[Federal Register Volume 87, Number 161 (Monday, August 22, 2022)]
[Notices]
[Pages 51432-51433]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18065]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0893]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Center for Devices 
and Radiological Health Appeals Processes

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) 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 September 21, 2022.

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 0910-0738. 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-45, 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.

Center for Devices and Radiological Health Appeals Processes

OMB Control Number 0910-0738--Extension

    This information collection supports implementation of 
recommendations found in FDA guidance. As discussed in the document 
entitled ``Guidance for

[[Page 51433]]

Industry and Food and Drug Administration Staff; Center for Devices and 
Radiological Health (CDRH) Appeals Processes'' (July 2019), there are 
various processes by which appeals requests regarding review of 
decisions or actions by CDRH may be submitted to the Agency. The 
guidance is available for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes. The 
guidance document provides general format and content recommendations 
in this regard, discusses applicable regulations with regard to the 
timing of such submissions, and describes the collection of information 
not expressly specified under existing regulations such as the 
submission of the request for review, minor clarifications as part of 
the request, and supporting information. While CDRH already possesses 
in the administrative file the information that would form the basis of 
a decision on a matter under appeal, the submission of information as 
recommended in the guidance regarding the appeal request itself, as 
well as data and information relied on by the requestor in the appeal, 
will help facilitate timely resolution of the decision under review. We 
are accounting for burden respondents may incur as a result of these 
Agency recommendations in this collection request. Additional 
information about the CDRH appeals process is described in the 
companion guidance entitled ``Center for Devices and Radiological 
Health (CDRH) Appeals Processes: Questions and Answers About 517A--
Guidance for Industry and Food and Drug Administration Staff'' (March 
2020), also available for download from our website at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/center-devices-and-radiological-health-cdrh-appeals-processes-
questions-and-answers-about-517a.
    In the Federal Register of February 18, 2022 (87 FR 9365) we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
    CDRH Appeals Processes: Guidance for Industry and FDA Staff         Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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Recommended format and content elements............................              35                1               35                8              280
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    We estimate 35 requests will be submitted annually to review 
decisions and actions by CDRH employees, we attribute one respondent 
per submission, and we assume each request will take 8 hours to 
prepare. Based on our evaluation of the information collection since 
last OMB approval, we have made no adjustments to the currently 
approved burden estimate.

    Dated: August 17, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18065 Filed 8-19-22; 8:45 am]
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