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 200703-0910-006

OMB: 0910-0452

Federal Form Document

ICR Details
0910-0452 200703-0910-006
Historical Active 200401-0910-005
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 05/15/2007
Retrieve Notice of Action (NOA) 03/13/2007
  Inventory as of this Action Requested Previously Approved
05/31/2010 36 Months From Approved 05/31/2007
156 0 168
12 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

Not associated with rulemaking

  71 FR 65535 11/08/2006
72 FR 7440 02/15/2007
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 156 168 0 -12 0 0
Annual Time Burden (Hours) 12 116 0 -104 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
There was a decrease(adjustment) in the number of burden hours based on FDA,s review of submissions submitted from July 1, 2005 to June 20, 2006 and from previous discussions with sponsors regarding the time necessary to fill out this form.

$438
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman

  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.
03/13/2007


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