[Federal Register Volume 63, Number 108 (Friday, June 5, 1998)]
[Notices]
[Pages 30763-30765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-14917]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities: Proposed Collection; 
Comment Request

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, 
and each proposed reinstatement of an existing collection, and to allow 
60 days for public comment in response to the notice. This notice 
solicits comments on premarket notification submission 510(k), subpart 
E, to 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

[[Page 30764]]

introduction into interstate commerce, for commercial distribution of a 
device intended for human use.

DATES: Submit written comments on the collection of information by 
August 4, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

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: 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 reinstatement 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 listed 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.

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


[[Page 30765]]

    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: May 28, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-14917 Filed 6-4-98; 8:45 am]
BILLING CODE 4160-01-F