Agency Information Collection Activities; Proposed Collection; Comment Request; Premarket Notification, 44130-44132 [2013-17554]
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44130
Federal Register / Vol. 78, No. 141 / Tuesday, July 23, 2013 / Notices
status of the application. With the
concurrence of the applicant, a different
schedule may be established.
Prior to this meeting, FDA must
inform the applicant in writing of any
identified deficiencies and what
information is required to correct those
deficiencies. FDA must also promptly
notify the applicant if FDA identifies
additional deficiencies or of any
additional information required to
complete Agency review.
Recordkeeping:
§ 814.82(a)(5) and (a)(6)—Maintenance
of records
The recordkeeping burden under this
section requires the maintenance of
records, used to trace patients and the
organization and indexing of records
into identifiable files to ensure the
device’s continued safety and
effectiveness. These records are required
of all applicants who have an approved
PMA.
PMAs have been required since 1976,
and there are 556 active PMAs that
could be subject to these requirements,
based on actual FDA data, and
approximately 25 new PMAs are
approved every year. The aggregate
burden for the estimated 600 PMA
holders of approved original PMAs for
the next few years is estimated to be
10,200 hours.
The applicant determines which
records should be maintained during
product development to document and/
or substantiate the device’s safety and
effectiveness. Records required by the
current good manufacturing practices
for medical devices regulation (part 820)
may be relevant to a PMA review and
may be submitted as part of an
application. In individual instances,
records may be required as conditions of
approval to ensure the device’s
continuing safety and effectiveness.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN1
Number of
respondents
Activity/21 CFR or FD&C act section
Research conducted outside the United States (814.15(b))
PMA application (814.20) ....................................................
PMA amendments and resubmitted PMAs (814.37(a)–(c)
and (e)) .............................................................................
PMA supplements (814.39(a)) .............................................
Special PMA supplement—changes being affected
(814.39(d)) ........................................................................
30-day notice (814.39(f)) .....................................................
Postapproval requirements (814.82(a)(9)) ...........................
Periodic reports (814.84(b)) .................................................
Agreement meeting (520(g)(7)) ...........................................
Expedited review request (515(d)(5) of the FD&C Act) ......
Determination Meeting (513(1)(3)(D) of the FD&C Act) ......
Panel meeting (515(c)(3) of the FD&C Act) ........................
Day 100 meeting (515(d)(3) of the FD&C Act) ...................
Total ..............................................................................
1 There
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
25
40
1
1
25
40
2
668
50
26,720
120
650
1
1
120
650
167
60
20,040
39,000
80
1,500
230
600
3
5
5
10
10
1
1
1
1
1
1
1
1
1
80
1,500
230
600
3
5
5
10
10
6
16
135
10
50
10
50
30
10
480
24,000
31,050
6,000
150
50
250
300
100
........................
........................
........................
........................
148,190
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN1
Activity/21 CFR section
Number of
recordkeepers
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeping
Total hours
Maintenance of records (814.82(a)(5) and (a)(6)) ...............
600
1
600
17
10,200
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. 2013–17549 Filed 7–22–13; 8:45 am]
ehiers on DSK2VPTVN1PROD with NOTICES
BILLING CODE 4160–01–P
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.
15:40 Jul 22, 2013
Jkt 229001
PO 00000
Frm 00039
Fmt 4703
Submit either electronic or
written comments on the collection of
information by September 23, 2013.
DATES:
The Food and Drug
Administration (FDA) is announcing an
SUMMARY:
VerDate Mar<15>2010
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.
Sfmt 4703
E:\FR\FM\23JYN1.SGM
23JYN1
Federal Register / Vol. 78, No. 141 / Tuesday, July 23, 2013 / Notices
Submit electronic
comments on the collection of
information to https://
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.
ADDRESSES:
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, daniel.gittleson@fda.hhs.gov.
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.
ehiers on DSK2VPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
VerDate Mar<15>2010
15:40 Jul 22, 2013
Jkt 229001
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 § 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 § 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 § 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 § 807.93 (510(k) statement). If the
PO 00000
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44131
510(k) submitter includes a 510(k)
statement in the 510(k) submission,
§ 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 § 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 § 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:
E:\FR\FM\23JYN1.SGM
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44132
Federal Register / Vol. 78, No. 141 / Tuesday, July 23, 2013 / Notices
Number of responses per respondent
Number of
respondents
Activity/21 CFR part/section/form No.
Total annual responses
Average burden
per response
308,100
978
Total hours
510(k) submission (807 subpart E) .................
Summary cover sheet (807.87) and FDA 3514
3,900
1,956
1
1
3,900
1,956
Status request (807.90(a)(3)) and FDA 3541 ..
218
1
218
Standards (807.87(d) and (f)); FDA 3654 .......
510(k) summary and statement (807.92 and
807.93) .........................................................
2,700
1
2,700
79
0.5
(30 minutes)
0.25
(15 minutes)
10
225
10
2,250
10
22,500
Total ..........................................................
............................
............................
............................
............................
358,633
1 There
[FR Doc. 2013–17554 Filed 7–22–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0001]
Food Advisory Committee; Notice of
Meeting
Food and Drug Administration,
HHS.
ehiers on DSK2VPTVN1PROD with NOTICES
ACTION:
27,000
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.
AGENCY:
55
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Food Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 23 and 24, 2013,
from 8:30 a.m. to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993.
Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
Oak Campus.’’ Please note that visitors
to the White Oak Campus must enter
through Building 1.
Contact Person: Karen Strambler,
Center for Food Safety and Applied
Nutrition (CFSAN), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740,
VerDate Mar<15>2010
15:40 Jul 22, 2013
Jkt 229001
FoodAdvisoryCommittee@fda.hhs.gov,
240–402–2589 or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). A notice in the
Federal Register about last minute
modifications that impact a previously
announced advisory committee meeting
cannot always be published quickly
enough to provide timely notice.
Therefore, you should always check the
Agency’s Web site at https://
www.fda.gov/AdvisoryCommittees/
default.htm and scroll down to the
appropriate advisory committee meeting
link, or call the advisory committee
information line to learn about possible
modifications before coming to the
meeting.
Agenda: On September 23 and 24,
2013, the Food Advisory Committee
will meet to discuss detection signals
for noteworthy chemical hazards in
foods, dietary supplements, and
cosmetics and consider possible sources
of information, data on chemical
hazards, and how CFSAN might
recognize and best take advantage of
those data.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its Web site prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s Web site after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before September 16, 2013.
Oral presentations from the public will
be scheduled between approximately 11
PO 00000
Frm 00041
Fmt 4703
Sfmt 9990
a.m. to 12 p.m. on September 24, 2013.
Those individuals interested in making
formal oral presentations should notify
the contact person and submit a brief
statement of the general nature of the
evidence or arguments they wish to
present, the names and addresses of
proposed participants, and an
indication of the approximate time
requested to make their presentation on
or before August 26, 2013. Time allotted
for each presentation may be limited. If
the number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by September 9, 2013.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with physical
disabilities or special needs. If you
require special accommodations due to
a disability, please contact Karen
Strambler at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: July 17, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–17599 Filed 7–22–13; 8:45 am]
BILLING CODE 4160–01–P
E:\FR\FM\23JYN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 141 (Tuesday, July 23, 2013)]
[Notices]
[Pages 44130-44132]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17554]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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,
daniel.gittleson@fda.hhs.gov.
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:
[[Page 44132]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR part/section/form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
-----------------------------------------------------------------------------------------
Total..................................................... ................ ................ ................ ................ 358,633
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
