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Proposed Rule

Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction; Public Hearing; Correction

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notification of public hearing; request for comments; correction.

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SUMMARY:

The Food and Drug Administration (FDA) is correcting a notice entitled “Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction; Public Hearing” that appeared in the Federal Register of June 21, 2019. The document was published with incorrect presenter registration and slide deck submission deadlines. This document corrects those deadlines.

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FOR FURTHER INFORMATION CONTACT:

Nicole Zelenak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6429, Silver Spring, MD 20993-0002, 301-796-9030.

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SUPPLEMENTARY INFORMATION:

In the Federal Register of Friday, June 21, 2019 (84 FR 29112), in FR Doc. 2019-13219, on page 29114, the following correction is made:

On page 29114, in the first column, in the “Presenter” bulleted paragraph, the fourth and fifth sentences “Presenters must register no later than August 9, 2019. Slide decks are due to CDER-PublicMeeting@fda.hh.gov in PDF or PowerPoint format no later than August 23, 2019.” are corrected to read “Presenters must register no later than September 6, 2019. Slide decks are due to CDER-PublicMeeting@fda.hh.gov in PDF or PowerPoint format no later than September 6, 2019.”

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Dated: August 16, 2019.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

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[FR Doc. 2019-18090 Filed 8-21-19; 8:45 am]

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