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 


khammond on DSKJM1Z7X2PROD with NOTICES
40594 Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 

1Form FDA 3500A is approved under OMB 

control number 0910–0291. 2 In the Federal Register of August 17, 2018 (83 

FR 40973), FDA issued a notification permitting 

manufacturers to report certain device malfunction 

MDRs in summary form on a quarterly basis. 

3Available at: https://www.fda.gov/downloads/ 

ForIndustry/UserFees/MedicalDeviceUserFee/ 

UCM535548.pdf. 4 Device user facility means a hospital, 

ambulatory surgical facility, nursing home, 

outpatient diagnostic facility, or outpatient 

treatment facility as defined in § 803.3 (21 CFR 

803.3), which is not a physician’s office (also 

defined in § 803.3). 

devices to FDA. These provisions are 

codified in part 803 (21 CFR part 803), 

Medical Device Reporting. As amended 

most recently by the FDA 

Reauthorization Act of 2017 (FDARA) 

(Pub. L. 115–52), medical device 

manufacturers and importers must 

submit medical device reports (MDRs) 

using FDA’s electronic submission 

system. User facilities, however, may 

elect to submit reports using paperbased Form FDA 3500A—MedWatch— 

Mandatory Reporting (approved under 

OMB control number 0910–0291). The 

regulations also establish recordkeeping 

requirements and provide for certain 

exemptions, variances, or alternative 

forms of reporting. Exemptions and/or 

variances from individual reporting 

must be requested in writing and must 

receive Agency approval. Additionally, 

the regulations permit user facilities to 

submit paper-based annual reports, for 

which we have developed Form FDA 

3419 entitled ‘‘Medical Device 

Reporting Annual User Facility Report.’’ 

This information collection also 

includes the use of existing formats 

such as Form FDA 3500A 1— 

MedWatch—Mandatory Reporting to 

allow manufacturers to summarize in a 

single report multiple events with 

shared characteristics for device 

associated reportable malfunction 

events. For example, the Voluntary 

Malfunction Summary Reporting 

Program (VMSRP) 2 provides 

recommendations for manufacturers of 

certain devices to submit a single report 

that summarizes multiple device 

associated reportable malfunction 

events on a quarterly basis. The VMSRP 

was established under section 

519(a)(1)(B)(ii) of the FD&C Act and 

reflects goals for streamlining 

malfunction reporting as outlined in the 

Medical Device User Fee Amendments 

(MDUFA) IV ‘‘Commitment Letter’’ for 

2018 through 2022 agreed to by FDA 

and industry and submitted to Congress. 

The Commitment Letter was finalized 

with the passage of FDARA on August 

18, 2017, and, as passed, is entitled 

‘‘MDUFA Performance Goals And 

Procedures, Fiscal Years 2018 Through 

2022.’’ 3

The information that is obtained from 

this information collection will be used 

to evaluate risks associated with 

medical devices and enable FDA to take 

appropriate measures to protect the 

public health. Complete, accurate, and 

timely adverse event information is 

necessary for the identification of 

emerging device problems so the 

Agency can protect the public health 

under section 519 of the FD&C Act. FDA 

makes the releasable information 

available to the public for downloading 

on its website. Respondents are 

manufacturers and importers of medical 

devices and device user facilities.4

In the Federal Register of April 29, 

2021 (86 FR 22671), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. No comments were 

received. Upon our own review, 

however, we have updated submission 

figures from our VMSRP program and 

supplemental reports under § 803.56 (21 

CFR 803.56) to reflect an increase in 

submissions. Since publication of our 

60-day notice, therefore, we have 

modified our estimated burden for 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity/21 CFR section FDA form No. Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 2

Exemptions/Variances—803.19 ................ ........................ 6 135.8 815 0.10 (6 minutes).82 

User Facility Reporting—803.30 and 

803.32.

........................ 271 17.2 4,661 0.35 (21 minutes).1,631 

User Facility Annual Reporting—803.33 ... 3,419 93 2 186 1 ..................... 186 

Importer Reporting, Death and Serious Injury—803.40 and 803.42......................... 112 440.25 49,308 0.10 (6 minutes).4,931 

Manufacturer Reporting—803.50, 803.52 

and 803.53.

........................ 1,799 809.83 1,456,884 0.10 (6 minutes).145,688 

Voluntary Malfunction Summary Reporting 

Program.

........................ 67 695.15 46,575 0.10 (6 minutes).4,658 

Supplemental Reports—803.56 ................ ........................ 1,291 438 565,458 0.10 (6 minutes).56,546 

Total .................................................... ........................ ........................ ........................ ........................ ........................ 213,722 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 Number has been rounded. 

The number of respondents to the 

information collection is based on 

MDRs received by FDA recently. The 

annual frequency per response and total 

annual responses shown are based on 

the number of MDRs reported during 

the same period. Based on the scope and 

conditions of the VMSRP and our 

experience with MDR reporting, FDA 

estimates that approximately 10 percent 

of malfunction reports would continue 

to be submitted as individual reports. 

Approximately 62 percent of the 

manufacturer reports received under 

§§ 803.50, 803.52 and 803.53 are 

malfunction reports (903,268 of the 

1,456,884 total annual responses 

received in 2020). 

Supplemental Reports—§ 803.56. We 

have increased our estimate, of the 

number of supplemental reports to 

reflect a corresponding increase of 

annual submissions, as reflected in table 

1, row 7. 

Voluntary Malfunction Summary 

Reporting Program. The VMSRP 

includes the same respondent pool as 

individual manufacturer reporting. 

Based on a current review of Agency 

data, we have increased our estimate to 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices 40595 

reflect an increase in annual submissions, as reflected in table 1, row 

6. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity/21 CFR section Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

MDR Procedures—803.17 ................................................... 1,799 1 1,799 3.3 5,937 

MDR Files—803.18 .............................................................. 1,799 1 1,799 1.5 2,699 

Total .............................................................................. ........................ ........................ ........................ ........................ 8,636 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The number of respondents in table 2 

is based on the MDRs reported to FDA’s 

internal databases recently. We believe 

that the majority of respondents 

(manufacturers, user facilities, and 

importers) have already established 

written procedures and MDR files to 

document complaints and information 

to meet the MDR requirements as part 

of their internal quality control system. 

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Activity/21 CFR section Number of 

respondents 

Number of 

disclosures 

per 

respondent 

Total annual 

disclosures 

Average 

burden per 

disclosure 

Total hours 2

Importer Reporting, Death and Serious Injury—803.40 and 

803.42.

112 25 2,800 0.35 (21 minutes).980 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

2 Number has been rounded. 

The number of respondents for each 

CFR section in table 3 was identified 

from the MDRs reported to FDA’s 

internal databases during the period 

recently. 

Since the publication of the 60 day 

notice we have adjusted our burden 

estimate. Our estimated burden for the 

information collection reflects an 

increase of 155,360 total burden hours 

and a corresponding increase of 

1,566,458 total annual responses. This 

increase corresponds with data obtained 

from our database. 

Dated: July 21, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–16034 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–0706] 

Animal Drug User Fee Rates and 

Payment Procedures for Fiscal Year 

2022 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the fee rates and payment 

procedures for fiscal year (FY) 2022 

animal drug user fees. The Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act), as amended by the Animal Drug 

User Fee Amendments of 2018 (ADUFA 

IV), authorizes FDA to collect user fees 

for certain animal drug applications and 

supplemental animal drug applications, 

for certain animal drug products, for 

certain establishments where such 

products are made, and for certain 

sponsors of such animal drug 

applications and/or investigational 

animal drug submissions. This notice 

establishes the fee rates for FY 2022. 

FOR FURTHER INFORMATION CONTACT: Visit 

FDA’s website at https://www.fda.gov/ 

ForIndustry/UserFees/ 

AnimalDrugUserFeeActADUFA/ 

default.htm or contact Lisa Kable, 

Center for Veterinary Medicine (HFV– 

10), Food and Drug Administration, 

7500 Standish Pl., Rockville, MD 20855, 

240–402–6888, Lisa.Kable@fda.hhs.gov. 

For general questions, you may also 

email FDA’s Center for Veterinary 

Medicine (CVM) at: cvmadufa@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 740 of the FD&C Act (21 

U.S.C. 379j–12) establishes four 

different types of user fees: (1) Fees for 

certain types of animal drug 

applications and supplemental animal 

drug applications; (2) annual fees for 

certain animal drug products; (3) annual 

fees for certain establishments where 

such products are made; and (4) annual 

fees for certain sponsors of animal drug 

applications and/or investigational 

animal drug submissions (21 U.S.C. 

379j–12(a)). When certain conditions are 

met, FDA will waive or reduce fees (21 

U.S.C. 379j–12(d)). 

For FYs 2019 through 2023, the FD&C 

Act establishes aggregate yearly base 

revenue amounts for each fiscal year (21 

U.S.C. 379j–12(b)(1)). Base revenue 

amounts are subject to adjustment for 

inflation and workload (21 U.S.C. 379j– 

12(c)(2) and (3)). Beginning with FY 

2021, the annual fee revenue amounts 

are also subject to adjustment to reduce 

workload-based increases by the amount 

of certain excess collections or to 

account for certain collection shortfalls 

(21 U.S.C. 379j–12(c)(3) and (g)(5)). Fees 

for applications, establishments, 

products, and sponsors are to be 

established each year by FDA so that the 

percentages of the total revenue that are 

derived from each type of user fee will 

be as follows: (1) Revenue from 

application fees shall be 20 percent of 

total fee revenue; (2) revenue from 

product fees shall be 27 percent of total 

fee revenue; (3) revenue from 

establishment fees shall be 26 percent of 


khammond on DSKJM1Z7X2PROD with NOTICES