[Federal Register: November 26, 2003 (Volume 68, Number 228)]
[Page 66448-66449]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003N-0513]

Electronic Submissions of Food Contact Notifications; Notice of
Pilot Project

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


SUMMARY:  The Food and Drug Administration (FDA) is seeking volunteers
to participate in the Food Contact Notification (FCN) Electronic
Submissions Pilot Project developed by

[[Page 66449]]

the Office of Food Additive Safety (OFAS) in the Center for Food Safety
and Applied Nutrition (CFSAN). The purpose of the project is to test
the efficiency and practicality of a prototype procedure for filing
FCNs in electronic format as an alternative to the current paper-based
process. FDA believes that this pilot will assist the agency in
developing a draft guidance under its good guidance practice (GGP)

DATES:  Submit written requests to participate in the pilot project by
December 26, 2003. Comments on this pilot project may be submitted at
any time. The pilot is anticipated to last 180 days beginning January
26, 2004.

ADDRESSES:  Submit written requests to participate and comments
regarding the pilot project to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments

Safety and Applied Nutrition (HFS-275), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3392, e-mail: kenneth.mcadams@cfsan.fda.gov, or
    Kimberly Smeds, Center for Food Safety and Applied Nutrition (HFS-
275), Food and Drug Administration, 5100 Paint Branch Pkwy., College
Park, MD 20740-3835, 202-418-3424, e-mail: kimberly.smeds@cfsan.fda.gov.


I. Background

    In 1997, the Food and Drug Administration Modernization Act of 1997
(FDAMA) amended section 409 of the Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 348) to establish a premarket notification process
as the primary method for authorizing new uses of food additives that
are ``food contact substances.'' A food contact substance is defined in
section 409(h)(6) of the act as ``any substance intended for use as a
component of materials used in manufacturing, packing, packaging,
transporting, or holding food if such use is not intended to have any
technical effect in such food.'' The act further states that the
notification process is to be utilized for authorizing the marketing of
food contact substances except in instances where the Secretary of
Health and Human Services determines that the submission and review of
a food additive petition would be necessary to provide adequate
assurance of safety, or where FDA and any manufacturer or supplier
agree that a petition may be submitted. In the Federal Register of May
21, 2002 (67 FR 35724), the agency issued a final rule on premarket
notification for food contact substances (21 CFR 170.100 through
    The FCN process has improved the efficiency of the FDA premarket
approval of new food contact substances. More than 200 FCNs have become
effective since the process began. FDA FORM 3480 currently provides the
format by which information submitted in an FCN is organized to
facilitate review by the agency. In order to further improve the
efficiency of the FDA premarket approval of new food contact
substances, FDA is developing a procedure to allow for the submission
of FCNs in electronic format. This procedure includes the use of a
software tool to assist a notifier in assembling an FCN. The present
pilot project represents the final phase of the agency's development of
the software tool for FCN submissions prior to FDA's announcing the
availability of such a tool and accompanying guidance in accordance
with the agency's GGPs under 21 CFR 10.115. FDA is initiating this
pilot to obtain useful feedback during this initial phase in order to
maximize efficiency and practicality of the electronic submission
process before making it available to the general public for comment.
    After completion of the pilot, FDA expects to issue guidance to the
public for the electronic filing of FCNs in accordance with GGPs under
21 CFR 10.115.

II. Pilot Project Description

    Due to the fact that a limited number of voluntary participants
will be needed for the pilot, FDA will use its discretion in selecting
the volunteers based on their previous experience in filing FCNs and on
the number of FCNs they expect to file during the pilot. The sponsors
who participate in the pilot will be asked to submit at least four FCNs
in an electronic format during the pilot, using the procedure being
tested. Existing regulatory requirements for the submission of FCNs
will not be waived, suspended, or modified for the purposes of this
pilot project.
    The procedure uses an electronic fillable portable document format
(PDF) version of FDA FORM 3480 that serves as an organizational
backbone to which notifiers may attach studies, data, and other
information in electronic format via a software package provided by the
agency. It is designed to enable the notifier to submit all the items
that constitute a complete FCN in a prescribed structure, removing the
need for pagination and providing definitive locations within a set
file structure for each type of information, so that the agency in turn
can more efficiently review the submission. Pilot participants will be
asked to use the procedure and software tool to submit FCNs
electronically, and to provide feedback on the process to FDA. Because
the process of receiving electronic submissions will be under
development during the pilot, FDA will require that participants submit
a signed paper copy of each submission along with the electronic
version. The paper copy will serve as the official copy under existing
regulations during the pilot project. FDA will provide written
instructions to individual participants on using the software tool, on
assembling and submitting an electronic FCN, and on how to provide
feedback. Feedback from pilot participants will assist the agency in
improving the software tool and completing development of the

III. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: November 19, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-29462 Filed 11-25-03; 8:45 am]