Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 22983-22984 [2018-10552]
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22983
Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices
ANNUAL BURDEN ESTIMATES
Total number
of respondents
Instrument
TANF Administrator Web Survey (State and County) .........
Site Visit Discussion Guide for TANF Staff .........................
Site Visit Discussion Guide for Staff at CoC/Partner Organizations ...........................................................................
Site Visit Focus Group Guide ..............................................
Estimated Total Annual Burden
Hours: 83.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. Email
address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–10550 Filed 5–16–18; 8:45 am]
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Jkt 244001
Annual
number of
respondents
Number of
responses per
respondent
69
17
1
1
.5
1.5
35
26
20
20
7
7
1
1
1.5
1.5
11
11
Food and Drug Administration
[Docket No. FDA–2018–N–1561]
Anesthesiology and Respiratory
Therapy Devices Panel of the Medical
Devices Advisory Committee; Notice of
Meeting
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Anesthesiology and
Respiratory Therapy Devices Panel of
the Medical Devices Advisory
Committee. The general function of the
committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public.
DATES: The meeting will be held on June
14, 2018 from 8 a.m. to 6 p.m.
ADDRESSES: Gaithersburg Holiday Inn,
Grand Ballroom, 2 Montgomery Village
Ave., Gaithersburg, MD 20879. The
hotel’s telephone number is 301–948–
8900. Answers to commonly asked
questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FOR FURTHER INFORMATION CONTACT:
Evella Washington, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. G640, Silver Spring,
MD 20993–0002, Evella.Washington@
fda.hhs.gov, 301–796–6683, 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.
SUMMARY:
PO 00000
Annual burden
hours
206
50
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Average
burden hours
per response
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Therefore, you should always check the
Agency’s website 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.
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss,
make recommendations and vote on
information related to PneumRx, Inc.’s
premarket approval application for the
PNEUMRX ELEVAIR Endobronchial
Coil System, which is a first of a kind
implantable lung reduction coil for the
proposed indication for use in patients
with homogeneous and/or
heterogeneous severe emphysema to
improve quality of life, lung function,
and exercise capacity.
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 website 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 website 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 June 7, 2018. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. 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 May 30,
E:\FR\FM\17MYN1.SGM
17MYN1
22984
Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices
2018. 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 May 31, 2018.
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 disabilities.
If you require accommodations due to a
disability, please contact Artair Mallett
at Artair.Mallett@fda.hhs.gov or 301–
796–9638 at least 7 days in advance of
the meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website 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: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10552 Filed 5–16–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2347]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food and
Cosmetic Export Certificate
Application Process
AGENCY:
Food and Drug Administration,
HHS.
daltland on DSKBBV9HB2PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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:
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18:36 May 16, 2018
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Fax written comments on the
collection of information by June 18,
2018.
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 0910–0793. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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.
DATES:
Food and Cosmetic Export Certificate
Application Process
OMB Control Number 0910–0793—
Revision
This information collection supports
FDA’s Center for Food Safety and
Applied Nutrition’s (CFSAN) export
certificate application process. Some
countries may require manufacturers of
FDA-regulated products to provide
certificates for products they wish to
export to that country. Accordingly,
firms exporting products from the
United States often ask FDA to provide
such a ‘‘certificate.’’ In many cases,
foreign governments are seeking official
assurance that products exported to
their countries can be marketed in the
United States, or that they meet specific
U.S. requirements. In some cases,
review of an FDA export certificate may
be required as part of the process to
register or import a product into another
country. An export certificate generally
indicates that the particular product is
marketed in the United States or
otherwise eligible for export and that
the particular manufacturer has no
unresolved enforcement actions
pending before, or taken by, FDA.
Interested persons may request a
certificate from CFSAN electronically
via the Certificate Application Process
(CAP), a component of FDA Industry
Systems, or by contacting CFSAN for
assistance. To facilitate the application
process we have eliminated paper-based
forms. For food products, we have
PO 00000
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expanded the electronic options for
providing facility and product
information. Respondents will now be
able to identify facilities based on a food
facility registration number, FDA
Establishment Identification number, or
Data Universal Numbering System
number. The system uses these
identifiers to locate and auto-populate
name and address information,
eliminating the need for users to
manually enter this information and
reducing the time to complete the
application. Respondents can also
upload product information via a
spreadsheet, which reduces the time
needed to enter product information,
particularly for applications that
include multiple products. All
information is entered using electronic
Forms FDA 3613d, 3613e, 3613g, and
3613l and used to evaluate certificate
requests.
While burden associated with
information collection activities for
export certificates issued for other FDAregulated products is approved under
OMB control number 0910–0498, this
collection specifically supports export
certificates issued by CFSAN. Also,
because we have eliminated paperbased forms, respondents who require
assistance with completing export
certificate applications online may
contact CFSAN directly by email
(CFSANExportCertification@
fda.hhs.gov) or telephone (240–402–
2307). Instructions for Form FDA 3613d
are available online at https://
www.fda.gov/cosmetics/
internationalactivities/exporters/
ucm353912.htm and instructions for
Form FDA 3613e are available online at
https://www.fda.gov/Food/
GuidanceRegulation/ImportsExports/
Exporting/ucm260280.htm. Draft
screenshots of Form FDA 3613g and
3613l are available for comment online
at https://www.fda.gov/Food/
GuidanceRegulation/ImportsExports/
Exporting/default.htm.
Description of Respondents: The
respondents to this collection of
information are firms interested in
exporting U.S.-manufactured food and
cosmetic products to foreign countries
that require export certificates.
In the Federal Register of January 2,
2018 (83 FR 133), we published a notice
soliciting public comment of the
information collection. Two comments
were received in support of the
information collection. One comment
included technical suggestions as well
regarding respondents’ ability to review
and edit data that might have been
entered improperly. We appreciate this
comment and continue to seek ways to
utilize improved information collection
E:\FR\FM\17MYN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Notices]
[Pages 22983-22984]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10552]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-1561]
Anesthesiology and Respiratory Therapy Devices Panel of the
Medical Devices Advisory Committee; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Anesthesiology and Respiratory
Therapy Devices Panel of the Medical Devices Advisory Committee. The
general function of the committee is to provide advice and
recommendations to the Agency on FDA's regulatory issues. The meeting
will be open to the public.
DATES: The meeting will be held on June 14, 2018 from 8 a.m. to 6 p.m.
ADDRESSES: Gaithersburg Holiday Inn, Grand Ballroom, 2 Montgomery
Village Ave., Gaithersburg, MD 20879. The hotel's telephone number is
301-948-8900. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
FOR FURTHER INFORMATION CONTACT: Evella Washington, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993-0002,
[email protected], 301-796-6683, 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 website 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.
SUPPLEMENTARY INFORMATION:
Agenda: The committee will discuss, make recommendations and vote
on information related to PneumRx, Inc.'s premarket approval
application for the PNEUMRX ELEVAIR Endobronchial Coil System, which is
a first of a kind implantable lung reduction coil for the proposed
indication for use in patients with homogeneous and/or heterogeneous
severe emphysema to improve quality of life, lung function, and
exercise capacity.
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 website 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 website 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 June
7, 2018. Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. 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 May 30,
[[Page 22984]]
2018. 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 May 31, 2018.
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
disabilities. If you require accommodations due to a disability, please
contact Artair Mallett at [email protected] or 301-796-9638 at
least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website 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: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-10552 Filed 5-16-18; 8:45 am]
BILLING CODE 4164-01-P
