HEPATITIS REQUIREMENTS TO PERMIT SHIPMENT BEFORE COMPLETION OF HEPATITIS B SURFACE ANTIGEN TESTING

ICR 198505-0910-003

OMB: 0910-0168

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0168 198505-0910-003
Historical Active 198310-0910-002
HHS/FDA
HEPATITIS REQUIREMENTS TO PERMIT SHIPMENT BEFORE COMPLETION OF HEPATITIS B SURFACE ANTIGEN TESTING
No material or nonsubstantive change to a currently approved collection   No
Emergency 05/17/1985
Approved with change 05/17/1985
Retrieve Notice of Action (NOA) 05/17/1985
  Inventory as of this Action Requested Previously Approved
12/31/1986 12/31/1986 12/31/1986
1 0 1
50 0 1
0 0 0

FDA IS PROPOSINT TO AMEND ITS BIOLOGICS REGULATIONS TO PERMIT SHIPMENT OF ANY BLOOD PRODUCT FOR FURTHER MANUFACTURING, SUCH AS SOURCE LEUKOCYTES FOR MAKING INTERFERON, BEFORE THE TEST FOR HEPATITIS B SURFACE ANTIGEN IS COMPLETED AND THE TEST RESULTS ARE RECEIVED BY THE COLLECTION FACILITY.

None
None


No

1
IC Title Form No. Form Name
HEPATITIS REQUIREMENTS TO PERMIT SHIPMENT BEFORE COMPLETION OF HEPATITIS B SURFACE ANTIGEN TESTING

  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 1 1 0 0 0 0
Annual Time Burden (Hours) 50 1 0 49 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.
05/17/1985


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