[Federal Register Volume 66, Number 238 (Tuesday, December 11, 2001)]
[Notices]
[Pages 64046-64047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30492]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1681]


Guidance on Use of Potassium Iodide as a Thyroid Blocking Agent 
in Radiation Emergencies; 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 entitled ``Potassium Iodide as a Thyroid 
Blocking Agent in Radiation Emergencies.'' This guidance updates a 
notice of availability entitled ``Potassium Iodide as a Thyroid-
Blocking Agent in a Radiation Emergency: Final Recommendations on Use'' 
published in the Federal Register on June 29, 1982, concerning the 
prophylactic use of potassium iodide (KI) in the event of release of 
radioactive isotopes of iodine. In this guidance, FDA maintains its 
position that KI is a safe and effective means by which to prevent 
radioiodine uptake by the thyroid gland and, thus, reduce the risk of 
thyroid cancer in the event of a radiation emergency. The guidance 
recommends lower radioactive exposure thresholds for KI prophylaxis as 
well as lower doses of KI for neonates, infants, and children than 
previously recommended.

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 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 
guidance document.

FOR FURTHER INFORMATION CONTACT: Rose Cunningham, Center for Drug 
Evaluation and Research (HFD-6), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-6779.

SUPPLEMENTARY INFORMATION:

I. Background

    The Federal Emergency Management Agency (FEMA) has established 
roles and responsibilities for Federal agencies in assisting State and 
local governments in their radiological emergency planning and 
preparedness activities. The Federal agencies, including the Department 
of Health and Human Services (DHHS), are intended to accomplish these 
roles and responsibilities as part of the Federal Radiological 
Preparedness Coordinating Committee. Among other responsibilities, DHHS 
is to provide guidance on the use of radioprotective substances to 
reduce radiation doses to specific organs from the release into the 
environment of large quantities of radioactivity. FDA is specifically 
charged with providing guidance on the prophylactic use of KI in the 
event of release of radioactive isotopes of iodine.
    As part of its responsibilities as established by FEMA, on June 29, 
1982, FDA published in the Federal Register a notice entitled 
``Potassium Iodide as a Thyroid-Blocking Agent in a Radiation 
Emergency: Final Recommendations on Use'' (47 FR 28158). In that 
notice, the agency made recommendations regarding the use of KI as a 
thyroid blocking agent. During 1999 to 2000, the agency reviewed 
additional data gathered primarily after the Chernobyl reactor 
accident. On January 4, 2001 (66 FR 801), the agency issued a draft 
guidance that revised some of the 1982 recommendations. The initial 
comment period on the draft guidance closed on February 5, 2001. On 
February 9, 2001 (66 FR 9711), the agency extended the comment period 
to April 30, 2001. After consideration of all comments, the agency is 
issuing this final version of the guidance. Other than clarifying 
edits, the agency has made no substantial changes to the 
recommendations incorporated in the draft guidance. In this guidance 
the agency maintains its position that KI is a safe and effective means 
by which to prevent radioiodine uptake by the thyroid gland and thus to 
reduce the risk of thyroid cancer in the event of a radiation 
emergency. FDA proposes lower radioactive exposure thresholds for KI 
prophylaxis as well as lower doses of KI for neonates, infants, and 
children than previously recommended. FDA's revised recommendations are 
in general accordance with those of the World Health Organization, as 
expressed in its ``Guidelines for Iodine Phrophylaxis Following Nuclear 
Accidents'' (1999), except for minor modifications.
    The recommendations in the guidance were prepared by FDA scientists 
from the Center for Drug Evaluation and Research and from the Center 
for Devices and Radiological Health, in consultation with other 
governmental experts.
    This level 1 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 the use of potassium iodide as a 
thyroid blocking agent in radiation emergencies. 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 requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may, at any time, submit written or electronic 
comments on the guidance to the Dockets Management Branch (address 
above). Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number

[[Page 64047]]

found in brackets in the heading of this document. The 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: December 3, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-30492 Filed 12-10-01; 8:45 am]
BILLING CODE 4160-01-S