[Federal Register: August 1, 2003 (Volume 68, Number 148)]
[Notices]
[Page 45257]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au03-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 1998N-1109]
Mercury Compounds in Drugs and Food; List
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is updating a list of
drug and biologic products that contain intentionally introduced
mercury compounds, e.g., phenylmercuric acetate, phenylmercuric
nitrate, thimerosal. This list is part of the implementation of the
Food and Drug Administration Modernization Act of 1997 (FDAMA).
DATES: Comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the document
entitled ``Mercury in Drug and Biologic Products; 2003 Update'' 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/fdama/mercury300.htm. Submit
written comments on the document to the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
.
FOR FURTHER INFORMATION CONTACT: Gerald M. Rachanow, Center for Drug
Evaluation and Research (HFD-560), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-2222.
SUPPLEMENTARY INFORMATION:
I. Background
FDAMA (Public Law 105-115) was enacted on November 21, 1997.
Section 413 of FDAMA, entitled ``Food and Drug Administration Study of
Mercury Compounds in Drugs and Food,'' 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. The statute did not differentiate
whether the mercury compound was present in the products as an active
or an inactive ingredient and required FDA to compile the list and
provide the analysis within 2 years after the date of its enactment.
FDA prepared this list and announced its availability in the
Federal Register of November 19, 1999 (64 FR 63323). The list is
entitled ``Mercury in Drug and Biologic Products'' and is available on
the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/fdama/mercury300.htm.
Five manufacturers and distributors subsequently informed FDA that
10 products had been reformulated to delete the mercury ingredients or
were no longer being marketed. However, FDA did not update the list at
that time.
II. Updating the List
In the Federal Register of February 3, 2003 (68 FR 5299), FDA
published a notice requesting information to update this list. FDA was
aware that other manufacturers or distributors with products on the
list had reformulated their products since 1999. FDA requested any
affected manufacturer or distributor to inform us which product(s) on
the list had been reformulated and no longer contain mercury
ingredients. Eleven manufacturers provided information, which resulted
in 39 additional products being deleted from the list and one product
being added to the list. The new list now includes 171 products. The
list continues to provide information and does not set forth any
requirements.
III. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. A copy of the list and received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
Dated: July 24, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-19620 Filed 7-31-03; 8:45 am]
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