
[Federal Register Volume 84, Number 46 (Friday, March 8, 2019)]
[Notices]
[Pages 8530-8532]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-04207]


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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 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 the 
processes available to outside stakeholders to request additional 
review of decisions or actions by Center for Devices and Radiological 
Health (CDRH) employees.

DATES: Submit either electronic or written comments on the collection 
of information by May 7, 2019.

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 May 7, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 7, 2019. 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:
     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-2011-D-0893 for ``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.
     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.gpo.gov/fdsys/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://

[[Page 8531]]

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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), 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

    The guidance document entitled ``Guidance for Industry and Food and 
Drug Administration Staff; Center for Devices and Radiological Health 
Appeals Processes'' \1\ describes the processes available to outside 
stakeholders to request additional review of decisions or actions by 
CDRH employees. FDA is seeking approval for the reporting burden 
associated with requests for additional review of decisions and actions 
by CDRH employees as described in the guidance.
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    \1\ https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm284670.pdf.
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    Individuals outside of FDA who disagree with a decision or action 
taken by CDRH and wish to have it reviewed or reconsidered have several 
processes for resolution from which to choose, including requests for 
supervisory review of an action, petitions, and hearings. Of these, by 
far the most commonly used is a request for supervisory review under 
Sec.  [thinsp]10.75 (21 CFR 10.75) (``10.75 appeal''). Section 517A of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360g-1), 
added by section 603 of the Food and Drug Safety and Innovation Act, 
includes requirements pertaining to the process and timelines for 10.75 
appeals of ``significant decisions'' regarding 510(k) premarket 
notifications, applications for premarket approvals (PMAs), and 
applications for investigational device exemptions (IDEs).
    A request for review under Sec.  [thinsp]10.75 should be based on 
the information that was already present in the administrative file at 
the time of the decision that is being reviewed as provided in Sec.  
[thinsp]10.75(d). Section 517A of the FD&C Act refers to significant 
decisions regarding the information in the administrative file for 
premarket notification (section 510(k) of the FD&C Act (21 U.S.C. 
360(k))), PMA (section 515 (21 U.S.C. 360e)), and IDE (section 520(g) 
(21 U.S.C. 360j(g))) submissions that is collected under existing 
regulations that specify the information manufacturers must submit so 
that FDA may properly evaluate the safety and effectiveness of medical 
devices. The information collections associated with these regulations 
are currently approved by the OMB as follows: The collections of 
information in 21 CFR part 807, subpart E (premarket notification) have 
been approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 814 (premarket approval) have been approved 
under OMB control number 0910-0231; and the collections of information 
in 21 CFR part 812 (investigational device exemption) have been 
approved under OMB control number 0910-0078.
    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 particular information regarding the request 
itself and the data and information relied on by the requestor in the 
appeal would facilitate timely resolution of the decision under review. 
The guidance 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                         Number of
                                                                        Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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CDRH Appeals processes guidance document...........................              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.


[[Page 8532]]

    Our estimated burden for the information collection reflects a 
decrease of 15 responses and a corresponding overall decrease of 120 
hours. We attribute this adjustment to a decrease in the number of 
submissions we received over the last few years.

    Dated: March 4, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-04207 Filed 3-7-19; 8:45 am]
BILLING CODE 4164-01-P


