FDA NCTR On-Site Animal Care and Technical Procedures   3

The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) requires support services for the Center's animal research program, to include at a minimum the provision of superlative care to all research animals, sanitation of all animal care and diet preparation/formulation facilities, and the provision of protocol-specified technical procedures support; the requirement also includes those ancillary tasks necessary to the accomplishment of these services, i.e., quality control, occupational safety and health measures, inventory control, equipment maintenance, development and maintenance of standard operating procedures, and a comprehensive training and cross-training program. These services are of paramount importance to the Center as the essential elements of the FDA's research mission can be accomplished only through animal research. Animal-based research projects are highly-regulated and demand nonpareil execution in accordance with approved scientific protocols and the Performance Work Statement (PWS) Attachment 1 - Performance Work Statement (PWS) and Appendices 1-4.

Please see the following attachments:

FDA Solicitation 75F40123R00001

Attachment 1: Performance Work Statement and Appendices 1-4, 94 total pages

Appendix 1: Historical and Estimated Workload

Appendix 2: Government Furnished Property

Appendix 3: Facility Floor Plan

Appendix 4: Quality Assurance Surveillance Plan (QASP)

Attachment 2: Pricing Worksheet Labor Categories

Attachment 3: CBA, 32 pages

Attachment 4: Wage Determination No. 2015-5121, Rev. 20, 11 pages

Attachment 5: Form 3398, 1 page

Attachment 6: Past Performance Evaluation Questionnaire (PPEQ), 7 pages

Attachment 7: Sample Client Authorization Letter, 1 page

Attachment 8: SCA Incumbent Employees Length of Service, 1 page

Background
The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) requires animal care and technical procedures services for the Center’s animal research program. The solicitation 75F40123R00001 has been amended to answer contractor-posed questions and provide revised solicitation and attachments based on these questions and answers.

Work Details
The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR) requires support services for the Center’s animal research program, to include the provision of superlative care to all research animals, sanitation of all animal care and diet preparation/formulation facilities, and the provision of protocol-specified technical procedures support; the requirement also includes those ancillary tasks necessary to the accomplishment of these services, i.e., quality control, occupational safety and health measures, inventory control, equipment maintenance, development and maintenance of standard operating procedures, and a comprehensive training and cross-training program.
These services are of paramount importance to the Center as the essential elements of the FDA's research mission can be accomplished only through animal research.

Period of Performance
The anticipated performance period for the base year and option periods is from June 25, 2023, to July 24, 2028.

Place of Performance
The services will be performed at FDA NCTR in Jefferson, Arkansas.