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
2010_register
executive
2010-12-08
article
Biologics Price Competition and Innovation Act of 2009; Meetings on User Fee Program for Biosimilar and Interchangeable Biological Product Applications; Request for Notification of Stakeholder Intention To Participate
Notices
D09002ee1bdd12ad3
D09002ee1bdd12b78
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) is issuing this notice to request that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in consultation meetings relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitted under the Public Health Service Act (PHS Act). FDA is holding these consultation meetings to satisfy the requirement in the Patient Protection and Affordable Care Act that FDA consult with such public stakeholders regarding the development of recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of biosimilar and interchangeable biological product applications for fiscal years (FYs) 2013 through 2017. To ensure continuity and to support the development of recommendations for establishing a user fee program for biosimilars and interchangeable products, the Agency requests stakeholder representation throughout this consultation process.
75 FR 76472
https://www.govinfo.gov/app/details/FR-2010-12-08/2010-30713
2010-30713
fr08de10-96
4160-01-P
Docket No. FDA-2010-N-0602
https://www.govinfo.gov/app/details/FR-2010-12-08/2010-30713
https://www.govinfo.gov/content/pkg/FR-2010-12-08/html/2010-30713.htm
https://www.govinfo.gov/content/pkg/FR-2010-12-08/pdf/2010-30713.pdf
2 p.
76472
76473
75 FR 76472
Biologics Price Competition and Innovation Act of 2009; Meetings on User Fee Program for Biosimilar and Interchangeable Biological Product Applications; Request for Notification of Stakeholder Intention To Participate; Federal Register Vol. 75, Issue
NOTICE
2010-30713
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2011-01-10
Docket No. FDA-2010-N-0602
4160-01-P
2010-30713
Notice; request for notification of participation.
The Food and Drug Administration (FDA) is issuing this notice to request that public stakeholders, including patient and consumer advocacy groups, health care professionals, and scientific and academic experts, notify FDA of their intent to participate in consultation meetings relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitted under the Public Health Service Act (PHS Act). FDA is holding these consultation meetings to satisfy the requirement in the Patient Protection and Affordable Care Act that FDA consult with such public stakeholders regarding the development of recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of biosimilar and interchangeable biological product applications for fiscal years (FYs) 2013 through 2017. To ensure continuity and to support the development of recommendations for establishing a user fee program for biosimilars and interchangeable products, the Agency requests stakeholder representation throughout this consultation process.
Submit notification of intention to participate by January 10, 2011. Stakeholder discussions with FDA will occur during negotiations with the regulated industry.
Sunanda Bahl, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, rm. 1168, Silver Spring, MD 20993-0002, 301- 796-3584, FAX: 301-847-8443, e-mail: sunanda.bahl@fda.hhs.gov.
Meetings:
User Fee Program for Biosimilar and Interchangeable Biological Product Applications
,
BiosimilarsUserFeeProgram@fda.hhs.gov
sunanda.bahl@fda.hhs.gov
http://edocket.access.gpo.gov/2010/pdf/2010-24853.pdf
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/UCM215031
http://www.regulations.gov
Federal Register
Vol. 75, no. 235
Office of the Federal Register, National Archives and Records Administration
2010-12-08
continuing
daily
deposited
born digital
369 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2010-12-08
P0b002ee180b73349
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr08de10
https://www.govinfo.gov/app/details/FR-2010-12-08
https://www.govinfo.gov/content/pkg/FR-2010-12-08/pdf/FR-2010-12-08.pdf
https://www.govinfo.gov/content/pkg/FR-2010-12-08/xml/FR-2010-12-08.xml
fdlp
76251
76609
DGPO
2010-12-08
2023-05-01
FR-2010-12-08
machine generated
eng
FR
FR-2010-12-08
75
235