Outsourcing facilities must register annually with the U.S. Food and Drug Administration (FDA) and pay an annual establishment fee. FDA offers a reduced annual fee for small businesses, which the agency defines as facilities “with gross annual sales totaling $1,000,000 or less in the 12 months ending on April 1 of the FY immediately preceding the FY in which the annual establishment fee is assessed.”
An outsourcing facility that qualifies as a small business must complete and submit a Small Business Establishment Fee Reduction Request form (Form 3908) to FDA by April 30, 2015 in order to be eligible for the reduced small business fee for fiscal year (FY) 2016. The request must be submitted annually, so small businesses that requested the reduced fee in April 2014 will need to submit a request again this year. FDA will publish its fee rates for FY 2016 no later than 60 days before the start of the FY.
FDA’s FY 2015 fee rates for outsourcing facility establishments are as follows:
- Outsourcing facility – $16,442
- Small business – $5,103
- Reinspection fee – $15,308
Existing outsourcing facilities were required to complete their annual registration between October 1 and December 31, 2014, but a facility can newly register as an outsourcing facility at any time throughout the year. Even if a facility registers outside the annual registration period, the facility must pay the full fee. Once a facility registers, FDA will send an invoice for the annual fee and the facility will have 15 days to pay in full.
To learn more about registration, fees, and drug product reporting for outsourcing facilities, read about FDA’s three outsourcing facility guidances published in November 2014.
Registrar Corp can register a facility as an outsourcing facility and assist in submitting a request for a reduced small business fee. For questions regarding FDA’s regulations for drug and outsourcing facilities, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24 hours a day through the Live Help service: https://www.registrarcorp.com/livehelp.