viable plan for sustaining the animal colonies and animal-based activities beyond the funding requested under this announcement? Are appropriate research animals available for the proposed activities? Are appropriate methods proposed for recovery of human samples? Is there an appropriate statement that funding provided under this announcement will not duplicate or overlap with reimbursement provided by FEMA, under a contract for insurance, or by self-insurance? Is the plan for long-term sustained support of the animal resources fitting for continued maintenance of the investment to establishing the animal colonies with the funds provided under this project?

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? Can the proposed animals, materials or equipment be used to support research in a timely fashion relative to the institutional environment and state of the physical plant?

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

Protections for Human Subjects

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

Not Applicable

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

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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.

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

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

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

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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

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, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

Awards will be subject to additional quarterly financial and programmatic reporting requirements. Details for submission of these required reports will be provided in the terms of award.

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.

Awards will be subject to additional quarterly financial and programmatic reporting requirements. The NIH will closely monitor all grants.

Not Applicable

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590 or RPPR) 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.

Awards will be subject to additional quarterly financial and programmatic reporting requirements. Details for submission of these quarterly reports will be provided in the terms of award.

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

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: [email protected]

Oleg Mirochnitchenko, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-435-0744
Email: [email protected]

Sally Mulhern, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-408-9724
Email: [email protected]

Judy Musgrave
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0841
Email: [email protected]

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

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