[Federal Register Volume 64, Number 237 (Friday, December 10, 1999)]
[Notices]
[Pages 69270-69271]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32000]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0407]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Reclassification Petitions for Medical Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

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 10, 2000.

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 20503, Attn: 
Wendy Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

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)

     FDA has the 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 medical device from any one of three classes (I, II, and III) to 
another class. The reclassification procedures (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.
     In the Federal Register of September 17, 1999 (64 FR 50516), the 
agency requested comments on the proposed collections of information. 
No significant comments were received.
     FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
                                                      Annual
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours
                                    Respondents      Response        Responses       Response
----------------------------------------------------------------------------------------------------------------
860.123                                11               1              11             500           5,500
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


[[Page 69271]]

     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.
    In addition, FDA is correcting a document that appeared in the 
Federal Register of Friday, September 17, 1999 (64 FR 50516). On page 
50517, in Table 1 of the document, ``860.133'' is corrected to read 
``860.123''.

    Dated: December 3, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-32000 Filed 12-9-99; 8:45 am]
BILLING CODE 4160-01-F