Department of Health
and Human Services (HHS)
and Human Services (HHS)
March 22, 2021
PAR-20-181 - Limited Competition: National Primate Research Centers (P51) (Clinical Trials Not Allowed)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Research Infrastructure Programs (ORIP)
The purpose of this Notice is to correct PAR-20-181 such that 1) it now includes a required Center Bibliography in the Overall Component of the application instructions and 2) the application instructions now require each Core Service Unit (Core Services Components) to serve two or more center investigator laboratories.
Section IV. Application and Submission Information of PAR-20-181 has been modified as follows:
The Research & Related Other Project Information (Overall) subsection currently reads:
Research & Related Other Project Information (Overall)
Follow standard instructions.
Other Attachments: The following attachments must 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,
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 including NIH intramural investigators. 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:
The Research & Related Other Project Information (Overall) subsection is modified to read (added text shown below in bold italics):
Research & Related Other Project Information (Overall)
Follow standard instructions.
Other Attachments: The following attachments must 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 including NIH intramural investigators. 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 only been provided with biological materials such as tissues or fluids.
Have had an interaction with the NPRC limited to educational or consultative activities.
Have only purchased animals.
Have only contracted for fee-for-service activities.
Center Bibliography: Please title this attachment “Center Bibliography” and provide a full list of publications by Core Scientists, as well as Core Scientists’ papers accepted for publication, that resulted in whole or in part from investigations undertaken with NPRC resources during all years of the previous renewal period. Publications by affiliate and visiting scientists without Core Scientists as co-authors should not be included. For each cited paper, include names of all authors, full article title, journal name, volume number, year of publication, and inclusive pages. Do not include abstracts. Do not include manuscripts that are submitted but not yet accepted for publication. Underline the name of the NPRC Core Scientist(s) in each reference. All listed publications must be compliant according to the NIH public access policy (see https://publicaccess.nih.gov/).
The PHS 398 Research Plan (Core Services) subsection currently reads:
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 proposed grant period.
For individuals who are not Key Personnel, a list of unit personnel, base institutional affiliation, and role in relation to the NPRC.
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.
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: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
The PHS 398 Research Plan (Core Services) subsection is modified to read (added text shown below in bold italics):
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:
Each Core Service Unit must serve two or more center investigator laboratories. It is not permitted to specify a Core Service Unit that serves only one investigator laboratory. 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 proposed grant period.
For individuals who are not Key Personnel, a list of unit personnel, base institutional affiliation, and role in relation to the NPRC.
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.
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: Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.
All other aspects of this FOA remain unchanged.
Sheri Ann Hild, Ph.D.
Office of Research Infrastructure Programs (ORIP)
Phone: (301) 594-8937
Email: [email protected]