United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
2020_register
executive
2020-03-11
article
Q3D(R1) Elemental Impurities; International Council for Harmonisation; Guidance for Industry; Availability
Notices
D09002ee1bdb5e5cf
D09002ee1bdb5e632
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised final guidance for industry entitled ``Q3D(R1) Elemental Impurities.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This guidance finalizes the draft guidance ``Q3D(R1) Elemental Impurities'' published on July 13, 2018. This guidance revises the existing guidance for industry ``Q3D Elemental Impurities'' and provides an updated permitted daily exposure (PDE) for the cadmium inhalation route of exposure. The updated PDE of 3 micrograms ([micro]g)/day is based on a modifying factor approach like that used for calculating the PDEs for the cadmium oral and parenteral routes of exposure. This revised guidance is intended to correct a calculation error in the PDE for cadmium by the inhalation route of exposure.
85 FR 14203
https://www.govinfo.gov/app/details/FR-2020-03-11/2020-04995
2020-04995
fr11mr20-36
4164-01-P
Docket No. FDA-2013-D-1156
https://www.govinfo.gov/app/details/FR-2020-03-11/2020-04995
https://www.govinfo.gov/content/pkg/FR-2020-03-11/html/2020-04995.htm
https://www.govinfo.gov/content/pkg/FR-2020-03-11/pdf/2020-04995.pdf
3 p.
14203
14205
85 FR 14203
Q3D(R1) Elemental Impurities; International Council for Harmonisation; Guidance for Industry; Availability; Federal Register Vol. 85, Issue
NOTICE
2020-04995
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2013-D-1156
4164-01-P
2020-04995
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised final guidance for industry entitled ``Q3D(R1) Elemental Impurities.'' The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. This guidance finalizes the draft guidance ``Q3D(R1) Elemental Impurities'' published on July 13, 2018. This guidance revises the existing guidance for industry ``Q3D Elemental Impurities'' and provides an updated permitted daily exposure (PDE) for the cadmium inhalation route of exposure. The updated PDE of 3 micrograms ([micro]g)/day is based on a modifying factor approach like that used for calculating the PDEs for the cadmium oral and parenteral routes of exposure. This revised guidance is intended to correct a calculation error in the PDE for cadmium by the inhalation route of exposure.
The announcement of the guidance is published in the Federal Register on March 11, 2020.
Regarding the guidance: Tim McGovern, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6426, Silver Spring, MD 20993-0002, 240-402-0477.
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 85, no. 48
Office of the Federal Register, National Archives and Records Administration
2020-03-11
continuing
daily
deposited
born digital
259 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2020-03-11
P0b002ee1a61f4e81
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr11mr20
https://www.govinfo.gov/app/details/FR-2020-03-11
https://www.govinfo.gov/content/pkg/FR-2020-03-11/pdf/FR-2020-03-11.pdf
https://www.govinfo.gov/content/pkg/FR-2020-03-11/xml/FR-2020-03-11.xml
fdlp
14143
14392
DGPO
2020-03-11
2023-04-27
FR-2020-03-11
machine generated
eng
FR
FR-2020-03-11
85
48