Draft “Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals;” Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA), in collaboration with the U.S. Department of Agriculture (USDA), is announcing the availability of a draft document entitled “Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals” dated September 2002. The draft guidance document is intended to provide guidance to sponsors, manufacturers, licensees, and applicants of products derived from bioengineered plants or plant materials. The draft guidance document provides recommendations on the use of bioengineered plants or plant materials to produce biological products, including intermediates, protein drugs, medical devices, new animal drugs, and veterinary biologics.

DATES:

Submit written or electronic comments on the draft guidance to ensure their adequate consideration in preparation of the final document by January 10, 2003. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Office of Communication, Training, and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed adhesive label to assist the office in processing your requests. The document also may be obtained by mail by calling the CBER Voice Information System at 1-800-835-4709 or 301-827-1800, or by fax by calling the FAX Information System at 1-888-CBER-FAX or 301-827-3844. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit written comments on the document to the Dockets Management Branch (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:

Valerie A. Butler, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

FDA, in collaboration with USDA, is announcing the availability of a draft document entitled “Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals” dated September 2002. The draft guidance document provides recommendations on the use of bioengineered plants or plant materials to produce biological products, including intermediates, protein drugs, medical devices, new animal drugs, and veterinary biologics. The draft guidance document does not address nonprotein drugs, botanicals, or allergenic products for human use. The draft guidance document outlines important scientific questions and information that should be addressed during the preparation of an investigational new drug application, investigational device exemption, biologics license application, new drug application, investigational new animal drug file, new animal drug application, premarket approval, or 510(k), to FDA or a U.S. veterinary biological product license application to USDA.

The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance document represents the agency's current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statutes and regulations.

II. Comments

The draft guidance document is being distributed for comment purposes only and is not intended for implementation at this time. Interested persons may submit to the Dockets Management Branch (see ADDRESSES) written or electronic comments regarding the draft guidance document. Submit written or electronic comments to ensure adequate consideration in preparation of the final document by January 10, 2003. Two copies of any written comments are to be submitted, except individuals may submit one copy. Comments should be identified with the docket number found in the brackets in the heading of this document. A copy of the document and received comments are available for public examination in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/cber/guidelines.htm or http://www.fda.gov/ohrms/dockets/default.htm.