Dockets Entered on March 22, 2004

Dockets Management



Dockets Entered On March 22, 2004 Table of Contents



Docket #	Title

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary

2001P-0075	Switch Status of Emergency Contraceptives from Rx to OTC

2003D-0554	Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
2003D-0562	Compliance Policy Guide Sec.110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002
2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
2003N-0222	Agency Information Collection Activities: Proposed Collection; Comment Request; Product Jurisdiction; Assignment of Agency Component for Review of Premarket Applications
2003P-0555	Maintain the Electroconvulsive Therapy Device in Class III for All Indications
2004D-0035	Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis


1981N-0033P	Antiplaque & Antiplaque-Related Claims

EC 3	Banks, Todd J.	Vol #:	86

1993D-0398	Microbiological Testing Antimicrobial Drug Residues in Foods

EC 2	Ms. Mary Black	Vol #:	1

1997S-0162	30-Day Structure Function Claim Notification Letters Dietary
LET 13340	Enzymatic Natural Medicines	Vol #:	110

LET 13341	Enzymatic Therapy Naural Medicines	Vol #:	110

LET 13342	NutriSystem, Inc.	Vol #:	110

LET 13343	Enzymatic Therapy Natural Medicines	Vol #:	110

LET 13344	PhytoPharmica Natural Medicines	Vol #:	110

LET 13345	Enzymatic Therapy Natural Medicines	Vol #:	110

LET 13346	Integrative Therapeutics Inc.	Vol #:	110

LET 13347	Integrative Therapeutics Inc.	Vol #:	110

LET 13348	Integrative Therapeutics Inc,	Vol #:	110

LET 13349	Integrative Therapeutics Inc.	Vol #:	110

LET 13350	Integrative Therapeutics Inc.	Vol #:	110

LET 13351	Integrative Therapeutics Inc.	Vol #:	110

LET 13352	Integrative Therapeutics Inc.	Vol #:	110

LET 13353	Integrative Therapeutics Inc.	Vol #:	110

LET 13354	Integrative Therapeutics Inc.	Vol #:	110

LET 13355	Integrative Therapeutics Inc.	Vol #:	110

LET 13356	Integrative Therapeutics Inc.	Vol #:	110

LET 13357	Integrative Therapeutics Inc.	Vol #:	110

LET 13358	Intetrative Therapeutics Inc.	Vol #:	110

LET 13359	Integrative Therapeutics Inc.	Vol #:	110

LET 13360	Integrative Therapeutics Inc.	Vol #:	110

LET 13361	Integrative Therapeutics Inc.	Vol #:	110

LET 13362	Integrative Therapeutics Inc.	Vol #:	110

LET 13363	Integrative Therapeutics Inc.	Vol #:	110

LET 13364	Integrative Therapeutica Inc.	Vol #:	110

LET 13365	Integrative Therapeutics Inc.	Vol #:	110



LET 13366	Integrative Therapeutics Inc.	Vol #:	110

LET 13367	Integrative Therapeutics Inc.	Vol #:	110

LET 13368	Intetrative Therapeutics Inc.	Vol #:	110

LET 13369	Integrative Therapeutics Inc.	Vol #:	110

LET 13370	Integrative Therapeutics Inc.	Vol #:	110

LET 13371	Integrative Therapeutics Inc.	Vol #:	110

LET 13372	Integrative Therapeutics Inc.	Vol #:	110

LET 13373	Integrative Therapeutics Inc.	Vol #:	110

LET 13374	Integrative Therapeutics Inc.	Vol #:	110

LET 13375	Integrative Therapeutics Inc.	Vol #:	110

LET 13376	Integrative Therapeutics Inc.	Vol #:	110

LET 13377	Perrigo Company of South Carolina	Vol #:	110

LET 13378	Membrell, LLC	Vol #:	110

LET 13379	Membrell, LLC	Vol #:	110

2001P-0075	Switch Status of Emergency Contraceptives from Rx to OTC

C 370	Form Letters	Vol #:	177

C 371	Form Letters	Vol #:	178

C 372	Form Letters	Vol #:	179

C 373	Form Letters	Vol #:	180

C 374	Form Letters	Vol #:	181

C 375	Form Letters	Vol #:	182

C 376	Form Letters	Vol #:	183

C 377	Form Letters	Vol #:	184

C 378	Form Letters	Vol #:	185

C 379	Form Letters	Vol #:	186

C 380	Form Letters	Vol #:	187

C 381	Form Letters	Vol #:	188

C 382	Form Letters	Vol #:	189

C 383	Form Letters	Vol #:	190

C 384	Form Letters	Vol #:	191

C 385	Form Letters	Vol #:	194

C 386	Form Letters	Vol #:	195

C 387	Form Letters	Vol #:	197

C 388	Form Letters	Vol #:	198

C 389	T. Smith	Vol #:	162

C 390	J. Serda	Vol #:	162



C 391	S. Long	Vol #:	162

C 392	J. Long	Vol #:	162

C 393	N. Bracy	Vol #:	162

C 394	J. Butcher	Vol #:	162

C 395	W. Ramey	Vol #:	162

C 396	13 signatures	Vol #:	162

C 397	13 signatures	Vol #:	162

C 398	13 signatures	Vol #:	162

C 399	3 signatures	Vol #:	162

C 400	14 signatures	Vol #:	162

C 401	Pro-Life Office	Vol #:	162

C 402	P. Ritter, Jr.	Vol #:	162

C 403	H. Custodio	Vol #:	162

C 404	Illegible	Vol #:	162

C 405	M. Carr	Vol #:	162

C 406	T. Lober	Vol #:	162

C 407	R. Lober	Vol #:	162

C 408	M. Lober	Vol #:	162

C 409	J. Lober	Vol #:	162

C 410	P. Lober	Vol #:	162

C 411	T. Washeba	Vol #:	162

C 412	M. Norton	Vol #:	162

C 413	C. Buonopane	Vol #:	162

C 414	R. Mauro	Vol #:	162

C 415	L. Mauro	Vol #:	162

C 416	P. Schiller, RN	Vol #:	162

C 417	S. Schiller	Vol #:	162

C 418	L.L. Pallos, PhD	Vol #:	162

C 419	S. Blanchard	Vol #:	162

C 420	B. Blanchard	Vol #:	162

C 421	L. Lavoie	Vol #:	162

C 422	P. Reed	Vol #:	162

C 423	D. Nealon	Vol #:	162

C 424	R. Martin	Vol #:	162

C 425	Medical Arts Associates, Ltd	Vol #:	162

C 426	R. Grossman, MD	Vol #:	162

C 427	B. Peters, MD	Vol #:	162



C 428	American Academy of Pediatrics (AAP)	Vol #:	162

C 429	Columbia University	Vol #:	162

C 430	Women's Health Practice	Vol #:	162

C 431	S. Jacobson, MD	Vol #:	162

C 432	S. McIsaac, MD	Vol #:	162

C 433	M. Whang	Vol #:	162

C 434	T. Ault	Vol #:	162

C 435	J. Pozar, RN	Vol #:	162

C 436	M. Creinin, MD	Vol #:	162

C 437	E. Elizabeth Simoneau	Vol #:	162

C 438	S. Epstein	Vol #:	162

C 439	H. Stutman	Vol #:	162

C 440	H. Russell	Vol #:	162

C 441	J. Maggs, PhD	Vol #:	162

C 442	M. Mossman	Vol #:	162

C 443	M. Mossman	Vol #:	162

C 444	R. Seymour	Vol #:	162

C 445	C. Briscoe	Vol #:	162

C 446	C. Schmidt	Vol #:	162

C 447	J. A Schmidt	Vol #:	162

C 448	P. Forcier	Vol #:	162

C 449	M. Pesarchick	Vol #:	162

C 450	R. Towsley	Vol #:	162

C 451	M. Pesarchick	Vol #:	162

C 452	Univeristy of Rochester	Vol #:	162

C 453	E. Pearce	Vol #:	162

C 454	S. Ruby	Vol #:	162

C 455	Boston University School of Medicine	Vol #:	162

C 456	Duke University Medical Center	Vol #:	162

C 457	W. Ho	Vol #:	162

C 458	N. Guinn, MD	Vol #:	162

C 459	E. Perrin, MD	Vol #:	162

C 460	J. Curington, MD	Vol #:	162

C 461	Lawrence Family Medicine & Obstetrics	Vol #:	162

C 462	Westside Regional Center	Vol #:	162

C 463	Physicians to Women, Inc.	Vol #:	162

C 464	E. Godfrey,MD,MPH	Vol #:	162



C 465	S. Sklar, MD	Vol #:	162

C 466	Univeristy of California San Francisco	Vol #:	162

C 467	R. Rupp, MD	Vol #:	162

C 468	Physicians for Reproductive Choice and Health	Vol #:	162

C 469	University of Pennsylvania Health System	Vol #:	162

C 470	University of Minnesota	Vol #:	162

C 471	Bowdoin College	Vol #:	162

C 472	New Jersey Medical School	Vol #:	162

C 473	K. LeFevre	Vol #:	162

C 474	H. Brown, MD	Vol #:	162

C 475	Richard B. Braunstein, MD, Inc.	Vol #:	162

C 476	P. Palm,MS,RNC	Vol #:	162

C 477	Illegible	Vol #:	162

C 478	S. Morian	Vol #:	162

C 479	M. Paul	Vol #:	162

C 480	L. Baker	Vol #:	162

C 481	G. Jacobson, MD	Vol #:	162

C 482	B. Peters, MD	Vol #:	162

EC 604	Dr. Angela Allerman	Vol #:	163

EC 605	Texas Christian University	Vol #:	163

EC 606	Ms. ruth anne rosenberg	Vol #:	163

EC 607	Mr. Russell Shaw	Vol #:	163

EC 608	Ms. nancy ferguson	Vol #:	163

2002D-0428	Information for the use of Human Blood & Blood Components

EC 2	McGinnis, William	Vol #:	1

2002N-0276	Bioterrorism Preparedness; Registration of Food Facilities

EC 348	Rosenblum, Charles	Vol #:	20

2002N-0278	Bioterrorism; Prior Notice of Imported Food Shipments
EC 385	Rosenblum, Charles	Vol #:	22

EC 386	terstiege, gerard	Vol #:	22

EC 387	Leitner, John A.	Vol #:	22

2003D-0092	Food and Cosmetic Security Guidances

EC 19	Prashant, Singamsetti	Vol #:	1

2003D-0290	Compounding of Drugs for Use in Animals Compliance Policy Guide



EC 14	Mrs. Virginia Collins	Vol #:	1

2003D-0386	Guidance for Industry on Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP

EC 1	Rockel, Cynthia	Vol #:	1

2003D-0478	Guidance on Marketed Unapproved Drugs Compliance Policy Guide

EC 23	Mrs. Gail Tanner	Vol #:	5

2003D-0498	Compliance Program Guidance Manual 7371.009; BSE/Ruminant Feed Ban Inspections; Availability

EC 8	McGinnis, William	Vol #:	1

EC 9	Mrs. penina serour	Vol #:	1

2003D-0545	Questions and Answers Regarding Registration of Food Facilities

EC 3	Mrs. Selina Hughes	Vol #:	1

EC 4	student student	Vol #:	1

2003D-0554	Compliance Policy Guide Sec. 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

EC 2	Bacardi- Martini Product Development	Vol #:	1

EC 3	Bacardi-Martini Product Development, Inc.	Vol #:	1

EC 4	Mr. Ted Bateh	Vol #:	1

2003D-0558	Guidance Levels for Radionuclides in Domestic and Imported Foods

EC 2	generette, lloyd	Vol #:	1

2003D-0562	Compliance Policy Guide Sec.110.300 Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

EC 1	www.mdzx.com, offshorepharmacy.com	Vol #:	1

2003E-0245	Patent Extension for Remodulin (Treprostinil sodium), 5,153,222

EC 1	Maebius, Stephen	Vol #:	1

2003N-0069	FDA Task Force on Consumer Health Info for Better Nutrition

EC 92	Whitney, Lucile	Vol #:	5

EC 93	Mrs. Rebecca Mount	Vol #:	5

2003N-0076	Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements

EC 8	Mr. Christopher Czerwonka	Vol #:	3

EC 9	Northland Cranberries, Inc.	Vol #:	3

EC 10	Mr. Jeffrey Schultz	Vol #:	3

2003N-0222	Agency Information Collection Activities: Proposed Collection; Comment Request; Product Jurisdiction; Assignment of Agency Component for Review of Premarket Applications

SS 1	Supporting Statement	Vol #:	1



2003P-0555	Maintain the Electroconvulsive Therapy Device in Class III for All Indications

EC 9	kravitz, yvonne	Vol #:	1

EC 10	kravitz, melvin	Vol #:	1

EC 11	kravitz, martha	Vol #:	1

EC 12	levy, cacilie	Vol #:	1

EC 13	kravitz, cynthia	Vol #:	1

EC 14	Disability Rights Center	Vol #:	1

EC 15	Mr. Frederick Dorman	Vol #:	1

2004D-0002	Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative Breast Implants

EC 2	Johnston, Kathy Keithley	Vol #:	1

EC 3	Walker, J	Vol #:	1

2004D-0028	Draft Consumer Advisory regarding Advice for Subgroups of a Population regarding Mercury in Fish and Shellfish
EC 2	Mills, Krista	Vol #:	1

EC 3	Mrs. pnina srour	Vol #:	1

EC 4	Mr. revJ.Lee Osborne	Vol #:	1

EC 5	Ms. Julia Shrader-Lauinger	Vol #:	1

EC 6	Dr. John Stea	Vol #:	1

EC 7	Mrs. Michelle Yamada	Vol #:	1

2004D-0035	Guidance for Industry on the Preclinical and Clinical Evaluation of Agents Used in the Prevention or Treatment of Postmenopausal Osteoporosis

EC 1	Perceptive Informatics, Inc.	Vol #:	1

2004N-0115	Prescription Drug Importation Study

EC 1	Mr. Paul Warburton	Vol #:	1

Page created on March 23, 2004 kk
Page updated on April 1, 2004 rc

FDA/Dockets Management