Document ID: FDA-2008-N-0088-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2008-02-05T05:00Z

[Federal Register: February 5, 2008 (Volume 73, Number 24)]
[Notices]               
[Page 6731-6732]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05fe08-71]                         

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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