Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components

ICR 200009-0910-012

OMB: 0910-0116

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0116 200009-0910-012
Historical Active 199712-0910-004
HHS/FDA
Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components
Extension without change of a currently approved collection   No
Regular
Approved without change 11/20/2000
Retrieve Notice of Action (NOA) 09/28/2000
  Inventory as of this Action Requested Previously Approved
11/30/2003 11/30/2003 02/28/2001
397 0 42
332,403 0 283,400
0 0 0

The CGMP and related regulations establish accountability and traceability in the processing and handling of blood and blood components and enable FDA to perform meaningful inspections. The recordkeeping requirements serve preventative and remedial purposes, and the reporting requirements inform FDA of any deviations that occur and that may require immediate corrective action. The disclosure requirements identify the various blood and blood components and important properties of the product, demonstrate that the CGMP requirements have been met, and facilitate the tracing of a product back to its original source..

None
None


No

1
IC Title Form No. Form Name
Current Good Manufacturing Practices and Related Regulations for Blood and 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 397 42 0 0 355 0
Annual Time Burden (Hours) 332,403 283,400 0 0 49,003 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.
09/28/2000


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