Document ID: FDA-2011-N-0793-0005
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: 2015-06-12T04:00Z

[Federal Register Volume 80, Number 113 (Friday, June 12, 2015)]
[Notices]
[Pages 33523-33524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14359]

[[Page 33523]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0793]

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.

-----------------------------------------------------------------------

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: Fax written comments on the collection of information by July 
13, 2015.

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 oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.

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--21 CFR 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), 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; (2) immediately notify 
health professionals and device-user facilities of the order; and (3) 
instruct such professionals and facilities to cease use of such device.
    Further, the provisions under section 518(e) of the FD&C Act set 
out the following three-step procedure for issuance of a mandatory 
device recall order:
     If there is a reasonable probability that a device 
intended for human use would cause serious, adverse health consequences 
or death, FDA may issue a cease distribution and notification order 
requiring the appropriate person to immediately:
    [cir] Cease distribution of the device,
    [cir] notify health professionals and device user facilities of the 
order, and
    [cir] instruct those professionals and facilities to cease use of 
the device;
     FDA will provide the person named in the cease 
distribution and notification order with the opportunity for an 
informal hearing on whether the order should be modified, vacated, or 
amended to require a mandatory recall of the device; and
     After providing the opportunity for an informal hearing, 
FDA may issue a mandatory recall order if the Agency determines that 
such an order is necessary.
    The information collected under the recall authority provisions 
will be used by FDA to do the following: (1) Ensure that all devices 
entering the market are safe and effective; (2) accurately and 
immediately detect serious problems with medical devices; and (3) 
remove dangerous and defective devices from the market.
    In the Federal Register of March 11, 2015 (80 FR 13586), 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\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
   Collection activity--21 CFR       Number of     responses per   Total annual     burden per      Total hours
             Section                respondents     respondent       responses       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
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

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

[[Page 33524]]

                           Table 3--Estimated Annual Third-Party Disclosure Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                    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
 Followup--810.15(d)..........
Notification of Consignees by               10                 1              10               1              10
 Recipients--810.15(e)........
    Total.....................  ..............  ................  ..............  ..............              42
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: June 8, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14359 Filed 6-11-15; 8:45 am]
 BILLING CODE 4164-01-P