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

ICR 201704-0910-002

OMB: 0910-0233

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2017-04-14
IC Document Collections
IC ID
Document
Title
Status
5829
Modified
210409
Modified
210408
Modified
ICR Details
0910-0233 201704-0910-002
Historical Active 201402-0910-004
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 06/27/2017
Retrieve Notice of Action (NOA) 04/25/2017
  Inventory as of this Action Requested Previously Approved
06/30/2020 36 Months From Approved 06/30/2017
7 0 3
560 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
  
None

Not associated with rulemaking

  81 FR 75824 11/01/2016
82 FR 19063 04/25/2017
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 7 3 0 0 4 0
Annual Time Burden (Hours) 560 160 0 0 400 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$1,000
No
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.
04/25/2017


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