40592 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

Application No. Drug Applicant 

ANDA 204464 ...................... Sodium Fluoride F–18 Injection, 10–200 millicurie/mL ... Decatur Memorial Hospital, 2300 North Edward St., 

Suite 100, Decatur, IL 62526. 

ANDA 206177 ...................... Docetaxel Injection, 20 mg/mL (20 mg/mL), 80 mg/4 

mL (20 mg/mL), and 200 mg/10 mL (20 mg/mL).

DFB Oncology, LLC, 3909 Hulen St., Fort Worth, TX 

76107. 

ANDA 206631 ...................... Olmesartan Medoxomil Tablets, 5 mg, 20 mg, and 40 

mg.

Lupin Limited, U.S. Agent, Lupin Pharmaceuticals, Inc., 

111 South Calvert St., Harborplace Tower, 21st 

Floor, Baltimore, MD 21202. 

ANDA 209399 ...................... Olanzapine Tablets, 2.5 mg, 5 mg, and 10 mg .............. Jiangsu Hansoh Pharmaceutical Group Co., Ltd., U.S. 

Agent, eVenus Pharmaceutical Laboratories Inc., 506 

Carnegie Center, Suite 100, Princeton, NJ 08540. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of August 27, 

2021. Approval of each entire 

application is withdrawn, including any 

strengths and dosage forms 

inadvertently missing from the table. 

Introduction or delivery for introduction 

into interstate commerce of products 

without approved new drug 

applications violates section 301(a) and 

(d) of the Federal Food, Drug, and 

Cosmetic Act (21 U.S.C. 331(a) and (d)). 

Drug products that are listed in the table 

that are in inventory on August 27, 2021 

may continue to be dispensed until the 

inventories have been depleted or the 

drug products have reached their 

expiration dates or otherwise become 

violative, whichever occurs first. 

Dated: July 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16047 Filed 7–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2169] 

Jacobo Geissler: Final Debarment 

Order 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) debarring 

Jacobo Geissler for a period of 5 years 

from importing articles of food or 

offering such articles for importation 

into the United States. FDA bases this 

order on a finding that Mr. Geissler was 

convicted of a felony count under 

Federal law for conduct relating to the 

importation into the United States of an 

article of food. Mr. Geissler was given 

notice of the proposed debarment and 

an opportunity to request a hearing 

within the timeframe prescribed by 

regulation. As of April 7, 2021 (30 days 

after receipt of the notice), Mr. Geissler 

has not responded. Mr. Geissler’s failure 

to respond and request a hearing 

constitutes a waiver of Mr. Geissler’s 

right to a hearing concerning this 

matter. 

DATES: This order is applicable July 28, 

2021. 

ADDRESSES: Submit applications for 

termination of debarment to the Dockets 

Management Staff, Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852, 240–402– 

7500, or at https://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Jaime Espinosa, Division of Enforcement 

(ELEM–4029), Office of Strategic 

Planning and Operational Policy, Office 

of Regulatory Affairs, Food and Drug 

Administration, 12420 Parklawn Dr., 

Rockville, MD 20857, 240–402–8743, or 

at debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(b)(1)(C) of the FD&C Act 

(21 U.S.C. 335a(b)(1)(C)) permits FDA to 

debar an individual from importing an 

article of food or offering such an article 

for import into the United States if FDA 

finds, as required by section 

306(b)(3)(A) of the FD&C Act, that the 

individual has been convicted of a 

felony for conduct relating to the 

importation into the United States of 

any food. 

On October 13, 2020, Mr. Geissler was 

convicted as defined in section 

306(l)(1)(A) of the FD&C Act (21 U.S.C. 

335a(l)(1)(A)), in the U.S. District Court 

for the Northern District of Texas-Dallas 

Division, when the court accepted his 

plea of guilty and entered judgment 

against him for the offense of conspiracy 

to introduce misbranded food into 

interstate commerce with an intent to 

defraud and mislead in violation of 18 

U.S.C. 371 (21 U.S.C. 331(a) and 21 

U.S.C. 333(a)(2)). 

FDA’s finding that the debarment is 

appropriate is based on the felony 

conviction referenced herein. The 

factual basis for this conviction is as 

follows: As contained in the Factual 

Resume, dated February 24, 2019, in Mr. 

Geissler’s case, he was the Chief 

Executive Officer (CEO) and coowner of 

USPlabs, LLC (USP Labs). USP Labs 

sold dietary supplements. Beginning in 

or around October 2008 and continuing 

until at least around August 2014, Mr. 

Geissler engaged in a conspiracy with 

others to import a variety of chemicals 

with false labeling in order to either use 

those chemicals in dietary supplements 

which would themselves also contain 

false labeling, or to determine whether 

those chemicals could be used in new 

dietary supplements. To further this 

conspiracy, Mr. Geissler’s 

coconspirators ordered chemicals from a 

Chinese company to be used as 

ingredients in dietary supplements and 

had them labeled falsely as other food 

substances. USP Labs sold dietary 

supplements called Jack3d and OxyElite 

Pro, which originally contained a 

substance called 1,3-dimethylamine 

(DMAA), which is also known as 

methylhexaneamine. USP Labs 

imported the DMAA it used in its 

products, Jack3d and OxyElite Pro, from 

a Chinese chemical factory by using 

false and fraudulent Certificate of 

Analysis (COA) and other false and 

fraudulent documentation and labeling. 

At least some of the false COAs that 

USP Labs caused to be created for their 

DMAA shipments stated falsely that the 

substance in the shipments had been 

extracted from the geranium plant. 

Further, as contained in the factual 

resume and superseding indictment, 

filed January 5, 2016, in December 2011, 

Mr. Geissler instructed a Chinese 

company via email to misbrand a 

shipment of nine different chemicals 

sent from China to USP Labs in Texas. 

One of those synthetic chemicals was 

called ‘‘aegeline.’’ The first aegeline 

containing version of OxyElite Pro, 

which was called OxyElite ‘‘New 

Formula’’, went on sale in December 

2012, but did not sell as well as the 

DMAA-containing version. Therefore, in 

the summer 2013, USP Labs began using 


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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40593 

pulverized roots of cynanchum 

auriculatum, in addition to aegeline, in 

its OxyElite Pro ‘‘Advanced Formula’’ 

supplement. The cynanchum 

auriculatum-containing product was 

called OxyElite Pro ‘‘Advanced 

Formula.’’ On or about June 15, 2013, 

Mr. Geissler’s coconspirator instructed a 

Chinese chemical seller to have two 

metric tons of ground cynanchum 

auriculatum root powder, rather than an 

extract, shipped internationally to 

laboratories in California for inclusion 

in USP Labs’ products, using the false 

name ‘‘cynanchum auriculatum root 

extract.’’ USP Labs then used the 

substance in its OxyElite Pro 

‘‘Advanced Formula’’ supplement 

which it shipped to retailers and 

wholesalers using false labels. When 

there was a liver-injury outbreak, USP 

Labs put out a misleading press release 

stating that the ingredients in OxyElite 

Pro had been studied and showed ‘‘no 

negative liver issues,’’ but USP Labs 

knew that a study had shown ‘‘liver 

issues’’ related to cynanchum 

auriculatum. Mr. Geissler did, with 

intent to defraud and mislead, cause the 

shipment of misbranded OxyElite Pro 

‘‘Advanced Formula’’ to be shipped in 

interstate commerce. The conspirators 

collected millions in revenue. 

As a result of this conviction FDA 

sent Mr. Geissler, by certified mail on 

March 4, 2021, a notice proposing to 

debar him for a period of 5 years from 

importing articles of food or offering 

such articles for import into the United 

States. The proposal was based on a 

finding under section 306(b)(1)(C) of the 

FD&C Act that Mr. Geissler’s felony 

conviction of conspiracy to introduce 

misbranded food into interstate 

commerce with an intent to defraud and 

mislead in violation of 18 U.S.C. 371 (21 

U.S.C. 331(a) and 21 U.S.C. 333(a)(2)), 

constitutes conduct relating to the 

importation of an article of food into the 

United States because the offense 

involved a conspiracy with others to 

import a variety of chemicals with false 

labeling in order to either use those 

chemicals in dietary supplements which 

would themselves also contain false 

labeling or to determine whether those 

chemicals could be used in new dietary 

supplements. 

The proposal was also based on a 

determination, after consideration of the 

relevant factors set forth in section 

306(c)(3) of the FD&C Act, that Mr. 

Geissler should be subject to a 5-year 

period of debarment. The proposal also 

offered Mr. Geissler an opportunity to 

request a hearing, providing him 30 

days from the date of receipt of the letter 

in which to file the request, and advised 

Mr. Geissler that failure to request a 

hearing constituted a waiver of the 

opportunity for a hearing and of any 

contentions concerning this action. Mr. 

Geissler failed to respond within the 

timeframe prescribed by regulation and 

has, therefore, waived his opportunity 

for a hearing and waived any 

contentions concerning his debarment 

(21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(b)(1)(C) of the FD&C Act, under 

authority delegated to the Assistant 

Commissioner, finds that Mr. Jacobo 

Geissler has been convicted of a felony 

count under Federal law for conduct 

relating to the importation into the 

United States of an article of food and 

that he is subject to a 5-year period of 

debarment. 

As a result of the foregoing finding, 

Mr. Geissler is debarred for a period of 

5 years from importing articles of food 

or offering such articles for import into 

the United States, effective July 28, 

2021. Pursuant to section 301(cc) of the 

FD&C Act (21 U.S.C. 331(cc)), the 

importing or offering for import into the 

United States of an article of food by, 

with the assistance of, or at the direction 

of Jacobo Geissler is a prohibited act. 

Any application by Mr. Geissler for 

termination of debarment under section 

306(d)(1) of the FD&C Act should be 

identified with Docket No. FDA–2020– 

N–2169 and sent to the Dockets 

Management Staff (ADDRESSSES). The 

public availability of information in 

these submissions is governed by 21 

CFR 10.20. 

Publicly available submissions will be 

placed in the docket and will be 

viewable at https://www.regulations.gov 

or at the Dockets Management Staff (see 

ADDRESSES) between 9 a.m. and 4 p.m., 

Monday through Friday, 240–402–7500. 

Dated: July 19, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16045 Filed 7–27–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6730] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Medical Device 

Reporting 

AGENCY: Food and Drug Administration, 

Health and Human Services (HHS). 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by August 27, 

2021. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0437. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Amber Sanford, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–8867, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Medical Device Reporting—21 CFR Part 

803 

OMB Control Number 0910–0437— 

Extension 

This information collection supports 

FDA regulations and FDA’s Medical 

Device Reporting program. Section 

519(a), (b), and (c) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 360i(a), (b), and (c)) requires user 

facilities, manufacturers, importers, and 

distributors of medical devices to report 

adverse events involving medical 


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