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, 70666-70667 [2023-22463]
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ddrumheller on DSK120RN23PROD with NOTICES1
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vial, were withdrawn from sale for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withdrawn for safety or effectiveness.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vial, and 2 g/vial, were not withdrawn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withdrawn for reasons of safety or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
VerDate Sep<11>2014
17:34 Oct 11, 2023
Jkt 262001
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.
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
SUMMARY:
PO 00000
Frm 00029
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\12OCN1.SGM
12OCN1
Federal Register / Vol. 88, No. 196 / Thursday, October 12, 2023 / Notices
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.
70667
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
1 There
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
ddrumheller on DSK120RN23PROD with NOTICES1
[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.
VerDate Sep<11>2014
17:34 Oct 11, 2023
Jkt 262001
ACTION:
Notice.
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
SUMMARY:
PO 00000
Frm 00030
Fmt 4703
Sfmt 4703
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
E:\FR\FM\12OCN1.SGM
12OCN1
]]>Agencies
[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70666-70667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-22463]
-----------------------------------------------------------------------
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,
[email protected].
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-allegations-regulatory-misconduct/allegations-regulatory-misconduct-form), by email, or by regular mail.
[[Page 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/medical-device-safety/reporting-allegations-regulatory-misconduct.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Electronic submission of voluntary allegations 2,500 1 2,500 0.25 (15 minutes)................. 625
to CDRH.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There 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
