Substantial Evidence of Effectiveness of New Animal Drugs

ICR 200401-0910-004

OMB: 0910-0356

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0356 200401-0910-004
Historical Active 200011-0910-005
HHS/FDA
Substantial Evidence of Effectiveness of New Animal Drugs
Extension without change of a currently approved collection   No
Regular
Approved without change 03/12/2004
Retrieve Notice of Action (NOA) 01/09/2004
  Inventory as of this Action Requested Previously Approved
03/31/2007 03/31/2007 03/31/2004
860 0 860
544,036 0 544,036
0 0 0

The Animal Drug Availability Act (ADAA), enacted on October 9, 1996, amended section 512(d)(3) of the Federal Food, Drug, and Cosmetic Act to redefine "substantial evidence" in a manner to encourage the submission of new animal drug applications and encourage dose range labeling. Submissions of substantial evidence are made in support of New Animal Drug Applications (NADA). Respondents are sponsors of NADAs.

None
None


No

1
IC Title Form No. Form Name
Substantial Evidence of Effectiveness of New Animal Drugs

  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 860 860 0 0 0 0
Annual Time Burden (Hours) 544,036 544,036 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.
01/09/2004


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