Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type a Medicated Articles

ICR 201203-0910-004

OMB: 0910-0575

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2009-01-12
Supporting Statement A
2012-06-06
ICR Details
0910-0575 201203-0910-004
Historical Active 200901-0910-005
HHS/FDA
Waivers of Invivo Demonstration of Bioequivalence of Animal Drugs in Soluble Powder Oral Dosage Form and Type a Medicated Articles
Extension without change of a currently approved collection   No
Regular
Approved with change 06/12/2012
Retrieve Notice of Action (NOA) 03/19/2012
  Inventory as of this Action Requested Previously Approved
06/30/2015 36 Months From Approved 06/30/2012
36 0 18
530 0 265
0 0 0

This guidance describes the procedures that the Agency recommends for the review of requests for waiver of invivo demonstration of bioequivalence for generic soluble powder oral dosage form products and Type A Medicated Articles. The respondents are animal drug manufacturers.

US Code: 21 USC 301 Name of Law: Federal Food Drug and Cosmetic Act
  
None

Not associated with rulemaking

  76 FR 65734 10/11/2011
77 FR 15764 03/16/2012
Yes

  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 36 18 0 0 18 0
Annual Time Burden (Hours) 530 265 0 0 265 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The change in burden estimate is due to a change in estimation in the number of responses per respondent. On occasion, FDA may need additional information. Usually a waiver is granted based on the initial request or after additional information is provided after the initial request. As a result, we've included an estimate of two responses per respondent.

$4,000
No
No
No
No
No
Uncollected
Denver Presley 3018271462

  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.
03/19/2012


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