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] 

DOCKETS ENTERED on November 15, 1999

Table of Contents

(Hyper links are part of the Docket  title - not all dockets/documents are linked)

[FDA DOCKETS PAGE][FDA HOME PAGE]
 
84N-0102 Orphan Product Designations*
86P-0297 Standards of Identity to Amend Certain Chocolate Products *
93P-0091 Amend Standard Identity Cacao Products re: White Chocolate *
95N-0304 Ephedrine Alkaloids: Reports of Adverse Events; Availability *
95S-0316 75-Day Premarket Notifications for New Dietary Ingredients *
97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container *
97N-0289 Pregnancy Labeling; Content & Format Requirements *
97N-0511 Procedures the safe and sanitary processing/importing juice *
98D-0449 Inspection of Medical Device Manufacturers*
98D-0834 Non-Contraceptive Estrogen Class Labeling *
98D-0969 Effects of antimicrobial new animal drugs/use in food-produc *
98P-0151 Introduction Of Downed Cattle Into The Food Supply *
99P-4053 Sympathominetic Amine Phentermine*
99P-4108 Exempt Performance Std Electrode Lead Wires & Patient Cables *
99P-4208 Revise the Labeling Requir. for Foods Contain'g Sorbitol *
83N-0118 CERTAIN PRESCRIPTION DRUGS TO RELIEF COUGH/COLD/ALLERGY

WDL 2 Alpharma USPD, Inc. Vol#: 3

84F-0050 SAFE USE OF POLYSORBATE AS AN EMULSIFIER

FONS1 Vol#: 2

84N-0102 Orphan Product Designations

LST 90 October 1999 Vol#: 2

86P-0297 Standards of Identity to Amend Certain Chocolate Products

C 42 Richard J. Durbin (CI) Vol#: 3

93P-0091 Amend Standard Identity Cacao Products re: White Chocolate

C 11 Richard J. Durbin (CI) Vol#: 1

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

LET 47 Dan Burton (CI) Vol#: 291

95S-0316 75-Day Premarket Notifications for New Dietary Ingredients

RPT 54 McNeil Consumer Healthcare Vol#: 31

97N-0023 Chlorofluorocarbon Propellants in Self-Pressurized Container

C 9606 SEIU, Service Employees Intl. Union Vol#: 197

97N-0074 President's National Food Safety Initiative

C 163 Charlotte Marchese Vol#: 11

C 164 Jane Saks Vol#: 11

C 165 Madeline Day Vol#: 11

97N-0289 Pregnancy Labeling; Content & Format Requirements

ANS 1 HFD-6 to Rosario Zisa, C.P.A. Vol#: 6

97N-0511 Procedures the safe and sanitary processing/importing juice

LET 7 American Fresh Juice Council Vol#: 13

98D-0449 Inspection of Medical Device Manufacturers

C 4 HIMA Vol#: 1

98D-0834 Non-Contraceptive Estrogen Class Labeling

C 9 Schering AG Vol#: 1

98D-0969 Effects of antimicrobial new animal drugs/use in food-produc

LET 5 American Veterinary Med Assn. Vol#: 3

LET 6 American Veterinary Med Assn. Vol#: 3

98P-0151 Introduction Of Downed Cattle Into The Food Supply

C 2288 Grace Nazzaro Vol#: 64

99H-1218 Civil Money Penalty; James Morgan d/b/a Morgan's Bestway

ANS 1 Morgan's Bestway Vol#: 1

99H-1249 Civil Money Penalty; Addie Bolden d/b/a Bolden's Grocery

ANS 1 Bolden's Grocery Vol#: 1

99H-1281 Civil Money Penalty;Sam R Palazzolo d/b/a Palazzolos Grocery

ANS 1 Palazzolo's Grocery Vol#: 1

99H-1548 Civil Money Penalties;Denny's Ent Inc,d/b/a Denny's Conoco

ANS 1 Denny's Ent Inc Vol#: 1

99H-1584 Civil Money Penalty; Little Five Points Pharmacy Inc dba Lit

LET 2 Office of Tobacco Programs Vol#: 1

99H-2329 Civil Money Penalty;Steve Marrow,dba Home Town Cafe

LET 2 Office of Tobacco Programs Vol#: 1

99H-2632 Civil Money Penalty;Camp Oil Company,dba Sav-A-Ton

RMO 1 Camp Oil Co,dba Sav-A-Ton Vol#: 1

99H-2765 Civil Money Penalty;Sixty One Quick Stop Inc,dba 61 Quick

LET 2 Office of Tobacco Programs Vol#: 1

99H-3002 Civil Money Penalty;Baker Energy Inc,dba Texaco Food Mart #2

LET 2 Office of Tobacco Programs Vol#: 1

99H-3014 Civil Money Penalty;Roswil Inc,dba Ramey's Supermarket

ANS 1 Roswil Inc,dba Ramey's Suppermarket Vol#: 1

99H-3092 Civil Money Penalty;Danville Village Market Enterprises of

LET 2 Office of Tobacco Programs Vol#: 1

99H-4029 Civil Money Penalty;Balafas Enterprises Inc,dba Campus Liquo

ANS 2 Balafas Ents Inc Vol#: 1

99H-4078 Civil Money Penalty;Charles Domiano and Beverly Domiano,dba

ANS 1 Rasai Landing Store Vol#: 1

99H-4087 Civil Money Penalty;McLain Grocery Co Inc,dba Piggly Wiggly

LET 2 Office of Tobacco Programs Vol#: 1

99H-4183 Civil Money Penalty;Colorado Retail Ventures Services, LLC,

LET 2 Office of Tobacco Programs Vol#: 1

99H-4184 Civil Money Penalty;Colorado Retail Ventures Services LLC,

LET 2 Office of Tobacco Programs Vol#: 1

99H-4192 Civil Money Penalty;Muzammil Columbia Heights Corp,dba Colum

ANS 1 Muzammil Columbia Heights Corp Vol#: 1

99H-4243 Civil Money Penalty;Honey Farms Inc,dba Honey Farms #77

ANS 1 Honey Farms Store #77 Vol#: 1

99H-4246 Civil Money Penalty;Jerry Conley,dba Conley's Country Corne

ANS 1 Conley's Country Corner Vol#: 1

99H-4252 Civil Money Penalty;Ray E Abbott,dba Abbott's Food Center

LET 2 Office of Tobacco Programs Vol#: 1

99H-4284 Civil Money Penalty;Carlisle's Big Star #53 Inc,dba Carlisle

ANS 1 Carlisle's Big Star #53 Inc Vol#: 1

99H-4324 Civil Money Penalty;Jerry's Foods Inc,dba Jerry's Foods

ANS 1 Jerry's Foods Vol#: 1

LET 2 Office of Tobacco Programs Vol#: 1

99H-4350 Civil Money Penalty;Sung Park & Ae Park,dba Bob's Carryout

ANS 1 Sung Park & Ae Park,dba Bob's Carryout Vol#: 1

99H-4391 Civil Money Penalty;Russell Ramage,dba Westfield Store

ANS 1 Russell Ramage,dba Westfield Store Vol#: 1

99H-4466 Civil Money Penalty;Hyde Park Variety Food Mart Inc,dba Hyde

LET 2 Office of Tobacco Programs Vol#: 1

99H-4523 Civil Money Penalty;Auto Service & Supply Co Inc,dba West Te

ANS 1 Auto Service & Supply Co,dba West Texaco Vol#: 1

99H-4573 Civil Money Penalty;Gibbs Oil Co Ltd Partnership,dba Gibbs

ANS 1 Gibbs Oil Co Ltd Partnership Vol#: 1

99H-4582 Civil Money Penalty;Zdzislaw Czerwionka & Jerry Grabinski

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4583 Civil Money Penalty;Terry's Place Inc,dba Blairstown Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4584 Civil Money Penalty;Daniel Collier & Beatrice Collier,dba Bu

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4585 Civil Money Penalty;Jae C Yun,dba Chevron Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4586 Civil Money Penalty;Eckerd Corp,dba Eckerd Drug

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4587 Civil Money Penalty;Juong Ho Park,dba Fred's Sundries

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4588 Civil Money Penalty;Gary Norris,dba H & H Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4589 Civil Money Penalty;Joel Platke,dba Joel's Shell Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4590 Civil Money Penalty;Thomas Lesperance,dba Neighbors Variety

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4591 Civil Money Penalty;William Vlihos,dba Pleasant Valley Super

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4592 Civil Money Penalty;D H Pub Ltd,dba The Pub

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4593 Civil Money Penalty;Paul Edge,dba Riverside Grocery

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4594 Civil Money Penalty;Subramonia Pillai,dba 17-82 Quick Stop

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4595 Civil Money Penalty;Mehandi Dossani Inc,dba Shell Food Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4596 Civil Money Penalty;Jones Petroleum Co Inc,dba Stark Road Su

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4597 Civil Money Penalty;Keith Oil Co,dba Starvin Sam's Mini Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4598 Civil Money Penalty;John Kay,dba 202 Food Market

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4599 Civil Money Penalty;Wal-Mart Stores Inc,dba Wal-Mart

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4600 Civil Money Penalty;Wawa Inc,dba Wawa Food Market #826

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4601 Civil Money Penalty;Wawa Inc,dba Wawa Food Market #810

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4602 Civil Money Penalty;Phuong Nguyen,dba Westernco's Donut Hous

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99H-4603 Civil Money Penalty;Kwok Cheong Wong,dba Wing Cheong

LET 1 Office of Tobacco Programs Vol#: 1

NPH 1 HHS/CDER/FDA Vol#: 1

99P-4053 Sympathominetic Amine Phentermine

C 1 Medeva Pharmaceuticals, Inc. Vol#: 2

99P-4108 Exempt Performance Std Electrode Lead Wires & Patient Cables

SUP 1 Bard Electrophysiology Div of C.R.Bard I Vol#: 1

99P-4208 Revise the Labeling Requir. for Foods Contain'g Sorbitol

SUP 1 CSPI Vol#: 1
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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