36C10G18R0003-00003002.xlsx
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- 36C10G18R0003
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This document contains a questions and answers file related to a solicitation for biologics and biological implants to be used by the Department of Veterans Affairs. The solicitation will result in multiple award ID/IQ contracts for products such as allografts and xenografts regulated as Human Cell, Tissue, and Cellular and Tissue-Based Products under Section 361 of the Public Health Service Act. Acceptable labeling must follow ISBT 128 standards for allografts and FDA-approved UDI standards for xenografts. Questions addressed include ordering and billing processes, distribution through prime vendors, pricing terms, compliance with FDA schedules, and product evaluation criteria. The period of performance is one base year with four option years, and the government anticipates awarding up to 30 contracts by May 2018 with potential subsequent periods.
36C10G18R0003 00003 Response to Vendor Questions 36C10G18R0003 Amendment 0003.xlsx
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Sheet1
| Questions and Responses |
| Solicitation 36C10G18R0003 Biologics and Biologic Implants |
| Number | Page No. | Section Number | Question | Response | |||
| 1 | How will the orders flow? Will the VA order through Prime Vendors, and the PV send the orders to the Contractor to fulfill and drop ship to the VA? Please provide a flow chart of the proposed ordering process. | See Section 5.4 Ordering for ordering flow. Attachment 3 – Excel Price-Cost Schedule, TAB 2 – MSPV Participation, is merely an indication that offeror is willing or not willing to participate in the MSPV program. If willing, then the authorized Government Prime Vendor and awardee shall have agreement (terms and conditions regarding time, quantity, method of delivery, payment terms, and chargeback agreements) determined between awardee and Government Prime Vendor subject to coordination and final approval by the Government. | |||||
| 2 | How will the billing be processed? Through the Prime Vendor or direct from the Contractor? | See response to Question 1 above. | |||||
| 3 | If Prime Vendors are used, is it the expectation that the PV will waive the administration fee? | The Distribution Fee charged by the Medical Surgical Prime Vendor (MSPV) Prime Vendor will apply and be charged. | |||||
| 4 | 28 | C.12 SAC 16-01 | |||||
| a. | Will the 3% Service Level Agreement Fee be in addition to the .05% Industrial Funding Fee? | There should be no Industrial Funding Fee (IFF) fee since this is not a GSA/FSS schedule purchase. | |||||
| 5 | 74 | Volume II - Price | Define Most Favored Government Customer, does this include DoD, IHS, VA, etc.? What is the time period, last 12 months, if other please provide the time frame? Also, customers that receive favorable pricing typically enter into future purchase commitments. Will this procurement lead to purchase commitments from VA customer? | Yes, Most Favored Government Customer can include DoD, HHS etc. Yes, within the last 12 months. This is no guarantee beyond the minimum identified in Section 1.6 Contract Minimum and Maximum Dollar Values. | |||
| 6 | 8 and 12 | 3.1.15/5.2.3 | Of the three issuing agencies for the UDI labeling, is there a preference on which one to use? | See response to Question 50 below. | |||
| 7 | 8 and 12 | 3.1.15/5.2.3 | Will the FDA implementation schedule for the UDI be followed? Please add or describe the schedule and implementation goals. | Yes, the Food and Drug Administration (FDA) implementation schedule for UDI will be followed. | |||
| 8 | How will the volume of the manufacturers be evaluated? If it ran through another vendor will that only be counted for the manufacturer? | ||||||
| Up until June 30, 2017, Vendor A's product SKUs were filled by Vendor A and Vendor Be. Please confirm that all Vendor A's SKUs will be attributed to Vendor A the manufacturer and that the other vendor will not be given credit for those sales in the evaluation as a basis for an award. | Products can only appear on one Offeror, either on a manufacturers contract or distributors contract but not on both. | ||||||
| 9 | 5 | 1.4.1 | Typically products shipped to the VA do not have patient ID associate with the order. Will the VAs start providing so this can be included? | There will no change to current order and shipping labeling requirements. | |||
| 10 | 5 | 1.4.2 | Is Microsoft Office encryption not an option? | No it is not an option. | |||
| 11 | 8 and 73 | 3.1.5 / g (certifications) | The products being offered are Human Cell, Tissue, and Cellular Tissue Products (HCT/Ps) (as defined in the Food and Drug Administration (FDA) regulations 21 CFR Part 1271 and Section 361 of the Public Health Services Act (PHS Act). | See response to Question 50 below. | |||
| They do not require FDA premarket approval or clearance. | |||||||
| A product is eligible for regulation as a 361 HCT/P solely under Part 1271 if it meets the criteria in 21 CFR 1271.10 and is not subject to premarket clearance or approval. | |||||||
| The products being offered meet all of the four criteria of HCT/Ps: | |||||||
| *Minimal manipulation | |||||||
| *No synthetic carrier added | |||||||
| *For homologous use | |||||||
| *Local implementation, direct to site: no systemic effect and not dependent on the metabolic activity of cells for its primary function |
| We understand ISBT 128 labeling is required for biological drugs and devices. It is currently not required for 361 HCT/P's. | |||||
| 1. Are we still required to follow the ISBT labeling? | |||||
| 2. If we implement, do we need to go back and relabel existing product using ISBT 128? | |||||
| 12 | 9 | 3.3.2 | Can the contract term be less than 60 months? | No. | |
| 13 | 12 and 13 | 5.2.2 / 5.2.5.1 | The solicitation states that contractor shall offer "state-of-the-art" biologics/new products (pg12); however it also states that new additions will not be accepted during the 1st twelve months after award. Can you please clarify the process if a new product or version of the product becomes available during the first year of the contract? | During the first year of the contract award no new additions will be accepted for consideration of inclusion in the contract. | |
| 14 | 14 and 38 | 5.2.5.2 / C.15 52.216-2 | Can you clarify price increases? Page 14 states only downward price changes are allowed but page 38 addresses price increases. | Section C.15 Economic Price Adjustment allows both price decrease and increase. No price increase will be considered in year one of the contract (See amendment to the solicitation for details). | |
| 15 | When is anticipated award effective date? | The latest anticipated award effective date will be 30 September 2018. Awards maybe made on incremental basis dependent upon technical evaluation and fair and reasonable pricing. | |||
| 16 | Please provide guidance for manufacturer response to solicitation that includes distribution through a named distributor. | This is not a set-aside. It is incumbent upon the Offeror to determine the most appropriate arrange in response to the solicitation. | |||
| 17 | Once all companies have been awarded for the IDIQ 36C10G18R0003 will there be a particular order in which each company will be allowed to provide the required supplies. For example a rotation of companies, lowest price, first response, etc.? | Orders will be placed by respective VA Medical Center based upon clinician determination as to best result for best clinical patient outcome. | |||
| 18 | Volume III requires an explanation of how large business will ensure that they sub contract out to small businesses. If your company is already considered a small business how would you suggest we respond to Volume III? As a small business we feel our company is adequately able to fulfill all supply orders for the entire duration of the contract with no assistance from other companies. How would you suggest we incorportae these details into our proposal and possibly into Volume III? | If offeror is a small business then Volume III is not required to be submitted. However, FAR 52.219-8 is applicable to all Offerors. A small business offeror shall include a statement in the proposal certifying they are small business in SAM (www.sam.gov ) under NAICS code 339113 (see amendment to solicitation for details). | |||
| 19 | Can reps and certs be completed in SAM or do they need to be attached as part of the submission? | Per E.16 Proposal Submission Instruction (Volume IV), offerors shall completed provision 52.212-3, Representations and Certifications, if not completed in System for Award Management (SAM). | |||
| 20 | Our quality assurance plans are provided by our manufacturer, do you want his provided in our technical response or are you looking for a quality assurance surveillance plan from the company itself? | The QASP will be provided by the Government. | |||
| 21 | The soliciatation states under Delivery/Guidelines/Regulations, on pages 16-18, it talks about the different measures of payment for the awarded company based on a dollar value. What proof is needed to be shown in the proposal that the company is able to accept credit card payment? | Offeror is assumed to accept credit card payment unless exception is taken to this requirement. The current method of payment for prosthetic purchases is GPC. | |||
| 22 | 6 | 1.7.4 | Should Section B.11 read B 5.11? | Yes. See Amendment to solicitation conformed copy. | |
| 23 | 8 | 3.1.5 | In regards to the "All allograft products shall be Food and Drug Administration (FDA) approved " statement, Do you consider products regulated solely as "361 products" FDA approved? (Regulated under 21 CFR 1271.3(d)(1) and Section 361 of the PHS Act). | See response to Question 8 above. | |
| 24 | 9 | 3.2.1 | Should B.6 (delivery schedule) read B 5.6 Delivery Schedule? | B.6 should be B.5.6(delivery requirements) see Amendment to solicitation. | |
| 25 | 17 | 5.6.6 | Is it the intention of this IDIQ to have a unilateral Consignment Agreement or will a separate bilateral Consignment Agreement be negotiated by an authorized Medical Facility CO placed against the IDIQ? | Consignment agreements are bi-lateral and established each VA Medical Center based upon clinical needs. Consignment agreement can only be established by a warranted CO. | |
| 26 | Attachment 6 | K & M | Should one of the sections be deleted due to a duplication? | Yes. See Amendment to solicitation and revised Attachment 6. | |
| 27 | Attachment 6 | L & N | Should one of the sections be deleted due to a duplication? | Yes. See Amendment to solicitation and revised Attachment 6. | |
| 28 | 12 | B5.4 | What impact will the MPT increase from $3500-$10K have on this RFP. Will it apply | The MTP identified in this solicitation will increase once the VA Office of Finances implements policy and increases the limits on the GPC. | |
| 29 | 40 | D1 | Would a detailed sales report, by facility, be acceptable vs. PO#/patient names/SSN for implants (HIPPA concerns) | D.1 is Invoice Inquiry Tracker for vendor to submit when payment inquiry is made and information is required for VA to research inquiry. | |
| 30 | 69 | E16 | Please clarify the reason for the two submission dates | Two ensure an adequate number of proposals are received in response to the solicitation. | |
| 31 | 28 | C12A | Will the SLA Fee remain 3% for this RFP and will it be paid separately, each Quarter | Yes. The SAC SLA fee is remitted quarterly based upon orders placed. | |
| 32 | General Question | Will the awarding of this IDIQ affect ECAT eligibility? | VA IDIQ is separate and not part of DLA ECAT. | ||
| 33 | General Question | When is award to be announced / made effective? | See response to Question 15 above. | ||
| 34 | 15 | 5.5 | Is the SLA fee in replacement of IFF or are they separate? | See response to Question 4 above. | |
| 35 | Tech. Spreadsheet | What is the difference is Section L verses Section N? Letter of Commitment for Manufacturers | See response to Question 27 above. | ||
| 36 | 1 | B | on Technical Sheet, answer YES for the same sheet? | Yes. | |
| 37 | 15 | 5.5 | QSR template. Will you provide a template? | No, Per 5.5.1 QSR template format is be developed by the contractor and submitted to Government for review upon award. A sample may be provided upon request after award. | |
| 38 | General Question | Vendor C recently acquired Vendor D. We are currently adding allVendor D products to the Vendor C FSS Schedule but it is still in modification. Should we submit 2 bids: 1 for Vendor C and it's products and 1 for Vendor D and it's products OR should Vendor C submit 1 bid and include all Vendor C and Vendor D products on that bid? | This is an open market solicitation and separate from GSA/FSS. A complete proposal should be submitted. | ||
| 39 | 13 | 5.2.3 | There are a few references to 510K approval throughout the solicitation document. Certain Human Cell and Tissue Based Products are regulated under Section 361 of the Public Health Service Act. Can we assume that 510K and 361 approval references are idential as appropriate for the type of biologic product offered? | See response to Question 6 above. | |
| 40 | 17 | 5.6.4 | This paragraph reads, in part, that the supplier must be able to deliver any offered product within a few hours, seven days a week. This would appear to require the suppliers to have representative coverage of each VA medical center, each with the ability to deliver product within hours of a call. Is this the intent of this requirement? | Yes | |
| 41 | 73 | Vol I.g.1 | Does this requirement for lab certification apply to sterility testing? | Yes | |
| 42 | 5 | 1.4.2 | Do all Departments within the VA have access to view emails sent using Virtru Pro Program? | Virtru Pro Program emails contain the necessary ability for recipients to read. | |
| 43 | 6 | 1.7.2 | What is the process if vendors request clarification on CDR's before responding? How quickly should the COR/POC respond to those types of requests? Will the Government consider assigning a local point of contact to coordinate questions/concerns and/or proposed resolutions with? Could the COR/POC decide to withdraw the CDR if additional facts made available warrant it? | The contractor will request clarification and the COR will reach out to the local medical center for information. The CDR is not withdrawn but if it is baseless, it is not held against the vendor. | |
| 44 | 10 | 3.5.6 | Per paragraph 3.5.6 of the solicitation, the contractor is required to purchase, at their own expense, and install on contractor owned systems a specific brand of encryption software. This solicitation utilizes FAR part 12 policies and procedures and per FAR part 12 the Contracting Officer shall not include additional terms and conditions in a solicitation for commercial items in a manner that is inconsistent with customary commercial practice unless a waiver is approved in accordance with agency procedures. The solicitation will result in a commercial contract and commercial contracts shall follow commercial practices. We assert that the mandatory purchase, installation and use of a specific brand name of software is inconsistent with commercial customary practices and we request this requirement be removed from the solicitation. | No. There may be instances in which the contractor is required to transmit electronically PHI and PII. VA has approved methods as identified in this solicitation. | |
| 45 | 10 | 3.5.7.1 | Per 3.5.7.1 The offeror is required to comply with the directive of NIST SP 800-18. This directive is titled "Guide for Developing Security Plans for Federal Information Systems: and pertains to federal information systems. After reviewing the NIST SP 800-18 we fail to see how this directive would apply to a contract vehicle for the purchase of implantable biologic materials. Could the Contracting Officer please clarify to what extent this directive will affect the resulting contract? What Federal System does the contract require the contractor have access to? | 3.5.7 and 3.5.7.1 are removed from the solicitation (see Amendment to solicitation for details). | |
| 46 | 18 | 5.6.6.7 | Consignment Agreement periodic inventories are currently left at the discretion of each particular VISN, but this solicitation requires quarterly inventories with a copy to the Contracting Officer. In our experience, the Government assigns inventory points of contact(s), usually within Logistics, and a local COR is assigned to develop initial inventories, in addition to validating periodic inventories. Will these methods be utilized for this requirement? If VISNs will continue to have discretion on the management of Consignment Agreement inventories, we recommend removal of the quarterly periodic inventory requirement. | Consignment agreements are established at the local level. At a minimum quarterly period inspection is required (see Amendment to solicitation for details). | |
| 47 | 73 | G.(4) | Pursuant to 21 CFR 801 and 21 CFR 830, commercial manufacturers of allograft products are required to adhere to FDA UDI labelling standards, which includes but is not limited to ISBT 128. As this solicitation is for commercial items subject to FAR part 12, the requirement of an exclusive labelling requirement for allograft products is inconsistent with customary commercial practices for allograft labelling and FDA regulations. Further, otherwise requiring the allograft manufacturer to certify its conversion from its current FDA compliant UDI system to ISBT 128 within one year, and the costs associated with this conversion, is also inconsistent with customary commercial practices. We request VAAR 852-211-172 and solicitation to be modified to permit product labelling to meet current FDA labelling standards. | See response to Question 6 above. | |
| 48 | Would FDA-approved medical device products that contain human cells be considered as included within scope of products covered by the IDIQ? | See response to Question 50 below. | |||
| 49 | Would FDA-cleared (e.g., 510(k) clearance) medical device products that contain animal tissue be considered as included within the scope of products covered by the IDIQ? | See response to Question 50 below. | |||
| 50 | Are only those products that have either FDA approval or clearance considered as included within the scope of products? (products that are deemed to be Section 361 HCT/Ps under the Public Health Service Act have no approval or clearance so we’re trying to confirm whether those products are covered under the IDIQ) | Only 361 products are allowed to be offered and use of ISBT 128 for labeling of allografts is required after one year of effective date of award and any of the FDA approved UDI (GS1 and HIBCC) for xenografts. | |||
| 51 | will these slides from the vitual pre-proposal conference be made available after the presentation is over? | Yes. See Amendment to solicitation. | |||
| 52 | Is there an SDVOSB Preference | Per SF1449, block 10 this requirement is unrestricted. | |||
| 53 | Are 361 products allowed as they are FDA registered and reviewed rather going through an FDA approval? | Yes. See response to Question 50 above. | |||
| 54 | please confim that if 30 awards are made from the May 21 RFO, the open season will close and there will be no rfps for the August 15, and November 15 periods | The dates in your question were from the draft solicitation notice. The solicitation has 2 submission dates of May 21 and Aug 15. Per E.16 Proposal Submission Instructions, If there is reasonable expectation that number of awards will be made by Offerors received in first submission , the solicitation will be amendment and closed. | |||
| 55 | Please share the informataion that is being sent to the caller as what he is asking is exactly what I'm asking. I'm not with his company, however. | See response to Question 57 below. | |||
| 56 | please share the information that Mr. Rogers requested with the group. This will apply to multiple companies. Thank you | See response to Question 57 below. | |||
| 57 | This is the write-up concerning my talks with Alex No, an ISBT 128 official at ICCBBA: ICCBBA is the international standards organization responsible for the management and development of the ISBT 128 Standard, and is a not-for-profit nongovernmental organization in official relations with the World Health Organization (WHO). I explained to Alex No what type of HCT/P products (Company Name) has and how we are currently distributing only 361 products. He stated: “ The ISBT 128 standard and its accompanying UDI is only applicable to HCT/Ps that are Medical Devices such as 510Ks and PMAs. It does not apply to HCT/P products that meet the regulatory definition of a 361 product.” I then mentioned that we had received a document recently from the Veterans Administration that potentially proposed that our HCT/P products must be coded to ISBT 128 standards with an accompanying UDI. Alex then stated that he felt “the VA might be in error for our HCT/P 361 products to have a UDI. This is also not an AATB Require | See response to Question 50 above. | |||
| 58 | The RFQ stated that 60% of the procurement for the awards were going to be designated for SDVOSB's. Is this not correct? | In the draft the solicitation, the 60% reference was only provided as example when completing a small business subcontracting plan goals. | |||
| 59 | how are we to respond to Volume III if we are a small business not partnering with a large business? | See response to Question 18 above. | |||
| 60 | In Solicitation paragraph 1.5 It states that any offeror shall acknowledge all amendments to the solicitation, however I have not seen any SF30s posted on FBO. Is there an intention to post said SF30s or shall offerors acknowledge amendment receipt in a different manner? | The solicitation was incorrectly posted on April 12, 2018 as a combined synopsis/solicitation rather than a solicitation connected to the presolicitation notice. On May 3, 2018 the combined synopsis/solicitation was deleted from FedBizOpps in its entirety and the solicitation was republished and properly connected to the presolicitation notice as Amendment 1 without SF30.Per E.16 Proposal Submission Instructions (Volume IV). The contractor shall acknowledge amendments in Section 1.5 (see Amendment to solicitation for details). | |||
| 61 | Can you go back to the oral presentation slide please? Will advance notice be given so that company travel arrangements can be made? | ||||
| We will provide as much advance notice as we can due to scheduling of space and travel arrangements of government employees. | |||||
| 62 | What is the VA's total spend in this category | Per Section 1.6 Contract Minimum and Maximum Dollar Values. The estimated value of all awards under this effort is $2,103,393,326.64 over a period of 60 months. | |||
| 63 | Per 3.5.7.1 The offeror is required to comply with the directive of NIST SP 800-18. This directive is titled “Guide for Developing Security Plans for Federal Information Systems” and pertains to federal information systems. After reviewing the NIST SP 800-18 we fail to see how this directive would apply to a contract vehicle for the purchase of implantable biologic materials. Could the Contracting Officer please clarify to what extent this directive will affect the resulting contract? What Federal Systems does this contract require the contractor have access to? | See response to Question 45 above. | |||
| 64 | Since there are no preferences or evaluation factors within the RFP for SDVOSBs, how will sub plans be monitored to ensure opportunities for the Veteran Community? Will the reports basen the monitoring be published? | See B.2 Subcontracting Monitoring and Compliance for details. The contractor is required to report subcontracting in the Electronic Subcontracting Reporting System annually. Reports are not published for public. However the reports are reviewed annually by the Contracting Officer and Agency Small Business Representative. | |||
| 65 | Per paragraph B.3.5.6 the VA is requiring offerors to purchase a special encryption software called "Virtru Pro".Why is Microsoft encryption not enough? 3.5.6 also states that transmission by fax is also allowable. Will fax allowable in lieu of encrypted email? | Virtru Pro is the acceptable encryption program identified by the VA ISO/Privacy Officer. Fax is acceptable form of transmission. | |||
| 66 | How long with the review of the ISBT 128 issue take? This is something that will impact the timeline for the submission deadline of May 21st. | The review will be completed as quickly as possible and solicitation due date adjusted as necessary and static number is not available. | |||
| 67 | When you did your commercial market survey, did industry provide you with their standard commercial practice. If so, how many are meeting the ISBT requirement presently? | The Government assessed standard commercial practice as it relates to the formulation of requirement. As companies continue to align their practices with industry standards. The number of companies meeting ISBT fluctuates. | |||
| 68 | I have a skin substitute, (Named Product Line), and all product codes have been included in the MSPV. This is a porcine product and we need some direction regarding whether or not this product fits into this solicitation. Our competitor products are (Various Named Product Lines). Is (our Named Product Line) considered to be in that grouping and we need to respond. We have been watching the evolution of this solicitation and at first, it appeared to us that the interest was implant. Now, has that focus changed? | See response to Question 50 above. | |||
| 69 | Can products from two or more distributors offer the same products? If the answer is no, can this restriction be removed from the solicitation? The issue we are encountering with this response is the manufacturers we are working with cannot restrict which distributors respond to this solicitation according to their legal agreements with these companies to ensure there is no duplication in the products offered by the network of distributors. |
| The distributors geographical coverage shall not overlap. | |||
| 70 | We are requesting the response deadline be extended by at least 1 week to give us extra time to prepare our proposal. Can you accommodate this request? | The solicitation is extend to close on Thursday, Mat 24, 2018 at Noon EST. See Amendment 0003 to solicitation.. | |
| 71 | a. In the Biologics Solicitation is states that only 361 products can be offered (“Only 361 products are allowed to be offered and use of ISBT 128 for labeling of allografts is required after one year of effective date of award and any of the FDA approved UDI (GS1 and HIBCC) for xenografts.”). |
b. Are you stating that even if a supplier has more than 361 products, they can only offer 361?
c. Can the others be added at a later time?
| a. This contract is for biologics identified under 361 HCT/P. We are only seeking those products from a vendor. Non biologic products that do not fit under 361 HCT/P will not be added. b. Yes. c. No. | |||
| 72 | (Vendor) is respectfully requesting a 72 hour extension to allow sufficient preparation time for our submission given the modifications, the Q&A and latest industry feedback from the pre-proposal conference. I imagine most of the other vendors would appreciate the extension. Monday noon is effectively tomorrow end of business | See response to Question 70 above. |
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