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Regulatory Information
2019_register
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2019-10-25
article
Pediatric Stakeholder Meeting; Public Meeting; Request for Comments
Notices
D09002ee1bdb6b4fd
D09002ee1bdb6b59b
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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United States Government Agency or Subagency
The Food and Drug Administration's (FDA or the Agency) Office of Pediatric Therapeutics (OPT), the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are announcing a public meeting seeking input from patient/ parent groups, consumer groups, regulated industry, academia, and other interested parties to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (see the SUPPLEMENTARY INFORMATION section for additional background information).
84 FR 57451
https://www.govinfo.gov/app/details/FR-2019-10-25/2019-23264
2019-23264
fr25oc19-87
4164-01-P
Docket No. FDA-2019-N-4560
https://www.govinfo.gov/app/details/FR-2019-10-25/2019-23264
https://www.govinfo.gov/content/pkg/FR-2019-10-25/html/2019-23264.htm
https://www.govinfo.gov/content/pkg/FR-2019-10-25/pdf/2019-23264.pdf
2 p.
57451
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84 FR 57451
Pediatric Stakeholder Meeting; Public Meeting; Request for Comments; Federal Register Vol. 84, Issue
NOTICE
2019-23264
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-11-21
Docket No. FDA-2019-N-4560
4164-01-P
2019-23264
Notice of public meeting; request for comments.
The Food and Drug Administration's (FDA or the Agency) Office of Pediatric Therapeutics (OPT), the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are announcing a public meeting seeking input from patient/ parent groups, consumer groups, regulated industry, academia, and other interested parties to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (see the SUPPLEMENTARY INFORMATION section for additional background information).
The public meeting will be held on November 21, 2019, from 9 a.m. to 3 p.m. Registration to attend the meeting should be received by November 15, 2019. Onsite registration on the day of the meeting will be based on space availability. Submit either electronic or written comments on the public meeting by December 19, 2019. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Terrie Crescenzi, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, terrie.crescenzi@fda.hhs.gov or Elizabeth Sanford, Office of Pediatric Therapeutics, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, elizabeth.sanford@fda.hhs.gov.
Meetings:
Pediatric Stakeholder
,
elizabeth.sanford@fda.hhs.gov
opt@fda.hhs.gov
terrie.crescenzi@fda.hhs.gov
http://www.regulations.gov
https://collaboration.fda.gov/pediatriclegislation/
https://www.eventbrite.com/e/stakeholder-input-on-pediatric-legislation-registration-74306461627
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 207
Office of the Federal Register, National Archives and Records Administration
2019-10-25
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Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2019-10-25
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https://www.govinfo.gov/app/details/FR-2019-10-25
https://www.govinfo.gov/content/pkg/FR-2019-10-25/pdf/FR-2019-10-25.pdf
https://www.govinfo.gov/content/pkg/FR-2019-10-25/xml/FR-2019-10-25.xml
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