GOOD LABORATORY PRACTICE REGULATIONS FOR NONCLINICAL LABORATORY STUDIES -- 21 CFR PART 58

ICR 199207-0910-002

OMB: 0910-0119

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
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ICR Details
0910-0119 199207-0910-002
Historical Active 198805-0910-005
HHS/FDA
GOOD LABORATORY PRACTICE REGULATIONS FOR NONCLINICAL LABORATORY STUDIES -- 21 CFR PART 58
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 09/03/1992
Retrieve Notice of Action (NOA) 07/16/1992
  Inventory as of this Action Requested Previously Approved
09/30/1995 09/30/1995
24,100 0 0
755,800 0 0
0 0 0

THE GLP REGULATIONS ARE INTENDED TO ASSURE THE QUALITY AND INTEGRITY O THE SAFETY DATA SUBMITTED TO FDA IN SUPPORT OF THE APPROVAL OF REGULAT PRODUCTS. THE REQUIRED INFORMATION WILL HELP ASSURE THAT ONLY SAFE PRODUCTS ARE APPROVED FOR MARKETING.

None
None


No

1
IC Title Form No. Form Name
GOOD LABORATORY PRACTICE REGULATIONS FOR NONCLINICAL LABORATORY STUDIES -- 21 CFR PART 58

  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 24,100 0 0 24,100 0 0
Annual Time Burden (Hours) 755,800 0 0 755,800 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.
07/16/1992


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