83 FR 22983 - Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 96 (May 17, 2018)

Page Range		22983-22984
FR Document		2018-10552

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.

Federal Register, Volume 83 Issue 96 (Thursday, May 17, 2018)

[Federal Register Volume 83, Number 96 (Thursday, May 17, 2018)]
[Notices]
[Pages 22983-22984]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10552]


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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.

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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, 
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. 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 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

22984 Federal Register / Vol. 83, No. 96 / Thursday, May 17, 2018 / Notices

2018. Time allotted for each DATES: Fax written comments on the expanded the electronic options for
presentation may be limited. If the collection of information by June 18, providing facility and product
number of registrants requesting to 2018. information. Respondents will now be
speak is greater than can be reasonably ADDRESSES: To ensure that comments on able to identify facilities based on a food
accommodated during the scheduled the information collection are received, facility registration number, FDA
open public hearing session, FDA may OMB recommends that written Establishment Identification number, or
conduct a lottery to determine the comments be faxed to the Office of Data Universal Numbering System
speakers for the scheduled open public Information and Regulatory Affairs, number. The system uses these
hearing session. The contact person will OMB, Attn: FDA Desk Officer, Fax: 202– identifiers to locate and auto-populate
notify interested persons regarding their 395–7285, or emailed to oira_ name and address information,
request to speak by May 31, 2018. submission@omb.eop.gov. All eliminating the need for users to
Persons attending FDA’s advisory comments should be identified with the manually enter this information and
committee meetings are advised that the OMB control number 0910–0793. Also reducing the time to complete the
Agency is not responsible for providing application. Respondents can also
include the FDA docket number found
access to electrical outlets. upload product information via a
in brackets in the heading of this
FDA welcomes the attendance of the spreadsheet, which reduces the time
document.
public at its advisory committee needed to enter product information,
FOR FURTHER INFORMATION CONTACT: particularly for applications that
meetings and will make every effort to
Domini Bean, Office of Operations, include multiple products. All
accommodate persons with disabilities.
Food and Drug Administration, Three information is entered using electronic
If you require accommodations due to a
White Flint North, 10A–12M, 11601 Forms FDA 3613d, 3613e, 3613g, and
disability, please contact Artair Mallett
Landsdown St., North Bethesda, MD 3613l and used to evaluate certificate
at Artair.Mallett@fda.hhs.gov or 301–
20852, 301–796–5733, PRAStaff@ requests.
796–9638 at least 7 days in advance of
fda.hhs.gov. While burden associated with
the meeting.
SUPPLEMENTARY INFORMATION: In information collection activities for
FDA is committed to the orderly
compliance with 44 U.S.C. 3507, FDA export certificates issued for other FDA-
conduct of its advisory committee
has submitted the following proposed regulated products is approved under
meetings. Please visit our website at
collection of information to OMB for OMB control number 0910–0498, this
https://www.fda.gov/
review and clearance. collection specifically supports export
AdvisoryCommittees/
certificates issued by CFSAN. Also,
AboutAdvisoryCommittees/ Food and Cosmetic Export Certificate because we have eliminated paper-
ucm111462.htm for procedures on Application Process based forms, respondents who require
public conduct during advisory
OMB Control Number 0910–0793— assistance with completing export
committee meetings.
Revision certificate applications online may
Notice of this meeting is given under contact CFSAN directly by email
the Federal Advisory Committee Act (5 This information collection supports (CFSANExportCertification@
U.S.C. app. 2). FDA’s Center for Food Safety and fda.hhs.gov) or telephone (240–402–
Dated: May 10, 2018. Applied Nutrition’s (CFSAN) export 2307). Instructions for Form FDA 3613d
Leslie Kux, certificate application process. Some are available online at https://
Associate Commissioner for Policy.
countries may require manufacturers of www.fda.gov/cosmetics/
FDA-regulated products to provide internationalactivities/exporters/
[FR Doc. 2018–10552 Filed 5–16–18; 8:45 am]
certificates for products they wish to ucm353912.htm and instructions for
BILLING CODE 4164–01–P
export to that country. Accordingly, Form FDA 3613e are available online at
firms exporting products from the https://www.fda.gov/Food/
DEPARTMENT OF HEALTH AND United States often ask FDA to provide GuidanceRegulation/ImportsExports/
HUMAN SERVICES such a ‘‘certificate.’’ In many cases, Exporting/ucm260280.htm. Draft
foreign governments are seeking official screenshots of Form FDA 3613g and
Food and Drug Administration assurance that products exported to 3613l are available for comment online
their countries can be marketed in the at https://www.fda.gov/Food/
United States, or that they meet specific GuidanceRegulation/ImportsExports/
[Docket No. FDA–2014–N–2347]
U.S. requirements. In some cases, Exporting/default.htm.
Agency Information Collection review of an FDA export certificate may Description of Respondents: The
Activities; Submission for Office of be required as part of the process to respondents to this collection of
Management and Budget Review; register or import a product into another information are firms interested in
Comment Request; Food and country. An export certificate generally exporting U.S.-manufactured food and
Cosmetic Export Certificate indicates that the particular product is cosmetic products to foreign countries
Application Process marketed in the United States or that require export certificates.
otherwise eligible for export and that In the Federal Register of January 2,
AGENCY: Food and Drug Administration, the particular manufacturer has no 2018 (83 FR 133), we published a notice
HHS. unresolved enforcement actions soliciting public comment of the
ACTION: Notice. pending before, or taken by, FDA. information collection. Two comments
Interested persons may request a were received in support of the
daltland on DSKBBV9HB2PROD with NOTICES

SUMMARY: The Food and Drug certificate from CFSAN electronically information collection. One comment
Administration (FDA, Agency, or we) is via the Certificate Application Process included technical suggestions as well
announcing that a proposed collection (CAP), a component of FDA Industry regarding respondents’ ability to review
of information has been submitted to the Systems, or by contacting CFSAN for and edit data that might have been
Office of Management and Budget assistance. To facilitate the application entered improperly. We appreciate this
(OMB) for review and clearance under process we have eliminated paper-based comment and continue to seek ways to
the Paperwork Reduction Act of 1995. forms. For food products, we have utilize improved information collection

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Document Created: 2018-05-17 00:51:22
Document Modified: 2018-05-17 00:51:22

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		The meeting will be held on June 14, 2018 from 8 a.m. to 6 p.m.
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.
FR Citation		83 FR 22983

83 FR 22983 - Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 96 (May 17, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration