Proposed Rule2022-21809
Administrative Destruction
Primary source
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Published
October 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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."
Full Text
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<title>Federal Register, Volume 87 Issue 194 (Friday, October 7, 2022)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
[[Page 60948]]
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> further community spread of the disease;
<bullet> a delay in the correct diagnosis and initiation of
appropriate treatment for the actual cause of the tested individual's
illness;
<bullet> waste of healthcare resources and additional, unnecessary
evaluations based on results from inaccurate tests;
<bullet> 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;
<bullet> 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
<bullet> 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:
<bullet> scratches on the cornea;
<bullet> corneal infection (an ulcer or sore on the cornea);
<bullet> conjunctivitis (pink eye);
<bullet> decreased vision; and
<bullet> 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 <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
[[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. References without asterisks are not on public
display at <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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). <a href="https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx">https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx</a>.
*2. FDA. ``Beware of Fraudulent Coronavirus Tests, Vaccines and
Treatments.'' Content current as of February 3, 2022. <a href="https://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments">https://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatments</a>.
*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. <a href="https://www.fda.gov/news-events/fda-voices/fda-protects-patients-and-consumers-fraud-during-covid-19">https://www.fda.gov/news-events/fda-voices/fda-protects-patients-and-consumers-fraud-during-covid-19</a>.
*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. <a href="https://www.cbp.gov/document/annual-report/cbp-trade-and-travel-fiscal-year-2021-report">https://www.cbp.gov/document/annual-report/cbp-trade-and-travel-fiscal-year-2021-report</a>.
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. <a href="https://www.cbp.gov/newsroom/national-media-release/cbp-continues-seize-large-number-counterfeit-and-unapproved-covid-19">https://www.cbp.gov/newsroom/national-media-release/cbp-continues-seize-large-number-counterfeit-and-unapproved-covid-19</a>.
*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. <a href="https://www.fda.gov/news-events/congressional-testimony/covid-19-update-federal-response-09232020">https://www.fda.gov/news-events/congressional-testimony/covid-19-update-federal-response-09232020</a>.
*8. FDA. ``Counterfeit At-Home OTC COVID-19 Diagnostic Tests.''
Content Current as of April 29, 2022. <a href="https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/counterfeit-home-otc-covid-19-diagnostic-tests">https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/counterfeit-home-otc-covid-19-diagnostic-tests</a>; 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. <a href="https://www.fda.gov/medical-devices/letters-health-care-providers/certain-covid-19-serologyantibody-tests-should-not-be-used-letter-clinical-laboratory-staff-and">https://www.fda.gov/medical-devices/letters-health-care-providers/certain-covid-19-serologyantibody-tests-should-not-be-used-letter-clinical-laboratory-staff-and</a>.
9. ABC Action News, Philadelphia. ``20 Million Fake Masks Seized
Since Beginning of Year, CBP Officials Say.'' 6ABC, April 8, 2021.
<a href="https://6abc.com/fake-covid-masks-cbp-seized-coronavirus-counterfeit/10499964/">https://6abc.com/fake-covid-masks-cbp-seized-coronavirus-counterfeit/10499964/</a>.
*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. <a href="https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html">https://www.cdc.gov/niosh/npptl/usernotices/counterfeitResp.html</a>.
*11. U.S. Customs and Border Protection. ``Over 65K Counterfeit
3M Masks Seized in Chicago.'' Released and last modified March 5,
2021. <a href="https://www.cbp.gov/newsroom/local-media-release/over-65k-counterfeit-3m-masks-seized-chicago">https://www.cbp.gov/newsroom/local-media-release/over-65k-counterfeit-3m-masks-seized-chicago</a>.
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. <a href="https://www.cbp.gov/newsroom/local-media-release/cbp-baltimore-field-office-continues-seize-unapproved-ppe-and-covid-19">https://www.cbp.gov/newsroom/local-media-release/cbp-baltimore-field-office-continues-seize-unapproved-ppe-and-covid-19</a>.
*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. <a href="https://www.cbp.gov/newsroom/local-media-release/cbp-baltimore-field-office-seizes-nearly-59000-counterfeit-covid-19">https://www.cbp.gov/newsroom/local-media-release/cbp-baltimore-field-office-seizes-nearly-59000-counterfeit-covid-19</a>.
*15. CDC. ``Healthy Contact Lens Wear and Care: Fast Facts.''
Last reviewed December 30, 2021. <a href="https://www.cdc.gov/contactlenses/fast-facts.html">https://www.cdc.gov/contactlenses/fast-facts.html</a>.
*16. FDA. ``Focusing on Contact Lens Safety.'' Content current
as of October 16, 2019. <a href="https://www.fda.gov/consumers/consumer-updates/focusing-contact-lens-safety">https://www.fda.gov/consumers/consumer-updates/focusing-contact-lens-safety</a>.
*17. FDA. `` `Colored' and Decorative Contact Lenses: A
Prescription Is a Must.'' Content current as of July 31, 2019.
<a href="https://www.fda.gov/consumers/consumer-updates/colored-and-decorative-contact-lenses-prescription-must">https://www.fda.gov/consumers/consumer-updates/colored-and-decorative-contact-lenses-prescription-must</a>.
*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. <a href="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">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</a>;
and FDA. ``Enforcement Report, Event 85923.'' Accessed March 29,
2022. <a href="https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=85923">https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=85923</a>.
*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. <a href="https://www.justice.gov/opa/pr/owner-major-online-colored-contact-lens-business-sentenced-46-months-prison-largest-ever">https://www.justice.gov/opa/pr/owner-major-online-colored-contact-lens-business-sentenced-46-months-prison-largest-ever</a>.
*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. <a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/pensacola-woman-pleads-guilty-selling-counterfeit-contact-lenses">https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/pensacola-woman-pleads-guilty-selling-counterfeit-contact-lenses</a>.
*21. CDC. ``National Diabetes Statistics Report: 2020: Estimates
of Diabetes and Its Burden in the United States.'' Accessed March
29, 2022. <a href="https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf">https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf</a>.
*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. <a href="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">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</a>.
*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. <a href="https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations">https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations</a>.
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
</pre></body>
</html>Indexed from Federal Register on October 7, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.