[Federal Register Volume 66, Number 200 (Tuesday, October 16, 2001)]
[Notices]
[Pages 52629-52630]
From the Federal Register Online via the Government Printing 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
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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
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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
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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
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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\
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21 CFR No. of Annual Frequency per Total Annual Hours per
Section Recordkeepers Recordkeeper Records Recordkeeper Total Hours
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807.31 9,900 10 99,000 0.50 49,500
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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 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