Document text
Machine-read from the scan, so expect some errors. Lines that couldn’t be read are left out.
Page 1
1274 PROPOSED RULE MAKING shipped in complete conformity with the Chemical Iorm ' use to investigational radioactive biologics. fatty nciils. studies. ogics san ar o regulations issued by the Atomic Energy hwp This exemption Iodine 131-. Labeled fats and,'or Fat nhsorption (b) It fs the opinion of the Atomic Energy Commission, the division of b10oftHetlt:Pa& & DO....... 3facromprrntrdiodinntril humin LUW SCOICI. Administration that this exemption serum nllii~niin. should not apply for certain specific ,Do Colloidal micm Livrr sciiiis. drugs and that these drugs should be aPpropriately labeled for uses for which strated by new-drug applications or DO....... Iallnntrd humen Blood volunio through licensing by the Public Health DO ....... Rose ~eirgai.......LjIwr fuiiction Service in the case of biologics. Con- studies. tinued distribution under the investiga- Do Iodonprncrt. sodi- Kidney functionuni iodohip- studits tional exemption alien the drugs are ln- punte. sodium tended for established uses nil1 not be urn dlprotrizo-(c) Based on its experience in regu-- are, sodium maceuticals, the Atomic Energy Commis- sodium !otIi3tor fWy acids. studies. nyloii nbbon. mcnt 01 wncir. Iron turnoverconsiders that applicants may reasonably be expected to submit admuate evidence of safety and effectiveness for use Iridium lci?-+. seeds en w rti in as recommended in appropriate labeling; uses in this tabulation: JIrrcury30 .do 110. Pliosplionls Soluble plioilhotc. Trriitnicnt of polspllusplllltr. meiit of plrurnl Strontium 6.5- Silr.ita or chloride. Bona scans on 14 7 I Cesium 13: ... ~ i i c x v c lin nrrriirs 1titrn;titinl or intra-, nrurn nltiuiuiii. pvotoiii 1 Do..... Lalirlid r l Ihod Do. nndlor npplicnlor caritnry tnnt- mtiou. nleiit of plcurnt Food and Drug ..... YCJIIS. peiience nith the isotopes listed in para-Food. Druq. and Cosiiietic A c t (secs. 50js 1033: 21 U.S.C. 355. 3 7 l i a ) 1 and uncicr Energy Co!nmiwion. the Division of Bioof Fcocl i1nd Druzi 621 CFR 2.120). and 1 h......... tutes of Health. and the Food and Drug tutes of Hca!tii and the Atonlic EK'rgy Do. ........ .#Io............ c gatlonal-use labeiias when they w e Conxissicn. tlie Cc?:!:t:~i~sior~erof Food actually intended for use in iiiedical and Druzs proposes that the follO\r.iX cilii5ims. practice. for any of the indications listed shouldgluc,brviiiir,milurn di(,rotrizoute. submit. within 90 days after the effccffve date of this section, to the Bureau the Commissioner of Food and DrWs exempted investigational radioactive ne:v drugs from 3 130.3 provided tlicy were ioi li:d.tin.~Lv. FEDERAL REGISTER, VOL. 36. NO. 1 (-WEDNESDAY, JANU.\RY 27, 1971
Page 2
PROPOSED RULE MAKING of Drugs, Food and Drug Administration, 5600 Fishers Lane, Rockville. hld. tice of Claimed Investigational Exemption for a New Drug” for each such drug for ahich the manufacturer or distributor does not have an approved new-drug application pursuant to section 505(b) of the Federal Food. Drug. and Cosmetic tional Esemption for a New Drug” should be submitted in accordance with B 130.3. and any new-drug application should be submitted in accordance with I 130.4. ( 3 ) If the drug is a biologic, a “Notice of Claimed Investigational Exemption for a New Drug” or a n application for a 11cense under the Public Health Service Act of July 1. 1944, should be submitted to the Division of Biologics Standards of the Xistionnl Institutes of Health. Public Health Service. Building 29. 9000 (4) After such 90-day period. the isoed for the uses stated, will no longer be the act or from 130.3 is in effect or has been in eEect for radioactive drugs preisotopes, naturally occurring isotopes, or cold substances used in conjunction nith Interested persons may, nithin 30 days after pub!icntton hereof in the FEDERAL REGISTEX,file with the Hearkg Clerk, Welfare. Eccm 6-62. 5600 Fishers Lane. Rockville. 3rd. 20852, written comments (preferably in quintuplicate) regarding this proposal. Comments may be accompanied by a memorandum or brief in Comtriissioner of Food and Drugs.