83 FR 29790 - 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 | 29790-29791 | |
| FR Document | 2018-13710 |
[Federal Register Volume 83, Number 123 (Tuesday, June 26, 2018)] [Notices] [Pages 29790-29791] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-13710] ----------------------------------------------------------------------- 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 12, 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 11, 2018. Submit either electronic or written comments on this public meeting by July 11, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 11, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 11, 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 2, 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 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 ADDRESSES), 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: 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/ [[Page 29791]] 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) 210795, tafenoquine tablet, 150 milligram, sponsored by GlaxoSmithKline Intellectual Property Development Ltd., England, for the proposed indication of the radical cure (prevention of relapse) of Plasmodium vivax malaria. 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 July 2, 2018. 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 June 26, 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 June 27, 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 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 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 20, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-13710 Filed 6-25-18; 8:45 am] BILLING CODE 4164-01-P
![29790 Federal Register / Vol. 83, No. 123 / Tuesday, June 26, 2018 / Notices
Washington, DC 20503; FAX: (202) 395– acceptance receipt is on or before that Dockets Management Staff between 9
7285; email: oira_submission@ date. a.m. and 4 p.m., Monday through
omb.eop.gov. Comments received on or before July Friday.
2, 2018, will be provided to the • Confidential Submissions—To
Robert Sargis,
committee. Comments received after submit a comment with confidential
Reports Clearance Officer. that date will be taken into information that you do not wish to be
[FR Doc. 2018–13604 Filed 6–25–18; 8:45 am] consideration by FDA. made publicly available, submit your
BILLING CODE 4184–47–P You may submit comments as comments only as a written/paper
follows: submission. You should submit two
Electronic Submissions copies total. One copy will include the
DEPARTMENT OF HEALTH AND information you claim to be confidential
HUMAN SERVICES Submit electronic comments in the with a heading or cover note that states
following way: ‘‘THIS DOCUMENT CONTAINS
Food and Drug Administration • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ FDA
https://www.regulations.gov. Follow the will review this copy, including the
[Docket No. FDA–2018–N–1073] instructions for submitting comments. claimed confidential information, in its
Comments submitted electronically, consideration of comments. The second
Antimicrobial Drugs Advisory
including attachments, to https:// copy, which will have the claimed
Committee; Notice of Meeting;
www.regulations.gov will be posted to confidential information redacted/
Establishment of a Public Docket;
the docket unchanged. Because your blacked out, will be available for public
Request for Comments
comment will be made public, you are viewing and posted on https://
AGENCY: Food and Drug Administration, solely responsible for ensuring that your www.regulations.gov. Submit both
HHS. comment does not include any copies to the Dockets Management Staff.
ACTION: Notice; establishment of a confidential information that you or a If you do not wish your name and
public docket; request for comments. third party may not wish to be posted, contact information be made publicly
such as medical information, your or available, you can provide this
SUMMARY: The Food and Drug anyone else’s Social Security number, or information on the cover sheet and not
Administration (FDA) announces a confidential business information, such in the body of your comments and you
forthcoming public advisory committee as a manufacturing process. Please note must identify the information as
meeting of the Antimicrobial Drugs that if you include your name, contact ‘‘confidential.’’ Any information marked
Advisory Committee. The general information, or other information that as ‘‘confidential’’ will not be disclosed
function of the committee is to provide identifies you in the body of your except in accordance with 21 CFR 10.20
advice and recommendations to FDA on comments, that information will be and other applicable disclosure law. For
regulatory issues. The meeting will be posted on https://www.regulations.gov. more information about FDA’s posting
open to the public. FDA is establishing • If you want to submit a comment
of comments to public dockets, see 80
a docket for public comment on this with confidential information that you
FR 56469, September 18, 2015, or access
document. do not wish to be made available to the
the information at: https://www.gpo.gov/
public, submit the comment as a
DATES: The meeting will be held on July fdsys/pkg/FR-2015-09-18/pdf/2015-
written/paper submission and in the
12, 2018, from 8:30 a.m. to 4 p.m. 23389.pdf.
manner detailed (see ‘‘Written/Paper
ADDRESSES: FDA White Oak Campus, Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’).
10903 New Hampshire Ave., Bldg. 31 read background documents or the
Conference Center, the Great Room (Rm. Written/Paper Submissions electronic and written/paper comments
1503), Silver Spring, MD 20993–0002. Submit written/paper submissions as received, go to https://
Answers to commonly asked questions follows: www.regulations.gov and insert the
including information regarding special • Mail/Hand delivery/Courier (for docket number, found in brackets in the
accommodations due to a disability, written/paper submissions): Dockets heading of this document, into the
visitor parking, and transportation may Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
be accessed at: https://www.fda.gov/ Drug Administration, 5630 Fishers and/or go to the Dockets Management
AdvisoryCommittees/AboutAdvisory Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061,
Committees/ucm408555.htm. • For written/paper comments Rockville, MD 20852.
FDA is establishing a docket for submitted to the Dockets Management FOR FURTHER INFORMATION CONTACT:
public comment on this meeting. The Staff, FDA will post your comment, as Kalyani Bhatt, Center for Drug
docket number is FDA–2018–N–1073. well as any attachments, except for Evaluation and Research, Food and
The docket will close on July 11, 2018. information submitted, marked and Drug Administration, 10903 New
Submit either electronic or written identified, as confidential, if submitted Hampshire Ave., Bldg. 31, Rm. 2417,
comments on this public meeting by as detailed in ‘‘Instructions.’’ Silver Spring, MD 20993–0002, 301–
July 11, 2018. Please note that late, Instructions: All submissions received 796–9001, Fax: 301–847–8533, email:
untimely filed comments will not be must include the Docket No. FDA– AMDAC@fda.hhs.gov, or FDA Advisory
considered. Electronic comments must 2018–N–1073 for ‘‘Antimicrobial Drugs Committee Information Line, 1–800–
be submitted on or before July 11, 2018. Advisory Committee; Notice of Meeting; 741–8138 (301–443–0572 in the
The https://www.regulations.gov Establishment of a Public Docket; Washington, DC area). A notice in the
sradovich on DSK3GMQ082PROD with NOTICES
electronic filing system will accept Request for Comments.’’ Received Federal Register about last minute
comments until midnight Eastern Time comments, those filed in a timely modifications that impact a previously
at the end of July 11, 2018. Comments manner (see ADDRESSES), will be placed announced advisory committee meeting
received by mail/hand delivery/courier in the docket and, except for those cannot always be published quickly
(for written/paper submissions) will be submitted as ‘‘Confidential enough to provide timely notice.
considered timely if they are Submissions,’’ publicly viewable at Therefore, you should always check the
postmarked or the delivery service https://www.regulations.gov or at the FDA’s website at https://www.fda.gov/
VerDate Sep<11>2014 17:24 Jun 25, 2018 Jkt 244001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 E:\FR\FM\26JNN1.SGM 26JNN1](https://thefederalregister.org/doc/83_FR_29913/page/1.svg)
![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
VerDate Sep<11>2014 17:24 Jun 25, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\26JNN1.SGM 26JNN1](https://thefederalregister.org/doc/83_FR_29913/page/2.svg)
Document Created: 2018-06-26 00:51:56
Document Modified: 2018-06-26 00:51:56
| 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 12, 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 29790 |
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