FDA-26-PWS-135129.pdf

FDA-26-PWS-135129

Statement of Work

In-Person Training Program – Advanced Manufacturing Technologies

1. BACKGROUND

Advanced manufacturing technologies — including continuous manufacturing, additive manufacturing, along with platform and modular technologies — represent a significant evolution in pharmaceutical production. These technologies offer the potential to increase manufacturing flexibility and strengthen supply chain resilience. FDA has actively encouraged the adoption of advanced manufacturing technologies through FDA's Advanced Manufacturing Working Group published report, the Modernizing Pharmaceutical Manufacturing initiative, and the Emerging Technology Program.

As FDA staff are increasingly called upon to review, inspect, and develop policy related to facilities utilizing advanced manufacturing technologies, it is essential that CDER employees develop a strong foundational understanding of the scientific and engineering principles underlying these technologies, as well as the regulatory frameworks that govern them. In-person training delivered by subject matter experts is requested to promote active engagement and facilitate the applied, discussion-based learning that advanced manufacturing topics require.

2. PURPOSE AND OBJECTIVES

The purpose of this contract is to engage subject matter experts (SMEs) to deliver in-person training on advanced pharmaceutical manufacturing technologies for employees in CDER. The training is intended to build staff capacity to effectively review, inspect, and develop policy related to facilities and products utilizing advanced manufacturing approaches.

The objectives of this training are as follows:

• Develop foundational understanding of advanced manufacturing technologies — Participants will gain a working knowledge of the scientific and engineering principles underlying key advanced manufacturing modalities, including continuous manufacturing, 3D printing of drug products, and platform and modular manufacturing systems, with emphasis on how these technologies differ from traditional batch manufacturing in design, operation, and quality control.

• Apply regulatory frameworks to advanced manufacturing contexts — Participants will examine how existing CGMP regulations and international guidelines — including ICH Q13, ICH Q9, and ICH Q10 — apply to advanced manufacturing processes and will develop familiarity with areas where regulatory flexibility or additional guidance may be warranted.

• Build applied skills through case study analysis — Participants will engage with real-world and hypothetical case studies drawn from advanced manufacturing contexts, including continuous manufacturing deviation investigations, real-time release testing scenarios, and 3D-printed drug product review situations, to develop practical analytical skills applicable to their regulatory duties.

• Strengthen inspection and compliance readiness — Participants will develop an understanding of how advanced manufacturing operations are assessed during FDA inspections, including common findings, emerging best practices, and the application of Process Analytical Technology (PAT) and real-time release testing frameworks.

3. SCOPE OF THE WORK

The advanced manufacturing training program shall offer four in-person sessions. The length of each session will be commensurate with the topic, not exceeding a maximum length of three days or daily maximum of seven hours for each session. Requirements for each training session:

• Deliver in-person training on advanced manufacturing topics

• Address the scientific and engineering principles underlying the session's technology focus

• Incorporate case studies or hands-on activities drawn from real-world advanced manufacturing scenarios

• Include knowledge check questions

Example Session Topics:

In-Person Session #1 — Introduction to Advanced Manufacturing Technologies: Overview of key advanced manufacturing modalities (continuous manufacturing, 3D printing, platform and modular technologies), their benefits, current industry adoption, and implications for pharmaceutical quality and supply chain resilience.

In-Person Session #2 — Regulatory Framework for Advanced Manufacturing: Examination of how existing regulatory requirements and international guidelines — including ICH Q9, ICH Q10, ICH Q12, and ICH Q13 — apply to advanced manufacturing processes, including areas of regulatory flexibility and emerging policy considerations.

In-Person Session #3 — Quality Systems and Process Analytical Technology (PAT) in Advanced Manufacturing: Application of quality risk management principles and PAT tools to advanced manufacturing processes, including real-time release testing, control strategy development, and data integrity considerations specific to continuous and novel manufacturing systems.

In-Person Session #4 — Case Studies and Inspection Readiness for Advanced Manufacturing:

Applied case study analysis of advanced manufacturing operations from a regulatory perspective, including review of inspection findings, common compliance challenges, and best practices for assessing advanced manufacturing facilities.

4. DELIVERABLES

• Training plan describing proposed topics, materials, speakers, and approach

• Four in-person training sessions, including a final knowledge check quiz or exam

• Certificates of completion to be maintained as part of the training record

• Pre-training reading package or background materials for each session to establish baseline knowledge among participants

• Case study materials tailored to advanced manufacturing scenarios for use during training sessions

• A curated resource list of relevant FDA guidances, ICH guidelines, and key scientific literature provided to participants following each session

5. CONTRACTOR QUALIFICATIONS

• Direct experience with advanced manufacturing technologies, including continuous manufacturing, 3D printing of drug products, or platform and modular manufacturing systems, in an industry, academic, or regulatory context.

• Deep familiarity with the regulatory and scientific frameworks governing advanced manufacturing, including ICH Q9, ICH Q10, ICH Q12, ICH Q13, and relevant FDA guidance documents such as those addressing process validation, PAT, data integrity, and quality systems.

• Credentials or demonstrated experience developing and delivering adult learning curricula, preferably to regulatory scientists, inspectors, or other technical audiences.

• Experience delivering training to regulatory or scientific audiences is strongly preferred given the technical nature of the subject matter and the FDA audience.

6. PERIOD OF PERFORMANCE

The period of performance shall be four sessions not exceeding three days for each session or seven hours each day that will be scheduled one year from the date the contract is awarded.

7. PLACE OF PERFORMANCE

Work shall be performed at the FDA campus in White Oak, Silver Spring, MD.

8. CONTRACT TYPE

Firm Fixed price

9. GOVERNMENT-FURNISHED PROPERTY/INFORMATON

The Government shall provide:

• Access to the White Oak Campus

• Conference room to deliver the training

• Audio/Visual/IT support for the conference room

• Technical points of contact for the training

10. SECURITY AND CONFIDENTIALITY REQUIREMENTS

Performance of work will not require contractor to have access to and use of data and information that may be considered proprietary to regulated industry, a government agency or Government contractor, or that may otherwise be of such nature that its dissemination or use would be adverse to the interest of FDA or others. Contractor shall be responsible for knowledge of and compliance with all applicable federal information.

11. ACCEPTANCE CRITERIA

All deliverables shall be subject to FDA review and acceptance. Deliverables must:

• Be complete, accurate, and professionally prepared

• Meet the requirements specified in this SOW

• Be submitted in the formats specified by the COR

• Be accepted in writing by the COR within 15 business days of submission

Deliverables not meeting acceptance criteria shall be revised and resubmitted within 10 business days of notification.

12. GOVERNMENT POINTS OF CONTACT

Contracting Officer (CO): Kyle Smith Contracting Officer's Representative (COR): TBD Technical Point of Contact: TBD

13. CLAUSES / INSTRUCTIONS / EVALUATION

HHSAR 352.211-1 Public Accommodations and Commercial Facilities (Nov 2025) (RFO DEVIATION) (Full Text)

(a) The Contractor must submit an approved plan ensuring events comply with 28 CFR part 36 (disability access) to the Contracting Officer Representative prior to the event, covering all, or a master plan for, events.

(b) The contractor must manage the contract to comply with 28 CFR part 36 standards.

(End of clause)

HHSAR 352.222-70, Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) HHSAR 352.224-70, Privacy Act (Dec 2015)

HHSAR 352.232-71, Electronic Submission of Payment Requests (Feb 2022)

General FAR Clauses (Incorporated by Reference)

• FAR 52.04-13, System for Award Management Maintenance (Oct 2018)

• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug 2020)

• FAR 52.204-27, Prohibition on a ByteDance Covered Application (Jun 2023)

• FAR 52.212-1, Instructions to Offerors—Commercial Products and Commercial Services

(Nov 2023)

• FAR 52.212-3, Offeror Representations and Certifications—Commercial Products and

Commercial Services (May 2024)

• FAR 52.212-4, Contract Terms and Conditions—Commercial Products and Commercial

Services (Nov 2023)

• FAR 52.232-39, Unenforceability of Unauthorized Obligations (Jun 2013)

• FAR 52.232-40, Providing Accelerated Payments to Small Business Subcontractors (Mar

2023)

General FAR Clauses (Full Text)

FAR 52.214-34 Submission of Offers in the English Language (Apr 1991) Offers submitted in response to this solicitation shall be in the English language. Offers received in other than the English language shall be rejected.

FAR 52.214-35 Submission of Offers in U.S. Currency (Apr 1991) Offers submitted in response to this solicitation shall be in terms of U.S. dollars. Offers received in other than U.S. dollars shall be rejected.

FAR 52.212-1 Instructions to Offerors—Commercial Products and Commercial Services (Nov 2023) (Incorporated by Reference) Addendum to FAR 52.212-1 — Proposal Submission Instructions

1. Submission Format: Offerors must submit their proposals electronically via email to the Contracting Officer at kyle.smith@fda.hhs.gov no later than 8/4/2026 12:00PM ET.

Proposals must be submitted in two (2) separate volumes as outlined below. Files must be in PDF format or Microsoft Word/Excel.

2. Volume I – Technical Proposal (Pass/Fail Evaluation): Do not include any pricing information in Volume I. This volume must contain:

o Section 1 (Instructor Qualifications): Resumes for all proposed instructors demonstrating a minimum of 3 years of professional experience teaching the requested topics and required certifications.

o Section 2 (Curriculum Alignment): A detailed syllabus or course outline mapped to the learning objectives outlined in the Performance Work Statement (PWS).

o Section 3 (Past Performance References): A list of a minimum of 2 references for identical or similar training delivered within the last 5 years, including client name, contract number, dollar value, and point of contact.

3. Volume II – Price Proposal: This volume must contain:

o A completed Price Schedule outlining the firm-fixed-price per training session mailto:kyle.smith@fda.hhs.gov and the total cumulative price.

o Prices must include all labor, training materials, instructor travel, and administrative overhead.

FAR 52.212-2 Evaluation—Commercial Products and Commercial Services (Oct 2024) (Full Text)

(a) Basis for Contract Award: The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

1. Factor 1: Technical Acceptability

2. Factor 2: Price

Award will be made on the basis of the lowest evaluated price of proposals meeting or exceeding the acceptability standards for the non-cost factor. Trade-offs are not permitted.

Offers will be evaluated for Technical Acceptability on a "Pass/Fail" (Acceptable/Unacceptable) basis. An offer must receive a rating of "Acceptable" on Factor 1 to be eligible for award. The Government will sort all offers by total evaluated price. The technical proposal of the lowest-priced offer will be evaluated first. If found acceptable, award will be made without further evaluation of other offers.

(b) Technical Acceptability Standards: To be determined "Acceptable" under Factor 1, the offeror’s proposal must demonstrate compliance with the following minimum requirements:

• Subfactor 1.1: Instructor Qualifications. Proposed instructors possess a minimum of 3 years of professional experience delivering the requested training topics and hold required certifications.

• Subfactor 1.2: Curriculum Alignment. The submitted syllabus or course outline aligns entirely with all learning objectives detailed in the PWS.

• Subfactor 1.3: Past Performance. Provides a minimum of 2 references for identical or similar in-person training services delivered within the past 5 years with satisfactory or higher performance ratings.

(c) Price Evaluation: The Government will evaluate the total proposed price for fairness and reasonableness based on market competition.

FAR 52.212-3 Offeror Representations and Certifications—Commercial Products and Commercial Services (May 2024) (Incorporated by Reference)

FAR 52.212-4 Contract Terms and Conditions—Commercial Products and Commercial Services (Nov 2023) (Incorporated by Reference) Addendum to FAR 52.212-4

• Paragraph (i) Payment: Payment shall be made on a Firm-Fixed-Price basis upon successful completion, delivery, and Government acceptance of each individual training session. Invoices shall be submitted electronically through IPP. Price includes all instructor labor, travel, and student materials. No separate travel reimbursement or material fees will be authorized.

FAR 52.212-5 Contract Terms and Conditions Required To Implement Statutes or Executive Orders—Commercial Products and Commercial Services (March 2026)

(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 products and commercial services:

• (1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements

• (2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab

• (3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment

• (4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations

• (5) 52.233-3, Protest After Award

• (6) 52.233-4, Applicable Law for Breach of Contract Claim

(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 products and commercial services:

• (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards.

• (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with

Contractors Debarred, Suspended, or Proposed for Debarment.

• (28) 52.219-28, Post-Award Small Business Program Representation.

• (31) 52.222-21, Prohibition of Segregated Facilities.

• (32) 52.222-26, Equal Opportunity.

• (35) 52.222-36, Equal Opportunity for Workers with Disabilities.

• (43) 52.222-50, Combating Trafficking in Persons.

• (50) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving.

• (55) 52.225-13, Restrictions on Certain Foreign Purchases.

• (60) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management.