Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol

ICR 200702-0910-011

OMB: 0910-0524

Federal Form Document

Forms and Documents
Form and Instruction
Supporting Statement A
IC Document Collections
ICR Details
0910-0524 200702-0910-011
Historical Active 200310-0910-013
Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol
Extension without change of a currently approved collection   No
Approved without change 04/27/2007
Retrieve Notice of Action (NOA) 02/21/2007
  Inventory as of this Action Requested Previously Approved
04/30/2010 36 Months From Approved 04/30/2007
103 0 100
21 0 20
0 0 0

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.


Not associated with rulemaking

  71 FR 65534 11/08/2006
72 FR 7437 02/15/2007

  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

Saleda Perryman


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:
    (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;
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.

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