1030 Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Proposed Rules 

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 

6https://www.deadiversion.usdoj.gov/drugreg/ 

index.html#regapps. 

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 

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 http:// 

www.regulations.gov and follow the 

online instructions at that site for 

submitting comments. Upon completion 

of your submission, you will receive a 

Comment Tracking Number for your 

comment. Please be aware that 

submitted comments are not 

instantaneously available for public 

view on Regulations.gov. If you have 

received a Comment Tracking Number, 

your comment has been successfully 

submitted and there is no need to 

resubmit the same comment. 

• Paper comments: Paper comments 

that duplicate 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 http://

www.regulations.gov. Such information 

includes personal identifying 

information (such as your name, 

address, etc.) voluntarily submitted by 

the commenter. The Freedom of 

Information Act applies to all comments 

received. If you want to submit personal 

identifying information (such as your 

name, address, etc.) as part of your 

comment, but do not want it to be made 

publicly available, you must include the 

phrase ‘‘PERSONAL IDENTIFYING 

INFORMATION’’ in the first paragraph 

of your comment. You must also place 

all of the personal identifying 

information you do not want made 

publicly available in the first paragraph 

of your comment and identify what 

information you want redacted. 

If you want to submit confidential 

business information as part of your 

comment, but do not want it to be made 

publicly available, you must include the 

phrase ‘‘CONFIDENTIAL BUSINESS 

INFORMATION’’ in the first paragraph 

of your comment. You must also 

prominently identify the confidential 

business information to be redacted 

within the comment. 

Comments containing personal 

identifying information or confidential 

business information identified as 

directed above will be made publicly 

available in redacted form. If a comment 

has so much confidential business 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be made publicly available. 

Comments posted to http://

www.regulations.gov may include any 

personal identifying information (such 

as 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 http://

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 


jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Proposed Rules 1031 

7 21 CFR 1301.13, 1301.14, 1309.12, 1309.32, 

1309.33, 1309.34, and 1321.01. 

8The average annual number of applications from 

2017 to 2019 is 636,097. 636,097 × 0.7 percent = 

4,453. 

9Based 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. 

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. 

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. 

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. 

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. 


jbell on DSKJLSW7X2PROD with PROPOSALS
1032 Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Proposed Rules 

10The 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. 

11 82 FR 9339. 

12The average annual number of applications 

from 2017 to 2019 is 636,097. 636,097 × 0.7 percent 

= 4,453. 

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

Business activity 2017 

(percent) 

2018 

(percent) 

2019 

(percent) 

Average 

(percent) 

Number of 

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 


jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Proposed Rules 1033 

TABLE 1—PERCENTAGE AND NUMBER OF PAPER REGISTRATIONS BY BUSINESS ACTIVITY—Continued 

Business activity 2017 

(percent) 

2018 

(percent) 

2019 

(percent) 

Average 

(percent) 

Number of 

registrations 

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 Practitioner,* Narcotic Treatment Program, Hospital/Clinic.541940 Veterinary Services. 

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 Importer, 

Chemical Exporter.

424690 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. 

TABLE 3—AVERAGE ANNUAL REVENUE OF SMALLEST OF SMALL ENTITIES

NAICS code NAICS code description 

Enterprise 

size 

(number of 

employees) 

Number of 

establishments 

Average 

revenue per 

establishment 

($) 

325 .................... Chemical Manufacturing .............................................................................. 0–4 3,148 1,938,546 

325411 .............. Medicinal and Botanical Manufacturing ....................................................... 0–4 108 727,444

325412 .............. Pharmaceutical Preparation Manufacturing ................................................. *5–9 129 2,639,287

424210 .............. Drugs and Druggists’ Sundries Merchant Wholesalers ............................... 0–4 3,630 1,367,131 


jbell on DSKJLSW7X2PROD with PROPOSALS
1034 Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Proposed Rules 

13Based 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. 

14 2 U.S.C. 1501, et seq. 15 44 U.S.C. 3501–3521. 16 44 U.S.C. 3507(d). 17Copies of existing information collections 

approved by OMB may be obtained at http://

www.reginfo.gov/public/do/PRAMain. 

TABLE 3—AVERAGE ANNUAL REVENUE OF SMALLEST OF SMALL ENTITIES—Continued 

NAICS code NAICS code description 

Enterprise 

size 

(number of 

employees) 

Number of 

establishments 

Average 

revenue per 

establishment 

($) 

424690 .............. Other Chemical and Allied Products Merchant Wholesalers ...................... 0–4 3,352 2,007,996 

445110 .............. Supermarkets and Other Grocery (except Convenience) Stores ............... 0–4 23,710 453,787 

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 Supercenters ........................................................... 0–4 12 326,333 

541380 .............. Testing Laboratories .................................................................................... 0–4 2,415 297,737 

541712 .............. Research and Development in the Physical, Engineering, and Life 

Sciences (except Biotechnology).

0–4 5,013 427,790 

541940 .............. Veterinary Services ...................................................................................... 0–4 8,881 292,166 

561612 .............. Security Guards and Patrol Services .......................................................... 0–4 2,162 114,198 

5621 .................. Waste Collection .......................................................................................... 0–4 3,853 365,902 

5622 .................. Waste Treatment and Disposal ................................................................... 0–4 616 461,159 

611310 .............. Colleges, Universities, and Professional Schools ....................................... 0–4 372 913,078 

621111 .............. Offices of Physicians (except Mental Health Specialists) ........................... 0–4 95,648 447,715 

621112 .............. Offices of Physicians, Mental Health Specialists ........................................ 0–4 8,980 253,837 

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 Practitioners (except Physicians) ........................ 0–4 16,149 145,005 

621391 .............. Offices of Podiatrists .................................................................................... 0–4 5,300 288,546 

621420 .............. Outpatient Mental Health and Substance Abuse Centers .......................... 0–4 1,810 211,249 

621491 .............. HMO Medical Centers ................................................................................. * 5–9 16 620,188 

621493 .............. Freestanding Ambulatory Surgical and Emergency Centers ...................... 0–4 1,011 549,974 

622110 .............. General Medical and Surgical Hospitals ..................................................... 0–4 39 10,621,308 

622210 .............. Psychiatric and Substance Abuse Hospitals ............................................... * 20–99 27 5,142,444

622310 .............. Specialty (except Psychiatric and Substance Abuse) Hospitals ................. 0–4 21 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. 

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. 

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. 

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


jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Proposed Rules 1035 

18Calculated based on total annual hour burden 

and the number of respondents (124,766/617,086 = 

0.202186). 

19Calculated based on total annual hour burden 

and the number of respondents (3,253/16,338 = 

0.199106). 

20Calculated based on total annual hour burden 

and the number of respondents (357/1,900 = 

0.187895). 

21Calculated based on total annual hour burden 

and the number of respondents (183/1,001 = 

0.182817). 

22 44 U.S.C. 3506(c)(2). 

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 

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 

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. 


jbell on DSKJLSW7X2PROD with PROPOSALS
1036 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. 

■ 2. In § 1301.13, revise paragraphs 

(e)(2) and (3) to read as follows: 

§ 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. 

* * * * * 

■ 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: 

§ 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: 

Authority: 21 U.S.C. 802, 821, 822, 823, 

824, 830, 871(b), 875, 877, 886a, 952, 953, 

957, 958. 

■ 5. Revise § 1309.12 to read as follows: 

§ 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. 

■ 6. In § 1309.32, revise paragraphs (a) 

through (c) to 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. 

(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 

■ 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 DEA mailing addresses. 

* * * * * 


jbell on DSKJLSW7X2PROD with PROPOSALS
Federal Register / Vol. 86, No. 4 / Thursday, January 7, 2021 / Proposed Rules 1037 

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 .........

Drug Enforcement Administration, Attn: Registration Section/DRR, P.O. 

Box 2639, Springfield, VA 22152. 

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 

AGENCY: Bureau of Indian Affairs, Office 

of the Secretary, Interior. 

ACTION: Proposed rule. 

SUMMARY: 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 

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: 

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 


jbell on DSKJLSW7X2PROD with PROPOSALS