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2018-10-25
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Packaging, Storage, and Disposal Options To Enhance Opioid Safety-Exploring the Path Forward; Public Workshop; Request for Comments
Notices
D09002ee1bdba951e
D09002ee1bdba959a
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Packaging, Storage, and Disposal Options To Enhance Opioid Safety--Exploring the Path Forward.'' The purpose of this 2-day public workshop is to host a scientific discussion with experts and seek input from interested stakeholders regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products (opioids); guiding principles and considerations for the design of packaging, storage, and disposal options for opioids; integrating packaging, storage, and disposal options into existing health care and pharmacy systems, including both open and closed health care systems (e.g., a closed system such as the U.S. Department of Veterans Affairs); data needs and how to address challenges in assessing the impact of packaging, storage, and disposal options in both the premarket and postmarket settings; and ways in which FDA could encourage the development and assessment of packaging, storage, and disposal options for opioids that have the potential to enhance opioid safety.
82 FR 50429
https://www.govinfo.gov/app/details/FR-2017-10-31/2017-23535
2017-23535
fr31oc17-61
4164-01-P
Docket No. FDA-2017-N-5897
https://www.govinfo.gov/app/details/FR-2017-10-31/2017-23535
https://www.govinfo.gov/content/pkg/FR-2017-10-31/html/2017-23535.htm
https://www.govinfo.gov/content/pkg/FR-2017-10-31/pdf/2017-23535.pdf
3 p.
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82 FR 50429
Packaging, Storage, and Disposal Options To Enhance Opioid Safety-Exploring the Path Forward; Public Workshop; Request for Comments; Federal Register Vol. 82, Issue
NOTICE
2017-23535
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2018-02-12
Docket No. FDA-2017-N-5897
4164-01-P
2017-23535
Notice of public workshop; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Packaging, Storage, and Disposal Options To Enhance Opioid Safety--Exploring the Path Forward.'' The purpose of this 2-day public workshop is to host a scientific discussion with experts and seek input from interested stakeholders regarding the role of packaging, storage, and disposal options within the larger landscape of activities aimed at addressing abuse, misuse, or inappropriate access of prescription opioid drug products (opioids); guiding principles and considerations for the design of packaging, storage, and disposal options for opioids; integrating packaging, storage, and disposal options into existing health care and pharmacy systems, including both open and closed health care systems (e.g., a closed system such as the U.S. Department of Veterans Affairs); data needs and how to address challenges in assessing the impact of packaging, storage, and disposal options in both the premarket and postmarket settings; and ways in which FDA could encourage the development and assessment of packaging, storage, and disposal options for opioids that have the potential to enhance opioid safety.
The public workshop will be held on December 11 and 12, 2017, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by February 12, 2018. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Irene Z. Chan, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4420, Silver Spring, MD 20993-0002, 301-796-3962, Irene.Chan2@fda.hhs.gov; or Michelle Eby, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4422, Silver Spring, MD 20993-0002, 301-796-4714, Michelle.Eby@fda.hhs.gov.
Meetings:
Packaging, Storage, and Disposal Options to Enhance Opioid SafetyExploring the Path Forward; Public Workshop
,
Irene.Chan2@fda.hhs.gov
Michelle.Eby@fda.hhs.gov
https://healthpolicy.duke.edu/events/exploring-packaging-storage-and-disposal-solutions-enhance-opioid-safety
https://nakamotoevents.wufoo.com/forms/pads-task-force-public-meeting/
https://www.fda.gov/Drugs/NewsEvents/ucm571797.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 82, no. 209
Office of the Federal Register, National Archives and Records Administration
2017-10-31
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2017-10-31
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https://www.govinfo.gov/app/details/FR-2017-10-31
https://www.govinfo.gov/content/pkg/FR-2017-10-31/pdf/FR-2017-10-31.pdf
https://www.govinfo.gov/content/pkg/FR-2017-10-31/xml/FR-2017-10-31.xml
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