Attachment 1 - Autoinjector SOW FY2426Mar24.pdf

Medical Waste (Auto-injector) 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.

DRAFT

1. SCOPE

The purpose of this solicitation is to establish a base plus four-year central contract, hereafter referred to as the Contractor, 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 auto-injectors and Midazolam. The number of sites and quantities that need disposal service will vary from year-to-year. The contract will include service for both the continental United States and outside the continental United States. 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 AFMED Agency/SG4M to establish an efficient process to remove and dispose of expired auto-injectors. ATNAA, Diazepam, and Midazolam to be processed will cover expired auto-injectors and auto-injectors 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 auto-injectors currently expired and projected to expire 2024-2026. Auto-injectors set to expire in calendar years 2027-2028 are unknown.

Because the number of auto-injectors that require disposal can vary, the quantities provided in the Appendix are projections only. Additionally, Midazolam is not included in the appendix because disposal quantities are unknown. 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

Acronym Term

ATNAA Antidote Treatment Nerve Agent Autoinjector

CFR Code of Federal Regulation

CONUS Continental United States

COR Contracting Officer Representative

DAF Department of the Air Force

DEA Drug Enforcement Administration

DoD Department of Defense

DoDAAC Department of Defense Activity Address Code

DOT Department of Transportation

EPA U.S. Environmental Protection Agency

FDA Food and Drug Administration

OCONUS Outside the Continental United States

OSHA Occupational Safety and Health Administration

SLEP Shelf-Life Extension Program

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 auto-injectors, 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 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 Contractor shall provide on-site servicing. The Contractor will contact eligible DAF customers directly to arrange pick-up dates. The Contractor will work on-site to inventory all auto-injectors and prepare them for transport to the disposal facility for processing. The Contractor shall package the designated auto-injectors and transport them to the Contractor’s facility for disposal. The Contractor shall pick-up auto-injectors from the customer’s facility by close of business the same day as inventory is completed and boxed for disposal. 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 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 6505013627427), Diazepam (NSN 6505012740951) auto-injectors, 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 auto-injectors 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 AFMED Agency/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 auto-injectors 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 auto-injectors 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) days of pick-up.

Additionally, the Contractor shall provide a detailed disposal report to each facility and the COR within 15 calendar days after processing the auto-injectors 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 Government Holidays – The following information is provided to assist the Contractor in scheduling returns for on-site service:

a. New Year’s Day January 1st

b. Martin Luther King’s Birthday Third Monday in January

c. President’s Day Third Monday in February

d. Memorial Day Last Monday in May

e. Independence Day July 4th

f. Labor Day First Monday in September

g. Columbus Day Second Monday in October

h. Veterans Day November 11th

i. Thanksgiving Day Fourth Thursday in November

j. Christmas Day December 25th

NOTE: Should any of these holidays fall on a Saturday or Sunday, the contractor should contact the returning facility to determine on which day (Friday or Monday) the holiday will be observed.

Appendix 1

See attachment for appendix 1.