Performance Work Statement - ORA SPL Requirement.docx

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:

1. Create new labels.

· Draft labels.

· Submit drafts to FDA review for approval.

· Create final label.

2. Update existing labels

· Draft labels.

· Submit drafts to FDA review for approval.

· Create final label.

3. 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:

1. Product Identification Information

2. Indications and Usage

3. Dosage and Administration

4. Warnings and Precautions

5. Adverse Reactions

6. Clinical Pharmacology

7. 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 DoD networks on‐site or remotely; (2) remote access, via logon, to a DoD network using DoD‐approved remote access procedures; or (3) physical access to multiple DoD facilities or multiple non‐DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

7.4 Contractors That Do Not Require a CAC but Require Access to a DoD Facility or Installation. CAC not required.

Contractor and all associated sub‐contractor’s employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC‐III) and Terrorist Screening Database (Army Directive 2014‐05/AR 190‐13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative); or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

8. Other Requirements

8.1 Contractor Identification

When Contractor personnel perform the services required in this task order on a Government installation, they are required to possess and wear an identification badge that displays his or her name and the name of the Company. The Contractor shall ensure that Contractor personnel identify themselves as Contractor personnel when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

While performing in a Contractor capacity, Contractor personnel shall refrain from using their retired or reserve component military rank or title in all written or verbal communications.

9. Non-Disclosure/Non-Use Agreement

The Contractor shall ensure that the Non-Disclosure/Non-Use Agreement is signed by all staff assigned to or performing on this task order before performing any work, including all Subcontractors and consultants. The Non-Disclosure/Non-Use Agreement shall be cosigned by a corporate official (Contractor Task Manager(s) or higher). The Contractor shall also ensure that all staff understand and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other Contractors. Assignment of staff members who have not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor. Contractors will submit a signed Non-Disclosure Agreement. Requiring activity must ensure the NDA has been approved by its supporting Staff Judge Advocate.

10. Organizational Conflict of Interest (OCI) Category

The DHA R&D MRDC has categorized all service procurements into one of the following three as defined below, for purpose of identifying, avoiding or mitigating against Organizational Conflicts of Interests (OCIs) in accordance with FAR Subpart 9.5. These categories are defined as follows:

Category 1: DHA R&D MRDC Internal Support: Services which, by their very nature, give the Contractor access to potential requirements and extensive data about Category 2 and Category 3 contractors.

Category 2: Admin/Acquisition Support/IT: Services which assist DHA R&D MRDC in acquisition processes. This includes, for example: requirements analysis, acquisition support, budget planning and management, business process reengineering, program planning and execution support, independent technical management support, and IM/IT support. Contractor access to potential requirements and extensive data about Category 3 contractors.

Category 3: Product Support: Services or end items required to meet the mission requirements of DHA R&D MRDC activities and acquisition programs. This includes, for example: concept exploration and development; system design; system development and integration; Commercial Off-The-Shelf (COTS) procurement and integration; internal development testing; deployment; installation; operations; and maintenance.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information. Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that DHA R&D MRDC presumes that award of a contract or order in the subject category will give rise to real or apparent OCIs with respect to requirements in the other two categories; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in DHA R&D MRDC requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all DHA R&D MRDC requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying, avoiding and/or mitigating against OCIs, DHA R&D MRDC will examine all of its requirements and acquisitions regardless of the cognizant contracting activity (e.g., Defense Health Agency Contracting Activity (DHACA), General Services Administration (GSA), other agency Multiple Award Schedules, etc.) or the type of contract vehicle used (e.g., Federal Supply Schedule (FSS) order, Fair Opportunity competitive order under Multiple Award Indefinite Delivery Indefinite Quantity (IDIQ) Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each DHA R&D MRDC solicitation will therefore be designated as falling within one of the three above-mentioned categories. The work called for under this contract has been determined by DHA R&D MRDC to fall within the following OCI category:

Category 3: DHA R&D MRDC Product Support

11. Protection of Information/Public Releases The Contractor shall coordinate and discuss with the designated Government POC all corporate publications (e.g., news releases, abstracts from meetings, etc.) that contain references to this contract. Additionally, prior to releasing any of the above, the Contractor shall provide a copy of the release to the Contracting Officer for comments and approval to release.

12. Contractor Employees/Contractor Identification

The Contractor shall ensure that contractor personnel identify themselves as contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in all written or verbal communications associated with the contract under which they provide services.

13. Performance Requirements Summary Matrix

By monitoring the Contractor, the designated Government POC will determine whether the performance levels set forth in the contract have been attained. Performance standards are specified in the following Performance Requirements Summary Matrix in the Standard and Acceptable Quality Level (AQL) columns. References which may be used by the designated Government POC to determine whether the performance levels have been attained include the following:

10. Deliverable/Delivery Schedule

Delivery Schedule Abbreviations The following abbreviations are used in the delivery/deliverable schedule:

A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E), and/or hard copy (H).