CDER SBIA Update: GDUFA FY 2015 Self-Identification Period

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry

---

GDUFA FY 2015 Self-Identification Period

Generic Drug User Fee Amendments of 2012 (GDUFA) requires that generic drug facilities, and certain sites and organizations identified in a generic drug submission to submit, update, or reconfirm identification information to the Food and Drug Administration (FDA) annually.  For fiscal year 2015 self-identification reporting period will begin on May 1, 2014, and close June 1, 2014. 21 (U.S.C. § 379j–42(f)(2)(B)).

Please note that registration and listing under section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360) is a different process than self-identification under GDUFA. Many persons will thus be required to submit information separately to the respective systems. Each system populates its own database to meet unique requirements and deadlines. Both, however, are built on the same platform and based on the same technical standards. 

Additional information including who is required to self-identify, how the information is submitted to FDA, the penalty for failure to self-identify, and the technical specifications are available at the following url: http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm.

If you need further technical assistant with self-identification process, please contact CDEReFacility@fda.hhs.gov.  For general questions about GDUFA self-identification requirements, please contact AskGDUFA@fda.hhs.gov.

Additional resources are available at:

- Technical Walk-Through and Live Question and Answer Session 
11/19/2012 and 11/20/2012

- Overview and Technical Walk-Through of Self-Identification Process
9/21/2012 

Background information is available at www.fda.gov/gdufa.  Staff is available at 866-405-5367 or at askGDUFA@fda.hhs.gov to answer any questions. 

Interested parties can register to receive email updates about GDUFA at https://public.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_243.

  

  

---

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