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

ICR 201507-0910-006

OMB: 0910-0759

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-07-14
ICR Details
0910-0759 201507-0910-006
Historical Active 201312-0910-003
HHS/FDA 20991
Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products; Final Rule
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 09/30/2015
Retrieve Notice of Action (NOA) 07/15/2015
  Inventory as of this Action Requested Previously Approved
09/30/2018 36 Months From Approved
225 0 0
450 0 0
0 0 0

The final rule requires all applicants of covered approved drugs or biological products and all manufacturers of covered 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 of the product in the United States. Covered drugs include those that are life supporting, life sustaining, or intended for use in the prevention or treatment of a debilitating disease or condition, including any such drug used in emergency medical care or during surgery; and that are not radiopharmaceutical products. The requirements in §§ 310.306, 314.81(b)(3)(iii), and 600.82 as added or amended by the final rule are designed to implement sections 506C and 506E of the Federal Food, Drug, and Cosmetic Act as required by Congress in the Food and Drug Administration Safety and Innovation Act.

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

0910-AG88 Final or interim final rulemaking 80 FR 38915 07/08/2015

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 225 0 0 225 0 0
Annual Time Burden (Hours) 450 0 0 450 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
No
This is a new approval request. The total burden hours for the final rule is unchanged from the November 4, 2013, proposed rule.

$441,000
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.
07/15/2015


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