[Federal Register Volume 63, Number 198 (Wednesday, October 14, 1998)]
[Notices]
[Pages 55132-55133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27493]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0494]


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

DATES:  Submit written comments on the collection of information by 
November 13, 1998.

ADDRESSES:  Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:  Margaret R. Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION:  In compliance with section 3507 of the PRA 
(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 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, the owner or operator must be prepared to submit to FDA 
upon specific request all labeling and advertising mentioned in the 
previous paragraph (Sec. 807.31(e)).
     The information collected through these provisions is used by FDA 
to identify firms subject to the agency's regulations and is used to 
identify geographic distribution in order to effectively allocate its 
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.
     In the Federal Register of July 16, 1998 (63 FR 38409), the agency 
requested comments on the proposed collections of information. No 
significant comments were received.
     FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
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                                                      Annual
   21 CFR          FDA Form           No. of       Frequency per   Total Annual      Hours per      Total Hours
   Section                          Respondents      Response        Responses       Response
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807.22(a)     Form 2891--Initial    1,462               1           1,462                .25          366
               Establishment,
               Registration
807.22(b)     Form 2892--Device     5,640               1           5,640                .50        2,820
               Listing (initial
               and update)
807.22(a)     Form 2891(a)--       22,000               1          22,000                .25        5,500
               Registration
               Update
807.31(e)                             200               1             200                .50          100
Total                                                                                               8,786
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 55133]]


                                Table 2.--Estimated Annual Recordkeeping Burden1
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                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper
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807.31                              7,900              10          79,000               0.5        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 Tables 1 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) 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: October 6, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-27493 Filed 10-13-98; 8:45 am]
BILLING CODE 4160-01-F