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Dockets Management
Dockets Entered On April 14, 2004
Table of Contents
Docket # Title
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003P-0126 Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
2003P-0387 Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
2004D-0002 Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
2004P-0175 ANADA for ageneric intravaginal progesterone insert for cattle that differs from the pioneer product (EAZI-BREED TM CIDR
2004P-0177 Provide Certification to Congress Under Section 804(l) of Chapter VII of the Federal Food, Drug, and Cosmetics Act, and to Authorize a Pilot Program for Imporatation of Prescription Drugs in Illinois
1993D-0398 Microbiological Testing Antimicrobial Drug Residues in Foods
EC 6 mother of 3 Vol #: 1
1997S-0162 30-Day Structure Function Claim Notification Letters Dietary
LET 13586 General Vitamin Corporation Vol #: 113
LET 13587 General Vitamin Corporation Vol #: 113
LET 13588 General Vitamin Corporation Vol #: 113
LET 13589 General Vitamin Corporation Vol #: 113
LET 13590 General Vitamin Corporation Vol #: 113
LET 13591 General Vitamin Corporation Vol #: 113
LET 13592 General Vitamin Corporation Vol #: 113
LET 13593 General Vitamin Corporation Vol #: 113
LET 13594 General Vitamin Corporation Vol #: 113
LET 13595 General Vitamin Corporation Vol #: 113
LET 13596 General Vitamin Corporation Vol #: 113
LET 13597 General Vitamin Corporation Vol #: 113
LET 13598 General Vitamin Corporation Vol #: 113
2001P-0075 Switch Status of Emergency Contraceptives from Rx to OTC
EC 713 Miss. Orit Zeevi Vol #: 163
EC 714 Dr. Charles Brady Vol #: 163
EC 715 Mr. David Anderson Vol #: 163
2002D-0325 Polyvinychloride using Plasticier di-(2-ethyhexyl)phthalate
EMC 158 Robyn Hunter Vol #: 3
EMC 159 Maria Stahl Vol #: 3
EMC 160 Alan Masliuk Vol #: 3
2002D-0369 Developmental Toxicity Testing
EC 1 mother of 3 Vol #: 1
2003D-0498 Compliance Program Guidance Manual 7371.009; BSE/Ruminant Feed Ban Inspections; Availability
EC 11 mother of 3 Vol #: 1
2003N-0076 Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
EC 15
Attachment
American Bakers Association Vol #: 3
2003N-0312 Discussion of Animal Feed Safety System (AFSS): A Comprehensive Risk-Based Safety Program for the Manufacture and Distribution of Animal Feeds
EC 2 mother of 3 Vol #: 4
2003P-0126 Refrain from approving (ANDA)for Levothyroxine Sodium Tablet
C 3 Fredric J. Cohen, M.D. Vol #: 3
2003P-0387 Request that the Commissioner of Food and Drug take action described methodology for oral levothyroxine sodium drug products
C 3 Fredric J. Cohen, M.D. Vol #: 3
2004D-0002 Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants
C 11 R.M. Rahn Vol #: 1
C 12 Breast Cancer Action Vol #: 1
EMC 8 National Women's Health Network Vol #: 1
EMC 9 National Center for Policy Research for Women & Families Vol #: 1
EMC 10 University of Utah SOM Vol #: 1
EMC 11 Neal R. Reisman, M.D., J.D. Vol #: 1
EMC 12 Paul R. Weiss, M.D. Vol #: 1
EMC 13 Bruce Cunningham Vol #: 1
EMC 14 James H. Wells, M.D. Vol #: 1
EMC 15 Marlene Keeling Vol #: 1
EMC 16 Scott L. Spear, M.D. Vol #: 1
EMC 17 Karol A. Gutowski, M.D. FACS Vol #: 1
EMC 18 Karen M. Backer, Ph.D. Vol #: 1
EMC 19 Anne Taylor, M.D. Vol #: 1
2004P-0175 ANADA for ageneric intravaginal progesterone insert for cattle that differs from the pioneer product (EAZI-BREED TM CIDR
ACK 1 Intervet Inc. Vol #: 1
CP 1 Intervet Inc. Vol #: 1
2004P-0177 Provide Certification to Congress Under Section 804(l) of Chapter VII of the Federal Food, Drug, and Cosmetics Act, and to Authorize a Pilot Program for Imporatation of Prescription Drugs in Illinois
ACK 1 HFA-305 to Illinois Attorney Generals Office Vol #: 1
CP 1
Tab 1, 2, 3, 4, 5
State of Illinois Vol #: 1
2004Q-0144 Qualified Health Claim (QHC): Chromium picolinate and Diabetes
EC 1 Mr. alan metz Vol #: 1

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