TRANSMITTAL OF PERIODIC REPORTS AND PROMOTIONAL MATERIAL FOR NEW ANIMAL DRUGS (21 CFR 500 SUBPART D)

ICR 198805-0910-001

OMB: 0910-0019

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0019 198805-0910-001
Historical Active 198502-0910-002
HHS/FDA
TRANSMITTAL OF PERIODIC REPORTS AND PROMOTIONAL MATERIAL FOR NEW ANIMAL DRUGS (21 CFR 500 SUBPART D)
Revision of a currently approved collection   No
Regular
Approved without change 07/01/1988
Retrieve Notice of Action (NOA) 05/02/1988
  Inventory as of this Action Requested Previously Approved
04/30/1991 04/30/1991 07/31/1988
3,500 0 3,000
17,275 0 15,000
0 0 0

THESE REPORTING AND RECORDKEEPING REQUIREMENTS ARE REQUIRED OF APPLICANTS OF APPROVED NEW ANIMAL DRUGS OR MEDICATED FEEDS. FDA USES THIS INFORMATION TO DETERMINE IF APPROVAL SHOULD BE WITHDRAWN OR SUSPENDED. FDA CAN WITHDRAW OR SUSPEND APPROVAL IF INFORMATION INDICATES A PRODUCT IS UNSAFE OR INEFFECTIVE OR IF THE APPLICANT DOES NOT COMPLY WITH THESE REQUIREMENTS.

None
None


No

1
IC Title Form No. Form Name
TRANSMITTAL OF PERIODIC REPORTS AND PROMOTIONAL MATERIAL FOR NEW ANIMAL DRUGS (21 CFR 500 SUBPART D) FDA 2301

  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 3,500 3,000 0 500 0 0
Annual Time Burden (Hours) 17,275 15,000 0 2,275 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.
05/02/1988


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