108

Guidance for Industry

How to Submit Information in Electronic Format by E-Mail

**(THIS VERSION OF THE GUIDANCE REPLACES THE VERSION MADE AVAILABLE IN
MAY 2004)**

This guidance document is intended to provide instructions on how to
submit information in electronic format by e-mail to the Center for
Veterinary Medicine (CVM or the Center). The guidance was revised to
update the web links and the contact email and phone number.

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.

E-mail submissions that follow this 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 sponsor 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 information.

For questions regarding this document, contact Margaret Zabriski, Center
for Veterinary Medicine (HFV-016), Food and Drug Administration, 7519
Standish Place, Rockville, MD 20855, 240-276-9143, e-mail:
<margaret.zabriski@fda.hhs.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 0910-0454. The time
required to complete this information collection is estimated to vary
between 5 and 20 minutes per response, including the time to review
instructions, search existing data resources, gather the necessary data,
and complete and review the information collection.

**U.S. Department of Health and Human Services\
Food and Drug Administration\
Center for Veterinary Medicine\
January 17, 2006**

Table of Contents

**I.** **Introduction [3](#introduction)**

II\. Communication between CVM and industry
[4](#communication-between-cvm-and-industry)

III\. REGISTRATION TO send ELECTRONIC SUBMISSIONS LISTED IN ELECTRONIC
SUBMISSIONS DOCKET
[4](#registration-to-send-electronic-submissions-listed-in-electronic-submissions-docket)

Agency Certification: [4](#agency-certification)

Center Registration: [4](#center-registration)

A. Sponsor Registration and Password Initialization
[5](#sponsor-registration-and-password-initialization)

Example of Registration Letter [6](#example-of-registration-letter)

B. Creating Individual Passwords and Using the Electronic Submission
System (ESS)
[7](#creating-individual-passwords-and-using-the-electronic-submission-system-ess)

C. Adding New Participants to a Registered Sponsor
[7](#adding-new-participants-to-a-registered-sponsor)

D. Other Changes to the Sponsor Registration
[7](#other-changes-to-the-sponsor-registration)

IV\. Processing procedures for eLECTRONIC SUBMISSIONS
[8](#processing-procedures-for-electronic-submissions)

A. Gateway Information and Communication
[8](#gateway-information-and-communication)

B. E-mail Address [10](#e-mail-address)

C. Subject Line of E-mail [10](#subject-line-of-e-mail)

D. PDF File of Electronic Submission
[11](#pdf-file-of-electronic-submission)

E. Electronic Signature [11](#electronic-signature)

V. SECURITY MEASURES FOR ELECTRONIC SUBMISSIONS
[11](#security-measures-for-electronic-submissions)

A. Disclosure/Non-Disclosure [12](#disclosurenon-disclosure)

Protecting the Confidentiality of the Information in Electronic
Submissions
[12](#protecting-the-confidentiality-of-the-information-in-electronic-submissions)

Authentication Verification [12](#authentication-verification)

Unique Two-Part Electronic Signature
[12](#unique-two-part-electronic-signature)

Verification of the Sender\'s Identity
[13](#verification-of-the-senders-identity)

B. Verification of Date of Submission
[13](#verification-of-date-of-submission)

C. Submission Integrity [13](#submission-integrity)

VI\. CHECKLIST FOR ELECTRONIC SUBMISSIONS
[13](#checklist-for-electronic-submissions)

Guidance for Industry[^1]

How to submit information in Electronic Format by e-mail

# Introduction

This guidance provides general standards which should be used for the
submission of any information in electronic format to the Center for
Veterinary Medicine (CVM) by e‑mail.

**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.**

CVM's ability to receive and process information submitted
electronically is limited by its current information technology
capabilities and the requirements of the Electronic Records; Electronic
Signatures regulation, 21 CFR 11. The Center will accept certain types
of submissions by e-mail with no requirement for a paper copy. The list
of these submissions is published in the Electronic Submissions Docket
No. 92S-0251 (available on the FDA Home Page,
[http://www.fda.gov](http://www.fda.gov/)).

The Electronic Records; Electronic Signatures regulation (21 CFR 11)
requires that the Agency identify in the Electronic Submissions Docket
the types of documents or parts of documents acceptable for official
electronic submission.

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.

# Communication between CVM and industry

Successful electronic submission of information for review and
evaluation by e‑mail requires a successful partnership between CVM and
regulated industry. Information needs to be exchanged and errors need to
be resolved. The Center has set up a hotline to resolve any problems and
questions (301-827-8277). The sponsor should identify one person to be
the Sponsor Coordinator who will be responsible for communication with
the Center.

# REGISTRATION TO send ELECTRONIC SUBMISSIONS LISTED IN ELECTRONIC SUBMISSIONS DOCKET

### Agency Certification:

To participate in CVM's electronic submissions by e‑mail, the sponsor
provides certification to the Agency's Office of Regional Operations
that the sponsor's electronic signature is the legally binding
equivalent of the signer's handwritten signature as required by 21 CFR
11.100(c).

The suggested certification statement to provide is:

"Pursuant to Section 11.100 of Title 21 of the Code of Federal
Regulations, this is to certify that \[Company Name\] of \[Company
Address\] intends that all electronic signatures executed by our
employees, agents, or representatives, located anywhere in the world,
are the binding legal equivalent of traditional handwritten signatures."

### Center Registration:

In addition, CVM needs other information to ensure the confidentiality,
integrity, security, and authenticity of data submitted to the Center in
electronic format by e‑mail. This information includes the password that
will be used by individuals to submit information electronically on the
sponsor\'s behalf. Use of the password to encrypt information sent by
e-mail will help assure the security of submissions and together with an
individual e-mail address will constitute an electronic signature (21
CFR 11.200(a)).

Sponsors wishing to provide regulatory submissions in electronic format
to CVM register once for all types of submissions listed for CVM in the
Electronic Submissions Docket. If a regulated sponsor 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 information.

## Sponsor Registration and Password Initialization

Sponsors wishing to submit information electronically should send a
single, original, signed paper registration letter to CVM. In an
attachment to this letter, the sponsor should identify:

-   The name, mailing address, phone number, and e‑mail address of the
    Sponsor Coordinator;

-   The name, mailing address, phone number, and e‑mail address for each
    person who will be submitting information electronically;

-   The password used to encrypt the electronic registration letter that
    will be submitted by e‑mail. This password will be used by CVM to
    encrypt the response to the registration letter; and

-   The subject of the letter should be **Registration Letter for
    Electronic Submission to CVM** to clearly identify the purpose of
    the letter.

An encrypted, identical electronic copy of the registration letter
should be sent by e‑mail to cvmdcu@fda.hhs.gov with the subject line of
the e-mail reading **REGISTER**. CVM will decrypt the electronic
registration letter with the password identified in the paper copy of
the registration letter.

The Center will send two acknowledgements to the sponsor: (1) a paper
letter acknowledging receipt of the registration and stating that the
sponsor appears to be able to make electronic submissions that are
compatible with CVM\'s current technology, (2) after CVM successfully
accesses the electronic registration letter, an electronic receipt for
the registration letter, by e‑mail, to the Sponsor Coordinator as an
encrypted Portable Document Format (PDF) file (compatible with Adobe^®^
Acrobat^®^ version 5.05)[^2].

### Example of Registration Letter

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

HFV-199

Attention: Lesley Groves

Office of New Animal Drug Evaluation\
Center for Veterinary Medicine\
7500 Standish Place\
Rockville, Maryland 20855

Subject: Registration Letter for Electronic Submission to CVM

To Whom It May Concern:

This letter notifies the Center for Veterinary Medicine (CVM) of our
intent to use e‑mail to submit documents listed in the Electronic
Submissions Docket No. 92S‑0251. An attachment to this registration
letter contains the name of the person who will serve as our Sponsor
Coordinator and the names of the persons who will be submitting
electronic information, along with their mailing addresses, phone
numbers, e‑mail addresses, and a password for initializing the
Electronic Submission System.

We have certified to the Food and Drug Administration, Office of
Regional Operations, that the electronic signatures used to submit
information on our behalf are intended to be the legally binding
equivalent of traditional handwritten signatures.

We are submitting an electronic copy of this request to cvmdcu@fda.gov
encrypted with our password.

We look forward to receipt of CVM\'s letter acknowledging our intent to
submit information by e‑mail and stating that we appear to be able to
make electronic submissions that are compatible with CVM\'s current
technology.

Sincerely yours,

Attachment

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

## Creating Individual Passwords and Using the Electronic Submission System (ESS)

After receiving the paper and electronic acknowledgements, the Sponsor
Coordinator and each person submitting electronic submissions should
choose an individual password and notify CVM ESS of the new password
using [Form]{.smallcaps} FDA 3538 (Electronic Submission System
Participant Password or Addition) by an e‑mail message sent to
cvmdcu@fda.hhs.gov.

-   Each person should fill out part I of [form]{.smallcaps} FDA 3538.

-   The subject line of this e‑mail message should be **MANAGE**.

-   Passwords should be changed prior to sending your first electronic
    submission to the ESS. The new password should not be used until the
    acknowledgment has been received from CVM of a successful password
    change

Passwords should be changed after an appropriate period of time to
assure security. CVM will monitor the aging of passwords and suggest
re‑initialization periodically. Changes to passwords follow the same
process used to establish the initial password change using
[form]{.smallcaps} FDA 3538.

Any registered user can send a blank e-mail message with the subject
line of **ECHO** to confirm that they are recognized by the ESS. The
system will respond with basic information confirming the identity of
the sender and that the ESS is functioning.

## Adding New Participants to a Registered Sponsor

The Sponsor Coordinator may add participants to the ESS by using
[form]{.smallcaps} FDA 3538 sent to cvmdcu@fda.hhs.gov.

-   The Sponsor Coordinator should fill out all fields in part II of
    [form]{.smallcaps} FDA 3538.

-   The subject line of this e‑mail message should be **MANAGE**.

## Other Changes to the Sponsor Registration

The Sponsor Coordinator may request changes in electronic submission
registration. These changes may include, but are not limited to,
removing an authorized sender, adding or removing a Sponsor Coordinator,
changes to e‑mail addresses, changes to sponsor names, etc.

To request a change, the Sponsor Coordinator should send an e‑mail
message to cvmdcu@fda.hhs.gov with the subject line of **CHANGE**. The
e‑mail message should have a PDF file attached that has been encrypted
by the Sponsor Coordinator's password. The attached PDF file should
contain the specified change(s) that the Sponsor Coordinator is
requesting.

This does not include any changes to an individual password. See Section
III.B of this document for those changes.

# Processing procedures for eLECTRONIC SUBMISSIONS

Information transmitted to CVM by e‑mail should adhere to minimum
standards to ensure confidentiality, integrity, security and
authenticity. CVM can process only submissions that comply with the
Electronic Records; Electronic Signatures regulation. In addition,
procedures described in this guidance take into consideration the
current information technology capabilities of CVM. Adherence to these
standards is verified by the Center\'s e‑mail processing, and generally
only submissions in full compliance can be successfully processed as
electronic submissions. If sponsors wish to use a different approach,
they should discuss it first with CVM.

Sponsors should send each electronic submission as a PDF file
(compatible with Adobe^®^ Acrobat^®^ version 5.05) attached to an
e‑mail. Each e‑mail with the attached submission should be sent to
cvmdcu@fda.hhs.gov. Submissions are acknowledged with a receipt issued
within two working days from CVM confirming the submission was
successfully processed.

## Gateway Information and Communication 

The configuration of a sponsor\'s e‑mail software or Internet gateway is
critical to the successful interchange of electronic information with
CVM over the Internet. Electronic mail formats are not completely
standardized, however, most gateways can be configured to accommodate
the more recent and reliable formats. Many gateways limit the size of
attachments allowed. Therefore, for the purpose of interchange with CVM,
the attachment size should be limited to no more than 50 Megabytes (50
MB).

The CVM gateway should have a MIME type e‑mail encoding of the level
that allows 8‑bit or binary attachments for sending e‑mail with an
attachment.

The sponsor\'s e‑mail software or Internet gateway should be configured
to generate \"MIME-Version: 1.0\" in the header field and recognize the
Content‑Transfer‑Encoding header field in the e‑mail message. It should
be able to decode all received data encoded by either quoted-printable
or Base64 implementation and be able to encode and label 8-bit or binary
data using a Content-Transfer-Encoding type of either quoted-printable
or Base64 as appropriate. This will allow attached password-encrypted
PDF files to be transmitted as part of the transmission package.

The sponsor's e‑mail software or Internet gateway should explicitly
handle the following media type values:

Text:

-   It should recognize and display \"text\" mail with the character set
    US‑ASCII.

-   It should recognize other character sets at least to the extent of
    being able to inform the user about what character set the message
    uses.

-   It should recognize the ISO-8859 character sets to the extent of
    being able to display those characters that are common to the
    ISO-8859 and US‑ASCII, namely all characters represented by octet
    values 1-127.

Multi-part and application:

-   It should at a minimum provide facilities to treat any unrecognized
    subtypes as if they were \"application/octet-stream."

-   It should offer the ability to remove either of the quoted-printable
    or Base64 encoding defined in this document if they were used and
    put the resulting information in a user file.

-   It should recognize a mixed subtype and display all relevant
    information on the message level and the body part header level and
    then display or offer to display each of the body parts
    individually.

The following is an example of the items in an Internet e‑mail header
that CVM uses to identify the sender, the function, or the type of the
e‑mail.

The table below shows most of the fields in a typical RFC822 header.

  ---------------------------- ----------------------------------------------------
  **[Field]{.underline}**      **[Example]{.underline}**

  From:                        Sponsorcontact@sponsor.com

  To:                          Cvmdcu@fda.hhs.gov

  Cc:                          Sponsorcoordinator@sponsor.com

  Subject:                     Email Configuration

  Date:                        11 May 1998 16:11:43 --0400

  Importance:                  Normal

  Mime-Version:                1.0

  Content-Type:                Multipart/mixed;
                               boundary=\"\_\_NextPart\_\_11:05:1998\_(27624)\"

  Content-Transfer-Encoding:   7bit
  ---------------------------- ----------------------------------------------------

When a multipart MIME message is assembled, the text will have a set of
lines such as this in front of it, including the part boundary string
that was specified in the header.

The example immediately below uses the ISO-8859-1 character set rather
than US‑ASCII, but limits the characters to 7-bit, that is octets
ranging from 1-127:

\_\_NextPart\_\_11:05:1998\_(27624)

Content-Type: text/plain; charset=iso-8859-1

Content-Transfer-Encoding: 7bit

The lines in the example below might precede an attached file called
cvmform.pdf:

\_\_NextPart\_\_11:05:1998\_(27624)

Content-Type: application/octet-stream; name=cvmform.pdf

Content-Transfer-Encoding: base64

Note that the content is identified simply as
\"application/octet-stream\". If PDF had been defined to the originating
e‑mail agent, it might have been identified as \"application/pdf\". If
PDF was defined to the receiving agent as a type that should be
processed by Adobe^^ Acrobat^^, the agent would launch Acrobat^^ to
view the file. When the receiving agent does not recognize the
Content-Type, it should treat it as \"application/octet-stream," decode
it, and offer the recipient the option to save it as a user file.

## E-mail Address

Sponsors should register their e‑mail addresses with CVM as outlined in
Section III. This will allow CVM to process the sponsors' submissions.
The e‑mail address registered with CVM should match exactly the e‑mail
address of the received submission.

## Subject Line of E-mail

The subject line is an integral part of CVM's processing of electronic
information submitted by e‑mail. Each electronic submission of
information is identified, checked, and processed based on the subject
line of the e‑mail message. The subject line for an e‑mail message
containing an attached submission should be the single word identified
in the appropriate guidance. It should be only the single word,
capitalized, non-quoted, and should contain no special characters. Any
additional information in the subject line will cause a fatal error and
CVM will not be able to process the submission.

The following are subject lines which should be used for electronic
submission to CVM.

  --------------------- ----------------------------------------------------
  **[Subject            **[Type of Electronic Submission]{.underline}**
  Line]{.underline}**   

  **REGISTER**          Electronic copy of registration letter specifying
                        sponsor\'s intent to submit information
                        electronically

  **CHANGE**            Electronic notification of changes in conditions of
                        registration

  **MANAGE**            Electronic request to change an individual password
                        or add new participants to registered sponsors using
                        [form]{.smallcaps} FDA 3538

  **ECHO**              No submission -- blank e-mail will respond with
                        electronic acknowledgement to registered sender
  --------------------- ----------------------------------------------------

## PDF File of Electronic Submission

For purposes of any electronic submission, the sponsor should use the
appropriate format provided by CVM, which should be submitted to CVM as
an encrypted PDF file (compatible with Adobe^®^ Acrobat^®^ version 5.05)
attached to an e‑mail message. Forms for electronic submissions are
available on CVM's Home Page, <http://www.fda.gov/cvm>.

There should be only one PDF attachment per e‑mail, and it should be no
larger than 50 Megabytes (50 MB) in size. It should conform to the
format and standards for the specific type of electronic submission as
detailed in the appropriate guidance. The Center\'s automated processing
performs a check of the number of attachments and will not process an
electronic submission with more than one attachment.

Sponsors should use ISO 9660 Interchange Level 1 file naming convention,
i.e., up to 8 characters (A-Z, 0-9, and \_) for the file name and PDF
for the file extension (8.3 naming convention); an example using this
convention would be filename.PDF.

## Electronic Signature

Each person who intends to submit electronic submissions will have a
unique electronic signature to verify the sender\'s identity. The unique
electronic signature will consist of the sender\'s e‑mail address and
the individual's password.

This password should consist of **12** case-sensitive alphanumeric
characters. The sender uses the password to encrypt the file before
transmitting it to CVM. Only CVM\'s electronic submission system and the
person who submits the electronic submission should know the password
and be able to open the file.

CVM will acknowledge each electronic submission by creating a new e‑mail
message (i.e., not by using a \"Reply\" feature) and sending the
acknowledgement to the sender. CVM's acknowledgement will be a
password-encrypted message attached to an e‑mail message. CVM will use
the individual's password to encrypt the file.

Individuals who submit information electronically must follow the
electronic signature requirements described in 21 CFR 11.100-11.300.
These requirements must be followed for CVM to accept electronic
submissions as the official copy, instead of paper. If sponsors are not
capable of meeting these requirements sponsors must submit information
on paper.

# SECURITY MEASURES FOR ELECTRONIC SUBMISSIONS

Corporations have used the Internet as an expeditious vehicle for the
exchange of information for several years. However, many corporations
and government agencies have avoided using the Internet for the exchange
of sensitive and/or confidential information because of concerns about
security. In developing an electronic submission project using the
Internet as the message‑carrying vehicle, four areas of security should
be addressed adequately by all participants prior to its adoption.

## Disclosure/Non-Disclosure

Information submitted to CVM is subject to the Freedom of Information
Act and FDA\'s regulations on public information at 21 CFR Parts 20 and
514. Some information, such as trade secrets, certain commercial and
financial information is confidential in nature and is non-disclosable.
Therefore, using the Internet to submit confidential information can be
done only with adequate encryption. CVM currently recommends that this
encryption be in the form of a password-protected PDF file. CVM will
continue to monitor and assess the adequacy of this level of security
and determine whether or not a different encryption method is necessary.

### Protecting the Confidentiality of the Information in Electronic Submissions

The ESS will only accept encrypted PDF files to protect the
confidentiality of submitted information. The person submitting the
electronic information should encrypt the file with his/her password.

### Authentication Verification

Currently, CVM receives paper submissions from sponsors by US Postal
Service, Federal Express, United Parcel Service, etc. With these
submissions, there is a cover letter on sponsor letterhead signed by an
authorized sponsor official. This information allows CVM to authenticate
that the submission is from the stated sponsor. Any electronic
submission should also provide a means by which CVM can authenticate the
origin of the electronic document, such as the unique two-part
electronic signature.

### Unique Two-Part Electronic Signature

The registration letter should contain the name and e‑mail address for
each authorized sender. Subsequent to the receipt of CVM\'s
acknowledgment letter for the registration, each sender should submit to
CVM ESS a password change using [form]{.smallcaps} FDA 3538 as described
in Section III.B of this guidance. The unique combination of the e‑mail
address and the password will serve as the electronic signature under 21
CFR 11.200(a)(1) and will authenticate the identity of the sender. CVM
will maintain a database of electronic signatures and will automatically
reject any electronic submission received that does not match the unique
combination of e‑mail address and password.

### Verification of the Sender\'s Identity

An additional precaution will be taken to ensure that the e‑mail message
received at CVM did indeed come from the sender designated. CVM will
acknowledge receipt of the electronic submission as described in section
IV. If a sender receives an acknowledgment but has not sent an e‑mail to
CVM, he/she should immediately report this to CVM by telephone to
301-827-8277.

## Verification of Date of Submission

Currently, time-sensitive information is submitted by certified mail so
that the sponsor has a record verifying the date and name of an
individual who received the information at CVM. This also provides a
legal basis by which drug sponsors can assert their compliance with laws
and regulations.

Currently, CVM uses the date on the cover letter to determine whether
information was submitted within the time required by statute or
regulation. If CVM is able to open and read the file, the date within
the file will serve as the date of submission.

## Submission Integrity

The integrity of the content of a submission to CVM is the
responsibility of the sponsor. If sections of a paper submission are
missing or illegible, CVM requires the sponsor to provide copies of the
missing or illegible information. A remote possibility exists that
intentional or unintentional changes could be made to an electronic
submission that could not be made to a paper submission. For example,
unintentional \"scrambling\" of the submission may occur during
transmission so that CVM receives a corrupted, unusable file. Further, a
submission could be intentionally changed if a message is intercepted
en route, changes are made to the content and then the message is sent
on as if from the original sender.

CVM will rely on the password encryption of the PDF file to ensure the
integrity of the electronic submission. If the file is received by CVM
intact and can be decrypted and opened by Adobe^^ Acrobat^^, then CVM
will assume no changes occurred to the submission once it was e‑mailed
from the sponsor. If CVM receives a corrupted file and can identify who
the sender is, CVM will notify the sender that its file was corrupted
and the sender should resubmit the file.

# CHECKLIST FOR ELECTRONIC SUBMISSIONS

To make electronic submissions, sponsors should:

1.  Have MIME (base64) compliant access to the Internet. See Section
    IV.A for details.

```{=html}
<!-- -->
```
1.  Use the appropriate form provided by CVM.

```{=html}
<!-- -->
```
1.  Conform to an ISO 9660 Interchange Level 1 compatible naming
    convention for PDF files e‑mailed to CVM. The name of the attached
    file should be 8 characters or less with the letters PDF as an
    extension, i.e., xxxxxxxx.PDF. See Section IV.D for details.

```{=html}
<!-- -->
```
1.  Register with CVM once for all types of submissions listed in the
    Electronic Submissions Docket.

REGISTRATION PROCESS (See Section III for details.):

1.  Send a single, original, signed registration letter to CVM. See
    Section III.A. for an example of the registration letter. The letter
    should contain:

    a.  the name, mailing address, phone number, and e‑mail address of
        the Sponsor Coordinator;

    b.  the names, mailing addresses, phone numbers, and e‑mail
        addresses for each person who will submit electronic
        submissions;

    c.  a 12 character, case-sensitive alphanumeric character sponsor
        password. See Section III.A for details; and

    d.  the subject of letter should be **Registration Letter for
        Electronic Submission to CVM** to clearly identify the purpose
        of the letter.

2.  Create a PDF copy of the registration letter. Encrypt the PDF file
    with the sponsor password, attach it to an e‑mail message, and send
    it to cvmdcu@fda.hhs.gov. The subject line of the e‑mail message
    should be the word **REGISTER**.

3.  CVM will send an e-mail to the Sponsor Coordinator named in the
    registration letter. The message will have an encrypted PDF file
    attached containing an acknowledgment of receipt of the registration
    letter. The password necessary to decrypt the PDF file receipt will
    be the sponsor password sent in the registration letter. A paper
    response will also be sent. If the sponsor has not received both of
    these acknowledgments within 30 days contact CVM by calling the
    electronic Document Control Unit at 301-827-8277.

4.  The Sponsor Coordinator and each identified contact should choose an
    individual password before sending an electronic submission.
    Directions for informing CVM of the new individual password will be
    included in the Center\'s response to the registration letter. The
    subject line of the e‑mail message should be **MANAGE**. See Section
    III.B of this guidance for details.

5.  The sponsor should not send an electronic submission until CVM
    acknowledges the receipt of an individual password by e‑mail.

[^1]: This guidance has been prepared by CVM at FDA. For additional
    copies, access the document on the Internet at 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]: FDA use of specific products does not constitute an endorsement of
    that product.