36S79725R0001 0002_1.docx

SUBJECT*

Upper Artificial Limbs

GENERAL INFORMATION

SET-ASIDE

PO Box 76 1st Ave., One Block N of 22nd

Hines IL 60141

POINT OF CONTACT*

PLACE OF PERFORMANCE

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Questions Answered , PWS updates Amendment to a Previous Combined Solicitation

Page 1 of

Amendment to a Previous Combined Solicitation

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

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:

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

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; 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 is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, 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.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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.

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

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

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

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

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

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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

VA NAC / 003B6A

PO Box 76 1st Ave., One Block N of 22nd Hines IL 60141 Department of Veterans Affairs OPAL / National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines IL 60141 To all Offerors/Bidders

36S79725R0001

X X X ** HOUR & DATE for Receipt of Offers is EXTENDED to: 04-02-2026 16:00 CDT

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Questions Answered , PWS updates Updates to the PWS:

MINIMUM TECHNICAL REQUIREMENTS (ARTIFICIAL LIMBS – UPPER EXTREMITY PRODUCT(S) #11

B.15 CONTRACT PRODUCT TRAINING

e) Location(s):

(1) Contractors are encouraged to provide training at Government medical centers or by electronic means including recorded material (e.g., CD-ROM) or telecommunication media (videoconference), or Internet-based distance learning. Training may be held at the contractor’s facility, business office, or hotel. Facility means the contractor’s home office, manufacturing plant, or a wholly owned subsidiary facility where customer service personnel are located.

(2) The contractor shall reserve a minimum of two (2) seats for DLC personnel to attend any in-person training.

1. Is there an opportunity or interest in fabrication services? Custom options?

Yes, there is an opportunity for fabrication and assembly services, particularly in relation to partial hand prostheses. The vendor providing the specified components will be responsible for assembly services when applicable.

2. Due to the cost of some of the products, it is not possible to offer a satisfaction period. We request that products be subject to the warranty policy and not a satisfaction period.

Unfortunately, a satisfaction period is a mandatory requirement and all products must adhere to the satisfaction period specified.

3. There are specific products that are not kept in inventory due to the many SKU's/variations associated with the product. These products may require longer than a 5-day delivery. Are there exceptions to this statement?

Exceptions to the delivery timeline for products with many SKU variations can be made on a case-by-case basis by reaching out to the CO and COR

4. Is ISO 9001 and/or ISO 13485 mandatory to be considered? Is there an alternative to being ISO certified?

FDA regulated medical devices require documented certification.

5. If we have devices that include both the terminal device and the wrist within one part number, should we put this just under the terminal device tab.

Yes, placing it under the terminal device tab would be acceptable.

6. Do you have any information or reports regarding volume? As we look at volume discounts, it would be good to see what the volume is in Upper Limb that the VA already sees?

This will be a new national contract, so there is no anticipated volume of orders available at this time. While historical data from the Prosthetic and Sensory Aids Service (PSAS) has been provided, it only includes dollar sales figures and does not specify the number of orders. Therefore, we do not have specific volume information regarding Upper Limb national orders at this time.

7. Can the annual training at the DLC be done virtually?

Training can be done virtually.

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