PRODUCT LICENSE APPLICATION FOR THE MANUFACTURERS OF WHOLE BLOOD AND BLOOD COMPONENTS

ICR 198204-0910-005

OMB: 0910-0077

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0077 198204-0910-005
Historical Active 198004-0910-006
HHS/FDA
PRODUCT LICENSE APPLICATION FOR THE MANUFACTURERS OF WHOLE BLOOD AND BLOOD COMPONENTS
Revision of a currently approved collection   No
Regular
Approved without change 06/07/1982
Retrieve Notice of Action (NOA) 04/08/1982
  Inventory as of this Action Requested Previously Approved
05/31/1984 05/31/1984 05/31/1982
84 0 84
69 0 63
0 0 0

IN ACCORDANCE WITH SECTION 351 OF THE PHS ACT AND TITLE 21CFR SECTION 601.2 ALL MANUFACTURERS OF BIOLOGICAL PRODUCTS MUST SUBMIT APPLICATION FOR REVIEW AND APPROVAL TO THE BUREAU OF BIOLOGICS PRIOR TO MARKETING A PRODUCT. FORM FD 3098 IS COMPLETED BY ALL MANUFACTURERS OF WHOLE BLOOD AND BLOOD COMPONENTS WHEN APPLYING FOR A LICENSE FOR A NEW PRODUCT OR WHEN UPDATING INFORMATION ON AN ALREADY LICENSED PRODUCT.

None
None


No

1
IC Title Form No. Form Name
PRODUCT LICENSE APPLICATION FOR THE MANUFACTURERS OF WHOLE BLOOD AND BLOOD COMPONENTS FDA 3098, 3098A, 3098B, 3098C, 3098D, 3098E

  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 84 84 0 0 0 0
Annual Time Burden (Hours) 69 63 0 0 6 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.
04/08/1982


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