Blood Establishment Registration and Product Listing -- Form FDA 2830

ICR 199912-0910-005

OMB: 0910-0052

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
0910-0052 199912-0910-005
Historical Active 199703-0910-003
HHS/FDA
Blood Establishment Registration and Product Listing -- Form FDA 2830
Extension without change of a currently approved collection   No
Regular
Approved without change 02/15/2000
Retrieve Notice of Action (NOA) 12/20/1999
This collection is approved on the condition that FDA add the OMB number and expiration date to the top right hand corner of FDA form 2830.
  Inventory as of this Action Requested Previously Approved
02/28/2003 02/28/2003 04/30/2000
3,600 0 3,300
1,969 0 1,800
0 0 0

All owners or operators of establishments that engage in the manufacturing of blood products are required to register pursuant to 21 CFR part 607.

None
None


No

1
IC Title Form No. Form Name
Blood Establishment Registration and Product Listing -- Form FDA 2830 2830

  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 3,600 3,300 0 0 300 0
Annual Time Burden (Hours) 1,969 1,800 0 0 169 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.
12/20/1999


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