| | | | | | | | | | |
|
|
| Dockets Entered
On July 10, 2007
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 2005N-0272
|
| Irradiation in the Production, Processing & Handling of Food
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| 2006D-0480
|
| Guidance for Industry
on Complementary & Alternative Medicine Products & Their Regulation
by the Food and Drug Administration
|
|
|
| 2007M-0244
|
| BP060002 /0 Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit
|
|
|
| 2007M-0263
|
| BP050069/0 - Roche COBAS AmpliPrep/COBAS TaqManHIV-1 Test, 48 Tests, COBAS AmpliPrep/COBAS Taqman Wash Reagents, 5.1.L
|
|
|
| 2007P-0085
|
| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
|
|
|
| 2007P-0273
|
| Request that CDER update the
official drug labels for penicillin G potassium and penicillin G sodium
for injection
|
|
|
| 2007P-0274
|
| Request that CDRH allow 510(k) clearance of devices for antimicrobial susceptibility testing of Streptococcus pneumoniae with pencillin
|
|
|
| 2007P-0275
|
| to permit an ANDA Suitability for Nabumetone Tablets 1000 mg
|
|
|
| 2005N-0272
|
| Irradiation in the Production, Processing & Handling of Food
|
|
|
| C 725
|
| A. G. Silvestri
|
| Vol #:
|
| 14
|
|
|
| C 726
|
| T. Bengaff
|
| Vol #:
|
| 14
|
|
|
| C 727
|
| J. And W. Macdonald
|
| Vol #:
|
| 14
|
|
|
| C 728
|
| G. Brooklyn
|
| Vol #:
|
| 14
|
|
|
| C 729
|
| L. Brooks
|
| Vol #:
|
| 14
|
|
|
| C 730
|
| P. Thompson
|
| Vol #:
|
| 14
|
|
|
| C 731
|
| A. Moore
|
| Vol #:
|
| 14
|
|
|
| C 732
|
| J. Wasserman
|
| Vol #:
|
| 14
|
|
|
| C 733
|
| J. Brainard
|
| Vol #:
|
| 14
|
|
|
| C 734
|
| M. L. Finkel
|
| Vol #:
|
| 14
|
|
|
| C 735
|
| L. Neustadt
|
| Vol #:
|
| 14
|
|
|
| C 736
|
| B. Seth
|
| Vol #:
|
| 14
|
|
|
| C 737
|
| S. Odlum
|
| Vol #:
|
| 14
|
|
|
| C 738
|
| L. Hamilton
|
| Vol #:
|
| 14
|
|
|
| C 739
|
| A. Randall
|
| Vol #:
|
| 14
|
|
|
| C 740
|
| P. Scott
|
| Vol #:
|
| 14
|
|
|
| C 741
|
| F. Vincent
|
| Vol #:
|
| 14
|
|
|
| C 742
|
| D. Colvin
|
| Vol #:
|
| 14
|
|
|
| C 743
|
| V. Guzzardo
|
| Vol #:
|
| 14
|
|
|
| C 744
|
| H. Maher
|
| Vol #:
|
| 14
|
|
|
| C 745
|
| C. Hodges
|
| Vol #:
|
| 14
|
|
|
| C 746
|
| J. E. Whitney
|
| Vol #:
|
| 14
|
|
|
| C 747
|
| J. Fawcett
|
| Vol #:
|
| 14
|
|
|
| C 748
|
| A. Webb
|
| Vol #:
|
| 14
|
|
|
| C 749
|
| B. Anderson
|
| Vol #:
|
| 14
|
|
| | | | | | | |
|
|
| C 750
|
| A. Weber
|
| Vol #:
|
| 14
|
|
|
| C 751
|
| C. Burton
|
| Vol #:
|
| 14
|
|
|
| C 752
|
| A. Aspinall
|
| Vol #:
|
| 14
|
|
|
| C 753
|
| S. Napps
|
| Vol #:
|
| 14
|
|
|
| C 754
|
| C. Wills
|
| Vol #:
|
| 14
|
|
|
| C 755
|
| C. Coslet
|
| Vol #:
|
| 14
|
|
|
| C 756
|
| J. Henry
|
| Vol #:
|
| 14
|
|
|
| C 757
|
| S. Parks
|
| Vol #:
|
| 14
|
|
|
| C 758
|
| F. Gadea
|
| Vol #:
|
| 14
|
|
|
| C 759
|
| W. K. Harrison
|
| Vol #:
|
| 14
|
|
|
| C 760
|
| A. Ptak
|
| Vol #:
|
| 14
|
|
|
| C 761
|
| A. Houck
|
| Vol #:
|
| 14
|
|
|
| C 762
|
| L. Saldana
|
| Vol #:
|
| 14
|
|
|
| C 763
|
| J. Jones
|
| Vol #:
|
| 14
|
|
|
| C 764
|
| E. Beeche
|
| Vol #:
|
| 14
|
|
|
| C 765
|
| B. Webb
|
| Vol #:
|
| 14
|
|
|
| C 766
|
| L. Spade
|
| Vol #:
|
| 14
|
|
|
| C 767
|
| J. Pakaki
|
| Vol #:
|
| 14
|
|
|
| C 768
|
| J. Parker
|
| Vol #:
|
| 14
|
|
|
| C 769
|
| P. Whitson
|
| Vol #:
|
| 14
|
|
|
| C 770
|
| R. Mcbee-bonello
|
| Vol #:
|
| 14
|
|
|
| C 771
|
| F. Delshad
|
| Vol #:
|
| 14
|
|
|
| C 772
|
| J. Rex
|
| Vol #:
|
| 14
|
|
|
| C 773
|
| K. Beroset
|
| Vol #:
|
| 14
|
|
|
| C 774
|
| J. Masi
|
| Vol #:
|
| 14
|
|
|
| C 775
|
| C. Capp
|
| Vol #:
|
| 14
|
|
|
| C 776
|
| R. Weinstein
|
| Vol #:
|
| 14
|
|
|
| C 777
|
| P. Valenti
|
| Vol #:
|
| 14
|
|
|
| C 778
|
| R. Jordan
|
| Vol #:
|
| 14
|
|
|
| C 779
|
| J. Kendall
|
| Vol #:
|
| 14
|
|
|
| C 780
|
| Dr. Spicer
|
| Vol #:
|
| 14
|
|
|
| C 781
|
| B. Walter
|
| Vol #:
|
| 14
|
|
|
| C 782
|
| Dr. J. Cerutti
|
| Vol #:
|
| 14
|
|
|
| C 783
|
| W. Spangler
|
| Vol #:
|
| 14
|
|
|
| C 784
|
| N. Booker
|
| Vol #:
|
| 14
|
|
|
| C 785
|
| D. Gillespie
|
| Vol #:
|
| 14
|
|
|
| C 786
|
| A. Kiefer
|
| Vol #:
|
| 14
|
|
| | | | | | | | |
|
|
| C 787
|
| J. Chiralo
|
| Vol #:
|
| 14
|
|
|
| C 788
|
| L. Bagot-parker
|
| Vol #:
|
| 14
|
|
|
| C 789
|
| R. A. Jones
|
| Vol #:
|
| 14
|
|
|
| C 790
|
| L. (poppy) Miller
|
| Vol #:
|
| 14
|
|
|
| C 791
|
| E. Kovalsky
|
| Vol #:
|
| 14
|
|
|
| C 792
|
| C. Lewis
|
| Vol #:
|
| 14
|
|
|
| C 793
|
| B. Tomlinson
|
| Vol #:
|
| 14
|
|
|
| C 794
|
| J. Katz
|
| Vol #:
|
| 14
|
|
|
| C 795
|
| A. Peterson
|
| Vol #:
|
| 14
|
|
|
| C 796
|
| D. Dionne
|
| Vol #:
|
| 14
|
|
|
| C 797
|
| L. Watkins
|
| Vol #:
|
| 14
|
|
|
| C 798
|
| D. Artley
|
| Vol #:
|
| 14
|
|
|
| C 799
|
| D. Higgins
|
| Vol #:
|
| 14
|
|
|
| C 800
|
| H. Spergel
|
| Vol #:
|
| 14
|
|
|
| C 801
|
| C. Baumgarten
|
| Vol #:
|
| 14
|
|
|
| C 802
|
| S. Edwards
|
| Vol #:
|
| 14
|
|
|
| 2005P-0411
|
| Seeking FDA Actions to Counter Flagrant Violations of the Law by Pharmacies Compounding Bio-Identical Hormone Replacement Therapy Drugs
|
|
|
| C 18325
|
| M. Robertson
|
| Vol #:
|
| 198
|
|
|
| 2006D-0480
|
| Guidance for Industry
on Complementary & Alternative Medicine Products & Their Regulation
by the Food and Drug Administration
|
|
|
| EC 1860
|
| AMTA
|
| Vol #:
|
| 28
|
|
|
| EC 1861
|
| Mrs. Cindy Shranko
|
| Vol #:
|
| 28
|
|
|
| EC 1862
|
| Mrs. Robin Campbell
|
| Vol #:
|
| 28
|
|
|
| EC 1863
|
| Dr. Ken Parker
|
| Vol #:
|
| 28
|
|
|
| EC 1864
|
| Mrs. Royce Maxfield
|
| Vol #:
|
| 28
|
|
|
| EC 1865
|
| Mrs. Vivian Menjivar, LMT
|
| Vol #:
|
| 28
|
|
|
| EC 1866
|
| N/A
|
| Vol #:
|
| 28
|
|
|
| EC 1867
|
| Mrs. Jeanna Johnson
|
| Vol #:
|
| 28
|
|
|
| EC 1868
|
| Mrs. Kristi Stutt
|
| Vol #:
|
| 28
|
|
|
| EC 1869
|
| Mrs. Victoria Galindo
|
| Vol #:
|
| 28
|
|
|
| EC 1870
|
| Mrs. JOANN HOWELL
|
| Vol #:
|
| 28
|
|
|
| EC 1871
|
| Mrs. Frances Molinengo
|
| Vol #:
|
| 28
|
|
|
| EC 1872
|
| Miss. Tara Dickinson
|
| Vol #:
|
| 28
|
|
|
| EC 1873
|
| Mr. Kevin Zorda
|
| Vol #:
|
| 28
|
|
|
| EC 1874
|
| Mrs. PJ Snell
|
| Vol #:
|
| 28
|
|
|
| EC 1875
|
| Ms. Beca Foster
|
| Vol #:
|
| 28
|
|
| | | | | | | |
|
|
| EC 1876
|
| Mrs. melody henderson
|
| Vol #:
|
| 28
|
|
|
| EC 1877
|
| Ministry of Truth
|
| Vol #:
|
| 28
|
|
|
| EC 1878
|
| Mr. JOHN CROWLEY
|
| Vol #:
|
| 28
|
|
|
| EC 1879
|
| Ms. Colete Duchnowski
|
| Vol #:
|
| 28
|
|
|
| EC 1880
|
| Mrs. DANA LEMASTER
|
| Vol #:
|
| 28
|
|
|
| EC 1881
|
| Mrs. Thresa Aguayo
|
| Vol #:
|
| 28
|
|
|
| EC 1882
|
| Ms. Linda Mogitz
|
| Vol #:
|
| 28
|
|
|
| EC 1883
|
| BioPharma Scientific, Inc
|
| Vol #:
|
| 28
|
|
|
| EC 1884
|
| Mrs. Sharon Hall
|
| Vol #:
|
| 28
|
|
|
| EC 1885
|
| Mr. John Ellis
|
| Vol #:
|
| 28
|
|
|
| EC 1886
|
| Mrs. Kelli Miller
|
| Vol #:
|
| 28
|
|
|
| EC 1887
|
| Ms. Judy Wessler
|
| Vol #:
|
| 28
|
|
|
| EC 1888
|
| Mr. Lucson Pierre-Charles
|
| Vol #:
|
| 28
|
|
|
| EC 1889
|
| Ms. coleen hulse
|
| Vol #:
|
| 28
|
|
|
| EC 1890
|
| Shakti's Elements
|
| Vol #:
|
| 28
|
|
|
| EC 1891
|
| Alki View Massage
|
| Vol #:
|
| 28
|
|
|
| EC 1892
|
| Mrs. Denise Bailey
|
| Vol #:
|
| 28
|
|
|
| EC 1893
|
| Mrs. Linda Densmore
|
| Vol #:
|
| 28
|
|
|
| EC 1894
|
| Dr. Bob Burdette
|
| Vol #:
|
| 28
|
|
|
| EC 1895
|
| Mr. Nathan Peterson
|
| Vol #:
|
| 28
|
|
|
| EC 1896
|
| Mrs. Anne-Marie Lake
|
| Vol #:
|
| 28
|
|
|
| EC 1897
|
| Ms. Phylis Dixon
|
| Vol #:
|
| 28
|
|
|
| EC 1898
|
| Mrs. Sandra Nye
|
| Vol #:
|
| 28
|
|
|
| EC 1899
|
| Ms. Kimberly Smith
|
| Vol #:
|
| 28
|
|
|
| EC 1900
|
| Dr. Jon Ruthven
|
| Vol #:
|
| 28
|
|
|
| EC 1901
|
| Mrs. Kathleen Baker
|
| Vol #:
|
| 28
|
|
|
| EC 1902
|
| Mrs. Gail Stavro
|
| Vol #:
|
| 28
|
|
|
| EC 1903
|
| Ms. debra dresbach
|
| Vol #:
|
| 28
|
|
|
| EC 1904
|
| none
|
| Vol #:
|
| 28
|
|
|
| EC 1905
|
| Mrs. Katrina Adickes
|
| Vol #:
|
| 28
|
|
|
| EC 1906
|
| Mr. George J, Hoprich
|
| Vol #:
|
| 28
|
|
|
| EC 1907
|
| Ms. Tina Noyes
|
| Vol #:
|
| 28
|
|
|
| EC 1908
|
| Mrs. Juliet Neal-Boyd
|
| Vol #:
|
| 28
|
|
|
| EC 1909
|
| Mr. Stuart Funk
|
| Vol #:
|
| 28
|
|
|
| EC 1910
|
| Ms. Heather Dunado
|
| Vol #:
|
| 28
|
|
|
| EC 1911
|
| Mr. J. ULYSSES RUIZ
|
| Vol #:
|
| 28
|
|
|
| EC 1912
|
| Ms. Dee Lee
|
| Vol #:
|
| 28
|
|
| | | | | | | |
|
|
| EC 1913
|
| Health Wealth
|
| Vol #:
|
| 28
|
|
|
| EC 1914
|
| Ms. Katriana Sweet
|
| Vol #:
|
| 28
|
|
|
| EC 1915
|
| Mrs. Angela Mullis
|
| Vol #:
|
| 28
|
|
|
| EC 1916
|
| Mrs. Anne Green
|
| Vol #:
|
| 28
|
|
|
| EC 1917
|
| Mr. Luis Delgado
|
| Vol #:
|
| 28
|
|
|
| EC 1918
|
| HOME
|
| Vol #:
|
| 28
|
|
|
| EC 1919
|
| Ms. Mary Stock
|
| Vol #:
|
| 28
|
|
|
| EC 1920
|
| Mr. Jeffrey Kaplan
|
| Vol #:
|
| 28
|
|
|
| EC 1921
|
| Seagate
|
| Vol #:
|
| 28
|
|
|
| EC 1922
|
| Ms. Avis Valle
|
| Vol #:
|
| 28
|
|
|
| EC 1923
|
| Mr. James Ross
|
| Vol #:
|
| 28
|
|
|
| EC 1924
|
| Mrs. A Butler
|
| Vol #:
|
| 28
|
|
|
| EC 1925
|
| Ms. Charna Rosenholtz
|
| Vol #:
|
| 28
|
|
|
| EC 1926
|
| Ms. Cindy Lannin
|
| Vol #:
|
| 28
|
|
|
| EC 1927
|
| Ms. Nancy Johnson
|
| Vol #:
|
| 28
|
|
|
| EC 1928
|
| Mrs. Pat McGee
|
| Vol #:
|
| 28
|
|
|
| EC 1929
|
| Mr. Vinton Ervin
|
| Vol #:
|
| 28
|
|
|
| EC 1930
|
| Mrs. Susan Covey
|
| Vol #:
|
| 28
|
|
|
| EC 1931
|
| Mr. Guy Smith
|
| Vol #:
|
| 28
|
|
|
| EC 1932
|
| Ms. Diane DeMars
|
| Vol #:
|
| 28
|
|
|
| EC 1933
|
| Ms. Kim Blue
|
| Vol #:
|
| 28
|
|
|
| EC 1934
|
| Mr. JOE CHRISTIANO
|
| Vol #:
|
| 28
|
|
|
| EC 1935
|
| Mr. Jason Flora
|
| Vol #:
|
| 28
|
|
|
| EC 1936
|
| Dr. William Schnoebelen
|
| Vol #:
|
| 28
|
|
|
| EC 1937
|
| Ms. Marci Cantor
|
| Vol #:
|
| 28
|
|
|
| EC 1938
|
| Mrs. Sharon Buchta
|
| Vol #:
|
| 28
|
|
|
| EC 1939
|
| Dr. dennis waugaman
|
| Vol #:
|
| 28
|
|
|
| EC 1940
|
| Mr. Dan Barwick
|
| Vol #:
|
| 28
|
|
|
| EC 1941
|
| Mr. James Ponczek
|
| Vol #:
|
| 28
|
|
|
| EC 1942
|
| Mr. Donald Upp
|
| Vol #:
|
| 28
|
|
|
| EC 1943
|
| Mrs. nancy dillon
|
| Vol #:
|
| 28
|
|
|
| EC 1944
|
| Mrs. Maria Yauri
|
| Vol #:
|
| 28
|
|
|
| EC 1945
|
| Mrs. Cay Eckland
|
| Vol #:
|
| 28
|
|
|
| EC 1946
|
| Mr. Russell Hamerly
|
| Vol #:
|
| 28
|
|
|
| EC 1947
|
| Ms. Vikki Walton
|
| Vol #:
|
| 28
|
|
|
| EC 1948
|
| Mr. Timothy Baur
|
| Vol #:
|
| 28
|
|
|
| EC 1949
|
| None
|
| Vol #:
|
| 28
|
|
| | | | | | | |
|
|
| EC 1950
|
| Mr. Richard Anderson
|
| Vol #:
|
| 28
|
|
|
| EC 1951
|
| Mr. Pat Jaeger
|
| Vol #:
|
| 28
|
|
|
| EC 1952
|
| Mr. Dennis Roberts
|
| Vol #:
|
| 28
|
|
|
| EC 1953
|
| Ms. Dawn Barrett
|
| Vol #:
|
| 28
|
|
|
| EC 1954
|
| Mrs. Tammie Nelson
|
| Vol #:
|
| 28
|
|
|
| EC 1955
|
| Mr. Collin Offermans
|
| Vol #:
|
| 28
|
|
|
| EC 1956
|
| EASI
|
| Vol #:
|
| 28
|
|
|
| EC 1957
|
| Mr. William DeSimone
|
| Vol #:
|
| 28
|
|
|
| EC 1958
|
| Turtle Island Earth Stewards
|
| Vol #:
|
| 28
|
|
|
| EC 1959
|
| Mrs. Terri Sparenborg
|
| Vol #:
|
| 28
|
|
|
| EC 1960
|
| AMTA
|
| Vol #:
|
| 28
|
|
|
| EC 1961
|
| Mr. PAX DEBEJAR
|
| Vol #:
|
| 28
|
|
|
| EC 1962
|
| Ms. Sherri Ronsse
|
| Vol #:
|
| 28
|
|
|
| EC 1963
|
| Miss. suzanne barrett
|
| Vol #:
|
| 28
|
|
|
| EC 1964
|
| Ms. Susan Schultz
|
| Vol #:
|
| 28
|
|
|
| EC 1965
|
| Mr. Jose Trujillo
|
| Vol #:
|
| 28
|
|
|
| EC 1966
|
| Mrs. Irene Clark
|
| Vol #:
|
| 28
|
|
|
| EC 1967
|
| Mrs. Gloria Uridel
|
| Vol #:
|
| 28
|
|
|
| EC 1968
|
| Mrs. Nikki Pricken
|
| Vol #:
|
| 28
|
|
|
| EC 1969
|
| Dr. Katherine Machara
|
| Vol #:
|
| 28
|
|
|
| EC 1970
|
| Ms. Sabine Won
|
| Vol #:
|
| 28
|
|
|
| EC 1971
|
| Ms. Linda Hughes
|
| Vol #:
|
| 28
|
|
|
| EC 1972
|
| Ms. georgia westover
|
| Vol #:
|
| 28
|
|
|
| EC 1973
|
| Mrs. Kristine Marsh
|
| Vol #:
|
| 28
|
|
|
| EC 1974
|
| Mrs. Gwyn Olson
|
| Vol #:
|
| 28
|
|
|
| EC 1975
|
| Mr. Michael Faure
|
| Vol #:
|
| 28
|
|
|
| EC 1976
|
| Mr. Bruno Mariano
|
| Vol #:
|
| 28
|
|
|
| EC 1977
|
| Mr. Jim Tobin
|
| Vol #:
|
| 28
|
|
|
| EC 1978
|
| Dr. Pierre Wauters
|
| Vol #:
|
| 28
|
|
|
| EC 1979
|
| Dr. Tom Rasmussen
|
| Vol #:
|
| 28
|
|
|
| EC 1980
|
| Ms. Mae Woo
|
| Vol #:
|
| 28
|
|
|
| EC 1981
|
| Ms. Mere Herndon
|
| Vol #:
|
| 28
|
|
|
| EC 1982
|
| naturelowers
|
| Vol #:
|
| 28
|
|
|
| EC 1983
|
| Mr. Joseph Monyok
|
| Vol #:
|
| 28
|
|
|
| EC 1984
|
| Mr. Larry Eastlund
|
| Vol #:
|
| 28
|
|
|
| EC 1985
|
| Ms. leandre tankersley
|
| Vol #:
|
| 28
|
|
|
| EC 1986
|
| Ms. Barbara Brown
|
| Vol #:
|
| 28
|
|
| | | | | | | |
|
|
| EC 1987
|
| Mr. Kurt Milkowski
|
| Vol #:
|
| 28
|
|
|
| EC 1988
|
| Mr. Ana L
|
| Vol #:
|
| 28
|
|
|
| EC 1989
|
| Ms. Dorothy Morales
|
| Vol #:
|
| 28
|
|
|
| EC 1990
|
| Ms. Joan Elliott
|
| Vol #:
|
| 28
|
|
|
| EC 1991
|
| Ms. Tammy Shearer
|
| Vol #:
|
| 28
|
|
|
| EC 1992
|
| Desert Lake Technologies, LLC
|
| Vol #:
|
| 28
|
|
|
| EC 1993
|
| Mrs. Barbara Cefalu
|
| Vol #:
|
| 28
|
|
|
| EC 1994
|
| Mr. Jim Hill
|
| Vol #:
|
| 28
|
|
|
| EC 1995
|
| Ms. Nancy Roberts
|
| Vol #:
|
| 28
|
|
|
| EC 1996
|
| Ms. Gina Renee
|
| Vol #:
|
| 28
|
|
|
| EC 1997
|
| Mr. Ted Luce
|
| Vol #:
|
| 28
|
|
|
| EC 1998
|
| Miss. Gail Lemieux
|
| Vol #:
|
| 28
|
|
|
| EC 1999
|
| American Massage Therapy Association
|
| Vol #:
|
| 28
|
|
|
| EC 2000
|
| Mrs. Kathy Teal
|
| Vol #:
|
| 28
|
|
|
| EC 2001
|
| Intracom
|
| Vol #:
|
| 29
|
|
|
| EC 2002
|
| Hawaii-PAAM
|
| Vol #:
|
| 29
|
|
|
| EC 2003
|
| Mr. Achille Lalonde
|
| Vol #:
|
| 29
|
|
|
| EC 2004
|
| Ms. L. Manchester
|
| Vol #:
|
| 29
|
|
|
| EC 2005
|
| Mr. Thomas McManus
|
| Vol #:
|
| 29
|
|
|
| EC 2006
|
| Mr. Kevin Ragland
|
| Vol #:
|
| 29
|
|
|
| EC 2007
|
| Mr. Jesus Chargualaf
|
| Vol #:
|
| 29
|
|
|
| EC 2008
|
| Ms. Lori DAmato
|
| Vol #:
|
| 29
|
|
|
| EC 2009
|
| Mrs. Anne Butcher
|
| Vol #:
|
| 29
|
|
|
| EC 2010
|
| Ms. Hazel Matsuda-Begy
|
| Vol #:
|
| 29
|
|
|
| EC 2011
|
| Deep Tissue Spokane
|
| Vol #:
|
| 29
|
|
|
| EC 2012
|
| Dr. Charles Manuel
|
| Vol #:
|
| 29
|
|
|
| EC 2013
|
| Mr. STEVEN TORTI
|
| Vol #:
|
| 29
|
|
|
| EC 2014
|
| Mrs. Nancy Caroll
|
| Vol #:
|
| 29
|
|
|
| EC 2015
|
| Profesional member AMTA
|
| Vol #:
|
| 29
|
|
|
| EC 2016
|
| Dr. Paul Madar
|
| Vol #:
|
| 29
|
|
|
| EC 2017
|
| Mr. C.J. Rafferty
|
| Vol #:
|
| 29
|
|
|
| EC 2018
|
| private consumer
|
| Vol #:
|
| 29
|
|
|
| EC 2019
|
| Ms. Susan Goins
|
| Vol #:
|
| 29
|
|
|
| EC 2020
|
| Mr. Ray Pokorski
|
| Vol #:
|
| 29
|
|
|
| EC 2021
|
| Mrs. Beth Boyer
|
| Vol #:
|
| 29
|
|
|
| EC 2022
|
| Citizen
|
| Vol #:
|
| 29
|
|
|
| EC 2023
|
| none
|
| Vol #:
|
| 29
|
|
| | | | | | | |
|
|
| EC 2024
|
| Mrs. Debbie coutant
|
| Vol #:
|
| 29
|
|
|
| EC 2025
|
| Mrs. Katherine Dewar
|
| Vol #:
|
| 29
|
|
|
| EC 2026
|
| Caring Massage Therapy
|
| Vol #:
|
| 29
|
|
|
| EC 2027
|
| Anti-Aging Clinic Assoc., Inc.
|
| Vol #:
|
| 29
|
|
|
| EC 2028
|
| Ms. Joan Neitzke
|
| Vol #:
|
| 29
|
|
|
| EC 2029
|
| Mrs. Vicki Cowell
|
| Vol #:
|
| 29
|
|
|
| EC 2030
|
| Mr. Charles Brown
|
| Vol #:
|
| 29
|
|
|
| EC 2031
|
| Ms. Sandra Carlos
|
| Vol #:
|
| 29
|
|
|
| EC 2032
|
| Mr. Karl Uhlig
|
| Vol #:
|
| 29
|
|
|
| EC 2033
|
| Mrs. Anna Brewer
|
| Vol #:
|
| 29
|
|
|
| EC 2034
|
| Ms. Mary Latham
|
| Vol #:
|
| 29
|
|
|
| EC 2035
|
| Mr. Kenn Razano
|
| Vol #:
|
| 29
|
|
|
| EC 2036
|
| Ms. W Webb
|
| Vol #:
|
| 29
|
|
|
| EC 2037
|
| Mr. Charles Waldron
|
| Vol #:
|
| 29
|
|
|
| EC 2038
|
| Ms. Jessica Ryder
|
| Vol #:
|
| 29
|
|
|
| EC 2039
|
| Mrs. L. J. Adams
|
| Vol #:
|
| 29
|
|
|
| EC 2040
|
| Mr. John Miksa
|
| Vol #:
|
| 29
|
|
|
| EC 2041
|
| Ms. Gail Duboe
|
| Vol #:
|
| 29
|
|
|
| EC 2042
|
| Ms. Helen Sullivan
|
| Vol #:
|
| 29
|
|
|
| EC 2043
|
| Ms. Angelo Marsico
|
| Vol #:
|
| 29
|
|
|
| EC 2044
|
| Mr. J Scott Dickerson
|
| Vol #:
|
| 29
|
|
|
| EC 2045
|
| Mr. Gonzalo Delgado
|
| Vol #:
|
| 29
|
|
|
| EC 2046
|
| Mr. lance morgan
|
| Vol #:
|
| 29
|
|
|
| EC 2047
|
| Mrs. Linda Frye
|
| Vol #:
|
| 29
|
|
|
| EC 2048
|
| Ms. Becky Kesling
|
| Vol #:
|
| 29
|
|
|
| EC 2049
|
| Mrs. Malda Burns
|
| Vol #:
|
| 29
|
|
|
| EC 2050
|
| Mr. Raymond Carpenter
|
| Vol #:
|
| 29
|
|
|
| EC 2051
|
| Mr. Dana Tavares
|
| Vol #:
|
| 29
|
|
|
| EC 2052
|
| Ms. Marijo Jamie Brown
|
| Vol #:
|
| 29
|
|
|
| EC 2053
|
| ASHA, School of Massage
|
| Vol #:
|
| 29
|
|
|
| EC 2054
|
| Mr. Steven Wilson
|
| Vol #:
|
| 29
|
|
|
| EC 2055
|
| Mr. Ernest Stoller
|
| Vol #:
|
| 29
|
|
|
| EC 2056
|
| The Annie Appleseed Project
|
| Vol #:
|
| 29
|
|
|
| EC 2057
|
| Ms. Meri Walker
|
| Vol #:
|
| 29
|
|
|
| EC 2058
|
| Mrs. Shannon Smith
|
| Vol #:
|
| 29
|
|
|
| EC 2059
|
| Ms. Susan StPeter
|
| Vol #:
|
| 29
|
|
|
| EC 2060
|
| Mrs. Jeanne Bortolotti
|
| Vol #:
|
| 29
|
|
| | | | | | | |
|
|
| EC 2061
|
| The Body Connection
|
| Vol #:
|
| 29
|
|
|
| EC 2062
|
| Dr. sue peck
|
| Vol #:
|
| 29
|
|
|
| EC 2063
|
| Mrs. Marilyn Hilliard
|
| Vol #:
|
| 29
|
|
|
| EC 2064
|
| Window of Hope Ministry
|
| Vol #:
|
| 29
|
|
|
| EC 2065
|
| Ms. Gayle Smith
|
| Vol #:
|
| 29
|
|
|
| EC 2066
|
| AMTA FSMTA ABMP
|
| Vol #:
|
| 29
|
|
|
| EC 2067
|
| personal
|
| Vol #:
|
| 29
|
|
|
| EC 2068
|
| Mr. Eric van der Lelij
|
| Vol #:
|
| 29
|
|
|
| EC 2069
|
| American Massage Therapy Association
|
| Vol #:
|
| 29
|
|
|
| EC 2070
|
| Mr. Scott Buchanan
|
| Vol #:
|
| 29
|
|
|
| EC 2071
|
| Mrs. sandra ISROW
|
| Vol #:
|
| 29
|
|
|
| EC 2072
|
| Mrs. Jerri Rudnick
|
| Vol #:
|
| 29
|
|
|
| EC 2073
|
| none
|
| Vol #:
|
| 29
|
|
|
| EC 2074
|
| Mr. Marc Pritchard
|
| Vol #:
|
| 29
|
|
|
| EC 2075
|
| Nat'l Cert. Massage Therapist and WA State LMP
|
| Vol #:
|
| 29
|
|
|
| EC 2076
|
| none
|
| Vol #:
|
| 29
|
|
|
| EC 2077
|
| Mr. Mirto Capeder
|
| Vol #:
|
| 29
|
|
|
| EC 2078
|
| Mrs. Vicki Cowell
|
| Vol #:
|
| 29
|
|
|
| EC 2079
|
| Ms. michele bonilla
|
| Vol #:
|
| 29
|
|
|
| EC 2080
|
| none
|
| Vol #:
|
| 29
|
|
|
| EC 2081
|
| NCBTMB
|
| Vol #:
|
| 29
|
|
|
| EC 2082
|
| Ms. Jo Bex
|
| Vol #:
|
| 29
|
|
|
| EC 2083
|
| Ms. Karen Scherwood
|
| Vol #:
|
| 29
|
|
|
| EC 2084
|
| Ms. Patricia Osbourn
|
| Vol #:
|
| 29
|
|
|
| EC 2085
|
| Ms. Nancy Pocklington
|
| Vol #:
|
| 29
|
|
|
| EC 2086
|
| Mr. Brandon Grotelueschen
|
| Vol #:
|
| 29
|
|
|
| EC 2087
|
| Mrs. Katie Johanson
|
| Vol #:
|
| 29
|
|
|
| EC 2088
|
| Mrs. Deborah Lindquist
|
| Vol #:
|
| 29
|
|
|
| EC 2089
|
| Ms. nan trees
|
| Vol #:
|
| 29
|
|
|
| EC 2090
|
| Mr. David Pilewskie
|
| Vol #:
|
| 29
|
|
|
| EC 2091
|
| Dr. Alexander Andreyewsky
|
| Vol #:
|
| 29
|
|
|
| EC 2092
|
| Mr. Jason Mumma
|
| Vol #:
|
| 29
|
|
|
| EC 2093
|
| Mrs. Elizabeth Lower
|
| Vol #:
|
| 29
|
|
|
| EC 2094
|
| Mr. Bill Horning
|
| Vol #:
|
| 29
|
|
|
| EC 2095
|
| Mr. Joshua Toben
|
| Vol #:
|
| 29
|
|
|
| EC 2096
|
| Mr. Michael Ivey
|
| Vol #:
|
| 29
|
|
|
| EC 2097
|
| Mr. Douglas Allen
|
| Vol #:
|
| 29
|
|
| | | | | | | | |
|
|
| EC 2098
|
| Mr. Mark Crouse
|
| Vol #:
|
| 29
|
|
|
| EC 2099
|
| Mrs. Shannon Rottinghaus
|
| Vol #:
|
| 29
|
|
|
| EC 2100
|
| Ms. Mel Ting
|
| Vol #:
|
| 29
|
|
|
| EC 2101
|
| Ms. Deborah Ley
|
| Vol #:
|
| 29
|
|
|
| EC 2102
|
| Ms. Janet Ashworth
|
| Vol #:
|
| 29
|
|
|
| EC 2103
|
| Mr. Brian Gleason
|
| Vol #:
|
| 29
|
|
|
| EC 2104
|
| Mr. Roman Libov
|
| Vol #:
|
| 29
|
|
|
| EC 2105
|
| Ms. Roseann Dudrick
|
| Vol #:
|
| 29
|
|
|
| EC 2106
|
| Kaiser Permanente
|
| Vol #:
|
| 29
|
|
|
| EC 2107
|
| conscious Choices
|
| Vol #:
|
| 29
|
|
|
| EC 2108
|
| Ms. Jan Weiss
|
| Vol #:
|
| 29
|
|
|
| EC 2109
|
| Mr. Don Hirth
|
| Vol #:
|
| 29
|
|
|
| EC 2110
|
| Mr. frans offermans
|
| Vol #:
|
| 29
|
|
|
| EC 2111
|
| Mrs. Kelley Fifarek
|
| Vol #:
|
| 29
|
|
|
| EC 2112
|
| Healthy Touch Massage Therapy, LLC
|
| Vol #:
|
| 29
|
|
|
| EC 2113
|
| Ms. Laura Lander
|
| Vol #:
|
| 29
|
|
|
| EC 2114
|
| Mr. Jackson Brown
|
| Vol #:
|
| 29
|
|
|
| EC 2115
|
| Natural Results
|
| Vol #:
|
| 29
|
|
|
| EC 2116
|
| Janis Pulliam, Massage and Wellness
|
| Vol #:
|
| 29
|
|
|
| EC 2117
|
| Mr. Eugene Manley
|
| Vol #:
|
| 29
|
|
|
| EC 2118
|
| IWest Internet Services
|
| Vol #:
|
| 29
|
|
|
| EC 2119
|
| Mr. william floyd
|
| Vol #:
|
| 29
|
|
|
| EC 2120
|
| Dr. John L Lentz
|
| Vol #:
|
| 29
|
|
|
| EC 2121
|
| Mrs. Anne Seals
|
| Vol #:
|
| 29
|
|
|
| EC 2122
|
| Alternative Medicine Products user
|
| Vol #:
|
| 29
|
|
|
| EC 2123
|
| Mrs. Rachel Jimenez
|
| Vol #:
|
| 29
|
|
|
| EC 2124
|
| Ms. Sally Morton
|
| Vol #:
|
| 29
|
|
|
| EC 2125
|
| Mrs. Pattie Campbell
|
| Vol #:
|
| 29
|
|
|
| EC 2126
|
| Mrs. Jerry Rowland
|
| Vol #:
|
| 29
|
|
|
| EC 2127
|
| Ms. Cam Moore
|
| Vol #:
|
| 29
|
|
|
| EC 2128
|
| Mr. Philip Stucker
|
| Vol #:
|
| 29
|
|
|
| EC 2129
|
| Ms. Ariel Hubbard
|
| Vol #:
|
| 29
|
|
|
| EC 2130
|
| Mr. Timothy Hoog
|
| Vol #:
|
| 29
|
|
|
| 2007M-0244
|
| BP060002 /0 Abbott RealTime HIV-1 Amplification Reagent Kit, Abbott RealTime HIV-1 Calibrator Kit, Abbott RealTime HIV-1 Control Kit
|
|
|
| AAV 1
|
| Abbott Molecular, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2007M-0263
|
| BP050069/0 - Roche COBAS AmpliPrep/COBAS TaqManHIV-1 Test, 48 Tests, COBAS AmpliPrep/COBAS Taqman Wash Reagents, 5.1.L
|
|
| | | | | | | | |
|
|
| AAV 1
|
| Roche Molecular Systems, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2007P-0085
|
| Adopt Regulations of General Applicability to all Food Standards that would Permit Deviations from the Requirements of the Individual Food Standards of Identity
|
|
|
| EC 981
|
| Ms. Jeanne Smedes
|
| Vol #:
|
| 11
|
|
|
| EC 982
|
| Mr. Matt Stewart
|
| Vol #:
|
| 11
|
|
|
| EC 983
|
| Mr. Michael Simon
|
| Vol #:
|
| 11
|
|
|
| EC 984
|
| Ms. JoAnne Meyer
|
| Vol #:
|
| 11
|
|
|
| EC 985
|
| Ms. Karalee LaRochelle
|
| Vol #:
|
| 11
|
|
|
| EC 986
|
| Mr. Stephen Dodge
|
| Vol #:
|
| 11
|
|
|
| EC 987
|
| Ms. Sherry Glover
|
| Vol #:
|
| 11
|
|
|
| EC 988
|
| Mr. Michael Cantor
|
| Vol #:
|
| 11
|
|
|
| EC 989
|
| Dr. Charles Smith
|
| Vol #:
|
| 11
|
|
|
| EC 990
|
| don'tmesswithourchocolate.org
|
| Vol #:
|
| 11
|
|
|
| EC 991
|
| Ms. Jessica Reed
|
| Vol #:
|
| 11
|
|
|
| EC 992
|
| Rose's Chocolate Treasures
|
| Vol #:
|
| 11
|
|
|
| EC 993
|
| Ms. Robyn Schwartz
|
| Vol #:
|
| 11
|
|
|
| EC 994
|
| MHSAA
|
| Vol #:
|
| 11
|
|
|
| EC 995
|
| Don't Mess With Our Chocolate
|
| Vol #:
|
| 11
|
|
|
| EC 996
|
| Ms. Kelly O'Ceriann
|
| Vol #:
|
| 11
|
|
|
| EC 997
|
| Mr. Mark Gabel
|
| Vol #:
|
| 11
|
|
|
| EC 998
|
| Ms. olivia lieber
|
| Vol #:
|
| 11
|
|
|
| EC 999
|
| Ms. Alanna McDonald
|
| Vol #:
|
| 11
|
|
|
| EC 1000
|
| Mr. Phil Clawson
|
| Vol #:
|
| 11
|
|
|
| EC 1001
|
| Don't Mess With Our Chocolate
|
| Vol #:
|
| 11
|
|
|
| EC 1002
|
| Mrs. Lillian Schulz
|
| Vol #:
|
| 11
|
|
|
| EC 1003
|
| Ms. Sylvie Shirazi
|
| Vol #:
|
| 11
|
|
|
| EC 1004
|
| Copper Turtle Gourmet Confections
|
| Vol #:
|
| 11
|
|
|
| EC 1005
|
| Don't Mess With Our Chocolate
|
| Vol #:
|
| 11
|
|
|
| EC 1006
|
| Don't Mess with Our Chocolate.
|
| Vol #:
|
| 11
|
|
|
| EC 1007
|
| Ms. Nicole Gauvin
|
| Vol #:
|
| 11
|
|
|
| EC 1008
|
| Ms. Melissa Barna
|
| Vol #:
|
| 11
|
|
|
| EC 1009
|
| Ms. Christina Daub
|
| Vol #:
|
| 11
|
|
|
| EC 1010
|
| Ms. kristin hawkins
|
| Vol #:
|
| 11
|
|
|
| EC 1011
|
| Don't Mess With Our Chocolate
|
| Vol #:
|
| 12
|
|
|
| EC 1012
|
| Don't Mess With Our Chocolate
|
| Vol #:
|
| 12
|
|
|
| EC 1013
|
| Don't Mess With Our Chocolate
|
| Vol #:
|
| 12
|
|
|
| EC 1014
|
| Don't mess with our chocolate
|
| Vol #:
|
| 12
|
|
| | | | | | | | |
|
|
| EC 1015
|
| Ms. Susan Gideon
|
| Vol #:
|
| 12
|
|
|
| EC 1016
|
| Mrs. tami young
|
| Vol #:
|
| 12
|
|
|
| EC 1017
|
| Mr. Thomas Lopez
|
| Vol #:
|
| 12
|
|
|
| EC 1018
|
| Miss. Christina Abood
|
| Vol #:
|
| 12
|
|
|
| EC 1019
|
| Don't Mess with our Chocolate
|
| Vol #:
|
| 12
|
|
|
| EC 1020
|
| Ms. Sarah Hughes
|
| Vol #:
|
| 12
|
|
|
| EC 1021
|
| Miss. Tanya Telson
|
| Vol #:
|
| 12
|
|
|
| EC 1022
|
| Ms. Jennie Ladew
|
| Vol #:
|
| 12
|
|
|
| EC 1023
|
| Ms. b ber
|
| Vol #:
|
| 12
|
|
|
| EC 1024
|
| Mr. joshua moore
|
| Vol #:
|
| 12
|
|
|
| EC 1025
|
| Ms. Catherine Nash
|
| Vol #:
|
| 12
|
|
|
| EC 1026
|
| Don't Mess With Our Chocolate
|
| Vol #:
|
| 12
|
|
|
| EC 1027
|
| Mrs. Rosemary Beddingfield
|
| Vol #:
|
| 12
|
|
|
| EC 1028
|
| Mr. Matthew Lamberti
|
| Vol #:
|
| 12
|
|
|
| EC 1029
|
| Ms. elise perelman
|
| Vol #:
|
| 12
|
|
|
| EC 1030
|
| Mr. Herb Czerwon
|
| Vol #:
|
| 12
|
|
|
| EC 1031
|
| Mrs. Karen Parks
|
| Vol #:
|
| 12
|
|
|
| EC 1032
|
| Ms. Betty Wanderer
|
| Vol #:
|
| 12
|
|
|
| EC 1033
|
| Mr. David Munson
|
| Vol #:
|
| 12
|
|
|
| EC 1034
|
| Don't Mess With Our Chocolate
|
| Vol #:
|
| 12
|
|
|
| EC 1035
|
| Miss. Germaine Cheong
|
| Vol #:
|
| 12
|
|
|
| EC 1036
|
| Ms. Elizabeth Graham
|
| Vol #:
|
| 12
|
|
|
| EC 1037
|
| Ms. Pat Gamsby
|
| Vol #:
|
| 12
|
|
|
| EC 1038
|
| Ms. Janine Paolucci
|
| Vol #:
|
| 12
|
|
|
| EC 1039
|
| FDA
|
| Vol #:
|
| 12
|
|
|
| EC 1040
|
| Raffine, LLC
|
| Vol #:
|
| 12
|
|
|
| 2007P-0273
|
| Request that CDER update
the official drug labels for penicillin G potassium and penicillin G
sodium for injection
|
|
|
| BKG 1
|
| Clinical and Laboratory Standards Institute
|
| Vol #:
|
| 1
|
|
|
| REF 1
|
| Clinical and Laboratory Standards Institute
|
| Vol #:
|
| 2
|
|
|
| 2007P-0274
|
| Request that CDRH allow 510(k) clearance of devices for antimicrobial susceptibility testing of Streptococcus pneumoniae with pencillin
|
|
|
| BKG 1
|
| Clinical and Laboratory Standards Institute
|
| Vol #:
|
| 1
|
|
|
| REF 1
|
| Clinical and Laboratory Standards Institute
|
| Vol #:
|
| 2
|
|
|
| 2007P-0275
|
| to permit an ANDA Suitability for Nabumetone Tablets 1000 mg
|
|
|
| ACK 1
|
| Lachman Consultant Services, Inc
|
| Vol #:
|
| 1
|
|
|
| CP 1
|
| Lachman Consultant Services, Inc
|
| Vol #:
|
| 1
|
|
|