21 CFR Part 314, Subpart C - Abbreviated Applications

The Food and Drug Administration (FDA or Agency) is delaying the compliance date for the final rule for the electronic submission of postmarketing safety reports for human drugs and biological products that published in the Federal Register of June 10, 2014. The rule amended FDA's postmarketing safety reporting regulations for human drugs and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is also announcing the availability of the Safety Reporting Portal (SRP), a Web-based electronic submission system, for the electronic submission of postmarketing individual case safety reports (ICSRs) of adverse events for human drug and nonvaccine biological products. The SRP is intended to facilitate the secure electronic submission of postmarketing ICSRs and ICSR attachments to the FDA Adverse Event Reporting System (FAERS) database. The SRP creates a simple and efficient mechanism for electronic reporting of ICSRs that does not require an internal database that is compatible with the International Conference on Harmonisation-based direct submission system. FDA is delaying the compliance date for the final rule because FDA understands that not all persons subject to mandatory postmarketing reporting requirements who wish to use the newly available Safety Reporting Portal (SRP) will have the opportunity to register for an account and test the submission process prior to June 10, 2015, the effective date of the final rule.

The Food and Drug Administration (FDA or Agency) is delaying the compliance date for the final rule for the electronic submission of postmarketing safety reports for human drugs and biological products that published in the Federal Register of June 10, 2014. The rule amended FDA's postmarketing safety reporting regulations for human drugs and biological products to require that persons subject to mandatory reporting requirements submit safety reports in an electronic format that FDA can process, review, and archive. FDA is also announcing the availability of the Safety Reporting Portal (SRP), a Web-based electronic submission system, for the electronic submission of postmarketing individual case safety reports (ICSRs) of adverse events for human drug and nonvaccine biological products. The SRP is intended to facilitate the secure electronic submission of postmarketing ICSRs and ICSR attachments to the FDA Adverse Event Reporting System (FAERS) database. The SRP creates a simple and efficient mechanism for electronic reporting of ICSRs that does not require an internal database that is compatible with the International Conference on Harmonisation-based direct submission system. FDA is delaying the compliance date for the final rule because FDA understands that not all persons subject to mandatory postmarketing reporting requirements who wish to use the newly available Safety Reporting Portal (SRP) will have the opportunity to register for an account and test the submission process prior to June 10, 2015, the effective date of the final rule.

The Food and Drug Administration (FDA) is extending the comment period for the proposed rule that appeared in the Federal Register of February 6, 2015. In the proposed rule, FDA requested comments on its proposal to implement portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). FDA also requested comment on its proposal to amend certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD&C Act. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.