DRUGS FOR HUMAN USE

ICR 197705-0910-006

OMB: 0910-0001

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
109260 Migrated
ICR Details
0910-0001 197705-0910-006
Historical Active
HHS/FDA
DRUGS FOR HUMAN USE
Extension without change of a currently approved collection   No
Regular
Approved without change 05/26/1977
Retrieve Notice of Action (NOA) 05/23/1977
  Inventory as of this Action Requested Previously Approved
05/31/1982 05/31/1982
700 0 0
8,400 0 0
0 0 0

THE NEW DRUG APPLICATION IS SUBMITTED BY FIRMS TO REQUEST APPROVAL OF A DRUG FOR DISTRIBUTION IN INTERSTATE COMMERCE. THE INFORMATION SUBMITTED IS EVALUATED TO DETERMINE THE SAFETY AND EFFICACY OF THE DRUG, THE ADEQUACY OF DIRECTIONS FOR USE AND WARNINGS AGAINST MISUSES APPEARING IN THE PROPOSED LABELING, THE COMPLETENESS OF CLINICAL EXPERIENCE AND THE ADEQUACY OF CONTROLS USED IN THE MANUFACTURE OF DRUG

None
None


No

1
IC Title Form No. Form Name
DRUGS FOR HUMAN USE FD-356H

  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 700 0 0 0 700 0
Annual Time Burden (Hours) 8,400 0 0 0 8,400 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.
05/23/1977


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