Federal Register / Vol. 87, No. 69 / Monday, April 11, 2022 / Rules and Regulations 21019 

animals be amended to provide for the 

safe use of methyl esters of conjugated 

linoleic acid as a source of fatty acids in 

lactating dairy cow diets and for the use 

of silicon dioxide as a carrier for the 

methyl esters of conjugated linoleic 

acid. 

In 2020, 21 CFR 573.940 was 

amended to provide for the safe use of 

silicon dioxide as an anticaking agent, 

grinding aid, antifoaming agent, or 

carrier in animal feed components 

(ingredients, intermediate premixes, 

premixes, supplements, or concentrates) 

across food substances under FAP 2308 

(85 FR 33539, June 2, 2020). 

II. Conclusion 

FDA concludes that the data establish 

the safety and utility of methyl esters of 

conjugated linoleic acid (cis-9, trans-11 

and trans-10, cis-12 octadecadienoic 

acids) for early lactation dairy cows to 

reduce the energy concentration in milk, 

and that the food additive regulations 

should be amended as set forth in this 

document. 

III. Public Disclosure 

In accordance with § 571.1(h) (21 CFR 

571.1(h)), the petition and documents 

we considered and relied upon in 

reaching our decision to approve the 

petition will be made available for 

public disclosure (see FOR FURTHER

INFORMATION CONTACT). As provided in 

§ 571.1(h), we will delete from the 

documents any materials that are not 

available for public disclosure. 

IV. Analysis of Environmental Impact 

We have determined under 21 CFR 

25.32(r) that this action is of a type that 

does not individually or cumulatively 

have a significant effect on the human 

environment. Therefore, neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

V. Objections and Hearing Requests 

Any person who will be adversely 

affected by this regulation may file with 

the Dockets Management Staff (see 

ADDRESSES) either electronic or written 

objections. Each objection shall be 

separately numbered, and each 

numbered objection shall specify with 

particularity the provision of the 

regulation to which objection is made 

and the grounds for the objection. Each 

numbered objection on which a hearing 

is requested shall specifically so state. 

Failure to request a hearing for any 

particular objection shall constitute a 

waiver of the right to a hearing on that 

objection. Each numbered objection for 

which a hearing is requested shall 

include a detailed description and 

analysis of the specific factual 

information intended to be presented in 

support of the objection in the event 

that a hearing is held. Failure to include 

such a description and analysis for any 

particular objection shall constitute a 

waiver of the right to a hearing on the 

objection. 

List of Subjects in 21 CFR Part 573 

Animal feeds, Food additives. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 573 is 

amended as follows: 

PART 573—FOOD ADDITIVES 

PERMITTED IN FEED AND DRINKING 

WATER OF ANIMALS 

■ 1. The authority citation for part 573 

continues to read as follows: 

Authority: 21 U.S.C. 321, 342, 348. 

■ 2. In § 573.637, revise the introductory 

text and paragraph (b) to read as 

follows: 

§ 573.637 Methyl esters of conjugated 

linoleic acid (cis-9, trans-11 and trans-10, 

cis-12-octadecadienoic acids). 

The food additive, methyl esters of 

conjugated linoleic acid (cis-9, trans-11 

and trans-10, cis-12-octadecadienoic 

acids) may be safely used in swine feed 

and feed for early lactation dairy cows 

(less than 100 days in milk) in 

accordance with the prescribed 

conditions: 

* * * * * 

(b) The additive is used or intended 

for use in the feed of: 

(1) Growing and finishing swine as a 

source of fatty acids at levels not to 

exceed 0.6% in the finished feed. 

(2) Early lactation dairy cows to 

reduce the energy concentration in milk 

when fed at levels not to exceed 33 

grams per cow per day. 

* * * * * 

Dated: April 4, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–07680 Filed 4–8–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Parts 1301, 1309, and 1321 

[Docket No. DEA–587] 

RIN 1117–AB58 

Requiring Online Submission of 

Applications for and Renewals of DEA 

Registration 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: This rulemaking amends the 

Drug Enforcement Administration’s 

(DEA) regulations to now require all 

applications for DEA registrations, and 

renewal of those registrations, to be 

submitted online. 

DATES: This final rule is effective May 

11, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Scott A. Brinks, Diversion Control 

Division, Drug Enforcement 

Administration; Mailing Address: 8701 

Morrissette Drive, Springfield, VA 

22152, Telephone: (571) 776–2265. 

SUPPLEMENTARY INFORMATION: 

Legal Authority 

The Drug Enforcement 

Administration (DEA) has the legal 

authority to amend its regulations to 

require online applications pursuant to 

the Controlled Substances Act (CSA). 

The CSA grants the Attorney General 

authority to promulgate rules and 

regulations relating to: The registration 

and control of the manufacture, 

distribution, and dispensing of 

controlled substances and listed 

chemicals; reporting changes to 

professional or business addresses; and 

the efficient execution of his statutory 

functions. 21 U.S.C. 821, 822(a), 827(h), 

871(b), 957(a). The Attorney General is 

further authorized by the CSA to 

promulgate rules and regulations 

relating to the registration and control of 

importers and exporters of controlled 

substances and listed chemicals. 21 

U.S.C. 958(f). The Attorney General has 

delegated this authority to the 

Administrator of DEA. 28 CFR 0.100(b). 

Need for Regulatory Changes 

Regulatory changes are needed to 

modernize DEA’s approach to 

registration and renewal applications. 

The proposed changes require online 

submission and eliminate inefficient 

paper applications. Typographical 

errors or missing pieces of information 

routinely resulted in delayed or rejected 

applications. DEA has determined the 


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1https://www.deadiversion.usdoj.gov/drugreg/

index.html#regapps. 

2See Reporting of Theft or Significant Loss of 

Controlled Substances, 85 FR 45547 (July 29, 2020) 

(published notice of proposed rulemaking 

proposing to require all DEA Form 106’s to be 

submitted electronically); see Suspicious Orders of 

Controlled Substances, 85 FR 69282 (Nov. 2, 2020) 

(published notice of proposed rulemaking 

proposing centralized electronic reporting for 

Suspicious Orders Report System (SORS) based on 

Congressional mandate); see Agency Rule List—Fall 

2021 (2021), https://www.reginfo.gov/public/do/ 

eAgendaMain?operation=OPERATION_GET_

AGENCY_RULE_LIST¤tPub=

true&agencyCode=&showStage=active&agencyCd=

1100&csrf_token=F19C7C599C70B80C228EC16

B60AEB150F6339AF3C80

E56FE003EEB7D3A758895B

C8E16A215E8A0466326EBFBA8639F799E09 (Fall 

2021 Unified Agenda of Regulatory and 

Deregulatory Actions, Active Regulatory Actions 

Listed By Agency, Agency Rule list noting proposed 

rule stage for Electronic Submission of DEA Form 

41 (Registrant Record of Controlled Substances 

Destroyed)—1117–AB59). 

3 21 CFR 1301.13, 1301.14, 1309.12, 1309.32, 

1309.33, 1309.34, and 1321.01. 

4 21 CFR 1301.13(e)(1)(iv). 

5 21 CFR 1301.13(e)(1)(1)(i)–(iii), (v)–(vi), and 

(viii)–(x). 

6 21 CFR 1301.13(e)(1)(vii). 

7 21 CFR 1309.21. 

8 21 CFR 1301.13(e)(1) and 1309.21. 

online application process will prove 

more efficient and effective for both 

DEA and registrants. 

Purpose of the Rule 

This rule mitigates issues created by 

paper applications by simplifying the 

process by which registrants submit 

new applications for registration, or 

renew current registrations. Previously, 

DEA regulations permitted the 

aforementioned DEA Registration Forms 

(224/224a, 225/225a, 363/363a, and 

510/510a) to be submitted either 

through a secure online portal or via 

delivery to DEA Headquarters.1 This 

rule amends DEA regulations by 

requiring all registration and renewal 

applications be submitted only through 

the secure online portal. The 

Administration believes this rule will 

mitigate some of the issues associated 

with paper applications by reducing 

inefficiencies and facilitating the 

application process. After careful 

consideration, DEA has determined that 

it is not necessary to amend the 

proposed regulations related to batch 

processing, because the regulations 

currently allow, and will continue to 

allow, the submission of batch 

applications. This rule is consistent 

with agency-wide efforts to reduce 

reliance on antiquated paper 

submissions and to facilitate electronic 

document processing.2

Summary of Changes 

This rule amends DEA regulations by 

revising current sections to clarify how 

registrants must apply, by adding new 

instructions, and by removing obsolete 

instructions. The rule amends existing 

DEA regulations in seven sections.3

Title 21 CFR 1301.13 and 1301.14 are 

amended to remove the option to submit 

paper forms and provide instructions for 

online application and payment 

instructions. This rule also amends 

§ 1301.14 (b), which will become 

obsolete with the adoption of the secure 

application portal. Section 1309.12 is 

amended to specify which payment 

options DEA will accept now that paper 

applications are no longer accepted. 

Section 1309.32 removes the option to 

submit paper forms and provides 

instructions for online applications and 

payments for listed chemical handlers. 

Section 1309.33 clarifies the online 

application and payment process while 

removing paragraph (b), which will 

become obsolete with the secure 

application portal. Section 1309.34 is 

also amended to clarify the handling of 

defective applications. Section 1321.01 

is amended to remove reference to 

submitting paper forms by mail to any 

DEA Registration Unit address. 

This rule affects DEA Forms relating 

to applications for registration and 

renewal of registrations, namely DEA 

Forms 224, 224a, 225, 225a, 363, 363a, 

510, and 510a. DEA Form 224 applies to 

new registration applications for 

practitioners, hospitals and clinics, 

retail pharmacies, online pharmacies, 

central fill pharmacies, and teaching 

institutions.4 DEA Form 225 applies to 

new registration applications for 

manufacturers, distributors, researchers, 

canine handlers, analytical laboratories, 

importers, and exporters.5 DEA Form 

363 applies to new registration 

applications for narcotic treatment 

programs.6 DEA Form 510 applies to 

new registration applications for all 

domestic handlers of List I chemicals .7

DEA Forms 224a, 225a, 363a, and 510a 

address registration renewal 

applications.8

Discussion of Comments 

Introduction 

On January 7, 2021, DEA published a 

notice of proposed rulemaking 

(‘‘NPRM’’) that proposed requiring that 

all applications for DEA registrations, 

and renewal of those registrations, be 

submitted online. 86 FR 1030 (Jan. 7, 

2021). DEA received four comments 

from the public on this NPRM, three 

from individuals and one from the 

National Association of Chain Drug 

Stores (NACDS). After closely analyzing 

each comment, DEA is promulgating 

this rule as proposed in the NPRM with 

one exception: DEA is clarifying that 

Automated Clearing House (ACH) fund 

transfers will be accepted as payment 

for registrations and renewals. 

Comment From National Association of 

Chain Drug Stores 

DEA received a comment from 

NACDS on March 8, 2021, about 

problems that may arise once paper 

applications and payments are no longer 

accepted. In particular, NACDS 

expressed concern about ambiguity 

surrounding whether DEA will accept 

‘‘batch’’ renewals, whether the whole 

batch will be denied if one application 

is denied, and whether alternative 

payment options will be accepted. DEA 

has reviewed these comments and 

revised § 1309.12(b) to specify that ACH 

funds transfer will be accepted as a 

payment option, in addition to credit 

cards and other forms of payment that 

may become available. 

First, NACDS observed that DEA 

neither proposes to modify nor to 

address ‘‘batch’’ submissions, a process 

by which companies seek to renew their 

registrations for multiple locations with 

a single packet covering a number of 

DEA registrations and licenses. The 

packet usually contains a single signed 

affidavit as well as a single payment. 

NACDS believes this process allows 

corporations to manage the licensing 

and registration process of thousands of 

sites efficiently. Thus, NACDS 

expressed its desire that DEA continue 

to permit registrants to submit batch 

applications. 

NACDS argued, and DEA agrees, that 

this process streamlines the renewal 

process for both companies and DEA. 

Accordingly, DEA’s online portal will 

accept online batch applications and 

single payments for batch renewals. 

After careful consideration, however, 

DEA has determined that it is not 

necessary to amend the proposed 

regulations on this point. 

Next, NACDS asserted that, ‘‘[c]larity 

is needed regarding the rejection of an 

application submitted in a batch 

submission.’’ In particular, NACDS 

argued it is unclear whether individual 

applications in a batch could be 

rejected, or whether a single faulty 

application would cause its entire batch 

to be rejected. NACDS therefore 

proposes that DEA create an electronic 

means for registrants to correct issues 

with individual applications in a batch, 

rather than having to resubmit a batch 

or otherwise inhibit the application 

process. 

Amending DEA regulations is 

unnecessary, as this comment displays 

a fundamental misunderstanding of the 

online application process itself. Step 


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one of this process involves inputting 

all necessary information and attaching 

all relevant documents. Step two 

involves an internal automated 

verification process through which 

DEA’s system analyzes all information 

submitted and determines if an 

application is complete. Only 

completed applications actually are 

processed, including for payment. Since 

this process ensures that applicants will 

not be able to submit incomplete 

applications, NACDS’ concern that 

entire batches could be rejected based 

on individual application deficiencies is 

moot. 

Last, NACDS noted that in 

§ 1309.12(b), the only payment option 

listed is ‘‘credit card.’’ NACDS thus 

assumed that the only form of payment 

DEA accepts is a credit card. NACDS 

noted that this would be troublesome 

for payments made in batch renewals 

(which can cost in excess of $1 million), 

as strict corporate policies and 

procedures often demand that large 

financial transactions be conducted via 

certified bank check. 

DEA understands and appreciates the 

concerns expressed by NACDS, and has 

therefore amended § 1309.12(b) to 

provide that payment shall be made 

online by Automated Clearing House 

(ACH) funds transfer, by credit card, or 

by any other means made available at 

the time of submission using the secure 

application portal at 

www.DEAdiversion.usdoj.gov. DEA 

recognizes that some companies may be 

required to alter their payment methods 

based on this rule change, as bank 

checks may be the most convenient 

option for some registrants. DEA 

believes, however, that the expansion of 

this rule to permit ACH transfers will 

mitigate many of the issues typically 

surrounding the financial, procedural, 

or security concerns for applicants. On 

balance, DEA also believes that this 

regulation change will promote the 

policy of increasing efficiency while 

maintaining a convenient payment 

process. In keeping with its broader 

policy of reducing reliance on tangible 

forms of payment, DEA will not accept 

bank checks for the foreseeable future. 

Other Comments 

One commenter supported the 

proposed amendments, stating the rule 

would be beneficial given the utilization 

of modern technology to submit 

documents electronically, as is common 

among other agencies. Moreover, the 

commenter noted that processes that 

were traditionally done via mail, such 

as fingerprints and verification of 

payment, can easily be verified and 

submitted electronically. Last, the 

commenter noted that the rule would be 

beneficial given the ‘‘current situation 

and restrictions given in-person 

interaction.’’ 

Another commenter supported the 

rule as a ‘‘good change for the DEA,’’ 

noting that it will prove better for the 

environment, more efficient, and that 

‘‘online is the future.’’ The commenter 

does note, however, that there is a 

privacy concern given the potential for 

this information to be accessed via 

hacking. DEA routinely evaluates the 

security mechanisms of all of its 

electronic processes, and expends 

considerable time and resources to 

protect the privacy of all registrants and 

applicants. 

Last, one citizen requested 

information as to where to locate DEA 

Form 225. Given the nature of the 

rulemaking process, DEA considers this 

comment to be a mistake, but 

nevertheless refers the commenter to 

www.deadiversion.usdoj.gov for further 

information. 

DEA has reviewed closely all 

comments, and decided to promulgate 

the regulations as written with the 

exception of permitting ACH funds 

transfers as a payment option. DEA 

appreciates the public’s participation in 

the rulemaking process, and encourages 

the public to continue submitting 

comments in the future for all proposed 

rules. 

Regulatory Analyses 

Executive Orders 12866, 13563, 

Regulatory Planning and Review, and 

Improving Regulation and Regulatory 

Review 

This rule was promulgated in 

accordance with the principles of 

Executive Orders (E.O.) 12866 and 

13563. E.O. 12866 directs agencies to 

assess all costs and benefits of available 

regulatory alternatives and, if regulation 

is necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health, and safety 

effects; distributive impacts; and 

equity). E.O. 13563 is supplemental to 

and reaffirms the principles, structures, 

and definitions governing regulatory 

review established in E.O. 12866. 

E.O. 12866 classifies a ‘‘significant 

regulatory action,’’ requiring review by 

the Office of Management and Budget 

(OMB), as any regulatory action that is 

likely to result in a rule that may: (1) 

Have an annual effect on the economy 

of $100 million or more or adversely 

affect in a material way the economy, a 

sector of the economy, productivity, 

competition, jobs, the environment, 

public health or safety, or State, local, 

or tribal governments or communities; 

(2) create a serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; (3) 

materially alter the budgetary impact of 

entitlements, grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof; or (4) raise novel 

legal or policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in the E.O. 

This final rule implements all of the 

changes discussed in the NPRM, and 

thus imposes no additional costs on 

registrants. OMB has determined that 

this final rule is not a ‘‘significant 

regulatory action’’ under E.O. 12866, 

section 3(f), Regulatory Planning and 

Review, and accordingly this rule has 

not been reviewed by OMB. 

Executive Order 12988, Civil Justice 

Reform 

This rule meets the applicable 

standards set forth in sections 3(a) and 

3(b)(2) of E.O. 12988, Civil Justice 

Reform to eliminate ambiguity, 

minimize litigation, establish clear legal 

standards, and reduce burdens. DEA 

expects the instant validation of online 

registration applications to reduce 

ambiguity and reduce the number of 

errors in submissions and reduce 

burdens on both DEA and registrants. 

Executive Order 13132, Federalism 

This rule does not have federalism 

implications warranting the application 

of E.O. 13132. The rule does not have 

substantial direct effects on the States, 

on the relationship between the 

National Government and the States, or 

on the distribution of power and 

responsibilities among the various 

levels of government. 

Executive Order 13175, Consultation 

and Coordination With Indian Tribal 

Governments 

The rule does not have substantial 

direct effects on one or more Indian 

tribes, on the relationship between the 

Federal Government and Indian tribes, 

or on the distribution of power and 

responsibilities between the Federal 

Government and Indian tribes. 

Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

requires an agency to analyze options 

for regulatory relief of small entities 

unless it can certify that the rule will 

not have a significant impact on 

substantial number of small entities. 

DEA has analyzed the economic impact 

of each provision of this rule and 

estimates that it will have minimal 

economic impact on affected entities, 

including small businesses, nonprofit 


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9 2 U.S.C. 1501, et seq. 

10 44 U.S.C. 3501–3521. 

11 44 U.S.C. 3507(d). 

12Copies of existing information collections 

approved by OMB may be obtained at https://

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

13 5 U.S.C. 804(3); see 5 U.S.C. 551(4). 

14 5 U.S.C. 804(2)(A)–(C). 

organizations, and small governmental 

jurisdictions. 

In accordance with the RFA, DEA 

reviewed the economic impact of this 

rule on small entities and evaluated the 

impact in the NPRM. DEA’s economic 

impact evaluation indicated that the 

rule proposed in the NPRM would not 

have a significant economic impact on 

a substantial number of small entities. 

This conclusion applies equally to the 

final rule, which implements all of the 

changes discussed in the NPRM. 

Unfunded Mandates Reform Act of 1995 

In accordance with the Unfunded 

Mandates Reform Act of 1995 (UMRA),9

DEA has determined that this action 

will not result in any Federal mandate 

that may result ‘‘in the expenditure by 

State, local, and tribal governments, in 

the aggregate, or by the private sector, of 

$100,000,000 or more (adjusted 

annually for inflation) in any 1 year.’’ 

Therefore, neither a Small Government 

Agency Plan nor any other action is 

required under the UMRA. 

Paperwork Reduction Act 

This rule modifies existing 

collection(s) of information required 

under the Paperwork Reduction Act 

(PRA).10 Pursuant to the PRA,11 DEA 

has identified the collections of 

information below related to this rule. A 

person is not required to respond to a 

collection of information unless it 

displays a valid OMB control number.12

DEA is amending its regulations for 

all new and renewal registration 

applications to implement the 

requirement of online submission 

through the DEA Diversion Control 

Division website. This amendment will 

improve the submission process by 

aligning it with the Administration’s 

current requirements for other online 

form submissions. The online 

submission of DEA Forms 224/224a, 

225/225a, 363/363a, 510/510a are now 

filed with DEA through the DEA 

Diversion Control Division secure 

network (available on the DEA 

Diversion Control Division website). 

The online submission of new and 

renewal applications will ensure the 

Administration’s receipt of applications 

in a more timely and organized manner. 

DEA solicited comments from the 

public regarding the following: 

• Whether the proposed collection of 

information is necessary for the proper 

performance of the functions of DEA, 

including whether the information will 

have practical utility. 

• The accuracy of DEA’s estimate of 

the burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used. 

• Recommendations to enhance the 

quality, utility, and clarity of the 

information to be collected. 

• Recommendations to minimize the 

burden of the collection of information 

on those who are to respond, including 

through the use of automated collection 

techniques or other forms of information 

technology. 

DEA solicited comments on the 

aforementioned subjects and received 

no comments. As a result, DEA is 

finalizing the collection with no 

changes. 

Congressional Review Act 

This rulemaking is a ‘‘rule’’ pursuant 

to the Congressional Review Act, 5 

U.S.C. 801 et seq.13 This rulemaking is 

not a ‘‘major rule’’ as it does not have 

an annual effect on the economy of over 

100 million dollars, constitute a major 

increase in cost for registrants, nor does 

it have significant adverse effects on the 

United States domestic or foreign 

economy.14 DEA will submit a copy of 

this final rule to both Houses of 

Congress and to the Comptroller 

General. 

List of Subjects 

21 CFR Part 1301 

Administrative practice and 

procedure, Drug traffic control, Security 

measures. 

21 CFR Part 1309 

Administrative practice and 

procedure, Drug traffic control, Exports, 

Imports, Security measures. 

21 CFR Part 1321 

Administrative practice and 

procedure. 

For the reasons stated in the 

preamble, DEA amends 21 CFR parts 

1301, 1309, and 1321 as follows: 

PART 1301—REGISTRATION OF 

MANUFACTURERS, DISTRIBUTORS, 

AND DISPENSERS OF CONTROLLED 

SUBSTANCES 

■ 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. Amend § 1301.13 by revising 

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 calendar days prior to 

their registration expiration date. 

Registrants are responsible for 

maintaining a current email address in 

application portal on DEA’s website. 

DEA Forms 224a, 225a, and 363a may 

be obtained online at 

www.DEAdiversion.usdoj.gov. Only 

renewal applications submitted online 

through the secure application portal on 

DEA’s website will be accepted for 

processing. 

* * * * * 

■ 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: 


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§ 1309.12 Time and method of payment; 

refund. 

(a) For each application for 

registration or reregistration to 

manufacture, distribute, import, or 

export the applicant shall pay the fee 

when the application for registration or 

reregistration is submitted for filing 

online using the secure application 

portal at www.DEAdiversion.usdoj.gov. 

(b) Payment shall be made online by 

Automated Clearing House funds 

transfer, by credit card, or by any other 

means made available at the time of 

submission using the secure application 

portal at www.DEAdiversion.usdoj.gov. 

■ 6. Amend § 1309.32 by revising 

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 § 1309.21, shall apply for 

reregistration on DEA Form 510a using 

the secure application portal at 

www.DEAdiversion.usdoj.gov. 

(c) DEA Forms 510 and 510a may be 

obtained online at 

www.DEAdiversion.usdoj.gov. DEA will 

send renewal notifications via email to 

registrants approximately calendar 60 

days prior to their registration 

expiration date. Registrants are 

responsible for keeping their email 

address current in the secure 

application portal on DEA’s website 

throughout the duration of their 

registration. Only applications 

submitted online through the secure 

application portal on DEA’s website will 

be accepted for processing. 

* * * * * 

■ 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 

entries in the table under ‘‘DEA 

Registration Section’’ to read as follows: 

§ 1321.01 DEA mailing addresses. 

* * * * * 

TABLE OF DEA MAILING ADDRESSES

Code of Federal Regulations section—topic DEA mailing address 

*******

DEA Registration Section 

1301.03—Procedures information request (controlled substances registration).Drug Enforcement Administration, Attn: Registration Section/DRR P.O. 

Box 2639, Springfield, VA 22152. 

1301.18(c)—Research project controlled substance increase request.

1301.51—Controlled substances registration modification request.

1301.52(b)—Controlled substances registration transfer request.

1301.52(c)—Controlled substances registration discontinuance of business activities notification.

1309.03—List I chemicals registration procedures information request.

1309.61—List I chemicals registration modification request.

* * * * * * * 

* * * * * 

Anne Milgram, 

Administrator. 

[FR Doc. 2022–07570 Filed 4–8–22; 8:45 am] 

BILLING CODE 4410–09–P 

NATIONAL ARCHIVES AND RECORDS 

ADMINISTRATION 

36 CFR Part 1213 

[FDMS No. NARA–22–0008; NARA–2022– 

044] 

RIN 3095–AC08 

Agency Guidance Procedures 

AGENCY: National Archives and Records 

Administration (NARA). 

ACTION: Final rule. 

SUMMARY: We are amending our 

regulations on general procedures 

applying to guidance documents NARA 

and its components issue. We are 

removing provisions added to comply 

with requirements in the Executive 

order of October 9, 2019, ‘‘Promoting 

the Rule of Law through Improved 

Agency Guidance Documents,’’ which 

was revoked by the Executive order of 

January 20, 2021, ‘‘Revocation of Certain 

Executive Orders Concerning Federal 

Regulation.’’ 

DATES: This rule is effective on May 11, 

2022. 

ADDRESSES: Regulatory and External 

Policy Program (MP), Suite 4100, 

National Archives and Records 

Administration, 8601 Adelphi Road, 

College Park, MD 20740–6001. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly Keravuori, Regulatory and 

External Policy Program Manager, by 


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