Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol

Forms and Documents

Document	Type	Status	Availability
Form 3536 Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol	Form and Instruction	Modified	Available
SS- 0910-0524.doc	Supporting Statement A	Uploaded 0000-00-00	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
6242	Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol	Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0524	ICR Reference No: 200702-0910-011
Status: Historical Active	Previous ICR Reference No: 200310-0910-013
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol
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: 04/27/2007
	Date Received in OIRA: 02/21/2007
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2010	36 Months From Approved	04/30/2007
Responses	103	0	100
Time Burden (Hours)	21	0	20
Cost Burden (Dollars)	0	0	0

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Abstract: The Federal Food, Drug and Cosmetic Act (the Act) prohibits the introduction into interstate commerce of new animal drugs that are not the subject of an approved new animal drug application (NADA). Section 512(b) of the Act and the regulations in part 514 of Title 21 of the Code of Federal Regulations describe the information that must be submitted to FDA, specifically to the Center for Veterinary Medicine (CVM), as part of an NADA. Upon request, CVM reviews study protocols for safety and effectivenss. This protocol review facilitates the animal drug review process by improving the likelihood that the study design will be relevant to NADA approval.

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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:
	71 FR 65534	11/08/2006
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 7437	02/15/2007
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
Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol	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	103	100	0	0	3	0
Annual Time Burden (Hours)	21	20	0	0	1	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: $0

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]? Uncollected

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)? Uncollected

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: 02/21/2007

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