Applications for Food and Drug Administration Approval to Market a New Drug; Revision of Postmarketing Reporting Requirements--Discontinuance

ICR 201212-0910-012

OMB: 0910-0699

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2012-12-13
IC Document Collections
IC ID
Document
Title
Status
200543
Modified
200542
Modified
ICR Details
0910-0699 201212-0910-012
Historical Active 201112-0910-005
HHS/FDA
Applications for Food and Drug Administration Approval to Market a New Drug; Revision of Postmarketing Reporting Requirements--Discontinuance
Reinstatement without change of a previously approved collection   No
Regular
Approved without change 02/08/2013
Retrieve Notice of Action (NOA) 12/19/2012
  Inventory as of this Action Requested Previously Approved
02/29/2016 36 Months From Approved
85 0 0
240 0 0
0 0 0

The Food and Drug Administration (FDA) published an interim final rule on December 19, 2011 amending its postmarketing reporting regulations implementing certain provisions of the Federal Food, Drug and Cosmetic Act (FD&C Act). The provisions of the FD&C Act require manufacturers who are the sole manufacturers of certain drug products to notify FDA at least 6 months before discontinuance of manufacture of the products. The interim final rule modified the term "discontinuance" and clarified the term "sole manufacturer" with respect to notification of discontinuance requirements. The broader reporting resulting from these changes will enable FDA to improve its collection and distribution of drug shortage information to physician and patient organizations and to work with manufacturers and other stakeholders to respond to potential drug shortages.

US Code: 21 USC 506C Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

0910-ZA43 Final or interim final rulemaking 76 FR 78530 12/19/2011

  77 FR 45619 08/01/2012
77 FR 72353 12/05/2012
No

2
IC Title Form No. Form Name
Notification of Discontinuance
Certification of Good Cause

  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 85 0 0 0 0 85
Annual Time Burden (Hours) 240 0 0 0 0 240
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
No
No
No
Uncollected
ILa Mizrachi 301 796-7726 [email protected]

  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.
12/19/2012


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