REPORTING REQUIREMENTS APPLICABLE TO NORMAL SERUM ALBUMIN AND PLASMA PROTEIN FRACTION

ICR 198310-0910-006

OMB: 0910-0155

Federal Form Document

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ICR Details
0910-0155 198310-0910-006
Historical Active 198302-0910-002
HHS/FDA
REPORTING REQUIREMENTS APPLICABLE TO NORMAL SERUM ALBUMIN AND PLASMA PROTEIN FRACTION
Extension without change of a currently approved collection   No
Regular
Approved without change 12/19/1983
Retrieve Notice of Action (NOA) 10/27/1983
  Inventory as of this Action Requested Previously Approved
07/31/1984 07/31/1984 10/31/1983
1,640 0 1,640
13,120 0 13,120
0 0 0

SECTIONS 640.85 AND 640.95 REQUIRE THE REPORTING OF INFORMATION ON EACH LOT OF NORMAL SERUM ALBUMIN AND PLASMA PROTEIN FACTION FOR FDA TESTING, EVALUATION, AND OFFICIAL RELEASE PRIOR TO DISBRIBUTION OF THE LOT BY THE MANUFACTURER. THIS INFORMATION IS USED TO ENSURE THE SAFETY OF THOSE USING THESE PRODUCTS.

None
None


No

1
IC Title Form No. Form Name
REPORTING REQUIREMENTS APPLICABLE TO NORMAL SERUM ALBUMIN AND PLASMA PROTEIN FRACTION

  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 1,640 1,640 0 0 0 0
Annual Time Burden (Hours) 13,120 13,120 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
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.
10/27/1983


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