Needles and Syringes
AMENDMENT 3 (8 June 2020): 1. Combined Synopsis/Solicitation has been modified. The due date for Proposals has been extended to Tuesday, 9 June, 2020 at 4:30pm Eastern Time. See revised "Amendment 3" ... AMENDMENT 3 (8 June 2020): 1. Combined Synopsis/Solicitation has been modified. The due date for Proposals has been extended to Tuesday, 9 June, 2020 at 4:30pm Eastern Time. See revised "Amendment 3" Combined Synopsis-Solicitation Attachment and revision to below "Description" section which reflect this Proposal date extension. REMINDER: Use the updated "Attachment 4-Pricing Template" attachment from "Amendment 2" when preparing proposals in response to this solicitation. AMENDMENT 2 (3 June 2020): 1. Attachment 4-Pricing Template has been modified. See revised "Amendment 2" Pricing Template attachment. Use this updated Pricing Template when preparing responses to this solicitation. 2. Government responses to additional questions (from the 2 June 2020 deadline) have been added. See attachment "W911SR-20-R-0003 Industry Question Matrix Round 2-Amendment 2". NOTE: The previously answered questions are incorporated into this new document as well. AMENDMENT 1 (28 May 2020): 1. Combined Synopsis/Solicitation has been modified. New due date for Questions is 2 June 2020 at 4:30pm Eastern Time. New due date for Proposals is 8 June 2020 at 4:30pm Eastern Time. See revised "Amendment 1" Combined Synopsis-Solicitation attachment and revision to below "Description" section. 2. Statement of Work has been modified. See corrections to clerical errors in section 4.1.1.1 and 4.2.1. See revised "Amendment 1" Statement of Work attachment. 3. Government responses to initial questions have been added. See attachment "W911SR-20-R-0003 Industry Question Matrix 28 May 2020". Classification Original Set Aside: Not applicable. Product Service Code: 6515 - MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES NAICS Code: 339112 Place of Performance: Contractor’s Facility Description This a combined synopsis/solicitation for the immediate purchase of commercial items in response to the COVID-19 pandemic. This synopsis/solicitation is for the urgent purchase of United Stated Food and Drug Administration (FDA) approved Combination Needle and Syringe Units or individual Needles and Syringes. The Government expects multiple awards from this solicitation in order to reach the needed amount of 500 Million total needles and syringes within the next year, with as many as possible by December 31, 2020. This solicitation will be competing two (2) main supplies (see below for more details); (1) Needles with one (1) milliliter (1ml) syringes; and (2) Needles with three (3) milliliter (3ml) Syringes. This synopsis/solicitation is prepared in accordance with the format in FAR subpart 12.603, “Streamlined solicitation for commercial items,” and FAR 18 as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Proposals are being requested. The solicitation number is W911SR20R0003 and the solicitation is issued as a Request for Proposal (RFP). This commercial acquisition will be executed in support of the COVID-19 National Emergency Response. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-06 May 6, 2020. The North American Industry Classification System (NAICS) code for this procurement is 339112, Surgical Medical Instrument Manufacturing. The acquisition is being competed full and open with no small business restriction. The Department of Health and Human Services (HHS), Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA) is seeking to acquire FDA-approved, Combination Needle and Syringe Units or individual Needles and Syringes. The Offeror’s proposal shall be in full compliance with the instructions in this combined synopsis/solicitation. This solicitation includes the following attachments: Attachment 1 – Statement of Work, Needles and Syringes; Attachment 2 - Proposal Template, Technical Acceptability; Attachment 3 – Contract Data Requirements List (CDRL); and Attachment 4 - Pricing Template. The Government intends to award a firm-fixed price contract. The evaluation method will be Lowest Price Technically Acceptable (LPTA). The Government reserves the right to incorporate any portion(s) of the winning proposal into the resultant contract. This synopsis/solicitation is being executed under a certified Short of Award under AFARS 5132.702 as “Funds are not presently available for this acquisition. No contract award will be made until appropriated funds are made available.” The period of performance for this requirement will not exceed twelve (12) months from the date of contract award. The period of performance could be less if industry is able to supply the required quantity of 500 Million syringes/needles sooner. The Government’s intent is to receive all 500 Million (or as many as possible) by December 2020. Each proposal shall indicate how many units the vendor can provide by December 31, 2020 as well as how many units can be provided by twelve (12) months from the date of contract award (assuming all 500 Million cannot be provided by December 2020). Proposals will only be accepted from offerors that can propose a one-to-one (1:1) ratio syringes and needles with a minimum total quantity of five (5) million each by December 31, 2020. In order to meet the specified quantities upon contract award and comply with the specifications in the Attachment #1 Statement of Work, the following may be proposed: (1) individually wrapped sterile syringes with individually wrapped sterile needles, (2) sterile needle/syringe combination unit, or (3) a mixture of combinations units and individually wrapped syringes with equal number of individually wrapped needles. As described above, this solicitation will be competing two main syringe sizes (1ml and 3ml) with needles. Each syringe sizes with needles will be considered a separate contract, unless an offeror proposes and is selected to receive an award to both 1ml and 3ml syringes with needles; then that Offeror will receive only one award for both syringe sizes with needles. The solicitation will compete, based on the requirement in the attached Statement of Work, the following syringe sizes with specified needles: Competition #1: 270 Million 1ml syringes with Needles: 50% of the 1ml syringes with 25 gauge 1” Needles, and 50% of the 1ml syringes with 23 gauge 1” or 1.5” Needles. Competition #2: 230 Million 3ml syringes with Needles: 50% of the 3ml syringes with 25 gauge 1” Needles, and 50% of the 3ml syringes with 23 gauge 1” or 1.5” Needles. Based on the stated requirements above, the Government reserves the right to exceed the number of the stated syringe sizes (270-1ml versus 230-3ml) and/or the 50% stated needle gauge sizes in the event the stated numbers above cannot be reached to meet the overall objective of 37- total needles and syringes. Any mixture of the “two competitions” above will be allowed to reach the required 5 Million Total Needles and Syringes by December 31, 2020. The Offeror shall submit a Proposal comprised of the following: Technical and Price: TECHNICAL PROPOSAL: 1. The Offeror shall submit a Technical Narrative clearly depicting how the proposed products meet the specifications stated herein. 2. All Offeror shall specify the Country of Origin (as prescribed in Attachment 2 and the specified provision, 252.225-7000 Buy American-Balance of Payments Program Certificate). 3. The Offeror shall include Technical/Product Literature (e.g. Specification Sheets, pictures) providing supporting/justifying information as part of or as an attachment to the Technical Narrative. The Government will not make any assumptions regarding the technical acceptability of any product proposed. 4. The Offeror shall complete and submit Attachment 2, Proposal Template-Technical Acceptability to demonstrate the proposed supply meets the Government required specifications. Failure to complete and submit Attachment 2 will deem the proposal as non-responsive and the proposal shall be ineligible for evaluation. Completion of Attachment 2 by the Offeror with simply stating “meets,” “equal,” or other similar descriptions that lack sufficient technical descriptions will not be acceptable and shall provide supporting information in the Technical Narrative stated in #1 of this section above. 5. The Contractor shall provide copies of 510(k) Approval Letters for ALL supplies (syringes and needles) to demonstrate compliance with Section 510(k) of the Food, Drug and Cosmetic Act. (See also Statement of Work Section 4.1.2). Technical Schedule and Quantities: The Offeror shall describe its approach for providing the required quantities, while meeting the delivery schedule of the Syringe and Needle Units. The Offeror shall detail any associated risks for this award. The Offeror shall clearly state the schedule for each item; which includes the actual or forecasted rate of how many Needle and Syringe Units can be manufactured/supplied per month. PRICE PROPOSAL: The Offeror shall submit a Price Quotation (using the Pricing Template, Attachment 3). The Offeror shall propose firm-fixed-price for each item on an FOB Destination basis. Failure to complete the entire pricing sheet will deem the Offeror’s proposal as “unresponsive” and therefore, unacceptable. Pricing to Delivery Address: Due to the delivery locations being considered “sensitive,” the Offeror shall use the following deliveries cities/states for pricing purposes; (1) Atlanta, GA; (2) Memphis, TN; (3) Dallas, TX; (4) Baltimore, MD; (5) Salt Lake City, UT; (6) Indianapolis, IN; and (7) Los Angeles, CA. The Government will provide the address(es) at the Post-Award Meeting. Small Business Subcontracting Plan: To the maximum extent practicable given the short suspense and urgent nature of the COVID-19 pandemic, any large business Offeror shall submit a Small Business Subcontracting Plan. Award(s) will be made to the Offeror(s) whose proposal(s) is/are the LPTA. The Government reserves the right to award contracts to multiple offerors off of this solicitation in order to meet (or get as close as possible) the required syringe/needle quantity of 500 million total units. The Government will not consider an individual contract award to an Offeror who cannot provide at least five (5) million syringe/needle total units by December 31, 2020. The Government will only accept proposals for either: Sterile Syringe/Needle Combination units packaged together. Sterile Syringes and compatible Sterile Needles packaged individually on a one-to-one basis. Note: The Government understands and is aware some vendors only produced either the syringes or the needles. In this case, the Government hopes these types of contractors will team/partner/etc., with another company to meet the requirement that a Contractor shall only provide one-to-one syringes and needles. NO PROPOSALS WILL BE ACCEPTED FOR JUST NEEDLES OR JUST SYRINGES BY THEMSELVES. Multiple Awards and Fair and Reasonable Pricing: In the event multiple offerors are needed to satisfy the quantity requirement of a total of 500 Million needles and syringes, the Government will not award a contract to any vendor whose pricing has been determined to not be fair and reasonable. Further, if applicable FAR Part 25 will apply regarding exceptions for Buy American Act and Trade Agreements. TECHNICAL EVALUATION: The Government will evaluate whether the Offeror’s technical proposal is acceptable to meet or exceed the specifications of the medical items listed in Attachment 1. Per the above section, proposals for a syringe/needle quantity of less than 5 million units will not be considered technically acceptable. Failure to submit the required 510(k) Approval Letters for all components of the Syringe and Needles Sets will deem the proposal Technically Unacceptable. PAST PERFORMANCE EVALUATION: The Government will review past performance using the Federal Awardee Performance and Integrity Information System (FAPIIS) as part of Technical Acceptability. TECHNICAL RATINGS: “Acceptable”: The proposal is Acceptable if it meets the minimum specifications as depicted in Attachment 2, provides the required quantities in the timeframe desired, and based on the Offeror’s recent, relevant performance record, the Government has a reasonable expectation the Offeror shall successfully perform the required effort. “Unacceptable”: The Proposal is Unacceptable if it fails to meet the minimum specifications as depicted in Attachment 2, and/or cannot provide the required quantities (minimum of five (5) Million) in the timeframe desired, and/or based on the Offeror’s recent, relevant performance record, the Government has a low or no expectation that the Offeror shall successfully perform the required effort. PRICE EVALUATION: The Government will evaluate whether the proposed prices are fair and reasonable per FAR 12.209. The LPTA aspect to this award will result in the technically acceptable proposals being “ranked” from lowest to highest in price up to the number with multiple contractors receiving award up to the maximum limit (if achievable) of 500 Million needles and syringes as demonstrated in the table below. The Procuring Contracting Officer will determine if offerors are responsible in accordance with FAR Subpart 9.1. Proposals received from Offerors determined to be not responsible pursuant to FAR Subpart 9.1 shall not be considered for award. EVALUATIONS: See below for an example of a situation where multiple contract awards may be made, while other contractors may not receive award: Offeror Quantity (in Millions)* Price (ea)* Technically Acceptable Contract Award Note Offeror A 220 $0.12 Yes Yes Fair and Reasonable price and technically acceptable so an award is made. Offeror B 150 $0.14 Yes Yes Fair and Reasonable price and technically acceptable so an award is made. Offeror C 80 $0.15 Yes Yes Fair and Reasonable price and technically acceptable so an award is made. Offeror D 150 $0.17 Yes Yes Fair and Reasonable price and technically acceptable so an award is made, HOWEVER, the award can only be up to 50 Million units because the ceiling of 500 Million units has been met. Offeror E 50 $0.18 Yes No Does NOT receive because although being technical acceptable and having a reasonable price the ceiling was hit with Offeror D Offeror F 10 $1.00 Yes No Does NOT receive award as pricing is determined to be not fair and reasonable. Offeror G 4 $0.14 No No Does NOT receive award as they are not technically acceptable (could not provide the 5 Million quantity minimum *The prices and quantities shown here are examples and NOT meant to imply these quantities are achievable or the prices are what the Government believes are applicable to the items. SMALL BUSINESS SUBCONTRACTING PLAN: The Small Business Subcontracting Plan (SBSP) is not an element of evaluation. The Contracting Officer, as part of assessing an offeror’s degree of responsibility for award, will review the offeror’s submission in light of the short proposal suspense. Elements of the SBSP may be required to be completed after award. APPLICABLE SOLICITATION PROVISIONS: Provision Title Date 52.204-7 System for Award Management OCT 2018 52.204-16 Commercial and Government Entity Code Reporting JUL 2019 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment DEC 2019 52.207-6 Solicitation of Offers from Small Business Concerns and Small Business Teaming Arrangements or Joint Ventures (Multiple-Award Contracts) OCT 2016 52.209-7 Information Regarding Responsibility Matters OCT 2018 52.212-1 Instructions to Offerors—Commercial Items CD 2018-O0018 OCT 2018 52.212-2 Evaluation-Commercial Items OCT 2014 52.212-3 Offeror Representations and Certifications—Commercial Items--Alternate I OCT 2014 252.203-7005 Representation Relating to Compensation of Former DoD Officials NOV 2011 252.204-7016 Covered Defense Telecommunications Equipment or Services--Representation DEC 2019 252.204-7017 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services--Representation DEC 2019 252.219-7000 Advancing Small Business Growth SEP 2016 252.225-7000 Buy American--Balance of Payments Program Certificate--Basic NOV 2014 252.225-7020 Trade Agreements Certificate--Basic NOV 2014 252.225-7031 Secondary Arab Boycott of Israel JUN 2005 252.225-7050 Disclosure of Ownership or Control by the Government of a Country that is a State Sponsor of Terrorism DEC 2018 252.247-7022 Representation of Extent of Transportation by Sea JUN 2019 APPLICABLE CONTRACT CLAUSES: Clause Title Date Included in FAR 52.212-5 52.203-6 Restrictions on Subcontractor Sales to the Government--Alternate I OCT 1995 Yes 52.203-12 Limitation on Payments to Influence Certain Federal Transactions OCT 2010 52.203-13 Contractor Code of Business Ethics and Conduct OCT 2015 Yes 52.203-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements JAN 2017 Yes 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards OCT 2018 Yes 52.204-13 System for Award Management Maintenance OCT 2018 52.204-18 Commercial and Government Entity Code Maintenance JUL 2016 52.204-21 Basic Safeguarding of Covered Contractor Information Systems JUN 2016 52.204-23 Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities JUL 2018 Yes 52.204-25 Prohibition of Contracting for Certain Telecomunications and Video Surveillance Services or Equipment AUG 2019 Yes 52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment OCT 2015 Yes 52.209-9 Updates of Publicly Available Information Regarding Responsibility Matters OCT 2018 Yes 52.209-10 Prohibition on Contracting with Inverted Domestic Corporations NOV 2015 Yes 52.212-4 Contract Terms and Conditions—Commercial Items OCT 2018 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Items MAR 2020 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns--Alternate I MAR 2020 Yes 52.219-8 Utilization of Small Business Concerns OCT 2018 Yes 52.219-9 Small Business Subcontracting Plan MAR 2020 Yes 52.219-16 Liquidated Damages - Subcontracting Plan JAN 1999 Yes 52.219-28 Post-Award Small Business Program Rerepresentation MAR 2020 Yes 52.222-3 Convict Labor JUNE 2003 Yes 52.222-19 Child Labor—Cooperation with Authorities and Remedies JAN 2020 Yes 52.222-21 Prohibition of Segregated Facilities APR 2015 Yes 52.222-26 Equal Opportunity--Alternate I FEB 1999 Yes 52.222-35 Equal Opportunity for Veterans--Alternate I JUL 2014 Yes 52.222-36 Equal Opportunity for Workers with Disabilities--Alternate I JUL 2014 Yes 52.222-37 Employment Reports on Veterans FEB 2016 Yes 52.222-40 Notification of Employee Rights Under the National Labor Relations Act DEC 2010 Yes 52.222-50 Combating Trafficking in Persons JAN 2019 Yes 52.222-54 Employment Eligibility Verification OCT 2015 Yes 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving AUG 2011 Yes 52.225-13 Restrictions on Certain Foreign Purchases JUN 2008 Yes 52.232-33 Payment by Electronic Funds Transfer—System for Award Management OCT 2018 Yes 52.232-40 Providing Accelerated Payments to Small Business Subcontractors DEC 2013 52.233-3 Protest after Award AUG 1996 Yes 52.233-4 Applicable Law for Breach of Contract Claim OCT 2004 Yes 52.242-5 Payments to Small Business Subcontractors JAN 2017 Yes 52.252-2 Clauses Incorporated by Reference FEB 1998 252.203-7000 Requirements Relating to Compensation of Former DoD Officials SEP 2011 252.203-7003 Agency Office of the Inspector General AUG 2019 252.204-7003 Control of Government Personnel Work Product APR 1992 252.204-7015 Notice of Authorized Disclosure of Information for Litigation Support MAY 2016 252.204-7018 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services DEC 2019 252.205-7000 Provision of Information to Cooperative Agreement Holders DEC 1991 252.211-7003 Item Unique Identification and Valuation MAR 2016 252.219-7003 Small Business Subcontracting Plan (DoD Contracts)--Basic DEC 2019 252.223-7008 Prohibition of Hexavalent Chromium JUN 2013 252.225-7001 Buy American and Balance of Payments Program--Basic DEC 2017 252.225-7012 Preference for Certain Domestic Commodities DEC 2017 252.225-7021 Trade Agreements--Basic SEP 2019 252.226-7001 Utilization of Indian Organizations, Indian-Owned Economic Enterprises, and Native Hawaiian Small Business Concerns APR 2019 252.227-7015 Technical Data--Commercial Items FEB 2014 252.227-7037 Validation of Restrictive Markings on Technical Data SEP 2016 252.232-7003 Electronic Submission of Payment Requests and Receiving Reports DEC 2018 252.232-7006 Wide Area WorkFlow Payment Instructions DEC 2018 252.232-7010 Levies on Contract Payments DEC 2006 252.232-7017 Accelerating Payments to Small Business Subcontractors--Prohibition on Fees and Consideration APR 2020 252.243-7002 Requests for Equitable Adjustment DEC 2012 252.244-7000 Subcontracts for Commercial Items JUN 2013 252.247-7023 Transportation of Supplies by Sea--Basic FEB 2019 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns (DEVIATION 2020-O0008) MAR 2020 52.219-9 Small Business Subcontracting Plan (DEVIATION) 2018-O0018 MAR 2020 PROPOSAL SUBMISSION INSTRUCTIONS: Questions regarding this Proposal shall be submitted in writing and directed via e-mail to the Contracting Officer, Aaron Skinner, aaron.d.skinner.civ@mail.mil and the Contract Specialists, Gentian Mulla, gentian.mulla.civ@mail.mil and Tyler Gates, tyler.n.gates2.civ@mail.mil. All correspondence shall reference RFP Number: W911SR20R0003. The cut-off for questions is June 2, 2020 at 4:30 p.m. Eastern Time. Any answers that the Government provides will be distributed electronically so all interested parties will see all questions submitted by potential Offerors and the Government’s answers. The identity of the person or company asking the question(s) will not be disclosed. Proposal Submission: All proposals shall be submitted via direct email to the Contracting Officer, Aaron Skinner, aaron.d.skinner.civ@mail.mil and the Contract Specialists, Gentian Mulla, gentian.mulla.civ@mail.mil and Tyler Gates, tyler.n.gates2.civ@mail.mil by June 09, 2020 at 4:30 p.m. Eastern Time. It is the Offeror’s responsibility to ensure its Proposal is received by the date and time specified above. If the Offeror’s proposal is not received by the Contracting Officer by the exact date and time specified above, it may be determined late, not evaluated, and may not be considered for Award. Proposal, as the term is used here, means ALL parts of the Proposal.
Data sourced from SAM.gov.
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