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)

Activity Code

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

Announcement Type

Reissue of PAR-11-001

Related Notices
  • May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062.
Funding Opportunity Announcement (FOA) Number

PAR-17-255

Companion Funding Opportunity

None

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

93.351; 93.840; 93.839; 93.838; 93.837; 93.233; 93.856; 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 reagents, the creation of genetically modified swine and the procurement, preservation, and distribution of those swine 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

April 14, 2017

Open Date (Earliest Submission Date)

May 21, 2017

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

June 21, 2017, September 25, 2017 and January 25, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date

January 26, 2018

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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.

Learn more about the various submission options.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information


Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

This FOA invites applications for the continued support and advancement of the NSRRC. This FOA focuses on providing a resource accessible to the biomedical research community. The main purpose of the research funding by the Office of Research Infrastructure Programs (ORIP) is to increase the understanding of human health and disease through the continued support of 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. Thus, experiments in swine may be much more predictive of therapeutic treatments in humans than experiments in rodents. Swine represent an excellent animal model to study critical aspects of basic scientific knowledge that impact advances in biomedical research. This resource is supporting several clinical breakthroughs in the fields of regenerative medicine (as part of the precision medicine initiative), infectious diseases, cancer and vaccine development amongst others. To highlight one significant contribution, genetically modified pig-to-primate organ transplantation models are successfully breaking new ground as alternatives for the shortage of human organ donors.

Continuity of the NSRRC will ensure that biomedical investigators across a variety of disciplines have access to critically needed swine models. The NSRRC’s function is 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 and information and training related to use of swine models in biomedical research. It will continue to develop methods for improving the health of swine strains by establishing standards and procedures for generating specific-pathogen free and more vigorous swine strains and characterizing diseases endemic to laboratory swine stocks. 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 14 years ago under  RFA-RR-03-003 as a cooperative agreement (U42) to provide swine models, biological materials related to health and disease, and support for biomedical research. The NSRRC is a unique resource that supports the creation, curation, preservation, and distribution of swine in support of basic and clinical NIH-funded research.

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

  • Genetic services for the creation of models that can appropriately represent human diseases;
  • Model creation, basic characterization, distribution, preparation, storage of animals and their tissues and biological materials;
  • Curation (establishment, characterization, maintenance) and distribution of swine models;
  • Creation of reagents for distribution to the swine research community as requested or needed;
  • Protection and preservation of genetic stock.

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.

Funds Available and Anticipated Number of Awards

NIH intends to fund one award in FY18.

Award Budget

The Direct costs requested cannot exceed a 5% increase over the direct costs awarded in the last year of the funded grant period.

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 in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

  Only grantees previously funded under PAR-11-001 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 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) (formerly CCR) – 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.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. 
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  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 NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

A button to access the online ASSIST system 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

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, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions – Application Guide, Electronic Submission of Grant Applications.

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

  6

Core (use for Resource Section)

12

Project (use for Applied Research Section)

  6

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

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
  • Resource Section: required; maximum of 1
  • Applied Research Section: required; maximum of 1
Overall Component

When preparing your application in ASSIST, 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 Location(s) (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 & 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 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 allocates animals to specific researchers. The ORIP expects that allocation is on a first come - first served basis, with NIH-funded researchers having priority. Animals in excess of the demands of NIH researchers 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, and distribution of the models, tissues/biological material (sperm, embryos, stem cells), reagents and dissemination of information.
  • Address any recommendations of an advisory board/committee - including external advisors.

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, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan for the overall application in this section.

Appendix:

 Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

PHS Assignment Request Form (Overall)

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

Resource Section

When preparing your application in ASSIST, 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 Section)

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 Section)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource Section)

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) (Resource Section)

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 Section)
  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core 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 Section)

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 Section)

Introduction to Application: For Resubmission 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, their cryopreservation and distribution.

Resource Management and Plan

1. Resource Management

Describe:

  • The administrative roles and responsibilities of the PD/PI(s), the organization of the resource, including collaborators, interactions with advisor 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.
  • The features of the institutional environment that are relevant to the effective progress of the proposed program. As appropriate, describe available resources, such as laboratory facilities, participating and affiliated units, geographical distribution of space and personnel, and consultative resources.
  • Information on the support and commitment of the parent institution for the resource.
  • A plan to document the impact of the resource on biomedical research.

2. Resource Plan

Describe a detailed plan covering the following areas:

  • How the resource will manage the model creations request (including how the requests will be prioritized), the number of models to be created on an annual basis, considering the current infrastructure of the NSRRC. Applicants must also address the role of an advisory board/ committee.
  • 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 developing procedural and managerial husbandry techniques and practices appropriate for a state-of-the-art facility for the animals.
  • Phenotypic characterization of swine strains with regards to development, function, and pathology, including surveillance for infectious agents in both animals and germplasm.
  • Maintenance of a local web accessible, electronic database for live animals and for cryopreserved germplasm and biological materials (such as embryos, DNA, antibodies). The local NSRRC database should provide access to the NSRRC swine strain/models catalog and their respective genetic background, description about requesting swine strains creation, application forms for submission of candidate strains to the NSRRC, and information on standard supply levels and pricing of NSRRC swine strains.
  • Development of capabilities for cryopreservation of embryo and sperm, storage facilities, and expertise for the reconstitution of cryopreserved embryos and gametes.
  • Implementing licensing terms, use-restrictions including patent 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 will 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.
  • Cost-recovery for supplies and long-term maintenance of the resource. The NSRRC will establish a distribution fee schedule that is intended to defray the costs associated with specialized swine breeding for swine stains and lines, genetic quality control, animal health monitoring, cryopreservation, customer service, and technical information and support that is acceptable to the NIH.
  • How the NSRRC will serve as a source of information, standard operating procedures (SOPs) distribution, and a site for training and educational activities related to research which employs swine.
  • The Core Lead for the resource or his/her designee is required to attend the biennial meeting of Resource Directors of the Division of Comparative Medicine, ORIP.

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:

Address Data Sharing Plan in the Overall Section.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.   

PHS Inclusion Enrollment Report (Resource Section)

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

Applied Research Section

When preparing your application in ASSIST, 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 Section)

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 Section)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Applied Research Section)

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 Section)

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 Section)

  • 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 Section)

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 Section)

Introduction to Application: For Resubmission 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 animal 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:

Address a Data Sharing Plan in the Overall Section.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report (Applied Research Section)

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

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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.

Post Submission Materials

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

Section V. Application Review Information
1. Criteria

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

The U42 application is a multicomponent application, with an "Overall" component that is the aggregate of the Resource and the Applied Research Sections. During the review process, reviewers will first consider each of the review criteria listed for each of the Cores and provide an overall impact score for each Core. Once the Cores are completed, scoring will be assigned for the Overall application.

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 Center that by its nature is not innovative may be essential to advance a field.

Significance

Does the proposed Center address the needs of the research programs 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? Does the proposed Center address the needs of the research 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 strengthen the Center and the value of the swine as a model? 

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 have they demonstrated experience and an ongoing record of accomplishments in managing swine research? Do the investigators demonstrate significant experience with coordinating collaborative basic research? If the Center is multi-PD/PI, 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 needed? Do they have appropriate experience and expertise to accomplish the overarching goals of the Center? Have they demonstrated a record of accomplishments managing the resource? Do the investigators demonstrate significant expertise to create the right models requested by the research community? If the Center is multi-PD/PI, 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? 

Innovation

Does the application propose novel organizational concepts, management strategies, or instrumentation in coordinating the research program the Center will serve? Are the concepts, strategies, or instrumentation novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts, management strategies or instrumentation proposed? Are the models created 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 program the Center will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the program/projects/network/consortium/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 an appropriate plan for work-flow and a well-established timeline proposed?  Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for the vertebrate animals created? Are they participating in the Resource Identification Initiative, to support Rigor and Reproducibility in science?

Environment

Will the institutional environment in which the Center will operate contribute to the probability of success in facilitating the research program it serves? Are the institutional support, 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 electronic information handling?

Review Criteria for the Resource Section

Reviewers will consider each of the review criteria below in the determination of scientific merit, and provide an overall impact score for the Resource Section. 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 adequately described?
  • 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 Core Lead have the expertise and the administrative leadership to achieve the overarching goals of the NSRRC?
  • Does the applicant/organization have a demonstrated track record of running an established swine center that includes recognized expertise, knowledge of managing such a resource, including an advising service to recommend/select the best model possible to create?
  • Are the different aspects of the resource adequately described?
  • Is the function of an advisory board/committee adequately described and appropriate?
  • Has the Center the infrastructure for holding, preserving and distributing the annual number of models to be created?
  • Does the applicant adequately address how prioritization of the models to be created will be done?
  • 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 and protocols and information to access, request, donate, and distribute swine?
  • Does the application address evaluation of mechanisms, a continuous process to improve programs, and implementation of improvement plans of the resource's procedures and programs?
  • Is there sufficient evidence of the ability of the resource to create, acquire, evaluate, characterize, cryopreserve, store, and distribute genetically modified swine?
  • Is the proposed plan for the continuation of the NSRRC adequate to accomplish the work set to create, acquire, characterize, cryopreserve, store, and distribute genetically modify swine, biological materials and reagents?
  • Are the mechanisms to request model creations, biological material and reagents in place to have an expedited service?
  • Is there evidence of appropriate administrative experience to support and maintain the research resource of the NSRRC for another 5 years?
  • Are key personnel responsibilities clearly delineated for the different aspects of the resource: model creation, acquisition, characterization, cryopreservation, and distribution for genetically modify swine, and biological materials and reagents?
  • Are the plans for promoting swine as alternative biological models adequate? Are the SOPs available to the investigators?
  • Does the Core Lead have the proven experience and expertise to continue directing the Resource?
  • Does the Core Lead have the required level of seniority and authority within the applicant organization?
  • Are adequate plans provided for the regular evaluation of production and scientific progress; prioritization of model creation and allocations; regular interaction with the EAB; biosecurity; remote site for backup the genetic stocks; detailed cost-recovery program; internet site to promote and display information on the models available?
Review Criteria for the Applied Research Section

Reviewers will consider each of the review criteria below in the determination of scientific merit, and provide an overall impact score for the Applied Research Section. An application does not need to be strong in all categories to be judged likely to have major scientific impact.

  • Are there detailed plans describing the proposed research and how this will enhance the Center?
  • Will the proposed research lead to improvement in the creation, preservation, 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 community benefit from the research project?
  •  Will the proposed research protocols and results be accessible to the research community?
Additional Review Criteria - Overall, Resource Section and Applied Research Section
 

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 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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

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 children 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 Section, and Applied Research Section

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 .


Authentication of Key Biological and/or Chemical Resources

For projects 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 the 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:

  • 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.

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. 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 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 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.

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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 “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 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 awardee is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipient's activities by involvement in and otherwise working jointly with the award recipient 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 awardee for the project as a whole, although specific tasks and activities may be shared among the awardee 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 developing 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, function, and pathology, including surveillance for infectious agents in both animals and germplasm.
  • Maintenance of a local electronic database for live animals and for cryopreserved materials (such as embryos, DNA, antibodies). This local NSRRC database should provide access to an NSRRC swine strain catalog and appropriate strain detail pages, information about requesting swine strains, application forms for submission of candidate strains to the NSRRC, and information on standard supply levels and pricing of NSRRC swine strains. The local database must be connected to a web site and accessible from the WWW to allow investigators access to the database.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies.

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

The ORIP Project Scientists will:

  • 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 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 Center go/no-go decision-making on acceptance of model development 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 workgroups as a voting member; however, NIH voting membership will not exceed one-third of the total PSC 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.

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.

The ORIP Program Officer will:

  • 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 PSC.
  • Help the PSC draft and apply operating policies and policies addressing recurring situations that require coordinated action.

Areas of Joint Responsibility include:

Program Steering Committee:

The ORIP Project Scientist and the PD(s)/PI(s) of the Center funded under this FOA will be responsible for forming a PSC. The PSC will act as the main governing board for the awardee’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.

The Program Steering Committee will:

  • Participate in monitoring the scientific progress of the U42.
  • 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.
  • Reviewing 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 database, administrative directions, and reporting procedures.
  • Be responsible for reviewing and approving 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. The workgroups will make recommendations to the PSC.
  • 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.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16

3. Reporting

When multiple years are involved, awardees 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 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. 

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, 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 75 – Award Term and Conditions 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 registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

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

Scientific/Research Contact(s)

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

Nasri Nabavi
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3538
Email: NNABAVI@niaid.nih.gov

Lisa Schwartz Longacre
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-402-4826
Email: schwartzlongal@nhlbi.nih.gov

Peer Review Contact(s)

Ross D. Shonat, Ph.D. 
Center for Scientific Review (CSR) 
Telephone: 301-435-2786
Email: ross.shonat@nih.gov

Financial/Grants Management Contact(s)

Shannon Oden
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-594-3028
Email: Odens@mail.nih.gov

Jason Lundgren
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2973
Email:  lundgrenj@niaid.nih.gov

Debbie Chen
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301- 827-8023
Email:  debbie.chen@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.

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