General Licensing Provisions; Section 351(k) Biosimilar Applications

ICR 201507-0910-001

OMB: 0910-0719

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-07-06
ICR Details
0910-0719 201507-0910-001
Historical Active 201206-0910-004
HHS/FDA CDER
General Licensing Provisions; Section 351(k) Biosimilar Applications
Extension without change of a currently approved collection   No
Regular
Approved without change 12/09/2015
Retrieve Notice of Action (NOA) 07/08/2015
  Inventory as of this Action Requested Previously Approved
12/31/2018 36 Months From Approved 12/31/2015
12 0 5
6,030 0 2,584
0 0 0

The information collection establishes an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product, and sets forth the requirements for an application for a proposed biosimilar product and an application or a supplement for a proposed interchangeable product. The information submitted in a 351(k) application or supplement is used by FDA to make a determination of biosimilarity or interchangeability of a proposed 351(k) product.

US Code: 42 USC 262(k) Name of Law: Public Health Service Act
  
None

Not associated with rulemaking

  80 FR 5761 02/03/2015
80 FR 37635 07/01/2015
Yes

  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 12 5 0 0 7 0
Annual Time Burden (Hours) 6,030 2,584 0 0 3,446 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$12,482,982
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.
07/08/2015


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