82332 Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Rules and Regulations 

methods of execution (i.e., Order Book or 

Request-for-Quote to a minimum of 3 

counterparties) could force market 

participants to break up the package into 

their individual components, which would 

increase transaction costs and risks, and 

thereby defeat the economic purpose and 

efficiency of the package transaction. 

Commenters supported the rule as proposed. 

It is therefore appropriate for the Commission 

to codify that flexible methods of execution 

may be used for the swap components of this 

limited set of package transactions. 

The final rule also exempts from the trade 

execution requirement swap transactions that 

are components of ‘‘new issuance bond’’ 

package transactions, and amends part 37 to 

provide flexibility in the execution methods 

a SEF may offer counterparties to correct 

clerical or operational errors. While 

providing additional flexibility for resolving 

error trades, the rule limits the number of 

instances in which such errors may be 

corrected, and preserves important 

protections to guard against abuse. Notably, 

the Commission requires market participants 

to provide prompt notice to a SEF of an error 

trade, enabling the SEF to conduct real-time 

market monitoring and fulfill other selfregulatory obligations. In addition, the rule 

makes clear that a SEF must maintain rules 

and procedures that are fair, transparent, 

incentivize timely resolution of an error 

trade, and allow for such resolution without 

disclosing the identity of counterparties to 

one another where the swaps trading is 

subject to the post-trade name give up 

prohibition. 

Given the tailored nature of these 

amendments and the appropriate safeguards, 

I support this final rule. I thank the staff of 

the Division of Market Oversight for their 

work on this rule and their helpful 

engagement with my office. 

[FR Doc. 2020–26555 Filed 12–17–20; 8:45 am] 

BILLING CODE 6351–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Parts 101 and 102 

[Docket No. FDA–2019–D–0892] 

The Use of an Alternate Name for 

Potassium Chloride in Food Labeling; 

Guidance for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the availability of a final 

guidance for industry entitled ‘‘The Use 

of an Alternate Name for Potassium 

Chloride in Food Labeling.’’ This 

guidance explains our intent to exercise 

enforcement discretion for the 

declaration of the name ‘‘potassium 

salt,’’ as an alternative to ‘‘potassium 

chloride,’’ in the ingredient statement 

on the labels of foods that contain 

potassium chloride as an ingredient. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on December 18, 2020. 

ADDRESSES: You may submit either 

electronic or written comments on FDA 

guidances at any time as follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment 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 

comments, that information will be 

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

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment 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 comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, 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– 

2019–D–0892 for ‘‘The Use of an 

Alternate Name for Potassium Chloride 

in Food Labeling.’’ Received comments 

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 a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies 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.’’ We 

will review this copy, including the 

claimed confidential information, in our 

consideration of comments. 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 comments 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 comments 

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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidance to the Office 

of Nutrition and Food Labeling, Center 

for Food Safety and Applied Nutrition, 

Food and Drug Administration, 5001 

Campus Dr., College Park, MD 20740. 

Send two self-addressed adhesive labels 

to assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance. 

FOR FURTHER INFORMATION CONTACT: 

Andrea Krause, Center for Food Safety 

and Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2371. 


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Federal Register / Vol. 85, No. 244 / Friday, December 18, 2020 / Rules and Regulations 82333 

1All functions vested in the Attorney General by 

the CSA have been delegated to the Administrator 

of DEA. 28 CFR 0.100(b). 

2This document uses both the CSA spelling 

‘‘marihuana’’ and the modern spelling ‘‘marijuana’’ 

interchangeably. 

3As defined in Section 802(16). 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the availability of 

a guidance for industry entitled ‘‘The 

Use of an Alternate Name for Potassium 

Chloride in Food Labeling.’’ We are 

issuing this guidance consistent with 

our good guidance practices regulation 

(21 CFR 10.115). The guidance 

represents the current thinking of FDA 

on this topic. It does not establish any 

rights for any person and is not binding 

on FDA or the public. You can use an 

alternative approach if it satisfies the 

requirements of the applicable statutes 

and regulations. 

In the Federal Register of May 20, 

2019 (84 FR 22749), we made available 

a draft guidance for industry entitled 

‘‘The Use of an Alternate Name for 

Potassium Chloride in Food Labeling’’ 

(‘‘draft guidance’’), which was intended 

to explain to food manufacturers our 

intent to exercise enforcement 

discretion for the declaration of the 

name ‘‘potassium chloride salt’’ in the 

ingredient statement on food labels as 

an alternative to the common or usual 

name ‘‘potassium chloride.’’ The draft 

guidance considered, in part, a NuTek 

Food Science citizen petition requesting 

that we issue guidance recognizing 

‘‘potassium salt’’ as an additional 

common or usual name for potassium 

chloride (see Citizen Petition from 

NuTek Food Science, LLC, dated June 

27, 2016, FDA–2016–P–1826–0001 at 

page 1). Additionally, we specifically 

invited comment on how the use of the 

name ‘‘potassium chloride salt’’ in the 

ingredient statement as an alternative to 

‘‘potassium chloride’’ would improve 

consumer understanding of the 

ingredient and what alternate names to 

‘‘potassium chloride salt’’ would better 

promote consumer understanding of 

potassium chloride (84 FR 22749 at 

22750 through 22751). We gave 

interested parties until July 19, 2019, to 

submit comments for us to consider 

before beginning work on the final 

version of the guidance. 

In response to requests for more time 

to comment on the draft guidance, we 

issued a notice in the Federal Register 

of July 10, 2019 (84 FR 32848) extending 

the comment period to September 17, 

2019. We received more than 70 

comments on the draft guidance. Many 

comments expressed concerns that 

declaration of the alternate name 

‘‘potassium chloride salt’’ would be 

confusing or would not achieve the 

public health goal of reduced sodium 

consumption, as food manufacturers 

would likely not use the alternate name. 

Food manufacturers, public health and 

consumer advocacy groups provided 

comments and data supporting 

‘‘potassium salt’’ as an alternate name to 

‘‘potassium chloride.’’ 

After careful review and 

consideration of the comments to the 

draft guidance, some of which led us to 

further review of relevant published 

literature, we have modified the final 

guidance. Changes to the guidance 

include: 

• Exercising enforcement discretion 

for declaration of ‘‘potassium salt,’’ 

rather than ‘‘potassium chloride salt,’’ in 

the ingredient statement on food labels 

as an alternative to declaration of the 

common or usual name ‘‘potassium 

chloride;’’ and 

• Further explaining potassium 

chloride’s technical role as a partial 

substitute for sodium chloride in food 

manufacturing through the inclusion of 

additional examples and references. 

As discussed in the final guidance, we 

have made these changes with the 

following considerations in mind: 

Potential public health benefits to the 

U.S. population from reduced sodium 

and increased potassium intake, the 

recognition that potassium chloride can 

substitute for sodium chloride in a 

variety of food manufacturing 

applications across a number of food 

categories, and the unlikelihood that the 

alternate name will mislead consumers. 

The guidance announced in this 

notice finalizes the draft guidance dated 

May 2019. 

II. Paperwork Reduction Act of 1995 

While this guidance contains no 

collection of information, it does refer to 

previously approved FDA collections of 

information. Therefore, clearance by the 

Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995 (PRA) (44 U.S.C. 3501– 

3521) is not required for this guidance. 

The previously approved collections of 

information are subject to review by 

OMB under the PRA. The collections of 

information in 21 CFR part 101 have 

been approved under OMB control 

number 0910–0381. 

III. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/FoodGuidances or 

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

FDA website listed in the previous 

sentence to find the most current 

version of the guidance. 

Dated: December 11, 2020. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2020–27750 Filed 12–17–20; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

21 CFR Parts 1301 and 1318 

[Docket No. DEA–506] 

RIN 1117–AB54 

Controls To Enhance the Cultivation of 

Marihuana for Research in the United 

States 

AGENCY: Drug Enforcement 

Administration, Department of Justice. 

ACTION: Final rule. 

SUMMARY: The Drug Enforcement 

Administration (DEA) is amending its 

regulations to facilitate the cultivation 

of marihuana for research purposes and 

other licit purposes to enhance 

compliance with the Controlled 

Substances Act, including registering 

cultivators consistent with treaty 

obligations. This final rule adopts, with 

minor modifications, the notice of 

proposed rulemaking published on 

March 23, 2020, including regulations 

that govern applications by persons 

seeking to become registered with DEA 

to grow marihuana as bulk 

manufacturers, and regulations related 

to the purchase and sale of this 

marihuana by DEA. 

DATES: This final rule is effective 

January 19, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Scott A. Brinks, Regulatory Drafting and 

Policy Support Section (DPW), 

Diversion Control Division, Drug 

Enforcement Administration; Mailing 

Address: 8701 Morrissette Drive, 

Springfield, Virginia 22152–2639; 

Telephone: (571) 362–3261. 

SUPPLEMENTARY INFORMATION: 

Legal Authority and Background 

The Controlled Substances Act (CSA) 

requires all persons who seek to 

manufacture a controlled substance to 

obtain a DEA registration.1 21 U.S.C. 

822(a)(1). The CSA defines 

‘‘manufacture’’ to include the 

‘‘production’’ of a controlled substance, 

which in turn includes, among other 

things, the planting, cultivation, 

growing, or harvesting of a controlled 

substance. 21 U.S.C. 802(15), (22). Thus, 

any person who seeks to plant, 

cultivate, grow, or harvest marihuana 2 3


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