Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Notices 11079 

management of the patient’s disease. In 

addition, FDA committed to meet 

certain performance goals under the 

sixth authorization of the Prescription 

Drug User Fee Act. These goal 

commitments were developed in 

consultation with patient and consumer 

advocates, healthcare professionals, and 

other public stakeholders, as part of 

negotiations with regulated industry. 

Section J.1 of the commitment letter, 

‘‘Enhancing the Incorporation of the 

Patient’s Voice in Drug Development 

and Decision-Making’’ (https://

www.fda.gov/downloads/ForIndustry/ 

UserFees/PrescriptionDrugUserFee/ 

UCM511438.pdf), outlines work, 

including the development of a series of 

guidance documents and associated 

public workshops to facilitate the 

advancement and use of systematic 

approaches to collect and use robust 

and meaningful patient and caregiver 

input that can more consistently inform 

drug development, and, as appropriate, 

regulatory decision making. 

IV. Electronic Access 

Persons with access to the internet 

may obtain the guidance at https://

www.fda.gov/drugs/guidancecompliance-regulatory-information/ 

guidances-drugs, https://www.fda.gov/ 

vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://

www.fda.gov/regulatory-information/ 

search-fda-guidance-documents, or 

https://www.regulations.gov. 

Dated: February 22, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–04152 Filed 2–25–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0002] 

New Animal Drugs; Withdrawal of 

Approval of New Animal Drug 

Application 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notification of withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of a new animal drug 

application (NADA) at the sponsor’s 

request because the product is no longer 

manufactured or marketed. 

DATES: The approval is withdrawn as of 

February 28, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Sujaya Dessai, Center for Veterinary 

Medicine (HFV–212), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–402–5761, 

sujaya.dessai@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Elanco US 

Inc., 2500 Innovation Way, Greenfield, 

IN 46140, has requested that FDA 

withdraw approval of NADA 093–329 

for use of a prolonged-release bolus 

containing sulfamethazine in cattle 

because the product is no longer 

manufactured or marketed. 

Therefore, under authority delegated 

to the Commissioner of Food and Drugs 

and in accordance with § 514.116 Notice 

of withdrawal of approval of application 

(21 CFR 514.116), notice is given that 

approval of NADA 093–329, and all 

supplements and amendments thereto, 

is hereby withdrawn February 28, 2022. 

Elsewhere in this issue of the Federal 

Register, FDA is amending the animal 

drug regulations to reflect the voluntary 

withdrawal of approval of this 

application. 

Dated: February 14, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–03539 Filed 2–25–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–N–0030] 

Fresenius Kabi USA, LLC, et al.; 

Withdrawal of Approval of Five 

Abbreviated New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of five 

abbreviated new drug applications 

(ANDAs) from multiple applicants. The 

applicants notified the Agency in 

writing that the drug products were no 

longer marketed and requested that the 

approval of the applications be 

withdrawn. 

DATES: Approval is withdrawn as of 

March 30, 2022 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1676, 

Silver Spring, MD 20993–0002, 240– 

402–6980, Martha.Nguyen@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

applicants listed in the table have 

informed FDA that these drug products 

are no longer marketed and have 

requested that FDA withdraw approval 

of the applications under the process 

described in § 314.150(c) (21 CFR 

314.150(c)). The applicants have also, 

by their requests, waived their 

opportunity for a hearing. Withdrawal 

of approval of an application or 

abbreviated application under 

§ 314.150(c) is without prejudice to 

refiling. 

Application No. Drug Applicant 

ANDA 065408 .... Epirubicin Hydrochloride (HCl) Injection, 150 milligrams (mg)/ 

75 milliliters (mL) (2 mg/mL), 10 mg/5 mL (2 mg/mL), 50 

mg/25 mL (2 mg/mL), and 200 mg/100 mL (2 mg/mL).

Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, 

IL 60047. 

ANDA 065411 .... Epirubicin HCl Injection, 200 mg/100 mL (2 mg/mL) and 50 

mg/25 mL (2 mg/mL).

Do. 

ANDA 065440 .... Idarubicin HCl Injection, 1 mg/mL ............................................ Do. 

ANDA 077790 .... Fludarabine Phosphate for Injection, 50 mg/vial ..................... Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045. 

ANDA 091008 .... Gabapentin Capsules, 100 mg, 300 mg, and 400 mg ............ Jiangsu Hengrui Pharmaceuticals Co., Ltd., U.S. Agent, 

Venus Pharmaceutical Laboratories Inc., 506 Carnegie 

Center, Suite 100, Princeton, NJ 08540. 


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