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DOCKETS ENTERED on 3/24/03

Docket Number - Title

90N-0302 Informed Consent for Human Drugs & Biologics; Determination

REF 1 OMB Review on 10/5/99 Vol#: 5

95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability

EC 372 Mrs. Linda Edwards Vol#: 307

EC 373 Dr. Berend Snijders Vol#: 307

EC 374 Dr. Bram Snijders Vol#: 307

EC 375 Mrs. R Wolffensperger Vol#: 307

EC 376 ID of Wellness International Network Vol#: 307

EC 377 ISS Research Vol#: 307

EC 378 Nutrition S'Mart Vol#: 307

EC 379 Number Not Used Vol#: 307

EC 380 American Natural & Specialty Brands Vol#: 307

EC 381 Protec Lab Vol#: 307

EC 382 cpr Vol#: 307

EC 383 Supplement Synergy Vol#: 307

EC 384 Pioneer Nutritional Formulas, Inc. Vol#: 307

EC 385 Vitamin Cottage Natural Grocers Vol#: 307

EC 386 Wellness International Network, Ltd. Vol#: 307

EC 387 Mr. Harry Werbe Vol#: 307

EC 388 Vitamer Labs Vol#: 307

EC 389 Secrets of the Amazon Vol#: 307

EC 390 Alpha-Omega Nutrition Vol#: 307

EC 391 The Health Hut Vol#: 307

EC 392 Rainbow Whole Foods Co-operative Grocery Vol#: 307

EC 393 Mr. Stephen Melnychuk Vol#: 307

EC 394 E. B. Botanicals, LLC Vol#: 307

EC 395 Mrs. Pat Griffiths Vol#: 307

EC 396 Mr. Ryan Waymire Vol#: 307

EC 397 Mr. Michael Simone Vol#: 307

EC 398 Mac's Medicine Mart Vol#: 307

EC 399 NCNIH INC Vol#: 307

EC 400 Mr. Gairy Plummer Vol#: 307

EC 401 Mrs. Carol Simone Vol#: 307

EC 402 The Clubhouse Vol#: 307

EC 403 Champions Health Food Vol#: 307

EC 404 Mr. Timothy Johanek Vol#: 307

EC 405 WIN ART BUSINESS Vol#: 307

EC 406 Mr. Jacob Trinka Vol#: 307

EC 407 Harvest Moon Natural Foods Vol#: 307

EC 408 GNC Franchisee Vol#: 307

EC 409 The Fruitful Yield, Inc. Vol#: 307

EC 410 Harvest Moon Natural Foods Vol#: 307

EC 411 Mr. Gary Gromet Vol#: 307

EC 412 Advanced Nutritional Innovations Vol#: 307

EC 413 ShoHealth Now Vol#: 307

EC 414 Mrs. Kristi Meltzer Vol#: 307

EC 415 SuperNutrition Vitamins Vol#: 307

EC 416 Vibrant Health Vol#: 307

EC 417 Dr. Arthur Presser Vol#: 307

EC 418 Mr. William Duncan Vol#: 307

EC 419 Flash 5 Energy Foods Vol#: 307

EC 420 Sweet Annie Herbs Vol#: 307

EC 421 Ms. Robert Kroboth Vol#: 307

96N-0048 Sterility Requirements for Inhalation Solution Products

REF 1 OMB Review on 5/26/00 Vol#: 2

97S-0163 Dietary Supplements, Courtesy Letters (Letters of Objection)

LET 671 HFS-800 to Golden Temple of Oregon, Inc Vol#: 19

LET 672 HFS-800 to FoodScience Corporation Vol#: 19

LET 673 HFS-800 to Natural Source International Vol#: 19

LET 674 HFS-800 to Oregon's Wild Harvest Vol#: 19

LET 675 HFS-800 to Knature Corporation Vol#: 19

LET 676 HFS-800 to Biozeal dba ChildLife Nutriti Vol#: 19

LET 677 HFS-800 to Natural Balance Vol#: 19

LET 678 HFS-800 to Herbo, Inc. Vol#: 19

LET 679 HFS-800 to M.K. Health Distributor's Vol#: 19

LET 680 HFS-800 to Recovery Pharmaceuticals Vol#: 19

LET 681 HFS-800 to Metagenics Vol#: 19

LET 682 HFS-800 to Taisho Pharmaceutical Califor Vol#: 19

98N-0040 Regs for In Vivo Radiopharm used for Diagnosis & Monitoring

REF 3 OMB Review on 5/17/99 Vol#: 2

98N-0237 Efficacy of New Drugs for use Against Lethal or Permanently

REF 2 OMB Review on 10/5/99 Vol#: 3

00N-0018 Reclassification of the knee joint Patellofemorotibal Metal

BKG 2 Guidance for Industry and FDA Vol#: 1

NFR 1 Vol#: 1

00N-0504 Egg Safety Action Plan

C 101 Evelyn V. Knazek Vol#: 10

C 102 Dorothy C. Ramsaier Vol#: 10

C 103 J. Capzzelli Vol#: 10

C 104 Gisela Ritter Gall Vol#: 10

C 105 Virginia A. Lamarche Vol#: 10

C 106 Nancie Sailor Vol#: 10

C 107 Ida M. Callan Vol#: 10

C 108 Lyn Rosen Vol#: 10

C 109 Lois A. Klingeman Vol#: 10

C 110 Margaret R. McGinnis Vol#: 10

C 111 Barbara Keenan Vol#: 10

C 112 Voices for Animals Vol#: 10

C 113 Gloria Mack Vol#: 10

C 114 Charlotte Marchese Vol#: 10

C 115 C. C. Jacobson Vol#: 10

C 116 Doris McGinnis Vol#: 10

C 117 Claire Martineau Vol#: 10

C 118 Dorothy Faiance Vol#: 10

C 119 Elsie L. Stebbings Vol#: 10

C 120 Norma B. Hamilton, M.D. Vol#: 10

C 121 Kathryn A. Hart Vol#: 10

C 122 M. Belcastro Vol#: 10

C 123 Ken & Arylane Hill & Family Vol#: 10

C 124 Mrs. Frances Krohn Vol#: 10

C 125 Patricia Nesbitt Vol#: 10

00N-1269 Labeling for human prescription drug/Biologic Products

REF 1 OMB Review on 12/22/00 Vol#: 6

00N-1528 Proposal to Debar Delfina Hernandez;Notice of Opportunity

LET 3 HFD-1 Vol#: 1

01D-0583 Food Security Guidance

GDL 3 GUIDANCE Vol#: 1

GDL 4 GUIDANCE Vol#: 1

NAD 2 Vol#: 1

02D-0402 Field offices on "Regulatory procedures Manual, Chapter 9

EC 4 Merck KGaA Vol#: 1

02E-0149 Genesis Neurostimulation System, U.S. Patent No. 4,793,353

N 1 Vol#: 1

02F-0160 Safe use of Vitamin D3 in Calcium-Fortified Fruit Juices

EC 4 Ms. Courtney Rhea Vol#: 1

EC 5 Ms. Linda Davison Vol#: 1

EC 6 Mrs. Ilene Dill Vol#: 1

EC 7 Ms. Michelle Boyd Vol#: 1

02N-0281 General Administrative Procedures Petition reconsideration

NAL 1 Vol#: 1

SS 1 SUPPORTING STATEMENT Vol#: 1

02N-0291 Proposal to Debar Baldev Raj Bhutani;Notice of Opportunity

SUP 2 Baldev R. Bhutani, Ph.D. Vol#: 1

02N-0528 Risk Management Workshop, April 9-11, 2003 [PDUFA III]

APE 6 First Genetic Trust Vol#: 1

APE 7 American Pharmaceutical Association,APhA Vol#: 1

EAPE2 Stephen A. Goldman Consulting Services, Vol#: 1

EAPE3 Public Citizen Health Research Group Vol#: 1

EAPE4 CRF Box Inc. Vol#: 1

EAPE5 Pharmacovigilance & RIsk Management Inc Vol#: 1

EAPE6 PhRMA Vol#: 1

EAPE7 American Society of Health-System Pharma Vol#: 1

EAPE8 Ukrops Super Markets, Inc. Vol#: 1

03D-0025 Mammography Quality Standards Act Final Regs.Modifications

EC 1 Number Not Used Vol#: 1

03D-0092 Food and Cosmetic Security Guidances

GDL 1 GUIDANCE Vol#: 1

GDL 2 GUIDANCE Vol#: 1

NAD 1 Vol#: 1

03N-0024 Prohibiting extralabel use phenylbutazone animal/human drugs

EC 1 Dairy Farmers of America Vol#: 1

NCR 1 Vol#: 1

03N-0034 FDA Safety Alert/ Public Health Advisory Readership Survey

EC 5 Venus Nutrition Vol#: 1

EC 6 Number Not Used Vol#: 1

03N-0059 Pharmaceutical cGMPs for 21st Century: A Risk-Based Approach

EC 16 Wells & Associates Vol#: 1