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 


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16478 Federal Register / Vol. 87, No. 56 / Wednesday, March 23, 2022 / Notices 

contacting the Designated Federal 

Officer (see FOR FURTHER INFORMATION

CONTACT). Due to a change in the 

Committee name and description of 

duties, a final rule will be published in 

the Federal Register amending 21 CFR 

14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. App.). For general information 

related to FDA advisory committees, 

please visit us at https://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: March 16, 2022. 

Andi Lipstein Fristedt, 

Deputy Commissioner for Policy, Legislation, 

and International Affairs, U.S. Food and Drug 

Administration. 

[FR Doc. 2022–05973 Filed 3–22–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Meeting of the National Advisory 

Committee on Rural Health and Human 

Services 

AGENCY: Health Resources and Services 

Administration (HRSA), Department of 

Health and Human Services. 

ACTION: Notice. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, this 

notice announces that the Secretary’s 

National Advisory Committee on Rural 

Health and Human Services 

(NACRHHS) has scheduled a public 

meeting. Information about NACRHHS 

and the agenda for this meeting can be 

found on the NACRHHS website at 

https://www.hrsa.gov/advisorycommittees/rural-health/index.html. 

DATES: 

• Monday, April 11, 2022, 12:00 

p.m.–5:00 p.m. Eastern Time (ET); 

• Tuesday, April 12, 2022, 12:00 

p.m.–4:00 p.m. ET; and 

• Wednesday, April 13, 2022, 12:00 

p.m.–5:00 p.m. ET. 

ADDRESSES: This meeting will be held 

virtually via Zoom webinar. While this 

meeting is open to the public, advance 

registration is required. 

Please register online at https://

us02web.zoom.us/meeting/register/ 

tZIudyqqDojHNMeqq9vMuklHBHhNftNoLAM 

by the deadline of 12:00 p.m. ET on 

April 8, 2022. Instructions on how to 

access the meeting via Zoom will be 

provided upon registration. 

FOR FURTHER INFORMATION CONTACT: 

Steven Hirsch, Administrative 

Coordinator at the Federal Office of 

Rural Health Policy, HRSA, 5600 

Fishers Lane, 17W59D, Rockville, 

Maryland 20857; 301–443–7322; or 

shirsch@hrsa.gov. 

SUPPLEMENTARY INFORMATION: 

NACRHHS provides advice and 

recommendations to the Secretary of 

Health and Human Service on policy, 

program development, and other 

matters of significance concerning both 

rural health and rural human services. 

During the April 11–13, 2022, 

meeting, NACRHHS will discuss two 

topics: Access to Emergency Medical 

Services in Rural America and Rural 

Human Services Programs and Issues. 

Agenda items are subject to change as 

priorities dictate. Refer to the 

NACRHHS website for any updated 

information concerning the meeting. 

Members of the public will have the 

opportunity to provide comments. 

Public participants wishing to provide 

oral comments must submit a written 

version of their statement at least 3 

business days in advance of the 

scheduled meeting. Oral comments will 

be honored in the order they are 

requested and may be limited as time 

permits. Public participants wishing to 

offer a written statement should send it 

to Steven Hirsch, using the contact 

information above, at least 3 business 

days prior to the meeting. 

Individuals who plan to attend and 

need special assistance or another 

reasonable accommodation should 

notify Steven Hirsch at the address and 

phone number listed above at least 10 

business days prior to the meeting. 

Maria G. Button, 

Director, Executive Secretariat. 

[FR Doc. 2022–06084 Filed 3–22–22; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the National Advisory Board 

on Medical Rehabilitation Research. 

The meeting will be held as a virtual 

meeting and is open to the public. 

Individuals who plan to view the virtual 

meeting and need special assistance, 

such as sign language interpretation or 

other reasonable accommodations, 

should notify the Contact Person listed 

below in advance of the meeting. The 

meeting will be videocast and can be 

accessed from the NIH Videocasting 

website (http://videocast.nih.gov). 

Name of Committee: National Advisory 

Board on Medical Rehabilitation Research. 

Date: May 2–3, 2022. 

Time: May 2, 2022, 10:00 a.m. to 3:00 p.m. 

Agenda: NICHD Director’s report; NCMRR 

Director’s report; Research talk on Peripheral 

Nerve Regeneration; Concept Clearance; Mini 

Symposium on Assessments for 

Rehabilitation (neurophysiologic and clinical 

measures). 

Place: Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, National Institutes of Health, 

6710B Rockledge Drive, Room 2116, 

Bethesda, MD 20892–7510 (Virtual Meeting). 

Time: May 3, 2022, 10:00 a.m. to 3:00 p.m. 

Agenda: Progress on the NIH 

Rehabilitation Research Plan; NIH Data 

Sharing Plan; NIH Updates on Equity, 

Diversity, and Inclusion; Effect of COVID–19 

on People with Disabilities; Review of 

NCMRR Infrastructure Support; Comments 

from Parting Board Members; Agenda 

Planning for Next Board Meeting in 

December 2022. 

Place: Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, National Institutes of Health, 

6710B Rockledge Drive, Room 2116, 

Bethesda, MD 20892–7510 (Virtual Meeting). 

Contact Person: Ralph M. Nitkin, Ph.D., 

Deputy, National Center for Medical 

Rehabilitation Research and Director, 

Biological Sciences and Career Development 

Program, Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development, National Institutes of Health, 

6710B Rockledge Drive, Room 2116, 

Bethesda, MD 20892–7510, (301) 402–4206 

nitkinr@mail.nih.gov. 

Information is also available on the 

Institute’s/Center’s home page: https://

www.nichd.nih.gov/about/advisory/nabmrr, 

where an agenda and any additional 

information for the meeting will be posted 

when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 

93.865, Research for Mothers and Children; 

93.929, Center for Medical Rehabilitation 

Research; 93.209, Contraception and 

Infertility Loan Repayment Program, National 

Institutes of Health, HHS) 

Dated: March 17, 2022. 

Melanie J. Pantoja, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2022–06074 Filed 3–22–22; 8:45 am] 

BILLING CODE 4140–01–P 


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