LICENSE APPLICATIONS FOR THE MFG. OF ALLERGENICS AND PLASMA DERIVATIVES PRODUCTS AND GENERAL ESTABLISHMENT

ICR 198212-0910-001

OMB: 0910-0124

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0124 198212-0910-001
Historical Active 198111-0910-003
HHS/FDA
LICENSE APPLICATIONS FOR THE MFG. OF ALLERGENICS AND PLASMA DERIVATIVES PRODUCTS AND GENERAL ESTABLISHMENT
Revision of a currently approved collection   No
Regular
Approved without change 01/26/1983
Retrieve Notice of Action (NOA) 12/03/1982
  Inventory as of this Action Requested Previously Approved
01/31/1986 01/31/1986 12/31/1982
46 0 57
296 0 342
0 0 0

SECTION 351 OF THE PUBLIC HEALTH SERVICE ACT AND 21 CFR 601.2 REQUIRES ALL MANUFACTURERS OF BIOLOGICAL PRODUCTS TO SUBMIT APPLICATIONS FOR REVIEW AND APPROVAL TO THE BUREAU OF BIOLOGICS PRIOR TO MARKETING A PRODUCT. A SEPARATE LICENSE IS ISSUED TO THE MANUFACTURER FOR EACH APPROVED PRODUCT APPLICATION. THE DATA IS USED TO DETERMINE IF THE MANUFACTURER IS IN COMPLIANCE WITH LICENSE PROVISIONS OF THE REGULA TIONS.

None
None


No

1
IC Title Form No. Form Name
LICENSE APPLICATIONS FOR THE MFG. OF ALLERGENICS AND PLASMA DERIVATIVES PRODUCTS AND GENERAL ESTABLISHMENT FDA 3210, FDA 3213, FDA 3214

  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 46 57 0 0 -11 0
Annual Time Burden (Hours) 296 342 0 0 -46 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.
12/03/1982


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