Salmonella Discovery System Pilot Study

ICR 200207-0910-004

OMB: 0910-0493

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
6198
Migrated
ICR Details
0910-0493 200207-0910-004
Historical Active
HHS/FDA
Salmonella Discovery System Pilot Study
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 09/20/2002
Retrieve Notice of Action (NOA) 07/30/2002
Approved consistent with FDA memo of 9-11-02 including reestimate of burden to 80 hours per respondent.
  Inventory as of this Action Requested Previously Approved
09/30/2005 09/30/2005
12 0 0
960 0 0
0 0 0

We have developed new MCASE quantitative structure activity relationship expert system (MCASE-ES) modules that predict the mutagenic response, mutagenic potency, and mechanism of mutagenesis of test chemicals in Salmonella typhimurium. This system produces mutagenicity predictions with high specificity and predictive value by basing positive predictions only on significant, structurally similar mutagenicity alerts that had been detected by two or more Salmonella tester strain modules. We prepared a total of sixteen different MCASE-ES modules, five using data from tests done with no exogenous.....

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1
IC Title Form No. Form Name
Salmonella Discovery System Pilot Study

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 12 0 0 12 0 0
Annual Time Burden (Hours) 960 0 0 960 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
07/30/2002


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