[Federal Register Volume 70, Number 247 (Tuesday, December 27, 2005)]
[Notices]
[Pages 76461-76462]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-7804]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0350]


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

DATES: Fax written comments on the collection of information by January 
26, 2006.

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 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: Denver Presley, Office of Management 
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1472.

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--(OMB Control Number 
0910-0138)--Extension

    FDA has the responsibility under sections 513(e), 513(f), 514(b), 
515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360c(e), 360c(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.
    Respondents are device manufacturers seeking reclassification.
    In the Federal Register of September 14, 2005 (70 FR 54392), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of       Annual Frequency per     Total Annual        Hours per
                    21 CFR Section                         Respondents            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.


[[Page 76462]]

    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 that 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: December 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-7804 Filed 12-23-05; 8:45 am]
BILLING CODE 4160-01-S