Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 22983-22984 [2018-10552]

Download as PDF 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] daltland on DSKBBV9HB2PROD with NOTICES BILLING CODE 4184–09–P VerDate Sep<11>2014 18:36 May 16, 2018 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 Frm 00040 Fmt 4703 Sfmt 4703 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: VerDate Sep<11>2014 18:36 May 16, 2018 Jkt 244001 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 Frm 00041 Fmt 4703 Sfmt 4703 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 17MYN1

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]


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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.

-----------------------------------------------------------------------

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