8592 Federal Register / Vol. 87, No. 31 / Tuesday, February 15, 2022 / Notices 

cause psychoactive effects and adverse 

events, including deaths similar to 

heroin, fentanyl, and other opioids. As 

of January 2021, metonitazene has been 

identified in eight blood specimens 

associated with postmortem death 

investigations in the United States. 

There are no commercial or approved 

medical uses for metonitazene. On 

December 7, 2021, the DEA issued a 

temporary order (86 FR 69182) to 

control metonitazene as a Schedule I 

substance under the CSA, therefore 

additional permanent controls may be 

needed if metonitazene is placed in 

Schedule I of the 1961 Convention. 

Eutylone (chemical name: 1-(1,3- 

benzodioxol-5-yl)-2-(ethylamino)butan1-one) is a designer drug of the 

phenethylamine class. Eutylone is a 

synthetic cathinone with chemical 

structural and pharmacological 

similarities to Schedule I and II 

amphetamines and cathinones, such as 

to 3,4- 

methylenedioxymethamphetamine, 

methylone, and pentylone. Eutylone 

emerged in the United States illicit, 

synthetic drug market in 2014 as 

evidenced by its identification in drug 

seizures. Other evidence indicates that 

eutylone, like other Schedule I synthetic 

cathinones, is abused for its 

psychoactive effects. Adverse effects 

associated with synthetic cathinones 

abuse include agitation, hypertension, 

tachycardia, and death. Eutylone is not 

approved for medical use in the United 

States. As a positional isomer of 

pentylone, eutylone is controlled in 

Schedule I of the CSA. As such, 

additional permanent controls will not 

be needed if eutylone is placed in 

Schedule II of the Convention on 

Psychotropic Substances. 

FDA, on behalf of the Secretary of 

HHS, invites interested persons to 

submit comments on the notifications 

from the United Nations concerning 

these drug substances. FDA, in 

cooperation with the National Institute 

on Drug Abuse, will consider the 

comments on behalf of HHS in 

evaluating the WHO scheduling 

recommendations. Then, under section 

201(d)(2)(B) of the CSA, HHS will 

recommend to the Secretary of State 

what position the United States should 

take when voting on the 

recommendations for control of 

substances under the 1971 Convention 

at the CND meeting in March 2022. 

Comments regarding the WHO 

recommendations for control of 

brorphine and metonitazene under the 

1961 Single Convention will also be 

forwarded to the relevant Agencies for 

consideration in developing the U.S. 

position regarding narcotic substances 

at the CND meeting. 

Dated: February 9, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03229 Filed 2–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–D–0575 and FDA– 

2021–N–0764] 

Compliance Policy Guide Sec. 510.800 

Beverages—Serving Size Labeling; 

Compliance Policy Guide Sec. 540.420 

Raw Breaded Shrimp—Microbiological 

Criteria for Evaluating Compliance 

With Current Good Manufacturing 

Practice Regulations; and Compliance 

Policy Guide Sec. 562.800 Vending 

Machine Food—Labeling; Withdrawal 

of Guidances 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing the withdrawal of three 

compliance policy guides (CPG) entitled 

‘‘Compliance Policy Guide Sec. 510.800 

Beverages—Serving Size Labeling,’’ 

‘‘Compliance Policy Guide Sec. 540.420 

Raw Breaded Shrimp—Microbiological 

Criteria for Evaluating Compliance with 

Current Good Manufacturing Practice 

Regulations,’’ and ‘‘Compliance Policy 

Guide Sec. 562.800 Vending Machine 

Food—Labeling.’’ We are withdrawing 

these CPGs because they have become 

outdated or have been superseded by 

subsequent FDA actions. 

DATES: The withdrawal is applicable 

February 15, 2022. 

ADDRESSES: For access to the docket, go 

to https://www.regulations.gov and 

insert docket number FDA–2010–D– 

0575 for ‘‘Compliance Policy Guide Sec. 

510.800 Beverages—Serving Size 

Labeling’’ or FDA–2021–N–0764 for 

‘‘Compliance Policy Guide Sec. 540.420 

Raw Breaded Shrimp—Microbiological 

Criteria for Evaluating Compliance with 

Current Good Manufacturing Practice 

Regulations’’ and ‘‘Compliance Policy 

Guide Sec. 562.800 Vending Machine 

Food—Labeling’’ 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: 

Kevin Kwon, Office of Compliance 

(HFS–605), Center for Food Safety and 

Applied Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–4597; 

or Alexandra Jurewitz, Office of 

Regulations and Policy (HFS–024), 

Center for Food Safety and Applied 

Nutrition, Food and Drug 

Administration, 5001 Campus Dr., 

College Park, MD 20740, 240–402–2378. 

SUPPLEMENTARY INFORMATION: 

I. Background 

We are announcing the withdrawal of 

three CPGs entitled ‘‘Compliance Policy 

Guide Sec. 510.800 Beverages—Serving 

Size Labeling,’’ ‘‘Compliance Policy 

Guide Sec. 540.420 Raw Breaded 

Shrimp—Microbiological Criteria for 

Evaluating Compliance with Current 

Good Manufacturing Practice 

Regulations,’’ and ‘‘Compliance Policy 

Guide Sec. 562.800 Vending Machine 

Food—Labeling.’’ 

CPG Sec. 510.800 entitled 

‘‘Beverages—Serving Size Labeling’’ was 

first issued in December 2010. This CPG 

provided guidance for FDA staff and 

industry as to when we would typically 

consider not taking enforcement action 

in connection to a ‘‘12 [fluid ounce] 

(360 [milliliter])’’ labeled serving size on 

specific types of beverages larger than 

20 fluid ounces. On May 27, 2016, FDA 

issued a final rule entitled ‘‘Food 

Labeling: Serving Sizes of Foods That 

Can Reasonably Be Consumed at One 

Eating Occasion; Dual-Column Labeling; 

Updating, Modifying, and Establishing 

Certain Reference Amounts Customarily 

Consumed; Serving Size for Breath 

Mints; and Technical Amendments’’ (81 

FR 34000). The final rule amended the 

Reference Amounts Customarily 

Consumed (RACCs) that are used by 

manufacturers to determine serving 

sizes for certain foods, including certain 

beverages. Our regulations, at 21 CFR 

101.12(b), table 2, lists the categories for 

each type of food product and each 

category’s current RACC. Due to the 

updated RACCs for certain beverages, 

CPG Sec. 510.800 is now obsolete, and 

the enforcement discretion provided in 

this CPG is no longer applicable. 

Therefore, CPG Sec. 510.800 is being 

withdrawn. 

CPG Sec. 540.420 entitled ‘‘Raw 

Breaded Shrimp—Microbiological 

Criteria for Evaluating Compliance with 

Current Good Manufacturing Practice 

Regulations’’ was first issued in August 

1983. This CPG used data collected in 

fiscal year 1978 and listed an outdated 

sampling and compliance structure. The 

compliance criteria and the 

methodology used in the CPG have 

become outdated and are no longer 

useful. This CPG is superseded by the 


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Federal Register / Vol. 87, No. 31 / Tuesday, February 15, 2022 / Notices 8593 

Seafood Hazard Analysis Critical 

Control Point regulation in 21 CFR part 

123. Seafood processors must prevent 

food safety hazards using critical 

controls and appropriate verification 

activities, such as end-product and inprocess testing (21 CFR part 123). This 

CPG is also superseded by FDA’s Fish 

and Fishery Products Hazards and 

Controls Guidance (Ref. 1), which 

describes controls for food safety 

hazards related to breaded shrimp. For 

these reasons, CPG Sec. 540.420 is now 

obsolete and is being withdrawn. 

CPG 562.800 entitled ‘‘Vending 

Machine Food—Labeling’’ was first 

issued in September 1976. This CPG 

provided guidance for FDA staff and 

industry regarding certain mandatory 

label information for foods and 

beverages dispensed in vending 

machines after movement in interstate 

commerce. 

On March 23, 2010, President Obama 

signed the Patient Protection and 

Affordable Care Act of 2010 (ACA; Pub, 

L, 111–148) into law. Section 4205 of 

the ACA amended section 403(q) of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 343(q)) and 

section 403A of the FD&C Act (21 U.S.C. 

343–1), which governs Federal 

preemption of State and local food 

labeling requirements. Section 4205 of 

the ACA added section 403(q)(5)(H)(viii) 

to the FD&C Act to require that if an 

article of food is sold from a vending 

machine that (1) does not permit a 

prospective purchaser to examine the 

Nutrition Facts Panel before purchasing 

the article or does not otherwise provide 

visible nutrition information at the 

point of purchase; and (2) is operated by 

a person who is engaged in the business 

of owning or operating 20 or more 

vending machines, then the vending 

machine operator must provide a sign in 

close proximity to each article of food 

or the selection button that includes a 

clear and conspicuous statement 

disclosing the number of calories 

contained in the article of food. 

In the Federal Register of December 1, 

2014 (79 FR 71259), we issued a final 

rule to implement these labeling 

requirements; the regulations are 

codified at 21 CFR 101.8. With this 

regulatory change, CPG 562.800 is now 

obsolete and is being withdrawn. 

II. Reference 

The following reference is on display 

at the Dockets Management Staff (see 

ADDRESSES) and is available for viewing 

by interested persons between 9 a.m. 

and 4 p.m., Monday through Friday; it 

is also available electronically at https:// 

www.regulations.gov. 

1. FDA, ‘‘Fish and Fishery Products Hazards 

and Controls Guidance, 4th Edition,’’ 

June 2021. 

Dated: February 9, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03224 Filed 2–14–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: Public 

Comment Request HRSA Ryan White 

HIV/AIDS Program Part F AIDS 

Education and Training Center 

Program Evaluation Activities, OMB 

No. 0915–0281—Extension 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement for opportunity for public 

comment on proposed data collection 

projects of the Paperwork Reduction Act 

of 1995, HRSA announces plans to 

submit an Information Collection 

Request (ICR), described below, to the 

Office of Management and Budget 

(OMB). Prior to submitting the ICR to 

OMB, HRSA seeks comments from the 

public regarding the burden estimate, 

below, or any other aspect of the ICR. 

DATES: Comments on this ICR should be 

received no later than April 18, 2022. 

ADDRESSES: Submit your comments to 

paperwork@hrsa.gov or mail the HRSA 

Information Collection Clearance 

Officer, Room 14N136B, 5600 Fishers 

Lane, Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, email paperwork@hrsa.gov 

or call Samantha Miller, the acting 

HRSA Information Collection Clearance 

Officer at (301) 443–9094. 

SUPPLEMENTARY INFORMATION: When 

submitting comments or requesting 

information, please include the 

information request collection title for 

reference, pursuant to the Paperwork 

Reduction Act of 1995. 

Information Collection Request Title: 

HRSA AIDS Education and Training 

Center Evaluation Activities, OMB No. 

0915–0281—Extension. 

Abstract: The Ryan White HIV/AIDS 

Program’s (RWHAP) AIDS Education 

and Training Center (AETC) Program, 

authorized under Title XXVI of the 

Public Health Service Act, supports a 

network of regional and national centers 

that conduct targeted, multi-disciplinary 

education and training programs for 

health care providers treating people 

with HIV. The RWHAP AETC Program’s 

purpose is to increase the number of 

health care providers who are 

effectively educated and motivated to 

counsel, diagnose, treat, and medically 

manage people with HIV. 

The RWHAP AETC Program 

recipients gather data on the training 

activities they conduct using two data 

collection instruments. The Event 

Record (ER) gathers information about 

each training activity including training 

programs, individual clinical 

consultations, group clinical 

consultations, and technical assistance 

events. Information on the people 

trained, the length of training, the 

content and level of the training and 

collaborations with other organizations 

is also collected. The Participant 

Information Form (PIF) collects 

information from each of the training 

participants, including demographics, 

profession, the types of HIV services 

they provide, and the characteristics of 

the patient population they serve. The 

RWHAP AETC Program recipients are 

required to report aggregated data on the 

training activities and trainees to HRSA 

once a year. HRSA is requesting an 

extension of the current ER and PIF 

with minor changes. To more accurately 

capture the length of a training event, 

RWHAP AETC trainers will be asked to 

report the event’s end date in addition 

to the start date on the ER. Additionally, 

if an event was not supported by 

RWHAP AETC core funding, 

respondents will be able to skip three 

subsequent questions on the ER that are 

not applicable. Respondents will have 

the option to report multiple clinic and 

health professional program 

identification numbers to reflect 

multiple affiliations on the ER. 

Additional options were added for 

seven questions in the ER to allow for 

more complete responses (e.g., an 

‘‘other’’ response option was added to 

two questions). In addition to changes 

on the ER, minor revisions were made 

to the response options for multiple 

questions on the PIF to improve clarity 

(e.g., ‘‘Substance Abuse’’ was changed 

to ‘‘Substance Use Disorder’’). 

Need and Proposed Use of the 

Information: HRSA uses the data 

collected when conducting RWHAP 

AETC programmatic assessments to 

determine future program needs. These 

data allow HRSA to identify where gaps 

exist in training HIV professionals as 

well as to measure whether training 


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