Abbreviated NDAs & 505(b)(2) Applications; Proposed Revisions to Implement Portions of the Medicare Prescription Drug, Improvement, & Modernization Act of 2003 & Other Changes - Proposed Rule

ICR 201501-0910-016

OMB: 0910-0786

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-02-11
ICR Details
0910-0786 201501-0910-016
Historical Inactive
HHS/FDA CDER
Abbreviated NDAs & 505(b)(2) Applications; Proposed Revisions to Implement Portions of the Medicare Prescription Drug, Improvement, & Modernization Act of 2003 & Other Changes - Proposed Rule
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 05/18/2015
Retrieve Notice of Action (NOA) 02/12/2015
In accordance with 5 CFR 1320, OMB is not approving the collection at this time. Prior to publication of the final rule, the agency should provide a summary of all comments related to the information collection requirements contained in the rule and any changes made in response to these comments.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
0 0 0

The proposed rule would implement portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act 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.

US Code: 42 USC 1305 Name of Law: PHS Act
   Statute at Large: 117 Stat. 2067 Name of Statute: Medicare Prescription Drug, Improvement, and Modernization Act of 2003
   PL: Pub.L. 108 - 173 1(a) Name of Law: MMA
  
None

0910-AF97 Proposed rulemaking 80 FR 6802 02/06/2015

No

Yes
Changing Regulations
No
This is a new data collection.

$212,090,000
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@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.
02/12/2015


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