[Federal Register Volume 66, Number 130 (Friday, July 6, 2001)]
[Notices]
[Pages 35642-35644]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16987]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0266]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 information collection 
requirements for medical device registration and listing.

DATES: Submit written or electronic comments on the collection of 
information by September 4, 2001.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.fda.gov/dockets/ecomments. Submit written comments on the 
collection of information to the Dockets Management Branch (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: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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: (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.

Medical Device Registration and Listing--21 CFR 807.22 and 807.31 
(OMB Control No. 0910-0387)--Extension

    Section 510 of the Federal Food, Drug, and Cosmetic Act (the act) 
(21 U.S.C. 360) requires that manufacturers and initial importers 
engaged in the manufacture, preparation, propagation, compounding, 
assembly, or processing of medical devices intended for human use and 
in commercial distribution register their establishments and list the 
devices they manufacture with FDA. This is accomplished by completing 
FDA Form 2891 entitled ``Initial Registration of Device Establishment'' 
and FDA Form 2892 entitled ``Medical Device Listing.'' In addition, 
each year active, registered establishments must notify FDA of changes 
to the current registration and device listing for the establishment. 
Annual changes to current registration information are preprinted on 
FDA Form 2891a and sent to registered establishments. The form must be 
sent back to FDA's Center for Devices and Radiological Health, even if 
no changes have occurred. Changes to listing information are submitted 
on Form 2892. On August 14, 2001, all hospitals who reprocess single-
use devices will be required to register and list their activities. 
Under the Food and Drug Administration Modernization Act of 1997, 
foreign manufacturers are now required to register their establishments

[[Page 35643]]

and list their devices, but foreign registration and listing will be 
covered under a separate information requirement. FDA will also accept 
voluntary registration and listings from firms not covered above that 
wish to be registered with FDA.
    In addition, under Sec. 807.31 (21 CFR 807.31), each owner or 
operator is required to maintain a 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 above, the owner or operator must be prepared to submit to 
FDA all labeling and advertising mentioned above (Sec. 807.31(e)).
    The information collected through these provisions is used by FDA 
to identify firms subject to FDA's regulations and is used to identify 
geographic distribution in order to effectively allocate FDA's field 
resources for these inspections and to identify the class of the device 
that determines the inspection frequency. When complications occur with 
a particular device or component, manufacturers of similar or related 
devices can be easily identified.
    The likely respondents to this information collection will be 
domestic 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 Year 1 Annual Reporting Burden\1\
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                                                                                     No. of     Annual Frequency  Total Annual   Hours per
            21 CFR Section                              FDA Form                   Respondents    per Response      Responses    Response    Total Hours
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807.22(a)                              Form 2891 Initial Establishment             2,045               1           2,045            0.25       511
                                        Registration
807.22(a) (hospital reuse              Form 2891 Initial Establishment             2,000               1           2,000            0.25       500
 manufacturers)                         Registration
807.22(b)                              Form 2892 Device Listing--initial and       3,450               1           3,450            0.50     1,725
                                        updates
807.22(b) (hospital reuse              Form 2892 Device Listing--initial and       2,000              10          20,000            0.50    10,000
 manufacturers)                         updates
807.22(a)                              Form 2891(a)--Registration Update          16,500               1          16,500            0.25     4,125
807.31(e)                                                                            200               1             200            0.50       100
                                                                                                                                           -------------
  Total year 1 burden hours                                                                                                                 16,961
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                                             Table 2.--Estimated Subsequent Years Annual Reporting Burden\1\
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                                                                                   No. of     Annual Frequency  Total Annual    Hours per
         21 CFR Section                             FDA Form                     Respondents    per Response      Responses     Response     Total Hours
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807.22(a)                        Form 2891 Initial Establishment Registration    2,245               1           2,245             0.25        561
807.22(b)                        Form 2892 Device Listing--initial and updates   3,650               1           3,650             0.50      1,825
807.22(a)                        Form 2891(a)--Registration Update              18,500               1          18,500             0.25      4,625
807.31(e)                                                                          200               1             200             0.50        100
                                                                                                                                           -------------
  Total year 2 and year 3                                                                                                                    7,111
   burden hours
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                               Table 3.--Estimated Annual Recordkeeping Burden\1\
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  21 CFR                          Annual Frequency per   Total Annual
  Section   No. of Recordkeepers      Recordkeeping         Records     Hours per Recordkeeper     Total Hours
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807.31           9,900                    10             99,000                   0.50            49,500
                                                                                               -----------------
  Total                                                                                           49,500
   burden
   hours
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    This year's submission has broken out annual costs into two 
distinct phases, and the tables above summarized the estimated annual 
reporting burden hours for medical device establishments to report in 
compliance with the provisions imposed by this regulation.

Hospital Reprocessing of Single-Use Medical Devices

    On August 14, 2001, hospitals who reprocess single-use devices will 
be

[[Page 35644]]

required to register their establishments and list those devices they 
reprocess. FDA has estimated that there will be approximately 2,000 
such establishments that will fall into this category. The first year 
of the requirement will cause a one-time bolus of information to be 
submitted. FDA has separated the burden estimates into two tables to 
indicate year 1 (table 1 of this document) and subsequent year's 
estimates (table 2 of this document). Year 1 will include burden hours 
based on this bolus of submissions during the first year and subsequent 
year's estimates will indicate an adjustment for the new registrants 
for year 2 and beyond.

Burden Hour Explanation

    The annual reporting burden hours to respondents for registering 
establishments and listing devices is estimated to be 16,961 hours, and 
recordkeeping burden hours for respondents is estimated to be 49,500 
hours. The estimates cited in the tables above are based primarily upon 
the annual FDA accomplishment report, which includes actual FDA 
registration and listing figures from fiscal year (FY) 2000. These 
estimates are also based on FDA estimates of FY 00 data from current 
systems, conversations with industry and trade association 
representatives, and from internal review of the documents referred to 
in the previous tables.
    According to 21 CFR part 807, all owners/operators are required to 
list, and establishments are required to register. Each owner/operator 
has an average of two establishments, according to statistics gathered 
from FDA's registration and listing database. The database has 16,500 
active establishments listed in it. Based on past experience, the 
agency anticipates that approximately 4,045 registrations will be 
processed during the first year (because of hospitals who reprocess 
single-use), and 2,045 registrations thereafter. The agency also 
anticipates that approximately 5,450 initial and update device listings 
will be submitted the first year (due to hospitals who reprocess 
single-use devices), and 3,450 thereafter. FDA anticipates reviewing 
200 historical files annually. Finally, because initial importers 
(currently estimated at 6,200) do not have to maintain historical files 
and because of the addition of 2,000 hospitals who reprocess single-use 
medical devices, FDA estimates that the number of recordkeepers 
required to maintain the initial historical information will be 9,900.

    Dated: June 29, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-16987 Filed 7-5-01; 8:45 am]
BILLING CODE 4160-01-C