[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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