[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\
------------------------------------------------------------------------
                                    Annual
 21 CFR   FDA Form      No. of    Frequency    Total      Hours    Total
Section      No.     Respondents      of       Annual      per     Hours
                                   Response  Responses  Response
------------------------------------------------------------------------
807.22(  2891        2,900        1          2,900      .25       725
 a) and  Establishm
 807.40   ent of
          Registrat
          ion
------------------------------------------------------------------------
807.22(  2892        4,400        1          4,400      .50       2,200
 b)       Medical
          Device
          Listing
------------------------------------------------------------------------
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    ..........  ...........  .........  .........  ........  9,300
 Year 1
Burden
 Hours
------------------------------------------------------------------------
\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
------------------------------------------------------------------------
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
------------------------------------------------------------------------
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
------------------------------------------------------------------------
807.31    16,200          4              64,800    .50            32,400
------------------------------------------------------------------------
Total     ..............  .............  ........  .............  32,400
 Burden
 Hours
------------------------------------------------------------------------
\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