82 FR 56975 - 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 230 (December 1, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 230 (December 1, 2017)
| Page Range | 56975-56976 | |
| FR Document | 2017-25911 |
[Federal Register Volume 82, Number 230 (Friday, December 1, 2017)] [Notices] [Pages 56975-56976] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-25911] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6293] 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 or Agency) 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 the Agency on FDA's 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 January 11, 2018, from 8:30 a.m. to 4 p.m. ADDRESSES: College Park Marriott Hotel and Conference Center, Chesapeake Ballroom, 3501 University Blvd. East, Hyattsville, MD 20783. The conference center's telephone number is 301-985-7300. Answers to commonly asked questions about FDA Advisory Committee meetings 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-6293. The docket will close on January 10, 2018. Submit either electronic or written comments on this public meeting by January 10, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 10, 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 December 27, 2017, will be provided to the committee. Comments received after that date will be taken into consideration by the Agency. 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-6293 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.'' The Agency 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 [[Page 56976]] 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 FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's 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) 210693, ciprofloxacin dispersion for inhalation, sponsored by Aradigm Corp., for the proposed indication of treatment of non-cystic fibrosis bronchiectasis patients with chronic lung infections with Pseudomonas aeruginosa. 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 December 27, 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 December 18, 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 December 19, 2017. Persons attending FDAs advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require 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: November 24, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-25911 Filed 11-30-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices 56975
has identified no data or other FDA’s regulatory issues. The meeting comments, that information will be
information suggesting that these will be open to the public. FDA is posted on https://www.regulations.gov.
products were withdrawn for reasons of establishing a docket for public • If you want to submit a comment
safety or effectiveness. We have comment on this document. with confidential information that you
carefully reviewed our files for records DATES: The meeting will be held on do not wish to be made available to the
concerning the withdrawal of January 11, 2018, from 8:30 a.m. to 4 public, submit the comment as a
METICORTEN (prednisone) tablets, 1 p.m. written/paper submission and in the
mg and 5 mg, from sale. We have also manner detailed (see ‘‘Written/Paper
ADDRESSES: College Park Marriott Hotel Submissions’’ and ‘‘Instructions’’).
independently evaluated relevant
and Conference Center, Chesapeake
literature and data for possible Written/Paper Submissions
Ballroom, 3501 University Blvd. East,
postmarketing adverse events. We have
Hyattsville, MD 20783. The conference Submit written/paper submissions as
reviewed the available evidence and
center’s telephone number is 301–985– follows:
determined that this drug product was
not withdrawn from sale for reasons of
7300. Answers to commonly asked • Mail/Hand delivery/Courier (for
questions about FDA Advisory written/paper submissions): Dockets
safety or effectiveness.
Committee meetings may be accessed at: Management Staff (HFA–305), Food and
Accordingly, the Agency will
https://www.fda.gov/Advisory Drug Administration, 5630 Fishers
continue to list METICORTEN
Committees/AboutAdvisoryCommittees/ Lane, Rm. 1061, Rockville, MD 20852.
(prednisone) tablets, 1 mg and 5 mg, in • For written/paper comments
ucm408555.htm.
the ‘‘Discontinued Drug Product List’’ submitted to the Dockets Management
FDA is establishing a docket for
section of the Orange Book. The Staff, FDA will post your comment, as
public comment on this meeting. The
‘‘Discontinued Drug Product List’’ well as any attachments, except for
docket number is FDA–2017–N–6293.
delineates, among other items, drug information submitted, marked and
The docket will close on January 10,
products that have been discontinued identified, as confidential, if submitted
2018. Submit either electronic or
from marketing for reasons other than as detailed in ‘‘Instructions.’’
written comments on this public
safety or effectiveness. FDA will not Instructions: All submissions received
meeting by January 10, 2018. Please
begin procedures to withdraw approval must include the Docket No. FDA–
note that late, untimely filed comments
of approved ANDAs that refer to this 2017–N–6293 for ‘‘Antimicrobial Drugs
will not be considered. Electronic
drug product. Additional ANDAs for Advisory Committee; Notice of Meeting;
comments must be submitted on or
this drug product may also be approved Establishment of a Public Docket;
before January 10, 2018. The https://
by the Agency as long as they meet all Request for Comments.’’ Received
www.regulations.gov electronic filing
other legal and regulatory requirements comments, those filed in a timely
system will accept comments until
for the approval of ANDAs. If FDA manner (see ADDRESSES), will be placed
midnight Eastern Time at the end of
determines that labeling for this drug in the docket and, except for those
January 10, 2018. Comments received by
product should be revised to meet submitted as ‘‘Confidential
mail/hand delivery/courier (for written/
current standards, the Agency will Submissions,’’ publicly viewable at
paper submissions) will be considered
advise ANDA applicants to submit such https://www.regulations.gov or at the
timely if they are postmarked or the
labeling. Dockets Management Staff between 9
delivery service acceptance receipt is on
Dated: November 27, 2017. or before that date. a.m. and 4 p.m., Monday through
Leslie Kux, Comments received on or before Friday.
Associate Commissioner for Policy. December 27, 2017, will be provided to • Confidential Submissions—To
[FR Doc. 2017–25900 Filed 11–30–17; 8:45 am] the committee. Comments received after submit a comment with confidential
that date will be taken into information that you do not wish to be
BILLING CODE 4164–01–P
consideration by the Agency. made publicly available, submit your
You may submit comments as comments only as a written/paper
DEPARTMENT OF HEALTH AND follows: submission. You should submit two
HUMAN SERVICES copies total. One copy will include the
Electronic Submissions information you claim to be confidential
Food and Drug Administration Submit electronic comments in the with a heading or cover note that states
following way: ‘‘THIS DOCUMENT CONTAINS
[Docket No. FDA–2017–N–6293] • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
https://www.regulations.gov. Follow the Agency will review this copy, including
Antimicrobial Drugs Advisory
instructions for submitting comments. the claimed confidential information, in
Committee; Notice of Meeting;
Comments submitted electronically, its consideration of comments. The
Establishment of a Public Docket;
including attachments, to https://www. second copy, which will have the
Request for Comments
regulations.gov will be posted to the claimed confidential information
AGENCY: Food and Drug Administration, docket unchanged. Because your redacted/blacked out, will be available
HHS. comment will be made public, you are for public viewing and posted on
ACTION: Notice; establishment of a solely responsible for ensuring that your https://www.regulations.gov. Submit
public docket; request for comments. comment does not include any both copies to the Dockets Management
confidential information that you or a Staff. If you do not wish your name and
SUMMARY: The Food and Drug third party may not wish to be posted, contact information to be made publicly
sradovich on DSK3GMQ082PROD with NOTICES
Administration (FDA or Agency) such as medical information, your or available, you can provide this
announces a forthcoming public anyone else’s Social Security number, or information on the cover sheet and not
advisory committee meeting of the confidential business information, such in the body of your comments and you
Antimicrobial Drugs Advisory as a manufacturing process. Please note must identify the information as
Committee. The general function of the that if you include your name, contact ‘‘confidential.’’ Any information marked
committee is to provide advice and information, or other information that as ‘‘confidential’’ will not be disclosed
recommendations to the Agency on identifies you in the body of your except in accordance with 21 CFR 10.20
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![56976 Federal Register / Vol. 82, No. 230 / Friday, December 1, 2017 / Notices
and other applicable disclosure law. For location of the advisory committee public conduct during advisory
more information about FDA’s posting meeting, and the background material committee meetings.
of comments to public dockets, see 80 will be posted on FDA’s Web site after Notice of this meeting is given under
FR 56469, September 18, 2015, or access the meeting. Background material is the Federal Advisory Committee Act (5
the information at: https://www.gpo.gov/ available at https://www.fda.gov/ U.S.C. app. 2).
fdsys/pkg/FR-2015-09-18/pdf/2015- AdvisoryCommittees/Calendar/ Dated: November 24, 2017.
23389.pdf. default.htm. Scroll down to the Leslie Kux,
Docket: For access to the docket to appropriate advisory committee meeting
read background documents or the Associate Commissioner for Policy.
link.
electronic and written/paper comments [FR Doc. 2017–25911 Filed 11–30–17; 8:45 am]
Procedure: Interested persons may
received, go to https://www. present data, information, or views,
BILLING CODE 4164–01–P
regulations.gov and insert the docket orally or in writing, on issues pending
number, found in brackets in the before the committee. All electronic and
heading of this document, into the DEPARTMENT OF HEALTH AND
written submissions submitted to the HUMAN SERVICES
‘‘Search’’ box and follow the prompts Docket (see ADDRESSES) on or before
and/or go to the Dockets Management
December 27, 2017, will be provided to Food and Drug Administration
Staff, 5630 Fishers Lane, Rm. 1061,
the committee. Oral presentations from
Rockville, MD 20852. [Docket No. FDA–2017–N–6591]
the public will be scheduled between
FOR FURTHER INFORMATION CONTACT: approximately 1:30 p.m. and 2:30 p.m.
Lauren D. Tesh, Center for Drug Barr Laboratories, Inc. et al.;
Those individuals interested in making
Evaluation and Research, Food and Withdrawal of Approval of 68
formal oral presentations should notify
Drug Administration, 10903 New Abbreviated New Drug Applications
the contact person and submit a brief
Hampshire Ave., Bldg. 31, Rm. 2417, statement of the general nature of the AGENCY: Food and Drug Administration,
Silver Spring, MD 20993–0002, 301– evidence or arguments they wish to HHS.
796–9001, Fax: 301–847–8533, email: present, the names and addresses of
AMDAC@fda.hhs.gov, or FDA Advisory ACTION: Notice.
proposed participants, and an
Committee Information Line, 1–800– indication of the approximate time SUMMARY: The Food and Drug
741–8138 (301–443–0572 in the requested to make their presentation on Administration (FDA or Agency) is
Washington, DC area). A notice in the or before December 18, 2017. Time withdrawing approval of 68 abbreviated
Federal Register about last minute allotted for each presentation may be new drug applications (ANDAs) from
modifications that impact a previously limited. If the number of registrants multiple applicants. The holders of the
announced advisory committee meeting requesting to speak is greater than can applications notified the Agency in
cannot always be published quickly be reasonably accommodated during the writing that the drug products were no
enough to provide timely notice. scheduled open public hearing session, longer marketed and requested that the
Therefore, you should always check the FDA may conduct a lottery to determine approval of the applications be
Agency’s Web site at https:// the speakers for the scheduled open withdrawn.
www.fda.gov/AdvisoryCommittees/ public hearing session. The contact
default.htm and scroll down to the DATES: Approval is withdrawn as of
person will notify interested persons January 2, 2018.
appropriate advisory committee meeting regarding their request to speak by
link, or call the advisory committee December 19, 2017. FOR FURTHER INFORMATION CONTACT:
information line to learn about possible Trang Tran, Center for Drug Evaluation
modifications before coming to the Persons attending FDAs advisory and Research, Food and Drug
meeting. committee meetings are advised that the Administration, 10903 New Hampshire
Agency is not responsible for providing Ave., Bldg. 75, Rm. 1671, Silver Spring,
SUPPLEMENTARY INFORMATION: access to electrical outlets.
Agenda: The committee will discuss MD 20993–0002, 240–402–7945.
new drug application (NDA) 210693, FDA welcomes the attendance of the SUPPLEMENTARY INFORMATION: The
ciprofloxacin dispersion for inhalation, public at its advisory committee holders of the applications listed in
sponsored by Aradigm Corp., for the meetings and will make every effort to table 1 in this document have informed
proposed indication of treatment of non- accommodate persons with disabilities. FDA that these drug products are no
cystic fibrosis bronchiectasis patients If you require special accommodations longer marketed and have requested that
with chronic lung infections with due to a disability, please contact FDA withdraw approval of the
Pseudomonas aeruginosa. Lauren D. Tesh at least 7 days in applications under the process in
FDA intends to make background advance of the meeting. § 314.150(c) (21 CFR 314.150(c)). The
material available to the public no later FDA is committed to the orderly applicants have also, by their requests,
than 2 business days before the meeting. conduct of its advisory committee waived their opportunity for a hearing.
If FDA is unable to post the background meetings. Please visit our Web site at Withdrawal of approval of an
material on its Web site prior to the https://www.fda.gov/Advisory application or abbreviated application
meeting, the background material will Committees/AboutAdvisoryCommittees/ under § 314.150(c) is without prejudice
be made publicly available at the ucm111462.htm for procedures on to refiling.
TABLE 1
sradovich on DSK3GMQ082PROD with NOTICES
Application No. Drug Applicant
ANDA 040135 ......... Estropipate Tablets USP, 0.75 milligrams (mg), 1.5 mg, Barr Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
and 3 mg. USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 040755 ......... Carisoprodol Tablets USP, 350 mg ...................................... Sun Pharmaceutical Industries, Ltd., c/o Sun Pharma-
ceutical Industries, Inc., 270 Prospect Plains Rd.,
Cranbury, NJ 08512.
VerDate Sep<11>2014 16:44 Nov 30, 2017 Jkt 244001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\01DEN1.SGM 01DEN1](https://thefederalregister.org/doc/82_FR_57205/page/2.svg)
Document Created: 2018-10-25 10:45:29
Document Modified: 2018-10-25 10:45:29
| 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 January 11, 2018, 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 FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency's 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 56975 |
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