Title 10 - Atomic Energy, Chapter 1 - Atomic Energy Commission, Part 37 - Radioisotope Research Support Program (Reprinted from Federal Register of July 2, 1955) (Application Enclosed)

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FOLDER A AIOMIC 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 appllcations. 37.12 Discount purchase procedures. 37.13 Procedures for suppliers. Interpret or apply sew. 31, 81, 68 Stat. 927, $ 3 7 . 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 $37.2 Scope. The scope of the program set forth in this part extends only t o purchases of radioisotopes for use in research in the fields of agriculture and biomedicine, including research in medical therapy and diagnosis, and permits such purchases a t 20 percent of the current, prices established by the Commission. Discount purchases are not permitted for radioisotopes used in routine clinical treatment, in fixed souxces such as strontium applicators, teletherapy units, cobalt-60 needles and applicators, gold 198 colloid, or Y-90 colloid. All discount purchases of radioisotopes are subject to budgetary limitations ana t h e availability of funds, and to the byproduct license requirements of Part 30 of 9 37.3 Definitions. As used in this mestic user of radioisotopes that is a n individual, corporation. partnership, firm, association, trust, estate, public or Privaae institutioc. group, a State or any politxal subdivision of, or any political entity within a State, or a legal succesSOT. representative, agent 01‘agency of AUTHORITY: $ 5 37.1 to 37.13 issued under the term “applicant” shall not include, for purposes of this part, any agencies of the United States Government or any contractor operated facility, wholly supported by the AEC. Energy Commission or its duly authoric) “Director” means the Director, Division of Biology and Medicine, or his duly authorized representative. cility which produces radioisotopes for to which the Commissicn has issued a uct material as defined in section 11 teJ of the Atomic Energy Act of 1954. by the Atomic Energy Commission under the authority of section 81 of the Atomic Energy Act of 1954, engaged in the business of selling radioisotopes. 5 37.4 interpretations. Except as specifically authorized by t h e Commission in writing, no interpretation of the mezning of the regulations in this part by any officer or employee of the Commission other than by the General Counsel. in writing, will be recognized to be binding upon the Commission. munications concerning the program established in this part, and applications filed in connection with it, should be addressee to the Uniaed States Atomic Biology and Medicine. cant desiring to purchase radioisotopes at discount from the AEC established price, pursuant ts this part shall file with the Director a Form AEC-372, “Application for Radioisotope Research applicant to: State name and address: agree to limit she use of the radioisotopes purchased a t discount solely to the purposes permitted by the program; agree to make the results of the research available either for publication or to the AEC; agree t o treat Restricted Data developed in the course of t-ie research in accordance with rne security requirements of the Atcmic Energy Act of 1954 and the guarding of Restricted Data : summarize the nature of the research in connection with which the radioisotopes will be used; state the location at which the research is to be conductled; briefly describe facilities to be used for the particular research proposed ; summarize briefly the research experience of the applicant ; list its licenses or authorizations permitting the procurement Of radioisotopes ior use in connection with the research proposed; and, state whether or not the contemplated medical research involves human applications, and if so, whether or not the applicant is a Doctor of Medicine and licensed to practice in the jurisdiction in which the research will be conducted. 37.7 Additional information. The Direc,tor may, at any time after the filing of the original application and before the expiration of the Discount Certificate, require additional information in order to enable him to determine whether the Discount Certificate should be granted or denied or whether it should be modified, suspended, or revoked. The applicant must evidence, in its application and any supporting information submitted supplementary thereto, that it is qualified to conduct the research proposed, and that the research proposed constitutes a well considered program justifying a n authorization to purchase radioisotopes at a discount. $ 37.9 issuance. The Director will review each application and, upon making a finding that the applicant satisfies the requirements of 9 37.8 will issue to the applicant three original cnpies of a Dis5 37.10 Disapproval of applications. If the Director determines that the spplicant does not satisfy the requirements of 5 37.8. h e will so notify the applicant and include in the notice a statement of the reasons for that determination. The Director’s determination shall be final. ta’l Is merely evidence that its holder may purchase radioisotopes a t the discount sptxified thereon; (bi Does not, in any way, affect any limitations imposed by or abrogate any requirements of byproduct licenses or radioisotope authorizations issued or required pursuant to the Atomic Energy limitations pursuant to 3 37.11 ib) of this part, sets no limits on the types or quantities of radioisotopes purchased; ( e ) Is valid only during the fiscal year (July 1-June 30) in which it is issued but may be reissued for the ensuing

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fiscal year upon the submission and approval of a new 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 Energy Act of 1954 or Commission regulations. The Certificate holder shall be notified promptly of a suspension or revocation for cause and the reasons therefor. g 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 a n exact signed copy of the T h e undersigned certifles to the supplier and to t h e U.S. Atomic Energy Commlsslon Issued to the undersigned by the Director, Dlvision of Biology and Medicine. U. s. Atomic Energy Commission, authorizing the purchase of radioisotopes at 20 percent Of AEC established price; that isotopes purchased under this authority will be used Only for agricultural and biomedical research, including research in medical therapy and dlagnosis: that the undersigned is authorized, pursuant to the regulations in Title 10, Part 30, Code of Federal Regulatlons, Radloisotope Distribution, to procure such radioisotopes; and, that all of the information set forth and the statements made herein are to the best of (its) (my) 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 Certiflcate as furnished by the Commission, or a certified true copy ( 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 ~egulations 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 ) Evidence of the amount of the discount given to the purchaser. ( d ) The distributor shall, within a reasonable time after receipt of a request for credit, require any supplementary supporting data that may be necessary and notify the supplier of the credit day of June 1955. U. S. GOVERNMENT PRINTING OFFICE: 1955 0-351327

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Expiration Date Type of Isotope APPLICATION FOR RADIOISOTOPE RESEARCH SUPPORT Name and Address of Applicant Signature of Applicmt FOR USE BY AEC I. REVIEN. The above application has been reviewed and approval i s is not 0 recommended. Date Seientlfic Reviewer -. APPROVAL AND ISSUANCE. T h e above application is approved, and Discount Certificate No. expires -. h a s been issued to the above named applicant.