N62645-13-R-0036_Combined_Syn_Sol_Amend_0001.doc

N62645-13-R-0036

Solicitation N62645-13-R-0036

Amendment 0001

09 October 2013

Answers to Questions The purpose of this amendment is to answer questions to the combined synopsis/solicitation. All other terms and conditions remain unchanged and in full effect.

Question 01: Is it a mandatory requirement for the product to be FDA approved?

Answer 01: Yes. In accordance with the combined synopsis/solicitation, Statement of Work Paragraphs 1.3 – 1.3.1, “Immunoassay kits are medical devices and shall have clearance from the Food and Drug Administration (FDA) to be marketed.”

Question 02: Is this opportunity available to tenderer’s from non-U.S. companies?

Answer 02: Per the combined synopsis/solicitation, please review and comply with the following Federal Acquisition Regulation (FAR) and Department of Defense FAR Supplement (DFARS) regulations:

- 52.225-13 Restrictions on Certain Foreign Purchases

- 252.225-7012 Preference For Certain Domestic Commodities

- 252.225-7020 Trade Agreements Certificate

- 252.225-7020 Trade Agreements

Question 03: Can you make it a SDVOSB set aside?

Answer 03: At this time the Naval Medical Logistics Command does not intend to set this requirement aside for Service-Disabled Veteran-owned Small Business. Market research conducted did not support that a minimum of two or more small businesses could satisfy this requirement; therefore, it is not appropriate for a small business set-aside. Competing this requirement on an unrestricted basis does not preclude a small business from the potential of filling this.