Guidance for Indusry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office of New Animal Drug Evaluation

ICR 200401-0910-005

OMB: 0910-0452

Federal Form Document

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ICR Details
0910-0452 200401-0910-005
Historical Active 200009-0910-009
HHS/FDA
Guidance for Indusry on How to Use E-Mail to Submit a Request for a Meeting or Teleconference to the Office of New Animal Drug Evaluation
Extension without change of a currently approved collection   No
Regular
Approved without change 03/12/2004
Retrieve Notice of Action (NOA) 01/14/2004
  Inventory as of this Action Requested Previously Approved
03/31/2007 03/31/2007 03/31/2004
168 0 168
116 0 116
0 0 0

Sponsors often meet with CVM scientist to formulate a national approach to studies to be conducted and to discuss how to meet the statutory requirements for new animal drug approval under section 512 of the FD&C Act. Requests for meetings and teleconferences about NAD submissions are currently submitted on paper to CVM. This guidance describes the procedure for persons to submit a request for a meeting or teleconference electronically on FDA Form 3489.

None
None


No

  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 168 168 0 0 0 0
Annual Time Burden (Hours) 116 116 0 0 0 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.
01/14/2004


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