Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification

ICR 201509-0910-006

OMB: 0910-0806

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-09-17
ICR Details
0910-0806 201509-0910-006
Historical Active
HHS/FDA CDER
Guidance for Industry on Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 12/09/2015
Retrieve Notice of Action (NOA) 09/21/2015
  Inventory as of this Action Requested Previously Approved
12/31/2018 36 Months From Approved
426,160 0 0
86,832 0 0
0 0 0

Manufacturers, repackagers, wholesale distributors, and dispensers must: (1) Notify FDA when they have determined that a product in their possession or control is illegitimate or if a manufacturer when they determine that a product has a high risk of illegitimacy; (2) terminate such notifications after consultation with FDA; (3) notify certain immediate trading partners about an illegitimate product or if a manufacturer about a product with a high risk of illegitimacy; and (4) notify immediate trading partners when such notifications are terminated.

US Code: 21 USC 360eee-1(h)(2) Name of Law: FD&C Act
   PL: Pub.L. 113 - 54 582(h)(2) Name of Law: DSCSA
  
None

Not associated with rulemaking

  79 FR 33564 06/11/2014
80 FR 55364 09/15/2015
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 426,160 0 0 426,160 0 0
Annual Time Burden (Hours) 86,832 0 0 86,832 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Miscellaneous Actions
No
This is a new data collection.

$547,764
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.
09/21/2015


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