New Animal Drug Application, 21 CFR Part 514

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 356V Form FDA 356V	Form and Instruction	Modified	Available
0032 SS 4-16-13.doc	Supporting Statement A	Uploaded 2013-05-01	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5688	Requesting presubmission conferences		Modified
197519	Form FDA 356V	Form and Instruction	Modified
197518	Evidence to establish safety and effectiveness		Modified
197517	Requirements for liquid medicated feed		Modified
197516	Submission of data, studies, and other information		Modified
197515	Labeling and other changes to an approved application		Modified
197514	Labeling and other changes to an approved application		Modified
197513	Manufacturing changes to an approved application		Modified
197512	Applications and amended applications		Modified

ICR Details

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
	Date Received in OIRA: 05/15/2013
Terms of Clearance:

table that charts list comparision

	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

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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.

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Authorizing Statute(s): US Code: 21 USC 512 Name of Law: null
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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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

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Number of Information Collection (IC) in this ICR: 9

table that charts list of burden

IC Title	Form No.	Form Name
Requesting presubmission conferences
Applications and amended applications
Manufacturing changes to an approved application
Labeling and other changes to an approved application
Labeling and other changes to an approved application
Submission of data, studies, and other information
Requirements for liquid medicated feed
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)

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ICR Summary of Burden

table that charts list 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.

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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

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Common Form ICR:  No

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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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