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:
201904-0910-009
Status:
Historical Active
Previous ICR Reference No:
201605-0910-004
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CVM
Title:
Antimicrobial Animal Drug Distribution Reports and Recordkeeping
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
06/11/2019
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/09/2019
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
06/30/2022
36 Months From Approved
06/30/2019
Responses
388
0
565
Time Burden (Hours)
9,026
0
9,813
Cost Burden (Dollars)
541,018
0
419,709
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):
US Code:
21 USC 360b
Name of Law: FFDCA
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:
Not associated with rulemaking
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
83 FR 49395
10/01/2018
30-day Notice:
Federal Register Citation:
Citation Date:
84 FR 20142
05/08/2019
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
5
IC Title
Form No.
Form Name
New animal drug sponsors w/active applications; electronic submissions
FDA 3744
Antimicrobial Animal Drug Distribution Report
New animal drug sponsors w/active applications; paper submissions
FDA 3744
Antimicrobial Animal Drug Distribution Report
New animal drug sponsors w/inactive applications; electronic submissions
FDA 3744
Antimicrobial Animal Drug Distribution Report
New animal drug sponsors w/inactive applications; paper submissions
FDA 3744
Antimicrobial Animal Drug 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
388
565
0
0
-177
0
Annual Time Burden (Hours)
9,026
9,813
0
0
-787
0
Annual Cost Burden (Dollars)
541,018
419,709
0
0
121,309
0
Burden increases because of Program Change due to Agency Discretion:
No
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
FDA removed the one-time burden of 787 hours which represented the time needed to review the provisions of the final rule and develop a compliance plan in the first year of compliance. Otherwise, FDA has not made adjustments to burden estimates as reported in tables 1 and 2.
Annual Cost to Federal Government:
$341,614
Does this IC contain surveys, censuses, or employ statistical methods?
No
Does this ICR request any personally identifiable information (see
OMB Circular No. A-130
for an explanation of this term)? Please consult with your agency's privacy program when making this determination.
No
Does this ICR include a form that requires a Privacy Act Statement (see
5 U.S.C. §552a(e)(3)
)? Please consult with your agency's privacy program when making this determination.
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:
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@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:
05/09/2019
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