[Federal Register Volume 68, Number 161 (Wednesday, August 20, 2003)]
[Notices]
[Pages 50153-50155]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-21226]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0187]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Postmarket Surveillence of Medical Devices

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

[[Page 50154]]

and Budget (OMB) for review and clearance under the Paperwork Reduction 
Act of 1995.

DATES: Submit written comments on the collection of information by 
September 19, 2003.

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.

Postmarket Surveillance of Medical Devices--21 CFR Part 822 (OMB 
Control Number 0910-0449)--Extension

    Section 522(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360l(a)) authorizes FDA to require manufacturers to 
conduct postmarket surveillance (PS) of any device that meets the 
criteria set forth in the statute.
    The PS regulation in part 822 (21 CFR part 822) establishes 
procedures that FDA uses to approve and disapprove PS plans. The 
regulation provides specific, clear, and flexible instructions to 
manufacturers so they know what information is required in a PS plan 
submission. FDA reviews submissions in accordance with Sec. Sec.  
822.15 through 822.18 (which describe the grounds for approving or 
disapproving a PS plan). If this information is not collected, FDA 
cannot ensure that the PS will result in the collection of useful data 
that can reveal unforeseen adverse events or other information 
necessary to protect the public health.
    Respondents to this collection of information are those 
manufacturers who require PS of their products. As previously stated, 
the collection of data and information under these regulations is 
conducted on a very infrequent basis and only as necessary.
    In the Federal Register of May 15, 2003 (68 FR 26307), 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 as follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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          21 CFR Section              No. of Respondents      No. of Responses     Total Annual Responses     Hours per Response        Total Hours
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822.9 and 822.10                                       5                      1                         5                    120                    600
822.21                                                 2                      1                         2                     40                     80
822.26                                                 1                      1                         1                      8                      8
822.27                                                 1                      1                         1                     40                     40
822.28                                                 1                      1                         1                     40                     40
822.29                                                 1                      1                         1                    120                    120
822.30                                                 1                      1                         1                     40                     40
822.34                                                 1                      1                         1                     20                     20
822.38                                                23                      2                        46                     80                  3,680
Totals                              .....................  .....................  ........................  .....................                 4,628
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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\1\
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                                                         Annual Frequency per
         21 CFR Section           No. of Recordkeepers      Recordkeeping        Total Annual Records     Hours per Recordkeeper        Total Hours
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822.31                                             23                      1                        23                        20                    460
822.32                                             69                      1                        69                        10                    690
Totals                           .....................  .....................  ........................  ........................                 1,150
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates, based on current staffing and resources, only one 
actual PS action and manufacturers' aversion to the stigma of PS over 
the past year. One PS action will be issued for generic devices 
comprising of approximately five manufacturers. Each manufacturer will 
be required to submit a PS plan (Sec. Sec.  822.9 and 822.10) and 
interim and final reports on the progress of the surveillance (Sec.  
822.38). FDA anticipates that, on a case-by-case basis, requests for 
additional information may be made from a manufacturer. FDA expects 
that a small number of respondents will propose changes to their PS 
plans (Sec.  822.21), request a waiver of a specific requirement of 
this regulation (Sec.  822.29), or request exemption from the 
requirement to conduct PS of their device (Sec.  822.30). FDA's 
experience has shown that a few respondents will go out of business 
(Sec.  822.26) or cease marketing the device subject to PS (Sec.  
822.28) each year. In addition, manufacturers must certify transfer of 
records when ownership changes (Sec.  822.34).
    Section 822.25 does not constitute information collections subject 
to review under the PRA because ``* * * they entail no burden other 
than that necessary to identify the respondent, the date, the 
respondent's address, and the nature of the instrument * * *'' (5 CFR 
1320.3(h)(1)).
    FDA expects that at least some of the manufacturers will be able to 
satisfy the PS requirement using information or data they already have. 
For purposes of calculating burden, however, FDA has assumed that each 
PS order can only be satisfied by a 3-year clinically-based 
surveillance plan, using three investigators. These estimates are based 
on FDA's knowledge and experience with limited implementation of 
section 522 of the act under the Safe Medical Devices Act of 1990. 
Therefore, FDA would expect that the recordkeeping requirements would 
apply to a maximum of 23 manufacturers (6 added each year) and 69 
investigators (3 years per surveillance plan). After 3 years,

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FDA would expect these numbers to remain level as the surveillance 
plans conducted under the earliest orders reach completion and new 
orders are issued.

    Dated: August 13, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-21226 Filed 8-19-03; 8:45 am]
BILLING CODE 4160-01-S