FDA makes available guidance on use of KI in radiation emergencies

["Jacobus, John (OD/ORS)" <jacobusj@ors.od.nih.gov>]

This appeared in today's Federal Register.  Sorry of the length.



-- John 

John Jacobus, MS

Certified Health Physicist 

3050 Traymore Lane

Bowie, MD  20715-2024



E-mail:  jenday1@email.msn.com (H)      

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

[Federal Register: December 11, 2001 (Volume 66, Number 238)]

[Notices]               

[Page 64046-64047]               



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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

. . .



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

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.

. . .

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