[Federal Register Volume 73, Number 84 (Wednesday, April 30, 2008)]
[Notices]
[Pages 23467-23468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-9374]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0088] (formerly Docket No. 2008N-0016)
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 May 30,
2008.
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: 202-395-6974, or e-mailed to [email protected]. 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: 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: 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 (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. FDA expects 20,000 to 30,000 establishments will need
to register between now and December 31, 2008. 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 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 in Sec.
807.31 (21 CFR 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 section 514 or section 515 of
Federal Food, Drug, and Cosmetic Act (the act), 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
[[Page 23468]]
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.
In the Federal Register of February 5, 2008 (73 FR 6731), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
21 CFR Section Respondents per 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 Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
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807.31(a 16,200 4 64,800 .50 32,400
through d)
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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 document 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.
Dated: April 23, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-9374 Filed 4-29-08; 8:45 am]
BILLING CODE 4160-01-S