[Federal Register Volume 76, Number 219 (Monday, November 14, 2011)]
[Pages 70460-70461]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-29255]



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.


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.

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 

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                                         Number of
                           21 CFR section                               Number of      responses per     Total annual   Average  burden    Total hours
                                                                       respondents       respondent       responses       per response
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 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]