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FDADocs 5/9/2008 | 0 (0) | 13 | 0 | 0 | English
DEPARTMENT
OF E&ALTH AND HUMAN SERVICES
Public Health Service Food and Drug Administration 5100 Paint Branch Parkway College Park, Maryland 20740
I
APR 1 8 2005
Michael J. O’ Flaherty Olsson, Frank and Weeda, P.C. 1400-16” St., N.W., Suilte 400 Washington, D.C. 20036-2200
Dear Mr. O’ Flaherty: This is to inform you that the notification you s ... more>>
FDADocs 5/9/2008 | 0 (0) | 15 | 0 | 0 | English
Breakout Group 6B Question 1) What components do you agree with? Why? Question 2) What components do you disagree with? Why? • How can you decide on oversight before deciding risk? • Thinking that tolerances should be established by the government? • Focus on significant significance of risks • Flexibility needed? • What are the real priorities? • ... more>>
FDADocs 5/9/2008 | 0 (0) | 15 | 0 | 0 | English
,M “‘W G #
DEPAFiTMltNT
“I
OF HiA$TH
’
AND HUMAN SEItVICES
Public Health Service 8 Food and Drug Administration 5100 Paint Branch Parkway College Park, Maryland 20740 ,
1
s
APR 1 3 2005
I Ivan J. Wasserman Couier Shannon Scott, PLLC Washington Harbour, Suite 400 3050 K St., N W Washington, DC 20007 Dear M r. Wasserman: , ’I
This is to info ... more>>
FDADocs 5/9/2008 | 0 (0) | 11 | 0 | 0 | English
Breakout Group 5B Question 1) Was our explanation of the risk-ranking method understood? How can we improve its clarity? • More no than yes. • Yes, it is clear. • Who are the risk managers? • What do they need or looking for? • Who would it include? Scoring • How do you do this without data? • Bottom up approach o Some concerns • Absence of data o ... more>>
FDADocs 5/9/2008 | 0 (0) | 14 | 0 | 0 | English
Breakout Group 6A - FRAMEWORK COMPONENTS AND HOW CAN AFSS HELP YOU? Question 1) – What components do you agree with? Why? Component #4 • Agree with regulatory oversight because of states’ rights. • Uniformity/consistency among states/across nation. • Provides credibility and continuity to inspections (based on risk). • Prioritization of inspections ... more>>
FDADocs 5/9/2008 | 0 (0) | 25 | 0 | 0 | English
Breakout Group 5A- Risk and Risk-Ranking Method Question 1) Was our explanation of the risk-ranking method understood? How can we improve its clarity? • Will political factors influence the risk-ranking process? • CVM will provide initial risk-ranking, both health & exposure scoring, then open up for public comment. • Environmental factors will not ... more>>
FDADocs 5/9/2008 | 0 (0) | 14 | 0 | 0 | English
Break out Group 3A We have identified one gap for Component #3 of the AFSS.
1. Currently, the FDA has regulations that govern the controls used in the manufacturing, packaging, storage, and use of medicated animal feed. However, to have a comprehensive Animal Feed Safety System (AFSS), a broader regulatory approach may be required to address feed s ... more>>
FDADocs 5/9/2008 | 0 (0) | 14 | 0 | 0 | English
Breakout Group 3B
Identified Gap in Process Controls for the Production of Feed Ingredients and Mixed Feed 1. Currently, the FDA has regulations that govern the controls used in the manufacturing, packaging, storage, and use of medicated animal feed. However, to have a comprehensive Animal Feed Safety System (AFSS), a broader regulatory approach ma ... more>>
FDADocs 5/9/2008 | 0 (0) | 18 | 0 | 0 | English
Breakout Group 1A Question 1) What parts of the definition for comprehensive do you agree with? [There are 8 parts to the draft definition of comprehensive.] With the definition of comprehensive- that it covers the full scope of facilities involved in the production of feed ingredients Part 1) It would apply to the whole range of feed products, inc ... more>>
FDADocs 5/9/2008 | 0 (0) | 14 | 0 | 0 | English
Breakout Group 1B WE AGREE WITH 1, 4, 5, 7, 8. See notes below. Question 1) What parts of the definition for comprehensive do you agree with? Question 2) What parts of the definition for comprehensive do you disagree with? Why? Item 2 –add storage, transportation, and use Item 3—add storage, distribution, transportation and use. Item 6—further defi ... more>>
FDADocs 5/9/2008 | 0 (0) | 16 | 0 | 0 | English
FDADocs 5/9/2008 | 0 (0) | 12 | 0 | 0 | English
FDADocs 5/9/2008 | 0 (0) | 12 | 0 | 0 | English
DEPARTMENT
OF HEALTH & HIMAN
SERVICES
Public Health Service Food and Drug Admiaistration
Date:
From:
Consumer Safety Officer, Division of Dietary Supplement Programs , Office of Nutritional Products, Labeling and Dietary Supplements,HFS-8 10 75-Day Premarket Notification of New Dietary Ingredients Dockets Management &anch, HFA-305 Subject of ... more>>
FDADocs 5/9/2008 | 0 (0) | 31 | 0 | 0 | English
FDADocs 5/9/2008 | 0 (0) | 28 | 0 | 0 | English
United States Patent: 5,667,770
Page 1 of 11
USPTOPATENT
FULL-TEXT AND IMAGE DATABAGE
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-
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United States Patent Szweda, et aI. -
spa7,no September 16,1997
Long wearing fipsfick
Abstract
A lipstick is provided formulated to include a wax and a phytosphingosine type ceramide. The c ... more>>
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