Guidance for Industry
Providing Regulatory Submissions
in Electronic Format 
General Considerations
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologic Evaluation and Research (CBER)
January 1999
IT 2 Guidance for Industry
Providing Regulatory Submissions in
Electronic Format 
General Considerations
Additional copies are available from:
Office of Training and Communications
Division of Communications Management
Drug Information Branch, HFD-210
5600 Fishers Lane
Rockville, MD  20857
(Tel) 301-827-4573
(Internet)  http://www.fda.gov/cder/guidance/index.htm
or
Office of Communication,
Training, and Manufacturers Assistance (HFM-40)
Center for Biologics Evaluation and Research (CBER)
1401 Rockville Pike, Rockville, MD 20852-1448
http://www.fda.gov/cber/guidelines.htm
(Fax) 888-CBERFAX or 301-827-3844
(Voice Information) 800-835-4709 or 301-827-1800
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
Center for Biologics Evaluation and Research (CBER)
January 1999
IT 2
2 TABLE OF CONTENTS
I. INTRODUCTION.....................................................................................................4
II.  BACKGROUND.......................................................................................................4
III. WHAT FILE FORMATS SHOULD I USE FOR ELECTRONIC DOCUMENTS?6
A.Version..................................................................................................................7
B. Fonts......................................................................................................................7
C. Page Orientation...................................................................................................8
D.Page Size and Margins..........................................................................................8
E. Source of Electronic Document............................................................................8
F. Methods for Creating PDF Documents and Images..............................................8
G.Hypertext Linking and Bookmarks.......................................................................9
H.Page Numbering.................................................................................................10
I. Document Information Fields..............................................................................10
J. Open Dialog Box.................................................................................................10
K.Naming PDF Files..............................................................................................10
L. Security................................................................................................................11
M.Indexing PDF Documents...................................................................................11
N.Plug Ins...............................................................................................................11
O.Electronic Signatures..........................................................................................12
IV. WHAT FILE FORMATS SHOULD I USE FOR ELECTRONIC
DATASETS ?..........................................................................................................12
A.SAS System XPORT Transport Format
(Version 5 SAS Transport Format)..........................................................................12
B. Other Dataset Formats........................................................................................13
V. WHAT ARE THE PROCEDURES FOR SENDING ELECTRONIC
SUBMISSIONS FOR ARCHIVE ?.........................................................................14
A.CDER..................................................................................................................14
B. CBER..................................................................................................................14
VI. WHAT TYPE OF MEDIA SHOULD I USE?........................................................15
VII. HOW SHOULD I PREPARE THE MEDIA FOR ELECTRONIC SUBMISSIONS
FOR ARCHIVE ?....................................................................................................15
VIII. HOW DO THE CENTERS PROCESS ELECTRONIC SUBMISSIONS
FOR ARCHIVE?.....................................................................................................16
A.CDER..................................................................................................................16
B. CBER..................................................................................................................16
IX. WHAT IF I HAVE A QUESTION ?.......................................................................17
A.CDER..................................................................................................................17
B. CBER..................................................................................................................17
3 1
GUIDANCE FOR INDUSTRY
Providing Regulatory Submissions in Electronic Format 
General Considerations
I. INTRODUCTION
This is one in a series of guidance documents intended to assist you when making
regulatory submissions in electronic format to the Center for Drug Evaluation and
Research (CDER) and the Center for Biologics Evaluation and Research (CBER), Food
and Drug Administration (FDA).  This guidance discusses general issues common to all
types of electronic regulatory submissions.  In some cases, the guidance for one center
differs from that for the other center because of differences in procedures and in the
computer infrastructures in the centers.  We will work to minimize these differences
wherever possible.
Agency guidance documents on electronic regulatory submissions will be updated
regularly to reflect the evolving nature of the technology involved and the experience of
those using this technology.
II.  BACKGROUND
In the Federal Register of March 20, 1997 (62 FR 13430), the FDA published the
Electronic Records; Electronic Signatures regulations (21 CFR Part 11). This regulation
provided for the voluntary submission of parts or all of regulatory records in electronic
format without an accompanying paper copy. Publication of this regulation resulted in a
series of related actions:
                                                
1 This guidance has been prepared by the Center for Drug Evaluation and Research (CDER) and the
Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration.  This
guidance document represents the Agency's current thinking on regulatory submissions in electronic
format.  It does not create or confer any rights for or on any person and does not operate to bind FDA or the
public.  An alternative approach may be used if such approach satisfies the requirements of the applicable
statute, regulations, or both.
On June 1, 1998, the President instructed all Federal agencies to ensure the use of plain language in
all new documents.  This guidance reflects Agency efforts to comply with the President's plain language
initiative.
4 March 1997:
The Agency established public docket number 92S-0251 to provide a permanent
location for a list of the Agency units that are prepared to receive electronic
submissions and the specific types of regulatory records that can be accepted in
electronic format (62 FR 13467, March 20, 1997).  This docket can be accessed
on the Internet at
http://www.fda.gov/ohrms/dockets/dockets/92s0251/92s0251.htm.
September 1997:
CDER published a guidance for industry entitled Archiving Submissions in
Electronic Format  NDAs (62 FR 49695, September 23, 1997) to assist
applicants wanting to make electronic submissions of case report forms (CRFs)
and case report tabulations (CRTs) as part of the NDA archival submission.
April 1998:
CDER issued a draft guidance for industry, Providing Regulatory Submissions in
Electronic Format  NDAs, which expanded on the September 1997 guidance by
providing information on submitting a complete archival copy of the NDA in
electronic format (63 FR 17185; April 8, 1998).
June 1998:
CBER published the following draft guidances to assist applicants in their efforts
to submit electronic documents to the Center for review and archive as part of
their BLA or PLA/ELA submissions:
Electronic Submissions of a Biologics License Application (BLA), Product
License Application (PLA) /Establishment License Application (ELA) to the
Center for Biologics Evaluation and Research (63 FR 29741, 6/1/98).
Electronic Submissions of Case Report Forms (CRFs), Case Report
Tabulations(CRTs) and Data to the Center for Biologics Evaluation and Research
(63 FR 29739; 6/1/98).
Pilot Program for Electronic Investigational New Drug (eIND) Applications for
Biological Products (63 FR 29740; 6/1/98).
Instructions for Submitting Electronic Lot Release Protocols to the Center for
Biologics Evaluation and Research (63 FR 29742; 6/98).
5 January 1999:
CDER and CBER finalized this joint guidance on general considerations for
electronic submissions.  Subsequent guidances will focus on specific submission
types.
The Agency envisions the series of guidance documents on electronic regulatory
submissions to provide guidance on the following:
  General considerations for all electronic submissions (e.g., file formats)
  NDAs to CDER (including supplements and amendments)
  Marketing Applications to CBER (e.g., BLAs, PLAs, ELAs, NDAs)
  Abbreviated New Drug Applications (ANDAs)
  Postmarketing Safety Reports
  Investigational New Drug Applications (INDs)
  Annual Reports
  Drug Master Files (DMFs)
  Launch Material
  Advertising
  Other
As individual documents are completed, they will be issued first in draft for comment,
then finalized and added to the series.  The guidances will be updated regularly to reflect
the continuously evolving nature of the technology and experience of those using this
technology.
III. WHAT FILE FORMATS SHOULD I USE FOR ELECTRONIC
DOCUMENTS?
Regulations in 21 CFR Part 11 require that the Agency be able to generate from any
document provided in electronic format an accurate and complete paper copy that is both
legible ("human readable") and suitable for inspection, review, and copying.  Therefore,
documents submitted in electronic format should:
  Enable the user to easily view a clear and legible copy of the information
  Enable the user to print each document page by page, as it would have
been provided in paper, maintaining fonts, special orientations, table
formats, and page numbers
  Include a well-structured table of contents and allow the user to navigate
easily through the submission
6   Allow the user to copy text and images electronically into common word
processing documents
To achieve the above goals, you should submit all electronic documents in Portable
Document Format (PDF).  CDER and CBER are prepared to archive documents provided
as PDF files. PDF is an open, published format created by Adobe Systems Incorporated
(http://www.adobe.com). You do not need to use a product from Adobe or from any
specific company to produce your PDF documents.  PDF has been accepted as a standard
for providing documents in electronic format by the International Conference on
Harmonisation (ICH).
The following recommendations will help you create PDF files that we can review and
archive.
A. Version
We should be able to read all PDF files with version 3.0 of the Acrobat Reader
with the search plug in.  We should not need any additional software to read and
navigate the PDF files.
B. Fonts
PDF viewing software automatically substitutes a font to display text if the font
used to create the text is unavailable on the reviewers computer.  Font
substitution can affect a documents appearance and structure, and in some cases
it can affect the information conveyed by a document.  We cannot guarantee the
availability of any one font.  Therefore, you should embed all fonts you are using
in the PDF files to ensure that those fonts will always be available to the reviewer.
When embedding fonts, all characters for the font should be embedded, not just a
subset of the fonts being used in the document.
One problem associated with embedding fonts is that embedding requires
additional computer storage space.  Three techniques to help limit the storage
space taken by embedding fonts include:
  Limiting the number of fonts used in each document
  Using only True Type or Adobe Type 1 fonts
  Avoiding customized fonts
Resizing a document because the contents are too small to read is inefficient.  We
believe that Times New Roman, 12-point font, the font used for this document, is
adequate in size for reading narrative text.  Although sometimes tempting for use
in tables and charts, fonts smaller than 12 points should be avoided whenever
possible.
7 We recommend the use of a black font color.  Blue font may be used for hypertext
links (preferred for submissions to CBER).  If a font color other than black is
used, avoid light colors that do not print well on grayscale printers.  You can test
the color reproduction prior to submission by printing sample pages from the
document using a grayscale printer.
C. Page Orientation
Pages should be properly oriented.  For example, you should set the page
orientation of landscape pages to landscape prior to saving the PDF document in
final form to ensure correct page presentation.
D. Page Size and Margins
The print area for pages should fit on a sheet of paper that is 8.5 inches by 11
inches.  You should allow a margin of at least 1 inch on all sides to avoid
obscuring information if the pages are subsequently printed and bound.
E. Source of Electronic Document
PDF documents produced by scanning paper documents are usually inferior to
those produced from an electronic source document.  Scanned documents are
more difficult to read and do not allow us to search or copy and paste text for
editing. They should be avoided if at all possible. If you use optical character
recognition software, you should verify that all imaged text converted by the
software is accurate.
F. Methods for Creating PDF Documents and Images
Choose a method for creating PDF documents that produces the best replication
of a paper document.  You can ensure that the paper and PDF version of the
document are the same by printing the document from the PDF version.
Documents that are available only in paper should be scanned at resolutions that
will ensure the pages are legible both on the computer screen and when printed.
At the same time, you should also limit the file size.  We recommend scanning at
a resolution of 300 dots per inch (dpi) to balance legibility and file size.  We
discourage the use of grayscale or color because of file size.  After scanning,
avoid resampling to a lower resolution.
When creating PDF files containing images, you should not resample images.
Resampling does not preserve all of the pixels in the original.  For PDF images,
you can use one of the following lossless compression techniques (with the
8 exception that, when submitting to CBER, standard radiographic images, PET,
and SPECT images should not be compressed).
  For lossless compression of color and grayscale images, use Zip/Flate (one
technique with two names).  This is specified in Internet RFC 1950 and
RFC 1951 (http://info.internet.isi.edu/in-notes/rfc/files/rfc1950.txt).
  For lossless compression of black and white images, use the CCITT Group
4 Fax compression technique.  It is specified as CCITT recommendations
T.6 (1988) - Facsimile coding schemes and coding control functions for
Group 4 facsimile apparatus.
Paper documents containing handwritten notes should be scanned at 300 dpi.
Handwritten notes should be done in black ink for clarity.
For photographs, the image should be obtained with a resolution of 600 dpi.  If
black and white photos are submitted, consider 8-bit gray scale images.  If color
photos are submitted, consider 24-bit RGB images.  A captured image should not
be subjected to nonuniform scaling (i.e., sizing).
Gels and karyotypes should be scanned directly, rather than from photographs.
Scanning should be at 600 dpi and 8-bit grayscale depth.
Plotter output graphics should be scanned or captured digitally at 300 dpi.
High-pressure liquid chromatography or similar images should be scanned at 300
dpi.
G. Hypertext Linking and Bookmarks
Hypertext links and bookmarks are techniques used to improve navigation
through PDF documents.  Hypertext links can be designated by rectangles using
thin lines or by blue text (the latter is preferred by CBER).  In CDER, you can use
invisible rectangles for hypertext links in a table of contents to avoid obscuring
text. Recommendations for hypertext linking and bookmarks are provided in the
guidance for the specific submission type.
In general, for documents with a table of contents, provide bookmarks and
hypertext links for each item listed in the table of contents including all tables,
figures, publications, other references, and appendices.  These bookmarks and
hypertext links are essential for the efficient navigation through documents. In
general, including a bookmark to the main table of contents for a submission or
item is helpful. Make the bookmark hierarchy identical to the table of contents.
Avoid using bookmark levels in addition to those present in the table of contents.
9 Each additional level increases the need for space to read the bookmarks.  We
recommend using no more than 4 levels in the hierarchy.
Hypertext links throughout the body of the document to supporting annotations,
related sections, references, appendices, tables, or figures that are not located on
the same page are helpful and improve navigation efficiency.  Use relative paths
when creating hypertext linking to minimize the loss of hyperlink functionality
when folders are moved between disk drives.  Absolute links that reference
specific drives and root directories will no longer work once the submission is
loaded onto our network servers.
When creating bookmarks and hyperlinks, choose the magnification setting
Inherit Zoom so that the destination page displays at the same magnification level
that the reviewer is using for the rest of the document.
H. Page Numbering
If a submission includes more than one document, you need not provide
pagination for the entire submission.  Include page numbers only for individual
documents.
It is easier to navigate though an electronic document if the page numbers for the
document and the PDF file are the same.  To accomplish this, the initial page of
the paper document should be numbered page 1.
I. Document Information Fields
Document information fields are used to search for individual documents and to
identify the document when found.  Recommendations for the document
information fields will be provided in the guidance for the specific submission
type.
J. Open Dialog Box
The open dialog box sets the document view when the file is opened.  The initial
view of the PDF files should be set as Bookmarks and Page.  If there are no
bookmarks, set the initial view as Page only.  Set the Magnification and Page
Layout to default.
K. Naming PDF Files
We are recommending names for folders and selected files in individual
guidances for specific submission types.  For uniformity, we hope that you use
our specific naming conventions when they are provided.  Reviewers are trained
to look for these folders and files, and using the recommended names should help
10 avoid misunderstandings, improve communication, and speed the review of a
submission.
When we do not specify a file name, you can use file names up to 32 characters in
length with a 3-character extension.  Avoid using punctuation, spaces, or other
nonalphanumeric symbols in file names.
L. Security
You should not include any security settings or password protection for PDF files.
Allow printing, changes to the document, selecting text and graphics, and adding
or changing notes and form fields.  Our internal security and archival processes
will maintain the integrity of the submitted files.  A read-only copy of the files,
generated from the submitted files, will be provided to the reviewer.
M. Indexing PDF Documents
We use full text indexes to help find specific documents and/or search for text
within documents.  When a document or group of documents is indexed, all
words and numbers in the file and all information stored in the Document
Information fields are stored in special index files that are functionally accessible
using the search tools available in Acrobat.  Portions of a document that are
imaged are not indexed.  Even if the document only contains images, the text in
the Document Information fields of the file will be indexed.
These full text indexes should not be confused with a table of contents.  Adobe
Acrobat Catalog is one example of a tool that can be used to index PDF
documents.  Indexes should not require extensions or additions to off-the-shelf
Acrobat programs.
With many submissions, we ask that you associate the table of contents file for a
section with the corresponding full text index file.  By associate, we mean that
when the table of contents file is opened, the index file is automatically added to
the available index list and is ready to be used.
Further recommendations for full text indexes will be provided in guidance for the
specific submission types.
N. Plug Ins
It is acceptable to use plug ins to assist in the creation of a submission.  However,
the review of the submission should not require the use of any plug ins, in
addition to those provided with Acrobat Reader 3 because we are not prepared to
archive additional plug-in functionality.
11 O. Electronic Signatures
We are developing procedures for archiving documents with electronic signatures.
Until those procedures are in place, documents for which regulations require an
original signature, such as certifications, must be accompanied by a paper copy
that includes the handwritten signature and the submission identifier (e.g., NDA
number).
IV. WHAT FILE FORMATS SHOULD I USE FOR ELECTRONIC
DATASETS ?
Regulations in 21 CFR Part 11 require all datasets provided in electronic format to
provide an accurate and complete copy of the data suitable for inspection, review, and
copying.  Currently, we are able to accept and archive datasets in SAS System XPORT
transport format (Version 5 SAS transport file).  We plan on providing guidance for
additional file format types for datasets.  See Section B, below.  See also
recommendations provided in guidance for the specific submission types.
A.  SAS System XPORT Transport Format (Version 5 SAS Transport
Format)
SAS XPORT transport format, also called Version 5 SAS transport format, is an
open format published by the SAS Institute. The description of this SAS transport
file format is in the public domain.  Data can be translated to and from this SAS
transport format to other commonly used formats without the use of programs
from SAS Institute or any specific vendor.
You should follow the recommendations in this section to create SAS transport
files that we can review and archive.
1. Version
In SAS, SAS XPORT transport files are created by PROC XCOPY in
Version 5 of SAS software and by the XPORT engine in Version 6 and
higher of SAS Software.  We are unable to archive SAS Transport files
processed by the CPORT engine.
You can find the record layout for SAS XPORT transport files in SAS
technical support TS-140.  This document and additional information
about the SAS Transport file layout can be found on the SAS world wide
web page at http://www.sas.com/fda-esub.
12 2. Transformation of Datasets
We use a variety of software tools to analyze the datasets. Stat/Transfer
from Circle Systems and DBMS/copy from Conceptual Software Inc., are
two programs used to transfer data to various formats used for analysis.
SAS Viewer version 7 is used to open SAS transport files directly.
3. Naming SAS Transport Files
All SAS transport files should use xpt as the file extension.
4. Compression Of SAS Transport Files
The SAS transport files should not be compressed.
5. Content Of Datasets And Organization
You should provide a single transport file for each dataset.  Many of the
software tools used by the reviewers require datasets to be loaded into
random access memory (RAM) prior to opening the file.  Therefore,
dataset files should be organized so that their size is generally less than 25
MB per file.  The datasets should be accompanied by data definition tables
that include the variable name, a description of the variable, the type of
variable (e.g., number, character, date), and codes used in the dataset.  For
derived variables, the method of deriving the variable should also be
included in this table.  Variable names are limited to 8 characters.  You
should include a descriptive name up to 32 characters in the label header.
Further recommendations for content of SAS Transport files are provided
in guidance for each specific submission type.
We recommend that you discuss the content of the datasets with the
review division prior to submission.
B. Other Dataset Formats
Although we are not prepared to archive other dataset file formats at this time,
additional file formats are being considered, such as structured ASCII for ANDA
and postmarketing safety data. Structured ASCII  is also being explored for use
with the chemistry, biopharmaceutic, and clinical pharmacology data for NDAs.
As these projects mature, we will provide additional guidance.
13 V. WHAT ARE THE PROCEDURES FOR SENDING ELECTRONIC
SUBMISSIONS FOR ARCHIVE ?
Submissions should be sent directly to the appropriate center involved.  The procedure
for handling paper submissions is unchanged from the past.
A. CDER
Send one copy of the electronic regulatory submission for archive to the CDER
Central Document Room (CDR) as follows:
Central Document Room
Center for Drug Evaluation and Research
Food and Drug Administration
12229 Wilkins Avenue
Rockville, MD 20852
CDER uses this copy to make other copies as needed (see section VIII, below, on
processing electronic submissions).
B. CBER
Send two copies of the electronic regulatory submission as described in this
guidance to CBERs Document Control Center (DCC) as follows:
Center for Biologics Evaluation and Research
Attn: (Insert Responsible Office)
HFM-99, Room 200N
1401 Rockville Pike
Rockville, MD 20852-1448
It is essential to communicate with the appropriate CBER office prior to
submitting an electronic document, notifying us of your intention to submit an
electronic document at least six to eight months in advance of the target date for
the submission. At that time, the sponsor should forward a completed copy of the
appropriate application specific questionnaire
(http://www.fda.gov/cber/guidelines.htm).
Subsequent to the receipt of the questionnaire, a teleconference will be scheduled
with the appropriate CBER staff.  The objective of the teleconference is to convey
information relating to the proposed electronic submission's management
paradigm, content, format, and structure.  Moreover, we will discuss any issues
specific to your submission that may not have been fully addressed in the general
considerations guidance.
14 VI. WHAT TYPE OF MEDIA SHOULD I USE?
CDER and CBER are prepared to accept electronic submissions provided on the
media listed in the table below.  To optimize processing efficiency, we
recommend choosing media with a capacity most appropriate to the size of the
submission.  Whenever possible, applicants should choose media capable of
holding the submission on the fewest number of units.
Recommendations for Media
Size of Submission Media and format Units
Less than 10MB 3.5 inch DOS Formatted Floppy Disks 1 to 10
Less than 3.25GB CD-ROM ISO 9660 1 to 5 CDs
Greater than 3.25GB Digital Tape - Digital Equipment Corp. No limit
DLT 20/40 and 10/20 GB format using
OPENVMS with VMS backup or NT server
4.0 with NT backup or backup exec.
VII. HOW SHOULD I PREPARE THE MEDIA FOR ELECTRONIC
SUBMISSIONS FOR ARCHIVE ?
Send all electronic media adequately secured in a standard binder marked clearly on the
outside ELECTRONIC REGULATORY SUBMISSION FOR ARCHIVE.  CDs should
be packaged carefully to ensure that they arrive in a usable condition.  Particularly
vulnerable are diskettes and CD jewel cases shipped in envelopes without bubble-type
protective material or stiff backing.  The use of a jiffy-type bag by itself to ship media
will not provide adequate protection for shipping electronic media.
The first binder with electronic media should include only a paper copy of the cover letter
for the submission, a paper copy of the appropriate FDA form for the submission (e.g.,
for an NDA/BLA include FDA form 356h), and the electronic media for archiving.
Please attach labels to the media including the CD jewel cases.  Label the media with the
following:
  Submission identifier (e.g., NDA, BLA number)
  Proprietary and generic name.
  Company name
  Submission serial number, if applicable.
  Submission date: in the format of DD-MMM-YYYY (for example, 01-Jan-1997).
  Disk/CD-ROM/tape number (the number should include the total number
submitted such as Disk # of #)
15 When sending CD ROMS to CBER, number them from 0.001 through 0.XXX for the
original submission, and 1.001 through 1.XXX for subsequent submissions with
additional information.
VIII. HOW DO THE CENTERS PROCESS ELECTRONIC SUBMISSIONS FOR
ARCHIVE?
A. CDER
When an electronic submission arrives in CDER, we copy the electronic files to
tape to create an archival copy of the submission.  We also copy the files to a
network server to create a read-only copy for the reviewer. We use internal
procedures to track submissions (do not send roadmap files described below with
submissions to CDER).
B. CBER
When an electronic submission arrives in CBER, one copy of the media is
archived; the second copy of the submissions media is copied to a network server
to create a read-only copy for the reviewer.
The structure and content of electronic submissions to CBER should be based
upon the application (e.g., BLAs, PLA/ELAs).  Subsequent to the delivery of the
electronic application, any additional electronic and/or paper information will be
added to the existing network copy of the submission and distributed to
appropriate reviewers.  The root directory of an electronic application should
contain a roadmap.pdf file to orient the review team to the original application
and to any and all subsequent information added to the application.
CBER suggests that a roadmap.pdf file be used to establish hypertext links to the
applications main table of contents, and to the applications folders and files.
This roadmap or home page should be updated and resubmitted as additional
information to the application.
The roadmap file should not contribute in any way to the content of what is under
review.  It is a map, intended to facilitate navigation through the contents of an
application.  The application's roadmap.pdf file should be easily updated or
modified, for example, using the Replace File command under the Document
menu option in Adobe Exchange.  This function will automatically replace the old
hypertext links to previously submitted sections of the application, leaving only
the task of creating the new links corresponding to newly submitted information.
In addition to providing a navigable guide to the application, the roadmap.pdf file
should include the sponsors submission date in the DD-MMM-YYYY format
16 (e.g., 01-Jan-1999).  The contents of the original application and any subsequent
amendments to that application should be briefly described in a roadmap.pdf
table.  The location of these files and folders on the submitted media should be
indicated in the roadmap.pdf.  Where portions of an application have been
submitted only as a paper documents, they should be included in the roadmap and
table of contents and tagged as paper only.
A summation of the electronic document, using at least 40 key words from the
main document should be included with all electronic applications delivered to
CBER.  This summation should be located in the root directory on the CDROM
or DLT tape.  The file containing the key words should be an ASCII text file
entitled Summary.txt.
IX. WHAT IF I HAVE A QUESTION ?
A. CDER
You may direct questions regarding the preparation of submissions in electronic
format in CDER to the Electronic Submissions Coordinator, email
ESUB@CDER.fda.gov.
B. CBER
You may direct questions regarding the preparation of submissions in electronic
format in CBER to the Electronic Submissions Coordinator email
ESUBPREP@CBER.fda.gov.
17