[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Pages 76008-76009]
From the Federal Register Online via the Government Publishing 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,
[email protected].
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