Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...

ICR 201908-0910-017

OMB: 0910-0513

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Form and Instruction
Modified
Supporting Statement A
2019-09-10
IC Document Collections
IC ID
Document
Title
Status
6229 Modified
179904 Modified
ICR Details
0910-0513 201908-0910-017
Active 201611-0910-004
HHS/FDA CDER
Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-month Stays on Approval of Abbreviated New Drug Applications Certifying That...
Extension without change of a currently approved collection   No
Regular
Approved without change 10/08/2019
Retrieve Notice of Action (NOA) 09/10/2019
  Inventory as of this Action Requested Previously Approved
10/31/2022 36 Months From Approved 10/31/2019
1,454 0 1,499
17,770 0 19,780
1,563,760 0 0

The information collection supports Form FDA 3542 and 3542a as used by new drug application (NDA) holders to submit patent declarations as prescribed by agency regulations. The information collected is required by statue and used by the agency for listing such information in the "Orange Book."

US Code: 21 USC 355 Name of Law: THe Federal Food, Drug, and Cosmetic Act; New Drugs
  
None

Not associated with rulemaking

  84 FR 22858 05/20/2019
84 FR 46735 09/05/2019
No

2
IC Title Form No. Form Name
Form FDA 3542 FDA 3542 Patent Declaration After Filing NDA or Supplement
Form FDA 3542a FDA 3542a Patent Declaration With Filing of NDA or Supplement

  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 1,454 1,499 0 0 -45 0
Annual Time Burden (Hours) 17,770 19,780 0 0 -2,010 0
Annual Cost Burden (Dollars) 1,563,760 0 0 0 1,563,760 0
No
No
The information collection reflects adjustment. Based on fewer submissions we have decreased our cumulative estimate by 45 annual hours and 2,010 responses.

$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.
09/10/2019


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