Notice2023-22463
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
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
October 12, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 196 (Thursday, October 12, 2023)</title>
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[Federal Register Volume 88, Number 196 (Thursday, October 12, 2023)]
[Notices]
[Pages 70666-70667]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-22463]
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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.
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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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#92c2c0d3c1e6f3f4f4d2f4f6f3bcfafae1bcf5fde4"><span class="__cf_email__" data-cfemail="134341524067727575537577723d7b7b603d747c65">[email protected]</span></a>.
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 (<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.
[[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: <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>.
We estimate 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 response Total hours
respondents respondent responses
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Electronic submission of voluntary allegations 2,500 1 2,500 0.25 (15 minutes)................. 625
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: 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
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