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2018-02-26
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Interim Results of Study of Workload Volume and Full Costs Associated With Review of Biosimilar Biological Product Applications
Notices
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D09002ee1bdc2ae1c
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 (FDA or Agency) is announcing an opportunity for public comment on the interim results of a study of the workload volume and full costs associated with the process for the review of biosimilar biological product applications (interim report). This study was conducted by an independent consulting firm, and it fulfills FDA's statutory requirement under the first authorization of the Biosimilar User Fee Act of 2012 (BsUFA), which enables FDA to collect user fees for the review of biosimilar biological applications for fiscal years 2013 to 2017. This notice solicits comments on the interim report.
80 FR 57621
https://www.govinfo.gov/app/details/FR-2015-09-24/2015-24227
2015-24227
fr24se15-70
4164-01-P
Docket No. FDA-2015-N-3155
https://www.govinfo.gov/app/details/FR-2015-09-24/2015-24227
https://www.govinfo.gov/content/pkg/FR-2015-09-24/html/2015-24227.htm
https://www.govinfo.gov/content/pkg/FR-2015-09-24/pdf/2015-24227.pdf
1 p.
57621
57621
80 FR 57621
Interim Results of Study of Workload Volume and Full Costs Associated With Review of Biosimilar Biological Product Applications; Federal Register Vol. 80, Issue
NOTICE
2015-24227
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2015-10-26
Docket No. FDA-2015-N-3155
4164-01-P
2015-24227
Notice; request for comments.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the interim results of a study of the workload volume and full costs associated with the process for the review of biosimilar biological product applications (interim report). This study was conducted by an independent consulting firm, and it fulfills FDA's statutory requirement under the first authorization of the Biosimilar User Fee Act of 2012 (BsUFA), which enables FDA to collect user fees for the review of biosimilar biological applications for fiscal years 2013 to 2017. This notice solicits comments on the interim report.
The interim report will be released on September 24, 2015, and will be available at http://www.fda.gov/downloads/ForIndustry/UserFees/ BiosimilarUserFeeActBsUFA/UCM459686.pdf. Submit either electronic or written comments on the interim report by October 26, 2015.
Mark Ascione, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1150, Silver Spring, MD 20993-0002, 301- 796-7652, FAX: 301-847-8443.
Interim Results of Study of Workload Volume and Full Costs Associated with Review of Biosimilar Biological Product Applications
,
http://uscode.house.gov/view.xhtml?req=granuleid:U.S.C.-prelim-title21-section379j-53&num=0&edition=prelim
http://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM459686.pdf
http://www.regulations.gov
Federal Register
Vol. 80, no. 185
Office of the Federal Register, National Archives and Records Administration
2015-09-24
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Table of Contents:
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https://www.govinfo.gov/content/pkg/FR-2015-09-24/pdf/FR-2015-09-24.pdf
https://www.govinfo.gov/content/pkg/FR-2015-09-24/xml/FR-2015-09-24.xml
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2018-02-26
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FR-2015-09-24
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