[Federal Register Volume 66, Number 200 (Tuesday, October 16, 2001)]
[Notices]
[Pages 52629-52630]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-25920]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0266]


Agency Information Collection Activities; Submission for OMB 
Review; 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 that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
November 14, 2001.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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 
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.
    In the Federal Register of July 6, 2001 (66 FR 35642), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                              Table 1.--Estimated Year 1 Annual Reporting Burden\1\
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                                                           Annual
   21 CFR Section         FDA Form          No. of      Frequency per   Total Annual    Hours per    Total Hours
                                          Respondents     Response       Responses      Response
----------------------------------------------------------------------------------------------------------------
807.22(a)            Form 2891 Initial     2,045              1           2,045            0.25          511
                      Establishment
                      Registration
807.22(a) (hospital  Form 2891 Initial     2,000              1           2,000            0.25          500
 reuse                Establishment
 manufacturers)       Registration
807.22(b)            Form 2892 Device      3,450              1           3,450            0.50        1,725
                      Listing--initial
                      and updates
807.22(b) (hospital  Form 2892 Device      2,000             10          20,000            0.50       10,000
 reuse                Listing--initial
 manufacturers)       and updates
807.22(a)            Form 2891(a)--       16,500              1          16,500            0.25        4,125
                      Registration
                      Update
807.31(e)                                    200              1             200            0.50          100
                                                                                                   -------------
  Total year 1                                                                                        16,961
   burden hours
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 52630]]


                         Table 2.--Estimated Subsequent Years Annual Reporting Burden\1\
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                                                           Annual
  21 CFR Section         FDA Form          No. of      Frequency per    Total Annual    Hours per    Total Hours
                                         Respondents      Response       Responses      Response
----------------------------------------------------------------------------------------------------------------
807.22(a)           Form 2891 Initial     2,245               1           2,245            0.25          561
                     Establishment
                     Registration
807.22(b)           Form 2892 Device      3,650               1           3,650            0.50        1,825
                     Listing--initial
                     and updates
807.22(a)           Form 2891(a)--       18,500               1          18,500            0.25        4,625
                     Registration
                     Update
807.31(e)                                   200               1             200            0.50          100
                                                                                                   -------------
  Total year 2 and                                                                                     7,111
   year 3 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\
----------------------------------------------------------------------------------------------------------------
   21 CFR          No. of         Annual Frequency per     Total Annual         Hours per
  Section      Recordkeepers          Recordkeeper            Records         Recordkeeper        Total Hours
----------------------------------------------------------------------------------------------------------------
807.31             9,900                   10                99,000                 0.50            49,500
                                                                          ---------------------
  Total                                                                                             49,500
   burden
   hours
----------------------------------------------------------------------------------------------------------------
\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 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 2000 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: October 9, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-25920 Filed 10-15-01; 8:45 am]
BILLING CODE 4160-01-S