Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition

ICR 200605-0910-003

OMB: 0910-0439

Federal Form Document

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ICR Details
0910-0439 200605-0910-003
Historical Active 200304-0910-007
Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition
Extension without change of a currently approved collection   No
Approved without change 07/14/2006
Retrieve Notice of Action (NOA) 05/30/2006
Please note that since the last submission three years ago, the F DA has ammended its regulation regarding labeling requirements fo r aluminum content in LVPs, SVPs and PBPs used in TPN. The final rule was effective on Jul 26, 2004, and since then, FDA expects to receive significantly fewer submissions per year, which has be en reflected in the significant decrease in respondents and burde n hours. If additional changes are made resulting in a change in burden hours, the FDA can submit the changes using an 83-C.
  Inventory as of this Action Requested Previously Approved
07/31/2009 07/31/2009 07/31/2006
10 0 265
140 0 3,710
0 0 0

FDA regulations specify labeling requirements for the aluminum content in LVPs and PBP's used in TPN. An upper limit of aluminum is permitted in LVPs and applicants must submit to FDA validated assay methods for determining aluminum content in parenteral drug products.



IC Title Form No. Form Name
Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition

  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 10 265 0 0 -255 0
Annual Time Burden (Hours) 140 3,710 0 0 -3,570 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0



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    (ii) Use of information;
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