[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38061-38062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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 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:
     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.
     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 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, 
[email protected].

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

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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 (https://www.fda.gov/medical-devices/reporting-allegations-regulatory-misconduct/allegations-regulatory-misconduct-form), 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 (https://www.fda.gov/medical-devices/medical-device-safety/reporting-allegations-regulatory-misconduct).
    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