SOL_Aspen_Unscrambler.docx

Statement of Work (SOW)/Performance Work Statement (PWS): Prediction Model Building Software for Product Performance Assessment The Office of Pharmaceutical Quality and Research (OPQR) established digital twin platform under its high-performance computing (HPC) cloud environment. The digital twin platform requires software to perform multivariate data analysis for assessing in-house data. To conduct research and regulatory assessment of pharmaceutical manufacturing and to address emerging product quality issues OPQR needs to acquire this standalone software under its HPC environment.

The Division of Product Quality and Research (DPQR) needs advanced process analytical technology (PAT) software to mine big data stores to drive greater consistency in quality and efficient output. The software should analyze large and complex data sets quickly, easily and accurately and should be able to improve and optimize product quality at molecular level. The software will be installed in the HPC environment. This software should quickly identify the parameters most critical to quality, cycle time and other key KPIs with unique capabilities for spectroscopy and chemometrics import material, sensor, process and spectral data in all the formats with features to easily plot, preprocess and model spectral data.

The software should provide a comprehensive capability to enable real-time testing by analyzing sensor and quality data in real time with direct import from online instruments or through historians. For on-line PAT method deployment, the software should enable flexibility and scalability to accommodate widely.

As the system will be installed in FDA DPQR proprietary HPC cluster, there is no security risk. Technical risks on knowledge transfer are mitigated via training and support packages included. Administrative and financial risks are mitigated via annual renewal of the subscription contract.

Government Point of Contacts

TPOC Jayanti Das (Jayanti.das@fda.hhs.gov) COR Dongkai Zhu (Dongkai.zhu@fda.hhs.gov) CS Allison Meads (Allison.Meads@fda.hhs.gov) CO Steven Gagnon (Steven.Gagnon@fda.hhs.gov) Introduction The Division of Product Quality and Research (DPQR) needs advanced process analytical technology (PAT) software to mine big data stores to drive greater consistency in quality and efficient output. The software should analyze large and complex data sets quickly, easily and accurately and should be able to improve and optimize product quality at molecular level. The software will be installed in the HPC environment. This software should

· Quickly identify the parameters most critical to quality, cycle time and other key KPIs with unique capabilities for spectroscopy and chemometrics

· Import material, sensor, process and spectral data in all the formats with features to easily plot, preprocess and model spectral data.

Background The requested software will be used for multivariate data analysis for different applications such as near infrared spectroscopy, Raman spectroscopy, and is also used for development of predictive models for use in real-time spectroscopic analysis of materials. The software is used in spectroscopy (IR, NIR, Raman, etc.), chromatography, and process applications in research and non-destructive quality control systems in pharmaceutical manufacturing and sensory analysis.

Objective The software should provide a comprehensive capability to enable real-time testing by analyzing sensor and quality data in real time with direct import from online instruments or through historians. For on-line PAT method deployment, the software should enable flexibility and scalability to accommodate widely.

As the system will be installed in FDA DPQR proprietary HPC cluster, there is no security risk. Technical risks on knowledge transfer are mitigated via training and support packages included. Administrative and financial risks are mitigated via annual renewal of the subscription contract.

Scope of Work Prediction Model Building Software for Product Performance Assessment The required technical features of software are:

· Import material, sensor, process, and spectral data in all the formats

· Perform online or offline analysis to easily plot, preprocess and model spectral data

· Identify the parameters most critical to quality, cycle time and other key KPIs with unique capabilities for spectroscopy and chemometrics

· Develop prediction model development that can help to improve and optimize product quality

· Quality control, FDA 21 CFR Part 11 Compliance and Audit Trail Support.

· Cloud-based, fully integrated software platform with proven regulatory science application.

· The platform needs to demonstrate a proven track record on solving pharmaceutical and regulatory science challenges involving spectral data

· The platform needs to be deployed on FDA HCP clusters with a linux based system that meets the required system specifications.

· Browser based user interface, with multi-user support.

Deliverables The vendor will cover all costs associated with the following:

· System software, shipping, and delivery.

· Software installation support on FDA DPQR in house HPC cluster with the help of client’s IT professional.

· On-demand customer support.

The instrument will be delivered to the following location:

ATTN: Jayanti Das Food and Drug Administration 10903 New Hampshire Ave Building 64, Room 1068 Silver Spring, MD 20993 Contract Type Firm Fixed price Period of Performance The period of performance will end upon the successful completion of installation of software and at least twelve months of warranty.

Place of Performance The software will be installed at the FDA’s White Oak campus, Building 64. This standalone software will be installed under the local network of the Office of Pharmaceutical Quality and Research (OPQR) in Bldg 64, first floor.

Personnel This is a product that is needed in order to conduct critical scientific work for the agency and if an employee is in need of using this product, we will ensure this is accomplished through an alternative means and by working with the individual to ensure he/she is able to perform his/her work.

COR/CO Authority Contracting Officer Representative (COR) Authority The Contracting Officer’s Representative (COR) is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its COR designation.

Contracting Officer’s Authority The Contracting Officer (CO) identified above has responsibility for ensuring the performance of all necessary actions for effective contracting; ensuring compliance with the terms of the contract and safeguarding the interests of the United States in its contractual relationships. The CO is the only individual who has the authority to enter into, administer, or terminate this contract and is the only person authorized to approve changes to any of the requirements under this contract, and notwithstanding any provision contained elsewhere in this contract, this authority remains solely with the CO.

No statement, whether oral or written, by anyone other than the Contracting Officer, shall be interpreted as modifying the terms and conditions of this Task Order. It is the Contractor’s responsibility to contact the CO immediately if there is even the appearance of any technical direction that is or may be outside the scope of the contract. The Government will not reimburse the Contractor for any work not authorized by the CO.

HHSAR Clauses 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause- Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

(End Of Clause) 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:

(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 Web site: (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 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) Invoicing Instructions FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury's Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in FAR 32.905(b), "Content of Invoices" and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions - Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov c.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

f. 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.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

(End of Instructions)