Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol

ICR 200310-0910-013

OMB: 0910-0524

Federal Form Document

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0910-0524 200310-0910-013
Historical Active
Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol
New collection (Request for a new OMB Control Number)   No
Approved without change 02/13/2004
Retrieve Notice of Action (NOA) 10/28/2003
  Inventory as of this Action Requested Previously Approved
02/28/2007 02/28/2007
100 0 0
20 0 0
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.......



IC Title Form No. Form Name
Draft Guidance for Industry: How to Use E-Mail to Submit a Study Protocol 3536

  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 100 0 0 100 0 0
Annual Time Burden (Hours) 20 0 0 20 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0



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).
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    (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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