CURRENT GOOD MANUFACTURING PRACTICES FOR FINISHED PHARMACEUTICALS -- 21 CFR 211

ICR 199509-0910-006

OMB: 0910-0139

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0139 199509-0910-006
Historical Active 199209-0910-002
HHS/FDA
CURRENT GOOD MANUFACTURING PRACTICES FOR FINISHED PHARMACEUTICALS -- 21 CFR 211
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 09/30/1995
Retrieve Notice of Action (NOA) 09/30/1995
  Inventory as of this Action Requested Previously Approved
02/29/1996 02/29/1996 11/30/1995
4,700 0 4,700
297,228 0 297,228
0 0 0

THESE RECORDS ARE KEPT BY DRUG MANUFACTURERS IN ORDER TO ASSURE FDA THAT THEY ARE MANUFACTURING FINISHED PHARMACEUTICALS IN ACCORDANCE WITH CURRENT GOOD MANUFACTURING PRACTICES.

None
None


No

1
IC Title Form No. Form Name
CURRENT GOOD MANUFACTURING PRACTICES FOR FINISHED PHARMACEUTICALS -- 21 CFR 211

  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 4,700 4,700 0 0 0 0
Annual Time Burden (Hours) 297,228 297,228 0 0 0 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.
09/30/1995


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