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CDER Small Business and Industry Assistance (CDER SBIA) Webinar on Fees Associated with Human Drug Compounding By Registered Outsourcing Facilities, April 24, 2014
On Thursday April 24, 2014, at 1 pm EDT, CDER Small Business and Industry Assistance (CDER SBIA) will present a webinar entitled Fees Associated with Human Drug Compounding By Registered Outsourcing Facilities.
The purpose of this webinar is to announce the recently-published human drug compounding fee draft guidance for industry and, in particular, to draw attention to the current open period for small businesses to request a reduction in the required establishment fee. Qualified small businesses pay a fee that is one-third the amount of non-small businesses. The draft guidance covers fee requirements for human drug compounding outsourcing facilities that have elected to register with the FDA under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 503B requires outsourcing facilities to pay certain fees.
The draft guidance describes the annual establishment fee, the reinspection fee, annual adjustments to those fees, how and when to submit payments, the consequences of failure to pay fees, and how to qualify as a small business to obtain a reduction in the establishment fee. To qualify for a reduction in the annual establishment fee for fiscal year 2015, entities should complete FDA Form 3908 located in Appendix 1 of the draft guidance and submit the completed form to FDA no later than April 30, 2014. Failure to submit a complete small business reduction request form by April 30, 2014 will result in a denial of the request, and the company will have to pay the full fee should it choose to register.
Speaker:
Jonathan Gil, J.D.
Regulatory Counsel
Division of User Fee Management
Office of Management (OM)
Center for Drug Evaluation and Research (CDER)
Jonathan Gil is a regulatory Counsel in CDER’s Office of Management, Division of User Fee Management. Jonathan has a B.S. degree and a J.D. degree, and is a subject matter expert on the fee provisions of the Compounding Quality Act.
To register for this Event, please go the following link: https://collaboration.fda.gov/sbia0424/event/registration.html
(Registration password needs to be 8 characters and alphanumeric)
Note: Your registration acknowledgement will include the webinar access link.
Audio will broadcast from your computer speakers.
Closed captioning will be provided.
Questions/Comments can be submitted live via a Q/A chat window.
Please note: There is a user capacity limit for this webinar. For those who cannot enter the webinar, please know that it will be recorded and a link will be posted to this page within one business day.
Presentation Information:
- Federal Register (FR) Notice of Availability
- Draft Guidance for Industry:Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act; Availability
For questions concerning the webinar, please contact CDER SBIA at:
(866) 405-5367 | (301) 796-6707
CDER SBIA webinar series: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm070334.htm
The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.
- Email: CDERSBIA@fda.hhs.gov
- Phone: 1-866-405-5367
- Phone: (301) 796-6707
- Website: http://www.fda.gov/cdersbia
Please take our CDER Small Business survey: https://www.surveymonkey.com/s/CDERSBIA_Evaluation
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