View Information Collection Request (ICR) Package
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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:
0910-0659
ICR Reference No:
201605-0910-004
Status:
Historical Active
Previous ICR Reference No:
201304-0910-007
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CVM
Title:
Antimicrobial Animal Drug Distribution Reports and Recordkeeping
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:
06/13/2016
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/12/2016
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2019
36 Months From Approved
11/30/2016
Responses
565
0
350
Time Burden (Hours)
9,813
0
9,354
Cost Burden (Dollars)
419,709
0
6,975
Abstract:
This information collection requires that sponsors of each new animal drug that contains an antimicrobial agent submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals, including information on any distributor-labeled product. Its purpose is to ensure that the FDA has the necessary information to examine safety concerns related to the use of antibiotics in food-producing animals.
Authorizing Statute(s):
PL:
Pub.L. 110 - 316 105
Name of Law: Animal Drug User Fee Amendments
Citations for New Statutory Requirements:
PL: Pub.L. 110 - 316 105 Name of Law: Animal Drug User Fee Amendments
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
0910-AG45
Final or interim final rulemaking
81 FR 29129
05/11/2016
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
80 FR 28863
05/20/2015
30-day Notice:
Federal Register Citation:
Citation Date:
81 FR 29129
05/11/2016
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
New animal drug sponsors w/active applications; electronic submissions
FDA 3744
Antimicrobial Animal Drug Sales and Distribution Report
New animal drug sponsors w/active applications; paper submissions
FDA 3744
Antimicrobial Animal Drug Sales and Distribution Report
New animal drug sponsors w/inactive applications; electronic submissions
FDA 3744
Antimicrobial Animal Drug Sales and Distribution Report
New animal drug sponsors w/inactive applications; paper submissions
FDA 3744
Antimicrobial Animal Drug Sales and Distribution Report
ONE TIME Burden; administrative review of rulemaking and species-specific information
Recordkeeping under 21 USC 360b(l)(3)(C)
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
565
350
177
37
1
0
Annual Time Burden (Hours)
9,813
9,354
787
-330
2
0
Annual Cost Burden (Dollars)
419,709
6,975
0
410,223
2,511
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:
Miscellaneous Actions
Short Statement:
Information collection is being revised to reflect current rulemaking.
Annual Cost to Federal Government:
$355,469
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:
05/12/2016
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