83 FR 13490 - 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 61 (March 29, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 61 (March 29, 2018)
| Page Range | 13490-13491 | |
| FR Document | 2018-06307 |
[Federal Register Volume 83, Number 61 (Thursday, March 29, 2018)] [Notices] [Pages 13490-13491] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-06307] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0875] 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 May 22, 2018, from 8 a.m. to 4:30 p.m. ADDRESSES: College Park Marriott Hotel and Conference Center, General Vessey Ballroom, 3501 University Blvd., Hyattsville, MD 20783. The conference center's telephone number is 301-985-7300. 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 College Park Marriott Hotel and Conference Center can be accessed at: https://www.marriott.com/hotels/travel/wasum-college-park-marriott-hotel-and-conference-center/. FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-0875. The docket will close on May 21, 2018. Submit either electronic or written comments on this public meeting by May 21, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before May 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of May 21, 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 May 8, 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-0875 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 the ADDRESSSES section), 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 [[Page 13491]] 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: Agenda: The committees will be asked to discuss new drug application (NDA) 209588, for buprenorphine sublingual spray, submitted by INSYS Development Company, Inc., for the treatment of moderate-to- severe acute pain where the use of an opioid analgesic is appropriate. The committees will also be asked to discuss 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 committees. Written submissions may be made to the contact person on or before May 8, 2018. 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 April 30, 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 May 1, 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]hs.gov 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: March 21, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-06307 Filed 3-28-18; 8:45 am] BILLING CODE 4164-01-P
![13490 Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices
Dated: March 20, 2018. electronic filing system will accept Safety and Risk Management Advisory
Leslie Kux, comments until midnight Eastern Time Committee; Notice of Meeting;
Associate Commissioner for Policy. at the end of May 21, 2018. Comments Establishment of a Public Docket;
[FR Doc. 2018–06253 Filed 3–28–18; 8:45 am] received by mail/hand delivery/courier Request for Comments.’’ Received
BILLING CODE 4164–01–P
(for written/paper submissions) will be comments, those filed in a timely
considered timely if they are manner (see the ADDRESSSES section),
postmarked or the delivery service will be placed in the docket and, except
DEPARTMENT OF HEALTH AND acceptance receipt is on or before that for those submitted as ‘‘Confidential
HUMAN SERVICES date. Submissions,’’ publicly viewable at
Comments received on or before May https://www.regulations.gov or at the
Food and Drug Administration 8, 2018, will be provided to the Dockets Management Staff between 9
[Docket No. FDA–2018–N–0875]
committees. Comments received after a.m. and 4 p.m., Monday through
that date will be taken into Friday.
Joint Meeting of the Anesthetic and consideration by FDA. Confidential Submissions—To submit
Analgesic Drug Products Advisory You may submit comments as a comment with confidential
Committee and the Drug Safety and follows: information that you do not wish to be
Risk Management Advisory Electronic Submissions made publicly available, submit your
Committee; Notice of Meeting; comments only as a written/paper
Submit electronic comments in the submission. You should submit two
Establishment of a Public Docket;
following way: copies total. One copy will include the
Request for Comments • Federal eRulemaking Portal: information you claim to be confidential
AGENCY: Food and Drug Administration, https://www.regulations.gov. Follow the with a heading or cover note that states
HHS. instructions for submitting comments. ‘‘THIS DOCUMENT CONTAINS
ACTION: Notice; establishment of a Comments submitted electronically, CONFIDENTIAL INFORMATION.’’ FDA
public docket; request for comments. including attachments, to https:// will review this copy, including the
www.regulations.gov will be posted to claimed confidential information, in its
SUMMARY: The Food and Drug the docket unchanged. Because your consideration of comments. The second
Administration (FDA) announces a comment will be made public, you are copy, which will have the claimed
forthcoming public advisory committee solely responsible for ensuring that your confidential information redacted/
meeting of the Anesthetic and Analgesic comment does not include any blacked out, will be available for public
Drug Products Advisory Committee and confidential information that you or a viewing and posted on https://
the Drug Safety and Risk Management third party may not wish to be posted, www.regulations.gov. Submit both
Advisory Committee. The general such as medical information, your or copies to the Dockets Management Staff.
function of the committees is to provide anyone else’s Social Security number, or If you do not wish your name and
advice and recommendations to FDA on confidential business information, such contact information be made publicly
regulatory issues. The meeting will be as a manufacturing process. Please note available, you can provide this
open to the public. FDA is establishing that if you include your name, contact information on the cover sheet and not
a docket for public comment on this information, or other information that in the body of your comments and you
document. identifies you in the body of your must identify the information as
DATES: The meeting will be held on May comments, that information will be ‘‘confidential.’’ Any information marked
22, 2018, from 8 a.m. to 4:30 p.m. posted on https://www.regulations.gov. as ‘‘confidential’’ will not be disclosed
• If you want to submit a comment
ADDRESSES: College Park Marriott Hotel except in accordance with 21 CFR 10.20
with confidential information that you
and Conference Center, General Vessey and other applicable disclosure law. For
do not wish to be made available to the
Ballroom, 3501 University Blvd., more information about FDA’s posting
public, submit the comment as a
Hyattsville, MD 20783. The conference of comments to public dockets, see 80
written/paper submission and in the
center’s telephone number is 301–985– FR 56469, September 18, 2015, or access
manner detailed (see ‘‘Written/Paper
7300. Answers to commonly asked the information at: https://www.gpo.gov/
Submissions’’ and ‘‘Instructions’’).
questions about FDA Advisory fdsys/pkg/FR-2015-09-18/pdf/2015-
Committee meetings may be accessed at: Written/Paper Submissions 23389.pdf.
https://www.fda.gov/Advisory Submit written/paper submissions as Docket: For access to the docket to
Committees/AboutAdvisoryCommittees/ follows: read background documents or the
ucm408555.htm. Information about the • Mail/Hand delivery/Courier (for electronic and written/paper comments
College Park Marriott Hotel and written/paper submissions): Dockets received, go to https://
Conference Center can be accessed at: Management Staff (HFA–305), Food and www.regulations.gov and insert the
https://www.marriott.com/hotels/travel/ Drug Administration, 5630 Fishers docket number, found in brackets in the
wasum-college-park-marriott-hotel-and- Lane, Rm. 1061, Rockville, MD 20852. heading of this document, into the
conference-center/. • For written/paper comments ‘‘Search’’ box and follow the prompts
FDA is establishing a docket for submitted to the Dockets Management and/or go to the Dockets Management
public comment on this meeting. The Staff, FDA will post your comment, as Staff, 5630 Fishers Lane, Rm. 1061,
docket number is FDA–2018–N–0875. well as any attachments, except for Rockville, MD 20852.
The docket will close on May 21, 2018. FOR FURTHER INFORMATION CONTACT:
sradovich on DSK3GMQ082PROD with NOTICES
information submitted, marked and
Submit either electronic or written identified, as confidential, if submitted Moon Hee V. Choi, Center for Drug
comments on this public meeting by as detailed in ‘‘Instructions.’’ Evaluation and Research, Food and
May 21, 2018. Please note that late, Instructions: All submissions received Drug Administration, 10903 New
untimely filed comments will not be must include the Docket No. FDA– Hampshire Ave., Bldg. 31, Rm. 2417,
considered. Electronic comments must 2018–N–0875 for ‘‘Joint Meeting of the Silver Spring, MD 20993–0002, 301–
be submitted on or before May 21, 2018. Anesthetic and Analgesic Drug Products 796–9001, Fax: 301–847–8533, email:
The https://www.regulations.gov Advisory Committee and the Drug AADPAC@fda.hhs.gov, or FDA
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![Federal Register / Vol. 83, No. 61 / Thursday, March 29, 2018 / Notices 13491
Advisory Committee Information Line, conduct a lottery to determine the fulfills its commitment under the
1–800–741–8138 (301–443–0572 in the speakers for the scheduled open public Generic Drug User Fee Amendments of
Washington, DC area). A notice in the hearing session. The contact person will 2017 (GDUFA II) to develop an annual
Federal Register about last minute notify interested persons regarding their list of regulatory science initiatives
modifications that impact a previously request to speak by May 1, 2018. specific to generic drugs. FDA will take
announced advisory committee meeting Persons attending FDA’s advisory the information it obtains from the
cannot always be published quickly committee meetings are advised that public workshop into account in
enough to provide timely notice. FDA is not responsible for providing developing its fiscal year (FY) 2019
Therefore, you should always check the access to electrical outlets. regulatory science initiatives.
FDA’s website at https://www.fda.gov/ For press inquiries, please contact the DATES: The public workshop will be
AdvisoryCommittees/default.htm and Office of Media Affairs at fdaoma@ held on May 24, 2018 from 8:30 a.m. to
scroll down to the appropriate advisory fda.hhs.gov or 301–796–4540. 4:30 p.m. Submit either electronic or
committee meeting link, or call the FDA welcomes the attendance of the written comments on this public
advisory committee information line to public at its advisory committee workshop by June 25, 2018. See the
learn about possible modifications meetings and will make every effort to SUPPLEMENTARY INFORMATION section for
before coming to the meeting. accommodate persons with disabilities. registration date and information.
SUPPLEMENTARY INFORMATION: If you require accommodations due to a ADDRESSES: The public workshop will
Agenda: The committees will be disability, please contact Moon Hee V. be held at the FDA White Oak Campus,
asked to discuss new drug application Choi (see FOR FURTHER INFORMATION 10903 New Hampshire Ave., Bldg. 31
(NDA) 209588, for buprenorphine CONTACT) at least 7 days in advance of Conference Center, the Great Room (Rm.
sublingual spray, submitted by INSYS the meeting. 1503, sections B and C), Silver Spring,
Development Company, Inc., for the FDA is committed to the orderly MD 20993–0002. Entrance for the public
treatment of moderate-to-severe acute conduct of its advisory committee workshop participants (non-FDA
pain where the use of an opioid meetings. Please visit our website at employees) is through Bldg. 1, where
analgesic is appropriate. The https://www.fda.gov/Advisory routine security check procedures will
committees will also be asked to discuss Committees/AboutAdvisoryCommittees/ be performed. For parking and security
whether this product should be ucm111462.htm for procedures on information, please refer to https://
approved. public conduct during advisory www.fda.gov/AboutFDA/
FDA intends to make background committee meetings. WorkingatFDA/BuildingsandFacilities/
material available to the public no later Notice of this meeting is given under WhiteOakCampusInformation/
than 2 business days before the meeting. the Federal Advisory Committee Act (5 ucm241740.htm.
If FDA is unable to post the background U.S.C. app. 2). You may submit comments as
material on its website prior to the Dated: March 21, 2018. follows. Please note that late, untimely
meeting, the background material will Leslie Kux, filed comments will not be considered.
be made publicly available at the Associate Commissioner for Policy. Electronic comments must be submitted
location of the advisory committee [FR Doc. 2018–06307 Filed 3–28–18; 8:45 am] on or before June 25, 2018. The https://
meeting, and the background material www.regulations.gov electronic filing
BILLING CODE 4164–01–P
will be posted on FDA’s website after system will accept comments until
the meeting. Background material is midnight Eastern Time at the end of
available at https://www.fda.gov/ DEPARTMENT OF HEALTH AND June 25, 2018. Comments received by
AdvisoryCommittees/Calendar/ HUMAN SERVICES mail/hand delivery/courier (for written/
default.htm. Scroll down to the paper submissions) will be considered
appropriate advisory committee meeting Food and Drug Administration timely if they are postmarked or the
link. delivery service acceptance receipt is on
Procedure: Interested persons may [Docket No. FDA–2017–N–6644]
or before that date.
present data, information, or views,
Fiscal Year 2018 Generic Drug Electronic Submissions
orally or in writing, on issues pending
Regulatory Science Initiatives; Public
before the committees. Written Submit electronic comments in the
Workshop; Request for Comments
submissions may be made to the contact following way:
person on or before May 8, 2018. Oral AGENCY: Food and Drug Administration, • Federal eRulemaking Portal:
presentations from the public will be HHS. https://www.regulations.gov. Follow the
scheduled between approximately 1 ACTION: Notice of public workshop; instructions for submitting comments.
p.m. and 2 p.m. Those individuals request for comments. Comments submitted electronically,
interested in making formal oral including attachments, to https://
presentations should notify the contact SUMMARY: The Food and Drug www.regulations.gov will be posted to
person and submit a brief statement of Administration (FDA, the Agency, or the docket unchanged. Because your
the general nature of the evidence or we) is announcing the following public comment will be made public, you are
arguments they wish to present, the workshop entitled ‘‘FY 2018 Generic solely responsible for ensuring that your
names and addresses of proposed Drug Regulatory Science Initiatives.’’ comment does not include any
participants, and an indication of the The purpose of the public workshop is confidential information that you or a
approximate time requested to make to provide an overview of the status of third party may not wish to be posted,
sradovich on DSK3GMQ082PROD with NOTICES
their presentation on or before April 30, regulatory science initiatives for generic such as medical information, your or
2018. Time allotted for each drugs and an opportunity for public anyone else’s Social Security number, or
presentation may be limited. If the input on these initiatives. FDA is confidential business information, such
number of registrants requesting to seeking this input from a variety of as a manufacturing process. Please note
speak is greater than can be reasonably stakeholders—industry, academia, that if you include your name, contact
accommodated during the scheduled patient advocates, professional societies, information, or other information that
open public hearing session, FDA may and other interested parties—as it identifies you in the body of your
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Document Created: 2018-03-29 00:25:06
Document Modified: 2018-03-29 00:25:06
| 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 May 22, 2018, from 8 a.m. to 4:30 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 13490 |
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