Patent Term Restoration

ICR 200409-0910-002

OMB: 0910-0233

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
5829
Migrated
ICR Details
0910-0233 200409-0910-002
Historical Active 200108-0910-003
HHS/FDA
Patent Term Restoration
Extension without change of a currently approved collection   No
Regular
Approved without change 11/08/2004
Retrieve Notice of Action (NOA) 09/10/2004
  Inventory as of this Action Requested Previously Approved
11/30/2007 11/30/2007 11/30/2004
9 0 1
800 0 100
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."

None
None


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 9 1 0 8 0 0
Annual Time Burden (Hours) 800 100 0 700 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
09/10/2004


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