[Federal Register Volume 67, Number 140 (Monday, July 22, 2002)]
[Notices]
[Pages 47818-47819]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-18463]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0309]


Agency Information Collection Activities; Proposed Collection; 
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 an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing information 
collection, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
requirements for reclassification petitions for medical devices.

DATES: Submit written and electronic comments on the collection of 
information by September 20, 2002.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

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: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

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 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

[[Page 47819]]

of premarket approval for class III devices.
    Description of respondents: Device manufacturers.
    FDA estimates the burden of this collection of information as 
follows:

             Table 1.--Estimated Annual Reporting Burden\1\
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                                    Annual
                        No. of    Frequency    Total      Hours    Total
   21 CFR Section    Respondents     per       Annual      per     Hours
                                   Response  Responses  Response
------------------------------------------------------------------------
860.123                     6           1          6       500    3,000
Totals                                                            3,000
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\1\There are no capital costs or operating and maintenance costs
  associated with this collection of information.

    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 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: July 15, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-18463 Filed 7-19-02; 8:45 am]
BILLING CODE 4160-01-S