rfq_-_1152225.doc

FEDERAL BUSINESS OPPORTUNITIES NOTICE

REQUISITION#1152225

Contracting Office Address

Department of Health and Human Services, Office of Acquisition Grants and Services, 5630 Fishers Lane, Rockville MD, 20857

BACKGROUND

Center of Drug Evaluation Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. Drug companies include reports using SimCYP® software in Investigational New Drug and New Drug Applications (INDs and NDAs). Such data must be analyzed/verified by FDA clinical pharmacology reviewers using the same tool.SimCYP® software is population-based, physiologically-based pharmacokinetic (PBPK) modeling and simulation software, developed by SimCYP® Limited (Sheffield, UK). The software provides a user-friendly platform for clinical and non-clinical pharmacologists to readily input data gathered from preclinical and clinical phases. The resulting PBPK model allows users to conduct mechanistic modeling and simulations to address a variety of important clinical and nonclinical pharmacology questions. Office of Clinical Pharmacology (OCP) reviewers have been using and applying the outcomes of this tool for 6 years and it is essential to OCP’s review process. These exercises include the use of the software in numerous submissions by different sponsors and in decision making processes by OCP reviewers during review. In addition, OCP reviewers have applied the software, along with other PKPD and PBPK tools, to support the update of regulatory guidance documents, such as drug-drug interaction guidance and renal impairment guidance.

DESCRIPTION

The requirement will be awarded using Simplified Acquisition Procedures in accordance with FAR Part 13.

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals/bids/quotes are being requested and a written solicitation will not be issued.

The solicitation number is 1152225. This solicitation is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-83 (August 3, 2015).

This is a firm fixed price requirement for license renewal for several SimCYP® licenses. The associated North American Industry Classification System (NAICS) Code is 541511 - Custom Computer Programming Services. The size standard is 500 employees. This contract will be awarded with a base year plus two option years.

REQUIREMENT:

Vendor will provide license renewal, as well as annual maintenance and support. Delivery method is via download.

PERIOD OF PERFORMANCE

Estimated dates: September 21, 2015 to September 20, 2018

DELIVERABLES REQUIRED

The licenses for renewal are - 4 - Simcyp Simulator Server-Managed licenses 4 - Simcyp Simulator PC-based licenses

1 - Simcyp Paediatric Server-Managed license 1 -Simcyp Paediatric PC-based license 1-CSS license

4- SimCYP simulator Server-Managed licenses

4- SimCYP Simulator PC based licenses

1- SimCYP Paediatric Server-Managed license

1- SimCYP Paediatric PC based license

1- SimCYP CSS license

Option Yr. 1 Estimated date Sept 21, 2016 – Sept 20, 2017

4- SimCYP simulator Server-Managed licenses

4- SimCYP Simulator PC based licenses

1- SimCYP Paediatric Server-Managed license

1- SimCYP Paediatric PC based license

1- SimCYP CSS license

Option Yr. 2 Estimated date Sept 21, 2017 – Sept 20, 2018

Grand Total

Contract type: Commercial Item-Firm Fixed Price. Simplified procurement procedures will be utilized.

The selected Offeror must comply with the following commercial item terms and conditions. FAR 52.212-1, Instructions to Offerors - Commercial, applies to this acquisition. The selected Offeror must submit a completed copy of the provision at 52.212-3, Offeror Representations and Certifications - Commercial Items. FAR 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition.

The following FAR clauses in paragraph (b) of FAR clause 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items, will apply: 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.225-13, 52.232-34. The full text of a FAR clause may be accessed electronically at https://www.acquisition.gov/far/index.html.

52.217-9 -- Option to Extend the Term of the Contract (March 2000).

(a) The Government may extend the term of this contract by written notice to the Contractor; 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 3 years.

Award will be based on technically acceptable and lowest price.

QUOTES PROVIDED MUST ADDRESS ALL REQUIREMENTS. ALL QUOTES SUBMITTED MUST BE VALID FOR 45 DAYS. Offers are due in person, by mail, e-mail or fax on or before September 11, 2015 by 15:00 hours (Eastern Standard Time), at Food and Drug Administration OC/OSS/OFFAS, Attn: Lisa Jackson, 5630 Fishers Lane, Rockville MD, 20877. ph (240) 402-0093, fax (301)827-7101 email: lisa.jackson@fda.hhs.gov .

For information regarding this solicitation, please contact Lisa Jackson at (240) 402-0093, fax, (301) 827-7101, email: lisa.jackson@fda.hhs.gov .

Place of Performance

US Food & Drug Administration

10903 New Hampshire Ave

Building 51 Room 3182 Silver Spring MD 20903