Document ID: FDA-2018-N-0405-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Recall Authority
Posted Date: 2018-02-22T05:00Z

[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7740-7742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03605]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0405]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Medical Device Recall Authority

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 related to Medical 
Device Recall Authority.

DATES: Submit either electronic or written comments on the collection 
of information by April 23, 2018.

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 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of April 23, 2018. 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-2018-N-0405 for ``Medical Device Recall Authority.'' 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

[[Page 7741]]

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://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, 
[email protected].

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.

Medical Device Recall Authority--21 CFR Part 810

OMB Control Number 0910-0432--Extension

    This collection of information implements section 518(e) of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360h(e)) and 
part 810 (21 CFR part 810), mandatory medical device recall authority 
provisions. Section 518(e) of the FD&C Act provides FDA with the 
authority to issue an order requiring an appropriate person, including 
manufacturers, importers, distributors, and retailers of a device, if 
FDA finds that there is reasonable probability that the device intended 
for human use would cause serious adverse health consequences or death, 
to: (1) Immediately cease distribution of such device and (2) 
immediately notify health professionals and device-user facilities of 
the order and to instruct such professionals and facilities to cease 
use of such device.
    FDA will then provide the person named in the cease distribution 
and notification order with the opportunity for an informal hearing on 
whether the order should be amended to require a mandatory recall of 
the device.
    If, after providing the opportunity for an informal hearing, FDA 
determines that such an order is necessary, the Agency may amend the 
order to require a mandatory recall.
    FDA issued part 810 to implement the provisions of section 518 of 
the FD&C Act. The information collected under the mandatory recall 
authority provisions will be used by FDA to implement mandatory 
recalls.

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of                        Average
   Collection activity/21 CFR        Number of     responses per   Total annual     burden per      Total hours
             section                respondents     respondent       responses       response
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Collections Specified in the                   2               1               2               8              16
 Order--810.10(d)...............
Request for Regulatory Hearing--               1               1               1               8               8
 810.11(a)......................
Written Request for Review--                   1               1               1               8               8
 810.12(a)-(b)..................
Mandatory Recall Strategy--                    2               1               2              16              32
 810.14.........................
Periodic Status Reports--                      2              12              24              40             960
 810.16(a)-(b)..................
Termination Request--810.17(a)..               2               1               2               8              16
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total Hours.................  ..............  ..............  ..............  ..............           1,040
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                               Table 2--Estimated Annual Recordkeeping Burden \1\
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                                                     Number of                     Average  burden
   Collection activity/21 CFR       Number of       records per     Total annual         per         Total hours
            section               recordkeepers     recordkeeper       records      recordkeeping
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Documentation of Notifications                 2                1               1                8             8
 to Recipients--810.15(b)......
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 7742]]

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
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                                                    Number of                         Average
  Collection activity/21 CFR       Number of     disclosures per   Total annual     burden per      Total hours
            section               respondents       respondent      disclosures     disclosure
----------------------------------------------------------------------------------------------------------------
Notification to Recipients--                  2                1               2              12              24
 810.15(a)-(c)................
Notification to Recipients;                   2                1               2               4               8
 Follow-up--810.15(d).........
Notification of Consignees by                10                1              10               1              10
 Recipients--810.15(e)........
                               ---------------------------------------------------------------------------------
    Total.....................  ...............  ...............  ..............  ..............              42
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The burden estimate has not changed for information collection 
related to section 518(e) of the FD&C Act and part 810 since the last 
OMB approval.

    Dated: February 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03605 Filed 2-21-18; 8:45 am]
 BILLING CODE 4164-01-P