GOOD MANUFACTURING PRACTICES FOR BLOOD AND BLOOD COMPONENTS

ICR 198303-0910-011

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
IC ID
Document
Title
Status
109619
Migrated
ICR Details
0910-0116 198303-0910-011
Historical Active 198101-0910-001
HHS/FDA
GOOD MANUFACTURING PRACTICES FOR BLOOD AND BLOOD COMPONENTS
Revision of a currently approved collection   No
Regular
Approved without change 06/07/1983
Retrieve Notice of Action (NOA) 03/09/1983
APPROVED FOR SIX MONTHS. IN REVISING GMP REGULATIONS FOR BLOOD, FDA SHOULD EITHER ADOPT EXISTING RECORDKEEPING REQUIREMENTS ADOPTED BY THE AMERICAN ASSOCIATION OF BLOOD BANKS(AABB) OR EXEMPT AABB MEMBERS FROM THE FDA REQUIREMENTS. ONLY BY CHOOSING ONE OF THESE ALTERNATIVES WILL OMB CONSIDER FDA'S CORRECTION OF BURDEN AS VALID.
  Inventory as of this Action Requested Previously Approved
11/30/1983 11/30/1983 03/31/1983
12,000,040 0 12,000,040
3,000,000 0 3,000,000
0 0 0

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

None
None


No

1
IC Title Form No. Form Name
GOOD MANUFACTURING PRACTICES 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 12,000,040 12,000,040 0 0 0 0
Annual Time Burden (Hours) 3,000,000 3,000,000 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.
03/09/1983


© 2022 OMB.report | Privacy Policy