[Federal Register Volume 68, Number 22 (Monday, February 3, 2003)]
[Notices]
[Pages 5299-5300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2378]


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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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for information.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a

[[Page 5300]]

request for information to update a list of drug and biologic products 
that contain intentionally introduced mercury compounds, e.g., 
phenylmercuric acetate, phenylmercuric nitrate, and thimerosal. This 
request is part of the implementation of the Food and Drug 
Administration Modernization Act of 1997 (FDAMA).

DATES: Submit written and electronic comments and information by April 
4, 2003.

ADDRESSES: Submit written comments 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: 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).

II. Request for Information

    The agency is aware that some manufacturers or distributors with 
products on the list have reformulated their products since 1999. 
Accordingly, the agency would like to update the list to delete any 
products that no longer contain mercury ingredients. The agency is 
requesting any affected manufacturer or distributor with a product(s) 
on the list that no longer contains mercury to send an acknowledgement 
to the agency [to Docket No. 98N-1109] stating that the product(s) has 
been reformulated to no longer contain mercury. The agency will compile 
this information and announce the availability of an updated list in a 
future issue of the Federal Register.
    The agency wishes to assure that it has a copy of the revised 
labeling for any product that has been reformulated. Part 207 (21 CFR 
part 207) entitled ``Registration of Producers of Drugs and Listing of 
Drugs in Commercial Distribution'' provides that owners or operators of 
drug establishments that engage in the manufacture, preparation, 
propagation, compounding, or processing of a drug or drugs register and 
submit a list of every drug in commercial distribution (Sec.  
207.20(a)). Owners or operators of establishments that distribute under 
their own label or trade name a drug manufactured or processed by a 
registered establishment may submit listing information directly to FDA 
and obtain a labeler code (Sec.  207.20(b)). Registrants are required 
to provide a copy of all current labeling for each new drug (Sec.  
207.25(b)(2)) and human prescription drug that is not a new drug (Sec.  
207.25(b)(4)), and a copy of the label for each human over-the-counter 
drug listed that is not a new drug (Sec.  207.25(b)(5)). Information 
about inactive ingredients in the product is requested but not required 
(Sec.  207.31(b)).
    Owners and operators of all registered establishments are required 
to update their drug listing information every June and December (Sec.  
207.21(b)). The updated information includes listing each drug for 
which commercial distribution has been discontinued or for which any 
material change has occurred in any information previously submitted 
(e.g., reformulation) (Sec.  207.30(a)(2) and (a)(4), respectively). 
The agency is requesting that any manufacturers or distributors who 
have reformulated their products to remove the mercury ingredients 
update their labeling in accordance with part 207. These submissions 
should be highlighted with the words ``Mercury List'' on the envelope. 
The submission of information to FDA under part 207 is an approved 
collection of information under the Office of Management and Budget 
(OMB) control number 0910-0045 entitled ``Registration of Producers of 
Drugs and Listing of Drugs in Commercial Distribution,'' which expires 
July 31, 2004.
    Affected manufacturers or distributors should submit the 
acknowledgement information to the Dockets Management Branch (see 
ADDRESSES). Two copies of all written information are to be submitted. 
Anyone submitting information electronically may submit one 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 Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

III. Electronic Access

    The list is entitled ``Mercury in Drug and Biologic Products'' and 
is available on the Internet at http://www.fda.gov/cder/fdama/mercury300.htm.

    Dated: January 15, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-2378 Filed 1-31-03; 8:45 am]
BILLING CODE 4160-01-S