Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Premarket Notification, 64220-64221 [2013-25298]
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64220
Federal Register / Vol. 78, No. 208 / Monday, October 28, 2013 / Notices
The above estimates for respondents
and numbers of responses are based on
the annualized numbers of petitions and
notifications qualifying for § 25.32(i)
and (q) that the Agency has received in
the past 3 years. Please note that, in the
past 3 years, there have been no
submissions that requested an action
that would have been subject to the
categorical exclusion in § 25.32(o). To
avoid counting this burden as zero, we
have estimated the burden for this
categorical exclusion at one respondent
making one submission a year for a total
of one annual submission.
To calculate the estimate for the hours
per response values, we assumed that
the information requested in this
guidance for each of these three
categorical exclusions is readily
available to the submitter. For the
information requested for the exclusion
in § 25.32(i), we expect that submitter
will need to gather information from
appropriate persons in the submitter’s
company and to prepare this
information for attachment to the claim
for categorical exclusion. We believe
that this effort should take no longer
than 1 hour per submission. For the
information requested for the exclusions
in § 25.32(o) and (q), the submitters will
almost always merely need to copy
existing documentation and attach it to
the claim for categorical exclusion. We
believe that collecting this information
should also take no longer than 1 hour
per submission.
Dated: October 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–25300 Filed 10–25–13; 8:45 am]
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; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Notification
AGENCY:
Food and Drug Administration,
wreier-aviles on DSK5TPTVN1PROD with NOTICES
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.
SUMMARY:
VerDate Mar<15>2010
14:52 Oct 25, 2013
Jkt 232001
Fax written comments on the
collection of information by November
27, 2013.
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.
DATES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
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:
Premarket Notification—(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
PO 00000
Frm 00027
Fmt 4703
Sfmt 4703
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
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)
E:\FR\FM\28OCN1.SGM
28OCN1
Federal Register / Vol. 78, No. 208 / Monday, October 28, 2013 / Notices
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.
64221
In the Federal Register of July 23,
2013 (78 FR 44130), 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
respondents
Activity/21 CFR part/Section/Form No.
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
510(k) submission (807 subpart E) .......................
Summary cover sheet (807.87) and FDA 3514 ....
Status request (807.90(a)(3)) and FDA 3541 .......
Standards (807.87(d) and (f)); FDA 3654 .............
510(k) summary and statement (807.92 and
807.93).
3,900
1,956
218
2,700
225
1
1
1
1
10
3,900
1,956
218
2,700
2,250
79 .................................
0.5 (30 minutes) ...........
0.25 (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: October 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–25298 Filed 10–25–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
wreier-aviles on DSK5TPTVN1PROD with NOTICES
CDC/HRSA Advisory Committee on
HIV, Viral Hepatitis and STD Prevention
and Treatment; Notice of Meeting
In accordance with section l0(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following virtual committee
meeting.
Name: CDC/HRSA Advisory
Committee on HIV, Viral Hepatitis and
STD Prevention and Treatment
Dates and Times: November 13, 2013,
10:00 a.m.–4:30 p.m. November 14,
2013, 10:00 a.m.–12:30 p.m.
Place: This meeting is accessible via
audio conference call and Adobe
Connect Pro.
Status: This meeting is open to the
public. The available lines will
accommodate approximately 300
people.
Purpose: This Committee is charged
with advising the Director, CDC, and the
Administrator, HRSA, regarding
activities related to prevention and
control of HIV/AIDS, Viral Hepatitis and
other STDs, the support of health care
services to persons living with HIV/
AIDS, and education of health
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14:52 Oct 25, 2013
Jkt 232001
professionals and the public about HIV/
AIDS, Viral Hepatitis, and other STDs.
Agenda: Agenda items include: (1)
Affordable Care Act (ACA) Updates; (2)
Clinical Workforce Issues; and (3) CHAC
Workgroup Updates. Agenda items are
subject to change as priorities dictate.
To register for this event, please go to
the following link: https://
hrsa.connectsolutions.com/
advisorychac/event/registration.html.
After you register, you should receive
a confirmation email with a URL link
for access to this event. You will also
need to enter your Adobe Connect user
name and password. If you’ve never
used Adobe Connect, get a quick
overview: https://www.adobe.com/go/
connectpro_overview.
The public can join the meeting by:
1. (Audio Portion) Calling the Toll
free Phone Number 1–888–324–9564
and providing the Participant Pass Code
4805129, and
2. (Visual Portion) Connecting to the
Advisory Committee Adobe Connect Pro
Meeting using the following URL:
https://hrsa.connectsolutions.com/
advisorychac/event/login.html (copy
and paste the link into your browser if
it does not work directly).
Participants should call and connect
15 minutes prior to the meeting in order
for logistics to be set up. Call (301) 443–
9684 or send an email to sgordon@
hrsa.gov if you are having trouble
registering for this meeting; or call (301)
443–2843 or send an email to lfores@
hrsa.gov if you are having trouble
connecting to the meeting site.
Public Comment: Persons who desire
to make an oral statement may request
it at the time of the public comment
PO 00000
Frm 00028
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period. Public participation and ability
to comment will be limited to space and
time as it permits.
FOR FURTHER INFORMATION CONTACT:
Shelley B Gordon, Health Resources and
Services Administration, HIV/AIDS
Bureau, 5600 Fishers Lane, Rockville,
Maryland 20857, telephone at (301)
443–9684.
Dated: October 21, 2013.
Bahar Niakan,
Director, Division of Policy and Information
Coordination.
[FR Doc. 2013–25231 Filed 10–25–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Environmental
Health Sciences; Notice of Closed
Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
E:\FR\FM\28OCN1.SGM
28OCN1
Agencies
[Federal Register Volume 78, Number 208 (Monday, October 28, 2013)]
[Notices]
[Pages 64220-64221]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-25298]
-----------------------------------------------------------------------
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
November 27, 2013.
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, 1350 Piccard Dr., PI50-400B, Rockville,
MD 20850, 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--(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)
[[Page 64221]]
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.
In the Federal Register of July 23, 2013 (78 FR 44130), 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/21 CFR part/Section/ Number of responses per Total annual Average burden Total hours
Form No. respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
510(k) submission (807 subpart 3,900 1 3,900 79.............. 308,100
E).
Summary cover sheet (807.87) 1,956 1 1,956 0.5 (30 minutes) 978
and FDA 3514.
Status request (807.90(a)(3)) 218 1 218 0.25 (15 55
and FDA 3541. minutes).
Standards (807.87(d) and (f)); 2,700 1 2,700 10.............. 27,000
FDA 3654.
510(k) summary and statement 225 10 2,250 10.............. 22,500
(807.92 and 807.93).
---------------------------------------------------------------------------------
Total..................... .............. .............. .............. ................ 358,633
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-25298 Filed 10-25-13; 8:45 am]
BILLING CODE 4160-01-P