[Federal Register: September 14, 2005 (Volume 70, Number 177)]
[Page 54392-54393]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2005N-0350]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Reclassification Petitions for Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on reclassification petitions for 
medical devices.

DATES: Submit written or electronic comments on the collection of 
information by November 14, 2005.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Submit written comments on 

the collection of information to the Division of Dockets Management 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Reclassification Petitions for Medical Devices--21 CFR 860.123 (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.
    FDA estimates the burden of this collection of information as 

[[Page 54393]]

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

    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: September 7, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-18221 Filed 9-13-05; 8:45 am]