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e-CFR data is current as of January 19, 2021

Title 44Chapter ISubchapter F → Part 328


Title 44: Emergency Management and Assistance


PART 328—COVID-19 ALLOCATION ORDERS AND PRIORITY ORDER REVIEW UNDER THE DEFENSE PRODUCTION ACT (Eff. until 6-30-21)


Contents
§328.101   Basis and purpose.
§328.102   Requirements.
§328.103   Designation of covered materials.
§328.104   Investigations and injunctions; penalties.

Authority: 50 U.S.C. 4511, et seq.; E.O. 13909, 85 FR 16227; E.O. 13911, 85 FR 18403; DHS Delegation Number 09052, Rev. 00 (Jan. 3, 2017); DHS Delegation Number 09052, Rev. 00.1 (Apr. 1, 2020); Presidential Memorandum on Allocating Certain Scarce or Threatened Health and Medical Resources to Domestic Use (Apr. 3, 2020).

Source: 85 FR 86842, Dec. 31, 2020, unless otherwise noted.

Effective Date Note: At 85 FR 86842, Dec. 31, 2020, part 328 was revised, effective until June 30, 2021.

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§328.101   Basis and purpose.

(a) Basis. The rules in this part are issued pursuant to section 101 of the Defense Production Act of 1950, as amended, 50 U.S.C. 4511, and complementary authorities, including such authorities as are contained in subchapter III of chapter 55 of title 50, United States Code (50 U.S.C. 4554, 4555, 4556, and 4559), which have been delegated to the Federal Emergency Management Agency (FEMA).

(b) Purpose. The purpose of the rules in this part are to aid the response of the United States to the spread of COVID-19 by ensuring that scarce and critical health and medical resources are appropriately allocated for domestic use.

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§328.102   Requirements.

(a) Allocation order and requirement for the Administrator's approval. All shipments of covered materials, as designated in §328.103, shall be allocated for domestic use, and may not be exported from the United States without explicit approval by FEMA.

(b) Procedures. U.S. Customs and Border Protection (CBP), in coordination with such other officials as may be appropriate, will notify FEMA of an intended export of covered materials. CBP must temporarily detain any shipment of such covered materials, pending the Administrator's determination whether to return for domestic use or issue a rated order for part or all of the shipment, pursuant to the Administrator's delegated authorities. The Administrator will make such a determination within a reasonable timeframe after notification of an intended export.

(c) Administrator's determination. In making the determination described in paragraph (b) of this section, the Administrator may consult other agencies and will consider the totality of the circumstances, including the following factors:

(1) The need to ensure that scarce or threatened items are appropriately allocated for domestic use;

(2) Minimization of disruption to the supply chain, both domestically and abroad;

(3) The circumstances surrounding the distribution of the materials and potential hoarding or price-gouging concerns;

(4) The quantity and quality of the materials;

(5) Humanitarian considerations; and

(6) International relations and diplomatic considerations.

(d) Exemption. (1) The Administrator has determined in the interest of promoting the national defense to generally allow the export of covered materials from shipments made by or on behalf of U.S. manufacturers with continuous export agreements with customers in other countries since at least January 1, 2020, so long as at least 80 percent of such manufacturer's domestic production of such covered materials, on a per item basis, was distributed in the United States in the preceding 12 months. If FEMA determines that a shipment of covered materials falls within the exemption in this paragraph (d), such materials may be exported without further review by FEMA, provided that the Administrator may waive the exemption in this paragraph (d) and fully review shipments of covered materials under paragraph (b) of this section, if the Administrator determines that doing so is necessary or appropriate to promote the national defense. FEMA will communicate to CBP regarding the application of the exemption in this paragraph (d) to shipments identified by CBP.

(2) The Administrator may establish, in his or her discretion, additional exemptions that he or she determines necessary or appropriate to promote the national defense and will announce any such exemptions by notice in the Federal Register.

(e) Exportations prohibited. The exportation of covered materials other than in accordance with this section is prohibited.

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§328.103   Designation of covered materials.

(a) The Administrator has designated the following materials as “covered materials” under this part:

(1) Surgical N95 Filtering Facepiece Respirators, including devices that are disposable half-face-piece non-powered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates;

(2) PPE surgical masks as described by 21 CFR 878.4040, including masks that cover the user's nose and mouth providing a physical barrier to fluids and particulate materials, that meet fluid barrier protection standards pursuant to—

(i) ASTM F 1862; and

(ii) Class I or Class II flammability tests under CPSC CS 191-53, NFPA Standard 702-1980, or UL 2154 standards;

(3) PPE nitrile gloves, specifically those defined at 21 CFR 880.6250 (exam gloves) and 878.4460 (surgical gloves) and such nitrile gloves intended for the same purposes;

(4) Level 3 and 4 Surgical Gowns and Surgical Isolation Gowns that meet all of the requirements in ANSI/AAMI PB70 and ASTM F2407-06 and are classified by Surgical Gown Barrier Performance based on AAMI PB70; and

(5) Syringes and hypodermic needles (whether distributed separately or attached together) that are either:

(i) Piston syringes that allow for the controlled and precise flow of liquid as described by 21 CFR 880.5860, that are compliant with ISO 7886-1:2017 and use only Current Good Manufacturing Practices (CGMP) processes; or

(ii) Hypodermic single lumen needles that have engineered sharps injury protections as described in the Needlestick Safety and Prevention Act, Pub. L. 106-430, 114 Stat. 1901 (Nov. 6, 2000).

(b) Upon determination that additional items are scarce and necessary for national defense, and that consideration under the allocation order in this part is the only way to meet national defense requirements without significant disruption to the domestic markets, the Administrator may designate additional materials as “covered materials” in the list provided in paragraph (a) of this section. The Administrator will publish notice of these additional “covered materials” in the Federal Register.

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§328.104   Investigations and injunctions; penalties.

(a) To administer or enforce this part, the Administrator may exercise the authorities available under section 705 of the Defense Production Act of 1950, as amended, 50 U.S.C. 4555, including the conduct of investigations, requests for information or testimony, and inspections of records or premises. Before such authorities are utilized, the Administrator will determine the scope and purpose of the investigation, inspection, or inquiry, and be assured that no adequate and authoritative data are available from any Federal or other responsible agency.

(b) Whenever, in the judgment of the Administrator, any person has engaged or is about to engage in any acts or practices that constitute or will constitute a violation of any provision of this part, or order issued thereunder, the Administrator may exercise the authorities available under section 706 of the Defense Production Act of 1950, as amended, 50 U.S.C. 4556, including applying for a preliminary, permanent, or temporary injunction, restraining order, or other order to enforce compliance with this part.

(c) Any person who willfully engages in violations of this part is subject to penalties available under section 103 of the Defense Production Act of 1950, as amended, 50 U.S.C. 4513, or other available authority.

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