83 FR 45941 - 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 | 45941-45942 | |
| FR Document | 2018-19667 |
[Federal Register Volume 83, Number 176 (Tuesday, September 11, 2018)] [Notices] [Pages 45941-45942] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-19667] ----------------------------------------------------------------------- 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 11, 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 10, 2018. Submit either electronic or written comments on this public meeting by October 10, 2018. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before October 10, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of October 10, 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 3, 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 [[Page 45942]] 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: Agenda: The committee will be asked to discuss new drug application (NDA) 210730, for oliceridine 1 milligram/milliliter injection, submitted by Trevena, Inc., for the management of moderate-to-severe acute pain in adult patients for whom an intravenous opioid is warranted. The committee will also be asked to discuss the efficacy and safety data and benefit-risk considerations. 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 3, 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 25, 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 26, 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. 2018-19667 Filed 9-10-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices 45941
removed. The ANDA applicants Drug Products Advisory Committee. The as a manufacturing process. Please note
referencing these NDAs subsequently general function of the committee is to that if you include your name, contact
followed suit and submitted provide advice and recommendations to information, or other information that
supplements proposing to remove the FDA on regulatory issues. The meeting identifies you in the body of your
SBIAB indication from their labeling. will be open to the public. FDA is comments, that information will be
The Agency approved these establishing a docket for public posted on https://www.regulations.gov.
supplements. comment on this document. • If you want to submit a comment
Further, based on a review of relevant DATES: The meeting will be held on with confidential information that you
information, FDA concluded that the October 11, 2018, from 8 a.m. to 5 p.m. do not wish to be made available to the
SBIAB indication is not appropriate public, submit the comment as a
ADDRESSES: FDA White Oak Campus,
because most cases of SBIAB are written/paper submission and in the
10903 New Hampshire Ave., Bldg. 31,
considered to be viral or non-infectious. manner detailed (see ‘‘Written/Paper
Conference Center, the Great Room (Rm. Submissions’’ and ‘‘Instructions’’).
As an antibacterial drug, CEFZIL 1503), Silver Spring, MD 20993–0002.
(cefprozil) is not considered to be Answers to commonly asked questions Written/Paper Submissions
effective to treat SBIAB. Such use of including information regarding special
CEFZIL (cefprozil) would likely result Submit written/paper submissions as
accommodations due to a disability, follows:
in inappropriate antibacterial drug use. visitor parking, and transportation may • Mail/Hand delivery/Courier (for
Accordingly, the risk benefit balance for be accessed at: https://www.fda.gov/ written/paper submissions): Dockets
the treatment of SBIAB with CEFZIL AdvisoryCommittees/ Management Staff (HFA–305), Food and
(cefprozil) is unfavorable and does not AboutAdvisoryCommittees/ Drug Administration, 5630 Fishers
support approval of these products (or ucm408555.htm. Lane, Rm. 1061, Rockville, MD 20852.
ANDAs referencing them) for this FDA is establishing a docket for • For written/paper comments
indication. public comment on this meeting. The submitted to the Dockets Management
The Agency will continue to list docket number is FDA–2018–N–3276. Staff, FDA will post your comment, as
CEFZIL (cefprozil) tablets, 250 mg and The docket will close on October 10, well as any attachments, except for
500 mg, and CEFZIL (cefprozil) for oral 2018. Submit either electronic or information submitted, marked and
suspension, 125 mg/5 mL and 250 mg/ written comments on this public identified, as confidential, if submitted
5 mL, in the ‘‘Discontinued Drug meeting by October 10, 2018. Please as detailed in ‘‘Instructions.’’
Product List’’ section of the Orange note that late, untimely filed comments Instructions: All submissions received
Book. FDA will continue to accept and, will not be considered. Electronic must include the Docket No. FDA–
where appropriate, approve ANDAs that comments must be submitted on or 2018–N–3276 for ‘‘Anesthetic and
refer to these drug products, but does before October 10, 2018. The https:// Analgesic Drug Products Advisory
not intend to do so if they propose to www.regulations.gov electronic filing Committee; Notice of Meeting;
include the SBIAB indication (see, e.g., system will accept comments until Establishment of a Public Docket;
section 505(j)(2)(A)(v) and (j)(4)G) of the midnight Eastern Time at the end of Request for Comments.’’ Received
FD&C Act and 21 CFR 314.94(a)(8)(iv) October 10, 2018. Comments received comments, those filed in a timely
and 314.127(a)(7)). If FDA determines by mail/hand delivery/courier (for manner (see ADDRESSES), will be placed
that labeling for this drug product written/paper submissions) will be in the docket and, except for those
should be revised, the Agency will considered timely if they are submitted as ‘‘Confidential
advise ANDA applicants to submit such postmarked or the delivery service Submissions,’’ publicly viewable at
labeling. acceptance receipt is on or before that https://www.regulations.gov or at the
Dated: September 4, 2018. date. Dockets Management Staff between 9
Leslie Kux, Comments received on or before a.m. and 4 p.m., Monday through
Associate Commissioner for Policy. October 3, 2018, will be provided to the Friday.
[FR Doc. 2018–19663 Filed 9–10–18; 8:45 am] committee. Comments received after • Confidential Submissions—To
that date will be taken into submit a comment with confidential
BILLING CODE 4164–01–P
consideration by FDA. information that you do not wish to be
You may submit comments as made publicly available, submit your
DEPARTMENT OF HEALTH AND follows: comments only as a written/paper
HUMAN SERVICES submission. You should submit two
Electronic Submissions copies total. One copy will include the
Food and Drug Administration Submit electronic comments in the information you claim to be confidential
following way: with a heading or cover note that states
[Docket No. FDA–2018–N–3276] • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ FDA
Anesthetic and Analgesic Drug
instructions for submitting comments. will review this copy, including the
Products Advisory Committee; Notice
Comments submitted electronically, claimed confidential information, in its
of Meeting; Establishment of a Public
including attachments, to https:// consideration of comments. The second
Docket; Request for Comments
www.regulations.gov will be posted to copy, which will have the claimed
AGENCY: Food and Drug Administration, the docket unchanged. Because your confidential information redacted/
HHS. comment will be made public, you are blacked out, will be available for public
daltland on DSKBBV9HB2PROD with NOTICES
ACTION: Notice; establishment of a solely responsible for ensuring that your viewing and posted on https://
public docket; request for comments. comment does not include any www.regulations.gov. Submit both
confidential information that you or a copies to the Dockets Management Staff.
SUMMARY: The Food and Drug third party may not wish to be posted, If you do not wish your name and
Administration (FDA) announces a such as medical information, your or contact information be made publicly
forthcoming public advisory committee anyone else’s Social Security number, or available, you can provide this
meeting of the Anesthetic and Analgesic confidential business information, such information on the cover sheet and not
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![45942 Federal Register / Vol. 83, No. 176 / Tuesday, September 11, 2018 / Notices
in the body of your comments and you will be posted on FDA’s website after Dated: September 4, 2018.
must identify the information as the meeting. Background material is Leslie Kux,
‘‘confidential.’’ Any information marked available at https://www.fda.gov/ Associate Commissioner for Policy.
as ‘‘confidential’’ will not be disclosed AdvisoryCommittees/Calendar/ [FR Doc. 2018–19667 Filed 9–10–18; 8:45 am]
except in accordance with 21 CFR 10.20 default.htm. Scroll down to the BILLING CODE 4164–01–P
and other applicable disclosure law. For appropriate advisory committee meeting
more information about FDA’s posting link.
of comments to public dockets, see 80 DEPARTMENT OF HEALTH AND
Procedure: Interested persons may
FR 56469, September 18, 2015, or access HUMAN SERVICES
present data, information, or views,
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/2015- orally or in writing, on issues pending Food and Drug Administration
23389.pdf . before the committee. All electronic and
written submissions submitted to the [Docket No. FDA–2013–D–0286]
Docket: For access to the docket to
read background documents or the Docket (see ADDRESSES) on or before
Agency Information Collection
electronic and written/paper comments October 3, 2018, will be provided to the
Activities; Submission for Office of
received, go to https:// committee. Oral presentations from the
Management and Budget Review;
www.regulations.gov and insert the public will be scheduled between
Comment Request; Guidance for
docket number, found in brackets in the approximately 1 p.m. and 2 p.m. Those Industry: Formal Meetings Between the
heading of this document, into the individuals interested in making formal Food and Drug Administration and
‘‘Search’’ box and follow the prompts oral presentations should notify the Biosimilar Biological Product
and/or go to the Dockets Management contact person and submit a brief Sponsors or Applicants
Staff, 5630 Fishers Lane, Rm. 1061, statement of the general nature of the
Rockville, MD 20852. evidence or arguments they wish to AGENCY: Food and Drug Administration,
FOR FURTHER INFORMATION CONTACT: present, the names and addresses of HHS.
Moon Hee V. Choi, Center for Drug proposed participants, and an ACTION: Notice.
Evaluation and Research, Food and indication of the approximate time
SUMMARY: The Food and Drug
Drug Administration, 10903 New requested to make their presentation on
Administration (FDA or we) is
Hampshire Ave., Bldg. 31, Rm. 2417, or before September 25, 2018. Time
announcing that a proposed collection
Silver Spring, MD 20993–0002, 301– allotted for each presentation may be
of information has been submitted to the
796–9001, Fax: 301–847–8533, email: limited. If the number of registrants
Office of Management and Budget
AADPAC@fda.hhs.gov, or FDA requesting to speak is greater than can
(OMB) for review and clearance under
Advisory Committee Information Line, be reasonably accommodated during the the Paperwork Reduction Act of 1995.
1–800–741–8138 (301–443–0572 in the scheduled open public hearing session,
DATES: Fax written comments on the
Washington, DC area). A notice in the FDA may conduct a lottery to determine
collection of information by October 11,
Federal Register about last minute the speakers for the scheduled open
2018.
modifications that impact a previously public hearing session. The contact
ADDRESSES: To ensure that comments on
announced advisory committee meeting person will notify interested persons
cannot always be published quickly regarding their request to speak by the information collection are received,
enough to provide timely notice. OMB recommends that written
September 26, 2018.
Therefore, you should always check the comments be faxed to the Office of
Persons attending FDA’s advisory Information and Regulatory Affairs,
FDA’s website at https://www.fda.gov/ committee meetings are advised that
AdvisoryCommittees/default.htm and OMB, Attn: FDA Desk Officer, Fax: 202–
FDA is not responsible for providing 395–7285, or emailed to oira_
scroll down to the appropriate advisory access to electrical outlets.
committee meeting link, or call the submission@omb.eop.gov. All
advisory committee information line to For press inquiries, please contact the comments should be identified with the
learn about possible modifications Office of Media Affairs at fdaoma@ OMB control number 0910–0802. Also
before coming to the meeting. fda.hhs.gov or 301–796–4540. include the FDA docket number found
in brackets in the heading of this
SUPPLEMENTARY INFORMATION: FDA welcomes the attendance of the
document.
Agenda: The committee will be asked public at its advisory committee
to discuss new drug application (NDA) meetings and will make every effort to FOR FURTHER INFORMATION CONTACT:
210730, for oliceridine 1 milligram/ accommodate persons with disabilities. Domini Bean, Office of Operations,
milliliter injection, submitted by If you require accommodations due to a Food and Drug Administration, Three
Trevena, Inc., for the management of disability, please contact Moon Hee V. White Flint North, 10A–12M, 11601
moderate-to-severe acute pain in adult Choi (see FOR FURTHER INFORMATION Landsdown St., North Bethesda, MD
patients for whom an intravenous CONTACT) at least 7 days in advance of 20852, 301–796–5733, PRAStaff@
opioid is warranted. The committee will the meeting. fda.hhs.gov.
also be asked to discuss the efficacy and SUPPLEMENTARY INFORMATION: In
FDA is committed to the orderly
safety data and benefit-risk compliance with 44 U.S.C. 3507, FDA
conduct of its advisory committee
considerations. has submitted the following proposed
meetings. Please visit our website at
FDA intends to make background collection of information to OMB for
material available to the public no later https://www.fda.gov/Advisory
review and clearance.
daltland on DSKBBV9HB2PROD with NOTICES
than 2 business days before the meeting. Committees/AboutAdvisoryCommittees/
Guidance for Industry: Formal
If FDA is unable to post the background ucm111462.htm for procedures on
Meetings between the Food and Drug
material on its website prior to the public conduct during advisory
Administration and Biosimilar
meeting, the background material will committee meetings. Biological Product Sponsors or
be made publicly available at the Notice of this meeting is given under Applicants.
location of the advisory committee the Federal Advisory Committee Act (5 OMB Control No. 0910–0802—
meeting, and the background material U.S.C. app. 2). Extension.
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Document Created: 2018-09-11 01:03:26
Document Modified: 2018-09-11 01:03:26
| 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 11, 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 45941 |
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