[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