[Federal Register: December 27, 2005 (Volume 70, Number 247)]
[Page 76461-76462]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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

    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\
                                                              No. of       Annual Frequency per     Total Annual        Hours per
                    21 CFR Section                         Respondents            Response           Responses           Response         Total Hours
860.123                                                                 6                     1                  6                500              3,000
\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]