PRODUCT LICENSE APPLICATION FOR THE MANUFACTURE OF BLOOD GROUPING SERUM

ICR 198112-0910-003

OMB: 0910-0061

Federal Form Document

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Document
Name
Status
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IC Document Collections
ICR Details
0910-0061 198112-0910-003
Historical Active 197712-0910-001
HHS/FDA
PRODUCT LICENSE APPLICATION FOR THE MANUFACTURE OF BLOOD GROUPING SERUM
Revision of a currently approved collection   No
Regular
Approved without change 12/22/1981
Retrieve Notice of Action (NOA) 12/01/1981
  Inventory as of this Action Requested Previously Approved
12/31/1984 12/31/1984 12/31/1981
10 0 40
30 0 40
0 0 0

SECTION 351 OF THE PUBLIC HEALTH SERVICE ACT AND 21 CFR 601.2 REQUIRES UFACTURERS OF BIOLOGICAL PRODUCTS TO SUBMIT APPLICATIONS FOR REVIEW AND APPROVAL TO THE BUREAU OF BIOLOGICS PRIOR TO MARKETING PRODUCT. FORM FD 3066 IS USED BY ALL MANUFACTURERS OF BLOOD GROUPING SERA WHEN APPLYING FOR A LICENSE FOR A NEW PRODUCT OR WHEN UPDATING INFORMATION (CHANGES IN MANUFACTURING PROCEDURES, LABELING, ETC.) ON AN ALREADY LICENSED PRODUCT.

None
None


No

1
IC Title Form No. Form Name
PRODUCT LICENSE APPLICATION FOR THE MANUFACTURE OF BLOOD GROUPING SERUM FDA 3066

  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 10 40 0 0 -30 0
Annual Time Burden (Hours) 30 40 0 0 -10 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.
12/01/1981


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