Dockets Entered on August 8, 2007

Dockets Management



Dockets Entered On August 8, 2007



Docket #	Title

1996N-0417	CGMP in Mfg. Packing or Holding Dietary Supplements

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

2000N-1269	Labeling for human prescription drug/Biologic Products

2001D-0286	In Vitro HIV Drug Resistance Genotype Assays [510(k)s]

2002D-0081	Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood

2002P-0317	Recall Aspartame as a Neurotoxic Drug

2003V-0521	Laser Light Show

2004V-0053	Laser Light Show

2005H-0271	Civil Money Penalty: TMJ Implants, Inc.

2005N-0272	Irradiation in the Production, Processing & Handling of Food

2005P-0273	Add Calcium to the Mandatory List

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

2005V-0172	Laser Light Show

2006D-0347	Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

2006N-0454	Use of Ozone-Depleting Substances; Removal of Essential-Use Designations

2006P-0205	Require Vitamin D be added to cereal-grain products

2006P-0394	Revise the labeling requirements for eggs sold in the United States

2006P-0445	Determine if Mivacron (mivacurium chloride injection) was withdrawn for safety or efficacy reasons

2006P-0520	Determination for Methotrexate Injection, USP, Preservative Free, Eq. 500 mg base/20 mL, NDA 11-719)

2007N-0121	Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing

2007N-0294	Medical Devices; Immunology and Microbiology Devices: Classification of In Vitro HIV Drug Resistance Genotype Assay

2007P-0316	Risperdal (Risperidone) Tablets

2007V-0312	Laser Display Device

2007V-0314	Laser Light Show

2007V-0315	Projector for a Laser Light Show

1996N-0417	CGMP in Mfg. Packing or Holding Dietary Supplements

C 265	Randall L. Ball	Vol #:	52

C 266	Patricia Dodge	Vol #:	52

C 267	Ruth Hagemann	Vol #:	53

C 268	Karyn LaGrange	Vol #:	53

C 269	The Women of Elk Mountain Herbs	Vol #:	53

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

LET 20526	PuraPharm	Vol #:	179

2000N-1269	Labeling for human prescription drug/Biologic Products



C 86	Jonathan D. Loo	Vol #:	9

2001D-0286	In Vitro HIV Drug Resistance Genotype Assays [510(k)s]

GDL 2	Guidance	Vol #:	1

NAD 2	FDA	Vol #:	1

2002D-0081	Hepatitis B Surface Antigen (HBSAG) Assays to Test Blood

GDL 2	Guidance	Vol #:	1

NAD 2	FDA	Vol #:	1

2002P-0317	Recall Aspartame as a Neurotoxic Drug

EMC 837	Mission Possible International	Vol #:	11

2003V-0521	Laser Light Show

VRA 2	Lynne L. Rice	Vol #:	1

2004V-0053	Laser Light Show

VRA 3	Lynne L. Rice	Vol #:	1

2005H-0271	Civil Money Penalty: TMJ Implants, Inc.

LET 9	TMJ Implants, Inc, and Robert W. Christensen and Maureen K. Mooney	Vol #:	245

MO 27	TMJ Implants, Inc, and Robert W. Christensen and Maureen K. Mooney	Vol #:	245

2005N-0272	Irradiation in the Production, Processing & Handling of Food

C 3588	D. Fritzler	Vol #:	40

C 3589	B. Oaks	Vol #:	40

C 3590	P. Cooper	Vol #:	40

C 3591	D. M. Clark	Vol #:	40

C 3592	J. Cobb	Vol #:	40

C 3593	M. B. Haynes	Vol #:	40

C 3594	Y. Simkhayeva	Vol #:	40

C 3595	K. Nixon	Vol #:	40

C 3596	B. Flenner	Vol #:	40

C 3597	S. Peters	Vol #:	40

C 3598	L. Scalza	Vol #:	40

C 3599	S. Grace	Vol #:	40

C 3600	E. M. Stephens-kahl	Vol #:	40

C 3601	K. Spinks	Vol #:	40

C 3602	D. Bruno	Vol #:	40



C 3603	C. Chalkley	Vol #:	40

C 3604	P. Mcquire	Vol #:	40

C 3605	M. Hall	Vol #:	40

C 3606	D. Vanhouten	Vol #:	40

C 3607	T. Orvik	Vol #:	40

C 3608	C. Carlomagno	Vol #:	40

C 3609	R. E. Sijan	Vol #:	40

C 3610	J. M. Sully	Vol #:	40

C 3611	S. Easter	Vol #:	40

C 3612	J. Lukas	Vol #:	40

C 3613	K. Devon	Vol #:	40

C 3614	E. Golesch	Vol #:	40

C 3615	F. Adkins	Vol #:	40

C 3616	F. L. Hill	Vol #:	40

C 3617	M. Bradley	Vol #:	40

C 3618	R. Delaney	Vol #:	40

C 3619	S. Klingeisen	Vol #:	40

C 3620	F. Zedek	Vol #:	40

C 3621	G. Steel	Vol #:	40

2005P-0273	Add Calcium to the Mandatory List

SUP 3	RUTGERS, Ernest Mario School of Pharmacy	Vol #:	2

2005P-0411	Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs

C 18333	S. Lindsey	Vol #:	198

2005V-0172	Laser Light Show

VRA 2	Lynne L. Rice	Vol #:	1

2006D-0347	Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays

EXT 4	Amy M. Miller	Vol #:	3

2006N-0454	Use of Ozone-Depleting Substances; Removal of Essential-Use Designations

C 345	R. Ostermann	Vol #:	36

C 346	G. Durham	Vol #:	3

C 347	S. Adams	Vol #:	3

C 348	J Daggett	Vol #:	3

C 349	B. Woodring	Vol #:	3

C 350	W. Reed	Vol #:	3



C 351	M. Sullivan	Vol #:	3

C 352	J. Kelly	Vol #:	3

C 353	H. Vieweg	Vol #:	3

C 354	S. Thomas	Vol #:	3

C 355	L Tanoos	Vol #:	3

C 356	R. Kerns	Vol #:	3

C 357	E. Doenges	Vol #:	3

C 358	E. Niman	Vol #:	3

C 359	H. Osterholt	Vol #:	3

C 360	V. Reiter	Vol #:	3

C 361	P. Brown	Vol #:	3

C 362	N. Sauer	Vol #:	3

C 363	S. Herman	Vol #:	3

C 364	A. Kessler	Vol #:	3

C 365	L. Kosoowski	Vol #:	3

C 366	R. Puccio	Vol #:	3

C 367	A. Gal	Vol #:	3

C 368	K Moore	Vol #:	3

C 369	S. Pechmann	Vol #:	3

C 370	B. Alfieri	Vol #:	3

C 371	G. Lowe	Vol #:	3

C 372	L. Lewis	Vol #:	3

C 373	J. Haefner	Vol #:	3

C 374	L. Klipp	Vol #:	3

C 375	J. Chapman	Vol #:	3

C 376	R. Raper	Vol #:	3

C 377	B. Hewitt	Vol #:	3

C 378	P. Jones	Vol #:	3

C 379	D. Quartaro	Vol #:	3

C 380	G. Boulder	Vol #:	3

C 381	P. Colby	Vol #:	3

C 382	J. Snyder	Vol #:	3

C 383	G. Harris	Vol #:	3

C 384	K. Larkin	Vol #:	3

C 385	E. Landers	Vol #:	3

C 386	B. Hockin	Vol #:	3

C 387	H. Carbaugh	Vol #:	3



C 388	R. Tartaglia	Vol #:	3

C 389	T. Greenburg	Vol #:	34

C 390	A. Pfabe	Vol #:	3

C 391	E. Martin	Vol #:	3

C 392	V. Smith	Vol #:	3

C 393	G. Vomero	Vol #:	3

C 394	B. Mezzetti	Vol #:	3

C 395	R. Chlebowski	Vol #:	3

C 396	G. McKown	Vol #:	3

C 397	A. Munkacsy	Vol #:	3

C 398	T. Mattox	Vol #:	3

C 399	B. Tilley	Vol #:	3

C 400	H. Schultz	Vol #:	3

C 401	C. Basham	Vol #:	3

C 402	C. Lamphier	Vol #:	3

C 403	B. Toland	Vol #:	3

C 404	R. Shock	Vol #:	3

C 405	D Campbell	Vol #:	3

C 406	E. Johnson	Vol #:	3

C 407	P. Brown	Vol #:	3

C 408	A. Hash	Vol #:	3

C 409	R. Bowley	Vol #:	3

C 410	T. Harrison	Vol #:	3

C 411	G. Edington	Vol #:	3

C 412	B Keutzer	Vol #:	3

C 413	B Sims	Vol #:	3

C 414	M. Zinthez	Vol #:	3

C 415	J. Mazen	Vol #:	3

C 416	L. Biesenkamp	Vol #:	3

C 417	C. Batto	Vol #:	3

C 418	O. Reynolds	Vol #:	3

C 419	M. Nickerson	Vol #:	3

C 420	B. Ross	Vol #:	3

C 421	M. Davis	Vol #:	3

C 422	B. Bayer	Vol #:	3

C 423	E. Bradley	Vol #:	3

C 424	W. Robb	Vol #:	3



C 425	D. Turner	Vol #:	3

C 426	D. Williams	Vol #:	3

C 427	R. Yohman	Vol #:	3

C 428	L. McCune	Vol #:	3

C 429	J. Burket	Vol #:	3

C 430	Irene M. DeMarco	Vol #:	3

C 431	Jane Riohwalski	Vol #:	3

C 432	R. R. Wheeler	Vol #:	3

C 433	G. Favreau	Vol #:	3

C 434	R. Jeloleniewski	Vol #:	3

C 435	S. Guderey	Vol #:	3

C 436	C. Hjort	Vol #:	3

C 437	F. Colwell	Vol #:	3

C 438	H. Faulkner	Vol #:	3

C 439	A. Boyer	Vol #:	3

C 440	C. Dantonio	Vol #:	3

C 441	E. Saunders	Vol #:	3

C 442	M. Collins	Vol #:	3

C 443	L. Kafer	Vol #:	3

C 444	J. Hepler	Vol #:	3

C 445	C. Stafford	Vol #:	3

C 446	V. Shugart	Vol #:	3

C 447	B. Moore	Vol #:	3

C 448	M. Watson	Vol #:	3

C 449	M. Worley	Vol #:	3

C 450	D. Facolis	Vol #:	3

C 451	G. Call	Vol #:	3

C 452	A. Marshalek	Vol #:	3

C 453	M. Mannula	Vol #:	3

C 454	M. Byard	Vol #:	3

C 455	F. Gombos	Vol #:	3

C 456	C. Burkett	Vol #:	3

C 457	J. Roppa	Vol #:	3

C 458	T. Moore	Vol #:	3

C 459	E. Wolfe	Vol #:	3

C 460	A. Seymore	Vol #:	3

C 461	F. Hartel	Vol #:	3



C 462	E. Truby	Vol #:	3

C 463	B. Cohen	Vol #:	3

C 464	J. Cosnano	Vol #:	3

C 465	P. Richards	Vol #:	3

C 466	M. Haines	Vol #:	3

C 467	M. Baldwin	Vol #:	3

C 468	E. Bisig	Vol #:	3

C 469	L. Brady	Vol #:	3

C 470	M. Crayne	Vol #:	3

C 471	M. Weale	Vol #:	3

C 472	D. Covaleski	Vol #:	3

C 473	M. Hick	Vol #:	3

C 474	I Fine	Vol #:	3

C 475	R. Goss	Vol #:	3

C 476	K .Lockard	Vol #:	3

C 477	C. Green	Vol #:	3

C 478	B. Buley	Vol #:	3

C 479	J. Calletts	Vol #:	3

C 480	D. Schroeder	Vol #:	3

C 481	N. Lessand	Vol #:	3

C 482	J. Stippick	Vol #:	3

C 483	L. Kupperman	Vol #:	3

C 484	D. Lesser	Vol #:	3

C 485	M. Anderson	Vol #:	3

C 486	M. Stilwell	Vol #:	3

C 487	M. Joust	Vol #:	3

C 488	V. Bieger	Vol #:	3

C 489	R. Sutton	Vol #:	3

C 490	E. Walker	Vol #:	3

2006P-0205	Require Vitamin D be added to cereal-grain products

SUP 3	RUTGERS, Ernest Mario School of Pharmacy	Vol #:	2

2006P-0394	Revise the labeling requirements for eggs sold in the United States

C 128	Paul Moss	Vol #:	7

2006P-0445	Determine if Mivacron (mivacurium chloride injection) was withdrawn for safety or efficacy reasons

N 1	FDA	Vol #:	1



2006P-0520	Determination for Methotrexate Injection, USP, Preservative Free, Eq. 500 mg base/20 mL, NDA 11-719)

N 1	FDA	Vol #:	1

2007N-0121	Use of Medication Guides to Distribute Drug Risk Information to Patients; Public Hearing

C 10	National Community Pharmacists Association	Vol #:	7

2007N-0294	Medical Devices; Immunology and Microbiology Devices: Classification of In Vitro HIV Drug Resistance Genotype Assay

NFR 1	FDA	Vol #:	1

2007P-0316	Risperdal (Risperidone) Tablets

ACK 1	FDA/DDM to Teva Pharmaceuticals USA	Vol #:	1

CP 1	Teva Pharmaceuticals USA	Vol #:	1

2007V-0312	Laser Display Device

ACK 1	FDA / DDM/ to Catawba Science Center	Vol #:	1

VAR 1	Catawba Science Center	Vol #:	1

2007V-0314	Laser Light Show

ACK 1	FDA / DDM to Williamsville Space Lab Planetium	Vol #:	1

VAR 1	Williamsville Space Lab Planetium	Vol #:	1

2007V-0315	Projector for a Laser Light Show

ACK 1	Hollywood Pro Lighting	Vol #:	1

VAR 1	Hollywood Pro Lighting	Vol #:	1

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FDA/Dockets Management