FDA-19-SOL-1209336-_final.doc

COMBINED SYNOPSIS/SOLICITATION FOR ICON NONMEM Software and Support Solicitation Number: 19-FDA-SOL-1209336

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.

The Food and Drug Administration intends to award a sole source, firm-fixed price purchase order to ICON Clinical Research LLC, 2100 Pennbrook Parkway, North Wales, PA 19454-4105 in accordance with FAR part 13.106-1(b)(1)(i). This procurement is being conducted under simplified acquisitions procedures in accordance with FAR Parts 12 and 13.

ii. The solicitation number is 19-FDA-SOL-1209336.

iii. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2019-02, Effective 5 June 2019.

iv. The associated North American Industry Classification System (NAICS) Code is 511210, Software Publishers; Small Business Size Standard is $38.5 million.

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 with:

a) Pricing for all line items

b) If re-seller, must submit authorized letter from Original Equipment Manufacturer (OEM).

c) Accessibility Conformance Report (ACR) Quotes that do not price all line items may be deemed non-responsive.

Period for Acceptance of Offers: The offeror agrees to hold the prices firm for 30 calendar days after quote due date.

NONMEM Software and Support

NONMEM Software and Support

NONMEM Software and Support

NONMEM Software and Support

vi. Description Requirements – ICON NONMEM Software

1. 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 analyzed using non-linear mixed effects modeling. The data must be independently analyzed and verified by Office of Clinical Pharmacology drug reviewers. NONMEM software is used to complete the analysis of the non-linear mixed effects models.

2. OBJECTIVES

This software will allow Office of Clinical Pharmacology drug reviewers to complete the review of Investigational New Drug (IND) and New Drug Applications (NDA), which is the primary role of the Office.

3. Specifications The software shall possess the following salient characteristics:

· The following population analysis methods must be available:

· First Order Conditional Estimation (FOCE)

· Laplace Conditional Estimation

· Iterative Two Stage (ITS)

· Importance Sampling Expectation-Maximization (IMP)

· Stochastic Approximation Expectation-Maximization (SAEM)

· Markov-Chain Monte Carlo Bayesian Analysis (BAYES)

· Parallel computing of a single problem over multiple cores or computers

· Dynamic memory allocation according to problem size.

· Capable of using the first-order conditional estimation method.

· Multiple mixed effects levels, with random effects across groups of individuals such as clinical site

· Symbolic reference to thetas, etas, and epsilons.

· Variance matrix parameters output in covariance and correlation format.

· Variance matrix parameters in covariance, correlation, or Cholesky format.

· Enhanced annealing feature for SAEM to facilitate estimation of fixed effect parameters (THETAs) that do not have associated inter-subject variance (ETA’s).

· Boot-strap simulations

· Perform Monte Carlo search of population parameters and select the set that provides the lowest starting objective function for an estimation.

· Perform Monte Carlo search for initial best estimates of etas for each subject. Together with a Monte Carlo search of best initial population parameters, this provides a global search technique for the traditional methods, with less reliance on starting position for incidence of success.

· FOCE/Laplace and ITS assessment using only numerical eta derivatives for search of best etas and/or eta Hessian matrix assessment.

· Conditional Individual Weighted Residual (CIWRES) added to residual variance diagnostics. Includes evaluation for L2 correlated data as well.

· Allow input and reporting of thetas in their natural domain, even when linear Mu referencing.

· XML report files

· Nelder-Mead optimization option for best fit individual etas

· Option to use either eigenvalue square root or Cholesky square root algorithms for assessing weighted residual diagnostics.

· Analytical and numerical derivatives of predicted and residual variance values with respect to eta

· Features to facilitate stochastic differential equations (SDE).

4. DELIVERABLES / SPECIFIC TASKS

The deliverables for this purchase are continuing maintenance and support, including patches/updates of NONMEM software.

5. Government Furnished Equipment (GFE)/ Government Furnished Information (GFI)

No Government Furnished Equipment or Government Furnished Information will be provided.

6. Period of Performance

The software license period, maintenance, support and updates will be from July 15, 2019–July 14, 2020.

7. Security and privacy requirements

This is a software purchase. The contractor will not be provided with any FDA data.

8. section 508 requirements

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase information and communication technology (ICT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of information and communication technology (ICT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the Requirements Statement, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

Unless an agency exception to this requirement exists, the Contractor must conform to applicable Section 508 standards and must apply best practices associated with Section 508 compliance during the application design, development, and testing phases. The Contractor shall utilize FDA approved tools to verify the compliance with the Section 508 standards and ensure the delivery of the fully compliant products. The following Section 508 standards (revised in January 2018) are applicable to this requirement:

· E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

· E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

· E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

· E205 Electronic Content (Appendix A, Application and Scoping)

· E207 Software

· Chapter 5 Software

· Chapter 6 Support Documentation

9. CONTRACT TYPE

This is a firm fixed price purchase order.

10. GOVERNMENT POINTS OF CONTACT

Contract Specialist

Mark Brady U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

4041 Powder Mill Road Beltsville, MD 20705

240-402-7404 Mark.Brady@fda.hhs.gov

Contracting Officer

Phillip Frame

U.S. Food and Drug Administration

Office of Acquisitions and Grants Services

4041 Powder Mill Road, Office# 42053

Beltsville, MD 20705

240-402-7578

Phillip.Frame@fda.hhs.gov

Technical Point of Contact TBD at time of award

11. CONTRACTING OFFICER AUTHORITY

The Contracting Officer (CO) is the sole person authorized to make or approve any changes in any of the requirements of this order and notwithstanding any provisions contained elsewhere in the order, the said authority remains solely with the CO. In the event the Contractor makes any changes at the direction of any person other than the CO, the change shall be considered to have been made without authority and no adjustment will be made in the delivery order terms and conditions, including price. The CO shall be the only individual authorized to accept nonconforming work, waive any requirement of the order and modify any term or condition of the order. The CO is the only individual who can legally obligate Government funds.

The Contracting Officer’s Representative (COR) or Project Officer is not authorized to make any commitments or otherwise obligate the Government or authorize any changes which affect the order price, terms or conditions. The COR/Project Officer is responsible for the technical aspects of the project and serves as technical liaison with the contractor and is responsible for the final inspection and acceptance, and such other responsibilities as may be specified in the order.

12. ORDER OF PRECENDENCE

The contractor shall follow the terms and conditions of this order. Should the contractor include any additional terms and conditions resulting in conflicts between this document and the contractor’s document, the order of precedence shall be as specified in FAR Clause 52.212-4 of the contract. Any indemnification language indemnifying the contractor of any liability and governing law language in the contractor’s terms and conditions shall be invalid and shall be stricken and removed from this order. Any additional terms and conditions shall not be prohibited by applicable laws and regulations. Any additional terms and conditions identified with a web link and/or incorporated by reference shall be stricken and removed from this order.

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 sections v) and vi) 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:

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:

· 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018)

· 52.219-06 Notice of Total Small Business Set-Aside (Nov 2011)

· 52.222-3 Convict Labor (June 2003)

· 52.222-19 Child Labor—Cooperation With Authorities and Remedies (Jan 2018)

· 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)

· 52.225-13 Restrictions on Certain Foreign Purchases (Jun 2008)

· 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/HHSAR PROVISIONS

FAR 52.212-1

Instructions to Offerors- Commercial Items (JAN 2017)

FAR 52.225-25

Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications

FAR 52.252-1

Solicitation Provisions Incorporated by Reference (Feb 1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/.

(End of Clause)

HHSAR 352.239-73 Electronic Information and Technology Accessibility Notice (December 18, 2015)

FAR CLAUSES

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 this/these address(es):

https://www.acquisition.gov/.

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 prior to expiration of term provided that the Government gives the Contractor a preliminary written notice of its intent to extend at any time 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 five (5) years.

FAR 52.232-39 Unenforceability of Unauthorized Obligations (Jun 2013) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) FAR 52.233-3 Protest after Award (Aug. 1996) FAR 52.233-4 Applicable Law for Breach Of Contract Claim (OCT 2004)

HHSAR CLAUSES

HHSAR 352.239-74 Electronic and Information Technology Accessibility (December 18, 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:

· E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

· E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

· E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

· E205 Electronic Content (Appendix A, Application and Scoping)

· 302 Functional Performance Criteria (Appendix C, Application and Scoping Requirements)

· Chapter 4 Hardware

· Chapter 6 Support Documentation

· E207 Software (Appendix A, Application and Scoping Requirements)

· Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements) (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)

xiv. All responsible sources may submit a quote, which if timely received, shall be considered. The quote and any questions shall reference solicitation number 19-FDA-SOL-1209336.

Questions must be submitted by June 20, 2019 by 12:00 PM EST to all point of contacts listed below.

All quotes must be submitted via email to the point of contacts listed below on or before June 25, 2019 by 12:00 AM EST.

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.

xv. Point of Contacts:

Mark Brady at Mark.Brady@fda.hhs.gov.

Phillip Frame at Phillip.Frame@fda.hhs.gov