Document ID: FDA-2010-N-0606-0002
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: 2011-03-30T04:00Z

[Federal Register Volume 76, Number 61 (Wednesday, March 30, 2011)]
[Notices]
[Pages 17656-17657]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-7389]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 April 
29, 2011.

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 e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0387. 
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, e-mail: 
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.

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, 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 (21 U.S.C. 360j(e)).
    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.
    The annual respondent reporting burden for device establishment

[[Page 17657]]

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.
    In the Federal Register of December 7, 2010 (75 FR 76008), 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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                                                                                           No. of                       Average  burden
                           21 CFR section                                 No. of       responses per     Total annual    per  response     Total hours
                                                                       respondents       respondent      respondents       (in hours)
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807.31(d)(2).......................................................           2,250                1            2,250              0.5            1,125
807.31(e)..........................................................          22,500                1           22,500              0.5           11,250
                                                                                                                                        ----------------
    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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                                                                                                                        Average  burden
                                                                          No. of       No. of records    Total annual         per
                           21 CFR section                             recordkeepers         per            records       recordkeeping     Total hours
                                                                                        recordkeeper                       (in hours)
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807.31(a) to (c)...................................................          22,500                4           90,000              0.5           45,000
                                                                                                                                        ----------------
    Total..........................................................  ...............  ...............  ...............  ...............          45,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: March 24, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-7389 Filed 3-29-11; 8:45 am]
BILLING CODE 4160-01-P