[Federal Register Volume 74, Number 44 (Monday, March 9, 2009)]
[Pages 10052-10053]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-4829]



Food and Drug Administration

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

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.

[[Page 10053]]

ACTION: Notice.


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 
8, 2009.

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: 202-395-6974, or e-mailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 0910-0138. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of 
Information Management (HFA-710), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-796-3793.

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 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 (the 
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 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 
are 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 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.
    In the Federal Register of December 4, 2008 (73 FR 73938), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 

                                                     Table 1.--Estimated Annual Reporting Burden\1\
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
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 that: (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 2, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-4829 Filed 3-6-09; 8:45 am]