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 Center for Research Resources (NCRR) (IC Removed per NOT-OD-12-075)
Funding Opportunity Title	Limited Competition:  National Primate Research Centers (P51)
Activity Code	P51 Primate Research Center Grants
Announcement Type	New
Related Notices	September 28, 2012 – See Notice NOT-OD-12-161. NIH Announces Plans to Transition to Electronic Submission of Multi-Project Applications August 15, 2012 - Applications submitted in response to PAR-11-136 will be accepted on the non-standard due date of February 25, 2013, replacing the January 25, 2013 date for the September 2013 Council round. See Notice NOT-OD-12-135. March 6, 2012 - See Notice NOT-OD-12-075. Notice of Change in Participation of NIH Institutes and Centers. May 11, 2011 - See Notice NOT-RR-11-006 This Notice clarifies the fact that letters of support are not necessary or expected and will not be accepted for P51 grant applications submitted.
Funding Opportunity Announcement (FOA) Number	PAR-11-136
Companion FOA	None
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.351
FOA Purpose	This FOA issued by the National Center for Research Resources (NCRR), National Institutes of Health (NIH), encourages grant applications that support the activities of the National Primate Research Centers (NPRCs). Nonhuman primates (NHPs) are most closely related to humans, both physiologically and genetically. Therefore, NHPs are critical animal models for translational research aimed at understanding human biology, both in normal and diseased states. Proper husbandry and management of NHPs requires specialized physical and intellectual resources, which are most effectively and economically provided in centralized primate centers, the resources of which are made available to investigators on a national basis. The NPRCs provide these resources that complement and help enable the missions of the NIH Institutes and Centers, the grantees of which utilize NHPs to study specific diseases.

Posted Date	March 9, 2011
Letter of Intent Due Date	Not Applicable
Application Due Date(s)	Standard dates applly
AIDS Application Due Date(s)	Not applicabler
Scientific Merit Review	Standard dates apply
Advisory Council Review	Standard dates apply
Earliest Start Date(s)	Standard dates apply
Expiration Date	May 8, 2014
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Note:  A new version of the paper PHS 398 application form and instructions (revised 6/2009) must now be used. Download the new application form and instructions from http://grants.nih.gov/grants/forms.htm.

Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The National Center for Research Resources (NCRR) of the National Institutes of Health (NIH) funds a National Primate Research Center (NPRC) program, the goal of which is to facilitate the effective use of NHPs by scientists engaged in biomedical research. The NPRC program complements and enables the missions of the other NIH Institutes and Centers, the grantees of which utilize NHPs to study specific diseases. NCRR’s Division of Comparative Medicine (DCM) currently funds eight NPRCs, which are centralized facilities in various parts of the country, and are available to investigators on a national basis. Individual NPRCs can have specific areas of emphasis, but each is expected to provide a variety of services both individually and through inter-NPRC collaborations to a wide range of investigators.  Applicants to this FOA are limited to existing NPRCs.  Investigators who want to use the resources available at the NPRCs should consult http://ncrr.nih.gov/comparative_medicine/resource_directory/primates.asp.

The overall objective of the NPRC program is to provide support for scientists who use NHPs in their research. This is accomplished by funding NPRCs that provide the animals, facilities, and expertise needed to enable research using NHPs. More specifically, support is provided to:

• Develop and sustain national resources for normative data, consultative and collaborative expertise, biologic and genetic material, and specialized facilities, equipment, and expertise that support NHP-related research.
• Breed and provide animals suitable for research using NHPs.
• Study the biology of NHP species that are of potential research importance for the purpose of enhancing their scientific utility, health, and well-being.
• Develop improved practices of NHP breeding, husbandry and genetic definition to help meet research needs for pedigreed, disease-free animals of defined quality, and to ensure the continued availability of species of biomedical research importance whose wild populations are considered threatened or endangered.
• Develop NHP models of human disease and facilitate their use.
• Conduct pilot (basic and applied) biomedical research projects in areas requiring the use of NHPs. Pilot projects are aimed at helping to solve problems related to human health, and they should lead to independent grant support related to the disease or health problem being studied.
• Provide opportunities for local, national, and international research involvement and experience in primatology to graduate and undergraduate students, postdoctoral fellows, visiting scientists and faculty members, as well as short-term learning assignments for students of the health professions.
• Disseminate the findings of studies and technical advances in NHP research to the scientific community via reports published in internationally-recognized, peer-reviewed journals and other appropriate media.

An NPRC receives funding from the NCRR through a base grant using the NIH P51 activity code  (hereafter referred to as the P51 base grant). The P51 base grant provides the nucleus of support for the NPRC. By accepting the grant award, the grantee institution agrees to make the facilities and resources available to selected affiliate and visiting scientists from other institutions, as well as to its own scientists. The P51 base grant is not intended to provide the total funding for the NPRC. Funding of NPRC operations should be augmented by other sources such as program income, peer reviewed research grants, contracts, or cooperative agreements and other sources, as appropriate.

P51 base grant awards are made under authorization of Title 111, Part A, Section 301 of the Public Health Service Act (Public Law 78-410, as amended, 42-USC-241) and administered under PHS Grants Policies and Federal Regulations 42 CFR Part 52 and 45 CFR Part 74. The P51 base grants are subject to the policies and procedures set forth in the most current version of the NIH Grants Policy Statement, hereafter referred to as the Grants Policy Statement.  However, there are special circumstances related to the administration and operation of the NPRCs that require additional guidelines as set forth in this document. These guidelines are intended to supplement the existing Grants Policy Statement and to provide guidance for unique management aspects of the program.

An NPRC is a distinct organizational and structural component affiliated with a major research institution. The grantee institution is the recipient of the P51 base grant funds and assumes legal responsibility and accountability for use and disposition of these funds in accordance with PHS policy. The grantee institution is responsible for the scientific programs being conducted at, with or through the NPRC. The grantee institution is responsible for the academic environment of the NPRC by providing access to joint appointments in appropriate departments and by encouraging cooperative activities and interchange between the NPRC and the grantee institution’s other scientific and technical staff.

The P51 base grant supports the specialized facilities, scientific and technical personnel, and NHP species needed for the conduct of biomedical and behavioral research.  Activities and costs supported by the P51 base grant can include, but are not limited to:

• Personnel, including salaries for:
  • The Center Director, Associate and Assistant Director(s).
  • Clinical veterinarians, veterinary technical support and animal care staff.
  • Administrative staff and support services if clearly justified and not included as Facilities and Administration (F&A) costs.
  • Personnel, including pathologists and behaviorists, involved in monitoring and maintaining the health of the NPRC animals and providing for the care and well-being of those animals.
  • Core scientists and technical staff.
• Establishment, development and maintenance of animal colonies, including the base breeding colony.
• Maintenance, operation, and renovation of the NPRC buildings and outdoor facilities, except for those costs reimbursed under F&A rates.
• Central administration of the NPRC, except for those costs reimbursed under F&A rates.
• Pathology services, including surveillance of diseases in the colony.
• Clinical laboratory services related to colony health surveillance and support of research.
• Genetics-based services used for colony management and characterization.
• Bioengineering, medical arts, computation and photographic services, with costs and charges consistent with grantee institution practices.
• NPRC-specific library services except for those costs reimbursed under F&A rates.
• The animal colony records systems. Some NPRCs include databases and informational services associated with finance, administration, and operations in the animal colony records system.
• Activities and services associated with consortium-based activities.
• Pilot and Resource-Related Research Projects.

The specific content of the grant application will depend on the organizational structure of the NPRC. In general, an NPRC is comprised of major functional sections, which may include individual components. Individual NPRCs have latitude in regard to functional organization, which may depend, in part, on the requirements of the grantee institution and on the specific activities of the NPRC.

 A component is defined as a functional group within an NPRC that has an internal organizational chart and reporting structure, as well as specific resources and responsibilities that make an essential contribution to the research activities and day-to-day operations of the NPRC. These components are described in the renewal application for the NPRC and are peer-reviewed.

Specific points regarding some of the NPRC functions are as follows:

The Program Director / Principal Investigator (PD/PI) is designated by the grantee institution and has ultimate responsibility for the conduct of NPRC operations. The NIH communicates with the PD/PI on broad institutional issues relating to the NPRC. The PD/PI should hold a position in the grantee institution that crosses organizational lines, for example, as the Vice President for Research or Dean of the graduate school, medical school or health sciences center. The PD/PI must occupy a senior level position in the grantee institution to assure administrative continuity of the NPRC’s programs and to avoid dependence on individual departments within the grantee institution. The PD/PI of an NPRC is required to commit at least 0.12 person-month  effort (based on a 12 month calendar year appointment) to the P51 base grant. However, he/she derives no salary from the P51 base grant. Multiple PD/PIs are not permitted on the P51 base grant.

The Center Director is a senior scientist appointed by the PD/PI and the grantee institution and approved by NCRR. The Center Director is responsible for the day-to-day management and scientific direction of the NPRC. The Center Director should be an established scientist with a doctoral degree in one of the health science disciplines and a recipient of peer-reviewed biomedical research support. The Center Director is responsible to the PD/PI and derives a significant portion of his or her salary for providing scientific leadership and administrative oversight of the NPRC. Support for a Center Director from the P51 base grant is normally between 3 and 9 person-months (based on a 12 month calendar year appointment) for administrative responsibilities.

Core scientists direct research programs and/or provide scientific expertise, veterinary expertise or leadership in specific subject areas. Core scientists may have full- or part-time permanent appointments at the NPRC. Core scientists are considered part of the intellectual infrastructure of the NPRC and provide expertise regarding NHPs for the conduct of research projects, including investigations by affiliate and visiting scientists.

Core scientists are appointed by the Center Director in accord with the host institution’s academic and personnel policies and are directly responsible to the Center Director for performance of duties that contribute to the aims of the NPRC. Joint appointments of core scientists in academic departments are encouraged to foster mutually beneficial relationships between the NPRC and other components of the grantee institution. Core scientists can potentially represent many different disciplines, depending on the needs of the NPRC.

Except as discussed below, no more than 40 percent of a core scientist’s salary can be supported by the P51 base grant. Salary support, in addition to that provided by the P51 base grant, may be derived through a joint appointment within the grantee institution. The specific level of outside funding versus P51 base grant funding for a core scientist will depend on the responsibilities of the core scientist.

Core scientists may, with appropriate justification and depending on availability of funds, receive up to 100 percent salary support from the P51 base grant. Such full-time support must be justified on the basis of short-term, interim funding or continuity of specialized functions and responsibilities critical to the NPRC’s overall operation. The grantee institution must specifically justify support of any core scientist at greater than 40 percent salary each year in the non-competing renewal application. Core scientists who receive their full salary from the base grant may devote up to 1.2 person-months, based on a 12 month calendar year appointment o scholarly activities in an academic department, usually in the grantee institution.

Regardless of the source of funding, core scientists must devote at least 1.2 person-months, based on a 12 month calendar year appointment to service that is directly related to supporting the scientific programs and activities of the NPRC. In addition, a core scientist must devote at least 6 person-months, based on a 12 month calendar year appointment to NHP-related research.

Affiliate scientists are investigators from outside the NPRC who conduct research on NHPs and collaborate with NPRC staff in the conduct of this research. Scientists from within the grantee institution, but who do not have appointments at the NPRC, are considered affiliate scientists, as are investigators from outside the grantee institution.

Affiliate scientists obtain approval from the Center Director to use the resources of the NPRC prior to submission of a grant application. Contingent on the awarding of funds, they are assured of a working relationship with NPRC staff and have access to the facilities and resources of the NPRC for regular or intermittent periods necessary to complete a project. Affiliate scientists do not derive salary support from the P51 base grant.

Scientists who visit or consult with the NPRC to learn a procedure or obtain advice, but who otherwise do not use NPRC resources, are not considered affiliate scientists. Likewise, investigators who obtain services, resources such as animals, or materials such as tissue samples on a fee for service basis, but who otherwise do not collaborate with NPRC personnel, are not considered affiliate scientists.

Visiting scientists are established investigators in residence at the NPRC for a limited period by virtue of an appointment approved by the Center Director. A visiting scientist is directly responsible to the Center Director. The studies of visiting scientists must be enhanced by access to an NPRC’s resources, and the NPRC is expected to benefit from access to a visiting scientist’s expertise and knowledge. Visiting scientists typically provide their own salary support, with facilities and resource support provided by the NPRC.

In addition to affiliate and visiting scientists, other investigators may collaborate directly with NPRC core scientists on specific research projects, using varying amounts of NPRC resources. These collaborative scientists are usually identified as co-authors on papers or co-investigators on grant proposals with NPRC core scientists, if not otherwise designated as affiliate or visiting scientists.

The NPRCs are guided in their governance by two or more Advisory Committees, described below. The roles of these Advisory Committees is to provide a balanced perspective of external advice and review to more fully inform internal executive management and decision-making.

Minimum requirements for these committees are described below. Within these minimum parameters, the exact composition of the committees, terms of service, and the frequency and type of meetings can vary depending on the needs of the individual NPRCs. The Center Director has the option of appointing additional advisory committees to augment these standing committees, depending on the unique needs of the NPRC, which can vary because of differences in leadership structures, NHP populations, university affiliations, community interactions and other factors that affect governance.

Each NPRC must have a National Scientific Advisory Board (NSAB), which provides guidance to the PD/PI and Center Director on all aspects of the NPRC, including scientific direction. The NSAB reports to the PD/PI of the NPRC. The NSAB must consist of at least six eminent scientists from outside the NPRC, with experience using NHPs for research. Overall, the composition of the NSAB must reflect the range of technical subjects that are pursued at the NPRC. It is permissible to have limited representation (maximum of two members) on the NSAB from other NPRCs, which may facilitate NPRC consortium activities. Individuals serving on the NSAB are appointed annually, are typically reappointed for 3-5 consecutive terms and may serve concurrently on the NSAB of, at most, one other NPRC.

The NSAB must meet at the NPRC as a full group or as specialty subgroups, at least on an annual basis, to review and provide advice regarding the development and conduct of the NPRC’s scientific programs, resource programs and general policies. Periodic teleconferences or videoconferences involving the entire NSAB or a subcommittee may be scheduled between annual meetings to address continuing or unanticipated scientific or administrative issues at the NPRC. The NSAB must have a chairperson, who is appointed by the NPRC Director, in consultation with the PD/PI. A record of the conclusions of the NSAB must be maintained in the office of the Center Director and made available for DCM program staff visits.

Each NPRC also must have a Research Advisory Committee (RAC), which provides advice to the Center Director regarding prioritization of projects and resources. Final decisions regarding prioritization are at the discretion of the Center Director. The RAC must consist of at least four members appointed by the Center Director with the concurrence of the PD/PI. Members of the RAC must be core scientists representative of the functional components within the NPRC. The RAC must meet at least monthly to discuss the research programs of the NPRC and to review all new project proposals that will use NPRC resources in regard to feasibility in the context of NPRC capabilities. In addition, the RAC must review the scientific merit of all new project proposals that have not undergone NIH peer review and that will use NPRC resources. Records summarizing the recommendations of the RAC must be maintained in the office of the Center Director and made available at review site visits and DCM program staff visits.

Animal colonies are key components of the function of an NPRC, and efficient and humane management of the NHP colonies is a key element for an NPRC. Each NPRC must support breeding colonies to provide for national research needs. NPRCs that have limited space for breeding colonies can fund breeding colonies at other sites. In this case, the NPRC that funds the off-site breeding colony will have the primary responsibility for decisions regarding its management. The NPRC must be able to provide animals upon request from existing pools of research animals, while maintaining an appropriate number of animals for breeding purposes. A computer-based system for tracking animals in the research and breeding colonies must be in place.

Various NHP species can be accommodated at an NPRC. Generally, demand on a national level and availability are necessary for support of a given species through the P51 base grant. The major support for infrastructure, space, and resources should be used for maintenance and husbandry of those species for which there is major national demand. Additional factors, such as conditions and practices to allow social interactions that contribute to the psychological well-being of the animals may also influence resource allocation for a given species. It is also acceptable for P51 base grant funding to be used to ensure the continued availability of species of biomedical research importance whose wild populations are considered threatened or endangered. The NPRC must have programs in place to maintain the genetic diversity of animal colonies and for environmental enrichment.

Animal colonies must meet the following criteria:

• The NPRC must maintain an exemplary program of animal care and use consistent with current Public Health Service (PHS) policy. Basic evidence for this is accreditation by the American Association for the Accreditation of Laboratory Animal Care (AAALAC).
• All animals must be procured, owned, and quarantined by the NPRC, unless a specific exemption is authorized by the Center Director. To the extent feasible, the NPRC must breed and characterize the NHPs needed for its programs. In cases where facilities for breeding are limited, an NPRC’s animals can be bred at another facility. Animals may be exchanged among NPRCs as appropriate.
• The NPRC must maintain control of all of its animals, either physically or through appropriate contractual arrangements. This includes space assignment of animals, removal or reentry of NHPs to the NPRC, animal health and care, including humane treatment and attention to psychological well-being, and all other aspects of the use of animals within the NPRC.
• Non-primate species can be used and housed at an NPRC if at least one of the following conditions is met: a) The non-primate species is appropriate for preliminary or pilot studies on development of techniques and procedures in preparation for definitive studies in NHPs; b) Use of the non-primate species will conserve NHP resources and the endpoint studies will be conducted in NHPs; c) The non-primate species is used to develop expertise and technology in newly developing fields of research that can be applied to NHPs; d) The non-primate species is used to study inter-relationships with NHPs, and it is reasonable to assume that the studies may have direct applicability to NHP research; e) The non-primate species is used as an adjunct to studies on NHP species.

Research is carried out in components, often referred to as Departments, Divisions or Program Areas, organized according to specific areas of scientific research. Investigations carried out by core scientists relating to their specific research grants (for example, NIH R01 grants) can be performed in the same laboratories as activities related to NPRC activities, such as collaborations with affiliate or visiting scientists. However, the P51 base grant is not intended to fund R01 type research performed by core scientists. Research projects in scientific components supported by the P51 base grant can fall under the following categories:

• Collaborative research in which core scientists interact with other core, affiliate, or visiting scientists.
• Pilot Research Projects.
• Resource Related Research Projects.

A scientific component can also contain entities that provide core services, either to multiple components within the NPRC or to the individual scientific component.

An NPRC must have a pilot research program and must fund at least one pilot research project per year. The number of pilot research projects supported by the P51 base grant can vary, depending on the availability of funds and is at the discretion of the Center Director. Pilot research must include activities related to the use of NHPs for biomedical research or for studies enhancing the welfare or husbandry of NHPs. Pilot research should be developmental or high risk and should be used to generate preliminary data or results necessary to apply for support from sources of funding such as NIH R01 grants. The following guidelines apply to the use of P51 base grant funds to support pilot research projects:

• All activities related to the use of NHPs must be conducted on-site at the NPRC. Other activities can be performed at other sites, depending on the nature of the pilot project.
• Pilot research funds may not be used to provide interim support for established projects or for investigations funded from other sources.
• An NPRC may budget up to a maximum of $500,000 direct costs per year to support the pilot research program. Pilot program funds can be supplemented by funds associated with specific Funding Opportunity Announcements or Program Announcements.The direct cost for a single pilot research project must not exceed $100,000 per year for a maximum of two years of support.
• All pilot research projects must be planned, conducted, and carried out under the supervision of at least one core scientist at the NPRC. A core scientist must assume responsibility for overall management, coordination, and progress reports.
• Pilot projects can be performed either by NPRC personnel or by qualified personnel who are not NPRC core scientists. The principal investigator of a pilot project need not be an NPRC core scientist. However, NPRC personnel must be involved in some capacity in the pilot project. At least one-half of funded pilot projects must involve the active participation of non-core scientists.
• The NPRC must publicize its pilot research program on a national level beyond the NPRC consortium and grantee institution, for example, through a website, providing information at national meetings, etc.
• NPRCs are encouraged to solicit and consider pilot projects that involve translational research, including collaborations with clinical entities such as Clinical and Translational Science Awards, Research Centers in Minority Institutions, Centers for AIDS Research, etc.
• Individual NPRCs are given discretion regarding the format and length of the pilot proposal. However, the proposal must contain sufficient information to allow evaluation of merit from the written application alone by the NPRC’s review committee. Funds for the approved project may be used for personnel, for example, additional technicians who are not already being supported by the P51 base grant; supplies; animals and animal care costs; items of equipment costing less than $5,000 (equipment costing more than $5,000 must be approved by NCRR prior to beginning the pilot project); consultants and other special services, including NPRC core unit services such as surgery, pathology, assays, or clinical services.
• The Center Director must appoint a review committee of not less than four members, who will evaluate proposals and provide advice to the Center Director or his/her designee as Director of the Pilot Program regarding priorities for support. Two of the four reviewers must be from outside the NPRC and the grantee institution, but can be affiliate scientists.
• Each NPRC should institute a scoring system for evaluation and a means for obtaining short written critiques of the proposal from the review committee. The written critiques and scores must be maintained by the Center Director and made available to DCM staff during a programmatic site visit.

Resource-Related Research Projects (RRRPs) directly enhance the NPRC’s resources and ability to meet the needs of researchers using NHPs. Examples of RRRPs can include, but are not limited to, investigations aimed at improving NHP husbandry and welfare, or improving techniques for characterizing diseased and/or normal animals that are used in NHP research.

RRRPs are not a required component on the P51 base grant. However, if a RRRP is proposed or will be continued in the first year of a renewal cycle, then a description of the project must be included in the grant application. Requirements for the RRRP are as follows:

• The principal investigator of a RRRP must be an NPRC core scientist.
• At least 75 percent of the activities funded by the RRRP must be performed on site at the NPRC.
• RRRPs also can involve investigators outside of the NPRC and the grantee institution.
• A single RRRP cannot exceed $500,000 total costs per year.
• The period of the RRRP can be up to five years.

A maximum of $600,000 of IM funds may be requested for each year of the P51 base grant application.  These funds can be used to upgrade the physical plant (repairs and renovation of facilities) and to replace obsolete shared resources and equipment. A single improvement project or equipment purchase cannot exceed $500,000 in total costs.  IM funds cannot be used for construction. Requested items can be utilized by one or several components of the NPRC.

NPRCs must publicize their capabilities on a national level, for example through a website, providing information at national meetings, etc. This information should be provided to all interested investigators, not just core and affiliate scientists. Each NPRC is also strongly encouraged, but not required, to have a local community engagement program to educate the public about the importance of the research at the NPRC and the link between animal research and improvements in human health. 

The NPRCs are expected to participate in consortium-based activities that will enhance the resources of the program and promote cost savings by standardizing common activities across all of the NPRCs. An example of this type of activity includes, but is not limited to, participation in NPRC Working Groups, the goals of which are to consolidate system-wide activities. Working Groups are formed by NPRC representatives in consultation with NCRR staff. The Center Director will appoint at least one representative to each Working Group. The function and identity of Working Groups will change over time, as problems are solved and new problems and topic areas arise.

Requests for use of available NPRC resources (including animals, space, core facilities, etc.) must be prioritized from highest to lowest priority as follows, with investigators funded by:

1.  NIH extramural grants (highest priority).

2.  NIH intramural funding.

3.  Nonprofit or not-for-profit funding.

4.  For-profit funding.

If a proposed project is funded by more than one source, the highest priority source should be used for determining priorities. Within the above categories, projects must be prioritized on a first-come, first-served basis, with no preference given to scientists within the grantee institution or NPRC versus scientists from outside the grantee institution.

Funding Instrument	Grant
Application Types Allowed	Renewal Resubmission Revision The OER Glossary and the PHS398 Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The number of awards is contingent upon NIH appropriations, and the submission of a sufficient number of meritorious applications.
Award Budget	Application budgets must reflect actual needs of the proposed project. Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the PHS398 Application Guide.
Award Project Period	The scope of the proposed activities should determine the project period. The maximum 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.

Higher Education Institutions:

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

This FOA is limited to organizations that currently have a NPRC funded by NCRR using the P51 activity code.  Applications from other organizations will be returned without peer review.

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

• Central Contractor Registration (CCR) – must maintain an active registration, to be renewed at least annually
• eRA Commons

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

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Project Director/Principal Investigator (PD/PI) 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.

Multiple PD/PIs are not allowed.

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

 Only one application per organization is permitted.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed. Resubmission applications may be submitted, according to the NIH Policy on Resubmission Applications from the PHS398 Application Guide.   

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

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

Martha Matocha, Ph.D.
Scientific Review Officer
National Center for Research Resources
National Institutes of Health, DHHS
6701 Democracy Blvd., Room 1070
Bethesda, MD 20892-4874
Bethesda, MD 20817 (FedEx or courier)
Tel 301-435-0813 (direct line)

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

This section should provide information regarding the function of the NPRC as a whole and should only include the information that is not specific to individual components of the NPRC. This section should not duplicate the detailed information in the sections describing specific functional components.

Page Limits:

• 30 pages total for the Overall Research Strategy section, which should discuss issues that relate to the NPRC as a whole, not to individual components.  Biographical sketches are not included in the 30-page limit; follow the PHS398 directions for biographical sketches.

The organization of the Overview section is at the discretion of the applicant, but at a minimum must include the following:

• An organizational chart that shows:
  • the relationship of the PD/PI and Center Director to the senior administration of the grantee institution.
  • the major functional units within the NPRC, with reporting relationships made clear.
  • the advisory boards and their relationship to the components of the NPRC.
• Background and mission of the NPRC.
• Overview of the relationship of the NPRC to the grantee institution.
• Overview of the organization and administration of the NPRC.
• Overview of the animal colonies.
• A table that lists all cores, indicating the component in which each core resides. A component is defined as a functional group within an NPRC that has an internal organizational chart and reporting structure, as well as specific resources and responsibilities that make an essential contribution to the research activities and day-to-day operations of the NPRC.
• Overview of training and outreach.
• Description of the oversight committees, including functions and composition.
• Progress during the past performance period (usually the past five years), including NPRC-level major accomplishments. For major scientific accomplishments, include only those that have been funded, at least in part, by the P51 base grant.
• Contribution of the major accomplishments during the past performance period to the mission and goals of the NPRC, including the significance of each accomplishment. For each accomplishment, provide the relevant publication(s) where appropriate. As related to the NPRC Administration and Animal Services components, describe any activities that resulted in more efficient NPRC operations.
• Changes in key personnel since the last review.
• For each of the key personnel listed on PHS 398 form page 3, as well as for all other doctoral-level personnel who receive salary support from the P51 base grant, provide a biographical sketch and a listing of research support, using the current format required by the NIH. Include this information for the PD/PI first, followed by the remainder of the personnel in alphabetical order. At the beginning of this section, provide an index with page numbers for each individual biographical sketch and other support entry. Do not place this information in an appendix.
• Biographical sketches and the listing of other support are not part of the 30-page limit for the Overview section.
• Summary of plans, challenges, and opportunities for the requested period of support.
• For Renewal and Revision Applications, a Progress Report discussing NPRC-wide progress. Progress Reports for individual components should be placed in the sections for those components.
• For Resubmission applications, a one-pagesummary of the responses to the comments in the previous summary statement that pertain to the NPRC as a whole. Responses to the previous summary statement regarding specific components should be included in the sections for those components.

The component preface information is not subject to page limits. Do not include information that belongs in the content section or your application may be will not be reviewed.. Include the following information in the preface to each component:

• Title page.
• Component organizational chart.
• List of component personnel, base institutional affiliation, and role in relation to the NPRC.
• Description of the component, limited to one page.
• Detailed budget for the initial year and a budget for the subsequent years (do not include any items that are treated by the grantee institution as F&A costs according to a Federal Rate Negotiation Agreement).
• Budget justification.
• A table showing the sources and amounts of funding for the component for the last funded year of the existing P51 base grant and the first proposed year of the P51 base grant renewal. Sources of funding should be broken down as follows, and as applicable to the component:           
  • P51 base grant support.
  • Program income derived from the P51 base grant.
  • Other sources.
• Resources and Environment: use the NIH Resources Format Page, listing relevant equipment and resources.
• A list of publications arising from contributions by the component, where applicable. Do not include abstracts or manuscripts that are submitted but not yet accepted for publication.

Page limits are set for the Research Strategy section for each component, not per major section. Major sections may include the components listed (a, b, c…) if applicable.

For all component within a Renewal or Revision Application, include a Progress Report regarding the specific component.  For a Resubmission application, include a one page response to the previous summary statement for the specific component. 

ADMINISTRATION

The components within Administration should provide services across the entire NPRC and are usually under the direct supervision of the Center Director or his/her designee.  Examples of administrative components may include the following.  The specific titles of these components may differ among NPRCs.

a)  Administration Overview

b)  Director’s Office

c)  Business Office

d)  Environmental Health and Safety

e)  Computer Services

f)   Information Technology

g)  NPRC-specific Library Services

h)  Bioengineering Services

i)   Photography Services

j)   Education and Training Programs

k)  Public Affairs Office

l)   Other components, as relevant to the specific NPRC

   a) Administration Overview

The Research Strategy section is limited to 12 pages. For a Renewal or Revision Application, include a Progress Report regarding overall Administration.  For a Resubmission application, include a one page response to the previous summary statement for overall Administration.

• The Overview of Administration should include a discussion of the following, at a minimum:
  • The organizational structure of the grantee institution should be described as it relates to the NPRC, including the institutional chain of professional and administrative responsibilities. If these relationships involve more than one institution, describe the lines of authority and submit a letter of agreement signed by the responsible officer of each organization that supports the application.
  • The structure of the NPRC administration and its relationship to and interaction with the grantee institution.
  • The administrative relationship among the Principal Investigator, Center Director, Associate Directors, Assistant Directors, and advisory boards and committees and the responsibilities of the Center Director and Associate or Assistant Directors.
  • A listing of committees, their functions, record keeping, and composition. Include the NSAB, the RAC, and other committees with advisory roles on specific aspects of the NPRC’s research projects, such as the Institutional Animal Care and Use Committee (IACUC). Provide a membership list, including academic titles, for each committee member.
  • Provide a process outline for review and approval of research proposals; indicate the procedures for coordination among the Principal Investigator, Center Director, RAC, and individual investigators regarding review and approval of submitted research projects.

b)  Individual Administration Components

The Research Strategy section for each Administrative Component is limited to 12 pages. 

• Address the progress and major accomplishments achieved by the component during the past grant period.
• Discuss the service plan and/or research plan for the next grant period.
• For a Renewal or Revision Application, include a Progress Report for the individual component. For a Resubmission application, include a one page response to the previous summary statement for each component.  

ANIMAL SERVICES

Animal Services components vary widely across NPRCs. Many subunits within Animal Services function across several or all components of the NPRC and are under the direct supervision of the Center Director or his/her designee. Some units sustain animal well being or breeding and, therefore, do not serve any specific component of the NPRC.

Per Animal Services component: The Research Strategy section is limited to 12 pages.

For each component defined by the NPRC, include the following if appropriate to the component:

• Indicate if a unit serves a specific NPRC component or functions across several components.
  • Include summary information on the following.  This can be in a table format.
  • the types of services provided.
  • the number of users of a service.
  • the usage per investigator.
  • unit cost per occurrence.
  • total cost per service.
• Describe the record keeping systems, including a computer-based system that must be in place for tracking animals in the research and breeding colonies.
• Each component must contain a section that refers to standard operating procedures (SOPs) that must be in place for animal care, such as those published in the Guide for the Care and Use of Laboratory Animals (http://www.nap.edu/openbook.php?record_id=5140&page=R2). Routine daily maintenance and other procedures will be observed during the review site visit, and documentation, including SOPs and IACUC minutes, may be requested by the reviewers.
• Training of animal care staff and all personnel who have contact with NHPs must occur on a regular basis with documentation in personnel files. Emergency measures for accidental exposures, scratches, and bites must be included for all personnel who come in contact with NHPs. Documentation of these procedures will be required at the review site visit.
• For a Renewal or Revision Application, include a Progress Report for the individual component. For a Resubmission application, include a one page response to the previous summary statement for each component.  

CORE SCIENCE SERVICES

Cores that are contained within a specific component should be described in the section of the grant application for that specific component. Cores that do not fit within a specific component should be described in the Core Science Services section of the grant application. Cores must serve two or more investigators.

Per core: The Research Strategy section is limited to 6 pages. 

For a Renewal or Revision Application, include a Progress Report for the individual core.

For a Resubmission application, include a one page response to the previous summary statement for each core.  

For each component defined by the NPRC, include the following if appropriate to the component:

• The types of services provided;
• The number and affiliation of users.

Although not required, most NPRCs have a Tissue and Reagent Distribution Program, often organized as a core.

This Research Strategy section is limited to 6 pages. 

For a Renewal or Revision Application, include a Progress Report for the individual component. For a Resubmission application, include a one page response to the previous summary statement for each component.  

Provide the following information for the Tissue and Reagent Distribution Program:

• A description of the program, including the types of material distributed and methods for publicity, prioritization, and distribution.
• A table listing for each year of the previous funding period, the number of samples distributed, the number of investigators and institutions that received samples, and the amount of program income obtained. Indicate the number of samples provided to each of the following: core scientists, affiliate scientists, visiting scientists, and other scientists. Segment this list by broad category, such as tissues, biological samples, and genetic samples. It is not necessary to segment the list by species. Note that external investigators whose sole interaction with the NPRC is through this program are not considered affiliate scientists.

SCIENTIFIC COMPONENTS.

Per component: The Research Strategy section is limited to 12 pages.  

For a Renewal or Revision Application, include a Progress Report for the individual component. For a Resubmission application, include a one page response to the previous summary statement for each component.  

a)  Research Strategy. The Research Strategy Section should include the following:

• Progress and major accomplishments achieved during the past grant period. For scientific components, progress and major accomplishments should not include detailed descriptions of individual research projects of the core scientists, except if these are directly related to the core scientist’s role in the administration of the NPRC or as a facilitator of interactions with other scientists who use NHPs in their research.
• Service plan and/or research plan for the requested period of support. For scientific components, service and research plans should not include detailed descriptions of the individual research projects of core scientists, except if these are directly related to the core scientist’s role in the administration of the NPRC or as a facilitator of interactions with other scientists who use NHPs in their research.

b)  For each Core Scientist listed in the key personnel section, include a narrative, not to exceed one   page in length that includes (does not count towards page limits):

• A brief overview (one paragraph maximum) of the core scientist’s research program. This is provided solely as context for the core scientist’s role in the NPRC. The merit of individual research programs funded by sources outside of the P51 base grant will not be evaluated by the reviewers.
• Contribution of the core scientist to the mission of the NPRC, including administrative duties, interactions with affiliate scientists and visiting scientists, and other relevant activities.

c)  For the externally funded research projects performed within the component, provide a list  (does     not count towards page limits):

• For each project, list the project title, type of grant award, such as an NIH R01, the Principal Investigator, the grantee institution, and a one-sentence description of the purpose of the investigations carried out using NPRC resources. This list should include all projects performed by core scientists, affiliate scientists, and visiting scientists. These projects have been peer-reviewed and deemed to be scientifically meritorious; individual projects are not reviewed again in the NPRC review. The projects are included to provide an overview of the types of investigations carried out using the resources of the NPRC research component.

PILOT RESEARCH PROGRAM

Each NPRC must have a Pilot Research Program that solicits proposals from outside investigators and funds collaborative projects with NPRC core scientists. All of the funded pilot project grant applications should be available to reviewers at the time of the site visit.  The Research Strategy section is limited to 12 pages.  For a Renewal or Revision Application, include a Progress Report. For a Resubmission application, include a one page response to the previous summary statement.

Provide the following information on the Pilot Research Program:

• Overall description of the Pilot Research Program, including governance and review procedures.
• Documentation of the mechanisms used to publicize the Pilot Research Program.
• For each year of the previous funding period, a list of the reviewers of the pilot project proposals, including titles and institutional affiliations (if provided in table format, does not count towards page limit).
• A table (does not count towards page limit) that lists, for each year of the previous funding period:
  • the number of applications received. 
  • the number of applications funded.
  • the number of funded projects that involved researchers inside and outside of the NPRC, respectively.
  • the total amount of pilot funding.
• Plans for the Pilot Research Program for the next funding period, including any changes from the previous funding period, anticipated funding levels, and plans to publicize the program.
• For the previous funding period, provide, for each funded pilot project, a narrative not more than one page in length that includes the following (these one-page descriptions do not count towards the page limits:
  • Project title.
  • Name, title, and institutional affiliation of the principal investigator.
  • Year(s) funded.
  • Abstract, including Specific Aims.
  • Full bibliographic material on each paper published, in press or submitted, resulting from the pilot project. Do not include abstracts.
  • Grant applications and funded grants resulting from the pilot project.

RESOURCE RELATED RESEARCH PROJECTS (RRRPs) 

This Research Strategy section of each RRRP is limited to 12 pages.   For a Renewal or Revision Application, include a Progress Report for the RRRP.  For a Resubmission application, include a one page response to the previous summary statement for the RRRPReferences do not count towards the page limit. Refrain from including extraneous information in sections that do not have page limits.

• Use the same format as for a NIH R01 application, including a cover page, key personnel, budget, and narrative, including specific aims, background, and a brief description of preliminary data, experimental plan, and references.
• As appropriate to the project, address the five points for vertebrate animal welfare, four points for protections of human subjects, and biohazard comments required by the PHS 398 instructions. These pages do not count towards the page limit.
• Include the names of core personnel and the names and biographical sketches for non-core personnel, as applicable. These pages do not count towards the page limit.

IMPROVEMENT AND MODERNIZATION (IM)

The Research Strategy section is limited to 12 pages.  For a Renewal or Revision Application, include a Progress Report for IM. For a Resubmission application, include a one page response to the previous summary statement for IM.  

• Provide a list that includes each item, the cost, and a justification. No single item can total more than $500,000 total costs.
• Provide copies of price quotations, if available. Quotations are not included in the 12 page limit.

OUTREACH AND COMMUNITY ENGAGEMENT

The Research Strategy section is limited to 6 pages.  For a Renewal or Revision Application, include a Progress Report for the component. For a Resubmission Application, include a one page response to the previous summary statement for the component.  

• Describe the methods used to advertise NPRC capabilities to potential collaborators outside of the grantee institution.
• Although not required, most NPRCs also engage in outreach to the local communities in which they are located. If applicable, describe activities involving community engagement, including educating the public about the research at the NPRC and the link between animal research and improvements in human health.

NPRC CONSORTIUM-BASED ACTIVITIES

The NPRCs engage in consortium-based activities aimed at cooperative projects that will provide improvements across the NPRCs.

The Reseach Strategy section is limited to 6 pages.  For a Renewal or Revision Application, include a Progress Report for the component. For a Resubmission Application, include a one page response to the previous summary statement for the component,  

• Describe the participation of the NPRC in these activities, and the results obtained.
• Provide a Table that lists the various NPRC Consortium working groups and the NPRC personnel and their titles, who have participated in each working group.  Table does not count toward the 6 page limit.

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

 Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modifications:

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

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide, with the following modifications.  Inclusion of additional information other than what is specified here may result in the application not being reviewed. 

Some materials other than publications that are related to Center Grant applications (but not typically included in research grant applications) may be included as appendices.  The appendix may be used to provide materials that are too cumbersome to include in the Research Strategy sections without disrupting the narrative flow.  These appendix items provide background material related to the NPRC, and are not scored by the reviewers.  The following should be included:

Table of Employees and Employee Effort

• Include a table  containing the following for each NPRC employee, listed by last name in alphabetical order:
  • Name and degree.
  • Title  and role in the NPRC.
  • Functional component association(s).
• For activities related to the NPRC, indicate person months funded, respectively, by:
  • The P51 base grant .
  • Program Income derived from the P51 base grant.
  • Other sources.

Note that if all of an employee’s effort relates to the NPRC, the sum of the various effort designations will equal 12 person months. If the employee expends effort on non-NPRC activities, the sum of the percent efforts listed in the table will be less than 12 person months. If the renewal application proposes new employees that have not yet been hired, include these as “TBN” in the table, with the information as above for named employees.

List of Affiliate and Visiting Scientists

• Provide an alphabetical list of affiliate scientists and visiting scientists, including their full names and academic affiliations.
• Do not include the investigators who:
  • have been provided with biological materials such as tissues or fluids only.
  • have had an interaction with the NPRC limited to educational or consultative activities.
  • have purchased animals only.
  • have contracted for fee-for-service activities only.

Center Bibliography

• Cite published papers and papers accepted for publication that resulted in whole or in part from investigations undertaken with NPRC resources during the previous funding period. Include names of all authors, full title, the name, volume, and year of the journal, and the inclusive pages.
  • Underline the name of an NPRC core scientist if it appears in a reference.
  • Place an asterisk beside a reference that cites the NPRC (either by name or by P51 base grant number).
• Do not include the following:
  • publications by individuals whose sole interaction with the NPRC has involved obtaining animals or biological samples that are available to any qualified scientist.
  • publications by core, affiliate or visiting scientists for work that is not related to the NPRC.
  • manuscripts submitted for publication but not yet accepted.
  • abstracts.

Overall Sources of Support

• Include a budget summary showing overall sources of support. For the first budget year requested, provide a table that lists each of the budget categories from the first year composite budget, (e.g., personnel, consultant costs, equipment, supplies, etc.) and the projected sources of funding for each component, categorized as follows: For the particular budget category, show the:
  • Funds requested from the P51 base grant application (these should be the same as those listed in the “Detailed Budget for the Initial Project Period.”
  • Projected support from program income obtained from the P51 grant.
  • Projected support from other sources.
  • Projected total support.

At the bottom of the table, provide a total for each of the categories, , a – d, above. This total should equal the overall support for the entire NPRC.

Applications from foreign organizations will not be accepted.

Part I. Overview Information contains information about Key Dates. 

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

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

This initiative is not subject to intergovernmental review.

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

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

Applications must be postmarked on or before the due dates in Part I. Overview Information.

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

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

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

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.

For this particular announcement, note the following:

The review of an NPRC will comprise the following:  a) A site visit at which certain of the structural components of the NPRC are evaluated and scored individually; b) A Special Emphasis Panel (SEP) following the site visit at which the site visit report and the components not site visited will be evaluated. Each member of the SEP will provide an Overall Impact score for the Center based on the information in the written application, results of the site visit, and SEP critiques and deliberations.

Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the NPRC 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 activities proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

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

•   Overall: Does the NPRC function as a national resource that effectively provides the expertise, animals, infrastructure and other components needed to perform biomedical research using NHPs? Does the NPRC develop and sustain national resources for normative data, consultative and collaborative expertise, biologic and genetic material, and specialized facilities, equipment, and expertise that support NHP-related research? Does the NPRC develop and maintain animal colonies, including the base breeding colony, and provide animals suitable for research using NHPs?

•   Administration: Are the progress and accomplishments during the current period of grant support supportive of the mission of the NPRC as a national resource? Are the service and/or research plan for the next grant period appropriate and meritorious? Is the component integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?

•   Animal Services: Are the progress and accomplishments during the current period of grant support supportive of the mission of the NPRC as a national resource? Are the service and/or research plan for the next grant period appropriate and meritorious? Does the unit serve the needs of core, affiliate, visiting, and external scientists who use NHPs in a variety of research areas? Are resources available to investigators on a local, regional, and national basis? Is the component integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?

•   Core Science Services: Are the progress and accomplishments during the current period of grant support supportive of the mission of the NPRC as a national resource? Are the plans for the next grant period appropriate and meritorious? Has the applicant demonstrated the need for the core and are there sufficient users of the core? Does the unit serve the needs of core, affiliate, visiting, and external scientists who use NHPs in a variety of research areas? Are resources available to investigators on a local, regional, and national basis? Is the core integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?

•   Scientific Components: Are the progress and accomplishments during the current period of grant support supportive of the mission of the NPRC as a national resource? Are the service and/or research plan for the next grant period appropriate and meritorious? Does the component serve the needs of core, affiliate, visiting, and external scientists who use NHPs in a variety of research areas? Are resources available to investigators on a local, regional, and national basis? Is the component integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?

•   Pilot Research Program: Are the progress and accomplishments during the current period of grant support supportive of the mission of the NPRC as a national resource? Are the service and/or research plan for the next grant period appropriate and meritorious? Does the program serve the needs of core, affiliate, visiting, and external scientists who use NHPs in a variety of research areas? Does the program publicize opportunities on a national level beyond the NPRC consortium and the grantee institution? Has the program been successful in supporting projects that resulted in grant applications and funded grants? Have the projects resulted in publications? Is the Pilot Research Program integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?

•   Resource Related Research Projects (RRRPs): Does the project address an important problem? Will the project improve the ability of the NPRC to meet the needs of researchers using NHPs, or otherwise advance the ability to use NHPs in research? Are the plans for the project appropriate and meritorious? Is the project integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?

•   Improvement and Modernization (IM): Are the progress and accomplishments during the current period of grant support supportive of the mission of the NPRC as a national resource? Are the service plans for the next grant period appropriate and meritorious? Are the requested improvement and modernization projects relevant to the scope of the NPRC and appropriately justified? Is the component integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?

•   Outreach and Community Engagement: Are the progress and accomplishments during the current period of grant support supportive of the mission of the NPRC as a national resource? Are the service and/or research plan for the next grant period appropriate and meritorious? Is the component integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?

• Consortium Activities:  Has the NPRC contributed to the success of consortium activities? 

Investigator(s)

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

•   Overall: Does the PD/PI occupy a senior level position that crosses organizational lines in the grantee institution? Is the Center Director an established scientist with a doctoral degree in one of the health science disciplines and a recipient of peer-reviewed biomedical research support? Does the Center Director demonstrate effective oversight and leadership of the NPRC? Does the Center Director dedicate a significant portion of his or her effort to providing scientific leadership and administrative oversight of the NPRC?

Are the core staff of the NPRC at the forefront of NHP research and husbandry? Do the core scientists provide expertise regarding NHPs for the conduct of research projects, including investigations by affiliate and visiting scientists?

Is the NPRC guided by appropriately-constituted advisory committees? Is there an NSAB that provides guidance to the PD/PI and Center Director on all aspects of the NPRC, including scientific direction? Does the NSAB consist of at least six eminent scientists from outside the NPRC who have experience using NHPs for research? Does the composition of the NSAB reflect the range of technical subjects pursued at the NPRC?

•   Administration Components: Are the lines of administrative responsibilities within the NPRC and the relationships among the Principal Investigator, the Center Director, and the Associate and Assistant Directors clearly delineated? Are the delegation and execution of responsibilities by the Center Director and Associate and Assistant Directors appropriate? Is the relationship between the NPRC and the grantee institution described? Is the institutional chain of administrative and professional responsibilities described?

Is the NPRC guided by appropriately-constituted advisory committees? Is there an NSAB that provides guidance to the PD/PI and Center Director on all aspects of the NPRC, including scientific direction? Is the role of the NSAB in providing guidance for the planning and development of scientific programs and for administrative issues sufficient? Does the NSAB consist of at least six eminent scientists from outside the NPRC who have experience using NHPs for research? Does the composition of the NSAB reflect the range of technical subjects pursued at the NPRC? Does the NSAB have a chairperson and meet at the NPRC at least on an annual basis?

Is there a RAC that provides advice to the Center Director regarding prioritization of projects and resources? Are the composition, attendance, frequency of meetings, and role in advising the Center Director of the RAC sufficient? Are the assigned functions of the RAC appropriate? Does the RAC consist of at least four members who are core scientists representative of the functional components within the NPRC? Does the RAC meet at least monthly to discuss the research programs of the NPRC and to review all new project proposals that will use NPRC resources with regard to feasibility in the context of NPRC capabilities? Does the RAC review the scientific merit of all new project proposals that have not undergone NIH peer review and that will use NPRC resources? Are there appropriate records available summarizing recommendations made by the RAC?

•   Animal Services Components: Are the Animal Services Director and Associate Director(s) appropriately trained and qualified to carry out their responsibilities? Do these individuals demonstrate appropriate oversight and leadership? Do these individuals dedicate sufficient time to accomplish NPRC goals? Are clinical staff members of sufficient numbers and adequate training to support the needs of the NPRC? Do animal care staff follow SOPs for animal care, and do they receive training on an ongoing basis?

•   Core Science Services Components: Are the Core Service Director and Associate Director(s) appropriately trained and qualified to carry out their responsibilities? Do these individuals demonstrate appropriate oversight and leadership? Is the core staffed with sufficient numbers of appropriately-trained personnel to support the services offered?

•   Scientific Components: Are the Scientific Division Director and Associate Director(s) suitably trained and qualified to carry out their responsibilities with respect to the NPRC? Do these individuals demonstrate appropriate oversight and leadership? Does the component leadership facilitate interactions with other core, affiliate, visiting, and external scientists who use NHPs in their research? Are the nature, scope, and effectiveness of the plans for coordination and cooperation among scientists appropriate and will they contribute to the NPRC? Do the core scientists devote at least 10 percent of their total professional time to service that is directly related to supporting the scientific programs and activities of the NPRC? Does each core scientist devote at least 50 percent of his/her research effort to NHP-related research?

•   Pilot Research Program: Have pilot project investigators been solicited on a national level beyond the NPRC consortium and the grantee institution? Are the pilot investigators sufficiently trained, experienced, and qualified to carry out the work proposed? Are the qualifications and expertise of the review panel appropriate to evaluate pilot project applications? 

•   Resource Related Research Projects: Is/are the investigator(s) appropriately trained, experienced, and qualified to carry out the proposed work?

•   Improvement and Modernization (IM): Will the project be monitored by qualified individuals at the NPRC? Will the work be performed by skilled professionals?

•   Outreach and Community Engagement: Is the staff appropriately trained, experienced, and qualified to fulfill their responsibilities?

• Consortium Activities:  Does the NPRC allocate appropriate numbers and types of personnel to participate effectively in consortium activities?

Innovation

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

Overall: Does the NPRC develop improved practices of NHP breeding, husbandry, and genetic management to help meet research needs for pedigreed, disease-free animals of defined quality, and, if relevant to the particular NPRC, to ensure the continued availability of species of biomedical research importance whose wild populations are considered threatened or endangered?

Does the NPRC study the biology of NHP species that are of potential research importance for the purpose of enhancing their scientific utility, health, and well-being?

Does the NPRC conduct pilot (basic and applied) biomedical research projects in areas requiring the use of NHPs that are aimed at solving problems related to human health and may lead to independent grant support related to the disease or health problem being studied?

Does the NPRC facilitate the use of animal models of human disease?

•   Administration Components: Are the structure of the component and the method of providing service innovative?

•   Animal Services: Does the NPRC develop improved practices of NHP breeding, husbandry, and genetic management to help meet research needs for pedigreed, disease-free animals of defined quality, and, if relevant to the partciular NPRC,  to ensure the continued availability of species of biomedical research importance whose wild populations are considered threatened or endangered?  Is the computer-based system for animal records, including health, research, and breeding colony records, state of the art? Are innovative procedures used for training animal care staff? 

•   Core Science Services: Are up to date procedures incorporated into core services? As appropriate to user needs, are new services being developed and made available? Are the facilities state of the art?

•   Scientific Components: Does the component facilitate the use of animal models of human disease? Is the research addressed by the scientific component in the forefront of NHP research?

•   Pilot Research Program: Does the NPRC conduct pilot (basic and applied) biomedical research projects in areas requiring the use of NHPs that are aimed at solving problems related to human health? Are the projects supported cutting edge and likely to lead to independent grant support related to the disease or health problem being studied? Do the projects employ novel concepts, approaches or methods? Are the aims original and innovative? Do the projects challenge existing paradigms or develop new methodologies or technologies?

•   Resource Related Research Projects: Does the project study the biology of NHP species that are of potential research importance for the purpose of enhancing their scientific utility, and/or health and well-being? Does the project develop improved practices of NHP breeding, husbandry, and genetic definition to help meet research needs for pedigreed, disease-free animals of defined quality and ensure the continued availability of species of biomedical research importance? Does the project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?

•   Improvement and Modernization (IM): Will the proposed IM project result in improved equipment and/or facilities?

•   Outreach and Community Engagement: Are the service plans for the next grant period innovative?

Consortium Activities:  Does the NPRC promote innovative methods to enhance the activities of the NPRC consortium? 

Approach

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

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

•   Overall: Does the NPRC maintain an exemplary program of animal care and use consistent with current Public Health Service (PHS) policy? Is the NPRC accredited by AAALAC? Are standards of animal care state of the art? 

Does the NPRC provide opportunities for local, national, and international research involvement and experience in primatology to graduate and undergraduate students, postdoctoral fellows, visiting scientists, and faculty members, as well as short-term learning assignments for students of the health professions?

Does the NPRC develop and maintain animal colonies, including the base breeding colony, and provide animals suitable for research using NHPs? Is the NPRC able to provide animals upon request from existing pools of research animals, while maintaining an appropriate number of animals for breeding purposes? Are the majority of infrastructure, space, and resources used for maintenance and husbandry of those species for which there is major national demand? Are animals provided according to the prioritization scheme mandated by the NCRR? Are animals provided to researchers on a national basis?

Are requests for the use of available NPRC resources appropriately prioritized?

Is there a computer-based system in place for tracking animals in the research and breeding colonies?

Are genetics-based services used for colony management and characterization? Does the NPRC have programs in place to maintain the genetic diversity of animal colonies?

Do conditions and practices allow social interactions that contribute to the psychological well-being of the animals? Does the NPRC have programs in place for environmental enrichment?

Are there clinical laboratory services related to colony health surveillance and to the support of research?

Does the NPRC have a pilot research program and fund at least one pilot research project per year? Does pilot research include activities related to the use of NHPs for biomedical research or studies enhancing the welfare or husbandry of NHPs? How successful have the recipients of pilot research awards been in leveraging their results to apply for support from sources of funding such as NIH R01 grants? Does the NPRC publicize its pilot research program on a national level beyond the NPRC consortium and grantee institution? Does the NPRC have a review committee of not less than four members who evaluate proposals? Are two of the four reviewers from outside the NPRC and the grantee institution?

Do the RRRPs, if supported, directly enhance the NPRC’s resources and ability to meet the needs of researchers using NHPs?

Does the NPRC publicize its capabilities on a national level to all interested investigators? If the NPRC has a community engagement program, has it taken steps to educate the public about the importance of the research at the NPRC and the link between animal research and improvements in human health?

Does the NPRC disseminate the findings of studies and technical advances in NHP research to the scientific community via reports published in internationally-recognized, peer-reviewed journals and other appropriate media?

•   Administration Components: In terms of organizational framework, is the administration of the various components of the NPRC effective? Is there appropriate financial management of the P51 base grant? Are the derivation and use of program income described?

For each administrative component, is the service available to all appropriate personnel and components of the NPRC? Is there potential duplication of services within various components of the NPRC?

Is the NPRC guided by appropriately-constituted advisory committees? Is there an NSAB that provides guidance to the PD/PI and Center Director on all aspects of the NPRC, including scientific direction? Does the NSAB consist of at least six eminent scientists from outside the NPRC who have experience using NHPs for research? Does the composition of the NSAB reflect the range of technical subjects pursued at the NPRC?

Is there a RAC that provides advice to the Center Director regarding prioritization of projects and resources? Does the RAC meet at least monthly to discuss the research programs of the NPRC and to review all new project proposals that will use NPRC resources with regard to feasibility in the context of NPRC capabilities? Are there appropriate records available summarizing recommendations made by the RAC? Are requests for the use of available NPRC resources appropriately prioritized? Are animals provided according to the prioritization scheme mandated by the NCRR? Are animals provided to researchers on a national basis?

•   Animal Services: Does the NPRC maintain an exemplary program of animal care and use consistent with current Public Health Service (PHS) policy? Is the NPRC accredited by AAALAC? Are standards of animal care state of the art? 

Are there clinical laboratory services available related to colony health surveillance and to the support of research?

Are the NHP colonies managed efficiently? Are all aspects of colony management well documented? Is an effective computer-based colony management system in place? Does the colony management system include all relevant parameters? Is sufficient attention being given to issues of genetic management? Do individual colonies exhibit acceptable levels of reproductive capacity?

Are there conditions and practices in place to allow social interactions that contribute to the psychological well-being of the animals for a given species? Does the NPRC have programs in place for environmental enrichment?

Are animal care personnel well trained and are refresher courses available? Are safety and emergency measures adequate?

Does the component disseminate the findings of studies and technical advances in NHP research to the scientific community through reports published in internationally-recognized, peer-reviewed journals and other appropriate media?

If non-primate species are housed at the NPRC, is at least one of the following conditions met:

            a) The non-primate species is appropriate for preliminary or pilot studies on development of techniques and procedures in preparation for definitive studies in NHPs. b) Use of the non-primate species will conserve NHP resources and the endpoint studies will be conducted in NHPs.  c) The non-primate species is used to develop expertise and technology in newly      developing fields of research that can be applied to NHPs.  d) The non-primate species is used to study inter-relationships with NHPs, and it is reasonable to assume that the studies may have direct applicability to NHP research.  e) The non-primate species is used as an adjunct to        studies on NHP species.

•   Core Science Services: Are core services available to core, affiliate, visiting, and external scientists? Are specific services utilized by a significant number of investigators? Are some services used by only a few scientists, and is this appropriate? Is there any duplication of services across components?

•   Scientific Components: Does the component provide opportunities for local, national, and international research involvement and experience in primatology to graduate and undergraduate students, postdoctoral fellows, visiting scientists, and faculty members, as well as short-term learning assignments for students of the health professions?

Does the NPRC disseminate the findings of studies and technical advances in NHP research to the scientific community through reports published in internationally-recognized, peer-reviewed journals and other appropriate media?

•   Pilot Research Program: Does the NPRC have a Pilot Research Program and fund at least one pilot research project per year? Is the Pilot Research Program publicized on a national level beyond the NPRC consortium and grantee institution? Have new affiliate investigators and/or research programs been incorporated? Are the numbers of applications received and funded adequate and appropriate?

Does pilot research include activities related to the use of NHPs for biomedical research or studies enhancing the welfare or husbandry of NHPs? Are metrics for success provided in terms of the number of publications, grants submitted, grants funded? How successful have the recipients of pilot research awards been in leveraging their results to apply for support from sources of funding such as NIH R01 grants? How successful have the recipients been in terms of publications resulting from the pilot projects?

Does the NPRC have a review committee of not less than four members who evaluate proposals and provide advice to the Center Director regarding priorities for support? Is the composition of the review committee appropriate, and are two of the four reviewers from outside the NPRC and the grantee institution? Is there a scoring system for evaluation and a means for obtaining short written critiques of the proposal from the review committee? Do the format and length of the pilot proposal permit sufficient information to allow evaluation from the written application alone?

•   Resource Related Research Projects: Do the RRRPs, if supported, directly enhance the NPRC’s resources and ability to meet the needs of researchers using NHPs?

•   Improvement and Modernization (IM): Are the functional components that will be directly affected by the IM project listed? Is justification provided for all equipment items requested? Is a clear IM plan presented?

•   Outreach and Community Engagement: Does the NPRC publicize its capabilities on a national level to all interested investigators? If the NPRC has a community engagement program, has it taken steps to educate the public about the importance of the research at the NPRC and the link between animal research and improvements in human health?

• Consortium Activities:  Does the NPRC participate in all relevant consortium activities?  Has participation by the NPRC in specific consortium acitivies contributed to the success of those activities?

Environment

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

  • Overall: Do the facilities make possible research by core, affiliate, and visiting scientists? 

Are the maintenance, operation, and renovation of the NPRC buildings and outdoor facilities appropriate and necessary for the functioning of the NPRC?

Do major resources such as instrumentation and the physical plant (including animal housing, laboratories, and service components) facilitate the objectives of the NPRC?

•   Administration Components: Is the administrative component integrated into the overall NPRC activities?

•   Animal Services Components: Do major resources including animal housing, laboratories, and service components facilitate the objectives of the unit? Are the maintenance, operation, and renovation of the NPRC animal housing  facilities appropriate and necessary for the functioning of the unit? Do the facilities make possible research by core, affiliate, and visiting scientists? As appropriate, is outside scientific expertise available to advise on governance, management, and function of the unit? Is the component integrated into the overall NPRC activities?

•   Core Science Services: Do major resources including animal housing, laboratories, and service components facilitate the objectives of the unit? Are the maintenance, operation, and renovation of the NPRC buildings and outdoor facilities appropriate and necessary for the functioning of the unit? Do the facilities make possible research by core, affiliate, and visiting scientists? As appropriate, is outside scientific expertise available to advise on governance, management, and function of the unit? Is the component integrated into the overall NPRC activities?

•   Scientific Components: Do major resources including animal housing, laboratories, and service components facilitate the objectives of the unit? Are the maintenance, operation, and renovation of the NPRC buildings and outdoor facilities appropriate and necessary for the functioning of the unit? Do the facilities make possible research by core, affiliate, and visiting scientists? As appropriate, is outside scientific expertise available to advise on governance, management, and function of the unit? Is the component integrated into the overall NPRC activities?

•   Pilot Research Program: Do major resources including animal housing, laboratories, and service components facilitate the objectives of the projects? Are the maintenance, operation, and renovation of the NPRC buildings and outdoor facilities appropriate and necessary for the projects? As appropriate, is scientific expertise available to advise on projects? Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Is the component integrated into the overall NPRC activities?

•   Resource-Related Research Projects: Do major resources including animal housing, laboratories, and service components facilitate the objectives of the project? Are the maintenance, operation, and renovation of the NPRC buildings and outdoor facilities appropriate and necessary for the project? As appropriate, is scientific expertise available to provide advice on the project? Does the scientific environment in which the work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there evidence of institutional support? Is the component integrated into the overall NPRC activities?

•   Improvement and Modernization (IM): Do the applicants describe the need for each requested item relative to the overall requirements of the NPRC?

• Consortium activities:  Do participants in consortium activities have an appropriate level of support from the NPRC administration?  Is the physical environment supporting specific consortium activities adequate?

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

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

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

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

      For Administrative  Services:

• Evaluate the cost effectiveness and the appropriateness of service fees and/or per diem charges.
• Does the NPRC recover a reasonable proportion of the actual costs of resources and services provided by the base grant?
• Is all program income (per diems, income from sales, etc.) used to further the objectives of the NPRC?

       For Animal Services:

• Is the service unit cost reasonable?
• Does the NPRC recover income (per diems, income from sales, etc.) that is used to further eligible program objectives (OMB A-110, C24b(1)

      For Core Services:

• Are appropriate charge back schedules in place?
• Does the NPRC recover a reasonable proportion of the actual costs of resources and services provided by the base grant (see Section IV-H)?

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the National Center for Research Resources , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the National Advisory Research Resources Councill. The following will be considered in making funding decisions:

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. 

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.      

Any application awarded in response to this FOA will be subject to the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

Not Applicable.

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and Financial Status Report are required when an award is relinquished when a recipient changes institutions or when an award is terminated.

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. 

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

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

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

John D. Harding, PhD
National Center for Research Resources  (NCRR)
Telephone: 301-435-0776
Email: hardingj@mail.nih.gov

Martha Matocha, Ph.D.
Scientific Review Officer
National Center for Research Resources
National Institutes of Health, DHHS
6701 Democracy Blvd., Room 1070
Bethesda, MD 20892-4874
Bethesda, MD 20817 (FedEx or courier)
Tel 301-435-0813 (direct line)

Ms. Jean Richelsen
National Center for Research Resources  (NCRR)
Telephone: 301-594-4874
Email: richelsj@mail.nih.gov

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

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