Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes

ICR 200702-0910-009

OMB: 0910-0450

Federal Form Document

Forms and Documents
ICR Details
0910-0450 200702-0910-009
Historical Active 200401-0910-002
Guidance for Industry on How to Use E-Mail to Submit a Notice of Intent to Slaughter for Human Food Purposes
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
2 0 84
1 0 33
0 0 0

Section 512 (j) of the Federal Food and Cosmetic Act (21 U.S.C. 360b(j)) gives FDA the authority to issue regulations setting out the conditions for marketing animals treated with investigational drugs for food use. Under this authority, FDA's regulations at 511.1 (b) (4) (21 CFR 511.1 (b)(4) provides that sponsors must obtain authorization to slaughter these animals for food. CVM issues a slaughter authorization letter to new animal drug sponsors which set the terms under which these animals may by slaughtered. This guidance will give sponsors the option to submit a slaughter notice electronically as an e-mail.


Not associated with rulemaking

  71 FR 65532 11/08/2006
72 FR 7660 02/16/2007

  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 2 84 0 0 -82 0
Annual Time Burden (Hours) 1 33 0 0 -32 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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