[Federal Register Volume 73, Number 24 (Tuesday, February 5, 2008)]
[Notices]
[Pages 6731-6732]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-2079]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2008N-0016]
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 public comments on the reporting and
recordkeeping burden associated with the paperwork requirements under
Sec. 807.31 (21 CFR 807.31), which requires device establishments to
retain and, upon FDA's specific request, submit certain additional
listing information.
DATES: Submit written or electronic comments on the collection of
information by April 7, 2008.
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: Denver Presley Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472
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--21 CFR 80.31; (OMB Control Number 0910-0387)--Extension
The Food and Drug Administration Amendments Act of 2007 (the 2007
Amendments), 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. See section 224 of the 2007
Amendments. The 2007 Amendments provides for an October 1, 2007,
effective date by which FDA expects approximately 30,000 establishments
to begin registering. FDA is seeking OMB approval for the information
collected by electronic means. Registration by electronic means for
device establishments will mean replacement of FDA Forms 2891 and
2891a, ``Registration of Device Establishment'' and FDA Form 2892
``Medical Device Listing,'' with electronic versions. However, for OMB
approval of the extension request for this collection of
[[Page 6732]]
information, FDA is revising the scope to address only the reporting
and recordkeeping requirements by non-electronic means as described in
this document and set forth under Sec. 807.31 for `` Additional
Listing Information.'' To reflect the revised scope of this collection
of information, FDA has modified the title.
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 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. Along with the recordkeeping
requirements, under Sec. 807.31(e), the owner or operator must 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 or 515 of Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d and 360e,
respectively), or restrictions imposed by 21 CFR 801.109 or otherwise
by section 520(e) of the act.
The information collected under these provisions is used by FDA to
identify: (1) Firms subject to FDA's regulations, (2) geographic
distribution in order to effectively allocate FDA's field resources for
these 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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No. of Annual Frequency of Total Annual Hours per
21 CFR Section Respondents Response Responses Response Total Hours
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807.31(e) 200 1 200 .50 100
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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 Annual Frequency of Total Annual
21 CFR Section Recordkeepers Recordkeeping Records Hours per Record Total Hours
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807.31(a) through (d ) 16,200 4 64,800 .50 32,400
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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 listing is estimated to be 100 hours and the annual
respondent recordkeeping burden is estimated to be 32,400 hours. The
estimates cited in tables 1 and 2 of this documet are based primarily
on the annual FDA accomplishment report, which includes actual FDA
registration and listing data derived for fiscal year (FY) 2006. These
estimates are also based on FDA estimates of FY 2006 data from current
systems and conversations with industry and trade association
representatives. FDA anticipates reviewing annually, 200 historical
files.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will
be accepted by FDA through the FDMS only.
Dated: January 30, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-2079 Filed 2-4-08; 8:45 am]
BILLING CODE 4160-01-S