[Federal Register Volume 66, Number 138 (Wednesday, July 18, 2001)]
[Notices]
[Pages 37479-37480]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-17977]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N-0178]


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Premarket Notification 510(k) Submissions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 
August 17, 2001.

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.

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 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

[[Page 37480]]

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.
    In the Federal Register of April 30, 2001 (66 FR 21398), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

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


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                             No. of       Annual frequency    Total annual        Hours per
    21 CFR section        recordkeepers   of recordkeeping       records        recordkeeper       Total hours
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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: July 12, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-17977 Filed 7-17-01; 8:45 am]
BILLING CODE 4160-01-S