38230 Federal Register / Vol. 86, No. 136 / Tuesday, July 20, 2021 / Rules and Regulations 

1 21 U.S.C. 821, 827, 871(b). 

2 21 U.S.C. 958(f). 

3 28 CFR 0.100(b). 

4New Single-Sheet Format for U.S. Official Order 

Form for Schedule I and II Controlled Substances 

(DEA Form 222) 84 FR 51368, Sept. 30, 2019. 

Airspace Designations and Reporting 

Points, dated July 21, 2020, and 

effective September 15, 2020, is 

amended as follows: 

Paragraph 6005 Class E Airspace Areas 

Extending Upward From 700 Feet or More 

Above the Surface of the Earth. 

* * * * * 

ANE ME E5 Monhegan Island, ME [New] 

Monhegan Island Heliport, ME 

(Lat. 43°45′52′′ N, long. 69°18′52′′ W) 

That airspace extending upward from 700 

feet above the surface of the earth within a 

6-mile radius of Monhegan Island Heliport. 

Issued in College Park, Georgia, on July 12, 

2021. 

Andreese C. Davis, 

Manager, Airspace & Procedures Team South, 

Eastern Service Center, Air Traffic 

Organization. 

[FR Doc. 2021–15284 Filed 7–19–21; 8:45 am] 

BILLING CODE 4910–13–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Part 1305 

[Docket No. DEA–662] 

RIN 1117–AB61 

Clarification Regarding the Supplier’s 

DEA Registration Number on the 

Single-Sheet DEA Form 222 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Direct final rule. 

SUMMARY: The Drug Enforcement 

Administration (DEA) is issuing this 

direct final rule to amend DEA 

regulations to clarify that either the 

purchaser or the supplier may enter a 

supplier’s DEA registration number on 

the Single-Sheet DEA Form 222. 

DATES: This direct final rule is effective 

on October 18, 2021 without further 

action, unless significant adverse 

comment is received by August 19, 

2021. If the Drug Enforcement 

Administration (DEA) receives 

significant adverse comment, it will 

publish a withdrawal of the rule in the 

Federal Register by September 20, 2021. 

Electronic comments must be 

submitted, and written comments must 

be postmarked, on or before August 19, 

2021. Commenters should be aware that 

the electronic Federal Docket 

Management System will not accept 

comments after 11:59 p.m. Eastern Time 

on the last day of the comment period. 

ADDRESSES: To ensure proper handling 

of comments, please reference ‘‘Docket 

No. DEA–662’’ on all correspondence, 

including any attachments. 

Electronic comments: DEA encourages 

that all comments be submitted 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 an electronic submission 

are not necessary and are discouraged. 

Should you wish to mail a paper 

comment in lieu of an electronic 

comment, it should be sent via regular 

or express mail to: Drug Enforcement 

Administration, Attention: 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; Telephone: (571) 776– 

2265. 

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 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 confidential 

business information to be redacted 

within the comment. 

Comments containing personal 

identifying information and confidential 

business information as directed above 

will generally be made publicly 

available in redacted form. If a comment 

has so much confidential business 

information or personal identifying 

information that it cannot be effectively 

redacted, all or part of that comment 

may not be made publicly available. 

Comments posted to http://

www.regulations.gov may include any 

personal identifying information (such 

as name, address, and phone number) 

included in the text of your electronic 

submission that is not identified as 

directed above as confidential. 

An electronic copy of this direct final 

rule is available at http://

www.regulations.gov under FDMS 

Docket ID: DEA–2020–0036. 

Legal Authority and Background 

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; 

maintenance and submission of records 

and reports; and for the efficient 

execution of his statutory functions.1

The CSA further authorizes the Attorney 

General to promulgate rules and 

regulations relating to the registration 

and control of importers and exporters 

of controlled substances.2 The Attorney 

General has delegated this authority to 

the Administrator of DEA.3

The DEA Form 222 is used by DEA 

registrants to order schedule I and II 

controlled substances. In September 

2019, DEA issued a final rule to 

implement a new single-sheet DEA 

Form 222 (single-sheet form) to replace 

the three-part carbon copy form 

(triplicate form), and allowed a 

transition period for use of existing 

stocks of the triplicate form until 

October 30, 2021 (or earlier if the 

registrant exhausts its supply).4 Both the 

single-sheet and triplicate forms require 

certain information to be completed 


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Federal Register / Vol. 86, No. 136 / Tuesday, July 20, 2021 / Rules and Regulations 38231 

5 21 CFR 1305.13(b). 6 21 CFR 1305.13(b). 

pertaining to the supplier (i.e., supplier 

name, address, and DEA registration 

number). The final rule set forth a 

procedure for the supplier filling DEA 

Forms 222 and providing its DEA 

registration number, among other 

things, and specifically provides that 

‘‘[a] supplier may fill the order . . . and 

must record on the original DEA Form 

222 its DEA registration number.’’ 5

As previously noted, both the singlesheet and triplicate forms require the 

supplier’s DEA registration number to 

be recorded. On the triplicate form, the 

field for the supplier’s DEA registration 

number is located within a section titled 

‘‘TO BE FILLED IN BY SUPPLIER.’’ 

However, on the single-sheet form, the 

field for the supplier’s DEA registration 

number is located directly above a 

section titled ‘‘TO BE FILLED IN BY 

PURCHASER.’’ This has led to some 

confusion regarding who must record 

the supplier’s DEA registration number 

on the single-sheet DEA Form 222. 

Clarification on Completing the 

Supplier’s DEA Registration Number 

Information 

Since the publication of the singlesheet final rule, DEA has received 

inquiries regarding whether the 

purchaser or the supplier should enter 

the supplier’s DEA registration number 

on the single-sheet form. DEA is 

amending its regulations to clarify that 

either the purchaser or the supplier may 

fill in this information. DEA also notes 

that the single-sheet form has been 

slightly modified—and approved by the 

Office of Management and Budget 

(OMB) in July 2020—by the addition of 

a line that separates the field for the 

supplier’s DEA registration number 

from the field titled, ‘‘PART 2: TO BE 

FILLED IN BY PURCHASER,’’ in which 

the supplier’s business name and 

address are recorded. This revised 

version of the form is being provided to 

any registrant requesting paper DEA 

Forms 222 pursuant to 21 CFR 1305.11. 

Regulatory Analyses 

Administrative Procedure Act 

An agency may find good cause to 

exempt a rule from prior public notice 

provisions of the Administrative 

Procedure Act (APA) (5 U.S.C. 

553(b)(B)), if it is determined to be 

unnecessary, impracticable, or contrary 

to the public interest. This rule clarifies 

that either the purchaser or supplier 

may enter the supplier’s DEA 

registration number on the single-sheet 

DEA Form 222. Furthermore, DEA notes 

that this rule does not impose any new 

requirements as the supplier’s DEA 

registration number is already required 

to be entered on the single-sheet form.6

Therefore, DEA concludes it is 

unnecessary to issue this rule for public 

notice and comment, prior to issuing a 

final rule, and finds good cause to 

exempt this rule from the provisions of 

the APA under 5 U.S.C. 553(b)(B). For 

the same reasons, DEA has determined 

that this rule is suitable for direct final 

rulemaking. Although DEA does not 

expect to receive significant adverse 

comment on this rule, DEA has decided 

to allow for public comment. If DEA 

receives significant adverse comment 

within 30 days of the publication of this 

final rule, it will publish a timely 

withdrawal of the rule in the Federal 

Register. 

Executive Orders 12866 (Regulatory 

Planning and Review) and 13563 

(Improving Regulation and Regulatory 

Review) 

This direct final rule was developed 

in accordance with the principles of 

Executive Orders (E.O.) 12866 and 

13563. E.O. 12866 directs agencies to 

assess all costs and benefits of available 

regulatory alternatives and, if regulation 

is necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects; distributive impacts; and 

equity). E.O. 13563 is supplemental to 

and reaffirms the principles, structures, 

and definitions governing regulatory 

review as established in E.O. 12866. 

OMB’s Office of Information and 

Regulatory Affairs (OIRA) has 

determined that this direct final rule is 

not a significant regulatory action as 

defined by E.O. 12866, section 3(f). 

Analysis of Benefits and Costs 

DEA has analyzed the economic 

impact of this direct final rule and 

estimates the annual cost to be $0. This 

rule is minor and technical in nature, 

merely clarifying existing DEA 

regulations and requirements. Current 

regulations require the supplier’s DEA 

registration number to be entered on the 

single-sheet DEA Form 222. Thus, this 

rule does not impose any new 

requirement and there is no new cost or 

labor burden associated with this rule. 

While this direct final rule will result 

in no economic impact on registrants or 

DEA, DEA believes there are certain 

benefits of this rule. This rule is 

expected to enhance clarity as well as 

flexibility, by clearly stating that either 

the purchaser or the supplier may enter 

the supplier’s DEA registration number 

on the DEA Form 222. While DEA does 

not have a basis to quantify the benefits, 

DEA believes the benefits are real and 

welcomed by the affected registrants. 

Executive Order 12988, Civil Justice 

Reform 

This direct final rule meets the 

applicable standards set forth in 

sections 3(a) and 3(b)(2) of E.O. 12988 

to eliminate drafting errors and 

ambiguity, minimize litigation, provide 

a clear legal standard for affected 

conduct, and promote simplification 

and burden reduction. 

Executive Order 13132, Federalism 

This direct final rule does not have 

federalism implications warranting the 

application of E.O. 13132. The direct 

final 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 

This direct final rule does not have 

tribal implications warranting the 

application of E.O. 13175. It does not 

have substantial direct effects on one or 

more Indian tribes, on the relationship 

between the Federal government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

Federal government and Indian tribes. 

Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601–612) applies to rules that 

are subject to notice and comment 

under section 553(b) of the APA or other 

laws. As explained above, DEA 

determined that there is good cause to 

exempt this direct final rule from notice 

and comment. Consequently, the RFA 

does not apply to this direct final rule. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act (UMRA) of 1995, 

2 U.S.C. 1501 et seq., DEA has 

determined that this action 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 million 

or more (adjusted annually for inflation) 

in any one year. Therefore, neither a 

Small Government Agency Plan nor any 

other action is required under UMRA of 

1995. 


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38232 Federal Register / Vol. 86, No. 136 / Tuesday, July 20, 2021 / Rules and Regulations 

Paperwork Reduction Act of 1995 

This direct final rule does not impose 

a new collection requirement under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3521). This direct final rule 

does not impose new recordkeeping or 

reporting requirements on State or local 

governments, individuals, businesses, or 

organizations. Although the direct final 

rule is applicable to an existing 

collection of information, the rule 

merely clarifies certain recordkeeping 

requirements that already apply to 

registrants using DEA Form 222 and 

therefore does not impose any new 

collection of information requirement. 

An agency may not conduct or sponsor, 

and a person is not required to respond 

to, a collection of information unless it 

displays a currently valid OMB control 

number. 

Congressional Review Act 

OIRA has determined that this direct 

final rule is not a major rule as defined 

by Subtitle E of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (known as the Congressional 

Review Act or CRA), 5 U.S.C. 804(2). 

This direct final rule will not result in 

an annual effect on the economy of $100 

million or more; a major increase in 

costs or prices; or significant adverse 

effects on competition, employment, 

investment, productivity, innovation, or 

the ability of United States-based 

companies to compete with foreignbased companies in domestic and 

export markets. However, pursuant to 

the CRA, DEA is submitting a copy of 

this direct final rule to both Houses of 

Congress and to the Comptroller 

General. 

List of Subjects 

21 CFR Part 1305 

Drug traffic control, Reporting and 

recordkeeping requirements. 

For the reasons set out above, DEA 

amends 21 CFR part 1305 as follows: 

PART 1305—ORDERS FOR SCHEDULE 

I AND II CONTROLLED SUBSTANCES 

■ 1. The authority citation for part 1305 

continues to read as follows: 

Authority: 21 U.S.C. 821, 828, 871(b), 

unless otherwise noted. 

■ 2. In § 1305.12, add a sentence to the 

end of paragraph (c) to read as follows: 

§ 1305.12 Procedure for executing DEA 

Forms 222. 

* * * * * 

(c) * * * The supplier’s DEA 

registration number may be entered by 

the purchaser or the supplier. 

* * * * * 

■ 3. In § 1305.13, revise the first 

sentence of paragraph (b) to read as 

follows: 

§ 1305.13 Procedure for filling DEA Forms 

222. 

* * * * * 

(b) A supplier may fill the order, if 

possible and if the supplier desires to do 

so, and must record on the original DEA 

Form 222 its DEA registration number 

(if not previously entered by the 

purchaser) and the number of 

commercial or bulk containers 

furnished on each item and the date on 

which containers are shipped to the 

purchaser. * * * 

* * * * * 

Anne Milgram, 

Administrator. 

[FR Doc. 2021–15323 Filed 7–19–21; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF LABOR 

Occupational Safety and Health 

Administration 

29 CFR Part 1910 

[Docket No. OSHA–2020–0004] 

RIN 1218–AD36 

Occupational Exposure to COVID–19; 

Emergency Temporary Standard 

AGENCY: Occupational Safety and Health 

Administration (OSHA), Department of 

Labor. 

ACTION: Interim final rule; extension of 

comment period. 

SUMMARY: The period for submitting 

public comments is being extended by 

30 days to allow stakeholders interested 

in the emergency temporary standard 

(ETS) additional time to review the ETS 

and collect information and data 

necessary for comment. 

DATES: The comment period for the 

interim final rule (ETS) that was 

published June 21, 2021, at 86 FR 

32376, effective June 21, 2021, is 

extended. Comments on any aspect of 

the ETS and whether the ETS should be 

adopted as a permanent standard must 

be submitted by August 20, 2021. 

ADDRESSES: 

Written comments: You may submit 

comments and attachments, identified 

by Docket No. OSHA–2020–0004, 

electronically at www.regulations.gov, 

which is the Federal e-Rulemaking 

Portal. Follow the online instructions 

for making electronic submissions. 

Instructions: All submissions must 

include the agency’s name and the 

docket number for this rulemaking 

(Docket No. OSHA–2020–0004). All 

comments, including any personal 

information you provide, are placed in 

the public docket without change and 

may be made available online at 

www.regulations.gov. Therefore, OSHA 

cautions commenters about submitting 

information they do not want made 

available to the public or submitting 

materials that contain personal 

information (either about themselves or 

others), such as Social Security 

Numbers and birthdates. 

Docket: To read or download 

comments or other material in the 

docket, go to Docket No. OSHA–2020– 

0004 at www.regulations.gov. All 

comments and submissions are listed in 

the www.regulations.gov index; 

however, some information (e.g., 

copyrighted material) is not publicly 

available to read or download through 

that website. All comments and 

submissions, including copyrighted 

material, are available for inspection 

through the OSHA Docket Office. 

Documents submitted to the docket by 

OSHA or stakeholders are assigned 

document identification numbers 

(Document ID) for easy identification 

and retrieval. The full Document ID is 

the docket number (OSHA–2020–0004) 

plus a unique four-digit code (e.g., 

OSHA–2020–0004–1033). When citing 

materials in the docket, OSHA includes 

the term ‘‘Document ID’’ followed by 

the last four digits of the Document ID 

number (e.g., Document ID 1033). 

Document ID numbers are used to 

identify docket materials in this notice. 

However, OSHA identified supporting 

information in the ETS (86 FR 32376) by 

author name and publication year, when 

appropriate. The agency has also 

provided a spreadsheet in the docket 

that identifies the full Document ID for 

each reference cited in the ETS (see 

Document ID 1042). This information 

can be used to search for a supporting 

document in the docket at http://

www.regulations.gov. Contact the OSHA 

Docket Office at 202–693–2350 (TTY 

number: 877–889–5627) for assistance 

in locating docket submissions. 

FOR FURTHER INFORMATION CONTACT:

General information and press 

inquiries: Contact Frank Meilinger, 

Director, Office of Communications, 

U.S. Department of Labor; telephone 

(202) 693–1999; email 

meilinger.francis2@dol.gov. 

For technical inquiries: Contact 

Andrew Levinson, Directorate of 

Standards and Guidance, U.S. 

Department of Labor; telephone (202) 

693–1950. 


khammond on DSKJM1Z7X2PROD with RULES