Guidance for Industry: How to Submit a Request for a Meeting or Teleconference in Electronic Format by E-Mail

88
Guidance for Industry
How to Submit a Request for a Meeting or
Teleconference 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 instruction on how to submit a request
for a meeting or teleconference in electronic format by e-mail to the Office of New
Animal Drug Evaluation (ONADE) at 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: [email protected].
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 0910-0452. The time required to complete this information
collection is estimated to vary from 15 minutes to 2 hours 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

Page 1

Table of Contents
I.

INTRODUCTION .........................................................................................................3

II.

REQUEST FOR A MEETING OR TELECONFERENCE FORM ..............................4

III.

CHECKLIST FOR ELECTRONIC SUBMISSION OF A REQUEST FOR A
MEETING OR TELECONFERENCE USING FORM FDA 3489...............................5

Page 2

CONTAINS NON-BINDING RECOMMENDATIONS

GUIDANCE FOR INDUSTRY1
HOW TO SUBMIT A REQUEST FOR A MEETING OR
TELECONFERENCE IN ELECTRONIC FORMAT BY
E-MAIL
This guidance represents the Agency’s current thinking on how to submit a
request for a meeting or teleconference in electronic format to the Office of
New Animal Drug Evaluation by e-mail. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. You can
use an alternative approach if the approach satisfies the requirements of the
applicable statue and regulations. If you want to discuss an alternative
approach, contact the FDA staff responsible for implementing this guidance.
If you cannot identify the appropriate FDA staff, call the appropriate number
listed on the title page of this guidance.

I.

INTRODUCTION
This guidance provides advice to industry regarding the procedures to submit a
request for a meeting or teleconference in electronic format to the Office of New
Animal Drug Evaluation 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.
Any person intending to file a new animal drug application or abbreviated new
animal drug application is entitled to request meetings and/or teleconferences to reach
agreement regarding a submission or investigational requirement (21 USC
3606(b)(3)). Every person outside the Federal Government may request a meeting
with representative(s) of FDA to discuss a matter (21 CFR 10.65(c)). This guidance
document describes the procedures that should be followed by persons who submit a
request for a meeting or teleconference to the Office of New Animal Drug Evaluation
in electronic format by e-mail. The procedures are designed to ensure compliance
with FDA’s regulations governing Electronic Records found in 21 CFR Part 11,
taking into account CVM’s current information technology capability and its ability
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.

Page 3

CONTAINS NON-BINDING RECOMMENDATIONS
to ensure the confidentiality, integrity, security and authentication of data submitted
to the Center in electronic format by e-mail.
To submit a request for a meeting or teleconference electronically, the sponsor should
use the Request for a Meeting or Teleconference form provided by CVM (FORM FDA
34892 OMB No. 0910-0452). The sponsor should enter the data directly into an
Adobe® Acrobat® form, attach the Agenda for the meeting, and submit the form to
CVM as an Adobe® PDF file (compatible with Adobe® Acrobat® 5.05).3
The electronic submission of a request for meeting or teleconference is part of the
Center’s ongoing initiative to provide a method for paperless submissions.
The meeting and teleconference requests should be submitted by an 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. CVM
will assign an Electronic Submissions System (ESS) password for each participant, 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 attached to an email message. A sponsor
should attach only one meeting request 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 the
requirements of Part 11 are met (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 meeting request
electronically, the sponsor should consult with CVM regarding alternative methods
for electronic submission that meet the requirements of Part 11 or submit the request
in paper.

II.

REQUEST FOR A MEETING OR TELECONFERENCE FORM
A copy of FORM FDA 3489 Request for a Meeting or Teleconference (for use with
electronic submissions) is available on the CVM Electronic Submission Page at
http://www.fda.gov/cvm/index/esubs/esubstoc.html.

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.

Page 4

CONTAINS NON-BINDING RECOMMENDATIONS

III.

CHECKLIST FOR ELECTRONIC SUBMISSION OF A REQUEST
FOR A MEETING OR TELECONFERENCE USING FORM FDA
3489

Note these instructions are for Adobe Acrobat 5.0. Other versions may be different.
A sponsor submitting an electronic request for a meeting or teleconference should
create an agenda as a single Portable Document Format (PDF) file. This file will be
attached to the FORM FDA 3489. This checklist describes the process sponsors
should follow to fill out the form, attach the agenda, and submit the information
1. Open the Meeting Request FORM FDA 3489.
2. Fill in all of the applicable fields of FORM FDA 3489.
3. If the “Multiple Documents” box in A2 is selected, up to 20 documents can be
entered into the fields provided. If you are amending a pending meeting request
involving multiple documents, then you must enter all of pending documents
being amended in the fields provided. If the “Multiple Documents” box is not
selected, enter the single document information in A3.
4. Select the “Insert Comments” button to add a PDF file containing any comments
regarding the meeting request.
5. Select the “Insert Agenda” to add the PDF file containing the Agenda. The form
cannot be successfully validated until an agenda has been attached.
6. 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.
7. Select the “Add Password” button to change Document Security
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.
8. Select the “Save” button to save all changes in the form.
9. The “Signature” button is currently disabled on the form.
10. Once the form is validated and secured, select the “Send to CVM” button.
a) The form will be automatically addressed to [email protected]. Additional
addresses can be added to the addressee and/or the cc block.
b) The form automatically adds “MEETING” as the subject line.
11. 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

Page 5

CONTAINS NON-BINDING RECOMMENDATIONS
Unit at 301-827-8277 to report the problem and find out what happened to your
submission.
After review of the agenda and proposed dates, CVM will contact the sponsor to
finalize details of the meeting.

Page 6