87

Guidance for Industry

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

Draft Guidance\
For Comment Purposes Only

This draft guidance describes how to use e-mail to submit Notices of
Intent to Slaughter for Human Food Purposes (slaughter notices) to the
Center for Veterinary Medicine (CVM or the Center) and the U.S.
Department of Agriculture (USDA).

This draft guidance represents the Center's current thinking about using
e-mail to submit slaughter notices. It does not create or confer any
rights for or on any person and does not bind the Food and Drug
Administration (FDA), USDA, or the public.

E-mail submissions that follow this draft guidance will be compatible
with CVM's current information technology capabilities. This will help
ensure the confidentiality, integrity, security, and authenticity of
data submitted to the Center. If a regulated company or person wishes to
use an electronic approach other than that set forth in this guidance
document, the Center will, on request, discuss alternative methods of
submitting slaughter notices.

Comments and suggestions regarding this document should be sent to
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fisher's Lane, Rm. 1061, Rockville, MD 20852. All comments should be
identified with the Docket No. 00D-1314).

> For questions regarding this draft document, contact Janis R.
> Messenheimer, Center for Veterinary Medicine, (HFV-135), Food and Drug
> Administration, 7500 Standish Place, Rockville, MD 20855,
> 301-827-7578, E-mail: <jmessenh@cvm.fda.gov>.

**U.S. Department of Health and Human Services\
Food and Drug Administration\
Center for Veterinary Medicine\
May 22, 2000**

Table of Contents

I. Background [3](#background)

II\. checklist for submitting a slaughter notice USING ADOBEACROBAT 4.0
[4](#checklist-for-submitting-a-slaughter-notice-using-adobeacrobat-4.0)

III\. Notice of Intent to Slaughter Form
[5](#notice-of-intent-to-slaughter-for-human-food-purposes-form)

Guidance for Industry[^1]

How to Use E-Mail to Submit a slaughter notice

# Background 

Section 512(j) of the Federal Food, Drug, and Cosmetic Act gives FDA the
authority to issue regulation setting out the conditions for marketing
animals treated with investigational new animal drugs may be marketed
for food use. Under this authority, FDA\'s regulations at 21 CFR
511.1(b)(4) provide that sponsors must obtain authorization to slaughter
these animals for food. Under 21 CFR 511.1(b)(5), CVM issues a slaughter
authorization letter to new animal drug sponsors (sponsors) which sets
the terms under which animals treated with investigational new animal
drugs may be slaughtered. 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. Currently, slaughter
notices are submitted to CVM and USDA on paper. This guidance will give
sponsors the option to submit a slaughter notice as an e-mail attachment
to CVM and USDA by the Internet.

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

This draft 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.

This draft document contains specific instructions for submitting
slaughter notices. Guidance #108, How to Use E-Mail to Submit
Information to CVM, contains general instructions and specifications on
submitting information electronically to CVM by e‑mail. It is available
on the CVM Home Page. When guidance #108 becomes final, sponsors should
first register and follow the instructions in that guidance before
submitting slaughter notices as an e-mail attachment.

# checklist for submitting a slaughter notice USING ADOBEACROBAT 4.0[^2]

A sponsor submitting an electronic slaughter notice should send the
notice as a single Portable Document Format (PDF) file attached to an
e-mail. This checklist describes the process sponsors should follow to
create a PDF file using a word processing program, print it to the
Acrobat Distiller, and submit the information. The PDF file can be
created using other software.

1.  Use a word processing software package to create a document
    following the form and containing the information requested in
    Section III.

2.  Make sure Acrobat Distiller is selected as the default printer.

3.  Fill in all pertinent sections of the slaughter notice FDA Form
    #3488.

4.  Print the word processing document to Acrobat Distiller to create a
    PDF file.

5.  Name the PDF file using an 8.3 file naming convention. Save the PDF
    file in the appropriate directory location and close the file.

6.  Open the PDF file in Adobe Acrobat 4.0, select "Save As" and select
    the "Security" options for "Specify Password To: Open the Document".
    Enter your password and click OK. Verify the password by entering it
    again and then "Save" the PDF file.

7.  Open your e-mail program and begin a new message.

8.  Address it to **cvmdcu@cvm.fda.gov** and
    **manzoor.chaudry@usda.gov**.

9.  Type the nine character word **SLAUGHTER** in the subject line,
    using all capital letters. Do not include any other punctuation or
    information in the subject line.

10. Do not type anything in the body of the message.

11. Attach the PDF file of the slaughter notice to the e-mail message.

12. Send the e-mail message.

13. If you have not received an acknowledgment receipt from CVM
    (stars@cvm.fda.gov) within three business days 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.

# Notice of Intent to Slaughter FOR HUMAN FOOD PURPOSES Form

A copy of the FDA Form #3488 for electronic Notice of Intent to
Slaughter for Human Food Purposes follows.

Notice of Intent to Slaughter for Human Food Purposes

+-----------------------------------+-----------------------------------+
| Food and Drug Administration      | Date:                             |
|                                   |                                   |
| Center for Veterinary Medicine    | INAD No:                          |
| (HFV-)                            |                                   |
|                                   | Study ID:                         |
| 7500 Standish Place               |                                   |
|                                   |                                   |
| Rockville, Maryland 20855         |                                   |
|                                   |                                   |
| (E-mail:cvmdcu@cvm.fda.gov)       |                                   |
+-----------------------------------+-----------------------------------+

The sponsor, , submits a notice of intent to slaughter animals treated
with investigational new animal drugs according to the conditions of
authorization, CVM letter dated , and, **at least 10 days prior to
slaughter**. This information is submitted in electronic form to CVM and
USDA.

I. Animals Intended For Slaughter

1.  Compound(s) used\
    Established name(s)­:      \
    Trade name(s):      

2.  Species of animals:

3.  Name and address of investigator:

4.  Name and address of slaughter facility:\
    \
    \
    \
    \
    Establishment number:

5.  Number of animals being slaughtered Treated: Control:

6.  Approximate date of slaughter:

7.  Length of withdrawal period observed:

8.  Comments:

II\. Sponsor Information

1.  Sponsor's name:

2.  Sponsor's address:

3.  Sponsor contact's name:

> Telephone:
>
> Fax:
>
> E-mail address:

[^1]: This draft guidance and form have been prepared by CVM at FDA. For
    additional copies of this draft guidance and form, access the
    document on the Internet by connecting to the CVM Home Page at
    http://www.fda.gov/cvm, or send a request to the Communications
    Staff, HFV-12, 7500 Standish Place, Rockville, MD 20855.

[^2]: This checklist uses Adobe Acrobat 4.0 for the purpose of example.
    FDA use of specific products does not constitute endorsement of
    those products. Sponsors can use other software to create files.