82 FR 38909 - Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management 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 157 (August 16, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 157 (August 16, 2017)
| Page Range | 38909-38910 | |
| FR Document | 2017-17303 |
[Federal Register Volume 82, Number 157 (Wednesday, August 16, 2017)] [Notices] [Pages 38909-38910] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-17303] ======================================================================= ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-4836] Joint Meeting of the Anesthetic and Analgesic Drug Products 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 advisory committee meeting of the Anesthetic and Analgesic Drug Products 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 September 14, 2017, from 8 a.m. to 12:30 p.m. ADDRESSES: Tommy Douglas Conference Center, the Ballroom, 10000 New Hampshire Ave., Silver Spring, MD 20903. Answers to commonly asked questions about FDA Advisory Committee meetings may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. Information about the Tommy Douglas Conference Center can be accessed at: https://www.tommydouglascenter.com/. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-4836. The docket will close on September 13, 2017. Submit either electronic or written comments on this public meeting by September 13, 2017. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before September 13, 2017. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of September 13, 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 August 30, 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-4836 for ``Anesthetic and Analgesic Drug Products 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 [[Page 38910]] 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.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: Stephanie L. Begansky, 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 committees will discuss supplemental new drug application (sNDA) 021306, for BUTRANS (buprenorphine) transdermal system submitted by Purdue Pharma L.P., evaluating BUTRANS in pediatric patients ages 7 through 16 years for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees will be asked to discuss the findings of the clinical study of BUTRANS conducted in pediatric patients, and whether they support additional labeling. 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 committees. All electronic and written submissions submitted to the docket (see ADDRESSES) on or before August 30, 2017, will be provided to the committees. Oral presentations from the public will be scheduled between approximately 10:15 a.m. and 11:15 a.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 August 22, 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 August 23, 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 Stephanie L. Begansky 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: August 11, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017-17303 Filed 8-15-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices 38909
health information, such as medical DEPARTMENT OF HEALTH AND acceptance receipt is on or before that
records or other individually HUMAN SERVICES date.
identifiable health information. In Comments received on or before
addition, your comment should not Food and Drug Administration August 30, 2017, will be provided to the
include any ‘‘trade secret or any committees. Comments received after
[Docket No. FDA–2017–N–4836]
commercial or financial information that date will be taken into
which . . . is privileged or Joint Meeting of the Anesthetic and consideration by the Agency.
confidential’’—as provided by Section Analgesic Drug Products Advisory You may submit comments as
Committee and the Drug Safety and follows:
6(f) of the FTC Act, 15 U.S.C. 46(f), and
FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2)— Risk Management Advisory Electronic Submissions
including in particular competitively Committee; Notice of Meeting; Submit electronic comments in the
sensitive information such as costs, Establishment of a Public Docket; following way:
sales statistics, inventories, formulas, Request for Comments • Federal eRulemaking Portal: https://
patterns, devices, manufacturing AGENCY: Food and Drug Administration, www.regulations.gov. Follow the
processes, or customer names. HHS. instructions for submitting comments.
Comments containing material for Comments submitted electronically,
ACTION: Notice; establishment of a
which confidential treatment is including attachments, to https://
public docket; request for comments.
requested must be filed in paper form, www.regulations.gov will be posted to
must be clearly labeled ‘‘Confidential,’’ SUMMARY: The Food and Drug the docket unchanged. Because your
and must comply with FTC Rule 4.9(c). Administration (FDA or Agency) comment will be made public, you are
announces a forthcoming public solely responsible for ensuring that your
In particular, the written request for
advisory committee meeting of the comment does not include any
confidential treatment that accompanies
Anesthetic and Analgesic Drug Products confidential information that you or a
the comment must include the factual third party may not wish to be posted,
and legal basis for the request, and must Advisory Committee and the Drug
Safety and Risk Management Advisory such as medical information, your or
identify the specific portions of the anyone else’s Social Security number, or
Committee. The general function of the
comment to be withheld from the public confidential business information, such
committees is to provide advice and
record. See FTC Rule 4.9(c). Your as a manufacturing process. Please note
recommendations to the Agency on
comment will be kept confidential only FDA’s regulatory issues. The meeting that if you include your name, contact
if the General Counsel grants your will be open to the public. FDA is information, or other information that
request in accordance with the law and establishing a docket for public identifies you in the body of your
the public interest. Once your comment comment on this document. comments, that information will be
has been posted on the public FTC Web posted on https://www.regulations.gov.
DATES: The public meeting will be held
site—as legally required by FTC Rule • If you want to submit a comment
on September 14, 2017, from 8 a.m. to
4.9(b)—we cannot redact or remove with confidential information that you
12:30 p.m.
your comment from the FTC Web site, do not wish to be made available to the
ADDRESSES: Tommy Douglas Conference public, submit the comment as a
unless you submit a confidentiality
Center, the Ballroom, 10000 New written/paper submission and in the
request that meets the requirements for
Hampshire Ave., Silver Spring, MD manner detailed (see ‘‘Written/Paper
such treatment under FTC Rule 4.9(c), 20903. Answers to commonly asked
and the General Counsel grants that Submissions’’ and ‘‘Instructions’’).
questions about FDA Advisory
request. Committee meetings may be accessed at: Written/Paper Submissions
Visit the Commission Web site at https://www.fda.gov/ Submit written/paper submissions as
https://www.ftc.gov to read this Notice. AdvisoryCommittees/ follows:
The FTC Act and other laws that the AboutAdvisoryCommittees/ • Mail/Hand delivery/Courier (for
Commission administers permit the ucm408555.htm. Information about the written/paper submissions): Dockets
collection of public comments to Tommy Douglas Conference Center can Management Staff (HFA–305), Food and
consider and use in this proceeding as be accessed at: https:// Drug Administration, 5630 Fishers
appropriate. The Commission will www.tommydouglascenter.com/. Lane, Rm. 1061, Rockville, MD 20852.
consider all timely and responsive FDA is establishing a docket for • For written/paper comments
public comments that it receives on or public comment on this meeting. The submitted to the Dockets Management
before October 16, 2017. You can find docket number is FDA–2017–N–4836. Staff, FDA will post your comment, as
more information, including routine The docket will close on September 13, well as any attachments, except for
uses permitted by the Privacy Act, in 2017. Submit either electronic or information submitted, marked and
written comments on this public identified, as confidential, if submitted
the Commission’s privacy policy, at
meeting by September 13, 2017. Please as detailed in ‘‘Instructions.’’
https://www.ftc.gov/site-information/
note that late, untimely filed comments Instructions: All submissions received
privacy-policy. must include the Docket No. FDA–
will not be considered. Electronic
David C. Shonka, comments must be submitted on or 2017–N–4836 for ‘‘Anesthetic and
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Acting General Counsel. before September 13, 2017. The https:// Analgesic Drug Products Advisory
[FR Doc. 2017–17318 Filed 8–15–17; 8:45 am]
www.regulations.gov electronic filing Committee and the Drug Safety and Risk
system will accept comments until Management Advisory Committee;
BILLING CODE 6750–01–P
midnight Eastern Time at the end of Notice of Meeting; Establishment of a
September 13, 2017. Comments received Public Docket; Request for Comments.’’
by mail/hand delivery/courier (for Received comments, those filed in a
written/paper submissions) will be timely manner (see ADDRESSES), will be
considered timely if they are placed in the docket and, except for
postmarked or the delivery service those submitted as ‘‘Confidential
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![38910 Federal Register / Vol. 82, No. 157 / Wednesday, August 16, 2017 / Notices
Submissions,’’ publicly viewable at Therefore, you should always check the speakers for the scheduled open public
https://www.regulations.gov or at the Agency’s Web site at https:// hearing session. The contact person will
Dockets Management Staff between 9 www.fda.gov/AdvisoryCommittees/ notify interested persons regarding their
a.m. and 4 p.m., Monday through default.htm and scroll down to the request to speak by August 23, 2017.
Friday. appropriate advisory committee meeting Persons attending FDA’s advisory
• Confidential Submissions—To link, or call the advisory committee committee meetings are advised that the
submit a comment with confidential information line to learn about possible Agency is not responsible for providing
information that you do not wish to be modifications before coming to the access to electrical outlets.
made publicly available, submit your meeting. FDA welcomes the attendance of the
comments only as a written/paper public at its advisory committee
SUPPLEMENTARY INFORMATION: Agenda:
submission. You should submit two meetings and will make every effort to
The committees will discuss accommodate persons with disabilities.
copies total. One copy will include the supplemental new drug application
information you claim to be confidential If you require special accommodations
(sNDA) 021306, for BUTRANS due to a disability, please contact
with a heading or cover note that states (buprenorphine) transdermal system
‘‘THIS DOCUMENT CONTAINS Stephanie L. Begansky at least 7 days in
submitted by Purdue Pharma L.P., advance of the meeting.
CONFIDENTIAL INFORMATION.’’ The evaluating BUTRANS in pediatric
Agency will review this copy, including FDA is committed to the orderly
patients ages 7 through 16 years for conduct of its advisory committee
the claimed confidential information, in management of pain severe enough to
its consideration of comments. The meetings. Please visit our Web site at
require daily, around-the-clock, long- https://www.fda.gov/
second copy, which will have the term opioid treatment and for which
claimed confidential information AdvisoryCommittees/
alternative treatment options are AboutAdvisoryCommittees/
redacted/blacked out, will be available inadequate. The committees will be
for public viewing and posted on ucm111462.htm for procedures on
asked to discuss the findings of the public conduct during advisory
https://www.regulations.gov. Submit clinical study of BUTRANS conducted committee meetings.
both copies to the Dockets Management in pediatric patients, and whether they Notice of this meeting is given under
Staff. If you do not wish your name and support additional labeling. the Federal Advisory Committee Act (5
contact information to be made publicly FDA intends to make background U.S.C. app. 2).
available, you can provide this material available to the public no later
information on the cover sheet and not Dated: August 11, 2017.
than 2 business days before the meeting.
in the body of your comments and you Anna K. Abram,
If FDA is unable to post the background
must identify this information as material on its Web site prior to the Deputy Commissioner for Policy, Planning,
‘‘confidential.’’ Any information marked Legislation, and Analysis.
meeting, the background material will
as ‘‘confidential’’ will not be disclosed be made publicly available at the [FR Doc. 2017–17303 Filed 8–15–17; 8:45 am]
except in accordance with 21 CFR 10.20 location of the advisory committee BILLING CODE 4164–01–P
and other applicable disclosure law. For meeting, and the background material
more information about FDA’s posting will be posted on FDA’s Web site after
of comments to public dockets, see 80 DEPARTMENT OF HEALTH AND
the meeting. Background material is
FR 56469, September 18, 2015, or access HUMAN SERVICES
available at https://www.fda.gov/
the information at: https://www.gpo.gov/ AdvisoryCommittees/Calendar/ Food and Drug Administration
fdsys/pkg/FR-2015-09-18/pdf/2015- default.htm. Scroll down to the
23389.pdf. appropriate advisory committee meeting [Docket No. FDA–2017–P–0495]
Docket: For access to the docket to link.
read background documents or the Procedure: Interested persons may Determination That CORDARONE
electronic and written/paper comments present data, information, or views, (Amiodarone Hydrochloride) Tablets,
received, go to https:// 200 milligrams, Were Not Withdrawn
orally or in writing, on issues pending
www.regulations.gov and insert the From Sale for Reasons of Safety or
before the committees. All electronic
docket number, found in brackets in the Effectiveness
and written submissions submitted to
heading of this document, into the the docket (see ADDRESSES) on or before AGENCY: Food and Drug Administration,
‘‘Search’’ box and follow the prompts August 30, 2017, will be provided to the HHS.
and/or go to the Dockets Management committees. Oral presentations from the ACTION: Notice.
Staff, 5630 Fishers Lane, Rm. 1061, public will be scheduled between
Rockville, MD 20852. approximately 10:15 a.m. and 11:15 a.m. SUMMARY: The Food and Drug
FOR FURTHER INFORMATION CONTACT: Those individuals interested in making Administration (FDA or Agency) has
Stephanie L. Begansky, Center for Drug formal oral presentations should notify determined that CORDARONE
Evaluation and Research, Food and the contact person and submit a brief (amiodarone hydrochloride) tablets, 200
Drug Administration, 10903 New statement of the general nature of the milligrams (mg), were not withdrawn
Hampshire Ave., Bldg. 31, Rm. 2417, evidence or arguments they wish to from sale for reasons of safety or
Silver Spring, MD 20993–0002, 301– present, the names and addresses of effectiveness. This determination means
796–9001, Fax: 301–847–8533, email: proposed participants, and an that FDA will not begin procedures to
withdraw approval of abbreviated new
asabaliauskas on DSKBBXCHB2PROD with NOTICES
AADPAC@fda.hhs.gov, or FDA indication of the approximate time
Advisory Committee Information Line, requested to make their presentation on drug applications (ANDAs) that refer to
1–800–741–8138 (301–443–0572 in the or before August 22, 2017. Time allotted this drug product, and it will allow FDA
Washington, DC area). A notice in the for each presentation may be limited. If to continue to approve ANDAs that refer
Federal Register about last minute the number of registrants requesting to to the product as long as they meet
modifications that impact a previously speak is greater than can be reasonably relevant legal and regulatory
announced advisory committee meeting accommodated during the scheduled requirements.
cannot always be published quickly open public hearing session, FDA may FOR FURTHER INFORMATION CONTACT:
enough to provide timely notice. conduct a lottery to determine the Jennifer Forde, Center for Drug
VerDate Sep<11>2014 18:33 Aug 15, 2017 Jkt 241001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 E:\FR\FM\16AUN1.SGM 16AUN1](https://thefederalregister.org/doc/82_FR_39066/page/2.svg)
Document Created: 2017-08-16 10:26:58
Document Modified: 2017-08-16 10:26:58
| 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 public meeting will be held on September 14, 2017, from 8 a.m. to 12:30 p.m. | |
| Contact | Stephanie L. Begansky, 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 38909 |
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