96654 Federal Register / Vol. 89, No. 234 / Thursday, December 5, 2024 / Notices 

(PDPs), and Programs of All-Inclusive 

Care for the Elderly (PACE) 

organizations report financial 

information demonstrating the 

organization has a fiscally sound 

operation. The FSRR is designed to 

capture financial data of these 

contracting entities. The Division of 

Finance and Benefits (DFB) within the 

Medicare Advantage Contract 

Administration Group (MCAG) of CMS 

is assigned the responsibility of 

reviewing ongoing financial 

performance of the contracting entities. 

All contracting organizations must 

submit audited annual financial 

statements one time per year. In 

addition to the audited annual 

submission, Health Plans with a 

negative net worth and/or a net loss and 

the amount of that loss is greater than 

one-half of the organization’s total net 

worth submit quarterly financial 

statements for fiscal soundness 

monitoring. Part D organizations are 

required to submit three (3) quarterly 

financial statements. Lastly, PACE 

organizations are required to file four (4) 

quarterly financial statements for the 

first three (3) years in the program. After 

the first three (3) years, PACE 

organizations with a negative net worth 

and/or a net loss and the amount of that 

loss is greater than one-half of the 

organization’s total net worth must 

submit quarterly financial statements for 

fiscal soundness monitoring. Form 

Number: CMS–906 (OMB control 

number: 0938–0496); Frequency: 

Quarterly and Yearly; Affected Public: 

Private Sector (Business or other forprofits, Not-for-Profit Institutions); 

Number of Respondents: 251; Total 

Annual Responses: 1,004; Total Annual 

Hours: 335. (For policy questions 

regarding this collection contact Christa 

M. Zalewski at (410) 786–1971.) 

William N. Parham, III, 

Director, Division of Information Collections 

and Regulatory Impacts, Office of Strategic 

Operations and Regulatory Affairs. 

[FR Doc. 2024–28458 Filed 12–4–24; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–5354] 

Determination That Bentyl Preservative 

Free (Dicyclomine Hydrochloride) 

Injection, 10 Milligrams/Milliliters, 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Withdrawn From Sale for Reasons of 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. 

TABLE 1—DRUG PRODUCTS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

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

NDA 008370 ............ BENTYL PRESERVATIVE 

FREE.

Dicyclomine Hydrochloride Injectable; Injection .......... 10 Milligrams (mg)/Milliliters (mL).AbbVie. 

NDA 012104 ............ KENALOG ........................ Triamcinolone Acetonide Spray; Topical .................. 0.147 mg/Gram (g) .......... Sun Pharmaceutical Industries Limited. 

NDA 017806 ............ THALLOUS CHLORIDE 

TL 201.

Thallous Chloride TL–201 Injectable; Intravenous ..... 1 Millicurie (mCi)/mL; 2 

mCi/mL.

Lantheus. 

NDA 017823 ............ HALOG ............................. Halcinonide ...................... Solution; Topical .............. 0.10% ............................... Sun Pharmaceutical Industries Limited. 

NDA 018849 ............ LIDEX ............................... Fluocinonide ..................... Solution; Topical .............. 0.05% ............................... Alvogen. 

NDA 020551 ............ NIMBEX ........................... Cisatracurium Besylate .... Injectable; Injection .......... Equivalent to (EQ) 2 mg 

Base/mL.

AbbVie. 

NDA 020551 ............ NIMBEX PRESERVATIVE 

FREE.

Cisatracurium Besylate .... Injectable; Injection .......... EQ 2 mg Base/mL; EQ 10 

mg Base/mL.

AbbVie. 


khammond on DSK9W7S144PROD with NOTICES
Federal Register / Vol. 89, No. 234 / Thursday, December 5, 2024 / Notices 96655 

TABLE 1—DRUG PRODUCTS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS—Continued 

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

NDA 020837 ............ XOPENEX ........................ Levalbuterol Hydrochloride.Solution; Inhalation .......... EQ 0.0103% Base; EQ 

0.021% Base; EQ 

0.042% Base; EQ 

0.25% Base.

Hikma. 

NDA 020857 ............ COMBIVIR ....................... Lamivudine; Zidovudine ... Tablet; Oral ...................... 150 mg; 300 mg ............... Viiv Health Care. 

NDA 020977 ............ ZIAGEN ............................ Abacavir Sulfate ............... Tablet; Oral ...................... EQ 300 mg Base ............. Viiv Health Care. 

NDA 021205 ............ TRIZIVIR .......................... Abacavir Sulfate, 

Lamivudine, Zidovudine.

Tablet; Oral ...................... EQ 300 mg Base, 150 

mg, 300 mg.

Viiv Health Care. 

NDA 021223 ............ ZOMETA .......................... Zoledronic Acid ................ Injectable; Intravenous ..... EQ 4 mg Base/100 mL; 

EQ 4 mg Base/5 mL.

Novartis. 

NDA 021548 ............ LEXIVA ............................. Fosamprenavir Calcium ... Tablet; Oral ...................... EQ 700 mg Base ............. Viiv Health Care. 

NDA 021695 ............ ANTARA (MICRONIZED) Fenofibrate ....................... Capsule; Oral ................... 90 mg ............................... Lupin. 

NDA 021738 ............ EXTINA ............................ Ketoconazole ................... Aerosol, Foam; Topical .... 2% .................................... Mylan. 

NDA 021861 ............ PATANASE ...................... Olopatadine Hydrochloride Spray, Metered; Nasal ..... 0.665 mg/Spray ................ Novartis. 

NDA 022128 ............ SELZENTRY .................... Maraviroc ......................... Tablet; Oral ...................... 25 mg; 75 mg ................... Viiv Health Care. 

NDA 022350 ............ ONGLYZA ........................ Saxagliptin Hydrochloride Tablet; Oral ...................... EQ 2.5 mg Base; EQ 5 

mg Base.

AstraZeneca AB. 

NDA 050440 ............ KEFLET ............................ Cephalexin ....................... Tablet; Oral ...................... EQ 250 mg Base; EQ 500 

mg Base.

Eli Lilly and Company. 

NDA 050558 ............ ZINACEF .......................... Cefuroxime Sodium ......... Injectable; Intramuscular, 

Intravenous.

EQ 750 mg Base/Vial; EQ 

1.5 g Base/Vial; EQ 7.5 

g Base/Vial.

PAI Pharma. 

NDA 050567 ............ POLYTRIM ....................... Polymyxin B Sulfate, 

Trimethoprim Sulfate.

Solution/Drops; Ophthalmic.10,000 Units/mL, EQ 1 

mg Base/mL.

Allergan. 

NDA 050588 ............ CEFOTAN ........................ Cefotetan Disodium ......... Injectable; Injection .......... EQ 10 g Base/Vial ........... PAI Pharma. 

NDA 050795 ............ DORYX ............................ Doxycycline Hyclate ......... Tablet, Delayed Release; 

Oral.

EQ 75 mg Base; EQ 150 

mg Base.

Mayne Pharma. 

NDA 200678 ............ KOMBIGLYZE XR ............ Metformin Hydrochloride, 

Saxagliptin Hydrochloride.

Tablet, Extended Release; 

Oral.

500 mg, EQ 5 mg Base; 1 

g, EQ 5 mg Base; 1 g, 

EQ 2.5 mg Base.

AstraZeneca AB. 

NDA 201194 ............ OXYCODONE HYDROCHLORIDE.Oxycodone Hydrochloride Solution; Oral ................... 5 mg/5 mL ........................ VistaPharm, LLC. 

NDA 204427 ............ KERYDIN ......................... Tavaborole ....................... Solution; Topical .............. 5% .................................... Anacor Pharmaceuticals, 

Inc. 

NDA 204592 ............ ZORVOLEX ...................... Diclofenac ........................ Capsule; Oral ................... 35 mg ............................... Zyla. 

NDA 204790 ............ TIVICAY ........................... Dolutegravir Sodium ........ Tablet; Oral ...................... EQ 10 mg Base; EQ 25 

mg Base.

Viiv Health Care. 

NDA 215868 ............ MIDAZOLAM IN 0.8% 

SODIUM CHLORIDE.

Midazolam ........................ Solution; Intravenous ....... 50 mg/50 mL (1 mg/mL) .. Exela Pharma. 

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 

List’’ identifies, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. 

Approved ANDAs that refer to the 

drug products listed are unaffected by 

the discontinued marketing of the 

products subject to these applications. 

Additional ANDAs that refer to these 

products may also be approved by the 

Agency if they comply with relevant 

legal and regulatory requirements. If 

FDA determines that labeling for these 

drug products should be revised to meet 

current standards, the Agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: November 27, 2024. 

P. Ritu Nalubola, 

Associate Commissioner for Policy. 

[FR Doc. 2024–28433 Filed 12–4–24; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2024–N–0604] 

Yong Sheng Jiao; 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 a request for a hearing 

submitted by Yong Sheng Jiao, also 

known as Yongsheng Jiao and Wilson 

Jiao (Jiao), and is issuing an order under 

the Federal Food, Drug, and Cosmetic 

Act (FD&C Act) debarring Jiao for 5 

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 Jiao was convicted of a 

felony under Federal law for conduct 

relating to the importation into the 

United States of any drug or controlled 

substance under the FD&C Act. In 

determining the appropriateness and 

period of Jiao’s debarment, FDA 

considered the relevant factors listed in 

the FD&C Act. Jiao submitted a request 

for hearing but failed to file with the 

Agency information and analyses 

sufficient to create a basis for a hearing. 

DATES: The order is applicable 

December 5, 2024. 

ADDRESSES: Any application for 

termination of debarment by Jiao under 

section 306(d) of the FD&C Act (21 

U.S.C. 335a(d)) (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 


khammond on DSK9W7S144PROD with NOTICES