Structured Product Labeling (SPL) HT9426-26-Q-E022

PERFORMANCE WORK STATEMENT (PWS) - DRAFT Title: StructureD prODUCT LABELING (SPL) Requiring Activity/Agency Name: Office of Regulated Activities (ORA) in support of the Defense Health Agency Research and Development (DHA R&D) Medical Research and Development Command (MRDC) 1. Background Office of Regulated Activities of the DHA R&D – MRDC has a requirement to manage, process, and complete initial labeling and labeling changes in electronic structured product label document submissions to the FDA. Structured Product Labeling (SPL) is a Health Level Seven (HL7) standard based on Clinical Document Architecture and HL7 Reference Information Model (RIM) accredited by the American National Standards Institute (ANSI) for the exchange of product information. The DHA R&D – MRDC currently has 2 licensed New Drug Application (NDA) products which require SPL submissions for up to 5 levels of primary and secondary labeling. 2. Scope The ORA requires SPL in order to carry out mission essential work. The SPL will include the following 3 types of submission requests from the regulatory Sponsor: Create new labels. Draft labels. Submit drafts to FDA review for approval. Create final label. Update existing labels Draft labels. Submit drafts to FDA review for approval. Create final label. Submit final labels to FDA for specific product application. 3. Details When creating labels as described in Section 1, the Contractor must: Adhere to the latest technical conformance criteria for SPL documents used by FDA. Use XML (eXtensible Markup Language) format, allowing for consistent, machine-readable data. Validation systems consistent with FDA compliance regulations Establish processes and procedures to ensure quality and content consistency. The labeling must maintain consistency with the product's approval to ensure all information is accurate and up to date. Have a documented procedure for sending content of Labeling to Regulatory Authorities. Have documented system configuration management processes. Establish procedures for records management ensuring that the most current information is always accessible. It is essential to promptly update the SPL when any changes to the product labeling occur. Establish procedures for complying with US FDA and ICH Guidelines, as well as industry standards on SPL submissions requirements. Elements of Labeling covering SPL system capabilities SPL should include specific elements such as: Product Identification Information Indications and Usage Dosage and Administration Warnings and Precautions Adverse Reactions Clinical Pharmacology Other relevant sections based on the product type. 4. Optional Surge Support – Structured Product Labeling 4.1 Scope of surge Operations The Government may require an increased volume of SPL services above the baseline CLINs. When directed by the Contracting Officer (CO), the Contractor shall provide surge support to execute identical product labeling tasks. All surge support operations shall adhere to the exact quality, security, and material standards defined for the base requirements. 4.2 Activation and Execution Surge support is strictly an optional requirement. The Government may exercise this option unilaterally via a formal contract modification. The Contractor shall not commence surge operations or incur costs against the Surge CLINs until explicitly authorized in writing by the CO. 5. Non‑Personal Services All services under this contract are strictly non‑personal. No contractor employee shall be supervised or controlled as a Government employee. 5.1 Severable Services This requirement is severable. Each SPL requirement is a distinct and complete unit of service. 5.2 Inherently Governmental Functions No inherently governmental functions are included in this requirement. 5.3 Acquisition Functions Closely Associated with Inherently Governmental Functions This requirement does not include acquisition functions closely associated with inherently governmental functions. 6. General Information 6.1 Period of Performance Base year and four one-year Option Periods beginning approximately 15 June 2026. 6.2 Recognized Federal Holidays The contractor is not required to perform services on the following recognized Federal Holidays: New Year’s Day Dr. Martin Luther King Jr.’s Birthday Washington’s Birthday Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day 6.3 Type of Contract This contract will be Firm-Fixed-Price. 6.4 Deliverables: All deliverables shall be submitted to the designated Government POC: TBD Title: TBD E-Mail: TBD 7. Training/Security Requirements 7.1 General Training Requirements 7.2 Access and General Protection Policy and Procedures Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204‐9, Personal Identity Verification of Contractor Personnel) as directed by DOD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes. 7.3 Contractors Requiring Common Access Card (CAC) Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated National Agency Check with Inquiries (NACI) or an equivalent or higher investigation in accordance with Army Directive 2014‐05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) Both physical access to a DoD facility and access, via logon, to …