[Federal Register: October 29, 2004 (Volume 69, Number 209)]
[Notices]
[Page 63156-63158]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29oc04-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0436]
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 information
collection, 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 and electronic comments on the collection of
information by December 28, 2004.
ADDRESSES: Submit electronic comments on the collection of information
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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 Robbins, Office of Management
Programs (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 Parts 807.22, 807.31,
and 807.40 (OMB Control No. 0910-0387--Extension)
Section 510 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 360) requires domestic establishments engaged in the
manufacture, preparation, propagation, compounding, assembly, or
processing of medical devices intended for human use and commercial
distribution register their establishments and list the devices they
manufacture with FDA. This is accomplished by completing FDA Form 2891
``Registration of Device Establishment'' and FDA Form 2892 ``Medical
Device Listing.'' The term ``device'' is defined in section 201(h) of
the act (21 U.S.C. 321) and includes all in vitro diagnostic products
and in vitro diagnostic biological products not subject to licensing
under section 351 of the Public Health Service Act (42 U.S.C. 262). The
FDA Modernization Act of 1997 (FDAMA) added a requirement for foreign
establishments to appoint a United States agent and submit the
information to FDA on Form 2891 as part of its initial and updated
registration information. In addition, each year, active, registered
establishments must notify FDA of changes to the current registration
and
[[Page 63157]]
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.
Under Sec. 807.31 (21 CFR 807.31), 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 above, the owner or operator must be prepared to submit to
FDA all labeling and advertising mentioned above (Sec. 807.31(e)).
Section 807.40 describes the role of the United States agent. The
U.S. agent must reside or have a physical place of business in the
United States, and each foreign establishment must submit U. S. agent
information as part of its initial and updated registration process.
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 and foreign device establishments and U.S. agents 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:
Estimated Annual Reporting Burden
Table 1A.--Estimated Year 1 Annual Reporting Burden\1\
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Annual
21 CFR FDA Form No. of Frequency Total Hours Total
Section No. Respondents of Annual per Hours
Response Responses Response
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807.22( 2891 2,900 1 2,900 .25 725
a) and Establishm
807.40 ent of
Registrat
ion
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807.22( 2892 4,400 1 4,400 .50 2,200
b) Medical
Device
Listing
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807.22( 2891a 25,100 1 25,100 .25 6,275
a) and Annual
807.40 Registrat
ion of
Medical
Device
Establish
ment
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807.31( .......... 200 1 200 .50 100
e)
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Total .......... ........... ......... ......... ........ 9,300
Year 1
Burden
Hours
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\1\There are no capital costs or operating and maintenance costs
associated with this collection of information.
Table 1B.--Estimated Subsequent Years Annual Reporting Burden\1\
------------------------------------------------------------------------
Annual
21 CFR FDA Form No. of Frequency Total Hours Total
Section No. Respondents of Annual Per Hours
Response Responses Response
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807.22( 2891 3,100 1 3,100 .25 775
a) and Registrat
807.40 ion of
Establishm
ent
------------------------------------------------------------------------
807.22( 2892 4,600 1 4,600 .50 2,300
b) Medical
Device
Listing
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807.22( 2891a 25,100 1 25,100 .25 6,275
a) and Annual
807.40 Registrat
ion of
Medical
Device
Establish
ment
------------------------------------------------------------------------
807.31( .......... 200 1 200 .50 100
e)
------------------------------------------------------------------------
Total .......... ........... ......... ......... ........ 9,450
Year 2
and 3
Burden
Hours
------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs
associated with this collection of information.
[[Page 63158]]
Table 2.--Estimated Annual Recordkeeping Burden\1\
------------------------------------------------------------------------
Annual Total
21 CFR No. of Frequency per Annual Hours Per Total
Section Recordkeepers Recordkeeper Records Recordkeeper Hours
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807.31 16,200 4 64,800 .50 32,400
------------------------------------------------------------------------
Total .............. ............. ........ ............. 32,400
Burden
Hours
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\1\The burdens are explained as follows:
The annual reporting burden hours to respondents for registering
establishments and listing devices is estimated to be 9,450 hours, and
recordkeeping burden hours for respondents is estimated to be 32,400
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) 2003. These
estimates are also based on FDA estimates of FY 2003 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 and U.S. agents 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 25,100 active establishments listed in it. Based on past
experience, the agency anticipated that approximately 7,300
registrations will be processed during the first year, and 3,100
thereafter. FDA anticipates reviewing 200 historical files annually.
Dated: October 22, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24192 Filed 10-28-04; 8:45 am]
BILLING CODE 4160-01-S