Transmittal of Annual Reports for Drugs and Biologics for Human Use FDA 2252 PSC Printing Services

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Specifications	Transmittal of Annual Reports for Drugs and Biologics for Human Use FDA 2252 PSC Printing Services
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( ) TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE (21 CFR 314.81) DATE SUBMITTED Form Approved: OMB No.

Specifications	Transmittal of Annual Reports for Drugs and Biologics for Human Use FDA 2252 PSC Printing Services
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Content	( ) TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE (21 CFR 314.81) DATE SUBMITTED Form Approved: OMB No. 0910-0001 Expiration Date: See OMB Statement on Reverse Side. NOTE: This report is required by law (21 USC 355; 21 CFR 314.81). Failure to report can result in withdrawal of approval of the New Drug or Biologics License Application. INSTRUCTIONS Complete a transmittal for each application for which an annual report is being submitted. If submitting electronically, submit one copy of the form and annual report to FDA. If submitting in paper submit two copies of the transmittal form along with two copies of the annual report to FDA. If any part of the annual report applies to more than one application, list in item 7 all other applications to which such parts apply. 1. Application Type 2. Application Number Report No. (For FDA Use Only) APPLICANT NOTE Reference NDA and Y, or BLA numbers (entered on Acknowledgement Copy) in any subsequent correspondence regarding report. 3. APPLICANT 4. PHONE NUMBER 5. TYPE OF REPORT (Check one) ANNUAL OTHER 6. DRUG/BIOLOGIC NAME 7. OTHER NDA OR BLA NUMBERS (List all numbers if any part of report applies to more than one number.) 8. PERIOD COVERED BY REPORT FROM TO YEAR MONTH YEAR MONTH 9. NDA REPORT INFORMATION REQUIRED (See 314.81 for description) (Enter type of information attached under “Identiﬁ cation.” If you have nothing to report, enter None.) (INFORMATION IN “9b” AND “9c” IS ALWAYS REQUIRED.) § TYPE OF INFORMATION IDENTIFICATION (Electronic ﬁ le name or eCTD location or a. SUMMARY OF SIGNIFICANT NEW INFORMATION b. DISTRIBUTION DATA c. LABELING (Whether or not previously submitted) d. CHEMISTRY MANUFACTURING AND CONTROLS CHANGES SUPAC e. NONCLINICAL LABORATORY STUDIES f. CLINICAL DATA g. STATUS REPORTS OF POSTMARKETING STUDY COMMITMENTS h. STATUS OF OTHER POSTMARKETING STUDIES (e.g.,voluntary studies,CMC commitment studies, and product stability studies) i. LOG OF OUTSTANDING REGULATORY BUSINESS (Optional) 10. BLA REPORT INFORMATION REQUIRED (See § 601.70 for description) TYPE OF INFORMATION CONTENTS (Check box) a. ANNUAL PROGRESS REPORTS OF POSTMARKETING STUDIES 11. TYPED NAME AND TITLE OF RESPONSIBLE OFFICIAL OR AGENT 12. APPLICANT’S RETURN ADDRESS Name of Sponsor / Applicant / Submitter Address 1 Address 2 City State ZIP or Postal Code 13. SIGNATURE FDA USE ONLY NDA OR ANDA NUMBER DATE OF RECEIPT FORM FDA 2252 (12/11) Previous Edition Is ObsoletePage 1 of PSC Publishing Services (301) 443-6740 EF Volume No.(s) / Tab(s) / Page(s) of Report) Add Continuation Page Sign 2
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Transmittal of Annual Reports for Drugs and Biologics for Human Use FDA 2252 PSC Printing Services

Transmittal of Annual Reports for Drugs and Biologics for Human Use FDA 2252 PSC Printing Services

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