Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution

ICR 201406-0910-009

OMB: 0910-0045

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2014-06-18
ICR Details
0910-0045 201406-0910-009
Historical Active 201203-0910-007
HHS/FDA CDER
Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution
Revision of a currently approved collection   No
Regular
Approved without change 08/29/2014
Retrieve Notice of Action (NOA) 06/23/2014
FDA is reminded to submit collections as "extensions" when they do not include changes. Also, prior terms remain in effect: This approval does not extend to those provisions proposed in the August 29, 2006 NPRM (71 Fed. Reg. 51276). When that rule is finalized, FDA must submit those changes for approval before they go into effect.
  Inventory as of this Action Requested Previously Approved
08/31/2017 36 Months From Approved 08/31/2015
45,168 0 45,168
227,222 0 227,222
0 0 0

Sections 701 and 702 of FDASIA direct the Secretary to specify a UFI system for registration of domestic and foreign drug establishments, and that each initial and annual drug establishment registration include a UFI. The "Guidance for Industry on Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration" specifies that FDA's preferred UFI for a drug establishment is the DUNS number. The DUNS number is available free of charge to all drug establishments. As explained in the guidance, however, if a company wants to use an alternative UFI for its drug establishment, it may contact FDA.

PL: Pub.L. 110 - 85 510(p) Name of Law: FDAAA
  
None

Not associated with rulemaking

  78 FR 54899 09/06/2013
79 FR 33756 06/12/2014
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 45,168 45,168 0 0 0 0
Annual Time Burden (Hours) 227,222 227,222 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$4,800,000
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.
06/23/2014


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