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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:
0910-0032
ICR Reference No:
201305-0910-003
Status:
Historical Active
Previous ICR Reference No:
201104-0910-011
Agency/Subagency:
HHS/FDA
Agency Tracking No:
19439
Title:
New Animal Drug Application, 21 CFR Part 514
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:
07/02/2013
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/15/2013
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
07/31/2016
36 Months From Approved
07/31/2013
Responses
1,367
0
1,517
Time Burden (Hours)
28,218
0
33,146
Cost Burden (Dollars)
0
0
0
Abstract:
Certain information that submitted as part of a New Animal Drug Application (NADA) must include safety and effectiveness data, proposed labeling, product manufacturing information, and where necessary, complete information on food safety (including microbial food safety) and any methods used to determine residues of new animal drugs in edible tissues from food producing animals.
Authorizing Statute(s):
US Code:
21 USC 512
Citations for New Statutory Requirements:
None
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:
77 FR 69630
11/20/2012
30-day Notice:
Federal Register Citation:
Citation Date:
78 FR 27969
05/13/2013
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
9
IC Title
Form No.
Form Name
Applications and amended applications
Evidence to establish safety and effectiveness
Form FDA 356V
FDA 356V
Application for Approval of a New Animal Drug (Or Submission to Support New Animal Drug Approval)
Labeling and other changes to an approved application
Labeling and other changes to an approved application
Manufacturing changes to an approved application
Requesting presubmission conferences
Requirements for liquid medicated feed
Submission of data, studies, and other information
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
1,367
1,517
0
0
-150
0
Annual Time Burden (Hours)
28,218
33,146
0
0
-4,928
0
Annual Cost Burden (Dollars)
0
0
0
0
0
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:
Although the number of respondents has increased (an adjustment from 154 to 169 due to natural increases in the animal drug industry) the overall burden has reduced from 33,146 to 28,218 because we have determined that it takes less time to complete the form due to electronic capability.
Annual Cost to Federal Government:
$11,705,426
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:
05/15/2013
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