Food and Drug Administration, Dockets Management Branch, 5630 Fishers Lane - Room 1061- HFA-305, Rockville, MD, 20852; 301-827-6860; Fax 301-827-6870 [E-mail Us]

DOCKETS ENTERED on November 27, 2001

TABLE OF CONTENTS

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93P-0310 White Chocolate Deviating From Identity Standard; TPMT *
98D-0997 Metered dose Inhaler and Dry Powder Inhaler Drug Products *
99P-5198 Request amendment of the definition of milk *
00N-1396 Bioengineered Foods Consumed By Humans or Animals *
00P-1276 Health Claim: Plant stanol esters and heart disease *
01D-0195 The Leaveraging Handbook, An Agency Resource for eff Collabo *
01D-0220 Biological Prod Deviation Reporting for Blood & Plasma Estab *
01D-0269 Clinical Studies Section for Prescription Drugs & Biologics *
01D-0361 Guidance ICH Q1D Bracketing and Matrixing Designs for Stabil *
01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA *
01N-0397 Transportation Safety & Potentially Sedating or Impairing *
01N-0402 Third-Party Submissions review/quality system inspections *
01N-0423 Substances Prohibited from use in animal food/Feed Ruminant *
01N-0437 New Animal Drugs for Investigational *
01N-0450 Prescription Drug User Fee Act (PDUFA) *
01P-0250 Dissemination of Non-Misleading Information/Off-Label Uses *
01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II *
01P-0529 Request that '365 Patent Not be Re-listed in Orange Book *
77N-0085 Saccharin and Its Salts

CA 17879 Don & Sharon Carter Vol#: 402

CA 17941 D. W. Helling Vol#: 403

CA 17969 R. L. Irvin Vol#: 403

CA 18015 John C. Webb Vol#: 403

CA 18281 Jon Ohman Vol#: 407

CA 18308 Emil Hein Vol#: 407

93P-0310 White Chocolate Deviating From Identity Standard; TPMT

LET 99 Parmalat Canada Bakery Division Vol#: 2

98D-0997 Metered dose Inhaler and Dry Powder Inhaler Drug Products

C 29 IPAC-RS Vol#: 4

99D-1454 Nasal spray, inhalation solution, suspension&spray drug prod

C 21 IPAC-RS Vol#: 2

99D-2405 Information Request and Discipline Review Letter

GDL 2 Guideline Vol#: 1

NAD 2 Vol#: 1

99P-5198 Request amendment of the definition of milk

ANS 2 HF-40 to Minnesota Farmers Union Vol#: 1

00N-1396 Bioengineered Foods Consumed By Humans or Animals

C 9146 Mary Ellen Norpel Vol#: 401

C 9147 Fay Gougakis Vol#: 401

00P-0586 Amend Pt 133.3 re:Milk and Nonfat Milk for use in Standardiz

ANS 2 HF-40 to Minnesota Farmers Union Vol#: 2

00P-1275 Health Claim: Vegetable oil sterol esters & coronary heart d

C 21 Keller & Heckman Vol#: 18

C 22 Unilever Bestfoods North America Vol#: 18

C 23 Archer Daniels Midland Company Vol#: 18

C 24 Forbes Medi-Tech Vol#: 18

00P-1276 Health Claim: Plant stanol esters and heart disease

C 24 Keller & Heckman Vol#: 18

C 25 Unilever Bestfoods North America Vol#: 18

C 26 Forbes Medi-Tech Vol#: 18

C 27 Archer Daniels Midland Company Vol#: 18

EC 1 American Heart Association Vol#: 18

01D-0195 The Leaveraging Handbook, An Agency Resource for eff Collabo

EC 1 Edix, Inc Vol#: 1

01D-0220 Biological Prod Deviation Reporting for Blood & Plasma Estab

C 8 San Diego Blood Bank Vol#: 1

C 9 Puget Sound Blood Center Vol#: 1

01D-0269 Clinical Studies Section for Prescription Drugs & Biologics

C 7 Bristol-Myers Squibb Pharm. Res Institut Vol#: 1

01D-0361 Guidance ICH Q1D Bracketing and Matrixing Designs for Stabil

C 2 Abbott Laboratories Vol#: 1

C 3 Merck & Co., Inc. Vol#: 1

01N-0174 Agency Information Collection Recall Regulations

N 2 Vol#: 1

01N-0196 Phenylpropanolamine proposal to withdraw approval of NDA

C 9 Novartis Consumer Health, Inc. Vol#: 1

01N-0256 Use of Opiate Analgesics in Various Patient Population inclu

EC 199 Home Vol#: 4

EC 200 Endometriosis Research Center Vol#: 4

01N-0397 Transportation Safety & Potentially Sedating or Impairing

C 4 Thomas N. Tiedt, Ph.D. Vol#: 2

C 5 Bensinger, DuPont & Associates Vol#: 1

EC 3 Mrs. Sharon Sember Vol#: 2

01N-0402 Third-Party Submissions review/quality system inspections

EC 2 Ms. Lisa Long Vol#: 1

01N-0423 Substances Prohibited from use in animal food/Feed Ruminant

CH 21 Vantage Point Holsteins Inc. Vol#: 5

CH 22 Vic Edgerton Vol#: 5

CH 23 T. K. Eick Vol#: 5

CH 24 Linda K. F. Vesper Vol#: 5

CH 25 National By-Products, Inc. Vol#: 5

CH 26 Pennsylvania Department of Agriculture Vol#: 5

CH 27 Micro Tracers, Inc. Vol#: 5

CH 28 CSPI Vol#: 5

CH 29 State of North Carolina's Vol#: 5

CH 30 National Grain and Feed Association Vol#: 5

CH 31 National Cattlemen's Beef Association Vol#: 5

CH 32 Association of American Railroad Vol#: 5

CH 33 National Milk Producers Federation Vol#: 5

TS 16 University of Berne/Switzerland Vol#: 5

TS 17 H.J. Bakerk & Bro., Inc. Vol#: 5

01N-0437 New Animal Drugs for Investigational

EC 1 Mr. zia zahiri Vol#: 1

01N-0450 Prescription Drug User Fee Act (PDUFA)

EAPE1 Aventis Pharmaceuticals Vol#: 1

EAPE2 Elan Corporation Vol#: 1

EAPE3 Food & Drug Administration Vol#: 1

EAPE4 FDC Reports Vol#: 1

EAPE5 Dow Jones Newswires Vol#: 1

EAPE6 Oracle Partners Vol#: 1

EAPE7 Bristol-Myers Squibb Vol#: 1

EAPE8 Schwab Washington Research Group Vol#: 1

EAPE9 FDA/CDER Vol#: 1

EAPE10 Natl. Organization for Rare Disorders Vol#: 1

EAPE11 Schering-Plough Vol#: 1

EAPE12 PDA Vol#: 1

EAPE13 Pharmacia Corporation Vol#: 1

EAPE14 Wyeth-Ayerst Pharmaceuticals Vol#: 1

EAPE15 Immunex Corporation Vol#: 1

EAPE16 Merrill lynch Vol#: 1

EAPE17 Congressional Research Service Vol#: 1

EAPE18 Novartis Pharmaceuticals Corp. Vol#: 1

EAPE19 Novartis Pharmaceuticals Vol#: 1

EAPE20 Pfizer Inc Vol#: 1

EC 1 Number Not Used Vol#: 1

01N-0459 Food Labeling; Notification Procedures on Dietary Supplement

EC 3 --------- Vol#: 1

01P-0250 Dissemination of Non-Misleading Information/Off-Label Uses

LET 1 HF-11 to Washington Legal Foundation Vol#: 1

01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II

EMC 13 Richard G. Shuster Vol#: 1

EMC 14 Gretchen Whitney Vol#: 1

EMC 15 John F. Sorg Vol#: 1

EMC 16 Gerald Bozarth Vol#: 1

EMC 17 Meryl Nass, MD Vol#: 1

EMC 18 Jeffrey N. Jeffords Vol#: 1

EMC 19 Jim Daniel Vol#: 1

EMC 20 Bruce & Sara-Lee Beller Vol#: 1

EMC 21 Michael McDermott Vol#: 1

EMC 22 Kevin R. Harkness Vol#: 1

EMC 23 Teresa & Ken Jones Vol#: 1

EMC 24 Teresa & Ken Jones Vol#: 1

EMC 25 Christine L. Lincoln Vol#: 1

EMC 26 Ralph Bell Vol#: 1

EMC 27 Eligible Vol#: 1

EMC 28 Richard G. Shuster Vol#: 1

EMC 29 Theresa Harmon Vol#: 1

01P-0529 Request that '365 Patent Not be Re-listed in Orange Book

ACK 1 HFA-305 Vol#: 1

CP 1 Mylan Pharmaceuticals, Inc. Vol#: 1