[Federal Register Volume 64, Number 180 (Friday, September 17, 1999)]
[Notices]
[Pages 50516-50517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24237]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-0407]


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 comments on the collection of information by 
November 16, 1999.
ADDRESSES: 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 below.
    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 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.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 50517]]



                                 Table 1.--Estimated Annual Reporting Burden \1\
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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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860.133                                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.

    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: September 13, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning and Legislation.
[FR Doc. 99-24237 Filed 9-16-99; 8:45 am]
BILLING CODE 4160-01-F