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Proposed Rule2026-10128

Revision of Applications for Manufacturing and Procurement Quotas

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Published

May 20, 2026

Issuing agencies

Justice DepartmentDrug Enforcement Administration

Abstract

The Drug Enforcement Administration (DEA) proposes to revise existing regulations relating to the management of quotas for schedule I and II controlled substances and the list I chemicals, ephedrine, pseudoephedrine, and phenylpropanolamine, to be utilized by DEA- registered manufacturers. This rule is being proposed to: restructure DEA's manufacturing and procurement quota regulations for more clarity and consistency; clarify which use-specific subcategories for quotas should be used for controlled substances that will be sold domestically and controlled substances that will be exported; and revise the applications for individual manufacturing and procurement quota. The changes are necessary to increase visibility into the controlled substance supply chain by providing DEA with more detailed information allowing the agency to react more precisely in preventing drug shortages; and to ensure that enough of the schedule I and II controlled substances and three list I chemicals can be manufactured to meet estimated scientific, medical, lawful export, and inventory needs. This rule also contains revisions to use gender neutral language and other non-substantive revisions.

Full Text

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<title>Federal Register, Volume 91 Issue 97 (Wednesday, May 20, 2026)</title>
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[Federal Register Volume 91, Number 97 (Wednesday, May 20, 2026)]
[Proposed Rules]
[Pages 29394-29407]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10128]

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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1303 and 1315

[Docket No. DEA-1278]
RIN 1117-AB86

Revision of Applications for Manufacturing and Procurement Quotas

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration (DEA) proposes to revise
existing regulations relating to the management of quotas for schedule
I and II controlled substances and the list I chemicals, ephedrine,
pseudoephedrine, and phenylpropanolamine, to be utilized by DEA-
registered manufacturers. This rule is being proposed to: restructure
DEA's manufacturing and procurement quota regulations for more clarity
and consistency; clarify which use-specific subcategories for quotas
should be used for controlled substances that will be sold domestically
and controlled substances that will be exported; and revise the
applications for individual manufacturing and procurement quota. The
changes are necessary to increase visibility into the controlled
substance supply chain by providing DEA with more detailed information
allowing the agency to react more precisely in preventing drug
shortages; and to ensure that enough of the schedule I and II
controlled substances and three list I chemicals can be manufactured to
meet estimated scientific, medical, lawful export, and inventory needs.
This rule also contains revisions to use gender neutral language and
other non-substantive revisions.

DATES: Comments must be received by July 20, 2026. 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: Comments must be submitted in one of the following two ways
(please choose only one of the ways listed):
<bullet> Electronically at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Follow the
``Submit a comment'' instructions. If you are reading this document on
<a href="http://federalregister.gov">federalregister.gov</a>, you may use the green ``SUBMIT A PUBLIC COMMENT''
button beneath this rulemaking's title to submit a comment to the
<a href="http://regulations.gov">regulations.gov</a> docket.
<bullet> You may mail written comments to the following address:
Drug Enforcement Administration, Attn: DEA Federal Register
Representative/DPW, 8701 Morrissette Drive, Springfield, Virginia
22152. Mailed comments must be received by the close of the comment
period.
Do not include any personally identifiable information (such as
name, address, or other contact information) or confidential business
information that you do not want publicly disclosed. All comments are
public records; they are publicly displayed exactly as received, and
will not be deleted, modified, or redacted. Comments may be submitted
anonymously.
Follow the search instructions on <a href="https://www.regulations.gov">https://www.regulations.gov</a> to
view public comments.

FOR FURTHER INFORMATION CONTACT: Heather Achbach, Regulatory Drafting &
Policy Section, Diversion Control Division, Drug Enforcement
Administration; Telephone: (571) 776-3882.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

Please note that all comments received in response to this docket
are considered part of the public record. The Drug Enforcement
Administration (DEA) will make all comments available for public
inspection online at <a href="http://www.regulations.gov">http://www.regulations.gov</a>. Such information
includes personal or business identifiers (such as name, address, state
or federal identifiers, etc.) voluntarily submitted by the commenter.
Generally, all information voluntarily submitted by the commenter,
unless clearly marked as Confidential Information in the method
described below, will be publicly posted. Comments may be submitted
anonymously. The Freedom of Information Act applies to all comments
received.
Commenters submitting comments which include personal identifying
information (PII), confidential, or proprietary business information
that the commenter does not want made publicly available should submit
two copies of the comment. One copy must be marked ``CONTAINS
CONFIDENTIAL INFORMATION'' and should clearly identify all PII or
business information the commenter does not want to be made publicly
available, including any supplemental materials. DEA will review this
copy, including the claimed PII and confidential business information,
in its consideration of comments. The second copy should be marked ``TO
BE PUBLICLY POSTED'' and must have all

[[Page 29395]]

claimed confidential PII and business information already redacted. DEA
will post only the redacted comment on <a href="http://www.regulations.gov">http://www.regulations.gov</a> for
public inspection.
For easy reference, an electronic copy of this document and
supplemental information to this notice of proposed rulemaking are
available at <a href="http://www.regulations.gov">http://www.regulations.gov</a>.

Legal Authority

DEA implements and enforces the Controlled Substances Act (CSA)
which authorizes the Administrator of the DEA (by delegation from the
Attorney General) to promulgate rules and regulations that the
Administrator deems necessary and appropriate for the efficient
execution of the Administrator's functions. 21 U.S.C. 871(b). The CSA
also requires the Administrator to establish the aggregate production
quota (APQ) for each basic class of controlled substance listed in
schedules I and II and the assessment of annual needs (AAN) for three
list I chemicals annually. The APQ and AAN represent the total quantity
to be manufactured in the United States (U.S.) each calendar year to
provide for the estimated medical, scientific, research, and industrial
needs of the U.S., the lawful export requirements, and the
establishment and maintenance of reserve stocks. 21 U.S.C. 826(a). The
Administrator also is required to fix manufacturing quotas for
registered manufacturers of the same controlled substances. In fixing
those quotas, the Administrator is required to consider, among other
things, the manufacturer's current rate of disposal, the manufacturer's
production cycle, and the manufacturer's inventory position. 21 U.S.C.
826(c).

Background

In the August 2023 final rule ``Management of Quotas for Controlled
Substances and List I Chemicals,'' \1\ DEA revised its regulations to
align with the Agency's business practices and to reduce the potential
for diversion. That rule also moved a section of DEA's regulations to
aid in clarifying the procurement quota regulations. DEA acknowledges
the need for further clarification and now aims to add more
organization to the procurement and individual manufacturing quota
section of DEA's regulations.
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\1\ 88 FR 60117, August 31, 2023.
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Purpose

While the CSA requires DEA to consider production cycles in
establishing quotas, DEA currently has limited insight into
manufacturers' intended production calendars for the quota year. At
present, DEA obtains production cycle information irregularly from
individual manufacturers. Furthermore, while manufacturers currently
note on quota applications the amounts requested for domestic products
as opposed to products for export, DEA's quota subcategories do not
formally account for that distinction. The absence of a formalized
process for collecting this data makes it more difficult for DEA to
assess midyear whether quotas remain adequate to meet estimated
domestic needs. This restricts DEA's ability to help prevent drug
shortages by adjusting quota allotments based on manufacturers'
production timelines. Thus, this rule aims to implement two of the four
steps to increase manufacturer transparency and receive better data
regarding drug production cycles mentioned by the Agency in a November
2023 letter to manufacturers: (1) requiring drug manufacturers to
submit their anticipated production timelines for medications to DEA as
a part of their application for quota; and (2) specifying whether a
manufacturer's quota allotment is for the production of products for
the domestic market or export market.\2\
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\2\ Letter issued by the Administrator, November 1, 2023, Quota-
Shortages Letter.pdf (<a href="http://dea.gov">dea.gov</a>) <a href="https://www.dea.gov/sites/default/files/2023-11/Quota-Shortages%20Letter.pdf">https://www.dea.gov/sites/default/files/2023-11/Quota-Shortages%20Letter.pdf</a>.
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Through this Notice of Proposed Rulemaking (NPRM), DEA proposes to
require additional information to be submitted during the application
process for individual manufacturing quotas and procurement quotas for
controlled substances in schedules I and II and the list I chemicals.
In addition, DEA proposes to revise existing subcategories and add
additional subcategories to both the regulations and the relevant quota
applications. These changes would assist DEA in complying with its
statutory responsibilities in reviewing applications for individual
manufacturing quota and procurement quota. The provisions being
proposed in this rule will help DEA anticipate shortages in drugs
containing these controlled substances or manufactured using these
listed chemicals and will reduce related potential burdens on patients
by allowing DEA to adjust quotas more quickly. The structural changes
will provide a cohesive organization of the quota sections of the
regulations.

Subcategories

DEA formalized use-specific subcategories for individual
manufacturing and procurement quotas. These subcategories allow DEA to
avoid ``double counting'' legitimate needs as the material moves from
registrant to registrant, preventing an artificial increase in the
APQ.\3\ The current use-specific subcategories are:
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\3\ ``Management of Quotas for Controlled Substances and List I
Chemicals,'' 88 FR 60117, August 31, 2023.
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<bullet> Quota for Commercial Sale;
<bullet> Quota for Transfer;
<bullet> Quota for Product Development;
<bullet> Quota for Replacement; and
<bullet> Quota for Packaging/Repackaging and Labeling/Relabeling.
The use-specific subcategories help DEA achieve its key objective
for the quota system which is to track how much of a schedule I or II
controlled substance or list I chemical is available, ensuring that
there is sufficient material to provide for the estimated medical,
scientific, research, and industrial needs of the U.S., for lawful
export requirements, and for the establishment and maintenance of
reserve stocks. DEA now seeks to clearly delineate the amount of quota
needed to meet domestic needs and the amount needed for lawful exports.

Individual Manufacturing Quota and Procurement Quota

An individual manufacturing quota is the maximum quantity of a
schedule I or II controlled substance or list I chemical a bulk
manufacturer is authorized to manufacture in a calendar year.\4\ The
sum of all individual manufacturing quotas issued to bulk manufacturers
for a particular basic class of controlled substance in schedule I or
II or list I chemical must be less than or equal to the established APQ
for that basic class or AAN for that chemical, as established under 21
CFR 1303.11 and 1315.11. A bulk manufacturer may request, at any time
during the calendar year to which it applies, an adjustment in its
quota for a schedule I or II controlled substance or list I
chemical.\5\ DEA's determinations of individual manufacturing quota
amounts are informed by the relevant procurement quotas. Only DEA-
registered bulk manufacturers may apply for, and be issued, individual
manufacturing quotas.
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\4\ 21 CFR 1303.21 and 1315.21.
\5\ 21 CFR 1303.25(a), 1315.25(a).
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A procurement quota, in contrast, establishes the maximum quantity
of a schedule I or II controlled substance or

[[Page 29396]]

list I chemical a registrant is authorized to acquire in a calendar
year for the purpose of further manufacturing, which may include
manufacturing bulk controlled substances into dosage-forms, converting
a controlled substance into another schedule I or II controlled
substance (with corresponding individual manufacturing quota for that
new drug code), packaging, repackaging, labeling, and/or relabeling.\6\
The manufacturer must apply \7\ for a procurement quota using DEA Form
250. Finished dosage-form manufacturers, packagers, and labelers may
apply for procurement quota only.
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\6\ 21 U.S.C. 802(15); 21 CFR 1303.03(c) and 1315.30(b).
\7\ 21 CFR 1303.15(b) and 1315.32(a).
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In establishing manufacturing and procurement quotas, DEA is
required by the CSA to consider the manufacturer's production cycle. 21
U.S.C. 826(c). Historically and to date, DEA has received little data
about such production cycles. Even as manufacturing practices have
evolved, supply chains have become significantly more efficient, and
manufacturers have improved the data they use to create sales
forecasts, DEA has continued to receive the same types of data about
manufacturers' production cycles that DEA received in decades past. The
lack of more detailed information has made it difficult for DEA to have
accurate and timely visibility into the controlled substance supply
chain, preventing the agency from reacting with greater precision in
preventing drug shortages. To increase manufacturing transparency and
receive better data to inform DEA's quota determinations under the CSA,
DEA now seeks to require drug manufacturers to submit additional
information about their anticipated production cycles at the time of
application for quota. To achieve this, DEA is proposing to require
bulk manufacturers to provide certain information when applying for
individual manufacturing quota under proposed 21 CFR 1303.22(c) for
controlled substances and proposed 21 CFR 1315.22(c) for listed
chemicals. DEA likewise is proposing to require non-bulk manufacturers
to submit additional information when applying for procurement quota
under proposed 21 CFR 1303.14(b) for controlled substances and proposed
21 CFR 1315.32(b) for listed chemicals.

Discussion of Proposed Changes

Restructuring Regulations for Procurement Quota

Under DEA's ``Management of Quota for Controlled Substances and
List I Chemicals'' rulemaking,\8\ DEA relocated 21 CFR 1303.12 to 21
CFR 1303.15 but left all the phases of the procurement quota
application and determination process together in that section. In
contrast, in 21 CFR 1303.21 through 1303.27, DEA uses separate sections
and subsections for each phase in the individual manufacturing quota
process.
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\8\ 88 FR 60117, August 31, 2023.
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For controlled substances, DEA proposes to discuss the process of
applying for and granting procurement quotas in three sections: 21 CFR
1303.13, 1303.14, and 1303.15. To do so, DEA would move existing text.
This reconfiguration of text would add significant clarity and would
more closely mirror the organization of the regulations relating to
individual manufacturing quotas for controlled substances. DEA would
move the current 21 CFR 1303.13, relating to adjustments of APQs, to
the reserved 21 CFR 1303.12; move the current Procurement Quotas
heading to before 1303.13; move the current 1303.15(a) to 1303.13; move
1303.15(b) and (e) to a new section 1303.14 and break the current
1303.15(b) into six paragraphs; move the current 1303.15(c) and (f) up
to 1303.15(a) and (b), respectively; move the current 1303.15(d) to 21
CFR 1303.17; and move the current text of 1303.17 relating to
abandonment of procurement quotas to a new 21 CFR 1303.18.
For the listed chemicals, DEA proposes creating five new sections
for the procurement quota process. DEA would be moving paragraphs (f),
(h), and (i) of 21 CFR 1315.32 to 21 CFR 1315.35(a), (b), and (c),
respectively. In addition, DEA proposes to move 1315.32(g) to 21 CFR
1315.37. Last for the restructuring, DEA would move the current 21 CFR
1315.37 to 21 CFR 1315.38. DEA also would make appropriate changes to
the cross-references within these sections. These changes would allow
for the listed chemical procurement quota regulations to align with, as
best as possible, the procurement quota regulations for controlled
substances.
DEA is also proposing changes to current practices by requiring DEA
Form 250 and DEA Form 189 to be completed in the online Quota
Management System. DEA is proposing corresponding changes to eliminate
cross-references to the Table of DEA Mailing Addresses in 21 CFR
1321.01 that currently appear (for example in 21 CFR 1303.15, 1303.22,
1315.22, and 1315.32) and to eliminate the option of obtaining copies
of the application forms from DEA (as currently provided in 21 CFR
1303.22, 1315.22, and 1315.32).
In moving the current text of 21 CFR 1303.15(a) to the new 1303.13,
DEA is proposing a minor non-substantive change to more clearly reflect
that DEA's reference to the manufacturing of ``dosage forms or other
substances'' is merely an illustrative example of the types of
manufacturing that may be undertaken with, and that require, a
procurement quota. Procurement quota has always been required for the
acquisition of any schedule I or II controlled substance for the
purpose of any manufacturing after its initial bulk manufacture.\9\ In
addition, DEA is proposing other minor non-substantive revisions
including using gender neutral language and ensuring the word
``schedules'' is lowercase.
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\9\ ``The procurement quota form DEA 250 is required for dosage
form manufacturers, compound pharmacies, labelers/re-labelers, and
packagers/re-packagers.'' Quota Manual, <a href="https://www.deadiversion.usdoj.gov/quotas/quotas_userguide.pdf">https://www.deadiversion.usdoj.gov/quotas/quotas_userguide.pdf</a>.
``Manufacturers of Schedule I and II controlled substances'' and
``[m]anufacturers of the List I chemicals ephedrine,
pseudoephedrine, and phenylpropanolamine'' must apply for quota,
with no limitation with respect to the type of manufacturer. <a href="https://www.deadiversion.usdoj.gov/quotas/quota-apps.html">https://www.deadiversion.usdoj.gov/quotas/quota-apps.html</a>.
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Procurement Quota Application

DEA proposes to require non-bulk manufacturers to provide
additional information when applying for procurement quota under 21 CFR
1303.14(b) for controlled substances and under 21 CFR 1315.32(b) for
listed chemicals. Manufacturers would be required to provide this
additional information on the DEA Form 250. The specified information
would give DEA more insight into the manufacturer's production cycle
for that controlled substance. As noted above, the CSA requires DEA to
consider the manufacturer's production cycle in establishing quotas.
This information will provide DEA with a better understanding of when
the finished drug product will be estimated to enter the domestic
market or be exported. This will better allow DEA to assess midyear
whether quotas remain adequate to meet the estimated needs in the
United States and for lawful export requirements. That is, with
additional insight into the products that have yet to reach the
market--information that DEA currently lacks--DEA can more
comprehensively consider whether quotas need to be increased in order
to meet the CSA's directives. DEA also can utilize this information to
help prevent relevant drug shortages by adjusting quota allotments
based on manufacturers' timelines.

[[Page 29397]]

For each basic class or chemical (as applicable) desired to be
procured or used, the application would be required to include the
following information:
1. The length of time it will take to receive the controlled
substance or active pharmaceutical ingredient (API) after receiving the
quota letter from DEA pursuant to 21 CFR 1303.15 or 1315.35;
2. The supplier of the basic class or chemical, if obtaining it
from another registrant;
3. The length of time it will take to begin the production cycle
after receiving the controlled substance or chemical;
4. The estimated length of time it will take to perform the
production cycle; and
5. The length of time it will take for the applicant to ship the
finished goods to the next registrant in the supply chain after
production is complete.

Individual Manufacturing Quota Application

DEA similarly is proposing to require additional information from
bulk manufacturers when applying for individual manufacturing quota
under 21 CFR 1303.22(c) for the relevant controlled substances and
under 21 CFR 1315.22(c) for the relevant listed chemicals. The
requested additional information would be added to DEA Form 189 and
would require the manufacturer to be more transparent with DEA
regarding the production timeline. The information gained would provide
insight into the processing timeline in much the same way as it would
for procurement quota. Obtaining this information at the time of
application allows DEA to more quickly respond to any problems that
arise during the year and helps prevent possible drug shortages due to
lack of available API.
For each basic class or chemical (as applicable), the application
would be required to include the following information:
1. The desired individual manufacturing quota;
2. The length of time it will take to start the production cycle
after receiving the quota letter from DEA pursuant to 21 CFR 1303.21 or
1315.21;
3. The length of time it will take to perform the production cycle;
4. The length of time it will take for the applicant to ship the
finished goods to the next registrant in the supply chain after
production is complete; and
5. Any additional factors which the applicant finds relevant to the
fixing of the individual manufacturing quota, including the trend of
(and recent changes in) the applicant's and the national rates of net
disposal, the applicant's production cycle and current inventory
position, the economic and physical availability of raw materials for
use in manufacturing and for inventory purposes, yield and stability
problems, potential disruptions to production (including possible labor
strikes) and recent unforeseen emergencies such as floods and fires.

Use-Specific Subcategories for Domestic Use and Exportation

As noted above, DEA currently has limited insight into how much
quota will be utilized to manufacture API and finished products for
export as opposed to domestic use. Currently, the use-specific
subcategories of quota for commercial sale, product development, and
packaging/repackaging and labeling/relabeling do not distinguish
between quota utilized in the production of API or finished drug
products to be consumed domestically versus quota utilized in the
production of items to be exported.
To obtain this important data, DEA proposes to bifurcate these
subcategories. For example, ``Quota for Commercial Sale'' would be
separated into two further subcategories: ``Quota for Domestic
Commercial Sale,'' which would apply to quota used to manufacture API
or finished drug products that will remain in the U.S., and ``Quota for
Commercial Manufacturing for Export,'' which would apply to quota used
to manufacture API or finished drug products for lawful export
purposes. Similarly, ``Product Development'' would be separated further
into ``Quota for Domestic Product Development,'' which would apply to
quota used in the development of finished drug products that will
remain in the U.S., and ``Quota for Product Development for Export,''
which would apply to quota that will be used for the development of
finished drug products for lawful export purposes. Finally,
``Packaging/Repackaging and Labeling/Relabeling'' would be separated
further into ``Quota for Packaging/Labeling Domestic,'' which would
apply to quota used in the packaging/repackaging and labeling/
relabeling of API and/or finished products that will remain in the
U.S., and ``Quota for Packaging/Labeling for Export,'' which would
apply to quota that will be used in the packaging/repackaging and
labeling/relabeling of API and/or finished products for lawful export
purposes.
Specifically, DEA would add two further subcategories to the
current subcategory Quota for Commercial Sale in 21 CFR 1303.04(a) and
1315.07(a). The first further subcategory would be (1) ``Quota for
Domestic Commercial Sale'' to specify that this subcategory applies
when the quota being requested will be used for controlled substances
(or list I chemicals) that will be manufactured and distributed within
the U.S. The ``Quota for Commercial Manufacturing for Export'' category
would be subcategory (2) and would be used by a manufacturer if they
will export the item that they are manufacturing. That subcategory also
would be used if the manufacturer knows the item being manufactured
will be exported after some later manufacturing step performed by
another registered manufacturer. If the bulk and dosage form
manufacturers do not know whether the finished product will be
exported, but the manufacturer who is assigned to package/repackage or
label/relabel the finished product does know, the last manufacturer in
the supply chain will apply for ``Quota for Packaging/Labeling for
Export'' quota to reflect this information. However, registrants would
be required to provide correct and detailed information about the next
destination of the product.
Similarly, DEA would add two further subcategories to the current
subcategory Quota for Product Development in 21 CFR 1303.04(c) and
1315.07(c). The first further subcategory would be (1) ``Quota for
Domestic Product Development'' for quota used in the development of
finished drug products that will remain in the U.S. The ``Quota for
Product Development for Export'' category would be subcategory (2) and
would apply to quota that will be used for the development of finished
drug products where the approval and distribution will occur outside
the U.S. DEA likewise would add two further subcategories to the
current subcategory ``Quota for packaging/repackaging and labeling/
relabeling'' in 21 CFR 1303.04(e) and 1315.07(e). The first further
subcategory would be (1) ``Quota for Packaging/Labeling Domestic'' and
the ``Quota for Packaging/Labeling for Export'' category would be
subcategory (2) in the section.
These further subcategories would allow DEA to better track
material that is being utilized under the current ``Quota for
Commercial Sale,'' ``Quota for Product Development,'' and ``Quota for
Packaging/Repackaging and Labeling/Relabeling'' subcategories. This
would allow DEA to better execute its responsibility to establish
quotas to account for both the needs within the United States and for
lawful export requirements. This additional data also would allow DEA
to better anticipate how much of a drug is available for

[[Page 29398]]

legitimate domestic patient, industrial, scientific and research needs
as opposed to the needs of foreign markets.
DEA has decided that the existing subcategories for quotas for
transfer and replacement do not need to be revised to distinguish their
application between domestic use and export use. The amount necessary
for domestic use and export use is already accounted for in the quota
for commercial sale applications; therefore, bifurcating these two
categories would be redundant.
The domestic/export distinction would be applicable for controlled
substances and list I chemicals requiring a quota for manufacturing
purposes as defined in the CSA. While DEA is currently focused on the
manufacturing of drug products containing schedule II controlled
substances, for example medications used in the treatment of pain or
attention deficit/hyperactivity disorder as these medications are
important in healthcare, they need to be manufactured and consumed
responsibly. The aggregate production quotas for controlled substances
are affected by both legitimate domestic medical needs and exportation
to meet global requirements and therefore the submission of separate
detailed data will enhance DEA's visibility into production and the
supply chain.
In proposing these changes, DEA also proposes minor clarifying
changes in 21 CFR 1303.04(a) and (c) and 1315.07(c). Those sections
currently refer specifically to approval of drug products by the U.S.
Food and Drug Administration (FDA). DEA understands that manufacturers
in the U.S. may manufacture products that are authorized for marketing
in countries other than the U.S. To avoid any potential confusion, DEA
is proposing to expand the existing references to FDA approval to also
include approval or authorization by equivalent foreign regulatory
bodies. DEA views this as merely clarifying DEA's intent without
effecting any substantive change. Similarly, DEA proposes to revise the
text of 21 CFR 1303.04(a) and 1315.07(a), relating to quota for
commercial sale, to reflect that both apply to bulk API that is
produced by a registrant, in addition to API that is acquired by a
registrant. These changes clarify the manner in which the text applies
to individual manufacturing quotas. As these provisions have always
applied to individual manufacturing quotas, DEA does not view these
changes as substantive.

Regulatory Analysis

Executive Orders 12866, 13563, and 14192 (Regulatory Review)

DEA has determined that this rulemaking is not a ``significant
regulatory action'' under section 3(f) of Executive Order (E.O.) 12866,
Regulatory Planning and Review. Accordingly, this proposed rule has not
been submitted to the Office of Management and Budget (OMB) for review.
This proposed rule has been drafted and reviewed in accordance with
E.O. 12866, ``Regulatory Planning and Review,'' section 1(b),
Principles of Regulation; E.O. 13563, ``Improving Regulation and
Regulatory Review,'' section 1(b), General Principles of Regulation;
and E.O. 14192, ``Unleashing Prosperity Through Deregulation.''
DEA proposes to revise existing regulations that manage the quotas
for controlled substances and the list I chemicals, ephedrine,
pseudoephedrine, and phenylpropanolamine, held by DEA-registered
manufacturers. This rule is being proposed to: restructure DEA's
procurement quota regulations for more clarity and consistency, clarify
which subcategories for quotas should be used for controlled substances
that will be sold domestically and controlled substances that will be
exported, and revise the applications for individual manufacturing and
procurement quota. The changes are necessary to ensure clarity, provide
DEA with adequate information about manufacturing to help the agency
foresee and prevent both shortages and oversupply, and to ensure enough
of the schedule I and II controlled substances and three list I
chemicals can be manufactured to meet estimated scientific, medical,
lawful export, and inventory needs. Additionally, DEA proposes to
codify current practices by requiring DEA Form 250 and DEA Form 189 to
be completed online. This NPRM has been determined not to be a
significant regulatory action under E.O. 12866 with an estimated annual
cost of $50,496. This rule is not subject to E.O. 14192 because it is
not a significant regulatory action under section 3(f) of E.O. 12866.
This NPRM contains three types of changes. First, DEA proposes to
require non-bulk manufacturers to submit additional information online
on the DEA Form 250 to give DEA more insight into their procurement
process and their production cycle. Second, DEA proposes to require
bulk manufacturers to submit additional information online on the DEA
Form 189 to give DEA more insight into their production cycle. Third,
DEA proposes to revise the use-specific subcategories for procurement
and individual manufacturing quotas for controlled substances and
listed chemicals to help in the administration of these quotas. DEA
would add new further subcategories to DEA's regulations in 21 CFR
1303.04 for controlled substances and 21 CFR 1315.07 for listed
chemicals. The revised subcategories would allow for the continued
tracking of material being moved at all stages of manufacturing so that
DEA is able to anticipate how much of a drug is available in the U.S.
DEA has examined the benefits and costs of each provision of this
proposed rule and are as follows.
Benefits
This NPRM would expand upon previously implemented regulations by
requiring additional information from registrants applying for
individual manufacturing quotas and procurement quotas for controlled
substances in schedules I and II and the list I chemicals. In addition,
DEA would revise the subcategories in its regulations and the relevant
applications. The changes proposed in this NPRM would enable DEA to
receive better data on the manufacturer's anticipated drug production
cycles at the time the manufacturer applies for individual
manufacturing quota or procurement quota. The provisions being proposed
in this notice of proposed rulemaking will help DEA anticipate
shortages and reduce burdens on patients by allowing DEA to adjust more
quickly. Finally, codifying the current practice for completing DEA
Form 250 and DEA Form 189 online provides clarity and alignment between
practice and regulations.
Impact on Non-Bulk Manufacturer
As discussed above, DEA proposes to require additional information
from non-bulk manufacturers when applying for procurement quota under
21 CFR 1303.14(b) for controlled substances and under 21 CFR 1315.32(b)
for listed chemicals. The information would be added to DEA Form 250
and would require the manufacturer to give DEA more insight into their
production cycle timeline, including the timeline for procurement of
materials. Based on the estimated time to complete the current
application, DEA estimates an additional 20 minutes will be needed to
provide the additional information and minimal additional time to
complete the new use-specific subcategory for procurement quotas.

[[Page 29399]]

Impact on Bulk Manufacturer
As discussed above, DEA is proposing to require additional
information from bulk manufacturers when applying for individual
manufacturing quota under 21 CFR 1303.22(c) for controlled substances
and under 21 CFR 1315.22(c) for listed chemicals. For each basic class
or chemical (as applicable) desired to be synthesized or extracted, the
applicant would be required to include the additional information. The
information would be added to DEA Form 189 and would require the
manufacturer to be more transparent with DEA regarding the production
timeline. DEA estimates an additional 20 minutes will be needed to
provide the additional information and minimal additional time to
complete the new use-specific subcategory for individual manufacturing
quotas. The current practices are used as baseline for the purposes of
this analysis.
Costs
DEA estimates, under the proposed rule, there is a cost associated
with the estimated additional 20 minutes to complete DEA Form 189 and
250.
The U.S. Bureau of Labor Statistics (BLS) data indicates that the
median hourly wage for a purchasing manager is $63.15.\10\ According to
the BLS Employer Costs for Employee Compensation (ECEC), for private
industry workers, average total benefits is 29.4 percent and wages and
salaries is 70.6 percent of total compensation. The total benefits of
29.4 percent equate to a 41.6 (29.4/70.6) percent load on wages and
salaries.\11\ Adding the 41.6 percent load on the median salary, the
loaded median hourly wage for a purchasing manager is $89.42 ($63.15 x
1.416). Based on the estimated additional 20 minutes (0.33 hours) to
complete both DEA Forms 189 and 250, the estimated cost to a purchasing
manager is $29.81.
---------------------------------------------------------------------------

\10\ BLS, Occupational Employment and Wage Statistics, May 2022
National Occupational Employment and Wage Estimates, 11-3061
Purchasing Managers, <a href="https://www.bls.gov/oes/current/oes_nat.htm">https://www.bls.gov/oes/current/oes_nat.htm</a>.
(Accessed 11/15/2023.)
\11\ BLS, Employer costs for employee compensation--June 2023
<a href="https://www.bls.gov/news.release/pdf/ecec.pdf">https://www.bls.gov/news.release/pdf/ecec.pdf</a>. (Accessed 11/15/
2023.)
---------------------------------------------------------------------------

Number of Affected Persons
DEA estimated the number of affected persons based on the total
number of DEA Forms 189 and 250 received in 2022. In 2022, DEA received
875 DEA Forms 189 from 40 bulk manufacturers and 2,514 DEA Forms 250
from 291 non-bulk manufacturers and six bulk manufacturers. Table 1
summarizes the total number of affected registrants.

Table 1--Number of Affected Registrants
------------------------------------------------------------------------
Affected
Business activity registrants
------------------------------------------------------------------------
Bulk Manufacturer....................................... 40
Non-Bulk Manufacturer................................... 291
---------------
Total............................................... 331
------------------------------------------------------------------------

Applying the estimated cost of $29.81 per application to the 875
and 2,514 (6 from bulk and 2,508 from non-bulk manufacturers) Forms 189
and 250 received, DEA estimates the total cost of this proposed rule is
$101,026: $26,084 (875 x $29.81) for DEA Form 189 by bulk
manufacturers, $179 (6 x $29.81) for DEA Form 250 by bulk
manufacturers, and $74,763 (2,508 x $29.81) for DEA Form 250 by non-
bulk manufacturers. Table 2 summarizes the total cost burden of both
DEA Form 189 and 250 applications.

Table 2--Total Cost Burden
----------------------------------------------------------------------------------------------------------------
DEA Form 189 DEA Form 250
Business activity ($) ($) Total ($)
----------------------------------------------------------------------------------------------------------------
Bulk Manufacturers.............................................. 26,084 179 26,263
Non-Bulk Manufacturers.......................................... .............. 74,763 74,763
-----------------------------------------------
Total cost burden........................................... 26,084 74,763 101,026
----------------------------------------------------------------------------------------------------------------
* Numbers are rounded as shown.

As described earlier, the proposed change to require DEA Form 250
and DEA Form 180 to be completed online codifies current practices. All
such forms are already submitted to DEA online and meet the
requirements of the proposed change. Therefore, there is no cost
associated with this proposed change.
Executive Order 12988, Civil Justice Reform
The provisions of this regulation meet the applicable standards set
forth in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform,
to eliminate ambiguity, minimize litigation, provide a clear legal
standard for affected conduct, and promote simplification and burden
reduction.
Executive Order 13132, Federalism
This rulemaking does not have federalism implications warranting
the application of E.O. 13132. The rule does not have substantial
direct effects on the States, on the relationship between the national
government and the States, or the distribution of power and
responsibilities among the various levels of government.
Executive Order 13175, Consultation and Coordination With Indian Tribal
Governments
This rule does not have tribal implications warranting the
application of E.O. 13175. It does not have direct effects 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.
Executive Order 14267, Reducing Anti-Competitive Regulatory Barriers
The proposed rule does not reduce competition, entrepreneurship,
and innovation.
Executive Order 14294, Overcriminalization of Federal Regulations
Executive Order 14294 specifies that all notices of proposed
rulemaking (NPRMs) and final rules published in the Federal Register,
the violation of which may constitute criminal regulatory offenses,
should include a statement identifying that the rule or proposed rule
is a criminal regulatory offense, the authorizing statute, and the mens
rea requirement for each element of the offense. This NPRM does not
involve a criminal regulatory offense and thus E.O. 14294 does not
apply.

[[Page 29400]]

Regulatory Flexibility Act
The Administrator, in accordance with the Regulatory Flexibility
Act (RFA), has reviewed this proposed rule and by approving it,
certifies that it will not, if promulgated, have a significant economic
impact on a substantial number of small entities.
The RFA requires agencies to analyze options for regulatory relief
of small entities unless it can certify that this rule will not have a
significant impact on a substantial number of small entities. For the
purposes of the RFA, small entities include small businesses, nonprofit
organizations, and small governmental jurisdictions. DEA evaluated the
impact of this rule on small entities, and discussions of its findings
are below.
DEA is proposing to expand upon existing regulations by requiring
additional information be provided during the application process for
individual manufacturing quotas and procurement quotas for controlled
substances in schedules I and II and the three list I chemicals. In
addition, DEA proposes to revise its subcategories in its regulations
and the relevant applications for controlled substance and list I
chemical quotas. Finally, DEA is proposing to require DEA Form 250 and
DEA Form 189 to be completed online. The proposed change codifies
current practices as all such forms are already submitted to DEA online
and meet the requirements of the proposed change. Therefore, there is
no cost associated with this proposed change.
The provisions being proposed in this rule will help DEA execute
its functions as defined in 21 U.S.C. 826, will help DEA anticipate and
prevent shortages, and will help reduce burdens on patients by allowing
DEA to adjust more quickly. The structural changes will provide a
cohesive organization of the quota sections.
This proposed rule would, if implemented, affect bulk manufacturers
and non-bulk manufacturers who apply for individual manufacturing quota
and procurement quota. Based on a review of the North American Industry
Classification System (NAICS) codes for the best representation of
affected industries, DEA estimates that the proposed rule primarily
affects the following industries:\12\
---------------------------------------------------------------------------

\12\ Executive Office of the President, Office of Management and
Budget. ``North American Industry Classification System, United
States, 2017.'' <a href="https://www.census.gov/naics/">https://www.census.gov/naics/</a>. (Accessed 11/15/
2023.)
---------------------------------------------------------------------------

<bullet> 325411--Medicinal and Botanical Manufacturing.
<bullet> 325412--Pharmaceutical preparation Manufacturing.
Small Business Administration (SBA) size standards for 325411--
Medicinal and Botanical Manufacturing, 325412--Pharmaceutical
preparation Manufacturing are 1,000 and 1,250 employees,
respectively.\13\
---------------------------------------------------------------------------

\13\ SBA, ``Table of Small Business Size Standards Matched to
North American Industry Classification System Codes, Effective
August 19, 2019.''
---------------------------------------------------------------------------

The U.S. Census Bureau's Statistics of U.S. Businesses (SUSB) is an
annual series that provides economic data by enterprise size and
industry. SUSB data contains the number of firms for various employment
or revenue size ranges for each industry. Specifically, SUSB data
contains the number of firms by size ranges for each NAICS code. For
the purposes of this analysis, the term ``firm'' as defined in the SUSB
data is used interchangeably with ``entity'' as defined in the RFA.
Comparing the size ranges to the SBA size standards, DEA estimated the
number of entities in each affected industry, number of small entities
in each affected industry, and number of affected small entities. For
NAICS code 325411, there are 667 firms of which 635 are small firms.
For NAICS code 325412, there are 1,154 firms, of which 1,080 are small
firms.\14\
---------------------------------------------------------------------------

\14\ SUSB, 2020 SUSB Annual Data Tables by Establishment
Industry, 2020, Data by Enterprise Receipt Size, U.S. 2020 SUSB
Annual Data Tables by Establishment Industry (<a href="http://census.gov">census.gov</a>). (Accessed
11/15/2023)

Table 3--Number of Small Entities
--------------------------------------------------------------------------------------------------------------------------------------------------------
SBA size
standard
NAICS NAICS description Enterprise size Firms (number of Small firms
employees)
--------------------------------------------------------------------------------------------------------------------------------------------------------
325411................................... Medicinal and Botanical <500 employees............. 626 1,000 626
Manufacturing. 500-749 employees.......... 9 .............. 9
1,000-1,499 employees...... 3 ..............
2,000-2,499 employees...... 3 ..............
2,500-4,999 employees...... 10 ..............
5,000+ employees........... 12 ..............
----------------------------------------------------------------------------
Total..................... * 667 1,300 635
325412................................... Pharmaceutical Preparation <500 employees............. 1,041 1,041
Manufacturing. 500-749 employees.......... 22 .............. 22
750-999 employees.......... 10 10
1,000-1,499 employees...... 11 7
1,500-1,999 employees...... 10 ..............
2,000-2,499 employees...... 5 ..............
2,500-4,999 employees...... 16 ..............
5,000+ employees........... 39 ..............
----------------------------------------------------------------------------
Total..................... 1,154 1,080
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: 2020 SUSB Annual Data Tables by Establishment Industry, 2017, Data by Enterprise Receipt Size, U.S., 6-digit NAICS. (Accessed 11/20/2023)
* Sum of the line items do not equal the ``Total'' in the original.

DEA calculated the percent of firms that are small firms for each
industry, then applied these percentages to the number of affected
entities to estimate the number of affected small entities. Based on
the analysis above 95.2 percent (635/667) and 93.6 percent (1,080/
1,154) of entities in 325411 and 325412 are small firms, respectively.
Based on this analysis, DEA estimates 308 small entities would be
affected by this proposed rule, 38 (40 x 0.952) in the

[[Page 29401]]

325411--Medicinal and Botanical Manufacturing industry and 272 (291 x
0.936) in the 325412--Pharmaceutical preparation manufacturing
industry.
In summary, this proposed rule is estimated to affect 38 of 635
small entities in the 325411--Medicinal and Botanical Manufacturing
industry and 272 of 1,080 small entities in the 325412--Pharmaceutical
preparation manufacturing industry. Therefore, this proposed rule will
not affect a substantial number of small entities. Table 4 summarizes
the number of firms, small firms, and affected small entities for each
affected NAICS code.

Table 4--Small Firms, Affected Entities, and Affected Small Firms
----------------------------------------------------------------------------------------------------------------
Affected Affected Affected small
NAICS code Firms Small firms entities entities (%) entities
----------------------------------------------------------------------------------------------------------------
325411.......................... 663 635 40 95.8 38
325412.......................... 1,154 1,080 291 93.6 272
----------------------------------------------------------------------------------------------------------------

DEA also estimated the impact on small entities by comparing the
average cost of the rule to annual receipts on a `per entity' basis.
The estimated average cost of this proposed rule is $652 ($26,084/40)
and $257 ($74,763/291) for entities in 325411 and 325412, respectively.
Table 5 summarizes the average cost per entity.

Table 5--Average Cost Per Entity
------------------------------------------------------------------------
Bulk Non-bulk
manufacturer manufacturer
------------------------------------------------------------------------
Total cost burden....................... $26,084 $74,763
Number of entities...................... 40 291
Cost per entity......................... 652 257
------------------------------------------------------------------------

From 2017 SUSB data, the most recent year with receipts data, the
average annual receipts are lowest for the smallest of small entities,
with ``<5 employees,'' with average annual revenues of $689,768 and
$1,183,789 per entity, respectively.\15\ The average annual costs of
$652 and $257 are 0.095 percent ($652/$689,768) and 0.022 percent
($257/$1,183,789) for industries in 325411 and 325412, respectively. If
the impact is not significant for the smallest of small entities, the
impact is not significant for the larger small entities. Table 6
summarizes the impact on the smallest of small entities.
---------------------------------------------------------------------------

\15\ SUSB, The Number of Firms and Establishments, Employment,
Annual Payroll, and Receipts by State, Industry, and Enterprise
Employment Size: 2017, <a href="https://www2.census.gov/programs-surveys/susb/tables/2017/us_state_naics_detailedsizes_2017.xlsx">https://www2.census.gov/programs-surveys/susb/tables/2017/us_state_naics_detailedsizes_2017.xlsx</a>. (Accessed
11/20/2023.)

Table 6--Impact on smallest of small entities
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average cost
Receipts Average annual Average cost of average
NAICS code Enterprise size Firms ($1,000) receipts ($) per entity ($) annual receipt
(percent)
--------------------------------------------------------------------------------------------------------------------------------------------------------
325411.................................... <5 employees................ 142 97,947 689,768 652 0.095
325412.................................... <5 employees................ 331 391,834 1,183,789 257 0.022
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: SUSB, The Number of Firms and Establishments, Employment, Annual Payroll, and Receipts by State, Industry, and Enterprise Employment Size: 2017,
<a href="https://www2.census.gov/programs-surveys/susb/tables/2017/us_state_naics_detailedsizes_2017.xlsx">https://www2.census.gov/programs-surveys/susb/tables/2017/us_state_naics_detailedsizes_2017.xlsx</a>. (Accessed 11/20/2023.)

As discussed above, this proposed rule would affect 38 of 635 small
entities in NAICS 325411 and 272 of 1,080 entities in NAICS 325412.
Additionally, the economic impact of the proposed rule, as compared to
estimated annual receipts, is 0.095 and 0.022 percent for NAICS 325411
and 325412, respectively. Therefore, DEA estimates the proposed rule
will not have a significant economic impact on a substantial number of
small entities.
Unfunded Mandates Reform Act of 1995
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995,
2 U.S.C. 1501 et seq., DEA has determined that this action will not
result in 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 for inflation) in any
one year.'' Therefore, neither a Small Government Agency Plan nor any
other action is required under UMRA of 1995.
Paperwork Reduction Act of 1995
This proposed rule would modify existing collections of information
under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501-3521. DEA has
identified the following collections of information related to this
proposed rule: 1117-006 and 1117-0008. An agency may not conduct or
sponsor, and a person is not required to respond to a collection of
information unless it displays a valid OMB control number. Copies of
existing information collections approved by OMB may be

[[Page 29402]]

obtained at <a href="http://www.reginfo.gov/public/do/PRAMain">http://www.reginfo.gov/public/do/PRAMain</a>.
A. Collections of Information Associated with the Proposed Rule
1. Title: Application for Individual Manufacturing Quota for a
Basic Class of Controlled Substance and for Ephedrine, Pseudoephedrine,
and Phenylpropanolamine.
OMB Control Number: 1117-0006.
DEA Form Number: DEA-189.
DEA proposes modifying this application by requiring bulk
manufacturers to submit additional information on the form when
applying for individual manufacturing quota for controlled substances
and listed chemicals. While the current form is online, DEA is
proposing to eliminate the paper form making the form online only. The
applicant would also be required to provide the following:
(1) the desired individual manufacturing quota;
(2) the length of time it will take to start the production cycle
after receiving the quota letter from DEA pursuant to 21 CFR 1303.21
and 1315.21;
(3) the length of time it will take to complete the production
cycle;
(4) the length of time it will take for the applicant to ship the
finished goods to the next registrant in the supply chain after
production is complete; and
(5) any additional factors which the applicant finds relevant to
the fixing of his individual manufacturing quota, including the trend
of (and recent changes in) his and the national rates of net disposal,
his production cycle and current inventory position, the economic and
physical availability of raw materials for use in manufacturing and for
inventory purposes, yield and stability problems, potential disruptions
to production (including possible labor strikes) and recent unforeseen
emergencies such as floods and fires.
DEA is also proposing to bifurcate the current subcategories found
on the form for ``Quota for Commercial Sale,'' ``Quota for Product
Development,'' and ``Quota for packaging/repackaging and labeling/
relabeling.'' DEA proposes that ``Quota for Commercial Sale'' would be
separated into two further subcategories: ``Quota for Domestic
Commercial Sale,'' for quota to be used for controlled substances and
ephedrine, pseudoephedrine, and phenylpropanolamine products and bulk
API acquired by outsourcing facilities, manufacturers, etc. that will
be manufactured and distributed within the U.S., and ``Quota for
Commercial Manufacturing for Export,'' which would apply to quota used
to manufacture controlled substances and ephedrine, pseudoephedrine,
and phenylpropanolamine products and bulk API acquired by outsourcing
facilities, manufacturers, etc. for lawful export purposes. Similarly,
``Product Development'' would be separated further into ``Quota for
Domestic Product Development,'' and ``Quota for Product Development for
Export.'' Finally, ``Quota for packaging/repackaging and labeling/
relabeling'' would be separated further into ``Quota for Packaging/
Labeling Domestic,'' and ``Quota for Packaging/Labeling for Export.''
Like the other subcategories, these subcategories would be requested on
the existing online form.
DEA estimates the following number of respondents and burden
associated with this collection of information:
<bullet> Number of respondents: 40.
<bullet> Frequency of response: 21.88 annually (as needed,
calculated value).
<bullet> Number of responses: 875.
<bullet> Burden per response: 50 min.
<bullet> Total annual hour burden: 729 hours.
2. Title: Application for Procurement Quota for Controlled
Substances and for Ephedrine, Pseudoephedrine, and Phenylpropanolamine.
OMB Control Number: 1117-0008.
DEA Form Number: DEA-250.
DEA proposes modifying this application by requiring non-bulk
manufacturers to submit additional information on the form when
applying for procurement quota for controlled substances and listed
chemicals. While the current form is online, DEA is proposing to
eliminate the paper form making the form online only. Applicants would
be required to also provide the following for each basic class or
chemical (as applicable) desired to be procured or used for the next
calendar year:
(1) the length of time it will take to receive the controlled
substance or active pharmaceutical ingredient after receiving the quota
letter from DEA pursuant to 21 CFR 1303.15 and 1315.35;
(2) the supplier of the basic class or chemical, if obtaining it
from another registrant;
(3) the length of time it will take to start production after
receiving the controlled substance or chemical;
(4) the estimated length of time it will take to perform the
production cycle; and
(5) the length of time it will take for the applicant to ship the
finished goods to the next registrant in the supply chain after
production is complete.
DEA is also proposing to bifurcate the current subcategories found
on the form for ``Quota for Commercial Sale,'' ``Quota for Product
Development,'' and ``Quota for packaging/repackaging and labeling/
relabeling.'' DEA proposes that ``Quota for Commercial Sale'' would be
separated into two further subcategories: ``Quota for Domestic
Commercial Sale,'' for quota to be used for controlled substances and
ephedrine, pseudoephedrine, and phenylpropanolamine that will be
manufactured and distributed within the U.S., and ``Quota for
Commercial Manufacturing for Export,'' which would apply to quota used
to manufacture controlled substances and the three listed chemicals for
lawful export purposes. Similarly, ``Product Development'' would be
separated further into ``Quota for Domestic Product Development,'' and
``Quota for Product Development for Export.'' Finally, ``Quota for
packaging/repackaging and labeling/relabeling'' would be separated
further into ``Quota for Packaging/Labeling Domestic,'' and ``Quota for
Packaging/Labeling for Export.'' Like the other subcategories, these
subcategories would be requested on the existing online form.
DEA estimates the following number of respondents and burden
associated with this collection of information:
<bullet> Number of respondents: 291.
<bullet> Frequency of response: 8.64 annually (as needed,
calculated value).
<bullet> Number of responses: 2,514.
<bullet> Burden per response: 50 min.
<bullet> Total annual hour burden: 2,095 hours.
B. Request for Comments Regarding the Proposed Collections of
Information
Written comments and suggestions from the public and affected
entities concerning the proposed collections of information are
encouraged. Under the PRA, the DEA is required to provide a notice
regarding the proposed collections of information in the Federal
Register with the notice of proposed rulemaking and solicit public
comment. Pursuant to section 3506(c)(2) of the PRA (44 U.S.C.
3506(c)(2)), the DEA solicits comment on the following issues:
<bullet> Whether the proposed collection of information is
necessary for the proper performance of the functions of the DEA,
including whether the information will have practical utility.
<bullet> The accuracy of the DEA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used.
<bullet> Recommendations to enhance the quality, utility, and
clarity of the information to be collected.
<bullet> Recommendations to minimize the burden of the collection
of information

[[Page 29403]]

on those who are to respond, including through the use of automated
collection techniques or other forms of information technology.
All comments concerning collections of information under the
Paperwork Reduction Act must be submitted to the Office of Information
and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ,
Washington, DC 20503. Please state that your comments refer to RIN
1117-AB86/Docket No. DEA-1278. All comments must be submitted to OMB on
or before July 20, 2026. The final rule will respond to any OMB or
public comments on the information collection requirements contained in
this proposed rule.
If you need a copy of the proposed information collection
instrument(s) with instructions or additional information, please
contact the Regulatory Drafting and Policy Support Section (DPW),
Diversion Control Division, Drug Enforcement Administration; Mailing
Address: 8701 Morrissette Drive, Springfield, Virginia 22152;
Telephone: (571) 776-3882.

List of Subjects

21 CFR Part 1303

Administrative practice and procedure, Drug traffic control.

21 CFR Part 1315

Administrative practice and procedure, Chemicals, Drug traffic
control, Imports, Reporting and recordkeeping requirements.

For the reasons stated in the preamble, DEA proposes to amend 21
CFR parts 1303 and 1315 as follows:

PART 1303--QUOTAS

0
1. The authority citation for 21 CFR part 1303 continues to read as
follows:

Authority: 21 U.S.C. 821, 826, 871(b).

0
2. Revise Sec. 1303.04 to read as follows:

Sec. 1303.04 Subcategories of manufacturing and procurement quotas.

* * * * *
(a) Quota for commercial sale. This subcategory is divided into
Quota for Domestic Commercial Sale and Quota for Commercial
Manufacturing for Export. This is a quota for the amount of bulk active
pharmaceutical ingredients (API) initially produced or acquired by a
registrant for the manufacture of drug products approved by the U.S.
Food and Drug Administration or an equivalent foreign regulatory body,
and bulk API acquired by outsourcing facilities, manufacturers, etc.
This type of quota may only be used to support commercial manufacturing
efforts and may not be used to support other manufacturing efforts.
(1) Quota for domestic commercial sale. This quota category is used
to capture bulk API produced by a bulk manufacturer or moving from a
bulk manufacturer to other registered manufacturers to support
commercial manufacturing for the domestic market. This type of quota
may only be used to support commercial manufacturing efforts for the
domestic market and may not be used to support the manufacture of
products for export or other manufacturing efforts.
(2) Quota for commercial manufacturing for export. This is a quota
for the amount of bulk active pharmaceutical ingredients initially
produced by the bulk manufacturer or acquired by a registrant that will
be manufactured domestically to be exported to another country. This
type of quota may only be used to support commercial manufacturing for
export activities for the foreign market and may not be used to support
the manufacture of products for domestic use or other manufacturing
efforts. Such quotas are limited to the purpose of exportation.
* * * * *
(c) Quota for product development. This is a quota for the amount
of material needed for product development and validation of
manufacturing efforts. This quota is limited to that activity only and
only for the development efforts noted in the application; it shall not
be used or substituted for commercial production or the development of
a different product. This quota is issued with the understanding that
this material is not intended for commercial use, with the exception of
validation batches post-approval by the country's drug regulatory
agency. Validation batches shall be noted specifically in an
application and shall be considered product development material that
will be taken into account for net disposal once a product is approved
by the country's drug regulatory agency for commercial sale. No
inventory will be granted for these efforts, nor will replacement quota
be considered for destroyed material issued under this quota
subcategory. This subcategory is further divided into Quota for
Domestic Product Development and Quota for Product Development for
Export.
(1) Quota for domestic product development. This will apply to
quota used toward the development of finished drug products that will
remain in the U.S.
(2) Quota for product development for export. This will apply to
quota that will be used toward the development of finished drug
products where the approval and distribution will occur outside the
U.S.
* * * * *
(e) Quota for packaging/repackaging and labeling/relabeling. This
is the quota for the amount of material moved to a registrant to
undergo packaging and labeling activities. This quota is limited to
that activity only and only for the packaging/repackaging and labeling/
relabeling noted in the application; it may not be used or substituted
for commercial production. Packaging/repackaging and labeling/
relabeling quota is intended for tracking of controlled substances as
they undergo packaging/labeling activities; however, packaging/
repackaging and labeling/relabeling quotas shall not be counted against
the aggregate production quotas. This subcategory is further divided
into Quota for Packaging/Labeling Domestic and Quota for Packaging/
Labeling for Export, which also apply to repackaging and relabeling.
(1) Quota for packaging/labeling domestic. This would apply to
quota used in the packaging/repackaging and labeling/relabeling of API
and/or finished products that will remain in the U.S.
(2) Quota for packaging/labeling for export. This would apply to
quota that will be used in the packaging/repackaging and labeling/
relabeling of API and/or finished products for lawful export purposes.
0
3. Redesignate Sec. 1303.13 as Sec. 1303.12 and reserve the new Sec.
1303.13.
0
4. Move the undesignated center heading before Sec. 1303.15 to before
Sec. 1303.13.
0
5. Amend newly reserved Sec. 1303.13 by revising and republishing to
read as follows:

Sec. 1303.13 Procurement quotas.

In order to determine the estimated needs for, and to insure an
adequate and uninterrupted supply of, basic classes of controlled
substances listed in schedules I and II (except raw opium being
imported by the registrant pursuant to an import permit) the
Administrator shall issue procurement quotas authorizing persons to
procure and use quantities of each basic class of such substances for
the purpose of manufacturing, including manufacturing such class into
dosage forms or into other substances. The Administrator may establish
a procurement quota in terms of pharmaceutical dosage-forms prepared
from or containing the schedule I or II controlled substance, if they
determine it will assist in avoiding the

[[Page 29404]]

overproduction, shortages, or diversion of a controlled substance.
0
6. Add Sec. 1303.14 to read as follows:

Sec. 1303.14 Applications for procurement quotas.

(a) Any person who is registered to manufacture controlled
substances listed in any schedule and who desires to use during the
next calendar year any basic class of controlled substances listed in
schedule I or II (except raw opium being imported by the registrant
pursuant to an import permit) for purposes of manufacturing, shall
apply in the online Quota Management System on DEA Form 250 for
procurement quota and shall state separately for each subcategory, as
defined in 21 CFR 1303.04, each quantity of such basic class desired. A
separate application must be made for each basic class desired to be
procured or used, by filing an application electronically in the online
Quota Management System. DEA Form 250 shall be filed on or before April
1 of the year preceding the calendar year for which the procurement
quota is being applied.
(b) For each basic class desired to be procured or used for the
next calendar year, the applicant must provide the following
information:
(1) each purpose for which the basic class is desired, the quantity
desired for that purpose during the next calendar year, and the
quantities used and estimated to be used, if any, for that purpose
during the current and preceding 2 calendar years;
(2) whether the applicant intends to manufacture the basic class
themselves or obtain it from another registrant and, if obtaining it
from another registrant, the supplier's name;
(3) the length of time it will take to receive the controlled
substance after receiving the quota letter from DEA pursuant to Sec.
1303.15;
(4) the length of time it will take to start production after
receiving the controlled substance;
(5) the estimated length of time that it will take to perform their
portion of the production cycle; and
(6) for quota categories other than product development and
transfer, the length of time it will take for the applicant to ship the
finished goods to the next registrant in the supply chain after the
current registrant's production activity is complete.
(c) If the purpose is to manufacture the basic class into dosage
form, the applicant shall state the official name, common or usual
name, chemical name, or brand name of that form.
(d) If the purpose is to manufacture another substance, the
applicant shall state the official name, common or usual name, chemical
name, or brand name of the substance, and, if a controlled substance
listed in any schedule, the schedule number and Administration
Controlled Substances Code Number, as set forth in part 1308 of this
chapter, of the substance.
(e) If the purpose is to manufacture another basic class of
controlled substance listed in schedule I or II, the applicant shall
also state the quantity of the other basic class which the applicant
has applied to manufacture pursuant to Sec. 1303.22 and the quantity
of the first basic class necessary to manufacture a specified unit of
the second basic class.
(f) The Administrator may require additional information from an
applicant which, in the Administrator's judgment, may be helpful in
detecting or preventing diversion, including customer identities and
amounts of the controlled substance sold to each customer.
(g) The following persons need not obtain a procurement quota:
(1) Any person who is registered to manufacture a basic class of
controlled substance listed in schedule I or II and who uses all of the
quantity they manufactured in the manufacture of a substance not
controlled under the Act;
(2) Any person who is registered or authorized to conduct chemical
analysis with controlled substances (for controlled substances to be
used in such analysis only); and
(3) Any person who is registered to conduct research with a basic
class of controlled substance listed in schedule I or II and who is
authorized to manufacture a quantity of such class pursuant to Sec.
1301.13 of this chapter.
0
7. Revise and republish Sec. 1303.15 to read as follows:

Sec. 1303.15 Procedure for issuing and certifying available
procurement quota.

(a) The Administrator shall, on or before December 1 of the year
preceding the calendar year during which the quota shall be effective,
issue to each qualified applicant a procurement quota authorizing them
to procure and use:
(1) All quantities of such class necessary to manufacture all
quantities of other basic classes of controlled substances listed in
Schedules I and II which the applicant is authorized to manufacture
pursuant to Sec. 1303.23; and
(2) Such other quantities of such class as the applicant has
applied to procure and use and are consistent with their past use,
estimated needs, and the total quantity of such class that will be
produced.
(b) Any person to whom a procurement quota has been issued,
authorizing that person to procure and use a quantity of a basic class
of controlled substances listed in schedules I or II during the current
calendar year, shall, at or before the time of giving an order to
another manufacturer requiring the distribution of a quantity of such
basic class, certify in writing to such other registrant that the
quantity of such basic class ordered does not exceed the person's
unused and available procurement quota of such basic class for the
current calendar year. The written certification shall be executed by
the same individual who signed the DEA Form 222 transmitting the order.
A registrant shall not fill an order from persons required to apply for
a procurement quota under Sec. 1303.14 unless the order is accompanied
by a certification as required under this section. The certification
required by this section shall contain the following: The date of the
certification; the name and address of the registrant to whom the
certification is directed; a reference to the number of the DEA Form
222 to which the certification applies; the name of the person giving
the order to which the certification applies; the name of the basic
class specified in the DEA Form 222 to which the certification applies;
the appropriate schedule within which is listed the basic class
specified in the DEA Form 222 to which the certification applies; a
statement that the quantity (expressed in grams) of the basic class
specified in the DEA Form 222 to which the certification applies does
not exceed the unused and available procurement quota of such basic
class, issued to the person giving the order, for the current calendar
year; and the signature of the individual who signed the DEA Form 222
to which the certification applies.
0
8. Revise and republish Sec. 1303.17 to read as follows:

Sec. 1303.17 Adjusting procurement quotas.

Any person to whom a procurement quota has been issued may at any
time request an adjustment in the quota by applying to the
Administrator with a statement showing the need for the adjustment.
Such application shall be filed electronically with the UN Reporting
and Quota Section, Diversion Control Division, Drug Enforcement
Administration in the online Quota Management System. The Administrator
shall increase or decrease the procurement quota of such person if and
to the extent that the Administrator finds, after considering the
factors

[[Page 29405]]

enumerated in Sec. 1303.15(a) and any occurrences since the issuance
of the procurement quota, that the need justifies an adjustment.
0
9. Add Sec. 1303.18 to read as follows:

Sec. 1303.18 Abandonment of procurement quota.

Any manufacturer assigned a procurement quota for any basic class
of controlled substance listed in schedule I or II pursuant to Sec.
1303.15 may at any time abandon their right to manufacture all or any
part of such quota by filing a notice of such abandonment with the UN
Reporting and Quota Section, Diversion Control Division, Drug
Enforcement Administration in the online Quota Management System. The
Administrator may, in their discretion, allocate such amount among the
other manufacturers in proportion to their respective quotas.
0
10. Revise and republish Sec. 1303.22 to read as follows:

Sec. 1303.22 Procedure for applying for individual manufacturing
quotas.

(a) Any person who is registered to manufacture any basic class of
controlled substance listed in schedule I or II and who desires to
manufacture a quantity of such class shall apply in the online Quota
Management System on DEA Form 189 for a manufacturing quota and shall
state separately for each subcategory, as defined in Sec. 1303.04,
each quantity of such class desired. A separate application must be
made for each basic class desired to be manufactured by filing an
application electronically in the online Quota Management System. DEA
Form 189 shall be filed on or before May 1 of the year preceding the
calendar year for which the manufacturing quota is being applied.
(b) For the basic class desired to be manufactured the applicant
must provide the following information for each of the current and
preceding 2 calendar years:
(1) The authorized individual manufacturing quota, if any;
(2) The actual or estimated quantity manufactured;
(3) The actual or estimated net disposal;
(4) The actual or estimated inventory allowance pursuant to Sec.
1303.24; and
(5) The actual or estimated inventory as of December 31.
(c) For each basic class desired to be manufactured for the next
calendar year, the applicant must provide the following information:
(1) the desired individual manufacturing quota;
(2) the length of time it will take to start production after
receiving the quota letter from DEA pursuant to Sec. 1303.21;
(3) the length of time it will take to perform their portion of the
production cycle;
(4) the length of time it will take for the applicant to ship the
finished goods to the next registrant in the supply chain after the
current registrant's production activity is complete; and
(5) Any additional factors which the applicant finds relevant to
the fixing of the individual manufacturing quota, including any of the
following:
(i) The trend of (and recent changes in) the applicant's and the
national rates of net disposal.
(ii) The applicant's production cycle and current inventory
position.
(iii) The economic and physical availability of raw materials for
use in manufacturing and for inventory purposes.
(iv) Yield and stability problems.
(v) Potential disruptions to production (including possible labor
strikes).
(vi) Recent unforeseen emergencies such as floods and fires.
* * * * *

PART 1315--IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE,
PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE

0
11. The authority citation for part 1315 continues to read as follows:

Authority: 21 U.S.C. 802, 821, 826, 871(b), 952.

0
12. Revise Sec. 1315.07 to read as follows:

Sec. 1315.07 Subcategories of manufacturing and procurement quotas.

* * * * *
(a) Quota for commercial sale. This subcategory is divided into
Quota for Domestic Commercial Sale and Quota for Commercial
Manufacturing for Export. This quota is for the amount of bulk active
pharmaceutical ingredients (API) initially produced or acquired by a
registrant for the manufacture of ephedrine, pseudoephedrine, and
phenylpropanolamine products and bulk API acquired by outsourcing
facilities, manufacturers, etc. This type of quota shall only be used
to support commercial manufacturing efforts and shall not be used to
support other manufacturing efforts.
(1) Quota for domestic commercial sale. This quota category is used
to capture bulk API produced by a bulk manufacturer or moving from a
bulk manufacturer to other registered manufacturers to support
commercial manufacturing for the domestic market. This type of quota
may only be used to support commercial manufacturing efforts for the
domestic market and may not be used to support the manufacture of
products for export or other manufacturing efforts.
(2) Quota for commercial manufacturing for export. This is a quota
for the amount of bulk API initially produced by the bulk manufacturer
or acquired by a registrant that will be manufactured domestically to
be exported to another country. This type of quota may only be used to
support commercial manufacturing for export activities for the foreign
market and may not be used to support the manufacture of products for
domestic use or other manufacturing efforts. Such quotas are limited to
the purpose of exportation.
* * * * *
(c) Quota for product development. This is a quota for the amount
of material needed for product development and validation manufacturing
efforts. This quota is limited to that activity only and only for the
development efforts noted in the application; it shall not be used or
substituted for commercial production or the development of a different
product. This quota is issued with the understanding that this material
is not intended for commercial use, with the exception of validation
batches following approval by the country's drug regulatory agency or
authorization through compliance with an FDA OTC monograph (or its
equivalent in that country). Validation batches shall be noted
specifically in an application and shall be considered product
development material that will be taken into account once a product is
approved or otherwise authorized by the country's drug regulatory
agency for commercial sale. No inventory shall be granted for these
efforts, nor shall replacement quota be considered for destroyed
material issued under this quota subcategory. This subcategory is
further divided into Quota for Domestic Product Development and Quota
for Product Development for Export.
(1) Quota for domestic product development. This will apply to
quota used toward the development of finished drug products that will
remain in the U.S.
(2) Quota for product development for export. This will apply to
quota that will be used toward the development of finished drug
products where the approval and distribution will occur outside the
U.S.
* * * * *

[[Page 29406]]

(e) Quota for packaging/repackaging and labeling/relabeling. This
is quota for the amount of material moved to a registrant to undergo
packaging and labeling activities. This quota is limited to that
activity only and only for the packaging/repackaging and labeling/
relabeling noted in the application; it shall not be used or
substituted for commercial production or the packaging of a different
product. This subcategory is further divided into Quota for Packaging/
Labeling Domestic and Quota for Packaging/Labeling for Export, which
also apply to repackaging and relabeling.
(1) Quota for packaging/labeling domestic. This would apply to
quota used in the packaging/repackaging and labeling/relabeling of API
and/or finished products that will remain in the U.S.
(2) Quota for packaging/labeling for export. This would apply to
quota that will be used in the packaging/repackaging and labeling/
relabeling of API and/or finished products for lawful export purposes.
0
13. Revise and republish Sec. 1315.22 to read as follows:

Sec. 1315.22 Procedure for applying for individual manufacturing
quotas.

(a) Any person who is registered to manufacture ephedrine,
pseudoephedrine, or phenylpropanolamine and who desires to manufacture
a quantity of the chemical must apply in the online Quota Management
System on DEA Form 189 for a manufacturing quota for the quantity of
the chemical desired and shall state separately for each subcategory,
as defined in Sec. 1315.07, each quantity of such chemical. A separate
application must be made for each chemical desired to be manufactured
by filing an application electronically in the online Quota Management
System. DEA Form 189 must be filed on or before April 1 of the year
preceding the calendar year for which the manufacturing quota is being
applied.
(b) For each chemical desired to be manufactured the applicant must
provide the following information for each of the current and preceding
2 calendar years,:
(1) The authorized individual manufacturing quota, if any;
(2) The actual or estimated quantity manufactured;
(3) The actual or estimated net disposal;
(4) The actual or estimated inventory allowance pursuant to Sec.
1315.24; and
(5) The actual or estimated inventory as of December 31.
(c) For each chemical desired to be manufactured for the next
calendar year, the applicant must provide the following information:
(1) the desired individual manufacturing quota;
(2) the length of time that it will take to start production after
receiving the quota letter from DEA pursuant to Sec. 1315.21;
(3) the length of time it will take to perform their portion of the
production cycle;
(4) the length of time it will take for the applicant to ship the
finished goods to the next registrant in the supply chain after the
current registrant's production activity is complete; and
(5) Any additional factors that the applicant finds relevant to the
fixing of the individual manufacturing quota, including any of the
following:
(i) The trend of (and recent changes in) the applicant's and the
national rates of net disposal.
(ii) The applicant's production cycle and current inventory
position.
(iii) The economic and physical availability of raw materials for
use in manufacturing and for inventory purposes.
(iv) Yield and stability problems.
(v) Potential disruptions to production (including possible labor
strikes).
(vi) Recent unforeseen emergencies such as floods and fires.
0
14. Amend Sec. 1315.32 by revising and republishing paragraphs to read
as follows:

Sec. 1315.32 Obtaining a procurement quota.

(a) Any person who is registered to manufacture ephedrine,
pseudoephedrine, or phenylpropanolamine, or whose requirement of
registration is waived pursuant to Sec. 1309.24 of this chapter, and
who desires to use during the next calendar year any ephedrine,
pseudoephedrine, or phenylpropanolamine for purposes of manufacturing
(including repackaging or relabeling), must apply in the online Quota
Management System on DEA Form 250 for a procurement quota for the
chemical and shall state separately for each subcategory, as defined in
21 CFR 1315.07, each quantity of such chemical. A separate application
must be made for each chemical desired to be procured or used by filing
an application electronically in the online Quota Management System.
DEA Form 250 shall be filed on or before April 1 of the year preceding
the calendar year for which the procurement quota is being applied.
(b) The applicant must state separately all of the following:
(1) Each purpose for which the chemical is desired;
(2) The quantity desired for each purpose during the next calendar
year;
(3) The length of time applicant expects it will take to receive
the active pharmaceutical ingredient after receiving the quota letter
from DEA pursuant to Sec. 1315.35;
(4) The supplier of the chemical;
(5) The length of time it will take to start production after
receiving the chemical;
(6) The estimated length of time it will take to perform their
portion of the production cycle;
(7) The length of time it will take for the applicant to ship the
finished goods to the next registrant in the supply chain after the
current registrant's production activity is complete;
(8) The quantities used and estimated to be used, if any, for that
purpose during the current and preceding 2 calendar years;
(9) If the purpose is to manufacture the chemical into dosage form,
the applicant must state the official name, common or usual name,
chemical name, or brand name of that form. If the dosage form produced
is a controlled substance listed in any schedule, the applicant must
also state the schedule number and National Drug Code Number, of the
substance; and
(10) If the purpose is to manufacture another chemical, the
applicant must state the official name, common or usual name, chemical
name, or brand name of the substance and the DEA Chemical Code Number,
as set forth in part 1310 of this chapter.
0
15. Add Sec. 1315.35 to read as follows:

Sec. 1315.35 Issuing and certifying available procurement quota.

[[Page 29407]]

the time of placing an order with another registrant requiring the
distribution of a quantity of the chemical, certify in writing to the
other registrant that the quantity of ephedrine, pseudoephedrine, or
phenylpropanolamine ordered does not exceed the person's unused and
available procurement quota of the chemical for the current calendar
year. The written certification must be executed by a person authorized
to sign the registration application pursuant to Sec. 1301.13 or Sec.
1309.32(g) of this chapter or by a person granted power of attorney
under Sec. 1315.33 to sign the certifications. A copy of such
certification must be retained by the person procuring the quantity of
ephedrine, pseudoephedrine, or phenylpropanolamine for two years from
the date of the certification. Registrants must not fill an order from
persons required to apply for a procurement quota under Sec. 1315.32
unless the order is accompanied by a certification as required under
this section.
(c) The certification required by paragraph (b) of this section
must contain all of the following:
(1) The date of the certification.
(2) The name and address of the registrant to whom the
certification is directed.
(3) A reference to the purchase order number to which the
certification applies.
(4) The name of the person giving the order to which the
certification applies.
(5) The name of the chemical to which the certification applies.
(6) A statement that the quantity (expressed in grams) of the
chemical to which the certification applies does not exceed the unused
and available procurement quota of the chemical, issued to the person
giving the order, for the current calendar year.
(7) The signature of the individual authorized to sign a
certification as provided in paragraph (b) of this section.
0
16. Revise and republish Sec. 1315.37 to read as follows:

Sec. 1315.37 Adjustment of procurement quota.

Any person to whom a procurement quota has been issued may at any
time request an adjustment in the quota by applying to the
Administrator with a statement showing the need for the adjustment. The
application must be filed with the UN Reporting & Quota Section,
Diversion Control Division, Drug Enforcement Administration in the
online Quota Management System. The Administrator shall increase or
decrease the procurement quota of the person if and to the extent that
the Administrator finds, after considering the factors enumerated in
Sec. 1315.35(a) and any occurrences since the issuance of the
procurement quota, that the need justifies an adjustment.
0
17. Add Sec. 1315.38 to read as follows:

Sec. 1315.38 Abandonment of procurement quota.

Any manufacturer assigned a procurement quota for a chemical
pursuant to Sec. 1315.35 may at any time abandon their right to
manufacture all or any part of such quota by filing a notice of such
abandonment with the UN Reporting and Quota Section, Diversion Control
Division, Drug Enforcement Administration in the online Quota
Management System. The Administrator may, in their discretion, allocate
the amount among the other manufacturers in proportion to their
respective quotas.

Signing Authority

This document of the Drug Enforcement Administration was signed on
May 15, 2026, by DEA Administrator Terrance C. Cole. 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.

Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2026-10128 Filed 5-19-26; 8:45 am]
BILLING CODE 4410-09-P

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