Federal Register / Vol. 87, No. 131 / Monday, July 11, 2022 / Notices 41135 

III. Petitions 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit either electronic or written 

comments and, under 21 CFR 60.24, ask 

for a redetermination (see DATES). 

Furthermore, as specified in § 60.30 (21 

CFR 60.30), any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period. To 

meet its burden, the petition must 

comply with all the requirements of 

§ 60.30, including but not limited to: 

must be timely (see DATES), must be 

filed in accordance with § 10.20, must 

contain sufficient facts to merit an FDA 

investigation, and must certify that a 

true and complete copy of the petition 

has been served upon the patent 

applicant. (See H. Rept. 857, part 1, 98th 

Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Submit petitions electronically to 

https://www.regulations.gov at Docket 

No. FDA–2013–S–0610. Submit written 

petitions (two copies are required) to the 

Dockets Management Staff (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. 

Dated: July 1, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14674 Filed 7–8–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2022–D–1385] 

Patient-Focused Drug Development: 

Selecting, Developing, or Modifying 

Fit-for-Purpose Clinical Outcome 

Assessments; Draft Guidance for 

Industry, Food and Drug 

Administration Staff, and Other 

Stakeholders; Availability; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; correction. 

SUMMARY: The Food and Drug 

Administration (FDA) is correcting a 

notice entitled ‘‘Patient-Focused Drug 

Development: Selecting, Developing, or 

Modifying Fit-for-Purpose Clinical 

Outcome Assessments; Draft Guidance 

for Industry, Food and Drug 

Administration Staff, and Other 

Stakeholders; Availability’’ that 

appeared in the Federal Register of June 

30, 2022. The document announced the 

publication of a draft guidance, the third 

in a series of four methodological 

patient-focused drug development 

guidance documents that describe how 

stakeholders (patients, researchers, 

medical product developers, and others) 

can collect and submit patient 

experience data and other relevant 

information from patients and 

caregivers to be used for medical 

product development and regulatory 

decision-making. The document was 

published with the incorrect docket 

number. This document corrects that 

error. 

FOR FURTHER INFORMATION CONTACT: Lisa 

Granger, Office of Policy, Planning, 

Legislation and International Affairs, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, Rm. 

3330, Silver Spring, MD 20993–0002, 

301–796–9115, email: Lisa.Granger@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of Friday, June 30, 

2022 (87 FR 39101), in FR Doc. 2022– 

13952, the following corrections are 

made: 

1. On page 39101, in the third column 

in the header of the document, ‘‘Docket 

No. FDA–2018–N–2455’’ is corrected to 

read ‘‘Docket No. FDA–2022–D–1385.’’ 

2. On page 39102, in first column in 

‘‘Instructions,’’ ‘‘Docket No. FDA–2018– 

N–2455’’ is corrected to read ‘‘Docket 

No. FDA–2022–D–1385.’’ 

Dated: July 5, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–14677 Filed 7–8–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2020–N–2143] 

Xellia Pharmaceuticals USA, LLC; 

Withdrawal of Approval of an 

Abbreviated New Drug Application for 

Bacitracin for Injection 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration’s (FDA or Agency) 

Center for Drug Evaluation and Research 

(CDER) is withdrawing the approval of 

an abbreviated new drug application 

(ANDA) for bacitracin for injection, 

50,000 units/vial (ANDA 203177), held 

by Xellia Pharmaceuticals USA, LLC 

(Xellia). Xellia has requested 

withdrawal of approval of this 

application and has waived its 

opportunity for a hearing. 

DATES: Approval is withdrawn as of July 

11, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Sungjoon Chi, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6216, 

Silver Spring, MD 20993–0002, 301– 

402–9674, Sungjoon.Chi@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: On 

January 31, 2020, FDA requested that all 

application holders of bacitracin for 

injection voluntarily request withdrawal 

of approval of their applications under 

§ 314.150(d) (21 CFR 314.150(d)). 

Bacitracin for injection is an antibiotic 

for intramuscular administration, the 

use of which is limited to the treatment 

of infants with pneumonia and 

empyema caused by staphylococci 

shown to be susceptible to the drug. 

Bacitracin for injection poses serious 

risks, including nephrotoxicity and 

anaphylactic reactions. Health care 

professionals generally no longer use 

bacitracin for injection to treat infants 

with pneumonia and empyema because 

other effective FDA-approved 

treatments are available that do not have 

these risks. 

In April 2019, FDA’s Antimicrobial 

Drugs Advisory Committee met and 

discussed the safety and effectiveness of 

bacitracin for injection. The advisory 

committee voted almost unanimously, 

with one abstention, that the benefits of 

bacitracin for intramuscular injection do 

not outweigh its risks, including 

nephrotoxicity and anaphylactic 

reactions, for the drug’s only approved 

indication. Based on FDA’s review of 

currently available data and 

information, the Agency believes that 

the potential problems associated with 

bacitracin for injection are sufficiently 

serious that the drug should be removed 

from the market. 

In a letter dated June 14, 2021, Xellia 

requested that FDA withdraw approval 

of ANDA 203177 under § 314.150(d) 

and waived its opportunity for a 

hearing. Therefore, for the reasons 

discussed above, which the applicant 

does not dispute in its letter requesting 

withdrawal of approval under 

§ 314.150(d), FDA’s approval of ANDA 

203177 and all amendments and 

supplements thereto, is withdrawn (see 

DATES). Distribution of Xellia’s 

bacitracin for injection (50,000 units/ 

vial) into interstate commerce without 

an approved application is illegal and 

subject to regulatory action (see sections 

505(a) and 301(d) of the Federal Food, 


khammond on DSKJM1Z7X2PROD with NOTICES