[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
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
