87

Guidance for Industry

How to Submit a Notice of Intent to Slaughter for Human Food Purposes in
Electronic Format by E‑mail

**(THIS VERSION OF THE GUIDANCE REPLACES THE VERSION MADE AVAILABLE IN
February 2001)**

> This guidance document is intended to provide instructions on how to
> submit a notice of intent to slaughter for human food purposes in
> electronic format by e‑mail to the Center for Veterinary Medicine (CVM
> or the Center).

Comments and suggestions regarding this document should be sent to
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit electronic
comments to <http://www.fda.gov/dockets/ecomments>. All comments should
be identified with the exact title of the document.

For questions regarding this document, contact Margaret Zabriski, Center
for Veterinary Medicine (HFV-016), Food and Drug Administration, 7519
Standish Place, Rockville, MD 20855, 301-827-4023, E‑mail:
<margaret.zabriski@fda.gov>.

According to the Paperwork Reduction Act of 1995, a collection of
information should display a valid OMB control number. The valid OMB
control number for this information collection is 0910-0450. The time
required to complete this information collection is estimated to vary
between 15 minutes to 1 hour per response, including the time to review
instructions, search existing data resources, gather the data needed,
and complete and review the information collection.

**U.S. Department of Health and Human Services\
Food and Drug Administration\
Center for Veterinary Medicine\
May 21, 2004**

Table of Contents

I. Introduction [3](#introduction)

II\. Notice of Intent to Slaughter FOR HUMAN FOOD PURPOSES Form
[5](#notice-of-intent-to-slaughter-for-human-food-purposes-form)

III\. checklist for Electronic submission of a Notice of Intent to
Slaughter FOR HUMAN FOOD PURPOSES using form fda 3488
[5](#checklist-for-electronic-submission-of-a-notice-of-intent-to-slaughter-for-human-food-purposes-using-form-fda-3488)

Guidance for Industry[^1]

How to Submit a Notice of Intent to Slaughter for Human Food Purposes in
Electronic Format by E‑mail

# Introduction

This guidance provides advice to industry regarding the procedures to
submit a Notice of Intent to Slaughter for Human Food Purposes in
electronic format by e‑mail to the Center for Veterinary Medicine (CVM).

**FDA's guidance documents, including this guidance, do not establish
legally enforceable responsibilities. Instead, guidances describe the
Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited. The use of the word "should" in Agency guidances means that
something is suggested or recommended, but not required.**

Section 512(j) of the Federal Food, Drug, and Cosmetic Act gives FDA the
authority to issue regulations that set out the conditions on which
investigational animals may be marketed for food-use. FDA\'s regulations
21 CFR 511.1(b)(4) provide that sponsors must obtain authorization to
use the edible products derived from investigational food-producing
animals for food. Under 21 CFR 511.1(b)(5), CVM may issue an
authorization letter permitting a new animal drug sponsor (sponsor) to
use edible products from investigational animals under specific
conditions. USDA also monitors the slaughter of animals treated with
investigational new animal drugs under the authority of the Meat
Inspection Act, 21 USC 601-95. To assist CVM and USDA with this
monitoring, the authorization letter states that sponsors must submit
slaughter notices each time such animals are to be slaughtered unless
this notice is waived in the authorization letter. This guidance will
give sponsors the option to submit a slaughter notice as an e-mail
attachment to CVM.

The electronic submission of slaughter notices is part of the Center's
ongoing initiative to provide a method for paperless submissions.

This guidance implements provisions of the Government Paperwork
Elimination Act, Pub. L. No. 105-277, 112 Stat. 2681 (1998), which
requires that executive agencies, by October 21, 2003, provide: (1) for
the option of the electronic maintenance, submission, or disclosure of
information, if practicable, as a substitute for paper; and (2) for the
use and acceptance of electronic signatures when practicable.

To electronically submit a slaughter notice, the sponsor should use the
Notice of Intent to Slaughter for Human Food Purposes form provided by
CVM (FORM FDA 3488[^2] OMB No. 0910-0450) the sponsor should enter the
data directly into an Adobe^®^ Acrobat^®^ form and submit the form to
CVM as an Adobe^®^ PDF file (compatible with Adobe^®^ Acrobat^®^
5.05).[^3]

The form should be submitted by e‑mail message from the sponsor to CVM.
For reasons of security and verifying the sender's identity, the sponsor
should register each individual participant, including a sponsor
coordinator and all individuals who will be sending submissions by
e‑mail, with the Center as outlined in Guidance for Industry #108 "How
to Submit Information in Electronic Format by E-Mail" available at the
Center's Guidance Page
(<http://www.fda.gov/cvm/guidance/published.htm>).

CVM intends to accept only PDF forms submitted as attachments to an
e‑mail message. A sponsor should attach only one PDF attachment per
e‑mail message. The maximum file size for submitting information
electronically by e‑mail is 50 Megabytes (50 MB). No information should
be included in the body of the e‑mail message.

Electronic records may be submitted instead of paper records provided
they meet the requirements of 21 CFR 11.2. The procedures in this
guidance are designed to provide for a means of electronic submission
that meet the requirements of Part 11. If a sponsor does not follow this
guidance to submit a Notice of Intent to Slaughter for Human Food
Purposes electronically, the sponsor should consult with CVM regarding
alternative methods for electronic submission that meet the requirements
of Part 11 or submit the slaughter notice in paper.

# Notice of Intent to Slaughter FOR HUMAN FOOD PURPOSES Form

A copy of [form]{.smallcaps} FDA 3488 Notice of Intent to Slaughter for
Human Food Purposes (for use with electronic submissions) is available
on the CVM Electronic Submission Page at
<http://www.fda.gov/cvm/index/esubs/esubstoc.html>.

# checklist for Electronic submission of a Notice of Intent to Slaughter FOR HUMAN FOOD PURPOSES using form fda 3488

*Note these instructions are for Adobe Acrobat 5.0. Other versions may
be different.*

1.  Open the Intent to Slaughter [Form]{.smallcaps} FDA 3488.

2.  Fill in all pertinent sections of [Form]{.smallcaps} FDA 3488.

3.  Select the "Insert Comments" button to add a PDF file containing any
    comments regarding the form.

4.  Once the form is completed, select the "Validate" button to verify
    all of the required fields are completed. Those fields that are
    required will be highlighted and must be completed before the form
    can be sent to CVM.

5.  Select the "Add Password" button to change Document Security

```{=html}
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```
a.  Select "Adobe Standard Security" in the "Document Security" window.

b.  Select the "Change Settings" button.

c.  In the "Specify Password" section select the "Password Required to
    Open Document" checkbox.

d.  Enter your "Current" Electronic Submissions System (ESS) password in
    the "User Password" field.

e.  Press "Ok" and save your PDF form to your local system.

```{=html}
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```
6.  Select "Save" to save all information on the form.

7.  *The "Signature" button is currently disabled on the form*.

8.  Once the form is validated and secured, select the "Send to CVM"
    button.

    a.  The form will be automatically addressed to cvmdcu@fda.gov.
        Additional addresses can be added to the addressee and/or the cc
        block.

    b.  The form automatically adds "**SLAUGHTER**" as the subject line.

9.  If you do not receive an acknowledgment receipt from CVM by the
    third business day after you have sent the submission, call the
    Electronic Document Control Unit at 301-827-8277 to report the
    problem and find out what happened to your submission.

    Sponsors are requested to submit their slaughter notification to FDA
    and USDA **at least** **10 days prior** to shipment for slaughter
    unless conditions outlined in the authorization letter waived this
    requirement.

[^1]: This guidance has been prepared by CVM at FDA. For additional
    copies, access the document on the CVM Home Page
    (<http://www.fda.gov/cvm/default.html>), or send a request to the
    Communications Staff, HFV-12, 7519 Standish Place, Rockville, MD
    20855.

[^2]: A copy of the form along with instructions for completing it can
    be found on the CVM Electronic Submissions Project Page,
    <http://www.fda.gov/cvm/index/esubs/esubstoc.html>.

[^3]: FDA use of specific products does not constitute an endorsement of
    those products.