36E79718R0024-00001000.docx

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 ITE

M 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 r eference 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

BY

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) 00001 04-02-2018

Department of Veterans Affairs OPAL / National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines IL 60141 To all Offerors/Bidders

36E79718R0024 04-02-2018

X X X Administrative Amendment to RFP 36E79718R0024

This Amendment is issued to delete clauses and replace with corrected clauses as attached.

Amendment is also issued to correct the header on Pages 6 through 73, should read "36E79718R0024 in lieu of

VA-797-06-RP-0010.

The offer due date re mains unchanged, all offers must be received on or before April 17, 2018, 2:30pm CT.

DELETE “CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES” on Pages 6 and 7 and replace with the following:

CONTINUATION OF STANDARD FORM 1449: SCHEDULE OF SUPPLIES/SERVICES

Please be advised the following are included in the solicitation and are highlighted here.

Proposals may be delivered to Department of Veterans Affairs, National Acquisition Center, National Contract Service (003B6C3), 1st Avenue, 1 Block North of Cermak Road, Building 37, Hines, IL 60141. Proposals will also be accepted in Microsoft Word or PDF form via e-mail at adrienne.albachiara@va.gov with a scanned (pdf) copy of the signed SF1449. Offerors are not required to submit an original proposal if an electronic proposal was received. Please note that faxed proposals are not acceptable and will be rejected. Reference FAR 52.212-1(f) regarding timeliness of submission of offers.

If the offeror is not the manufacturer of the offered items, the offeror shall submit a letter of commitment from the manufacturer to the offeror which will assure the offeror of a source of supply sufficient to satisfy the Government's requirements for the contract period. “Manufacturer” is defined as the entity that measures, mixes, weighs, and compounds the active and inactive ingredients into a capsule or tablet. This requirement shall be met before contract award. The offeror must maintain the same manufacturer (NDA/ANDA/BLA) for the duration of the contract period. Offers that fail to meet this requirement before contract award shall be rejected and shall receive no further consideration. (See Addendum 52.212-1 – Instruction to Offerors).

One award will be made in the aggregate for all line items for the base year, including all four option years. To be considered for award, offerors must propose a price for line items 1, 2, and 3a or 3b for the base year and each option year. Proposals that fail to include a price for the base year and each of the four option years for line item 1, 2, and 3a or 3b may be rejected and receive no further consideration.

(Refer to Schedule of Supplies for package size details and estimates)

Offered prices shall include a 0.50% Cost Recovery Fee (See Scope of Contract, paragraph 12).

The Government reserves the right not to award a contract on this solicitation should offered prices match or exceed current Federal Supply Schedule prices.

The Government will evaluate offers in accordance with the policies and procedures of the Federal Acquisition Regulation (FAR) Part 25. The Government will only consider offers of U.S.-made or designated country end products unless no offers for such products are received or insufficient to fulfill the requirements. If the Contracting Officer determines that there are no offers for such products sourced from countries that are Trade Agreement Act (TAA) compliant, then the Contracting Officer may determine to consider products not covered by the Trade Agreement Act (TAA) pursuant to FAR Part 25.

Acknowledgement of Amendments. The following amendments are acknowledged as part of this solicitation. (Please complete if applicable)

The System for Award Management (SAM) is an online system that replaces CCR/FedReg, ORCA, and EPLS. Contractors should now go to www.sam.gov to find their information. Training tools are available on the SAM website at www.sam.gov for familiarization with the SAM system. Prospective contractors shall maintain a current and accurate record in the SAM database. SAM updates are required, as necessary, but at least annually. (see 52.212-4(t) and 52.212-1(k)).

Subcontracting Plan Requirements: Pursuant to the requirements of Public Law 95-507, all large business concerns are required to have an approved subcontracting plan for contracts valued over $700,000 before the Government can award a contract (see FAR 52.219-9 for details). Offerors must submit a currently approved commercial plan or a new plan for review and approval. Attachment “D” includes all of the elements required to be addressed and is included to facilitate the submission of a subcontracting plan.

As prescribed in FAR Part 42.15, the VA evaluates contractor performance on all contracts that exceed $150,000, and shares those evaluations with other federal government agencies. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement, VA will be using an online database, the Contractor Performance Assessment Reporting System (CPARS). Annual reporting of past performance will be completed at http://www.cpars.gov and uploaded to PPIRS (Past Performance Information Retrieval System).

DELETE “1.3 Government Purchase Compliance.” on Page 8 and replace with the following:

1.3 Government Purchase Compliance. VA, FHCC, SVH (Option 2), DOD, IHS, and BOP will purchase their requirements for the strengths of the drugs listed in the schedule through the PPV Programs except when: (1) the contracted items is/are unavailable to meet the needs of the Government, or (2) an alternate is requested by the prescribing healthcare provider. Additionally, IHS will not participate if the awardee does not have a Centers of Medicare or Medicaid (CMS) reimbursable product(s). In the event that either 1, 2, or 3 applies, these instances will be considered exceptions to section C.4 – 52.216-21, Requirements. VA’s PPV contract has ordering lock-out procedures in place to support VA contract compliance and to prevent purchases of non-contract products. Participants of the VA PPV Program include VA, FHCC, SVH (Option 2), IHS, and BOP. DOD manages compliance through individual facility tracking reports.

DELETE “7. THERAPEUTIC EQUIVALENCE” on Page 11 and replace with the following:

7. THERAPEUTIC EQUIVALENCE

To be considered, the offered product must have received a therapeutic equivalence code of “A” by the Food and Drug Administration, in accordance with the Federal Food, Drug, and Cosmetic Act. In that case, no award will be made other than to the innovator unless the non-innovator vendor submits acceptable data demonstrating bioequivalence.

DELETE “11) NOTICE TO DEALERS AND SUPPLIERS” on Pages 52 and 53 and replace with the following:

11) NOTICE TO DEALERS AND SUPPLIERS

(a) If the offeror is not the manufacturer of the offered items, the offeror shall submit: A letter of commitment from the manufacturer to the offeror which will assure the offeror of a source of supply sufficient to satisfy the Government's requirements for the contract period. “Manufacturer” is defined as the entity that measures, mixes, weighs, and compounds the active and inactive ingredients into a capsule or tablet. If the offeror and its manufacturer are affiliates, the letter of commitment or evidence as required herein is required of the manufacturing facility, regardless of the relationship with the offeror. The offeror must maintain the same manufacturer (NDA/ANDA/BLA) for the duration of the contract period. Manufacturers must also certify whether or not the end product offered in response to this solicitation is TAA compliant. Offers that fail to meet this requirement before contract award shall be rejected and shall receive no further consideration.

In addition to identifying Country of Origin for the end product offered under this solicitation in accordance with contract clause 52.212-3 Offeror Representation and Certifications, the offeror shall also identify the Country of Origin for all active pharmaceutical ingredients (APIs). Offerors shall certify whether the offered end product meets one of the definitions in FAR 52.225-5 of either “U.S.-made end product” or “Designated country end product.”

The Government will evaluate offers in accordance with the policies and procedures of the Federal Acquisition Regulation (FAR) Part 25. The Government will only consider offers of U.S.-made or designated country end products unless no offers for such products are received or are insufficient to fulfill the requirements.

(b) To be considered acceptable, the letter of commitment:

1. Shall be on the manufacturer’s letterhead.

1. Shall be dated.

1. Shall reference the solicitation number and the product committed to the manufacture.

1. Shall state that the manufacturer assures the offeror of an uninterrupted source of supply sufficient to satisfy the Government’s requirements for the contract period, and that the manufacturer is currently manufacturing the product.

1. Manufacturer shall state whether or not the end product is TAA compliant and disclose the country of origin of the API and the final country of the end product.

1. Shall be signed by an officer of the manufacturer’s company (include printed name, title and telephone number).

DELETE “E.2 52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (JUL 2016)” on Pages 53 and 54 and replace with the following:

E.2 52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE REPORTING (JUL 2016)

(a) Definition. As used in this provision – Commercial and Government Entity (CAGE) code” means–

(1) An identifier assigned to entities located in the United States or its outlying areas by the Defense Logistics Agency (DLA) Commercial and Government Entity (CAGE) Branch to identify a commercial or government entity; or

(2) An identifier assigned by a member of the North Atlantic Treaty Organization (NATO) or by the NATO Support and Procurement Agency (NSPA) to entities located outside the United States and its outlying areas that the DLA Commercial and Government Entity (CAGE) Branch records and maintains in the CAGE master file. This type of code is known as a NATO CAGE (NCAGE) code.

(b) The Offeror shall enter its CAGE code in its offer with its name and address or otherwise include it prominently in its proposal. The CAGE code entered must be for that name and address. Enter “CAGE” before the number. The CAGE code is required prior to award.

(c) CAGE codes may be obtained via–

(1) Registration in the System for Award Management (SAM) at www.sam.gov. If the Offeror is located in the United States or its outlying areas and does not already have a CAGE code assigned, the DLA Commercial and Government Entity (CAGE) Branch will assign a CAGE code as a part of the SAM registration process. SAM registrants located outside the United States and its outlying areas shall obtain a NCAGE code prior to registration in SAM (see paragraph (c)(3) of this provision).

(2) The DLA Contractor and Government Entity (CAGE) Branch. If registration in SAM is not required for the subject procurement, and the offeror does not otherwise register in SAM, an offeror located in the United States or its outlying areas may request that a CAGE code be assigned by submitting a request at https://cage.dla.mil.

(3) The appropriate country codification bureau. Entities located outside the United States and its outlying areas may obtain an NCAGE code by contacting the Codification Bureau in the foreign entity’s country if that country is a member of NATO or a sponsored nation. NCAGE codes may be obtained from the NSPA at https://eportal.nspa.nato.int/AC135Public/scage/CageList.aspx if the foreign entity’s country is not a member of NATO or a sponsored nation. Points of contact for codification bureaus, as well as additional information on obtaining NCAGE codes, are available at http://www.nato.int/structur/AC/135/main/links/contacts.htm.

(d) Additional guidance for establishing and maintaining CAGE codes is available at https://cage.dla.mil.

(e) When a CAGE Code is required for the immediate owner and/or the highest-level owner by 52.204-17 or 52.212-3(p), the Offeror shall obtain the respective CAGE Code from that entity to supply the CAGE Code to the Government.

(f) Do not delay submission of the offer pending receipt of a CAGE code.

DELETE “E.10 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (JAN 1998)” on Pages 56 and 57 and replace with the following:

E.10 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (JAN 1998)

As an alternative to filing a protest with the contracting officer, an interested party may file a protest with the Deputy Assistant Secretary for Acquisition and Materiel Management, Acquisition Administration Team, Department of Veterans Affairs, 810 Vermont Avenue, NW., Washington, DC 20420, or for solicitations issued by the Office of Construction and Facilities Management, the Director, Office of Construction and Facilities Management, 810 Vermont Avenue, NW., Washington, DC 20420. The protest will not be considered if the interested party has a protest on the same or similar issues pending with the contracting officer.

PLEASE NOTE: The correct mailing information for filing alternate protests is as follows: Deputy Assistant Secretary for Acquisition and Logistics, Risk Management Team, Department of Veterans Affairs, 810 Vermont Avenue, NW, Washington, DC 20420 or for solicitations issued by the Office of Construction and Facilities Management, Director, Office of Contruction and Facilities Management, 811 Vermont Avenue, NW, Washington, DC 20420.