Reporting Associated with New Animal Drug Applications

Forms and Documents

Document Name	Status
Form 356V Reporting Associated with New Animal Drug Applications Form and Instruction	Modified
Form FDA 356V Form FDA 356V Form and Instruction	Removed
0032 SUPPORTING STATEMENT 2016.doc Supporting Statement A	2016-06-02

IC Document Collections

IC ID	Document Title	Status
5688	Reporting Associated with New Animal Drug Applications Form and Instruction	Modified
197519	Form FDA 356V Form and Instruction	Removed
197518	Evidence to establish safety and effectiveness	Removed
197517	Requirements for liquid medicated feed	Removed
197516	Submission of data, studies, and other information	Removed
197515	Labeling and other changes to an approved application	Removed
197514	Labeling and other changes to an approved application	Removed
197513	Manufacturing changes to an approved application	Removed
197512	Applications and amended applications	Removed

ICR Details

OMB Control No: 0910-0032	ICR Reference No: 201605-0910-014
Status: Historical Active	Previous ICR Reference No: 201305-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Reporting Associated with 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: 08/11/2016
	Date Received in OIRA: 06/03/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2019	36 Months From Approved	08/31/2016
Responses	1,008	0	1,367
Time Burden (Hours)	21,959	0	28,218
Cost Burden (Dollars)	0	0	0

---

Abstract: Under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(b)(1)), any person may file a new animal drug application (NADA) seeking our approval to legally market a new animal drug. Section 512(b)(1) sets forth the information required to be submitted in a NADA. Sections 514.1, 514.4, 514.6, 514.8, and 514.11 of our regulations (21 CFR 514.1, 514.4, 514.6, 514.8, and 514.11) further specify the information that the NADA must contain. The application 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 drug chemicals in edible tissue from food producing animals. FDA Guidance #152 outlines a risk assessment approach for evaluating the microbial food safety of antimicrobial new animal drugs. We request that applicants utilize Form FDA 356V, as appropriate, to ensure efficient and accurate processing of information to support new animal drug approval.

---

Authorizing Statute(s): US Code: 21 USC 512 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:
	81 FR 10871	03/02/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 35744	06/03/2016
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
Reporting Associated with New Animal Drug Applications	356V	Application for Approval of a New Animal Drug (or Submission to Support New Animal Drug Approval)
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)

---

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	1,008	1,367	0	0	-359	0
Annual Time Burden (Hours)	21,959	28,218	0	0	-6,259	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 169 to 182 due to natural increases in the animal drug industry) the overall burden has reduced from 28,218 to 21,959 because we have determined that the number of responses per respondent has decreased. The previously approved ICR submitted to OMB in 2013 included nine ICs entered into ROCIS. Upon this submission we are consolidating the ICs, thereby, reducing the number of ICs in ROCIS to one. The information collection activities, however, remain broken down in this supporting statement document.

---

Annual Cost to Federal Government: $9,584,960

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

---

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: 06/03/2016

---