GOOD MANUFACTURING PRACTICES FOR BLOOD NAND BLOOD COMPONENTS

ICR 198101-0910-001

OMB: 0910-0116

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
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ICR Details
0910-0116 198101-0910-001
Historical Active
HHS/FDA
GOOD MANUFACTURING PRACTICES FOR BLOOD NAND BLOOD COMPONENTS
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 03/23/1981
Retrieve Notice of Action (NOA) 01/08/1981
  Inventory as of this Action Requested Previously Approved
03/31/1983 03/31/1983
12,000,040 0 0
3,000,000 0 0
0 0 0

THE GMP REGULATIONS FOR THE COLLECTION, PROCESSING, AND STORAGE OF BLOOD AND BLOOD COMPONENTS ARE INTENDED TO MINIMIZE THE DANGERS OF HEPATITIS IN BLOOD-BASED THERAPY AND TO ASSURE THE PRODUCTION OF BLOOD AND BLOOD COMPONENTS OF UNIFORM HIGH QUALITY.

None
None


No

1
IC Title Form No. Form Name
GOOD MANUFACTURING PRACTICES FOR BLOOD NAND BLOOD COMPONENTS

  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 12,000,040 0 0 12,000,040 0 0
Annual Time Burden (Hours) 3,000,000 0 0 3,000,000 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.
01/08/1981


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