[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 Burden<SUP>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                   
----------------------------------------------------------------------------------------------------------------
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 Burden<SUP>1                                
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                                                  Annual                                                        
  21 CFR Section      No. of Recordkeepers     Frequency per   Total Annual      Hours per        Total Hours   
                                               Recordkeeping      Records      Recordkeeper                     
----------------------------------------------------------------------------------------------------------------
807.31              7,900                          10          79,000               0.5            39,500       
TOTALS                                                                                             39,500       
----------------------------------------------------------------------------------------------------------------
\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