70666 Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 

LLC submitted a citizen petition dated 

June 27, 2023 (Docket No. FDA–2023– 

P–2655), also requesting that the Agency 

determine whether the sterile dry 

powder excipient-free formulation of 

CYTOXAN (cyclophosphamide) for 

Injection, 500 mg/vial, 1 g/vial, and 2 g/ 

vial, were withdrawn from sale for 

reasons of safety or effectiveness. 

Although the citizen petitions did not 

specifically address the sterile dry 

powder with sodium chloride 

formulation of CYTOXAN 

(cyclophosphamide) for Injection, 500 

mg/vial, 1 g/vial, and 2 g/vial, this 

formulation also has been discontinued. 

We have also determined whether the 

sterile dry powder with sodium chloride 

formulation of CYTOXAN 

(cyclophosphamide) for Injection, 500 

mg/vial, 1 g/vial, and 2 g/vial, was 

withdrawn for safety or effectiveness. 

After considering the citizen petitions 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that CYTOXAN 

(cyclophosphamide) for Injection 

(sterile dry powder excipient-free 

formulation), 500 mg/vial, 1 g/vial, and 

2 g/vial, and CYTOXAN 

(cyclophosphamide) for Injection 

(sterile dry powder with sodium 

chloride formulation), 500 mg/vial, 1 g/ 

vial, and 2 g/vial, were not withdrawn 

for reasons of safety or effectiveness. 

The petitioners have identified no data 

or other information suggesting that the 

sterile dry powder excipient-free 

formulation of CYTOXAN 

(cyclophosphamide) for Injection, 500 

mg/vial, 1 g/vial, and 2 g/vial, or the 

sterile dry powder with sodium chloride 

formulation of CYTOXAN 

(cyclophosphamide) for Injection, 500 

mg/vial, 1 g/vial, and 2 g/vial, were 

withdrawn for reasons of safety or 

effectiveness. We have carefully 

reviewed our files for records 

concerning the withdrawal of the sterile 

dry powder excipient-free formulation 

of CYTOXAN (cyclophosphamide) for 

Injection, 500 mg/vial, 1 g/vial, and 2 g/ 

vial, and the sterile dry powder with 

sodium chloride formulation of 

CYTOXAN (cyclophosphamide) for 

Injection, 500 mg/vial, 1 g/vial, and 2 g/ 

vial, from sale. We have also 

independently evaluated relevant 

literature and data for possible 

postmarketing adverse events. We have 

found no information that would 

indicate that these drug products were 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the Agency has 

determined that the sterile dry powder 

excipient-free formulation of CYTOXAN 

(cyclophosphamide) for Injection, 500 

mg/vial, 1 g/vial, and 2 g/vial, and the 

sterile dry powder with sodium chloride 

formulation of CYTOXAN 

(cyclophosphamide) for Injection, 500 

mg/vial, 1 g/vial, and 2 g/vial, drug 

products have been discontinued from 

marketing for reasons other than safety 

or effectiveness. FDA will not begin 

procedures to withdraw approval of 

approved ANDAs that have the sterile 

dry powder excipient-free formulation 

or the sterile dry powder with sodium 

chloride formulation. ANDAs that refer 

to CYTOXAN (cyclophosphamide) for 

Injection, 500 mg/vial, 1 g/vial, and 2 g/ 

vial may be approved by the Agency as 

long as they meet all other legal and 

regulatory requirements for the approval 

of ANDAs. 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: October 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22494 Filed 10–11–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–2030] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Allegations of 

Regulatory Misconduct Voluntarily 

Submitted to the Center for Devices 

and Radiological Health 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) is 

announcing that a proposed collection 

of information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Submit written comments 

(including recommendations) on the 

collection of information by November 

13, 2023. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0769. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Domini Bean, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 301–796–5733, PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Allegations of Regulatory Misconduct 

Voluntarily Submitted to the Center for 

Devices and Radiological Health 

OMB Control Number 0910–0769— 

Extension 

This information collection supports 

the voluntary submission of allegations 

of regulatory misconduct to FDA’s 

Center for Devices and Radiological 

Health (CDRH). An allegation of 

regulatory misconduct is a claim that a 

medical device manufacturer or 

individuals marketing medical devices 

or electronic products regulated by 

CDRH may be doing so in a manner that 

violates the law. Reporting these 

allegations can help make FDA aware of 

regulatory concerns it may not learn of 

otherwise. This information can help 

FDA identify the potential risks to 

patients and determine whether further 

investigation is warranted, as well as 

any steps needed to address or correct 

a potential violation. Anyone may file a 

complaint reporting an allegation of 

regulatory misconduct. FDA encourages 

people submitting allegations to include 

supporting information and contact 

information in case additional 

information is needed for FDA to 

understand the allegation and act on the 

report; however, you can choose to 

submit a report anonymously. FDA will 

not share your identity or contact 

information with anyone outside FDA 

unless required to do so by law, 

regulation, or court order. 

Allegations of regulatory misconduct 

may include failure to register and list 

a medical device, marketing uncleared 

or unapproved products, failure to 

follow quality system requirements, or 

misleading promotion. 

You can submit an allegation through 

the Allegations of Regulatory 

Misconduct Form (https://www.fda.gov/ 

medical-devices/reporting-allegationsregulatory-misconduct/allegationsregulatory-misconduct-form), by email, 

or by regular mail. 


ddrumheller on DSK120RN23PROD with NOTICES1
Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices 70667 

FDA published a 60-day notice for 

public comment in the Federal Register 

of June 12, 2023 (88 FR 38061) and 

received comments. While one 

comment appeared to question the 

purpose of the information collection, 

another comment supported FDA 

activities regarding the reporting of 

information covered by the collection. 

No comment suggested that we revise 

our burden estimate. 

We also received suggestions on how 

our submission form might be 

improved. In response to this comment, 

we are revising the submission form 

using asterisks to more clearly indicate 

which fields are required for submission 

versus non-required fields. The form 

also has been updated to allow 

submission of the company’s website. 

Similarly, one comment noted that 

current procedures do not allow for 

complete anonymity when submitting 

allegations of regulatory misconduct to 

FDA. The comment suggests changing 

the submission process to allow 

submission of attachments to the form, 

rather than via separate email. While we 

have not made changes regarding the 

submission process at this time, we 

appreciate these suggestions and 

continue to consider enhancements and 

updates to our systems as our limited 

resources permit. We recognize that 

confidentiality is an important concern. 

Under the Freedom of Information Act 

(FOIA) (5 U.S.C. 552), the public has 

broad access to government documents. 

However, FOIA provides certain 

exemptions from mandatory public 

disclosure of government records (5 

U.S.C. 552(b)(1–9)). FDA will make the 

fullest possible disclosure of records to 

the public, consistent with the rights of 

individuals to privacy, the property 

rights of persons in trade and 

confidential commercial or financial 

information. 

Finally, one comment expressed 

concern regarding verification by FDA 

of the accuracy and validity of the 

information (allegations) submitted. 

Allegations of regulatory misconduct 

related to medical devices are reviewed 

by CDRH. CDRH prioritizes the review 

of allegations based on the level of 

potential risks, within the context of an 

overall benefit-risk profile, to patients, 

and takes responsive action accordingly. 

We note, however, that subsequent 

questions or inquiry intended to clarify 

information submitted is not considered 

a collection of information under the 

PRA (see 5 CFR 1320.3(h)(9)) subject to 

OMB review and approval. To learn 

more about CDRH’s process for handling 

allegations, please visit: https://

www.fda.gov/medical-devices/medicaldevice-safety/reporting-allegationsregulatory-misconduct. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average burden 

per 

response 

Total hours 

Electronic submission of voluntary allegations to 

CDRH.

2,500 1 2,500 0.25 (15 minutes) 625 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

We recently consolidated the intake of 

allegations across CDRH Offices. This 

has improved our estimate and we have 

adjusted the number of responses 

accordingly. The number of responses is 

based on the voluntary allegations 

received by CDRH in 2022. The adjusted 

estimated burden for the information 

collection reflects an increase of 900 

responses and a corresponding increase 

of 225 hours. 

Dated: October 5, 2023. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2023–22463 Filed 10–11–23; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2023–N–3848] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Regulations for In 

Vivo Radiopharmaceuticals Used for 

Diagnosis and Monitoring 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (PRA), Federal Agencies are 

required to publish notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, and 

to allow 60 days for public comment in 

response to the notice. This notice 

solicits comments on the collections of 

information in the regulations for in 

vivo radiopharmaceuticals used for 

diagnosis and monitoring. 

DATES: Submit either electronic or 

written comments on the collection of 

information by December 11, 2023. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before December 11, 

2023. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of December 11, 2023. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

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

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment 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 

comments, that information will be 

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

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 


ddrumheller on DSK120RN23PROD with NOTICES1