General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting, 17173-17174 [2019-08261]

Download as PDF jbell on DSK30RV082PROD with NOTICES Federal Register / Vol. 84, No. 79 / Wednesday, April 24, 2019 / Notices copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/ blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug Evaluation and Research, HFD–21, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993–0002, 301– 796–9001, Fax: 301–847–8533, email: AMDAC@fda.hhs.gov, 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 FDA’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 new drug application (NDA) 212862, VerDate Sep<11>2014 17:20 Apr 23, 2019 Jkt 247001 pretomanid tablets for oral administration, submitted by The Global Alliance for TB Drug Development, Inc., proposed as part of a combination regimen with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive multidrug-resistant tuberculosis (TB). 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. All electronic and written submissions submitted to the Docket (see the ADDRESSES section) on or before May 22, 2019, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 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 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. Persons attending FDA’s advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at fdaoma@ fda.hhs.gov or 301–796–4540. 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 LaToya Bonner (see FOR FURTHER INFORMATION CONTACT) PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 17173 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/AboutAdvisory Committees/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 18, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–08175 Filed 4–23–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–1281] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the General and Plastic Surgery 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 May 30, 2019, from 10 a.m. to 4 p.m. and on May 31, 2019, from 8 a.m. to 4 p.m. ADDRESSES: The meeting will be held at the Gaithersburg Holiday Inn, Grand Ballroom, Two Montgomery Village Ave., Gaithersburg, MD 20879. The hotel’s telephone number is 301–948– 8900; additional information available online at: https:// www.reservations.com/hotel/holidayinn-gaithersburg?rmcid=rcc4&mscl kid=8cda4d308856180123cc11aeb932 c40b&utm_source=bing&utm_medium= cpc&utm_campaign=Top%20Hotels& utm_term=Holiday%20Inn% 20Gaithersburg&utm_content=Holiday %20Inn%20Gaithersburg_1736466. 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/ SUMMARY: E:\FR\FM\24APN1.SGM 24APN1 jbell on DSK30RV082PROD with NOTICES 17174 Federal Register / Vol. 84, No. 79 / Wednesday, April 24, 2019 / Notices AdvisoryCommittees/AboutAdvisory Committees/ucm408555.htm. FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993, Patricio.garcia@fda.hhs.gov, 301–796–6875, 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 May 30, 2019, the committee will discuss and make recommendations regarding the reclassification of surgical stapler devices for internal use from Class I (general controls) to Class II (special controls). On May 31, 2019, the committee will discuss and make recommendations regarding the reclassification of certain absorbable hemostatic agents from Class III to Class II (special controls). 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/Committees MeetingMaterials/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 May 20, 2019. Oral presentations from the public will be scheduled on May 30 and 31, 2019, between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT) and VerDate Sep<11>2014 17:20 Apr 23, 2019 Jkt 247001 indicate which session they would like to present. The notification should include 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 10, 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 sessions. The contact person will notify interested persons regarding their request to speak by May 13, 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 AnnMarie Williams at annmarie.williams@ fda.hhs.gov or 301–796–5966 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 18, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–08261 Filed 4–23–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–D–1262] Surgical Staplers and Staples for Internal Use—Labeling Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is SUMMARY: PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 announcing the availability of the draft guidance entitled ‘‘Surgical Staplers and Staples for Internal Use—Labeling Recommendations.’’ FDA is issuing this draft guidance to provide labeling recommendations for surgical staplers and staples for internal use. These labeling recommendations are being issued because malfunctions and misuse associated with these devices have resulted in serious adverse events, including deaths. This draft guidance is not final nor is it currently in effect. DATES: Submit either electronic or written comments on the draft guidance by June 24, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ E:\FR\FM\24APN1.SGM 24APN1

Agencies

[Federal Register Volume 84, Number 79 (Wednesday, April 24, 2019)]
[Notices]
[Pages 17173-17174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08261]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1281]


General and Plastic Surgery 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 General and Plastic Surgery 
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 May 30, 2019, from 10 a.m. to 4 p.m. 
and on May 31, 2019, from 8 a.m. to 4 p.m.

ADDRESSES: The meeting will be held at the Gaithersburg Holiday Inn, 
Grand Ballroom, Two Montgomery Village Ave., Gaithersburg, MD 20879. 
The hotel's telephone number is 301-948-8900; additional information 
available online at: https://www.reservations.com/hotel/holiday-inn-gaithersburg?rmcid=rcc4&msclkid=8cda4d308856180123cc11aeb932c40b&utm_source=bing&utm_medium=cpc&utm_campaign=Top%20Hotels&utm_term=Holiday%20Inn%20Gaithersburg&utm_content=Holiday%20Inn%20Gaithersburg_1736466. 
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/

[[Page 17174]]

AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Patricio Garcia, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G610, Silver Spring, MD 20993, 
[email protected], 301-796-6875, 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 May 30, 2019, the committee will discuss and make 
recommendations regarding the reclassification of surgical stapler 
devices for internal use from Class I (general controls) to Class II 
(special controls). On May 31, 2019, the committee will discuss and 
make recommendations regarding the reclassification of certain 
absorbable hemostatic agents from Class III to Class II (special 
controls).
    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/CommitteesMeetingMaterials/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 May 
20, 2019. Oral presentations from the public will be scheduled on May 
30 and 31, 2019, between approximately 1 p.m. and 2 p.m. Those 
individuals interested in making formal oral presentations should 
notify the contact person (see FOR FURTHER INFORMATION CONTACT) and 
indicate which session they would like to present. The notification 
should include 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 10, 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 
sessions. The contact person will notify interested persons regarding 
their request to speak by May 13, 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 AnnMarie Williams at [email protected] or 301-796-
5966 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 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08261 Filed 4-23-19; 8:45 am]
 BILLING CODE 4164-01-P

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