Beta.SAM Question and Answers SPE1C1-20-R-0139.docx

Based on questions received in response to the solicitation, the following clarification is provided for solicitation SPE1C1-20-R-0139:

1. All offerors shall review the language at FAR 25.003 and DFARS 225.003 for definitions and what it means to be considered a domestic, qualifying or designated country end product. To determine if a proposed item meets the requirements of each specific lot, offerors should review the following regulations which include lists of compliant countries:

a. Berry Compliant Lots: DFARS clause 252.225-7012 Preference for Certain Domestic Commodities

b. Buy American Act Compliant Lots: DFARS 225-872-1 provides a list of Buy American Act qualifying countries

c. Trade Agreement Act Compliant Lots (if applicable): FAR Subpart 25.4 provides a list of applicable Trade Agreements.

Offers not meeting the requirements for Berry Amendment or BAA compliant offers under the first two lots or sub-lots of the solicitation, or offers not proposing to use a domestic fabric as the primary end item fabric, may submit a proposal under the third lot or sub-lot which is subject to the application of the provisions of the TAA.

2. The solicitation is requiring commercial-off-the-shelf gowns and is not defining a required material. The only requirement is that the material does not include latex, meets the requirements listed in the product description, and there are test reports and/or COC as required in the solicitation and/or proposal submission form for the proposed item’s material.

3. A premarket document number (510(k) clearance) from the FDA is not required for this item, regardless of the protection level, ONLY if the item is marketed as an isolation gown. If an offeror’s proposed gown is marketed as a surgical isolation gown, a premarket document number (510(k) clearance) from the FDA IS REQUIRED and the following shall be attached to the proposal submission form:

a. U.S. FOOD AND DRUG ADMINISTRATION (FDA) REGISTRATION AND DATE REGISTERED.

b. LISTINGS AND DATE LISTED FOR FDA PRODUCT CODE OF "FYA".

c. PREMARKET DOCUMENT NUMBER (510(K) CLEARANCE) FOR FDA PRODUCT CODE OF "FYA".

NOTE: There are no exceptions or emergency use authorizations (EUAs) that allow the requirement of a 510K & FDA registration to be waived. Any offeror submitting a proposal without this information and/or claiming an exception or EUA is applicable will be rejected for noncompliance the solicitation's terms and conditions.

4. Minimum length is of the gown is not spelled out explicitly. It is the Offeror's/Contractor's responsibility to ensure that the offered item(s) will provide adequate protection and coverage to the user. ASTM F3352 states, in part, that the gown must provide coverage "from the knees up to but not including the neck." Please review Section 5 "Design Requirements" in ASTM F3352-19 for more information.