SRM 3949 Folate Vitamers Human serum

TITLE: The National Institute of Standards and Technology (NIST) has a requirement for Preparation of SRM 3949 Folate Vitamers in Frozen Human Serum. The contractor will prepare 1,000 bottles of each of Levels 1, 2, and 3 of SRM 3949. Each bottle will contain nominally 1 mL of serum (1.1 mL dispensed with accuracy better than 0.1 mL). Prior to filling, the contractor will label vials with labels that are appropriate for use at low temperature; these labels will be provided by NIST. THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A SEPARATE WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THE SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES UNDER THE AUTHORITY OF FAR 13. This solicitation is a Request for Quotation Proposal (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-60 1352.215-72 INQUIRIES (APR 2010) Offerors must submit all questions concerning this solicitation in writing to michael.szwed@nist.gov. Questions should be received no later than 4 calendar days after the issuance date of this solicitation. Any responses to questions will be made in writing, without identification of the questioner, and will be included in an amendment to the solicitation. Even if provided in other form, only the question responses included in the amendment to the solicitation will govern performance of the contract. (End of Provision) The associated North American Industrial Classification System (NAICS) code for this procurement is 325413 with a small business size standard of 500 employees. This acquisition is set aside for small business. All offerors shall provide a quotation for the following line items: Line Item 0001: SRM 3949 Folate Vitamers in frozen Human Serum Vials. There are a total of 3000 vials. The 3000 vials shall be 1000 vials each of level one, level two and level three of SRM 3949. PERFORMANCE WORK STATEMENT Preparation of SRM 3949 Folate Vitamers in Frozen Human Serum I. BACKGROUND Standard Reference Material (SRM) 1955 Homocysteine and Folate in Frozen Human Serum was issued by NIST in 2005 and was developed in collaboration with the Centers for Disease Control and Prevention (CDC). SRM 1955 consists of three pools with varying concentrations of folate species (vitamers). In the age of folic acid fortification in the U.S., there is continued interest in monitoring the folate status of both individuals and populations because adverse health effects could occur from inadequate folate intake and excessive intake of folic acid. In addition, concentrations of the folate species 5-methyltetrahydrofolate (5-methylTHF) and folic acid (PGA) currently detected in serum may exceed the highest concentration of these species found in SRM 1955 (? 37 nmol/L for 5-methyltetrahydrofolate and ? 1 nmol/L for folic acid). Also, other folate species, such as tetrahydrofolic acid (THF), 5-formyltetrahydrofolic acid (5-formylTHF), and 5,10-methenyltetrahydrofolic acid (5,10-methenylTHF) as well as an oxidation product of 5-methylTHF called MeFox may also be present in serum samples. SRM 1955 does not have certified values for these folate species. There is currently less than a five year supply of SRM 1955, and SRM 3949 Folate Vitamers in Frozen Human Serum shall be developed as a replacement for SRM 1955. II. SCOPE OF WORK The contractor shall produce approximately 1000 sales units of this SRM, and each unit consists of three vials of serum (1 mL) at each of three different folate vitamer concentration levels. The contractor shall acquire approximately 3.3 L human serum to prepare the three pools required. The specific target values for each pool are listed below. Unless otherwise noted, all concentrations must be achieved through blending of donor units of human serum. Fortification (spiking) of serum to achieve the target concentrations shall not be considered technically acceptable for Levels 1 and Level 2, but shall be considered technically acceptable to achieve the target concentrations of 5-formylTHF and 5,10-methenylTHF for Level 3. Dilution of serum with phosphate-buffered saline (PBS) may be required to achieve the target concentration of 5-methylTHF in Level 1. Supplementation of donors with folic acid (i.e., a multivitamin containing 400 - g/tablet) approximately 1 hr prior to blood draw shall likely be required to achieve the target concentration of folic acid in Level 2. Ascorbic acid (0.5% w/v) should be added to the serum as early as possible to minimize oxidation of folate species. Ideally, the ascorbic acid should be added to serum as soon as the serum is prepared from whole blood. Level 1: Human serum containing 10 nmol/L - 5 nmol/L 5-methylTHF and 1 nmol/L - 0.5 nmol/L PGA Level 2: Human serum containing 50 nmol/L - 5 nmol/L 5-methylTHF and 10 nmol/L - 4 nmol/L folic acid Level 3: Human serum containing 30 nmol/L - 5 nmol/L 5-methylTHF; 5 nmol/L - 3 nmol/L PGA; 5 nmol/L - 3 nmol/L THF; 5 nmol/L - 3 nmol/L 5-formylTHF; 5 nmol/L - 3 nmol/L 5,10-methenylTHF; and 5 nmol/L - 3 nmol/L MeFox The contractor shall collect serum units along with pilot tubes containing a minimum of 1 mL serum for each donor unit. These pilot tubes shall be provided to NIST for measurement of folate species content by liquid chromatography-tandem mass spectrometry. NIST will specify a blending protocol to achieve target concentrations in each of the three levels. The donor units selected shall then be pooled. The contractor shall thoroughly blend and filter (2 micrometer) the serum. The contractor shall then dispense the serum into labeled amber glass serum bottles capable of withstanding ultracold temperatures (-80 ?C), each containing nominally 1 mL of serum (1.1 mL dispensed with an accuracy better than 0.1 mL), and seal under nitrogen with a butyl rubber stopper and an aluminum crimp cap. The aluminum crimp cap shall be a different color for each of the three different levels. The contractor shall acquire the serum, amber glass serum bottles (3 mL) capable of withstanding ultra-cold temperatures (minimum of -80 degrees C), butyl rubber stoppers, and color-coded aluminum crimp caps (one color for each of the three levels); blend serum pools as necessary; label the bottles prior to filling; and ship the material on dry ice overnight to NIST. NIST shall provide the labels for all three levels. III. SPECIFIC TASKS The contractor shall collect serum units along with pilot tubes containing a minimum of 1 mL serum for each donor unit. These pilot tubes shall be provided to NIST for measurement of folate vitamer content by liquid chromatography-tandem mass spectrometry. NIST will specify a blending protocol to achieve target concentrations in each of the three levels. The contractor shall acquire a total of approximately 3.3 L of human serum containing appropriate levels to blend into the three pools. The target concentrations for the three human serum pools are listed below: Level 1: Human serum containing 10 nmol/L - 5 nmol/L 5-methylTHF and 1 nmol/L - 0.5 nmol/L PGA Level 2: Human serum containing 50 nmol/L - 5 nmol/L 5-methylTHF and 10 nmol/L - 4 nmol/L folic acid Level 3: Human serum containing 30 nmol/L - 5 nmol/L 5-methylTHF; 5 nmol/L - 3 nmol/L PGA; 5 nmol/L - 3 nmol/L THF; 5 nmol/L - 3 nmol/L 5-formylTHF; 5 nmol/L - 3 nmol/L 5,10-methenylTHF; and 5 nmol/L - 3 nmol/L MeFox The contractor shall thoroughly blend and filter (2 micrometer) the serum. The contractor shall test the serum pools for biosafety. All sera shall be demonstrated to be non-reactive when tested for hepatitis B surface antigen, hepatitis C virus, human immunodeficiency virus, and human immunodeficiency virus antigen 1 by tests licensed by the U.S. Food and Drug Administration. The contractor shall prepare 1,000 bottles of each of Levels 1, 2, and 3 of SRM 3949. Each bottle shall contain nominally 1 mL of serum (1.1 mL dispensed with accuracy better than 0.1 mL). Prior to filling, the contractor shall label vials with labels that are appropriate for use at low temperature; these labels shall be provided by NIST. Provision for an overage of 5 % (50 vials) of each level is permitted, however if additional vials of one level are provided, a similar number of vials of the other two levels must also be provided. Bottles shall be amber glass, and be capable of withstanding ultra-cold temperatures. Bottles shall be sealed with a butyl rubber stopper, and a color-coded aluminum crimp cap shall be applied. Bottles shall be transferred, in fill order, from the bottling equipment to a box in a "Z" pattern, filling each row left to right. The location of the first bottle in each box shall be noted on each side of the outside corner of the box, and boxes shall be numbered sequentially. Boxes shall be labeled to indicate their contents. Materials shall be stored frozen (-80 degrees C) prior to overnight shipment on dry ice to NIST. Delivery is expected within 120 days after receipt of labels by the contractor. IV. PROTECTION OF HUMAN SUBJECTS Research involving human subjects is not permitted under this award unless expressly authorized in writing by the NIST Contracting Officer. Such writing shall specify the details of the approved research involving human subjects and shall be incorporated by reference into this Contract. The Federal Policy for the Protection of Human Subjects (the "Common Rule"), adopted by the Department of Commerce at 15 CFR Part 27, requires Contractors to maintain appropriate policies and procedures for the protection of human subjects in research. The Common Rule defines a "human subject" as a living individual about whom an investigator conducting research obtains 1) data through intervention or interaction with the individual, or 2) identifiable private information. The term "research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The Common Rule also sets forth categories of research that may be considered exempt from this policy. These categories may be found at 15 CFR 27.101(b). In the event the human subjects research involves pregnant women, prisoners, or children, Contractor is also required to follow the guidelines set forth at 45 CFR Part 46 Subpart B, C and D, as appropriate, for the protection of members of a protected class. Should research involving human subjects be included in the proposal, prior to issuance of an award, Contractor shall submit the following documentation to the NIST Contracting Officer: Documentation to verify that Contractor has established a relationship with an appropriate Institutional Review Board ("cognizant IRB"). An appropriate IRB is one that is located within the United States and within the community in which the human subjects research shall be conducted; Documentation to verify that the cognizant IRB is registered with the United States Department of Health and Human Services' Office for Human Research Protections ("OHRP") and is designated as Contractor's cognizant IRB; Documentation to verify that Contractor has a valid Federal-wide Assurance (FWA) issued by OHRP. Prior to starting any research involving human subjects, Contractor shall submit appropriate documentation to the Contracting Officer for NIST institutional review and approval. This documentation may include: (1)Copies of the human subjects research protocol, all questionnaires, surveys, advertisements, and informed consent forms approved by the cognizant IRB; (2)Documentation of approval for the human subjects research protocol, questionnaires, surveys, advertisements, and informed consent forms by the cognizant IRB; (3)Documentation of continuing IRB approval by the cognizant IRB at appropriate intervals as designated by the IRB, but not less than annually; (4)Documentation to support an exemption for the project from the Common Rule [NOTE: this option is not available for activities that fall under 45 CFR Part 46 Subpart C]; and/or (5)Documentation to support a request for a deferral of review for research involving human subjects beginning after year 1 of the project; In addition, if Contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed consent form approved by the cognizant IRB, Contractor shall submit a copy of all modified material along with documentation of approval for said modification by the cognizant IRB to the NIST Contracting Officer for NIST Institutional review and approval. Contractor may not implement any IRB approved modification without written approval by the NIST Contracting Officer. No work involving human subjects may be undertaken, conducted, or costs incurred and/or charged to the project, until the NIST Contracting Officer approves the required appropriate documentation in writing. V. DELIVERABLES The contractor shall provide NIST with 1,000 bottles of each of the three materials as described above. Each bottle shall contain 1 mL of serum. An allowance is made for an overage of 5 % (50 vials) of each level. However, if additional vials of one level are provided, a similar number of vials of the other levels must be provided. The contractor shall provide NIST with details of the steps involved in material preparation. Documentation indicative of biosafety shall be required with shipment of the final material. VI. DELIVERABLE DUE DATES AND/OR PERIOD OF PERFORMANCE Delivery is expected within 120 days after the contractor receives the labels from NIST. VII. GOVERNMENT-FURNISHED PROPERTY, DATA, AND/OR INFORMATION NIST shall provide the contractor with labels appropriate for use at the low temperature at which NIST shall store the material upon receipt. VIII. PERFORMANCE REQUIREMENT SUMMARY Required Service Production of 1,000 bottles of each of Levels 1, 2, and 3 of SRM 3949 with an overage allowance of 5 % (50 bottles) of each level. A similar number of bottles of each level must be provided. Performance Standard 1. Materials shall be prepared and packaged as described in the PWS and meet all specifications set forth in the PWS. 2. A minimum of 1,000 bottles of each of the three materials shall arrive intact and unbroken. Acceptable Quality Level The material must be suitable for use as an SRM. If deficiencies or inconsistencies between the material and the documentation are found, or if less than the stated number of bottles are received intact, the contractor has 30 days to correct the deficiency. Monitoring Method The NIST Point of Contact (POC) shall know that the SRMs were successfully prepared when they are analyzed as part of the value assignment process. PROVISIONS AND CLAUSES: The following provisions and clauses apply to this acquisition and are hereby incorporated by reference. All FAR clauses may be viewed at http://acquisition.gov/comp/far/index.html. Those marked with an asterisk are provided in full text in Attachment 1. Provisions 52.212-1, Instructions to Offerors-Commercial Items 52.212-3 Offeror Representations and Certifications-Commercial Items Offerors shall complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3 Offerors Representations and Certifications- Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. Clauses 52.212-4 Contract Terms and Conditions-Commercial Items 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (APR 2010) 52.203-6, Restrictions on Subcontractor Sales to the Government 52.204-10 - Reporting Executive Compensation and First-Tier Subcontract Awards. 2.223-18, Contractor Policy to Ban Text Messaging while Driving- 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns 52.219-8, Utilization of Small Business Concerns 52.222-3, Convict Labor; 52.222-19 Child Labor - Cooperation with Authorities and Remedies; 52.222-21, Prohibition of Segregated Facilities; 52-222-26, Equal Opportunity; 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans 52.222-36, Affirmative Action for Workers with Disabilities; 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans 52.223-18, Contractor Policy to Ban Text Messaging while Driving 52.225-1, Buy American Act - Supplies 52.225-13 Restriction on Certain Foreign Purchases; 52.232-30, Installment Payments for Commercial Items 52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration. 52.247-34 F.O.B. Destination 52.211-16 Variation in Quanity 52.252-2 Clauses Incorporated by Reference 1352.201-70 Contracting Officer's Authority 1352.209-73 Compliance With The Laws 1352.237-71 Security Processing Requirements - Low Risk Contracts 1352.235-70 Protection of human subjects. 1352.235-70 Protection of human subjects. Protection of Human Subjects (APR 2010) (a) Research involving human subjects is not permitted under this award unless expressly authorized in writing by the Contracting Officer. Such authorization will specify the details of the approved research involving human subjects and will be incorporated by reference into this contract. (b) The Federal Policy for the Protection of Human Subjects (the "Common Rule"), adopted by the Department of Commerce at 15 CFR part 27, requires contractors to maintain appropriate policies and procedures for the protection of human subjects in research. The Common Rule defines a "human subject" as a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information. The term "research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. The Common Rule also sets forth categories of research that may be considered exempt from 15 CFR part 27. These categories may be found at 15 CFR 27.101(b). (c) In the event the human subjects research involves pregnant women, prisoners, or children, the contractor is also required to follow the guidelines set forth at 45 CFR part 46 subpart B, C and D, as appropriate, for the protection of members of a protected class. (d) Should research involving human subjects be included in the proposal, prior to issuance of an award, the contractor shall submit the following documentation to the Contracting Officer: (1) Documentation to verify that contractor has established a relationship with an appropriate Institutional Review Board ("cognizant IRB"). An appropriate IRB is one that is located within the United States and within the community in which the human subjects research will be conducted; (2) Documentation to verify that the cognizant IRB possesses a valid registration with the United States Department of Health and Human Services' Office for Human Research Protections ("OHRP"); (3) Documentation to verify that contractor has a valid Federal-wide Assurance (FWA) issued by OHRP. (e) Prior to starting any research involving human subjects, the contractor shall submit appropriate documentation to the Contracting Officer for institutional review and approval. This documentation may include: (1) Copies of the human subjects research protocol, all questionnaires, surveys, advertisements, and informed consent forms approved by the cognizant IRB; (2) Documentation of approval for the human subjects research protocol, questionnaires, surveys, advertisements, and informed consent forms by the cognizant IRB; (3) Documentation of continuing IRB approval by the cognizant IRB at appropriate intervals as designated by the IRB, but not less than annually; and/or (4) Documentation to support an exemption for the project from the Common Rule [ Note: this option is not available for activities that fall under 45 CFR part 46 subpart C]. (f) In addition, if the contractor modifies a human subjects research protocol, questionnaire, survey, advertisement, or informed consent form approved by the cognizant IRB, the contractor shall submit a copy of all modified material along with documentation of approval for said modification by the cognizant IRB to the Contracting Officer for institutional review and approval. The contractor shall not implement any IRB approved-modification without written approval by the Contracting Officer. (g) No work involving human subjects may be undertaken, conducted, or costs incurred and/or charged to the project, until the Contracting Officer approves the required appropriate documentation in writing. (End of provision) INSTRUCTIONS: Central Contractor Registration In accordance with FAR 52.204-7, the awardee must be registered in the Central Contractor Registration (www.ccr.gov) prior to award. Refusal to register shall forfeit award. Due Date for Quotation Venders shall submit their quotations electronically via Federal Business Opportunities thru the FBO Bid Module for this requirement not later than 1:00 p.m. Eastern Time on Thursday, September 6, 2012. FAX quotations shall not be accepted. E-mail quotations shall not be accepted. Quotations shall not be deemed received by the Government until the quotation is entered into the FBO Bid Module set forth above. Addendum to FAR 52.212-1, Quotation Preparation Instructions 1) Price Quotation: The vender shall propose a firm-fixed-price, preferably FOB Destination, for CLIN. 0001 . Price quotations shall remain valid for a period of 60 days from the date quotations are due. 2) Technical Quotation: The vender shall submit technical information with pricing information. The technical quotation shall address the following: Technical Capability: The offeror shall submit a technical description or product literature for the equipment it is proposing, which clearly identifies the manufacturer, make and model. The offeror must demonstrate that its proposed equipment meets or exceeds each minimum requirement described in the statement of work by providing a citation to the relevant section of its technical description or product literature and include Warranty: terms and conditions. If applicable, evidence that the vender is authorized by the original equipment manufacturer to provide the item(s) in the quotation should be included. Acceptance of Terms and Conditions: This is an open-market solicitation for the supply of Human Serum as defined herein. The Government intends to award a Purchase Order as a result of this solicitation that will include the clauses set forth herein. "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." Note: This procurement is not being conducted under the GSA Federal Supply Schedule (FSS) program or another Government-Wide Area Contract (GWAC). If an offeror submits a quotation based upon an FSS or GWAC contract, the Government will accept the quoted price. However, the terms and conditions stated herein will be included in any resultant Purchase Order, not the terms and conditions of the offeror's FSS or GWAC contract, and the statement required above shall be included in the quotation. QUOTATION EVALUATION: Evaluation Factors Award shall be made to the offeror whose product meets or exceeds the technical specifications and is the lowest price. Technical Capability: No prototypes, demonstration models, used or refurbished instruments will be considered. Evaluation of technical capability shall be based on the information provided in the quotation. NIST will evaluate whether the offeror has demonstrated that its proposed quotation meets or exceeds all minimum requirements. Quotations that do not demonstrate they meet the Scope of Work on all requirements will not be considered further for award. If a vender does not indicate whether its proposed equipment meets a certain minimum requirement, NIST will determine that it does not. Price: The Government will evaluate price for reasonableness. Non-Governmental Acquisition Support The Government may utilize non-Governmental acquisition support for processing of quotations submitted in response to this solicitation. These individual(s) will have access to the quotation information and will be assisting the Contracting Officer in the procurement process by performing services including, but not limited to, preparing the quotations for submission to the technical evaluators, performing past performance checks, and preparing award documents. The non-Governmental acquisition support will not conduct technical evaluations of any quotation and will not be involved in the final decision as to the awardee under this procurement. 1352.233-70 AGENCY PROTESTS (APR 2010) (a) An agency protest may be filed with either: (1) the contracting officer, or (2) at a level above the contracting officer, with the appropriate agency Protest Decision Authority. See 64 Fed. Reg. 16,651 (April 6, 1999) (b) Agency protests filed with the Contracting Officer shall be sent to the following address: NIST/ACQUISITION MANAGEMENT DIVISION ATTN: Cheryl Rice, CONTRACTING OFFICER 100 Bureau Drive, MS 1640 Gaithersburg, MD 20899 (c) Agency protests filed with the agency Protest Decision Authority shall be sent to the following address: NIST/ACQUISITION MANAGEMENT DIVISION ATTN: HEAD OF THE CONTRACTING OFFICE (HCO) 100 Bureau Drive, MS 1640 Gaithersburg, MD 20899 (d) A complete copy of all agency protests, including all attachments, shall be served upon the Contract Law Division of the Office of the General Counsel within one day of filing a protest with either the Contracting Officer or the Protest Decision Authority. (e) Service upon the Contract Law Division shall be made as follows: U.S. Department of Commerce Office of the General Counsel Chief, Contract Law Division Room 5893 Herbert C. Hoover Building 14th Street and Constitution Avenue, N.W. Washington, D.C. 20230. FAX: (202) 482-5858 1352.233-71 GAO AND COURT OF FEDERAL CLAIMS PROTESTS (APR 2010) (a) A protest may be filed with either the Government Accountability Office (GAO) or the Court of Federal Claims unless an agency protest has been filed. (b) A complete copy of all GAO or Court of Federal Claims protests, including all attachments, shall be served upon (i) the Contracting Officer, and (ii) the Contract Law Division of the Office of the General Counsel, within one day of filing a protest with either GAO or the Court of Federal Claims. (c) Service upon the Contract Law Division shall be made as follows: U.S. Department of Commerce Office of the General Counsel Chief, Contract Law Division Room 5893 Herbert C. Hoover Building 14th Street and Constitution Avenue, N.W. Washington, D.C. 20230. FAX: (202) 482-5858 (End of clause)