83 FR 28850 - 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 120 (June 21, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 120 (June 21, 2018)
| Page Range | 28850-28851 | |
| FR Document | 2018-13296 |
[Federal Register Volume 83, Number 120 (Thursday, June 21, 2018)] [Notices] [Pages 28850-28851] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-13296] ----------------------------------------------------------------------- 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 August 8, 2018, from 8:30 a.m. to 1 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 August 7, 2018. Submit either electronic or written comments on this public meeting by August 7, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before August 7, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of August 7, 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 24, 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 [[Page 28851]] 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: Lauren D. Tesh, 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/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 applications 209816, for omadacycline tablets, and 209817, for omadacycline injection, sponsored by Paratek Pharmaceuticals, Inc., for the proposed indications for the treatment of community acquired bacterial pneumonia and acute bacterial skin and skin structure infections. 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 ADDRESSES) on or before July 24, 2018, will be provided to the committee. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon. 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 16, 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 17, 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 Lauren Tesh (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 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-13296 Filed 6-20-18; 8:45 am] BILLING CODE 4164-01-P
![28850 Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices
• Federal eRulemaking Portal: National Occupational Research system will accept comments until
https://www.regulations.gov. Follow the Agenda for HCSA. Comments midnight Eastern Time at the end of
instructions for submitting comments. expressing support or with specific August 7, 2018. Comments received by
• Mail: National Institute for recommendations to improve the mail/hand delivery/courier (for written/
Occupational Safety and Health, NIOSH Agenda are requested. A copy of the paper submissions) will be considered
Docket Office, 1090 Tusculum Avenue, draft Agenda is available at https:// timely if they are postmarked or the
MS C–34, Cincinnati, Ohio 45226–1998. www.regulations.gov (see Docket delivery service acceptance receipt is on
Instructions: All submissions received Number CDC–2018–0050). or before that date.
in response to this notice must include Comments received on or before July
John J. Howard,
the agency name and docket number 24, 2018, will be provided to the
[CDC–2018–0050; NIOSH–314]. All Director, National Institute for Occupational committee. Comments received after
Safety and Health, Centers for Disease Control
relevant comments received will be that date will be taken into
and Prevention.
posted without change to https:// consideration by FDA.
[FR Doc. 2018–13308 Filed 6–20–18; 8:45 am]
www.regulations.gov, including any You may submit comments as
BILLING CODE 4163–19–P follows:
personal information provided. For
access to the docket to read background Electronic Submissions
documents or comments received, go to
DEPARTMENT OF HEALTH AND Submit electronic comments in the
https://www.regulations.gov. All
HUMAN SERVICES following way:
information received in response to this
notice will also be available for public • Federal eRulemaking Portal:
Food and Drug Administration https://www.regulations.gov. Follow the
examination and copying at the NIOSH
Docket Office, 1150 Tusculum Avenue, [Docket No. FDA–2018–N–1073] instructions for submitting comments.
Room 155, Cincinnati, OH 45226–1998. Comments submitted electronically,
Antimicrobial Drugs Advisory including attachments, to https://
FOR FURTHER INFORMATION CONTACT:
Committee; Notice of Meeting; www.regulations.gov will be posted to
Emily Novicki NORACoordinator@ Establishment of a Public Docket; the docket unchanged. Because your
cdc.gov), National Institute for Request for Comments comment will be made public, you are
Occupational Safety and Health, Centers
AGENCY: Food and Drug Administration, solely responsible for ensuring that your
for Disease Control and Prevention,
HHS. comment does not include any
Mailstop E–20, 1600 Clifton Road NE,
confidential information that you or a
Atlanta, GA 30329, phone (404) 498– ACTION: Notice; establishment of a
third party may not wish to be posted,
2581 (not a toll free number). public docket; request for comments.
such as medical information, your or
SUPPLEMENTARY INFORMATION: The anyone else’s Social Security number, or
SUMMARY: The Food and Drug
National Occupational Research Agenda confidential business information, such
Administration (FDA) announces a
(NORA) is a partnership program as a manufacturing process. Please note
forthcoming public advisory committee
created to stimulate innovative research that if you include your name, contact
meeting of the Antimicrobial Drugs
and improved workplace practices. The information, or other information that
Advisory Committee. The general
national agenda is developed and identifies you in the body of your
function of the committee is to provide
implemented through the NORA sector comments, that information will be
advice and recommendations to FDA on
and cross-sector councils. Each council posted on https://www.regulations.gov.
regulatory issues. The meeting will be
develops and maintains an agenda for • If you want to submit a comment
open to the public. FDA is establishing
its sector or cross-sector. with confidential information that you
Background: The National a docket for public comment on this
document. do not wish to be made available to the
Occupational Research Agenda for public, submit the comment as a
Healthcare and Social Assistance DATES: The meeting will be held on
written/paper submission and in the
(HCSA) is intended to identify the August 8, 2018, from 8:30 a.m. to 1 p.m. manner detailed (see ‘‘Written/Paper
research, information, and actions most ADDRESSES: FDA White Oak Campus, Submissions’’ and ‘‘Instructions’’).
urgently needed to prevent occupational 10903 New Hampshire Ave., Bldg. 31
injuries. The National Occupational Conference Center, the Great Room (Rm. Written/Paper Submissions
Research Agenda for HCSA provides a 1503), Silver Spring, MD 20993–0002. Submit written/paper submissions as
vehicle for stakeholders to describe the Answers to commonly asked questions follows:
most relevant issues, gaps, and safety including information regarding special • Mail/Hand delivery/Courier (for
and health needs for the sector. Each accommodations due to a disability, written/paper submissions): Dockets
NORA research agenda is meant to visitor parking, and transportation may Management Staff (HFA–305), Food and
guide or promote high priority research be accessed at: https://www.fda.gov/ Drug Administration, 5630 Fishers
efforts on a national level, conducted by AdvisoryCommittees/AboutAdvisory Lane, Rm. 1061, Rockville, MD 20852.
various entities, including: government, Committees/ucm408555.htm. • For written/paper comments
higher education, and the private sector. FDA is establishing a docket for submitted to the Dockets Management
The first National Occupational public comment on this meeting. The Staff, FDA will post your comment, as
Research Agenda for HCSA was docket number is FDA–2018–N–1073. well as any attachments, except for
published in 2009 for the second decade The docket will close on August 7, information submitted, marked and
of NORA (2006–2016). The revised 2018. Submit either electronic or identified, as confidential, if submitted
amozie on DSK3GDR082PROD with NOTICES1
agenda was developed considering new written comments on this public as detailed in ‘‘Instructions.’’
information about injuries and illnesses, meeting by August 7, 2018. Please note Instructions: All submissions received
the state of the science, and the that late, untimely filed comments will must include the Docket No. FDA–
probability that new information and not be considered. Electronic comments 2018–N–1073 for ‘‘Antimicrobial Drugs
approaches will make a difference. As must be submitted on or before August Advisory Committee; Notice of Meeting;
the steward of the NORA process, 7, 2018. The https:// Establishment of a Public Docket;
NIOSH invites comments on the draft www.regulations.gov electronic filing Request for Comments.’’ Received
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![Federal Register / Vol. 83, No. 120 / Thursday, June 21, 2018 / Notices 28851
comments, those filed in a timely modifications that impact a previously Persons attending FDA’s advisory
manner (see ADDRESSES), will be placed announced advisory committee meeting committee meetings are advised that
in the docket and, except for those cannot always be published quickly FDA is not responsible for providing
submitted as ‘‘Confidential enough to provide timely notice. access to electrical outlets.
Submissions,’’ publicly viewable at Therefore, you should always check the For press inquiries, please contact the
https://www.regulations.gov or at the FDA’s website at https://www.fda.gov/ Office of Media Affairs at fdaoma@
Dockets Management Staff between 9 AdvisoryCommittees/default.htm and fda.hhs.gov or 301–796–4540.
a.m. and 4 p.m., Monday through scroll down to the appropriate advisory FDA welcomes the attendance of the
Friday. committee meeting link, or call the public at its advisory committee
• Confidential Submissions—To advisory committee information line to meetings and will make every effort to
submit a comment with confidential learn about possible modifications accommodate persons with disabilities.
information that you do not wish to be before coming to the meeting. If you require accommodations due to a
made publicly available, submit your SUPPLEMENTARY INFORMATION: disability, please contact Lauren Tesh
comments only as a written/paper Agenda: The committee will discuss (see FOR FURTHER INFORMATION CONTACT)
submission. You should submit two new drug applications 209816, for at least 7 days in advance of the
copies total. One copy will include the omadacycline tablets, and 209817, for meeting.
information you claim to be confidential omadacycline injection, sponsored by FDA is committed to the orderly
with a heading or cover note that states Paratek Pharmaceuticals, Inc., for the conduct of its advisory committee
‘‘THIS DOCUMENT CONTAINS proposed indications for the treatment meetings. Please visit our website at
CONFIDENTIAL INFORMATION.’’ FDA of community acquired bacterial https://www.fda.gov/
will review this copy, including the pneumonia and acute bacterial skin and AdvisoryCommittees/AboutAdvisory
claimed confidential information, in its skin structure infections. Committees/ucm111462.htm for
consideration of comments. The second FDA intends to make background procedures on public conduct during
copy, which will have the claimed material available to the public no later advisory committee meetings.
confidential information redacted/ than 2 business days before the meeting. Notice of this meeting is given under
blacked out, will be available for public If FDA is unable to post the background the Federal Advisory Committee Act (5
viewing and posted on https:// material on its website prior to the U.S.C. app. 2).
www.regulations.gov. Submit both meeting, the background material will Dated: June 15, 2018.
copies to the Dockets Management Staff. be made publicly available at the Leslie Kux,
If you do not wish your name and location of the advisory committee Associate Commissioner for Policy.
contact information be made publicly meeting, and the background material [FR Doc. 2018–13296 Filed 6–20–18; 8:45 am]
available, you can provide this will be posted on FDA’s website after
information on the cover sheet and not BILLING CODE 4164–01–P
the meeting. Background material is
in the body of your comments and you available at https://www.fda.gov/
must identify the information as AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND
‘‘confidential.’’ Any information marked default.htm. Scroll down to the HUMAN SERVICES
as ‘‘confidential’’ will not be disclosed appropriate advisory committee meeting
except in accordance with 21 CFR 10.20 link. Food and Drug Administration
and other applicable disclosure law. For Procedure: Interested persons may
more information about FDA’s posting present data, information, or views, [Docket No. FDA–2018–D–1919]
of comments to public dockets, see 80 orally or in writing, on issues pending
FR 56469, September 18, 2015, or access Major Depressive Disorder: Developing
before the committee. All electronic and
the information at: https://www.gpo.gov/ Drugs for Treatment; Draft Guidance
written submissions submitted to the
fdsys/pkg/FR-2015-09-18/pdf/2015- for Industry; Availability
Docket (see ADDRESSES) on or before
23389.pdf. July 24, 2018, will be provided to the AGENCY: Food and Drug Administration,
Docket: For access to the docket to committee. Oral presentations from the HHS.
read background documents or the public will be scheduled between ACTION: Notice of availability.
electronic and written/paper comments approximately 11 a.m. and 12 noon.
received, go to https:// Those individuals interested in making SUMMARY: The Food and Drug
www.regulations.gov and insert the formal oral presentations should notify Administration (FDA or Agency) is
docket number, found in brackets in the the contact person and submit a brief announcing the availability of a draft
heading of this document, into the statement of the general nature of the guidance for industry entitled ‘‘Major
‘‘Search’’ box and follow the prompts evidence or arguments they wish to Depressive Disorder: Developing Drugs
and/or go to the Dockets Management present, the names and addresses of for Treatment.’’ The purpose of this
Staff, 5630 Fishers Lane, Rm. 1061, proposed participants, and an draft guidance is to assist sponsors in
Rockville, MD 20852. indication of the approximate time the clinical development of drugs for
FOR FURTHER INFORMATION CONTACT: requested to make their presentation on the monotherapeutic, combination, and
Lauren D. Tesh, Center for Drug or before July 16, 2018. Time allotted for adjunctive treatment of major
Evaluation and Research, Food and each presentation may be limited. If the depressive disorder (MDD). Specifically,
Drug Administration, 10903 New number of registrants requesting to this draft guidance addresses FDA’s
Hampshire Ave., Bldg. 31, Rm. 2417, speak is greater than can be reasonably current thinking regarding the overall
amozie on DSK3GDR082PROD with NOTICES1
Silver Spring, MD 20993–0002, 301– accommodated during the scheduled development program and clinical trial
796–9001, Fax: 301–847–8533, email: open public hearing session, FDA may designs for antidepressant drug
AMDAC@fda.hhs.gov, or FDA Advisory conduct a lottery to determine the products. This draft guidance is
Committee Information Line, 1–800– speakers for the scheduled open public intended to serve as a focus for
741–8138 (301–443–0572 in the hearing session. The contact person will continued discussions among FDA,
Washington, DC area). A notice in the notify interested persons regarding their pharmaceutical sponsors, the academic
Federal Register about last minute request to speak by July 17, 2018. community, and the public. This draft
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Document Created: 2018-06-21 01:23:31
Document Modified: 2018-06-21 01:23:31
| 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 August 8, 2018, from 8:30 a.m. to 1 p.m. | |
| Contact | Lauren D. Tesh, 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 28850 |
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