Reporting Associated with New Animal Drug Applications and Veterinary Master Files

Forms and Documents

Document	Type	Status	Availability
Form 356V Reporting Associated with New Animal Drug Applications	Form and Instruction	Modified	Available
0032 supporting statement final 5-14-2019.doc	Supporting Statement A	Uploaded 2019-05-20	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
5688	Reporting Associated with New Animal Drug Applications	Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0032	ICR Reference No: 201905-0910-005
Status: Active	Previous ICR Reference No: 201605-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Reporting Associated with New Animal Drug Applications and Veterinary Master Files
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: 07/26/2019
	Date Received in OIRA: 06/26/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2022	36 Months From Approved	08/31/2019
Responses	1,008	0	1,008
Time Burden (Hours)	22,083	0	21,959
Cost Burden (Dollars)	0	0	0

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Abstract: Any person may file a new animal drug application (NADA) seeking FDA approval to legally market a new animal drug. 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 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. Respondents may choose to use veterinary master files to provide and organize confidential detailed information to the Agency. Veterinary master files can be used as repositories for information that can be referenced in multiple submissions to the Agency, thus minimizing paperwork burden.

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Authorizing Statute(s): US Code: 21 USC 512 Name of Law: FD&C Act
  

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:
	84 FR 4479	02/15/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 29866	06/25/2019
Did the Agency receive public comments on this ICR? No

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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)

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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	1,008	0	0	0	0
Annual Time Burden (Hours)	22,083	21,959	0	0	124	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: Based on a review of the information collection since our last request for OMB approval, we have made the following adjustments: In previous submissions of this ICR we included the time necessary to compile and submit information to veterinary master files within the burden estimates provided for applications and amended applications (for NADAs and INAD files). In this request for OMB extension of approval, we anticipate respondents’ need for increased use of veterinary master files and therefore seek approval for such increase. We have separately estimated the burden of the “Use of veterinary master files during all phases of product development (including product development that precedes the establishment of an INAD file or the submission of an NADA)” in table 1, row 10. We report an additional 300 burden hours and 15 total annual responses in row 10, representing such increased use of veterinary master files. In addition, we are also correcting several rounding errors that were made in our last request for OMB approval. Thus, our estimated burden for the information collection reflects a net overall increase of 124 hours and a corresponding increase of 14 responses.

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Annual Cost to Federal Government: $10,315,360

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? 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: 06/26/2019

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