Federal Register: December 27, 2005 (Volume 70, Number 247)
DOCID: FR Doc E5-7804
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket ID: [Docket No. 2005N-0350]
DOCUMENT ACTION: Notice.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Reclassification Petitions for Medical Devices
DATES: Fax written comments on the collection of information by January 26, 2006.
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.
Agency information collection activities; proposals, submissions, and approvals,
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(OMB Control Number 09100138)Extension
FDA has the responsibility under sections 513(e), 513(f), 514(b), 515(b), and 520(l) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360c(e), 360c(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, II, and III) to another class. The reclassification content 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.
Respondents are device manufacturers seeking reclassification.
In the Federal Register of September 14, 2005 (70 FR 54392), FDA
published a 60day notice requesting public comment on the information collection provisions. No comments were received.
Table 1.Estimated Annual Reporting Burden\1\ No. of Annual Frequency per Total Annual Hours per 21 CFR Section Respondents 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. [[Page 76462]]
Based on current trends 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 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: December 8, 2005.
Assistant Commissioner for Policy.
[FR Doc. E57804 Filed 122305; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Denver Presley, Office of Management Programs (HFA250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 3018271472.