[Federal Register Volume 66, Number 83 (Monday, April 30, 2001)]
[Notices]
[Pages 21398-21399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-10624]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0178]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Premarket Notification 510(k) Submissions

<BD>AGENCY: <RM>Food and Drug Administration, HHS.

<BD>ACTION: <RM>Notice.

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<BD>SUMMARY: <RM>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 
<CS>Federal Register <RM>concerning each proposed collection of 
information, including each proposed extension of an existing 
collection of information, and to allow 60 days for public comment in 
response to the notice. This notice solicits comments on information 
collection requirements for premarket notification 510(k) submissions.

<BD>DATES: <RM>Submit written or electronic comments on the collection 
of information by June 29, 2001.

<BD>ADDRESSES: <RM>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.

<BD>FOR FURTHER INFORMATION CONTACT: <RM>Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

<BD>SUPPLEMENTARY INFORMATION: <RM>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 <CS>Federal Register <RM>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.

Premarket Notification 510(k) Submissions (21 CFR Part 807) (OMB 
Control No. 0910-0120)--Extension

    Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360(k)) requires a person who intends to market a 
medical device to submit a premarket notification submission to FDA at 
least 90 days before proposing to begin the introduction, or delivery 
for introduction into interstate commerce, for commercial distribution 
of a device intended for human use. The definition of ``person'' has 
been expanded to include hospitals who reuse or remanufacture single-
use medical devices. The estimated submissions below include those 
submitted by hospitals remanufacturing single-use medical devices.
    Section 510(k) of the act allows for exemptions to the 510(k) 
submissions (i.e., a premarket notification submission would not be 
required if FDA determines that premarket notification is not necessary 
for the protection of the public health, and they are specifically 
exempted through the regulatory process). Under 21 CFR 807.85, 
``Exemption from premarket notification,'' a device is exempt from 
premarket notification if the device intended for introduction into 
commercial distribution is not generally available in finished form for 
purchase and is not offered through labeling and advertising by the 
manufacturer, importer, or distributor for commercial distribution. In 
addition, the device must meet one of the following

[[Page 21399]]

conditions: (1) It is intended for use by a patient or dentist (or 
other specially qualified persons), or (2) it is intended solely for 
use by a physician or dentist and is not generally available to other 
physicians or dentists.
    A commercial distributor who places a device into commercial 
distribution for the first time under their own name and a repackager 
who places their own name on a device, and does not change any other 
labeling or otherwise affect the device, shall be exempted from 
premarket notification if the device was legally in commercial 
distribution before May 28, 1976, or a premarket notification was 
submitted by another person.
    The information collected in a premarket notification is used by 
the medical, scientific, and engineering staffs of FDA in making 
determinations as to whether or not devices can be allowed to enter the 
U.S. market. The premarket notification review process allows for 
scientific and/or medical review of devices, subject to section 510(k) 
of the act, to confirm that the new devices are as safe and as 
effective as legally marketed predicate devices. This review process, 
therefore, prevents potentially unsafe and/or ineffective devices, 
including those with fraudulent claims, from entering the U.S. market. 
This information will allow FDA to collect data to ensure that the use 
of the device will not present an unreasonable risk for the subject's 
rights. The respondents to this information collection will primarily 
be medical device manufacturers and businesses.
    FDA Form 3514 was developed to assist respondents in organizing 
510(k) data for submission to FDA. This form also assists respondents 
in organizing and submitting data for other FDA medical device programs 
such as premarket approval applications, investigational device 
exemptions, and humanitarian device exemptions.
    FDA estimates the burden of this collection of information as 
follows:

                                                     <CS>Table 1.--Estimated Annual Reporting Burden\1\<RM>
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                                                                     No. of       Annual Frequency    Total Annual        Hours per
               21 CFR Section                     Form No.         Respondents       per Response       Responses         Response         Total Hours
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807.81 and 807.87 (part 807, subpart E)                            4,000                 1             4,000                80           320,000
                                              FDA 3514             2,000                 1             2,000                  .5           1,000
                                                                                                                                       -----------------
  Total                                                                                                                                  321,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


                               <CS>Table 2.--Estimated Annual Recordkeeping Burden\1\<RM>
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                                          Annual Frequency
    21 CFR Section           No. of              per          Total Annual        Hours per        Total Hours
                          Recordkeepers     Recordkeeping        Records        Recordkeeper
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807.93                     2,000                10            20,000                 0.5          10,000
                                                                                               -----------------
  Total                                                                                           10,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    FDA has based these estimates on conversations with industry and 
trade association representatives, and from internal review of the 
documents listed in tables 1 and 2 of this document. The total burden 
for using voluntary FDA Form 3514 is estimated to be approximately 
1,000 hours and has been included in this information collection. Once 
this information collection has been approved, the burden for FDA Form 
3514 will be reported and approved in each of the following OMB 
information collections: 0910-0078, Investigational Device Exemption 
Reports and Records; 0910-0231, Premarket Approval of Medical Devices; 
and 0910-0332, Medical Devices, Humanitarian Devices.

    Dated: April 24, 2001.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 01-10624 Filed 4-27-01; 8:45 am]
BILLING CODE 4160-01-S