[Federal Register Volume 87, Number 34 (Friday, February 18, 2022)]
[Notices]
[Pages 9365-9366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03546]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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, Agency, or we) 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 certain Center for Devices and Radiological Health 
(CDRH) appeals processes.

DATES: Submit either electronic or written comments on the collection 
of information by April 19, 2022.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before April 19, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 19, 2022. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> 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.
    <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-2011-D-0893 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Center for Devices and 
Radiological Health Appeals Processes.'' 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.
    <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 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

[[Page 9366]]

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: 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#69393b283a1d080f0f290f0d084701011a470e061f"><span class="__cf_email__" data-cfemail="207072617354414646604644410e4848530e474f56">[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 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.

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 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.
    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: February 14, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-03546 Filed 2-17-22; 8:45 am]
BILLING CODE 4164-01-P


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