[Federal Register Volume 68, Number 228 (Wednesday, November 26, 2003)]
[Notices]
[Pages 66448-66449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29462]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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.

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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developing a draft guidance under its good guidance practice (GGP) 
procedures.

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://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Kenneth McAdams, Center for Food 
Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 202-418-3392, e-
mail: [email protected], 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: 
[email protected].

SUPPLEMENTARY INFORMATION:

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 
170.106).
    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 
procedure.

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]
BILLING CODE 4160-01-S