Process for Submission and Drug Listing Rx Human Drugs* Posting to Daily Med –SPL r3 - occurs via the FDA application process utilizing ELIPS –SPL r4 - occurs via the Drug Listing process utilizing eList Initial transition to SPL r4 will require duplicate submissions to the Application Process and the Drug Listing Process to accomplish posting to the Daily Med (those using the Gateway will have to make 2 submissions of the same file to different destinations at FDA). Work is underway to explore an option that employs hyper-linking. Prior to implementing eDrug Listing an electronic request for a labeler code and e-Registration must be completed When using SPL r4, Drug Listing must be executed promptly to ensure that labeling is posted to the Daily Med site in the time frame required. * Does not apply to OTC or Vet meds plb 8/2008 v6

NCE, PAS EDR Review and respond Initial SPL r3 (COL) Process Final SPLr3 (COL) Labeling on Daily Med Application process Submission: SPL(r3); Product Listing: Paper plb 8/2008 v6 ELIPS CBE Drug Listing process Paper Drug Listing Drug Listing process Paper Drug Listing EDRReview and respond Initial SPLr3 (COL) Process Final SPLr3 (COL) Labeling on Daily Med Application process ELIPS EDR ELIPS Labeling on Daily Med Annual Report Application process EDR Initial SPLr3 (COL) ELIPS Labeling on Daily Med EDR Drug Listing process Paper Drug Listing

NCE and PASCBE ELIST Gateway plb 8/2008 v6 Annual Report Submission: SPL(r4); Product Listing: Electronic-phase 1 Drug Listing process Labeling on Daily Med Labeling on EDR Review and respond Initial SPL r4 (CoL) Process Application process EDR Final SPLr4 (CoL) Final SPLr4 (CoL) ELIST Gateway Drug Listing process Labeling on Daily Med Labeling on EDR Review and respond Initial SPL r4 (CoL) Process Application process EDR Final SPLr4 (CoL)** Final SPLr4 (CoL)** Gateway Drug Listing process Labeling on Daily Med Labeling on ELIST **Submission of final SPL COL needed only if there are revisions to the originally implemented/submitted CoL. Initial SPL r4 (CoL) Gateway Drug Listing process Labeling on Daily Med Labeling on Initial SPL r4 (CoL) ELIST Application Process Initial SPL r4 (CoL) EDR *Site under development

NCE and PASCBE ELIST Gateway plb 8/2008 v6 Annual Report Submission: SPL(r4); Product Listing: Electronic-phase 2 Drug Listing process Labeling on Daily Med Labeling on EDR Review and respond Initial SPL r4 (CoL) Process Application process EDR Final SPLr4 (CoL) ELIST Gateway Drug Listing process Labeling on Daily Med Labeling on EDR Review and respond Initial SPL r4 (CoL) Process Application process EDR Final SPLr4 (CoL)** Gateway Drug Listing process Labeling on Daily Med Labeling on ELIST ** Submission of final SPL COL needed only if there are revisions to the originally implemented/submitted CoL. Initial SPL r4 (CoL) Gateway Drug Listing process Labeling on Daily Med Labeling on Initial SPL r4 (CoL) ELIST Application Process EDR ‘ Process under development * Site under development Hyperlink’ Hyperlink’ ** Hyperlink’