[Federal Register Volume 61, Number 236 (Friday, December 6, 1996)]
[Notices]
[Pages 64753-64754]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-31049]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0261]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Reinstatement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES: Submit written comments on the collection of information by 
January 6, 1997.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC, Attn: Desk 
Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Judy Bigelow, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, rm. 16B-19, Rockville, MD 20857, 301-827-1479.

SUPPLEMENTARY INFORMATION: In compliance with section 3507 of the 
Paperwork Reduction Act of 1995 (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 Part 860--
(OMB Control Number 0910-0138--Reinstatement)

    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 21 CFR part 860, subpart C, FDA 
has the responsibility to collect data and information contained in 
reclassification petitions. The reclassification provisions of the act 
allow any person to petition for reclassification of a medical device 
from any one of three classes (I, II, and III) to another class. The 
reclassification procedures regulation (Sec. 860.123) requires the 
submission of sufficient, valid scientific evidence demonstrating that 
the proposed classification will provide a reasonable assurance of 
safety and effectiveness of the device for its intended use. 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. The reclassification petitions requesting classification from 
class III to class II or class I, if approved, provide an alternative 
route to the market in lieu of premarket approval for class III 
devices.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 64754]]



                                        Estimated Annual Reporting Burden                                       
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
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860.123                                11               1              11             500           5,500       
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There are no capital costs or operating and maintenance costs associated with this collection of information.   

    Based on current trends, FDA anticipates that 11 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 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.

    Dated: November 27, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-31049 Filed 12-05-96; 8:45 am]
BILLING CODE 4160-01-F