Notice2023-12488
Agency Information Collection Activities; Proposed Collection; Comment Request; Allegations of Regulatory Misconduct Voluntarily Submitted to the Center for Devices and Radiological Health
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 12, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 information collection associated with allegations of regulatory misconduct voluntarily submitted to FDA's Center for Devices and Radiological Health (CDRH).
Full Text
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<title>Federal Register, Volume 88 Issue 112 (Monday, June 12, 2023)</title>
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[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38061-38062]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12488]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-2030]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Allegations of Regulatory Misconduct Voluntarily
Submitted to the Center for Devices and Radiological Health
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 information collection associated with
allegations of regulatory misconduct voluntarily submitted to FDA's
Center for Devices and Radiological Health (CDRH).
DATES: Either electronic or written comments on the collection of
information must be submitted by August 11, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 11, 2023. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-N-2030 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Allegations of Regulatory
Misconduct Voluntarily Submitted to the Center for Devices and
Radiological Health.'' Received comments, those filed in a timely
manner (see ADDRESSES), will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: JonnaLynn Capezzuto, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
<a href="/cdn-cgi/l/email-protection#7d2d2f3c2e091c1b1b3d1b191c5315150e531a120b"><span class="__cf_email__" data-cfemail="f7a7a5b6a483969191b7919396d99f9f84d9909881">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and
[[Page 38062]]
assumptions used; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) ways to minimize the burden
of the collection of information on respondents, including through the
use of automated collection techniques, when appropriate, and other
forms of information technology.
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 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 (<a href="https://www.fda.gov/medical-devices/reporting-allegations-regulatory-misconduct/allegations-regulatory-misconduct-form">https://www.fda.gov/medical-devices/reporting-allegations-regulatory-misconduct/allegations-regulatory-misconduct-form</a>), by email, or by regular mail.
Allegations of regulatory misconduct related to medical devices and
electronic products 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. There are
different processes based on the type of allegation and the
completeness of the information submitted. The general steps CDRH takes
after receiving an allegation of regulatory misconduct and some
examples of the kind of allegations FDA has received are provided on
our website (<a href="https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct">https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct</a>).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden per Total hours
respondents respondent responses response
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Electronic submission of 2,500 1 2,500 0.25 (15 minutes) 625
voluntary allegations to
CDRH.
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\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: June 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12488 Filed 6-9-23; 8:45 am]
BILLING CODE 4164-01-P
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