ESTABLISHMENT LICENSE APPLICATION AND SUPPLEMENTAL LICENSE APPLICATION FOR THE MANUFACTURE OF BLOOD AND BLOOD COMPONENTS

ICR 198605-0910-003

OMB: 0910-0041

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0041 198605-0910-003
Historical Active 198306-0910-001
HHS/FDA
ESTABLISHMENT LICENSE APPLICATION AND SUPPLEMENTAL LICENSE APPLICATION FOR THE MANUFACTURE OF BLOOD AND BLOOD COMPONENTS
Revision of a currently approved collection   No
Regular
Approved without change 07/09/1986
Retrieve Notice of Action (NOA) 05/23/1986
  Inventory as of this Action Requested Previously Approved
07/31/1989 07/31/1989 06/30/1986
235 0 195
513 0 152
0 0 0

THESE REPORTS ARE MAINTAINED BY SECTION 351 OF THE PHS ACT, THE FEDERAL FOOD, DRUG AND COSMETIC ACT, SECTION 502 AND 505 AND TITLE 21 CFR PART 600--"NO LICENSES MAY BE GRANTED UNLESS THIS COMPLETED APPLICATION HAS BEEN RECEIVED". REGULATIONS.

None
None


No

1
IC Title Form No. Form Name
ESTABLISHMENT LICENSE APPLICATION AND SUPPLEMENTAL LICENSE APPLICATION FOR THE MANUFACTURE OF BLOOD AND BLOOD COMPONENTS FDA 2599, 2599A

  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 235 195 0 0 40 0
Annual Time Burden (Hours) 513 152 0 0 361 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.
05/23/1986


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