6973GH-24-Q-00147 0001.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

5. PROJECT NO. (If applicable)2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ.NO.

PAGE OF PAGES

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6)

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

CODE

9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

Items 8 and 15, and returning is extended, is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required.)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

(x) A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO THE AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation date, etc.) SET FORTH IN ITEM 14.

E. IMPORTANT: Contractor is not, is required to sign this document and return

ORDER NO. IN ITEM 10A.

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0001 04/11/2024

AAQ-730 FAC. & AVIATION SAFETY ACQ

PO BOX 25082

BLDG 014-AHQ, ROOM 233A

OKLAHOMA CITY OK 73125

AAQ730-AFN

x

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

separate letter or telegram which includes a reference to the solicitation and amendment number. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE RECEIVED AT

THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By ___________ 1 x x

6973GH-24-Q-00147

1 copies to the issuing office.

04/11/2024

(x)

The purpose of Amendment 0001 is to incorporate Question and Answers.

I. Questions and Answers dated May 6, 2024, is hereby incorporated as follows:

Question 1: There is a section that requires both a FAT (Factory Acceptance Testing) and

SAT (Site Acceptance Testing) program be developed and submitted. This can take many different forms, but all require a substantial amount of resources, so I need to understand the expectation in more detail.

FAA Response:

In doing some research, I found the FDA requirements for X-Ray emitting manufacturers.

Continued ...

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. CONTRACT AUTHORITY 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

Kimberly D. Sites

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

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CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

6973GH-24-Q-00147/0001

Rather than having to generate new documentation, the requirement is satisfied if they can provide the documentation showing that they are in compliance with the FDA requirements:

The FDA regulates manufacturers of X-ray imaging devices through the Electronic Product Radiation

Control (EPRC) and the medical device provisions of the Federal Food, Drug, and Cosmetic (FD&C)

Act. FDA specifies requirements related to these provisions through "regulations" or "rules," which are mandatory, and it makes related recommendations through issuance of

"guidance(s)," which are not mandatory.

Electronic Product Radiation Control (EPRC) requirements for manufacturers and assemblers

Manufacturers and assemblers of electronic radiation-emitting products sold in the United

States are responsible for compliance with the radiological health regulations found in Title 21 of the Code of Federal Regulations (Subchapter J, Radiological Health).

Here’s the full link:

https://www.fda.gov/radiation-emitting-products/me dical-imaging/medical-x-ray-imaging

Question 2: I am verifying the Requirements for this RFO that the Detectors (hardware) be manufactured in the USA or TAA compliant?

FAA Response:

The Buy American Act (BAA) applies to any procurement of a supply that is over the Micro

Purchase Threshold (MPT), which is currently

$10,000, and can reasonably be procured as Made in US compliant. The Trade Agreements Act (TAA) applies to government contracts valued above the

TAA threshold, which is currently $183,000 for a supply contract. Our market research places this procurement firmly above the MPT but below the

TAA and has a reasonable expectation that a company can provide a Made in US compliant solution. Therefore the TAA rules do not apply.

II. All other Terms and conditions Remain unchanged, Proposals must be received by the FAA

Contract Specialist, caridad.daniel@faa.gov, no later than 3:00P.M.

Continued ...

ITEM NO. SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

NAME OF OFFEROR OR CONTRACTOR

3 3

CONTINUATION SHEET

REFERENCE NO. OF DOCUMENT BEING CONTINUED PAGE OF

(A) (B) (C) (D) (E) (F)

6973GH-24-Q-00147/0001

CT Monday, May 13, 2024.