83 FR 23467 - Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee, Renewal
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 98 (May 21, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 98 (May 21, 2018)
| Page Range | 23467-23467 | |
| FR Document | 2018-10731 |
[Federal Register Volume 83, Number 98 (Monday, May 21, 2018)] [Notices] [Page 23467] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-10731] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-N-0001] Advisory Committee; Anesthetic and Analgesic Drug Products Advisory Committee, Renewal AGENCY: Food and Drug Administration, HHS. ACTION: Notice; renewal of advisory committee. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee (the Committee) by the Commissioner of Food and Drugs (the Commissioner). The Commissioner has determined that it is in the public interest to renew the Committee for an additional 2 years beyond the charter expiration date. The new charter will be in effect until May 1, 2020. DATES: Authority for the Committee will expire on May 1, 2020, unless the Commissioner formally determines that renewal is in the public interest. FOR FURTHER INFORMATION CONTACT: Moon Hee 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, email: [email protected]. SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by the Department of Health and Human Services pursuant to 45 CFR part 11 and by the General Services Administration, FDA is announcing the renewal of the Committee. The Committee is a discretionary Federal advisory committee established to provide advice to the Commissioner. The Committee advises the Commissioner or designee in discharging responsibilities as they relate to helping to ensure safe and effective drugs for human use and, as required, any other product for which FDA has regulatory responsibility. The Committee reviews and evaluates available data concerning the safety and effectiveness of marketed and investigational human drug products including analgesics, e.g., abuse-deterrent opioids, novel analgesics, and issues related to opioid abuse, and those for use in anesthesiology and makes appropriate recommendations to the Commissioner. The Committee shall consist of a core of 11 voting members including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of anesthesiology, analgesics (such as: abuse deterrent opioids, novel analgesics, and issues related to opioid abuse) epidemiology or statistics, and related specialties. Members will be invited to serve for overlapping terms of up to 4 years. Almost all non-Federal members of this committee serve as Special Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who is identified with consumer interests and is recommended by either a consortium of consumer- oriented organizations or other interested persons. In addition to the voting members, the Committee may include one non-voting member who is identified with industry interests. Further information regarding the most recent charter and other information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticandAnalgesicDrugProductsAdvisoryCommittee/default.htm or by contacting the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In light of the fact that no change has been made to the committee name or description of duties, no amendment will be made to 21 CFR 14.100. This document is issued under the Federal Advisory Committee Act (5 U.S.C. app.). For general information related to FDA advisory committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm. Dated: May 15, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-10731 Filed 5-18-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 98 / Monday, May 21, 2018 / Notices 23467
be made publicly available at the venue https://www.fda.gov/Advisory effective drugs for human use and, as
of the advisory committee meeting, and Committees/AboutAdvisoryCommittees/ required, any other product for which
the background material will be posted ucm111462.htm for procedures on FDA has regulatory responsibility.
on FDA’s website after the meeting. public conduct during advisory The Committee reviews and evaluates
Background material will be available at committee meetings. available data concerning the safety and
http://www.fda.gov/Advisory Notice of this meeting is given under
the Federal Advisory Committee Act (5 effectiveness of marketed and
Committees/Calendar/default.htm.
Scroll down to the appropriate advisory U.S.C. app.2). investigational human drug products
committee meeting link. including analgesics, e.g., abuse-
Dated: May 15, 2018. deterrent opioids, novel analgesics, and
Procedure: On June 22, 2018, from 11
Leslie Kux, issues related to opioid abuse, and those
a.m. to 12:55 p.m. and 2:20 p.m. to 3:45
Associate Commissioner for Policy. for use in anesthesiology and makes
p.m.., the meeting is open to the public.
Interested persons may present data, [FR Doc. 2018–10734 Filed 5–18–18; 8:45 am] appropriate recommendations to the
information, or views, orally or in BILLING CODE 4164–01–P Commissioner.
writing, on issues pending before the The Committee shall consist of a core
committee. Written submissions may be of 11 voting members including the
made to the contact person on or before DEPARTMENT OF HEALTH AND
HUMAN SERVICES Chair. Members and the Chair are
June 15, 2018. Oral presentations from selected by the Commissioner or
the public will be scheduled between Food and Drug Administration designee from among authorities
approximately 12:25 p.m. to 12:55 p.m.
and from 3:15 p.m. to 3:45 p.m. on June [Docket No. FDA–2018–N–0001] knowledgeable in the fields of
22, 2018. Those individuals interested anesthesiology, analgesics (such as:
in making formal oral presentations Advisory Committee; Anesthetic and abuse deterrent opioids, novel
should notify the contact person and Analgesic Drug Products Advisory analgesics, and issues related to opioid
submit a brief statement of the general Committee, Renewal abuse) epidemiology or statistics, and
nature of the evidence or arguments related specialties. Members will be
AGENCY: Food and Drug Administration,
they wish to present, the names and HHS. invited to serve for overlapping terms of
addresses of proposed participants, and up to 4 years. Almost all non-Federal
ACTION:Notice; renewal of advisory
an indication of the approximate time members of this committee serve as
committee.
requested to make their presentation on Special Government Employees. The
or before June 7, 2018. Time allotted for SUMMARY: The Food and Drug core of voting members may include one
each presentation may be limited. If the Administration (FDA) is announcing the technically qualified member, selected
number of registrants requesting to renewal of the Anesthetic and Analgesic by the Commissioner or designee, who
speak is greater than can be reasonably Drug Products Advisory Committee (the is identified with consumer interests
accommodated during the scheduled Committee) by the Commissioner of and is recommended by either a
open public hearing session, FDA may Food and Drugs (the Commissioner). consortium of consumer-oriented
conduct a lottery to determine the The Commissioner has determined that organizations or other interested
speakers for the scheduled open public it is in the public interest to renew the persons. In addition to the voting
hearing session. The contact person will Committee for an additional 2 years members, the Committee may include
notify interested persons regarding their beyond the charter expiration date. The one non-voting member who is
request to speak by June 8, 2018. new charter will be in effect until May
Closed Committee Deliberations: On identified with industry interests.
1, 2020.
June 22, 2018 between 12:55 p.m. and Further information regarding the
DATES: Authority for the Committee will
1:40 p.m. and between 3:45 p.m. and most recent charter and other
expire on May 1, 2020, unless the
4:20 p.m., the meeting will be closed to information can be found at https://
Commissioner formally determines that
permit discussion where disclosure renewal is in the public interest. www.fda.gov/AdvisoryCommittees/
would constitute a clearly unwarranted CommitteesMeetingMaterials/Drugs/
FOR FURTHER INFORMATION CONTACT:
invasion of personal privacy (5 U.S.C. AnestheticandAnalgesicDrugProducts
Moon Hee Choi, Center for Drug
552b(c)(6)). During the closed sessions, AdvisoryCommittee/default.htm or by
Evaluation and Research, Food and
the Committee will discuss the research contacting the Designated Federal
Drug Administration, 10903 New
progress made by staff involved in the Officer (see FOR FURTHER INFORMATION
Hampshire Ave., Bldg. 31, Rm. 2417,
intramural research programs and make CONTACT). In light of the fact that no
Silver Spring, MD 20993–0002; 301–
recommendations regarding personnel change has been made to the committee
796–9001, email: AADPAC@
actions and staffing. name or description of duties, no
Persons attending FDA’s advisory fda.hhs.gov.
amendment will be made to 21 CFR
committee meetings are advised that the SUPPLEMENTARY INFORMATION: Pursuant
14.100.
Agency is not responsible for providing to 41 CFR 102–3.65 and approval by the
access to electrical outlets. Department of Health and Human This document is issued under the
FDA welcomes the attendance of the Services pursuant to 45 CFR part 11 and Federal Advisory Committee Act (5
public at its advisory committee by the General Services Administration, U.S.C. app.). For general information
meetings and will make every effort to FDA is announcing the renewal of the related to FDA advisory committees,
please check https://www.fda.gov/
sradovich on DSK3GMQ082PROD with NOTICES
accommodate persons with disabilities. Committee. The Committee is a
If you require accommodations due to a discretionary Federal advisory AdvisoryCommittees/default.htm.
disability, please contact Bryan Emery committee established to provide advice Dated: May 15, 2018.
at least 7 days in advance of the to the Commissioner.
Leslie Kux,
meeting. The Committee advises the
FDA is committed to the orderly Commissioner or designee in Associate Commissioner for Policy.
conduct of its advisory committee discharging responsibilities as they [FR Doc. 2018–10731 Filed 5–18–18; 8:45 am]
meetings. Please visit our website at relate to helping to ensure safe and BILLING CODE 4164–01–P
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Document Created: 2018-11-02 11:08:16
Document Modified: 2018-11-02 11:08:16
| 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; renewal of advisory committee. | |
| Dates | Authority for the Committee will expire on May 1, 2020, unless the Commissioner formally determines that renewal is in the public interest. | |
| Contact | Moon Hee 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, email: [email protected] | |
| FR Citation | 83 FR 23467 |
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