28834 Federal Register / Vol. 87, No. 91 / Wednesday, May 11, 2022 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0619] 

Advisory Committee; Gastrointestinal 

Drugs Advisory Committee; Renewal 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; renewal of Federal 

advisory committee. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

renewal of the Gastrointestinal Drugs 

Advisory Committee by the 

Commissioner of Food and Drugs (the 

Commissioner). The Commissioner has 

determined that it is in the public 

interest to renew the Gastrointestinal 

Drugs Advisory Committee for an 

additional 2 years beyond the charter 

expiration date. The new charter will be 

in effect until the March 3, 2024, 

expiration date. 

DATES: Authority for the Gastrointestinal 

Drugs Advisory Committee will expire 

on March 3, 2024, unless the 

Commissioner formally determines that 

renewal is in the public interest. 

FOR FURTHER INFORMATION CONTACT: 

Rhea Bhatt, Division of Advisory 

Committee and Consultant 

Management, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2434, 

Silver Spring, MD 20993–0002, 301– 

796–9001, email: GIDAC@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Pursuant 

to 41 CFR 102–3.65 and approval by the 

Department of Health and Human 

Services and by the General Services 

Administration, FDA is announcing the 

renewal of the Gastrointestinal Drugs 

Advisory Committee (the Committee). 

The Committee is a discretionary 

Federal advisory committee established 

to provide advice to the Commissioner. 

The Committee advises the 

Commissioner or designee in 

discharging responsibilities as they 

relate to helping to ensure safe and 

effective drugs for human use and, as 

required, any other product for which 

FDA has regulatory responsibility. 

The Committee reviews and evaluates 

available data concerning the safety and 

effectiveness of marketed and 

investigational human drug products for 

use in the treatment of gastrointestinal 

diseases and makes appropriate 

recommendations to the Commissioner. 

The Committee shall consist of a core 

of 11 voting members including the 

Chair. Members and the Chair are 

selected by the Commissioner or 

designee from among authorities 

knowledgeable in the fields of 

gastroenterology, endocrinology, 

surgery, clinical pharmacology, 

physiology, pathology, liver function, 

motility, esophagitis, and statistics. 

Members will be invited to serve for 

overlapping terms of up to 4 years. NonFederal members of this committee will 

serve as Special Government 

Employees, representatives, or ExOfficio members. Federal members will 

serve as Regular Government Employees 

or Ex-Officios. The core of voting 

members may include one technically 

qualified member, selected by the 

Commissioner or designee, who is 

identified with consumer interests and 

is recommended by either a consortium 

of consumer-oriented organizations or 

other interested persons. In addition to 

the voting members, the Committee may 

include one non-voting representative 

member who is identified with industry 

interests. There may also be an alternate 

industry representative. 

Further information regarding the 

most recent charter and other 

information can be found at https://

www.fda.gov/advisory-committees/ 

human-drug-advisory-committees/ 

gastrointestinal-drugs-advisorycommittee or by contacting the 

Designated Federal Officer (see FOR

FURTHER INFORMATION CONTACT). In light 

of the fact that no change has been made 

to The Committee name or description 

of duties, no amendment will be made 

to 21 CFR 14.100. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.). For general information 

related to FDA advisory committees, 

please visit us at http://www.fda.gov/ 

AdvisoryCommittees/default.htm. 

Dated: May 4, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–10040 Filed 5–10–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–1992] 

Marwan Massouh; Denial of Hearing; 

Final Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

denying Marwan Massouh’s (Dr. 

Massouh’s) request for a hearing and 

issuing an order under the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) debarring Dr. Massouh for 3 years 

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 Dr. 

Massouh was convicted of a 

misdemeanor under Federal law for 

causing the introduction or delivery for 

introduction into interstate commerce of 

drugs that were misbranded under the 

FD&C Act. Additionally, FDA finds that 

the conduct underlying Dr. Massouh’s 

conviction undermines the process for 

the regulation of drugs. In determining 

the appropriateness and period of Dr. 

Massouh’s debarment, FDA considered 

the relevant factors listed in the FD&C 

Act. Dr. Massouh failed to file with the 

Agency information and analyses 

sufficient to create a basis for a hearing 

concerning this action. 

DATES: This order is applicable May 11, 

2022. 

ADDRESSES: Any application for 

termination of debarment by Dr. 

Massouh under section 306(d) of the 

FD&C Act (application) may be 

submitted as follows: 

Electronic Submissions 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

An application submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

application will be made public, you are 

solely responsible for ensuring that your 

application 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 

application, that information will be 

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

• If you want to submit an 

application with confidential 

information that you do not wish to be 

made available to the public, submit the 

application 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 


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