Updated Solicitation.pdf

STATEMENT OF WORK

Pharmacological Mechanism‐Based Safety Prediction: Data Mining Software Acquisition and Support

1. BACKGROUND

The Food and Drug Administration (FDA)/Center for Drug Evaluation and Research (CDER) is interested in discovering unknown secondary targets for new pharmaceuticals. To do so, a tool that can predict a chemical’s potential targets is required.

2. OBJECTIVES

This contract is meant to directly address this matter by acquiring a tool to predict a chemical’s potential targets with high confidence and identify targets that are known. Targets known by the program and identified with high confidence will be evaluated for their potential to be associated with adverse events, addiction, and ability to treat disease in association with the chemical of interest and its proposed indication(s). The goal of this contract is to provide the Office of Surveillance and Epidemiology, the Office of New Drugs, and other interested offices with improved adverse event predictions and public health risk assessments.

All analysis performed of confidential data will be kept proprietary and within the confines of the FDA firewall.

3. SCOPE

The contractor/vendor shall provide FDA with a data mining and analysis platform that predicts pharmacological targets for chemicals.

This is an ongoing requirement and is expected to be renewed, for up to four (4) consecutive years to most effectively evolve this new approach to drug safety evaluation.

4. REQUIREMENTS

The Contractor shall work with CDER to develop any necessary elements to permit access to their IT infrastructure is currently in place that is required to carry out the target predictions.

Access to The Contractor’s infrastructure will be from FDA systems.

Provides a tool to predict drug targets of proprietary and publicly‐known chemicals that can be placed behind FDA’s firewall on ten (10) CDER workstations.

Provide technical, analytical and scientific support, including software documentation, as agreed upon in writing.

Provide ongoing technical and scientific support to facilitate data analysis and hypothesis generation.

Provide one (1), one (1)‐hour training session per month, to CDER safety program personnel on data entry and data search within the infrastructure. These training sessions will be held via webcast. One (1) in‐person meeting and training session will be held per year.

Provide updates to software training dataset one (1) time per year.

Provides extensive documentation about methodologies used in the target prediction tool, all validation studies performed to date as well as performance achieved in the validation studies, and targets available for prediction in the tool.

Provides scientific support and discussion on method optimization and best practices for using the tool.

Provides a written user guide, technical, and analytical support to facilitate target prediction and resulting analysis.

Tool must provide a measure of confidence in the prediction and a downloadable list of nearest neighbors and similarity scores for each prediction .

Tool must be able to process compounds individually and in batches from SMILES or SDF files.

5. DELIVERABLES / REPORTING REQUIREMENTS

The contractor/vendor shall provide the following deliverables.

Ref. Deliverable Date Due

1 Face-to-face pre-meeting with designated office management to specify standard operating procedures for the work and define detailed time lines

FDA shall review and approve in writing all procedures and timelines before work begins

No later than four

(4) weeks after contract award

2 Work with CDER to develop any necessary elements to permit access to the IT infrastructure required to carry out the safety prediction

Meetings shall be via conference call or web conference

Two (2) months post-award

3 Allow infrastructure access from ten (10) individual CDER workstations

Three (3) months

4 Begin providing ongoing technical support as agreed upon in writing to facilitate data analysis and hypothesis generation

Three (3) months post-award

5 Begin providing technical and analytical support as agreed upon in writing to most effectively identify targets of interest

Three (3) months post-award

6 Begin providing scientific support and discussion as agreed upon in writing to facilitate method optimization and develop best practices for generating and interpreting predictions

Three (3) months post-award

7 Provide written user guide and validation studies as agreed upon to facilitate target prediction and evaluation

Three (3) months

8 Provide one (1), one(1)-hour training session per month, to CDER safety program personnel on data entry and data search within the infrastructure

Subsequent training dates to be agreed upon in writing

Four (4) months

5.1 PLANNING

The contractor/vendor shall provide appropriately firewalled access to their internal IT infrastructure for FDA by directly working with FDA/CDER. The contractor/vendor and CDER shall have an initial meeting to specify standard operating procedures for the work and define detailed time lines.

5.2 Project Management and Control

The contractor/vendor shall provide monthly status reports to the PO on the status/progress of any outstanding deliverables and any current or anticipated problems with required activities.

Reports shall be received by the PO no later than the fifteenth (15th) of each month.

The contractor/vendor shall provide ongoing infrastructure maintenance with a response time of no more than forty‐eight (48) hours from the time of notification.

6. GOVERNMENT FURNISHED EQUIPMENT (GFE)/ GOVERNMENT

FURNISHED INFORMATION (GFI)

No Government Furnished Equipment or Government Furnished Information will be provided

7. PLACE OF PERFORMANCE

Work shall be completed at contractor’s site.

Unless otherwise specified, meetings between contractor/vendor and FDA shall be in person at FDA/CDER 10903 New Hampshire Avenue, Silver Spring, Maryland, or via conference call and/or web conferencing.

Any and all travel required for deliverables shall be at the expense of the contractor/vendor.

8. PERIOD OF PERFORMANCE

The base year will be for 1 year, (12) months.

Option Period 1: 1 year, (12) months.

Option Period 2: 1 year, (12) months.

Option Period 3: 1 year, (12) months.

Option Period 4: 1 year, (12) months.

9. SECURITY AND PRIVACY REQUIREMENTS

No Privacy requirements apply to this solicitation.

The Contractor shall not divulge or release data or information discussed in connection with the performance of the resulting contract, unless made public by FDA, except to authorized FDA personnel or upon written approval of the CO.

10. INSPECTION AND ACCEPTANCE CRITERIA

The Contracting Officer Representative will perform inspection and acceptance of materials and services to be provided.

11. CONTRACT TYPE

This is a firm fixed price order.

12. GOVERNMENT POINTS OF CONTACT

Contracting Officer (CO) Steven Chang 4041 Powder Mill Rd.

Beltsville, MD 20705 Tzeleong.Chang@fda.hhs.gov

Contract Specialist (CS) Jada Scott 4041 Powder Mill Rd.

Beltsville, MD 20705 Jada.Scott@fda.hhs.gov

13. 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 delivery order.

14. CLAUSES

HHSAR CLAUSES

The below Health and Human Services Acquisition Regulation (HHSAR) Clauses apply. HHSAR Clauses can be viewed in full text at: hhtps://www.hhs.gov/grants/contracts/contract‐policies‐ regulations/hhsar/index.html

352.203‐70 Anti Lobbying (DEC 2015)

352.222‐70 Contractor Cooperation in Equal Employment Opportunity Investigations (DEC 2015)

352.239‐74 Electronic Information and Technology Accessibility Notice (December 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‐andstandards/ 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

• E203 Access to Functionality

• E204 Functional Performance Criteria

• E205 Electronic Content

• 302 Functional Performance Criteria

• Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at http://508.hhs.gov/, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section‐508/additional‐resources/section‐508‐contacts/index.html.

(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)

FAR CLAUSES

The below Federal Acquisition Regulation (FAR) Clauses apply. FAR Clauses can be viewed in full text at: https://www.acquisition.gov/browse/index/far

52.232‐39 – Unenforceability of Unauthorized Obligations (Jun 2013)

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

52.217‐9 – Option to Extend the Term of the Contract

52.204‐25 ‐‐ Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2019)

15. PROVISIONS

Far Provisions

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 address: http://farsite.hill.af.mil/vffara.htm.

(End of Provision)

HHSAR Provisions

This solicitation incorporates one or more solicitation HHSAR provisions by reference, with the same force and effect as if they were given in full text. The full text of the HHSAR clauses may be accessed electronically at this address: http://www.hhs.gov/grants/contracts/contract‐policies‐ regulations/hhsar/index.html.

HHSAR 352.239‐73: Information and Communication Technology (ICT) Accessibility Notice (Dec 2015)

16. INSTRUCTIONS TO QUOTERS

Please read these instructions carefully. All items required to be included in the quotation as delineated in these instructions must be provided in Quoter’s quotations.

Quotes must be firm fixed price

Quoters responding to this Notice to Public must be registered with an Active status in the System for Award Management (SAM): www.sam.gov

Volume One – Technical

Demonstrates the Quoter’s capability to meet the requirements as described in Section 5.

Volume Two – Pricing

Total Pricing for Pharmacological Mechanism‐Based Safety Prediction: Data Mining Software

17. EVALUATION/AWARD BASIS

The Government shall award a firm fixed price order resulting from this solicitation to the responsible Quoter using the lowest price, technically acceptable (LPTA) evaluation method.

The Government intends to evaluate quotes and award an order without negotiation. Quoters' initial quote should contain the Quoters’ best terms from a price standpoint. The Government reserves the right negotiate if later determined by the Contracting Officer to be necessary.