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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0910-0363
ICR Reference No:
201505-0910-001
Status:
Historical Active
Previous ICR Reference No:
201412-0910-010
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CVM
Title:
Veterinary Feed Directive
Type of Information Collection:
Revision of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
07/07/2015
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/19/2015
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2018
36 Months From Approved
02/28/2018
Responses
3,019,749
0
2,250,321
Time Burden (Hours)
145,563
0
132,033
Cost Burden (Dollars)
11,584,259
0
0
Abstract:
A VFD drug is a drug intended for use in animal feeds and limited to use under the professional supervision of a licensed veterinarian. This information collection request supports the agency's regulations establishing the requirements for the distribution and use of VFD drugs and animal feeds containing VFD drugs. Respondents to the collection are VFD Feed distributors, veterinarians, and food animal producers.
Authorizing Statute(s):
PL:
Pub.L. 104 - 250 5
Name of Law: Animal Drug Availability Act
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AG95
Final or interim final rulemaking
80 FR 31707
06/03/2015
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
78 FR 75515
12/12/2013
30-day Notice:
Federal Register Citation:
Citation Date:
78 FR 75515
12/12/2013
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
6
IC Title
Form No.
Form Name
3rd Party: Acknowledgement Letter
3rd Party: Issuance of VFD by veterinarian
Notification of VFD distribution
Notification of business change by distributor
Review of VFD Final Rule by affected respondents (one time burden)
VFD Recordkeeping Requirements by Distributors
ICR Summary of Burden
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
3,019,749
2,250,321
0
769,428
0
0
Annual Time Burden (Hours)
145,563
132,033
0
13,530
0
0
Annual Cost Burden (Dollars)
11,584,259
0
0
11,584,259
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Changing Regulations
Burden decreases because of Program Change due to Agency Discretion:
Yes
Burden Reduction Due to:
Changing Regulations
Short Statement:
Previously the information collection provisions supporting the respective regulations were consolidated. Because of the changes in and renumbering of the individual regulations, we are now itemizing certain provisions for ease of reference and greater clarity. These changes are explained more fully in the agency's supporting statement.
Annual Cost to Federal Government:
$1,900
Does this IC contain surveys, censuses, or employ statistical methods?
No
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
No
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
No
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
No
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Domini Bean 301 796-5733 domini.bean@fda.hhs.gov
Common Form ICR:
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
05/19/2015
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