Document ID: FDA-2011-N-0776-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Reclassification Petitions for Medical Devices
Posted Date: 2012-03-26T04:00Z

[Federal Register Volume 77, Number 58 (Monday, March 26, 2012)]
[Notices]
[Pages 17483-17484]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-7142]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0776]

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.

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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 April 
25, 2012.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0138 and 
also include the FDA 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, 
Daniel.Gittleson@fda.hhs.gov.

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--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

[[Page 17484]]

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.
    In the Federal Register of November 14, 2011 (76 FR 70460), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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: March 20, 2012.
David Dorsey,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2012-7142 Filed 3-23-12; 8:45 am]
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