23184 Federal Register / Vol. 87, No. 75 / Tuesday, April 19, 2022 / Notices 

submitting the information to FDA each 

year. 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR part 10 have been approved under 

OMB control number 0910–0191. The 

collections of information in 21 CFR 

part 101 have been approved under 

OMB control number 0910–0381. The 

collections of information in section 

403(w) of the FD&C Act have been 

approved under OMB control number 

0910–0792. The collections of 

information in 21 CFR part 117 have 

been approved under OMB control 

number 0910–0751. The collections of 

information for Form FDA 3800 have 

been approved under OMB control 

number 0910–0645. The collections of 

information for Form FDA 3500 have 

been approved under OMB control 

number 0910–0291. The collections of 

information in 21 CFR 70.25, 71.1, 

170.36, 171.1, 172, 173, 179, and 180 

have been approved under OMB control 

number 0910–0016. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/FoodGuidances, 

https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://

www.regulations.gov. Use the FDA 

website listed in the previous sentence 

to find the most current version of the 

guidance. 

Dated: April 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08303 Filed 4–18–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0030] 

Fresenius Kabi USA, LLC, et al.; 

Withdrawal of Approval of Five 

Abbreviated New Drug Applications; 

Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice that appeared in the Federal 

Register on February 28, 2022. The 

document announced the withdrawal of 

approval of five abbreviated new drug 

applications (ANDAs) from multiple 

applicants as of March 30, 2022. The 

document indicated that FDA was 

withdrawing approval of the following 

ANDA after receiving a withdrawal 

request from Jiangsu Hengrui 

Pharmaceuticals Co., Ltd., U.S. Agent, 

Venus Pharmaceutical Laboratories Inc., 

506 Carnegie Center, Suite 100, 

Princeton, NJ 08540: ANDA 091008, 

Gabapentin Capsules, 100 milligrams 

(mg), 300 mg, and 400 mg. Before FDA 

withdrew the approval of this ANDA, 

Jiangsu Hengrui Pharmaceuticals Co., 

Ltd., informed FDA that it did not want 

the approval of the ANDA withdrawn. 

Because Jiangsu Hengrui 

Pharmaceuticals Co., Ltd., timely 

requested that approval of this ANDA 

not be withdrawn, the approval of 

ANDA 091008 is still in effect. 

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: In the 

Federal Register of February 28, 2022 

(87 FR 11079), appearing on page 11079 

in FR Doc. 2022–04153, the following 

correction is made: 

On page 11079, in the table, the entry 

for ANDA 091008 is removed. 

Dated: April 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–08299 Filed 4–18–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0317] 

Yvelice Villaman-Bencosme: Final 

Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) permanently debarring Yvelice 

Villaman-Bencosme from providing 

services in any capacity to a person that 

has an approved or pending drug 

product application. FDA bases this 

order on a finding that Yvelice 

Villaman-Bencosme was convicted of a 

felony under Federal law for conduct 

relating to the development or approval, 

including the process of development or 

approval, of a drug product under the 

FD&C Act. Ms. Villaman-Bencosme was 

given notice of the proposed permanent 

debarment and was given an 

opportunity to request a hearing to show 

why she should not be debarred. As of 

December 13, 2021 (30 days after receipt 

of the notice), Ms. Villaman-Bencosme 

had not responded. Ms. VillamanBencosme’s failure to respond and 

request a hearing constitutes a waiver of 

her right to a hearing concerning this 

action. 

DATES: This order is applicable April 19, 

2022. 

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, 

debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 306(a)(2)(A) of the FD&C Act 

(21 U.S.C. 335a(a)(2)(A)) requires 

debarment of an individual from 

providing services in any capacity to a 

person that has an approved or pending 

drug product application if FDA finds 

that the individual has been convicted 

of a felony under Federal law for 

conduct relating to the development or 

approval, including the process of 

development or approval, of any drug 

product under the FD&C Act. On March 

19, 2021, Ms. Villaman-Bencosme was 

convicted as defined in section 306(l)(1) 

of the FD&C Act when judgment was 

entered against her in the U.S. District 

Court for the Southern District of 

Florida-Miami Division, after her plea of 

guilty, to one count of Conspiracy to 

Commit Wire Fraud in violation of 18 

U.S.C. 1349. 

The factual basis for this conviction is 

as follows: Ms. Villaman-Bencosme was 

a licensed medical doctor who served as 

a clinical investigator at Unlimited 

Medical Research, LLC from about 

September 2013 through June 2016. Ms. 

Villaman-Bencosme conspired with 

others to unlawfully enrich herself by 

making materially false representations 

about clinical trials; fabricating data and 

the participation of subjects in those 

clinical trials; concealing from FDA, 

sponsors, and contract research 

organizations the fact that the data and 

participation of subjects had been 


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