Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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

Funding Opportunity Title

Limited Competition: National Primate Research Centers (P51)

Activity Code

P51 Primate Research Center Grants

Announcement Type

Reissue of PAR-14-226

Related Notices
Funding Opportunity Announcement (FOA) Number

PAR-17-144

Companion Funding Opportunity

None

Number of Applications

Only one application per institution is allowed as defined in Section III. 3. Additional Information on Eligibility.

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

93.351

Funding Opportunity Purpose

This FOA 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 require 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 to investigators/grantees who utilize NHPs in biomedical research and thereby complement and help enable the missions of the NIH Institutes and Centers. 

Key Dates

 

Posted Date

January 27, 2017

Open Date (Earliest Submission Date)

April 25, 2017

Letter of Intent Due Date(s)

Not applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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

AIDS Application Due Date(s)

Not Applicable  

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date

January 26, 2020

Due Dates for E.O. 12372

Not Applicable

** ELECTRONIC APPLICATION SUBMISSION REQUIRED**

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

Required Application Instructions

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


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners.

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

Learn more about the various submission options.

Table of Contents

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

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


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

The Office of Research Infrastructure Programs (ORIP) of the National Institutes of Health (NIH) funds the National Primate Research Center (NPRC) program, the goal of which is to facilitate the effective use of nonhuman primates (NHPs) by scientists engaged in biomedical research. The NPRC program complements and enables the missions of the other NIH Institutes and Centers by providing the NHPs, expertise, and resources required to study specific diseases. ORIP’s Division of Comparative Medicine (DCM) funds seven 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://dpcpsi.nih.gov/orip/cm/primate_resources_researchers#centers.

Objectives of the NPRC Program

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 capabilities that support NHP-related research.
  • Enhance rigor and reproducibility in NHP research by assisting investigators with experimental design, methodology, data analysis and interpretation, and standardized reporting of study results.
  • 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.
  • Continue to develop improved practices of NHP breeding, husbandry and methods to provide high quality animals to meet research needs for pedigreed, genetically-defined, and disease-free animals (e.g., specific pathogen free).
  • Develop additional methods to define animals in terms of phenotypic, immunological, or metabolic status.
  • 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.
  • Provide outreach, publicizing their capabilities on a national level as well as educating the public about research at the NPRCs and the link between animal research and improvements in human health.
The NPRC Base Grant

An NPRC receives funding from the ORIP through a base grant using the NIH P51 activity code funded through this FOA (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.

An NPRC is a distinct organizational and structural entity 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.

Organizational Structure and Operating Procedures of the NPRC

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 units.  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 unit 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 units are described in the renewal application for the NPRC and are peer-reviewed.

The Administration of the NPRC is covered by the required Governance Unit and Administrative Units, which should provide services across the entire NPRC. These are usually under the direct supervision of the Center Director or his/her designee. The Governance Unit covers the NPRC administrative leadership that oversees the functions of the NPRC, including obtaining input from advisory committees. Examples of administrative units include the following: Director's Office, Business Office, Environmental Health and Safety, Information Technology, NPRC-specific Library Services, Bioengineering Services, Photography Services, Education and Training Programs, Public Affairs Office, and Alteration and Renovations (A&R).  The specific titles of these units may differ among NPRCs.

Each NPRC must have a National Scientific Advisory Board (NSAB), which provides guidance to the PD(s)/PI(s) and Center Director on all aspects of the NPRC, including scientific direction. The NSAB reports to the PD(s)/PI(s) of the NPRC. The NSAB must consist of at least six experts in NHP research, such as senior scientists or relevant administrators, from outside the NPRC and grantee institution. 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 review site visits and 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. Members of the RAC must be core scientists representative of the functional units 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 Resource units vary widely among the various NPRCs. Many units within Animal Resources function across several or all units 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, serve several specific units of the NPRC. Animal colonies are key units 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. 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) International.
  • 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.

Pilot Research Program

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. From time to time specific areas of research, for example, genetics or regenerative medicine, may be emphasized by researchers using NHPs. The NPRCs can specifically solicit pilot projects in particularly topical areas. All of the funded pilot project grant applications should be available to reviewers at the time of the site visit.

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. As relevant, a subcontracting mechanism within the pilot project can be used to support a portion of the pilot project performed outside of the grantee institution.
  • Pilot research funds may not be used to provide interim support for established projects or for investigations funded from other sources.
  • 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 lead 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 over the award period must involve the active participation of investigators external to the NPRC. Targeting investigators who have not previously used NHPs is encouraged.
  • A portion of the funded pilot projects should involve non-tenured early stage investigators (within 10 years of terminal degree). Projects from early stage scientists should be given priority in the selection process. 
  • The NPRC must publicize its pilot research program on a national level beyond the NPRC and grantee institution, for example, through a website, providing information at national meetings, 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.
  • The research project plan and budget must be reviewed and approved by the Center Director or his/her designee.
  • 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. At least 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.
  • The NPRC may propose an expedited review process to be used under ORIP-approved exceptional circumstances. This exception involves urgently needed research that will use NHPs to understand the pathology of and/or development of vaccines or therapies for infection of an emerging pathogen that involves significant public health risk. ORIP Program staff will approve the exception request from the NPRCs to invoke the expedited review.
Prioritizing Requests for NPRC Resources

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.  Other Federal Agency funding.

4.  Nonprofit or not-for-profit funding.

5.  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.

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

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited, but need to reflect the actual needs of the proposed project. Renewal (Type 2) or Resubmission applications may propose no more than a 5 percent (direct cost) increase from the last non-competing year. Budgets exceeding this amount will not be accepted. 

Award Project Period

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

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

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

Only grantees previously funded under PAR-11-136 or PAR -14-226 are eligible to apply."

Foreign Institutions

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Required Registrations

Applicant Organizations

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

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

The PD(s)/PI(s) 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 a measureable effort to the P51 base grant.

2. Cost Sharing

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

3. Additional Information on Eligibility
Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

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

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

Page Limitations

Component Types Available in ASSIST

Research Strategy/Program Plan Page Limits

Overall

30

Admin Core (use for Governance Unit and Administrative Units)

12

Outreach

6

NPRC Consortium

6

Core (Use for Animal Resources, Core Services, Scientific Units)

12

Project (Use for Pilot Research, Resource Related Research Project)

12

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

Instructions for the Submission of Multi-Component Applications

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

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

  • Overall: required
  • Governance Unit: required; maximum of 1
  • Administrative Unit: required; maximum of 14
  • Animal Resources: required; maximum of 15
  • Core Services: optional; maximum of 15
  • Scientific Units: required; maximum of 15
  • Pilot Research: required; maximum of 1
  • Resource Related Research Project: optional; maximum of 2
  • Outreach: required; maximum of 1
  • NPRC Consortium; required; maximum of 1
Overall Component

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

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

SF424 (R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement  (Overall)

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

Research & Related Other Project Information (Overall)

Follow standard instructions.

Other Attachments: The following attachments should be included in the Overall Component in order to aid in the review of the applications. The file name provided for each attachment will be the name used for the bookmark in the application image. All attachments need to be in .pdf format.

Overall Sources of Support: Please title this attachment "Overall Sources of Support" and include a budget summary showing overall sources of support that are not listed on the budget forms for the NPRC. 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 unit. For the particular budget category, show the:

a) Support requested from the P51 base grant.

b) Projected support from program income obtained from the P51 base grant.

c) Projected support from other sources (not including the P51 base grant or        program income derived from the P51 base grant).

d) Total support for the NPRC.

At the bottom of the table, provide a total for each of the categories,   a – d above.

Table of Employees and Employee Effort: Please title this attachment “Employees and Effort” and include a table containing the following for each NPRC employee who is not designated as key personnel, listed by last name in alphabetical order:

Name and degree.

Title and role in the NPRC.

Functional unit 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 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: Please title this attachment “Affiliate and Visiting Scientists” and provide an alphabetical list of affiliate scientists and visiting scientists including their full names and academic affiliations.

Affiliate Scientists do not receive funding from the P51 base grant and are not Key Personnel. They 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. 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 and are not Key Personnel. 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.

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.
Project/Performance Site Location(s) (Overall)

Enter primary site only.

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

Research & Related Senior/Key Person Profile (Overall)

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

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

Budget (Overall)

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

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

PHS 398 Research Plan (Overall)

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

Specific Aims:  Provide the specific aims for the overall Center.          

Research Strategy:  This section should provide a general introduction to the NPRC and should only include information that is not specific to individual units of the NPRC. This section should not duplicate the detailed information in the sections describing specific functional components.

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

  • 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.  
  • An organizational chart that shows:
  • The relationship of the PD(s)/PI(s) 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 units 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 unit in which each core resides. A unit 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.
  • 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. As related to the NPRC Administration and Animal Services units, describe any activities that resulted in more efficient NPRC operations.
  • Changes in leadership personnel since the last review. Leadership personnel include at a minimum the PD/PI, NPRC Director, Directors/Heads of functional units, and Core Scientists.
  • Summary of plans, challenges, and opportunities for the requested period of support.

Vertebrate Animals: Prepare an overall VAS for general care, housing, procedures, and interventions to minimize pain and distress. Research specific procedures should be addressed in the relevant component. 

Letters of Support: Include letters of support that relate to the NPRC as a whole in this section. If more than one Institution provides financial support to any operations of the NPRC, submit a letter of agreement signed by the responsible officer of each Institution.

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

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

Appendix:

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

PHS Assignment Request Form (Overall)

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

Governance Unit

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

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

SF424 (R&R) Cover (Governance Unit)

Complete only the following fields:

  • Applicant Information
  • Type of Applicant (optional)
  • Descriptive Title of Applicant’s Project
  • Proposed Project Start/Ending Dates
PHS 398 Cover Page Supplement (Governance Unit)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Governance Unit)

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

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

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

Project /Performance Site Location(s) (Governance Unit)

List all performance sites that apply to the specific component.

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

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

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

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

PHS 398 Research Plan (Governance Unit)

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

Specific Aims:  Provide the specific aims for the governance unit.          

Research Strategy:  The Governance Unit is required

The Governance Unit should include a discussion of the following, at a minimum:

Describe the functions and qualifications of the Program Director(s)/ Principal Investigator (s) (PD(s)/PI(s)) beyond information described on the biosketch. 

The administrative relationship among the PD(s)/PI(s), Center Director, Associate Directors, Assistant Directors, and advisory boards and committees and the responsibilities of the Center Director and Associate or Assistant Directors.

Describe the oversight committees, including functions and composition. Describe the  NSAB, which provides guidance to the PD(s)/PI(s) and Center Director on all aspects of the NPRC, including scientific direction. The NSAB must consist of at least six experts in NHP research, such as senior scientists or relevant administrators, from outside the NPRC and grantee institution. Describe the  research areas of the NSAB members and how these are related to the  range of technical subjects 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.

Describe the RAC, which provides advice to the Center Director regarding prioritization of projects and resources. The RAC must consist of at least four members including core scientists representative of the functional units within the NPRC. Describe the frequency of RAC meetings and the process for review of research programs and new project proposals that will use NPRC resources considering feasibility in the context of NPRC capabilities. Describe the RAC's process for reviewing the scientific merit of all new project proposals that have not undergone NIH peer review and that will use NPRC resources.  Indicate the procedures for coordination among the PD(s)/PI(s), Center Director, RAC, and individual investigators regarding review and approval of submitted research projects.

Minimum requirements for these committees (NSAB and RAC) are described in Section I. 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. For all committees, provide a membership list, including academic titles, for each committee member.

Vertebrate Animals: If answered affirmative for Vertebrate Animals, refer to the overall VAS for general procedures and interventions to minimize pain and distress. For the specific unit, include any research-specific procedures, such as imaging or surgical procedures, as well as interventions to minimize pain and distress. Address species justifications related to the specific field of research. 

Letters of Support: The applicant may include letters of support related to the specific unit. 

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

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

Appendix:

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

PHS Inclusion Enrollment Report (Governance Unit)

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

Administrative Unit

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

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

Examples of administrative units include the following: Director's Office, Business Office, Environmental Health and Safety, Information Technology, NPRC-specific Library Services, Bioengineering Services, Photography Services, Education and Training Programs, Public Affairs Office, and Alterations and Renovations (A&R). If alterations and renovations are proposed, they should be conducted by a separate Alterations and Renovations Unit. The specific titles of these units may differ among NPRCs.

SF424 (R&R) Cover (Administrative Unit)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Administrative Unit)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Unit)

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

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

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

Other Attachments: If proposing Alterations and Renovations (A&R), submit the following. All attachments need to be in .pdf format.

Alteration and Renovations (A&R) Quotes: Please title this attachment "A&R Quotes" and provide copies of price quotations for equipment, as applicable. 

Project /Performance Site Location(s) (Administrative Unit)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Administrative Unit)

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

Budget (Administrative Unit)

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

Major A&R funds can be used to upgrade the physical plant (repairs and renovation of facilities) and to replace obsolete shared resources and equipment. For the entire NPRC, a maximum of $600,000 in total costs for A&R funds may be requested for each year of the P51 base grant application. A single A&R project or equipment purchase cannot exceed $500,000 in total costs. Construction is not allowed. 

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

PHS 398 Research Plan (Administrative Unit)

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

Specific Aims:  Provide the specific aims for the specific administrative unit.         

Research Strategy: The Administrative Units should provide services across the entire NPRC and are usually under the direct supervision of the Center Director or his/her designee. 

Include the following information for each individual administrative unit:

Description of the unit and unit organizational chart.

Address the progress and major accomplishments achieved by the unit during the past grant period. Describe the service plan and/or research plan for the next grant period.

List of unit personnel, who are not Key Personnel, base institutional affiliation, and role in relation to the NPRC.

A table showing the sources and amounts of funding for the individual unit for the last funded year of the existing P51 base grant and the first proposed year of the P51 base grant renewal. The table should provide detailed information, which is used to calculate the information in the Overall Section. Sources of funding should be broken down as follows, and as applicable to the unit:

  • Support from the P51 base grant.
  • Program income derived from the P51 base grant for that specific unit
  • Support from other sources (not including the P51 base grant or program income derived from the P51 base grant)
  • Total support for the unit.

Vertebrate Animals: If answered affirmative for Vertebrate Animals, refer to the overall VAS for general procedures and interventions to minimize pain and distress. For the specific unit, include any research-specific procedures, such as imaging or surgical procedures, as well as interventions to minimize pain and distress. Address species justifications related to the specific field of research.  

Letters of Support: The applicant may include letters of support related to the specific unit.  

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

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

Appendix:

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

PHS Inclusion Enrollment Report (Administrative Core)

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

Animal Resources

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

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

SF424 (R&R) Cover (Animal Resources)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Animal Resources)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Animal Resources)

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

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

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

Project /Performance Site Location(s) (Animal Resources)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Animal Resources)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. Among other personnel, Animal Resources may include Core Scientists, who direct research programs and/or provide scientific expertise, veterinary expertise or leadership in specific subject areas. The following statement pertains to Core Scientists in all units of the NPRC, including Animal Resources:
  • 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 grantee 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 units of the grantee institution. Core Scientists can potentially represent many different disciplines, depending on the needs of the NPRC.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (Animal Resources)

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

The following pertains to Core Scientists in all units of the NPRC, including Animal Resources: 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 4.8 person months 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 of their effort to scholarly activities in an academic department, usually in the grantee institution. 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.

Regardless of the source of funding, Core Scientists must devote at least 1.2 person months of their total professional time 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 of his/her research effort to NHP-related research.

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

PHS 398 Research Plan (Animal Resources)

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

Specific Aims:  Provide the specific aims for the specific animal resources unit. 

Research Strategy:

Animal Resource units vary widely among the various NPRCs and are described in Section I. For each animal resource unit defined by the NPRC, include the following if appropriate to the unit:

  • Description of the unit and unit organizational chart.
  • Address the progress and major accomplishments achieved by the unit during the past grant period.
  • Describe the service plan and/or research plan for the next grant period.
  • Indicate if a unit serves a specific NPRC unit or functions across several units.
  • Include summary information on the following. This can be in a table format.

o    The types of services provided.

o    The number of users of a service.

o    The usage per investigator.

o    Unit cost per occurrence.

o    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.
  • For breeding colonies, describe plans to maintain genetic diversity.
  • The section of the application describing each unit must contain a discussion of standard operating procedures (SOPs) for animal care that are designed to meet performance standards in accordance with federal, state and local laws and regulations (e.g., the Guide for the Care and Use of Laboratory Animals, http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf, Public Health Service (PHS) policy, and the Animal Welfare Act). Routine daily maintenance, social housing, environmental enrichment, 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.

Include the following information for each specific animal resource unit:

  • For individuals who are not Key Personnel, a list of unit personnel, base institutional affiliation, and role in relation to the NPRC.
  • A table showing the sources and amounts of funding for the unit for the last funded year of the existing P51 base grant and the first proposed year of the P51 base grant renewal. The table should provide detailed information, which is used to calculate the information in the Overall Section. Sources of funding should be broken down as follows, and as applicable to the unit:

o    Support from the P51 base grant.

o    Program income derived from the P51 base grant.

o    Support from other sources (not including the P51 base grant or program income derived from the P51 base grant). 

o    Total support for the unit.

Vertebrate Animals: If answered affirmative for Vertebrate Animals, refer to the overall VAS for general procedures and interventions to minimize pain and distress. For the specific unit, include any research-specific procedures, such as imaging or surgical procedures, as well as interventions to minimize pain and distress. Address species justifications related to the specific field of research.

Letters of Support: The applicant may include letters of support related to the specific unit. 

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

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

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

PHS Inclusion Enrollment Report (Animal Resources)

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

Core Services

When preparing your application in ASSIST, use Component Type ‘Core’

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

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

SF424 (R&R) Cover (Core Services)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Core Services)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Core Services)

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

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

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

Project /Performance Site Location(s) (Core Services)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Core Services)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Core Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. Among other personnel, Core Services may include Core Scientists, who direct research programs and/or provide scientific expertise, veterinary expertise or leadership in specific subject areas. The following statement pertains to Core Scientists in all units of the NPRC, including Core Services:
  • 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 grantee 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 units of the grantee institution. Core Scientists can potentially represent many different disciplines, depending on the needs of the NPRC.
  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (Core Services)

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

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

PHS 398 Research Plan (Core Services)

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

Specific Aims:  Provide the specific aims for the specific core services unit. 

Research Strategy: 

For each core service defined by the NPRC, include the following as appropriate to the unit:

  • Description of the unit and unit organizational chart.
  • The types of services provided.
  • The number and affiliation of users.
  • Address the progress and major accomplishments achieved by the unit during the past grant period.
  • Describe the service plan and/or research plan for the next grant period. Although not required, most NPRCs have a Tissue and Reagent Distribution Program, often organized as a core.

Provide the following information for the Tissue and Reagent Distribution Program, if applicable:

  • 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 of 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.

Include the following information in each core service:

  • For individuals who are not Key Personnel, a list of unit personnel, base institutional affiliation, and role in relation to the NPRC.
  • A table showing the sources and amounts of funding for the unit for the last funded year of the existing P51 base grant and the first proposed year of the P51 base grant renewal. The table should provide detailed information, which is used to calculate the information in the Overall Section. Sources of funding should be broken down as follows, and as applicable to the unit:

o    Support from the P51 base grant.

o    Program income derived from the P51 base grant.

o    Support from other sources (not including the P51 base grant or program income derived from the P51 base grant). 

o    Total support for the unit.

Vertebrate Animals: If answered affirmative for Vertebrate Animals, refer to the overall VAS for general procedures and interventions to minimize pain and distress. For the specific unit, include any research-specific procedures, such as imaging or surgical procedures, as well as interventions to minimize pain and distress. Address species justifications related to the specific field of research.

Letters of Support: The applicant may include letters of support related to the specific unit. 

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

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

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

PHS Inclusion Enrollment Report (Core Services)

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

Scientific Unit

When preparing your application in ASSIST, use Component Type ‘Core’

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

SF424 (R&R) Cover (Scientific Unit)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Scientific Unit)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific Unit)

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

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

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

Other Attachments: The following attachment should be included in each Scientific Unit Component in order to aid in the review of the applications. The file name provided for each attachment will be the name used for the bookmark in the application image. All attachments need to be in .pdf format.

Externally Funded Research Projects: Please title this attachment “Externally Funded Research Projects” and provide a list of projects performed within the Scientific Unit. For each project, list the project title, type of grant award, such as an NIH R01, the PD/PI of the project, 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 Scientific Unit.

Project /Performance Site Location(s) (Scientific Unit)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Scientific Unit)

  • In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
  • In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component. Among other personnel, Scientific Units may include Core Scientists, who direct research programs and/or provide scientific expertise, veterinary expertise or leadership in specific subject areas. The following statement pertains to Core Scientists in all units of the NPRC, including Scientific Units:

o    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.

o    Core Scientists are appointed by the Center Director in accord with the grantee 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 units of the grantee institution. Core Scientists can potentially represent many different disciplines, depending on the needs of the NPRC.

  • Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
  • If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.   

Budget (Scientific Unit)

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

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

PHS 398 Research Plan (Scientific Unit)

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

Specific Aims:  Provide the specific aims for the Scientific Unit. 

Research Strategy:  Research is carried out in units, often referred to as Divisions, Departments 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 Units 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 Unit can also contain entities that provide core services, either to multiple units within the NPRC or to the individual Scientific Unit.

Include the following for the Scientific Unit:

  • Description of the unit and unit organizational chart.
  • Progress and major accomplishments achieved during the past grant period. For Scientific Units, 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 Units, 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. For the interactions, consider plans to enhance rigor and reproducibility by assisting investigators with experimental design, methodology, data analysis and interpretation and standardized reporting of study results. 

For each Core Scientist listed in the key personnel section provide a narrative that includes:

  • 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.

Include the following information for each Scientific Unit:

  • For individuals who are not Key Personnel, a list of unit personnel, base institutional affiliation, and role in relation to the NPRC.A table showing the sources and amounts of funding for the unit for the last funded year of the existing P51 base grant and the first proposed year of the P51 base grant renewal. The table should provide detailed information, which is used to calculate the information in the Overall Section. Sources of funding should be broken down as follows, and as applicable to the unit:

o    Support from the P51 base grant.

o    Program income derived from the P51 base grant.

o    Support from other sources (not including the P51 base grant or program income derived from the P51 base grant). 

o    Total support for the unit.

Vertebrate Animals: If answered affirmative for Vertebrate Animals, refer to the overall VAS for general procedures and interventions to minimize pain and distress. For the specific unit, include any research-specific procedures, such as imaging or surgical procedures, as well as interventions to minimize pain and distress. Address species justifications related to the specific field of research.

Letters of Support: The applicant may include letters of support related to the specific unit. 

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

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

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

PHS Inclusion Enrollment Report (Scientific Unit)

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

Pilot Research

When preparing your application in ASSIST, use Component Type ‘Project’

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

SF424 (R&R) Cover (Pilot Research)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Pilot Research)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Pilot Research)

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

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

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

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

List all performance sites that apply to the specific component.

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

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

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

Budget (Pilot Research)

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

The following pertains specifically to budgets for Pilot Research:

  • 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.
  • The direct cost for a single pilot research project must not exceed $100,000 per year for a maximum of two years of support.
  • Funds may be requested for the following purposes:

o    Personnel, for example, additional technicians who are not already being supported by the P51 base grant;

o    Supplies;

o    Animals and animal care costs.

o    Items of equipment costing less than $5,000.

o    Consultants and other special services, including NPRC core unit services such as surgery, pathology, assays or clinical services.

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

PHS 398 Research Plan (Pilot Research)

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

Specific Aims:  Provide the specific aims for the Pilot Research Program. 

Research Strategy: 

The Pilot Research Program is required and described in Section I. Provide the following information on the Pilot Research Program:

  • Overall description of the Pilot Research Program, including governance, organizational chart, proposal format, and review procedures including a scoring system for evaluation and means for obtaining written critiques. Describe the composition of the review committee, which must consist of at least 4 members and at least 2 of the members must be external to the NPRC and grantee institution.
  • Describe any plans to encourage participation by early-state investigators and/or investigators who have not previously performed research with NHPs.
  • If proposed, outline the expedited review process to be used under ORIP-approved exceptional circumstances.
  • 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.
  • A table that lists, for each year of the previous funding period:

o    The number of applications received. 

o    The number of applications funded.

o    The number of funded projects that involved researchers inside and outside of the NPRC, respectively.

o    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. If a specific subject area has been the subject of pilot program solicitations, briefly justify the importance of that subject area for research using NHPs.
  • For the previous funding period, provide, for each funded pilot project, a narrative not more than one page in length that includes the following:

o    Project title.

o    Name, title, and institutional affiliation of the principal investigator.

o    Year(s) funded.

o    Abstract, including Specific Aims.

o    Full bibliographic material on each paper published, in press or submitted, resulting from the pilot project. Do not include abstracts.

o    Grant applications and funded grants resulting from the pilot project.

  • A table showing the sources and amounts of funding for the unit for the last funded year of the existing P51 base grant and the first proposed year of the P51 base grant renewal. The table should provide detailed information, which is used to calculate the information in the Overall Section. Sources of funding should be broken down as follows, and as applicable to the unit:

o    Support from the P51 base grant.

o    Program income derived from the P51 base grant.

o    Support from other sources (not including the P51 base grant or program income derived from the P51 base grant). 

o    Total support for the unit.

Vertebrate Animals: If answered affirmative for Vertebrate Animals, refer to the overall VAS for general procedures and interventions to minimize pain and distress. For the specific unit, include any research-specific procedures, such as imaging or surgical procedures, as well as interventions to minimize pain and distress. Address species justifications related to the specific field of research.

Letters of Support: The applicant may include letters of support related to the specific unit. 

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

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

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

PHS Inclusion Enrollment Report (Pilot Research)

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

Resource Related Research Project

When preparing your application in ASSIST, use Component Type ‘Project’

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

SF424 (R&R) Cover (Resource Related Research Project)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Resource Related Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Resource Related Research Project)

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

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

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

Project /Performance Site Location(s) (Resource Related Research Project)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Resource Related Research Project)

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

Budget (Resource Related Research Project)

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

  • A single Resource-Related Research Project (RRRP) cannot exceed $500,000 total costs per year.

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

PHS 398 Research Plan (Resource Related Research Project)

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

Specific Aims:  Provide the specific aims for the Resource Related Research Project. 

Research Strategy:  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.

Requirements for the RRRP are as follows:

  • The Lead 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. As applicable, a subcontract can be used to fund a portion of the RRRP that is performed outside of the grantee institution.
  • RRRPs also can involve investigators outside of the NPRC and the grantee institution.

Describe the Significance, Innovation, and Approach to the project, including a brief description of preliminary data, if applicable, as described in the SF424 (R&R) Application Guide. The RRRP is similar to  an ORIP/NIH R24 resource-related research project grant application. 

Vertebrate Animals: If answered affirmative for Vertebrate Animals, refer to the overall VAS for general procedures and interventions to minimize pain and distress. For the specific unit, include any research-specific procedures, such as imaging or surgical procedures, as well as interventions to minimize pain and distress. Address justifications for species, age, sex, and number of animals related to the specific research project.

Letters of Support:  The applicant may include letters of support related to the Resource Related Research Project.

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

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

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

PHS Inclusion Enrollment Report (Resource Related Research Project)

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

Outreach

When preparing your application in ASSIST, use Component Type ‘Outreach’

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

SF424 (R&R) Cover (Outreach)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Outreach)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Outreach)

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

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

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

Project /Performance Site Location(s) (Outreach)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (Outreach)

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

Budget (Outreach)

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

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

PHS 398 Research Plan (Outreach)

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

Specific Aims:  Provide the specific aims for the Outreach component. 

Research Strategy:  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.

  • Describe the unit and unit organizational chart.
  • Address the progress and major accomplishments achieved by the unit during the past grant period.
  • Describe the service plan and/or research plan for the next grant period. 
  • Describe the methods used to advertise NPRC capabilities to potential collaborators outside of the grantee institution.
  • 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.

Include the following information:

  • For those who are not Key Personnel, list of unit personnel, base institutional affiliation, and role in relation to the NPRC.
  • A table showing the sources and amounts of funding for the unit for the last funded year of the existing P51 base grant and the first proposed year of the P51 base grant renewal. The table should provide detailed information, which is used to calculate the information in the Overall Section. Sources of funding should be broken down as follows, and as applicable to the unit:    

o    Program income derived from the P51 base grant for that specific unit.

o    Support from other sources (not including the P51 base grant or program income derived from the P51 base grant).

o    Total support for the unit.

Vertebrate Animals: If answered affirmative for Vertebrate Animals, refer to the overall VAS for general procedures and interventions to minimize pain and distress. For the specific unit, include any research-specific procedures, such as imaging or surgical procedures, as well as interventions to minimize pain and distress. Address species justifications related to the specific field of research.

Letters of Support:  The applicant may include letters of support related to Outreach component.

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

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

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

PHS Inclusion Enrollment Report (Outreach)

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

NPRC Consortium  

When preparing your application in ASSIST, use Component Type ‘NPRC Consortium’.

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

SF424 (R&R) Cover (NPRC Consortium)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (NPRC Consortium)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (NPRC Consortium)

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

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

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

Project /Performance Site Location(s) (NPRC Consortium)

List all performance sites that apply to the specific component.

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

Research & Related Senior/Key Person Profile (NPRC Consortium)

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

Budget (NPRC Consortium)

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

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

PHS 398 Research Plan (NPRC Consortium)

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

Specific Aims:  Provide the specific aims for the NPRC Consortium. 

Research Strategy:  The NPRCs should propose and plan consortium-based activities, including, but not limited to meetings (teleconference, webinars, face-to-face) and sharing of best-practices, protocols, and data 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 ORIP 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 progress is achieved and new challenges are identified. Examples of Working Groups are Breeding Colony Management, Genetics and Genomics, Behavioral Management, Occupational Health and Safety, Pathology, and Training. Each Working Group will address clearly defined goals related to their area of expertise.

  • Describe the unit and unit organizational chart.
  • Describe the participation of the NPRC in these working group activities, and the results obtained.
  • Provide a Table that lists the various NPRC Consortium working groups and the personnel from the NPRC that is the subject of this specific grant application and their titles, who have participated in each working group. 

Include the following information:

  • For those who are not Key Personnel, a list of unit personnel, base institutional affiliation, and role in relation to the NPRC.
  • A table showing the sources and amounts of funding for the unit for the last funded year of the existing P51 base grant and the first proposed year of the P51 base grant renewal, without duplicating information from the budget form. The table should provide detailed information, which is used to calculate the information in the Overall Section. Sources of funding should be broken down as follows, and as applicable to the unit:          

o    Program income derived from the P51 base grant for that specific unit.

o    Support from other sources (not including the P51 base grant or program income derived from the P51 base grant).

o    Total support for the unit.

Vertebrate Animals: If answered affirmative for Vertebrate Animals, refer to the overall VAS for general procedures and interventions to minimize pain and distress. For the specific unit, include any research-specific procedures, such as imaging or surgical procedures, as well as interventions to minimize pain and distress. Address species justifications related to the specific field of research.

Letters of Support:  The applicant may include letters of support related to the NPRC Consortium.

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

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

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

PHS Inclusion Enrollment Report (NPRC Consortium)

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

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

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

  
Post Submission Materials

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

Section V. Application Review Information
1. Criteria

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

 Scoring: Reviewers will provide an overall impact score for the entire Center (Overall). Scores for each defined component will be obtained, but "criterion scores" will not be collected. All components will be considered in assigning the overall impact scores for the entire NPRC.

Overall Impact - Overall

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the Center proposed).

Scored Review Criteria Overall

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

Significance

Does the Center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the Center 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? 

Does the NPRC function as a national resource that effectively provides the expertise, animals, infrastructure and other units 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?

Investigator(s)

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

Does the PD(s)/PI(s) 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 the Governance of the NPRC appropriate with sufficient external input on administrative and scientific direction?

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? 

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?

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? 

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

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 International? 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 ORIP? Are animals provided to researchers on a national basis?

Are requests for the use of available NPRC resources appropriately prioritized? Is 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 clinical laboratory services related to colony health surveillance and to the support of research?

Does the pilot research program contribute to the national goals of the NPRC? Do the awarded pilot research projects contribute to the success of the recipients’ research program?  

Do the RRRPs, if proposed, 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?

Does the NPRC participate in all relevant NPRC Consortium activities? Has participation by the NPRC in specific NPRC Consortium activities 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? 

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 units) facilitate the objectives of the NPRC?

Additional Review Criteria - Overall

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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

Renewals

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

Revisions

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 recommended for 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.

Additional Review Considerations - Overall

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

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

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

Resource Sharing Plans

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


Authentication of Key Biological and/or Chemical Resources

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

Budget and Period of Support

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

Review Criteria - Governance/Administrative Unit

Reviewers will consider each of the review criteria outlined below to assess the scientific merit of the Governance/Administrative Unit but will give only one numeric rating for the entire unit as a component score (criterion scoring is not used for this component). A unit does not need to be strong in all categories to have major scientific impact. For example, a unit that by its nature is not innovative may be essential to advance the Center’s research.

Significance

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 unit integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?

Investigator(s)

Are the lines of administrative responsibilities within the NPRC and the relationships among the PD(s)/PI(s), 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?

Are unit Directors/Head(s) appropriately trained and qualified to carry out their responsibilities?

Innovation

Are the structure of the unit and the method of providing service innovative? Does the unit have access to state-of-the-art technology applicable to their function?

Approach

In terms of organizational framework, is the administration of the various units 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 unit, is the service available to all appropriate personnel and units of the NPRC? Is there potential duplication of services within various units of the NPRC? Are safety and emergency measures adequate?

For the Governance Unit, is there an NSAB that provides guidance to the PD(s)/PI(s) and Center Director on all aspects of the NPRC, including scientific direction? Does the NSAB consist of at least six experts in NHP research, such as senior scientists or relevant administrators, from outside the NPRC and grantee institution? Does the composition of the NSAB reflect the range of technical subjects pursued at the NPRC?

For the Governance Unit, 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 well-qualified members who are Core Scientists representative of the functional units 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 adequately review the scientific merit of all new project proposals that have not undergone NIH peer review and that will use NPRC resources? Are 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 ORIP? Are animals provided to researchers on a national basis?

Environment

Are the institutional support, equipment and other physical resources available to the staff adequate for the proposed activities? Is the administrative unit integrated into the overall NPRC activities?

Review Criteria - Animal Resources Units

Reviewers will consider each of the review criteria outlined below to assess the scientific merit of the Animal Resources Units, but will give only one numeric rating for the entire unit as a component score (criterion scoring is not used for this component). A unit does not need to be strong in all categories to have major scientific impact. For example, a unit that by its nature is not innovative may be essential to advance the Center’s research.

Significance

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 unit integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?

Investigator(s)

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 unit Directors/Head(s) appropriately trained and qualified to carry out their responsibilities? 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?

Innovation

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? 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? 

Approach

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 International? Are standards of animal care state-of-the-art?

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 requests for the use of available NPRC resources appropriately prioritized?

Are 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?

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

Does the animal services unit contribute to publications in NHP research?

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.

Environment

Do major resources including animal housing, laboratories, and service units 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?

Review Criteria – Core Services Units

Reviewers will consider each of the review criteria outlined below to assess the scientific merit of the Core Service Units, but will give only one numeric rating for the entire unit as a component score (criterion scoring is not used for this component). A unit does not need to be strong in all categories to have major scientific impact. For example, a unit that by its nature is not innovative may be essential to advance the Center’s research.

Significance

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?

Investigator(s)

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?

Innovation

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?

Approach

Are core services available to core, affiliate, visiting, and external scientists? Are specific services utilized by a significant number of investigators/laboratories? Are some services used by only a few scientists, and is this appropriate? Is there any duplication of services across units?

Environment

Do major resources including animal housing, laboratories, and service units 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 unit integrated into the overall NPRC activities?

 
Review Criteria – Scientific Units

Reviewers will consider each of the review criteria outlined below to assess the scientific merit of the Scientific Units, but will give only one numeric rating for the entire unit as a component score (criterion scoring is not used for this component). A unit does not need to be strong in all categories to have major scientific impact. For example, a unit that by its nature is not innovative may be essential to advance the Center’s research.

Significance

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? Do NPRC scientists interact with external investigators to assist with experimental design, data processing and reporting in efforts to enhance rigor and reproducibility? Are resources available to investigators on a local, regional, and national basis? Is the unit integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?

Investigator(s)

Are the Scientific Unit 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 unit 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 mission of the NPRC?

Innovation

Does the unit facilitate the use of animal models of human disease? Is the research addressed by the Scientific Unit at the forefront of NHP research?

Approach

Does the unit 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 Scientific Unit publish studies that advance NHP research in the specified field?

Environment

Do major resources including animal housing, laboratories, and service units 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 unit integrated into the overall NPRC activities?

Review Criteria – Pilot Research Program

Reviewers will consider each of the review criteria outlined below to assess the scientific merit of the Pilot Research Program, but will give only one numeric rating for the entire unit as a component score (criterion scoring is not used for this component). A unit does not need to be strong in all categories to have major scientific impact. For example, a unit that by its nature is not innovative may be essential to advance the Center’s research.

Significance

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 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? For the previous grant period, did at least 50% of funded pilot research projects involve the active participation of investigators external to the NPRC? For the previous grant period, did funded pilot research projects include early stage scientists as major participants (e.g., PI or MPI)? Is the Pilot Research Program integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?

Investigator(s)

Have pilot project investigators been solicited on a national level beyond the NPRC? 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? 

Innovation

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?

Approach

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 and grantee institution? Have new affiliate investigators and/or research programs been incorporated? Are the numbers of applications received and funded adequate and appropriate? If the NPRC has solicited applications in a specific subject area, is the subject area important for research using NHPs?

Does pilot research include 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?

Is the composition of the pilot program review committee appropriate? Are there a scoring system for evaluation and a means for obtaining short written critiques of the proposal from the review committee? Does the format and length of the pilot proposal permit sufficient information to allow evaluation from the written application alone? Does the selection process allow prioritization for early stage investigators? 

Environment

Do major resources including animal housing, laboratories, and service units 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 unit integrated into the overall NPRC activities?

 
Review Criteria – Resource Related Research Project (RRRP)

Reviewers will consider each of the review criteria outlined below to assess the scientific merit of the RRRP, but will give only one numeric rating for the entire RRRP as a component score (criterion scoring is not used for this component). A RRRP does not need to be strong in all categories to have major scientific impact. For example, a RRRP that by its nature is not innovative may be essential to advance the Center’s research.

Significance

Does the project(s) address an important problem or critical barrier to progress in the field? Is there a strong scientific premise for the project? Will the project(s) 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(s) appropriate and meritorious? Is the project(s) integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?

Investigator(s)

If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project? Is/are the investigator(s) appropriately trained, experienced, and qualified to carry out the proposed work?

Innovation

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?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals? Does the RRRP, if supported, directly enhance the NPRC’s resources and ability to meet the needs of researchers using NHPs?

Environment

Do major resources including animal housing, laboratories, and service units 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 unit integrated into the overall NPRC activities?

Review Criteria – Alterations and Renovations (A&R) Unit

Reviewers will provide only one overall numeric impact rating for the A&R Unit as a component score. Reviewers will consider the following aspects while determining scientific and technical merit of this component:

  • 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 A&R projects relevant to the scope of the NPRC and appropriately justified?
  • Is the unit integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?
  • Will the project be monitored by qualified individuals at the NPRC?
  • Will the work be performed by skilled professionals?
  • Will the proposed A&R project result in improved equipment and/or facilities?
  • Are the functional units that will be directly affected by the A&R project listed?
  • Is justification provided for all equipment items requested? Is a clear A&R plan presented?
  • Do the applicants describe the need for each requested item relative to the overall requirements of the NPRC?
 
Review Criteria – Outreach and Community Engagement

Reviewers will provide only one overall numeric impact rating for the Outreach and Community Engagement Unit as a component score. Reviewers will consider the following aspects while determining scientific and technical merit of this component:

  • 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 unit integrated into the overall NPRC activities and does it contribute to the goals of the NPRC?
  • Is the staff appropriately trained, experienced, and qualified to fulfill their responsibilities?
  • Are the service plans for the next grant period innovative?
  • 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?
  • Is the unit integrated into the overall NPRC activities?
Review Criteria – NPRC Consortium Activities

Reviewers will provide only one overall numeric impact rating for the NPRC Consortium Activities as a component score. Reviewers will consider the following aspects while determining scientific and technical merit of this component:

  • Does the NPRC allocate appropriate numbers and types of personnel to participate effectively in consortium activities?  
  • Does the NPRC promote innovative methods to enhance the activities of the NPRC consortium? 
  • Does the NPRC participate in all relevant consortium activities? 
  • Has participation by the NPRC in specific consortium activities contributed to the success of those 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?
2. Review and Selection Process

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

As part of the scientific peer review, all applications:

  • Will receive a written critique.

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

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

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

Section VI. Award Administration Information
1. Award Notices

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

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

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

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

2. Administrative and National Policy Requirements

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

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. Progress reports should briefly describe scientific progress of supported projects including status of pilot projects. Updates on services provided, training opportunities, infrastructure improvements, and inclusion of publications should be addressed. Contact Program Staff for guidance on formats.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement. 

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

Section VII. Agency Contacts

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

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Scientific/Research Contact(s)

Sheri Ann Hild, PhD
Office of Research Infrastructure Programs (ORIP)
Telephone: 301-594-8937
Email:hildsa@mail.nih.gov

Peer Review Contact(s)

Maribeth Champoux, PhD
Center for Scientific Review (CSR)
Telephone: 301-594-3163
Email: champoum@csr.nih.gov

Financial/Grants Management Contact(s)

Jenelle Wiggins
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0843
Email: jenelle.wiggins@nih.gov

Section VIII. Other Information

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

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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