Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway

Forms and Documents

Document Name	Status
Form FDA 3538 Guidance on How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway Form and Instruction	Modified
0454_Supporting Statement_2019.docx Supporting Statement A	2019-10-11

IC Document Collections

IC ID	Document Title	Status
6144	Guidance on How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0454	ICR Reference No: 201909-0910-003
Status: Active	Previous ICR Reference No: 201609-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Guidance for Industry on How to Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway
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: 11/18/2019
	Date Received in OIRA: 10/16/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2022	36 Months From Approved	11/30/2019
Responses	251	0	38
Time Burden (Hours)	20	0	3
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection request collects information from sponsors of new animal drug applications who wish to submit pre-market information to Center for Veterinary Medicine (CVM) using the FDA Electronic Submissions Gateway (ESG). These types of documents are listed in public docket FDA-1992-S-0039 as required by 21 CFR 11.2. CVM's guidance # 108 entitled "Guidance for Industry: How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway," outlines general standards to be used for the submission of any electronic information to CVM using the FDA ESG, including how to register with CVM's Electronic Submission System (ESS).

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Authorizing Statute(s): None

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 15621	04/16/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 55160	10/15/2019
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
Guidance on How to Submit Information in Electronic Format to CVM Using the FDA Electronic Submission Gateway	FDA 3538	Electronic Submission System Participant Management Form

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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	251	38	0	0	213	0
Annual Time Burden (Hours)	20	3	0	0	17	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 increase of 17 hours and a corresponding increase of 213 responses. We attribute this adjustment to the reauthorizations of both the Animal Drug User Fee Act and the Animal Generic Drug User Fee Act, which require sponsors to submit information electronically to CVM’s Office of New Animal Drug Evaluation. Because of this requirement, sponsors are now registering to use the CVM ESS in greater numbers than in previous years.

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Annual Cost to Federal Government: $950

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: 10/16/2019

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