[Federal Register Volume 87, Number 136 (Monday, July 18, 2022)]
[Proposed Rules]
[Pages 42662-42665]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15265]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1301

[Docket No. DEA-598]
RIN 1117-AB60


Providing Controlled Substances to Ocean Vessels, Aircraft, and 
Other Entities

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Advance notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration (DEA) is issuing this 
advance notice of proposed rulemaking to obtain information regarding 
the procurement of controlled substances by a medical officer for 
emergency kits on board ocean vessels, aircraft, and certain other 
entities. The regulations permitting controlled substances acquired by 
and dispensed under the general supervision of a medical officer to be 
stored in and dispensed from emergency kits on board ocean vessels, 
aircraft, and other entities were established in 1971 and have not been 
significantly modified since. DEA is considering revising these 
regulations and seeks to gain a better understanding of the industry's 
current needs and practices.

[[Page 42663]]


DATES: Electronic comments must be submitted, and written comments must 
be postmarked, on or before September 16, 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-AB60/Docket No. DEA-598'' 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 http://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 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 and are discouraged. 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.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting 
and Policy Support Section, Diversion Control Division, Drug 
Enforcement Administration; 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 http://www.regulations.gov. Such information includes personal 
identifying information (such as your name, address, etc.) voluntarily 
submitted by the commenter. 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 or personal identifying information 
that it cannot be effectively redacted, all or part of that comment may 
not be made publicly available. Comments posted to http://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 advance notice of proposed rulemaking is 
available at http://www.regulations.gov for ease of reference.

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, as amended.\1\ 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.
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    \1\ 21 U.S.C. 801-971.
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    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.\2\ The CSA authorizes the DEA 
Administrator (Administrator), by delegation from the Attorney General, 
to register an applicant to manufacture, distribute, or dispense 
controlled substances if such registration is determined to be 
consistent with the public interest.\3\ 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,\4\ or relating to the 
registration and control of the manufacture, distribution, and 
dispensing of controlled substances.\5\ By this authority, DEA is 
considering revising the regulations that permit controlled substances 
acquired by and dispensed under the general supervision of a medical 
officer to be stored in and dispensed from medicine chests, first aid 
packets, or dispensaries on board ocean vessels, aircraft, and in any 
other entity of fixed or transient location approved by the 
Administrator.\6\
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    \2\ 21 U.S.C. 822.
    \3\ 21 U.S.C. 823.
    \4\ 21 U.S.C. 871(b).
    \5\ 21 U.S.C. 821.
    \6\ 21 CFR 1301.25(a).
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Background

    The existing regulations in 21 CFR 1301.25 that allow controlled 
substances to be held for stocking, maintained in, and dispensed from 
medicine chests, first aid packets, and dispensaries on board ocean 
vessels, aircraft, and in certain other entities were published in 1971 
as part of the original regulations implementing the CSA.\7\ Since 
then, only minor changes have been made to these regulations. In 1972, 
21 CFR 301.28, ``Registration regarding ocean vessels,'' and 21 CFR 
301.29, ``Registration regarding commercial aircraft,'' were combined 
into one section, 21 CFR 301.28, ``Registration regarding ocean 
vessels, commercial aircraft and certain other entities.'' \8\ In 1973, 
all parts and sections of Title 21 of the CFR were re-designated upward 
by one thousand; thus, 21 CFR 301.28 became 21 CFR 1301.28.\9\ In 1997, 
the section was re-designated again and became 21 CFR

[[Page 42664]]

1301.25.\10\ DEA is soliciting information from entities acquiring 
controlled substances in accordance with 21 CFR 1301.25 to better 
understand current industry practices.
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    \7\ Proposed Regulations Implementing the Comprehensive Drug 
Abuse Prevention Act of 1970, 36 FR 4928 (March 13, 1971) and 
Regulations Implementing the Comprehensive Drug Abuse Prevention Act 
of 1970, 36 FR 7776 (April 24, 1971).
    \8\ 37 FR 15917 (August 8, 1972).
    \9\ 38 FR 26609 (September 24, 1973).
    \10\ 62 FR 13938 (March 24, 1997).
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Current Regulations

    The current regulations allow controlled substances to be kept in 
emergency kits on board vessels, aircraft, and other entities if they 
are acquired by and dispensed under the general supervision of a 
medical officer or the master or first officer of certain vessels.\11\ 
The regulations specify vessels as those engaged in international 
trade, in trade between ports of the United States, any merchant vessel 
belonging to the U.S. Government, and aircraft ``operated by an air 
carrier under a certificate of permit issued pursuant to the Federal 
Aviation Act of 1958 . . . .'' \12\ This language suggests that the 
regulations were intended to accommodate commercial entities. However, 
vessels and aircraft used primarily for recreation (e.g., private 
yachts, planes or jets) are not specifically addressed. Thus, DEA seeks 
information regarding emergency kits for recreational vessels and 
aircraft containing controlled substances acquired pursuant to the 
regulations in 21 CFR 1301.25. Specifically, DEA is seeking a detailed 
description of the circumstances in which controlled substances would 
be needed, the current process for obtaining controlled substances 
(e.g., through the use of a medical officer or directly from a pharmacy 
or distributor), and any recordkeeping procedures pertaining to the 
controlled substances in emergency kits on recreational vessels and 
aircraft.
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    \11\ 21 CFR 1301.25(a).
    \12\ 21 CFR 1301.25(a).
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    DEA notes that all passenger-carrying aircraft certified by the 
Federal Aviation Administration are required to have an approved 
emergency medical kit on board.\13\ However, the list of contents 
required to be maintained in approved emergency medical kits does not 
include any controlled substances.\14\ Thus, DEA seeks information with 
regard to the maintenance of controlled substances in emergency kits on 
commercial aircraft.
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    \13\ 14 CFR 121.803(c).
    \14\ 14 CFR part 121; Appendix A to part 121--First Aid Kits and 
Emergency Medical Kits.
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    The current regulations also allow controlled substances to be kept 
in emergency kits ``in any entity of fixed or transient location 
approved by the Administrator. . . .'' \15\ In a previously published 
notice of proposed rulemaking preamble, DEA stated that this provision 
was added to accommodate ``other situations where controlled substances 
are held at scattered locations for emergency purposes: [o]ffshore oil 
rigs, landing fields in Alaska, remote industrial locations, and so 
forth.'' \16\ DEA seeks information regarding controlled substances 
held in emergency kits at field sites of an industrial firm (e.g., 
airplane hangars, factories, mines, etc.), in oil rigs, platforms, 
barges, or any other technology related to offshore drilling and 
mining. Specifically, DEA is seeking a detailed description of the 
entity where the emergency kit is held, the process for obtaining 
controlled substances for the emergency kit, recordkeeping procedures, 
and controlled substance dispensing and administration requirements.
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    \15\ 21 CFR 1301.25(a)(3).
    \16\ Drug Abuse Prevention and Control Notice of Proposed Rule 
Making, 37 FR 10370 (May 20, 1972) and Drug Abuse Prevention and 
Control, 37 FR 15917 (August 8, 1972).
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Medical Officers

    The regulations require the medical officer to be licensed as a 
physician, employed by the owner or operator of the vessel, aircraft, 
or other entity, and registered with DEA at the principal office of the 
owner or operator of the vessel, aircraft, or other entity.\17\ The 
controlled substances must be ordered by the medical officer, who is 
the DEA registrant, and shipped to the registered location of the 
medical officer, as opposed to being shipped directly to the vessel, 
aircraft, or other entity. Representatives from the maritime industry 
have noted the challenges they face as a result of this requirement. In 
response to a previously published advance notice of proposed 
rulemaking (ANPRM),\18\ commenters reported that some medical officers 
are employed on a part-time basis and often serve as medical officers 
for more than one owner or operator. Commenters stated that this can 
result in significant delays and vessels being inadequately supplied, 
as controlled substances may sit at the medical officer's registered 
location for weeks. In addition, one commenter believed that the 
regulations do not provide any alternatives for fixed offshore 
installations with no medical officer to acquire controlled substances 
for emergency kits. However, DEA notes that for controlled substances, 
specifically those in schedule II, the regulations state that the 
controlled substances must be shipped only to the purchaser (i.e., the 
medical officer) at the registered location.\19\ Therefore, DEA seeks 
information regarding a registration option for ocean vessels, 
aircraft, and other entities.
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    \17\ 21 CFR 1301.25(b).
    \18\ 61 FR 49086 (September 18, 1996).
    \19\ 21 CFR 1305.13(c).
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    The regulations also provide that, in the absence of a registered 
medical officer, the master or first officer of a vessel may purchase 
controlled substances by personally appearing before a registered 
manufacturer, distributor, or authorized pharmacy.\20\ The master or 
first officer must present proper identification and a written 
requisition for the controlled substances, prepared using the vessel's 
official stationery or purchase order form. In response to a previously 
published ANPRM, commenters opposed the requirement that the master or 
first officer must personally appear at the vendor's place of business, 
stating that it did not align with current industry practice.\21\ The 
commenters also noted that having the master or first officer go ashore 
to purchase controlled substances is difficult because of their 
shipboard duties and the length of time vessels are in port. DEA seeks 
information regarding the purchase of controlled substances by the 
master or first officer of a vessel. Specifically, DEA wishes to 
understand whether masters or first officers routinely go ashore to 
purchase controlled substances or only occasionally.
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    \20\ 21 CFR 1301.25(d).
    \21\ 61 FR 49086 (September 18, 1996).
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Comments Requested

    DEA is soliciting information from the maritime and aviation and 
other industries to gain a better understanding of current industry 
practices, needs, and requirements with respect to controlled 
substances maintained in emergency kits. Although all comments are 
welcome, DEA is particularly interested in comments regarding the 
questions listed below.
    1. Please describe in detail the procedures followed by vessels, 
aircraft, or any other approved entity to obtain controlled substances 
for medicine chests, first aid packets, or dispensaries.
    2. Are there any other regulations, standards, or requirements 
(other than DEA regulations) that the entities must comply with when 
acquiring and maintaining controlled substances for medicine chests, 
first aid packets, or dispensaries?
    3. Is a medical officer always involved in the procurement of the 
controlled substances? If not, please describe in detail: (1) the 
circumstances under which controlled substances are acquired without a 
medical officer, and

[[Page 42665]]

(2) the process for acquiring controlled substances under such 
circumstances?
    4. Please describe in detail the current role of a medical officer, 
including all services provided, on board vessels, aircraft, or any 
other approved entity.
    5. Please describe in detail how controlled substances are acquired 
by those entities who do not employ a medical officer.
    6. Who generally supplies the controlled substances to the vessels, 
aircraft, or other entities? DEA-registered distributors, pharmacies, 
manufacturers, etc.?
    7. Please describe the safeguards that are in place to provide 
effective controls against diversion of controlled substances.
    a. Please describe the procedures that must be followed when 
handling controlled substances.
    b. Who has access to the controlled substances?
    c. Who is permitted to dispense or administer controlled substances 
and under what circumstances are they permitted to do so?
    d. Are there recordkeeping requirements for maintaining inventory, 
documenting any controlled substances administered, dispensed, lost, 
stolen, or disposed of?
    e. Who is responsible for recordkeeping?
    8. Please describe the procedures followed for disposing of 
damaged, expired, or otherwise unwanted controlled substances.
    9. Please describe the procedure for reporting theft or loss of 
controlled substances.
    10. Please provide any information that would help DEA quantify (or 
discuss qualitatively) the potential costs and benefits of a rule that 
would promote or restrict the use of contract and part-time medical 
officers.
    11. 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 require a DEA registration to obtain controlled 
substances for stocking, maintaining in, and dispensing from medicine 
chests, first aid packets, or dispensaries on board vessels, aircraft, 
or other entities.
    12. For the airline industry: Please confirm whether controlled 
substances are kept in emergency kits on board airplanes.
    a. If so, please describe how the controlled substances are 
obtained.
    b. Are medical officers frequently employed by the airline 
industry?
    c. If a medical emergency arises, who on the airplane is permitted 
to dispense or administer controlled substances, if needed?
    13. For vessels and other offshore entities (e.g., oil rigs and 
platforms, mobile offshore drilling units, mining sites, etc.): How and 
when are the controlled substances delivered?
    a. Are the controlled substances shipped from the medical officer 
to the vessel or other entity while in port or prior to offshore 
deployment?
    b. Are controlled substances ever shipped directly from the vendor 
to the vessel or other entity?
    c. Who on board the vessel or other entity is responsible for 
receiving the shipment?

Regulatory Analyses

    This ANPRM was developed in accordance with the principles of 
Executive Order (E.O.) 12866, ``Regulatory Planning and Review'' and 
E.O. 13563, ``Improving Regulation and Regulatory Review.'' Since this 
action is an ANPRM, the requirement of E.O. 12866 to assess the costs 
and benefits of this action does not apply.
    Furthermore, the requirements of the Regulatory Flexibility Act 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 of 
proposed rulemaking regarding this matter, DEA will conduct all 
relevant analyses as required by statute or Executive Order.

Signing Authority

    This document of the Drug Enforcement Administration was signed on 
July 13, 2022, by Administrator Anne Milgram. That document with the 
original signature and date is maintained by DEA. For administrative 
purposes only, and in compliance with requirements of the Office of the 
Federal Register, the undersigned DEA Federal Register Liaison Officer 
has been authorized to sign and submit the document in electronic 
format for publication, as an official document of DEA. This 
administrative process in no way alters the legal effect of this 
document upon publication in the Federal Register.

Scott Brinks,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2022-15265 Filed 7-15-22; 8:45 am]
BILLING CODE 4410-09-P