36C24822P1308_1.docx

Justification and Approval Notice Justification and Approval Notice

GENERAL INFORMATION

BASE NOTICE TYPE

Network Contracting Office 8 (NCO 8) Room 315, Bldg. 2 10,000 Bay Pines Blvd Bay Pines FL 33744

POINT OF CONTACT*

AWARD INFORMATION

MODIFICATION NUMBER

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

AGENCY’S URL

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DESCRIPTION

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C248-22-AP-3591

1. Contracting Activity: Department of Veterans Affairs, VISN 08, C. W. Bill Young VA Medical Center Medical Center Animal Maintenance contract.

2237: 516-22-3-7158-0082

1. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Research Service for animal maintenance, transport, housing, feeding, bedding, veterinarian care, utility usage, anesthesia administration, tail-clipping for genotyping, and vivarium staff and technicians and care support services for research conducted at the Roskamp Institute, $80,100.00.

1. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The Roskamp Institute Inc. (RI) is the only known contractor that is capable of providing veterinary support for this research requirement. The Roskamp Institute Inc. is the only source to be able to provide these veterinary services in accordance with the Institutional Animal Care and Use Committee (IACUC) and the only source to provide oversight and ensure compliance with all VA Animal Research performed at CWBYVAMC and/or KI sites. Animal-based research projects are highly regulated and demand VHAPM Part 813.106. exemplary execution. The regulations mention below are just a few established to regulate these kinds of services and thus severely limiting the pool of qualified vendors;

Federal Regulations, Policies and Procedures.

a. Animal Welfare Act as Amended (7 USC, 2131-2159). https://www.aphis.usda.gov/animal_welfare/downloads/awa/awa.pdf

b. Animal Welfare Act Regulations (Code of Federal Regulations, Title 9, Chapter 1, Subchapter A - Animal Welfare) (2013). https://www.aphis.usda.gov/animal_welfare/downloads/Animal%20Care%20Blue%20Book%20-%202013%20-%20FINAL.pdf

c. Guide for the Care and Use of Laboratory Animals, Eighth Edition, Institute of Laboratory Animal Resources (ILAR), Division of Earth and Life Sciences, National Research Council, 2011. http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf

d. Public Health Service Policy on Humane Care and Use of Laboratory Animals, Office of Laboratory Animal Welfare, National Institutes of Health, 2015. http://grants.nih.gov/grants/olaw/references/phspol.htm

e. American Veterinary Medical Association (AVMA) Guidelines for the Euthanasia of Animals, 2013 https://www.avma.org/KB/Policies/Documents/euthanasia.pdf

f. Occupational Safety and Health Administration Regulations (Standards – 29 CFR) including the Hazard Communication Standard (OSHA Standards, 29 CFR 1910.1200) and the Occupational Exposure to Hazardous Chemicals in Laboratories (29 CFR 1910.1450). http://www.osha.gov/pls/oshaweb/owastand.display_standard_group?p_toc_level=1&p_part_number=1910 http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10099 http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=standards&p_id=10106

g. Biosafety in Microbiological and Biomedical Laboratories (CDC-NIH, 2007); Biological Safety Level-2 (BSL-2) Manual and Biological Safety Level-3 (BSL-3) Manual. http://www.cdc.gov/biosafety/publications/bmbl5/index.htm

h. Good Laboratory Practice Regulations (21 CFR 58). http://www.access.gpo.gov/nara/cfr/waisidx_01/21cfr58_01.html

i. Environmental Protection Agency (EPA) Resource Conservation and Recovery Act Regulations.

https://www.epa.gov/rcra/resource-conservation-and-recovery-act-rcra-regulations

1. Description of market research conducted and results or statement why it was not conducted:

Not conducted as an agreement exists between Bay Pines VA and Roskamp Institute

Market research was conducted using NAICS code 541940 and the PSC of R416 via Federal Business Opportunities (FBO), SBA’s Dynamic Small Business website, SAM, NAC tools, GSA Advantage, NASA SEWP, and VETBIZ. Research was also conducted to understand the regulations required to conduct animal research which show that these services are typically found at sizable universities, sizable pharmaceutical and biomedical companies and hospitals. Additionally, the specific type of research will also severely limit the already scarce sources. These services also include mice veterinary care via a fully accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC), managed in accordance with the Guide for the Care and Use of Laboratory Animals (Guide), the Animal Welfare Regulations Title 9 Code of Federal Regulations Subchapter A, Animal Welfare, Parts 1-3 (AWR), the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy), and the local Institutional Animal Care and Use Committee Principles of Animal Care and Use and RosKamp Institute is the only Contractor capable of providing these necessary services.

Justification and Approval Notice