[Federal Register Volume 64, Number 223 (Friday, November 19, 1999)]
[Notices]
[Pages 63323-63324]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-30214]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98N-1109]
Mercury Compounds in Drugs and Food; List and Analysis;
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 document entitled ``Mercury Compounds in Drugs and
Food.'' The document discusses drugs (including biologics) and foods
that contain intentionally introduced mercury compounds. In addition,
for those products that contain intentionally introduced mercury
compounds, the document provides a quantitative and qualitative
analysis of the mercury compounds in the products. This document has
been prepared in response to the Food and Drug Administration
Modernization Act of 1997 (FDAMA), section 413, entitled ``Food and
Drug Administration Study of Mercury Compounds in Drugs and Food.''
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the document
entitled ``Mercury Compounds in Drugs and Food'' to the Drug
Information Branch (HFD-210), Center for Drug Evaluation and Research,
Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857.
Send one self-addressed adhesive label to assist that office in
processing your requests. Copies of the document are available on the
Internet at http://www.fda.gov/cder/index.htm. 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.
FOR FURTHER INFORMATION CONTACT:
For human drug products: Gerald M. Rachanow, Center for Drug
Evaluation and Research (HFD-560), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2222.
For human biological products: Robert A. Yetter, Center for
Biologics Evaluation and Research (HFM-10), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852, 301-827-0373.
For veterinary drug products: William C. Keller, Center for
Veterinary Medicine (HFV-210), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-6641.
For food and dietary supplement products: Sharon A. Ross, Center
for Food Safety and Applied Nutrition (HFS-456), Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202-205-5343.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled ``Mercury
Compounds in Drugs and Food.'' This document discusses drugs (including
biologics) and foods that contain intentionally introduced mercury
compounds. In addition, for those products that contain intentionally
introduced mercury compounds, the document provides a quantitative and
qualitative analysis of the mercury compounds in the products.
This document is part of FDA's implementation of FDAMA (Public Law
105-115), enacted on November 21, 1997. Section 413 of FDAMA required
FDA to: (1) Compile a list of drugs and foods that contain
intentionally introduced mercury compounds, and (2) provide a
quantitative and qualitative analysis of the mercury compounds in this
list. FDAMA required the agency to compile the list and provide the
analysis within 2 years after the date of its enactment.
The statute did not differentiate whether the mercury compound was
present in a product as an active or inactive ingredient, whether the
product was for human or veterinary use, or whether the product was
sold by prescription or over-the-counter. Food products include dietary
supplements.
In the Federal Register of December 14, 1998 (63 FR 68775) and
April 29, 1999 (64 FR 23083), FDA published notices requesting data and
information on any intentionally introduced mercury compounds in these
types of products. The agency asked manufacturers of affected products
to provide: (1) The commercial name of the product that contains the
mercury compound; (2) the chemical name, quantitative amount, and
purpose of the mercury compound present; (3) a copy of the product's
labeling; and (4) an estimate of the amount of the mercury compound
used annually in manufacturing the product.
The agency received 41 responses to the two request-for-data
notices. The agency also reviewed information contained in its Drug
Registration and Listing System and other sources to identify
additional products that contain intentionally introduced mercury
compounds. The document discusses the information that the agency
reviewed and provides a list and analysis of the products that were
identified. The document is intended to provide information and does
not set forth any requirements.
II. Comments
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments regarding this
document. Two copies of any comments are to be submitted, except that
individuals may submit one copy. Comments should be identified with the
docket number found in brackets in the heading of this document. A copy
of the document and received comments may be seen in the Dockets
Management Branch between 9
[[Page 63324]]
a.m. and 4 p.m., Monday through Friday.
Dated: November 15, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-30214 Filed 11-18-99; 8:45 am]
BILLING CODE 4160-01-F