36C10G18R0003-00002006.xlsx

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A Literature Review: The offeror shall provide descriptive product literature (prefer hyperlink to access contractor’s web site. "Descriptive literature," as used in this provision, means information (e.g., cuts, illustrations, drawings, and brochures) that is submitted as part of an offer. Descriptive literature is required to establish, for the purpose of evaluation and award, details of the product offered that are specified elsewhere in the solicitation and pertain to significant elements such as: (1) materials; (2) components; and (3) performance characteristics. The literature will be used to evaluate the depth & breadth of the offerors product line. Product Line (Provide product literature that demonstrates the breadth and depth of each product line, including but not limited to: size options, materiel options, preferable to be available with access on the contractor’s web site and must be capable of opening on a VA computer).

B Technical Acceptability Worksheet: The offeror shall provide a completed Attachment 6 Amendment 0002 - Technically Acceptability Worksheet to ensure each technical item has been addressed. If response is a “No” the comments shall include a justification/rationale. Failure to provide justification or rationale will deem proposal unacceptable and will not be considered further.

C Geographical Coverage: Provide a response if national and/or VISN geographical coverage is available and provide a listing to display location(s) of vendor representatives and demonstrate how national and/or VISN Geographical coverage will be provided to VA, if applicable. Demonstrate how the representatives will provide timely delivery for just-in-time or consignment to individual facilities; reps availability for consultations during surgery and provide other implant support needed as determined by physician. Award may be made under either type of coverage.

D Qualifications and Certification of Representatives: The offeror shall address company's requirements for representatives to provide support in the hospital and operating room. Narrative shall affirmatively state that the reps are technically qualified and experienced to provide product demonstrations to VA Operation Room staff. The narrative shall outline specific training and continuing education available. If distributors will the manufacture provide representatives for this support and provide letter from manufacture attesting to this support on behalf of distributor.

E Training: The contractor shall describe the commercial training available on the products. Ability and commitment to demonstrate to operating room and hospital personnel (Outline a proposed on-going demonstration program over life of the contract for hospital OR personnel and the frequency of such a program. The program shall include product features and surgical procedure demonstration to support the surgeon.

F Notification of Safety Recalls: Trends of Failure (Describe the procedures and policies on tracking Trends of Failure on products offered to VA and how that information is communicated to VA).

G Certifications: The offeror shall provide documentation (i.e., certificate, letter, etc.) that verifies registration as required by the Food and Drug Administration (FDA) under subpart B of part 1271 of title 21, Code of Federal Regulations, or any successor regulation. If a distributor then the information should be supplied from your manufacture and submitted with offer.

G.1 The offeror must provide a copy of the Centers for Medicare and Medicaid Services (CMS) Clinical Laboratory Improvement Amendment (CLIA) certificate for the facility that will be performing FDA required testing for allografts and xenografts during the contract period. (If Applicable). If you are a distributor then the information should be supplied from your manufacture and submitted with offer.

G.2 The offeror shall submit a copy of the FDA 3356: Establishment Registration and Listing for Human Cells, Tissues, and Cellular and Tissue Based Products (HCT/Ps) for their supplier facility. If you are a distributor then the information should be supplied from your manufacture and submitted with offer.

G.3 The offeror shall submit a copy of their Biological License, if manufacture of product intended for introduction into interstate commerce as defined by 21 CFR 601.2. If you are a distributor then the information should be supplied from your manufacture and submitted with offer

G.4 The offeror shall submit a verification statement that they agree to meet Industry labeling requirement ISBT 128 of Human allograft medical products. Xenograft products may use any of the standards (GS1 and HIBCC) currently FDA approved Unique Device Identifiers (UDI). (Offeror shall be in compliance by the first anniversary date of the effective date of the IDIQ Contract Award). If you are a distributor then the information should be supplied from the manufacture. Failure to meet labeling requirement by first anniversary date of effective award date of IDIQ contract award shall be removed from the Attachment 3 Amendment 0002 - Excel Price/Cost Schedule in the award resulting from this solicitation or terminated.

VOL II - PRICE DIQ PRICING PRICE/COST/ SCHEDULE: The offeror shall complete Attachment 3 Amendment 0002 – Excel Price Cost Schedule columns (B-F, H-V) and TAB – MSPV Participation. If a contract line item is being offered at no cost the offeror must indicate in excel price/cost schedule (as no charge “NC”).

The offeror shall provide Most Favored Customer (MFC) price, Most Favored Government (MFG) price, commercial catalog price, proposed price without SLA, SLA fee, and proposed price with SLA. The MFC/MFG is the commercial/Government customer who receives the best net price regardless of terms and conditions. Definitions are contained in Attachment 3. All offered pricing is to be inclusive of shipping charges per clause 52.247-34 FOB Destination.

VOL III - SAMLL BUSINESS SUBCONTRACTING PLAN SMALL BUSINESS SUBCONTRACTING PLAN

Each Large Business offeror shall provide a Small Business Subcontracting Plan that contains all of the elements required by FAR 52.219-9 or approved plan. If the large business does not have an approved Master Plan or approved Commercial Plan, then an Individual subcontracting plan must be submitted that includes an assurance that small businesses will be given the maximum practicable opportunity to participate in contract performance. A samll business offeror shall include a statement in the proposal certifying they are a small business in SAM (www.sam.gov) under NAICS code 339113.

Attachment 6 Amendment 00002

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