Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF AUGUST 22, 2014 FBO #4654
SOLICITATION NOTICE

B -- Induced Pluripotent Stem Cell Cardiomyocyte Generation

Notice Date

8/20/2014
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

541712 — Research and Development in the Physical, Engineering, and Life Sciences (except Biotechnology)
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

FDA-SOL-1133767
 

Archive Date

9/13/2014
 

Point of Contact

Howard S. Yablon, Phone: 2404027630
 

E-Mail Address

howard.yablon@fda.hhs.gov
(howard.yablon@fda.hhs.gov)
 

Small Business Set-Aside

N/A
 

Description

Solicitation Number: FDA-SOL-1133767 Subject: Induced Pluripotent Stem Cell Cardiomyocyte Generation Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. Solicitation FDA-SOL-1133767 is being issued as a Request for Quotation (RFQ). The solicitation and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-76. This requirement is being solicited under full and open competition using Simplified Acquisition Procedures per FAR Subpart 13.5. The associated North American Industrial Classification System (NAICS) code for this procurement is 541712, with a small business size standard of 500 employees. The U. S. Food & Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) is seeking to purchase a study in which the contractor is to the contractor to reprogram peripheral blood mononuclear cells (PBMCs) to induced pluripotent stem cells (iPSCs) and then differentiate the iPSCs to cardiomyocytes for 20 human subjects. The contractor would then work interactively with FDA while laboratory electrophysiology assays are performed to study the response of the iPSC-cardiomyocytes to the same drugs that were studied clinically. 1.1 Contract Type The government intends to award a firm-fixed price contract. 1.2 Pricing CLIN Description Qty Unit Price Unit of Issue Extended Price 0001 Reprogram peripheral blood mononuclear cells (PBMCs) to induced pluripotent stem cells (iPSCs) and then differentiate the iPSCs to cardiomyocytes for 20 human subjects. 1 $ ea $ Total $ SECTION 2 - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT Statement of Work Induced Pluripotent Stem Cell Cardiomyocyte Generation 2.1 Background: Individual patients respond differently to medical therapies. Personalized medicine uses a diagnostic test to predict how patients will respond to therapies. FDA is currently conducting a clinical study to evaluate the ability of novel electrocardiographic (ECG) methods to identify how five drugs interact with the heart's ion channels. The title of the study is "Five Period Crossover Study of the Ability of Late Sodium or Calcium Current Block (Mexiletine, Lidocaine or Diltiazem) to Balance the Electrocardiographic Effects of hERG Potassium Current Block (Dofetilide or Moxifloxacin)." However, these ECG methods can be used only after subjects receive the drugs. Methods have been developed to take blood or skin cells from individual subjects, reprogram the cells to induced pluripotent stem cells (iPSCs) and subsequently differentiate the cells to cardiomyocytes. The subject-specific iPSC-cardiomyocytes can then be studied in laboratory assays to determine how each subject's cells respond to drugs. Previously, this has been performed for patients with congenital long QT syndrome and it was shown that the subject-specific iPSC-cardiomyocytes exhibited the same characteristics (prolonged action potential duration or QT) as the patients clinical ECGs. 2.2 Objectives: The objective of this contract is to reprogram peripheral blood mononuclear cells (PBMCs) to induced pluripotent stem cells (iPSCs) and then differentiate the iPSCs to cardiomyocytes for 20 human subjects. The contractor would then work interactively with FDA while laboratory electrophysiology assays are performed to study the response of the iPSC-cardiomyocytes to the same drugs that were studied clinically. 2.3 Specific Requirements: Task 1: Study Protocol The Contractor shall develop a protocol for the planned study, which shall include at a minimum: • Key personnel • Facilities • Study Design including description of cell reprogramming into a pluripotent state along with cardiomyocyte differentiation • Data quality plan • Data storage and accessibility plan The Contractor shall submit the protocol to the Government for review. The Government will review the protocol and provide comments to the Contractor within 10 days of receiving the draft. After receiving comments from the Government on the protocol, the Contractor shall submit a final copy of the protocol to the FDA within 10 days. Task 2: Generation of Induced Pluripotent Stem Cells (iPSCs) The Contractor shall reprogram peripheral blood mononuclear cells (PBMCs) into induced pluripotent stem cells (iPSCs) for all 20 subjects. For each subject, sufficient iPSCs should be generated to differentiate the required number of iPSC-cardiomyocytes identified in Task 3. In addition, 5 vials (>1 million viable cells per vial) of iPSCs per subject should be shipped to FDA and 10 vials (>1 million viable cells per vial) of iPSCs per subject shall be stored until further instruction by FDA for potential submission to a biobank. Unused PBMCs shall be stored until further instruction from FDA to either destroy the samples or return to FDA upon request. The contractor shall have the ability to store all cells up until the end of the Contract (36 months). Upon complete generation of iPSCs, the contractor shall submit a report to FDA including quality control testing results. Task 3: Differentiation of iPSCs into Cardiomyocytes The Contractor shall perform terminal differentiation of iPSCs from Task 2 into cardiomyocytes (iPSC-cardiomyocytes). Differentiated iPSC-cardiomyocytes shall exhibit biochemical and electrophysiological characteristics of normal human ventricular cells, form electrically connected monolayers, and demonstrate spontaneous beating. The cells shall remain pure and alive in culture for at least three (3) weeks after plating to allow consistent drug testing. The contractor shall ship to FDA enough cells for plating ten 96-well plates of iPSC-cardiomyocytes in a beating syncytium for each of the 20 subjects. The iPSC-cardiomyocytes shall be shipped by the end of the first year of the contract. The Contractor shall provide FDA with all necessary plating and culturing media to maintain each batch of cells in culture, for up to 1 month if necessary. The Contractor shall provide FDA with certificates of analysis on each batch of iPSC-cardiomyocytes, including purity, sterility, plating efficiency, and viability of the cells, as well as results of functionality assessment analysis, including spontaneous beating rate and field potential duration according to the Contractor's quality control standards. Task 4: Communicate with FDA during electrophysiology assay study period (years 2 and 3) FDA will study subject-specific drug effects using iPSC-cardiomyocytes obtained from the Contractor. There may be need for FDA to communicate with the Contractor during this period and for the Contractor to work interactively with FDA during this phase including FDA's preparation of scientific manuscripts. The Contractor will not be required to take a lead role in writing the manuscripts. Contractor personnel contributing to the study as defined by standard peer-review journal guidelines would be co-authors on the manuscripts. 2.4 Deliverables: Deliverables are outlined in detail in the Task descriptions 1 through 4 in Section 2.3 above. Deliverable due dates are listed below. Description Due Date Task 1: Study protocol 30 calendar days after contract is awarded Task 2: iPSC generation for 20 subjects 6 months after contract is awarded Task 3: iPSC cardiomyocytes for 20 subjects 10 months after contract is awarded Task 4: Interactively communicate with FDA during publication preparation Until the end of the contract 2.5 Period of Performance: The period of performance for this study is 3-years. 2.6 Place of Performance: All work for Tasks 1 through 3 under this study shall be performed off-site at the Contractor's facility. The Contractor shall work interactively with FDA under Task 4 for the electrophysiology experiments that will be performed outside of the Contractor's facility. SECTION 3 - CONTRACT CLAUSES 3.1 FAR Clause 52.212-4 -Contract Terms and Conditions -- Commercial Items (May 2014) and below addendum is applicable 3.1.1 FAR 52.252-2 -- Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: www.acquisition.gov/far/index.html and http://www.hhs.gov/policies/hhsar/subpart301-1.html. FAR Clause Title Date Reference 52.227-14 Rights in Data -- General May 2014 27.409(b)(1) 52.232-40 Providing Accelerated Payments to Small Business Subcontractors Dec 2013 32.009-2 HHSAR Title Date Reference 352.202-1 Definitions Jan 2006 FAR 2.201 352.203-70 Anti-lobbying Jan 2006 303.808-70 352.222-70 Contractor Cooperation in Equal Employment Opportunity Investigations Jan 2010 322.810(h), 352.223-70 Safety and Health Jan 2006 323.7002(a) 352.224-70 Privacy Act Jan 2006 342.7003-1(a) 352.227-70 Publications and Publicity Jan 2006 327.404-70 352.239-73 Electronic and Information Technology Accessibility Jan 2010 339.201-70(c) 3.1.3 HHSAR 352.242-70 Key Personnel (January 2006) The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the contractor or Government. The Key Personnel under this Contract are: Principle Investigator -- must have a doctoral degree (PhD, MD or equivalent) with experience generating iPSCs and deriving iPSC-cardiomyocytes. 3.1.4 Contracting Officer's Representative (COR) The following COR will represent the Government for the purpose of this contract: TBD at Time of Award. FDA Street 1 Street 2 City/State/Zip Code a. The COR may be changed at any time by the Government without prior notice to the Contractor by a unilateral modification to the Contract. b. The responsibilities and limitations of the COR are as follows: (1) The COR is responsible for the technical aspects of the project and serves as technical liaison with the Contractor. The COR is also responsible for the final inspection and acceptance of all reports, and such other responsibilities as may be specified in the contract. (2) The COR is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the Contract price, terms or conditions. Any Contractor request for changes shall be referred to the Contracting Officer directly or through the COR. No such changes shall be made without the expressed prior authorization of the Contracting Officer (CO). The CO may designate assistant or alternate CORs to act for the COR by naming such assistant/alternate(s) in writing and transmitting a copy of such designation to the Contractor. 3.1.5 Contracting Officer (CO) The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in a task order; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract. The contact information for the Contracting Officer is: Gina Jackson Gina.Jackson@fda.hhs.gov Tel: (240)402-7590; Fax: (301) 827-7101 The contact information for the Contract Specialist is: Howard Yablon 5630 Fishers Lane Rockville, MD 20852 Howard.Yablon@fda.hhs.gov Tel: (240) 402-7630; Fax: (301) 827-7101 3.1.6 Contractor Performance Evaluation(s) In accordance with Federal Acquisition Regulation (FAR) 42.15, FDA will complete annual and final contractor performance evaluations. Annual evaluations will be prepared to coincide with the anniversary date of the contract. Additional interim performance evaluations may be prepared at Contracting Officer discretion, as necessary. Final performance evaluations will be completed upon contract expiration. FDA will utilize the Contractor Performance Assessment Reporting System (CPARS) in order to execute annual and final contractor performance evaluations. CPARS is a secure Internet website located at http://www.cpars.csd.disa.mil/cparsmain.htm. FDA will register the contractor in CPARS upon receipt of the name and email address of two (2) individuals who will be responsible for serving as the Contractor's primary and alternate CPARS contacts. Once FDA registers the contractor in CPARS, the Contractor will receive an automated CPARS email message which contains User IDs and instructions for creating a password. Once a performance evaluation is issued, the Contractor's primary and alternate CPARS contact will receive an email instructing them to logon to CPARS in order to review the performance evaluation. The Contractor has 30 days from the date of performance evaluation issuance in which to review the evaluation. If the Contractor is in agreement with the performance evaluation outcome, the evaluation becomes final. Should the Contractor be in disagreement with the performance evaluation outcome, rebuttal comments must be submitted via the CPARS within 30 days from date the evaluation was issued by FDA. Any disagreement between the Contracting Officer and the Contractor will be referred to a contracting official one level above the Contracting Officer, whose decision will be final. Copies of each performance evaluation and contractor responses, if any, will be retained as part of the official contract file and will be used to support future award decisions. Evaluations will also be stored for a 3 year period in the Past Performance Information Retrieval System (PPIRS) at www.ppirs.gov. Contractors may obtain CPARS training material and register for on-line training at http://www.cpars.csd.disa.mil/allapps/cpcbtdlf.htm. There is no fee for registration or use of the CPARS 3.1.7 Intellectual Rights and Confidentiality No information furnished to or generated by the Contractor in the performance of this study will be released to the public until it has been reviewed and accepted by the Government Contracting Officer's Representative for accuracy of factual data and interpretation. The Government shall own intellectual rights on the data and analysis resulting of this study and the Contractor shall not present or publish without written permission from the Government. The Government will decide on the authorship of any scientific paper(s) resulting from this study. 3.1.8 Security and Privacy Contractor personnel performing work under this contract shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems. The contractor agrees that contractor personnel will not divulge or release data or information developed or obtained in connection with the performance of the resulting contract, unless made public by FDA or upon written approval from the Government. Except as may otherwise be permitted by a data owner, the contractor personnel agrees not to use, disclose or reproduce proprietary data, other than as required in performance of the contact; provided, however, that nothing herein shall be construed as precluding the use of any data independently acquired by the contractor without such limitation. The contractor shall submit a roster, by name, position and responsibility, of all staff (including subcontractor staff) working under the contract that will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the COR, with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. Any revisions to the roster as a result of staffing changes shall be submitted within 15 calendar days of the change. Each contractor/subcontractor employee who may have access to non-public Department information and/or sensitive information under this contract may be required to sign a Confidentiality form and/or a FDA Form 3398: Contractor's Commitment to Protect Non-Public Information (NPI) Agreement available upon request from the FDA Intranet site. A copy of each signed and witnessed Non-Disclosure agreement shall be submitted to the COR or designee prior to performing any work under the contract. The COR or designee will inform the contractor of the forms and training that are required. However, it is the responsibility of the Contractor to assure that such forms have been signed. 3.1.9 Invoice Submission A. The contractor shall submit all invoices to all addresses in the manner specified below: (I) One original to the Contracting Specialist: U.S. Food and Drug Administration Office of Acquisition and Grants Services ATTN: Howard Yablon, Contracting Specialist 5630 Fishers Lane Room 2139, HFA-500 Rockville, MD 20852 Email: Howard.Yablon@fda,hhs,gov ****Acceptable methods of delivery include: mail, hand delivery and email***** (II) One copy to the Contracting Officer's Representative (COR), clearly marked "Courtesy Copy Only": U.S. Food and Drug Administration ATTN: (To be determined upon contract award); COR Address: Email: XXXXX@fda.hhs.gov *****Acceptable methods of delivery include: mail, hand delivery and email***** B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 -- Prompt Payment and 52.232-33 -- Payment by Electronic Funds Transfer-- System for Award Management and/or applicable Far Clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following: (I) Name and address of the contractor; (II) Invoice Date and Invoice Number; (III) Purchase order/Award Number; (IV) Description, Quantity, Unit of Measure, Unit Price, and Extended Price Supplies Delivered or Services Performed, including: (a) Period of Performance for which costs are claimed; (b) Itemized travel costs, including origin and destination; and (c) Any other supporting information necessary to clarify questionable expenditures; (V) Shipping number and date of shipping, including the bill of lading number and weight of shipment if shipped on government bill of lading; (VI) Terms of any discount for prompt payment offered; (VII) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment) (VIII) Name, title and phone number of person to notify in event of defective invoice; (IX) Taxpayer Identification Number (TIN); (X) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award. (XIII) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes: (a) List of all invoices submitted to date under the subject award, including the following: 1) Invoice number, Amount and Date Submitted; 2) Corresponding payment amount and date received. (b) Total amount of all payments received to date under the subject contract or order. (c) And, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current active period of performance. C. An electronic invoice is acceptable if submitted in Adobe Acrobat (PDF) Format. All items listed in (I) through (XII) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing. D. Questions regarding invoice payments should be directed to the FDA Payment Office at: Office of Financial Services Food and Drug Administration W032- Second Floor MAIL HUB 2145 10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov (End of Addendum to FAR 52.212-4) 3.2 FAR 52.212-5 -- Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items (Jun 2014) applies to this acquisition. The following clauses are applicable. 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct 1995) (41 U.S.C. 253g and 10 U.S.C. 2402). 52.204-10, Reporting Executive compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note). 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Aug 2013) (31 U.S.C. 6101 note). 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer)(15 U.S.C. 657a). 52.219-8, Utilization of Small Business Concerns (May 2014) (15 U.S.C. 637(d)(2) and (3)). 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)). 52.222-3, Convict Labor (June 2003) (E.O. 11755). 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2014) (E.O. 13126). 52.222-21, Prohibition of Segregated Facilities (Feb 1999). 52.222-26, Equal Opportunity (Mar 2007) (E.O. 11246). 52.222-35, Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212). 52.222-36, Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). 52.222-37, Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212). 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). 52.222-54, Employment Eligibility Verification (Aug 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011). 52.225-13, Restrictions on Certain Foreign Purchases (Jun 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury). 52.232-33, Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332). (End of Clause) SECTION 4 - SOLICITATION PROVISIONS 4.1 FAR 52.209-5 -- Certification Regarding Responsibility Matters (Apr 2010) (a) (1) The Offeror certifies, to the best of its knowledge and belief, that -- (i) The Offeror and/or any of its Principals -- (A) Are [_] are not [_] presently debarred, suspended, proposed for debarment, or declared ineligible for the award of contracts by any Federal agency; (B) Have [_] have not [_], within a three-year period preceding this offer, been convicted of or had a civil judgment rendered against them for: commission of fraud or a criminal offense in connection with obtaining, attempting to obtain, or performing a public (Federal, State, or local) contract or subcontract; violation of Federal or State antitrust statutes relating to the submission of offers; or commission of embezzlement, theft, forgery, bribery, falsification or destruction of records, making false statements, tax evasion, violating Federal criminal tax laws, or receiving stolen property (if offeror checks "have", the offeror shall also see 52.209-7, if included in this solicitation); and (C) Are [_] are not [_] presently indicted for, or otherwise criminally or civilly charged by a governmental entity with, commission of any of the offenses enumerated in paragraph (a)(1)(i)(B) of this provision; and (D) Have [_], have not [_], within a three-year period preceding this offer, been notified of any delinquent Federal taxes in an amount that exceeds $3,000 for which the liability remains unsatisfied. (1) Federal taxes are considered delinquent if both of the following criteria apply: (i) The tax liability is finally determined. The liability is finally determined if it has been assessed. A liability is not finally determined if there is a pending administrative or judicial challenge. In the case of a judicial challenge to the liability, the liability is not finally determined until all judicial appeal rights have been exhausted. (ii) The taxpayer is delinquent in making payment. A taxpayer is delinquent if the taxpayer has failed to pay the tax liability when full payment was due and required. A taxpayer is not delinquent in cases where enforced collection action is precluded. (2) Examples. (i) The taxpayer has received a statutory notice of deficiency, under I.R.C. §6212, which entitles the taxpayer to seek Tax Court review of a proposed tax deficiency. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek Tax Court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights. (ii) The IRS has filed a notice of Federal tax lien with respect to an assessed tax liability, and the taxpayer has been issued a notice under I.R.C. §6320 entitling the taxpayer to request a hearing with the IRS Office of Appeals contesting the lien filing, and to further appeal to the Tax Court if the IRS determines to sustain the lien filing. In the course of the hearing, the taxpayer is entitled to contest the underlying tax liability because the taxpayer has had no prior opportunity to contest the liability. This is not a delinquent tax because it is not a final tax liability. Should the taxpayer seek tax court review, this will not be a final tax liability until the taxpayer has exercised all judicial appeal rights. (iii) The taxpayer has entered into an installment agreement pursuant to I.R.C. §6159. The taxpayer is making timely payments and is in full compliance with the agreement terms. The taxpayer is not delinquent because the taxpayer is not currently required to make full payment. (iv) The taxpayer has filed for bankruptcy protection. The taxpayer is not delinquent because enforced collection action is stayed under 11 U.S.C. 362 (the Bankruptcy Code). (ii) The Offeror has [_] has not [_], within a three-year period preceding this offer, had one or more contracts terminated for default by any Federal agency. (2) "Principal," for the purposes of this certification, means an officer; director; owner; partner; or a person having primary management or supervisory responsibilities within a business entity (e.g., general manager; plant manager; head of a division or business segment; and similar positions). This Certification Concerns a Matter Within the Jurisdiction of an Agency of the United States and the Making of a False, Fictitious, or Fraudulent Certification May Render the Maker Subject to Prosecution Under Section 1001, Title 18, United States Code. (b) The Offeror shall provide immediate written notice to the Contracting Officer if, at any time prior to contract award, the Offeror learns that its certification was erroneous when submitted or has become erroneous by reason of changed circumstances. (c) A certification that any of the items in paragraph (a) of this provision exists will not necessarily result in withholding of an award under this solicitation. However, the certification will be considered in connection with a determination of the Offeror's responsibility. Failure of the Offeror to furnish a certification or provide such additional information as requested by the Contracting Officer may render the Offeror nonresponsible. (d) Nothing contained in the foregoing shall be construed to require establishment of a system of records in order to render, in good faith, the certification required by paragraph (a) of this provision. The knowledge and information of an Offeror is not required to exceed that which is normally possessed by a prudent person in the ordinary course of business dealings. (e) The certification in paragraph (a) of this provision is a material representation of fact upon which reliance was placed when making award. If it is later determined that the Offeror knowingly rendered an erroneous certification, in addition to other remedies available to the Government, the Contracting Officer may terminate the contract resulting from this solicitation for default. 4.2 FAR 52.212-1 Instructions to Offerors -- Commercial Items (Apr 2014) and below addendum applies to this acquisition 4.2.1 Offeror Response Dates and Time RFQ Due Date: All quotations shall be submitted electronically via email to Howard.Yablon@fda.hhs.gov before 2:00 PM, Eastern Time on August 29, 2014. Offerors that fails to submit all required documentation, complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. 4.3 FAR 52.212-2 Evaluation -- Commercial Items (Jan 1999) applies to this acquisition The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible quoter whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors, listed in descending order of importance, shall be used to evaluate quotes: Technical Approach/Capability, Relevant Past Performance, and Price. When combined, technical capability and relevant past performance are more important than price in determining the best value to the Government. If the Government determines non-price factors to be essentially equal, price becomes more important as the discriminating factor. Technical Capability The Government will evaluate technical capability based on the degree to which the quotation meets the Statement of Work identified in Section 2. Through the submission of your proposed Study Protocol and Implementation Plan, describe the approach for accomplishment of the work. The graphic and narrative plan shall describe the technical approach that will be used to conduct the study including overall research design, statistical methodology/approach, feasibility, and appropriateness of the proposed methods. Provide detailed description of the proposed facilities, proposed equipment, data management, quality control and quality assurance; describe organizational experience and personnel who will be assigned to this project. Identify key assumptions, if any. Quotes with phrases such as: "Standard procedures will be employed" and "Well-known techniques will be used" is inadequate and may not be considered. Limit Technical Approach/Capability Section to 10 pages. Recent and Relevant Past Performance Relevant past performance evaluation will take into account the currency, relevancy, type, scope, complexity and duration of past projects. Identify all ongoing and completed work (within the last 3 years from date of this solicitation). Identify experience including peer-reviewed publications, of performing induced pluripotent stem cells generation from human blood samples and differentiation of iPS cells into functional cardiomyocytes. For each of these past performance references, provide a detailed description of the work, the period of performance, your role and responsibilities as either a prime or subcontractor, the client name and address and client point of contact name, phone number, and email address. Provide this same information for any proposed subcontractor who will be performing a critical aspect of the required work or will otherwise be performing more than 25% of the total proposed price ((do not include actual subcontract price for this effort or total proposed price information in the past performance section of your quotation. Limit Past Performance to 30 pages. Price The Government will evaluate offers for award purposes based on total price. Offerors shall detail all direct and indirect costs supporting their firm fixed price, ensuring that the price proposal is consistent with the technical proposal in all respects since the price proposal may be used as an aid to further determine the Offeror's understanding of the technical requirements. Discrepancies may be viewed as a lack of understanding. The pricing structure provided in the price proposal shall easily tie back to the Study Protocol and Implementation Plan. The price proposal shall also include a proposed milestone/payment plan. The payment plan shall identify significant milestones, dates, and commensurate payment amounts (fixed price) for each milestone from date of award through the final presentation. 4.4 FAR 52.212-3 Offeror Representations and Certifications -- Commercial Items (May 2014) applies to this acquisition An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (o) of this provision. (End of Provision)
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1133767/listing.html)
 

Place of Performance

Address: 10903 New Hampshire, Silver Sping, Maryland, 20993, United States

Zip Code: 20993
 

Record

SN03472264-W 20140822/140820235300-771d95a8315a56cd92d504a847afc4f4 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |