SPE2D224R0005 0003 released.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

2. AMENDMENT/MODIFICATION NO.

See Block 14

4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

6. ISSUED BY CODE SPE2D2 7. ADMINISTERED BY (If other than Item 6) CODE

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

CODE FACILITY CODE

SPE2D224R0005

X

2024 MAR 12

10A. MODIFICATION OF CONTRACT/ORDER NO.

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 OffersX is extended, X is not extended.

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.

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

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:

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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:

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

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

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)

NSN 7540-01-152-8070

Previous edition unusable

STANDARD FORM 30 (REV. 10-83)

Prescribed by GSA FAR (48 CFR) 53.243

16B. UNITED STATES OF AMERICA15B. CONTRACTOR/OFFEROR

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

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

(a) By completing Items 8 and 15, and returning

DLA TROOP SUPPORT

MEDICAL SUPPLY CHAIN FSGB

700 ROBBINS AVENUE

PHILADELPHIA PA 19111

15C. DATE SIGNED 16C. DATE SIGNED

D. OTHER (Specify type of modification and authority)

4/19/2024

3. EFFECTIVE DATE

See Attached Continuation Sheet(s).

(X)

CHECK ONE

9A. AMENDMENT OF SOLICITATION NO.

9B. DATED (SEE ITEM 11)

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

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

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SPE2D224R0005 - 0003

The purpose of this amendment is to update the language of the solicitation.

The following changes have been made to the solicitation as shown below:

1. On page 45 of the solicitation under (e)(ii) and (e)(iii), language has changed from:

“Offers that fail to meet this requirement are not considered to be technically acceptable and may not be included in the competitive range.”

To:

“Offers that fail to meet this requirement may be considered technically unacceptable and may not be included in the competitive range at the discretion of the Contracting Officer, depending on the nature of the warning letter and whether corrective action has been taken by the offeror to address the violations contained in the warning letter as evidenced by an FDA close-out or cure letter, or by submission of a corrective action plan.”

2. On page 46-47 of the solicitation under (h), language has changed from:

“Tab H: FDA Warning Letter and Corrective Action Plan, if Applicable – any FDA warning letters and applicable corrective action plans that are relevant to this solicitation or that are required under applicable laws and regulations shall be included in Volume 1. If FDA warning letters and corrective action plans are non-applicable and the offeror is quoting as a distributor, the offeror must provide a statement on company letterhead that is signed and dated, that there are no applicable FDA warning letters and corrective action plans on the part of the distributor and on the part of the manufacturer and any applicable packaging and packing companies and that the distributor and manufacturer and any applicable packaging and packing companies are in good standing under applicable laws and regulations. If FDA warning letter and corrective action plans are non-applicable and the offeror is quoting as a manufacturer, the offeror must provide a statement on company letterhead that is signed and dated, that there are no applicable FDA warning letters and corrective action plans on the part of the manufacturer and any applicable packaging and packing companies and that the manufacturer and any applicable packaging and packing companies are in good standing under applicable laws and regulations. Offerors whose relevant facilities or products are the subject of an FDA warning letter may be deemed to be technically unacceptable in the Contracting Officer’s discretion, depending on the nature of the warning letter and whether corrective action has been taken by the offeror to address the violations contained in the warning letter, as evidenced by an FDA close-out letter. Offers that have an FDA Warning Letter may not be considered to be technically acceptable and may not be included in the competitive range, dependent on the nature of the Warning Letter and the Contracting Officer’s discretion. If there is an FDA Warning Letter and / or Corrective Action Plan, the aforementioned document(s) shall be submitted in the past performance section, tab 3 of the offeror’s proposal.

To:

“Tab H: FDA Warning Letter and Corrective Action Plan, if Applicable – any FDA warning letters and applicable corrective action plans that are relevant to this solicitation or that are required under applicable laws and regulations shall be included in Volume 1. If FDA warning letters and corrective action plans are non-applicable and the offeror is quoting as a distributor, the offeror must provide a statement on company letterhead that is signed and dated, that there are no applicable FDA warning letters and corrective action plans on the part of the distributor and on the part of the manufacturer and any applicable packaging and packing companies and that the distributor and manufacturer and any applicable packaging and packing companies are in good standing under applicable laws and regulations. If FDA warning letter and corrective action plans are non-applicable and the offeror is quoting as a manufacturer, the offeror must provide a statement on company letterhead that is signed and dated, that there are no applicable FDA warning letters and corrective action plans on the part of the manufacturer and any applicable packaging and packing companies and that the manufacturer and any applicable packaging and packing companies are in good standing under applicable laws and regulations. Offerors whose relevant facilities or products are the subject of an FDA warning letter may be deemed to be technically unacceptable in the Contracting Officer’s discretion, depending on the nature of the warning letter and whether corrective action has been taken by the offeror to address the violations contained in the warning letter, as evidenced by an FDA close-out or cure letter, or by submission of a corrective action plan. Offers that have an FDA Warning Letter may not be considered to be technically acceptable and may not be included in the competitive range, dependent on the nature of the Warning Letter and the Contracting Officer’s discretion. If there is an FDA Warning Letter and / or Corrective Action Plan, the aforementioned document

(s) shall be submitted in the past performance section, tab 3 of the offeror’s proposal.”

3. On page 75 of the solicitation under FAR 52.215-6 Place of Performance, language has changed from:

“Pursuant to the provision above, please review and provide the required information:

The U.S. Food and Drug Administration (FDA) is the Government agency responsible for providing and enforcing pharmaceutical current Good Manufacturing Practices (cGMP) standards for the pharmaceutical products included in this solicitation. Only offers from companies that have an acceptable cGMP status on record with the FDA for the facilities identified by the offeror in Paragraph 4 below will be considered for award. Before a contract can be awarded, any successful offeror’s (or its source’s) facilities shall have a current acceptable cGMP status with FDA.

1. If the products are to be manufactured at more than one location, each manufacturing facility and each facility address shall be listed along with the products manufactured at the facility. Subcontractors (i.e., packagers, labelers, etc.) that participate in the production of the products offered on this solicitation shall also be listed along with their addresses. All facilities described in this paragraph and listed below shall be in compliance with applicable FDA cGMP standards prior to contract award.”

To:

“Pursuant to the provision above, please review and provide the required information:

The U.S. Food and Drug Administration (FDA) is the Government agency responsible for providing and enforcing pharmaceutical current Good Manufacturing Practices (cGMP) standards for the pharmaceutical products included in this solicitation. The contracting officer may in their discretion consider offers from companies with open and unresolved cGMP compliance issues in an FDA warning letter. Before a contract can be awarded, the potential offeror shall submit evidence of current cGMP compliance status with the FDA, including applicable warning letters, corrective action plans, and any FDA close-out letters.

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1. If the products are to be manufactured at more than one location, each manufacturing facility and each facility address shall be listed along with the products manufactured at the facility. Subcontractors (i.e., packagers, labelers, etc.) that participate in the production of the products offered on this solicitation shall also be listed along with their addresses. Offerors whose relevant facilities or products are the subject of an FDA warning letter may be deemed to be technically unacceptable in the Contracting Officer’s discretion, depending on the nature of the warning letter and whether corrective action has been taken by the offeror to address the violations contained in the warning letter as evidenced by an FDA close-out or cure letter, or by submission of a corrective action plan.”

4. All other terms and conditions have remain unchanged.