Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 16676-16677 [2019-08033]

Download as PDF 16676 Federal Register / Vol. 84, No. 77 / Monday, April 22, 2019 / Notices The requirement for submission of warning plans for cigar products, and the specific requirements relating to the random display and distribution of required warning statements on cigar packaging and quarterly rotation of required warning statements in alternating sequence on cigar product advertising, appear in § 1143.5(c). The six warnings for cigars (five specifically for cigars and the one addictiveness warning) will be required to be randomly displayed in each 12month period, in as equal a number of times as is possible on each brand of cigar sold in product packaging and be randomly distributed in all areas of the United States in which the product is marketed accordance with a warning plan submitted to and approved by FDA. For advertisements, the warning statements must be rotated quarterly in alternating sequence in each advertisement for each brand of cigar in accordance with a warning plan submitted to and approved by FDA. FDA published a final guidance in August 2018 (https://www.fda.gov/ downloads/TobaccoProducts/Labeling/ RulesRegulationsGuidance/ UCM534739.pdf) to assist manufacturers, importers, distributors, and retailers of cigars with the submission of warning plans. FDA will work with the submitters to ensure that the plans submitted meet the established criteria for approval under 21 CFR part 1143. The warning statements on cigar packaging must be randomly displayed in each 12-month period, in as equal a number of times as is possible on each brand of cigar sold and are required to be randomly distributed in all areas of the United States in which the product is marketed in accordance with a warning plan submitted by the responsible cigar manufacturer, importer, distributor, or retailer to and approved by FDA. FDA also requires that the required warning statements be rotated quarterly in alternating sequence in each advertisement for each brand of cigar, regardless of whether the cigar is sold in product packaging. This rotation of warning statements in cigar advertisements also must be done in accordance with a warning plan submitted by the responsible cigar manufacturer, importer, distributor, or retailer to and approved by FDA. The burden estimates are based on FDA’s experience with cigar warning plans, smokeless warning plans, and the associated information collection (OMB control number 0910–0671) as well as warning plans for cigarettes submitted to the Federal Trade Commission prior to the implementation of the Tobacco Control Act on June 22, 2009. We estimate 10 entities will submit warning plans, and it will take an average of 120 hours per respondent to prepare and submit a warning plan for packaging and advertising for a total of 1,200 hours. TABLE 4—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity Total annual responses Average burden per response (in hours) Total hours Small-Scale Manufacturer Reporting ................................... 75 1 75 2 150 Total Small-Scale Manufacturer Report ....................... ........................ ........................ ........................ ........................ 150 1 There amozie on DSK9F9SC42PROD with NOTICES Number of responses per respondent are no capital costs or operating and maintenance costs associated with this collection of information. Generally, FDA considers a ‘‘smallscale tobacco product manufacturer’’ to be a manufacturer of any regulated tobacco product that employs 150 or fewer full-time equivalent employees and has annual total revenues of $5,000,000 or less. FDA considers a manufacturer to include each entity that it controls, is controlled by, or is under common control with such manufacturer. To help make FDA’s individual enforcement decisions more efficient, a manufacturer may voluntarily submit information regarding employment and revenues. FDA does not believe many manufacturers who fit the criteria of a small-scale tobacco product manufacturer would submit the voluntary information. FDA estimates that there are approximately 75 small-scale manufacturers who will voluntarily submit information. FDA believes it will take respondents 2 hours to voluntarily submit information regarding employment and revenues for a total of 150 hours. The total estimated burden for this information collection is 1,286,950 VerDate Sep<11>2014 17:22 Apr 19, 2019 Jkt 247001 reporting hours, and 1,040 annual responses. Our estimated burden for the information collection reflects an overall decrease of 39,050 hours and a corresponding decrease of 315 responses. We attribute this adjustment to updated information in the number of submissions we received over the last few years. Dated: April 17, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Circulatory System 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. SUMMARY: [FR Doc. 2019–08046 Filed 4–19–19; 8:45 am] The meeting will be held on June 19, 2019, from 8 a.m. to 5 p.m., and June 20, 2019, from 8 a.m. to 3 p.m. BILLING CODE 4164–01–P ADDRESSES: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–1677] Circulatory System Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: PO 00000 Notice. Frm 00040 Fmt 4703 Sfmt 4703 DATES: Gaithersburg Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., Gaithersburg, MD 20879. The hotel’s telephone number is 301– 948–8900; additional information is available online at: https:// www.ihg.com/holidayinn/hotels/us/en/ gaithersburg/wasrv/hoteldetail?cm_ mmc=Google. 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/Advisory Committees/AboutAdvisoryCommittees/ ucm408555.htm. E:\FR\FM\22APN1.SGM 22APN1 Federal Register / Vol. 84, No. 77 / Monday, April 22, 2019 / Notices CONTACT) 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. amozie on DSK9F9SC42PROD with NOTICES SUPPLEMENTARY INFORMATION: Agenda: On June 19 and 20, 2019, the committee will discuss and make recommendations on information related to recent observations of increased long-term mortality in peripheral arterial disease patients treated with paclitaxel-coated balloons and paclitaxel-eluting stents compared to patients treated with uncoated comparator devices. FDA requests panel input regarding the presence and magnitude of the signal and potential causes. FDA also seeks input regarding appropriate regulatory actions associated with the findings. 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 (see FOR FURTHER INFORMATION VerDate Sep<11>2014 17:22 Apr 19, 2019 Jkt 247001 on or before May 22, 2019. Oral presentations from the public will be scheduled on June 19, 2019, between approximately 1 p.m. and 2 p.m.; and on June 20, 2019, between approximately 10:30 a.m. and 11:30 a.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 14, 2019. 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 15, 2019. Representatives from industry, professional organizations, and societies interested in making formal presentations to the committee should notify the contact person on or before May 22, 2019. 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/Advisory Committees/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: April 17, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–08033 Filed 4–19–19; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 16677 DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: 4040–0004] Agency Information Collection Request. 60-Day Public Comment Request Office of the Secretary, HHS. Notice. AGENCY: ACTION: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. DATES: Comments on the ICR must be received on or before June 21, 2019. ADDRESSES: Submit your comments to Sherrette.Funn@hhs.gov or by calling (202) 795–7714. FOR FURTHER INFORMATION CONTACT: When submitting comments or requesting information, please include the document identifier 4040–0004–60D and project title for reference to Grants.gov Manager, Ed Calimag, at ed.calimag@hhs.gov or 202–690–7569. SUPPLEMENTARY INFORMATION: Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Title of the Collection: Application for Federal Assistance (SF–424). Type of Collection: Reinstatement without change. OMB No. 4040–0004. Abstract: The Application for Federal Assistance (SF–424) form provides the Federal grant-making agencies with a common and standard form for organizations to apply for financial assistance. Type of respondent: Organizations seeking financial assistance. This form is submitted to the Federal grant-making agencies for evaluation and review. SUMMARY: E:\FR\FM\22APN1.SGM 22APN1

Agencies

[Federal Register Volume 84, Number 77 (Monday, April 22, 2019)]
[Notices]
[Pages 16676-16677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08033]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1677]


Circulatory System 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 Circulatory System 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 19, 2019, from 8 a.m. to 5 
p.m., and June 20, 2019, from 8 a.m. to 3 p.m.

ADDRESSES: Gaithersburg Holiday Inn, Grand Ballroom, Two Montgomery 
Village Ave., Gaithersburg, MD 20879. The hotel's telephone number is 
301-948-8900; additional information is available online at: https://www.ihg.com/holidayinn/hotels/us/en/gaithersburg/wasrv/hoteldetail?cm_mmc=Google. 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.

[[Page 16677]]


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: On June 19 and 20, 2019, the committee will discuss and 
make recommendations on information related to recent observations of 
increased long-term mortality in peripheral arterial disease patients 
treated with paclitaxel-coated balloons and paclitaxel-eluting stents 
compared to patients treated with uncoated comparator devices. FDA 
requests panel input regarding the presence and magnitude of the signal 
and potential causes. FDA also seeks input regarding appropriate 
regulatory actions associated with the findings.
    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 (see FOR FURTHER 
INFORMATION CONTACT) on or before May 22, 2019. Oral presentations from 
the public will be scheduled on June 19, 2019, between approximately 1 
p.m. and 2 p.m.; and on June 20, 2019, between approximately 10:30 a.m. 
and 11:30 a.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 14, 2019. 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 15, 
2019.
    Representatives from industry, professional organizations, and 
societies interested in making formal presentations to the committee 
should notify the contact person on or before May 22, 2019.
    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: April 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08033 Filed 4-19-19; 8:45 am]
 BILLING CODE 4164-01-P

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