ATCH 1 - Autoinjector SOW FY24 4 Sept 24.docx

Medical Waste (Autoinjector) Removal and Disposal Services

STATEMENT OF WORK FOR:

Antidote Treatment Nerve Agent Autoinjectors (ATNAA), Diazepam and Midazolam Disposal

Prepared By:

AFMED Agency/SG4M, 693 Neiman St, Ft Detrick, MD 21702

Prepared on:

26 March 2024

Version: 1

DISTRIBUTION STATEMENT D. Distribution authorized to Department of Defense and U.S. DoD contractors only (Administrative or Operational Use/Export Controlled) (21 Aug 2023). Other requests for this document will be referred to the Acquisition and Program Management Competency.

1. SCOPE

This is a performance-based contract capable of assisting the Department of the Air Force (DAF) in removing and disposing of medical waste, specifically various amounts of expired unused Antidote Treatment Nerve Agent Autoinjectors (ATNAA), Diazepam autoinjectors and Midazolam. The number of sites and quantities that need disposal service will vary from year- to-year. The contract shall include service for both the continental United States (CONUS) and outside the continental United States (OCONUS). The Government’s need for on-site and/or off-site processing is imperative to assure optimum inventory control and to eliminate the violation of laws and regulations, especially in waste disposal. Contractors shall be compliant with all applicable regulations related to handling pharmaceutical waste, hazardous waste, and controlled substances.

It is the intent of AFMEDCOM/SG4M to establish an efficient process to remove and dispose of expired autoinjectors. The autoinjectors to be processed for ATNAA, Diazepam, and Midazolam will cover expired autoinjectors and autoinjectors set to expire during the contract period.

The proposed removal and disposal fee shall be the total cost for a central purchase and should cover all the contractor’s costs including, but not limited to, packaging, shipping, processing access to facilities and any other applicable fees in performance of the disposal service.

Appendix 1 identifies the locations, quantities of autoinjectors currently expired and projected to expire 2024-2026. Autoinjectors set to expire in calendar years 2027-2028 are unknown.

Because the number of autoinjectors that require disposal can vary, the quantities provided in the Appendix are projections only. Prior to the Contractors visit, each site requiring service will identify the quantity of expired ATNAA, Diazepam and Midazolam in the War Reserve Materiel program that will be disposed.

2. APPLICABLE DOCUMENT

3. ACRONYMS

4. REQUIREMENTS

4.1 REGULATORY COMPLIANCE

The Contractor shall be required to provide all plant, equipment, materials, and labor needed to process the removal and proper disposal of designated autoinjectors, including Schedule II-V controlled substances. The Contractor shall be responsible for complying with all applicable federal regulations such as the Code of Federal Regulation (CFR) Title 21 Food & Drugs, Title 29 Hazardous Materials, Title 40 Protection of the Environment, Title 49 Department of Transportation (DOT), U.S. Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA) and DoD regulations. The Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) state that all controlled substances to be destroyed by a registrant must obey DEA code 1317.95, be destroyed in compliance with pertinent Federal, State, tribal, and local laws, and regulations, and be presented irredeemable. The Contractor is required to consult with the regional offices of the federal regulatory agencies that have jurisdiction over their operations. This is to ensure compliance with the laws and regulations of host countries, in addition to adhering to the only acceptable method of destruction for pharmaceutical wastage, which is incineration. The Contractor shall also comply with applicable state/local regulations and consult with regional offices of the federal regulatory agencies that have jurisdiction over their operations to ensure compliance with laws and regulations of host countries.

4.2 LICENSES, PERMITS, REGISTRATION, INSURANCE

All necessary permits and licenses required by federal, state, and local authorities shall be acquired and maintained by the Contractor for the life of the contract. This includes required licenses, certifications, permits, and any other requirements for individual contractor staff as well as any required permits and licenses for interstate transport, and storage/disposal of hazardous and non-hazardous unserviceable items. This includes but is not limited to DEA, DOT, EPA, FDA, OSHA, and individual state and country regulations.

The Contractor shall be licensed DEA registrant to handle Schedule II-V Controlled Substances. A copy of all renewals shall be forwarded to the Contracting Officer for retention in the contract file. The Contractor shall have proper insurance coverage, including environmental remediation and be prepared to list the DoD and other eligible customers as additional insured if awarded a contract.

4.3 SERVICING/PROCESSING ARRANGEMENTS

The DAF customer will notify the COR and the Contractor to schedule pick-up date when a prepared autoinjector disposal shipment is ready for pick up. The DAF customer will submit the inventory manifest to the COR and Contractor no later than three (3) business days prior to the scheduled pick-up date.

The Contractor shall provide on-site servicing. The Contractor will contact eligible DAF customers directly to confirm scheduled pick-up dates with on-site point of contact identified in Attachment 1. The Contractor will work on-site to inventory all autoinjectors and prepare them for transport to the disposal facility for processing. The Contractor shall package the designated autoinjectors and transport them to the Contractor’s facility for disposal. The Contractor shall pick-up autoinjectors from the customer’s facility by close of business on the scheduled pick-up date. In addition, the Contractor shall comply with any participating customers’ additional security requirements and procedures for access to facilities. Facilities are located on military installations and the Contractor will need to possess the appropriate credentials to clear the check points. All costs associated with gaining access to a customer facility shall be the responsibility of the Contractor.

In the event on-site service cannot be provided, the Contractor shall provide all instructions, forms, labels, and DEA approved tamper-proof materials needed to ship the designated items to the Contractor’s disposal facility. Within 10 calendar days of receiving the goods, the Contractor shall process all designated items by inventorying, and processing items through the disposal process in accordance with all the applicable federal, state, and local regulations.

The Contractor will only accept ATNAA (NSN 6505-01-362-7427), Diazepam (NSN 6505-01-274-0951) autoinjectors, and Midazolam (NSN 6505-31-019-0519) within the war reserve materiel inventory.

4.4 SHIPPING

Whether the returns are processed using the Contractor’s on-site representative or via off-site processing, the Contractor is responsible for the transport/shipment from the customer’s facility to the Contractor’s disposal facility, including providing shipping materials and labels to ensure safe and accurate delivery of the shipment to its destination.

The Contractor is responsible for all shipping costs from the customer’s facility to the Contractor’s disposal facility, for all CONUS and OCONUS customers.

4.5 OCONUS CONSIDERATIONS

The Contractor shall be responsible for all transportation, lodging, telecommunications requirements, or any costs incurred to support their overseas service representative. The Contractor shall provide all equipment, materials, and labor needed to remove and dispose of the material.

4.6 CONTROLLED MATERIALS

The Contractor shall prepare all material for transport/shipping. Each box shall have a copy of the inventory inside the box. Coordination with local transportation assets and access to the facility remains the responsibility of the Contractor. The Contractor shall provide all instructions, applicable forms, and labels needed to ship designated items to the Contractor’s disposal facility, in the event on-site service cannot be provided.

The Contractor shall perform the removal and disposal of autoinjectors at the costs awarded herein for eligible DAF customers.

NOTE: All eligible customers of the program will have a six-character Department of Defense Activity Address Code (DoDAAC), which is the primary method used by AFMEDCOM/SG4M to identify each customer. The Contractor shall utilize the DoDAAC as one of the fields in identifying and reporting activity under this contract.

4.7 REPORTS

The Contractor shall prepare a detailed manifest of autoinjectors removed from the medical logistics facility and the customer must validate the contents of the list for accuracy. Any discrepancies shall be resolved prior to the removal of the autoinjectors from the customer’s facility by the Contractor. A copy of the manifest will be provided to the customer and emailed to the Contracting Officer Representative (COR) within three (3) business days of pick-up. The Contractor shall participate in the post-award meeting scheduled by the Government. The POC for the post-award meeting will be the COR. The COR will provide the following information to the Contractor during the post-award kick-off meeting: when each site collection begins, a complete address listing for each location, and the on-site POC information.

Additionally, the Contractor shall provide a detailed disposal report to each facility and the COR within 15 calendar days after processing the autoinjectors for disposal. This report should include at a minimum, the contract number, applicable order, or invoice number, DoDAAC, product name, National Stock Number (NSN) or catalog number, lot or batch number, and quantity.

Contact information:

COR Org box: usaf.detrick.afmra.mbx.sg4m-readiness-force-health-protection@health.mil

4.8 FEDERAL HOLIDAYS

Federal Government Holidays – Duty Hours: Normal duty hours are 7:30 am to 4:30pm, Monday through Friday (excluding Federal Holidays). For a list of Federal Holidays, see the Office of Personnel Management’s site at https://www.opm.gov/policy-data-oversight/pay-leave/federalholidays/#url=Overview.

5.0 PERFORMANCE OBJECTIVES

5.1 Services Summary (SS).

Paragraph

Appendix 1 See attachment for appendix 1.