Regulation of Telepharmacy Practice

CourtDrug Enforcement Administration,Justice Department
Citation86 FR 64096
Record Number2021-24948
SectionProposed rules
Published date17 November 2021
64096
Federal Register / Vol. 86, No. 219 / Wednesday, November 17, 2021 / Proposed Rules
(3) Model A320–211, –212, –214, –216,
–231, –232, and –233 airplanes.
(4) Model A321–111, –112, –131, –211,
–212, –213, –231, and –232 airplanes.
(d) Subject
Air Transport Association (ATA) of
America Code 25, Equipment/furnishings.
(e) Reason
This AD was prompted by reports of
damaged lower lateral fittings of the 80VU
rack, and reports of new damage on airplanes
on which certain optional service
information had been accomplished. The
FAA is issuing this AD to address damage or
cracking of the 80VU fittings and supports,
which could lead to possible disconnection
of the cable harnesses to one or more
computers, and if occurring during a critical
phase of flight, could result in reduced
control of the airplane.
(f) Compliance
Comply with this AD within the
compliance times specified, unless already
done.
(g) Requirements
Except as specified in paragraph (h) of this
AD: Comply with all required actions and
compliance times specified in, and in
accordance with, European Union Aviation
Safety Agency (EASA) AD 2021–0172, dated
July 20, 2021 (EASA AD 2021–0172).
(h) Exceptions to EASA AD 2021–0172
(1) Where EASA AD 2021–0172 refers to its
effective date, this AD requires using the
effective date of this AD.
(2) The remarks section of EASA AD 2021–
0172 does not apply to this AD.
(3) Where paragraph (3) of EASA AD 2021–
0172 specifies ‘‘any discrepancy,’’ for this AD
‘‘any discrepancy’’ includes broken fittings,
missing bolts, an electronics rack FIN 80VU
that is in contact with structure, any bush
that has migrated, burred material, and
cracks.
(i) Method of Compliance for Paragraphs (1),
(2), and (3) of EASA AD 2021–0172
Accomplishing inspections and correctives
actions in accordance with the
Accomplishment Instruction of Airbus
Service Bulletin A320–25–1BKJ, Revision 02,
dated April 9, 2020, with corrections
referenced in the Airbus Technical
Adaptation 80827186/024/2020, Issue 1,
dated September 18, 2020, is an acceptable
method of compliance for the inspections
and corrective actions specified in
paragraphs (1), (2), and (3) of EASA AD
2021–0172.
(j) Other FAA AD Provisions
The following provisions also apply to this
AD:
(1) Alternative Methods of Compliance
(AMOCs): The Manager, Large Aircraft
Section, International Validation Branch,
FAA, has the authority to approve AMOCs
for this AD, if requested using the procedures
found in 14 CFR 39.19. In accordance with
14 CFR 39.19, send your request to your
principal inspector or responsible Flight
Standards Office, as appropriate. If sending
information directly to the Large Aircraft
Section, International Validation Branch,
send it to the attention of the person
identified in paragraph (k)(2) of this AD.
Information may be emailed to: 9-AVS-AIR-
730-AMOC@faa.gov.
(i) Before using any approved AMOC,
notify your appropriate principal inspector,
or lacking a principal inspector, the manager
of the responsible Flight Standards Office.
(ii) AMOCs approved previously for AD
2013–25–11 are approved as AMOCs for the
corresponding provisions of EASA AD 2021–
0172 that are required by paragraph (g) of this
AD.
(2) Contacting the Manufacturer: For any
requirement in this AD to obtain instructions
from a manufacturer, the instructions must
be accomplished using a method approved
by the Manager, Large Aircraft Section,
International Validation Branch, FAA; or
EASA; or Airbus SAS’s EASA Design
Organization Approval (DOA). If approved by
the DOA, the approval must include the
DOA-authorized signature.
(3) Required for Compliance (RC): For any
service information referenced in EASA AD
2021–0172 that contains RC procedures and
tests: Except as required by paragraph (j)(2)
of this AD, RC procedures and tests must be
done to comply with this AD; any procedures
or tests that are not identified as RC are
recommended. Those procedures and tests
that are not identified as RC may be deviated
from using accepted methods in accordance
with the operator’s maintenance or
inspection program without obtaining
approval of an AMOC, provided the
procedures and tests identified as RC can be
done and the airplane can be put back in an
airworthy condition. Any substitutions or
changes to procedures or tests identified as
RC require approval of an AMOC.
(k) Related Information
(1) For information about EASA AD 2021–
0172, contact EASA, Konrad-Adenauer-Ufer
3, 50668 Cologne, Germany; telephone +49
221 8999 000; email ADs@easa.europa.eu;
internet www.easa.europa.eu. You may find
this EASA AD on the EASA website at
https://ad.easa.europa.eu. For Airbus service
information, contact Airbus SAS,
Airworthiness Office—EIAS, Rond-Point
Emile Dewoitine No: 2, 31700 Blagnac Cedex,
France; telephone +33 5 61 93 36 96; fax +33
5 61 93 44 51; email account.airworth-eas@
airbus.com; internet http://www.airbus.com.
You may view this material at the FAA,
Airworthiness Products Section, Operational
Safety Branch, 2200 South 216th St. Des
Moines, WA. For information on the
availability of this material at the FAA, call
206–231–3195. The EASA material may be
found in the AD docket on the internet at
https://www.regulations.gov by searching for
and locating Docket No. FAA–2021–0506.
(2) For more information about this AD,
contact Sanjay Ralhan, Aerospace Engineer,
Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th
St., Des Moines, WA 98198; telephone and
fax 206–231–3223; email sanjay.ralhan@
faa.gov.
Issued on November 8, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021–24791 Filed 11–16–21; 8:45 am]
BILLING CODE 4910–13–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Chapter II
[Docket No. DEA–759]
RIN 1117–AB74
Regulation of Telepharmacy Practice
AGENCY
: Drug Enforcement
Administration, Department of Justice.
ACTION
: Advanced notice of proposed
rulemaking.
SUMMARY
: The Drug Enforcement
Administration (DEA) is issuing this
advanced notice of proposed
rulemaking to obtain further
information regarding the practice of
telepharmacy. Telepharmacy is not
specifically defined by the Controlled
Substances Act (CSA) or DEA
regulations; however, to the extent
telepharmacies dispense controlled
substances, they are under the purview
of the CSA and DEA. DEA is
considering promulgating regulations
regarding telepharmacy and seeks to be
fully informed about the practice,
industry, and state regulation of
telepharmacy.
DATES
: Electronic comments must be
submitted, and written comments must
be postmarked, on or before January 18,
2022. Commenters should be aware that
the electronic Federal Docket
Management System will not accept
comments after 11:59 p.m. Eastern Time
on the last day of the comment period.
ADDRESSES
: To ensure proper handling
of comments, please reference ‘‘RIN
1117–AB74/Docket No. DEA–759’’ on
all correspondence, including any
attachments.
Electronic comments: DEA
encourages that all comments be
submitted electronically through the
Federal eRulemaking Portal, which
provides the ability to type short
comments directly into the comment
field on the web page or to attach a file
for lengthier comments. Please go to
https://www.regulations.gov and follow
the online instructions at that site for
submitting comments. Upon completion
of your submission, you will receive a
Comment Tracking Number for your
comment. Please be aware that
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submitted comments are not
instantaneously available for public
view on Regulations.gov. If you have
received a Comment Tracking Number,
your comment has been successfully
submitted, and there is no need to
resubmit the same comment.
Paper comments: Paper comments
that duplicate the electronic submission
are not necessary. Should you wish to
mail a paper comment in lieu of an
electronic comment, it should be sent
via regular or express mail to: Drug
Enforcement Administration, Attn: DEA
Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield, VA
22152–2639.
FOR FURTHER INFORMATION CONTACT
:
Scott A. Brinks, Regulatory Drafting and
Policy Support Section, Diversion
Control Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (571) 776–2265.
SUPPLEMENTARY INFORMATION
:
Posting of Public Comments
Please note that all comments
received in response to this docket are
considered part of the public record.
They will, unless reasonable cause is
given, be made available by DEA for
public inspection online at https://
www.regulations.gov. Such information
includes personal identifying
information (such as your name,
address, etc.) that you voluntarily
submit. The Freedom of Information Act
applies to all comments received. If you
want to submit personal identifying
information (such as your name,
address, etc.) as part of your comment,
but do not want it to be made publicly
available, you must include the phrase
‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also place
all of the personal identifying
information you do not want made
publicly available in the first paragraph
of your comment and identify what
information you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want it to be made
publicly available, you must include the
phrase ‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify the confidential
business information to be redacted
within the comment.
Comments containing personal
identifying information or confidential
business information identified as
directed above will be made publicly
available in redacted form. If a comment
has so much confidential business
information that it cannot be effectively
redacted, all or part of that comment
may not be made publicly available.
Comments posted to https://
www.regulations.gov may include any
personal identifying information (such
as your name, address, etc.) included in
the text of your electronic submission
that is not identified as directed above
as confidential.
An electronic copy of this advanced
notice of proposed rulemaking is
available at https://www.regulations.gov
for ease of reference.
Background and Purpose
I. Legal Authority
The Drug Enforcement
Administration (DEA) implements and
enforces the Comprehensive Drug Abuse
Prevention and Control Act of 1970,
often referred to as the Controlled
Substances Act (CSA) and the
Controlled Substances Import and
Export Act (CSIEA), (21 U.S.C. 801–
971), as amended. DEA publishes the
implementing regulations for these
statutes in 21 CFR parts 1300 to end.
These regulations are designed to ensure
a sufficient supply of controlled
substances for medical, scientific, and
other legitimate purposes, and to deter
the diversion of controlled substances
for illicit purposes.
As mandated by the CSA, DEA
establishes and maintains a closed
system of control for manufacturing,
distribution, and dispensing of
controlled substances, and requires any
person who manufactures, distributes,
dispenses, imports, exports, or conducts
research or chemical analysis with
controlled substances to register with
DEA, unless they meet an exemption,
pursuant to 21 U.S.C. 822. The CSA
authorizes the Administrator of DEA (by
delegation of authority from the
Attorney General) to register an
applicant to manufacture, distribute or
dispense controlled substances if the
Administrator determines such
registration is consistent with the public
interest. 21 U.S.C. 823. The CSA further
authorizes the Administrator to
promulgate regulations necessary and
appropriate to execute the functions of
subchapter I (Control and Enforcement)
and subchapter II (Import and Export) of
the CSA. 21 U.S.C. 871(b) and 958(f).
Pursuant to these authorities, DEA is
considering promulgating regulations
regarding telepharmacy and seeks to be
fully informed about the practice,
industry, and state regulation of
telepharmacy.
II. Telepharmacy
The term telepharmacy is not
currently defined by the CSA or DEA
regulation. Generally speaking,
however, telepharmacy is considered to
be the provision of pharmacist care by
a remote pharmacist, through the use of
telecommunications and other
technologies, to a patient located at a
dispensing site. Such pharmacist care
may include, but is not limited to: The
dispensing and distribution of
prescription drugs, drug use review,
patient counseling services, and drug
therapy monitoring. Depending on the
relevant state authority and regulations,
telepharmacies may fill paper
prescriptions or electronic
prescriptions.
While the practice of telepharmacy
varies from state to state, they generally
fall within one of two categories: (i)
Brick and mortar remote sites; and (ii)
self-service, automated machines. Brick
and mortar remote sites are traditional,
storefront businesses, physically staffed
by non-pharmacist employees, e.g.,
pharmacy technicians, who are remotely
supervised by a pharmacist located in a
separate ‘‘parent’’ or ‘‘hub’’ pharmacy,
via continuous and real-time computer,
video, and audio links (i.e.,
telecommunication connection).
Depending on the state, a pharmacy
technician may assist the remote
pharmacist by receiving and inputting
prescriptions into the pharmacy’s
information management system and
preparing prescriptions for dispensing.
Self-service, automated machines are
kiosks, resembling an Automatic Teller
Machine (ATM), which contain
pharmacy prescription medication/
inventory, labeling equipment, and the
telecommunication technology that
connects the patient-user to the remote
pharmacist via real-time video and
audio links. Such automated machines
may accept prescriptions or refill orders,
store prepackaged or repackaged
medications, label and dispense patient-
specific prescriptions, and ultimately
dispense the prescription to the patient-
user.
Telepharmacy has expanded
nationwide over the past two decades to
address the need for pharmacy care in
rural and other underserved
communities, which may have a
difficult time recruiting or supporting
the employment of a pharmacist full-
time. Despite the benefit of increased
access to pharmacist care, such
telepharmacies may pose a heightened
risk of diversion by not having a
pharmacist physically present to
supervise and oversee remote sites and
by not having any in-person monitoring
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of automated machines. As many of
these telepharmacies may dispense
controlled substances, DEA is
considering promulgating regulations
for a special or modified telepharmacy
registration.
III. Online Pharmacies Under the Ryan
Haight Act
As telepharmacies utilize the internet
to dispense controlled substances, they
may constitute Online Pharmacies
under the Ryan Haight Online Pharmacy
Consumer Protection Act of 2008 (Ryan
Haight Act) and must therefore either:
(1) Obtain a modified registration under
21 CFR 1301.19; or (2) meet one of the
exceptions to an Online Pharmacy
under 21 CFR 1300.04(h). The terms
‘‘internet’’ and ‘‘online pharmacy’’ are
defined in the CSA. The internet is
‘‘collectively the myriad of computer
and telecommunications facilities,
including equipment and operating
software, which comprise the
interconnected worldwide network of
networks that employ the Transmission
Control Protocol/internet Protocol, or
any predecessor or successor protocol to
such protocol, to communicate
information of all kinds by wire or
radio.’’ 21 U.S.C. 802 (50) and 21 CFR
1300.04(g).
An online pharmacy is defined as any
‘‘person, entity, or internet site, whether
in the United States or abroad, that
knowingly or intentionally delivers,
distributes, or dispenses, or offers or
attempts to deliver, distribute, or
dispense, a controlled substance by
means of the internet.’’ 21 U.S.C. 802
(52) and 21 CFR 1300.04(h). It is
unlawful for any person or entity to
operate as an online pharmacy, unless
that person or entity is a DEA registered
pharmacy under 21 CFR 1301.13 and
DEA has approved and issued that
person or entity a modified registration.
21 U.S.C. 823(f) and 21 CFR 1301.13(a).
DEA may deny registration of an
internet pharmacy if it determines the
issuance of the necessary license
modification would be inconsistent
with the public interest. 21 CFR
1301.19(a). To date, there are no online
pharmacies registered with DEA.
Paragraph (h) of 21 CFR 1300.04,
provides ten exceptions to the definition
of ‘‘online pharmacy,’’ eight of which
come directly from the Ryan Haight Act.
21 CFR 1300.04(h)(1)–(10); 21 U.S.C.
802(52)(B). The first seven exceptions of
the regulation provide exemptions for:
DEA-registered manufacturers,
distributors, and non-pharmacy
practitioners; certain hospitals and other
health care facilities associated with the
United States government, and their
respective agents and employees;
advertisements that do not attempt to
facilitate an actual transaction involving
a controlled substance; and non-
domestic persons, entities, or internet
sites that do not facilitate the delivery,
distribution, or dispensing of a
controlled substance to persons in the
U.S. The last three exceptions exempt
pharmacies whose dispensing of
controlled substances by means of the
internet consists solely of: Filling or
refilling prescriptions for controlled
substances in schedules III–V; filling
prescriptions that were electronically
prescribed; and transmitting
prescription information between a
pharmacy and an automated dispensing
system located in a long-term care
facility. Telepharmacies may not use the
internet to facilitate the dispensing of
controlled substances unless they have
been issued a modified registration
under 21 CFR 1301.19 or fall within one
of these exceptions.
IV. Electronic Prescriptions of
Controlled Substances (EPCS)
Exception
The one exception DEA finds
applicable in the context of
telepharmacy is the Electronic
Prescriptions of Controlled Substances
(EPCS) exception. The EPCS exception
provides that a DEA-registered
pharmacy is not an Online Pharmacy if:
‘‘. . . [its] dispensing of controlled
substances by means of the internet
consists solely of filling prescriptions
that were electronically prescribed in a
manner authorized by [chapter II of title
21 of the CFR] and otherwise in
compliance with the [Controlled
Substances Act]’’ (emphasis added). 21
CFR 1300.04(h)(9). Pharmacies are
authorized to fill electronically
transmitted prescriptions for controlled
substances provided that the pharmacy
complies with the requirements of parts
1306 and 1311 of the regulations. 21
CFR 1306.08. Under this EPCS
exception, telepharmacies are permitted
to fill electronic prescriptions of
controlled substances in compliance
with DEA’s EPCS regulations; however,
they are not permitted to fill paper
prescriptions of controlled substances.
The EPCS exception does not, however,
constitute a legal safe harbor that would
excuse or cure other regulatory
violations; telepharmacies must still
otherwise comply with DEA regulations
regarding registration, prescriptions,
security, recordkeeping, and reporting.
V. State Regulations
DEA is aware that several states have
authorized telepharmacy practice under
their general legislative authority and
through a variety of state regulatory
entities, including state boards of
pharmacy and state licensing
commissions. While DEA has obtained
some information regarding state
telepharmacy regulations, it does not
believe that the information it has is
complete. Therefore, as discussed
further below, DEA is specifically
seeking information from state
regulatory authorities regarding states’
legislative and/or regulatory
requirements for telepharmacy licensing
and regulations.
Comments Requested
DEA is soliciting information from the
state regulatory authorities, national and
professional associations, industry,
telepharmacy vendors and servicers,
and the general public so that DEA may
obtain a better understanding of
telepharmacy and how it is currently
working. DEA seeks to promulgate
requirements for telepharmacies in light
of the growth of this telehealth service
nationwide, particularly in how they
dispense controlled substances.
Commenters are encouraged to include
the question number enumerated below
in their response (e.g., ‘‘I.4’’ or ‘‘II.20’’).
Although all comments are welcome,
DEA is particularly interested in
comments regarding the questions listed
below and any other pertinent
information and input on telepharmacy.
I. State Regulatory Authorities
1. Please describe the organization
and operation of telepharmacy practices
authorized in your state. E.g., does your
state permit or license both remote
dispensing sites and automated
machines?
2. How many telepharmacies are
currently authorized or licensed in your
state? Do you foresee even greater
growth of telepharmacies in your state?
3. Please describe the telepharmacy
licensing process in your state,
including the criteria by which a
licensing application is or will be
approved or denied.
4. Is a patient-practitioner
relationship required prior to
telepharmacy services for a controlled
and/or non-controlled drug product?
5. How many remote dispensing sites/
automated machines can one remote
pharmacist supervise at one time? If
multiple remote sites, what happens
when the pharmacist is needed by
multiple remote dispensing sites at the
same time?
6. Are there limits to how many
remote pharmacists or organizations can
access a dispensing site or automated
machine?
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7. Is there a controlled substance
volume limit/restriction with
telepharmacies?
8. What additional policies and
procedures are required of
telepharmacies that are not required of
other pharmacies?
9. What additional security
requirements are required of
telepharmacies that are not required of
other retail or community pharmacies?
10. Are there any regulatory
considerations or policies regarding
transfer of controlled and/or non-
controlled substances to remote sites (in
cases where drugs are stored at the
remote site)?
11. Do remote dispensing sites or
automated machines need to be at the
same location as (or within a certain
distance from) the remote pharmacist?
Do the remote dispensing sites or
automated machines need to be a
certain distance from another remote
dispensing site or automated machine?
12. Does the remote pharmacist need
to be in the same state (board
jurisdiction) as the remote sites or
automated machines?
13. Are there other restrictions on
where a remote site or automated
machine may be located? E.g., are they
only permitted at hospitals? Can an
automated machine be placed outside a
gas station or convenience store, or in
proximity to a school? Does your state
allow telepharmacy services in nursing
homes, assisted living facilities, or for
hospice programs?
14. Does your state allow interstate
practice of telepharmacy, i.e. the
practice of telepharmacy across state
lines? Do out-of-state pharmacists
providing telepharmacy services into
your state need to register with your
state board?
15. Can a remote pharmacist with an
out-of-state license, who is authorized
under federal law to care for patients in
your state (e.g., Department of Veterans
Affairs pharmacists), serve as the
pharmacist for a dispensing site or
automated machine?
16. What recordkeeping and reporting
requirements are there for
telepharmacies?
17. Please describe the state’s
inspection process for telepharmacies.
18. Do the pharmacy technicians that
staff remote sites need to be certified or
licensed by the state? Can
telepharmacies hire pharmacy
technicians with criminal histories?
19. Does your state limit the type or
manner of prescriptions that can be
filled by the remote site or automated
machine? Are they only allowed to fill
non-controlled substances? Do they only
fill electronic prescriptions as opposed
to paper prescriptions? Are faxed
prescriptions permitted?
20. Are there any specific regulations
or considerations regarding prescribing
and dispensing of opioid reversal agents
by telepharmacy or automated
machines?
21. Please provide examples of major
issues associated with telepharmacy
that have been reported to your state
regulatory authorities?
22. Please provide any information
that could be used to help DEA quantify
or discuss qualitatively the potential
costs and benefits of a rule that would
either promote or restrict the use of
telepharmacy.
II. Industry and Health Care Providers
23. Are the remote sites or automated
machines typically owned and operated
by the owner of the parent or hub
pharmacy? If they do not share owners,
how is recordkeeping handled?
24. How are locations selected for the
remote sites or automated machines? If
locations are based on the
sociodemographic of a region or
community, can you provide the data or
information considered.
25. What additional training, if any,
do you provide telepharmacy
pharmacists and telepharmacy support
staff?
26. With the absence of the
pharmacist at the remote site and
automated machine, how does the
pharmacist adequately supervise and
oversee telepharmacy technicians and
staff?
27. If controlled substances are
dispensed at your telepharmacy
practice, are they stored and accounted
for separately from non-controlled
substances?
28. If your practice has not
implemented the use of electronic
prescriptions, what is preventing you
from full implementation?
29. For those that have not adopted
telepharmacy, what are the reasons or
barriers to adopting telepharmacy?
30. How does the pharmacist make
his or her final verification of the filled
prescription remotely?
31. Is your remote site or automated
machine registered with the DEA? If so,
under what business activity?
32. If you are a remote pharmacist at
a telepharmacy, how many remote sites
and automated machines can you
adequately supervise during the same
period of time?
33. Please provide any information
that could be used to help DEA quantify
or discuss qualitatively the potential
costs and benefits of a rule that would
either promote or restrict the use of
telepharmacy.
III. Telepharmacy Vendors and
Servicers
34. Please describe how telepharmacy
technology and systems safeguard
against diversion by the public at large,
as well as by employees at remote sites
and automated machines.
35. From a design standpoint, how are
automated machines used in
telepharmacy practices similar and
dissimilar from the Automatic
Dispensing Systems (ADSs) used at
Long Term Care Facilities?
36. Are your telepharmacy technology
and systems Health Insurance
Portability and Accountability Act
compliant?
37. Are your telepharmacy technology
and systems accessible for individuals
with disabilities, e.g., such as hearing
impaired or blind persons?
38. Do you offer 24/7 surveillance of
the telepharmacy remote site or
automated machine?
39. Please provide any information
that could be used to help DEA quantify
or discuss qualitatively the potential
costs and benefits of a rule that would
either promote or restrict the use of
telepharmacy.
Statutory and Executive Order Review
This advanced notice of proposed
rulemaking (ANPRM) has been drafted
and reviewed in accordance with
Executive Order 12866, ‘‘Regulatory
Planning and Review’’ and Executive
Order 13563, ‘‘Improving Regulation
and Regulatory Review.’’ The Office of
Management and Budget has
determined that this ANPRM is a
significant regulatory action under
Executive Order 12866, section 3(f), and
accordingly this ANPRM has been
reviewed by the Office of Management
and Budget. However, this action does
not propose or impose any
requirements.
Furthermore, the requirements of the
Regulatory Flexibility Act (RFA) do not
apply to this action because, at this
stage, it is an ANPRM and not a ‘‘rule’’
as defined in 5 U.S.C. 601. Following
review of the comments received in
response to this ANPRM, if DEA
proceeds with a notice or notices of
proposed rulemaking regarding this
matter, DEA will conduct all relevant
analyses as required by statute or
Executive order.
Anne Milgram,
Administrator.
[FR Doc. 2021–24948 Filed 11–16–21; 8:45 am]
BILLING CODE P
VerDate Sep<11>2014 16:34 Nov 16, 2021 Jkt 256001 PO 00000 Frm 00015 Fmt 4702 Sfmt 4702 E:\FR\FM\17NOP1.SGM 17NOP1
khammond on DSKJM1Z7X2PROD with PROPOSALS

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