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

ICR 202004-0910-006

OMB: 0910-0233

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2020-04-27
IC Document Collections
IC ID
Document
Title
Status
5829
Modified
210409
Unchanged
210408
Unchanged
ICR Details
0910-0233 202004-0910-006
Active 201704-0910-002
HHS/FDA CDER
Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions
Extension without change of a currently approved collection   No
Regular
Approved without change 04/29/2020
Retrieve Notice of Action (NOA) 04/27/2020
  Inventory as of this Action Requested Previously Approved
04/30/2023 36 Months From Approved 06/30/2020
18 0 7
594 0 560
0 0 0

This information collection supports regulations in 21 CFR part 60 pertaining to patent term restoration and the submission of requests for revision of the regulatory review period under 21 CFR 60.25; due diligence petitions under 21 CFR 60.30; and requests for hearings under 21 CFR 60.40.

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
  
None

Not associated with rulemaking

  84 FR 43606 08/21/2019
85 FR 3934 01/23/2020
No

3
IC Title Form No. Form Name
Revision of Regulatory Review Period Determinations
Due diligence petitions
Due diligence hearings

  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 18 7 0 0 11 0
Annual Time Burden (Hours) 594 560 0 0 34 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
    Yes
    No
No
No
No
Uncollected
Domini Bean 301 796-5733 domini.bean@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.
04/27/2020


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