PRODUCT LICENSE APPLICATION FOR THE MANUFACTURE OF REAGENT RED BLOOD CELLS

ICR 198310-0910-007

OMB: 0910-0062

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0062 198310-0910-007
Historical Active 197807-0910-002
HHS/FDA
PRODUCT LICENSE APPLICATION FOR THE MANUFACTURE OF REAGENT RED BLOOD CELLS
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 12/20/1983
Retrieve Notice of Action (NOA) 10/28/1983
  Inventory as of this Action Requested Previously Approved
12/31/1986 12/31/1986
7 0 0
300 0 0
0 0 0

ALL MANUFACTURERS OF BIOLOGICAL PRODUCTS MUST SUBMIT APPLICATIONS FOR REVIEW AND APPROVAL TO THE OFFICE OF BIOLOGICS PRIOR TO MARKETING A PRODUCT. CHANGES TO PREVIOUSLY APPROVED PRODUCTS, I.E., NEW MANUFACTURING PROCEDURES OR NEW LABELING MUST BE REVIEWED AND APPROVED BY THE OFFICE OF BIOLOGICS AND RECORDKEEPING REQUIREMENTS MUST BE COMPILED WITH (21 CFR 600.12).

None
None


No

1
IC Title Form No. Form Name
PRODUCT LICENSE APPLICATION FOR THE MANUFACTURE OF REAGENT RED BLOOD CELLS FD-3086

  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 7 0 0 0 7 0
Annual Time Burden (Hours) 300 0 0 0 300 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.
10/28/1983


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