Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification, 14223-14224 [2017-05300]
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Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Information collection activity
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Hours per
response
Total hours
Voluntary Genomic Data Submissions ................................
1
1
1
50
50
1
There are no capital costs or operating and maintenance costs associated with this collection.
Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
Premarket Notification—21 CFR Part
807, Subpart E
[FR Doc. 2017–05293 Filed 3–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0804]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Notification
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 17,
2017.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0120. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
20:02 Mar 16, 2017
Jkt 241001
OMB Control Number 0910–0120—
Reinstatement
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) require 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) (21 CFR
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
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
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
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
E:\FR\FM\17MRN1.SGM
17MRN1
14224
Federal Register / Vol. 82, No. 51 / Friday, March 17, 2017 / Notices
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.
In the Federal Register of November
18, 2016 (81 FR 81772), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Activity and 21 CFR part/section
Form FDA No.
510(k) submission (807 subpart E) ......
Summary cover sheet (807.87) ............
Status request (807.90(a)(3)) ...............
Standards (807.87(d) and (f)) ...............
510(k) statement (807.93) ....................
........................
3514
3541
3654
........................
3,900
1,956
218
2,700
225
1
1
1
1
10
3,900
1,956
218
2,700
2,250
79 .....................
.5 (30 minutes)
.25 (15 minutes)
10 .....................
10 .....................
308,100
978
55
27,000
22,500
Total ...............................................
........................
........................
........................
........................
...........................
358,633
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0762. Also
include the FDA docket number found
in brackets in the heading of this
document.
[FR Doc. 2017–05300 Filed 3–16–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
[Docket No. FDA–2013–D–0117]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Providing
Information About Pediatric Uses of
Medical Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by April 17,
2017.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
ADDRESSES:
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Total hours
VerDate Sep<11>2014
20:02 Mar 16, 2017
Jkt 241001
Providing Information About Pediatric
Uses of Medical Devices Under Section
515A of the Federal Food, Drug, and
Cosmetic Act
OMB Control Number 0910–0762—
Extension
The guidance document entitled
‘‘Providing Information About Pediatric
Uses of Medical Devices—Guidance for
Industry and Food and Drug
Administration Staff’’ suggests that
applicants who submit certain medical
device applications include, if readily
available, pediatric use information for
diseases or conditions that the device is
being used to treat, diagnose, or cure
that are outside the device’s approved or
proposed indications for use, as well as
an estimate of the number of pediatric
patients with such diseases or
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
conditions. The information submitted
will allow FDA to identify pediatric
uses of devices outside their approved
or proposed indication for use to
determine areas where further pediatric
device development could be useful.
This recommendation applies to
applicants who submit the following
applications: (1) Any request for a
humanitarian device exemption
submitted under section 520(m) of the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 360j(m)); (2)
any premarket approval application
(PMA) or supplement to a PMA
submitted under section 515 of the
FD&C Act (21 U.S.C. 360e); and (3) any
product development protocol
submitted under section 515 of the
FD&C Act.
Respondents are permitted to submit
information relating to uses of the
device outside the approved or
proposed indication if such uses are
described or acknowledged in
acceptable sources of readily available
information. We estimate that 20
percent of respondents submitting
information required by section 515A of
the FD&C Act will choose to submit this
information and that it will take 30
minutes for them to do so.
In the Federal Register of December 5,
2016 (81 FR 87575), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
E:\FR\FM\17MRN1.SGM
17MRN1
]]>Agencies
[Federal Register Volume 82, Number 51 (Friday, March 17, 2017)]
[Notices]
[Pages 14223-14224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05300]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0804]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket
Notification
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by April
17, 2017.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0120.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North 10A63, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Premarket Notification--21 CFR Part 807, Subpart E
OMB Control Number 0910-0120--Reinstatement
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) require 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) (21 CFR 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
[[Page 14224]]
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.
In the Federal Register of November 18, 2016 (81 FR 81772), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity and 21 CFR part/section Form FDA No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) submission (807 subpart E)...... .............. 3,900 1 3,900 79............................. 308,100
Summary cover sheet (807.87)........... 3514 1,956 1 1,956 .5 (30 minutes)................ 978
Status request (807.90(a)(3)).......... 3541 218 1 218 .25 (15 minutes)............... 55
Standards (807.87(d) and (f)).......... 3654 2,700 1 2,700 10............................. 27,000
510(k) statement (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: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05300 Filed 3-16-17; 8:45 am]
BILLING CODE 4164-01-P
