[Federal Register Volume 87, Number 69 (Monday, April 11, 2022)]
[Rules and Regulations]
[Pages 21019-21023]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-07570]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1301, 1309, and 1321

[Docket No. DEA-587]
RIN 1117-AB58


Requiring Online Submission of Applications for and Renewals of 
DEA Registration

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: This rulemaking amends the Drug Enforcement Administration's 
(DEA) regulations to now require all applications for DEA 
registrations, and renewal of those registrations, to be submitted 
online.

DATES: This final rule is effective May 11, 2022.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, VA 22152, Telephone: (571) 776-2265.

SUPPLEMENTARY INFORMATION:

Legal Authority

    The Drug Enforcement Administration (DEA) has the legal authority 
to amend its regulations to require online applications pursuant to the 
Controlled Substances Act (CSA). The CSA grants the Attorney General 
authority to promulgate rules and regulations relating to: The 
registration and control of the manufacture, distribution, and 
dispensing of controlled substances and listed chemicals; reporting 
changes to professional or business addresses; and the efficient 
execution of his statutory functions. 21 U.S.C. 821, 822(a), 827(h), 
871(b), 957(a). The Attorney General is further authorized by the CSA 
to promulgate rules and regulations relating to the registration and 
control of importers and exporters of controlled substances and listed 
chemicals. 21 U.S.C. 958(f). The Attorney General has delegated this 
authority to the Administrator of DEA. 28 CFR 0.100(b).

Need for Regulatory Changes

    Regulatory changes are needed to modernize DEA's approach to 
registration and renewal applications. The proposed changes require 
online submission and eliminate inefficient paper applications. 
Typographical errors or missing pieces of information routinely 
resulted in delayed or rejected applications. DEA has determined the

[[Page 21020]]

online application process will prove more efficient and effective for 
both DEA and registrants.

Purpose of the Rule

    This rule mitigates issues created by paper applications by 
simplifying the process by which registrants submit new applications 
for registration, or renew current registrations. Previously, DEA 
regulations permitted the aforementioned DEA Registration Forms (224/
224a, 225/225a, 363/363a, and 510/510a) to be submitted either through 
a secure online portal or via delivery to DEA Headquarters.\1\ This 
rule amends DEA regulations by requiring all registration and renewal 
applications be submitted only through the secure online portal. The 
Administration believes this rule will mitigate some of the issues 
associated with paper applications by reducing inefficiencies and 
facilitating the application process. After careful consideration, DEA 
has determined that it is not necessary to amend the proposed 
regulations related to batch processing, because the regulations 
currently allow, and will continue to allow, the submission of batch 
applications. This rule is consistent with agency-wide efforts to 
reduce reliance on antiquated paper submissions and to facilitate 
electronic document processing.\2\
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    \1\ https://www.deadiversion.usdoj.gov/drugreg/index.html#regapps.
    \2\ See Reporting of Theft or Significant Loss of Controlled 
Substances, 85 FR 45547 (July 29, 2020) (published notice of 
proposed rulemaking proposing to require all DEA Form 106's to be 
submitted electronically); see Suspicious Orders of Controlled 
Substances, 85 FR 69282 (Nov. 2, 2020) (published notice of proposed 
rulemaking proposing centralized electronic reporting for Suspicious 
Orders Report System (SORS) based on Congressional mandate); see 
Agency Rule List--Fall 2021 (2021), https://www.reginfo.gov/public/do/eAgendaMain?operation=OPERATION_GET_AGENCY_RULE_LIST&currentPub=true&agencyCode=&showStage=active&agencyCd=1100&csrf_token=F19C7C599C70B80C228EC16B60AEB150F6339AF3C80E56FE003EEB7D3A758895BC8E16A215E8A0466326EBFBA8639F799E09 (Fall 2021 Unified Agenda of Regulatory and 
Deregulatory Actions, Active Regulatory Actions Listed By Agency, 
Agency Rule list noting proposed rule stage for Electronic 
Submission of DEA Form 41 (Registrant Record of Controlled 
Substances Destroyed)--1117-AB59).
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Summary of Changes

    This rule amends DEA regulations by revising current sections to 
clarify how registrants must apply, by adding new instructions, and by 
removing obsolete instructions. The rule amends existing DEA 
regulations in seven sections.\3\ Title 21 CFR 1301.13 and 1301.14 are 
amended to remove the option to submit paper forms and provide 
instructions for online application and payment instructions. This rule 
also amends Sec.  1301.14 (b), which will become obsolete with the 
adoption of the secure application portal. Section 1309.12 is amended 
to specify which payment options DEA will accept now that paper 
applications are no longer accepted. Section 1309.32 removes the option 
to submit paper forms and provides instructions for online applications 
and payments for listed chemical handlers. Section 1309.33 clarifies 
the online application and payment process while removing paragraph 
(b), which will become obsolete with the secure application portal. 
Section 1309.34 is also amended to clarify the handling of defective 
applications. Section 1321.01 is amended to remove reference to 
submitting paper forms by mail to any DEA Registration Unit address.
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    \3\ 21 CFR 1301.13, 1301.14, 1309.12, 1309.32, 1309.33, 1309.34, 
and 1321.01.
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    This rule affects DEA Forms relating to applications for 
registration and renewal of registrations, namely DEA Forms 224, 224a, 
225, 225a, 363, 363a, 510, and 510a. DEA Form 224 applies to new 
registration applications for practitioners, hospitals and clinics, 
retail pharmacies, online pharmacies, central fill pharmacies, and 
teaching institutions.\4\ DEA Form 225 applies to new registration 
applications for manufacturers, distributors, researchers, canine 
handlers, analytical laboratories, importers, and exporters.\5\ DEA 
Form 363 applies to new registration applications for narcotic 
treatment programs.\6\ DEA Form 510 applies to new registration 
applications for all domestic handlers of List I chemicals .\7\ DEA 
Forms 224a, 225a, 363a, and 510a address registration renewal 
applications.\8\
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    \4\ 21 CFR 1301.13(e)(1)(iv).
    \5\ 21 CFR 1301.13(e)(1)(1)(i)-(iii), (v)-(vi), and (viii)-(x).
    \6\ 21 CFR 1301.13(e)(1)(vii).
    \7\ 21 CFR 1309.21.
    \8\ 21 CFR 1301.13(e)(1) and 1309.21.
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Discussion of Comments

Introduction

    On January 7, 2021, DEA published a notice of proposed rulemaking 
(``NPRM'') that proposed requiring that all applications for DEA 
registrations, and renewal of those registrations, be submitted online. 
86 FR 1030 (Jan. 7, 2021). DEA received four comments from the public 
on this NPRM, three from individuals and one from the National 
Association of Chain Drug Stores (NACDS). After closely analyzing each 
comment, DEA is promulgating this rule as proposed in the NPRM with one 
exception: DEA is clarifying that Automated Clearing House (ACH) fund 
transfers will be accepted as payment for registrations and renewals.

Comment From National Association of Chain Drug Stores

    DEA received a comment from NACDS on March 8, 2021, about problems 
that may arise once paper applications and payments are no longer 
accepted. In particular, NACDS expressed concern about ambiguity 
surrounding whether DEA will accept ``batch'' renewals, whether the 
whole batch will be denied if one application is denied, and whether 
alternative payment options will be accepted. DEA has reviewed these 
comments and revised Sec.  1309.12(b) to specify that ACH funds 
transfer will be accepted as a payment option, in addition to credit 
cards and other forms of payment that may become available.
    First, NACDS observed that DEA neither proposes to modify nor to 
address ``batch'' submissions, a process by which companies seek to 
renew their registrations for multiple locations with a single packet 
covering a number of DEA registrations and licenses. The packet usually 
contains a single signed affidavit as well as a single payment. NACDS 
believes this process allows corporations to manage the licensing and 
registration process of thousands of sites efficiently. Thus, NACDS 
expressed its desire that DEA continue to permit registrants to submit 
batch applications.
    NACDS argued, and DEA agrees, that this process streamlines the 
renewal process for both companies and DEA. Accordingly, DEA's online 
portal will accept online batch applications and single payments for 
batch renewals. After careful consideration, however, DEA has 
determined that it is not necessary to amend the proposed regulations 
on this point.
    Next, NACDS asserted that, ``[c]larity is needed regarding the 
rejection of an application submitted in a batch submission.'' In 
particular, NACDS argued it is unclear whether individual applications 
in a batch could be rejected, or whether a single faulty application 
would cause its entire batch to be rejected. NACDS therefore proposes 
that DEA create an electronic means for registrants to correct issues 
with individual applications in a batch, rather than having to resubmit 
a batch or otherwise inhibit the application process.
    Amending DEA regulations is unnecessary, as this comment displays a 
fundamental misunderstanding of the online application process itself. 
Step

[[Page 21021]]

one of this process involves inputting all necessary information and 
attaching all relevant documents. Step two involves an internal 
automated verification process through which DEA's system analyzes all 
information submitted and determines if an application is complete. 
Only completed applications actually are processed, including for 
payment. Since this process ensures that applicants will not be able to 
submit incomplete applications, NACDS' concern that entire batches 
could be rejected based on individual application deficiencies is moot.
    Last, NACDS noted that in Sec.  1309.12(b), the only payment option 
listed is ``credit card.'' NACDS thus assumed that the only form of 
payment DEA accepts is a credit card. NACDS noted that this would be 
troublesome for payments made in batch renewals (which can cost in 
excess of $1 million), as strict corporate policies and procedures 
often demand that large financial transactions be conducted via 
certified bank check.
    DEA understands and appreciates the concerns expressed by NACDS, 
and has therefore amended Sec.  1309.12(b) to provide that payment 
shall be made online by Automated Clearing House (ACH) funds transfer, 
by credit card, or by any other means made available at the time of 
submission using the secure application portal at 
www.DEAdiversion.usdoj.gov. DEA recognizes that some companies may be 
required to alter their payment methods based on this rule change, as 
bank checks may be the most convenient option for some registrants. DEA 
believes, however, that the expansion of this rule to permit ACH 
transfers will mitigate many of the issues typically surrounding the 
financial, procedural, or security concerns for applicants. On balance, 
DEA also believes that this regulation change will promote the policy 
of increasing efficiency while maintaining a convenient payment 
process. In keeping with its broader policy of reducing reliance on 
tangible forms of payment, DEA will not accept bank checks for the 
foreseeable future.

Other Comments

    One commenter supported the proposed amendments, stating the rule 
would be beneficial given the utilization of modern technology to 
submit documents electronically, as is common among other agencies. 
Moreover, the commenter noted that processes that were traditionally 
done via mail, such as fingerprints and verification of payment, can 
easily be verified and submitted electronically. Last, the commenter 
noted that the rule would be beneficial given the ``current situation 
and restrictions given in-person interaction.''
    Another commenter supported the rule as a ``good change for the 
DEA,'' noting that it will prove better for the environment, more 
efficient, and that ``online is the future.'' The commenter does note, 
however, that there is a privacy concern given the potential for this 
information to be accessed via hacking. DEA routinely evaluates the 
security mechanisms of all of its electronic processes, and expends 
considerable time and resources to protect the privacy of all 
registrants and applicants.
    Last, one citizen requested information as to where to locate DEA 
Form 225. Given the nature of the rulemaking process, DEA considers 
this comment to be a mistake, but nevertheless refers the commenter to 
www.deadiversion.usdoj.gov for further information.
    DEA has reviewed closely all comments, and decided to promulgate 
the regulations as written with the exception of permitting ACH funds 
transfers as a payment option. DEA appreciates the public's 
participation in the rulemaking process, and encourages the public to 
continue submitting comments in the future for all proposed rules.

Regulatory Analyses

Executive Orders 12866, 13563, Regulatory Planning and Review, and 
Improving Regulation and Regulatory Review

    This rule was promulgated in accordance with the principles of 
Executive Orders (E.O.) 12866 and 13563. E.O. 12866 directs agencies to 
assess all costs and benefits of available regulatory alternatives and, 
if regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, environmental, 
public health, and safety effects; distributive impacts; and equity). 
E.O. 13563 is supplemental to and reaffirms the principles, structures, 
and definitions governing regulatory review established in E.O. 12866.
    E.O. 12866 classifies a ``significant regulatory action,'' 
requiring review by the Office of Management and Budget (OMB), as any 
regulatory action that is likely to result in a rule that may: (1) Have 
an annual effect on the economy of $100 million or more or adversely 
affect in a material way the economy, a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or State, local, or tribal governments or communities; (2) 
create a serious inconsistency or otherwise interfere with an action 
taken or planned by another agency; (3) materially alter the budgetary 
impact of entitlements, grants, user fees, or loan programs or the 
rights and obligations of recipients thereof; or (4) raise novel legal 
or policy issues arising out of legal mandates, the President's 
priorities, or the principles set forth in the E.O.
    This final rule implements all of the changes discussed in the 
NPRM, and thus imposes no additional costs on registrants. OMB has 
determined that this final rule is not a ``significant regulatory 
action'' under E.O. 12866, section 3(f), Regulatory Planning and 
Review, and accordingly this rule has not been reviewed by OMB.

Executive Order 12988, Civil Justice Reform

    This rule meets 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, establish clear legal standards, and reduce 
burdens. DEA expects the instant validation of online registration 
applications to reduce ambiguity and reduce the number of errors in 
submissions and reduce burdens on both DEA and registrants.

Executive Order 13132, Federalism

    This rule 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 on the distribution of power and 
responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    The rule does not have substantial 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.

Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) requires an agency to analyze 
options for regulatory relief of small entities unless it can certify 
that the rule will not have a significant impact on substantial number 
of small entities. DEA has analyzed the economic impact of each 
provision of this rule and estimates that it will have minimal economic 
impact on affected entities, including small businesses, nonprofit

[[Page 21022]]

organizations, and small governmental jurisdictions.
    In accordance with the RFA, DEA reviewed the economic impact of 
this rule on small entities and evaluated the impact in the NPRM. DEA's 
economic impact evaluation indicated that the rule proposed in the NPRM 
would not have a significant economic impact on a substantial number of 
small entities. This conclusion applies equally to the final rule, 
which implements all of the changes discussed in the NPRM.

Unfunded Mandates Reform Act of 1995

    In accordance with the Unfunded Mandates Reform Act of 1995 
(UMRA),\9\ 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 annually for inflation) in any 1 year.'' 
Therefore, neither a Small Government Agency Plan nor any other action 
is required under the UMRA.
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    \9\ 2 U.S.C. 1501, et seq.
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Paperwork Reduction Act

    This rule modifies existing collection(s) of information required 
under the Paperwork Reduction Act (PRA).\10\ Pursuant to the PRA,\11\ 
DEA has identified the collections of information below related to this 
rule. A person is not required to respond to a collection of 
information unless it displays a valid OMB control number.\12\
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    \10\ 44 U.S.C. 3501-3521.
    \11\ 44 U.S.C. 3507(d).
    \12\ Copies of existing information collections approved by OMB 
may be obtained at https://www.reginfo.gov/public/do/PRAMain.
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    DEA is amending its regulations for all new and renewal 
registration applications to implement the requirement of online 
submission through the DEA Diversion Control Division website. This 
amendment will improve the submission process by aligning it with the 
Administration's current requirements for other online form 
submissions. The online submission of DEA Forms 224/224a, 225/225a, 
363/363a, 510/510a are now filed with DEA through the DEA Diversion 
Control Division secure network (available on the DEA Diversion Control 
Division website). The online submission of new and renewal 
applications will ensure the Administration's receipt of applications 
in a more timely and organized manner.
    DEA solicited comments from the public regarding the following:
     Whether the proposed collection of information is 
necessary for the proper performance of the functions of DEA, including 
whether the information will have practical utility.
     The accuracy of DEA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used.
     Recommendations to enhance the quality, utility, and 
clarity of the information to be collected.
     Recommendations to minimize the burden of the collection 
of information on those who are to respond, including through the use 
of automated collection techniques or other forms of information 
technology.
    DEA solicited comments on the aforementioned subjects and received 
no comments. As a result, DEA is finalizing the collection with no 
changes.

Congressional Review Act

    This rulemaking is a ``rule'' pursuant to the Congressional Review 
Act, 5 U.S.C. 801 et seq.\13\ This rulemaking is not a ``major rule'' 
as it does not have an annual effect on the economy of over 100 million 
dollars, constitute a major increase in cost for registrants, nor does 
it have significant adverse effects on the United States domestic or 
foreign economy.\14\ DEA will submit a copy of this final rule to both 
Houses of Congress and to the Comptroller General.
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    \13\ 5 U.S.C. 804(3); see 5 U.S.C. 551(4).
    \14\ 5 U.S.C. 804(2)(A)-(C).
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List of Subjects

21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Security measures.

21 CFR Part 1309

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Security measures.

21 CFR Part 1321

    Administrative practice and procedure.

    For the reasons stated in the preamble, DEA amends 21 CFR parts 
1301, 1309, and 1321 as follows:

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1301 continues to read as follows:

    Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 
886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.

0
2. Amend Sec.  1301.13 by revising paragraphs (e)(2) and (3) to read as 
follows:


Sec.  1301.13  Application for registration; time for application; 
expiration date; registration for independent activities; application 
forms, fees, contents and signature; coincident activities.

* * * * *
    (e) * * *
    (2) DEA Forms 224, 225, and 363 may be obtained online at 
www.DEAdiversion.usdoj.gov. Only applications submitted online through 
the secure application portal on DEA's website will be accepted for 
processing.
    (3) DEA will send renewal notifications via email to registrants 
approximately 60 calendar days prior to their registration expiration 
date. Registrants are responsible for maintaining a current email 
address in application portal on DEA's website. DEA Forms 224a, 225a, 
and 363a may be obtained online at www.DEAdiversion.usdoj.gov. Only 
renewal applications submitted online through the secure application 
portal on DEA's website will be accepted for processing.
* * * * *

0
3. Amend Sec.  1301.14 by:
0
a. Revising paragraph (a);
0
b. Removing paragraph (b);
0
c. Redesignating paragraphs (c) and (d) as paragraphs (b) and (c); and
0
d. Revising newly redesignated paragraph (b).
    The revisions read as follows:


Sec.  1301.14  Filing of application; acceptance for filing; defective 
applications.

    (a) All applications for registration shall be submitted for filing 
online using the secure application portal at 
www.DEAdiversion.usdoj.gov.
    (b) Application submitted for filing are dated by the system upon 
receipt. If found to be complete, the application will be accepted for 
filing. Applications failing to comply with the requirements of this 
part will be rejected by the system, with the applicate receiving error 
messages at the time of application.
* * * * *

PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS 
AND EXPORTERS OF LIST I CHEMICALS

0
4. The authority citation for part 1309 continues to read as follows:

    Authority: 21 U.S.C. 802, 821, 822, 823, 824, 830, 871(b), 875, 
877, 886a, 952, 953, 957, 958.

0
5. Revise Sec.  1309.12 to read as follows:

[[Page 21023]]

Sec.  1309.12  Time and method of payment; refund.

    (a) For each application for registration or reregistration to 
manufacture, distribute, import, or export the applicant shall pay the 
fee when the application for registration or reregistration is 
submitted for filing online using the secure application portal at 
www.DEAdiversion.usdoj.gov.
    (b) Payment shall be made online by Automated Clearing House funds 
transfer, by credit card, or by any other means made available at the 
time of submission using the secure application portal at 
www.DEAdiversion.usdoj.gov.

0
6. Amend Sec.  1309.32 by revising paragraphs (a) through (c) to read 
as follows:


Sec.  1309.32  Application forms; contents; signature.

    (a) Any person who is required to be registered pursuant to Sec.  
1309.21 and is not so registered, shall apply on DEA Form 510 using the 
secure application portal at www.DEAdiversion.usdoj.gov.
    (b) Any person who is registered pursuant to Sec.  1309.21, shall 
apply for reregistration on DEA Form 510a using the secure application 
portal at www.DEAdiversion.usdoj.gov.
    (c) DEA Forms 510 and 510a may be obtained online at 
www.DEAdiversion.usdoj.gov. DEA will send renewal notifications via 
email to registrants approximately calendar 60 days prior to their 
registration expiration date. Registrants are responsible for keeping 
their email address current in the secure application portal on DEA's 
website throughout the duration of their registration. Only 
applications submitted online through the secure application portal on 
DEA's website will be accepted for processing.
* * * * *

0
7. Revise Sec.  1309.33 to read as follows:


Sec.  1309.33  Filing of application; joint filings.

    All applications for registration shall be submitted online at 
www.DEAdiversion.usdoj.gov for filing. The appropriate registration fee 
and any required attachments must accompany the application.

0
8. Amend Sec.  1309.34 by revising paragraph (a) to read as follows:


Sec.  1309.34  Acceptance for filing; defective applications.

    (a) Applications submitted for filing are dated upon receipt. If 
the application is found to be complete, the application will be 
accepted for filing. Applications failing to comply with the 
requirements of this part will not be accepted for filing.
* * * * *

PART 1321--DEA MAILING ADDRESSES

0
9. The authority citation for part 1321 continues to read as follows:

    Authority: 21 U.S.C. 871(b).

0
10. Amend Sec.  1321.01 by revising the entries in the table under 
``DEA Registration Section'' to read as follows:


Sec.  1321.01  DEA mailing addresses.

* * * * *

                     Table of DEA Mailing Addresses
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 Code of Federal Regulations section--
                 topic                         DEA mailing address
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                              * * * * * * *
------------------------------------------------------------------------
                        DEA Registration Section
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1301.03--Procedures information request  Drug Enforcement
 (controlled substances registration).    Administration, Attn:
                                          Registration Section/DRR P.O.
                                          Box 2639, Springfield, VA
                                          22152.
1301.18(c)--Research project controlled
 substance increase request.
1301.51--Controlled substances
 registration modification request.
1301.52(b)--Controlled substances
 registration transfer request.
1301.52(c)--Controlled substances
 registration discontinuance of
 business activities notification.
1309.03--List I chemicals registration
 procedures information request.
1309.61--List I chemicals registration
 modification request.
 
                              * * * * * * *
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* * * * *

Anne Milgram,
Administrator.
[FR Doc. 2022-07570 Filed 4-8-22; 8:45 am]
BILLING CODE 4410-09-P