RECORDKEEPING REQUIREMENTS FOR EXEMPTION FROM FDA APPROVAL FOR NEW DRUGS USED IN NONHUMAN RESEARCH

ICR 198303-0910-008

OMB: 0910-0135

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0135 198303-0910-008
Historical Active 198110-0910-001
HHS/FDA
RECORDKEEPING REQUIREMENTS FOR EXEMPTION FROM FDA APPROVAL FOR NEW DRUGS USED IN NONHUMAN RESEARCH
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 04/28/1983
Retrieve Notice of Action (NOA) 03/16/1983
  Inventory as of this Action Requested Previously Approved
03/31/1986 03/31/1986
120 0 0
6,000 0 0
0 0 0

THIS ALLOWS FDA TO EXEMPT FROM APPROVAL THOSE DRUGS SHIPPED INTERSTATE FOR USE IN NONHUMAN LABORATORY RESEARCH. TO ENABLE FDA TO MONITOR AND ENFORCE THIS EXEMPTION, MANUFACTURERS ARE REQUIRED TO KEEP RECORDS OF WHERE SUCH DRUGS ARE SHIPPED.

None
None


No

1
IC Title Form No. Form Name
RECORDKEEPING REQUIREMENTS FOR EXEMPTION FROM FDA APPROVAL FOR NEW DRUGS USED IN NONHUMAN RESEARCH

  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 120 0 0 0 120 0
Annual Time Burden (Hours) 6,000 0 0 0 6,000 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
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.
03/16/1983


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