Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions

ICR 201402-0910-004

OMB: 0910-0233

Federal Form Document

Forms and Documents
Supporting Statement A
ICR Details
0910-0233 201402-0910-004
Historical Active 201101-0910-006
HHS/FDA 21436
Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions
Extension without change of a currently approved collection   No
Approved without change 04/21/2014
Retrieve Notice of Action (NOA) 02/19/2014
  Inventory as of this Action Requested Previously Approved
04/30/2017 36 Months From Approved 04/30/2014
3 0 3
160 0 160
0 0 0

Applicants must submit: (1) requests for revision of the regulatory review period under 21 CFR 60.25; (2) due diligence petitions under 21 CFR 60.30; and requests for hearings under 21 CFR 60.40 regarding decisions on the petitions.

US Code: 35 USC 156 Name of Law: Generic Animal Drug and Patent Term Restoration Act of 1988
   US Code: 21 USC 355(j) Name of Law: Drug Price Competition and Patent Term Restoration Act of 1984

Not associated with rulemaking

  78 FR 68454 11/14/2013
78 FR 7678 02/10/2014

  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 3 3 0 0 0 0
Annual Time Burden (Hours) 160 160 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Originally, the ICR submitted three years ago was submitted and/or lumped together as 1 IC, but, in reality there are 3 ICs. The submission of this ICR package will show in Part 2 each IC, and so the number of submissions and respondents under this information collection remains the same.

ILa Mizrachi 301 796-7726 [email protected]


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.

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