[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 Burden1
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Respondents Response Responses Response
----------------------------------------------------------------------------------------------------------------
807.81 and 807.87 5,000 1 5,000 80 400,000
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden1
----------------------------------------------------------------------------------------------------------------
Annual
21 CFR Section No. of Frequency per Total Annual Hours per Total Hours
Recordkeepers Recordkeeping Records Response
----------------------------------------------------------------------------------------------------------------
807.93 2,000 10 20,000 0.5 10,000
----------------------------------------------------------------------------------------------------------------
\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