RFQ_1162110_(FINAL)_FBO.pdf

RFQ -16-FDA-SOL-1162110

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.

This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-88.

Offerors must submit all questions concerning this solicitation in writing, via email to the Contract Specialist, Michael Parsons Pena at Michael.Parsons@fda.hhs.gov. Questions should be received no later than 10:00 AM Eastern Time on Friday, 15 July, 2016. All responses to questions will be made in writing, without identification of the questioner, and will be included in an amendment to the solicitation.

The associated North American Industrial Classification System (NAICS) code for this procurement is 511210 – Software Publishers with a small business size standard of $38.5M.

This acquisition is 100% set aside for small business. Brand Name or Equal.

Statement of Work

Background

The Office of Clinical Pharmacology receives Investigational New Drug (IND) and New Drug Applications

(NDA). Within these submissions sponsors include clinical pharmacology and pharmacometric data

(PK/PD modeling, non-linear mixed effects modeling (NLME), in vivo-in vitro correlations (IVIVC), and trial simulation). These data must be independently analyzed and verified by Office of Clinical

Pharmacology reviewers and pharmacometricians. Phoenix Quantum includes Phoenix WinNonlin, NLME, IVIVC, Connect, and Trial Simulator which provide the necessary tools to perform these data analyses.

Scope

General - The Contractor shall provide the software that CDER needs to support IND and NDA review.

This order is for the renewal of licenses for Phoenix Quantum (Phoenix WinNonlin, NLME, IVIVC, Connect, Trial Simulator), brand name or equal to.

mailto:Michael.Parsons@fda.hhs.gov

Contract Line Item Number(s):

CLIN Part Number Service /Supply Description

Quantity Unit Price Total Price

0001 PHXQUS91

or Equal Phoenix Quantum – 293 Annual Named Server Licenses of Phoenix Winonlin, Phoenix Connect, Phoenix NLME,and United Server License for Distributed Computing or Equal

0001 IVIVCPHXWNLS088

or Equal IVIVC Toolkit for Phoenix Winonlin Annual Named Server License or Equal

0001 PHLQTS088

or Equal Phoenix QT + Annual Named User Server License or Equal

0001 TS005

or Equal Trial Simulator Annual Float Licenses or Equal

Total Price

Requirements / Deliverables / Salient Characteristics

The deliverables for this requirement is continuing maintenance and support, including software updates of Phoenix Software. The software vendor shall provide support for the FDA regulatory environment which includes installation support. Updates and technical support should be available by telephone, email or fax during regular business hours.

FDA is purchasing this equipment on a “Brand Name or Equal” basis. The RFQ provides requirements or salient functional characteristics for each license required. For the purposes of this RFQ, FDA defines compatible as meaning that there will be no communication, integration, performance, maintainability issues in the interconnection of solutions with different configurations or workstation platforms.

To be considered for award, the proposed solution shall possess the following salient functional characteristics:

License salient functional characteristics:

Pharmacokinetic and Pharmacodynamic modeling and non-compartmental analysis

Process, visualize, and tabulate data

Generate high quality graphs, tables, and figures allowing for integrated communication of analysis results

Modeling tools to analyze population PK/PD studies

Nonlinear mixed effects modeling

Integration with third party tools such as SAS, S+, R, NONMEM and Excel

In vitro –in vivo correlations

Deconvolution (Wagner –Nelson, Loo Riegelman, and Numerical)

Convolution

Levy Plot – Assess time scale of dissolution experiments

Analysis of study design types:

o Bioequivalence and Bioavailability o Drug-Drug and Food-Drug Interactions o First-in-man o Dose Proportionality o Special Populations

The following Section 508 provisions apply to the content identified in this SOW:

o § 1194.21 Software applications and operating systems.

Maintenance and Support salient functional characteristics:

Updates and technical support should be available by telephone, email or fax during regular business hours.

Period of Performance

July 15, 2016 – July 14, 2017

Shall be delivered no later than 30 days after award.

Order Type

Firm Fixed Price

Place of Performance

TBD

Shipping Address

TBD

Inspection and Acceptance

The performance criteria for this task order shall be that all software with appropriate license keys, proof of entitlement certificates, maintenance support confirmation has been delivered to the FDA COR within 30 days after contract award.

The Contracting Officer’s Representative (COR) is responsible for the inspection and acceptance of the deliverables for this requirement.

FDA Points of Contact

Contracting Specialist (Primary POC): Office of Acquisitions and Grants Services ATTN: Michael Parsons 5630 Fishers Lane, Rm 2091 Rockville, MD 20857 michael.parsons@fda.hhs.gov 240-402-2924

Contracting Officer: Office of Acquisitions and Grants Services ATTN: Brendan McCarthy 5630 Fishers Lane Rockville, MD 20857 Brenadan.McCarthy@fda.hhs.gov 240-402-7540

Contracting Officer Representative (COR): TBD

Invoicing Instructions

FDA THREE-WAY-MATCHING INVOICE CLAUSE

A. THE CONTRACTOR SHALL SUBMIT ONE (1) ORIGINAL COPY OF EACH INVOICE TO THE ADDRESS

SPECIFIED BELOW:

Office of Financial Services Food and Drug Administration 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 Attn: Vendor Payments

301.827.3742 or 866.807.3742 fdavendorpaymentsteam@fda.gov

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;

mailto:michael.parsons@fda.hhs.gov mailto:Brenadan.McCarthy@fda.hhs.gov

(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;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) The contractor shall include the Contract Line Item/Funding line item number 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;

(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) Deleted

(xi) Name and telephone number of the FDA Contracting Officer (CO) and the Contracting Officer's Representative (COR) or other program center/office point of contact, as referenced on the order/contract;

(xii) Any other information or documentation required by the purchase order/award.

C. An electronic invoice shall be 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:

Food and Drug Administration/ Office of Financial Services, 10903 New Hampshire Ave WO32 - Second Floor, MAIL HUB 2145 Silver Spring, MD 20993-0002 Attn: Vendor Payments Phone 301-827-ERIC (3742)

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 (SAM) DATABASE) AND/OR OTHER

APPLICABLE FAR CLAUSES SPECIFIED HEREIN.

Provisions and Clauses:

The following provisions and clauses apply to this acquisition and are hereby incorporated by reference.

All FAR provisions and clauses may be viewed at http://acquisition.gov/comp/far/index.html. All Health and Human Services Acquisition Regulation clauses may be viewed at:

http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html.

Provisions:

52.211-6, Brand Name or Equal – (Aug 1999)

52.212-1, Instructions to Offerors – Commercial Items (Oct 2015)

52.212-3, Offeror Representations and Certifications – Commercial Items (Apr 2016) The Offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certifications electronically via the System for Award Management (SAM) website accessed through http://www.acquisition.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through

(r) of this provision and provide a written submission.

Contractor Tax Liability or Felony Conviction The Consolidated and Further Continuing Appropriations Act, 2015 Pub. L 113-235, Division E, Sections 744 and 745 prohibits covered agencies from using funds to enter into contracts with corporations that have unpaid federal tax delinquencies or certain felony convictions unless certain conditions are met.

The Offeror represents that – It is [ ] is not [ ] a corporation that was convicted of a felony criminal violation under a Federal or State law within the preceding 24 months.

It is [ ] is not [ ] a corporation that has any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability.

(End of provision)

52.203-98, Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements—Representation (DEVIATION 2015-02)

(a) In accordance with section 743 of Division E, Title VII, of the Consolidated and Further Continuing Resolution Appropriations Act, 2015 (Pub. L. 113-235), Government agencies are not permitted to use funds appropriated (or otherwise made available) under that or any other Act for http://acquisition.gov/comp/far/index.html http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html contracts with an entity that requires employees or subcontractors of such entity seeking to report fraud, waste, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

(b) The prohibition in paragraph (a) of this provision does not contravene requirements applicable to Standard Form 312, Form 4414, or any other form issued by a Federal department or agency governing the nondisclosure of classified information.

(c) Representation. By submission of its offer, the Offeror represents that it does not require employees or subcontractors of such entity seeking to report fraud, waste, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or subcontractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information.

(End of provision)

Clauses:

52.212-4, Contract Terms and Conditions – Commercial Items (May 2015)

52.212-5, Contract Terms and Conditions Required to Implement Statues of Executive Orders – Commercial Items (Jun 2016)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015)

(2) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(3) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77, 108- 78 (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the contracting officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015)

52.209-6, Protecting the Government’s Interests when Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015)

52.219-6, Notice of Total Small Business Set-Aside (Nov 2011)

52.219-28, Post Award Small Business Program Representation (Jul 2013)

52.222-3, Convict Labor (Jun 2003)

52.222-19, Child Labor – Cooperation with Authorities and Remedies (Feb 2016)

52.222-21, Prohibition of Segregated Facilities (Apr 2015)

52.222-26, Equal Opportunity (Apr 2015)

52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014)

52.222-50, Combating Trafficking in Persons (Mar 2015)

52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011)

52.232-33, Payment by Electronic Funds Transfer – System for Award Management (Jul 2013)

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or executive orders applicable to acquisitions of commercial items:

52.222-41, Service Contract Labor Standards (May 2014)

52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014)

(d) Comptroller General Examination of Record The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records -- Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)

(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c) and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

(ii) 52.219-8, Utilization of Small Business Concerns (Oct 2014) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iii) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (1) of FAR clause 52.222-17.

(iv) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

(v) 52.222-26, Equal Opportunity (Apr 2015) (E.O. 11246).

(vi) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(vii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(viii) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212).

(ix) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O.

13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(x) 52.222-41, Service Contract Labor Standards (May 2014), (41 U.S.C. chapter 67).

(xi) ____ (A) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O.

13627).

___ (B) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 E.O. 13627).

(xii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment--Requirements (May 2014) (41 U.S.C. chapter 67.)

(xiii) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services--Requirements (May 2014) (41 U.S.C. chapter 67)

(xiv) 52.222-54, Employment Eligibility Verification (Oct 2015) (E. O. 12989).

(xv) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xvi) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xvii) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations. (May 2014) (42 U.S.C.

1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xviii) 52.247-64, Preference for Privately-Owned U.S. Flag Commercial Vessels (Feb 2006) (46 U.S.C.

Appx 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of Clause)

52.232-40, Providing Accelerated Payment to Small Business Subcontractors (Dec 2013)

352.203-70, Anti-Lobbying (DEC 2015)

352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

352.239-74, Electronic and Information 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:

1194.21 Software applications and operating systems.

(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 http://www.hhs.gov/web/508 http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.access-board.gov/guidelines-and-standards/communications-and-it/about-the-section-508-standards http://www.ecfr.gov/cgi-bin/text-idx?node=pt48.1.2#se48.1.2_1101 http://www.hhs.gov/web/508 http://www.hhs.gov/web/508 level of conformance specified in the contract will be the responsibility of the Contractor at its own expense.

(End of clause)

These clauses may be downloaded from: http://www.hhs.gov/oamp/policies/hssar.doc

Instructions to Offerors:

Offerors should direct any questions about this RFQ to the Contract Specialist at the email address, Michael.parsons@fda.hhs.gov by 10:00 AM EST (Eastern Time) on Friday, July 15, 2016. Phone calls will not be accepted. Offerors shall submit their quotations (Attachment 1 Pricing Sheet) so that FDA receives them not later than 10:00 AM Eastern Time on July 19, 2016. Fax quotations shall not be accepted. E-mail quotations shall be accepted at Michael.parsons@fda.hhs.gov. Please reference RFQ # 1162110 in the subject line of email communications. Offerors quotations shall not be deemed received by the Government until the quotation is entered in the email inbox set forth above. Price quotations shall remain valid for a period of 60 days from the date quotations are due. Quotes must be firm-fixed priced and include all quantities.

ACCEPTANCE OF TERMS AND CONDITIONS (ADDENDUM TO FAR 52.212-1 (B) (11)): THIS IS AN OPEN- MARKET SOLICITATION FOR SERVICES 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 QUOTATION SHOULD INCLUDE ONE OF THE FOLLOWING STATEMENTS:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:

Offeror shall list exception(s) and rationale for the exception(s)

Quotation Evaluation:

Evaluation Factors:

Award shall be made to the responsible Offeror whose offer, conforming to the solicitation, represents the lowest price technically acceptable offer.

http://www.hhs.gov/oamp/policies/hssar.doc mailto:Michael.parsons@fda.hhs.gov