Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40591 

or via regular mail if email is not an 

option. Invoices must be paid within 30 

days. 

C. Fee Payment Procedures 

1. The preferred payment method is 

online using electronic check 

(Automated Clearing House (ACH) also 

known as eCheck) or credit card 

(Discover, VISA, MasterCard, American 

Express). Secure electronic payments 

can be submitted using the User Fees 

Payment Portal at—https://

userfees.fda.gov/pay. (Note: only full 

payments are accepted. No partial 

payments can be made online.) Once 

you search for your invoice, click ‘‘Pay 

Now’’ to be redirected to Pay.gov. 

Electronic payment options are based on 

the balance due. Payment by credit card 

is available for balances less than 

$25,000. If the balance exceeds this 

amount, only the ACH option is 

available. Payments must be made using 

U.S. bank accounts as well as U.S. credit 

cards. 

2. If paying with a paper check: 

Checks must be in U.S. currency from 

a U.S. bank and made payable to the 

Food and Drug Administration. 

Payments can be mailed to: Food and 

Drug Administration, P.O. Box 979033, 

St. Louis, MO 63197–9000. Include 

invoice number on check. If a check is 

sent by a courier that requests a street 

address, the courier can deliver the 

check to: U.S. Bank, Attn: Government 

Lockbox 979033, 1005 Convention 

Plaza, St. Louis, MO 63101. (Note: This 

U.S. Bank address is for courier delivery 

only. If you have any questions 

concerning courier delivery, contact the 

U.S. Bank at 314–418–4013). 

3. When paying by wire transfer, the 

invoice number must be included. 

Without the invoice number the 

payment may not be applied. Regarding 

reinspection fees, if the payment 

amount is not applied, the invoice 

amount will be referred to collections. 

The originating financial institution 

may charge a wire transfer fee. If the 

financial institution charges a wire 

transfer fee, it is required that the 

outsourcing facility add that amount to 

the payment to ensure that the invoice 

is paid in full. Use the following 

account information when sending a 

wire transfer: U.S. Dept of the Treasury, 

TREAS NYC, 33 Liberty St., New York, 

NY 10045, Acct. No. 75060099, Routing 

No. 021030004, SWIFT: FRNYUS33. If 

needed, FDA’s tax identification 

number is 53–0196965. 

Dated: July 20, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16057 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–2021–N–0652] 

Fresenius Kabi USA, LLC, et al.; 

Withdrawal of Approval of 15 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 15 abbreviated 

new drug applications (ANDAs) from 

multiple applicants. The applicants 

notified the Agency in writing that the 

drug products were no longer marketed 

and requested that the approval of the 

applications be withdrawn. 

DATES: Approval is withdrawn as of 

August 27, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave, Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 040265 ...................... Methotrexate Sodium Injection, Equivalent to (EQ) 25 

milligrams (mg) base/milliliters (mL).

Fresenius Kabi USA, LLC, Three Corporate Dr., Lake 

Zurich, IL 60047. 

ANDA 070963 ...................... Clonidine Hydrochloride (HCl) Tablets, 0.3 mg .............. Watson Laboratories, Inc. (an indirect, wholly owned 

subsidiary of Teva Pharmaceuticals USA, Inc.), 400 

Interpace Pkwy., Bldg. A, Parsippany, NJ 07054. 

ANDA 074292 ...................... Dobutamine HCl Injection, EQ 12.5 mg base/mL .......... Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045. 

ANDA 075069 ...................... Etodolac Tablets, 400 mg ............................................... Watson Laboratories, Inc. 

ANDA 075856 ...................... Midazolam HCl Injection, EQ 1 mg base/mL and EQ 5 

mg base/mL.

Hospira, Inc. 

ANDA 084504 ...................... Hydralazine HCl Tablets, 25 mg ..................................... Watson Laboratories, Inc. 

ANDA 090379 ...................... Budesonide Delayed Release Capsules, 3 mg .............. Barr Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400 

Interpace Pkwy., Bldg. A, Morris Corporate Center III, 

Parsippany, NJ 07054. 

ANDA 091590 ...................... Losartan Potassium Tablets, 25 mg, 50 mg, and 100 

mg.

Mylan Pharmaceuticals Inc., a Viatris Company, 81 

Chestnut Ridge Rd., P.O. Box 4310, Morgantown, 

WV 26504. 

ANDA 091652 ...................... Hydrochlorothiazide and Losartan Potassium Tablets, 

12.5 mg/50 mg, 12.5 mg/100 mg, and 25 mg/100 mg.

Do. 

ANDA 204361 ...................... Eptifibatide Injection, 2 mg/mL and 75 mg/100 mL ........ USV Private Limited, U.S. Agent, Omega Pharmaceutical Consulting, Inc., 752 West Shuhthagi Lane, 

New Harmony, UT 84757. 

ANDA 204362 ...................... Eptifibatide Injection, 2 mg/mL ........................................ Do. 


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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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