Date: Mon, 13 Dec 1999 21:25:56 -0600

Organization: Microsoft Corporation

Note: Is this just my take or does this "look like a pig and smell like a pig" to you also?

http://www.fda.gov/OHRMS/DOCKETS/98fr/121099e.txt

[Federal Register: December 10, 1999 (Volume 64, Number 237)] [Notices] [Page 69270-69271]

From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr10de99-65]

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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.

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 Jan. 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 Burden<SUP>1</SUP>

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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 theFederal 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