ESTABLISHMENT AND PRODUCT APPLICATIONS FOR LICENSE FOR THE MANUFACTURE OF BIOLOGICAL ALLERGENIC AND PLASMA DERIVATIVE PRODUCTS, BLOOD AND BLOOD COMPONENTS

ICR 199009-0910-003

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 199009-0910-003
Historical Active 198601-0910-003
HHS/FDA
ESTABLISHMENT AND PRODUCT APPLICATIONS FOR LICENSE FOR THE MANUFACTURE OF BIOLOGICAL ALLERGENIC AND PLASMA DERIVATIVE PRODUCTS, BLOOD AND BLOOD COMPONENTS
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 11/27/1990
Retrieve Notice of Action (NOA) 09/04/1990
This information collection is approved for use until May 31, 1992. In its next submission, FDA should explain its progress toward the computerization of the submission of licensing information and an evaluation of the effect improved technology would have on reporting and recordkeeping burdens.
  Inventory as of this Action Requested Previously Approved
05/31/1992 05/31/1992
1,113 0 0
83,661 0 0
0 0 0

SECTION 351, PHS ACT AND 21 CFR 601.2 REQUIRES ALL MANUFACTURERS OF BIOLOGICAL PRODUCTS TO SUBM APPLICATIONS FOR REVIEW AND APPROVAL TO FDA 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

None
None


No

1
IC Title Form No. Form Name
ESTABLISHMENT AND PRODUCT APPLICATIONS FOR LICENSE FOR THE MANUFACTURE OF BIOLOGICAL ALLERGENIC AND PLASMA DERIVATIVE PRODUCTS, BLOOD AND BLOOD COMPONENTS FDA-2599, 2599A, 2600, 2600B, 3066, 3086, 3096, 3098, 3098A, 3098B, 3098C, 3098D, 3098E, 3210, 3213

  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 1,113 0 0 1,113 0 0
Annual Time Burden (Hours) 83,661 0 0 83,661 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
09/04/1990


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