[Federal Register Volume 66, Number 3 (Thursday, January 4, 2001)]
[Notices]
[Pages 801-802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-189]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1681]


Draft Guidance on Potassium Iodide as a Thyroid Blocking Agent in 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availability of a draft guidance entitled ``Potassium Iodide as a 
Thyroid Blocking Agent in Radiation Emergencies.'' This draft guidance 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 In the draft guidance, FDA maintains 
its position that KI is a safe and effective means by which to prevent 
radioiodine uptake by the thyroid gland, under certain specified 
condition for use, and thus to obviate the risk of thyroid cancer in 
the event of a radiation emergency.

DATES: February 5, 2001.

ADDRESSES: Copies of this draft guidance are available on the Internet 
at http://www.fda.gov/cder/guidance/index.htm. Submit written requests 
for single copies of the draft guidance to the Drug Information Branch 
(HFD-210), 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 Submit written comments on the draft guidance to the Dockets 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.

FOR FURTHER INFORMATION CONTACT: Rose E. Cunningham, Executive 
Operations (HFD-06), Center for Drug Evaluation and Research, Food and 
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-
6779.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance entitled ``Potassium Iodide as a Thyroid Blocking Agent 
in Radiation Emergencies.''
    The Federal Emergency Management Agency 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 expected to accomplish these roles and 
responsibilities as part of the Federal Radiological Preparedness 
Coordinating Committee. Among other responsibilities, the 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.
    FDA is announcing the availability of a draft guidance that updates 
the notice of availability, ``Potassium Iodide as a Thyroid-Blocking 
Agent In a Radiation Emergency: Final Recommendations On Use,'' 
published in the Federal Register of June 29, 1982 (47 FR 28158). In 
this draft guidance, FDA maintains its position that KI is a safe and 
effective means by which to prevent radioiodine uptake by the thyroid 
gland, under certain specified conditions of use, and thus to lessen 
the risk of thyroid cancer in the event of a radiation emergency. In 
this draft guidance, 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 
(WHO), as expressed in its ``Guidelines for Iodine Phrophylaxis 
Following Nuclear Accidents'' (1999), though they differ from those of 
the WHO in two areas.
    First, for the sake of logistical simplicity, FDA recommends the 
65-milligram (mg) dose of KI for all school-age children while allowing 
for the full adult dose of 130 mg in adolescents approaching adult 
size. WHO recommends 130 mg KI for adults and adolescents (over 12 
years of age). Second, FDA recommends that KI prophylaxis in those 
under age 19 and in pregnant or lactating women be triggered at a 
predicted thyroid radioiodine exposure of 5 centiGray (cGy), while WHO 
establishes 1 cGy as the threshold for intervention. FDA has concluded 
from the Chernobyl data that the most reliable evidence demonstrates

[[Page 802]]

a significant increase in risk of childhood thyroid cancer at exposures 
of 5 cGy or greater.
    The recommendations in the draft guidance were prepared by 
scientists from the Center for Drug Evaluation and Research and from 
the Center for Devices and Radiological Health of FDA in consultation 
with other governmental experts.
    This draft guidance is being issued consistent with FDA's good 
guidance practices (65 FR 56468, September 19, 2000). The draft 
guidance represents the agency's current thinking on 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.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance. 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 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.

    Dated: December 26, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-189 Filed 1-3-01; 8:45 am]
BILLING CODE 4160-01-F