75000 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices 

and Enforcement, Office of Policy, 

Compliance, and Enforcement, Office of 

Regulatory Affairs, Food and Drug 

Administration, at 240–402–8743, or 

debarments@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

In a Federal Register notice dated 

August 18, 2023 (88 FR 56636), David 

Winne was permanently debarred from 

providing services in any capacity to a 

person with an approved or pending 

drug product application under section 

306(a) of the FD&C Act (21 U.S.C. 

335a(a)). The debarment was based on 

FDA’s finding that Mr. Winne was 

convicted of a felony under Federal law 

for conduct relating to the regulation of 

any drug product under the FD&C Act. 

On September 7, 2023, Mr. Winne 

applied for special termination of 

debarment, under section 306(d)(4) of 

the FD&C Act. 

Under section 306(d)(4)(C) of the 

FD&C Act, FDA may limit the period of 

debarment of a permanently debarred 

individual if the Agency finds that the 

debarred individual has provided 

substantial assistance in the 

investigation or prosecution of offenses 

described in section 306(a) or (b) of the 

FD&C Act or relating to a matter under 

FDA’s jurisdiction. In addition, 

pursuant to section 306(d)(4)(D)(ii) of 

the FD&C Act, in cases of an individual 

FDA may limit the period of debarment 

to less than permanent but to no less 

than 1 year, whichever serves the 

interest of justice and protects the 

integrity of the drug approval process. 

Special termination of debarment is 

discretionary with FDA. FDA generally 

considers a determination by the 

Department of Justice concerning the 

substantial assistance of a debarred 

individual conclusive in most cases. Mr. 

Winne cooperated with the United 

States Attorney’s Office in the 

investigation of several individuals, as 

substantiated by a letter submitted by 

the United States Attorney’s Office for 

the Southern District of New York to the 

sentencing judge in Mr. Winne’s case 

and which was submitted to the Agency 

by Mr. Winne. His cooperation 

contributed to the successful 

prosecution of these individuals. 

Accordingly, FDA finds that Mr. Winne 

provided substantial assistance as 

required by section 306(d)(4)(C) of the 

FD&C Act. 

The additional requisite showings, 

i.e., that termination of debarment 

serves the interest of justice and poses 

no threat to the integrity of the drug 

approval process, are difficult standards 

to satisfy. In determining whether these 

have been met, the Agency weighs the 

significance of all favorable and 

unfavorable factors in light of the 

remedial, public health-related purposes 

underlying debarment. Termination of 

debarment will not be granted unless, 

weighing all favorable and unfavorable 

information, there is a high level of 

assurance that the conduct that formed 

the basis for debarment has not recurred 

and will not recur, and that the 

individual will not otherwise pose a 

threat to the integrity of the drug 

approval process. 

The evidence FDA reviewed in 

support of termination shows that Mr. 

Winne was convicted for a first offense; 

that he has no prior or subsequent 

convictions for conduct described under 

the FD&C Act and has committed no 

other wrongful acts affecting the drug 

approval process. The evidence 

presented supports the conclusion that 

the conduct upon which Mr. Winne’s 

debarment was based is unlikely to 

recur. For these reasons, the Agency 

finds that termination of Mr. Winne’s 

debarment serves the interest of justice 

and will not pose a threat to the 

integrity of the drug approval process. 

Under section 306(d)(4)(D) of the 

FD&C Act, the period of debarment of 

an individual who qualifies for special 

termination may be limited to less than 

permanent but to no less than 1 year. 

Mr. Winne’s period of debarment, 

which commenced on August 18, 2023, 

has not lasted for at least 1 year. As 

such, his period of debarment cannot 

terminate until August 17, 2024. 

Accordingly, the Assistant 

Commissioner, Office of Human and 

Animal Food Operations, under section 

306(d)(4) of the FD&C Act and under 

authority delegated to the Assistant 

Commissioner, finds that David Winne’s 

application for special termination of 

debarment should be granted, and that 

the period of debarment should 

terminate on August 18, 2024, thereby 

allowing him to provide services in any 

capacity to a person with an approved 

or pending drug product application 

after that date. As a result of the 

foregoing findings, David Winne’s 

debarment is terminated effective 

August 17, 2024. 

Dated: October 26, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–24094 Filed 10–31–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–0008] 

Request for Nominations on Public 

Advisory Panels of the Medical 

Devices Advisory Committee 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

requesting that any industry 

organizations interested in participating 

in the selection of nonvoting industry 

representatives to serve on certain 

panels of the Medical Devices Advisory 

Committee (MDAC or the Committee) in 

the Center for Devices and Radiological 

Health (CDRH) notify FDA in writing. 

FDA is also requesting nominations for 

nonvoting industry representatives to 

serve on certain device panels of the 

MDAC in the CDRH. A nominee may 

either be self-nominated or nominated 

by an organization to serve as a 

nonvoting industry representative. 

Nominations will be accepted for 

current and upcoming vacancies 

effective with this notice. 

DATES: Any industry organization 

interested in participating in the 

selection of an appropriate nonvoting 

member to represent industry interests 

must send a letter stating that interest to 

the FDA by December 1, 2023 (see 

sections I and II of this document for 

further details). Concurrently, 

nomination materials for prospective 

candidates should be sent to FDA by 

December 1, 2023. 

ADDRESSES: All statements of interest 

from industry organizations interested 

in participating in the selection process 

of nonvoting industry representative 

nomination should be sent to Margaret 

Ames (see FOR FURTHER INFORMATION

CONTACT). All nominations for 

nonvoting industry representatives 

should be submitted electronically by 

accessing the FDA Advisory Committee 

Membership Nomination Portal: https:// 

www.accessdata.fda.gov/scripts/ 

FACTRSPortal/FACTRS/index.cfm or by 

mail to Advisory Committee Oversight 

and Management Staff, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5103, Silver Spring, 

MD 20993–0002. Information about 

becoming a member of an FDA advisory 

committee can also be obtained by 

visiting FDA’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices 75001 

FOR FURTHER INFORMATION CONTACT: 

Margaret Ames, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 5213, Silver Spring, 

MD 20993, 301–796–5960, email: 

Margaret.Ames@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Agency is requesting nominations for 

nonvoting industry representatives to 

the panels listed in table 1. 

I. Medical Devices Advisory Committee 

The Committee reviews and evaluates 

data on the safety and effectiveness of 

marketed and investigational devices 

and makes recommendations for their 

regulation. The panels of the Medical 

Devices Advisory Committee engage in 

a number of activities to fulfill the 

functions the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) envisions for 

device advisory panels. With the 

exception of the Medical Devices 

Dispute Resolution Panel, each panel, 

according to its specialty area, advises 

the Commissioner of Food and Drugs 

(the Commissioner) regarding 

recommended classification or 

reclassification of devices into one of 

three regulatory categories; advises on 

any possible risks to health associated 

with the use of devices; advises on 

formulation of product development 

protocols; reviews premarket approval 

applications for medical devices; 

reviews guidelines and guidance 

documents; recommends exemption of 

certain devices from the application of 

portions of the FD&C Act; advises on the 

necessity to ban a device; and responds 

to requests from the Agency to review 

and make recommendations on specific 

issues or problems concerning the safety 

and effectiveness of devices. With the 

exception of the Medical Devices 

Dispute Resolution Panel, each panel, 

according to its specialty area, may also 

make appropriate recommendations to 

the Commissioner on issues relating to 

the design of clinical studies regarding 

the safety and effectiveness of marketed 

and investigational devices. The 

Committee also provides 

recommendations to the Commissioner 

or designee on complexity 

categorization of in vitro diagnostics 

under the Clinical Laboratory 

Improvement Amendments of 1988. 

TABLE 1—PANELS AND FUNCTIONS

Panels Function 

Dental Products Panel .............................................. Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational products for use in dentistry, endodontics, or bone physiology relative to 

the oral and maxillofacial area and makes appropriate recommendations to the Commissioner. 

Ear, Nose, and Throat Devices Panel ...................... Reviews and evaluate data concerning the safety and effectiveness of marketed and investigational ear, nose, and throat devices and makes appropriate recommendations to 

the Commissioner. 

General and Plastic Surgery Devices Panel ............. Reviews and evaluate data concerning the safety and effectiveness of marketed and investigational general and plastic surgery devices and makes appropriate recommendations to the Commissioner. 

Hematology and Pathology Devices Panel ............... Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational in vitro devices for use in clinical laboratory medicine including pathology, 

hematology, histopathology, cytotechnology, and molecular biology and makes appropriate recommendations to the Commissioner. 

Orthopedic and Rehabilitation Devices Panel .......... Reviews and evaluates data concerning the safety and effectiveness of marketed and investigational orthopedic and rehabilitation devices and makes appropriate recommendations to the Commissioner. 

II. Qualifications 

Persons nominated for the device 

panels should be full-time employees of 

firms that manufacture products that 

would come before the panel, or 

consulting firms that represent 

manufacturers, or have similar 

appropriate ties to industry. 

III. Selection Procedure 

Any industry organization interested 

in participating in the selection of an 

appropriate nonvoting member to 

represent industry interests should send 

a letter stating that interest to the FDA 

contact (see FOR FURTHER INFORMATION

CONTACT) within 30 days of publication 

of this document (see DATES). Within the 

subsequent 30 days, FDA will send a 

letter to each organization that has 

expressed an interest, attaching a 

complete list of all such organizations, 

and a list of all nominees along with 

their current resumes. The letter will 

also state that it is the responsibility of 

the interested organizations to confer 

with one another and to select a 

candidate, within 60 days after the 

receipt of the FDA letter, to serve as the 

nonvoting member to represent industry 

interests for a particular device panel. 

The interested organizations are not 

bound by the list of nominees in 

selecting a candidate. However, if no 

individual is selected within 60 days, 

the Commissioner will select the 

nonvoting member to represent industry 

interests. 

IV. Application Procedure 

Individuals may self-nominate and/or 

an organization may nominate one or 

more individuals to serve as a nonvoting 

industry representative. Nomination 

must include a current, complete 

re ́sume ́ or curriculum vitae for each 

nominee including current business 

address and telephone number, email 

address if available, and a signed copy 

of the Acknowledgement and Consent 

form available at the FDA Advisory 

Committee Membership Nomination 

Portal (see ADDRESSES) within 30 days of 

publication of this document (see 

DATES). Nominations must also specify 

the advisory panel for which the 

nominee is recommended. Nominations 

must also acknowledge that the 

nominee is aware of the nomination 

unless self-nominated. FDA will 

forward all nominations to the 

organizations expressing interest in 

participating in the selection process for 

the particular device panels listed in 

table 1. (Persons who nominate 

themselves as nonvoting industry 

representatives will not participate in 

the selection process.) 

FDA seeks to include the views of 

women and men, members of all racial 

and ethnic groups, and individuals with 

and without disabilities on its advisory 

committees, and therefore encourages 

nominations of appropriately qualified 

candidates from these groups. 

This notice is issued under the 

Federal Advisory Committee Act (5 


ddrumheller on DSK120RN23PROD with NOTICES1
75002 Federal Register / Vol. 88, No. 210 / Wednesday, November 1, 2023 / Notices 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: October 27, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–24123 Filed 10–31–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–4319] 

Determination That CALCIUM 

DISODIUM VERSENATE (Edetate 

Calcium Disodium) Injection, 200 

Milligrams per Milliliter, and Other 

Drug Products Were Not Withdrawn 

From Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that the drug products listed 

in this document were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as they 

meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Stacy Kane, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 6236, Silver Spring, 

MD 20993–0002, 301–796–8363, 

Stacy.Kane@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Section 

505(j) of the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) (21 U.S.C. 

355(j)) allows the submission of an 

ANDA to market a generic version of a 

previously approved drug product. To 

obtain approval, the ANDA applicant 

must show, among other things, that the 

generic drug product: (1) has the same 

active ingredient(s), dosage form, route 

of administration, strength, conditions 

of use, and (with certain exceptions) 

labeling as the listed drug, which is a 

version of the drug that was previously 

approved and (2) is bioequivalent to the 

listed drug. ANDA applicants do not 

have to repeat the extensive clinical 

testing otherwise necessary to gain 

approval of a new drug application 

(NDA). 

Section 505(j)(7) of the FD&C Act 

requires FDA to publish a list of all 

approved drugs. FDA publishes this list 

as part of the ‘‘Approved Drug Products 

With Therapeutic Equivalence 

Evaluations,’’ which is generally known 

as the ‘‘Orange Book.’’ Under FDA 

regulations, a drug is removed from the 

list if the Agency withdraws or 

suspends approval of the drug’s NDA or 

ANDA for reasons of safety or 

effectiveness or if FDA determines that 

the listed drug was withdrawn from sale 

for reasons of safety or effectiveness (21 

CFR 314.162). 

Under § 314.161(a) (21 CFR 

314.161(a)), the Agency must determine 

whether a listed drug was withdrawn 

from sale for reasons of safety or 

effectiveness: (1) before an ANDA that 

refers to that listed drug may be 

approved, (2) whenever a listed drug is 

voluntarily withdrawn from sale and 

ANDAs that refer to the listed drug have 

been approved, and (3) when a person 

petitions for such a determination under 

21 CFR 10.25(a) and 10.30. Section 

314.161(d) provides that if FDA 

determines that a listed drug was 

withdrawn from sale for safety or 

effectiveness reasons, the Agency will 

initiate proceedings that could result in 

the withdrawal of approval of the 

ANDAs that refer to the listed drug. 

FDA has become aware that the drug 

products listed in the table are no longer 

being marketed. 

Application No. Drug name Active ingredient(s) Strength(s) Dosage form/route Applicant 

NDA 008922 .... CALCIUM DISODIUM 

VERSENATE.

Edetate Calcium Disodium.200 Milligrams (mg)/Milliliter (mL) ..... Injectable; Injection ........ Bausch Health US, LLC. 

NDA 011722 .... TENUATE ...................... Diethylpropion Hydrochloride.25 mg ................................................. Tablet; Oral .................... Nostrum Labs., Inc. 

NDA 012546 .... TENUATE DOSPAN ...... Diethylpropion Hydrochloride.75 mg ................................................. Tablets, Extended-Release; Oral.Do. 

NDA 019117 .... FLUOCINONIDE ............ Fluocinonide .................. 0.05% ................................................. Cream; Topical .............. Taro Pharms. U.S.A., 

Inc. 

NDA 019796 .... ELOCON ........................ Mometasone Furoate .... 0.1% ................................................... Lotion; Topical ............... Organon, LLC. 

NDA 020489 .... ANDRODERM ............... Testosterone .................. 2 mg/24 hours; 4 mg/24 hours .......... Film, Extended Release; 

Transdermal.

AbbVie Inc. 

NDA 020884 .... AGGRENOX ................... Aspirin; Dipyridamole ..... 25 mg; 200 mg .................................. Capsule, Extended Release; Oral.Boehringer Ingelheim 

Pharms., Inc. 

NDA 020903 .... REBETOL ...................... Ribavirin ......................... 200 mg ............................................... Capsule; Oral ................. Merck Sharp and Dohme 

Corp. 

NDA 020907 .... ACTIVELLA ................... Estradiol; Norethindrone 

Acetate.

0.5 mg; 0.1 mg .................................. Tablet; Oral .................... Amneal Pharms., LLC. 

NDA 020949 .... ACCUNEB ..................... Albuterol Sulfate ............ Equivalent to (EQ) 0.021% Base; EQ 

0.042% Base.

Solution; Inhalation ........ Mylan Specialty LP. 

NDA 021022 .... PENLAC ........................ Ciclopirox ....................... 8% ...................................................... Solution; Topical ............ Valeant International 

Bermuda. 

NDA 021449 .... HEPSERA ...................... Adefovir Dipivoxil ........... 10 mg ................................................. Tablet; Oral .................... Gilead Sciences, Inc. 

NDA 022052 .... ZYFLO CR ..................... Zileuton .......................... 600 mg ............................................... Tablet, Extended Release; Oral.Chiesi USA, Inc. 

NDA 022511 .... VIMOVO ........................ Esomeprazole Magnesium; Naproxen.EQ 20 mg Base; 375 mg; EQ 20 mg 

Base; 500 mg.

Tablet, Delayed Release; Oral.Horizon Medicines LLC. 

NDA 022569 .... LAZANDA ...................... Fentanyl Citrate ............. EQ 0.1mg Base; EQ 0.3 mg Base; 

EQ 0.4 mg Base.

Spray, Metered; Nasal ... BTcP Pharma, LLC. 

NDA 202788 .... SUBSYS ........................ Fentanyl ......................... 0.1 mg; 0.2 mg; 0.4 mg; 0.6 mg; 0.8 

mg; 1.2 mg; 1.6 mg.

Spray; Sublingual .......... Do. 

NDA 213645 .... DAPZURA RT ................ Daptomycin .................... 500 mg/Vial ........................................ Powder; Intravenous ...... Baxter Healthcare Corp. 

FDA has reviewed its records and, 

under § 314.161, has determined that 

the drug products listed were not 

withdrawn from sale for reasons of 

safety or effectiveness. Accordingly, the 

Agency will continue to list the drug 

products in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 


ddrumheller on DSK120RN23PROD with NOTICES1