82 FR 13608 - 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 48 (March 14, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 48 (March 14, 2017)
| Page Range | 13608-13609 | |
| FR Document | 2017-04983 |
[Federal Register Volume 82, Number 48 (Tuesday, March 14, 2017)] [Notices] [Pages 13608-13609] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-04983] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-1062] 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) 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. At least one portion of the meeting will be closed to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on April 5, 2017, from 8 a.m. to 5 p.m. ADDRESSES: Tommy Douglas Conference Center, the Ballroom, 10000 New Hampshire Ave., Silver Spring, MD 20903. The conference center's telephone number is 240-645-4000. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm. 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-1062 for ``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.'' 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 Division of Dockets Management 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 [[Page 13609]] 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. 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 Division of Dockets Management, 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 http://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) 209777, for oxycodone hydrochloride immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC., with the proposed indication of management of moderate to severe pain where the use of an opioid analgesic is appropriate. The product has been formulated with properties intended to deter abuse, and the applicant has submitted data to support these abuse-deterrent properties for this product. The committees will be asked to discuss the overall risk-benefit profile of the product, and whether the applicant has demonstrated abuse-deterrent properties for their product that would support 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 http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: On April 5, 2017, from 9:15 a.m. to 5 p.m., the meeting is open to the public. 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 the Addresses section) on or before March 22, 2017, will be provided to the committees. 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 March 14, 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 March 15, 2017. Closed Committee Deliberations: On April 5, 2017, from 8 a.m. to 9:15 a.m., the meeting will be closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the committees will discuss the drug development program of an investigational abuse-deterrent opioid product. Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2017-N-1062. The docket will close on April 4, 2017. Comments received on or before March 22, 2017, will be provided to the committees. Comments received after that date will be taken into consideration by the Agency. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact 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 http://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: March 9, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-04983 Filed 3-13-17; 8:45 am] BILLING CODE 4164-01-P
![13608 Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices
the information collection plan and transmit or otherwise disclose the Comments submitted electronically,
instruments, contact the Information information. including attachments, to https://
Collection Review Office, Centers for www.regulations.gov will be posted to
Leroy A. Richardson,
Disease Control and Prevention, 1600 the docket unchanged. Because your
Chief, Information Collection Review Office, comment will be made public, you are
Clifton Road NE., MS–D74, Atlanta, Office of Scientific Integrity, Office of the
Georgia 30329; phone: 404–639–7570; solely responsible for ensuring that your
Associate Director for Science, Office of the
Email: omb@cdc.gov. Director, Centers for Disease Control and comment does not include any
Prevention. confidential information that you or a
SUPPLEMENTARY INFORMATION: Under the third party may not wish to be posted,
[FR Doc. 2017–04942 Filed 3–13–17; 8:45 am]
Paperwork Reduction Act of 1995 (PRA) such as medical information, your or
BILLING CODE 4163–18–P
(44 U.S.C. 3501–3520), Federal agencies anyone else’s Social Security number, or
must obtain approval from the Office of confidential business information, such
Management and Budget (OMB) for each DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
collection of information they conduct HUMAN SERVICES that if you include your name, contact
or sponsor. In addition, the PRA also information, or other information that
requires Federal agencies to provide Food and Drug Administration identifies you in the body of your
notice in the Federal Register comments, that information will be
[Docket No. FDA–2017–N–1062] posted on https://www.regulations.gov.
concerning each proposed collection of
information, including each new • If you want to submit a comment
Joint Meeting of the Anesthetic and
with confidential information that you
proposed collection, each proposed Analgesic Drug Products Advisory
do not wish to be made available to the
extension of existing collection of Committee and the Drug Safety and public, submit the comment as a
information, and each reinstatement of Risk Management Advisory written/paper submission and in the
previously approved information Committee; Notice of Meeting; manner detailed (see ‘‘Written/Paper
collection before submitting the Establishment of a Public Docket; Submissions’’ and ‘‘Instructions’’).
collection to OMB for approval. Request for Comments
Written/Paper Submissions
Comments are invited on: (a) Whether AGENCY: Food and Drug Administration,
the proposed collection of information HHS. Submit written/paper submissions as
is necessary for the proper performance follows:
ACTION: Notice; establishment of a • Mail/Hand delivery/Courier (for
of the functions of the agency, including public docket; request for comments. written/paper submissions): Division of
whether the information shall have
SUMMARY: The Food and Drug Dockets Management (HFA–305), Food
practical utility; (b) The accuracy of the
Administration (FDA) announces a and Drug Administration, 5630 Fishers
agency’s estimate of the burden of the
forthcoming public advisory committee Lane, Rm. 1061, Rockville, MD 20852.
proposed collection of information; (c) • For written/paper comments
Ways to enhance the quality, utility, and meeting of the Anesthetic and Analgesic
Drug Products Advisory Committee and submitted to the Division of Dockets
clarity of the information to be Management, FDA will post your
collected; (d) Ways to minimize the the Drug Safety and Risk Management
Advisory Committee. The general comment, as well as any attachments,
burden of the collection of information except for information submitted,
function of the committees is to provide
on respondents, including through the marked and identified, as confidential,
advice and recommendations to the
use of automated collection techniques if submitted as detailed in
Agency on FDA’s regulatory issues. At
or other forms of information least one portion of the meeting will be ‘‘Instructions.’’
technology; and (e) Estimates of capital Instructions: All submissions received
closed to the public. FDA is establishing
or start-up costs and costs of operation, must include the Docket No. FDA–
a docket for public comment on this
maintenance, and purchase of services 2017–N–1062 for ‘‘Joint Meeting of the
document.
to provide information. Burden means Anesthetic and Analgesic Drug Products
the total time, effort, or financial DATES: The meeting will be held on Advisory Committee and the Drug
resources expended by persons to April 5, 2017, from 8 a.m. to 5 p.m. Safety and Risk Management Advisory
generate, maintain, retain, disclose or ADDRESSES: Tommy Douglas Conference Committee; Notice of Meeting;
provide information to or for a Federal Center, the Ballroom, 10000 New Establishment of a Public Docket;
agency. This includes the time needed Hampshire Ave., Silver Spring, MD Request for Comments.’’ Received
to review instructions; to develop, 20903. The conference center’s comments will be placed in the docket
telephone number is 240–645–4000. and, except for those submitted as
acquire, install and utilize technology
Answers to commonly asked questions ‘‘Confidential Submissions,’’ publicly
and systems for the purpose of
including information regarding special viewable at https://www.regulations.gov
collecting, validating and verifying
accommodations due to a disability, or at the Division of Dockets
information, processing and Management between 9 a.m. and 4 p.m.,
visitor parking, and transportation may
maintaining information, and disclosing be accessed at: http://www.fda.gov/ Monday through Friday.
and providing information; to train AdvisoryCommittees/ • Confidential Submissions—To
personnel and to be able to respond to AboutAdvisoryCommittees/ submit a comment with confidential
a collection of information, to search information that you do not wish to be
asabaliauskas on DSK3SPTVN1PROD with NOTICES
ucm408555.htm. You may submit
data sources, to complete and review comments as follows: made publicly available, submit your
the collection of information; and to comments only as a written/paper
Electronic Submissions submission. You should submit two
Submit electronic comments in the copies total. One copy will include the
following way: information you claim to be confidential
• Federal eRulemaking Portal: with a heading or cover note that states
https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ The
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![Federal Register / Vol. 82, No. 48 / Tuesday, March 14, 2017 / Notices 13609
Agency will review this copy, including the proposed indication of management During this session, the committees will
the claimed confidential information, in of moderate to severe pain where the discuss the drug development program
its consideration of comments. The use of an opioid analgesic is of an investigational abuse-deterrent
second copy, which will have the appropriate. The product has been opioid product.
claimed confidential information formulated with properties intended to Persons attending FDA’s advisory
redacted/blacked out, will be available deter abuse, and the applicant has committee meetings are advised that the
for public viewing and posted on submitted data to support these abuse- Agency is not responsible for providing
https://www.regulations.gov. Submit deterrent properties for this product. access to electrical outlets.
both copies to the Division of Dockets The committees will be asked to discuss FDA is establishing a docket for
Management. If you do not wish your the overall risk-benefit profile of the public comment on this meeting. The
name and contact information to be product, and whether the applicant has docket number is FDA–2017–N–1062.
made publicly available, you can demonstrated abuse-deterrent properties The docket will close on April 4, 2017.
provide this information on the cover for their product that would support Comments received on or before March
sheet and not in the body of your labeling. 22, 2017, will be provided to the
comments and you must identify this FDA intends to make background committees. Comments received after
information as ‘‘confidential.’’ Any material available to the public no later that date will be taken into
information marked as ‘‘confidential’’ than 2 business days before the meeting. consideration by the Agency.
will not be disclosed except in If FDA is unable to post the background FDA welcomes the attendance of the
accordance with 21 CFR 10.20 and other material on its Web site prior to the public at its advisory committee
applicable disclosure law. For more meeting, the background material will meetings and will make every effort to
information about FDA’s posting of be made publicly available at the accommodate persons with disabilities.
comments to public dockets, see 80 FR location of the advisory committee If you require accommodations due to a
56469, September 18, 2015, or access meeting, and the background material disability, please contact Stephanie L.
the information at: http://www.fda.gov/ will be posted on FDA’s Web site after Begansky at least 7 days in advance of
regulatoryinformation/dockets/ the meeting. Background material is the meeting.
default.htm. available at http://www.fda.gov/ FDA is committed to the orderly
Docket: For access to the docket to AdvisoryCommittees/Calendar/ conduct of its advisory committee
read background documents or the default.htm. Scroll down to the meetings. Please visit our Web site at
electronic and written/paper comments appropriate advisory committee meeting http://www.fda.gov/
received, go to https:// link. AdvisoryCommittees/
www.regulations.gov and insert the Procedure: On April 5, 2017, from AboutAdvisoryCommittees/
docket number, found in brackets in the 9:15 a.m. to 5 p.m., the meeting is open ucm111462.htm for procedures on
heading of this document, into the to the public. Interested persons may
public conduct during advisory
‘‘Search’’ box and follow the prompts present data, information, or views,
committee meetings.
and/or go to the Division of Dockets orally or in writing, on issues pending
Notice of this meeting is given under
Management, 5630 Fishers Lane, Rm. before the committees. All electronic
the Federal Advisory Committee Act (5
1061, Rockville, MD 20852. and written submissions submitted to
U.S.C. app. 2).
the Docket (see the Addresses section)
FOR FURTHER INFORMATION CONTACT: Dated: March 9, 2017.
on or before March 22, 2017, will be
Stephanie L. Begansky, Center for Drug
provided to the committees. Oral Leslie Kux,
Evaluation and Research, Food and
presentations from the public will be Associate Commissioner for Policy.
Drug Administration, 10903 New
scheduled between approximately 1:30 [FR Doc. 2017–04983 Filed 3–13–17; 8:45 am]
Hampshire Ave., Bldg. 31, Rm. 2417,
p.m. and 2:30 p.m. Those individuals BILLING CODE 4164–01–P
Silver Spring, MD 20993–0002, 301–
interested in making formal oral
796–9001, FAX: 301–847–8533, email:
presentations should notify the contact
AADPAC@fda.hhs.gov, or FDA person and submit a brief statement of
Advisory Committee Information Line, DEPARTMENT OF HEALTH AND
the general nature of the evidence or HUMAN SERVICES
1–800–741–8138 (301–443–0572 in the arguments they wish to present, the
Washington, DC area). A notice in the names and addresses of proposed Food and Drug Administration
Federal Register about last minute participants, and an indication of the
modifications that impact a previously approximate time requested to make
[Docket No. FDA–2017–N–1129]
announced advisory committee meeting their presentation on or before March
cannot always be published quickly Medical Devices; Exemptions From
14, 2017. Time allotted for each Premarket Notification: Class II
enough to provide timely notice. presentation may be limited. If the
Therefore, you should always check the Devices; Request for Comments
number of registrants requesting to
Agency’s Web site at http:// speak is greater than can be reasonably AGENCY: Food and Drug Administration,
www.fda.gov/AdvisoryCommittees/ accommodated during the scheduled HHS.
default.htm and scroll down to the open public hearing session, FDA may ACTION: Notice; request for comments.
appropriate advisory committee meeting conduct a lottery to determine the
link, or call the advisory committee speakers for the scheduled open public SUMMARY: The Food and Drug
information line to learn about possible hearing session. The contact person will Administration (FDA or Agency) has
asabaliauskas on DSK3SPTVN1PROD with NOTICES
modifications before coming to the notify interested persons regarding their identified a list of class II devices that,
meeting. request to speak by March 15, 2017. when finalized, will be exempt from
SUPPLEMENTARY INFORMATION: Closed Committee Deliberations: On premarket notification requirements,
Agenda: The committees will discuss April 5, 2017, from 8 a.m. to 9:15 a.m., subject to certain limitations. FDA is
new drug application (NDA) 209777, for the meeting will be closed to permit publishing this notice of that
oxycodone hydrochloride immediate- discussion and review of trade secret determination and requesting public
release oral tablets, submitted by and/or confidential commercial comment in accordance with
Inspirion Delivery Sciences, LLC., with information (5 U.S.C. 552b(c)(4)). procedures established by the 21st
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Document Created: 2017-03-14 02:52:12
Document Modified: 2017-03-14 02:52:12
| 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 April 5, 2017, from 8 a.m. to 5 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 http://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 13608 |
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