Amending Regulations To Require Online Submission of Applications for and Renewals of DEA Registration, 1030-1037 [2020-28532]
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Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Proposed Rules
Dated: December 29, 2020.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. 2020–29151 Filed 1–6–21; 8:45 am]
BILLING CODE 7590–01–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1301, 1309, and 1321
[Docket No. DEA–587]
RIN 1117–AB58
Amending Regulations To Require
Online Submission of Applications for
and Renewals of DEA Registration
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
AGENCY:
This rule proposes to amend
the Drug Enforcement Administration
(DEA) regulations to require all initial
and renewal applications for DEA
registration to be submitted online.
DATES: Electronic comments must be
submitted, and written comments must
be postmarked, on or before March 8,
2021. Commenters should be aware that
the electronic Federal Docket
Management System will not accept any
comments after 11:59 p.m. Eastern Time
on the last day of the comment period.
All comments concerning collections
of information under the Paperwork
Reduction Act must be submitted to the
Office of Management and Budget on or
before March 8, 2021.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–587’’ on all correspondence,
including any attachments.
• Electronic comments: The Drug
Enforcement Administration (DEA)
encourages that all comments be
submitted electronically through the
Federal eRulemaking Portal which
provides the ability to type short
comments directly into the comment
field on the web page or attach a file for
lengthier comments. Please go to https://
www.regulations.gov and follow the
online instructions at that site for
submitting comments. Upon completion
of your submission, you will receive a
Comment Tracking Number for your
comment. Please be aware that
submitted comments are not
instantaneously available for public
view on Regulations.gov. If you have
received a Comment Tracking Number,
your comment has been successfully
submitted and there is no need to
resubmit the same comment.
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SUMMARY:
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• Paper comments: Paper comments
that duplicate electronic submissions
are not necessary. Should you wish to
mail a paper comment, in lieu of an
electronic comment, it should be sent
via regular or express mail to: Drug
Enforcement Administration, Attn: DEA
Federal Register Representative/DPW,
8701 Morrissette Drive, Springfield,
Virginia 22152.
FOR FURTHER INFORMATION CONTACT:
Scott A. Brinks, Regulatory Drafting and
Policy Support Section, Diversion
Control Division, Drug Enforcement
Administration; Mailing Address: 8701
Morrissette Drive, Springfield, Virginia
22152; Telephone: (571) 362–3261.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments
received are considered part of the
public record. They will, unless
reasonable cause is given, be made
available by the Drug Enforcement
Administration (DEA) for public
inspection online at https://
www.regulations.gov. Such information
includes personal identifying
information (such as your name,
address, etc.) voluntarily submitted by
the commenter. The Freedom of
Information Act applies to all comments
received. If you want to submit personal
identifying information (such as your
name, address, etc.) as part of your
comment, but do not want it to be made
publicly available, you must include the
phrase ‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also place
all of the personal identifying
information you do not want made
publicly available in the first paragraph
of your comment and identify what
information you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want it to be made
publicly available, you must include the
phrase ‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify the confidential
business information to be redacted
within the comment.
Comments containing personal
identifying information or confidential
business information identified as
directed above will be made publicly
available in redacted form. If a comment
has so much confidential business
information that it cannot be effectively
redacted, all or part of that comment
may not be made publicly available.
Comments posted to https://
www.regulations.gov may include any
personal identifying information (such
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as name, address, and phone number)
included in the text of your electronic
submission that is not identified as
confidential as directed above.
An electronic copy of this proposed
rule is available at https://
www.regulations.gov for easy reference.
Legal Authority
The Controlled Substances Act (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).
DEA Form 224 applies to new
registration applications for retail
pharmacy, hospital/clinic, practitioner,
teaching institution, or mid-level
practitioner registrations.1 DEA Form
225 applies to new registration
applications for manufacturer,
distributor, researcher, canine handler,
analytical laboratory, importer, or
exporter registrations.2 DEA Form 363
applies to new registration applications
for narcotic treatment program
registrations.3 DEA Form 510 applies to
new registration applications for
domestic chemical registrations.4 DEA
Forms 224a, 225a, 363a, and 510a apply
to registration renewal applications.5
Purpose of the Proposed Rule
The purpose of this notice of
proposed rulemaking is to simplify the
form submission process by requiring
that all registration and renewal
applications be submitted online.
Currently, DEA regulations permit DEA
Registration Forms (224/224a, 225/225a,
363/363a, and 510/510a) to be
submitted either through the secure
online database, or by paper forms
delivered to DEA Headquarters.6 This
proposed rule will amend DEA
regulations to require that all
registration and renewal applications be
1 21
CFR 1301.13(e)(1)(iv).
CFR 1301.13(e)(1)(1)(i)–(iii), (v)–(vi), and
(viii)–(x).
3 21 CFR 1301.13(e)(1)(vii).
4 21 CFR 1309.21.
5 21 CFR 1301.13(e)(1) and 1309.21
6 https://www.deadiversion.usdoj.gov/drugreg/
index.html#regapps.
2 21
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Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Proposed Rules
submitted through the secure online
database, and that paper forms will no
longer be accepted. Submission through
the secure online database will be a
streamlined process which will benefit
both DEA and registrants.
Discussion of Regulatory Changes
Need for Regulatory Changes
Regulatory changes are needed to
conform existing DEA regulations
regarding the submission of registration
and renewal applications to the
Administration’s current requirements
that other DEA forms be submitted
online. This rule proposes to amend
existing DEA regulations in seven
sections.7 Title 21 CFR 1301.13 and
1301.14 are proposed to be amended to
remove the option to submit paper
forms and provide instructions for
online application and payment
instructions. The rule also proposes
removing 21 CFR 1301.14 (b), which
will become obsolete with the adoption
of the secure application portal. 21 CFR
1309.12 is proposed to be amended to
clarify payment options. Title 21 CFR
1309.32 is proposed to be amended to
remove the option to submit paper
forms and provide instruction for online
applications and payments for listed
chemical handlers. Title 21 CFR 1309.33
is proposed to be amended to clarify the
online application and payment process
while removing § 1309.33 (b), which
will become obsolete with the adoption
of the secure application portal. Title 21
CFR 1309.34 is proposed to be amended
to clarify the handling of defective
applications. Title 21 CFR 1321.01 is
proposed to be amended to remove
reference to submitting paper forms by
mail to any DEA Registration Unit
address.
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Regulatory Analyses
Executive Orders 12866, 13563, and
13771, Regulatory Planning and Review,
Improving Regulation and Regulatory
Review, and Reducing Regulation and
Controlling Regulatory Costs
This proposed rule was developed in
accordance with the principles of
Executive Orders (E.O.) 12866, 13563,
and 13771. 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,
7 21
CFR 1301.13, 1301.14, 1309.12, 1309.32,
1309.33, 1309.34, and 1321.01.
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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. DEA
has determined that this proposed rule
is not a ‘‘significant regulatory action’’
under E.O. 12866, section 3(f).
Analysis of Benefits and Costs
DEA has examined the benefits and
costs of this proposed rule. There has
been a continued decrease in the use of
paper forms from 2016 to 2020. Paper
forms as a percentage of total
applications decreased annually from
7.5 percent in 2016 to 2.8 percent, 1.5
percent, and 1.1 percent, in years 2017,
2018, and 2019, respectively. In the first
three months of 2020, 99.3 percent of all
DEA registration forms were submitted
electronically via DEA’s secure website
and 0.7 percent were submitted by
paper. While it is possible the
percentage of paper submissions will
continue to drop, DEA believes 0.7
percent is a reasonable estimate.
Therefore, this proposed rule will
impact the remaining 0.7 percent of
registration forms that are submitted by
paper, approximately 4,453 registrations
per year.8 Benefits include cost savings,
as discussed in the following
paragraphs, and increased simplicity in
the registration process. This proposed
rule will simplify the form submission
process and require that all new
applications and renewals be submitted
online. Additionally, electronic
submissions will increase efficiency and
accuracy.
There are no new costs associated
with this proposed rule. The labor
burden to submit an application is
estimated to be the same for electronic
8 The average annual number of applications from
2017 to 2019 is 636,097. 636,097 × 0.7 percent =
4,453.
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and paper submissions. No special
software is needed to complete an
online application via DEA’s public
website. Furthermore, all applicants,
including the estimated 0.7 percent of
applicants using paper forms, are
assumed to be able to access the internet
without incurring additional costs. DEA
believes providing a contact email
address on the application is indicative
of internet access. Although the
applicant’s contact email address is an
optional field, virtually all paper
submissions include contact email
addresses.9 Although online
applications are available at no
additional cost, DEA acknowledges
some applicants have a preference for
paper forms. DEA does not have a basis
to quantify this preference; however,
DEA believes any cost of eliminating
this preference is offset by the
qualitative cost savings discussion
below.
DEA anticipates there will be cost
savings associated with electronic
submissions. Some cost savings are
described qualitatively and some are
quantified. Many paper submissions
contain illegible or erroneous
information or omit required
information. Many such errors or
omissions, such as not including a
signature or paying the wrong amount
require DEA to contact applicants for
corrections or clarifications, a timeconsuming process for both DEA and
the applicant. Electronic submissions
are expected to virtually eliminate the
requirement for DEA to contact
applicants for clarification of form data
or for correction of submission errors, as
validation features in the system will
flag common errors before transmission.
DEA has not tracked the number or the
duration of such delays and does not
have a strong basis to quantify these cost
savings.
This proposed rule would eliminate
the need to print paper forms and
transmit them by mail or courier
service. DEA estimates there will be a
cost savings of $0.63 ($0.55 for postage
plus $0.08 for an envelope), or a total of
$2,805 per year for an estimated 4,453
responses per year. DEA assumes the
cost savings associated with eliminating
printing costs is negligible.
9 Based on review of applications from January
2020 to March 2020, there were 307 applications for
initial registration using the paper form. Six of 307
applications did not contain a contact email
address. DEA believes it is likely the six applicants
have email addresses (and have access to the
internet), but opted to not provide the email
address. Including the online applications, six of
30,509 applications for new registrations over the
three-month period, January-March 2020, did not
contain email addresses.
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Furthermore, DEA anticipates cost
savings from the elimination of
production costs (i.e., paper forms,
envelopes, postage, equipment, and
labor). Based on the information
collection requests for the registration
forms, recently approved by OMB,
DEA’s production costs of $49,910 will
be eliminated.10 In summary, DEA
estimates this proposed rule will result
in an annual cost savings of $52,715
($2,805 to applicants and $49,910 to
DEA).
Section 2(a) of E.O. 13771 11 requires
an agency, unless prohibited by law, to
identify at least two existing regulations
to be repealed when the agency publicly
proposes for notice and comment or
otherwise promulgates a new regulation.
In furtherance of this requirement,
Section 2(c) of E.O. 13771 requires that
the new incremental costs associated
with new regulations, to the extent
permitted by law, be offset by the
elimination of existing costs associated
with at least two prior regulations.
Because this proposed rule is estimated
to have a total cost of less than zero
(cost savings of $52,715 per year), DEA
expects the rule will be considered an
E.O. 13771 deregulatory action.
Executive Order 12988, Civil Justice
Reform
This proposed 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 proposed rule does not have
federalism implications warranting the
application of E.O. 13132. The proposed
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 proposed 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
In accordance with the Regulatory
Flexibility Act (RFA), the DEA has
reviewed the economic impact of this
proposed rule on small entities. DEA’s
economic impact evaluation indicates
that the rule will not, if promulgated,
have a significant economic impact on
a substantial number of small entities.
The 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 proposed rule and estimates that it
will have minimal economic impact on
affected entities, including small
businesses, nonprofit organizations, and
small governmental jurisdictions.
This proposed rule will simplify the
form submission process by requiring
all initial registration and renewal
applications be submitted online. The
rule would affect all applicants for DEA
registration or re-registration who would
use paper forms. There has been a
continued decrease in the use of paper
applications from 2016 to 2020. Paper
applications, as a percentage of total
applications, decreased annually from
7.5 percent in 2016 to 2.8 percent, 1.5
percent, and 1.1 percent, in years 2017,
2018, and 2019, respectively. In the first
three months of 2020, 99.3 percent of all
DEA Registration Forms were submitted
electronically via DEA’s secure website
and 0.7 percent were submitted by
paper. While it is possible the
percentage of paper submissions will
continue to drop, DEA believes 0.7
percent is a reasonable estimate.
Therefore, this proposed rule will
impact the remaining 0.7 percent of
registration forms that are submitted by
paper, approximately 4,453 registrations
per year.12
All registration business activities
(registrant-type) have used paper
registration forms in the past three
years. DEA estimated the number of
applications by business activity based
on the three-year average, 2017–2019, of
actual paper application submissions.
DEA applied the percentages for each
business activity to the estimated 4,453
paper registration per year. For example,
on average, 5.73 percent of total paper
registration forms were for pharmacy
registrations. Applying 5.73 percent to
the 4,453 estimated total paper
registrations, the estimated number of
paper registrations for pharmacy
registrations was 255 (4,453 × 5.73
percent). This calculation was
conducted for each business activity
and the results are in Table 1 below.
TABLE 1—PERCENTAGE AND NUMBER OF PAPER REGISTRATIONS BY BUSINESS ACTIVITY
2017
(percent)
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Business activity
Pharmacy .............................................................................
Hospital/Clinic ......................................................................
Practitioner ...........................................................................
Teaching Institution ..............................................................
Manufacturer ........................................................................
Distributor .............................................................................
Researcher/Canine Handler ................................................
Analytical Lab .......................................................................
Importer ................................................................................
Exporter ................................................................................
Reverse Distributor ..............................................................
Mid-level Practitioner (MLP) ................................................
Narcotic Treatment Program ...............................................
Chemical Manufacturer ........................................................
10 The estimated production cost is the sum of the
estimated production cost for each of the forms.
Office of Information and Regulatory Affairs,
Inventory of Currently Approved Information
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2018
(percent)
3.12
2.11
79.73
0.03
0.23
0.15
3.00
0.41
0.07
0.03
0.01
10.38
0.38
0.11
6.25
2.67
77.99
0.04
0.33
0.18
3.61
0.53
0.10
0.04
0.02
7.62
0.33
0.11
Collections, April 13, 2020, https://
www.reginfo.gov/public/do/PRAMain (accessed
April 13, 2020). See Paperwork Reduction Act
section below for specific OMB control numbers.
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2019
(percent)
7.81
3.57
74.13
0.01
0.39
0.28
2.96
0.51
0.10
0.07
0.04
9.40
0.38
0.10
11 82
Average
(percent)
5.73
2.78
77.29
0.03
0.32
0.20
3.19
0.48
0.09
0.05
0.03
9.14
0.36
0.11
Number of
registrations
255
124
3,442
1
14
9
142
22
4
2
1
407
16
5
FR 9339.
average annual number of applications
from 2017 to 2019 is 636,097. 636,097 × 0.7 percent
= 4,453.
12 The
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TABLE 1—PERCENTAGE AND NUMBER OF PAPER REGISTRATIONS BY BUSINESS ACTIVITY—Continued
2017
(percent)
Business activity
2018
(percent)
2019
(percent)
Average
(percent)
Number of
registrations
Chemical Importer ................................................................
Chemical Distributor .............................................................
Chemical Exporter ...............................................................
0.06
0.13
0.03
0.02
0.10
0.04
0.03
0.13
0.09
0.04
0.12
0.05
2
5
2
Total .....................................................................................
100.00
100.00
100.00
100.00
4,453
(Source: DEA)
As this proposed rule affects all
business activities that are required to
obtain a registration with DEA pursuant
to the CSA, this proposed rule would
affect small entities in a wide variety of
industries. Table 2 indicates the sectors,
as defined by the North American
Industry Classification System (NAICS),
affected by the proposed rule. Most DEA
registrants are, or are employed by,
small entities under Small Business
Administration (SBA) standards.
TABLE 2—INDUSTRIAL SECTORS OF DEA REGISTRANTS
Business Activity
NAICS Code
Manufacturer .............................................
325411
325412
424210
5621
5622
445110
446110
452210
452311
541380
611310
541715
Distributor, Importer, Exporter ..................
Reverse Distributor ...................................
Pharmacy ..................................................
Analytical Labs ..........................................
Teaching institute ......................................
Researcher ...............................................
Canine Handler .........................................
Practitioner, Mid-level Practitioner,* Narcotic Treatment Program, Hospital/Clinic.
Chemical Manufacturer .............................
Chemical Distributor, Chemical Importer,
Chemical Exporter.
NAICS Code Description
561612
541940
Medicinal and Botanical Manufacturing.
Pharmaceutical Preparation Manufacturing.
Drugs and Druggists’ Sundries Merchant Wholesalers.
Waste Collection.
Waste Treatment and Disposal.
Supermarkets and Other Grocery (except Convenience) Stores.
Pharmacies and Drug Stores.
Department Stores.
Warehouse Clubs and Supercenters.
Testing Laboratories.
Colleges, Universities and Professional Schools.
Research and Development in the Physical, Engineering, and Life Sciences (except
Nanotechnology and Biotechnology).
Security Guards and Patrol Services.
Veterinary Services.
621111
621112
621210
621330
621391
621420
621491
621493
622110
622210
622310
325
424690
Offices of Physicians (except Mental Health Specialists).
Offices of Physicians, Mental Health Specialists.
Offices of Dentists.
Offices of Mental Health Practitioners (except Physicians).
Offices of Podiatrists.
Outpatient Mental Health and Substance Abuse Centers.
HMO Medical Centers.
Freestanding Ambulatory Surgical and Emergency Centers.
General Medical and Surgical Hospitals.
Psychiatric and Substance Abuse Hospitals.
Specialty (except Psychiatric and Substance Abuse) Hospitals.
Chemical Manufacturing.
Other Chemical and Allied Products Merchant Wholesalers.
* Practitioners and mid-level practitioners are generally employed in one of these industries.
As shown in Table 2, the proposed
rule would affect a wide variety of
entities across many industry sectors.
As some industry sectors are expected
to consist primarily of DEA registrants
(i.e., 446110-Pharmacies and Drug
Stores, 622110-General Medical and
Surgical Hospitals, etc.), this proposed
rule is expected to affect some small
entities. For reference, Table 3 lists the
average annual revenue for the smallest
of small businesses in each industry
sector. The table below lists the results.
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TABLE 3—AVERAGE ANNUAL REVENUE OF SMALLEST OF SMALL ENTITIES
Enterprise
size
(number of
employees)
NAICS code
NAICS code description
325 ....................
325411 ..............
325412 ..............
424210 ..............
Chemical Manufacturing ..............................................................................
Medicinal and Botanical Manufacturing .......................................................
Pharmaceutical Preparation Manufacturing .................................................
Drugs and Druggists’ Sundries Merchant Wholesalers ...............................
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0–4
0–4
*5–9
0–4
07JAP1
Number of
establishments
Average
revenue per
establishment
($)
3,148
108
129
3,630
1,938,546
727,444
2,639,287
1,367,131
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TABLE 3—AVERAGE ANNUAL REVENUE OF SMALLEST OF SMALL ENTITIES—Continued
NAICS code
424690
445110
446110
452112
452910
541380
541712
Enterprise
size
(number of
employees)
NAICS code description
..............
..............
..............
..............
..............
..............
..............
541940 ..............
561612 ..............
5621 ..................
5622 ..................
611310 ..............
621111 ..............
621112 ..............
621210 ..............
621320 ..............
621330 ..............
621391 ..............
621420 ..............
621491 ..............
621493 ..............
622110 ..............
622210 ..............
622310 ..............
Other Chemical and Allied Products Merchant Wholesalers ......................
Supermarkets and Other Grocery (except Convenience) Stores ...............
Pharmacies and Drug Stores ......................................................................
Discount Department Stores ........................................................................
Warehouse Clubs and Supercenters ...........................................................
Testing Laboratories ....................................................................................
Research and Development in the Physical, Engineering, and Life
Sciences (except Biotechnology).
Veterinary Services ......................................................................................
Security Guards and Patrol Services ..........................................................
Waste Collection ..........................................................................................
Waste Treatment and Disposal ...................................................................
Colleges, Universities, and Professional Schools .......................................
Offices of Physicians (except Mental Health Specialists) ...........................
Offices of Physicians, Mental Health Specialists ........................................
Offices of Dentists ........................................................................................
Offices of Optometrists ................................................................................
Offices of Mental Health Practitioners (except Physicians) ........................
Offices of Podiatrists ....................................................................................
Outpatient Mental Health and Substance Abuse Centers ..........................
HMO Medical Centers .................................................................................
Freestanding Ambulatory Surgical and Emergency Centers ......................
General Medical and Surgical Hospitals .....................................................
Psychiatric and Substance Abuse Hospitals ...............................................
Specialty (except Psychiatric and Substance Abuse) Hospitals .................
Number of
establishments
Average
revenue per
establishment
($)
0–4
0–4
0–4
0–4
0–4
0–4
0–4
3,352
23,710
6,360
6
12
2,415
5,013
2,007,996
453,787
1,069,655
266,167
326,333
297,737
427,790
0–4
0–4
0–4
0–4
0–4
0–4
0–4
0–4
0–4
0–4
0–4
0–4
* 5–9
0–4
0–4
* 20–99
0–4
8,881
2,162
3,853
616
372
95,648
8,980
50,781
10,939
16,149
5,300
1,810
16
1,011
39
27
21
292,166
114,198
365,902
461,159
913,078
447,715
253,837
330,868
269,348
145,005
288,546
211,249
620,188
549,974
10,621,308
5,142,444
8,561,238
* The revenue figure for the smallest size category is unavailable. The revenue figure for the smallest size category with available revenue figure is used.
jbell on DSKJLSW7X2PROD with PROPOSALS
There are no new costs associated
with this proposed rule. The labor
burden to submit an application is
estimated to be the same for electronic
and paper submissions. No special
software is needed to complete an
online application via DEA’s public
website. Furthermore, all applicants,
including the estimated 0.7 percent of
applicants using paper forms, are
assumed to be able to access the internet
without incurring additional costs. DEA
believes using email for contact is
indicative of having internet access.
Although the applicant’s contact email
address is an optional field on a paper
registration application, virtually all
applications submitted include contact
email addresses.13 Although online
applications are available at no
additional cost, DEA acknowledges
some applicants have a preference for
paper forms. DEA does not have a basis
to quantify this preference; however,
DEA believes any costs associated with
eliminating this preference is offset by
13 Based on a review of applications submitted
from January 2020 to March 2020, there were 307
applications for initial registrations submitted using
the paper form. Six of those 307 applications did
not contain a contact email address. Including the
online applications, six of 30,509 applications for
new registrations over the three month period,
January-March 2020, did not contain email
addresses.
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17:45 Jan 06, 2021
Jkt 253001
the qualitative cost savings discussion
below.
DEA anticipates there will be cost
savings associated with electronic
submissions. Some cost savings are
described qualitatively and some are
quantified. Many paper applications
submitted contain illegible or erroneous
information or omit required
information. Many such errors or
omissions, such as not including a
signature or paying the wrong amount,
require DEA to contact applicants to
correct or clarify the information in the
paper form, consuming DEA’s and the
applicant’s time and resources.
Electronic submissions are expected to
virtually eliminate the requirement for
DEA to contact applicants for
clarifications of form data or correction
of submission errors, as validation
features in the system will flag common
errors prior to transmission. As DEA has
not tracked the number of delays or the
duration of such delays, DEA does not
have a basis to quantify the cost savings.
Furthermore, this proposed rule
would eliminate the need to print paper
forms and transmit by mail or courier
service. DEA estimates there will be a
cost savings of $0.63 ($0.55 for postage
plus $0.08 for an envelope) per each
paper form not submitted. DEA assumes
the cost savings associated with
eliminating printing costs is negligible.
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Therefore, this proposed rule, if
promulgated, 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 of 1995
(UMRA),14 DEA has determined that
this action would 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.
Paperwork Reduction Act
This proposed rule would modify
existing collection(s) of information
requirement under the Paperwork
Reduction Act (PRA).15 Pursuant to the
PRA,16 DEA has identified the
collections of information below related
to this proposed rule. A person is not
required to respond to a collection of
information unless it displays a valid
OMB control number.17
14 2
U.S.C. 1501, et seq.
U.S.C. 3501–3521.
16 44 U.S.C. 3507(d).
17 Copies of existing information collections
approved by OMB may be obtained at https://
www.reginfo.gov/public/do/PRAMain.
15 44
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jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Proposed Rules
A. Collections of Information Associated
With the Proposed Rule
1. Title: Application for RegistrationDEA 224, Application of Registration
Renewal-DEA 224A.
OMB Control Number: 1117–0014.
Form Number: DEA–224/224a.
DEA is proposing to amend 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
would 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 by
a Retail Pharmacy, Hospital/Clinic,
Practitioner, Teaching Institution, or
Mid-Level Practitioner would be 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 through the secure
database will ensure the
Administration’s receipt of applications
in a more timely and organized manner.
DEA estimates the following number
of respondents and burden associated
with this collection of information:
• Number of respondents: 617,086.
• Frequency of response: 1.
• Number of responses: 617,086.
• Burden per response: 0.202186 18
• Total annual hour burden: 124,766.
2. Title: Application for Registration
(DEA Form 225); Application for
Registration Renewal (DEA Form 225a);
Affidavit for Chain Renewal (DEA Form
225B).
OMB Control Number: 1117–0012.
Form Number: DEA–225/225(A).
DEA is proposing to amend its
regulations for all new and renewal
registration applications to implement
the requirement of electronic only
submission. This amendment would
clarify the submission process by
aligning it with the Administration’s
current requirements for other online
form submissions. The online
submission of DEA Forms 225/225a by
Manufacturer, Distributor, Researcher,
Canine Handler, Analytical Laboratory,
Importer, or Exporter would be filed
with DEA through the DEA Diversion
Control Diversion secure network
(available on the DEA Diversion Control
Division website). The online
submission of new and renewal
applications through the secure
database will ensure the
18 Calculated
based on total annual hour burden
and the number of respondents (124,766/617,086 =
0.202186).
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Administration’s receipt of applications
in a more timely and organized manner.
DEA estimates the following number
of respondents and burden associated
with this collection of information:
• Number of respondents: 16,338
• Frequency of response: 1
• Number of responses: 16,338
• Burden per response (hour):
0.199106 19
• Total annual hour burden: 3,253
3. Title: Application for Registration
(DEA Form 363) and Application for
Registration Renewal (DEA Form 363a).
OMB Control Number: 1117–0015.
Form Number: DEA–363/363a.
DEA is proposing to amend its
regulations for all new and renewal
registration applications to implement
the requirement of online submission.
This amendment would clarify the
submission process by aligning it with
the Administration’s current
requirements for other online form
submissions. The electronic submission
of DEA Forms 363/363a by a Narcotic
Treatment Program would be filed with
DEA through the DEA Diversion Control
Diversion secure network (available on
the DEA Diversion Control Division
website). The online submission of new
and renewal applications through the
secure database will ensure the
Administration’s receipt of applications
in a more timely and organized manner.
DEA estimates the following number
of respondents and burden associated
with this collection of information:
• Number of respondents: 1,900
• Frequency of response: 1
• Number of responses: 1,900
• Burden per response: 0.187895 20
• Total annual hour burden: 357
4. Title: Application for Registration
Under Domestic Chemical Diversion
Control Act of 1993 and Renewal
Application for Registration under
Domestic Chemical Diversion Control
Act of 1993.
OMB Control Number: 1117–0031.
Form Number: DEA 510/510a.
DEA is proposing to amend its
regulations for all new and renewal
registration applications to implement
the requirement of online submission.
This amendment would clarify the
submission process by aligning it with
the Administration’s current
requirements for other form
submissions. The electronic submission
of DEA Forms 510/510a by a Domestic
Chemical Handler would be filed with
19 Calculated based on total annual hour burden
and the number of respondents (3,253/16,338 =
0.199106).
20 Calculated based on total annual hour burden
and the number of respondents (357/1,900 =
0.187895).
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1035
DEA through the DEA Diversion Control
Diversion secure network (available on
the DEA Diversion Control Division
website). The online submission of new
and renewal applications through the
secure database will ensure the
Administration’s receipt of applications
in a more timely and organized manner.
DEA estimates the following number
of respondents and burden associated
with this collection of information:
• Number of respondents: 1,001
• Frequency of response: 1
• Number of responses: 1,001
• Burden per response (hour):
0.182817 21
• Total annual hour burden: 183
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, DEA is required to provide a
notice regarding the proposed
collections of information in the FR
with the notice of proposed rulemaking
and solicit public comment. Pursuant to
the PRA,22 DEA solicits comments on
the following issues:
• 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.
All comments concerning collections
of information under the PRA must be
submitted to the Office of Information
and Regulatory Affairs, OMB, Attention:
Desk Officer for the Department of
Justice, Washington, DC 20503. Please
state that your comments refer to RIN
1117–0014, 1117–0012, 1117–0015, or
1117–0031/Docket No. DEA–587. All
comments must be submitted to OMB
on or before March 8, 2021. The final
rule will respond to any OMB or public
comments on the information collection
requirements contained in this proposed
rule.
21 Calculated based on total annual hour burden
and the number of respondents (183/1,001 =
0.182817).
22 44 U.S.C. 3506(c)(2).
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Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Proposed Rules
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) 362–3261.
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 proposes to amend 21
CFR parts 1301 and 1309 as follows:
PART 1301—REGISTRATION OF
MANUFACTURERS, DISTRIBUTORS,
AND DISPENSERS OF CONTROLLED
SUBSTANCES
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.
§ 1301.13 Application for registration; time
for application; expiration date; registration
for independent activities; application
forms, fees, contents and signature;
coincident activities.
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*
*
*
*
(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 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
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17:45 Jan 06, 2021
Jkt 253001
§ 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
4. The authority citation for part 1309
continues to read as follows:
2. In § 1301.13, revise paragraphs
(e)(2) and (3) to read as follows:
■
*
registration. DEA Forms 224a, 225a, and
363a 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. Amend § 1301.14 by:
■ a. Revising paragraph (a);
■ b. Removing paragraph (b);
■ c. Redesignating paragraphs (c) and
(d) as paragraphs (b) and (c); and
■ d. Revising newly redesignated
paragraph (b).
The revisions read as follows:
§ 1309.32 Application forms; contents;
signature.
(a) Any person who is required to be
registered pursuant to § 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 Section 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 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.
*
*
*
*
*
■ 7. Revise § 1309.33 to read as follows:
§ 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.
■ 8. Amend § 1309.34 by revising
paragraph (a) to read as follows:
■
§ 1309.34 Acceptance for filing; defective
applications.
Authority: 21 U.S.C. 802, 821, 822, 823,
824, 830, 871(b), 875, 877, 886a, 952, 953,
957, 958.
(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.
*
*
*
*
*
■
5. Revise § 1309.12 to read as follows:
§ 1309.12
refund.
Time and method of payment;
(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
credit card at the time of submission
using the secure application portal at
www.DEAdiversion.usdoj.gov.
■ 6. In § 1309.32, revise paragraphs (a)
through (c) to read as follows:
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PART 1321—DEA MAILING
ADDRESSES
9. The authority citation for part 1321
continues to read as follows:
■
Authority: 21 U.S.C. 871(b).
10. Amend § 1321.01 by revising the
table heading and the entry under ‘‘DEA
Registration Section’’ to read as follows:
■
§ 1321.01
*
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*
DEA mailing addresses.
*
07JAP1
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1037
Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Proposed Rules
TABLE 1 TO § 1321.01—DEA MAILING ADDRESSES
Code of Federal Regulations Section—Topic
*
*
DEA mailing address
*
*
*
*
*
DEA Registration Section
1301.03—Procedures information request (controlled substances registration).
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.
*
*
*
*
*
*
*
*
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020–28532 Filed 1–6–21; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF THE INTERIOR
Bureau of Indian Affairs
25 CFR Part 15
Office of the Secretary
43 CFR Part 30
[212A2100DD/AAKC001030/
A0A501010.999900 253G]
RIN 1094–AA55
American Indian Probate Regulations
Bureau of Indian Affairs, Office
of the Secretary, Interior.
ACTION: Proposed rule.
AGENCY:
The Department of the
Interior (Department) is updating
regulations governing probate of
property that the United States holds in
trust or restricted status for American
Indians. Since the regulations were last
revised in 2008, the Department
identified opportunities for improving
the probate process. These proposed
revisions would allow the Office of
Hearings and Appeals (OHA) to
adjudicate probate cases more
efficiently by, among other things,
establishing an expedited process for
small, funds-only estates, reorganizing
the purchase-at-probate process so that
estates may be closed more quickly,
streamlining notice to co-owners who
are potential heirs while adding
electronic notice to all by website
posting, and specifying which reasons
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SUMMARY:
VerDate Sep<11>2014
17:45 Jan 06, 2021
Jkt 253001
Drug Enforcement Administration, Attn: Registration Section/DRR, P.O.
Box 2639, Springfield, VA 22152.
*
*
justify reopening of closed probate
estates. The proposed revisions would
also enhance OHA’s processing by
adding certainty as to how estates
should be distributed when certain
circumstances arise that are not
addressed in the statute.
DATES: Submit written comments by
March 8, 2021. A Tribal consultation
session will be held on February 9,
2021, at 2 p.m. Eastern Time and a
public hearing will be held on February
11, 2021, at 2 p.m. Eastern Time (see
Section V in the SUPPLEMENTARY
INFORMATION for details).
ADDRESSES: You may submit comments
by any one of the following methods:
• Federal Rulemaking Portal:
www.regulations.gov. The rule is listed
under Agency Docket Number DOI–
2019–0001.
• Email: Tribes may email comments
to: consultation@bia.gov. All others
should email their comments to:
comments@bia.gov.
• Mail or Courier: Ms. Elizabeth
Appel, Office of Regulatory Affairs &
Collaborative Action, U.S. Department
of the Interior, 1849 C Street NW, Mail
Stop 4660 MIB, Washington, DC 20240.
We cannot ensure that comments
received after the close of the comment
period (see DATES) will be included in
the docket for this rulemaking and
considered. Comments sent to an
address other than those listed above
will not be included in the docket for
this rulemaking. Locations of the Tribal
consultation session and public hearing
are listed in Section V of this rule.
FOR FURTHER INFORMATION CONTACT:
Elizabeth K. Appel, Director, Office of
Regulatory Affairs & Collaborative
Action—Indian Affairs,
Elizabeth.appel@bia.gov, (202) 273–
4680.
SUPPLEMENTARY INFORMATION:
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*
*
I. Executive Summary
II. Background
III. Proposed Resolution to Issues Identified
in ANPRM and Response to Comments
on the ANPRM
A. Issue 1: Gaps in AIPRA Intestacy
Distribution
B. Issue 2: Overly Burdensome ‘‘Purchase
at Probate’’ Process
C. Issue 3: Notice to Co-Owners Who Are
Potential Heirs
D. Issue 4: Insufficient Trust Funds for
Funeral Services
E. Issue 5: No Regulatory Process for
Exercise of ‘‘Tribal Purchase’’ Option
F. Issue 6: Minor Estate Inventory
Corrections
G. Issue 7: Judicial Authority
H. Issue 8: Indian Status Determinations
I. Issue 9: Increase Opportunities To Use
‘‘Renunciation’’ To Maintain Trust
Status of Property
J. Issue 10: Presumption of Death
K. Issue 11: Reopening Closed Probate
Cases
L. Issue 12: Streamlining Process for Small
Estates
M. Issue 13: Descent of Off-Reservation
Lands
IV. Overview of Proposed Rule
A. Summary of Proposed Changes
B. Crosswalk of Current Regulation to
Proposed Regulation
V. Tribal Consultation and Public Hearing
VI. Procedural Requirements
A. Regulatory Planning and Review (E.O.
12866 and 13563)
B. Reducing Regulations and Controlling
Regulatory Costs (E.O. 13771)
C. Regulatory Flexibility Act
D. Small Business Regulatory Enforcement
Fairness Act
E. Unfunded Mandates Act
F. Takings (E.O. 12630)
G. Federalism (E.O. 13132)
H. Civil Justice Reform (E.O. 12988)
I. Consultation With Indian Tribes (E.O.
13175)
J. Paperwork Reduction Act
K. National Environmental Policy Act
L. Effects on the Energy Supply (E.O.
13211)
M. Clarity of This Regulation
N. Public Availability of Comments
E:\FR\FM\07JAP1.SGM
07JAP1
]]>Agencies
[Federal Register Volume 86, Number 4 (Thursday, January 7, 2021)]
[Proposed Rules]
[Pages 1030-1037]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28532]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1301, 1309, and 1321
[Docket No. DEA-587]
RIN 1117-AB58
Amending Regulations To Require Online Submission of Applications
for and Renewals of DEA Registration
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
-----------------------------------------------------------------------
SUMMARY: This rule proposes to amend the Drug Enforcement
Administration (DEA) regulations to require all initial and renewal
applications for DEA registration to be submitted online.
DATES: Electronic comments must be submitted, and written comments must
be postmarked, on or before March 8, 2021. Commenters should be aware
that the electronic Federal Docket Management System will not accept
any comments after 11:59 p.m. Eastern Time on the last day of the
comment period.
All comments concerning collections of information under the
Paperwork Reduction Act must be submitted to the Office of Management
and Budget on or before March 8, 2021.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-587'' on all correspondence, including any
attachments.
Electronic comments: The Drug Enforcement Administration
(DEA) encourages that all comments be submitted electronically through
the Federal eRulemaking Portal which provides the ability to type short
comments directly into the comment field on the web page or attach a
file for lengthier comments. Please go to https://www.regulations.gov
and follow the online instructions at that site for submitting
comments. Upon completion of your submission, you will receive a
Comment Tracking Number for your comment. Please be aware that
submitted comments are not instantaneously available for public view on
Regulations.gov. If you have received a Comment Tracking Number, your
comment has been successfully submitted and there is no need to
resubmit the same comment.
Paper comments: Paper comments that duplicate electronic
submissions are not necessary. Should you wish to mail a paper comment,
in lieu of an electronic comment, it should be sent via regular or
express mail to: Drug Enforcement Administration, Attn: DEA Federal
Register Representative/DPW, 8701 Morrissette Drive, Springfield,
Virginia 22152.
FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Regulatory Drafting
and Policy Support Section, Diversion Control Division, Drug
Enforcement Administration; Mailing Address: 8701 Morrissette Drive,
Springfield, Virginia 22152; Telephone: (571) 362-3261.
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments received are considered part of the
public record. They will, unless reasonable cause is given, be made
available by the Drug Enforcement Administration (DEA) for public
inspection online at https://www.regulations.gov. Such information
includes personal identifying information (such as your name, address,
etc.) voluntarily submitted by the commenter. The Freedom of
Information Act applies to all comments received. If you want to submit
personal identifying information (such as your name, address, etc.) as
part of your comment, but do not want it to be made publicly available,
you must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the
first paragraph of your comment. You must also place all of the
personal identifying information you do not want made publicly
available in the first paragraph of your comment and identify what
information you want redacted.
If you want to submit confidential business information as part of
your comment, but do not want it to be made publicly available, you
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the
first paragraph of your comment. You must also prominently identify the
confidential business information to be redacted within the comment.
Comments containing personal identifying information or
confidential business information identified as directed above will be
made publicly available in redacted form. If a comment has so much
confidential business information that it cannot be effectively
redacted, all or part of that comment may not be made publicly
available. Comments posted to https://www.regulations.gov may include
any personal identifying information (such as name, address, and phone
number) included in the text of your electronic submission that is not
identified as confidential as directed above.
An electronic copy of this proposed rule is available at https://www.regulations.gov for easy reference.
Legal Authority
The Controlled Substances Act (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).
DEA Form 224 applies to new registration applications for retail
pharmacy, hospital/clinic, practitioner, teaching institution, or mid-
level practitioner registrations.\1\ DEA Form 225 applies to new
registration applications for manufacturer, distributor, researcher,
canine handler, analytical laboratory, importer, or exporter
registrations.\2\ DEA Form 363 applies to new registration applications
for narcotic treatment program registrations.\3\ DEA Form 510 applies
to new registration applications for domestic chemical
registrations.\4\ DEA Forms 224a, 225a, 363a, and 510a apply to
registration renewal applications.\5\
---------------------------------------------------------------------------
\1\ 21 CFR 1301.13(e)(1)(iv).
\2\ 21 CFR 1301.13(e)(1)(1)(i)-(iii), (v)-(vi), and (viii)-(x).
\3\ 21 CFR 1301.13(e)(1)(vii).
\4\ 21 CFR 1309.21.
\5\ 21 CFR 1301.13(e)(1) and 1309.21
---------------------------------------------------------------------------
Purpose of the Proposed Rule
The purpose of this notice of proposed rulemaking is to simplify
the form submission process by requiring that all registration and
renewal applications be submitted online. Currently, DEA regulations
permit DEA Registration Forms (224/224a, 225/225a, 363/363a, and 510/
510a) to be submitted either through the secure online database, or by
paper forms delivered to DEA Headquarters.\6\ This proposed rule will
amend DEA regulations to require that all registration and renewal
applications be
[[Page 1031]]
submitted through the secure online database, and that paper forms will
no longer be accepted. Submission through the secure online database
will be a streamlined process which will benefit both DEA and
registrants.
---------------------------------------------------------------------------
\6\ https://www.deadiversion.usdoj.gov/drugreg/#regapps.
---------------------------------------------------------------------------
Discussion of Regulatory Changes
Need for Regulatory Changes
Regulatory changes are needed to conform existing DEA regulations
regarding the submission of registration and renewal applications to
the Administration's current requirements that other DEA forms be
submitted online. This rule proposes to amend existing DEA regulations
in seven sections.\7\ Title 21 CFR 1301.13 and 1301.14 are proposed to
be amended to remove the option to submit paper forms and provide
instructions for online application and payment instructions. The rule
also proposes removing 21 CFR 1301.14 (b), which will become obsolete
with the adoption of the secure application portal. 21 CFR 1309.12 is
proposed to be amended to clarify payment options. Title 21 CFR 1309.32
is proposed to be amended to remove the option to submit paper forms
and provide instruction for online applications and payments for listed
chemical handlers. Title 21 CFR 1309.33 is proposed to be amended to
clarify the online application and payment process while removing Sec.
1309.33 (b), which will become obsolete with the adoption of the secure
application portal. Title 21 CFR 1309.34 is proposed to be amended to
clarify the handling of defective applications. Title 21 CFR 1321.01 is
proposed to be amended to remove reference to submitting paper forms by
mail to any DEA Registration Unit address.
---------------------------------------------------------------------------
\7\ 21 CFR 1301.13, 1301.14, 1309.12, 1309.32, 1309.33, 1309.34,
and 1321.01.
---------------------------------------------------------------------------
Regulatory Analyses
Executive Orders 12866, 13563, and 13771, Regulatory Planning and
Review, Improving Regulation and Regulatory Review, and Reducing
Regulation and Controlling Regulatory Costs
This proposed rule was developed in accordance with the principles
of Executive Orders (E.O.) 12866, 13563, and 13771. 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. DEA has determined
that this proposed rule is not a ``significant regulatory action''
under E.O. 12866, section 3(f).
Analysis of Benefits and Costs
DEA has examined the benefits and costs of this proposed rule.
There has been a continued decrease in the use of paper forms from 2016
to 2020. Paper forms as a percentage of total applications decreased
annually from 7.5 percent in 2016 to 2.8 percent, 1.5 percent, and 1.1
percent, in years 2017, 2018, and 2019, respectively. In the first
three months of 2020, 99.3 percent of all DEA registration forms were
submitted electronically via DEA's secure website and 0.7 percent were
submitted by paper. While it is possible the percentage of paper
submissions will continue to drop, DEA believes 0.7 percent is a
reasonable estimate. Therefore, this proposed rule will impact the
remaining 0.7 percent of registration forms that are submitted by
paper, approximately 4,453 registrations per year.\8\ Benefits include
cost savings, as discussed in the following paragraphs, and increased
simplicity in the registration process. This proposed rule will
simplify the form submission process and require that all new
applications and renewals be submitted online. Additionally, electronic
submissions will increase efficiency and accuracy.
---------------------------------------------------------------------------
\8\ The average annual number of applications from 2017 to 2019
is 636,097. 636,097 x 0.7 percent = 4,453.
---------------------------------------------------------------------------
There are no new costs associated with this proposed rule. The
labor burden to submit an application is estimated to be the same for
electronic and paper submissions. No special software is needed to
complete an online application via DEA's public website. Furthermore,
all applicants, including the estimated 0.7 percent of applicants using
paper forms, are assumed to be able to access the internet without
incurring additional costs. DEA believes providing a contact email
address on the application is indicative of internet access. Although
the applicant's contact email address is an optional field, virtually
all paper submissions include contact email addresses.\9\ Although
online applications are available at no additional cost, DEA
acknowledges some applicants have a preference for paper forms. DEA
does not have a basis to quantify this preference; however, DEA
believes any cost of eliminating this preference is offset by the
qualitative cost savings discussion below.
---------------------------------------------------------------------------
\9\ Based on review of applications from January 2020 to March
2020, there were 307 applications for initial registration using the
paper form. Six of 307 applications did not contain a contact email
address. DEA believes it is likely the six applicants have email
addresses (and have access to the internet), but opted to not
provide the email address. Including the online applications, six of
30,509 applications for new registrations over the three-month
period, January-March 2020, did not contain email addresses.
---------------------------------------------------------------------------
DEA anticipates there will be cost savings associated with
electronic submissions. Some cost savings are described qualitatively
and some are quantified. Many paper submissions contain illegible or
erroneous information or omit required information. Many such errors or
omissions, such as not including a signature or paying the wrong amount
require DEA to contact applicants for corrections or clarifications, a
time-consuming process for both DEA and the applicant. Electronic
submissions are expected to virtually eliminate the requirement for DEA
to contact applicants for clarification of form data or for correction
of submission errors, as validation features in the system will flag
common errors before transmission. DEA has not tracked the number or
the duration of such delays and does not have a strong basis to
quantify these cost savings.
This proposed rule would eliminate the need to print paper forms
and transmit them by mail or courier service. DEA estimates there will
be a cost savings of $0.63 ($0.55 for postage plus $0.08 for an
envelope), or a total of $2,805 per year for an estimated 4,453
responses per year. DEA assumes the cost savings associated with
eliminating printing costs is negligible.
[[Page 1032]]
Furthermore, DEA anticipates cost savings from the elimination of
production costs (i.e., paper forms, envelopes, postage, equipment, and
labor). Based on the information collection requests for the
registration forms, recently approved by OMB, DEA's production costs of
$49,910 will be eliminated.\10\ In summary, DEA estimates this proposed
rule will result in an annual cost savings of $52,715 ($2,805 to
applicants and $49,910 to DEA).
---------------------------------------------------------------------------
\10\ The estimated production cost is the sum of the estimated
production cost for each of the forms. Office of Information and
Regulatory Affairs, Inventory of Currently Approved Information
Collections, April 13, 2020, https://www.reginfo.gov/public/do/PRAMain (accessed April 13, 2020). See Paperwork Reduction Act
section below for specific OMB control numbers.
---------------------------------------------------------------------------
Section 2(a) of E.O. 13771 \11\ requires an agency, unless
prohibited by law, to identify at least two existing regulations to be
repealed when the agency publicly proposes for notice and comment or
otherwise promulgates a new regulation. In furtherance of this
requirement, Section 2(c) of E.O. 13771 requires that the new
incremental costs associated with new regulations, to the extent
permitted by law, be offset by the elimination of existing costs
associated with at least two prior regulations. Because this proposed
rule is estimated to have a total cost of less than zero (cost savings
of $52,715 per year), DEA expects the rule will be considered an E.O.
13771 deregulatory action.
---------------------------------------------------------------------------
\11\ 82 FR 9339.
---------------------------------------------------------------------------
Executive Order 12988, Civil Justice Reform
This proposed 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 proposed rule does not have federalism implications warranting
the application of E.O. 13132. The proposed 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 proposed 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
In accordance with the Regulatory Flexibility Act (RFA), the DEA
has reviewed the economic impact of this proposed rule on small
entities. DEA's economic impact evaluation indicates that the rule will
not, if promulgated, have a significant economic impact on a
substantial number of small entities.
The 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 proposed rule
and estimates that it will have minimal economic impact on affected
entities, including small businesses, nonprofit organizations, and
small governmental jurisdictions.
This proposed rule will simplify the form submission process by
requiring all initial registration and renewal applications be
submitted online. The rule would affect all applicants for DEA
registration or re-registration who would use paper forms. There has
been a continued decrease in the use of paper applications from 2016 to
2020. Paper applications, as a percentage of total applications,
decreased annually from 7.5 percent in 2016 to 2.8 percent, 1.5
percent, and 1.1 percent, in years 2017, 2018, and 2019, respectively.
In the first three months of 2020, 99.3 percent of all DEA Registration
Forms were submitted electronically via DEA's secure website and 0.7
percent were submitted by paper. While it is possible the percentage of
paper submissions will continue to drop, DEA believes 0.7 percent is a
reasonable estimate. Therefore, this proposed rule will impact the
remaining 0.7 percent of registration forms that are submitted by
paper, approximately 4,453 registrations per year.\12\
---------------------------------------------------------------------------
\12\ The average annual number of applications from 2017 to 2019
is 636,097. 636,097 x 0.7 percent = 4,453.
---------------------------------------------------------------------------
All registration business activities (registrant-type) have used
paper registration forms in the past three years. DEA estimated the
number of applications by business activity based on the three-year
average, 2017-2019, of actual paper application submissions. DEA
applied the percentages for each business activity to the estimated
4,453 paper registration per year. For example, on average, 5.73
percent of total paper registration forms were for pharmacy
registrations. Applying 5.73 percent to the 4,453 estimated total paper
registrations, the estimated number of paper registrations for pharmacy
registrations was 255 (4,453 x 5.73 percent). This calculation was
conducted for each business activity and the results are in Table 1
below.
Table 1--Percentage and Number of Paper Registrations by Business Activity
----------------------------------------------------------------------------------------------------------------
2017 2018 2019 Average Number of
Business activity (percent) (percent) (percent) (percent) registrations
----------------------------------------------------------------------------------------------------------------
Pharmacy........................ 3.12 6.25 7.81 5.73 255
Hospital/Clinic................. 2.11 2.67 3.57 2.78 124
Practitioner.................... 79.73 77.99 74.13 77.29 3,442
Teaching Institution............ 0.03 0.04 0.01 0.03 1
Manufacturer.................... 0.23 0.33 0.39 0.32 14
Distributor..................... 0.15 0.18 0.28 0.20 9
Researcher/Canine Handler....... 3.00 3.61 2.96 3.19 142
Analytical Lab.................. 0.41 0.53 0.51 0.48 22
Importer........................ 0.07 0.10 0.10 0.09 4
Exporter........................ 0.03 0.04 0.07 0.05 2
Reverse Distributor............. 0.01 0.02 0.04 0.03 1
Mid-level Practitioner (MLP).... 10.38 7.62 9.40 9.14 407
Narcotic Treatment Program...... 0.38 0.33 0.38 0.36 16
Chemical Manufacturer........... 0.11 0.11 0.10 0.11 5
[[Page 1033]]
Chemical Importer............... 0.06 0.02 0.03 0.04 2
Chemical Distributor............ 0.13 0.10 0.13 0.12 5
Chemical Exporter............... 0.03 0.04 0.09 0.05 2
-------------------------------------------------------------------------------
Total........................... 100.00 100.00 100.00 100.00 4,453
----------------------------------------------------------------------------------------------------------------
(Source: DEA)
As this proposed rule affects all business activities that are
required to obtain a registration with DEA pursuant to the CSA, this
proposed rule would affect small entities in a wide variety of
industries. Table 2 indicates the sectors, as defined by the North
American Industry Classification System (NAICS), affected by the
proposed rule. Most DEA registrants are, or are employed by, small
entities under Small Business Administration (SBA) standards.
Table 2--Industrial Sectors of DEA Registrants
------------------------------------------------------------------------
Business Activity NAICS Code NAICS Code Description
------------------------------------------------------------------------
Manufacturer................... 325411 Medicinal and Botanical
Manufacturing.
325412 Pharmaceutical
Preparation
Manufacturing.
Distributor, Importer, Exporter 424210 Drugs and Druggists'
Sundries Merchant
Wholesalers.
Reverse Distributor............ 5621 Waste Collection.
5622 Waste Treatment and
Disposal.
Pharmacy....................... 445110 Supermarkets and Other
Grocery (except
Convenience) Stores.
446110 Pharmacies and Drug
Stores.
452210 Department Stores.
452311 Warehouse Clubs and
Supercenters.
Analytical Labs................ 541380 Testing Laboratories.
Teaching institute............. 611310 Colleges, Universities
and Professional
Schools.
Researcher..................... 541715 Research and
Development in the
Physical, Engineering,
and Life Sciences
(except Nanotechnology
and Biotechnology).
Canine Handler................. 561612 Security Guards and
Patrol Services.
Practitioner, Mid-level 541940 Veterinary Services.
Practitioner,* Narcotic
Treatment Program, Hospital/
Clinic.
621111 Offices of Physicians
(except Mental Health
Specialists).
621112 Offices of Physicians,
Mental Health
Specialists.
621210 Offices of Dentists.
621330 Offices of Mental
Health Practitioners
(except Physicians).
621391 Offices of Podiatrists.
621420 Outpatient Mental
Health and Substance
Abuse Centers.
621491 HMO Medical Centers.
621493 Freestanding Ambulatory
Surgical and Emergency
Centers.
622110 General Medical and
Surgical Hospitals.
622210 Psychiatric and
Substance Abuse
Hospitals.
622310 Specialty (except
Psychiatric and
Substance Abuse)
Hospitals.
Chemical Manufacturer.......... 325 Chemical Manufacturing.
Chemical Distributor, Chemical 424690 Other Chemical and
Importer, Chemical Exporter. Allied Products
Merchant Wholesalers.
------------------------------------------------------------------------
* Practitioners and mid-level practitioners are generally employed in
one of these industries.
As shown in Table 2, the proposed rule would affect a wide variety
of entities across many industry sectors. As some industry sectors are
expected to consist primarily of DEA registrants (i.e., 446110-
Pharmacies and Drug Stores, 622110-General Medical and Surgical
Hospitals, etc.), this proposed rule is expected to affect some small
entities. For reference, Table 3 lists the average annual revenue for
the smallest of small businesses in each industry sector. The table
below lists the results.
Table 3--Average Annual Revenue of Smallest of Small Entities
----------------------------------------------------------------------------------------------------------------
Average
Enterprise Number of revenue per
NAICS code NAICS code description size (number establishments establishment
of employees) ($)
----------------------------------------------------------------------------------------------------------------
325............................ Chemical Manufacturing......... 0-4 3,148 1,938,546
325411......................... Medicinal and Botanical 0-4 108 727,444
Manufacturing.
325412......................... Pharmaceutical Preparation *5-9 129 2,639,287
Manufacturing.
424210......................... Drugs and Druggists' Sundries 0-4 3,630 1,367,131
Merchant Wholesalers.
[[Page 1034]]
424690......................... Other Chemical and Allied 0-4 3,352 2,007,996
Products Merchant Wholesalers.
445110......................... Supermarkets and Other Grocery 0-4 23,710 453,787
(except Convenience) Stores.
446110......................... Pharmacies and Drug Stores..... 0-4 6,360 1,069,655
452112......................... Discount Department Stores..... 0-4 6 266,167
452910......................... Warehouse Clubs and 0-4 12 326,333
Supercenters.
541380......................... Testing Laboratories........... 0-4 2,415 297,737
541712......................... Research and Development in the 0-4 5,013 427,790
Physical, Engineering, and
Life Sciences (except
Biotechnology).
541940......................... Veterinary Services............ 0-4 8,881 292,166
561612......................... Security Guards and Patrol 0-4 2,162 114,198
Services.
5621........................... Waste Collection............... 0-4 3,853 365,902
5622........................... Waste Treatment and Disposal... 0-4 616 461,159
611310......................... Colleges, Universities, and 0-4 372 913,078
Professional Schools.
621111......................... Offices of Physicians (except 0-4 95,648 447,715
Mental Health Specialists).
621112......................... Offices of Physicians, Mental 0-4 8,980 253,837
Health Specialists.
621210......................... Offices of Dentists............ 0-4 50,781 330,868
621320......................... Offices of Optometrists........ 0-4 10,939 269,348
621330......................... Offices of Mental Health 0-4 16,149 145,005
Practitioners (except
Physicians).
621391......................... Offices of Podiatrists......... 0-4 5,300 288,546
621420......................... Outpatient Mental Health and 0-4 1,810 211,249
Substance Abuse Centers.
621491......................... HMO Medical Centers............ * 5-9 16 620,188
621493......................... Freestanding Ambulatory 0-4 1,011 549,974
Surgical and Emergency Centers.
622110......................... General Medical and Surgical 0-4 39 10,621,308
Hospitals.
622210......................... Psychiatric and Substance Abuse * 20-99 27 5,142,444
Hospitals.
622310......................... Specialty (except Psychiatric 0-4 21 8,561,238
and Substance Abuse) Hospitals.
----------------------------------------------------------------------------------------------------------------
* The revenue figure for the smallest size category is unavailable. The revenue figure for the smallest size
category with available revenue figure is used.
There are no new costs associated with this proposed rule. The
labor burden to submit an application is estimated to be the same for
electronic and paper submissions. No special software is needed to
complete an online application via DEA's public website. Furthermore,
all applicants, including the estimated 0.7 percent of applicants using
paper forms, are assumed to be able to access the internet without
incurring additional costs. DEA believes using email for contact is
indicative of having internet access. Although the applicant's contact
email address is an optional field on a paper registration application,
virtually all applications submitted include contact email
addresses.\13\ Although online applications are available at no
additional cost, DEA acknowledges some applicants have a preference for
paper forms. DEA does not have a basis to quantify this preference;
however, DEA believes any costs associated with eliminating this
preference is offset by the qualitative cost savings discussion below.
---------------------------------------------------------------------------
\13\ Based on a review of applications submitted from January
2020 to March 2020, there were 307 applications for initial
registrations submitted using the paper form. Six of those 307
applications did not contain a contact email address. Including the
online applications, six of 30,509 applications for new
registrations over the three month period, January-March 2020, did
not contain email addresses.
---------------------------------------------------------------------------
DEA anticipates there will be cost savings associated with
electronic submissions. Some cost savings are described qualitatively
and some are quantified. Many paper applications submitted contain
illegible or erroneous information or omit required information. Many
such errors or omissions, such as not including a signature or paying
the wrong amount, require DEA to contact applicants to correct or
clarify the information in the paper form, consuming DEA's and the
applicant's time and resources. Electronic submissions are expected to
virtually eliminate the requirement for DEA to contact applicants for
clarifications of form data or correction of submission errors, as
validation features in the system will flag common errors prior to
transmission. As DEA has not tracked the number of delays or the
duration of such delays, DEA does not have a basis to quantify the cost
savings.
Furthermore, this proposed rule would eliminate the need to print
paper forms and transmit by mail or courier service. DEA estimates
there will be a cost savings of $0.63 ($0.55 for postage plus $0.08 for
an envelope) per each paper form not submitted. DEA assumes the cost
savings associated with eliminating printing costs is negligible.
Therefore, this proposed rule, if promulgated, 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 of 1995
(UMRA),\14\ DEA has determined that this action would 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.
---------------------------------------------------------------------------
\14\ 2 U.S.C. 1501, et seq.
---------------------------------------------------------------------------
Paperwork Reduction Act
This proposed rule would modify existing collection(s) of
information requirement under the Paperwork Reduction Act (PRA).\15\
Pursuant to the PRA,\16\ DEA has identified the collections of
information below related to this proposed rule. A person is not
required to respond to a collection of information unless it displays a
valid OMB control number.\17\
---------------------------------------------------------------------------
\15\ 44 U.S.C. 3501-3521.
\16\ 44 U.S.C. 3507(d).
\17\ Copies of existing information collections approved by OMB
may be obtained at https://www.reginfo.gov/public/do/PRAMain.
---------------------------------------------------------------------------
[[Page 1035]]
A. Collections of Information Associated With the Proposed Rule
1. Title: Application for Registration-DEA 224, Application of
Registration Renewal-DEA 224A.
OMB Control Number: 1117-0014.
Form Number: DEA-224/224a.
DEA is proposing to amend 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 would 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 by a Retail
Pharmacy, Hospital/Clinic, Practitioner, Teaching Institution, or Mid-
Level Practitioner would be 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 through the secure database will ensure the
Administration's receipt of applications in a more timely and organized
manner.
DEA estimates the following number of respondents and burden
associated with this collection of information:
Number of respondents: 617,086.
Frequency of response: 1.
Number of responses: 617,086.
Burden per response: 0.202186 \18\
---------------------------------------------------------------------------
\18\ Calculated based on total annual hour burden and the number
of respondents (124,766/617,086 = 0.202186).
---------------------------------------------------------------------------
Total annual hour burden: 124,766.
2. Title: Application for Registration (DEA Form 225); Application
for Registration Renewal (DEA Form 225a); Affidavit for Chain Renewal
(DEA Form 225B).
OMB Control Number: 1117-0012.
Form Number: DEA-225/225(A).
DEA is proposing to amend its regulations for all new and renewal
registration applications to implement the requirement of electronic
only submission. This amendment would clarify the submission process by
aligning it with the Administration's current requirements for other
online form submissions. The online submission of DEA Forms 225/225a by
Manufacturer, Distributor, Researcher, Canine Handler, Analytical
Laboratory, Importer, or Exporter would be filed with DEA through the
DEA Diversion Control Diversion secure network (available on the DEA
Diversion Control Division website). The online submission of new and
renewal applications through the secure database will ensure the
Administration's receipt of applications in a more timely and organized
manner.
DEA estimates the following number of respondents and burden
associated with this collection of information:
Number of respondents: 16,338
Frequency of response: 1
Number of responses: 16,338
Burden per response (hour): 0.199106 \19\
---------------------------------------------------------------------------
\19\ Calculated based on total annual hour burden and the number
of respondents (3,253/16,338 = 0.199106).
---------------------------------------------------------------------------
Total annual hour burden: 3,253
3. Title: Application for Registration (DEA Form 363) and
Application for Registration Renewal (DEA Form 363a).
OMB Control Number: 1117-0015.
Form Number: DEA-363/363a.
DEA is proposing to amend its regulations for all new and renewal
registration applications to implement the requirement of online
submission. This amendment would clarify the submission process by
aligning it with the Administration's current requirements for other
online form submissions. The electronic submission of DEA Forms 363/
363a by a Narcotic Treatment Program would be filed with DEA through
the DEA Diversion Control Diversion secure network (available on the
DEA Diversion Control Division website). The online submission of new
and renewal applications through the secure database will ensure the
Administration's receipt of applications in a more timely and organized
manner.
DEA estimates the following number of respondents and burden
associated with this collection of information:
Number of respondents: 1,900
Frequency of response: 1
Number of responses: 1,900
Burden per response: 0.187895 \20\
---------------------------------------------------------------------------
\20\ Calculated based on total annual hour burden and the number
of respondents (357/1,900 = 0.187895).
---------------------------------------------------------------------------
Total annual hour burden: 357
4. Title: Application for Registration Under Domestic Chemical
Diversion Control Act of 1993 and Renewal Application for Registration
under Domestic Chemical Diversion Control Act of 1993.
OMB Control Number: 1117-0031.
Form Number: DEA 510/510a.
DEA is proposing to amend its regulations for all new and renewal
registration applications to implement the requirement of online
submission. This amendment would clarify the submission process by
aligning it with the Administration's current requirements for other
form submissions. The electronic submission of DEA Forms 510/510a by a
Domestic Chemical Handler would be filed with DEA through the DEA
Diversion Control Diversion secure network (available on the DEA
Diversion Control Division website). The online submission of new and
renewal applications through the secure database will ensure the
Administration's receipt of applications in a more timely and organized
manner.
DEA estimates the following number of respondents and burden
associated with this collection of information:
Number of respondents: 1,001
Frequency of response: 1
Number of responses: 1,001
Burden per response (hour): 0.182817 \21\
---------------------------------------------------------------------------
\21\ Calculated based on total annual hour burden and the number
of respondents (183/1,001 = 0.182817).
---------------------------------------------------------------------------
Total annual hour burden: 183
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, DEA is required to provide a notice
regarding the proposed collections of information in the FR with the
notice of proposed rulemaking and solicit public comment. Pursuant to
the PRA,\22\ DEA solicits comments on the following issues:
---------------------------------------------------------------------------
\22\ 44 U.S.C. 3506(c)(2).
---------------------------------------------------------------------------
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.
All comments concerning collections of information under the PRA
must be submitted to the Office of Information and Regulatory Affairs,
OMB, Attention: Desk Officer for the Department of Justice, Washington,
DC 20503. Please state that your comments refer to RIN 1117-0014, 1117-
0012, 1117-0015, or 1117-0031/Docket No. DEA-587. All comments must be
submitted to OMB on or before March 8, 2021. The final rule will
respond to any OMB or public comments on the information collection
requirements contained in this proposed rule.
[[Page 1036]]
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) 362-3261.
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 proposes to amend 21
CFR parts 1301 and 1309 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. In Sec. 1301.13, revise 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 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. DEA Forms 224a, 225a, and 363a 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.
* * * * *
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:
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 credit card at the time of
submission using the secure application portal at
www.DEAdiversion.usdoj.gov.
0
6. In Sec. 1309.32, revise 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 Section 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 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 table heading and the entry
under ``DEA Registration Section'' to read as follows:
Sec. 1321.01 DEA mailing addresses.
* * * * *
[[Page 1037]]
Table 1 to Sec. 1321.01--DEA Mailing Addresses
------------------------------------------------------------------------
Code of Federal Regulations Section--
Topic DEA mailing address
------------------------------------------------------------------------
* * * * * * *
------------------------------------------------------------------------
DEA Registration Section
------------------------------------------------------------------------
1301.03--Procedures information request Drug Enforcement
(controlled substances registration). Administration, Attn:
1301.18(c)--Research project controlled Registration Section/DRR, P.O.
substance increase request. Box 2639, Springfield, VA
1301.51--Controlled substances 22152.
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.
* * * * * * *
------------------------------------------------------------------------
* * * * *
Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-28532 Filed 1-6-21; 8:45 am]
BILLING CODE 4410-09-P
