[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]
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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.
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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 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
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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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\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