Patent Term Restoration

ICR 200711-0910-005

OMB: 0910-0233

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2007-10-18
IC Document Collections
IC ID
Document
Title
Status
5829
Modified
ICR Details
0910-0233 200711-0910-005
Historical Active 200409-0910-002
HHS/FDA
Patent Term Restoration
Extension without change of a currently approved collection   No
Regular
Approved without change 01/02/2008
Retrieve Notice of Action (NOA) 11/20/2007
  Inventory as of this Action Requested Previously Approved
01/31/2011 36 Months From Approved 12/31/2007
11 0 9
1,000 0 800
0 0 0

The information collection deals with FDA's patent term restoration regulations on due diligence petitions for regulatory review period revision. When a patented product must receive FDA approval before marketing is permitted, the Patent and Trademark Office (PTO) may add a portion of FDA's review time to the term of a patent. Petitioners may request reductions in the regulatory review time if FDA marketing approval was not pursued with "due diligence."

US Code: 35 USC 156 Name of Law: Extention of patent term
  
None

Not associated with rulemaking

  72 FR 37242 07/09/2007
72 FR 57950 10/11/2007
No

1
IC Title Form No. Form Name
Patent Term Restoration

  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 11 9 0 0 2 0
Annual Time Burden (Hours) 1,000 800 0 0 200 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Eliazabeth Berbakos 3018271482

  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.
11/19/2007


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