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
2014_register
executive
2014-03-15
article
New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File
Proposed Rules
D09002ee1bdc6cb1e
D09002ee1bdc6cbe1
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 proposing to amend its regulation regarding the confidentiality of data and information in and about new animal drug application files to change when certain approval-related information would be disclosed by the Agency. This change would ensure that the Agency is able to update its list of approved new animal drug products within the statutory timeframe. It would also permit more timely public disclosure of approval-related information, increasing the transparency of FDA decision making in the approval of new animal drugs.
79 FR 14630
https://www.govinfo.gov/app/details/FR-2014-03-17/2014-05432
2014-05432
fr17mr14-7
4160-01-P
Docket No. FDA-2014-N-0108
https://www.govinfo.gov/app/details/FR-2014-03-17/2014-05432
https://www.govinfo.gov/content/pkg/FR-2014-03-17/html/2014-05432.htm
https://www.govinfo.gov/content/pkg/FR-2014-03-17/pdf/2014-05432.pdf
Administrative Practice and Procedure
Animal Drugs
Confidential Business Information
Reporting and Recordkeeping Requirements
3 p.
14630
14632
79 FR 14630
Code of Federal Regulations
Title 21 Part 514
21 CFR Part 514
New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File; Federal Register Vol. 79, Issue
PRORULE
2014-05432
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2014-06-02
Docket No. FDA-2014-N-0108
4160-01-P
2014-05432
Proposed rule.
The Food and Drug Administration (FDA or Agency) is proposing to amend its regulation regarding the confidentiality of data and information in and about new animal drug application files to change when certain approval-related information would be disclosed by the Agency. This change would ensure that the Agency is able to update its list of approved new animal drug products within the statutory timeframe. It would also permit more timely public disclosure of approval-related information, increasing the transparency of FDA decision making in the approval of new animal drugs.
Submit either electronic or written comments by June 2, 2014. If FDA receives any significant adverse comments, the Agency will publish a document in the Federal Register withdrawing the direct final rule within 30 days after the comment period ends. FDA will then proceed to respond to comments under this proposed rule using the usual notice and comment procedures.
Scott Fontana, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0656.
Administrative Practice and Procedure
Animal Drugs
Confidential Business Information
Reporting and Recordkeeping Requirements
New Animal Drug Applications:
Confidentiality of Data and Information in a New Animal Drug Application File
,
http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts
http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm
http://www.regulations.gov
Federal Register
Vol. 79, no. 51
Office of the Federal Register, National Archives and Records Administration
2014-03-17
continuing
daily
deposited
born digital
377 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2014-03-17
P0b002ee187f36a91
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr17mr14
https://www.govinfo.gov/app/details/FR-2014-03-17
https://www.govinfo.gov/content/pkg/FR-2014-03-17/pdf/FR-2014-03-17.pdf
https://www.govinfo.gov/content/pkg/FR-2014-03-17/xml/FR-2014-03-17.xml
fdlp
14609
14976
DGPO
2014-03-15
2023-04-29
FR-2014-03-17
machine generated
eng
FR
FR-2014-03-17
79
51