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Notice2019-036632019-03-01

International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; World Health Organization; Scheduling Recommendations; Cyclopropyl Fentanyl; Methoxyacetyl Fentanyl; Ortho-Fluorofentanyl; Para-Fluorobutyrfentanyl; N-Ethylnorpentylone; and Four Additional Substances; Request for Comments

Health and Human Services Department, Food and Drug Administration

Abstract

The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 18-22, 2019. This notice is issued under the Controlled Substances Act (CSA).

Action & Dates

Action
Notice of comment.
Dates
Submit either electronic or written comments by March 14, 2019. The short time period for the submission of comments is needed to ensure that the Department of Health and Human Services (HHS) may, in a timely fashion, carry out the required action and be responsive to the United Nations.

Public Comment

Comments Close
2019-03-14

Document Excerpt

Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2019-N-0671] AGENCY: Food and Drug Administration, HHS. ACTION: Notice of comment. SUMMARY: The Food and Drug Administration (FDA) is providing interested persons with the opportunity to submit written comments concerning recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions, under international treaties, on certain drug substances. The comments received in response to this notice will be considered in preparing the United States' position on these proposals for a meeting of the United Nations Commission on Narcotic Drugs (CND) in Vienna, Austria, in March 18-22, 2019. This notice is issued under the Controlled Substances Act (CSA). DATES: Submit either electronic or written comments by March 14, 2019. ( printed page 7071) The short time period for the submission of comments is needed to ensure that the Department of Health and Human Services (HHS) may, in a timely fashion, carry out the required action and be responsive to the United Nations. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before March 14, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of March 14, 2019. Comments received by mail/hand delivery/courier (for written/pape

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Full Document

Citation: 84 FR 7070