HEPATITIS REPORTING REQUIREMENTS -- 21 CFR 610

ICR 199208-0910-007

OMB: 0910-0168

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
109761
Migrated
ICR Details
0910-0168 199208-0910-007
Historical Active 198907-0910-007
HHS/FDA
HEPATITIS REPORTING REQUIREMENTS -- 21 CFR 610
Revision of a currently approved collection   No
Regular
Approved without change 11/09/1992
Retrieve Notice of Action (NOA) 08/26/1992
  Inventory as of this Action Requested Previously Approved
11/30/1995 11/30/1995 01/31/1993
92 0 10
46 0 60
0 0 0

INFORMATION IS NEEDED TO MONITOR AND LICENSE SHIPMENT OF HEPATITIS REACTIVE PRODUCTS AND TO MONITOR EMERGENCY SHIPMENT OF REACTIVE OR POTENTIALLY REACTIVE PRODUCTS FOR THE PURPOSE OF PROTECTING THE PUBLIC FROM THE HIGHLY CONTAGIOUS HEPATITIS VIRUS.

None
None


No

1
IC Title Form No. Form Name
HEPATITIS REPORTING REQUIREMENTS -- 21 CFR 610

  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 92 10 0 82 0 0
Annual Time Burden (Hours) 46 60 0 -14 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.
08/26/1992


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