[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Notices]
[Pages 84332-84335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28545]
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FEDERAL TRADE COMMISSION
[File No. 202 3065]
Steves Distributing, LLC; Analysis To Aid Public Comment
AGENCY: Federal Trade Commission.
ACTION: Proposed consent agreement; request for comment.
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SUMMARY: The consent agreement in this matter settles alleged
violations of federal law prohibiting unfair or deceptive acts or
practices. The attached Analysis to Aid Public Comment describes both
the allegations in the complaint and the terms of the consent order--
embodied in the consent agreement--that would settle these allegations.
DATES: Comments must be received on or before January 27, 2021
ADDRESSES: Interested parties may file comments online or on paper by
following the instructions in the Request for Comment part of the
SUPPLEMENTARY INFORMATION section below. Please write ``Steves
Distributing, LLC; File No. 202 3065'' on your comment, and file your
comment online at https://www.regulations.gov by following the
instructions on the web-based form. If you prefer to file your comment
on paper, mail your comment to the following address: Federal Trade
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite
CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the
following address: Federal Trade Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex
D), Washington, DC 20024.
FOR FURTHER INFORMATION CONTACT: Keith Fentonmiller (202-326-2775),
Bureau of Consumer Protection, Federal Trade Commission, 600
Pennsylvania Avenue NW, Washington, DC 20580.
SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34,
notice is hereby given that the above-captioned consent agreement
containing a consent order to cease and desist, having been filed with
and accepted, subject to final approval, by the Commission, has been
placed on the public record for a period of thirty (30) days. The
following Analysis to Aid Public Comment describes the terms of the
consent agreement and the allegations in the complaint. An electronic
copy of the full text of the consent agreement package can be obtained
at https://www.ftc.gov/news-events/commission-actions.
You can file a comment online or on paper. For the Commission to
consider your comment, we must receive it on or before January 27,
2021. Write ``Steves Distributing, LLC; File No. 202 3065'' on your
comment. Your comment--including your name and your state--will be
placed on the public record of this proceeding, including, to the
extent practicable, on the https://www.regulations.gov website.
Because of the public health emergency in response to the COVID-19
pandemic and the agency's heightened security screening, postal mail
addressed to the Commission will be subject to delay. We strongly
encourage you to submit your comments online through the https://www.regulations.gov website.
If you prefer to file your comment on paper, write ``Steves
Distributing, LLC; File No. 202 3065'' on your comment and on the
envelope, and mail your comment to the following address: Federal Trade
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite
CC-5610 (Annex D), Washington, DC 20580; or deliver your comment to the
following address: Federal Trade Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex
D), Washington, DC 20024. If possible, submit your paper comment to the
Commission by courier or overnight service.
Because your comment will be placed on the publicly accessible
website at https://www.regulations.gov, you are solely responsible for
making sure your comment does not include any sensitive or confidential
information. In particular, your comment should not include sensitive
personal information, such as your or anyone else's Social
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Security number; date of birth; driver's license number or other state
identification number, or foreign country equivalent; passport number;
financial account number; or credit or debit card number. You are also
solely responsible for making sure your comment does not include
sensitive health information, such as medical records or other
individually identifiable health information. In addition, your comment
should not include any ``trade secret or any commercial or financial
information which . . . is privileged or confidential''--as provided by
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2),
16 CFR 4.10(a)(2)--including in particular competitively sensitive
information such as costs, sales statistics, inventories, formulas,
patterns, devices, manufacturing processes, or customer names.
Comments containing material for which confidential treatment is
requested must be filed in paper form, must be clearly labeled
``Confidential,'' and must comply with FTC Rule 4.9(c). In particular,
the written request for confidential treatment that accompanies the
comment must include the factual and legal basis for the request, and
must identify the specific portions of the comment to be withheld from
the public record. See FTC Rule 4.9(c). Your comment will be kept
confidential only if the General Counsel grants your request in
accordance with the law and the public interest. Once your comment has
been posted on the https://www.regulations.gov website--as legally
required by FTC Rule 4.9(b)--we cannot redact or remove your comment
from that website, unless you submit a confidentiality request that
meets the requirements for such treatment under FTC Rule 4.9(c), and
the General Counsel grants that request.
Visit the FTC website at http://www.ftc.gov to read this Notice and
the news release describing the proposed settlement. The FTC Act and
other laws that the Commission administers permit the collection of
public comments to consider and use in this proceeding, as appropriate.
The Commission will consider all timely and responsive public comments
that it receives on or before January 27, 2021. For information on the
Commission's privacy policy, including routine uses permitted by the
Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.
Analysis of Proposed Consent Order To Aid Public Comment
The Federal Trade Commission (``FTC'' or ``Commission'') has
accepted, subject to final approval, an agreement containing a consent
order with Steves Distributing, LLC, a limited liability company doing
business as ``Steves Goods,'' and Steven Taylor Schultheis,
individually and as an officer and owner of Steves Distributing, LLC
(collectively, ``Respondents'').
The proposed consent order (``Order'') has been placed on the
public record for 30 days so that interested persons may submit
comments. Comments received during this period will become part of the
public record. After 30 days, the Commission will again review the
Order and the comments received, and will decide whether it should
withdraw the Order or make it final.
This matter involves the Respondents' advertising of cannabidiol
(``CBD'') and cannabigerol (``CBG''), cannabinoid compounds found in
hemp and cannabis. The complaint alleges that Respondents violated
Sections 5(a) and 12 of the FTC Act by disseminating false and
unsubstantiated advertisements claiming that: (1) CBD and CBG products
can effectively prevent, treat, or mitigate multiple diseases and other
health conditions; and (2) studies or scientific research prove that
CBD and CBG products effectively prevent, treat, or mitigate multiple
diseases and other health conditions.
The Order includes injunctive relief that prohibits these alleged
violations and fences in similar and related conduct. The product
coverage would apply to any dietary supplement, drug, or food the
respondent sells, markets, promotes, or advertises.
Provision I requires randomized, double-blind, placebo-controlled
clinical testing for the challenged claims or any disease treatment,
mitigation, or cure claim for a Covered Product. The Order defines
``Covered Product'' as any dietary supplement, food, or drug including
but not limited to CBD products or CBG products.
Provision II prohibits other misleading or unsubstantiated
representations about the health benefits, performance, efficacy,
safety, or side effects of any Covered Product or essentially
equivalent product. It also covers prevention claims not specifically
included in Provision I.
Provision III requires the preservation of certain records for any
testing Respondents rely upon as competent and reliable scientific
evidence. Provision IV addresses Respondents' false establishment
claims and generally prohibits misrepresentations regarding the
scientifically or clinically proven benefits of any product. Provision
V provides a safe harbor for FDA-approved claims.
Provisions VI and VII contain monetary payment provisions.
Provisions VIII, IX, and X require Respondents to provide customer
information to the Commission and to provide notice of the Order to
customers, affiliates and other resellers. Provision XI requires an
acknowledgement of receipt of the Order. It also requires the
individual Respondents to deliver a copy of the Order to certain
individuals in any business for which they are the majority owner or
which they control directly or indirectly.
Provisions XII, XIII, and XIV provide the required reporting,
recordkeeping, and compliance monitoring programs that must be put in
place. Provision XV explains when the Order is final and effective.
The purpose of this analysis is to aid public comment on the
Proposed Order. It is not intended to constitute an official
interpretation of the complaint or Proposed Order, or to modify in any
way the Proposed Order's terms.
By direction of the Commission.
April J. Tabor,
Acting Secretary.
Statement of Commissioner Rohit Chopra \1\
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\1\ In the Matter of EasyButter, LLC et al., Comm'n File No.
2023047; In the Matter of Reef Industries, Inc. et al., Comm'n File
No. 2023064; In the Mater of Steves Distributing, LLC et al., Comm'n
File No. 2023065; In the Matter of CBD Meds, Inc. et al., Comm'n
File No. 2023080; In the Matter of Epichouse, LLC et al., Comm'n
File No. 2023094; In the Matter of Bionatrol Health, LLC et al.,
Comm'n File No. 2023114.
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Summary
When companies lie about the effectiveness of their
treatments for serious conditions, this harms patients and diverts
sales away from firms that tell the truth.
Congress gave the FTC a new authority to crack down on
abuses in the opioid treatment industry, but the agency has not
prioritized this issue. This should change.
The FTC can increase its effectiveness when it comes to
health claims by shifting resources away from small businesses and by
deploying the unused Penalty Offense Authority.
Today, the Federal Trade Commission is taking action against
several outfits regarding their outlandish--and unlawful--claims about
cannabidiol (CBD). While CBD is currently the subject of considerable
scientific research, there is no evidence yet that CBD can treat or
cure cancer, Alzheimer's, or other serious diseases. Baseless claims
give patients false hope, improperly increase or divert their
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medical spending, and undermine ``a competitor's ability to compete''
on honest attributes.\2\
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\2\ In re Pfizer, Inc., 81 F.T.C. 23, 62 (1972).
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I support these actions and congratulate those who made them a
reality. Going forward, however, the FTC will need to refocus its
efforts on health claims by targeting abuses in the substance use
disorder treatment industry, shifting attention toward large
businesses, and making more effective use of the FTC's Penalty Offense
Authority.
First, COVID-19 and the resulting economic and social distress are
fueling new concerns about substance use disorders. In particular,
there are signs that the pandemic is leading to greater dependence on
opioids.\3\ It is critical that the FTC take steps to prevent
exploitation of patients seeking treatment for substance use disorders.
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\3\ See, e.g., Jon Kamp & Arian Campo-Flores, The Opioid Crisis,
Already Serious, Has Intensified During Coronavirus Pandemic, Wall
Street J. (Sept. 8, 2020), https://www.wsj.com/articles/the-opioid-crisis-already-serious-has-intensified-during-coronavirus-pandemic-11599557401; Issue brief: Reports of increases in opioid- and other
drug-related overdose and other concerns during COVID pandemic,
American Medical Association (last updated on Oct. 31, 2020),
https://www.ama-assn.org/delivering-care/opioids/covid-19-may-be-worsening-opioid-crisis-states-can-take-action.
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I am particularly concerned about abusive practices in the for-
profit opioid treatment industry, and believe this should be a high
priority. This industry has grown exponentially by profiting off those
suffering from addiction. Many of these outfits use lead generators to
steer Americans into high-cost, subpar treatment centers, and some even
hire intermediaries--so-called ``body brokers''--who collect kickbacks
from this harmful practice.\4\
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\4\ For example, recent reporting describes the ``Florida
Shuffle,'' where treatment facilities pay brokers to recruit
patients through 12-step meetings, conferences, hotlines, and online
groups, leading to serious harm. See German Lopez, She wanted
addiction treatment. She ended up in the relapse capital of America,
Vox (Mar. 2, 2020), https://www.vox.com/policy-and-politics/2020/3/2/21156327/florida-shuffle-drug-rehab-addiction-treatment-bri-jayne.
See also Letter from Commissioner Chopra to Congress on Deceptive
Marketing Practices in the Opioid Addiction Treatment Industry (July
28, 2018), https://www.ftc.gov/public-statements/2018/07/letter-commissioner-chopra-congress-deceptive-marketing-practices-opioid
(calling on the FTC to do more to tackle this problem).
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More than two years ago, Congress passed the SUPPORT for Patients
and Communities Act. Among other provisions, the Act authorized the
Commission to seek civil penalties, restitution, damages, and other
relief against outfits that engage in misconduct related to substance
use disorder treatment.\5\ The Commission is well positioned to help
shut down these abuses, ensure they are not profitable, and hold
predatory actors and their enablers to account.\6\
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\5\ Public Law 115-271 Sec. Sec. 8021-8023 (codified in 15
U.S.C. 45d). The Act also allows the Commission to prosecute
deceptive marketing of opioid treatment products. Notably, a number
of respondents in this sweep are alleged to have made claims that
CBD could replace OxyContin.
\6\ Given public reports regarding private equity rollups of
smaller opioid treatment facilities, the Commission can also examine
whether anticompetitive M&A strategies are leading to further
patient harm. See Statement of Commissioner Rohit Chopra Regarding
Private Equity Roll-ups and the Hart-Scott-Rodino Annual Report to
Congress, Comm'n File No. P110014 (July 8, 2020), https://www.ftc.gov/public-statements/2020/07/statement-commissioner-rohit-chopra-regarding-private-equity-roll-ups-hart.
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Unfortunately, the Commission has brought zero cases under this new
authority. While I have supported actions like this one that challenge
baseless CBD claims, as well as previous actions charging that pain
relief devices and similar products were sold deceptively,\7\ I am
concerned that we have largely ignored Congressional concerns about
unlawful opioid treatment practices. I urge my fellow Commissioners to
change course on our enforcement priorities, especially given our
limited resources.
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\7\ Press Release, Fed. Trade Comm'n, Marketers of Pain Relief
Device Settle FTC False Advertising Complaint (Mar. 4, 2020),
https://www.ftc.gov/news-events/press-releases/2020/03/marketers-pain-relief-device-settle-ftc-false-advertising.
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Second, the FTC should focus more of its enforcement efforts on
larger firms rather than small businesses. Today's actions focus on
very small players, some of which are defunct. While I appreciate that
small businesses can also harm honest competitors and families, they
are often judgment-proof, making it unlikely victims will see any
relief.\8\ I am confident that FTC staff can successfully challenge
powerful, well-financed defendants that break the law.
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\8\ In one of these matters, the respondents are paying nothing.
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Finally, the Commission should reduce the prevalence of unlawful
health claims by triggering civil penalties under the FTC's Penalty
Offense Authority.\9\ Under the Penalty Offense Authority, firms that
engage in conduct they know has been previously condemned by the
Commission can face civil penalties, in addition to the relief that we
typically seek.\10\ For example, the Commission routinely issues
warning letters to businesses regarding unsubstantiated health claims.
Future warning letters can be more effective if they include penalty
offense notifications.
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\9\ 15 U.S.C. 45(m)(1)(b).
\10\ See Rohit Chopra & Samuel A.A. Levine, The Case for
Resurrecting the FTC Act's Penalty Offense Authority (Oct. 29,
2020), https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3721256.
Particularly given challenges to the FTC's 13(b) authority,
incorporating a penalty offense strategy can safeguard the
Commission's ability to seek strong remedies against lawbreakers.
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The Commission has repeatedly found that objective claims require a
reasonable basis,\11\ and apprising firms of these findings--along with
a warning that noncompliance can result in penalties--makes it
significantly more likely they will come into compliance voluntarily.
In fact, when the Commission employed this strategy four decades ago,
it reportedly resulted in a ``high level of voluntary compliance
achieved quickly and at a low cost.'' \12\ Going forward, we should
pursue this strategy.
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\11\ This requirement was first established in the Commission's
1972 Pfizer decision, and it has been affirmed repeatedly. Pfizer,
Inc., supra note 2 (finding that ``[f]airness to the consumer, as
well as fairness to competitors'' compels the conclusion that
affirmative claims require a reasonable basis); In re Thompson
Medical Co., 104 F.T.C. 648, 813 (1984) (collecting cases), aff'd,
791 F.2d 189 (D.C. Cir. 1986). Appended to Thompson Medical was the
Commission's Policy Statement Regarding Advertising Substantiation,
which states that ``a firm's failure to possess and rely upon a
reasonable basis for objective claims constitutes an unfair and
deceptive act or practice in violation of Section 5 of the Federal
Trade Commission Act.'' Id. at 839. This standard continues to
govern the Commission's approach to substantiation, as recently
reaffirmed in the Commission's final order against POM Wonderful. In
re POM Wonderful LLC et al., 155 F.T.C. 1, 6 (2013).
\12\ Commissioner Bailey made this observation in the context of
opposing industry efforts to repeal this authority, an authority she
described as an ``extremely effective and efficient way to enforce
the law.'' Testimony of Commissioner Patricia P. Bailey Before the
Subcomm. on Com., Tourism and Transp. of the Comm. on Energy and
Com. of the H.R. Concerning the 1982 Reauthorization of the Fed.
Trade Comm'n, at 11 (Apr. 1, 1982), https://www.ftc.gov/system/files/documents/public_statements/693551/19820401_bailey_testimony_before_the_subcorrmittee_on_commerce_subcommittee_on_commerce_touri.pdf.
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I thank everyone who made today's actions possible, and look
forward to future efforts that address emerging harms using the full
range of our tools and authorities.\13\
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\13\ My colleague, Commissioner Christine S. Wilson, has issued
a statement in this matter. I agree that the Commission should not
prioritize close-call substantiation cases, especially those
involving small businesses.
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Concurring Statement of Commissioner Christine S. Wilson
Today the Commission announces six settlements with marketers of
cannabidiol (CBD) products resolving allegations that they made false,
misleading, and/or unsubstantiated express disease claims for their
products. I support these cases because accurate and complete
information about products contributes to the
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efficient functioning of the market and facilitates informed consumer
decision-making. In contrast, deceptive or false claims inhibit
informed decision-making and may cause economic injury to consumers.
The Commission's complaints in these matters allege that the
marketers claimed their products could treat, prevent, or cure diseases
or serious medical conditions, including cancer, heart disease,
Alzheimer's, diabetes, and Parkinson's disease, and that scientific
research or clinical studies supported these claims. In fact, according
to the Commission's complaints, the proposed respondents did not
conduct scientific research on the efficacy of their products to treat
these diseases or conditions. In addition, the complaints allege that
some of the proposed respondents claimed that their products could be
taken in lieu of prescription medication. The Commission has been
working with the FDA, and on its own, to combat false and
unsubstantiated claims for CBD products, including through warning
letters \1\ and a law enforcement action.\2\ Here, where consumers may
have foregone proven measures to address serious diseases and the
marketers have made virtually no effort to possess and rely on
scientific evidence to support their strong, express disease claims, as
we allege in our complaint, I agree that law enforcement is
appropriate.
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\1\ Press Release, FTC and FDA Warn Florida Company Marketing
CBD Products about Claims Related to Treating Autism, ADHD,
Parkinson's, Alzheimer's, and Other Medical Conditions, Oct. 22,
2019, available at https://www.ftc.gov/news-events/press-releases/2019/10/ftc-fda-warn-florida-company-marketing-cbd-productsabout-claims; Press Release, FTC Sends Warning Letters to Companies
Advertising Their CBD-Infused Products as Treatmentsfor Serious
Diseases, Including Cancer, Alzheimer's, and Multiple Sclerosis,
Sept. 10, 2019, available at https://www.ftc.gov/news-events/press-releases/2019/09/ftc-sends-warning-letters-companies-advertising-their-cbdinfused; Press Release, FTC Joins FDA in Sending Warning
Letters to Companies Advertising and Selling Products Containing
Cannabidiol (CBD) Claiming to Treat Alzheimer's, Cancer, and Other
Diseases, Apr. 2, 2019, available at https://www.ftc.gov/news-events/press-releases/2019/04/ftc-joins-fda-sending-warning-letters-companiesadvertising.
\2\ Press Release, FTC Order Stops the Marketer of ``Thrive''
Supplement from Making Baseless Claims It Can Treat, Prevent, or
Reduce the Risks from COVID-19, July 10, 2020, available at https://www.ftc.gov/newsevents/press-releases/2020/07/ftc-order-stops-marketer-thrive-supplement-making-baseless-claims.
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The Commission's proposed consent orders in these matters require
respondents to possess and rely on competent and reliable evidence,
defined as randomized, double-blind, placebo-controlled human clinical
trials to support disease and other serious health claims for these
types of products in the future.\3\ Although I support this requirement
in these cases, for these types of claims, I caution that the
Commission should impose this stringent substantiation requirement
sparingly. Credible science supports the use of CBD products to treat
certain conditions--specifically, the FDA has approved a drug
containing CBD as an active ingredient to treat rare, severe forms of
epilepsy.\4\ And I understand that many research studies are currently
seeking to determine whether there are other scientifically valid and
safe uses of this ingredient.
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\3\ See, e.g., Part I of Proposed Order, In the Matter of
Bionatrol Health, LLC, et. al. (Dec. 2020).
\4\ See FDA Press Release, FDA approves first drug comprised of
an active ingredient derived from marijuana to treat rare, severe
forms of epilepsy (June 25, 2018), available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms.
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I agree with my predecessors who have stated that the Commission
should be careful to avoid imposing an unduly high standard of
substantiation that risks denying consumers truthful, useful
information, may diminish incentives to conduct research, and could
chill manufacturer incentives to introduce new products to the
market.\5\ And I agree with the observation of my colleague
Commissioner Chopra in his statement that ``[b]aseless claims give
patients false hope, improperly increase or divert their medical
spending, and undermine `a competitor's ability to compete' on honest
attributes.'' \6\ Although I support these cases, I hope that the
Commission's actions here, which challenge wholly unsubstantiated
disease claims, do not discourage research into the potential
legitimate benefits of CBD and a wide array of other products. In
addition, going forward, I urge the Commission to focus our scarce
resources on marketers that make strong, express claims about diseases
and serious health issues with little to no scientific support and
engage in deceptive practices that cause substantial consumer injury.
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\5\ See, e.g., Statement of Commissioner Maureen K. Ohlhausen,
In the Matter of Health Discovery Corporation and FTC v. Avrom Boris
Lasarow, et al. (Feb. 2015), https://www.ftc.gov/public-statements/2015/02/dissenting-statement-commissioner-maureen-k-ohlhausen-matter-health; Statement of Commissioner Joshua D. Wright, FTC v.
Kevin Wright; HCG Platinum, LLC; and Right Way Nutrition, LLC (Dec.
2014), https://www.ftc.gov/public-statements/2014/12/statement-commissioner-joshua-d-wright-federal-trade-commission-v-kevin;
Statement of Commissioner Joshua D. Wright, In the Matter of
GeneLink, Inc., and foru International Corporation (January 2014),
https://www.ftc.gov/public-statements/2014/01/statement-commissioner-joshua-d-wright-matter-genelink-inc-foru; Statement of
Commissioner Maureen K. Ohlhausen Dissenting in Part and Concurring
in Part, In the Matter of GeneLink, Inc. and foru International
Corporation (January 2014), https://www.ftc.gov/public-statements/2014/01/statement-commissioner-maureen-k-ohlhausen-dissenting-part-concurring-part; Dissenting Statement of Commissioner Maureen K.
Ohlhausen, FTC v. Springtech 77376, et al. (July 2013), https://www.ftc.gov/public-statements/2013/07/dissenting-statement-commissioner-maureen-k-ohlhausen; see also J. Howard Beales, III and
Timothy J. Muris, In Defense of the Pfizer Factors, George Mason Law
& Economics Research Paper No. 12-49 (May 2012), available at:
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2087776.
\6\ See Statement of Commissioner Rohit Chopra Regarding the
Cannabidiol (CBD) Enforcement Actions (Dec. 17, 2020).
[FR Doc. 2020-28545 Filed 12-23-20; 8:45 am]
BILLING CODE 6750-01-P