PRODUCT LICENSE APPLICATION FOR THE MANUFACTURE OF HUMAN T-LYMPHOTROPIC VIRUS FOR IN-VITRO DIAGNOSTIC USE

ICR 198901-0910-001

OMB: 0910-0211

Federal Form Document

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ICR Details
0910-0211 198901-0910-001
Historical Active 198504-0910-001
HHS/FDA
PRODUCT LICENSE APPLICATION FOR THE MANUFACTURE OF HUMAN T-LYMPHOTROPIC VIRUS FOR IN-VITRO DIAGNOSTIC USE
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 02/28/1989
Retrieve Notice of Action (NOA) 01/04/1989
This information collection is approved subject to the following conditions: 1) FDA should re-evaluate its efforts in response to the justification questions on the use of information technology and consultation outsid the agency, 2) FDA should undertake activities in both of these areas to ensure adequate evaluation of the data collection and its burden, and 3) FDA's next information collection request should reflect changes as appropriate.
  Inventory as of this Action Requested Previously Approved
02/28/1990 02/28/1990
18 0 0
414 0 0
0 0 0

MANUFACTURERS OF HIV - TYPE OR II MUST SUBMIT AN APPLICATION FOR APPROVAL BY THE FDA PRIOR TO MARKETING A PRODUCT IN INTERSTATE COMMERCE. THE DATA IS USED BY THE AGENCY TO DETERMINE THAT THE MANUFACTURER IS IN COMPLIANCE WITH THE LICENSING PROVISIONS OF 21 CFR 601 PRIOR TO THE GRANTING OF A LICENSE TO MARKET THE PRODUCT.

None
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No

1
IC Title Form No. Form Name
PRODUCT LICENSE APPLICATION FOR THE MANUFACTURE OF HUMAN T-LYMPHOTROPIC VIRUS FOR IN-VITRO DIAGNOSTIC USE

  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 18 0 0 0 18 0
Annual Time Burden (Hours) 414 0 0 0 414 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.
01/04/1989


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