16214 Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 

stakeholders would like to share on this 

topic. In all cases, FDA encourages 

stakeholders to provide the specific 

rationale and basis for their comments, 

including available supporting 

information. 

1. Should FDA focus on adding MDE 

information for certain excipients? If so, 

which excipients should be prioritized 

for inclusion of MDE information and 

why? 

2. Should FDA focus on prioritizing 

excipients used in certain categories of 

drug products (e.g., oral or topical 

products)? If so, which categories and 

which specific excipients used in those 

categories should be prioritized and 

why? 

3. Is dosage form information in the 

IID helpful to your drug development 

program? If so, please explain how 

dosage form information in the IID is 

used in your drug development 

program. 

4. Is the current structure or format of 

the IID difficult to navigate? If so, how 

can it be improved? 

Dated: March 15, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–06031 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–0415] 

Irfanali Nisarali Momin: Final 

Debarment Order 

AGENCY: Food and Drug Administration, 

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 

Irfanali Nisarali 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 

Mr. Momin was convicted of one felony 

count under Federal law for conspiracy. 

The factual basis supporting Mr. 

Momin’s conviction, as described 

below, is conduct relating to the 

importation into the United States of a 

drug or controlled substance. Mr. 

Momin was given notice of the 

proposed debarment and was given an 

opportunity to request a hearing to show 

why he should not be debarred. As of 

December 26, 2021 (30 days after receipt 

of the notice), Mr. Momin had not 

responded. Mr. Momin’s failure to 

respond and request a hearing 

constitutes a waiver of his 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, Mr. 

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 him 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 Mr. Momin’s case, filed 

on September 23, 2020, to which he 

plead guilty, between August 2014 and 

November 2018, Mr. Momin along with 

his co-conspirators, illegally imported 

misbranded drugs from China that he 

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 drugs 

pursuant to section 503(b) of the FD&C 

Act (21 U.S.C. 353(b)). In order to evade 

U.S. import restrictions, Mr. Momin 

illegally imported misbranded drugs 

into the United States from China. As 

per the conspiracy Mr. 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. Mr. 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 Mr. Momin, by certified mail, on 

November 19, 2021, a notice proposing 

to debar him 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 Mr. 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 he 

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 Mr. Momin’s 

offense and concluded that the offense 

warranted the imposition of a 5-year 

period of debarment. 

The proposal informed Mr. Momin of 

the proposed debarment and offered 

him 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 him that failure to 

request a hearing constituted a waiver of 

the opportunity for a hearing and of any 

contentions concerning this action. Mr. 

Momin received the proposal and notice 

of opportunity for a hearing at his 

residence on November 26, 2021. Mr. 

Momin failed to request a hearing 

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). 


lotter on DSK11XQN23PROD with NOTICES1
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