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Animal & Veterinary

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CVM/Office of New Animal Drug Evaluation Reviewer's Chapter

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1243.2000--ONADE's General Review

Title	Date
1243.2010 Responsibilities for Creating and Keeping Records (PDF - 187KB)	July 2, 2003
1243.2030 Responding to Requests for Copies of Letters or Requests for Copies of Administrative Files (PDF - 38KB)	June 29, 2010
1243.2050 Refuse to File and Refuse to Review (PDF - 55KB)	April 26, 2010
1243.2180 New Animal Drug Applications, Form FDA 356V (PDF - 40KB)	July 7, 2009
1243.2340 Transfer of Ownership and Sponsor Name or Address Change Procedures in ONADE for NADA, ANADA, INAD, JINAD or VMF Submissions (PDF - 30KB)	Nov. 16, 2001
1243.2600 Review of ONADE Regulated Products that Contain Nanomaterials or Otherwise Involve the Use of Nanotechnolgy (PDF - 105KB)	August 30, 2011

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1243.3000--Admin Procedures for ONADE

Title	Date
1243.3005 Creating Clean Electronic Files (PDF - 90KB)	Jan. 26, 2009
1243.3009 Format and Style Conventions for Reviews and Submission Summaries (PDF - 100KB)	Oct. 14, 2011
1243.3010 Format and Style Conventions for Letters (PDF - 100KB)	Oct. 14, 2011
1243.3015 Proprietary Names (PDF - 117KB)	April 9, 2013
1243.3020 Managing the Review of Submissions in the STARS Queue (PDF - 36KB)	Jan. 26, 2009
1243.3022 Implementing the User Fee Acts (ADUFA II, AGDUFA) of 2008 (PDF - 280KB)	Dec. 13, 2011
1243.3024 Scheduling and Holding Meetings With Outside Parties (PDF - 106KB)	May 23, 2012
1243.3025 Preparing a Memorandum of Conference (MOC) (PDF - 160KB)	May 11, 2012
1243.3026 Amending STARS Submissions (PDF - 74KB)	June 18, 2010
1243.3029 Closing Out a Consulting Review for STARS Submissions (PDF - 63KB)	June 18, 2010
1243.3030 Completing Final Action Packages for STARS Submissions (PDF - 112KB)	April 6, 2009
1243.3040 Processing Suitability Petitions (PDF - 196KB)	Sept. 11, 2002
1243.3050 Identifying and Documenting Technical Section Requirements for Approval (PDF - 68KB)	June 9, 2011
1243.3051 Verifying Scope and Technical Section Status for Phased Review ([J]INAD) Projects in the End Game (PDF - 40KB)	June 9, 2011
1243.3200 Routing a Request to Obtain a Review of an INAD, JINAD, ANADA, NADA, or VMF Submission (PDF - 55KB)	Nov. 10, 2009
1243.3250 "Q" Submissions: Agency-Initiated Actions (PDF - 44KB)	July 26, 2011
1243.3300 FDA District Office Mail Codes (PDF - 69KB)	Feb. 20, 2009
1243.3810 Creating and Maintaining a Reference Copy of the Currently Approved Labeling for an Application (Volume 0) (PDF - 46KB)	March 1, 2012
1243.3900 Maintaining the Animaldrugs&fda.gov Database and Website (PDF - 44KB)	Oct. 5, 2010

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1243.4000--Investigational New Animal Drugs (INAD)

Title	Date
1243.4000 Processing a Request to Open a (J)INAD File (PDF - 38KB)	December 7, 2011
1243.4040 Investigational Food-use Authorizations: the role of the primary (AA) review divisions (PDF - 106KB)	July 7, 2009
1243.4041 Investigational Food-use Authorizations: the role of Division of Human Food Safety reviewer (PDF - 35KB)	April 7, 2009
1243.4060 Review of Protocols (PDF - 176KB)	April 26, 2010
1243.4065 Requirements For Investigational New Animal Drug Exemptions (PDF - 86KB)	April 6, 2009
1243.4066 Notice of Claimed Investigational Exemption (NCIE) (PDF - 62KB)	May 28, 2010
1243.4068 Acceptability of Submissions Containing Foreign Data to Support Safety and Effectiveness (PDF - 24KB)	Jan. 26, 2009
1243.4070 Integrating an End-Review Amendment (ERA) Into the Investigational New Animal Drug (INAD) Protocol (E) Submission Review Process (PDF - 281KB)	June 4, 2010
1243.4075 Integrating An End-Review Amendment (Era) Into The Investigational New Animal Drug Data (P) Submission Review Process (PDF - 179KB)	June 4, 2010
1243.4080 Labeling and All Other Information Technical Sections (Minor Technical Section or "M" Submissions) (PDF - 63KB)	April 12, 2012
1243.4085 All Other Information (PDF - 40KB)	April 12, 2012

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1243.5000--New Animal Drug Applications (NADA)

Title	Date
1243.5730 Integrating an End-Review Amendment (Era) Into the New Animal Drug Application Review Process (PDF - 169KB)	June 4, 2010
1243.5740 ANADA Memorandum Recommending Approval (PDF - 34KB)	Nov. 16, 2001
1243.5741 Memorandum Recommending Approval (MRA) for Original and Supplemental New Animal Drug Applications (NADA (PDF - 28KB)	Dec. 13, 2007
1243.5761 Freedom of Information Summary for Original and Supplemental NADA (PDF - 132KB)	March 1, 2012
1243.5762 Freedom of Information Summary for an ADAA Feed Combination NADA Approval (PDF - 150KB)	Dec. 4, 2008
1243.5780 Exclusivity Wording for Use In the Following Documents: Memorandum Recommending Approval and Letter to Applicant (PDF - 35KB)	Nov. 16, 2001
1243.5820 Approval Letters (PDF - 60KB)	August 31, 2011

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1243.6000--Supplemental NADAs

Title	Date
1243.6020 Review of NADA and ANADA Labeling Supplements (PDF - 120KB)	Nov. 10, 2009
1243.6030 Review of Labeling Changes in Manufacturing Supplements (PDF - 97KB)	June 17, 2009

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1243.7000--Environmental

Title	Date
1243.7220 Processing Environmental Impact Submissions for New Animal Drugs (PDF - 48KB)	Aug. 30, 2010

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1243.8000--Bioresearch Monitoring (BIMO)

Title	Date
1243.8215 Requesting a Bioresearch Monitoring (BIMO) Inspection (PDF - 59KB)	March 1, 2010
1243.8220 Requesting a BIMO Status Check (PDF - 53KB)	March 1, 2010
1243.8225 Routing and Review of BIMO Establishment Inspection Reports (EIRs) (PDF - 49KB)	March 1, 2010

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1243.8500--Chemistry Review

Title	Date
1243.8500 Making a Request for a (cGMP) Status for Approval Package (PDF - 60KB)	July 14, 2009

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