[Federal Register: December 4, 2008 (Volume 73, Number 234)]
[Notices]
[Page 73938-73939]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04de08-42]
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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