Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 46081-46083 [2017-21170]
Download as PDF
<![CDATA[
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
Application No.
Drug
ANDA 074801 .........................
Ketorolac Tromethamine Injection USP, 15 mg/mL and 30
mg/mL.
Buspirone HCl Tablets USP, 5 mg, 10 mg, and 15 mg .....
ANDA 075385 .........................
ANDA 075453 .........................
ANDA 076883 .........................
ANDA 077052 .........................
ANDA 077937 .........................
ANDA 078081 .........................
ANDA 078158 .........................
ANDA 078483 .........................
ANDA 080136 .........................
ANDA 080209 .........................
ANDA 080224 .........................
ANDA 083345 .........................
ANDA 083808 .........................
ANDA 084623 .........................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
084644
084710
085061
085933
086494
086821
087416
087546
087862
088147
.........................
.........................
.........................
.........................
.........................
.........................
.........................
.........................
.........................
.........................
ANDA 088367 .........................
ANDA 088542 .........................
ANDA 089162 .........................
ANDA 089347 .........................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
089393
089488
089521
089537
089744
089915
.........................
.........................
.........................
.........................
.........................
.........................
NDA 202258 ...........................
asabaliauskas on DSKBBXCHB2PROD with NOTICES
NDA 203093 ...........................
Applicant
Doxazosin Tablets USP, EQ 1 mg base, EQ 2 mg base,
EQ 4 mg base, and EQ 8 mg base.
Sotalol HCl Tablets USP, 80 mg, 120 mg, and 160 mg ....
Citalopram Hydrobromide Tablets, EQ 10 mg base, EQ
20 mg base, and EQ 40 mg base.
Meloxicam Tablets, 7.5 mg and 15 mg ..............................
Amlodipine Besylate Tablets, EQ 2.5 mg base, EQ 5 mg
base, and EQ 10 mg base.
Fosphenytoin Sodium Injection USP, EQ 50 mg Phenytoin Soudium/mL.
Zolpidem Tartrate Extended-Release Tablets USP, 6.25
mg and 12.5 mg.
Isoniazid Tablets, 100 mg ...................................................
Prednisone Tablets USP, 5 mg ..........................................
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA,
Inc.
Do.
Teva Pharmaceuticals USA, Inc.
Sun Pharmaceutical Industries, Inc.
Do.
Do.
Hospira, Inc.
Synthon Pharmaceuticals, Inc., 1007 Slater Rd., Suite 150, Durham, NC
27703.
Sun Pharmaceutical Industries, Inc.
Contract Pharmacal Corp., c/o SciRegs International Inc., 6333
Summercrest Dr., Columbia, MD 21045.
Hospira, Inc.
Sorbitol; Mannitol Irrigation Solution, 2.7 g/100 mL; 540
mg/100 mL.
Potassium Chloride for Injection Concentrate USP, 1
Do.
milliequivalent (mEQ)/mL, 1.5 mEQ/mL, and 2 mEQ/mL.
Quinidine Sulfate Tablets USP, 200 mg ............................. Contract Pharmacal Corp., c/o SciRegs International Inc.
Chlordiazepoxide HCl Capsules USP, 10 mg .................... Upsher-Smith Laboratories, Inc., 6701 Evenstad Dr., Maple Grove, MN
55369.
Chlordiazepoxide HCl Capsules USP, 5 mg ......................
Do.
Ogen (estropipate) Vaginal Cream USP, 1.5 mg/g ............ Pfizer Inc.
Folic Acid Tablets USP, 1 mg ............................................ Contract Pharmacal Corp., c/o SciRegs International Inc.
Phentermine HCl Tablets USP ........................................... Lemmon Co., 650 Cathill Rd., Sellersville, PA 18960.
Chlordiazepoxide HCl Capsules, 25 mg ............................. Teva Pharmaceuticals USA, Inc.
Hydroxyzine HCl Injection USP, 50 mg/mL ........................ Hospira, Inc.
Hydroxyzine HCl Injection USP, 25 mg/mL, Carpuject ......
Do.
Hydroxyzine HCl Injection USP, 50 mg/mL, Carpuject ......
Do.
Hydroxyzine HCl Tablets USP, 100 mg ............................. Sun Pharmaceutical Industries, Inc.
Aminophylline in Sodium Chloride 0.45% Injection, 100 Hospira, Inc.
mg/100 mL and 200 mg/100 mL.
Lidocaine HCl Injection USP, 10% .....................................
Do.
Lidocaine HCl Injection USP, 4% .......................................
Do.
Cyclopentolate HCl Ophthalmic Solution, 1% .................... Alcon Pharmaceuticals, Ltd., 6201 South Freeway TC–45, Fort Worth,
TX 76134.
Diatrizoate Meglumine and Diatrizoate Sodium Injection Bracco Diagnostics Inc., 259 Prospect Plains Rd., Bldg. H, Monroe
USP, 66%; 10%.
Township, NJ 08831.
Glycopyrrolate Injection USP, 0.2 mg/mL .......................... Hospira, Inc.
Diphenhydramine HCl Capsules, 25 mg ............................ Sun Pharmaceutical Industries, Inc.
Phenytoin Sodium Injection USP, 50 mg/mL, Ampule ....... Hospira, Inc.
Procainamide HCl Injection USP, 500 mg/mL, Carpuject ..
Do.
Phenytoin Sodium Injection USP, 50 mg/mL, Carpuject ....
Do.
Leucovorin Calcium for Injection, EQ 100 mg base/vial .... Pharmachemie B.V., c/o SICOR Pharmaceuticals, Inc., 19 Hughes,
Irvine, CA 92618.
Victrelis (boceprevir) Capsules, 200 mg ............................. Merck Sharp & Dohme Corp., Subsidiary of Merck & Company, Inc., 1
Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889.
Vitekta (elvitegravir) Tablets, 85 mg and 150 mg .............. Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn, effective
November 2, 2017. Introduction or
delivery for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
products that are listed in the table that
are in inventory on the date that this
notice becomes effective (see DATES)
may continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
VerDate Sep<11>2014
46081
16:49 Oct 02, 2017
Jkt 244001
Dated: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–21177 Filed 10–2–17; 8:45 am]
[Docket No. FDA–2017–N–4977]
BILLING CODE 4164–01–P
PO 00000
Food and Drug Administration
Joint Meeting of the
Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
SUMMARY:
Frm 00048
Fmt 4703
Sfmt 4703
E:\FR\FM\03OCN1.SGM
03OCN1
46082
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
advisory committee meeting of the
Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and Risk
Management Advisory Committee. The
general function of the committees 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 public meeting will be held
on October 31, 2017, from 8 a.m. to 5
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/AboutAdvisory
Committees/ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2017–N–4977.
The docket will close on October 27,
2017. Submit either electronic or
written comments on this public
meeting by October 27, 2017. Late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before October 27,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of October 27, 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
October 17, 2017, will be provided to
the committees. Comments received
after that date will be taken into
consideration by the Agency.
You may submit comments as
follows:
asabaliauskas on DSKBBXCHB2PROD with NOTICES
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
VerDate Sep<11>2014
16:49 Oct 02, 2017
Jkt 244001
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–4977 for
‘‘Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and Risk
Management 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 office
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
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
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 this 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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:
kalyani.bhatt@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
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 committees will discuss
new drug application (NDA) 209819,
buprenorphine subcutaneous injection,
submitted by Indivior Pharmaceuticals,
Inc., for treatment of opioid
dependence.
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/
E:\FR\FM\03OCN1.SGM
03OCN1
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
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 committees. All electronic
and written submissions submitted to
the Docket (see ADDRESSES) on or before
October 17, 2017, will be provided to
the committees. Oral presentations from
the public will be scheduled between
approximately 1 p.m. and 2 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 6, 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 10, 2017.
Persons attending FDA’s 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
Kalyani Bhatt 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/Advisory
Committees/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 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–21170 Filed 10–2–17; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:49 Oct 02, 2017
Jkt 244001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0502]
Range of Risk Evaluation and
Mitigation Strategies Platform
Standards Initiative: Needs
Assessment; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; request for comments.
The Food and Drug
Administration (FDA or the Agency) is
seeking public input on the design of
the REMS Platform Standards Initiative,
as well as methods and best practices
for its construction. To facilitate this,
FDA is making available the ‘‘REMS
Platform Standards Initiative: Needs
Assessment’’ (needs assessment), which
summarizes a range of risk evaluation
and mitigation strategies (REMS)
activities that could be standardized and
integrated into the health care system
through the use of electronic data
standards.
SUMMARY:
The comment period will be
open indefinitely.
DATES:
ADDRESSES:
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’’).
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
46083
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–
2013–N–0502 for ‘‘REMS Platform
Standards Initiative: Needs Assessment;
Request for Comments.’’ Received
comments 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 this 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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
E:\FR\FM\03OCN1.SGM
03OCN1
]]>Agencies
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46081-46083]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21170]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-4977]
Joint Meeting of the Psychopharmacologic Drugs Advisory Committee
and the Drug Safety and Risk Management 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
[[Page 46082]]
advisory committee meeting of the Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and Risk Management Advisory Committee.
The general function of the committees 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 public meeting will be held on October 31, 2017, from 8 a.m.
to 5 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-4977. The docket will close on October
27, 2017. Submit either electronic or written comments on this public
meeting by October 27, 2017. Late, untimely filed comments will not be
considered. Electronic comments must be submitted on or before October
27, 2017. The https://www.regulations.gov electronic filing system will
accept comments until midnight Eastern Time at the end of October 27,
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 October 17, 2017, will be provided
to the committees. 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-4977 for ``Psychopharmacologic Drugs Advisory Committee and
the Drug Safety and Risk Management 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 office 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 this 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.gpo.gov/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: kalyani.bhatt@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 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 committees will discuss new drug application (NDA)
209819, buprenorphine subcutaneous injection, submitted by Indivior
Pharmaceuticals, Inc., for treatment of opioid dependence.
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/
[[Page 46083]]
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 committees.
All electronic and written submissions submitted to the Docket (see
ADDRESSES) on or before October 17, 2017, will be provided to the
committees. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 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 6, 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 10, 2017.
Persons attending FDA's 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 Kalyani Bhatt 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 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21170 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P
