[Federal Register Volume 78, Number 141 (Tuesday, July 23, 2013)]
[Notices]
[Pages 44130-44132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17554]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0804]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Premarket Notification
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,
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 medical device premarket
notification.
DATES: Submit either electronic or written comments on the collection
of information by September 23, 2013.
[[Page 44131]]
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (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.
FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
[email protected].
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 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 these topics: (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--21 CFR Part 807, Subpart E (OMB Control Number
0910-0120)--Extension
Section 510(k) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 360(k)) and the implementing regulation under part
807 (21 CFR part 807, subpart E) 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. Based on the
information provided in the notification, FDA must determine whether
the new device is substantially equivalent to a legally marketed
device, as defined in Sec. 807.92(a)(3). If the device is determined
to be not substantially equivalent to a legally marketed device, it
must have an approved premarket approval application (PMA), Product
Development Protocol, Humanitarian Device Exemption (HDE), Petition for
Evaluation of Automatic Class III Designation (de novo), or be
reclassified into class I or class II before being marketed. FDA makes
the final decision of whether a device is substantially equivalent or
not equivalent.
Section 807.81 states when a premarket notification is required. A
premarket notification is required to be submitted by a person who is:
(1) Introducing a device to the market for the first time; (2)
introducing a device into commercial distribution for the first time by
a person who is required to register; and (3) introducing or
reintroducing a device which is significantly changed or modified in
design, components, method of manufacturer, or the intended use that
could affect the safety and effectiveness of the device.
Form FDA 3514, a summary cover sheet form, assists respondents in
categorizing administrative 510(k) information for submission to FDA.
This form also assists respondents in categorizing information for
other FDA medical device programs such as PMAs, investigational device
exemptions, and HDEs. Under Sec. 807.87(h), each 510(k) submitter must
include in the 510(k) either a summary of the information in the 510(k)
as required by Sec. 807.92 (510(k) summary) or a statement certifying
that the submitter will make available upon request the information in
the 510(k) with certain exceptions as per Sec. 807.93 (510(k)
statement). If the 510(k) submitter includes a 510(k) statement in the
510(k) submission, Sec. 807.93 requires that the official
correspondent of the firm make available within 30 days of a request
all information included in the submitted premarket notification on
safety and effectiveness. This information will be provided to any
person within 30 days of a request if the device described in the
510(k) submission is determined to be substantially equivalent. The
information provided will be a duplicate of the 510(k) submission
including any safety and effectiveness information, but excluding all
patient identifiers and trade secret and commercial confidential
information.
Section 204 of the Food and Drug Administration Modernization Act
(FDAMA) (Pub. L. 105-115) amended section 514 of the FD&C Act (21
U.S.C. 360d). Amended section 514 allows FDA to recognize consensus
standards developed by international and national organizations for use
in satisfying portions of device premarket review submissions including
premarket notifications or other requirements. FDA has published and
updated the list of recognized standards regularly since enactment of
FDAMA and has allowed 510(k) submitters to certify conformance to
recognized standards to meet the requirements of Sec. 807.87. Form FDA
3654, the 510(k) Standards Data Form, standardizes the format for
submitting information on consensus standards that a 510(k) submitter
chooses to use as a portion of their premarket notification submission
(Form FDA 3654 is not for declarations of conformance to a recognized
standard). FDA believes that use of this form will simplify the 510(k)
preparation and review process for 510(k).
Under Sec. 807.90, submitters may request information on their
510(k) review status 90 days after the initial login date of the
510(k). Thereafter, the submitter may request status reports every 30
days following the initial status request. To obtain a 510(k) status
report, the submitter should complete the status request form, Form FDA
3541, and fax it to the Center for Devices and Radiological Health
office identified on the form.
The most likely respondents to this information collection will be
specification developers and medical device manufacturers.
FDA estimates the burden of this collection of information as
follows:
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Number of
Activity/21 CFR part/section/form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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510(k) submission (807 subpart E)............................. 3,900 1 3,900 79 308,100
Summary cover sheet (807.87) and FDA 3514..................... 1,956 1 1,956 0.5 978
(30 minutes)
Status request (807.90(a)(3)) and FDA 3541.................... 218 1 218 0.25 55
(15 minutes)
Standards (807.87(d) and (f)); FDA 3654....................... 2,700 1 2,700 10 27,000
510(k) summary and statement (807.92 and 807.93).............. 225 10 2,250 10 22,500
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Total..................................................... ................ ................ ................ ................ 358,633
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: July 16, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-17554 Filed 7-22-13; 8:45 am]
BILLING CODE 4160-01-P