[Federal Register: September 12, 2002 (Volume 67, Number 177)]
[Notices]
[Page 57828-57829]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12se02-83]
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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 The draft
guidance document is intended to provide guidance to sponsors,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 The draft guidance document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DATES: Submit written or electronic comments on the draft guidance to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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Office of Communication, Training, and Manufacturers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for electronic access to the draft guidance document.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]
BILLING CODE 4160-01-S