NEW DRUG APPLICATION

ICR 198305-0910-001

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
109263 Migrated
ICR Details
0910-0001 198305-0910-001
Historical Active 198206-0910-007
HHS/FDA
NEW DRUG APPLICATION
Extension without change of a currently approved collection   No
Regular
Approved without change 07/21/1983
Retrieve Notice of Action (NOA) 05/26/1983
  Inventory as of this Action Requested Previously Approved
12/31/1983 12/31/1983 05/31/1983
4,500 0 4,500
1,109,174 0 1,109,174
0 0 0

THIS DATA IS SUBMITTED BY DRUG MANUFACTURERS. A NEW DRUG MAY NOT BE BE MARKETED IN THE U.S. UNLESS FDA HAS APPROVED AN APPLICATION FOR IT. THE NEW DRUG APPLICATION FORM FDA 356H DESCRIBES THE CONTENT AND FORMA REQUIREMENTS FOR AN ORIGINAL APPLICATION AND SUPPLEMENTS TO AN APPROVE APPLICATION.

None
None


No

1
IC Title Form No. Form Name
NEW DRUG APPLICATION 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 4,500 4,500 0 0 0 0
Annual Time Burden (Hours) 1,109,174 1,109,174 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.
05/26/1983


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