[Federal Register Volume 73, Number 234 (Thursday, December 4, 2008)]
[Notices]
[Pages 73938-73939]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28695]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0607]


Agency Information Collection Activities; Proposed Collection; 
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 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 February 2, 2009.

ADDRESSES:  Submit electronic comments on the collection of information 
to  http://www.regulations.gov. 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: Denver Presley, Jr.,Office Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3793.

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 Section 860.123 
(OMB Control Number 0910-0138)--Extension

    FDA has responsibility under sections 513(e) and (f), 514(b), 
515(b), and 520(l) of the Federal Food, Drug, and Cosmetic 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.e., 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 reclassification will provide a reasonable assurance of 
safety and effectiveness of the device type for its indications for 
use. Thus, 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 type or to seek reclassification from 
a lower to a higher class, thereby increasing the regulatory 
requirements. The reclassification petitions requesting classification 
from class III to class II or class I, if approved, provides an 
alternative route to the market in lieu of premarket approval for class 
III devices or from class I or II to one or the other class, which may 
increase requirements.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 73939]]



                                                     Table 1.--Estimated Annual Reporting Burden\1\
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                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         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 the last 3 years, 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: November 25, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-28695 Filed 12-3-08; 8:45 am]
BILLING CODE 4160-01-S