Document ID: FDA-2018-N-0405-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of
Management and Budget Review; Comment Request; Medical Device
Recall Authority
Posted Date: 2018-08-03T04:00Z

[Federal Register Volume 83, Number 150 (Friday, August 3, 2018)]
[Notices]
[Pages 38151-38153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16618]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the

[[Page 38152]]

Office of Management and Budget (OMB) for review and clearance under 
the Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by 
September 4, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0432. 
Also include the FDA docket number found in brackets in the heading of 
this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Medical Device Recall Authority

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.
    In the Federal Register of February 22, 2018 (83 FR 7740), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1--Estimated Annual Reporting Burden 1
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                                                     Number of
   Collection activity/21 CFR        Number of     responses per   Total annual   Average burden    Total hours
             section                respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
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
                                 -------------------------------------------------------------------------------
    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 section                     Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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Documentation of Notifications to Recipients--810.15(b)............               2                1                2                8               16
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                            Table 3--Estimated Annual Third-Party Disclosure Burden 1
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                                                     Number of
   Collection activity/21 CFR        Number of      disclosures    Total annual   Average burden    Total hours
             section                respondents   per respondent    disclosures   per disclosure
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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.

[[Page 38153]]

    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: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16618 Filed 8-2-18; 8:45 am]
 BILLING CODE 4164-01-P