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Type of IsotopeExpiration Date 25, D. C. Upon approval of this application, sender will receive an AEC Discount Certificate. 1. REQUEST. Application i s made under T i t l e 10 C.F.R. Part 37, for an AEC Discount Certificate with which radioisotopes may b e purchased a t 20% of the AEC established price for u s e in agricultural and biomedical research, including research in medical therapy and diagnosis. It i s understood that radiosotopes i n fixed sources such as strontium applicators and teletherapy units, cobalt-60 needles and applicators, gold 198 colloid, and Y-90 colloid, are not available a t a discount. 2. TERhZS AND CONDITIONS. The applicant agrees: (a) T o purchase such radioisotopes a t a discount for research purposes only and that radioisotopes so purchased will not b e used for routine clinical treatment and diagnosis; (b) That t h e results of the research utilizing radioisotopes purchased under t h e authority of a Discount Certificate will be available for ,publication or be otherwise available to the Atomic Energy Commission; (c) That in t h e event restricted data i s developed in the course of the research, such data will b e treated in accordance with t h e security requirements e s t a b lished under the Atomic Energy Act of 1954, and t h e regulations promulgated thereunder for t h e safeguarding of data 3. PURPOSES OF RESEARCH. Attach, as part of this application, a brief statement; (a) of the research in which radie isotopes purchased a t a discount will be used; (b) of the location and description of t h e laboratory facilities a t which the research i s to be conducted; (c) of the pertinent research experience of t h e applicant; and (d) whether or not the contemplated medical research involves human applications, and if so, whether or not t h e applicant is a Doctor of Medicine and licensed to practice in the jurisdiction in which the research will be conducted. thorization(s)) permitting the procurement of isotopes for the purposes stated under Item 2, above. Mail original to Director, Division of Biology & Medicine, U. S. Atomic Energy Commission, Washington 4. LICENSE (or Authorization). The applicant p o s s e s s e s the following Atomic Energy Commission License(s) (OK Au5. CERTIFICATION. The undersigned certifies that to the best of (its) (my) knowledge the above information and the statements contained herein are true and correct, and that the radioisotopes purchased under a Discount Certificate will b e used only for t h e purposes stated under Item 3, above. FOR USE BY AEC 6. REVIEW. T h e above application h a s been reviewed and approval is is not 0 recommended. 7. APPROVAL AND ISSUANCE. T h e above application is approved, and Discount Certificate No. expires -. has been issued to the above named applicant. Date Approving Of fic lal
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Expiration Date Type of Isotope Name and Address of Applicant Signature of Applicmt 6. REVIEW. T h e above application h a s been reviewed and approval is 0 is not 0 recommended. Date Scientific Reviewer 7. APPROVAL AND ISSUANCE. T h e above application is approved, and Discount certificate No. expires -. has been issued to the above named applicant. Date Approving Official
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ATOMIC ENERGY COMMISSION Pursuant to section 3 of the Administrative Procedure Act, Public Law 404, rule is published as a document subject to codification, effective July 1. 1955. 37.8 Requirements for approval. 37.10 Dlsapproval of sppllcations 37.12 Discount purchase procedures. 37.13 Procedures for suppliers. AUTHORITY: 8 f 37.1 to 37.13 issued under Interpret or apply sew. 31. 81, 68 Stat. 927, 9 37.1 Purpose. The regulations in this part set forth the Atomic Energy Commission’s criteria and procedures for the purchase of radioisotopes, at a discount, for use in research programs within the scope of the regulations in S 37.2 Sccqe. The scope of the program set forth in this part extends only to purchases 0: radioisotopes for use in research in the fields of agriculture and biomedicine, including research in nedi - cal therapy and diagnosis, and permits such purchases a t 20 percent of the current, prices established by the Commission. Ihscount purchases are not permitted for radioisotopes used in routine clinical treatment, in fixed sources such as strontium applicators, teletherapy units, cobalr-60 needles and applicators, gold 192 colloid, or Y-90 colloid. All discount purchases of radioisotopes are subject to bJdgetary limitations and the availability of funds, and to the byproduct license requirements of Part 30 of 8 37.3 Definitions. As used in this mestic user of radioisotopes that is a n individual, corporation. partnership, firm, associztion, trtist, estare, public or private institu:io?>. grocp, a State or any polit;:zl subdivision of. or any pclitical entity within a State, or a legal successor. representaiive. agent or agency of the foregoin?: Proridec; kowcver, That the "applicant" shall not Include. scribe facilities t.o be used for the parfor purposes of this part, any agencies ticulai. research proposed; SUmmarlze of the United States Government 0:’ any briefi]. the research experience Of the contractor operated facility, wholly sup- apphcarit : list Its licenses Or authorim - ported by the AEC. tions permitting the procurement Of Energy Commission 01’ Its duly author- the researc!] proposed; ana, state whether 0 1 no: the contemplated medi-ized representative. Division of Biology 2nd Medicine, or his tions, and if SO, whether or not the duly authorized representative. applicant is a Doctor of Medicine and Id) “Distributor” means any AEC f a - licensed t o practice in the jurisdiction in cillty which prcduces radioisotopes for which the research Rill be conducted. ( e l “PUrChaSer“ means any applicant nirec,tormay, at any time after the filt o which the COmmiSSiCn has issued a ing of the original application and beDiscount Certjficate. fore the expiration of the Discount Ceruct material as defined in section 1 1 (e) in enable him to determine of the Atomic Energy Act of 1954. whether the Discount Certificate should ( g f “Supplier” means anyone. licensed be granted or denied or whether it should by the Atomic Energy Commission under be modified, suspended, or revoked. the authority of section 81 of the Atomic Energy A c t of 1954, engaged in the busi- 5 37.8 Requirements f o r approval. The applicant must evidence, in its ap-ness of selling radioisotopes. plication and any supporting informa5 37.4 InterpretUtio?ls. Except as tion submitted supplementary thereto, specificalls authorized by the COmmiS- that it is qualified to conduct t h e resion in writing, no interpretation of the search proposed, and t h a t the research mezning of the regulations in this Part proposed constitutes a well considered by any officer or employee of the Corn- program justifying an authorization to mission other t h a n by the General Coun- radioisotopes at discount. sel. in writing, will be recognized t o be E 37.9 Issuance. The Director will re-binding upon the commission. view each application and, upon makin& F 37.5 Comnrunicutions. All COm- a finding that the applicant satisfies the munications concerning the Program eS- requirements of 37.8 will issue to the filed in connection a-ith it, should be count Certificate, addressee to the United States Atomic D, c,, Attention: Division of I f the Director determines t h a t the a?- pllcant does not sstisfy the recjuirements Biology and Medicine. of F 77.8, he will so notifp the appiicant F 37.6 Applications. l a ) Any appli- and include in the notice a statement Of cant desiring to purchase radioisotopes the reasons for that determination. T h e at discount from the AEC established Director‘s determination shall be final. price, pursuant t3 this part shsll file $ 3; 1; Discount Certificate. A Dis- ~ 7 i t h the Director a Form AEC-312, count Certificate: “Application for Radioisotope Research !.ai 1 s merely evidence that its holder Support.” may purchase radioisotopes a t the disapplicant t o : State name and address: ( b ) Does not, in any way, affect any agree to limit the use of the radioisotopes limitations imposed by or abrogate any purchased a t discount solely to the Pur- requirements of byproduct licenses or poses permitted by the Program ; agree radioisotope authorizations issued or reto make the results of the research avail- quired pursuant to the Atomic Energy able either for publication or to the AEC; Act of 1954; agree to treat ResLricted Data developed ( c ) Apart from any requirements or in the caUrse of t:ie research in accord- limitations pursuant to 5 37.1: ( b ) of ance with ine securic: requirements of this part, sets no limits on the types or the -4tcmic Energy Act of 1954 and the quantities of radioisotopes purchased; the nature of the research in connection with vrhich the radioisotope. v;ill be (e 1 IS valid Ollly during the fiscal Year June 30) in which it is issued ox the ensuing used; state the location at which i h search is to be conducted; briefly tb) Form AEC-372, will require the ccunt specified thereon;
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fiscal year upon the submission and approval of anea application; ( f ) May be modified from time to time, as the Director deems necessary, in accordance with Commission regulations and pursuant to established Commission policy; and (g) May be suspended or revoked by (1) If budgetary or fiscal limitations necessitate the discontinuance of the ited to, a material false statement in the application, revealed conditions or facts which would have warranted a disapproval of the application in the first instance, failure to fulfill the obligations undertaken in the application, or violation of or failure to observe any of the requirements. terms, or conditions of the Atomic Ehergy Act of 1954 or Commission regulations. The Certificate holder shall be notified promptly of a suspension or revocation for cause and the reasons therefor. 5 37.12 Discount purchase procedures. Discount Certificate holders may make discount purchases of radioisotopes: ( a ) By providing suppliers with a purchase order upon which. or affixed to which, is an exact signed copy of the The undersigned certifies to the supplier and to the U. S. Atomic Energy Commission issued to the undersigned by the Director. Division of Biology and Medicine. U. S. Atomic Energy Commlsslon. authorizing the purchase of radioisotopes a t 20 percent Of AEC established price; that isotopes purchased under this authority wlll be used only for agricultural and biomedical research. including research in medical therapy and diagnosis; that the undersigned is authorized. uursuant to the regulations in Title 10. Part 30, Code of Federal Regulations, Radioisotope Distribution, to procure such radioisotopes; and, that all of the information set forth and the statements made herein are to the best of (its) ( m y ) knowledge true ( b ) By forwarding to the supplier, along with the first purchase order placed with it during the fiscal year then current, a copy of the purchaser's Discount Certificate as furnished by the Commission, or a certified true copy Procedures for supp Ii eTs. ( a ) Suppliers that receive requests for discount purchases are, before honoring such requests, responsible for obtaining a certified purchase order and a copy of a Discount Certificate as required by (b) A supplier that has honored a discount purchase request for radioisotopes shall, within 45 days from the date of the discount sale, submit to the distributor from which the radioisotopes were obtained, a request for a credit, against the isotopes, in the dollar amount of the discounts the supplier has allowed under and in accordance with the regulations in this part. ted to a distributor shall summarize the total of the credit requested for the period covered and shall be accompanied by supporting documents, such as shipping memoranda, shipping tabulations, or receipted purchase orders, which include the following pertinent information with respect to each sale or shipment and such additional information as may be required by the distributor: (1) Name of purchaser in the same manner as it appears on the purchaser's (3) Type and quantity of radioisotopes sold and delivered; (5 1 Evidence of the amount of the discount given to the purchaser. ( d ) The distributor shall, within a reasonable time after receipt of a request fur credit, require any supplementary supporting data that may be necessary and notify the supplier of the credit day of June 1955. IF. R . Doc. 55-5349; Filed, July 1 , 1955;
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Expiration Date Type of Isotope APPLICATION FOR RADIOISOTOPE RESEARCH SUPPORT Neme and Addresa of Appllcnnt Signelure of Applicml 5. REVIEW. T h e above application h a s been reviewed and approval is 0 is not recommended. 7. APPROVAL AND ISSUANCE. T h e above application is approved, and Discount Certificate No. h a s been issued to the above named applicant.