[Federal Register Volume 67, Number 177 (Thursday, September 12, 2002)]
[Notices]
[Pages 57828-57829]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23105]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0324]


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.

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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 The draft 
guidance document is intended to provide guidance to sponsors, 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 The draft guidance document 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DATES: Submit written or electronic comments on the draft guidance to 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Training, and Manufacturers 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for electronic access to the draft guidance document.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

[[Page 57829]]

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.

    Dated: August 20, 2002.
Margaret M. Dotzel
Associate Commissioner for Policy.
[FR Doc. 02-23105 Filed 9-11-02; 8:45 am]
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