M5-Q50A-03-R8 01_SolicitationDocument_65IB_R8_6.21.2018.docx

01 - SOLICITATION DOCUMENT

THIS DOCUMENT CONTAINS CLAUSES,

PROVISIONS, AND INSTRUCTIONS PERTINENT

TO THIS SOLICITATION.

READ THIS DOCUMENT IN ITS ENTIRETY.

DO NOT RETURN THIS DOCUMENT

WITH YOUR OFFER.

01 – Solicitation Document M5-Q50A-03-R8

CP-20

NOTICE CONCERNING SOLICITATION

P.O. BOX 76, Bldg. 37 1st Avenue, 1 Block North of Cermak

HINES, IL 60141

CP-FSS-1-C (MAY 2000) Standing Solicitation No. M5-Q50A-03-R8 (Refreshed 06/21/2018)

WORLDWIDE FEDERAL SUPPLY SCHEDULE CONTRACT

FOR

FSC GROUP 65, PART I, SECTION B

COMMODITY: DRUGS, PHARMACEUTICALS & HEMATOLOGY RELATED PRODUCTS

FSC CLASS(ES) PRODUCT CODE(S):

6505 – DRUGS AND BIOLOGICALS 6508 – MEDICATED COSMETICS AND TOILETRIES

ANY INFORMATION THAT MAY BE DESIRED ON THIS PARTICULAR SOLICITATION CAN BE OBTAINED FROM THE ISSUING OFFICE ADDRESS SHOWN HEREIN.

TABLE OF CONTENTS

READ ME FIRST

Important Criteria to Consider:

ADDITIONAL COVER PAGES

Part I – TERMS AND CONDITIONS APPLICABLE TO GOODS AND SERVICES

Part II – CONTRACT TERMS AND CONDITIONS_________________________ 52.212-4 Contract Terms and Conditions – Commercial Items (Jan 2017) (Tailored) 3 Clauses for Addendum 52.212-4:

552.212-71 Contract Terms and Conditions Applicable to GSA Acquisition of

552.216-70 Economic Price Adjustment—FSS Multiple Award Schedule Contracts

CI-FSS-056 Federal Acquisition Regulation (FAR) Part 51 Deviation Authority (Federal

52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders – Commercial Items (Jan 2018) 41 Part III – VENDOR INSTRUCTIONS_________________________________ 52.212-1 Instructions to Offerors -- Commercial Items (Jan 2017) 47 Provisions for Addendum 52.212-1:

52.215-20 Requirements for Certified Cost or Pricing Data and Data Other Than

Part IV – EVALUATION FACTORS FOR CONTRACT AWARD________________ 552.212-73 Evaluation—Commercial Items (Multiple Award Schedule) (Aug 1997) 59 Part V – OFFEROR REPRESENTATIONS & CERTIFICATION________________ 52.212-3 Offeror Representations and Certifications --Commercial Items (Nov 2017) 59

ADDENDUM: REGULATIONS INCORPORATED BY REFERENCE

INCORPORATED UNDER 52.212-4:

52.202-1 Definitions (Nov 2013) 74

INCORPORATED UNDER 52.212-5:

52.232-34 Payment by Electronic Funds Transfer - Other Than System for Award Management

INCORPORATED UNDER 552.212-71:

552.238-71 Submission and Distribution of Authorized FSS Schedule Pricelists (Jul 2016) (Tailored) 125

INCORPORATED UNDER 552.212-72:

READ ME FIRST

DOING BUSINESS WITH VA

The Department of Veterans Affairs operates a nationwide system of hospitals, clinics, Veterans Integrated Service Networks (VISN), data processing centers, and National Cemeteries, all of which require a broad spectrum of goods and services. These goods and services are purchased on a national, regional, and local level – so no matter how large or small your business, VA is a potential customer. The VA Federal Supply Schedule (FSS) Program establishes long-term governmentwide contracts that allow VA and other government agencies to acquire a vast array of medical equipment and supplies directly from commercial suppliers.

IS A VA FSS CONTRACT RIGHT FOR YOU?

VA awards contracts to responsible companies offering commercial items at fair and reasonable prices. Contracting Officers determine whether prices are fair and reasonable by comparing the prices/discounts that a company offers the government with the prices/discounts offered to commercial customers; this practice is commonly known as “most favored customer” pricing. In order to make this comparison, VA requires offerors to furnish commercial pricelists and disclose information regarding their commercial pricing/discounting practices.

DO YOU QUALIFY FOR A VA FSS CONTRACT?

To qualify for a VA FSS contract you should:

1. Be able to demonstrate that your firm is responsible.

2. Complete the GSA “Pathway to Success” education seminar. Submit a copy of the certificate of completion with your proposal. Please note that this is only required for new offerors without an existing FSS contract.

3. Meet all the requirements of the solicitation.

4. Be able to fulfill all contract obligations outlined in the solicitation.

Contact the VA FSS Help Desk to discuss your firm’s eligibility!

IMPORTANT CRITERIA TO CONSIDER

Assess Your Competition It is recommended that you identify and assess your competition prior to submitting a proposal. This task can be completed by reviewing the Contract Catalog Search Tool, GSA eLibrary or GSA Advantage. These websites contain information regarding the supplies and services that current VA FSS contractors already offer. Your review of the competition should include: competitor’s pricing, delivery times, warranty terms, services, and any other elements that make their offering distinct when compared to your own.

Best Value Determination Schedule buyers award task/delivery orders to FSS contractors based upon a “best value” determination. In FAR 2.101, best value is defined as the “expected outcome of an acquisition that, in the Government’s estimation, provides the greatest overall benefit in response to the requirement.”

Factors that may be considered when making a best value determination include (but are not limited to):

· Price

· Special features of the service or supply required for effective performance

· Past performance records

· Quality of the proposed solutions and cost differences

· Trade-in considerations

· Warranty

· Delivery terms

· Expertise of the offeror

· Socioeconomic status Minimum Sales Criteria VA expects all FSS contractors to exceed $25,000 in sales within the first two years after contract award and $25,000 each succeeding year in order to retain your VA FSS contract. You should consider the difficulty you may have in meeting this performance requirement if your company is newly established or has low sales of the services/supplies you want to offer to the Government. If you decide to submit an offer under the VA FSS program, it is suggested that you draft a business plan covering how you intend to meet this performance requirement.

GETTING ON SCHEDULE

Once you’ve determined that a VA FSS contract is in your company’s best interest you will need to submit an offer for contract award. While not all firms are awarded VA FSS contracts, the VA FSS program is open to all responsible offerors. To be considered for contract award, you must demonstrate that your firm is responsible and is able to meet all Schedule program requirements, including price reasonableness. By following the best practices and understanding the review and award processes discussed in this document, vendors will be well equipped to submit a quality offer and negotiate to receive a Schedule contract.

Prior to submitting a proposal, interested companies should:

1. Choose the Schedule program that best aligns to the supplies and/or services your company wants to offer. Select the appropriate solicitation number to be linked directly to the solicitation files. Download the solicitation, including all corresponding documents, and follow the instructions for completion.

2. Read the entire Schedule solicitation thoroughly and respond to all requirements.

3. Make sure all offered line items fall within the scope of the Schedule solicitation.

4. Make sure the company is financially sound.

5. Be ready to negotiate the company’s best offer.

Other helpful hints:

(1) Obtain a Data Universal Numbering System (DUNS) Number, also known as the unique entity identifier.

(2) Register in the System for Acquisition Management (SAM) database. Vendors must be registered in SAM prior to the award of the Schedule contract (see FAR 52.212-4(t)). Contractors that complete electronic annual representations and certifications via the SAM website must update as necessary, but at least annually, to ensure they are kept current, accurate, and complete.

(3) Submit all required documents including Manufacturer Letter of Supply and proof of insurance as required.

BEST PRACTICES

Key Elements of a Successful Offer:

Ensuring these key elements are included in your proposal may expedite the review and award process:

· Scope – Are the supplies/services within the scope of the Schedule? See the Scope of Solicitation section in the Vendor Response Document 02.

· Past Performance – Does your firm meet its commitments and responsibilities?

· Financial Capability – Is your firm financially sound?

· Pricing – Is your proposed pricing competitive with current market conditions?

· Subcontracting Plan – Required if your firm is considered “other than a small business” and if the estimated value of the contract exceeds $700,000 (including all option periods).

· Other Regulatory Compliance – Is your firm debarred? Are all registration requirements complete? See the Compliance Requirements web page for a complete list of all required registrations.

Your regional Procurement Technical Assistance Center (PTAC) offers a wide range of assistance (most free of charge) through one-on-one counseling, classes, seminars, and matchmaking events. Contact your local PTAC for help in

· Determining your firm’s suitability for contracting

· Proposal preparation

· Securing necessary registrations and socioeconomic registrations

· Researching procurement histories

· Networking

· Identifying bid opportunities

· Contract performance issues

· Preparing for audit

PROPOSAL REVIEW & AWARD PROCESS

Review & Award Process

The goal of this review process is to ensure the vendor is responsible, the Government is receiving a fair and reasonable price, and that any potential contract award is in the best interest of the Government.

Process Time In general, proposals will be reviewed and, if applicable, awarded within six (6) months from the time they are assigned to a Contract Specialist. To further discuss the review process, please contact your assigned contract specialist or the FSS Help Desk. Well prepared offers with competitive pricing are easier to evaluate and, therefore, may expedite the award process. The offer process time can vary depending on:

· The timeliness of your responses to requests for clarification or additional information

· The quality and completeness of the proposal and subsequent clarification responses

· Complexity of the proposal, including number of line items offered

· Quality assurance reviews

TRAINING

Required Training New offerors without an existing FSS contract must successfully complete GSA’s Pathway to Success at GSA’s Vendor Education Center and include a copy of the certificate with their proposal. This seminar is designed to assist prospective Schedule contractors in making an informed business decision as to whether obtaining a GSA Schedule contract is in their best interests.

Please note that the individual whose name appears on the course completion certificate must be an officer of the company and also be designated as an authorized negotiator. This designation is made at K-FSS-1 Authorized Negotiators, located in the Vendor Response section of Document 02. The course must be completed within one year of the date of your proposal (the date listed on the SF 1449).

Recommended Training The VA FSS Service offers extensive training presentations on our VA FSS Training web page. Under our “Webinars” section, you will find presentations outlining the steps involved in getting a VA Schedule contract. These presentations describe:

· How to submit an offer

· How to effectively negotiate your offer

· The post-award contract administration process and reporting requirements

· FSS electronic tools Please utilize the two solicitation guides found in the “Solicitation Assistance” section of our VA FSS Training page. These guides will provide step-by-step instructions for completing the Vendor Response and Commercial Sales Practices sections of the solicitation and will assist you with submitting a more accurately prepared proposal.

Additionally, the FSS Training page offers best practice tip sheets offering information on the various aspects of the VA Schedules program.

GSA offers numerous in-person and virtual training sessions that provide attendees with an in-depth understanding of acquisition vehicles and policies. Visit the GSA Interact Training page as well as GSA’s YouTube channel and Schedule podcast offerings! Additional training is offered by the GSA Vendor Support Center.

Additional Information While VA provides its Government customers with training in “Using VA Schedules,” including information on the benefits of the Schedules Program, VA does not promote the use of any company’s specific Schedule contract. Vendors should be aware that obtaining a VA Schedule contract is not a guarantee of sales. Vendors awarded a VA Schedule contract will need to market their supplies and services to Government customers as they would to commercial customers.

Contact Us Contact the FSS Help Desk for additional information on submitting a proposal or on the VA FSS review and award process!

ADDITIONAL COVER PAGES

ATTENTION!

Offerors are hereby advised to read the entire solicitation document and retain a copy for your records. Offerors will be held accountable and responsible for complying with all of the provisions and clauses located within solicitation Documents 01, 02, and 04. As set forth under the solicitation checklist (see Vendor Response Document 02), offerors need only submit completed applicable sections and supporting documentation. However, all clauses will be incorporated into the contract award with full force and effect. We do not accept hard copy offers; all offers must be submitted electronically. Please consult our Electronic Acceptance of FSS Offers/Proposals web page for more information.

CP-FSS-2 SIGNIFICANT CHANGES (OCT 1988)

The attention of the offeror is invited to the following changes made since the issuance of the last solicitation for supplies/services covered herein:

(1) Regulations / Special Language Changes - Additions, deletions, updates, and revisions since the previous solicitation (M5-Q50A-03-R7), issued February 2014, and its subsequent amendments.

Removed:

52.203-11 Certification and Disclosure Regarding Payments to Influence Certain Federal Transactions (Sep 2007) 52.203-12 Limitation on Payments to Influence Certain Federal Transactions (Oct 2010) 52.203-15 Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (Jun 2010) 52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law (Feb 2016) 52.212-5 Contract Terms & Conditions Required to Implement Statutes or Executive Orders - Commercial Items (Alternate II – Oct 2015) 52.222-1 Notice to the Government of Labor Disputes (Feb 1997) 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) 552.238-76 Definition (Federal Supply Schedules) - Recovery Purchasing (Feb 2007) 552.238-80 Use of Federal Supply Schedule Contracts by Certain Entities - Recovery Purchasing (Feb 2007) 852.203-71 Display of Department of Veterans Affairs Hotline Poster (Dec 1992) 852.219-71 VA Mentor-Protégé Program (Dec 2009) AS1508 Option to Extend the Term of the Contract (Mar 2005) CP-FSS-4-A Solicitation Copies (Mar 1996, Tailored) ACH Form American Recovery and Reinvestment Act Program Participation Supplemental Commercial Sales Practices Added:

52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) 52.204-21 Basic Safeguarding of Covered Contractor Information Systems (Jun 2016) 52.204-22 Alternative Line Item Proposal (Jan 2017) 52.207-6 Solicitation of Offers from Small Business Concerns and Small Business Teaming Arrangements or Joint Ventures (Multiple-Award Contracts) (Oct 2016) 52.217-9 Option to Extend the Term of the Contract (Mar 2000) 52.223-20 Aerosols (Jun 2016) 52.223-21 Foams (Jun 2016) 52.224-3 Privacy Training (Jan 2017) 52.232-23 Assignment of Claims (May 2014) 52.242-5 Payments to Small Business Subcontractors (Jan 2017) 52.246-2 Inspection of Supplies – Fixed Price (Aug 1996) 552.238-79 Use of Federal Supply Schedule Contracts by Non-Federal Entities (Jul 2016) Alternate Contact for Contract Administration (Aug 2017) Ordering Contact (Mar 2018) Scope of Solicitation Warranty and Return Goods Policy (Aug 2017) Updated/Revised:

52.204-7 System for Award Management (Oct 2016) 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) 52.204-13 System for Award Management Maintenance (Oct 2016) 52.204-16 Commercial and Government Entity Code Reporting (Jul 2016) 52.204-18 Commercial and Government Entity Code Maintenance (Jul 2016) 52.212-1 Instructions to Offerors - Commercial Items (Jan 2017) 52.212-3 Offeror Representations and Certifications - Commercial Items (Nov 2017) 52.212-4 Contract Terms and Conditions - Commercial Items (Jan 2017) (Tailored) 52.212-5 Contract Terms & Conditions Required to Implement Statutes or Exec. Orders - Commercial Items (Jan 2018) 52.216-22 Indefinite Quantity (Oct 1995) 52.219-8 Utilization of Small Business Concerns (Nov 2016) 52.219-9 Small Business Subcontracting Plan (Jan 2017, Alternate II – Nov 2016) 52.219-14 Limitations on Subcontracting (Jan 2017) 52.222-19 Child Labor - Cooperation with Authorities and Remedies (Oct 2016) 52.222-26 Equal Opportunity (Sep 2016) 52.223-11 Ozone-Depleting Substances and High Potential Hydrofluorocarbons (Jun 2016) 52.225-5 Trade Agreements (Oct 2016) 552.211-78 Commercial Delivery Schedule (Multiple Award Schedule) (Feb 1996, Tailored, Notes) 552.211-89 Non-Manufactured Wood Package Material For Export (Jul 2016) 552.212-71 Contract Terms and Conditions Applicable to GSA Acquisition of Commercial Items (Jun 2016) 552.219-71 Notice to Offerors of Subcontracting Plan Requirements (Oct 2016, Tailored) 552.219-72 Preparation, Submission, and Negotiation of Subcontracting Plans (Oct 2016, Tailored) 552.238-71 Submission and Distribution of Authorized FSS Schedule Pricelists (Jul 2016, Tailored) 552.238-74 Industrial Funding Fee and Sales Reporting (Jan 2016, Tailored) 552.238-75 Price Reductions (Jul 2016) 552.238-78 Scope of Contract (Eligible Ordering Activities) (Jul 2016, Tailored) 552.238-81 Modification (Federal Supply Schedule) (Apr 2015, Alt I - Jun 2016, Tailored) A-FSS-11 Consideration of Offers under Standing Solicitation (Jan 2016, Tailored) AS212 Generic Item Modifications (Jun 2018) CP-FSS-2 Significant Changes (Oct 1988) CP-FSS-3 Notice: Requests for Explanation or Information (Mar 1996) CSP-1 (Tailored, Notes – Aug 2017) F-FSS-202-G Delivery Prices (Jan 1994, Note) G-FSS-900-C Contact for Contract Administration (Jul 2003, Tailored) I-FSS-600 Contract Price Lists (Oct 2016, Tailored) I-FSS-644 Dealers and Suppliers (Oct 1988, Notes – Mar 2018) Additional Discounts / Concessions Offered to the Government Agent Authorization (Mar 2018) Business Size Determination & NAICS Code Designation (Aug 2017) Compliance Confirmation (Apr 2018) Continuation of SF1449 Direct-To-Patient Distribution Program Participation (Apr 2018) eOffer (Mar 2018) Instructions for Pre-Award Review Process (Aug 2017) Minimum Acceptable Order Proposal (Aug 2016) Pricelist Proposal Preparation (Doc 03 Excel Spreadsheet) Proposed Pricing – Required Format

SF1449

Signatory Authority (Aug 2017) Small Business Subcontracting Plan (Aug 2017) Utilization of Dealers/Distributors (Aug 2017)

(2) Scope of Solicitation – Please see our new Scope of Solicitation located in Vendor Response Document 02 after the Continuation of SF1449.

(3) Electronic Acceptance of Offers (March 2018) - Beginning on January 1, 2015, VA FSS ceased accepting paper offers and began the acceptance of electronic offers/proposals. Any paper offers will be returned without consideration. The following protocol must be followed to avoid the return of your offer.

· File Format

· Fill-in documents may be submitted as Word or pdf documents. However, documents requiring a wet signature must be submitted separately in a pdf format if the offeror chooses to submit the fill-in documents in Word.

· Excel files should be submitted in their original Excel format.

· EMail Address: All potential contractors are required to submit an FSS offer electronically to vafssoffers@va.gov.

· eMail Subject Line: Identify in the subject line FSS-Offer-Schedule ID-Company Name.

· eMail Attachments: We can no longer accept zip files which may require you to submit your offer files in multiple e-mails. It is essential that you identify the number of emails you are sending in the subject line to ensure that we receive your entire offer.

EXAMPLE: FSS-Offer-Schedule ID-Company Name-1 of # (FSS-Offer 65IIA-ABC Medical – 1 of 4)

· CD-ROM: CD-ROM will only be accepted if your proposal is so large that it can’t be compressed and it is unmanageable to send multiple emails. Any offer where the Document 03 - Proposed Price List exceeds 5MB shall be submitted on CD in its entirety. Submission of offers on thumb drives is prohibited and will be rejected and returned.

· Documents Requiring Signature: Documents requiring signature include, but are not limited to, SF-1449, Signatory Authority, FMS Vendor File Request Form 10091, letters of supply, etc. Please note that the Signatory Authority Form and SF1449 signature date must be no later than 10 calendar days from submission of the proposal via the eOffer e-mail process. Failure to comply with this date restriction will result in your proposal being returned to you without further consideration. Please also note that we cannot accept digital/electronic signatures at this time, including .jpeg or other picture formats of signatures inserted into the document. Please apply a wet signature and submit a pdf copy of the signed document.

(4) 508 Compliance Section 508 of the Rehabilitation Act of 1973, as amended in 1998, requires Federal agencies to make their electronic and information technology (EIT) accessible to people with disabilities. With the requirement to submit all VA FSS offers electronically, effective January 1, 2015, you must ensure that all of the documents (e.g. Microsoft word documents, pdf documents, Excel files, etc.) you submit as part of your proposal are 508 compliant. A guide to 508 compliance for electronic documents is found on the Section508.gov website at https://www.section508.gov/content/build/create-accessible-documents. This guide provides information on formatting and testing and includes helpful checklists. You can find further information on Section 508 standards at https://www.section508.gov/content/learn/standards. This standards web page also includes a Quick Reference Guide to Section 508.

(5) Financial Services Center (FSC) Mandatory Electronic Invoice Submission Program The Department of Veterans Affairs published a final rule in the Federal Register on November 27, 2012 (https://federalregister.gov/a/2012-28612), to require contractors to submit payment requests in electronic form in order to enhance customer service, departmental productivity, and adoption of innovative information technology, including the appropriate use of commercial best practices. The rule was effective December 27, 2012, and will apply only to orders placed by VA ordering activities.

Benefits of e-Invoicing Electronic invoicing offers simple and secure solutions, complying with HIPAA, to eliminate the cost and time of processing paper invoices. The benefits of e-Invoicing include:

· Delivery of invoices directly into the FSC payment system and routed nationally for approval

· Elimination of mail processing time, postage, and invoice receipt inquires

· Elimination of data error and lost or misplaced invoices

· Verification of invoice receipt or rejection through automated notification reports

· No installation of hardware or software required VA’s Electronic Invoice Presentment and Payment System The FSC uses a third-party contractor, Tungsten, to transition vendors from paper to electronic invoice submission, a free invoice submission process. The Tungsten system conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site is found at http://www.x12.org.

Vendor e-Invoice Set-Up Information While most VA Vendors already use Tungsten, new vendors can contact Tungsten at the phone number or email addressbelow to begin submitting their electronic invoices to the VA Financial Services Center for payment processing, free of charge. If they have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below:

· Tungsten e-Invoice Setup Information: 1-877-489-6135

· Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

· FSC e-Invoice Contact Information: 1-877-353-9791

· FSC e-invoice email: vafsccshd@va.gov Additional Information:

http://www.tungsten-network.com/VeteransAffairs/ http://www.fsc.va.gov/FSC/FSC/Tungsten_Support_Videos_Ref_2014.pdf

(6) Prime Vendor Sales: Sales of items awarded under an FSS contract and sold to a Government prime vendor that are ultimately shipped to a Federal Government activity qualify as FSS sales; therefore, these sales (except those ordered under a Department of Defense Distribution and Pricing Agreement) must be reported as FSS sales and the IFF collected and remitted.

(7) Trade Agreements Act – Non-Availability Determination - Special Item Number (SIN) 42-2A product items that are not substantially transformed in the U.S. or a designated country under 52.225-5 Trade Agreements must be included in the offeror’s proposal to obtain a Federal Supply Schedule 65IB contract and listed as other end products as required by 52.212-3(g)(5)(ii). In accordance with Federal Acquisition Regulation 25.403(c) & 25.103(b)(2), the decision has been made that the Contracting Officer may make an individual non-availability determination pursuant to 1) information provided by the offeror that neither the offered 42-2A product items nor similar or like items are mined, produced, or manufactured in the United States or a designated country in sufficient quantity to fulfill the requirements, and 2) in light of the requirement set forth in 38 U.S.C. Section 8126(a)(1) that manufacturers shall make available for procurement on the Federal Supply Schedule of the General Services Administration each covered drug of the manufacturer.

CP-FSS-3 NOTICE: REQUESTS FOR EXPLANATION OR INFORMATION (MAR 1996)

Oral or written requests for explanation or information regarding this solicitation should be directed to:

Dept. of Veterans Affairs, National Acquisition Center (003B6B) P.O. Box 76 1st Avenue, 1 Block North of Cermak Rd., Bldg. 37 Hines, IL 60141 Phone: FSS Helpdesk (708) 786-7737 E-mail: FSS Helpdesk helpdesk.ammhinFSS@va.gov

CP-FSS-19 PRICING (DEC 1998) FSS A/L FC-98-2

Offerors are advised that separate pricing may be submitted for different countries if separate pricing is consistent with the offeror’s commercial sales practice.

INSTRUCTIONS FOR PRE-AWARD REVIEW PROCESS (AUG 2017)

All offers may be subject to a pre-award review at the discretion of the Contracting Officer (CO). A pre-award review will be requested from the Office of Contract Review (OCR) within the Department of Veterans Affairs’ Office of Inspector General for all offers with an estimated contract value (for a 10-year contract period) that exceeds $3,000,000 per year for a total of $30,000,000 for the base contract period plus the 5-year option period.

The purpose of performing a pre-award review is to assist the CO in making a determination as to the reasonableness of the offer. This is accomplished by reviewing the contractor’s proposal and additional documents to: (i) determine if the proposal and the supporting data are accurate, complete, and current; (ii) verify the contractor is offering the government most favored commercial customer (MFC) discounts; (iii) verify the validity of disclosed information relating to rebates, incentive programs, and other concessions: and, (iv) address other issues as deemed necessary by the CO or OCR. To help facilitate the process, the CO will notify the Offeror of those proposals forwarded to OCR for a pre-award review. OCR will contact the Offeror and issue a Request for Information for those reviews accepted by OCR. The Offeror is expected to provide the requested data and documents to OCR within 15 business days. Delays in receiving this information will delay the pre-award review process and could ultimately delay the negotiations and award of a contract under this solicitation.

Request for Electronic Data To respond to a pre-award review, you will be required to submit certain data, including sales transaction data. The sales transaction should include all products sold to all customers for the 6-month (minimum) period as determined by OCR. The transactions will include all transactions for FSS customers and non-FSS customers. This data must reconcile to your financial accounting records. The data should include all direct and indirect sales, if applicable. The direct and indirect sales can be provided in separate data tables. Although not required, it will expedite the process, if all data tables use the same record layout leaving fields that do not apply blank.

Please provide a record layout for the data describing field position, length, format (e.g. numeric, number of decimals, alpha, etc.) and a descriptive field name. We will need complete descriptions of all codes used in the data. Below is a sample record layout which describes the types of information needed in the electronic data. After reviewing this information, OCR suggests a discussion take place regarding the specifics of your data prior to extracting the data for the review.

Acceptable media/methods: CD-ROM, DVD, Internet Download; E-Mail (PGP Encryption available) Acceptable formats: ASCII Text (fixed width or delimited); Excel Sample Record Layout:

METRIC SYSTEM OF MEASUREMENT

Section 5164 of the Omnibus Trade and Competitiveness Act of 1988 (Public Law 100-418) designates the metric system of measurement as the preferred system of weights and measures for United States trade and commerce. It requires that each Federal agency use the metric system of measurement in its procurements, grants and other business-related activities. Offerors are advised that the use of the metric system of measurement is highly encouraged and that offers should be provided utilizing the metric system of measurement.

Offerors are also advised that, at the ordering activity level or as a result of a standardization effort, they may be required to submit all units of measure for products offered utilizing the metric system of measurement, or they may be required to identify the conversion on a separate document.

GENERAL INFORMATION

· Please note that new offerors with “covered drugs” under Public Law 102-585 should submit their Master Agreements (MA) and Pharmaceutical Pricing Agreement (PPA) (see Document 02 – Vendor Response) prior to submitting their offer.

· Please pay particular attention to all italicized, bolded notes. Several clauses have been limited in application to direct delivery orders or have been adapted to fit with the operations of the Government Pharmaceutical Prime Vendor (PPV) program and the requirements of Public law 102-585.

· Public Law 102-585, Section 603 - “Covered drug” manufacturers: Please note that you are required to contact your Contracting Officer to notify the VA of any transfer of ownership or of sole distribution rights of a covered drug to another company. This will allow the VA to ensure compliance with Public Law and to ensure that the current contractor’s liability will be limited.

· Please note that if you are a dealer/distributor, you are required to have your own unique labeler code to participate in the VA Pharmaceutical Prime Vendor (PPV) program. In addition, a commitment letter is required from the manufacturer (see clause I-FSS-644 Dealers and Suppliers in Document 02 – Vendor Response).

CP-19

PART I – TERMS AND CONDITIONS APPLICABLE TO GOODS AND SERVICES

CONTINUATION OF SF-1449 BLOCKS 19-21, SCHEDULE OF ITEMS

See Continuation of SF-1449 Blocks 19-21, Schedule of Items in Document 02 - Vendor Response.

NATIONAL DRUG CODES (JUN 2005)

NOTE: May not be applicable to SINs 42-1, 42-3, 42-5 and 622.

Offeror is required to enter the National Drug Code following each item pursuant to the instructions of the Commercial Sales Practices (CSP) section of this solicitation. If an NDC has not been assigned, then the offeror should so state. The shipping container shall be marked with the NDC, if available.

BAR CODING (MAY 2012)

All pharmaceutical products provided under this contract shall include bar code labeling at the unit-of-use package level. The bar code labeling must be in a linear format that conforms to all GS1-128 (formerly EAN.UCC) or Health Industry Business Communication Council (HIBCC) Health Industry Bar Code (HIBC) supplier labeling standards. The bar code symbology must comply with all GSI or HIBCC parameters including, but not limited to: symbology type or encoded pattern, bar and space dimensions and tolerances, and allowable ratio of wide to narrow elements.

The bar code may be any linear bar code symbology such as GS1-128 (formerly EAN.UCC), GS1 DataBar (formerly RSS), or Universal Product Code (if the UPC contains the National Drug Code or NDC). The bar code must encode the NDC, either alone or within the GS1 data structure (Global Trade Item Number (GTIN)).

The bar code printing must be American National Standards Institute (ANSI)/International Organization for Standardization (ISO)/IEC Quality Grade C or better. Manufacturers and packagers must ensure that production runs include an initial verification check, as well as routine audits to ensure the bar code is printed clearly and consistently to meet the quality standard of Grade C or better. Contractors shall be responsible for ensuring that bar code labels meet the quality requirements specified in this clause prior to shipping pharmaceutical products to any Government Prime Vendor or authorized ordering activity under this contract.

The bar code must be on the outside container or wrapper of the medication as well as on the immediate container, unless the bar code is readily visible and machine-readable through the outside container or wrapper. When the bar code is not easily machine-readable through the over wrap, the over wrap should contain the bar code.

The bar code must go on each cell of a blister pack. Furthermore, the bar code must remain intact under normal conditions of use; thus it should not be printed across the perforations of a blister pack.

When applicable to the symbology used, bar codes shall be surrounded by sufficient quiet zone so that the bar code can be scanned correctly. Bar code placement shall minimize curvature of the bar code. For example, bar codes should be placed in “ladder orientation” on vials or bottles to minimize curvature of the bar code. Bar code labeling shall not be placed solely on outer packaging.

It is recommended that bar code labeling also include the lot number and expiration date. If two separate distinctive bar codes are used, one for NDC and the other for lot number/expiration date, the lot number and expiration date bar code must not be in close proximity to the NDC barcode or in a format that may be confused with the NDC bar code. When applicable, all Healthcare Distribution Management Association (HDMA) guidelines shall be followed.

THERAPEUTIC EQUIVALENCE (FEB 2007)

NOTE: This requirement applies only to SINs 42-2a and 42-2b.

Only products that have received under the Federal Food, Drug and Cosmetic Act a therapeutic equivalence code of “A” by the Food and Drug Administration will be considered, unless all drugs in the family group are “B” rated. In that case, no award will be made other than to the innovator unless the non-innovator vendor submits acceptable data demonstrating bioequivalence.

AS1345 RECALLS (MAR 2009)

If a drug recall is initiated for any drug provided under this contract, regardless of whether it is a voluntary recall by the manufacturer or a recall required by the U.S. Food and Drug Administration (FDA); or, if FDA withdraws their approval to manufacture any drug that is included on this contract, the following action shall immediately be taken by the contractor:

Forward two copies of the recall notification along with any pertinent information to:

1) Chief, Contracting – Administration Section, Federal Supply Schedule Service (003A4B) VA National Acquisition Center P.O Box 76 Hines, IL 60141 Fax number (708) 786-4974

2) Deputy Chief Consultant (M/S119D) VHA Pharmacy Benefits Management Services 1st Ave., 1 Block North of Cermak Rd., Bldg. 37, Rm 139 Hines, IL 60141 Fax number (708) 786-7894

3) Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106 VHANCPSRecallsNotification@va.gov Phone Number: (734) 930-5865

4) All Government Prime Vendors that were sent shipments of the affected product(s).

5) All FSS ordering activities that were sent shipments of the affected product(s).

AS1346 LABELER CODES (JUN 2005)

(This applies to dealers wishing to participate in VA’s Pharmaceutical Prime Vendor (PPV) program. May not be applicable to SINs 42-1, 42-3, 42-5 and 622.)

Dealers must provide their own labeler code, to be used in the National Drug Code (NDC) number for the offered items. If a dealer does not have a labeler code, it must apply and be approved with the U.S. Food & Drug Administration (FDA) for its own labeler code prior to making an offer under this solicitation.

NEW DRUG APPLICATION (NOV 2005)

By signing this solicitation, the offeror certifies that it has on file (if any of the following are required by FDA for the offered drugs) an FDA approved New Drug Application (NDA), an approved abbreviated NDA (ANDA), or a Biologic License approval, as appropriate for the items offered in response to the solicitation.

AS3023 DIVERSION OF PHARMACEUTICAL PRODUCTS (SEP 2010)

(1) Pharmaceutical products ordered under Federal Supply Schedule (FSS) contracts are intended solely for the use of authorized ordering activities in carrying out their governmental missions; they are not intended for resale or barter. Any transfer of FSS contract items that does not serve the ordering activity's defined mission, as well as any transfer for the purpose of generating a profit on the difference between FSS prices and commercial prices (such as "AWP"), is an improper diversion of government supplies.

(2) The Contractor may require an ordering activity that is not listed in the appendices to GSA Adm. Order 4800.2E (and its later revisions) or a pharmaceutical prime vendor ordering on an activity's behalf to demonstrate its eligibility to place FSS orders. The Contractor may also require an authorized ordering activity to disclose the intended use of ordered pharmaceuticals before commencing delivery. The Contractor is not required to fill an FSS order (or that portion of an order) that investigational facts suggest will be diverted into the commercial market or will otherwise be diverted from usage by authorized FSS ordering activities. (An example of such facts might be the tripling of usual ordered quantities by an activity, coupled with its failure to demonstrate a corresponding increase in its institutional size or patient base.) However, the Contractor may not unreasonably delay filling an FSS order, pending its investigation of the intended use of the items ordered. Based on investigational facts that suggest that a pattern of diversion has occurred, a Contractor may elect not to fill indirect orders of an activity through an authorized Government PPV and, instead, to accept only direct orders.

(3) If…