Dockets Entered on December 21, 2006

Dockets Management



Dockets Entered On December 21, 2006 Table of Contents



Docket #	Title

1977N-0094I	Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro

1977N-0094L	Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling

1978N-0065	Skin Bleaching Drug Products

1988N-0258	Prescription Drug Marketing Act of 1987; Guideline

1992N-0297	Prescription Drug Marketing Act of 1987, Drug Amds of 1992

1999P-1340	Declared Eternity eau de Parfum Misbranded

2000N-1596	Uniform Compliance Date for Food Labeling Regulations

2002P-0166	Print clear, legible & intelligible product expiration date

2003N-0056	Patient Examination & Surgeons' Gloves; Test Procedures

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

2004P-0328	Restaurants indicate Food they serve contains trans fat from partially hydrogenated vegetable oils

2005D-0169	Guidance on Useful Written Consumer Medication Information (CMI)

2005D-0348	Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order

2006D-0303	Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements

2006D-0383	Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases

2006N-0062	Expanded Access to Investigational Drugs for Treatment Use

2006N-0067	Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

2006N-0464	Electronic Submission of Regulatory Information, and Creating an Electronic Platform for Enhanced Information Management; Public Hearing

2006N-0468	Training Program for Regulatory Project Managers; Information Available to Industry

2006P-0085	To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements

2006P-0522	Apply Bioequivalence Requirements Consistent with 21 CFR 320.24(b)(4) to any ANDA for a Generic Drug Product using Lidoderm as its RLD

1977N-0094I	Internal, Analgesic, Antipyretic, and Antirheumatic Drug Pro

EMC 1	Number not used	Vol #:	10

1977N-0094L	Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Proposed Amendment ot the Tentative Final Monograph; Required Warnings and Other Labeling



EC 1	N/A	Vol #:	1

EC 2	Dr. Ijeoma Eleazu	Vol #:	1

1978N-0065	Skin Bleaching Drug Products

C 61	Wake Forest University	Vol #:	15

EC 265	Ruth R. Kamienecki, D.O. P.C.	Vol #:	14

EC 266	Mrs. Janet Wilson	Vol #:	14

EC 267	Mrs. Holly McCormick	Vol #:	14

EC 268	Mrs. Pamela Vanvorst	Vol #:	14

EC 269	Mrs. Vickie Boren	Vol #:	14



EC 270	Mr. carlos mandry	Vol #:	14

EC 271	Miss. Wyrita L. Harris	Vol #:	14

EC 272	Mrs. lori lang	Vol #:	14

EC 273	Ms. JOANN SAGGESE	Vol #:	14

EC 274	Mrs. Reba Williams	Vol #:	14

EC 275	Obaji	Vol #:	14

EC 276	Mrs. Susan Bullock	Vol #:	14

EC 277	Ms. bonny weinheimer	Vol #:	14

EC 278	Ms. Dawn Joyner	Vol #:	14

EC 279	Ms. Deborah Thompson	Vol #:	14

EC 280	Mrs. Jacqueline Black	Vol #:	14

EC 281	Ms. Sandra Wendel	Vol #:	14

EC 282	Mrs. gail levine	Vol #:	14

EC 283	Ms. Katherine Hannon	Vol #:	14

EC 284	Mrs. Theresa Epting	Vol #:	14

EC 285	Mrs. Diana Martin	Vol #:	14

EC 286	Mrs. susan brewer	Vol #:	14

EC 287	Mrs. Sara Bowman	Vol #:	14

EC 288	Mrs. Susan Cheesman	Vol #:	14

EC 289	Mrs. Jill Corgiat	Vol #:	14

EC 290	Mrs. R. Williams	Vol #:	14

EC 291	Mrs. Vivian Margulies	Vol #:	14

EC 292	Mrs. Mari Manzanares	Vol #:	14

EC 293	Ms. susan bradshaw	Vol #:	14

EC 294	Wells Insititute for Health Awareness	Vol #:	14

EC 295	Individual	Vol #:	14

EC 296	Mrs. susan wilson	Vol #:	14

EC 297	REJUVENATIONS Facial Aesthetic Clinic	Vol #:	14

EC 298	Mrs. barb cummins	Vol #:	14

EC 299	Mrs. Lana Mecca	Vol #:	14

EC 300	Mrs. Jane Deitz	Vol #:	14

EC 301	Ms. Jill Brown	Vol #:	14

EC 302	Mrs. Andrea Nolte	Vol #:	14

EC 303	Ms. Juliana Ranke`	Vol #:	14

EC 304	Miss. Camille Zuenskes	Vol #:	14

EC 305	Miss. jennifer david	Vol #:	14

EC 306	Mrs. Porter Thompson	Vol #:	14



EC 307	DEBRA BURKE, INDEPENDANT	Vol #:	14

EC 308	N/A	Vol #:	14

EC 309	Ms. Mary Lobello	Vol #:	14

EC 310	Mrs. Rebecca Parsons	Vol #:	14

EC 311	Ms. Paula Cavender	Vol #:	14

EC 312	Mrs. Jessica Loeb	Vol #:	14

EC 313	Ms. Saori Yoshii	Vol #:	14

EC 314	Mrs. Dawn Everett	Vol #:	14

EC 315	Mrs. Beverly Aldridge	Vol #:	14

EC 316	Ms. pamela bell	Vol #:	14

EC 317	Mrs. Michelle Wood	Vol #:	14

EC 318	Ms. Carol McMahon	Vol #:	14

EC 319	Ms. M. Gail Rainwater	Vol #:	14

EC 320	Ms. Leila Thorne	Vol #:	14

EC 321	Esthetician	Vol #:	14

EC 322	Miss. Natalie Wells	Vol #:	14

EC 323	Ms. Robie Drew	Vol #:	14

EC 324	Ms. Shelah Bozeman	Vol #:	14

EC 325	Mrs. amy zortman	Vol #:	14

EC 326	Ms. debbie herbert	Vol #:	14

EC 327	Ms. Gayle McNeese	Vol #:	14

EC 328	Ms. Kathleen Frost	Vol #:	14

EC 329	Ms. Theresa Thompson	Vol #:	14

EC 330	Ms. Patricia Price	Vol #:	14

EC 331	Mrs. Heather Kamis	Vol #:	14

EC 332	Ms. Vivian Mastropietro	Vol #:	14

EC 333	Mrs. Andrea Clanton	Vol #:	14

EC 334	Mrs. Rowena STUART	Vol #:	14

EC 335	Mrs. Bonnie Woods	Vol #:	14

EC 336	Ms. Melody Rosenbalm	Vol #:	14

EC 337	Mrs. Jennifer Wilsey	Vol #:	14

EC 338	Ms. Lisa Styop	Vol #:	14

EC 339	Mrs. Margaret Campbell	Vol #:	14

EC 340	Mrs. Rebecca Ward	Vol #:	14

EC 341	Ms. donna shields	Vol #:	14

EC 342	Ms. Maria Rocco	Vol #:	14

EC 343	Mrs. Tamea Woodward	Vol #:	14



EC 344	Mrs. Donelle Stokes	Vol #:	14

EC 345	Mrs. Victoria Switzer	Vol #:	14

EC 346	Ms. Vicki Hodge	Vol #:	14

EC 347	Mrs. Stacy Walker	Vol #:	14

EC 348	Skin Deep Beauty Products	Vol #:	14

EC 349	Mrs. Carol Hobby	Vol #:	14

EC 350	Mrs. Julia Lee	Vol #:	14

EC 351	Mrs. Ying Yang	Vol #:	14

EC 352	Mrs. Sterling Waller	Vol #:	14

EC 353	Miss. Susan Thomas	Vol #:	14

EC 354	Miss. Nhia Yang	Vol #:	14

EC 355	Mrs. May Her	Vol #:	14

EC 356	Mrs. Vilai Xiong	Vol #:	14

EC 357	NA	Vol #:	14

EC 358	Mrs. Linda Yang	Vol #:	14

EC 359	Mrs. Jody Hoffman	Vol #:	14

EC 360	Miss. Samira Salman	Vol #:	14

EC 361	None	Vol #:	14

EC 362	Mrs. gretchen ballou	Vol #:	14

EC 363	Mrs. Lisa Redmond-Barry	Vol #:	14

EC 364	Ms. Beatrice Nelson	Vol #:	14

EC 365	Mrs. Joely Ng	Vol #:	14

EC 366	Ms. Carolyn Holmes	Vol #:	14

EC 367	Ms. Nyree Amedee	Vol #:	14

EC 368	Mrs. Alexandra Webster	Vol #:	14

EC 369	Ms. Lian Phua	Vol #:	14

EC 370	Mrs. Joyce Clark	Vol #:	14

EC 371	Ms. Ty Nichols	Vol #:	14

EC 372	Mrs. Pamela Anderson	Vol #:	14

EC 373	Mrs. Mary Saunders	Vol #:	14

EC 374	Mrs. Gina Stroberger	Vol #:	14

EC 375	Mrs. Elmira Heineck	Vol #:	14

EC 376	Miss. Selanee Henderson	Vol #:	14

EC 377	Mrs. Ellen Babin	Vol #:	14

EC 378	Ms. Sandra Mendoza	Vol #:	14

EC 379	Ms. Linda Ivory	Vol #:	14

EC 380	Ms. Patricia Ezell	Vol #:	14



EC 381	Mrs. Dorothy Rowley	Vol #:	14

EC 382	Electrical Engineer	Vol #:	14

EC 383	Ms. Karleen Knuth	Vol #:	14

EC 384	Dr. Zakia Rahman	Vol #:	14

EC 385	Dr. Richard Asarch	Vol #:	14

EC 386	Miss. ANTOINETTE CALABRESE	Vol #:	14

EC 387	Johns Hopkins University	Vol #:	14

EC 388	Physicians Day Spa	Vol #:	14

EC 389	Dr. Jordana Gilman	Vol #:	14

EC 390	Ms. Dinah Wagner	Vol #:	14

EC 391	Mrs. Heidi Grages	Vol #:	14

EC 392	Mrs. Bonita Loose	Vol #:	14

EC 393	Mrs. DIANNA BRITT	Vol #:	14

EC 394	Mrs. Lauri Solaimani	Vol #:	14

EC 395	Mrs. Janice Aicher	Vol #:	14

EC 396	Dr. Rochelle Weiss	Vol #:	14

EC 397	Ms. Maria Ferrari	Vol #:	14

EC 398	Mrs. Julie StJohn	Vol #:	14

EC 399	Mrs. Barbara Rubio	Vol #:	14

EC 400	individual	Vol #:	14

EC 401	Mrs. donia henderson	Vol #:	14

EC 402	Ms. gina cianciolo	Vol #:	14

EC 403	Emmanuel R. Loucas, M.D., P.C.	Vol #:	14

EC 404	Ms. Stephanie Caballero	Vol #:	14

EC 405	Ms. Nicole Wotus	Vol #:	14

EC 406	Ms. Elise Traynum	Vol #:	14

EC 407	Dr. Michael Wilkerson	Vol #:	14

EC 408	Dr. Barry Resnik	Vol #:	14

EC 409	Mrs. Brenda Redfern	Vol #:	14

EC 410	Dr. martin kay	Vol #:	14

EC 411	Ms. Robyn Hayes	Vol #:	14

EC 412	All One Skin Cancer	Vol #:	14

EC 413	Mrs. Sharon Fish	Vol #:	14

EC 414	Ms. Jennifer Maynard	Vol #:	14

EC 415	Mrs. Judy Cobern	Vol #:	14

EC 416	Mrs. Carol Mastro	Vol #:	14

EC 417	Dr. Nancy Samolitis	Vol #:	14



EC 418	Mrs. carol hansen	Vol #:	14

EC 419	Mrs. sanda giardini	Vol #:	14

EC 420	Miss. Cheryl Lewis	Vol #:	14

EC 421	Ms. Maribeth Nelson	Vol #:	14

EC 422	Ms. Rio Phior	Vol #:	14

EC 423	Mrs. LISA COTTLE	Vol #:	14

EC 424	Mrs. Laura Voigt	Vol #:	14

EC 425	Ms. Virginia Doebler	Vol #:	14

EC 426	Mrs. MARYCARMEN GONZALEZ	Vol #:	14

EC 427	Mrs. Carole Tomamichel	Vol #:	14

EC 428	Dr. rebecca fitzgerald	Vol #:	14

EC 429	Mrs. Darlene Burgess	Vol #:	14

EC 430	Ms. Sandra Felton	Vol #:	14

EC 431	Mrs. Krista Miller	Vol #:	14

EC 432	Ms. Stacy Sherbert	Vol #:	14

EC 433	Ms. Hannah Klingsberg	Vol #:	14

EC 434	Ms. Barbara Fishman	Vol #:	14

EC 435	Mrs. lisa smith	Vol #:	14

EC 436	Mrs. Catalina Saud	Vol #:	14

EC 437	Mrs. Lynn Babish	Vol #:	14

EC 438	Mrs. Susan Tilford	Vol #:	14

EC 439	Ms. Cara Dake	Vol #:	14

EC 440	Mrs. Alicia Arriaga	Vol #:	14

EC 441	Mrs. Leslie Tilton	Vol #:	14

EC 442	Dr. khanh nguyen	Vol #:	14

EC 443	Beta Sigma Phi, Northwest Medical Center, Tucson,A	Vol #:	14

EC 444	Ms. Sharon White	Vol #:	14

EC 445	Mrs. Sheryl Segovis	Vol #:	14

EC 446	Mrs. Kelly Major	Vol #:	14

EC 447	Mrs. Donna Sines	Vol #:	14

EC 448	Ms. Kirsten Sloneker	Vol #:	14

EC 449	Mrs. Myla Suarez	Vol #:	14

EC 450	Mrs. jean green	Vol #:	14

EC 451	Dr. Alexander Miller	Vol #:	14

EC 452	Ms. mary rawles	Vol #:	14

EC 453	Ms. Carole Bacon	Vol #:	14

EC 454	Mrs. Angie Baker	Vol #:	14



EC 455	Mrs. Karen Swain	Vol #:	14

EC 456	Ms. Christina Miller	Vol #:	14

EC 457	Mrs. Debra Bond	Vol #:	14

EC 458	Mrs. elizabeth moebius	Vol #:	14

EREG 1	Truett Laboratories	Vol #:	15

EXT 4	Venable, LLP	Vol #:	15

MT 1	Telephone Conversation between FDA and Venable, LLP	Vol #:	15

1988N-0258	Prescription Drug Marketing Act of 1987; Guideline

C 151	American Veterinary Distributors Association et al.	Vol #:	8

C 152	Midland Medical supply Co.	Vol #:	8

C 153	American Veterinary Distributors Association (AVDA)	Vol #:	8

1992N-0297	Prescription Drug Marketing Act of 1987, Drug Amds of 1992

C 145	American Veterinary Distributors Association et al	Vol #:	10

C 146	Midland Medical Supply CO.	Vol #:	10

C 147	American Veterinary Distributors Association (AVDA)	Vol #:	10

1999P-1340	Declared Eternity eau de Parfum Misbranded

C 763	V. Davis	Vol #:	25

EMC 664	V. Segreti	Vol #:	24

2000N-1596	Uniform Compliance Date for Food Labeling Regulations

NFR 4	FDA	Vol #:	1

2002P-0166	Print clear, legible & intelligible product expiration date

PDN 1	FDA to Auishalom Klammer	Vol #:	1

2003N-0056	Patient Examination & Surgeons' Gloves; Test Procedures

BKG 2	Background Information for NFR1	Vol #:	3

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

EMC 1405	J. Holmes	Vol #:	12

2004P-0328	Restaurants indicate Food they serve contains trans fat from partially hydrogenated vegetable oils

PDN 1	FDA to Center for Science in the Public Interest (CSPI)	Vol #:	1

2005D-0169	Guidance on Useful Written Consumer Medication Information (CMI)

EC 25	Mrs. Loretta Craig	Vol #:	2

2005D-0348	Guidance for Industry and Food and Drug Administration: Procedures for Handling Post-Approval Studies Imposed by PMA Order



GDL 2	Guideline	Vol #:	1

NAD 2	FDA	Vol #:	1

2006D-0303	Guidance for Industry on Public Availability of Labeling Changes in Changes Being Effected Supplements

EC 4	PHILA VA MED CENTER	Vol #:	1

2006D-0383	Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases



C 368	A. Partika	Vol #:	24

C 369	W. Shelley	Vol #:	24

C 370	D. Ake'	Vol #:	24

C 371	P. Corbett	Vol #:	24

C 372	P. Hagarty	Vol #:	24

C 373	J. Nagel	Vol #:	24

C 374	Dr. R. Ohm	Vol #:	24

C 375	M. Woellner	Vol #:	24

C 376	M. Glatz	Vol #:	24

C 377	H. Tenaglio	Vol #:	24

C 378	L. Schnorr	Vol #:	24

C 379	M. Hospador	Vol #:	24

C 380	. Hankel	Vol #:	24

C 381	D. Corbone	Vol #:	24

C 382	M. Baxa, RN	Vol #:	24

C 383	M and J Charlesworth	Vol #:	24

C 384	L. Whling	Vol #:	24

C 385	A. Beaver	Vol #:	24

C 386	H. McCarthy	Vol #:	24

C 387	r. Bonaro	Vol #:	24

C 388	R. Ziccardi	Vol #:	24

C 389	M. Aidala	Vol #:	24

C 390	R. Carney	Vol #:	24

C 391	R. ryan	Vol #:	24

C 392	S. Cooney	Vol #:	24

C 393	F. Pasko	Vol #:	24

C 394	M. Basciano	Vol #:	24

C 395	T. Fox	Vol #:	24

C 396	M. Luifker	Vol #:	24

C 397	Dr. J. Hartnett	Vol #:	24



C 398	L. Digregorio	Vol #:	24

C 399	R. Thoman	Vol #:	24

C 400	M. Dalessandro	Vol #:	24

C 401	A. Dunbar	Vol #:	24

C 402	A. Decker	Vol #:	24

C 403	M. Gillespie	Vol #:	24

C 404	E. Ryan	Vol #:	24

C 405	R. Johnson	Vol #:	24

C 406	E. Hoban	Vol #:	24

C 407	R. Gallagher	Vol #:	24

C 408	J. Eicher	Vol #:	24

C 409	W. Kaminski	Vol #:	24

C 410	M. Brehm	Vol #:	24

C 411	C. Fischer	Vol #:	24

C 412	P. McGinley	Vol #:	24

C 413	T. Winkle	Vol #:	24

C 414	B. Joseph	Vol #:	24

C 415	M. Landry	Vol #:	24

C 416	D. Phillips	Vol #:	24

C 417	Illegible	Vol #:	24

C 418	M ans S Tenbusch	Vol #:	24

C 419	P. McHugh	Vol #:	24

C 420	A. Bell	Vol #:	24

C 421	J. O'bringer	Vol #:	24

EC 3906	Mrs. Virginia Grant	Vol #:	18

EC 3907	Mr. John Rodgers	Vol #:	18

EC 3908	Mrs. Jean Karlovitz	Vol #:	18

EC 3909	Mrs. Susan Burgess	Vol #:	18

EC 3910	Mrs. Rena Helbling	Vol #:	18

EC 3911	Mrs. Judy Verschoor	Vol #:	18

EC 3912	Mrs. Suzanne Kerr	Vol #:	18

EC 3913	Southeastern Louisiana University	Vol #:	18

EC 3914	Miss. Esther McCarthy	Vol #: