Guidance for Industry: How to Submit a Protocol Without Data in Electronic Format to the Center for Veterinary Medicine

Forms and Documents

Document	Type	Status	Availability
Form 3536 Guidance for Industry: How to Submit a Study Protocol Without Data in Electronic Format to the Center for Veterinary Medicine	Form and Instruction	Modified	Available
Guidance - 0910-0524.pdf	Supplementary Document	Uploaded 2007-02-16	Available
SS-0910-0524.doc	Supporting Statement A	Uploaded 2010-04-27	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6242	Guidance for Industry: How to Submit a Study Protocol Without Data in Electronic Format to the Center for Veterinary Medicine	Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0524	ICR Reference No: 201004-0910-010
Status: Historical Active	Previous ICR Reference No: 200702-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance for Industry: How to Submit a Protocol Without Data in Electronic Format to the Center for Veterinary Medicine
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: 06/14/2010
	Date Received in OIRA: 04/30/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2013	36 Months From Approved	06/30/2010
Responses	43	0	103
Time Burden (Hours)	14	0	21
Cost Burden (Dollars)	0	0	0

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Abstract: Protocols for nonclinical laboratory studies ( safety studies) are required under 21 CFR 58.120 for approval of new animal drugs. Protocols for adequate and well - control effectiveness studies are required under 21 CFR 514.117(b)The establishment of a process for acceptance of the electronic submission of protocols for studies conducted by sponsors in support of new animal drug applications is part of CVMs ongoing initiative to provide a method for paperless submissions.

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Authorizing Statute(s): US Code: 21 USC 360 (b)(2) 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:
	75 FR 7277	02/18/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 22598	04/29/2010
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 for Industry: How to Submit a Study Protocol Without Data in Electronic Format to the Center for Veterinary Medicine	3536	Protocol for Non- Clinical Laboratory and Effectiveness Studies

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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	43	103	0	0	-60	0
Annual Time Burden (Hours)	14	21	0	0	-7	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:

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Annual Cost to Federal Government: $619

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]? Uncollected

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: 04/30/2010

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