83 FR 29791 - Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 123 (June 26, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 123 (June 26, 2018)
| Page Range | 29791-29792 | |
| FR Document | 2018-13711 |
[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)] [Notices] [Pages 29791-29792] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-13711] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-1073] Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. ACTION: Notice; establishment of a public docket; request for comments. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Antimicrobial Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on July 26, 2018, from 8:30 a.m. to 4 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993- 0002. 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. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-1073. The docket will close on July 25, 2018. Submit either electronic or written comments on this public meeting by July 25, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 25, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 25, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Comments received on or before July 12, 2018, will be provided to the committee. Comments received after that date will be taken into consideration by FDA. You may submit comments 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 [[Page 29792]] information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-1073 for ``Antimicrobial Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments.'' Received comments, those filed in a timely manner (see the ADDRESSES section), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two 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.thefederalregister.org/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.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: Kalyani Bhatt, Center for Drug Evaluation and Research, 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: [email protected], 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) 210607, tafenoquine tablet, 100 milligram (mg), sponsored by 60 Degrees Pharmaceuticals, LLC, for the proposed indication of prevention of malaria in adults for up to 6 months of continuous dosing. 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 July 12, 2018, 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 July 3, 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 July 5, 2018. 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 [email protected] 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 Kalyani Bhatt (see FOR FURTHER INFORMATION CONTACT) 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: June 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-13711 Filed 6-25-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices 29791
AdvisoryCommittees/default.htm and meetings and will make every effort to The docket will close on July 25, 2018.
scroll down to the appropriate advisory accommodate persons with disabilities. Submit either electronic or written
committee meeting link, or call the If you require accommodations due to a comments on this public meeting by
advisory committee information line to disability, please contact Kalyani Bhatt July 25, 2018. Please note that late,
learn about possible modifications (see FOR FURTHER INFORMATION CONTACT) untimely filed comments will not be
before coming to the meeting. at least 7 days in advance of the considered. Electronic comments must
SUPPLEMENTARY INFORMATION: meeting. be submitted on or before July 25, 2018.
Agenda: The committee will discuss FDA is committed to the orderly The https://www.regulations.gov
new drug application (NDA) 210795, conduct of its advisory committee electronic filing system will accept
tafenoquine tablet, 150 milligram, meetings. Please visit our website at comments until midnight Eastern Time
sponsored by GlaxoSmithKline https://www.fda.gov/Advisory at the end of July 25, 2018. Comments
Intellectual Property Development Ltd., Committees/AboutAdvisoryCommittees/ received by mail/hand delivery/courier
England, for the proposed indication of ucm111462.htm for procedures on (for written/paper submissions) will be
the radical cure (prevention of relapse) public conduct during advisory considered timely if they are
of Plasmodium vivax malaria. committee meetings. postmarked or the delivery service
FDA intends to make background Notice of this meeting is given under acceptance receipt is on or before that
material available to the public no later the Federal Advisory Committee Act (5 date.
than 2 business days before the meeting. U.S.C. app. 2). Comments received on or before July
If FDA is unable to post the background Dated: June 20, 2018. 12, 2018, will be provided to the
material on its website prior to the committee. Comments received after
Leslie Kux,
meeting, the background material will that date will be taken into
Associate Commissioner for Policy.
be made publicly available at the consideration by FDA.
location of the advisory committee [FR Doc. 2018–13710 Filed 6–25–18; 8:45 am]
You may submit comments as
meeting, and the background material BILLING CODE 4164–01–P follows:
will be posted on FDA’s website after
the meeting. Background material is Electronic Submissions
available at https://www.fda.gov/ DEPARTMENT OF HEALTH AND Submit electronic comments in the
AdvisoryCommittees/Calendar/ HUMAN SERVICES following way:
default.htm. Scroll down to the • Federal eRulemaking Portal:
Food and Drug Administration https://www.regulations.gov. Follow the
appropriate advisory committee meeting
link. [Docket No. FDA–2018–N–1073] instructions for submitting comments.
Procedure: Interested persons may Comments submitted electronically,
present data, information, or views, Antimicrobial Drugs Advisory including attachments, to https://
orally or in writing, on issues pending Committee; Notice of Meeting; www.regulations.gov will be posted to
before the committee. Written Establishment of a Public Docket; the docket unchanged. Because your
submissions may be made to the contact Request for Comments comment will be made public, you are
person on or before July 2, 2018. Oral AGENCY: Food and Drug Administration, solely responsible for ensuring that your
presentations from the public will be HHS. comment does not include any
scheduled between approximately 1:30 confidential information that you or a
p.m. and 2:30 p.m. Those individuals ACTION: Notice; establishment of a
third party may not wish to be posted,
interested in making formal oral public docket; request for comments.
such as medical information, your or
presentations should notify the contact SUMMARY: The Food and Drug anyone else’s Social Security number, or
person and submit a brief statement of Administration (FDA) announces a confidential business information, such
the general nature of the evidence or forthcoming public advisory committee as a manufacturing process. Please note
arguments they wish to present, the meeting of the Antimicrobial Drugs that if you include your name, contact
names and addresses of proposed Advisory Committee. The general information, or other information that
participants, and an indication of the function of the committee is to provide identifies you in the body of your
approximate time requested to make advice and recommendations to FDA on comments, that information will be
their presentation on or before June 26, regulatory issues. The meeting will be posted on https://www.regulations.gov.
2018. Time allotted for each open to the public. FDA is establishing • If you want to submit a comment
presentation may be limited. If the a docket for public comment on this with confidential information that you
number of registrants requesting to document. do not wish to be made available to the
speak is greater than can be reasonably public, submit the comment as a
accommodated during the scheduled DATES: The meeting will be held on July
written/paper submission and in the
open public hearing session, FDA may 26, 2018, from 8:30 a.m. to 4 p.m. manner detailed (see ‘‘Written/Paper
conduct a lottery to determine the ADDRESSES: FDA White Oak Campus, Submissions’’ and ‘‘Instructions’’).
speakers for the scheduled open public 10903 New Hampshire Ave., Bldg. 31
hearing session. The contact person will Conference Center, the Great Room (Rm. Written/Paper Submissions
notify interested persons regarding their 1503), Silver Spring, MD 20993–0002. Submit written/paper submissions as
request to speak by June 27, 2018. Answers to commonly asked questions follows:
Persons attending FDA’s advisory including information regarding special • Mail/Hand delivery/Courier (for
sradovich on DSK3GMQ082PROD with NOTICES
committee meetings are advised that accommodations due to a disability, written/paper submissions): Dockets
FDA is not responsible for providing visitor parking, and transportation may Management Staff (HFA–305), Food and
access to electrical outlets. be accessed at: https://www.fda.gov/ Drug Administration, 5630 Fishers
For press inquiries, please contact the AdvisoryCommittees/AboutAdvisory Lane, Rm. 1061, Rockville, MD 20852.
Office of Media Affairs at fdaoma@ Committees/ucm408555.htm. • For written/paper comments
fda.hhs.gov or 301–796–4540. FDA is establishing a docket for submitted to the Dockets Management
FDA welcomes the attendance of the public comment on this meeting. The Staff, FDA will post your comment, as
public at its advisory committee docket number is FDA–2018–N–1073. well as any attachments, except for
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![29792 Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices
information submitted, marked and Drug Administration, 10903 New speak is greater than can be reasonably
identified, as confidential, if submitted Hampshire Ave., Bldg. 31, Rm. 2417, accommodated during the scheduled
as detailed in ‘‘Instructions.’’ Silver Spring, MD 20993–0002, 301– open public hearing session, FDA may
Instructions: All submissions received 796–9001, Fax: 301–847–8533, email: conduct a lottery to determine the
must include the Docket No. FDA– AMDAC@fda.hhs.gov, or FDA Advisory speakers for the scheduled open public
2018–N–1073 for ‘‘Antimicrobial Drugs Committee Information Line, 1–800– hearing session. The contact person will
Advisory Committee; Notice of Meeting; 741–8138 (301–443–0572 in the notify interested persons regarding their
Establishment of a Public Docket; Washington, DC area). A notice in the request to speak by July 5, 2018.
Request for Comments.’’ Received Federal Register about last minute Persons attending FDA’s advisory
comments, those filed in a timely modifications that impact a previously committee meetings are advised that
manner (see the ADDRESSES section), announced advisory committee meeting FDA is not responsible for providing
will be placed in the docket and, except cannot always be published quickly access to electrical outlets.
for those submitted as ‘‘Confidential enough to provide timely notice. For press inquiries, please contact the
Submissions,’’ publicly viewable at Therefore, you should always check the Office of Media Affairs at fdaoma@
https://www.regulations.gov or at the FDA’s website at https://www.fda.gov/ fda.hhs.gov or 301–796–4540.
Dockets Management Staff between 9 AdvisoryCommittees/default.htm and FDA welcomes the attendance of the
a.m. and 4 p.m., Monday through scroll down to the appropriate advisory public at its advisory committee
Friday. committee meeting link, or call the meetings and will make every effort to
• Confidential Submissions—To advisory committee information line to accommodate persons with disabilities.
submit a comment with confidential learn about possible modifications If you require accommodations due to a
information that you do not wish to be before coming to the meeting. disability, please contact Kalyani Bhatt
made publicly available, submit your SUPPLEMENTARY INFORMATION: (see FOR FURTHER INFORMATION CONTACT)
comments only as a written/paper Agenda: The committee will discuss at least 7 days in advance of the
submission. You should submit two new drug application (NDA) 210607, meeting.
copies total. One copy will include the tafenoquine tablet, 100 milligram (mg), FDA is committed to the orderly
information you claim to be confidential sponsored by 60 Degrees conduct of its advisory committee
with a heading or cover note that states Pharmaceuticals, LLC, for the proposed meetings. Please visit our website at
‘‘THIS DOCUMENT CONTAINS indication of prevention of malaria in https://www.fda.gov/Advisory
CONFIDENTIAL INFORMATION.’’ FDA adults for up to 6 months of continuous Committees/AboutAdvisoryCommittees/
will review this copy, including the dosing. ucm111462.htm for procedures on
claimed confidential information, in its FDA intends to make background public conduct during advisory
consideration of comments. The second material available to the public no later committee meetings.
copy, which will have the claimed than 2 business days before the meeting. Notice of this meeting is given under
confidential information redacted/ If FDA is unable to post the background the Federal Advisory Committee Act (5
blacked out, will be available for public material on its website prior to the U.S.C. app. 2).
viewing and posted on https:// meeting, the background material will Dated: June 21, 2018.
www.regulations.gov. Submit both be made publicly available at the
copies to the Dockets Management Staff. Leslie Kux,
location of the advisory committee
If you do not wish your name and Associate Commissioner for Policy.
meeting, and the background material
contact information be made publicly [FR Doc. 2018–13711 Filed 6–25–18; 8:45 am]
will be posted on FDA’s website after
available, you can provide this the meeting. Background material is BILLING CODE 4164–01–P
information on the cover sheet and not available at https://www.fda.gov/
in the body of your comments and you AdvisoryCommittees/Calendar/
must identify the information as DEPARTMENT OF HEALTH AND
default.htm. Scroll down to the
‘‘confidential.’’ Any information marked HUMAN SERVICES
appropriate advisory committee meeting
as ‘‘confidential’’ will not be disclosed link. Food and Drug Administration
except in accordance with 21 CFR 10.20 Procedure: Interested persons may
and other applicable disclosure law. For present data, information, or views,
more information about FDA’s posting [Docket No. FDA–2017–D–6209]
orally or in writing, on issues pending
of comments to public dockets, see 80 before the committee. All electronic and
FR 56469, September 18, 2015, or access Agency Information Collection
written submissions submitted to the Activities; Submission for Office of
the information at: https://www.gpo.gov/ Docket (see the ADDRESSES section) on
fdsys/pkg/FR-2015-09-18/pdf/2015- Management and Budget Review;
or before July 12, 2018, will be provided Comment Request; Guidance for
23389.pdf. to the committee. Oral presentations
Docket: For access to the docket to Industry: Assessing User Fees Under
from the public will be scheduled the Biosimilar User Fee Amendments
read background documents or the between approximately 1:30 p.m. and
electronic and written/paper comments of 2017
2:30 p.m. Those individuals interested
received, go to https:// in making formal oral presentations AGENCY: Food and Drug Administration,
www.regulations.gov and insert the should notify the contact person and HHS.
docket number, found in brackets in the submit a brief statement of the general ACTION: Notice.
heading of this document, into the nature of the evidence or arguments
sradovich on DSK3GMQ082PROD with NOTICES
‘‘Search’’ box and follow the prompts they wish to present, the names and SUMMARY: The Food and Drug
and/or go to the Dockets Management addresses of proposed participants, and Administration (FDA) is announcing
Staff, 5630 Fishers Lane, Rm. 1061, an indication of the approximate time that a proposed collection of
Rockville, MD 20852. requested to make their presentation on information has been submitted to the
FOR FURTHER INFORMATION CONTACT: or before July 3, 2018. Time allotted for Office of Management and Budget
Kalyani Bhatt, Center for Drug each presentation may be limited. If the (OMB) for review and clearance under
Evaluation and Research, Food and number of registrants requesting to the Paperwork Reduction Act of 1995.
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Document Created: 2018-06-26 00:52:32
Document Modified: 2018-06-26 00:52:32
| 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; establishment of a public docket; request for comments. | |
| Dates | The meeting will be held on July 26, 2018, from 8:30 a.m. to 4 p.m. | |
| Contact | Kalyani Bhatt, Center for Drug Evaluation and Research, 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: [email protected], 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. | |
| FR Citation | 83 FR 29791 |
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