Copy 1 - Light blue folder
Copy 2 - Dark blue folder
Copy 3 - Brown folder
Copy 4 - May be bound in any color folder other than the three
listed above.
Holes should be punched on the left margin of the page utilizing a two
(2) hole punching machine. Hole center should be 0.5" from the left
margin of a page, one hole should be 1.25" and the other 9.75"
from the bottom of the page. The bottom of all pages bound within
a document should be uniform. If oversize pages exist, punch
and bind the pages in the volume.
In general, a petition volume should contain approximately 250
pages. However, in order not to separate a logical unit of
information (such as a toxicity study) between two volumes, the volume
page count may vary from 200 to 300 pages. Within these limits,
a logical unit of information should remain intact whenever
possible.
Before binding a volume, the orientation of the spines in the
binder should open toward the back cover of the binder, thus
permitting additional pages to be easily added to the rear of a
document.
Three sample formats for presenting this information on the label
are:
In addition to the above information, the name of the sponsor
(primary petitioner--not the representative or agent)
of the petition submission, the volume number,
and the total number of volumes should be identified on the label.
The label should be 2" high and 5" wide.
A sample label is shown below:
Volume _____ of _____
1. Introduction
The Center for Food Safety and Applied Nutrition (CFSAN) employs
modern records maintenance procedures to support and enhance
its review and evaluation of food additives, color
additives and ingredients that are alleged to be generally recognized
as safe (GRAS). Consequently, the preparation and organization
of material submitted to CFSAN can contribute to
the efficient evaluation of data within food and color additive and
GRAS affirmation petitions, master files, and related documents.
2. Background
This document has been prepared in response to the many requests from
industry for guidance in the preparation of petitions for submission
to the Center for Food Safety and Applied Nutrition.
These guidelines are not requirements of the FDA, but rather
represent a suggested format that can be followed by a petition if
so desired. Legal requirements for GRAS, color additive, and food
additive regulations can be found in 21 CFR Parts 71, 170 and 171.
3. Number of Copies
CFSAN requires the submission of three (3) identical copies of food
and color additive petitions.
For GRAS petitions, four (4) copies are required.
4. Pagination
Pagination of documents provides a location pointer for an automated
indexing system, facilitates manual review of the documents, and
contributes to the maintenance of uniform filing procedures.
The guidelines for the uniform pagination and binding
of petition submissions are:
To insert 4 pages between pages 001657 and 001658, number the
insert pages as follows: 001657.001, 001657.002, 001657.003, and 001657.004,
where the three digit numbers folowing the decimal point represent
the four (4) pages for insertion. Notice that the number
preceding the decimal point is 001657 in all cases.
5. Binding
All submissions should be bound within 11" x 8.5" colored folders
as follows:6. Labeling
The following information should be identified by the title on the
label:
Title of Petition
Primary Petitioner
7. Additional Submissions
Home
|
Guidance
Documents for Submitting Petitions
Updated by dms/ear 1996-APR-18
Hypertext updated by dms/ear 2000-MAY-10