Amendment A0001_CDER-2026-135968.pdf

PDF 629 KB Posted

Attached to
2D High-Density Multi-Electrode Array Electrophysiology Platform Federal contract opportunity
Solicitation number
RFQ_CBER-2026-135968
Issued by
Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services

About this file

This is Amendment A0001 to solicitation RFQ_CDER-2026-135968, issued by the Government on September 17, 2026, with an effective date of September 17, 2026. The amendment is not extended and the solicitation closing date and time will not be extended. The amendment pertains to clarification of the Government's final acceptance timeframe only and states that no further questions will be addressed regarding this solicitation.

The amendment clarifies that the 75-calendar-day completion period applies to the Contractor's completion of all required installation, system verification, calibration, training, and demonstration activities, but does not establish an automatic final acceptance date. Once the Contractor has satisfactorily completed all required activities, submitted all required documentation, and resolved any material deficiencies, the Government/Contracting Officer's Representative (COR) will complete its review and communicate final acceptance within five (5) business days. The two-year manufacturer warranty will begin on the date of Government final acceptance. All other terms and conditions of the solicitation remain unchanged.

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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 or (c) By separate letter or electronic communication 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 letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

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

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT 1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NUMBER 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQUISITION NUMBER 5. PROJECT NUMBER (If applicable)

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

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

FACILITY CODE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED (SEE ITEM 11)

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED (SEE ITEM 13)

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 is extended. is not extended.

12. ACCOUNTING AND APPROPRIATION DATA (If required) copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NUMBER AS DESCRIBED IN ITEM 14.

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

NUMBER IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation data, 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)

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.

15C. DATE SIGNED

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

16C. DATE SIGNED

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

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

PAGE OF PAGES

6. ISSUED BY CODE

8. NAME AND ADDRESS OF CONTRACTOR (Number, street, county, State and ZIP Code) (X)

CODE

15B. CONTRACTOR/OFFEROR

(Signature of person authorized to sign)

16B. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

Previous edition unusable

Amendment A0001 Solicitation RFQ_CDER-2026-135968 1

Amendment 0001 – Questions and Answers

Question: Within what timeframe will the Government communicate final acceptance after successful completion of all installation, verification, calibration, training, demonstration, and documentation requirements? Does the 75-calendar-day completion period mean final acceptance will occur no later than Day 75?

Government Response: The 75-calendar-day period applies to the Contractor’s completion of all required installation, system verification, calibration, training, and demonstration activities. It does not establish an automatic final acceptance date.

Once the Contractor has satisfactorily completed all required activities, submitted all required documentation, and resolved any material deficiencies, the Government/COR will complete its review and communicate final acceptance within five (5) business days.

The two-year manufacturer warranty will begin on the date of Government final acceptance. All other terms and conditions of the solicitation remain unchanged.

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Description[0]: The purpose of this amendment is to provide clarification regarding the Government’s final acceptance timeframe. No further questions will be addressed regarding this solicitation. The solicitation closing date and time will not be extended.
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