[Federal Register: January 13, 2005 (Volume 70, Number 9)]
[Notices]               
[Page 2413-2415]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ja05-76]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0436]

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

DATES: Fax written comments on the collection of information by 
February 14, 2005.

ADDRESSES: OMB is still experiencing significant delays in the regular 
mail, including first class and express mail, and messenger deliveries 
are not being accepted. To ensure that comments on the information 
collection are received, OMB recommends that written comments be faxed 
to the Office of Information and Regulatory Affairs, OMB, Attn: Fumie 
Yokota, Desk Officer for FDA, FAX: 202-395-6974.

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: 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 Parts 807.22, 
807.31, and 807.40 (OMB Control Number 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

[[Page 2414]]

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 U.S. 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 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 previously mentioned in this document, the owner or 
operator must be prepared to submit to FDA all labeling and advertising 
(Sec.  807.31(e)).
    Section 807.40 (21 CFR 807.40) describes the role of the U.S. 
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).
    In the Federal Register of October 29, 2004 (69 FR 63156), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    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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                                                                                 No. of       Annual Frequency   Total Annual     Hours Per      Total
                21 CFR Section                           FDA Form              Respondents      of Response        Responses       Response      Hours
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807.22(a) and 807.40                                  Form 2891 Initial and           2,900                  1           2,900            .25        725
                                                      Updates Establishment
                                                               Registration
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807.22(b)                                         Form 2892 Device Listing-           4,400                  1           4,400            .50      2,200
                                                        initial and updates
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807.22(a) and 807.40                                Form 2891a-Registration          25,100                  1          25,100            .25      6,275
                                                                     Update
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807.31(e)                                      ............................             200                  1             200            .50        100
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Total Year 1 Burden Hours                                                                                                                          9,300
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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\
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                                                                                 No. of       Annual Frequency   Total Annual     Hours Per      Total
                21 CFR Section                           FDA Form              Respondents      of Response        Responses       Response      Hours
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807.22(a) and 807.40                                  Form 2891 Initial and           3,100                  1           3,100            .25        775
                                                      Updates Establishment
                                                               Registration
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807.22(b)                                         Form 2892 Device Listing-           4,600                  1           4,600            .50      2,300
                                                        initial and updates
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807.22(a) and 807.40                                Form 2891a-Registration          25,100                  1          25,100            .25      6,275
                                                                     Update
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807.31(e)                                      ............................             200                  1             200            .50        100
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Total Year 2 and 3 Burden Hours                                                                                                                    9,450
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 2415]]


                                                     Table 2.--Estimated Annual Recordkeeping Burden
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                                                                              Annual Frequency     Total Annual         Hours Per
                  21 CFR Section                     No. of  Recordkeepers    per Recordkeeper       Records          Recordkeeper        Total Hours
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807.31                                                               16,200                  4             64,800                 .50             32,400
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Total Burden Hours                                                                                                                                32,400
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    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 tables 1A, 1B, and 2 of this document 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 tables 1A, 1B, and 2 of this document.
    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: January 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-676 Filed 1-12-05; 8:45 am]

BILLING CODE 4160-01-S