Applications for FDA Approval to Market a New Drug -- Part 314

ICR 200201-0910-011

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
ICR Details
0910-0001 200201-0910-011
Historical Active 199809-0910-006
HHS/FDA
Applications for FDA Approval to Market a New Drug -- Part 314
Extension without change of a currently approved collection   No
Regular
Approved without change 03/29/2002
Retrieve Notice of Action (NOA) 01/25/2002
Approved consistent with revised table for question 15 attached. FDA shall submit the forms newly consolidated under this collection with the 0910-0001 number on them by the end of April for OMB's docket. Finally follow-up questions have been submitted to FDA (see attaced) to which FDA will respond by 4-5-02.
  Inventory as of this Action Requested Previously Approved
03/31/2005 03/31/2005 03/31/2002
20,360 0 21,200
1,984,003 0 2,121,270
0 0 0

Information collection from applicants who apply for approval of a new drug application in order to market or to continue to market a drug.

None
None


No

1
IC Title Form No. Form Name
Applications for FDA Approval to Market a New Drug -- Part 314

  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 20,360 21,200 0 0 -840 0
Annual Time Burden (Hours) 1,984,003 2,121,270 0 0 -137,267 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.
01/25/2002


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