[Federal Register Volume 66, Number 6 (Tuesday, January 9, 2001)]
[Notices]
[Pages 1684-1685]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-534]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1669]


Electronic Filing of Drug Registration and Listing Information: 
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 a pilot project involving the electronic filing of 
drug registration and listing information, as described in FDA's 
regulations. Manufacturers, repackers, and relabelers who engage in the 
manufacture, preparation, propagation, or processing of human or 
veterinary drugs and human biological products are required under 
current regulations to submit a listing of every product in commercial 
distribution. This information is currently submitted in paper format. 
FDA is developing an electronic system for submitting the required 
information, and is seeking volunteers to test the pilot system.

DATES: Submit written requests to participate in the pilot project by 
February 8, 2001. Comments on this pilot project can be submitted at 
any time.

ADDRESSES: Submit written requests to participate and comments 
regarding this pilot project to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: James R. Hunter, Food and Drug 
Administration, Center for Drug Evaluation and Research (HFD-9), 5600 
Fishers Lane, Rockville, MD 20857, 301-594-6779, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Under current FDA's regulations (part 207 (21 CFR part 207)), 
manufacturers, repackers, and relabelers who engage in the manufacture, 
preparation, propagation, compounding, or processing of human or 
veterinary drugs and human biological products must register annually 
with FDA by submitting Form FDA 2656 (Registration of Drug 
Establishment). In addition, registrants must update their product 
listing information by using Form FDA 2657 and/or Form FDA 2658 every 
June and December, or at the discretion of the establishment, when any 
change occurs. This entire process is currently done manually (i.e., 
with a paper process). This process is very labor intensive and time 
consuming. FDA is trying to streamline the process by developing an 
electronic system in which registrants could automatically register and 
list, as well as provide updates.
    The purpose of the pilot project is twofold. First, the pilot 
project will test FDA's systems for receiving electronic filings under 
part 207. Second, the pilot project will provide volunteers with 
experience in using the prototype system that will enable them to 
provide technical feedback to FDA about the system.

II. Pilot Project Description

    The pilot project is part of FDA's efforts to implement electronic 
filing. Eventually, FDA staff expects to recommend that FDA require 
electronic filings under part 207. Participants in this pilot project 
will have the opportunity not only to assist FDA in making its 
determination on electronic filing, but also to familiarize themselves 
with the process at an early stage of development.

A. Initial Approach

    Initially, a limited group of voluntary participants will take part 
in testing the electronic filing prototype. This group will be 
incrementally expanded during the pilot project to ensure that as many 
volunteers as possible get the opportunity to participate and that all 
functional components of the system are adequately tested. The initial 
group of participants will include manufacturers, repackers, 
relabelers, and private label distributors of human prescription and 
over the counter drug and biological products and manufacturers of 
veterinary drug products that currently have more than 25 products 
listed with the agency. During the pilot project, information submitted 
will be made available to the public by the agency via the Internet at 
http://www.fda.gov/cder. Participants in the pilot project will be 
asked to test specific aspects of the electronic filing system and to 
provide technical feedback.

B. Scope

    Existing registration and listing requirements will not be waived, 
suspended, or modified for purposes of this pilot project. Thus, 
participants must continue to submit paper documents in accordance with 
FDA's existing filing requirements (part 207). The paper copy will 
serve as the official copy under existing regulations during the pilot 
project.
    The pilot project will test a prototype for electronic filing over 
the Internet of information to fulfill the requirements of section 510 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
    Written requests to participate in the pilot project should be 
submitted to the Dockets Management Branch (address above) and 
identified with the docket number found in brackets in the heading of 
this document. Include the participants name, company name, company 
address, and telephone number. In addition, include in your written 
request to participate the number of products you currently have listed 
with the agency, the number of establishments you currently have 
registered with the agency, the type of products you process (i.e., 
human, biologic, or veterinary), the process(es) you perform (i.e., 
manufacture, repackage, relabel, distribute), and the kind of products 
you process (i.e., prescription, over the counter, active 
pharmaceutical ingredients (bulk), or, homeopathic).
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this pilot project. Two 
copies of any comment are to be submitted, except that individuals may 
submit one copy. Comments are to be identified with the docket number 
found in brackets in the heading of this document. FDA will

[[Page 1685]]

consider comments in making its determination on electronic filing and 
in drafting a guidance document for submitting drug registration and 
listing information electronically. Received comments may be seen in 
the Dockets Management Branch between 9 a.m. and 5 p.m., Monday through 
Friday.

    Dated: December 29, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-534 Filed 1-8-01; 8:45 am]
BILLING CODE 4160-01-F