[Federal Register: March 8, 2004 (Volume 69, Number 45)]
[Notices]               
[Page 10725]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr04-71]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0111]

 
Guidance for Federal Agencies and State and Local Governments; 
Potassium Iodide Shelf Life Extension; 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 guidance for Federal agencies and State and local 
governments entitled ``Potassium Iodide Tablets Shelf Life Extension.'' 
This document is intended to provide guidance to Federal agencies and 
to State and local governments on testing to extend the shelf life of 
stockpiled potassium iodide (KI) tablets.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information (HFD-240), 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. Submit written comments 
on the guidance 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.
 See the SUPPLEMENTARY INFORMATION section for electronic 

access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Richard Adams, Center for Drug 
Evaluation and Research (HFD-643), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-5849.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for Federal 
agencies and State and local governments entitled ``Potassium Iodide 
Tablets Shelf Life Extension.'' This guidance is intended to provide 
Federal agencies and State and local governments with information on 
testing to extend the shelf life of stockpiled KI tablets. The agency 
has developed this document in response to several State inquiries on 
this topic.
    On December 11, 2001 (66 FR 64046), FDA provided guidance on the 
safe and effective use of KI tablets as an adjunct to other public 
health protective measures in the event that radioactive iodine is 
released into the environment. The guidance entitled ``Potassium Iodide 
as a Thyroid Blocking Agent in Radiation Emergencies'' updated FDA's 
1982 recommendations for the use of KI tablets to reduce the risk of 
thyroid cancer in radiation emergencies involving the release of 
radioactive iodine. The recommendations in that guidance addressed KI 
dosage and the projected radiation exposure at which the drug should be 
used.
    On April 2, 2003 (68 FR 16063), FDA made available a draft guidance 
entitled ``Potassium Iodide Tablets Shelf Life Extension.'' This 
guidance discussed FDA recommendations on the testing for shelf life 
extensions, the qualifications of laboratories suitable to conduct the 
tests, and issues regarding notification of holders of stockpiled KI 
tablets and end users about changes to batch shelf life once testing 
has been successfully conducted. The comment period for that draft 
guidance closed on June 2, 2003. Although the agency received no 
written comments on the draft guidance, we (FDA) have revised the 
guidance slightly to recommend confirmatory testing after 2 years, 
monitoring for discoloration and recordkeeping.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on this topic. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the applicable statues and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on the guidance at any 
time. Two copies of mailed comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. The 
guidance and 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. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/index.htm or http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www
.fda.gov/ohrms/dockets/default.htm.

    Dated: February 28, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-5107 Filed 3-5-04; 8:45 am]

BILLING CODE 4160-01-S