How to Prepare a Petition Submission (Paper Format)

 

Prepared for:
The Food and Drug Administration
Center for Food Safety and Applied Nutrition
Washington, D.C.
Under FDA Contract No. 223-94-2264

 

Contents

1. Introduction
2. Background
3. Number of Copies
4. Pagination
5. Binding
6. Labeling
7. Additional Submissions

 

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:

• Using black ink, the page number should be stamped with a six digit numbering machine. Leading zeros should be set on the numbering machine. For example, page number 14 should appear as 000014 when stamped. The pagination should continue sequentially throughout the document beginning with page number 000001. An average of 250 pages are suggested for each volume of a document. To insert a page after pagination use a three digit decimal insert page number as follows:

• 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 following the decimal point represent the four (4) pages for insertion. Notice that the number preceding the decimal point is 001657 in all cases.

• The page number should be clear and horizontal.
• Data should not be obscured by a page number.
• The page number should be located on the bottom right corner of the page whenever possible. When the reverse side of a page is paginated, the page number should be located on the lower left corner of the page.
• Every page containing information including the cover letter, divider tabs, photographs, charts, and graphs should be paginated. Blank pages within a document should not be paginated.
• If an error in pagination occurs, cover the incorrect page number with correction tape (double line width) and repaginate.
• The identical page in all copies should be assigned the same page number. This may be ensured by paginating a single original copy and then photocopying two (2) or three (3) additional copies.

 

5. Binding

All submissions should be bound within 11" x 8.5" colored folders as follows:

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.

 

6. Labeling

The following information should be identified by the title on the label:

• The name of the additive
• The technical effect
• The food product or food contact

Three sample formats for presenting this information on the label are:

1. FD&C Blue No. 6 as a Colorant in Contact Lenses
2. Chlorine as an Antimicrobial Agent for Meat Processing Equipment
3. Iron and Iron Salts as Nutritive Food Supplements

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:

 

Title of Petition Primary Petitioner Volume _____ of _____

 

7. Additional Submissions

• Petitioners are also encouraged to provide an index of the petitions which may be placed within the document following the cover letter.
• If the petition is available on microfiche, a copy of the fiche may be submitted along with the hard copy petition.