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
2015_register
executive
2015-09-04
article
VSTA Records and Reports Specific to International Standards for Pharmacovigilance
Proposed Rules
D09002ee1bdc2bd75
D09002ee1bdc2bdee
United States
Department of Agriculture
originator
org
United States Government Agency or Subagency
United States
Animal and Plant Health Inspection Service
originator
org
United States Government Agency or Subagency
We are proposing to amend the Virus-Serum-Toxin Act regulations concerning records and reports. This change would require veterinary biologics licensees and permittees to record and submit reports concerning adverse events associated with the use of biological products they produce or distribute. The information that must be included in the adverse event reports submitted to the Animal and Plant Health Inspection Service would be provided in separate guidance documents. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document.
80 FR 53475
https://www.govinfo.gov/app/details/FR-2015-09-04/2015-21997
2015-21997
fr04se15-12
RIN 0579-AE11
3410-34-P
Docket No. APHIS-2014-0063
https://www.govinfo.gov/app/details/FR-2015-09-04/2015-21997
https://www.govinfo.gov/content/pkg/FR-2015-09-04/html/2015-21997.htm
https://www.govinfo.gov/content/pkg/FR-2015-09-04/pdf/2015-21997.pdf
Animal Biologics
Reporting and Recordkeeping Requirements
4 p.
53475
53478
80 FR 53475
Code of Federal Regulations
Title 9 Part 101
9 CFR Part 101
Code of Federal Regulations
Title 9 Part 116
9 CFR Part 116
Regulation Identification Number 0579-AE11
RIN 0579-AE11
VSTA Records and Reports Specific to International Standards for Pharmacovigilance; Federal Register Vol. 80, Issue
PRORULE
2015-21997
DEPARTMENT OF AGRICULTURE
Animal and Plant Health Inspection Service
2015-11-03
Docket No. APHIS-2014-0063
3410-34-P
2015-21997
Proposed rule; withdrawal and reproposal.
We are proposing to amend the Virus-Serum-Toxin Act regulations concerning records and reports. This change would require veterinary biologics licensees and permittees to record and submit reports concerning adverse events associated with the use of biological products they produce or distribute. The information that must be included in the adverse event reports submitted to the Animal and Plant Health Inspection Service would be provided in separate guidance documents. This proposed rule replaces a previously published proposed rule, which we are withdrawing as part of this document.
We will consider all comments that we receive on or before November 3, 2015.
Dr. Donna L. Malloy, Section Leader, Operational Support, Center for Veterinary Biologics Policy, Evaluation, and Licensing, VS, APHIS, 4700 River Road Unit 148, Riverdale, MD 20737-1231; (301) 851-3426.
Animal Biologics
Reporting and Recordkeeping Requirements
VSTA Records and Reports Specific to International Standards for Pharmacovigilance
,
http://thedataweb.rm.census.gov/TheDataWeb_HotReport2/econsnapshot/2012/snapshot.hrml?NAICS=325413
http://thedataweb.rm.census.gov/TheDataWeb_HotReport2/econsnapshot/2012/snapshot.hrml?NAICS=325414
http://www.regulations.gov/#!docketDetail
http://www.vichsec.org/guidelines/pharmacovigilance.html
Regulations.gov
Federal Register
Vol. 80, no. 172
Office of the Federal Register, National Archives and Records Administration
2015-09-04
continuing
daily
deposited
born digital
242 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-09-04
P0b002ee18d772064
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr04se15
https://www.govinfo.gov/app/details/FR-2015-09-04
https://www.govinfo.gov/content/pkg/FR-2015-09-04/pdf/FR-2015-09-04.pdf
https://www.govinfo.gov/content/pkg/FR-2015-09-04/xml/FR-2015-09-04.xml
fdlp
53457
53689
DGPO
2015-09-04
2023-04-29
FR-2015-09-04
machine generated
eng
FR
FR-2015-09-04
80
172