[Federal Register Volume 67, Number 200 (Wednesday, October 16, 2002)]
[Notices]
[Page 63932]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-26329]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0309]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Reclassification Petitions for 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 and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
November 15, 2002.

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: 
Stuart Shapiro, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy 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 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Reclassification Petitions for Medical Devices--21 CFR 860.123 (OMB 
Control Number 0910-0138)--Extension

    FDA has the responsibility under sections 513(e) and (f), 514(b), 
515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360c(e) and (f), 360d(b), 360e(b), and 360j(l)) and 
part 860 (21 CFR part 860), subpart C, to collect data and information 
contained in reclassification petitions. The reclassification 
provisions of the act allow any person to petition for reclassification 
of a device from any one of the three classes (I, II, and III) to 
another class. The reclassification content regulation (Sec.  860.123) 
requires the submission of sufficient, valid scientific evidence 
demonstrating that the proposed classification will provide a 
reasonable assurance of safety and effectiveness of the device for its 
intended use. The reclassification provisions of the act serve 
primarily as a vehicle for manufacturers to seek reclassification from 
a higher to a lower class, thereby reducing the regulatory requirements 
applicable to a particular device. The reclassification petitions 
requesting classification from class III to class II or class I, if 
approved, provide an alternative route to the market in lieu of 
premarket approval for class III devices.
    Description of respondents: Device manufacturers.
    FDA estimates the burden of this collection as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                                                    Annual Frequency    Total Annual     Hours per
       21 CFR Section         No. of Respondents      per Response        Responses      response    Total Hours
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860.123                               6                    1                 6            500        3,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on current trends and actual reclassification petitions 
received, FDA anticipates that six petitions will be submitted each 
year. The time required to prepare and submit a reclassification 
petition, including the time needed to assemble supporting data, 
averages 500 hours per petition. This average is based upon estimates 
by FDA administrative and technical staff who are familiar with the 
requirements for submission of a reclassification petition, have 
consulted and advised manufacturers on these requirements, and have 
reviewed the documentation submitted.

    Dated: October 9, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-26329 Filed 10-15-02; 8:45 am]
BILLING CODE 4160-01-S