Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 16215 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

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

authority delegated to the Assistant 

Commissioner, finds that Mr. Irfanali 

Momin has been convicted of a felony 

under Federal law for conduct relating 

to the importation into the United States 

of any drug or controlled substance. 

FDA finds that the offense should be 

accorded a debarment period of 5 years 

as provided by section 306(c)(2)(A)(iii) 

of the FD&C Act. 

As a result of the foregoing finding, 

Mr. Momin is debarred for a period of 

5 years from importing or offering for 

import any drug into the United States, 

effective (see DATES). 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 any 

drug or controlled substance by, with 

the assistance of, or at the direction of 

Mr. Momin is a prohibited act. 

Any application by Mr. Momin for 

termination of debarment under section 

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

identified with Docket No. FDA–2021– 

N–0415 and sent to the Division of 

Dockets Management Staff (see 

ADDRESSSES). The public availability of 

information in these submissions is 

governed by 21 CFR 10.20(j). 

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: March 15, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–06052 Filed 3–21–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0417] 

Shiba I. Momin: Final Debarment Order 

AGENCY: Food and Drug Administration, 

Department of 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 

Shiba I. Momin for a period of 5 years 

from importing or offering for import 

any drug into the United States. FDA 

bases this order on a finding that Ms. 

Momin was convicted of one felony 

count under Federal law for Conspiracy. 

The factual basis supporting Ms. 

Momin’s conviction, as described 

below, is conduct relating to the 

importation into the United States of a 

drug or controlled substance. Ms. 

Momin was given notice of the 

proposed debarment and was given an 

opportunity to request a hearing to show 

why she should not be debarred. As of 

December 26, 2021 (30 days after receipt 

of the notice), Ms. Momin had not 

responded. Ms. Momin’s failure to 

respond and request a hearing 

constitutes a waiver of her right to a 

hearing concerning this matter. 

DATES: This order is applicable March 

22, 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, or 

at debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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

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

debarment of an individual from 

importing or offering for import any 

drug into the United States if FDA finds, 

as required by section 306(b)(3)(C) 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 drug or controlled 

substance. 

On February 12, 2021, Ms. Momin 

was convicted, as defined in section 

306(l)(1) of the FD&C Act, in the U.S. 

District Court for the District of Georgia, 

Rome Division, when the court entered 

judgment against her for the offense of 

conspiracy, in violation of 18 U.S.C. 

371. 

FDA’s finding that debarment is 

appropriate is based on the felony 

conviction referenced herein. The 

factual basis for this conviction is as 

follows: 

As contained in the Information in 

Ms. Momin’s case, filed on September 

23, 2020, to which she pleaded guilty, 

between August 2014 and November 

2018, Ms. Momin along with her coconspirators, illegally imported 

misbranded drugs from China that she 

marketed for male enhancement under 

names such as ‘‘Black Ant King,’’ 

‘‘Bull,’’ ‘‘Rhino 7,’’ ‘‘Super Hard,’’ ‘‘Herb 

Viagra,’’ ‘‘Jack Rabbit,’’ ‘‘Zhen Gongfu,’’ 

‘‘Stree Overlord,’’ ‘‘Pro Power Max,’’ ‘‘A 

Traditional Chinese Medicine-Kidney 

Reinforcing Pallet,’’ ‘‘Libigrow,’’ ‘‘Red 

Mamba,’’ ‘‘Rhino 69,’’ ‘‘Krazzy Rhino,’’ 

‘‘Rhino 25,’’ Hard Steel,’’ and ‘‘Black 

Mamba.’’ These products contained 

sildenafil, the active pharmaceutical 

ingredient in Pfizer, Inc.’s FDAapproved erectile dysfunction drug, 

VIAGRA, and/or tadalafil, the active 

pharmaceutical ingredient in Eli Lilly & 

Company’s FDA-approved erectile 

dysfunction drug, CIALIS. Both 

VIAGRA and CIALIS can be obtained in 

the United States only with a 

prescription from a practitioner licensed 

by law to administer such drug pursuant 

to section 503(b) of the FD&C Act (21 

U.S.C. 353(b)). In order to evade U.S. 

import restrictions, Ms. Momin illegally 

imported misbranded drugs into the 

United States from China. As per the 

conspiracy Ms. Momin was involved in, 

the U.S. Customs declarations on the 

boxes containing the misbranded drugs 

falsely declared the contents of the 

boxes to be something other than 

misbranded drugs, such as beauty 

products and health products, to make 

it appear that the boxes contained items 

that could legally be imported into the 

United States Ms. Momin then 

introduced and delivered for 

introduction into interstate commerce 

these misbranded drugs containing 

undeclared sildenafil and tadalafil, in 

violation of sections 301(a), 301(c), 

303(a)(2), 502(a), and 502(f) of the FD&C 

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

352(a) and 352(f)). 

As a result of this conviction, FDA 

sent Ms. Momin, by certified mail, on 

November 19, 2021, a notice proposing 

to debar her for a 5-year period from 

importing or offering for import any 

drug into the United States. The 

proposal was based on a finding under 

section 306(b)(3)(C) of the FD&C Act 

that Ms. Momin’s felony conviction 

under Federal law for conspiracy, in 

violation of 18 U.S.C. 371, was for 

conduct relating to the importation into 

the United States of any drug or 

controlled substance because she 

illegally imported and then introduced 

misbranded tadalafil and sildenafil into 

interstate commerce. In proposing a 

debarment period, FDA weighed the 

considerations set forth in section 

306(c)(3) of the FD&C Act that it 

considered applicable to Ms. Momin’s 

offense and concluded that the offense 

warranted the imposition of a 5-year 

period of debarment. 


lotter on DSK11XQN23PROD with NOTICES1
16216 Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 

The proposal informed Ms. Momin of 

the proposed debarment and offered her 

an opportunity to request a hearing, 

providing her 30 days from the date of 

receipt of the letter in which to file the 

request, and advised her that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Ms. 

Momin received the proposal and notice 

of opportunity for a hearing at her 

residence on November 26, 2021. Ms. 

Momin failed to request a hearing 

within the timeframe prescribed by 

regulation and has, therefore, waived 

her opportunity for a hearing and 

waived any contentions concerning her 

debarment (21 CFR part 12). 

II. Findings and Order 

Therefore, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

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

authority delegated to the Assistant 

Commissioner, finds that Ms. Shiba I. 

Momin has been convicted of a felony 

under Federal law for conduct relating 

to the importation into the United States 

of any drug or controlled substance. 

FDA finds that the offense should be 

accorded a debarment period of 5 years 

as provided by section 306(c)(2)(A)(iii) 

of the FD&C Act. 

As a result of the foregoing finding, 

Ms. Momin is debarred for a period of 

5 years from importing or offering for 

import any drug into the United States, 

effective (see DATES). 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 any 

drug or controlled substance by, with 

the assistance of, or at the direction of 

Ms. Momin is a prohibited act. 

Any application by Ms. Momin for 

termination of debarment under section 

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

identified with Docket No. FDA–2021– 

N–0417 and sent to the Dockets 

Management Staff (see ADDRESSES). The 

public availability of information in 

these submissions is governed by 21 

CFR 10.20(j). 

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: March 15, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–06036 Filed 3–21–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0336] 

Vaccines and Related Biological 

Products Advisory Committee; Notice 

of Meeting; Establishment of a Public 

Docket; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) announces a 

forthcoming public advisory committee 

meeting of the Vaccines and Related 

Biological Products Advisory 

Committee (VRBPAC). The general 

function of the committee is to provide 

advice and recommendations to FDA on 

regulatory issues. This meeting will be 

held to discuss considerations for use of 

COVID–19 vaccine booster doses and 

the process for COVID–19 vaccine strain 

selection to address current and 

emerging variants. The meeting will be 

open to the public. FDA is establishing 

a docket for public comment on this 

document. 

DATES: The meeting will be held 

virtually on April 6, 2022, from 8:30 

a.m. to 5 p.m. Eastern Time. Submit 

either electronic or written comments 

on this public meeting by April 5, 2022. 

Comments received on or before March 

31, 2022, will be provided to the 

committee. Comments received after 

March 31, 2022, and by April 5, 2022, 

will be taken into consideration by FDA. 

ADDRESSES: Please note that due to the 

impact of this COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. The 

online web conference meeting will be 

available at the following link on the 

day of the meeting: https://youtu.be/ 

x8rq247E80I. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2022–N–0336. 

The docket will close on April 5, 2022. 

Submit either electronic or written 

comments on this public meeting by 

April 5, 2022. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

April 5, 2022. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are received on or before 

that date. 

Comments received on or before 

March 31, 2022, will be provided to the 

committee. Comments received March 

31, 2022, and by April 5, 2022, will be 

taken into consideration by FDA. In the 

event that the meeting is cancelled, FDA 

will continue to evaluate any relevant 

applications or information, and 

consider any comments submitted to the 

docket, as appropriate. 

You may submit comments as 

follows: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2022–N–0336 for ‘‘Vaccines and Related 

Biological Products Advisory 

Committee (VRBPAC); Notice of 

Meeting; Establishment of a Public 

Docket; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 


lotter on DSK11XQN23PROD with NOTICES1