83 FR 45946 - Anesthetic and Analgesic Drug Products 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 176 (September 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 176 (September 11, 2018)
| Page Range | 45946-45947 | |
| FR Document | 2018-19668 |
[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)] [Notices] [Pages 45946-45947] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19668] [[Page 45946]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-3276] Anesthetic and Analgesic Drug Products 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. The general function of the committee 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 October 12, 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 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-2018-N-3276. The docket will close on October 11, 2018. Submit either electronic or written comments on this public meeting by October 11, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 11, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 11, 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 4, 2018, will be provided to the committee. 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-3276 for ``Anesthetic and Analgesic Drug Products 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 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 the 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: [[Page 45947]] Agenda: The committee will be asked to discuss new drug application (NDA) 209128, sufentanil sublingual tablets, submitted by AcelRx Pharmaceuticals, Inc., for the management of moderate-to-severe acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate, in adult patients in a medically supervised setting. The committee will also be asked to discuss risk- benefit considerations and whether this 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 committee. All electronic and written submissions submitted to the Docket (see ADDRESSES) on or before October 4, 2018, will be provided to the committee. 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 September 26, 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 September 27, 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: September 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-19668 Filed 9-10-18; 8:45 am] BILLING CODE 4164-01-P
![45946 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices
DEPARTMENT OF HEALTH AND Electronic Submissions submission. You should submit two
HUMAN SERVICES Submit electronic comments in the copies total. One copy will include the
following way: information you claim to be confidential
Food and Drug Administration with a heading or cover note that states
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
[Docket No. FDA–2018–N–3276]
instructions for submitting comments. CONFIDENTIAL INFORMATION.’’ FDA
Anesthetic and Analgesic Drug Comments submitted electronically, will review this copy, including the
Products Advisory Committee; Notice including attachments, to https:// claimed confidential information, in its
of Meeting; Establishment of a Public www.regulations.gov will be posted to consideration of comments. The second
Docket; Request for Comments the docket unchanged. Because your copy, which will have the claimed
comment will be made public, you are confidential information redacted/
AGENCY: Food and Drug Administration, blacked out, will be available for public
solely responsible for ensuring that your
HHS. viewing and posted on https://
comment does not include any
ACTION: Notice; establishment of a confidential information that you or a www.regulations.gov. Submit both
public docket; request for comments. third party may not wish to be posted, copies to the Dockets Management Staff.
such as medical information, your or If you do not wish your name and
SUMMARY: The Food and Drug contact information be made publicly
Administration (FDA) announces a anyone else’s Social Security number, or
confidential business information, such available, you can provide this
forthcoming public advisory committee information on the cover sheet and not
meeting of the Anesthetic and Analgesic as a manufacturing process. Please note
that if you include your name, contact in the body of your comments and you
Drug Products Advisory Committee. The must identify the information as
general function of the committee is to information, or other information that
identifies you in the body of your ‘‘confidential.’’ Any information marked
provide advice and recommendations to as ‘‘confidential’’ will not be disclosed
FDA on regulatory issues. The meeting comments, that information will be
posted on https://www.regulations.gov. except in accordance with 21 CFR 10.20
will be open to the public. FDA is and other applicable disclosure law. For
• If you want to submit a comment
establishing a docket for public more information about FDA’s posting
with confidential information that you
comment on this document. of comments to public dockets, see 80
do not wish to be made available to the
DATES: The meeting will be held on public, submit the comment as a FR 56469, September 18, 2015, or access
October 12, 2018, from 8 a.m. to 5 p.m. written/paper submission and in the the information at: https://www.gpo.gov/
ADDRESSES: FDA White Oak Campus, manner detailed (see ‘‘Written/Paper fdsys/pkg/FR-2015-09-18/pdf/2015-
10903 New Hampshire Ave., Bldg. 31 Submissions’’ and ‘‘Instructions’’). 23389.pdf.
Conference Center, the Great Room (Rm. Docket: For access to the docket to
1503), Silver Spring, MD 20993–0002. Written/Paper Submissions read background documents or the
Answers to commonly asked questions Submit written/paper submissions as electronic and written/paper comments
including information regarding special follows: received, go to https://
accommodations due to a disability, • Mail/Hand Delivery/Courier (for www.regulations.gov and insert the
visitor parking, and transportation may written/paper submissions): Dockets docket number, found in brackets in the
be accessed at: https://www.fda.gov/ Management Staff (HFA–305), Food and heading of this document, into the
AdvisoryCommittees/AboutAdvisory Drug Administration, 5630 Fishers ‘‘Search’’ box and follow the prompts
Committees/ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852. and/or go to the Dockets Management
FDA is establishing a docket for • For written/paper comments Staff, 5630 Fishers Lane, Rm. 1061,
public comment on this meeting. The submitted to the Dockets Management Rockville, MD 20852.
docket number is FDA–2018–N–3276. Staff, FDA will post your comment, as
FOR FURTHER INFORMATION CONTACT:
The docket will close on October 11, well as any attachments, except for
Moon Hee V. Choi, Center for Drug
2018. Submit either electronic or information submitted, marked and
Evaluation and Research, Food and
written comments on this public identified, as confidential, if submitted
Drug Administration, 10903 New
meeting by October 11, 2018. Please as detailed in ‘‘Instructions.’’
Hampshire Ave., Bldg. 31, Rm. 2417,
note that late, untimely filed comments Instructions: All submissions received
Silver Spring, MD 20993–0002, 301–
will not be considered. Electronic must include the Docket No. FDA–
796–9001, Fax: 301–847–8533, email:
comments must be submitted on or 2018–N–3276 for ‘‘Anesthetic and
AADPAC@fda.hhs.gov, or FDA
before October 11, 2018. The https:// Analgesic Drug Products Advisory
Advisory Committee Information Line,
www.regulations.gov electronic filing Committee; Notice of Meeting;
1–800–741–8138 (301–443–0572 in the
system will accept comments until Establishment of a Public Docket;
Washington, DC area). A notice in the
midnight Eastern Time at the end of Request for Comments.’’ Received
Federal Register about last minute
October 11, 2018. Comments received comments, those filed in a timely
modifications that impact a previously
by mail/hand delivery/courier (for manner (see ADDRESSES), will be placed
announced advisory committee meeting
written/paper submissions) will be in the docket and, except for those
cannot always be published quickly
considered timely if they are submitted as ‘‘Confidential
enough to provide timely notice.
postmarked or the delivery service Submissions,’’ publicly viewable at
Therefore, you should always check the
acceptance receipt is on or before that https://www.regulations.gov or at the
FDA’s website at https://www.fda.gov/
date. Dockets Management Staff between 9
daltland on DSKBBV9HB2PROD with NOTICES
AdvisoryCommittees/default.htm and
Comments received on or before a.m. and 4 p.m., Monday through
scroll down to the appropriate advisory
October 4, 2018, will be provided to the Friday.
committee meeting link, or call the
committee. Comments received after • Confidential Submissions—To
advisory committee information line to
that date will be taken into submit a comment with confidential
learn about possible modifications
consideration by FDA. information that you do not wish to be
before coming to the meeting.
You may submit comments as made publicly available, submit your
follows: comments only as a written/paper SUPPLEMENTARY INFORMATION:
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![Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 45947
Agenda: The committee will be asked meetings and will make every effort to SUPPLEMENTARY INFORMATION:
to discuss new drug application (NDA) accommodate persons with disabilities.
Intellectual Property
209128, sufentanil sublingual tablets, If you require accommodations due to a
submitted by AcelRx Pharmaceuticals, disability, please contact Moon Hee V. 1. U.S. Provisional Patent Application
Inc., for the management of moderate-to- Choi (see FOR FURTHER INFORMATION (Application No. 61/845,861) filed July
severe acute pain severe enough to CONTACT) at least 7 days in advance of 12, 2013, HHS Reference No.: E–482–
require an opioid analgesic and for the meeting. 2013/0–US–01
which alternative treatments are FDA is committed to the orderly 2. PCT Application (Application No. PCT/
inadequate, in adult patients in a conduct of its advisory committee US2014/045922) filed July 09, 2014,
medically supervised setting. The meetings. Please visit our website at HHS Reference No.: E–482–2013/0–PCT–
committee will also be asked to discuss https://www.fda.gov/Advisory 02
risk-benefit considerations and whether Committees/AboutAdvisoryCommittees/ 3. Canada Patent Application (Application
No. 2917545) filed 09 July 2014, HHS
this product should be approved. ucm111462.htm for procedures on
Reference No.: E–482–2013/0–CA–03
FDA intends to make background public conduct during advisory 4. European Patent Application (Application
material available to the public no later committee meetings. No. 14745037.3) filed 09 July 2014, HHS
than 2 business days before the meeting. Notice of this meeting is given under Reference No.: E–482–2013/0–EP–04
If FDA is unable to post the background the Federal Advisory Committee Act (5 5. U.S. Patent Application (Allowed
material on its website prior to the U.S.C. app. 2). Application No. 14/904,385) filed
meeting, the background material will Dated: September 4, 2018. January 11, 2016, HHS Reference No.: E–
be made publicly available at the 482–2013/0–US–05
Leslie Kux,
location of the advisory committee Associate Commissioner for Policy. The patent rights in these inventions
meeting, and the background material have been assigned and/or exclusively
[FR Doc. 2018–19668 Filed 9–10–18; 8:45 am]
will be posted on FDA’s website after licensed to the government of the
BILLING CODE 4164–01–P
the meeting. Background material is United States of America.
available at https://www.fda.gov/ The prospective exclusive license
AdvisoryCommittees/Calendar/ DEPARTMENT OF HEALTH AND territory may be where patent
default.htm. Scroll down to the HUMAN SERVICES applications are filed and the field of
appropriate advisory committee meeting use may be limited to ‘‘Photoactivatable
link. National Institutes of Health liposomal nanoparticle for the delivery
Procedure: Interested persons may
of an immunotherapeutic or
present data, information, or views, Prospective Grant of an Exclusive immunotherapeutic-enabling agent’’.
orally or in writing, on issues pending Patent License: Photoactivatable
before the committee. All electronic and Additional licensable fields of use are
Liposomal Nanoparticle for the available (e.g. encapsulating imaging
written submissions submitted to the Delivery of an Immunotherapeutic or
Docket (see ADDRESSES) on or before agent).
Immunotherapeutic-Enabling Agent
October 4, 2018, will be provided to the This technology discloses a
committee. Oral presentations from the AGENCY: National Institutes of Health, photoactivatable, lipid-based
public will be scheduled between HHS. nanoparticles containing at least one
approximately 1 p.m. and 2 p.m. Those ACTION: Notice. hydrophilic agent, wherein the agent
individuals interested in making formal could be an anti-cancer agent, an
SUMMARY: The National Cancer Institute, imaging agent, or an anti-inflammatory
oral presentations should notify the an institute of the National Institutes of
contact person and submit a brief agent and the lipid bilayer wall of the
Health, Department of Health and nanoparticle is comprised of (i) a lipid
statement of the general nature of the Human Services, is contemplating the
evidence or arguments they wish to bilayer comprising (a) 1,2-bis(tricosa-
grant of an Exclusive Patent License to 10,12-diynoyl)-sn-glycero-3-
present, the names and addresses of practice the inventions embodied in the
proposed participants, and an phosphocholine (DC8,9PC), (b) 1,2-
Patents and Patent Applications listed distearoyl-sn-glycero-3-
indication of the approximate time in the Supplementary Information
requested to make their presentation on phosphoethanolamine-N-
section of this notice to Nano Red LLC methoxy(polyethylene glycol) (DSPE–
or before September 26, 2018. Time (‘‘Nano Red’’) located in Milwaukee,
allotted for each presentation may be PEG) and (c)
Wisconsin. dipalmitoylphosphatidylcholine
limited. If the number of registrants
requesting to speak is greater than can DATES: Only written comments and/or (DPPC), and (ii) a tetrapyrollic
be reasonably accommodated during the applications for a license which are photosensitizer, 2-[1-hexyloxyethyl]-2-
scheduled open public hearing session, received by the National Cancer devinyl pyropheophorbide-a (HPPH),
FDA may conduct a lottery to determine Institute’s Technology Transfer Center and wherein the encapsulated agent is
the speakers for the scheduled open on or before September 26, 2018 will be released by exposure to near-infrared
public hearing session. The contact considered. light.
person will notify interested persons ADDRESSES: Requests for copies of the This notice is made in accordance
regarding their request to speak by patent application, inquiries, and with 35 U.S.C. 209 and 37 CFR part 404.
September 27, 2018. comments relating to the contemplated The prospective exclusive license will
Persons attending FDA’s advisory an Exclusive Patent License should be be royalty bearing, and the prospective
committee meetings are advised that directed to: Jasmine Yang, Sr. Licensing exclusive license may be granted unless
daltland on DSKBBV9HB2PROD with NOTICES
FDA is not responsible for providing and Patenting Manager, NCI Technology within fifteen (15) days from the date of
access to electrical outlets. Transfer Center, 9609 Medical Center this published notice, the National
For press inquiries, please contact the Drive, RM 1E530 MSC 9702, Bethesda, Cancer Institute receives written
Office of Media Affairs at fdaoma@ MD 20892–9702 (for business mail), evidence and argument that establishes
fda.hhs.gov or 301–796–4540. Rockville, MD 20850–9702 Telephone: that the grant of the license would not
FDA welcomes the attendance of the (240) 276–5530; Facsimile: (240) 276– be consistent with the requirements of
public at its advisory committee 5504 Email: jasmine.yang@nih.gov. 35 U.S.C. 209 and 37 CFR part 404.
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Document Created: 2018-09-11 01:02:16
Document Modified: 2018-09-11 01:02:16
| 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 October 12, 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 the 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 45946 |
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