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March 10 Through April 30, 2020, Public Meetings; Postponement, Cancellation, or Remote Only

The Food and Drug Administration is announcing that certain meetings involving the Center for Drug Evaluation and Research (CDER) from March 10 through April 30, 2020, are postp...

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket Nos. FDA-2020-N-0001, FDA-2020-N-0255, FDA-2020-N-0256, FDA-2020-N-0259, FDA-2018-N-4337]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration is announcing that certain meetings involving the Center for Drug Evaluation and Research (CDER) from March 10 through April 30, 2020, are postponed, cancelled, or modified to take place remotely.

DATES:

For dates that have been either postponed or cancelled, see table 1 in the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Kim Thomas, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6282, Silver Spring, MD 20993-0002, 301-796-2357, .

SUPPLEMENTARY INFORMATION:

Certain public meetings involving CDER from March 10 through April 30, 2020, are postponed, cancelled, or modified to take place remotely due to extenuating circumstances. The meetings that are postponed or canceled as part of this notice are listed in table 1. If a meeting is rescheduled, information about the rescheduled meeting will be provided in the future. The meeting that will no longer take place in person and instead take place by webcast only as part of this notice is listed in table 2.[1]

( printed page 15790)

Table 1—CDER Meetings Postponed or Cancelled
Meeting type Meeting title Original meeting date Docket No. Federal Register citation
Public Meeting Patient-Focused Drug Development for Stimulant Use Disorder Mar. 10, 2020 FDA-2020-N-0259 85 FR 8877, Feb. 18, 2020.
Public Meeting Patient-Focused Drug Development for Vitiligo Mar. 30, 2020 FDA-2020-N-0255 85 FR 8004, Feb. 12, 2020.
Public Meeting Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials Apr. 16, 2020 FDA-2020-N-0001 85 FR 14207, Mar. 11, 2020.
Public Meeting Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards Apr. 22, 2020 FDA-2018-N-4337 85 FR 6547, Feb. 5, 2020.

Table 2—CDER Meeting Held Remotely
Meeting type Meeting title Original meeting date Docket No. Federal Register citation Remote information
Public Meeting United States Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Apr. 3, 2020 FDA-2020-N-0256 85 FR 13659, Mar. 9, 2020 https://www.fda.gov/​drugs/​news-events-human-drugs/​health-canada-and-fda-joint-public-consultation-international-council-harmonisation-technical-0.

Dated: March 16, 2020.

Lowell J. Schiller,

Principal Associate Commissioner for Policy.

Footnotes

1.  Up-to-date information about public meetings involving CDER is available on the internet at https://www.fda.gov/​drugs/​news-events-human-drugs/​meetings-conferences-workshops-drugs.

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[FR Doc. 2020-05743 Filed 3-18-20; 8:45 am]

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“March 10 Through April 30, 2020, Public Meetings; Postponement, Cancellation, or Remote Only,” thefederalregister.org (March 19, 2020), https://thefederalregister.org/documents/2020-05743/march-10-through-april-30-2020-public-meetings-postponement-cancellation-or-remote-only.