[Federal Register: August 17, 2005 (Volume 70, Number 158)]
[Notices]               
[Page 48428]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17au05-90]                         


[[Page 48428]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N-0137]

 
Levothyroxine Sodium Therapeutic Equivalence; Public Meeting; 
Reopening of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; reopening of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is reopening until 
September 23, 2005, the comment period for the May 23, 2005, public 
meeting on the therapeutic equivalence of levothyroxine sodium drug 
products that was announced in the Federal Register of April 20, 2005 
(70 FR 20574). The public meeting included FDA staff and 
representatives of three medical societies: The American Thyroid 
Association (ATA), the Endocrine Society, and the American Association 
of Clinical Endocrinologists (AACE). FDA is taking this action in 
response to a request for an extension.

DATES:  Submit written or electronic comments on or before September 
23, 2005.

ADDRESSES:  Submit written comments 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: Rose Cunningham, Center for Drug 
Evaluation and Research (HFD-006), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20852, 301-443-5595, e-mail: 
cunninghamr@cder.fda.gov.


SUPPLEMENTARY INFORMATION:

I. Background

    On May 23, 2005, FDA cosponsored a public meeting on the 
therapeutic equivalence of levothyroxine sodium drug products. The 
meeting included FDA staff and representatives of three medical 
societies: The ATA, the Endocrine Society, and the AACE. The purpose of 
the meeting was to discuss FDA's regulatory standards and 
methodological approaches for determining therapeutic equivalence 
between levothyroxine sodium drug products. FDA asked interested 
constituencies, including patient advocacy and education groups, and 
pharmaceutical sponsors, to submit comments by July 23, 2005.
    By letter dated July 6, 2005, Abbott Laboratories (Abbott) 
requested that FDA extend the date for submission of comments. Abbott 
requested the extension to give interested parties the opportunity to 
comment meaningfully on the matters discussed at the meeting. The 
transcript became available on July 12, 2005.
    FDA has decided to reopen the comment period until September 23, 
2005.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the topics discussed 
at the May 23, 2005, meeting. Submit two copies of 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. Received comments are available for public examination 
in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

III. Transcript

    The transcript of the May 23, 2005, meeting is available on FDA's 
Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/meeting/levothyroxine2005.htm.


    Dated: August 10, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-16241 Filed 8-16-05; 8:45 am]

BILLING CODE 4160-01-S