GOOD MANUFACTURING PRACTICES FOR BLOOD AND BLOOD COMPONENTS - 21 CFR PART 606

ICR 198408-0910-009

OMB: 0910-0116

Federal Form Document

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Name
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ICR Details
0910-0116 198408-0910-009
Historical Active 198311-0910-006
HHS/FDA
GOOD MANUFACTURING PRACTICES FOR BLOOD AND BLOOD COMPONENTS - 21 CFR PART 606
Revision of a currently approved collection   No
Regular
Approved without change 11/26/1984
Retrieve Notice of Action (NOA) 08/28/1984
This information collection is approved through 12/85 to allow FDA time to complete the rulemaking procedure required by the 111/26/84 letter from James B. MacRae Jr. to Wallace Keene, Acting Deputy Assistant Secretary.
  Inventory as of this Action Requested Previously Approved
12/31/1985 12/31/1985 08/31/1984
2,060 0 2,060
3,000,000 0 3,000,040
0 0 0

THE GOOD MANUFACTURING PRACTICES 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 AND BLOOD COMPONENTS - 21 CFR PART 606

  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 2,060 2,060 0 0 0 0
Annual Time Burden (Hours) 3,000,000 3,000,040 0 -40 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes

$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.
08/28/1984


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