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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:
200803-0910-001
Status:
Historical Active
Previous ICR Reference No:
200411-0910-002
Agency/Subagency:
HHS/FDA
Agency Tracking No:
Title:
New Animal Drug Application, 21 CFR Part 514
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:
04/23/2008
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/04/2008
Terms of Clearance:
OMB revised the total number of respondents in the ROCIS submission to reflect the estimate provided in the supporting statement. The agency is reminded to ensure that the ROCIS data entry for burden and the information provided in the supporting statement are consistent before submission of an ICR.
Inventory as of this Action
Requested
Previously Approved
Expiration Date
04/30/2011
36 Months From Approved
04/30/2008
Responses
1,412
0
1,406
Time Burden (Hours)
30,421
0
340,858
Cost Burden (Dollars)
0
0
0
Abstract:
This clearance submission is a consolidation of information collection activities associated with approval of new animal drugs. To gain approval to market an animal drug, the applicant must file a New Animal Drug Application containing data to support the safety and effectiveness of the drug, appropriate labeling, product manufacturing information, and where applicable, methods to determine residues of the drug in edible tissue from food producing animals; file a petition to obtain a waiver from labeling requirements for certain drugs intended for use in animal feed or drinking water.
Authorizing Statute(s):
US Code:
21 USC 512
US Code:
21 USC 379 j-11
Citations for New Statutory Requirements:
US Code: 21 USC J - 11
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:
72 FR 37240
07/09/2007
30-day Notice:
Federal Register Citation:
Citation Date:
72 FR 70331
12/11/2007
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
New Animal Drug Application, 21 CFR Part 514
356 V
Application for Approval of A New Animal Drug
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
1,412
1,406
0
6
0
0
Annual Time Burden (Hours)
30,421
340,858
-310,437
0
0
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:
In addition to requesting extension of approval for the subject collection for OMB number 0910-0032, under 21 CFR Part 500, the Center for Veterinary Medicine (CVM) is also consolidating under this collection the following: OMB 0910-0555,0910-0356, 0910-0522, and 0910-0600. These collections are also approved under 21 CFR Part 500 and will be discontinued upon approval of the subject collection. Further, the Animal Drug User Fee Act of 2003 (ADUFA)(P.L. 108-130) (21 U.S.C.J-11), amended the Federal Food,Drug and Cosmetic Acr (FD&C Act) and authorizes FDA to collect fees for certain applications and establishments, product and sponsors.As a result of the ADUFA legislation, CVM recognized a decrease in the number of animal drug sponsors (respondents). Also, CVM has available better metrics with which to estimate paperwork. To comply with this consolidation, CVM has significantly revised the existing Form FDA 356 V which more closely follows the administrative process.This sequence of legislation and regulatory initiatives by CVM has resulted in a significant program change (decrease) for this consolidated collection of information, i.e. 0910-0032.
Annual Cost to Federal Government:
$9,544,675
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]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
Agency Contact:
Denver Presley 3018271462
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:
02/24/2008
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