21018 Federal Register / Vol. 87, No. 69 / Monday, April 11, 2022 / Rules and Regulations 

for the nine months ended September 30, 2022 

would apply the SAB to those periods. 

15For U.S. GAAP, see FASB ASC 250–10–50–1 

through 50–3; for IFRS, see IAS 8. See also, e.g., 

Item 302 of Regulation S–K and PCAOB Auditing 

Standard 2820 (par. 8). 

the filing does not include a subsequent 

interim period that also reflects 

application of this guidance, then the 

staff expects it to be applied 

retrospectively to the beginning of the 

two most recent annual periods ending 

before June 15, 2022. 

For all entities, in the financial 

statements that reflect the initial 

application of this guidance, the effect 

of the initial application should be 

reported in the carrying amounts of 

assets and liabilities as of the beginning 

of the annual period specified above. 

Entities should include clear disclosure 

of the effects of the initial application of 

this guidance.15

[FR Doc. 2022–07196 Filed 4–8–22; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 573 

[Docket No. FDA–2011–F–0365] 

Food Additives Permitted in Feed and 

Drinking Water of Animals; Methyl 

Esters of Conjugated Linoleic Acid 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Final rule. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or the 

Agency) is amending the regulations for 

food additives permitted in feed and 

drinking water of animals to provide for 

the safe use of methyl esters of 

conjugated linoleic acid for early 

lactation dairy cows to reduce the 

energy concentration in milk. This 

action is in response to a food additive 

petition filed by BASF Corp. 

DATES: This rule is effective April 11, 

2022. See section V of this document for 

further information on the filing of 

objections. Submit either electronic or 

written objections and requests for a 

hearing on the final rule by May 11, 

2022. 

ADDRESSES: You may submit objections 

and requests for a hearing as follows. 

Please note that late, untimely filed 

objections will not be considered. 

Electronic objections must be submitted 

on or before May 11, 2022. The https:// 

www.regulations.gov electronic filing 

system will accept objections until 

11:59 p.m. Eastern Time at the end of 

May 11, 2022. Objections received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

Electronic Submissions 

Submit electronic objections in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting objections. 

Objections submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

objection will be made public, you are 

solely responsible for ensuring that your 

objection does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

objection, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit an objection 

with confidential information that you 

do not wish to be made available to the 

public, submit the objection as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper objections 

submitted to the Dockets Management 

Staff, FDA will post your objection, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2011–F–0365 for ‘‘Food Additives 

Permitted in Feed and Drinking Water 

of Animals; Methyl Esters of Conjugated 

Linoleic Acid; Silicon Dioxide.’’ 

Received objections, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit an objection with confidential 

information that you do not wish to be 

made publicly available, submit your 

objections only as a written/paper 

submission. You should submit two 

copies in total. One copy will include 

the information you claim to be 

confidential with a heading or cover 

note that states ‘‘THIS DOCUMENT 

CONTAINS CONFIDENTIAL 

INFORMATION.’’ The Agency will 

review this copy, including the claimed 

confidential information, in its 

consideration of objections. The second 

copy, which will have the claimed 

confidential information redacted/ 

blacked out, will be available for public 

viewing and posted on https://

www.regulations.gov. Submit both 

copies to the Dockets Management Staff. 

If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your objections and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper objections 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Megan Hall, Center for Veterinary 

Medicine, Food and Drug 

Administration, 7519 Standish Pl. 

(HFV–221), Rockville, MD 20855, 301– 

796–3801, Megan.Hall@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In a document published in the 

Federal Register of June 6, 2011 (76 FR 

32332), FDA announced that we had 

filed a food additive petition (animal 

use) (FAP 2269) submitted by BASF 

Corp., 100 Campus Dr., Florham Park, 

NJ 07932. The petition proposed that 

the regulations for food additives 

permitted in feed and drinking water of 


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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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