Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs

ICR 201309-0910-002

OMB: 0910-0646

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-09-09
ICR Details
0910-0646 201309-0910-002
Historical Active 201108-0910-007
HHS/FDA 20461
Applications for Food and Drug Administration Approval to Market a New Drug; Postmarketing Reports; Reporting Information About Authorized Generic Drugs
Extension without change of a currently approved collection   No
Regular
Approved without change 05/23/2014
Retrieve Notice of Action (NOA) 09/12/2013
This collection is approved for 1 year to give FDA time to complete migration of this collection into Form 2252 or another viable alternative that eliminates duplication. See prior terms of clearance.
  Inventory as of this Action Requested Previously Approved
05/31/2015 36 Months From Approved 05/31/2014
1,000 0 1,200
290 0 520
0 0 0

The New Drug Application holders are required to notify the Agency when an authorized generic drug is marketed by clearly including this information in annual reports in an easily accessible place and by sending a copy of the relevant portion of the annual reports to a central office.

None
None

Not associated with rulemaking

  78 FR 27404 05/10/2013
78 FR 54898 09/06/2013
No

  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 1,000 1,200 0 0 -200 0
Annual Time Burden (Hours) 290 520 0 0 -230 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The reduction in burden hours from 520 to 290 is the result of more recent data on the number of submissions.

$0
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  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.
09/12/2013


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