[Federal Register Volume 80, Number 50 (Monday, March 16, 2015)]
[Notices]
[Pages 13586-13588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-05868]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the 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 the information collection 
requirements for medical device recall authority.

DATES: Submit either electronic or written comments on the collection 
of information by May 15, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the

[[Page 13587]]

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, <a href="/cdn-cgi/l/email-protection#95c5c7d4c6e1f4f3f3d5f3f1f4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="9bcbc9dac8effafdfddbfdfffab5f3f3e8b5fcf4ed">[email protected]</span></a>.

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 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:
    <bullet> 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;
    <bullet> 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
    <bullet> 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.
    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
   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
                                 -------------------------------------------------------------------------------
    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                1                8                8
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 13588]]



                           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
             section                respondents         per         disclosures     burden per      Total hours
                                                    respondent                      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
 Followup--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.


    Dated: March 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-05868 Filed 3-13-15; 8:45 am]
BILLING CODE 4164-01-P


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