[Federal Register Volume 68, Number 63 (Wednesday, April 2, 2003)]
[Notices]
[Pages 16063-16064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7817]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0111]


Draft Guidance for Federal Agencies and State and Local 
Governments; Potassium Iodide Shelf Life Extension; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for Federal agencies and State and 
local governments entitled ``Potassium Iodide 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. The draft guidance discusses 
FDA recommendations on the requisite testing for KI tablet shelf life 
extensions, the qualifications of laboratories suitable to conduct the 
tests, and issues regarding notification of holders of stockpiled KI 
tablets as well as end users about changes to batch shelf life once 
testing has been successfully conducted.

DATES: Submit written or electronic comments on the draft guidance by 
June 2, 2003. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES: Submit written requests for single copies of this draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.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:

[[Page 16064]]

I. Background

    In November 2001, 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 (66 FR 64046, December 11, 2001). 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. In April 2002, FDA issued another 
guidance, ``Frequently Asked Questions on Potassium Iodide (KI).'' 
Additional information was provided for emergency pediatric dosing in 
``Home Preparation Procedure for Emergency Administration of Potassium 
Iodide Tablets to Infants and Small Children,'' updated on July 3, 
2002.
    This draft guidance entitled ``Potassium Iodide Shelf Life 
Extension,'' is intended to provide Federal agencies and State and 
local governments information on testing to extend the shelf life of 
stockpiled potassium iodide (KI) tablets. The agency has developed this 
document in response to several State inquiries on this topic. This 
draft guidance discusses FDA recommendations on the requisite testing 
for such shelf life extensions, the qualifications of laboratories 
suitable to conduct the tests, and issues regarding notification of 
holders of stockpiled KI tablets as well as end users about changes to 
batch shelf life once testing has been successfully conducted.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 Dockets Management Branch (see 
ADDRESSES) written or electronic comments on the draft guidance. Two 
copies of any 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 
draft guidance and received comments are available for public 
examination in the Dockets Management Branch 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://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 25, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-7817 Filed 4-1-03; 8:45 am]
BILLING CODE 4160-01-S