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)

National Heart, Lung, and Blood Institute (NHLBI)

National Institute of Allergy and Infectious Diseases (NIAID)

Funding Opportunity Title
Limited Competition: Research Resource for the National Swine Resource and Research Center (U42 Clinical Trial Not Allowed)
Activity Code

U42 Animal (Mammalian and Nonmammalian) Model, and Animal and Biological Materials Resource Cooperative Agreements

Announcement Type
Reissue of PAR-17-255
Related Notices

NOT-OD-22-018 - Reminder: FORMS-G Grant Application Forms & Instructions Must be Used for Due Dates On or After January 25, 2022 - New Grant Application Instructions Now Available

NOT-OD-21-181 - Updates to the Non-Discrimination Legal Requirements for NIH Recipients

NOT-OD-21-169 - New NIH "FORMS-G" Grant Application Forms and Instructions Coming for Due Dates on or after January 25, 2022

NOT-OD-21-170 - Update: Notification of Upcoming Change in Federal-wide Unique Entity Identifier Requirements

NOT-OD-21-109 - Expanding Requirement for eRA Commons IDs to All Senior/Key Personnel

Funding Opportunity Announcement (FOA) Number
PAR-21-356
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.351, 93.839, 93.837, 93.840, 93.233, 93.838, 93.855
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to provide continued support for the National Swine Resource and Research Center (NSRRC). The NSRRC serves as a central resource for the creation of genetically modified swine in response to the needs of the community and the cryopreservation of genetic stocks, procurement, and distribution of those swine, reagents, and their biological materials; and as a source of information and training related to the use of these animals in biomedical research as models of human health and disease.

Key Dates

Posted Date
December 03, 2021
Open Date (Earliest Submission Date)
December 21, 2021
Letter of Intent Due Date(s)

Not Applicable

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
Not Applicable January 25, 2022 * Not Applicable July 2022 October 2022 December 2022
Not Applicable May 25, 2022 * Not Applicable November 2022 January 2023 April 2023
Not Applicable September 25, 2022 * Not Applicable March 2023 May 2023 July 2023

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
September 26, 2022
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.



  3. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

This FOA invites applications for the continued support and advancement of the National Swine Resource and Research Center (NSRRC). This FOA focuses on providing a resource accessible to the biomedical research community. The main purpose of funding animal model resources by the Office of Research Infrastructure Programs (ORIP) is to increase the understanding of human health and disease through the continued support of animal models, in this case large animal models (swine) to support biomedical research.

The use of swine as animal models has and will continue to contribute to the acquisition of new knowledge to improve both human and animal health. Domestic swine (Sus scrofa domesticus) are closely related to humans in terms of anatomy, genetics and physiology, with their organs sharing common functional features. Swine anatomy and size (from miniature to large breeds) facilitate performance of various surgical and non-surgical procedures used in human medicine (i.e., catheterization, heart surgery, and endoscopy) that are difficult to perform in other animal models, including rodents. The availability of the sequence of the pig genome and the identification of many putative disease-causing variants have extended the potential applications of the pig as a model for biomedical studies. Advances in genetic engineering, powered by new genome editing technologies linked to the swine genome, enhance the utility of swine as models of human genetic diseases. The ability to generate transgenics and knockouts in combination with somatic nuclear transfer procedures has enabled the NSRRC to create several pig models for specific human diseases, such as immunocompromised/humanized (severe combined immunodeficiency) pigs; αGal knockout and other genetically modified pigs for xenotransplantation of organs into nonhuman primates; models of mammary tumors, muscular dystrophy, phenylketonuria, and Fanconi anemia group A; and the oncopig for cancer research. Thus, swine hold promises of becoming better predictive animal models for clinical research and therapeutic treatments in humans, and for studying critical aspects of basic scientific knowledge that impact advances in biomedical research. Research with swine models is supporting several clinical breakthroughs in the fields of regenerative medicine (cell-based therapies to test human adult-derived stem cells in pig models of heart failure and fibrotic lung disease), infectious diseases (especially research on influenza pathogenesis, immunity, and transmission to inform the development of improved vaccine strategies and to enhance pandemic preparedness), cancer, vaccine development, inborn errors of metabolism and cardiovascular development and congenital heart disease, amongst others. To highlight one significant contribution, research using genetically modified pig-to-primate organ xenotransplantation is successfully breaking new ground for alternatives to address the severe shortage of human organ donors.

Continuity of the NSRRC will ensure that biomedical research investigators across a variety of disciplines have uninterrupted access to critically needed swine models. The NSRRC’s function is to serve as a national repository and stock center to fulfill the requests from the scientific community for the creation, acquisition, maintenance, preservation, and distribution of genetically modified swine models for studies of human diseases, as well as the cryopreservation, storage, and reconstitution of embryos and germplasm. In addition, the NSRRC will continue to serve as a central resource for reagents, information (i.e., genetic engineering strategies for model creation, swine husbandry, detection of pathogens, diagnostics for biosecurity) and training (i.e., pre-veterinary and veterinary students, veterinarians, graduate students, postdocs, scientists) related to use of swine models in biomedical research. It will continue to develop methods for improving the health and biosafety of swine strains by establishing standards and procedures for generating specific pathogen free and more vigorous swine strains, as well as for viral and pathogens surveillance and disease outbreak assessment and tracking. It is also essential that the NSRRC’s infrastructure can accommodate specific needs for isolation, growth, preservation, expansion, and distribution of cells, tissues, and organs from these animals.

The resource was originally founded in 2003 under RFA-RR-03-003 as a cooperative agreement (U42) to provide swine models and related biological materials to support biomedical research on the understanding of disease pathobiology. The NSRRC is a unique resource that supports the creation, curation, preservation, and distribution of swine for basic and pre-clinical research supported by NIH.

The NSRRC should include, but is not limited to, the following areas of service and support:

  • Model creation, characterization, maintenance, distribution, cryopreservation, and breeding of animals and distribution and preservation of tissues and biological materials.
  • Consulting and genetic services for the creation of models that can appropriately represent human diseases.
  • Curation (establishment, characterization, maintenance) and distribution of imported swine models.
  • Creation of web tools, reagents, biological materials (cell cultures, tissues, organs) to support the swine research community as requested or needed.
  • Protection and cryopreservation of genetic stocks by providing surveillance, detection and diagnosis of pathogens and infectious diseases that threaten laboratory swine stocks.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.

Application Types Allowed
Renewal
Resubmission

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Not Allowed: Only accepting applications that do not propose clinical trials.

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

NIH intends to fund one award. Future year amounts will depend on annual appropriations.

Award Budget

For Renewal applications including Renewal Resubmission applications, no more than a 5 percent increase of direct cost based on a previous non-competing year with the highest direct cost in the prior four-year funding cycle will be accepted.

Award Project Period

The scope of the proposed resource should determine the project period. The maximum project period is 5 years.

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

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Only grantees previously funded under PAR-17-255 are eligible to 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

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

Page Limitations

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

Component Component Type for Submission Page Limit Required/Optional Minimum Maximum
Overall Overall 6 Required 1 1
Resource Section Core 12 Required 1 1
Applied Research Section Project 6 Required 1 1

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

  • Overall: required
  • Core (Resource Section): required
  • Project (Applied Research Section): required

Overall Component

When preparing your application, use Component Type ‘Overall’.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: State concisely the goals of the proposed resource and summarize the expected outcome(s), including the impact that the results of the proposed resource will exert on the research field(s) that it supports.

Research Strategy: Applicants should:

• Provide a brief description of the purpose and history of the NSRRC, and the research communities that it serves.

• Regarding the operation and maintenance of the Center, provide an overview of how the models generated by this project i) will be made available rapidly and efficiently to NIH-supported investigators; and ii) would serve the needs of investigators in a variety of research areas on a local, regional, and national basis.

• Describe the process by which the awardee will allocate animals to specific researchers (prioritization of resources allocations). The ORIP expects that allocation will be on a first come - first served basis, with NIH-funded researchers having the highest priority. Animals in excess of NIH researchers' demand can be provided to researchers funded by other sources, only with prior approval of the ORIP Program Director.

• Describe how the Center will utilize innovative technologies to enhance and improve the quality of the resource’s capacity for curation, evaluation, characterization, cryopreservation, storage, virus/pathogens surveillance and distribution of the models, tissues/organs/biological material, and reagents.

• Describe what training opportunities the Center will provide to and how it will share information with the research community that it serves.

• Address any recommendations of an advisory board or steering committee.

Letters of Support: Statements of Institutional Commitment, Letters of Support from the past and potential future users of the resources and services, Letters of Collaborations, and other similar documents, if appropriate, should be included in this attachment (rather than in the Core and Project Sections).

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

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

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Overall)

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

Core (Resource)

When preparing your application, use Component Type ‘Core.’

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

SF424 (R&R) Cover (Resource)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates

 

PHS 398 Cover Page Supplement (Resource)

Enter Human Embryonic Stem Cells in each relevant component.

 

Research & Related Other Project Information (Resource)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

 

Project /Performance Site Location(s) (Resource)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Resource)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Resource Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

 

Budget (Resource)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Resource)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

 

Specific Aims: State concisely the goals of the proposed Resource Section and summarize the expected outcome(s), including the impact that the results of the proposed Resource Section will exert on ability of biomedical researchers at research centers, academic institutions, the NIH and other federal agencies to advance scientific knowledge in broad areas.

 

Research Strategy: A Research Performance Progress Report summarizing the achievements and progress of the NSRRC during the previous grant funding cycle must be included in this section; including the models created and their cryopreservation and distribution.

Resource Management and Plan

1. Resource Management.

Describe:

• Administrative roles and responsibilities of the PD/PI(s), the organization of the resource including collaborators, interactions with advisory/steering committee(s) (external and internal Advisory Boards, if applicable), research/services components and indicate how they contribute to reach the overarching goals of the NSRRC.

• Features of the institutional environment that are relevant to the effective progress of the proposed program.

• As appropriate, available resources, such as laboratory facilities, participating and affiliated units, geographical distribution of space and personnel, and consultative resources.

• Support and commitment of the parent institution for the resource.

• Plan to develop an active program for monitoring and documenting the impact of the resource on ongoing biomedical research activities.

• Disaster plan to minimize the resource’s losses in the event of a catastrophic disasters, such as fires, natural events (i.e., floods, tornados, hurricanes, earthquakes, storms) or data breach.

• Contingency plan in the event of unforeseen release of genetic modified pigs and crossbreeding with livestock.

2. Resource Plan

Describe a detailed plan covering the following areas:

• How the resource will manage model creation requests, including how the requests will be prioritized, and the number of models to be created on an annual basis, considering the current infrastructure of the NSRRC.

• Role of an advisory board or steering committee, including member composition and frequency of meetings.

• Ensuring compliance with the Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy), including completion of the Vertebrate Animals Section according to the criteria described below. All institutions are also required to comply, as applicable, with the Animal Welfare Act, and other Federal statutes and regulations relating to animals.

• Maintenance and distribution of the highest health status inbred swine strains, various hybrid and inbred lines, and swine lines with genetically selected or altered genes that will be transiently housed in the NSRRC.

• Establishment and maintenance of an animal barrier facility (specify pathogen free (SPF) swine strains) and development of procedural and managerial husbandry techniques and practices appropriate for a state-of-the-art facility to safeguard the animals.

• Depth of characterization of swine strains with regards to development, growth, and pathobiology, including surveillance for infectious agents in both animals and germplasm.

• High-quality, in-house data management and information system (database).

• Maintenance of a web-accessible electronic information system for listing and properly describing available live animals, cryopreserved germplasm and biological materials (such as embryos, DNA, antibodies) and for the dissemination of information related to genetic engineering strategies for model creation, swine husbandry, detection of pathogens and diagnostics for biosecurity.

• The local NSRRC electronic record management system should provide access to the NSRRC swine strain/models catalog and their respective genetic background, a description of the request procedure for creation of swine strains, application forms for submission of candidate strains to the NSRRC, and information on availability and pricing of NSRRC swine strains. The system should use proper language to harmonize ontologies across resources.

• Development of capabilities for cryopreservation of embryo and sperm, storage facilities, and in-house expertise for the recovery and revival of cryopreserved embryos and gametes.

• Implementing licensing terms, use/user-restrictions including patented technology, and material transfer agreements (MTAs). The NSRRC will distribute strains under the least restrictive terms possible, resulting in minimal administrative delays. Outgoing MTAs for all recipients of NSRRC strains or cryopreserved material should be established. NSRRC swine strains will be distributed to all non-profit and for-profit educational institutions (Colleges and Universities) for internal, non-commercial biomedical research purposes under the supervision of an appropriate oversight body (e.g., an IACUC); priority will be for NIH-funded researchers at those institutions. In any instance, the distributions should not restrict or limit the availability or access to the strain by the scientific community at large.

• Cost recovery for supplies, creation of resources, and long-term maintenance of these resources. The NSRRC will establish a distribution fee schedule that is intended to defray costs associated with the model creation, specialized husbandry for swine strains and lines, partial characterization (including genetic analysis), animal health monitoring, cryopreservation, delivery, customer service, and technical information and support that is acceptable to the NIH.

• Description of how the NSRRC will promote its resources, standard operating procedures (SOPs) distribution, and training and educational activities related to highlight the growing value of this large animal model for translational research.

• Description of training opportunities for pre-veterinary and veterinary students, veterinarians, graduate students, postdocs and scientists.

• Strategies for promoting acknowledgment by NSRRC users of the Center's support and contributions to scientific advances.

 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) 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.

 

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

 

PHS Human Subjects and Clinical Trials Information (Resource)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

 

Project (Applied Research)

When preparing your application, use Component Type ‘Project’

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

SF424 (R&R) Cover (Applied Research)

Complete only the following fields:

  • Applicant Information

  • Type of Applicant (optional)

  • Descriptive Title of Applicant’s Project

  • Proposed Project Start/Ending Dates

 

PHS 398 Cover Page Supplement (Applied Research)

Enter Human Embryonic Stem Cells in each relevant component.

 

Research & Related Other Project Information (Applied Research)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Applied Research)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Applied Research)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.

  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

 

Budget (Applied Research)

Budget forms appropriate for the specific component will be included in the application package.

The Applied Research Section may comprise no more than 10 percent of the direct costs associated with the grant.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Applied Research)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: State concisely the goals of the proposed Applied Research Section and summarize the expected outcome(s), including the impact that the results of the proposed Applied Research Section will exert on improving the value of the models created or on the scope of the Center.

 

Research Strategy: Describe what Applied Research will be conducted and how this innovative research will impact and improve the NSRRC’s activity (i.e., generate new information, services, products, or models that will improve the Resource mission). Examples of research projects would include, but are not limited to, the development, improvement, and application of emerging technologies for:

• Production of genetically engineered swine.

• Genotyping and phenotyping of swine models.

• Developing state-of-the-art testing methods for swine health surveillance and infectious disease monitoring and prevention.

• Cryopreservation methods for germ cells and embryos and tissues.

These examples are not intended to be limiting.

 

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) 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.

 

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

 

PHS Human Subjects and Clinical Trials Information (Applied Research)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. 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.

7. Other Submission Requirements and Information

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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 How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). 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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant 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 a Scientific/ Research Contact 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 SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

The U42 application is a multicomponent application, with an "Overall" component that is the aggregate of the Core (Resource) and the Project (Applied Research) Sections. During the review process, reviewers will first consider each of the review criteria listed for the Resource and Applied Research and provide "Merit Descriptors" for each of them. The three potential Merit Descriptors are outstanding, acceptable, or unacceptable. Once the Resource and Applied Research are completed, numerical scoring will be assigned for the Overall application. In the detailed sections below, each of the three Components' Review Criteria appear in the standard order used in FOAs.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center (NSRRC) 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 Center proposed).

Scored Review Criteria - Overall

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

How does the proposed Center meet the needs of the research program and community that it will serve? Is the scope of activities proposed for the Center appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the research program? Will successful completion of the aims strengthen the Center and improve the value of the swine as a model? Are the models created having an impact in biomedical research?

Investigator(s)

Are the PD(s)/PI(s) and other personnel well suited to their roles in the Center? Do they have appropriate experience and training, and an ongoing record of accomplishments in managing swine research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? Do the investigators have complementary and integrated expertise and skills; are their leadership approach, governance, plans for conflict resolution, and organizational structure appropriate for the Center? Does the applicant have experience overseeing selection and management of subawards, if included? Do they have appropriate experience and expertise to accomplish the overarching goals of the Center? Do the investigators demonstrate significant expertise to create the appropriate models requested by the research community?

Innovation

Does the application propose novel organizational concepts, management strategies, or electronic information/record management systems or instrumentation in coordinating and sustaining the research programs and community the Center will serve? Are they applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed? Are the models created using cutting-edge technologies and having an impact in biomedical research?

Approach

Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research community the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the program/ resource, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the resource is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the resource? Are appropriate plans for workflow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for the vertebrate animals created?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research and training programs that the community needs? Are the institutional support and infrastructure (equipment and other physical resources) available to the investigators adequate for the Center proposed? Will the Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support training and electronic information handling?

Review Criteria for the Resource Component

Reviewers will consider each of the review criteria below in the determination of scientific merit and provide a merit descriptor (outstanding, acceptable, unacceptable) for the Resource Component. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

• Are the goals and administrative structure proposed in the Resource Section adequate to achieve a robust center?

• Does the proposed administrative structure function to support and maintain the resource plan of the NSRRC and to promote it to the biomedical research community?

• Does the Resource (Core) Lead have the expertise and the administrative leadership to achieve the overarching goals of the Center? And the required level of seniority and authority within the applicant organization?

• Does the applicant/organization have a demonstrated track record of operating an established swine center that includes recognized expertise, knowledge of managing such a resource, including an advisory board or steering committee to recommend/select the best model possible to create?

• Are the different aspects of the resource adequately structured?

• Is the advisory board/steering committee appropriately staffed to complete the required functions?

• Does the Center have the necessary infrastructure for the creation, holding, preservation and distribution of the annual number of models to be created?

• Does the Center offer opportunities for training?

• Is the process for prioritization of models to be created aligned with the needs of the research community?

• Does the resource utilize state-of-the-art technologies to improve the design and creation of the models?

• Is there a plan to provide the resource's approaches, standard operating procedures (SOPs) and protocols as well as information for accessing, requesting, donating/importing, and distributing swine to the scientific community?

• Are the proposed evaluation mechanisms and processes adequate and will they result in improvements of the resources?

• Does the proposed plan for the continuation of the NSRRC adequate to accomplish the goals set to create, acquire, characterize, cryopreserve, store, and distribute genetically modify swine, biological materials, and reagents? Is past performance supportive of this continuation?

• Are the mechanisms to request model creations, biological material, and reagents as an expedited service adequate?

• Are key personnel responsibilities clearly delineated and appropriate for the different aspects of the resource: model creation, acquisition, characterization, cryopreservation, biosecurity; remote site for backup the genetic stocks; detailed cost-recovery program; internet site to promote and display information on the models available, and distribution for genetically modify swine, and biological materials and reagents?

• Are the plans for promoting swine as alternative biological models and for sharing supporting information adequate?

Review Criteria for the Applied Research Component

Reviewers will consider each of the review criteria below in the determination of scientific merit and provide a merit descriptor (outstanding, acceptable, unacceptable) for the Applied Research Component. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

• How will the plans for the proposed research enhance the Center? What is the potential impact of the proposed research to the Center?

• Will the proposed research lead to improvement in the creation, cryopreservation, or biosafety of the animals at the Center?

• Is the research project adequately developed and appropriate to improve and support the methods and technologies used to create and cryopreserve the models?

• How sound is the scientific rationale for the Applied Research Section to leverage the Resource Section?

• Will the biomedical/research community benefit from the research project?

• Will the proposed research protocols and results be accessible to the research community?

Additional Review Criteria - Overall

As applicable for the Center 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 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 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not applicable

Additional Review Considerations - Overall, Resource and Applied Research Components

As applicable for the Center 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) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For Centers involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

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 Center for Scientific Review, 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 will receive a written critique.

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.

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 NIH Council of Councils. 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.

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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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 recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. 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 terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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, Recipients, and Activities, including of note, but not limited to:

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75 and 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
 

The PD(s)/PI(s) will have the primary responsibility for:

  • Planning the activities, defining the aims and objectives, describing the methods, techniques, and other resources to be used and for carrying out the work described.
  • Maintenance and distribution of the highest health status inbred swine strains, various hybrid and inbred lines, and swine lines with genetically selected or altered genes (subsequently all called swine strains) that will be housed in the NSRRC.
  • Establishment and maintenance of an animal barrier facility (SPF swine strains) and development of procedural and managerial husbandry techniques and practices appropriate for a state-of-the-art facility for various swine strains.
  • Phenotypic characterization of swine strains with regards to development, growth, physiology, and pathobiology, including surveillance for infectious agents in both animals and germplasm.
  • Maintenance of a local electronic record management and information system for cataloging live animals and cryopreserved materials (such as sperm, eggs, embryos, DNA, antibodies). The local electronic management system must be connected to the web site and be accessible to investigators. Recipients will retain custody of and have primary rights to the data and software web tools developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.
  • Implementing licensing terms, use-restrictions including patent technology, and MTAs, in consultation with NIH-ORIP.
  • Attendance of the Core Lead of the resource or his/her designee at the biennial Comparative Medicine Resource Directors Meeting supported by ORIP.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

ORIP Project Scientists involvement:

  • Assist with facilitating the coordination and management of the resource ensuring that overall management of the Center is in compliance with NIH policies.
  • Coordinate and assist with establishing operating procedures regarding prioritization and sharing of swine models and related research data for use by other researchers.
  • Facilitate the development of networks among researchers, commercial interests, community interests, and governmental entities.
  • Participate in the Center go/no-go decision-making on acceptance of model creation requests. Review and comment on critical stages in the model creation process and the research project before subsequent stages are implemented.
  • Interact with PD(s)/PI(s) on a regular basis to monitor progress at the Center. Participate in research project update meetings with the PD/PI.
  • Have the option to recommend to the Program Officer withholding of support to the Center if aims are not met.
  • Have substantial scientific/programmatic involvement during conduct of this cooperative agreement, through technical assistance, advice, and coordination above and beyond normal program stewardship of grants.
  • Participate in all Program Steering Committee (PSC) activities, including conference calls, subcommittees, and special working groups as a voting member; however, NIH voting membership will not exceed one-third of the total PCS membership.

Additionally, an ORIP Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

ORIP Program Officer involvement:

  • Be responsible for the normal scientific and programmatic stewardship of the award.
  • Carry out continuous review of all activities to ensure the project aims are being met.
  • Pursue enforcement actions including withholding of support for failure to meet the terms and conditions of the award or failure to show satisfactory progress in achieving the aims.
  • With the help of the PD(s)/PI(s), organize the kick-off meeting within the first two months of award.
  • Be a member of the Program Steering Committee (PSC).
  • Assist the PSC in drafting and implementing operating policies and policies addressing recurring situations that require coordinated action.
  • Request information from the Center to support Congressional, NIH or Division inquiries.

Areas of Joint Responsibilities:

  • The PD(s)/PI(s) of the Center funded under this FOA and the ORIP Project Scientist will be responsible for forming a Program Steering Committee (PSC).
  • The PSC will act as the main governing board for the recipient’s project.
  • The PSC will include: the PD(s)/PI(s), all key personnel or up to two additional investigators associated with the NSRRC, one representative each from every NIH Institutes/Centers contributing to the funding of the NSRRC (voting), one expert scientist representing another ORIP-funded resource, a qualified veterinarian, the NIH Project Scientist (voting), the NIH Program Official (ex officio), and external scientist(s) as needed.
  • The number of NIH voting members of the PSC will be limited to a maximum of three; one vote will be represented by the ORIP Project Scientist. NIH PSC members may not chair the PSC. The structure of the PSC should be established at the first PSC meeting, which should take place within the first two months of funding.
  • The PSC will elect a chairperson who will be responsible for coordinating the PSC activities, preparing meeting agendas, and scheduling and chairing meetings.

Program Steering Committee Involvement:

  • Program Steering Committee (PSC) will participate in monitoring the scientific progress of the U42 award.
  • Advise the ORIP Project Scientist of scientific developments and opportunities that may enhance the goals of the program.
  • Convene quarterly meetings (in person or by video or audio teleconference) to monitor progress on the research project plan and to address issues or activities that impact the project.
  • Help to develop uniform procedures and policies for the operation of the program under this FOA.
  • Review the progress of the research activities, review and approve protocols, identify barriers or roadblocks, select strategies to surmount them, and identify opportunities for sharing techniques and tools developed within the NSRRC with the scientific community.
  • Review the final SOPs for quality control in husbandry, veterinary care, maintenance of the animal facility, shipping and receiving of animals and germplasm, maintenance of the electronic record management and information System, administrative directions, and reporting procedures.
  • Review and approve requests from investigators to have swine strains accepted into the NSRRC and deciding whether to maintain live animals or only cryopreserved germplasm.
  • Review and decide on requests for banked DNA, antibodies, or other materials.
  • Establish and restructure workgroups for specific tasks as the PSC deems appropriate and determine the composition of the workgroups. Members must have appropriate expertise in molecular genetics, laboratory or clinical research, animal care, or other areas as deemed necessary by the PSC. Members of the PSC may also serve on the workgroups.
  • As deemed necessary, invite additional, non-voting scientific advisors to meetings at which research priorities and opportunities are discussed.
3. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, 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. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Miguel Contreras, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-594-9410
Email: contre1@mail.nih.gov
 

Nasrin Nabavi, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 240-627-3538
E-mail: nnabavi@niaid.nih.gov
 

Lisa Schwartz-Longacre, PhD 
National Heart, Lung, And Blood Institute (NHLBI)
Phone: 301-402-4826
E-mail: schwartzlongal@mail.nih.gov

Peer Review Contact(s)

Center for Scientific Review (CSR)
FOAReviewContact@csr.nih.gov

Financial/Grants Management Contact(s)

Gavin Wilkom
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-827-7078
Email: wilkomg@mail.nih.gov
 

Sufiyan Saeed
National Institute of Allergy and Infectious Diseases (NIAID)
Phone: 240-627-3761
E-mail: sufiyan.saeed@nih.gov
 

Tawana Mckeither
National Heart, Lung, And Blood Institute (NHLBI)
Phone: 240-276-6300
E-mail: mckeitherta@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 Part 75 and 2 CFR Part 200.

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