[Federal Register Volume 64, Number 166 (Friday, August 27, 1999)]
[Notices]
[Pages 46917-46918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-22316]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2777]


Guidance for Industry on Possible Dioxin/PCB Contamination in 
Drugs and Biological Products; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Possible Dioxin/PCB

[[Page 46918]]

Contamination in Drugs and Biological Products.'' During January 
through June 1999, some poultry, swine, and ruminants in several 
European Union (EU) countries were fed with animal feed of Belgian 
origin contaminated with dioxins and polychlorinated biphenyls (PCB's). 
Manufacturers who are using materials derived from such animal sources 
in the manufacture of their products should verify that the materials 
they are using are not derived from animals affected during the 
contamination incident, or conduct suitable testing of the materials.

DATES:  Written comments on this guidance may be submitted at any time. 
General comments on agency guidances are welcome at any time.

ADDRESSES: Submit written comments to:
1. Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Submit written requests for copies of this guidance to:
2. Office of Training and Communications, Division of Communications 
Management, Drug Information Branch (HFD-210), Center for Drug 
Evaluation and Research, Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, http://www.fda.gov/cder/guidance/index.htm; 
or
3. Office of Communication, Training and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research, Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448; http://
www.fda.gov/cber/guidelines.htm; FAX: 1-888-CBERFAX or 301-827-3844, or 
call the Voice Information System at 800-835-4709 or 301-827-1800; or
4. Communications Staff (HFV-12), Center for Veterinary Medicine (CVM), 
7500 Standish Pl., Rockville, MD 20855; 301-594-1755, http://
www.fda.gov/cvm.

FOR FURTHER INFORMATION CONTACT: 
    Eric P. Duffy, Center for Drug Evaluation and Research (HFD-325), 
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 
301-594-0098;
    Christopher C. Joneckis, Center for Biologics Evaluation and 
Research (HFM-20), Food and Drug Administration, 1401 Rockville Pike, 
suite 200N, Rockville, MD 20852-1448, 301-827-5318; or
    John C. Matheson, Center for Veterinary Medicine (HFV-200), Food 
and Drug Administration, Center for Veterinary Medicine, 7500 Standish 
Pl., Rockville, MD 20855, 301-827-6649.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
guidance for industry entitled ``Possible Dioxin/PCB Contamination in 
Drugs and Biological Products.'' During January through June 1999, some 
poultry, swine, and ruminants in several EU countries were fed with 
animal feed of Belgian origin contaminated with dioxins and PCB's. As a 
result, animals that received the contaminated feed have become 
contaminated with dioxins and PCB's. Manufacturers who are using 
materials derived from these animal sources in the manufacture of 
animal or human drug products or biological products should verify that 
the materials they are using are not derived from animals affected 
during the contamination incident, or conduct suitable testing of the 
materials.
    This guidance document is being issued as a Level 1 guidance 
consistent with FDA's good guidance practices (62 FR 8961), February 
27, 1997). It is being implemented immediately without prior public 
comment because of the potential hazard to the public health.
    This guidance document may contain collections of information that 
require OMB clearance under the Paperwork Reduction Act of 1995. FDA 
will seek such approval and provide an opportunity for comment, as 
appropriate.
    The guidance represents the agency's current thinking on the 
implications of dioxin/PCB contamination in animal and human drug 
products and biological products. 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 requirements of the applicable statute, regulations, or both.
    Interested persons may submit written comments on the draft 
guidance to the Dockets Management Branch (address above). Two copies 
of any comments 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. The draft guidance and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: August 19, 1999.
 Margaret M. Dotzel,
 Acting Associate Commissioner for Policy.
[FR Doc. 99-22316 Filed 8-26-99; 8:45 am]
BILLING CODE 4160-01-F