Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Notices 16475 

collection of information is necessary 

for the proper performance of the 

functions of the Agency, including 

whether the information will have 

practical utility; (ii) evaluate the 

accuracy of the Agency’s estimate of the 

burden of the proposed collection of 

information, including the validity of 

the methodology and assumptions used; 

(iii) enhance the quality, utility, and 

clarity of the information to be 

collected; and (iv) minimize the burden 

of the collection of information on those 

who are to respond, including through 

the use of appropriate automated 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submission of 

responses. The EPA will consider the 

comments received and amend the ICR 

as appropriate. The final ICR package 

will then be submitted to OMB for 

review and approval. At that time, the 

EPA will issue another Federal Register 

notice to announce the submission of 

the ICR to OMB and the opportunity to 

submit additional comments to OMB. 

Abstract: Subtitle C of the Resource 

Conservation and Recovery Act (RCRA) 

creates a comprehensive program for the 

safe management of hazardous waste. 

Section 3004 of RCRA requires owners 

and operators of facilities that treat, 

store, or dispose of hazardous waste to 

comply with standards established by 

EPA that are to protect the environment. 

Section 3005 provides for 

implementation of these standards 

under permits issued to owners and 

operators by EPA or authorized States. 

Section 3005 also allows owners and 

operators of facilities in existence when 

the regulations came into effect to 

comply with applicable notice 

requirements to operate until a permit is 

issued or denied. This statutory 

authorization to operate prior to permit 

determination is commonly known as 

‘‘interim status.’’ Owners and operators 

of interim status facilities also must 

comply with standards set under 

Section 3004. 

This ICR examines the ground-water 

monitoring standards for permitted and 

interim status facilities at 40 CFR parts 

264 and 265, as specified. The groundwater monitoring requirements for 

regulated units follow a tiered approach 

whereby releases of hazardous 

contaminants are first detected 

(detection monitoring), then confirmed 

(compliance monitoring), and if 

necessary, are required to be cleaned up 

(corrective action). Each of these tiers 

requires collection and analysis of 

ground-water samples. Owners or 

operators that conduct ground-water 

monitoring are required to report 

information to the oversight agencies on 

releases of contaminants and to 

maintain records of ground-water 

monitoring data at their facilities. The 

goal of the ground-water monitoring 

program is to prevent and quickly detect 

releases of hazardous contaminants to 

groundwater, and to establish a program 

whereby any contamination is 

expeditiously cleaned up as necessary 

to protect human health and 

environment. 

Form Numbers: None. 

Respondents/affected entities: 

Business or other for-profit; and State, 

Local, or Tribal Governments. 

Respondent’s obligation to respond: 

Mandatory (RCRA Sections 3004 and 

3005). 

Estimated number of respondents: 

813. 

Frequency of response: Quarterly, 

semi-annually, and annually. 

Total estimated burden: 104,861 

hours per year. Burden is defined at 5 

CFR 1320.03(b). 

Total estimated cost: $20,491,681 (per 

year), includes $16,090,478 annualized 

capital or operation & maintenance 

costs. 

Changes in Estimates: The burden 

hours are likely to stay substantially the 

same. 

Dated: March 11, 2022. 

Carolyn Hoskinson, 

Director, Office of Resource Conservation and 

Recovery. 

[FR Doc. 2022–06106 Filed 3–22–22; 8:45 am] 

BILLING CODE 6560–50–P 

FEDERAL RESERVE SYSTEM 

Change in Bank Control Notices; 

Acquisitions of Shares of a Bank or 

Bank Holding Company 

The notificants listed below have 

applied under the Change in Bank 

Control Act (Act) (12 U.S.C. 1817(j)) and 

§ 225.41 of the Board’s Regulation Y (12 

CFR 225.41) to acquire shares of a bank 

or bank holding company. The factors 

that are considered in acting on the 

applications are set forth in paragraph 7 

of the Act (12 U.S.C. 1817(j)(7)). 

The public portions of the 

applications listed below, as well as 

other related filings required by the 

Board, if any, are available for 

immediate inspection at the Federal 

Reserve Bank(s) indicated below and at 

the offices of the Board of Governors. 

This information may also be obtained 

on an expedited basis, upon request, by 

contacting the appropriate Federal 

Reserve Bank and from the Board’s 

Freedom of Information Office at 

https://www.federalreserve.gov/foia/ 

request.htm. Interested persons may 

express their views in writing on the 

standards enumerated in paragraph 7 of 

the Act. 

Comments regarding each of these 

applications must be received at the 

Reserve Bank indicated or the offices of 

the Board of Governors, Ann E. 

Misback, Secretary of the Board, 20th 

Street and Constitution Avenue NW, 

Washington, DC 20551–0001, not later 

than April 7, 2022. 

A. Federal Reserve Bank of St. Louis 

(Holly A. Rieser, Manager) P.O. Box 442, 

St. Louis, Missouri 63166–2034. 

Comments can also be sent 

electronically to 

Comments.applications@stls.frb.org: 

1. The George N. Schulte Trust, 

George N. Schulte, as trustee, both of 

Dixon, Missouri; David R. Tritten and 

Elizabeth A. Tritten, both of 

Waynesville, Missouri; Beth A. Wright 

and Richard R. Wright, both of Iberia, 

Missouri; to retain voting shares of 

Milco Bancorporation, Inc., and thereby 

indirectly retain voting shares of Bank 

of Iberia, both of Iberia, Missouri. 

Board of Governors of the Federal Reserve 

System, March 18, 2022. 

Michele Taylor Fennell, 

Deputy Associate Secretary of the Board. 

[FR Doc. 2022–06152 Filed 3–22–22; 8:45 am] 

BILLING CODE P 

FEDERAL TRADE COMMISSION 

[File No. 152 3021/Docket No. 9397] 

Health Research Laboratories, LLC; 

Analysis of Proposed Consent Order 

To Aid Public Comment 

AGENCY: Federal Trade Commission. 

ACTION: Proposed consent agreement; 

request for comment. 

SUMMARY: The consent agreement in this 

matter settles alleged violations of 

federal law prohibiting unfair or 

deceptive acts or practices. The attached 

Analysis of Proposed Consent Order to 

Aid Public Comment describes both the 

allegations in the complaint and the 

terms of the consent order—embodied 

in the consent agreement—that would 

settle these allegations. 

DATES: Comments must be received on 

or before April 22, 2022. 

ADDRESSES: Interested parties may file 

comments online or on paper by 

following the instructions in the 

Request for Comment part of the 

SUPPLEMENTARY INFORMATION section 

below. Please write ‘‘Health Research 

Laboratories, LLC; Docket No. 9397’’ on 

your comment, and file your comment 


jspears on DSK121TN23PROD with NOTICES1
16476 Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Notices 

online at https://www.regulations.gov by 

following the instructions on the webbased form. If you prefer to file your 

comment on paper, mail your comment 

to the following address: Federal Trade 

Commission, Office of the Secretary, 

600 Pennsylvania Avenue NW, Suite 

CC–5610 (Annex D), Washington, DC 

20580. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Averill (202–326–2993), 

Bureau of Consumer Protection, Federal 

Trade Commission, 600 Pennsylvania 

Avenue NW, Washington, DC 20580. 

SUPPLEMENTARY INFORMATION: Pursuant 

to Section 6(f) of the Federal Trade 

Commission Act, 15 U.S.C. 46(f), and 

FTC Rule 2.34, 16 CFR 2.34, notice is 

hereby given that the above-captioned 

consent agreement containing a consent 

order to cease and desist, having been 

filed with and accepted, subject to final 

approval, by the Commission, has been 

placed on the public record for a period 

of thirty (30) days. The following 

Analysis to Aid Public Comment 

describes the terms of the consent 

agreement and the allegations in the 

complaint. An electronic copy of the 

full text of the consent agreement 

package can be obtained at https://

www.ftc.gov/news-events/commissionactions. 

You can file a comment online or on 

paper. For the Commission to consider 

your comment, we must receive it on or 

before April 22, 2022. Write ‘‘Health 

Research Laboratories, LLC; Docket No. 

9397’’ on your comment. Your 

comment—including your name and 

your state—will be placed on the public 

record of this proceeding, including, to 

the extent practicable, on the https://

www.regulations.gov website. 

Due to the COVID–19 pandemic and 

the agency’s heightened security 

screening, postal mail addressed to the 

Commission will be subject to delay. We 

strongly encourage you to submit your 

comments online through the https://

www.regulations.gov website. 

If you prefer to file your comment on 

paper, write ‘‘Health Research 

Laboratories, LLC; Docket No. 9397’’ on 

your comment and on the envelope, and 

mail your comment to the following 

address: Federal Trade Commission, 

Office of the Secretary, 600 

Pennsylvania Avenue NW, Suite CC– 

5610 (Annex D), Washington, DC 20580. 

If possible, submit your paper comment 

to the Commission by overnight service. 

Because your comment will be placed 

on the publicly accessible website at 

https://www.regulations.gov, you are 

solely responsible for making sure your 

comment does not include any sensitive 

or confidential information. In 

particular, your comment should not 

include sensitive personal information, 

such as your or anyone else’s Social 

Security number; date of birth; driver’s 

license number or other state 

identification number, or foreign 

country equivalent; passport number; 

financial account number; or credit or 

debit card number. You are also solely 

responsible for making sure your 

comment does not include sensitive 

health information, such as medical 

records or other individually 

identifiable health information. In 

addition, your comment should not 

include any ‘‘trade secret or any 

commercial or financial information 

which . . . is privileged or 

confidential’’—as provided by Section 

6(f) of the FTC Act, 15 U.S.C. 46(f), and 

FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— 

including in particular competitively 

sensitive information such as costs, 

sales statistics, inventories, formulas, 

patterns, devices, manufacturing 

processes, or customer names. 

Comments containing material for 

which confidential treatment is 

requested must be filed in paper form, 

must be clearly labeled ‘‘Confidential,’’ 

and must comply with FTC Rule 4.9(c). 

In particular, the written request for 

confidential treatment that accompanies 

the comment must include the factual 

and legal basis for the request and must 

identify the specific portions of the 

comment to be withheld from the public 

record. See FTC Rule 4.9(c). Your 

comment will be kept confidential only 

if the General Counsel grants your 

request in accordance with the law and 

the public interest. Once your comment 

has been posted on the https://

www.regulations.gov website—as legally 

required by FTC Rule 4.9(b)—we cannot 

redact or remove your comment from 

that website, unless you submit a 

confidentiality request that meets the 

requirements for such treatment under 

FTC Rule 4.9(c), and the General 

Counsel grants that request. 

Visit the FTC website at http://

www.ftc.gov to read this document and 

the news release describing the 

proposed settlement. The FTC Act and 

other laws that the Commission 

administers permit the collection of 

public comments to consider and use in 

this proceeding, as appropriate. The 

Commission will consider all timely 

and responsive public comments that it 

receives on or before April 22, 2022. For 

information on the Commission’s 

privacy policy, including routine uses 

permitted by the Privacy Act, see 

https://www.ftc.gov/site-information/ 

privacy-policy. 

Analysis of Proposed Consent Order To 

Aid Public Comment 

The Federal Trade Commission 

(‘‘FTC’’ or ‘‘Commission’’) has accepted, 

subject to final approval, an agreement 

containing a consent order from Health 

Research Laboratories, LLC; Whole 

Body Supplements, LLC; and their 

Managing Member and officer, Kramer 

Duhon (‘‘Respondents’’). 

The proposed consent order has been 

placed on the public record for thirty 

(30) days for receipt of comments by 

interested persons. Comments received 

during this period will become part of 

the public record. After thirty (30) days, 

the Commission will again review the 

agreement and the comments received 

and will decide whether it should 

withdraw from the agreement and take 

appropriate action or make final the 

agreement’s proposed order. 

This matter involves the Respondents’ 

advertising for Black Garlic Botanicals, 

BG18, The Ultimate Heart Formula, and 

Neupathic. The complaint alleges 

Respondents violated Sections 5(a) and 

12 of the FTC Act by disseminating false 

and unsubstantiated advertisements 

claiming that: (1) Black Garlic 

Botanicals, BG18, and The Ultimate 

Heart Formula will prevent, reduce the 

risk of, cure, mitigate, or treat 

cardiovascular disease, atherosclerosis, 

and/or hypertension; and (2) Neupathic 

will cure, treat, or mitigate diabetic 

neuropathy. Respondents Kramer 

Duhon and Health Research 

Laboratories are also parties to a 

previous federal court order in FTC and 

State of Maine v. Health Research 

Laboratories, LLC, et al., 2:17–cv– 

00467–JDL (D. Me. Jan. 16, 2018). 

The proposed consent order includes 

injunctive relief that addresses these 

alleged violations and contains 

provisions designed to prevent 

Respondents from engaging in similar 

acts and practices in the future. 

Part I would ban Respondents from 

advertising, marketing, promoting, or 

offering for sale any dietary 

supplements. Part II would ban 

Respondents from making any disease 

prevention, reduction of risk, cure, 

mitigation, or treatment claim when 

advertising, marketing, promoting, or 

offering for sale any product. 

Part III prohibits Respondents from 

making any representation about the 

health benefits, safety, performance, or 

efficacy of any food or drug, unless the 

representation is non-misleading, and at 

the time such representation is made, 

Respondents possess and rely upon 

competent and reliable scientific 

evidence that substantiates that the 

representation is true. For purposes of 


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Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Notices 16477 

this provision, ‘‘competent and reliable 

scientific evidence’’ means tests, 

analyses, research, or studies that: (1) 

Have been conducted and evaluated in 

an objective manner by experts in the 

relevant condition or function to which 

the representation relates; (2) are 

generally accepted by such experts to 

yield accurate and reliable results; and 

(3) are randomized, double-blind, and 

placebo-controlled human clinical 

testing of the product or of an 

essentially equivalent product, when 

experts would generally require such 

human clinical testing to substantiate 

that the representation is true. In 

addition, this provision requires that 

when such tests or studies are human 

clinical tests or studies, all underlying 

or supporting data and documents 

generally accepted by experts as 

relevant to an assessment of such testing 

must be available for inspection and 

production to the Commission. 

Part IV prohibits Respondents from 

making misrepresentations: (1) That the 

performance or benefits of any food or 

drug are scientifically or clinically 

proven or otherwise established; or (2) 

about the existence, contents, validity, 

results, conclusions, or interpretations 

of any test, study, or other research. 

Part V requires Respondents to 

preserve supporting data and 

documents relevant to assessing human 

clinical tests that they rely on to support 

claims within the scope of Part III of the 

proposed order. Part VI requires 

Respondents to send notices to 

consumers who purchased Black Garlic 

Botanicals, BG18, The Ultimate Heart 

Formula, or Neupathic informing them 

about this matter and the Commission’s 

order. Part VII prohibits Respondents 

and their officers, agents, and 

employees from disclosing, using, or 

receiving any benefit from customer 

information that Respondents obtained 

in connection with sales of Black Garlic 

Botanicals, BG18, The Ultimate Heart 

Formula, or Neupathic. Part VIII 

requires Respondents to cancel any 

subscription plan with a negative option 

feature related to Black Garlic 

Botanicals, BG18, The Ultimate Heart 

Formula, or Neupathic. 

Parts IX through XII of the proposed 

order relate to compliance reporting and 

monitoring. Part IX is an order 

acknowledgment and distribution 

provision requiring Respondents to 

acknowledge the order, to provide the 

order to current and future owners, 

managers, business partners, certain 

employees, and to obtain an 

acknowledgement from each such 

person that they received a copy of the 

order. Part X requires Respondents to 

submit a compliance report one year 

after the order is entered, and to 

promptly notify the Commission of 

corporate changes that may affect 

compliance obligations. Part XI requires 

Respondents to maintain, and upon 

request make available, certain 

compliance-related records. Part XII 

requires Respondents to provide 

additional information or compliance 

reports, as requested. 

Part XIII states that the proposed 

order will remain in effect for 20 years, 

with certain exceptions. 

The purpose of this analysis is to aid 

public comment on the proposed order. 

It is not intended to constitute an 

official interpretation of the complaint 

or proposed order, or to modify in any 

way the proposed order’s terms. 

By direction of the Commission. 

April J. Tabor, 

Secretary. 

[FR Doc. 2022–06079 Filed 3–22–22; 8:45 am] 

BILLING CODE 6750–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0335] 

Advisory Committee; Obstetrics, 

Reproductive and Urologic Drugs 

Advisory Committee; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Obstetrics, Reproductive 

and Urologic Drugs Advisory Committee 

(formerly known as the Bone, 

Reproductive and Urologic Drugs 

Advisory Committee) by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Obstetrics, 

Reproductive and Urologic Drugs 

Advisory Committee for an additional 2 

years beyond the charter expiration 

date. The new charter will be in effect 

until the March 23, 2024, expiration 

date. 

DATES: Authority for the Obstetrics, 

Reproductive and Urologic Drugs 

Advisory Committee (formerly known 

as the Bone, Reproductive and Urologic 

Drugs Advisory Committee) will expire 

on March 23, 2024, unless the 

Commissioner formally determines that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Joyce Frimpong, Division of Advisory 

Committee and Consultant 

Management, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, email: ORUDAC@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services, FDA is announcing the 

renewal of the Obstetrics, Reproductive 

and Urologic Drugs Advisory Committee 

(the Committee). The Committee is a 

discretionary Federal advisory 

committee established to provide advice 

to the Commissioner. The Committee 

advises the Commissioner or designee 

in discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

data on the safety and effectiveness of 

marketed and investigational human 

drug products for use in the practice of 

obstetrics, gynecology, urology and 

related specialties, and makes 

appropriate recommendations to the 

Commissioner. 

The Committee shall consist of a core 

of 11 voting members, including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 

obstetrics, gynecology, urology, 

pediatrics, epidemiology, or statistics 

and related specialties. Members will be 

invited to serve for overlapping terms of 

up to 4 years. Non-Federal members of 

this committee will serve as Special 

Government Employees, representatives 

or Ex-Officio members. Federal 

members will serve as Regular 

Government Employees or Ex-Officios. 

The core of voting members may 

include one technically qualified 

member, selected by the Commissioner 

or designee, who is identified with 

consumer interests and is recommended 

by either a consortium of consumeroriented organizations or other 

interested persons. In addition to the 

voting members, the Committee may 

include one non-voting representative 

member who is identified with industry 

interests. There may also be an alternate 

industry representative. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

human-drug-advisory-committees/ 

obstetrics-reproductive-and-urologicdrugs-advisory-committee or by 


jspears on DSK121TN23PROD with NOTICES1