[Federal Register Volume 63, Number 169 (Tuesday, September 1, 1998)]
[Notices]
[Pages 46462-46463]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-23402]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0336]


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

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 (the PRA).

DATES: Submit written comments on the collection of information by 
October 1, 1998.

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: 
Desk Officer for FDA.


[[Page 46463]]


FOR FURTHER INFORMATION CONTACT: Margaret R. 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 section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

Premarket Notification Submission 510(k), Subpart E--(OMB Control 
Number 0910-0120--Reinstatement)

     Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360(k)) and the implementing regulation, 21 CFR 807.81, 
require a person/manufacturer 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.
     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 or 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 named in order of the physician 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 and 
will not violate the subject's rights. The respondents to this 
information collection will primarily be medical device manufacturers 
and businesses.
     FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
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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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807.81 and 807.87                   5,000               1           5,000              80         400,000       
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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 Burden1                                
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                                                      Annual                                                    
         21 CFR Section               No. of       Frequency 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       
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\2\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. Based on the trend 
in the past 3 years, an estimated 5,000 submissions are expected each 
year. FDA's administrative and technical staff, who are familiar with 
the requirements for submission of premarket notifications, estimate 
that an average of 80 hours are required to prepare a submission 
(exclusive of preparing clinical data, research, etc.). FDA, therefore, 
estimates that a total of 400,000 hours of effort is required for the 
5,000 submissions. It is also estimated that the respondents will 
receive requests for an average of 20,000 documents. At an estimated 
one-half hour to process these documents, an additional 10,000 
recordkeeping hours are expected for this program.

    Dated: August 24, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-23402 Filed 8-31-98; 8:45 am]
BILLING CODE 4160-01-F