Document ID: FDA-2008-N-0088-0003
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Listing Information for Medical Device Registration and Listing
Posted Date: 2008-04-30T04:00Z

[Federal Register: April 30, 2008 (Volume 73, Number 84)]
[Notices]               
[Page 23467-23468]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30ap08-96]                         

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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 baguilar@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:  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