SF30 - Amendment 0006.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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

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

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of Amendment 0006 is to provide the Government's responses to questions received from industry in Section J of the solicitation, specif ically addressing the second round of inquiries concerning the Drug Level cut-off changes. Additionally, this amendment extends the proposal submission deadline to 01 August 2025.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 2

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

16C. DATE SIGNED

BY 31-Jul-2025

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

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

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X M0026325Q1010

X 9B. DATED (SEE ITEM 11)

04-Apr-2025

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer 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 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT 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.

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.

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

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

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

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

31-Jul-2025

CODE

REGIONAL CONTRACTING OFFICE

ATTN: DEDRIENE GREEN

P.O. BOX 5069 MCRD

(843)228-1955

PARRIS ISLAND SC 29905

M00263 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

M0026325Q1010

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION J - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

The following have been added by full text:

M0026325Q1010 Amendment 0006 Drug Testing Kits

Industry Question and Government Reponses

Question 1:

FDA 510(k) Approval vs. Forensic Use Only (FUO): Several of the specified cutoff levels (e.g., THC at 15 ng/mL, BZO at 200 ng/mL, and inclusion of K2/Synthetic Cannabinoids) do not currently align with FDA 510(k)-cleared devices, but may fall under Forensic Use Only devices commonly used in federal/government settings.

Can FUO-classified devices be submitted in place of 510(k)-cleared devices for this requirement?

Answer:

Any device that meets the testing requirement can be submitted for review.

Question 2:

Designer Amphetamines Panel: The term “Designer Amphetamines” is broad and typically interpreted to refer to MDMA in drug screening.

Can you confirm whether MDMA is the intended analyte for this panel?

Yes, MDMA is the intended drug.

Question 3:

Hydrocodone Panel Requirement: There is no FDA-cleared test specific solely for Hydrocodone at the specified 300 ng/mL cutoff.

Is there flexibility in this requirement to allow inclusion within broader opioid panels or FUO formulations?

Answer:

Yes, there is flexibility in the requirement to allow inclusion within broader opioid panels or FUO formulations, especially given that there is no FDA-cleared test specific solely for Hydrocodone at the specified 300 ng/mL cutoff.

Question 4:

Cannabinoids (Marijuana) Cutoff Concentration: The cutoff concentration for Cannabinoids is listed as 15 ng/mL, which appears significantly lower than what is commonly used for initial screening purposes across federal testing protocols.

Could you kindly confirm whether this level is correct, or if a revision may be forthcoming?

Yes, 15 ng/mL is the requirement.

(End of Summary of Changes)