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

ICR 200304-0910-007

OMB: 0910-0439

Federal Form Document

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ICR Details
0910-0439 200304-0910-007
Historical Active 200002-0910-003
Aluminum in Large and Small Volume Parenterals Used in Total Parenteral Nutrition
Extension without change of a currently approved collection   No
Approved without change 06/19/2003
Retrieve Notice of Action (NOA) 04/30/2003
  Inventory as of this Action Requested Previously Approved
07/31/2006 07/31/2006 06/30/2003
265 0 265
3,710 0 3,710
0 0 0

FDA is renewing its regulations to add certain labeling requirements concerning aluminum in LVP's and SVP's use in TPN. FDA also specifies an upper limit to aluminum permitted in LVP's and to require applicants and manufacturers to develop and to submit to FDA for approval validated assay methods for determining aluminum content in parenteral drug products. The added these requirements because of evidence linking the use of parenteral drug products containing aluminum to morbidity and mortality among patients in TPN therapy especially among premature neonates and patients with impaired kidney function.



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 265 265 0 0 0 0
Annual Time Burden (Hours) 3,710 3,710 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0



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    (ii) Use of information;
    (iii) Burden estimate;
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    (vi) Need to display currently valid OMB control number;
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