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 201611-0910-004

OMB: 0910-0513

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Unchanged
Form and Instruction
Unchanged
Justification for No Material/Nonsubstantive Change
2016-11-22
Supporting Statement A
2016-08-25
IC Document Collections
IC ID
Document
Title
Status
6229 Unchanged
179904 Unchanged
ICR Details
0910-0513 201611-0910-004
Historical Active 201608-0910-016
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...
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 11/23/2016
Retrieve Notice of Action (NOA) 11/22/2016
  Inventory as of this Action Requested Previously Approved
09/30/2019 09/30/2019 09/30/2019
1,499 0 1,499
19,780 0 19,780
0 0 0

The information collection supports Form FDA 3542 and 3542a as used by persons submitting new drug applications, abbreviated new drug applications, and supplements to drug applications to the Food and Drug Administration. Respondents to the collection are sponsors of these applications who must submit required patent information. 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(c)(2) Name of Law: THe Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 505(b)(1) Name of Law: The Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 355(b)1 Name of Law: THe Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 505(c)(2) Name of Law: The Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  81 FR 5465 02/02/2016
81 FR 54097 08/15/2016
No

  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 1,499 1,499 0 0 0 0
Annual Time Burden (Hours) 19,780 19,780 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects an increase attributed to an increased number of respondents subject to the submissions.

$0
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.
11/22/2016


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