Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice

ICR 200503-0910-003

OMB: 0910-0563

Federal Form Document

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ICR Details
0910-0563 200503-0910-003
Historical Active
HHS/FDA
Guidance for Industry: Formal Dispute Resolution; Scientific and Technical Issues Related to Pharmaceutical Current Good Manufacturing Practice
New collection (Request for a new OMB Control Number)   No
Regular
Approved with change 05/13/2005
Retrieve Notice of Action (NOA) 03/07/2005
  Inventory as of this Action Requested Previously Approved
05/31/2008 05/31/2008
30 0 0
790 0 0
0 0 0

This guidance was drafted as part of the FDA initiative "Pharmaceutical CGMPs for the 21st Century: A Risk Based Approach," which was announced in August 2002. The initiative focuses on FDA's current CGMP program and covers the manufacture of veterinary and human drugs, including human biological drug products.

None
None


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 30 0 0 30 0 0
Annual Time Burden (Hours) 790 0 0 790 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
03/07/2005


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