Document ID: FDA-2010-N-0606-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Additional Listing Information for Medical Device Registration and Listing
Posted Date: 2010-12-07T05:00Z

[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Pages 76008-76009]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30582]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0606]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Additional Listing Information for Medical Device 
Registration and Listing

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 reporting and 
recordkeeping burden requirements associated with additional listing 
information for medical device registration and listing by non-
electronic means.

DATES: Submit either electronic or written comments on the collection 
of information by February 7, 2011.

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 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.

Additional Listing Information for Medical Device Registration and 
Listing (OMB Control Number 0910-0387)--Extension

    The Food and Drug Administration Amendments Act of 2007 (FDAAA), 
enacted September 27, 2007, requires that device establishment 
registrations and listings under 21 U.S.C. 360(p) (including the 
submission of updated information) be submitted to the Secretary of 
Health and Human Services (the Secretary) by electronic means,

[[Page 76009]]

unless the Secretary grants a request for waiver of the requirement, 
because the use of electronic means is not reasonable for the person 
requesting the waiver. The collections of information under sections 
222, 223, and 224 of FDAAA have been approved under OMB control number 
0910-0625. Registration by electronic means for device establishments 
replaced FDA Forms 2891 and 2891a, ``Registration of Device 
Establishment,'' and FDA Form 2892, ``Medical Device Listing,'' with 
FDA Form 3673, ``Device Registration and Listing Module.'' The scope of 
this information collection addresses only the reporting and 
recordkeeping requirements by non-electronic means under Sec.  807.31 
(21 CFR 807.31).
    Under Sec.  807.31(a) through (d), each owner or operator is 
required to maintain an historical file containing the labeling and 
advertisements in use on the date of initial listing, and in use after 
October 10, 1978, but not before the date of initial listing. The owner 
or operator must maintain in the historical file any labeling or 
advertisements in which a material change has been made anytime after 
initial listing, but may discard labeling and advertisements from the 
file 3 years after the date of the last shipment of a discontinued 
device by an owner or operator. Section 807.31(e) requires that the 
owner or operator be prepared to submit to FDA copies of: (1) All 
device labeling, (2) all device labeling and representative 
advertising, or (3) only representative package inserts, depending upon 
whether the device is subject to the regulatory controls under sections 
514 and 515 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) 
(21 U.S.C. 360d and 360e), or restrictions imposed by 21 CFR 801.109 or 
otherwise by section 520(e) of the FD&C Act.
    The information collected under these provisions is used by FDA to 
identify: (1) Firms subject to FDA's regulations, (2) geographic 
distribution of firms in order to effectively allocate FDA's field 
resources for inspections, and (3) the class of the device that 
determines the frequency of inspection. As a result, when complications 
occur with a particular device or component, all manufacturers of 
similar or related devices can easily be identified.
    The likely respondents to this information collection are domestic 
and foreign device establishments who must register and submit a device 
list to FDA, e.g., establishments engaged in the manufacture, 
preparation, propagation, compounding, assembly, or processing of 
medical devices intended for human use and commercial distribution.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
         21 CFR Section              Number of     frequency of    Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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807.31(d)(2)....................           2,250               1           2,250              .5           1,125
807.31(e).......................          22,500               1          22,500              .5          11,250
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    Total.......................  ..............  ..............  ..............  ..............          12,375
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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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                                                      Annual
         21 CFR Section              Number of     frequency per   Total annual      Hours per      Total hours
                                   recordkeepers   recordkeeping      records         record
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807.31(a-c).....................          22,500               4          90,000            0.50          45,000
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    Total.......................  ..............  ..............  ..............  ..............          45,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The annual respondent reporting burden for device establishment 
registrations and listings for additional information is estimated to 
be 12,375 hours and the annual respondent recordkeeping burden is 
estimated to be 45,000 hours. Therefore, the total burden hours for 
this collection are estimated to be 57,375. The estimates cited in 
tables 1 and 2 of this document are based primarily on fiscal year 2010 
data from current systems and on conversations with industry and trade 
association representatives.

    Dated: December 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30582 Filed 12-6-10; 8:45 am]
BILLING CODE 4160-01-P