[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Proposed Rules]
[Pages 60947-60955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21809]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2021-N-1348]
RIN 0910-AI59


Administrative Destruction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
proposing a regulation to implement its new authority to destroy a 
device valued at $2,500 or less (or such higher amount as the Secretary 
of the Treasury may set by regulation), that has been refused admission 
into the United States under the Federal Food, Drug, and Cosmetic Act 
(FD&C Act), by providing to the owner or consignee notice and an 
opportunity to appear and introduce testimony prior to the destruction. 
Once finalized, this regulation will allow FDA to better protect the 
public health by preventing re-importation and deterring future 
shipments of refused devices subject to administrative destruction. We 
also discuss in this Notice of Proposed Rulemaking our intent to change 
FDA's procedures for administrative destruction of drugs and, if this 
proposed rule is finalized, these procedures will also include devices 
subject to administrative destruction. We described our current 
procedures in the proposed and final rules entitled ``Administrative 
Destruction of Certain Drugs Refused Admission to the United States.''

DATES: Either electronic or written comments on the proposed rule must 
be submitted by December 6, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 7, 2022. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are received on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2021-N-1348 for ``Administrative Destruction.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.

[[Page 60948]]

     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Ann M. Metayer, Office of Regulatory 
Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
32, Rm. 4375, Silver Spring, MD 20993-0002, 301-796-3324.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations/Commonly Used Acronyms in This Document
III. Background
    A. Introduction/History of This Rulemaking
    B. Need for the Regulation
    C. FDA's Current Regulatory Framework
IV. Legal Authority
V. Description of the Proposed Rule
VI. FDA Procedures for Administrative Destruction
VII. Proposed Effective Date
VIII. Preliminary Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
IX. Analysis of Environmental Impact
X. Paperwork Reduction Act of 1995
XI. Federalism
XII. Consultation and Coordination With Indian Tribal Governments
XIII. References

I. Executive Summary

A. Purpose of the Proposed Rule

    The proposed rule would provide to an owner or consignee notice and 
an opportunity to present testimony when the Agency intends to 
administratively destroy a device valued at $2,500 or less (or such 
higher amount as the Secretary of the Treasury may set by regulation) 
that has been refused admission into the United States. The 
Safeguarding Therapeutics Act (STA) (Pub. L. 116-304), signed into law 
on January 5, 2021, amended section 801(a) of the FD&C Act (21 U.S.C. 
381(a)) to provide FDA with the authority to administratively destroy 
certain refused devices without providing the owner or consignee with 
the opportunity for export. FDA proposes to amend Sec.  1.94 (21 CFR 
1.94) to provide to the owner or consignee of a refused device valued 
at $2,500 or less (or such higher amount as the Secretary of the 
Treasury may set by regulation) notice and an opportunity to present 
testimony to the Agency prior to destruction of the device.

B. Summary of the Major Provisions of the Proposed Rule

    The proposed rule would provide to an owner or consignee notice and 
an opportunity to present testimony when the Agency intends to 
administratively destroy a device valued at $2,500 or less (or such 
higher amount as the Secretary of the Treasury may set by regulation) 
that has been refused admission into the United States under section 
801(a) of the FD&C Act.
    FDA proposes to amend part 1 (21 CFR part 1) by expanding the scope 
of Sec.  1.94, which provides notice and opportunity to present 
testimony to the owner or consignee prior to the refusal and 
destruction of certain refused drugs, to also include notice and 
opportunity to present testimony prior to the refusal and destruction 
of certain refused devices.

C. Legal Authority

    The legal authority for this proposed rule includes sections 701 
and 801 of the FD&C Act (21 U.S.C. 371 and 381).

D. Costs and Benefits

    The primary public health benefit of the proposed rule, if 
finalized, would be the value of preventing additional illnesses or 
deaths by destroying, rather than returning, refused devices valued at 
$2,500 or less, which may pose a public health risk. This benefit would 
accrue whenever FDA's existing enforcement tools would not have 
prevented the violative device from entering the U.S. market. The 
estimated primary costs of the proposed rule include the additional 
costs to destroy, rather than return, refused devices valued at $2,500 
or less, and the additional costs to store these devices at 
International Mail Facilities (IMFs) prior to destruction. There would 
also be one-time costs to FDA to update its electronic Operational and 
Administrative System for Import Support (OASIS) and System for Entry 
Review and Import Operations (SERIO); revise its Regulatory Procedures 
Manual (RPM), Investigations Operations Manual (IOM), and additional 
FDA and inter-Agency operational procedures; and train employees on the 
new procedures. Express couriers would incur one-time costs to read and 
understand the rule. We estimate that the annualized benefits over 10 
years would range from $186,000 to $941,000 at a 7 percent discount 
rate and a 3 percent discount rate, with a primary estimate of 
$397,000. The annualized costs would range from $69,000 to $1.48 
million at a 7 percent discount rate, with a primary estimate of 
$454,000, and from $65,000 to $1.47 million at a 3 percent discount 
rate, with a primary estimate of $450,000.

II. Table of Abbreviations/Commonly Used Acronyms in This Document

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       Abbreviation/acronym                     What it means
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Agency............................  U.S. Food and Drug Administration.
CBP...............................  U.S. Customs and Border Protection.
CDC...............................  U.S. Centers for Disease Control and
                                     Prevention.
COVID-19..........................  Disease caused by the severe acute
                                     respiratory syndrome coronavirus 2
                                     (SARS-CoV-2).

[[Page 60949]]

 
FDA...............................  U.S. Food and Drug Administration.
FDASIA............................  Food and Drug Administration Safety
                                     and Innovation Act.
FD&C Act..........................  Federal Food, Drug, and Cosmetic
                                     Act.
NIOSH.............................  National Institute for Occupational
                                     Safety and Health.
OASIS.............................  FDA's Operational and Administrative
                                     System for Import Support.
SERIO.............................  FDA's System for Entry Review and
                                     Import Operations.
STA...............................  Safeguarding Therapeutics Act.
USPS..............................  United States Postal Service.
We, Our, Us.......................  U.S. Food and Drug Administration.
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III. Background

A. Introduction/History of the Rulemaking

    Section 708 in the Food and Drug Administration Safety and 
Innovation Act (FDASIA) (Pub. L. 112-144), enacted in 2012, gave FDA 
the authority to destroy, without providing an opportunity for export, 
any refused drug valued at $2,500 or less (or such higher amount as the 
Secretary of the Treasury may set by regulation) in section 801(a) of 
the FD&C Act. To implement that authority, FDA published a final rule 
in the Federal Register on September 15, 2015 (80 FR 55237) that 
revised Sec.  1.94 to provide notice and an opportunity for the owner 
or consignee to appear before the Agency and introduce testimony prior 
to the destruction of their drug. Section 801(a) of the FD&C Act 
further stated that this process may be combined with the notice and 
opportunity to introduce testimony on the admissibility of the drug 
under section 801(a) of the FD&C Act, provided appropriate notice is 
provided to the owner or consignee.
    The STA expanded FDA's administrative destruction authority to 
include any refused device valued at $2,500 or less (or such higher 
amount as the Secretary of the Treasury may set by regulation). To 
implement this authority, the proposed rule would amend Sec.  1.94 to 
provide to the owner or consignee of any refused device valued at 
$2,500 or less (or such higher amount as the Secretary of the Treasury 
may set by regulation) notice and an opportunity to appear and 
introduce testimony prior to the destruction.

B. Need for the Regulation

    FDA has refused devices, valued at $2,500 or less, sent to the 
United States via international mail or express couriers, including 
illegal devices that are being imported to diagnose, prevent, or treat 
COVID-19 such as test kits, respirators, and face masks. Other devices 
that pose significant public health concerns if counterfeit, 
unapproved, or unauthorized, or otherwise misbranded or adulterated 
include contact lenses and blood glucose test strips.
    On January 31, 2020, the Secretary of the Department of Health and 
Human Services (HHS) issued, pursuant to section 319 of the Public 
Health Service Act (42 U.S.C. 247d), a declaration of a public health 
emergency related to COVID-19 and mobilized the Operating Divisions of 
HHS (Ref. 1). Additionally, on February 4, 2020, the Secretary of HHS 
determined, pursuant to section 564 of the FD&C Act (21 U.S.C. 360bbb-
3), that there is a public health emergency that has a significant 
potential to affect national security or the health and security of 
U.S. citizens living abroad, and that involves the novel (new) 
coronavirus first detected in Wuhan City, Hubei Province, China in 2019 
(85 FR 7316). The virus is named severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2), which causes the disease COVID-19.
    Based on this determination, the Secretary of HHS declared that 
circumstances exist justifying the authorization of emergency use of 
certain devices (85 FR 17335). On March 11, 2020, the World Health 
Organization declared the SARS-CoV-2 outbreak to be a pandemic. Since 
these events, numerous individuals and entities have tried to profit 
from the pandemic by selling unproven and illegally marketed products 
making claims that their products can be used to treat, diagnose, or 
prevent COVID-19. FDA is particularly concerned that these deceptive 
and misleading products might cause consumers to delay or stop 
appropriate medical treatment, leading to serious and life-threatening 
harm. It is likely that the products do not do what they claim and the 
ingredients in them could cause adverse effects and could interact 
with, and potentially interfere with, essential medications (Ref. 2). 
Once COVID-19 reached the United States, FDA received complaints from 
American consumers ranging from bogus treatments or cures to 
inappropriately marketed test kits and fake or substandard personal 
protective equipment (Ref. 3).
    In March 2020, FDA launched Operation Quack Hack to leverage Agency 
expertise and use advanced analytics to protect consumers from 
fraudulent medical products related to COVID-19. FDA's Operation Quack 
Hack team had reviewed thousands of websites, social media posts, and 
online marketplace listings. We issued hundreds of abuse complaints to 
online marketplaces and domain registrars about fraudulent products 
related to COVID-19. As of January 2022, the Agency had issued 260 
warning letters to sellers of fraudulent COVID-19 products (Ref. 4).
    In Fiscal Year (FY) 2021 (October 1, 2020, to September 30, 2021), 
CBP seized 38,154 unauthorized COVID-19 test kits and just over 35 
million counterfeit face masks (Ref. 5). Particularly during a 
pandemic, timely access to accurate diagnostic tests is important not 
only for the individual patient, but for the public at large. We have 
observed numerous unauthorized test kits for COVID-19 being sold 
online. Some test developers falsely claim that their tests are FDA-
approved or authorized. Others have falsely claimed that their serology 
tests can diagnose COVID-19 or that they are authorized for at-home 
testing. As of June 1, 2020, Customs and Border Protection (CBP) had 
seized more than 107,300 unauthorized COVID-19 test kits (Ref. 6).
    As of September 2020, FDA had refused admission to more than 470 
shipments of test kits offered for import into the United States, 
representing more than 460,000 tests overall (Ref. 7). Based on 
internal data, FDA refused more than 408 shipments in FY 2021. We 
continue to issue Warning Letters and examine shipments of COVID-19 
test kits at International Mail Facilities (IMFs) and express couriers, 
detaining and refusing unapproved or unauthorized, counterfeit, or 
otherwise adulterated or misbranded test kits.
    Consumers using these illegal test kits risk unknowingly spreading 
SARS-CoV-2 or not getting treated appropriately for COVID-19. Public

[[Page 60950]]

health risks from use of illegal test kits include:
     further community spread of the disease;
     a delay in the correct diagnosis and initiation of 
appropriate treatment for the actual cause of the tested individual's 
illness;
     waste of healthcare resources and additional, unnecessary 
evaluations based on results from inaccurate tests;
     results from inaccurate tests may lead the tested 
individual to take fewer precautions against virus exposure. This may 
increase the individual's risk of infection and may lead them to not 
seek testing if later infected with SARS-CoV-2, potentially increasing 
community spread of the disease;
     unnecessary isolation of a tested individual that might 
limit contact with family or friends or increase contact with other 
potentially SARS-CoV-2 infected individuals, and limits in their 
ability to work; and
     misallocation of resources used for surveillance and 
prevention of COVID-19 (Ref. 8).
    From 2020 to 2021, CBP seized more than 34 million counterfeit face 
masks and respirators, most of them modeled to resemble N95 or KN95 
respirators. Around 20 million of those devices were seized in 2021 
(Ref. 9). The Centers for Disease Control and Prevention (CDC) has 
posted warnings about illegal respirators that are falsely represented 
to be approved by the National Institute for Occupational Safety and 
Health (NIOSH). These illegal respirators may not be capable of 
providing appropriate respiratory protection to medical professionals 
and frontline workers from SARS-CoV-2. When NIOSH becomes aware of 
marketed illegal respirators or those marketed respirators 
misrepresenting NIOSH approval, CDC posts these illegal respirators on 
its website to alert users, purchasers, and manufacturers of the 
legitimate respirators (Ref. 10). On March 1, 2021, CBP seized 65,280 
counterfeit 3M N95 respirators at the IMF in Chicago. The shipment was 
from Colombia. CBP officers noticed an unfamiliar chemical smell coming 
from the respirators and grammatical errors on the fake 3M packaging 
(Ref. 11). In February 2021, more than 108,000 counterfeit N95 masks--
marketed using 3M's branding--were seized by CBP in Cincinnati (Ref. 
12). In June 2020, CBP seized 10,000 KN-95 respirators that were 
manufactured in China and shipped from Israel. The respirators appeared 
to be of poor quality and packaging. The manufacturer was not 
registered with FDA and did not have an authorization from FDA to 
market the respirators in the United States (Ref. 13). CBP seized 
58,846 counterfeit facemasks in the fall of 2020. More than 17,000 of 
these facemasks were shipped from Hong Kong (Ref. 14).
    The risks posed by counterfeit, unapproved, or unauthorized, or 
otherwise misbranded or adulterated devices are not, however, limited 
to devices for COVID-19. An estimated 45 million Americans wear contact 
lenses (Ref. 15). FDA regulates all contact lenses as prescription 
devices. Contact lenses sold without a prescription from unlicensed 
vendors, including online distributors, may be contaminated and/or 
counterfeit and are not safe to use. Vendors that advertise colored and 
decorative contact lenses as cosmetics or sell them over the counter 
without a prescription, are adulterating and misbranding the device in 
violation of the FD&C Act and are also violating Federal Trade 
Commission regulations (Ref. 16).
    A prescription is needed for contact lenses because an eye doctor 
(ophthalmologist or optometrist) must measure each eye to properly fit 
the lenses and evaluate how the patients' eyes respond to contact lens 
wear. A poor fit can cause serious eye damage, including:
     scratches on the cornea;
     corneal infection (an ulcer or sore on the cornea);
     conjunctivitis (pink eye);
     decreased vision; and
     blindness.
    In addition to the risks above, vendors that sell decorative lenses 
without a prescription may give few or no instructions on how to clean 
and care for the lenses. Failure to use the proper solution to keep 
contact lenses clean and moist can lead to infections. Bacterial 
infections can be extremely rapid, result in corneal ulcers, and cause 
blindness--sometimes within as little as 24 hours if not diagnosed and 
treated promptly (Ref. 17).
    Chengdu Ai Qin E-commerce Co., Ltd initiated a nationwide recall of 
1,362 pairs of colored contact lenses in June 2020. These contact 
lenses were distributed without FDA approval or clearance. The recalled 
products were manufactured in August 2018 in China (Ref. 18).
    In January 2017, the owner and operator of Candy Color Lenses, a 
major online retailer of colored contact lenses in the United States, 
was sentenced to 46 months in prison for running an international 
operation importing contact lenses from suppliers in China and South 
Korea that he knew were counterfeit and/or unapproved for sale in the 
United States. Candy Color Lenses sold the contact lenses over the 
internet without a prescription to tens of thousands of customers in 
the United States. In addition to his prison sentence, the owner was 
ordered to remit $200,000 in restitution and forfeit $1.2 million in 
proceeds derived from his illegal scheme (Ref. 19).
    The owner of All about Ink, a tattoo shop in Pensacola, Florida, 
pleaded guilty in June 2019 to misdemeanor charges of receipt of 
adulterated and misbranded contact lenses, and sale of contact lenses 
without a prescription. In May 2015, law enforcement seized 
approximately 600 counterfeit contact lenses that were being imported 
from China by All about Ink. A number of these contact lenses were 
tested by FDA and contained microbial contamination. We determined that 
the types of bacteria in the contact lenses could be hazardous. Between 
July 2015 and October 2015, law enforcement made several undercover 
purchases of contact lenses from All about Ink. Following the 
undercover purchases, a Federal search warrant was executed at the 
tattoo shop and approximately 200 pairs of contact lenses were seized. 
Samples of the contact lenses purchased by undercover agents and the 
seized contact lenses were tested by FDA and a number of these lenses 
contained microbial contamination. A number of the contact lenses were 
also counterfeit (Ref. 20).
    In 2018, 34.2 million people of all ages--or 10.5 percent of the 
population in the United States--were estimated to have diabetes (Ref. 
21). Using a glucose meter to check and monitor blood sugar is a daily 
part of life for millions of these Americans. Glucose meters and test 
strips are devices regulated by FDA. Some consumers purchase preowned 
or unauthorized test strips online because they are cheaper. These test 
strips can potentially cause infection or lead to inaccurate test 
results, which can cause serious harm, including death. If a consumer 
receives an inaccurate result from a preowned or unauthorized test 
strip and uses this result as a basis for their treatment, they could 
take too much medication or not enough medication, potentially leading 
to serious injury, including death. It is also possible that preowned 
test strips may contain small amounts of blood from the previous owner, 
which can put consumers at risk of infection from potential cross-
contamination (Ref. 22).
    FDA issued a safety communication in April 2019 warning the public 
against using test strips, including glucose test strips, from a 
previous owner (preowned) or test strips that are not authorized for 
sale in the United States (Ref. 23). Certain test strips require

[[Page 60951]]

review by FDA prior to being marketed in the United States in order to 
provide a reasonable assurance of safety and effectiveness when the 
test strips are used as intended. Test strips not authorized for sale 
in the United States have not been reviewed by FDA and their ability to 
provide an accurate result is unknown. Unauthorized test strips can 
also be faulty or of poor quality. When FDA reporting requirements, 
such as adverse event reporting, are not followed, we may not become 
aware of product malfunctions or safety issues associated with these 
test strips.
    There is currently little deterrence against sellers shipping 
illegal devices or re-sending previously refused devices to the United 
States via international mail or an express courier. Devices that have 
been refused admission into the United States might be subsequently 
offered for re-importation by unscrupulous sellers who attempt to 
circumvent U.S. import regulatory systems. Under the proposed rule, FDA 
will be better able to deter such shipments by having an administrative 
mechanism for destroying a device valued at $2,500 or less (or such 
higher amount as the Secretary of the Treasury may set by regulation) 
that has been refused admission to the United States.

C. FDA's Current Regulatory Framework

    Based on our internal data, the majority of devices subject to 
administrative destruction come into the United States via an IMF or an 
express courier (Ref. 24). For international mail shipments, the United 
States Postal Service (USPS) routes the parcels to CBP. CBP interdicts 
certain shipments suspected to contain FDA-regulated products and turns 
the packages over to FDA for examination and determination of 
admissibility under the laws and regulations enforced by the Agency.
    A device that is imported or offered for import is subject to 
refusal of admission under section 801(a) of the FD&C Act if, among 
other reasons, it appears to be adulterated or misbranded in violation 
of section 501 or 502 of the FD&C Act (21 U.S.C. 351 or 352). In 
accordance with Sec.  1.94, FDA issues a notice of the Agency's 
intention to refuse a device to the owner or consignee, as defined in 
21 CFR 1.83, stating the reasons for the intended refusal. If the 
article was sent by international mail, FDA generally considers the 
addressee of that package to be the owner or consignee. The owner or 
consignee is given an opportunity to appear before the Agency and 
introduce testimony orally or in writing on why the device should not 
be refused admission into the United States. Under section 801(b) of 
the FD&C Act, the owner or consignee can also submit an application to 
recondition the device to bring it into compliance with the FD&C Act or 
to render it other than a food, drug, device, or cosmetic. If, after 
consideration of any testimony submitted at a Sec.  1.94 hearing or if 
no hearing is requested, we determine that the device should be refused 
admission, the Agency issues a notice of refusal to the owner or 
consignee.
    Devices that have been refused admission into the United States 
under section 801(a) of the FD&C Act are required to be destroyed by 
the owner or consignee unless they are exported within 90 days of the 
date of notice of the refusal. Refused devices that were shipped via 
international mail are not in the possession of the owner or consignee 
and currently are returned by FDA to USPS for return to the sender.
    Certain illegal devices may also be destroyed if they are seized 
and condemned under section 304 of the FD&C Act (21 U.S.C. 334) or if 
they are seized and forfeited under CBP's seizure and forfeiture 
authority, such as 19 U.S.C. 1595a(c).

IV. Legal Authority

    FDA has the legal authority under section 801(a) of the FD&C Act, 
as amended by the STA, to administratively destroy, without providing 
opportunity for export, any device valued at $2,500 or less (or such 
higher amount as the Secretary of the Treasury may set by regulation), 
that has been refused admission into the United States. A device that 
is imported or offered for import is subject to refusal of admission 
under section 801(a) of the FD&C Act if, among other reasons, it 
appears to be adulterated or misbranded in violation of section 501 or 
502 of the FD&C Act.
    Section 801(a) of the FD&C Act also directs FDA to issue 
regulations that provide the owner or consignee of a device designated 
by the Agency for administrative destruction with notice and an 
opportunity to introduce testimony to us prior to the destruction of 
the device. Section 801(a) of the FD&C Act further states that this 
process may be combined with the notice and opportunity to appear 
before FDA and introduce testimony on the admissibility of the device 
under section 801(a) of the FD&C Act, as long as appropriate notice is 
provided to the owner or consignee.
    Section 701(a) of the FD&C Act authorizes the Agency to issue 
regulations for the efficient enforcement of the FD&C Act.
    As used throughout, the term ``device'' means those articles 
meeting the definition of device in section 201(h) of the FD&C Act (21 
U.S.C. 321(h)), which includes devices intended for human or animal 
use. Section 201(h) of the FD&C Act defines the term ``device,'' in 
part, as an instrument, apparatus, implement, machine, contrivance, 
implant, in vitro reagent, or other similar or related article, 
including any component, part, or accessory, intended for use in the 
diagnosis of a disease or other condition or in the cure, mitigation, 
treatment, or prevention of a disease or intended to affect the 
structure or any function of the body, and that does not achieve its 
primary intended purposes through chemical action within or on the body 
of man or other animals or by being metabolized.

V. Description of the Proposed Rule

    To implement section 801(a) of the FD&C Act, as amended by the STA, 
the proposed rule would revise Sec.  1.94 so that the current notice 
and hearing provisions that apply to the administrative destruction of 
certain drugs would also apply to the administrative destruction of 
certain devices. Specifically, the proposed rule would amend Sec.  
1.94(a) to provide the owner or consignee of a refused device valued at 
$2,500 or less (or such higher amount as the Secretary of the Treasury 
may set by regulation) with notice and an opportunity to present 
testimony to the Agency prior to destruction of the device. The 
proposed rule would also amend Sec.  1.94(c) to specify that the notice 
and hearing for refusal of admission may be combined with the notice 
and hearing for destruction of the device.
    Once the proposed rule is finalized and in effect, FDA may destroy 
a device that is valued at $2,500 or less (or such higher amount as the 
Secretary of the Treasury may set by regulation) if, among other 
reasons, it is or appears to be adulterated or misbranded. As described 
above, FDA would provide to the owner or consignee notice and an 
opportunity to present testimony prior to the administrative 
destruction of such a device.

VI. FDA Procedures for Administrative Destruction

    In the preamble of the proposed rule (79 FR 25758) and the preamble 
of the final rule (80 FR 55237) for ``Administrative Destruction of 
Certain Drugs Refused Admission to the United States,'' FDA explained 
that the Agency

[[Page 60952]]

intended to exercise its new authority in section 801(a) of the FD&C 
Act, added by section 708 in FDASIA, by taking the further step of 
destroying a drug, only in situations where, after providing the owner 
or consignee with notice and the opportunity to introduce testimony, 
the Agency has determined that the drug is, in fact, adulterated, 
misbranded, or unapproved in violation of section 505 of the FD&C Act.
    The Agency intends to make a change to our procedures for 
destroying a refused drug from what was described in the preambles to 
the proposed and final rules for the administrative destruction of a 
drug. Under our revised procedures for destruction, FDA might not make 
a determination that a drug subject to administrative destruction is, 
in fact, adulterated, misbranded, counterfeit, or unapproved if the 
owner or consignee has not requested a hearing to contest the 
administrative destruction (including the basis for refusal of 
admission). This means that, if an owner or consignee does not request 
to present testimony contesting an administrative destruction, FDA 
might administratively destroy that drug if it appears to be 
adulterated, misbranded, or unapproved in violation of section 505 of 
the FD&C Act. FDA will continue to make a determination that a drug is, 
in fact, adulterated, misbranded, or unapproved in violation of section 
505 of the FD&C Act when an owner or consignee requests a hearing under 
Sec.  1.94 to contest the administrative destruction (including the 
basis for refusal of admission).
    We intend to use the same procedures for devices that are subject 
to administrative destruction if this proposed rule is finalized and 
becomes effective.
    At the time of the administrative destruction of refused drugs 
rulemaking, administrative destruction was a novel program for the 
Agency. The destruction program for drugs has now been in place at FDA 
for more than 5 years; it was implemented starting in April 2016. After 
careful monitoring of the program over that time, we believe that 
taking the further step of making a determination that a refused drug 
is, in fact, adulterated, misbranded, or unapproved in violation of 
section 505 of the FD&C Act is no longer warranted where an owner or 
consignee has not requested the opportunity to submit testimony to 
contest the destruction. Since we implemented the program, most (e.g., 
more than 99 percent in fiscal year 2021 (Ref. 25)) of the drugs valued 
at $2,500 or less that FDA initially determined to be subject to 
administrative destruction were later determined by FDA to be, in fact, 
adulterated, misbranded, or unapproved in violation of section 505 of 
the FD&C Act. Additionally, FDA has only received one request from an 
owner or consignee to introduce testimony to contest FDA's intention to 
destroy a drug since we implemented the program. Further, we have found 
that having our import reviewers take the further step of making and 
documenting a determination that a drug is, in fact, adulterated, 
misbranded, or unapproved in violation of section 505 of the FD&C Act 
can double the time it takes to designate a drug for refusal and 
destruction. Given our experience with the destruction program for 
drugs, the high volume of illegal drugs being imported via 
international mail and express couriers, and our limited resources to 
review drugs for admissibility, we intend to change our administrative 
destruction procedures as described above.
    Comments on these revised procedures for the administrative 
destruction of certain drugs and devices may be submitted in accordance 
with the instructions above for submitting comments to this proposed 
rule.

VII. Proposed Effective Date

    FDA intends that the effective date of the new regulatory 
requirements will be 30 days after publication of a final rule in the 
Federal Register.

VIII. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
believe that this proposed rule is not a significant regulatory action 
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because of the number of expected destructions per year and 
the very small value per event, we propose to certify that the proposed 
rule will not have a significant economic impact on a substantial 
number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $165 million, using the most current (2021) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.

B. Summary of Costs and Benefits

    The proposed rule, if finalized, would implement the authority of 
FDA to destroy a device valued at $2,500 or less (or such higher amount 
as the Secretary of the Treasury may set by regulation), that has been 
offered for import and refused admission into the United States under 
the FD&C Act, by providing notice and opportunity to the owner or 
consignee to appear and introduce testimony to FDA prior to the 
destruction. Because our internal data show that the majority of 
devices offered for import, valued at $2,500 or less, and refused in FY 
2022 were shipped via international mail and express couriers, FDA 
currently intends to implement the proposed rule, if finalized, at IMFs 
and express couriers (Ref. 24). We do not, therefore, consider impacts 
related to shipments via commercial air, land, and seaports.
    The costs and benefits of the proposed rule, if finalized, would 
depend on the number of administrative destructions that FDA orders 
each year for refused devices valued at $2,500 or less. For our primary 
estimates, we assume that FDA would order the destruction of 65 percent 
of refused devices valued at $2,500 or less. We additionally assume 
that FDA would contract out the act of destruction to a private firm 
and combine the notice and hearing process for destruction with the 
current notice and hearing process for refusal. We summarize the costs 
and benefits of the proposed rule, if finalized, in table 1.
    We estimate that the annualized benefits over 10 years would range 
from $186,000 to $941,000 at a 7 percent discount rate and a 3 percent 
discount rate, with a primary estimate of $397,000. The annualized 
costs would range from $69,000 to $1.48 million at a 7 percent discount 
rate, with a primary estimate of $454,000, and from

[[Page 60953]]

$65,000 to $1.47 million at a 3 percent discount rate, with a primary 
estimate of $450,000.
    Over 10 years, the present value of total benefits would range from 
$1.31 million to $6.61 million at a 7 percent discount rate, with a 
primary estimate of $2.79 million, and from $1.59 million to $8.03 
million at a 3 percent discount rate, with a primary estimate of $3.39 
million. The present value of total costs would range from $488,000 to 
$10.36 million at a 7 percent discount rate, with a primary estimate of 
$3.19 million, and from $555,000 to $12.54 million at a 3 percent 
discount rate, with a primary estimate of $3.84 million.

                                    Table 1--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                Units
                                                                                ------------------------------------
                  Category                     Primary       Low        High                               Period                   Notes
                                              estimate    estimate    estimate      Year      Discount     covered
                                                                                   dollars    rate  (%)    (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/year \1\      $0.397      $0.186      $0.941        2021           7    10 years  Benefits include cost savings to
                                                                                                                      express couriers and USPS.
                                                  0.397       0.186       0.941        2021           3    10 years
    Annualized Quantified..................  ..........  ..........  ..........  ..........           7  ..........  ...................................
                                                                                                      3
                                            ------------------------------------------------------------------------------------------------------------
    Qualitative............................  ..........  ..........  ..........  ..........  ..........  ..........  ...................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/year \1\       0.454       0.069       1.475        2021           7    10 years  ...................................
                                                 0.4500       0.065       1.470        2021           3    10 years  ...................................
    Annualized Quantified..................  ..........  ..........  ..........  ..........           7  ..........  ...................................
                                                                                                      3
                                            ------------------------------------------------------------------------------------------------------------
    Qualitative............................  ..........  ..........  ..........  ..........  ..........  ..........  ...................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized $millions/  ..........  ..........  ..........  ..........           7  ..........  ...................................
     year.                                                                                            3
--------------------------------------------------------------------------------------------------------------------------------------------------------
    From/To................................  From:
                                             To:                                 ..........
                                            ------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized $millions/    ..........  ..........  ..........  ..........           7  ..........  ...................................
     year.                                                                                            3
                                            ------------------------------------------------------------------------------------------------------------
    From/To................................  From:
                                             To:                                 ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
--------------------------------------------------------------------------------------------------------------------------------------------------------
    State, Local or Tribal Government: No estimated effect..............................................................................................
    Small Business: No estimated effect.................................................................................................................
    Wages: No estimated effect..........................................................................................................................
    Growth: No estimated effect.........................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ When calculating annualized benefits and costs, we assume that payments occur at the end of each period.

    The primary benefit of the proposed rule, if finalized, would be 
the value of additional illnesses or deaths averted from destroying, 
rather than returning, refused devices valued at $2,500 or less (or 
such higher amount as the Secretary of the Treasury may set by 
regulation). If a destroyed device is a counterfeit or an otherwise 
falsified version of an approved or cleared device, the owner of the 
approved or cleared device may benefit through increased sales, brand 
value, or research and development funding. The threat of destruction 
additionally may have a deterrent effect, reducing the amount of 
adulterated or misbranded (violative) devices that are offered for 
import into the United States. These benefits would accrue whenever 
FDA's existing enforcement tools would not have prevented the violative 
device from entering the U.S. market; the current policy for returning 
refused devices does not preclude the re-importation of the device into 
the United States in the future. We do not have enough information to 
quantify these benefits. Express couriers and the USPS would incur cost 
savings from returning fewer refused devices to their country of origin 
(the current procedure for refused devices valued at $2,500 or less).
    Quantified costs of the proposed rule, if finalized, would include 
the costs to FDA to destroy, rather than return, refused devices valued 
at $2,500 or less, and the additional costs to store these devices at 
IMFs prior to destruction. FDA would additionally incur one-time costs 
to update its electronic import systems, OASIS and SERIO; revise the 
RPM, IOM, and additional FDA and inter-Agency operational procedures; 
and train employees on the new procedures. Express couriers would incur 
one-time costs to read and understand the rule.
    If our assumptions do not hold, FDA may incur additional costs, 
including costs to purchase equipment to destroy refused devices, costs 
to train employees administering the destruction of refused devices, 
costs to separately notify the owners or consignees of refused devices, 
and costs to prepare for hearings on destruction that the owners or 
consignees of refused devices request.
    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. The full 
preliminary analysis of economic impacts is available in the docket for 
this proposed rule (Ref. 25) and at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

[[Page 60954]]

IX. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

X. Paperwork Reduction Act of 1995

    FDA has concluded that the requirements contained in this proposed 
rule are not subject to review by the Office of Management and Budget 
because they do not constitute a ``collection of information'' under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3518(c)(1)(B)(ii)).

XI. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
the proposed rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the rule does not contain policies that have 
federalism implications as defined in the Executive order and, 
consequently, a federalism summary impact statement is not required.

XII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rule does not contain policies that would have a 
substantial direct effect on one or more Indian Tribes, on the 
relationship between the Federal Government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. The Agency solicits comments from tribal 
officials on any potential impact on Indian Tribes from this proposed 
action.

XIII. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction. Some may be available at the website address, if listed. 
References without asterisks are available for viewing only at the 
Dockets Management Staff. FDA has verified the website addresses, as of 
the date this document publishes in the Federal Register, but websites 
are subject to change over time.

    *1. Secretary of Health and Human Services Alex M. Azar II. 
``Determination that a Public Health Emergency Exists.'' Last 
reviewed January 31, 2020 (subsequently renewed). https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
    *2. FDA. ``Beware of Fraudulent Coronavirus Tests, Vaccines and 
Treatments.'' Content current as of February 3, 2022. https://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments.
    *3. Assistant Commissioner for Regulatory Affairs Judy McMeekin 
and Deputy Commissioner for Medical and Scientific Affairs Anand 
Shah (hereinafter McMeekin and Shah). ``FDA Protects Patients and 
Consumers from Fraud During COVID-19.'' Content current as of July 
20, 2020. https://www.fda.gov/news-events/fda-voices/fda-protects-patients-and-consumers-fraud-during-covid-19.
    *4. FDA. Testimony of Acting Commissioner Janet Woodcock. 
Accessed July 11, 2022. Addressing New Variants: A Federal 
Perspective On The Covid-19 Response--01/11/2022 [bond] FDA
    *5. U.S. Customs and Border Protection. CBP Trade and Travel 
Report. Fiscal Year 2021/April 2022. Accessed July 11, 2022. https://www.cbp.gov/document/annual-report/cbp-trade-and-travel-fiscal-year-2021-report.
    6. U.S. Customs and Border Protection. ``CBP Continues to Seize 
Large Number of Counterfeit and Unapproved COVID-19 Products.'' 
Released June 5, 2020. Last modified February 3, 2021. https://www.cbp.gov/newsroom/national-media-release/cbp-continues-seize-large-number-counterfeit-and-unapproved-covid-19.
    *7. Commissioner of Food and Drugs Stephen M. Hahn, MD. 
``Testimony, COVID-19: An Update on the Federal Response, September 
22, 2020 (Before the Senate Committee on Health, Education, Labor, 
and Pensions).'' Content current as of September 24, 2020. https://www.fda.gov/news-events/congressional-testimony/covid-19-update-federal-response-09232020.
    *8. FDA. ``Counterfeit At-Home OTC COVID-19 Diagnostic Tests.'' 
Content Current as of April 29, 2022. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/counterfeit-home-otc-covid-19-diagnostic-tests; and FDA. ``Certain COVID-19 Serology/
Antibody Tests Should Not Be Used--Letter to Clinical Laboratory 
Staff and Health Care Providers.'' Content current as of June 19, 
2020. https://www.fda.gov/medical-devices/letters-health-care-providers/certain-covid-19-serologyantibody-tests-should-not-be-used-letter-clinical-laboratory-staff-and.
    9. ABC Action News, Philadelphia. ``20 Million Fake Masks Seized 
Since Beginning of Year, CBP Officials Say.'' 6ABC, April 8, 2021. 
https://6abc.com/fake-covid-masks-cbp-seized-coronavirus-counterfeit/10499964/.
    *10. CDC, National Institute for Occupational Safety and Health, 
National Personal Protective Technology Laboratory. ``Counterfeit 
Respirators/Misrepresentation of NIOSH-Approval.'' Last reviewed 
March 17, 2022. https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html.
    *11. U.S. Customs and Border Protection. ``Over 65K Counterfeit 
3M Masks Seized in Chicago.'' Released and last modified March 5, 
2021. https://www.cbp.gov/newsroom/local-media-release/over-65k-counterfeit-3m-masks-seized-chicago.
    12. ABC Action News, Philadelphia, supra reference 9.
    *13. U.S. Customs and Border Protection. ``CBP Baltimore Field 
Office Continues to Seize Unapproved PPE and COVID-19 Medications.'' 
Released June 5, 2020. Last modified February 3, 2021. https://www.cbp.gov/newsroom/local-media-release/cbp-baltimore-field-office-continues-seize-unapproved-ppe-and-covid-19.
    *14. U.S. Customs and Border Protection. ``CBP Baltimore Field 
Office Seizes nearly 59,000 Counterfeit COVID-19 Facemasks and Other 
Test Kits and Medications.'' Released October 7, 2020. Last modified 
February 3, 2021. https://www.cbp.gov/newsroom/local-media-release/cbp-baltimore-field-office-seizes-nearly-59000-counterfeit-covid-19.
    *15. CDC. ``Healthy Contact Lens Wear and Care: Fast Facts.'' 
Last reviewed December 30, 2021. https://www.cdc.gov/contactlenses/fast-facts.html.
    *16. FDA. ``Focusing on Contact Lens Safety.'' Content current 
as of October 16, 2019. https://www.fda.gov/consumers/consumer-updates/focusing-contact-lens-safety.
    *17. FDA. `` `Colored' and Decorative Contact Lenses: A 
Prescription Is a Must.'' Content current as of July 31, 2019. 
https://www.fda.gov/consumers/consumer-updates/colored-and-decorative-contact-lenses-prescription-must.
    *18. FDA. ``Chengdu Ai Qin E-Commerce Co., Ltd Issues Nationwide 
Recall of TTDEYE Brand Colored Contact Lenses.'' Published and 
content current as of June 24, 2020. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/chengdu-ai-qin-e-commerce-co-ltd-issues-nationwide-recall-ttdeye-brand-colored-contact-lenses; 
and FDA. ``Enforcement Report, Event 85923.'' Accessed March 29, 
2022. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=85923.
    *19. U.S. Department of Justice. ``Owner of Major Online Colored 
Contact Lens Business Sentenced to 46 Months in Prison in Largest-
Ever Scheme to Import and Sell Counterfeit and Misbranded Contact 
Lenses Prosecuted in the United States.'' Released and updated 
January 18, 2017. https://www.justice.gov/opa/pr/owner-major-online-colored-contact-lens-business-sentenced-46-months-prison-largest-ever.
    *20. U.S. Department of Justice. ``Pensacola Woman Pleads Guilty 
to Selling Counterfeit

[[Page 60955]]

Contact Lenses.'' Released and content current as of October 8, 
2019. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/pensacola-woman-pleads-guilty-selling-counterfeit-contact-lenses.
    *21. CDC. ``National Diabetes Statistics Report: 2020: Estimates 
of Diabetes and Its Burden in the United States.'' Accessed March 
29, 2022. https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf.
    *22. FDA. ``The FDA Warns Against Use of Previously Owned Test 
Strips or Test Strips Not Authorized for Sale in the United States: 
FDA Safety Communication.'' Issued April 8, 2019. Content current as 
of April 8, 2019. https://www.fda.gov/news-events/press-announcements/fda-warns-about-risks-using-home-use-test-strips-are-pre-owned-or-not-authorized-sale-us-including.
    *23. Id.
    *24. FDA. Office of Regulatory Affairs Reporting, Analysis, and 
Decision Support System (ORADSS). 2022 data as of July 12, 2022.
    25. FDA. Administrative Destruction: Preliminary--Regulatory 
Impact Analysis, Initial Regulatory Flexibility Analysis, Unfunded 
Mandates Reform Act Analysis, 2022. https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

List of Subjects in 21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling, 
Reporting, and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
1 is proposed to be amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for part 1 continues to read as follows:

    Authority: 15 U.S.C. 1333, 1453, 1454, 1455, 4402; 19 U.S.C. 
1490, 1491; 21 U.S.C. 321, 331, 332, 333, 334, 335a, 342, 343, 350c, 
350d, 350e, 350j, 350k, 352, 355, 360b, 360ccc, 360ccc-1, 360ccc-2, 
362, 371, 373, 374, 379j-31, 381, 382, 384, 384a, 384b, 384d, 387, 
387a, 387c, 393; 42 U.S.C. 216, 241, 243, 262, 264, 271; Pub. L. 
107-188, 116 Stat. 594, 668-69; Pub. L. 111-353, 124 Stat. 3885, 
3889.

0
2. In Sec.  1.94 revise paragraphs (a) and (c) to read as follows:


Sec.  1.94  Hearing on refusal of admission or destruction.

    (a) If it appears that the article may be subject to refusal of 
admission or that the article is a drug or device that may be subject 
to destruction under section 801(a) of the Federal Food, Drug, and 
Cosmetic Act, the division director shall give the owner or consignee a 
written or electronic notice to that effect, stating the reasons 
therefor. The notice shall specify a place and a period of time during 
which the owner or consignee shall have an opportunity to introduce 
testimony. Upon timely request giving reasonable grounds therefor, such 
time and place may be changed. Such testimony shall be confined to 
matters relevant to the admissibility or destruction of the article, 
and may be introduced orally or in writing.
* * * * *
    (c) If the article is a drug or device that may be subject to 
destruction under section 801(a) of the Federal Food, Drug, and 
Cosmetic Act, the division director may give the owner or consignee a 
single written or electronic notice that provides the notice of refusal 
of admission and the notice of destruction of an article described in 
paragraph (a) of this section. The division director may also combine 
the hearing on refusal of admission with the hearing on destruction of 
the article described in paragraph (a) of this section into a single 
proceeding.

    Dated: September 30, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-21809 Filed 10-6-22; 8:45 am]
BILLING CODE 4164-01-P