1210073_Q&A.docx

The purpose of this amendment is to post all questions and answers submitted as of 6/26/2019 in response to the solicitation:

Q1: #1., #4., and #19., #20 - Please confirm the below mesh/ grid size and gauge of stainless are accurate for each Primate Rack section.

a. Front panel = 1” sq. mesh, minimum of 8 Gauge (allows for better visibility into the cage);

A: Correct

b. Front shuttle Door/ animal access door = 1” sq. mesh, minimum of 8 Gauge (allows for better visibility into the cage);

A: Correct

c. Right and Left Side shuttle doors for social housing = 1/2” sq. mesh, 11 Gauge (prevents animal injuries):

A: Correct

d. Animal Compartment Floors = 1/2”, 11 Gauge (prevents animal injuries);

A: Each rack should have floors that are to 1”, 11-gauge removable wire floor on top cage with a solid removable catch pan. Bottom cage should be 1”, 11-gauge permanent floor with permanent flush pan that accepts a removable catch pan.

e. Animal Compartment Squeezebacks = 1/2” , 11 Gauge (prevents animal injuries);

A: 1”, 11-gauge with steel frame.

f. Animal Compartment Ceiling = 1” minimum of 8 G (allows for better light into the cage).

A: Correct

Q2: #14. Does FDA want to include Balconies or viewing boxes as a CLIN002? If so, please provide detailed specifications and Quantities.

A2: The racks need to be able to accept balconies on top and bottom cage of each rack, balconies are to be from floor of cage 17 inches high, 10.25 inches wide and 9 inches deep and quantity of 1 per cage

Q3: #15. Are reinforced bars truly necessary since the outside cage panels consist of the shuttle doors which are mentioned in section #4? Reinforcement bars welded to frame would interfere with horizontal animal movement.

A3: Reinforcement bars are only on the outside of the rear cage panels. With shuttle doors on both sides of each cage reinforcement bars are not needed, reinforcement on the rear of each cage.

Q4: #16. Are 32 oz bottles required? Are Sipper Tubes/ Stoppers required? If so, please confirm size of Sipper Tube (5/8” or 5/16”) A4: No bottle or stoppers are required, only bottle holders for each cage with 5/8” hole.

Q5: #13, #16, #19. Will FDA accept proposals that include estimated door opening dimensions instead of “minimum” dimensions as stated in the solicitation? This flexibility would allow manufacturers to accommodate bottle and feeder requests (#13, and #16).

Q5: Yes

Q6: #13, #16. Will proposals be accepted that offer alternative placements of bottle holders and feeders to fit all features on the front of the cage (due to limited space on front of cage)?

A6: Yes

Q7: Solicitation states: Rack design/plans shall be available for FDA review 21 days after award; prototype shall be available for review at contractor's facility 14 days after FDA acceptance of rack design/plans;

Can the availability of the prototype be extended to an industry standard of about 90 Days AFTER rack design/ plans/ approval drawings instead of 14?

A7: In consideration of this request, FDA will accommodate only up to 45 days for prototype production.

Q8: Solicitation states: Delivery, installation and staff familiarization training shall occur within the contractor's normal manufacturing lead times for these items but shall be no more than 240 calendars days from date of award.

Can delivery and installation be required 240 calendar days from date of “Approval Drawings” instead of “award”? (Approval process time frame varies with each end user and could impact lead time).

A8: In consideration of this request, delivery and installation shall be no more than 210 calendar days from date of “approval of prototype.”

END OF AMENDMENT NO.: 0001