Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products; Proposed Rule

ICR 201312-0910-003

OMB: 0910-0759

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2013-11-26
IC Document Collections
ICR Details
0910-0759 201312-0910-003
Historical Inactive
HHS/FDA 20991
Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products; Proposed Rule
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 01/27/2014
Retrieve Notice of Action (NOA) 12/10/2013
In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify 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 Food and Drug Administration is requesting OMB approval of information collection activities resulting from regulations at 21 CFR section 310.306, 314.81(b)(3)(iii), 314.92, and 600.82 as amended by the attached proposed rule, implementing section 506C and 506E of the Federal Food, Drug and Cosmetic Act. The proposed rule would require all applicants of covered, approved prescription drug or biological products, certain applicants of blood or blood compoents for transfusion, and all manufacturers of covered prescription drugs marketed without an approved application, to notify FDA electronically of a permanent discontinuance or an interruption in manufacturing of the product that is likely to lead to a meaningful disruption in supply (significant disruption in supply for blood or blood components) of the product in the United States. The proposed rule would also require applicants and unapproved drug manufacturers to respond to any non-compliance letters issued for failure to comply with the proposed rule.

PL: Pub.L. 112 - 144 506C&506E Name of Law: Food and Drug Administration Safety and Innovation Act
  
None

0910-AG88 Proposed rulemaking 78 FR 65904 11/04/2013

No

1
IC Title Form No. Form Name
Notifications required under proposed section 310.306, 314.81(b)(3)(iii) and 600.82

Yes
Miscellaneous Actions
No
This is a new approval request.

$6,600,000
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.
12/10/2013


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