Dockets Entered on February 15, 2007

Dockets Management



Dockets Entered On February 15, 2007



Docket #	Title

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

2003N-0573	Draft Animal Cloning Risk Assessment

2004D-0443	Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations

2004N-0408	Regulatory Site Visit Training Program

2005N-0279	Food Labeling; Gluten-Free Labeling of Foods

2005N-0394	FDAs Communication of Drug Safety Information; Public Hearing

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

2006N-0381	Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements

2006N-0430	Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation an

2006N-0434	Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance For Industry On How To Use E-Mail To Submit A Request For A Meeting Or Teleconference To The Office Of New Anim


2006N-0436	Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail to Submit A Study Protocol

2007D-0040	Guidance for Industry on Developing Products for Weight Management

2007E-0057	Patent Extension Application for EMSAM (selegiline transdermal system), U.S. Reissue No. 34,579

2007P-0044	Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis

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

LET 18559	Enzymatic Therapy, Inc.	Vol #:	169

LET 18560	New Chapter, Inc.	Vol #:	169

LET 18561	New Chapter, Inc.	Vol #:	169

LET 18562	New Chapter, Inc.	Vol #:	169

LET 18563	New Chapter, Inc.	Vol #:	169

LET 18564	New Chapter, Inc.	Vol #:	169

LET 18565	New Chapter, Inc.	Vol #:	169

LET 18566	PuraPharm Corporation	Vol #:	169

LET 18567	PuraPharm Corporation	Vol #:	169

LET 18568	PuraPharm Corporation	Vol #:	169

LET 18569	PuraPharm Corporation	Vol #:	169

LET 18570	PuraPharm Corporation	Vol #:	169

LET 18571	PuraPharm Corporation	Vol #:	169

LET 18572	PuraPharm Corporation	Vol #:	169

LET 18573	PuraPharm Corporation	Vol #:	169

LET 18574	PuraPharm Corporation	Vol #:	169

LET 18575	PuraPharm Corporation	Vol #:	169

LET 18576	PuraPharm Corporation	Vol #:	169

LET 18577	PuraPharm Corporation	Vol #:	169



LET 18578	PuraPharm Corporation	Vol #:	169

LET 18579	PuraPharm Corporation	Vol #:	169

LET 18580	PuraPharm Corporation	Vol #:	169

LET 18581	PuraPharm Corporation	Vol #:	169

LET 18582	PuraPharm Corporation	Vol #:	169

LET 18583	PuraPharm Corporation	Vol #:	169

LET 18584	PuraPharm Corporation	Vol #:	169

LET 18585	PuraPharm Corporation	Vol #:	169

LET 18586	PuraPharm Corporation	Vol #:	169

LET 18587	PuraPharm Corporation	Vol #:	169

LET 18588	PuraPharm Corporation	Vol #:	169

LET 18589	PuraPharm Corporation	Vol #:	169

LET 18590	PuraPharm Corporation	Vol #:	169

LET 18591	PuraPharm Corporation	Vol #:	169

LET 18592	PuraPharm Corporation	Vol #:	169

LET 18593	PuraPharm Corporation	Vol #:	169

LET 18594	PuraPharm Corporation	Vol #:	169

LET 18595	PuraPharm Corporation	Vol #:	169

LET 18596	PuraPharm Corporation	Vol #:	169

LET 18597	PuraPharm Corporation	Vol #:	169

LET 18598	PuraPharm Corporation	Vol #:	169

LET 18599	PuraPharm Corporation	Vol #:	169

LET 18600	PuraPharm Corporation	Vol #:	169

LET 18601	PuraPharm Corporation	Vol #:	169

2003N-0573	Draft Animal Cloning Risk Assessment

EC 3451	Mrs. Debbie Zook	Vol #:	21

EC 3452	Mrs. carolyn gray	Vol #:	21

EC 3453	Mr. Richard Riggs	Vol #:	21

EC 3454	Mrs. Karen Glauber	Vol #:	21

EC 3455	Ms. Chelsea Hibbard	Vol #:	21

EC 3456	Ms. Nina Altieri	Vol #:	21

EC 3457	Ms. Hilda Bolden	Vol #:	21

EC 3458	Ms. Therese DeCastris	Vol #:	21

EC 3459	Dr. Steven Handwerker	Vol #:	21

EC 3460	Ms. Charlotte Wager	Vol #:	21

EC 3461	Ms. Donna Angotti	Vol #:	21



EC 3462	Ms. mindy mayers	Vol #:	21

2004D-0443	Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Regulations

EC 10	Drugs Control Organization	Vol #:	2

2004N-0408	Regulatory Site Visit Training Program

EC 28	Cryobanks International, Inc.	Vol #:	1

2005N-0279	Food Labeling; Gluten-Free Labeling of Foods

EC 1638	Mrs. Mary Allen Sawtelle	Vol #:	31

EC 1639	Mrs. Mary S. Schutz	Vol #:	31

EC 1640	Mrs. Theresa Tucker	Vol #:	31

2005N-0394	FDAs Communication of Drug Safety Information; Public Hearing

C 6	J. Faulk	Vol #:	2

C 7	D. A. Sauer	Vol #:	2

C 8	P. Prouty	Vol #:	2

C 9	L. Horn and others	Vol #:	2

C 10	J. Jurkiewicz	Vol #:	2

C 11	D. Yoder	Vol #:	2

C 12	J. Rodriguez	Vol #:	2

C 13	A. Lee	Vol #:	2

C 14	M. Soptei	Vol #:	2

C 15	N. Kuriazi	Vol #:	2

C 16	J. Christoffersen	Vol #:	2

C 17	R. Compagni	Vol #:	2

C 18	M. Soptei	Vol #:	2

C 19	A. Lopez	Vol #:	2

C 20	C. Semento	Vol #:	2

C 21	P. Fisher	Vol #:	2

C 22	M. Soptei	Vol #:	2

C 23	A. Zyla	Vol #:	2

C 24	R. Bell	Vol #:	2

C 25	M. Soptei	Vol #:	2

C 26	R. Sampson	Vol #:	2

C 27	P. Brecto	Vol #:	2

C 28	B Bickel	Vol #:	2

C 29	D. Carey	Vol #:	2



C 30	D. Worthington	Vol #:	2

C 31	S. Dahl	Vol #:	2

C 32	L. Barillaro	Vol #:	2

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

C 18251	E. Marchury	Vol #:	198

C 18252	E. Pursell	Vol #:	198

C 18253	L. Ratliff	Vol #:	198

2006N-0381	Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements

N 2	FDA	Vol #:	1

2006N-0430	Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation an



NCR 1	FDA	Vol #:	1

2006N-0434	Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance For Industry On How To Use E-Mail To Submit A Request For A Meeting Or Teleconference To The Office Of New Anim



N 2	FDA	Vol #:	1

2006N-0436	Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on How to Use E-Mail to Submit A Study Protocol

N 2	FDA	Vol #:	1

2007D-0040	Guidance for Industry on Developing Products for Weight Management

GDL 1	Guidance	Vol #:	1

NAD 1	FDA	Vol #:	1

2007E-0057	Patent Extension Application for EMSAM (selegiline transdermal system), U.S. Reissue No. 34,579

APP 1	Somerset Pharmaceuticals, Inc.	Vol #:	1

2007P-0044	Ban Third Generation Oral Contraceptives Containing Desogestrel Due to Increased Risk of Venous Thrombosis

EC 1	N/A	Vol #:	1

EC 2	Ms. Cheryl Gonzalez	Vol #:	1

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FDA/Dockets Management