ANTIBIOTIC APPLICATION

ICR 198108-0910-004

OMB: 0910-0055

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
109510 Migrated
ICR Details
0910-0055 198108-0910-004
Historical Active 197609-0910-001
HHS/FDA
ANTIBIOTIC APPLICATION
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 10/15/1981
Retrieve Notice of Action (NOA) 08/19/1981
Approval is granted for six months only in order for OMB to review these requirements in more depth.
  Inventory as of this Action Requested Previously Approved
05/31/1982 05/31/1982
80 0 0
6,400 0 0
0 0 0

APPLICATION IS USED BY DRUG MANUFACTURERS WITH A VIEW TO OBTAINING APPROVAL FOR MARKETING A NEW ANTIBIOTIC PRODUCT.

None
None


No

1
IC Title Form No. Form Name
ANTIBIOTIC APPLICATION FD-1675

  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 80 0 0 0 80 0
Annual Time Burden (Hours) 6,400 0 0 0 6,400 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.
08/19/1981


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