U.S. flag

An official website of the United States government

Dot gov

Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Https

Secure .gov websites use HTTPS

A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites..

Information for Exporters with a Surplus of Medical Supplies and Equipment

Release Date:
January 26, 2021

FEMA published a Temporary Final Rule (TFR) in the Federal Register on December 31, 2020 which allocates certain scarce critical medical and healthcare resources for domestic use to ensure needs are met for the American public during the COVID-19 pandemic, and to ensure that domestic supplies of certain materials are not inappropriately exported abroad..

Although FEMA works to keep the TFR up to date to reflect current shortages, the agency recognizes that there may be situations in which the domestic supply of material covered in the TFR may exceed the domestic demand.

If you believe you have a surplus of a covered material and can demonstrate a good-faith and unsuccessful attempt to sell the material domestically, you may submit a request to FEMA to allow the material to be exported. (See information on submitting a request below.)

An extension of this TFR was made in December and it will remain in effect, with possible changes, until June 30, 2021.

Materials Covered Under the Allocation Order

FEMA is working in close coordination with Customs and Border Protection (CBP) and the members of the Export Cargo Review Working Group,  which includes representatives from the departments of State, Health and Human Service, Commerce, and Food and Drug Administration, to review shipments of the following materials:

  • Surgical N95 Respirators
  • Surgical masks, specifically PPE surgical masks that meet fluid barrier protection standards pursuant to specific industry standards
  • Nitrile gloves and exam gloves
  • Surgical Gowns and Surgical Isolation Gowns
  • Syringes and hypodermic needles (whether distributed separately or attached together) needed to administer the COVID-19 vaccinations that are either:
    • Piston syringes; or                       
    • Hypodermic single lumen needles with a safety feature Shipments of specified needles and syringes will only be held and returned to the U.S. supply chain if there is a critical need for such medical equipment to vaccinate the population against COVID-19. Note: Attached is a list of needles/syringes for COVID-19 vaccination GHX- SKUs currently assessed under the TFR. The list will be reviewed regularly and updated as needed.

To request an exemption due to a surplus of materials for export, please submit a Letter of Attestation with the following information to docs@cbp.dhs.gov:

  1.  The material you wish to export
  2. The commercially reasonable efforts you have made to market and sell the material domestically
  3. The difference, to the extent known, between the domestic demand and the domestic production
  4. How the proposed export volume will not interfere with continued satisfaction of domestic demand.

DHS-FEMA will review submitted Letters of Attestation and make every effort to provide parties with a Letter of Decision within three business days.

For more information on submitting Letters of Attestation and allocated exports, visit the CSMS #42506108- CBP Frequently Asked Questions About PPE Exports.

For information on additional exemptions to the allocation order, go to the Notice of Exemptions published in the Federal Register in April.

 

Tags:
Last updated February 12, 2021