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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:
0910-0669
ICR Reference No:
202202-0910-008
Status:
Active
Previous ICR Reference No:
201908-0910-009
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CVM
Title:
Abbreviated New Animal Drug Applications
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:
11/01/2022
Retrieve Notice of Action (NOA)
Date Received in OIRA:
09/27/2022
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
11/30/2025
36 Months From Approved
10/31/2022
Responses
63
0
51
Time Burden (Hours)
4,299
0
3,604
Cost Burden (Dollars)
0
0
0
Abstract:
This ICR collects information from animal drug manufacturers who seek approval of a generic copy of an approved new animal drug. The information required to be submitted as part of an abbreviated new animal drug application (ANADA) is described in section 512(n)(1) of the FD&C Act (21 U.S.C. 360b(n)(1)). Among other things, an ANADA is required to contain information to show that the proposed generic drug is bioequivalent to, and has the same labeling as, the approved new animal drug. We allow applicants to submit a complete ANADA or to submit information in support of an ANADA for phased review. Form FDA 356v facilitates a complete ANADA or a phased review submission to ensure efficient and accurate processing of information.
Authorizing Statute(s):
US Code:
21 USC 360b(b)(2)
Name of Law: FD&C Act
US Code:
21 USC 512(n)(1)
Name of Law: FD&C Act
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:
87 FR 15436
03/18/2022
30-day Notice:
Federal Register Citation:
Citation Date:
87 FR 57905
09/22/2022
Did the Agency receive public comments on this ICR?
Yes
Number of Information Collection (IC) in this ICR:
6
IC Title
Form No.
Form Name
Abbreviated New Animal Drug Applications
FDA 356v
Application for Approval of a New Animal Drug (Or Submission to Support New Animal Drug Approval)
Biowaiver request: Type A medicated article, same formulation/manufacturing process approach
Biowaiver request: Type A medicated article, using same API/solubility approach
Biowaiver request: powder oral dosage form, same formulation/manufacturing process approach
Biowaiver request: powder oral dosage form, using same API/solubility approach
Phased Review with Administrative ANADA
FDA 356v
Application for Approval of a New Animal Drug (Or Submission to Support New Animal Drug Approval)
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
63
51
0
0
12
0
Annual Time Burden (Hours)
4,299
3,604
0
0
695
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:
Our estimated burden for the information collection reflects an overall adjustment increase of 695 hours and a corresponding increase of 12 responses, based on an increase in the number of respondents submitting generic drug applications.
Annual Cost to Federal Government:
$5,102,971
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.
Yes
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?
No
Agency Contact:
Rachel Showalter 202 693-2146 Showalter.Rachel@dol.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:
09/27/2022
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