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Food a n d Drug Administration TIONS CONTAINING THERAPEUTIC OR DIAGNOSTIC SODIUM IODIDE Drugs for Human Use; Drug Eficacy The Food and Drug Administration has evaluated reports received from the National Academy of Sciences-National Research Council, Drug Efficacy Study Group, on the . following radioactive la. Sodium iodide 1-131 capsules: marketed as Radiocaps-131 by Abbott Laboratories, 14th and Sheridan Road, b. Sodium iodide 1-131 sterile solution; marketed as tracervial-131; Abbott c. Sodium iodide 1-131 oral solution: e. Sodium iodide 1-131 sterile solution: keted as Iodotope by E. R. Squibb a n d Sons, Inc.. Georges Road, New Brunswick. New Jersey 08903 (NDA 10-929). b. Sodium iodide 1-131 oral solution: marketed as Iodotope: Squibb (NDA keted as Iodotope: Squlbb (NDA 10-929). Such drugs a r e regarded as new drugs drug applications are required t o revise the labeling in and to update previously approved applications providing for such drugs. A ne;v drug application is required from any person marketing such drua A. Effectivcness classification. The 1. Sodiun? iodide 1-131 is effective as a dizanoscic azen: of thyroid function: i n 2. A s a thcrnpcutic agent. sockin iodide 1-131 is c-fiective for the treat xen t carcinoma of the thyroid. 3. Sodium iodide 1-131 is possibly effective for use in the mx::;cn;-nt of pectoris and ccn::cstive heart failurc. tion is preynrcd to approve abbrcvinted
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new-drug applications and abbreviated supplements to previously approved newdrug applications under conditions de1. Form of drug. Sodium iodide 1-131 preparations are in capsule or solution form suitable for oral administration or sterile solution form suitable for paren2 . Labeling conditions. a. The labels bear the statement “Caution: Federal laiv prohibits dispensing without preb. The drugs are labeled to comply r i t h all requirements of the Act and regulations. The labeling bears adequate information for safe and effective use of the drug and is in accord with the guidelines for uniform labeling published in The “Indications” section is as follows: (Labeling guidelines for the drug are available from the Administration on Rndfoiadide is indlcnted for use in performance of the radioactive iodide ( R A I ) uptake test to evaluate thyroid function. Dlagnostic doses may also be employed in locallzing met ~ rase sassociated with thyroid maiigTlierapeuric doses of radioiodide may be ism and se!ected cases of carcinomn of the thyroid. Palliative edects may be seen In CInOma of the thyroid. Stimulation of radlolodlde upcake may be xhleved by t h e adwill not be taken up by @ant cell and spindle cell carcinot~i3.of the thyroid or by amyloid The possibly effective indication may also be included for 6 months. 3. Xarketing status. Marketing of such drugs may be continued under conditions described in the notice entitled “Condied in Drug Efficacy Study” published i n tion which became effective on the basis of safety prior to Oct. 10. 1962), the submission of a supplement for relised 1abelinz. a n abbreviated supplement for drug in the formu!ation which is mzr- (il.fiil. and (iii) of the notice of July b. For m y person ~ v h odoes not hold a n tior.. the submisston of a n ai.breriaxd quate d i i 3 to assure tile biolonc availA’llicii is or is intcilded to be zxi : exd, as dexr:bed i:i paragrapii ta, (31 ~ i i iof c. For any distributor of the drug, the nourAcf.xer.: for any such d n q shipped described in paragraph tbj of that notice. d. For indications for which tlie drug has been c!ajsificd as possibly etfcctivc sbo.ce*, conmued usc as dcscribed in Hazardous Materials Regulations TRANSPORT OF RADIOACTIVE Request for Public Advice on Revision of lnternotionoi Regulations Pxrpose. This notice is intended to infora mterested persons of the recent issu3iice aiid ar’ailabilicp of 3 draft of proposed changes to t h e internatioiial re:ulatiom for the transportation of mdioaciive materials a n d to inrite &Zd‘,770Und. I n 1959. a t the request of the Eco;:omic and Social Coullcil of the dcx!opmciit of internatioiial rezulstions for tl;t safe transportation of radionctive lished by the Agency in 1961 were recorxxcrided to iiiember states as the basis cation to international transportation. As 8 result of estersive re\ision in 1963 and 1964. and further effort in 1966. tlie tioiti for Safe Transport of Radioactive ISER, VOL. 36, NO. 18--WEDNESDAY, JANUAR A copy of the NAS-NRC report has been furnished to each firm referred to above. Any other interested person may obtain a copy by request to the Food and Drug Administration, Press Relations Communications forwarded in response to this announcement should be identified with the reference number DES1 8200, directed to the attention of the appropriate office listed below, and addressed to the Food and Diug Administration. 5600 Fishers Lane, Rockville. Burenu of Drugs. (identify as s u c h ) : Drug Efficacy Study Implementation Project Office (BD-5), Bureau of Drugs. All other conmiurncations rezardinp this announcement: Drug Effrcacg Study Implei nieiltation Project Ofice (BD-5), Bureau of This notice is issued pursuant to proViS i Oll j of the Federal Food, Drug, and Cosmetic Act (secs. 503. 505, 52 Stat. and under authority delegated to the Commissioner of Food and Drugs (21 Dated: January 4. 1971. comments was then foraarded by the Department to the IAEA in July 1969. Some of these suggested changes were intended to make n more positive alimment of the US. regulations wit!i ti:e IAEA regulations possible. In all. t h e IAEA received more than 300 pages of comments from t h e member states. During the period of February 2-13, 1970, the IAEA convened a panel of experts to review t h e regulations and consider the comments which had been submitted by member states. The US. delegation on this review panel consisted of a three-man team, headed by the US. Department of Transportation representative, with one advisor from the US. Atomic Energy Commission and another from private industry. At this panel. 14 countries a n d 10 internatioiinl organizations were represented. As a result of this review panel’s efforts. a first working draft of a revision of the regulations was developed. I t :vas circulated t o the chairmen of the workilig groups of the review panel in April 1970. , Subsequently, a second revised draft was prepared and issued in Jime 1970 to all of the review panel yarticipants for their revien. T h e second drnft was also circlllated by the USAEC ta muiy interested persons. On December mitted n third revised draft to 311 IAE-1 The purpose of this public notice is t o inform all intcrested persons of the issuance a n d availability of thls third rethe Safe Transport of Padioactive Materials. Third Revised Draft, November Materials. Safety Series No. 6.” was pub lished in 1967. The IAEA regulations hat since been adopted generally by m0.i nations of the world as a basis for the! own national regulations governing th transportation of radioactive material: Since 1966, the US. Atomic Eiierg Commission has issued regulations whic: are substantially in conformance wit: IAEA standards for fissile radioactir, materials and large quantities of radioac tive materials. On October 4, 1968. tht Hazardous Materials Regulations Boa:( of the Department of Transportatior published amendments which were alsc in substantial conformance with thr In February 1969. remgnizing that tlir international standards should be revised from time to time 011 the basis o: scientific a n d technical advances, as weL as accumulated experience in their application, the IAEA invited all of its member states to submit comments and suggested changes to the regulations. Another aim was to remove any ambiguities and to simplify the presentatior. of the text of the regulations. Comments and suggested revisions t o the IAEA regulations were then collected by the Department from the US.Atomic Energy Commission, the American National Standards Institute, Atomic Industrial Forum, and others. As a result of that effort, a compilation of some 40
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In cooperation with t h e U.S. Atomic Energy Commission, the Department is making every effort to solicit comments .on this third draft. Copies are presently being distributed to all USAEC operating contractors, as well as to t h e Atomic Industrial Forum and the Americnn Nasile and Eadioactive Materials) for redistribution to their members and other A copy of this document may be obtained, free of charge. by writing to the Director, Office of Hazardous Materials, US. Departnient of Transpartation, 400 20590. Copies are elso ovnil:b;e from the Atomic Industrial Forum, 850 Third Avenue, Nen- Yorir, NY 10022. Comments on the third draft are in-, iited and should bc submitted in duplicate to the Director. Office of Hazardous Materials a t the above address, prior to quested by the I&-A by Nay. 31, 1971. These commects Kill be fomarded through the U.S. State Department by the Department of Transportation. A fmnl mceting of the re:iem panel of experts is presently scheduled to be convened by tile WEA in late October 1971. for the purpose of considering t!ie final cornmelib by the member states. and to prepare 3 final draft for submission to the MEA Board of Gx ern or s for meir approval. I t is contemplated that vision of IAEA Safety Series No. 6 someOfice of Hazardous ,lZateriak.