[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