83 FR 50663 - 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 83, Issue 195 (October 9, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 195 (October 9, 2018)
| Page Range | 50663-50664 | |
| FR Document | 2018-21810 |
[Federal Register Volume 83, Number 195 (Tuesday, October 9, 2018)] [Notices] [Pages 50663-50664] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-21810] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3467] 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 FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document. DATES: The meeting will be held on November 14, 2018, 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 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-2018-N-3467. The docket will close on November 13, 2018. Submit either electronic or written comments on this public meeting by November 13, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before November 13, 2018. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 13, 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 October 30, 2018, will be provided to the committees. Comments received after that date will be taken into consideration by FDA. You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2018-N-3467 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, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. Confidential Submissions--To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify the information as ``confidential.'' Any information marked as ``confidential'' will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For [[Page 50664]] 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: Moon Hee V. Choi, 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 FDA's website 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) 209774, for an immediate-release oral tablet formulation of oxycodone, which is intended to resist common methods of physical or chemical manipulation and to deter intravenous and intranasal abuse, submitted by SpecGx Inc., for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The committees will also be asked to determine whether the Applicant adequately demonstrated that the abuse-deterrent properties of the proposed product are sufficient to include this information in the product label, and whether the product should be approved. 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 website 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 website 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 October 30, 2018, 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 22, 2018. 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 23, 2018. Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets. For press inquiries, please contact the Office of Media Affairs at [email protected] or 301-796-4540. 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 Moon Hee V. Choi (see FOR FURTHER INFORMATION CONTACT) at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website 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: October 2, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-21810 Filed 10-5-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices 50663
person will notify interested persons The meeting will be held on
DATES: do not wish to be made available to the
regarding their request to speak by November 14, 2018, from 8 a.m. to 5 public, submit the comment as a
October 24, 2018. p.m. written/paper submission and in the
Persons attending FDA’s advisory manner detailed (see ‘‘Written/Paper
ADDRESSES: FDA White Oak Campus,
committee meetings are advised that Submissions’’ and ‘‘Instructions’’).
10903 New Hampshire Ave., Bldg. 31
FDA is not responsible for providing
Conference Center, the Great Room (Rm. Written/Paper Submissions
access to electrical outlets.
For press inquiries, please contact the 1503), Silver Spring, MD 20993–0002. Submit written/paper submissions as
Office of Media Affairs at fdaoma@ Answers to commonly asked questions follows:
fda.hhs.gov or 301–796–4540. about FDA Advisory Committee • Mail/Hand delivery/Courier (for
FDA welcomes the attendance of the meetings may be accessed at: https:// written/paper submissions): Dockets
public at its advisory committee www.fda.gov/AdvisoryCommittees/ Management Staff (HFA–305), Food and
meetings and will make every effort to AboutAdvisoryCommittees/ Drug Administration, 5630 Fishers
accommodate persons with disabilities. ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852.
If you require accommodations due to a FDA is establishing a docket for • For written/paper comments
disability, please contact Moon Hee V. public comment on this meeting. The submitted to the Dockets Management
Choi (see FOR FURTHER INFORMATION docket number is FDA–2018–N–3467. Staff, FDA will post your comment, as
CONTACT) at least 7 days in advance of The docket will close on November 13, well as any attachments, except for
the meeting. 2018. Submit either electronic or information submitted, marked and
FDA is committed to the orderly written comments on this public identified, as confidential, if submitted
conduct of its advisory committee meeting by November 13, 2018. Please as detailed in ‘‘Instructions.’’
meetings. Please visit our website at note that late, untimely filed comments Instructions: All submissions received
https://www.fda.gov/ will not be considered. Electronic must include the Docket No. FDA–
AdvisoryCommittees/AboutAdvi comments must be submitted on or 2018–N–3467 for ‘‘Joint Meeting of the
soryCommittees/ucm111462.htm for before November 13, 2018. The https:// Anesthetic and Analgesic Drug Products
procedures on public conduct during www.regulations.gov electronic filing Advisory Committee and the Drug
advisory committee meetings. system will accept comments until Safety and Risk Management Advisory
Notice of this meeting is given under 11:59 p.m. Eastern Time at the end of Committee; Notice of Meeting;
the Federal Advisory Committee Act (5 November 13, 2018. Comments received Establishment of a Public Docket;
U.S.C. app. 2). by mail/hand delivery/courier (for Request for Comments.’’ Received
written/paper submissions) will be comments, those filed in a timely
Dated: October 2, 2018.
considered timely if they are manner (see ADDRESSES), will be placed
Leslie Kux,
postmarked or the delivery service in the docket and, except for those
Associate Commissioner for Policy. submitted as ‘‘Confidential
acceptance receipt is on or before that
[FR Doc. 2018–21809 Filed 10–5–18; 8:45 am] date. Submissions,’’ publicly viewable at
BILLING CODE 4164–01–P Comments received on or before https://www.regulations.gov or at the
October 30, 2018, will be provided to Dockets Management Staff between 9
the committees. Comments received a.m. and 4 p.m., Monday through
DEPARTMENT OF HEALTH AND after that date will be taken into Friday.
HUMAN SERVICES consideration by FDA. • Confidential Submissions—To
You may submit comments as submit a comment with confidential
Food and Drug Administration
follows: information that you do not wish to be
[Docket No. FDA–2018–N–3467] made publicly available, submit your
Electronic Submissions comments only as a written/paper
Joint Meeting of the Anesthetic and Submit electronic comments in the submission. You should submit two
Analgesic Drug Products Advisory following way: copies total. One copy will include the
Committee and the Drug Safety and • Federal eRulemaking Portal: information you claim to be confidential
Risk Management Advisory https://www.regulations.gov. Follow the with a heading or cover note that states
Committee; Notice of Meeting; instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS
Establishment of a Public Docket; Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ FDA
Request for Comments including attachments, to https:// will review this copy, including the
AGENCY: Food and Drug Administration, www.regulations.gov will be posted to claimed confidential information, in its
HHS. the docket unchanged. Because your consideration of comments. The second
ACTION: Notice, establishment of a comment will be made public, you are copy, which will have the claimed
public docket; request for comments. solely responsible for ensuring that your confidential information redacted/
comment does not include any blacked out, will be available for public
SUMMARY: The Food and Drug confidential information that you or a viewing and posted on https://
Administration (FDA) announces a third party may not wish to be posted, www.regulations.gov. Submit both
forthcoming public advisory committee such as medical information, your or copies to the Dockets Management Staff.
meeting of the Anesthetic and Analgesic anyone else’s Social Security number, or If you do not wish your name and
Drug Products Advisory Committee and confidential business information, such contact information be made publicly
the Drug Safety and Risk Management as a manufacturing process. Please note available, you can provide this
amozie on DSK3GDR082PROD with NOTICES1
Advisory Committee. The general that if you include your name, contact information on the cover sheet and not
function of the committees is to provide information, or other information that in the body of your comments and you
advice and recommendations to FDA on identifies you in the body of your must identify the information as
regulatory issues. The meeting will be comments, that information will be ‘‘confidential.’’ Any information marked
open to the public. FDA is establishing posted on https://www.regulations.gov. as ‘‘confidential’’ will not be disclosed
a docket for public comment on this • If you want to submit a comment except in accordance with 21 CFR 10.20
document. with confidential information that you and other applicable disclosure law. For
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![50664 Federal Register / Vol. 83, No. 195 / Tuesday, October 9, 2018 / Notices
more information about FDA’s posting location of the advisory committee Dated: October 2, 2018.
of comments to public dockets, see 80 meeting, and the background material Leslie Kux,
FR 56469, September 18, 2015, or access will be posted on FDA’s website after Associate Commissioner for Policy.
the information at: https://www.gpo.gov/ the meeting. Background material is [FR Doc. 2018–21810 Filed 10–5–18; 8:45 am]
fdsys/pkg/FR-2015-09-18/pdf/2015- available at https://www.fda.gov/ BILLING CODE 4164–01–P
23389.pdf. AdvisoryCommittees/Calendar/
Docket: For access to the docket to default.htm. Scroll down to the
read background documents or the appropriate advisory committee meeting DEPARTMENT OF HEALTH AND
electronic and written/paper comments link. HUMAN SERVICES
received, go to https:// Procedure: Interested persons may
www.regulations.gov and insert the present data, information, or views, Health Resources and Services
docket number, found in brackets in the orally or in writing, on issues pending Administration
heading of this document, into the before the committees. All electronic
‘‘Search’’ box and follow the prompts and written submissions submitted to Charter Renewal for the Council on
and/or go to the Dockets Management Graduate Medical Education
the Docket (see ADDRESSES) on or before
Staff, 5630 Fishers Lane, Rm. 1061, October 30, 2018, will be provided to AGENCY: Health Resources and Services
Rockville, MD 20852. the committees. Oral presentations from Administration (HRSA), Department of
FOR FURTHER INFORMATION CONTACT: the public will be scheduled between Health and Human Services (HHS).
Moon Hee V. Choi, Center for Drug approximately 1 p.m. and 2 p.m. Those ACTION: Notice.
Evaluation and Research, Food and individuals interested in making formal
Drug Administration, 10903 New oral presentations should notify the SUMMARY: HHS is hereby giving notice
Hampshire Ave., Bldg. 31, Rm. 2417, contact person and submit a brief that the Council on Graduate Medical
Silver Spring, MD 20993–0002, 301– statement of the general nature of the Education (COGME) has been
796–9001, Fax: 301–847–8533, email: evidence or arguments they wish to rechartered. The date the renewed
AADPAC@fda.hhs.gov, or FDA present, the names and addresses of charter took effect is September 30,
Advisory Committee Information Line, proposed participants, and an 2018.
1–800–741–8138 (301–443–0572 in the indication of the approximate time FOR FURTHER INFORMATION CONTACT:
Washington, DC area). A notice in the requested to make their presentation on Kennita R. Carter, MD, Designated
Federal Register about last-minute or before October 22, 2018. Time Federal Official, COGME at 301–945–
modifications that impact a previously allotted for each presentation may be 3505 or email at kcarter@hrsa.gov. A
announced advisory committee meeting limited. If the number of registrants copy of the current committee
cannot always be published quickly requesting to speak is greater than can membership, charter, and reports can be
enough to provide timely notice. be reasonably accommodated during the obtained by accessing the website
Therefore, you should always check scheduled open public hearing session, http://www.hrsa.gov/advisory
FDA’s website at https://www.fda.gov/ FDA may conduct a lottery to determine committees/bhpradvisory/COGME/
AdvisoryCommittees/default.htm and the speakers for the scheduled open index.html.
scroll down to the appropriate advisory public hearing session. The contact SUPPLEMENTARY INFORMATION: COGME
committee meeting link, or call the person will notify interested persons provides advice and recommendations
advisory committee information line to regarding their request to speak by to the Secretary of the Department of
learn about possible modifications October 23, 2018. Health and Human Services (Secretary),
before coming to the meeting. Persons attending FDA’s advisory the Senate Committee on Health,
SUPPLEMENTARY INFORMATION: committee meetings are advised that Education, Labor and Pensions, and the
Agenda: The committees will discuss FDA is not responsible for providing U.S. House of Representatives
new drug application (NDA) 209774, for access to electrical outlets. Committee on Energy and Commerce on
an immediate-release oral tablet For press inquiries, please contact the matters concerning the supply and
formulation of oxycodone, which is Office of Media Affairs at fdaoma@ distribution of physicians in the United
intended to resist common methods of fda.hhs.gov or 301–796–4540. States, physician workforce trends,
physical or chemical manipulation and FDA welcomes the attendance of the training issues, financing policies and
to deter intravenous and intranasal public at its advisory committee other matters of significance concerning
abuse, submitted by SpecGx Inc., for the meetings and will make every effort to graduate medical education, as specified
management of pain severe enough to accommodate persons with disabilities. by section 762 of the Public Health
require an opioid analgesic and for If you require accommodations due to a Service (PHS) Act, as amended.
which alternative treatments are disability, please contact Moon Hee V. Additionally, COGME encourages
inadequate. The committees will also be Choi (see FOR FURTHER INFORMATION entities providing graduate medical
asked to determine whether the CONTACT) at least 7 days in advance of education to conduct activities to
Applicant adequately demonstrated that the meeting. voluntarily achieve the
the abuse-deterrent properties of the FDA is committed to the orderly recommendations of the Council;
proposed product are sufficient to conduct of its advisory committee develops, publishes, and implements
include this information in the product meetings. Please visit our website at performance measures and longitudinal
label, and whether the product should https://www.fda.gov/ evaluations; and recommends
be approved. AdvisoryCommittees/ appropriation levels for certain PHS Act
amozie on DSK3GDR082PROD with NOTICES1
FDA intends to make background AboutAdvisoryCommittees/ Title VII programs. The charter renewal
material available to the public no later ucm111462.htm for procedures on for COGME was approved on September
than 2 business days before the meeting. public conduct during advisory 30, 2018, which will also stand as the
If FDA is unable to post the background committee meetings. filing date. Renewal of the COGME
material on its website prior to the Notice of this meeting is given under charter gives authorization for the
meeting, the background material will the Federal Advisory Committee Act (5 Council to operate until September 30,
be made publicly available at the U.S.C. app. 2). 2020.
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Document Created: 2018-10-06 00:59:14
Document Modified: 2018-10-06 00:59:14
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice, establishment of a public docket; request for comments. | |
| Dates | The meeting will be held on November 14, 2018, from 8 a.m. to 5 p.m. | |
| Contact | Moon Hee V. Choi, 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 FDA's website 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 | 83 FR 50663 |
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