[Federal Register Volume 76, Number 221 (Wednesday, November 16, 2011)]
[Notices]
[Pages 71041-71042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29512]


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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 January 17, 2012.

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 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: 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

[[Page 71042]]

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), 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.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                    Number of     No. of responses    Total annual     Average burden
                        21 CFR Section                             respondents     per respondent       responses       per response       Total hours
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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.....................................................  ................  ................  ................  ................             1,082
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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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                                                                 No. of         No. of records      Total annual      Average burden
                      21 CFR Section                         recordkeepers     per recordkeeper       records       per recordkeeping     Total hours
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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.

Explanation for Burden Estimates

    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: November 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29512 Filed 11-15-11; 8:45 am]
BILLING CODE 4160-01-P