[Federal Register Volume 76, Number 219 (Monday, November 14, 2011)]
[Notices]
[Pages 70460-70461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29255]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0776]
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 the information collection
requirements for reclassification petitions for medical devices.
DATES: Submit either electronic or written comments on the collection
of information by January 13, 2012.
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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, (301) 796-5156,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the
[[Page 70461]]
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
Under sections 513(e) and (f), 514(b), 515(b), and 520(l) of the
Federal Food, Drug, and Cosmetic Act (FD&C 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, FDA has responsibility to collect data and information
contained in reclassification petitions. The reclassification
provisions of the FD&C Act allow any person to petition for
reclassification of a device from any of the three classes, i.e., I,
II, and III, to another class. The reclassification procedure
regulation requires the submission of specific data when a manufacturer
is petitioning for reclassification. This includes a ``Supplemental
Data Sheet,'' Form FDA 3427, and a ``Classification Questionnaire,''
Form FDA 3429. Both forms contain a series of questions concerning the
safety and effectiveness of the device type. Further, the
reclassification content regulation (Sec. 860.123) requires the
submission of 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 FD&C 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 applicable
to that device type. If approved, petitions requesting classification
from class III to class II or class I provide an alternative route to
market in lieu of premarket approval for class III devices. If
approved, petitions requesting reclassification from class I or II, to
a different class, may increase requirements.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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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 who: (1) Are familiar with
the requirements for submission of a reclassification petition, (2)
have consulted and advised manufacturers on these requirements, and (3)
have reviewed the documentation submitted.
Dated: November 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29255 Filed 11-10-11; 8:45 am]
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