[Federal Register Volume 63, Number 136 (Thursday, July 16, 1998)]
[Notices]
[Pages 38409-38410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-18877]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-0494]
Agency Information Collection Activities: Proposed Collection;
Comment Request
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,
and to allow 60 days for public comment in response to the notice. This
notice solicits comments on the requirements for domestic manufacturers
and initial importers of devices to register their establishments and
list their devices.
DATES: Submit written comments on the collection of information by
September 14, 1998.
ADDRESSES: 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: Margaret R. Schlosburg, Office of
Information Resources Management (HFA-250), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301827-1223
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, 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
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, ``Initial Registration of Device Establishment'' and FDA
Form 2892, ``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 pre-printed on FDA Form 2891a
and sent to registered establishments. The form must be sent back to
FDA's Center for Devices and Radiological Health (CDRH), even if no
changes have occurred. Changes to listing information are submitted on
Form 2892. Refurbishers/reconditioners are not required to register or
list; however, FDA will accept voluntary registration and listings from
firms 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 upon specific request 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
which determines the inspection frequency. When complications occur
with a particular device or component, manufacturers of similar or
related devices can easily be 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:
[[Page 38410]]
Table 1.--Estimated Annual Reporting Burden1
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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- 1,462 1 1,462 .25 366
Initial
Establishmen
t.
Registration
807.22(b) Form 2892- 5,640 1 5,640 .50 2,820
Device
Listing
(initial and
update)
807.22(a) Form 2891a- 22,000 1 22,000 .25 5,500
Registration
Update
807.31(e) 200 1 200 .50 100
TOTALS 8,786
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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 Burden1
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Annual
21 CFR Section No. of Recordkeepers Frequency per Total Annual Hours per Total Hours
Recordkeeping Records Recordkeeper
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807.31 7,900 10 79,000 0.5 39,500
TOTALS 39,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The annual reporting burden hours to respondents for registering
establishments and listing devices is estimated to be 8,786 hours, and
recordkeeping burden hours for respondents is estimated to be 39,500
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) 1997. These
estimates are also based on conversations with industry and trade
association representatives, and internal review of the FDA forms and
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 Data Base. The data base has 22,000
establishments listed in it. Based on past experience, the agency
anticipates that approximately 1,462 registrations will be processed
annually, and that 5,640 initial and update device listings will be
submitted. Although FDA only processed 12,237 annual registrations
during FY 1997 due to a delay in sending out the annual registration
forms, the normal amount of processing of annual registrations in the
past has been 22,000. FDA anticipates reviewing 200 historical files
annually. Finally, because initial importers (currently estimated at
6,200) do not have to maintain historical files, FDA estimates that the
number of recordkeepers required to maintain the initial historical
information will be 7,900 (which is the number of establishments,
22,000 minus the number of initial importers, 6,200, divided by 2, the
average number of establishments per owner/operator).
Dated: July 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-18877 Filed 7-15-98; 8:45 am]
BILLING CODE 4160-01-F