ML19211C228
| ML19211C228 | |
| Person / Time | |
|---|---|
| Issue date: | 12/04/1979 |
| From: | Ryan R NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | Felton J NRC OFFICE OF ADMINISTRATION (ADM) |
| References | |
| NUDOCS 8001110082 | |
| Download: ML19211C228 (3) | |
Text
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NUCLE All llEGUL ATOf tY COMMISSION
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$}'... l UEC 4 1919 MEMORANDuti FOR: Joseph M. Felton, Director Division of Rules and Records FROM:
Robert G. Ryan, Director Office of State Programs
SUBJECT:
PROPOSED FEDERAL REGISTER NOTICE Enclosed is a proposed Federal Register Notice. By this notice the U.S. Nuclear Regulatory Commission notes for the record that the Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for the Carter-Wallace firm for producing potassium iodide (KI) as a thyroid blocking egent for use in a radiological accident. When published we intend to distribute copies of the notice to all appropriate public agencies for any action they deem necessary.
Federal policy and guidance on the use of KI in a radiological emergency has not yet been developed and published by HHS (HEW).
For your information, this draft of the notice was cleared with Edward Nida, FDA Public Information Specialist. Mr. Nida also stated that he cleared the draft with Dr. Jerome A. Halperin, Deputy Director, Bureau of Drugs, FDA.
Mr. Nida may be reached at 301/443-3285.
Robert G. Ryan, Director Office of State Programs
Enclosure:
As stated.
1740 112 9 0 01110 0 7 E
FDA APPROVES NDA FOR CARTER - WALLACE, INC.
FOR KI AS THYR 0ID BLOCKING AGENT FOR USE IN A RADIOLOGICAL EMERGENCY AGENCY:
U.S. Nuclear Regulatory Commission ACTI0ti: Drug Availability Announcement
SUMMARY
- The Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Carter-Wallace of Cranberry, New Jersey for potassium iodide (KI) as a thyroid blocking agent for use in a radiological emergency.
The drug will be manufactured in both tablet and solution form. The use of this drug for this purpose was the subject of a study by the National Council on Radiation Protection and fleasurement (NCRP); and a report (No. 55) by the NCRP published in August 1,1977 entitled " Protection of the Thyroid Gland in the Event of Release of Radiciodine." The report recommended the consideration of the drug for the stated purpose.
Federal policy and guidance concerning the circumstances under which this drug would be used have not yet been published.
An invitation to drug manufacturers to submit a NDA to provide and market KI to support a radiological emergency preparedness program for possible accidents at a fixed nuclear facility was published in the Federal Register in Volume 43, No. 242, p. 58798 and dated Friday, December 15, 1978.
To obtain information on the form and availability of potassium iodide for the purpose of thyroid blocking in a radiation emergency, contact Carter-Nallace, Inc., Cranberry, New Jersey, 609/655-C000. This number can be used for all emergencies in the day or night. An additional
" backup" emergency number is 609/799-1167.
The name of the drug is
" Thyro-Clock."
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o EFFECTIVE DATE:
Immediately FOR FURTHER INF0PJ4ATION CONTACT:
Carter-l!allace, Inc., Cranberry, New Jersey (Phone-609/655-6000 or 609/799-1167).
Dated at Washington, D.C. this day of 1979.
FOR THE NUCLEAR REGULATORY C0!1.'11SSION Samuel J. Chilk Secretary of the Commission 1740 114
.