Document ID: FDA-2011-N-0793-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Medical Device Recall Authority
Posted Date: 2012-02-10T05:00Z

[Federal Register Volume 77, Number 28 (Friday, February 10, 2012)]
[Notices]
[Pages 7165-7166]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-3098]

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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.

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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 March 
12, 2012.

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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@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 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), 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:
    1. 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:
     Cease distribution of the device,
     Notify health professionals and device user facilities of 
the order, and
     Instruct those professionals and facilities to cease use 
of the device;
    2. 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
    3. 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 November 16, 2011 (76 FR 71041), 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                        Average
         21 CFR Section              Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
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810.10(d).......................               2               1               2               8              16
810.11(a).......................               1               1               1               8               8
810.12(a) and (b)...............               1               1               1               8               8
810.14..........................               2               1               2              16              32
810.15(a), (b), and (c).........               2               1               2              12              24
810.15(d).......................               2               1               2               4               8
810.15(e).......................              10               1              10               1              10
810.16(a) and (b)...............               2              12              24              40             960
810.17(a).......................               2               1               2               8              16
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    Total Hours.................  ..............  ..............  ..............  ..............           1,082
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

[[Page 7166]]

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

    The burden estimates for tables 1 and 2 of this document are based 
on FDA's experience with voluntary recalls under part 810 of the 
regulations. FDA expects no more than two mandatory recalls per year, 
as most recalls are done voluntarily. Since the last time this 
collection of information was submitted to OMB for renewal/approval, 
there has been one mandatory recall.

    Dated: February 6, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3098 Filed 2-9-12; 8:45 am]
BILLING CODE 4160-01-P