[Federal Register Volume 66, Number 28 (Friday, February 9, 2001)]
[Notices]
[Page 9711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-3417]


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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Draft Guidance on Potassium Iodide as a Thyroid Blocking Agent in 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; Extension of Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of comment period.

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SUMMARY: The Food and Drug Administration (FDA) is extending to April 
30, 2001, the comment period for the draft guidance entitled 
``Potassium Iodide as a Thyroid Blocking Agent in Radiation 
Emergencies'' that appeared in the Federal Register of January 4, 2001 
(66 FR 801). FDA is taking this action in response to a request for an 
extension.

DATES: Submit written comments on the draft guidance by April 30, 2001. 
General comments on agency guidance documents are welcome at any time.

ADDRESSES: Copies of this draft guidance are available on the Internet 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for single copies of the draft guidance to the Drug Information Branch 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 the office in processing your 
request. Submit written comments to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Requests and comments should be identified with 
the docket number found in brackets in the heading of this document.

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: In the Federal Register of January 4, 2001 
(66 FR 801), FDA published a notice announcing the availability of a 
draft guidance document entitled ``Potassium Iodide as a Thyroid 
Blocking Agent in Radiation Emergencies.'' This draft guidance updates 
the notice of availability entitled ``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 
potassium iodide 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.
    FDA received an e-mail request, dated January 4, 2001, requesting 
that the agency extend the comment period on the draft guidance by 60 
days, allowing 90 days for comments. Because the draft guidance 
introduces several new recommendations, the agency has decided to 
extend the comment period on the draft guidance to April 30, 2001, to 
allow the public more time to review and comment on its contents.
    Interested persons may submit to the Dockets Management Branch 
(address above) written comments on the draft guidance document by 
April 30, 2001. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments should be identified 
with the docket number found in brackets in the heading of this 
document. The draft guidance document and received comments may be seen 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: February 2, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-3417 Filed 2-8-01; 8:45 am]
BILLING CODE 4160-01-F