Abbreviated New Drug Applications and 505(b)(2) Applications

ICR 201610-0910-001

OMB: 0910-0786

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supplementary Document
2016-10-06
Supporting Statement A
2016-10-06
ICR Details
0910-0786 201610-0910-001
Historical Active 201501-0910-016
HHS/FDA CDER
Abbreviated New Drug Applications and 505(b)(2) Applications
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 11/21/2016
Retrieve Notice of Action (NOA) 10/06/2016
  Inventory as of this Action Requested Previously Approved
11/30/2019 36 Months From Approved
2,153 0 0
2,789 0 0
0 0 0

This information collection supports agency rulemaking that implements portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act. Specifically, those portions that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or abbreviated new drug applications (ANDAs); the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. Respondents to this collection of information are NDA applicants (including 505(b)(2) applicants) and ANDA applicants, patent owners, and their representatives.

US Code: 21 USC 355 Name of Law: FFDCA; New Drugs
  
PL: Pub.L. 108 - 173 Title XI Name of Law: Medicare Prescription Drug, Improvement, and Modernization Act of 2003

0910-AF97 Final or interim final rulemaking 81 FR 69580 10/06/2016

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 2,153 0 0 2,153 0 0
Annual Time Burden (Hours) 2,789 0 0 2,789 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
No
This is a new information collection in support of agency rulemaking.

$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.
10/06/2016


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