16212 Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 

Dated: March 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–06009 Filed 3–21–22; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0236] 

Prioritizing the Addition of Maximum 

Daily Exposure Information and 

Removing Dosage Form Information 

From the Inactive Ingredient Database; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

Department of Health and Human 

Services (HHS). 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, we, or Agency) is 

announcing the establishment of a 

docket to solicit comments that will 

assist the Agency in determining how 

best to prioritize the addition of 

maximum daily exposure (MDE) 

information for inactive ingredients that 

do not currently include MDE 

information in the Center for Drug 

Evaluation and Research’s Inactive 

Ingredient Database (IID) and whether to 

restructure the IID by removing dosage 

form information. 

DATES: Submit either electronic or 

written comments on the notice by June 

21, 2022. 

ADDRESSES: You may submit comments 

as follows. 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 

June 21, 2022. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

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–0236 for ‘‘Prioritizing the 

Addition of Maximum Daily Exposure 

Information and Removing Dosage Form 

Information From the Inactive 

Ingredient Database; Establishment of a 

Public Docket; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 


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Page l O - Eli Lilly and Company 

emergency use of drug; and biological products during the COVID-19 

pandemic under Section 564(b)(l )ofthe Act, 21 U.S.C. § 360bbb-3(b XI), 

unless the declaration is temiinated or au1horizatiort revoked sooner. 

IV. Duration of Authonzation 

This EUA will be effective until the declaration that circuinstances exist justifymgthe 

authorization of the emergency use of drugs and biological ptoductsdurmgthe COVID-19 

pandemic is tennmated under Section 564(b )(2) of the Actor the EDA is revoked under Section 

564(g)ofthe Act. 

Smcerely, 

Isl 

Jacquelme A. O'Shaughnessy, Ph,D. 

Acting Chief Scientist 

Food and DrugAdmmistration 
Federal Register / Vol. 87, No. 55 / Tuesday, March 22, 2022 / Notices 16213 

1For more information on the IID, see the draft 

guidance for industry entitled ‘‘Using the Inactive 

Ingredient Database’’ (July 2019). When final, this 

guidance will represent FDA’s current thinking on 

this topic. For the most recent version of a 

guidance, check the FDA guidance web page at 

https://www.fda.gov/regulatory-information/searchfda-guidance-documents. 

2See the GDUFA II commitment letter, p.17, at 

https://www.fda.gov/media/101052/download. 

3The IID is updated on a quarterly basis at 

https://www.accessdata.fda.gov/scripts/cder/iig/ 

index.cfm. 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

FOR FURTHER INFORMATION CONTACT: 

Susan Zuk, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 75, Rm. 6684, Silver Spring, 

MD 20993–0002, 240–402–9133, 

Susan.Zuk@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The IID provides information on 

inactive ingredients in FDA-approved 

drug products.1 An inactive ingredient, 

or excipient, is any component of a drug 

product other than an active ingredient 

(21 CFR 210.3(b)(8) and 314.3(b)). 

Generally, the IID identifies excipients 

that appear in approved drug products 

for a particular dosage form and route of 

administration. This information in the 

IID has been used by all segments of 

industry as an aid in developing new 

drug products, including new generic 

drug products. For example, excipients 

used in drug products submitted in an 

abbreviated new drug application are 

required to be safe at the levels 

proposed and under the conditions 

prescribed, recommended, or suggested 

in the labeling proposed for the drug 

(see sections 505(j)(4)(H)(i) and (ii) of 

the Federal Food, Drug, and Cosmetic 

Act (21 U.S.C. 355(j)(4)(H)(i) and (ii))). 

The IID provides evidence that a 

particular excipient was previously 

permitted by FDA in specific levels, 

routes of administration, and dosage 

forms in FDA-approved products. FDA 

may consult the IID when performing 

regulatory filing reviews and technical 

reviews of applications as part of an 

evaluation of whether the proposed 

levels of excipients in drug product 

formulations are acceptable or require 

additional documentation to support 

their use. 

FDA made certain enhancements to 

the IID in 2020 consistent with the 

Generic Drug User Fee Amendments 

(GDUFA) Reauthorization Performance 

Goals and Program Enhancements Fiscal 

Years 2018–2022 (GDUFA II 

commitment letter).2 One of these 

enhancements permits users to perform 

electronic queries to obtain accurate 

maximum daily intake (MDI) and MDE 

information for each route of 

administration for which data are 

available. MDE is defined as the total 

amount of the excipient that would be 

taken in a day based on the maximum 

daily dose of the drug products in 

which it is used. MDE can also be 

referred to as MDI for oral drug 

products. FDA has steadily increased 

the number of excipient records that 

display MDE with each publication of 

the IID,3 but not all excipients in the IID 

have MDE information. The inclusion of 

such information could enhance the 

ability of applicants to reference IID 

information in support of proposed 

levels of excipients in their drug 

products. In meetings with FDA, 

stakeholders have asked about FDA’s 

plan to prioritize the addition of MDE 

information and have suggested that 

FDA focus on specific excipients that 

the stakeholders consider to be of high 

priority. 

Further, some stakeholders have 

expressed that the numerous records in 

the IID for each excipient can be 

confusing. Each IID record includes the 

excipient, its route of administration, 

and its dosage form. An excipient search 

can yield a lengthy list of dosage forms 

for each route of administration, which 

could make finding the most 

appropriate IID record to reference 

challenging. Some stakeholders have 

suggested that FDA could remove 

dosage form information from the IID to 

simplify searches. We believe such an 

approach would be consistent with the 

GDUFA II commitment letter, which 

describes upgrades to the IID to provide 

excipient MDE information associated 

with particular routes of administration. 

However, we recognize that some 

stakeholders may find the IID’s dosage 

form information helpful for drug 

product development. For example, 

applicants may refer to this information 

to confirm that FDA has approved drug 

products in certain dosage forms that 

contain an excipient at a particular 

level. For these applicants, removal of 

dosage form information from the IID 

could hinder their drug development 

program. 

II. Other Issues for Consideration 

FDA is considering how best to 

prioritize the addition of MDE 

information and plans to target those 

excipients deemed to be high priority by 

various stakeholders. Under such a 

plan, individual excipients could be 

designated for prioritization from those 

currently listed in the IID without MDE 

information. Alternatively, priority 

excipients could be designated based on 

a category of drug products in which 

they are used (e.g., excipients used in 

oral or topical products), and then FDA 

would prioritize adding MDE 

information for those excipients 

included in that category of drug 

products. FDA intends to develop a 

priority list based on feedback to this 

Federal Register notice. FDA will 

consider those excipients that are a high 

priority for multiple stakeholders and 

will also consider stakeholders’ 

rationale for inclusion of specific 

excipients in developing the priority 

list. FDA is also considering how to post 

information about recent updates to the 

IID based on efforts related to this 

Federal Register notice. 

FDA intends also to explore the 

feasibility of modifying the IID structure 

to eliminate dosage form information if 

feedback to this Federal Register notice 

indicates that such action would benefit 

drug developers and other stakeholders. 

Interested persons are invited to 

provide detailed comments on all 

aspects described in this notice. To 

facilitate this input, FDA has developed 

the following list of questions. These 

questions are not meant to be 

exhaustive, and FDA is also interested 

in other pertinent information 


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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). 


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