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Appendix A: Study Approach and Methods
Pages 185-202

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From page 185... ... A 2-day workshop in August 2022 included sessions with federal funders of NHP research, representatives from domestic NHP breeding resources, investigators using NHP models, and stakeholders involved with the development and application of new approach methodologies. A third public meeting was held in November 2022 and included representatives from the NIH Office of Research Infrastructure Programs (ORIP) Read the entire page →
From page 186... ... Information Requests The committee sent formal information requests to several federal agencies and other stakeholder organizations to collect information that was not publicly available (see Table A-1) Read the entire page →
From page 187... ... importation data, 2019–2022 Food and Drug Administration Data on nonanimal methods successfully used in regulatory approvals National Primate Research Centers Information on recent NHP use trends and experiences National Resources and select research facilities Information on recent NHP use trends and experiences supported by the National Institutes of Health National Institutes of Health (NIH) Information on active NIH awards using NHPs (e.g., research domains, species used, number of animals used) Read the entire page →
From page 188... ... NIH In addition to the participation of NIH ICOs in the committee's public informationgathering sessions, the committee sent several information requests to NIH in efforts to gather quantitative and qualitative data on NHP use in extramural and intramural research projects, challenges related to supply and demand, and NIH-supported and -owned breeding colonies. Quantitative data from internal NIH data systems were not available to the committee because of privacy concerns by NIH about accessing internal records, and because no automated methods are in place for collecting the requested data. Read the entire page →
From page 189... ... OR LIMIT-TO ( FUND-SPONSOR,"National Eye Institute" ) OR LIMIT-TO ( FUND-SPONSOR,"Eunice Kennedy Shriver National Institute of Child Health and Human Development" ) Read the entire page →
From page 190... ... Keyword searches using NHP terminology did not provide a complete listing of active awards using NHPs. Unlike the prior review of NHP supply and use published by ORIP in 2018, the committee did not have access to internal NIH data systems to provide detailed information on current NHP use (e.g., information on research domain, species, quantity of NHPs planned for use, justification for the choice of model) Read the entire page →
From page 191... ... . The search was restricted to active project-driven research grants as categorized on NIH RePORTER as funding mechanisms for "Research Projects." It should be noted that this search of NIH RePORTER captured projects that did not use NHP models, such as those projects that used a search term in the abstract in reference to prior research using NHPs, and likely missed some projects that did use NHPs, such as those that did not include a keyword in 4 APHIS annual reports from research facilities provide information on the number of animals held, bred, or conditioned for research use and the number used for research purposes. Read the entire page →
From page 192... ... Because of the lack of information available about those respondents who did not choose to respond to the survey, no analysis of the representativeness of the respondents or the awards for which they reported information could be performed. Therefore, it is not known whether a higher or lower portion of researchers from a specific research domain, for example, responded to the survey as compared with the entire population of NIH-supported investigators using NHPs. Read the entire page →
From page 193... ... Any identifying information, including NIH grant numbers, was anonymized and the code key deleted. No identifiable survey data were shared with any committee members and only aggregate data were made available to the full committee. Read the entire page →
From page 194... ... Public Session Agenda August 25, 2022 8:30 am–5:30 pm (ET) Open Session 8:30 am Welcome and Opening Remarks Kenneth Ramos, Committee Chair Texas A&M University Session I LANDSCAPE ANALYSIS AND FUTURE PROJECTIONS FOR NONHUMAN PRIMATE USE IN RESEARCH TO ADVANCE HUMAN HEALTH AND SAFETY Purpose: • Explore current strengths and weaknesses of NIH-supported biomedical research using NHPs, current and future research priorities, and oppor tunities to improve human health. Read the entire page →
From page 195... ... APPENDIX A 195 National Institutes of Health Richard Wyatt Deputy Director, Office of Intramural Research National Institutes of Health Stephen Denny Director, Office of Animal Care and Use Office of Intramural Research National Institutes of Health 9:10 a.m. Committee Q&A 9:30 a.m. Read the entire page →
From page 196... ... Basso Director, Washington National Primate Research Center Nancy Haigwood Director, Oregon National Primate Research Center Paul Johnson Director, Yerkes National Primate Research Center Jon Levine Director, Wisconsin National Primate Research Center John Morrison Director, California National Primate Research Center Jay Rappaport Director, Tulane National Primate Research Center Corinna Ross Associate Director of Research, Southwest National Primate Research Center 11:45 a.m. Panel 2: Perspective from Other National Nonhuman Primate Resource Centers (Moderated Discussion) Read the entire page →
From page 197... ... 1:30 p.m. Opening Panel Session Remarks from Committee Moderator Myrtle Davis, Committee Member Bristol Myers Squibb 1:35 p.m. Read the entire page →
From page 198... ... Committee Q&A with Panels 3:30 p.m. Break Session IV NONHUMAN PRIMATE RESEARCHER PERSPECTIVES ON THE RESEARCH LANDSCAPE AND EMERGING TECHNOLOGIES Purpose: • Explore areas of emerging science that may benefit from NHP research. Read the entire page →
From page 199... ... 4:45 p.m. Opening Panel Session Remarks from Session V Moderator Kenneth Ramos, Committee Chair Texas A&M University Session Highlights from Previous Session Moderators Eliza Bliss-Moreau, Committee Member University of California, Davis Read the entire page →
From page 200... ... • Discuss future priority areas for NIH-supported NHP research based on public health needs and evolving science. • Explore opportunities for facilitating collaboration across researchers, including with researchers working with new approach methodologies that may be complementary, increase the value of models used, or reduce future reliance on NHP models. Read the entire page →
From page 201... ... Break Session II OPPORTUNITIES FOR COMPLEMENTARY AND COLLABORATIVE RESEARCH Purpose: • Identify examples of, or opportunities for, new approach methodologies (in vitro and in silico methods) to complement and/or reduce reliance on NHP research. Read the entire page →
From page 202... ... WRAP-UP DISCUSSION AND CLOSING REMARKS Kenneth Ramos, Committee Chair Texas A&M University 1:00 pm Adjourn Read the entire page →

From page 185...

... A 2-day workshop in August 2022 included sessions with federal funders of NHP research, representatives from domestic NHP breeding resources, investigators using NHP models, and stakeholders involved with the development and application of new approach methodologies. A third public meeting was held in November 2022 and included representatives from the NIH Office of Research Infrastructure Programs (ORIP)

Appendix A: Study Approach and Methods Pages 185-202

Appendix A: Study Approach and Methods
Pages 185-202