SOLICITATION NOTICE
76 -- TRIALTROVE ACCESS
- Notice Date
- 6/8/2018
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 511120
— Periodical Publishers
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services - Rockville, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001, United States
- ZIP Code
- 20857-0001
- Solicitation Number
- 18-223-SOL-00040
- Archive Date
- 6/30/2018
- Point of Contact
- Phillip K. Frame, Phone: 2404027578
- E-Mail Address
-
Phillip.Frame@fda.hhs.gov
(Phillip.Frame@fda.hhs.gov)
- Small Business Set-Aside
- Total Small Business
- Description
- i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) 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. In accordance with FAR 13.106-1(b) this is a sole source requirement. ii) The solicitation number is 18-223-SOL-00040. iii) The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-97, Effective 24 Jan 2018 iv) The associated North American Industry Classification System (NAICS) Code is 511120 - Periodical Publishers; Small Business Size Standard is 1,000 employees. v) The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. Please submit all quotes to be valid until September 30, 2018. CLINDescription QtyUnit of IssuePrice 0001‘TRIALTROVE' (base year) 1EA$ 0002‘TRIALTROVE' (option year) 1EA$ Total Amount$ vi) Description STATEMENT OF WORK (SOW) ‘TRIALTROVE' A. BACKGROUND The Office of Clinical Pharmacology (OCP) Genomics Group is in need of a Trialtrove, a product of Citeline platform with clinical trial protocol data that curates biomarkers for efficacy as well as safety used in trials including pharmacogenomic biomarkers used to select or stratify patients across different stages of drug development program. The FDA encourages biomarker use to facilitate the drug development process from preclinical investigations to use in clinical practice to post market stages. PharmaProjects, a Citeline product (https://fda-pipeline.citeline.com/CpAccount.aspx ) subscribed by FDA library contains highly detailed profiles of over 60,010 drugs, covering all drugs for all diseases, from the preclinical to commercialization stage. Drug development information is updated in realtime and flexibility to drill down to precise results, using advanced search fields to combine criteria and build custom complex queries. Trialtrove data integrated with Pharmaprojects, a Citeline product subscribed by FDA library will help analysis of use of biomarkers to add value to risk-benefit decision making recommendations by staff to safe and effective products. The results consist of tables and graphics which, with the built-in tools, can be further explored to understand better the significance and patterns in the data in biomarker integration in drug development pipeline. B. OBJECTIVE OF THE WEB BASED SUBSCRIPTION CONTRACT The web based subscription will be used to analyze the clinical protocols with genomic biomarkers to understand risk-benefit decision making and impact future ongoing drug development program submissions C. REQUIREMENTS/DELIVERABLES Web based IP address specific log in for 8 users for a base year and one option year. vii) Shipping Address: Food and Drug Administration Bldg 51 Rm 2164 10903 New Hampshire Ave Silver Spring, MD 20993 POC: To be Identified at Time of Award viii) The provision at 52.212-1, Instructions to Offerors-Commercial Items (Jan 2017), applies to this acquisition with the following addenda to the provision. Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2018. ix) The provision at 52.212-2, Evaluation-Commercial Items (Oct 2014), is applicable to this requirement. 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 offeror whose proposal meets the specifications listed under v) and vi) 3 of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. x) The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Nov 2017), applies to this acquisition. The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal. xi) The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (Jan 2017), applies to this acquisition with the following addenda: Invoice Submission: FDA Three-Way Match Invoicing Procedures A.The contractor shall submit all invoices to: U.S. FOOD AND DRUG ADMINISTRATION Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor MAIL HUB 2145 Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov *** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail. Provide a copy marked courtesy to the COR. The COR is (TBD) 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 other 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) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements); (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; (c) any other supporting information necessary to clarify questionable expenditures; (d) the contractor shall include the Contract Line Item/Funding line item for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed; (v) Shipping number and date of shipment, 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 (Prompt Payment terms other than NET 30); (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) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT); (xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award; (xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, 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, & date submitted (2) corresponding payment amount & 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; (xiii) Any other information or documentation required by the award. C.An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xiii) 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 the e-mail address provided above in Section A. xii) The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Jan 2018), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: •52.219-06 Notice of Total Small Business Set-Aside (Nov 2011) •52.222-21 Prohibition of Segregated Facilities (Apr 2015) •52.222-26 Equal Opportunity (Sept 2016) (E.O. 11246) •52.222-35 Equal Opportunity for Veterans (Jul 2015) (38 U.S.C. 4212) •52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793) •52.222-50 Combating Trafficking in Person (Mar 2015) •52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513) •52.232-33 Payment by Electronic Funds Transfer- System for Award Management (Jul 2013) (31 U.S.C. 3332) xiii) Additional contract requirement(s) or terms and conditions FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) FAR 52.217-9 Option to Extend the Term of the Contract (Mar 2000) (a) The Government may extend the term of this contract by written notice to the Contractor any time prior to the expiration of the current period of performance; provided that the Government gives the Contractor a preliminary written notice of its intent to extend before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 2 years. (End of clause) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html By reference: •352.239-73 Electronic Information and Technology Accessibility Notice (Dec 2015) In full text: •342.239-74 Electronic Information and Technology Accessibility (Dec 2015) (a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the "Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards" set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards. (b) The Section 508 accessibility standards applicable to this contract or order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2.101) when the contract or order duration is one year or less. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense. (c) The Section 508 accessibility standards applicable to this contract are: o1194.21 systems o1194.22 web based o1194.31 functional requirements o1194.41 documentation, support (d) In the event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website: (http://www.hhs.gov/web/508). If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense. (e) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the task/delivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508 Product Assessment Template and any other additional information necessary to assist the Government in determining that the EIT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found at http://www.hhs.gov/web/508. If it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its own expense. (End of clause) It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. xiv) All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number 18-223-SOL-00040. The quotes are due by email to the point of contact listed below on or before June 15, 2018 by 10:00 am ET. xv) Point of Contact: Phillip Frame at (240) 402-7578 or email at Phillip.Frame@fda.hhs.gov.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/18-223-SOL-00040/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN04949202-W 20180610/180608230418-3215c2473fcd1d39ecfa954da3751550 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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