82 FR 45596 - 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 82, Issue 188 (September 29, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 188 (September 29, 2017)
| Page Range | 45596-45597 | |
| FR Document | 2017-20949 |
[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)] [Notices] [Pages 45596-45597] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20949] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-5315] 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 November 16, 2017, 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-2017-N-5315. The docket will close on November 15, 2017. Submit either electronic or written comments on this public meeting by November 15, 2017. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 15, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of November 15, 2017. 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 November 1, 2017, 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-2017-N-5315 for ``Antimicrobial Drugs [[Page 45597]] 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 to 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: [email protected], or the 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 FDA's Web site 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) 209367, ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (>=18 years of age) with respiratory bacterial pathogens. 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 Web site 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 Web site 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 November 1, 2017, 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 October 24, 2017. 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 October 25, 2017. Persons attending FDA's advisory committee meetings are advised that FDA 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 special accommodations due to a disability, please contact Lauren D. Tesh at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site 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: September 26, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-20949 Filed 9-28-17; 8:45 am] BILLING CODE 4164-01-P
![45596 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices
the FDA Emerging Technology Team III. Electronic Access before November 15, 2017. The https://
(ETT), which includes relevant Persons with access to the Internet www.regulations.gov electronic filing
representation from all FDA may obtain the guidance at either system will accept comments until
pharmaceutical quality functions. The https://www.fda.gov/Drugs/ midnight Eastern Time at the end of
ETT works in partnership with relevant GuidanceCompliance November 15, 2017. Comments received
pharmaceutical quality offices and RegulatoryInformation/Guidances/ by mail/hand delivery/courier (for
assumes a leadership or co-leadership default.htm or https://www.regulations. written/paper submissions) will be
role for the cross-functional quality gov. considered timely if they are
assessment team (including review and postmarked or the delivery service
Dated: September 22, 2017.
on-site facility evaluation or inspection) acceptance receipt is on or before that
for submissions involving emerging Anna K. Abram, date.
technology. Deputy Commissioner for Policy, Planning, Comments received on or before
Legislation, and Analysis. November 1, 2017, will be provided to
This guidance finalizes the draft
[FR Doc. 2017–20861 Filed 9–28–17; 8:45 am] the committee. Comments received after
guidance issued December 23, 2015 (80
FR 79907). It provides further BILLING CODE 4164–01–P that date will be taken into
clarification on the criteria that the consideration by FDA.
proposed technology needs to meet for You may submit comments as
DEPARTMENT OF HEALTH AND follows:
its acceptance into the Emerging
HUMAN SERVICES
Technology Program. It also clarifies Electronic Submissions
types of novel technology (e.g., product Food and Drug Administration
technology, manufacturing process, and Submit electronic comments in the
control strategy) that can be covered by [Docket No. FDA–2017–N–5315] following way:
• Federal eRulemaking Portal:
the program.
Antimicrobial Drugs Advisory https://www.regulations.gov. Follow the
This guidance is being issued Committee; Notice of Meeting; instructions for submitting comments.
consistent with FDA’s good guidance Establishment of a Public Docket; Comments submitted electronically,
practices regulation (21 CFR 10.115). Request for Comments including attachments, to https://
The guidance represents the current www.regulations.gov will be posted to
thinking of FDA on advancement of AGENCY: Food and Drug Administration,
the docket unchanged. Because your
emerging technology applications for HHS.
comment will be made public, you are
pharmaceutical innovation and ACTION: Notice; establishment of a solely responsible for ensuring that your
modernization. It does not establish any public docket; request for comments. comment does not include any
rights for any person and is not binding confidential information that you or a
on FDA or the public. You can use an SUMMARY: The Food and Drug
Administration (FDA) announces a third party may not wish to be posted,
alternative approach if it satisfies the such as medical information, your or
requirements of the applicable statutes forthcoming public advisory committee
meeting of the Antimicrobial Drugs anyone else’s Social Security number, or
and regulations. confidential business information, such
Advisory Committee. The general
II. The Paperwork Reduction Act of function of the committee is to provide as a manufacturing process. Please note
1995 advice and recommendations to FDA on that if you include your name, contact
regulatory issues. The meeting will be information, or other information that
This guidance refers to previously identifies you in the body of your
approved collections of information open to the public. FDA is establishing
a docket for public comment on this comments, that information will be
found in FDA regulations. These posted on https://www.regulations.gov.
collections of information are subject to document.
• If you want to submit a comment
review by the Office of Management and DATES: The meeting will be held on
with confidential information that you
Budget (OMB) under the Paperwork November 16, 2017, from 8:30 a.m. to 4 do not wish to be made available to the
Reduction Act of 1995 (44 U.S.C. 3501– p.m. public, submit the comment as a
3520). The information to be included ADDRESSES: FDA White Oak Campus, written/paper submission and in the
in a meeting request for a product 10903 New Hampshire Ave., Bldg. 31 manner detailed (see ‘‘Written/Paper
submitted in an IND, BLA, or NDA is Conference Center, the Great Room (Rm. Submissions’’ and ‘‘Instructions’’).
approved by OMB control number 1503), Silver Spring, MD 20993–0002.
0910–0429 (‘‘Guidance for Industry on Answers to commonly asked questions Written/Paper Submissions
Formal Meetings Between the FDA and including information regarding special Submit written/paper submissions as
Sponsors or Applicants’’). Information accommodations due to a disability, follows:
to be included in a meeting request for visitor parking, and transportation may • Mail/Hand delivery/Courier (for
a product submitted in an ANDA is be accessed at: https://www.fda.gov/ written/paper submissions): Dockets
approved by OMB control number AdvisoryCommittees/ Management Staff (HFA–305), Food and
0910–0797 (‘‘Guidance on Controlled AboutAdvisoryCommittees/ Drug Administration, 5630 Fishers
Correspondence Related to Generic Drug ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852.
Development’’). The submission of INDs FDA is establishing a docket for • For written/paper comments
asabaliauskas on DSKBBXCHB2PROD with NOTICES
under 21 CFR 312.23 is approved by public comment on this meeting. The submitted to the Dockets Management
OMB control number 0910–0014; the docket number is FDA–2017–N–5315. Staff, FDA will post your comment, as
submission of BLAs under 21 CFR 601.2 The docket will close on November 15, well as any attachments, except for
and 601.12 is approved by OMB control 2017. Submit either electronic or information submitted, marked and
number 0910–0338; and the submission written comments on this public identified, as confidential, if submitted
of NDAs and ANDAs under 21 CFR meeting by November 15, 2017. Please as detailed in ‘‘Instructions.’’
314.50, 314.70, 314.71, 314.94, and note that late, untimely filed comments Instructions: All submissions received
314.97 is approved by OMB control will not be considered. Electronic must include the Docket No. FDA–
number 0910–0001. comments must be submitted on or 2017–N–5315 for ‘‘Antimicrobial Drugs
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![Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 45597
Advisory Committee; Notice of Meeting; 1–800–741–8138 (301–443–0572 in the public hearing session. The contact
Establishment of a Public Docket; Washington, DC area). A notice in the person will notify interested persons
Request for Comments.’’ Received Federal Register about last minute regarding their request to speak by
comments, those filed in a timely modifications that impact a previously October 25, 2017.
manner (see ADDRESSES), will be placed announced advisory committee meeting Persons attending FDA’s advisory
in the docket and, except for those cannot always be published quickly committee meetings are advised that
submitted as ‘‘Confidential enough to provide timely notice. FDA is not responsible for providing
Submissions,’’ publicly viewable at Therefore, you should always check access to electrical outlets.
https://www.regulations.gov or at the FDA’s Web site at https://www.fda.gov/ FDA welcomes the attendance of the
Dockets Management Staff between 9 AdvisoryCommittees/default.htm and public at its advisory committee
a.m. and 4 p.m., Monday through scroll down to the appropriate advisory meetings and will make every effort to
Friday. committee meeting link, or call the accommodate persons with disabilities.
• Confidential Submissions—To advisory committee information line to If you require special accommodations
submit a comment with confidential learn about possible modifications due to a disability, please contact
information that you do not wish to be before coming to the meeting. Lauren D. Tesh at least 7 days in
made publicly available, submit your SUPPLEMENTARY INFORMATION:
advance of the meeting.
comments only as a written/paper FDA is committed to the orderly
Agenda: The committee will discuss
submission. You should submit two conduct of its advisory committee
new drug application (NDA) 209367,
copies total. One copy will include the meetings. Please visit our Web site at
ciprofloxacin inhalation powder,
information you claim to be confidential https://www.fda.gov/
sponsored by Bayer HealthCare
with a heading or cover note that states AdvisoryCommittees/
Pharmaceuticals, Inc., for the proposed
‘‘THIS DOCUMENT CONTAINS AboutAdvisoryCommittees/
indication of reduction of exacerbations
CONFIDENTIAL INFORMATION.’’ FDA ucm111462.htm for procedures on
in non-cystic fibrosis bronchiectasis
will review this copy, including the public conduct during advisory
(NCFB) adult patients (≥18 years of age)
claimed confidential information, in its committee meetings.
with respiratory bacterial pathogens. Notice of this meeting is given under
consideration of comments. The second FDA intends to make background
copy, which will have the claimed the Federal Advisory Committee Act (5
material available to the public no later U.S.C. app. 2).
confidential information redacted/ than 2 business days before the meeting.
blacked out, will be available for public If FDA is unable to post the background Dated: September 26, 2017.
viewing and posted on https:// material on its Web site prior to the Anna K. Abram,
www.regulations.gov. Submit both meeting, the background material will Deputy Commissioner for Policy, Planning,
copies to the Dockets Management Staff. be made publicly available at the Legislation, and Analysis.
If you do not wish your name and location of the advisory committee [FR Doc. 2017–20949 Filed 9–28–17; 8:45 am]
contact information to be made publicly meeting, and the background material BILLING CODE 4164–01–P
available, you can provide this will be posted on FDA’s Web site after
information on the cover sheet and not the meeting. Background material is
in the body of your comments and you available at https://www.fda.gov/ DEPARTMENT OF HEALTH AND
must identify the information as AdvisoryCommittees/Calendar/ HUMAN SERVICES
‘‘confidential.’’ Any information marked default.htm. Scroll down to the
as ‘‘confidential’’ will not be disclosed Food and Drug Administration
appropriate advisory committee meeting
except in accordance with 21 CFR 10.20 link. [Docket No. FDA–2017–N–5608]
and other applicable disclosure law. For Procedure: Interested persons may
more information about FDA’s posting present data, information, or views, Opioid Policy Steering Committee;
of comments to public dockets, see 80 orally or in writing, on issues pending Establishment of a Public Docket;
FR 56469, September 18, 2015, or access before the committee. All electronic and Request for Comments
the information at: https://www.gpo.gov/ written submissions submitted to the AGENCY: Food and Drug Administration,
fdsys/pkg/FR-2015-09-18/pdf/2015- Docket (see ADDRESSES) on or before HHS.
23389.pdf. November 1, 2017, will be provided to
Docket: For access to the docket to ACTION: Notice; request for comments.
the committee. Oral presentations from
read background documents or the the public will be scheduled between SUMMARY: The Food and Drug
electronic and written/paper comments approximately 1:30 p.m. and 2:30 p.m. Administration (FDA or Agency) is
received, go to https:// Those individuals interested in making establishing a public docket to solicit
www.regulations.gov and insert the formal oral presentations should notify suggestions, recommendations, and
docket number, found in brackets in the the contact person and submit a brief comments from interested parties,
heading of this document, into the statement of the general nature of the including patients and patient
‘‘Search’’ box and follow the prompts evidence or arguments they wish to representatives, health care
and/or go to the Dockets Management present, the names and addresses of professionals, academic institutions,
Staff, 5630 Fishers Lane, Rm. 1061, proposed participants, and an regulated industry, and other interested
Rockville, MD 20852. indication of the approximate time organizations, on questions relevant to
asabaliauskas on DSKBBXCHB2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT: requested to make their presentation on FDA’s newly established Opioid Policy
Lauren D. Tesh, Center for Drug or before October 24, 2017. Time Steering Committee (OPSC). Opioid
Evaluation and Research, Food and allotted for each presentation may be addiction and the resulting overdoses
Drug Administration, 10903 New limited. If the number of registrants and deaths have created a national
Hampshire Ave., Bldg. 31, Rm. 2417, requesting to speak is greater than can crisis, which requires action by federal
Silver Spring, MD 20993–0002, 301– be reasonably accommodated during the agencies that may in some instances be
796–9001, Fax: 301–847–8533, email: scheduled open public hearing session, unprecedented in order to address the
AMDAC@fda.hhs.gov, or the FDA FDA may conduct a lottery to determine situation and attempt to turn the tide on
Advisory Committee Information Line, the speakers for the scheduled open the crisis. As a public health agency
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Document Created: 2017-09-29 03:27:16
Document Modified: 2017-09-29 03:27:16
| 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 November 16, 2017, from 8:30 a.m. to 4 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 the 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 FDA's Web site 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 | 82 FR 45596 |
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