ML20212N900

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Request for OMB Review & Supporting Statement Re 10CFR32, Specific Domestic Licenses to Mfg or Transfer Certain Items Containing Byproduct Matl. Estimated Respondent Burden Is 6,670 H
ML20212N900
Person / Time
Issue date: 03/10/1987
From: Norry P
NRC OFFICE OF ADMINISTRATION (ADM)
To:
References
OMB-3150-0001, OMB-3150-1, NUDOCS 8703130198
Download: ML20212N900 (32)
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Req ~uest for DMB-Revi6W - -d /. A- ~%

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. Read instructions before completing form. Do not use the same SF 83 Seed three copies of this form, the material to be reviewed, and for.

  • to request both an Executive Order 12291 review and approval under ,
  • papenyork-three copie,s.of the supportmg statement, to: .

~ the Paperwork Reduction Act. . i Answer all questions in Part 1. If this request is for review under E.O.' Office o'f'1nformation and Regulatory Affairs 12291, complete Part ll and sign the regulatory certification. If this Office of Management and Budget

. request is for approval under the Paperwork Reduction Act and 5 CFR Attention: Docket Library, Room 3201 1320, skip Part II, complete Part til and sign the paperwork certification. Washmgton, DC 20503 PART 1.-Complete This Part for All Requests.

1. C;partment/ager5cy and Bureau /of fice originating request 2. Agency code U.S. Nuclear Regulatory Commission 3- 1 5 0 3 N me of person who can best answer questions regard ng this request Telephone number Sterling Bell ( 3013 427-9026-TiItle of information collection or rulemaking 10 CFR Part 32 - Specific Domestic Licenses to Manufacture or Transfer Certain Items Containing Byproduct Material:
5. Legal cuthonty f or anformation. collection or rule (cite tinated States Code. Pcblic Law, of Enecutive Order)

_ _4 2 USC  ??Al(D) . o'r

6. Affected public(checA allthatapply) $ Q federalagencies oremployees 1 Indtvidu'ais oT households 3 Farms 6 O Non profitinstitutions 2 3 State or localgovernments 4 C Businesses or other for.prefit 7 O Small businesses or organizations PART ll.-Complete This Part Only if the. Request is for OMB Review Under Executive Order 12291
7. Regulition Identifier Number (RIN)

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[ type of st bmission (check one en each ca*egory) Type of review requested Classification Stage of de velopment 1 Q stanca.c 1 U Ma;e- 1 U Prcpesed er dv't 2 U Pere rg 2 U Nonma.cr 2 U Finaio' wer.m W *tn p er pmposal 3 C Emergency 3 C Feu! cr intenm f.rai. wthout pnor proposal 4 C statutory or judicral deachne

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!! No." did OME waive ttw arisyusi 3 U Ytes 4 2 No Certification for Regulatory submissions In subm.f t.ng this reqvest for OMS revew. tha con /ec y Mc y cc.nta

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PART lil.--Complete This Part Only if the Request 1s for Approv:1 cf 5 Collection .

of Information Under the Paperwork Reduction Act cnd 5 CFR 1320. .

j'3. Abs {ract-Desenbe needs, uses and affected public in 50 wor'ds or Igss Radioactive materials, Radia-tion safety ..

10 CFR Part 32 prescribes r'equirements .for.the issuance of specific licenses to persons who "

.manufactur'e or initially transfer items' containing byprod.uct material for sale or' distribution to exe'mpt persons,or general lice

' material into a product or m'ateri.nsees, al.- and re(juirements. for. license's. tolintroduce byproduct

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i4. Type of information' collection'(check only one) '

Lformation collections not containedin rules .

10 Regular submisson 2 O Emergency submission (certir,cationattached>

Information collections containedin rules 3 b Existing regulation (no change proposed) 6 Final or intenm finar without pnor NPRM 7. Enter date of expected or actual Federal 4 0 Notsce of proposed rulemaking(NPRM) A O Regular subm ssion Register publication at this stage of rulemaking 5 Final. NPRM was previously oubhshed B O Emergency submission (cerfilscateon attached) (month, day, year):

15. Type of review requested (check only one) 1 O New coiiection 4 Reinstatement of a previousiy approved coiiectioit for whien approvai 2 Revision of a currently approved collection has expired 3 L .1 Entension of the expiration date of a currently approved collection 5 Eusting collection in use without an OMB control number without any Change in the substance or in the method of collection
16. Agency report form number (s)(enclude standard /optionalform nu'mber(s)) 22. Purpose of intormation collection (chech as manyas apply) g ,

I l App!ication for benefits 2 Frogram evaluation, , *

17. Annuti reporting or d;sclosure burden 3 0 ceneraipurposestatistics 1 Numberof respondents . 306- 4 G Reguiatoryorcompliance

, 2 Number of responses per responderit 38.3 5 Program pianning or m'anagernent .

3 Total annual responses (line 1 times line 2) IL 725 s O Research 4 Hours per response ' O.57 7 Audit 5 Total hours (Isne 3 times line 4) 6,670

18. Annuai recordkeeping burden 23. Frequency ot recordkeeping or reporting (check all that apply) 1 Nurnber of recordkeepers 215 1 G Recor.dkeeping 2 Annual hours per recordkeeper. , 12.1 neporting .

3 TotaliecordPeepin'g hours ( e'I:n' 1 times linE2) c ~ 2.610 2 3 onoccasion 4 Recordkeeping retention period 5 years 3 weekiy

19. Tot:1 annual burden .

4 0 vontniy 1 Requested (lone 17-5 plus lone 18-3) . 9s200 5 3 ovarteriy .

2 fn current OMB inventory _ L 280._. 6 0 semi.annuariy 3 v* .necc e (1:ne i ins It'e 2) _0_4 ' 3 - wa:ty Lsplanation of ditterence .

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20. Current (most recent) oM8 coritroi namt>er or cormerit r:urnt'er  ! 24. W4 cmerts' obhgatson to comply (checA fne strongesf obligatton thaf ap#es)

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21. hequestec emprat.en cate j  ; 2 U Pyred to obtaen or re'ain a benefit

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l 25. Av the respondents pnmardy educational agenus or inst tut.ons c's t*.e p. mary rese cf S > co' etton related to Feceraf education programs? O ves I No

26. Dees the ar zy use sampg to sett responeris or cNs the army *eee o u ew a 'rm use of samphng er stat;stical ana'yts by respondems? . O ves I no
27. Regulatory authority for the information collection

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3 SUPPORTING ' STATEMENT <

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SPECIFIC DOMESTIC LICENSEES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL Justification ' .

Need for and Agency Use of the Information Collection

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'Section 32.11 of 10 ~CFR Part 32 establishes the information which 'needs to be- -

included in an application for a specific license which would~ authorize the introduction of byproduct material into a product or material ~and transfer of-the prodtict or material to persons exempt from licensing. Tfieapplicantmust

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provide information as to the product.or material into wfiich the byproduct material will be introduced, how the byproduct material will b'e introduced, the initial concentration of the byproduct material to be introduced and control methods to assure that no more than the specified concentration will be intro-duced, the estimated time interval between introduction and transfer of the product or material, estimated concentration of the byproduct material at time of transfer, ard reasonable assurance that the concentration will not exceed the values specified in Section 30.70, 10 CFR Part 30. The information is needed to determine the kind of products and materials into which byproduct material will be incorporated and provides NRC with information concerning those persons who would produce and transfer the products or materials.

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.Section 32.1'2 of 10 CFR Par;t 32 're. quires .an annual report fp6m licens'ees - -

authorized to distribute products and inaterials containing byproduct material under a license issued pursuant to Section 32.11, 10 CFR Part 32, to persons exempt from licensing. Tiie report must identify the type and quantity of each product or material into.which byproduct material was introduced, the type and quantityofeachradionuclideintroduced,andtheconcentration(tthetimeof transfer. Section 32.11 authorizes the licensee to introduce any byproduct

. material from a long schedule.of isotopes up to certain quantities into prod-ucts or materia.ls. This information, therefore, is needed so that. N'RC will be aware of what byproduct materials and the quantities thereof are introduced into materials which could e'nter the environment and/or be used by persons not .

subject to any regulatory requirements.

Section 32.14 of 10 CFR Part.32 establishes the information wh'ich needs to ce included in an application for. distribution of a variety of items containing byproduct to persons exempt from licensing. The items include timepieces, hands, and dials containing Hydrogen-3, and Promethium-147; electron tubes con-taining Hydrogen-3, Cobalt 60, Nickel-63, Krypton-85, Cesium-137, and Promethium-147; ionizing radiation measuring instruments containing a number of byproduct materials; and spark gap irradiators containing Cobalt-60. The information which needs to be included in the application is the chemical and physical form and maximum amount of byproduct material in the item, details of construction and design, method of containment or binding of the byproduct material in the product, procedures for and result of prototype testing of the t

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followed in fabi'ic'ation of product' ion lots of the product,' and the method of .

labelino or marking each product except timepieces. This information is needed for the NRC to make a determination that the method of containment or binding of the byproduct material in the product is such that the radioactive material will not be release'd or removed from the product under the most severe

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. conditions which are likely- to be encountered in normal use'and ' handling.

Section 32.15(b) of 10 CFR Part 32 provides that licensees may submit alterna-tive procedure.s to be used instead of random sample tabies and Lot Tolerance Percent Defective si'z e for acceptance or! rejection inspection as required for issuance of a license under Sectio'n 32.14. ~NRC Form 313, which'is used to coll.ect this information, has previously been cleared under 0MB' No. 3150-01'20, which should be' referred to for addi.tional -supporting information, burden.and cost data. .

Section 32.15(d) requires that licensees label or mark each unit of product, except for timepieces, hands or dials containing Tritium or Promethium-147, and its container so that the manufacturer and/or the initial transfer of the product and the byproduct material in the product can be identified by the con-sumer and if necessary, the NRC. This requirement is needed so that in the event of a recall or problems with the item, the public and the NRC can readily determine who the initial distritutor is from all the non-licensed distributors in the marketing chain.

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Section 32.116 of 10 CFR Par't 3I requires.a' report to NRC every'ff've ykars from

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licensees authorized to distribute products pursuant to Section 32.14, 10 CFR ~

Part 32, to persons exempt from licensing. The report must identify the product, the total quantity of the radionuclide and the number of units of each type of product distributed over a five year period. This information is needed so that the NRC will be.a' ware of the type arid qu'antity.of.,p'roducts and amount of radioactive material distributed to persons exempt from licensing.

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Section 32.'7(c) 1 of 10 CFR Part 32 establishes the"information which needs to be included in an application for manufacture or distribution of synthetic plastic resins containing Scandium-46 designed'for sand-consolidation in oil wells. The applicant must provide information as to the producii to manu-

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factured or. distributed a description of the control procedures to assure,that.

- the Scandium-46 in. the product will not exceed the specified~ concentration, and '

a description of the label which will be on' the product container which in-cludes the product name, a statement that the product contains radioactive Scandium and is designed only for sand-consolidation in oil wells, instructions for proper use of the product, and the manufacturer's name. This information is necessary so that the NRC may determine the adequacy of the product and that it meets the concentration limits specified for the Scandium-46.

Section 32.17(d) of 10 CFR Part 32 requires the applicant to submit, along with his application, copies of prototype labels and brochures that will accompany byproduct materials commercially distributed to persons exempt from NRC regula-tions. The information is needed for the NRC to make a determination that the

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tains radioactive diaterial and who the manufacturer was in t'he event a problem arises.

Section 32.18 of 10 CFR Part 32 specifies the requirements for a license'to distribute small quanti. ties of byproduct material to persons exempt from licensing. The requirements include the need for the applicant to provide copies of the labels which will be on the containers of the individual quan-tities of byproduct material and the brochures that will accompany the quan- ,

tities of the product-material. The 1abels must identify the.radiot.sotope and

' quantity of radioactive ^ material aiid bear the words, "Radioacti've Material."

The brochure must. set forth radiation safety precautions and instructions relating to the use, storage, and' disposal of the radioactive mate'r'ial. ' The information is needed so that NRC may determine'that the applicant is -familiar with the requirements and that the labels and brochures are' correct dnd adequately provide to the ultimate user appropriate information.

Section 32.18(d) of 10 CFR Part 32 requires the applicant to submit, along with

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his application, copies of prototype labels and brochures for staff review for l content as described in Section 32.19(c) and (d). This paragraph sets up the l

requirement for submission at the time of application for a license to distrib-uted exempt material.

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i Section 32.19(c) of 10 CFR Part 32 requires that the immediate container of each separately packaged cuantity of byproduct material bears a durable and

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- legible ~ 1& bel nich: identifies the isotope useland amount t[hereiri contained.

This requirement is needed so that individuals who fiandi'e these packages will know they contain radioactive material and in the event of an accident will know the type of isotope involved and the amount.

Section 32.19(d)'of.10.CFR Part 32 requires additional information on a label that is attached to the i;mnediate container or an accompanying brochure. This label is needed so that individuals who actually handle inner containers will.

_ know that'the material 'is exempt from NRC or Agreement State licensing:but in any event is mot for human use in any manner. .

Section'32.20 of I'0 CFR Part 32 ' requires an annual report from licensees autho-rized to. distribute small quantities of byproduc't material to persons exempt from licensing. .The report must identify each radioisotope and the total quan-tity of each . radioisotope distributed to persons exempt from licensing. A negative report is required so that the NRC will know that all licensees required to report under Section 32.20 have in fact , filed their report. If the NRC did not require negative reports, we would not have a way of knowing whether the licensee had zero distribution or just forgot to respond. This information is needed so that NRC will be aware of the amount of radioactive material distributed to persons over whom there are no regulatory controls.

Section 32.20(a) of 10 CFR Part 32 requires that the licensee maintain records

' of transfers for one year. NRC's planned rulemaking on record retention will

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change ~this~to three years. The records are revi[ewed'by NRC~inspegtor.s.to '

detennine. compliance with transfer documentation requirements.

Section 32.22 of 10 CFR Part 32 specifies the information which needs to be included in an application for manufacturer or initial distribution of self-luminous products containing Hydrogen-3, Krypton-85, or Promethium-147.. The self-luminous products would be possessed and used by persons exempt from licensing. The applicant must provide information relating to the design, manufacture, prototype ' testing, quali'ty control procedures, labeling or marking, and conditions of storage, use, and disposal of the product. This information is needed so that NRC may determine the' adequacy of the product and that the product meets the safety cri'teria for such products as set forth in NRC regulations.

Sec. tion 32.25(b) of 10' CFR Part 32 requires a. label to identi.fy the man 0fac-turer, producer, or initial tra'nsferor and the byproduct material. This infor-mation needs to be available on the device so that in the event it is lost or

'there is an accident, the appropriate party can be contacted for vital infor-mation to determine the degree of possible hazard.

l Section 32.25(c) of 10 CFR Part 32 reouf res a report every five years or upon license renewal from licensees authorized pursuant to Section 32.22 to distribute self-luminous products containing Hydrogen-3, Krypton-85, or Promethium-147 to persons exempt from licensing. The report must identify each product, the radioisotope in each product, the total quantity of radioactive material, and

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the n'mber u of units' of each ' product' distributed. . The infomation is n$eded so" ' '

tilat NRC'will be aware of'the kinds of products distributed, the number of products distributed, and the amount of radioactive material in the products.

The products distributed would. include products generally available to the; general public such as self-luminous backlit liquid crystal display digital

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Section.32.26 of 10 CFR Part 32 specifies the information which needs to be included in an application for a. license for manufacture 'or initia.1 transfer of gas. and aerosol detectors ' designed to protect life or property from, fires and

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airborne haiards. The gas and aerosol detectors would be possessed and used by persons exempt from licensing. Theapplicantmustprovideinformationrelating to the design: . manufacture, prototype. testing, quality control procedures,-

conditions' of handling, storage,.use, and disposal of the gas and aerosol detectors. .The information is needed so that NRC may determine that the prod-uct meets the safety crit'eria for gas and aerosol detectors as set forth in NRC regulations.

Section 32.29(b) of 10 CFR Part 32 requires a label on each point of sale package of an aerosol detector informing the consumer that the product contains byproduct material, how much, and that the detector has been manufactured in compliance with NRC safety criteria. The information is needed so that the consumer will be put on notice that the item contains a radioactive substance so that the consumer may then make a choice as to if they want a radioactive or non-radioactive aerosol detector in their home. This labeling information is for the use of the consumer and not for the NRC.

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Section 32.29(c) of 10 CFRPart 32 r'equires.a. report every five year,s or upon .

license renewal'from licensees authorized pur'suant to Sect' ion 32.26 to distribute gas and aerosol detectors to persons exempt from licensing. The report must identify the product, the radioisotope contained in the product, the total quantity of radioactive material, and the number of units of the product distribut'ed. This' information-is needed so that NRC wili be aware of the kinds of products distributed, which could include products available to the general public such as ionization-type smoke detectors.containin,g Americium-241.

Section 32.51 of 10 CFR Part 32 establishes ~the information which ne.eds to be included in an application for the manufacture of ~or initia'l distribution of

'ce'rtain devices containing byproduct material to persons gen.erally licensed pursuant.to Section 31.5 of 10. CFR Par.t .31. The types of ' devices which may be ,

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distributed to general licensees include devices designed arid manufac'tured.for the purpose o.f detecting, measuring, gauging or controllin'g thickness, density, level, interface location, radiation, leakage, qualitative or quantitative chemical composition, producing light, or an ionized atmosphere.

Section 32.51(a)(2) requires that the applicant must provide information relat-ing to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device. In the event the applicant desires testing of the device at longer than six-month intervals either for proper operation of the device's on-off mechanism and indicator and/or for leakage, the epplicant must provide evidence and justification for a longer

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. time interval. .In.the event the applicant. desires that the. generhl licensee,be' authorized to install the device, collect the sample to be analyzed for leakage .

of radioactive material, service the device, test the on-off mechanism and indicator, or remove the device from installation, the applicant must provide written instructions'to be followed by the general licensees'and estimated radiation doses associated with performance.of the operations. The information ,

is needed so that the NRC may detennine th'e adequacy of the device and that any operations to be conducted by the general licensee may be accomplished with minimum radiation dose to, personnel. 'The NRC. inust de'termine that use of the device and performance of any operations associated with the device Jnay be

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performed by individuals untrained in radiological protection.

Sect' ion 32.51(a)(3) of'10 CFR Part -32. requires.that'a durabl and legible label which contains' instructions, precaution' s , and requirements for safe installa-tion, leak testi.ng or lack of.the requirement for leak testing be placed upon

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the device. This requirement is needed because as a generally licensed device it is intended to be used safely by persons not having training in radiological protection. It is therefore necessary to instruct and warn all persons who come in contact with each device what it is and what safety procedures must be used in connection with the device (such as whether a leak test is necessary or not and if so, when it should be done. The condition imposed does not require any submission to NRC, but informs the general licensee of his status and duties as an NRC licensee.

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Siction 32.51a of.'10 CFR Part 32 .contains conditions of'a license which autho--

rizes'distributionoi'devicesto'generallicensees. Theconditt'onihposedis that the distributor provide a c6py of the general license in Section 31.5 to all general licensees so that they are aware of the fact that they are NRC licensees and have certain legal responsibilities.

Section 32.52(a) of 10 CFR Part 32 requires a quarterly report from licensees authorized pursuant,to Section 32.51 to distribute devices to general licensees. The report 'niust ' identify each general licensee by name and address, must identify an individual who may constitute a point of contact between NRC and the general licensee, the type and model number of device transferred, and the quantity and ' type of bypr.oduct material contiined in the device. If inter-mediate persons,will temporarily process; the device at the intend.e,d place of use. prior' to its possession by the u'ser,'the rep'or' t must identify each inter-mediate person by name, address, contact, and relationship to the intended user. As a generally licensed device rather than a "specifically licensed device " these reports are the only means the Commission has to keep track of the location of these radioactive devices. Section 32.52(b) requires that if transfers are made to general licensees in Agreement States, a report similar to the report required to be submitted to NRC must be filed with the respon-sible Agreement State agency. Section 32.52(c) requires that the licensee maintain records of transfers. The records must show name, address, point of address, point of contact for each general licensee, etc. In addition, the records nust show the date of transfer, the isotope and quantity of radioac-tivity in each device transferred, and the identity of any interrediate person.

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.This.information'is needed so that'NRC will be' aware of the location of devices.

in the pos' session of general licensee's. The reports a're used for inspection purposes to determine compliance by general licensees with the terms and con-ditions of the general , license in Section 31.5, 10 CFR Part 31.

Section'32'.53(b).of 10 CFR-Part,32 establishes the information which'needs to be included in an application for a specific license for manufacture, assembly, repair, or initial transfer of luminous safety devices containing Hydrogen-3 or P'romethium-147 for use in aircraft to general. licensees. the applicant must provide information as to the des'ign and construction of

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-devices, chemical and physical form arid amount of Hydrogen-3 or Promethium-147 ,

in each device.. method of binding or containing the Hydrogen-3 or Promethium-147 in the device, procedures for a'nd.,results of prototype testing of devices, and alternative qu5lity control pro'cedures 'to those specified' in .

NRC regulations. The information is necessary so that NRC may determine that ,

the method of incorporation and binding of the Hydrogen-3 or Promethium-147 in the device is such that the radioactive material will not be released under the most severe conditions likely to be encountered in normal use and handling of the device, Hydrogen-3 or Promethium-147 is incorporated or enclosed to preclude direct physical contact by any person with it, the device is designed so that it cannot be easily disassembled, that the prototype test results are satisfactory, and that the device meets the safety criteria specified in NRC regulations.

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Section 32.54(a). of 10 CFR Part 32 requires that;'a durable and legible label ,

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which contains information concerning the it.3 del' number, serial number, name of -

isotope used and the name of the manufacturer be affixed to the device. This condition does not require submission to the NRC. The required information is for the use of the general licensee.

Section 32.54(b) of 10 CFR Part 32 provides an alternative to Section 32.54(a) where it is not feasible to attach a label to the device which contains all the information called for in Section 32.54(a). Where a label containing all the information required in'Section 32.54(a) can not be attached to the. device, a label identifying only the manufacturer and isotope'6 sed may be used along with

'a leaflet bearing the additional information. The required information is for the use of the general licensee. . ,

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Section 32.56 of 10 CFR Part 32 requires an annual report from licensees autho-rized pursuant to Section 32.53 to distribute luminous safety devices contain-ing Hydrogen-3 or Promethium-147 for use in aircraft to general licensees. The reports must identify each general licensee by name, must specify the kinds and numbers of luminous devices transferred, and trust specify the quantity of Hydrogen-3 or Promethium-147 in each device. This infonnation is needed so that NRC may be aware of the persons using the devices and how many are trans-ferred. The information is used for inspection purposes for determining com-pliance by general licensees with the terms and conditions of the general license in Section 31.7 of 10 CFR Part 31.

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Sec.tio'n 32.5I(b). of 10' CFR Part 32'establ.ishes the requirements for a specific' .

license for manufacture or ' initial transfer of calibration or reference sources containing Americium-241. The applicant must provide information as to details ,

of construction and design of sources, chemical and physical form and maxium .

quantity of Americium-241 in the source, the method of incorporation and binding of the Americium-241 in the source, results of prototype testing, ,

quality control procedures to be followed in manufacture of the source, and labeling to be affixed to the source. This information is necessary so that . .

the NRC n'ay determine that the so'urce design and method of incorporating and

- tiinding of the Americium-241 in the source is such that the. Americium-241 will not be released or removed from the source under. normal conditions .of use and -

handling and that the scurce has been subjected to.and satisfactorily passed the required prototype' testing. - ,

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Section 32.58 of 10 CPt Part 32 requires that'each source or storage container, for the source have a label aftixed to it containing sufficient information relative to safe use and storage of the source. As a gene' rally licensed device rather than a "specifically licensed device," these devices are intended to be used safely by persons not having training in radiological protection.

Consequently, these labels are the only means the Commission has to inform anyone who may come in contact with them what they are and their model and serial number in the event they are lost and need to be identified. The required information is for the use of the general licensee.

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'Section' 32.6.1(b) of 10'CFR.Part 32: establishes the infomation which'needs to be included in an application for a license to' manufacture or initially transfer ice detection devices containing Strontium-90 to general licensees.

The applicant must provide information as,to deta.ils of construction and design of the source of radiation and its shielding, chemical and physical form -

,' and maximum quantity o'f Strontium-90 in the device, radiation profile of the device, procedures for and result of prototype testing, quality control procedures to'be followed,in manufacture of. the device, labeling of the device, ,

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and . instructions for handling' and installation of the device. [Theinformation is necessary so that the NRC may determine that the Strontium-90.in.the device will not.be released or. removed from the' device under the.most severe' conditions. likely to be encou'ntered in normal use and handling,'the. ,

Strontium-90,ts shielded so.that no individsal would receive a radiatiori dose - '

in' excess of 0.5 rem per year .the device is designed so that it cannot easily be disassembled, the device has been subjected to a' n d has satisfacto'ily r passed required prototype testing, and quality control procedures have been I

established.

t Section 32.61(d) of 10 CFR Part 32 requires that each device bear a durable legible label which includes the radiation caution symbol prescribed by Section 20.203(a) of 10 CFR Part 20 as well as instructions for proper disposal and statements that the device is generally licensed; however, assembly and repair of the device may be performed by a specific licensee. This information is for the safety and use of the licensee and his employees. Often such devices are not ear,ily recognizable as containing radioactive material. Therefore, labels

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- are necessarylfor'the safe,ty of users. to put them on notic.e.of the presence of" .

byproduct' material. There are currently no licensees subject to this requirement and none are anticipated for the foreseeable future. Hence, the burden shown is zero.

Sect' ion 32.70(b)of10CFRPart32establishesthe.informationwhichneedsto be included in an application for distribution of byproduct material for use by physicians under general license. The byproduct materials which may be distributed under general license include Iodine-131 as sodium' iodide for, thyroid uptake measurement, Iodine-131 as iodinated human serum albumin for blood and blood plasma determinations, Cobalt-58 and Cobalt-60 for measurement '

of intestinal absorption of cyanocobal' amin, and Chromium-51 as sodium chromate

, for red blood cell voluine dsterminations and red blood cell survival time .

determinations. The applicant mus-t provide evidence th'at the byproduct material is'to be manuf,actured, packaged, and labeled in accordance with a new drug application approved by the Commissioner of Food and Drugs, Food and Drug Administration, or is in accordance with a license for a biological product issued by the Secretary, Department of Health, Education, and Welfare (now Health and Human Services). The applicant must provide a croy of the statement which must be on the label or appears in the leaflet or brochure which accompanies the package containing the byproduct material. The statement must specify that the radioactive material may be received, possessed, and used only by physicians licensed to dispense drugs in the practice of medicine and that the receipt, possession, use, and transfer of the byproduct material is subject to the regulations and generrl license of the Nuclear Pegulatory Commission or an Agreerr.ent State.

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. Section32.70(c)of10CFR.Part32iequiresthata'.labeland/orbro'hureaccom- c pany the package which identifies it as a radioactive d. rug and gives the 'name of the manufacturer in addition to putting the user on notice that its receipt, possession, use and transfer are subject to the regulations of. the NRC. This information is for the safety and use of the general licensee.

Section.32.71 of 10 CFR Part 32 establishes the information which needs to be included in an application for a specific license to manufacture or distribute Iodine-125, Iodine-131, Carbon-14, Hydrogen-3, Iron-59, Selenium-7.5, or mock Iodine-125 cont'ained in prepackaged units to general licensees for in vitro clinical or latioratory testing. The applicant must prov'ide copies of the labels which will be af. fixed to each prepackaged unit and copies of the leaflet or brochure which accompanies the package. The leaflet or' brochure must con-tain information as to' the precautions to be observed in handling and storing the radioactive material. This information is necessary so that the NPC may .

determine that the labels are in compliance with the requirements in the NRC regulations and that the instructions contained in the leaflet and brochure are adequate.

Section 32.71(c) of 10 CFR Part 32 requires that each prepackaged unit bears a durable, clearly visible label identifying the radioactive contents as to chemical form and radionuclides as well as displaying the radiation caution symbol. This information is for the safety and use of the general licensee ard his employees,

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Section 32.'71.(d.) of 10 ~CFR Pa'rt. 32 requires that the label affixed to each' . .

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prepackaged unit or brochure'which accompan'ies the package contain a statement which tells who may receive, acquire, possess and use the material. As gen-erally licensed material rather than "specifically licensed material," this material is intended to be used safely by persons not having training in radio-logicla protection. Consequently, any person who.comes into contact with the-material must be informed as to what it is-and who may receive, possess and use the material.

The label shall also state the radioisotope's use, receipt, acquisit. ion, possession, and' transfer are subject to the regulations and a general license of the NRC or Agreement State. This requirement is for the use of the.

licensee. . .

Section 32.71(e) of 10 CFR Part 3'2 requires that the label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such byproduct material. As generally licensed material rather than "specifically licensed material," this material is intended to be used safely by persons not having training in radiological protection. Consequently, there must be a means to inform any person who comes into possession of the material of the adequate information as to the precautions to be observed in handling and storing such byproduct material. The label required in Section 32.71(e) pro-vides this information. This reonirement is for the use of the licensee.

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Section. 32.72(a)(2) of 10 CFR 'Part 32 , establishes. the . requirements for an .

application for a specific license to manufacture and distribute radio-pharmaceuticals containing byproduct material to persons licensed to use radiopharmaceuticals pursuant to Section 35.14 of 10 CFR Part 35. Section 35.14 provides for uses of radiopharmaceuticals by group of uses. The applicant must provide evidence that the.-radiopharmaceuticals will be manufactured, labeled, and packaged in accordance with the Federal Food, Drug and Cosmetic A'ct or the Public Health Service Act or evidence that the

'radiopharmaceuticals are not subject to these Acts., The applicant must provide.information on the radionuclides, chemical and physical form., packaging and labell'ng of the radiopharmaceuticals. . This information is necessary so that the NRC may determine that only those radiopharmaceuticals whose efficiency has been demonstrated w'ill be distributed to. group licensees, that 5

the packaging is appropriate for safe handling and storage of radiopharmaceuticals by group licensees, and that labels and other information accompanying the radiopharmaceuticals provide appropriate information to group licensees.

Section 32.72(a)(4)(1) requires that the license applicant submit to the NRC evidence that the label will comply with the Federal Food, Drugs and Cosmetic Act or the Public Health Service Act requirements. The informatior is needed to determine that the applicant has satisfied the requirements of other govern-mental agencies as required by law.

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Sectio'n .32.73(a)(2) of 10sCFR 'Part 32 establishes the requirements, for 'an . ,

application for a specific license to manufacture and distribute. generators or reagent kits containing byproduct materials to persons licensed pursuant to Section 35.14 of 10 CFR Part 35. The generators and reagent kits containing

' byproduct material would be used for preparation of radiopharmaceutical.s...The applicant must provid6 evidence that the-generator or reagent kit is to be manufactured, labeled and packaged in accordance with the Federal Food, Drug

. and Cosmetic Act or the Public Health. Service Act or that the applicant must ,

provideinformationonthe.radionuclide,chemicalandphysical" form,packagjpg, and labeling of the generator or reagent kit. This infomation is needed so -

that the NRC'may determine that'the product to be' distributed is efficacious; that the packaging is adequate, and .that t'he labels provide adequate informa-tion, from a radiation safety, standpoint, on 'proced.ures to. b'e' followed and equipment and shielding for eluting the generator or processing radioactive material with the generator kit'.

Section 32.73(a)'(4) of 10 CFR Part 32 requires that the label affixed to the i

generator or reagent kit contains information on the radionuclide, cuantity, and date of assay. This requirement is needed so that individuals who handle these packages will know that it contains radioactive material and the amount.

This information is for the safety and use of the general licensee and his

) employees.

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Section'.32.73(a)(5')..of 10 CFR Part 32 requires.that the labe'l affixed to'or.the enclosed' leaflet to the generator or reagent kit contain adequate information from a radiation safety standpoint to safely use the device. Also, it shall indicate that the kit or generator is approved for use by persons licensed by the NRC pursuant to Sections.35.1' 4 and 35.100 Group'III of 10 CFR Part 35 or equivalent licensses of Agreement States. .This inform. tion is for the safety '

and use of the general licensee and his employees.

Section 32'74(a)(2) of 10 CFR Part 32. establishes the. requirements for an application for a specific license to manufacture and distribute sources and .

devices co'ntaining byproduct mater'ial to persons licensed pursuant'to Section 35.14 of 10 CFR Part.35 to use such sources and devices. The sources and devices would be used as calibration or ref.erence sources or for uses listed in Group VI Schedule A, Section 35.100. The information must include the' type of source or device, byproduct material contained'in it, the chemical and physical form, amount, details of design and construction, procedures for and results of prototype tests, radiation profile for a device, quality control procedures, calibration, labels, and instructions to users. This information is needed so that the NRC may determine the adequacy of the source or device design and that the source or device will maintain fi.s integrity under stresses likely to be encountered in normal use and accidents, that the quality control procedures are adequate to assure that production sources and devices meet the standard of the design and prototype tests, that the calibration procedures are adequate, and the instructions for handling and storace are adequate from a radiation safety standpoint.

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handling and storing the source or device from a radiation safety standpoint be attached on a durable label, or where the instructions are too lengthy, they may be summarized, on thh label,and printed in detail on an accompanying bro-chure. This information'is for the safety and use of the general. licensee and

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his employees.* ,

Section 32.74(a)(3) of 10 CFR Part 32 lists tpe information required to be placed on the label to include the name of the radionuclide, ciuantity, and date ofassayaswellasastate'mentthatthesource'ordevice'islicenseldfordis-

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tribut. ion by NRC pu'rsuant to Sections.35.14 and 35'.100 Group.VI of 10 CFR Part

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35 'or under equivalent licensees of Agreement States.

The NRC normally requires testing of sources or devices containing byproduct matsrial to determine whether there has been leakage of the byproduct material.

Section 32.74(b) of 10 CFR Part 32 establishes the requirements'for information which needs to be submitted in the event the applicant who wishes to manufac-ture or distribute a source or device desires a leak test interval of more than six months. The applicant must provide information which demonstrates that the longer interval is justified by performance characteristics of the source or device or by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the sources. The in-formation is needed so that NRC may determine if the information submitted by the applicant provides sufficient justification for granting an extended leak test interval.

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' Reduction of Burden Through Information Technology.

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. s There are no legal obstacles to reducing the burden associated with this information collection. However, because of the. types of infonnation and the Iinfrequency of submission, the application and reports do not lend themselves readily to the"use of automated information ' technology .for submission.

Efforts to Avoid Duplication In general .information required by NRC in applications, reports, or. records concerning the tran5fer, receipt, possession, or use of'. byproduct material d.oes no't duplicate. Other' Federal information. '

collection requirements and 'is not'.available from any source other than' applicants or licensees. Portions of the needed information.might. also.be contained in'other information submittals .to NRC or other.. Federal agencies. .

However, duplication, ,1f any, ii slight, and the collection of this information- .

by use of specified forms and other required reports and records is the most .

effective and least burdensome means of obtaining the information.

l Effort to Identify Duplication l

l The Federal Information Locator System was searched to determine NRC and other Federal agency duplication. None was found.

Effort to use Similar Information There is no similar information available to the NRC.

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. - Effort to Reduch Small-Bus' ness. i Burden , . . .

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The majority of 1.icensees who use byproduct material are small'businesse's.

Since the health and safety consequences of improper handling or use of radioactive byproduct material are the same for large and small entities, it is not possible to reduce the burden on small busine'sses by less frequent or'less complete repo.i ting, recordkee~ ping, or ac' counting and control ' procedures.

Consequences of = Less Frequent Collection Required r'eports.are collected and evaluated o'n-a' continuing basis as events ,

. occur. Applications for new' licenses and amendments ,are submitted o'nly once.

Applications for rer.ewal.of licenses are submitted 'every five ' years. -

Information su.bmitted in previous applications may be referenced wit;hout being.

. resubmitted. The schedsle for collecting the information is th.e minimum

.' frequency necessary to assure that license ~es will continue'to conduct programs in a manner that will assure adequate protection of the public health and safety'.

Circumstances Which Justify Variation from OMB Guidelines Contrary to the OMB Guidelines in 5 CFR 1320.6(f), Section 32.52(c) requires that the licensee maintain records of transfer for a period of five years.

The records must be available so that NRC may determine the location of devices in the possession of general licenses if necessary, such as in the case of an incident, and so that NRC inspectors may examine the records to determine compliance with the terms of the general license and regulations. Regular periodic inspections may occur at up to five year intervals, depending on the type of licensee.

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Consultations Outside the Agency 'The~re have been no cons'ultations outside the -

age'ncy sinc'e the previous clearance of these information collection requirements.

Confidentia'lity of Information

'None, excep't for proprietary information. -

Sensitive Questions None.

. Description of the Information Collection

, Number and Type of Respondents -

These requirements Will affect approximately 306 license holders or applicants for a license to manufacture or initially transfer certain items containing byproduct material.

Record Retention Period Section 32.52(c) requires that the licensee maintain reccrds of transfer for a period of five years. The records must be available so that NRC may determine the location of devices in the possession of general licenses if necessary, such as in the case of an incident, and so that NRC inspectors may examine the records to determine compliance with the terms of the general license and regulations. Regular periodic inspections may occur at up to five year intervals, depending cr. the type of licensee.

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. Estimat6 of Coinpliance .' Burden ~- - i Reporting Requirements Licensee Total Annual No. of Licensee Staff Hours Licensee Burden Section Responses Annually Per Submitt'al (Hrs) 32.11 - See OMB Clearance No. 3150-0120 32.12 200 0.6 120 32.14 - See OMB Clearance No. 3150-0120 32.15(b) - See OMB Clearance No. 3150-0120 32.15(d) .

75 0.5 38 .

32.16 -

200 0.6 ,

120 ,

- See OMB Clearanc'e No, 3150 0120 '

'32 17(c) 32.1'7(d) - See OMB Clearance N'o. 3150-0120 32.18(d) - See OMB Cl.earance No'.- 3150-012.0 -

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32.19(c) 47' O.5 '24 32.19(d) 47 0. 5, 24 32.20(b) 200 0.6 120 i 32.22 - See OMB Clearance No. 3150-0120 32.25(b) 7 0.4 3 32.25(c) 200 0.6 120 32.26 - See OMB Clearance No. 3150-0120 32.29(b) 200 0.5 100 32.29(c) 200 0.6 120 32.51(a)(2) - See OMB Clearance No. 3150-0120 32.51(a)(3) 5000 0.5 2,500 32.51 a 5000 0.5 2,500 i

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Reporting Requirem~ents (co'ntin'ued) ~

~ .' Li~ensee c Total.' Annual No. of Licensee Staff Hours Licensee Burden Section Responses Annually Per Submittal (Hrs) 32.52(b) 15 24.0 360

. 32.53(b) - See OMB Clearance No. 3150-0120 32.54(a) 75 0.5 38 -

s 32.54(b) 12 0.5 6 32.56 200 0.5 100 32.57(b)- - See OMB Clearance No. 3150-0120 32.58 6 O.5 3-

~ 32.61-(b-)

- See.-0MB Clearance.No. 3.150-0120 -

32.61(d) 'O N/A 0

32.70(b) - See OMB C1.earance No. '3150-0120

-32.70(c) . 6 0.' 5 -3 32.71(c) 6 0.5 3 32.71(d) - Included in 32.71(c) 32.71(e) - Included in 32.71(c) 32.72(a)(2) - See OMB Clearance No. 3150-0120 32.72(a)(4)(i) - See OMB Clearance No. 3150-0120 32.73(a)(2) - See OMB Clearance No. 3150-0120 32.73(a)(4) 7 0.5 4 32.73(a)(5) - Included in 32.73(a)(4) 32.74(a)(2) - See OMB Clearance No. 3150-0120 32.74(a)(2)(viii) -

7 0.5 4 32.74(a)(3) - Included in 32.74(a)(2)(viii) 11,725 6,670

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Recordkeeping. Requiremeiit's ~

Annual Hours Total Recos No. of per Recordkeeping Retention Section Recordkeepers Recordkeeper Hours Period 32.20(a) 200 0.6 120 1 Year 32.52(c) 15 166.0 2,490 5 Years Total. Number of Recordkeepers: 215 -

Total Record Keeping Hours Annually: 2,610 Total Annual Burden Hours: 9,280 Estimated. Cost to Public to Respond Section Annual Cost to Res_ pond

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32.11 Seb 0MB Clearance'No.' 3150-0120 32.12 $7,200 32.14. - See OMB C1 arance No. 3159-0120 32.15(b) - See OMB Clearance No. 3150-0120 32.15(d) $2,280 32.16 $7,200 32.17(c) - See OMB Clearance No. 3150-0120 32.17(d) - See OMB Clearance No. 3150-0120 32.18(d) - See OPB Clearance No. 3150-0120 32.19(c) $1,440 32.19(d) $1,440 32.20(a) $7,200 32.20(b) $7,200 32.22 - See OMB Clearance No. 3150-0120 32.25(b) $ 180 32.25(c} $7,200

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' Estimated Cost to Public'to Respond.

Section Annual Cost to Respond 32.26 - See OMB Clearance No. 3150-0120 32.29(b) $ 6,000 32.29(c) .$ 7,200 32.51(a)(2) - See OMB Clearance No.' 3150-0120 32.51(a)(3) $150,000 32.51 a $150,000

$ 2'1',600 32.52(a)

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32.52(b) $ 21,600, 32.52(c) ~$149,400' -

32.53(b) - See OMB Clearance No. 3150-0120

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32.54(a) $ 2,28d ,

32.54('b) $ '360-32.56 $ 6,000 32.57(b) - See OMB Clearance No. 3150-0120 32.58 $ 180 32.61(b) - See OMB Clearance No. 3150-0120 32.61(d) 0 32.70(b) - See OMB Clearance No. 3150-0120 32.70(c) $ 180 32.71(c) $ 180 l

32.71(d) - Included in 31.71(c) l 32.71(e) - Included in 32.71(c) 32.72(a)(2) - See OPP Clearance No. 3150-0120 3P.72(a)(4)(i) - See n.vB Clearance No. .'150-0120 i

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j Estimated 'Co'st to Public 'to.' Respond (continued). , '.. , k 

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  • Section -

Annual Cost to Respond 32.73(a)(2) - See OMB Clearance No. 3150-0120 32.73(a)(4) $ 240 32.73(a)(5) - Included in 32.73(a)(4) 

         ,         32.74(d)(2)                          See OMB C'leaiance No. 3150-0120                                                                    ,

32.74(a)(2)(viii) $ 240 32.74(a)(3) - Included in 32.74(a)(2)(viii) 

                                                                                                         $556,800                                                     -
 .'                Source of Burden and Cost Data an'd Method of Est'imating a'nd Cost                                                          -

The estimates'are ba' sed on submittals to NRC in past years. ' Cost to licensees and applicants is calculated ,at a ra'te of $60,00.per hour. This. figure includes both salaries and overhead. ' Estimate of Cost to the Federal Government Annual Cost - NRC Staff Review (Professional effort - 960 hours 0$60/hr) = $57,600 for activities other than application review. Application review activities are attributable to and reported under NRC Form 313, OMB Clearance No. 3150-0120.

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