Structured Product Labeling (SPL)

Form / Attachment / Pricing Sheet

This document is a Non-Disclosure Agreement (NDA) required for contractor employees and subcontractors working under contract with the Defense Health Agency Research and Development (DHA R&D) Medical Research and Development Command (MRDC), Office of Regulated Activities (ORA). It outlines the obligations of individuals who may access sensitive or proprietary information.

• Confidential Information: Covers sensitive or proprietary business, technical, financial, and source selection information belonging to the Government or other Contractors. This includes, but is not limited to, cost/pricing data, Government spend plan data, PPBE documents, contractor technical proposals, independent Government cost estimates, negotiation strategies, and contractor data presented in negotiations.
• Obligations: Individuals agree not to use, discuss, divulge, or disclose such information except to authorized personnel involved in the contract's performance.
• Enforcement: The U.S. Government may seek legal remedies, including court orders, to enforce the agreement. Costs and attorney fees may be assessed against the individual if they lose such an action.
• Continuing Obligation: Individuals must reveal their continuing obligation under this agreement to prospective employers before accepting new employment.
• Exclusions: Obligations do not apply to information that is publicly available, disclosed with prior written approval, independently developed, disclosed pursuant to a court order (with notification), or inadvertently disclosed despite reasonable care.

Bidders must ensure that their employees and subcontractors understand and agree to the terms of this NDA if they are to be involved in the performance of the contract. This agreement is critical for protecting sensitive government and contractor information and may be a prerequisite for participation in certain contract activities.

Statement of Work (SOW) / Performance Work Statement (PWS)

This Performance Work Statement (PWS) outlines the requirements for Structured Product Labeling (SPL) services to support the Office of Regulated Activities (ORA) within the Defense Health Agency Research and Development (DHA R&D) – Medical Research and Development Command (MRDC). The primary goal is to manage, process, and complete initial labeling and labeling changes for electronic SPL submissions to the Food and Drug Administration (FDA).

• Create New Labels: Draft and submit new labels to the FDA for approval, and create final labels.

• Update Existing Labels: Draft and submit updates to existing labels to the FDA for approval, and create final labels.

• Submit Final Labels: Submit final labels to the FDA for specific product applications.

• Adherence to Standards: Comply with the latest FDA technical conformance criteria for SPL documents, use XML format, and align with FDA compliance regulations and validation systems.

• Process Management: Establish and maintain documented procedures for quality consistency, sending content to regulatory authorities, system configuration management, records management, and compliance with US FDA, ICH Guidelines, and industry standards.

• SPL Elements: Ensure SPL includes specific elements such as Product Identification, Indications and Usage, Dosage and Administration, Warnings and Precautions, Adverse Reactions, Clinical Pharmacology, and other relevant sections.

• Timely Delivery: Deliver quality SPL conforming to Government POC requests.

• Quality: Maintain consistency with product approvals and ensure accuracy and up-to-date information.

• Surveillance: Performance will be monitored through direct observation and inspection by the Government POC.

• Incentive: Positive Past Performance Rating.

• Period of Performance: Base year and four one-year Option Periods, beginning approximately June 15, 2026.

• Place of Performance: Not explicitly stated, but services are performed for the ORA/DHA R&D/MRDC.

• Non-Personal Services: Services are strictly non-personal; no contractor employee will be supervised as a Government employee.

• Severable Services: Each SPL requirement is a distinct and complete unit of service.

• Security: Compliance with installation access requirements, personal identity verification (including potential CAC issuance based on investigation), and adherence to Force Protection Conditions (FPCON).

• Identification: Contractor personnel must clearly identify themselves as contractors and refrain from using retired military rank or title.

• Non-Disclosure: All staff must sign a Non-Disclosure/Non-Use Agreement before performing work.

• Organizational Conflict of Interest (OCI): This requirement falls under Category 3: Product Support. Offerors must be aware of potential OCIs with other categories.

• Optional Surge Support: The Government may require increased SPL services, activated via contract modification.

• Deliverables: Include signed Non-Disclosure Agreements, OCI forms, Quality Control Plan, and Standard/Optional SPL Services as requested.

Form / Attachment / Pricing Sheet

This document is Attachment 3, "Past Performance References." It is a form designed for offerors to provide details about their relevant past performance on previous contracts. This information is crucial for the government's evaluation of the offeror's ability to successfully perform the work required by the solicitation.

• Offeror Name: The name of the company submitting the reference.
• Relationship to Offeror: Indicates if the work was performed as the prime contractor, subcontractor, or proposed subcontractor.
• Company who performed this work: The name of the entity that actually executed the work.
• Work Performed As: Specifies the role (Prime or Subcontractor).
• Name of Contracting Organization: The agency or entity that awarded the contract.
• Contract / Task Order Number: Identifies the specific contract or task order.
• Contract Type: The type of contract awarded (e.g., FFP, Cost-Plus).
• Total Awarded Price/Cost: The original or final awarded value.
• Delivery Date/Period of Performance: The duration of the contract.
• Contracting Officer and Program Manager Information: Contact details for key personnel.
• NAICS Code: The North American Industry Classification System code.
• CPARS/PPIRS Completed: Indicates if a Contractor Performance Assessment Reporting System (CPARS) or Past Performance Information Retrieval System (PPIRS) report exists.
• Description of the Requirement: A concise explanation of the work performed, specifically related to its relevance to the current solicitation's requirements.
• Performance: A section to detail any performance issues, corrective actions, and their outcomes.

Bidders must complete this form accurately and thoroughly for each relevant past performance reference. The information provided will be used to assess the bidder's experience and capability to meet the requirements of the current opportunity. Failure to provide complete and relevant past performance information may negatively impact the evaluation.

Form / Attachment / Pricing Sheet

This document is Attachment 2, an Organizational Conflict of Interest (OCI) Certification Form, required by the Defense Health Agency Research and Development (DHA R&D) Medical Research and Development Command (MRDC). Its purpose is to help identify, avoid, or mitigate Organizational Conflicts of Interest in accordance with FAR Subpart 9.5.

• OCI Categories Defined: The form defines three categories of services (Internal Support, Admin/Acquisition Support/IT, Product Support) and explains how participation in multiple categories may create OCIs.
• Offeror Responsibilities: It outlines the process for Offerors to certify their OCI status, including performing comparative analyses and submitting OCI Avoidance or Mitigation Plans if potential conflicts are identified.
• Certification Statement: Offerors must certify whether a real or perceived OCI will result from the proposed work, or if an OCI Avoidance or Mitigation Plan is attached.
• Subcontractor Requirements: Contractors must obtain similar OCI certifications from subcontractors, teaming partners, and consultants.

Bidders must carefully review the OCI categories and their own current and past work with DHA R&D MRDC. This form requires bidders to assess and certify their OCI status. Failure to adequately address potential OCIs, including submitting required analysis or mitigation plans, may lead to disqualification from the award process. Bidders must complete and submit this certification as part of their proposal.

Form / Attachment / Pricing Sheet

This document is a pricing sheet attachment for the "DHA Structured Product Labeling Requirement" opportunity. It outlines the CLINs (Contract Line Item Numbers), descriptions, quantities, and unit information for the services required across a base period and four option periods.

• Base Period: Includes CLINs 0001-0004 for Structured Product Labeling Generation, with optional surge support. All listed quantities are set to 2 for the base CLIN and 1 for optional surge support CLINs.
• Option Periods 1-4: Each option period (CLINs 1001-1004, 2001-2004, 3001-3004, 4001-4004) mirrors the structure of the base period, providing for Structured Product Labeling Generation and optional surge support.
• CLIN Type: All CLINs are designated as Firm-Fixed-Price (FFP).
• Unit of Issue: The unit of issue for all services is 'Job'.
• Pricing: All Unit Price and Total fields are currently listed as 0.0, indicating that specific pricing details are to be filled in by the bidder or will be determined through the solicitation process.

Bidders must use this pricing sheet to provide their proposed costs for the Structured Product Labeling Generation services. It details the structure of the contract, including the base period and potential option periods, and the quantities of 'Jobs' required for each. Bidders should carefully review the descriptions, particularly the PWS Sections 2 & 3 references, and complete the Unit Price and Total fields accurately for all CLINs to formulate their proposals.

Solicitation / RFP / RFQ

This solicitation is for "Structured Product Labeling Generation" services. The Defense Health Agency (DHA) Research and Development Medical Research and Development Command (MRDC) requires a contractor to manage, process, and complete initial labeling and labeling changes in electronic structured product label (eSPL) document submissions to the FDA. The MRDC currently has two licensed New Drug Application products requiring SPL submission for up to five levels of primary and secondary labeling.

• Manage, process, and validate XML-based eSPL files according to current FDA Comprehensive Packaging and Labeling standards.

• Utilize FDA-compliant validation software (e.g., Reed Tech, Pragmatic, or similar) for error-free submissions.

• Handle "Labeling Changes" (revisions), including version control and tracking of FDA interactions.

• Handle sensitive product data in a secure environment.

• Solicitation Number: HT942626QE022

• NAICS Code: 541690 (Other Management Consulting Services)

• Size Standard: $19,000,000.00

• Contract Type: Firm Fixed Price (FFP)

• Period of Performance: Base year (June 30, 2026 - June 29, 2027) with four (4) option years.

• Offer Due Date: June 05, 2026, 02:00 PM Eastern Time.

• Questions Due: May 26, 2026, 2:00 PM Eastern Time.

• Submission Volumes: Quotes must be submitted in three volumes: Technical Capability, Past Performance, and Price & Administrative.

• Evaluation Factors: The contract will be awarded on a best-value tradeoff basis, considering Technical Capability, Past Performance, and Price.

• This acquisition is UNRESTRICTED.

• The solicitation incorporates FAR clauses 52.212-1, 52.212-4, and 52.212-5 by reference.

• Attachments include: Non-Disclosure Agreement, Organizational Conflict of Interest Certification Form, Past Performance References, Pricing Sheet, and Performance Work Statement.