ML20012C928

Request for OMB Review for 10CFR32, Specific Domestic Licenses to Mfg or Transfer Certain Items Containing Byproduct Matl. Estimated Respondent Burden 8,870 H

ML20012C928
Person / Time
Issue date:	03/17/1990
From:	Amenta J NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
References
OMB-3150-0001, OMB-3150-1, NUDOCS 9003260128
Download: ML20012C928 (32)

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e SUPPORTING STATEMENT FOR 10 CFR PART 32 SPECIFIC DOMESTIC LICENSEES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL Justification Need for and Agency Use of the Information Collection 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 product or material to persons exempt from licensing.

The applicant must provide information as to the product or material into which the byproduct material will be introduced, how the byproduct material will be 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, and 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.

-These requirements will affect approximately 306 license holders or applicants for a license to manufacture" or: initially transfer certain.

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items containing byproduct material.

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Section 32.12 of 10 CFR Part 32 requires an annual report from licensees authorized.to distribute products and materials containing byproduct material under a license issued pursuant to Section 32.11, 10 CFR Part 32, to persons exempt from licensing.

The report must identify-the type and quantity'of each product or material into which byproduct material was introduced, the type and quantity of each radionuclide introduced, and the concentration at the time of 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 materials.

This information, therefore, is needed so that NRC'will be aware of what byproduct materials and the quantities-thereof are introduced into materials which could enter 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 which needs to be 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.

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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 y

product, quality control procedures and quality control standards to be

. followed in fabrication of production-lots of the product, and the method of-labeling 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 released or removed from the product under the.most severe-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 procedures to be used instead of random sample tables and tot Tolerance Percent Defective size for acceptance or rejection _ inspection as required forf issuance of a license under Section 32.14.

NRC Form 313, which is used to-collect this information, has previously been cleared under OMB No. 3150-0120, which should be referred to for additional 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-readi.ly determine who the initial distritutor is from all-the non-licensed distributors in the marketing chain, i

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~4-Section 32.16 of 10 CFR Part 32 requires a report to NRC every five years from 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 aware of the type and quantity of products and amount of radioactive material distributed to persons exempt from licensing; Section 32.17(c) 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

.bs wells.

The applicant must provide information as to the product to manu--

4 factureo 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 m

'. consumer will be aware, especially at time of purchase, that the product con-tains radioactive material.and who the manufacturer was in the event a problem arises.

Section 32.18 of 10 CFR Part 32 specifies the requirements for a license to distribute small quantities 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 labels must identify the radioisotope and-quantity of radioactive material and bear the words,

" Radioactive Material."

The brochure must set forth radiation safety precautions and. instructions relating to the use, storage, and disposal of the radioactive material.

The information is needed so that NRC may oetermine that the applicant is familiar with the requirements and that the labels and brochures are correct and adequately provide to the ultimate user appropriate information.

Section 32.18(d) of 10 CFR Part 32 requires.the applicant to submit, along with his application, copies of prototype labels and brochures for staff review for content as described in Section 32.19(c) and (d).

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

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

6-legible label which identifies the isotope used and amount therein contained.

This requirement is needed so that individuals who handle 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 immediate 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 not for human use in any manner.

Section 32.20 of 10 CFR Part 32 requires an annual report from licensees autho-rized to distribute small quantities of byproduct 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 cware 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.

The records are reviewed by NRC inspectors to determine compliance with transfer documentation requirements.

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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 frcm licensing.

Theapplicantmustprovideinformationrelatingtothedes10n, manufacture, prototype testing, quality 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 criteria for such products as set forth in NRC regulations.

Section 32.25(b) of 10 CFR Part 32 requires a label to identify the manufac-turer, producer, or initial transferor 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.

Section 32.25(c) of 10 CFR Part 32 requires 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 licensi_ng.

The report must identify each product, the radioisotope in each product, the total quantity of radioactive material, and the number of units of each product distributed.

The information is needed so.

that NRC will be aware of the kinds of products distributed, the number of

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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 watches.

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 -initial transfer of gas and aerosol detectors designed to protect life or property from fires and airborne hazards.

The gas and aerosol detectors-would be possessed and used by persons exempt from licensing.

The applicant must provide information relating 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 criteria for gas and aerosol (s'ectors 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

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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' i

for the use of the consumer and not for the NRC.

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. Section 32.29(c) of 10 CFR Part 32 requires a report-every five years'or upon license renewal from licensees authorized pursuant to Section 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 distributed.

This information is needed so that NRC will be aware of the kinds

,of products distributed, which could include products available to the general public such as ionization-type smoke detectors containing Americiutc241.

Section 32.51 of 10 CFR Part 32 establishes the information-which needs to be included in an application for the manufacture of or initial distribution of certain devices containing byproduct material to persons generally licensed pursuant to Section 31.5 of 10 CFR Part 31.

The types of devices which may be-distributed to general licensees include devices-designed and manufactured for the purpose of detecting, measuring, gauging or controlling thickness, density, f

level, interf ace 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 ~1nf6rmation relat-ing to the design, manufacture, prototype testing, quality ccatrol, 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 iproper operation of the device's on-off mechanism and indicator and/or for leakage, the applicant must provide evidence and justification for a longer 4

. time interval, In the event the applicant desires that the general 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 inrtructions to be followed by the general licensees' and estimated.

radiation' doses associated with performance of the operations.

The information is needed so tnat the NRC may determine the 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 must determine that use of thec device and performance of any operations associated with the device may be performed by individuals untrained in radiological protection.

Section 32.51(a)(3) of 10 CFR Part 32 requires that a durable and legible label l

l which contains instructions, precautions,.and requirements for safe installa-l l

tion, leak testing or lack of the requirement for leak testing be placed upon 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 j

protection.

It is therefore necessary to instruct and warn all persons who 1

i 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-j l

not and if so, when it should be done.

The condition impoced.does not require-any submission to NRC, but informs the general licensee of his status and duties j

as an NRC licensee.

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Section 32.51a of 10'CFR Port 32 contains conditions of a license which autho-'

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-rizes' distribution'of devices to general licensees.- The condition imposed is'-

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that the distributor provide a copy of the' general license in Section 31.5 to-all general licensees so that they are aware of the fact that they are NRC'

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l licensees and have'certain legal responsibilities.

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Section 32.52(a) of 10 CFR Part.32 requires a quarterly report'from.1.icensees-authorized pursuant to Section 32.51 to distribute devices to general:

licensees.

The report must identify each general. licensee;by name!and address, j

must identify an individual who may constitute'a point of' contact between NRC-r and the general licensee, the type and model number of device transferred, and the quantity and type of byproduct material contained in the device. - If-inter-:

mediate persons will temporarily process the device at the intended place.of-use prior to its possession.by the user, the report must identify each inter-mediate person by name, address, contact, and. relationship to the intended l

user.

As a generally licensed device rather than a "specifically licensed j

device," these reports are the only means the Commission has to keep track of i

l the location of these radioactive devices. -Section 32.52(b) requires that if l

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

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-address, point of contact for each general licensee, etc.

In addition, the I

records must show'the date of transfer, the isotope and quantity of radioac-tivity in each device transferred, and the identity.of any intermediate person.

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e iThis.information'is needed so that NRC will be aware of the-location of devices

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in the possession of general licensees.

The reports are 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.

J Section 32.53(b) of 10 CFR Part 32 establishes the information'which needs to be included-in an applicationLfor a specific license for manufacture,;

assembly, repair, or initial transfer of luminous safety devices containing Hydrogen-3 or Promethium-147 for use in aircraft to general licensees.

The applicant must provide information as to the design and construction of l

devices, chemical and physical form and amount of Hydrogen-3 or Promethium-147 1

in each device, method of binding or~containing the Hydrogen-3 or C

Promethium-147 in the device, procedures for and results of prot'otype testing _

of devices, and alternative quality control procedures _ to those specified in-NRC regulations.

The information is r.ecessary so that NRC may determine that the method of incorporation and binding of-the Hydrogen-3 or Promethium-147~in

- l the device is such that the radioactive material willinot 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 afdurable.and-legible _labell which contains information concerning the model 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-l for the use.of the general. licensee.

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Section 32.54(b) of 10 CFR Part-32 provides an alternative to Section 32.54(a) j 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 atlabel containing alltthe_

information required in Section 32.54(a)-can not'be attached--to the device; a label identifying only the manufacturer and isotope used may"be used along with-q a leaflet bearing the additional information.

The required information'is'for:

.f 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 _ bh name,. must specify the' kinds: and numbers of luminous devices transferred, and must specify the quantity of -

Hydrogen-3 or Promethium-147 in each device.

This information~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--

t ipliance 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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, L Section 32.57(b)'of 10 CFR Part-32 establishes 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'necessaryy so that; the NRC'may determine that the source design-and method offincorporating and-binding 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 offuse and-i handling and that the source has been subjected to'and satisfactorily passed I

the required prototype testing.

Section 32.58 of 10 CFR Part 32 requires that each source or storage' container for the source have a label affixed to it_containing. sufficient'information.

relative to safe use and storage of the source. -As a generally: licensed device-rather than a "specifically licensed device," these devices are intended to be used safely by persons not having training in radiological protection.

l 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.

l'!

-m j

.. Section 32.61(b) of 10 CFR Part 32 establishes the information 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 details of construction and design of the source of radiation and its shielding, chemical and physical-form and maximum quantity of Strontium-90 in the device, radiation profilo'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, and instructions for handling and instt11ation of the device.

The information is necessary so that the NRC may determine that the Strontium-90 in the device l

will not be released or removed from the-device under the most severe conditions likcly to be encountered in normal use and handling, the i

l Strontium-90 is shielded so that no individual would receive a radiation dose-in excess of 0.5 rem per year, the device is designed so that it cannot easily l

be disassembled, the device has been subjected to and has satisfactorily passed i

required prototype testing, and quality control procedures have been established.

)

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 I

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.

h the safety and use of the licensee and his employees.

Often such devices are not easily recognizable as containing radioactive material.

Therefore, labels j

i k

4 are necessary for the safety of users to put them on notice of the presence of j

byproduct material.

There are currently no licensees subject'to this requirement and none are anticipated for the foreseeable future.

Hence,-the i

burden shown is zero.

t Section 32.70(b) of 10 CFR Part 32 establishes the information which needs to be included in an application for distribution of byproduct material-for'use by-physicians under general license.

The byproduct materials which may be i

distributed under general license include lodine-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 cyanocobalamin, and Chromium-51 as sodium chromate i

for red blood cell volume determinations and red blood cell survival time determinations.

The applicant must provide evidence that the byproduct material is to be manufactured, 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 copy 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 on)y

- 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 general license of the Nuclear Regulatory Commission or I

an Agreement State.

-i Section32.70(c)of10CFRPart32requiresthat'alabeland/orbrochureaccom-pany.:the package which identifies.it as a radioactive drug and gives_ the name

[

i 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

~

~

i l-.

information is for the safety and use of the general licensee.

t j

i Section 32.71 of 10 CFR Part 32 establishes the-information which needs-to be i

included in an application for a specific license to manufacture or distribute-Iodine-125, Iodine-131, Carbon-14, Hydrogen-3,: Iron-59, Selenium-75, or mock I

Iodine-125 contained in prepackaged units to general l_icensees for in vitro clinical or laboratory testing.

The= applicant must provide copies of the-labels which will be affixed to each. prepackaged unit.and copies __of the leaflet or brochure which accompanies the package.

The leaflet or brochure must' con-i tain information a:: to the precautions to.be observed--in handlincj.andJstoring the radioactive material.

This information is-necessary so that the,NRC;may-determine that the labels'are~in compliance'withithe, 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 and_

-his employees.

yn

. Section 32.71(d) of 10 CFR Part 32 requires thtt the label: affixed'to each prepackaged unit or. brochure which accompanies 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; materialLis intended to be used safely by. persons not having~ training.in) radio-logical protection.. Consequently, any person who comes into contact with thel i

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, acquisition,_

~

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 E

licensee.

Section 32.71(e) of 10 CFR Part 32 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 ir. handling and storing ~ such l

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 l

means to inform any person who comes into possession of the material of the-ia 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-l vides this information.

This requirement isifor the use of the licensee.

.j i

l f

i 4

e,

l i

l l

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 1'

.manu acture, labeled, and packaged in accordance with the Federal Food, Drug-f d

and Cosmetic Act or the Public Health Service Act or evidence that the l

radiopharmaceuticals are not subject to these Acts.

The applicant must l

l provide information on tne radionuclides, chemical and physical form, packaging 1

and labeling of the radiopharmaceuticals.

This information is necessary so that the NRC may determine that only those radiopharmaceuticals whose efficiency has been demonstrated will be distributed to groupflicensees, that 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)(i) 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 information is needed to detennine that the applicant has satisfied the requirements of other govern-mental agencies ~ as required by law.

+

. Section 32.73(a)(2) of 10 CFR 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 radiopharmaceuticals.

The applicant must provide 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 provide information on the radionuclide, chemical and physical form, packaging, and labeling of the generator or reagent kit.

This information is needed so that the NRC may determine that the product to be distributed is efficacious, that the packaging is adequate, and that the labels provide adequate informa-tion, from a radiation safety standpoint, on procedures to be followed and equipment and shielding for eluting the generator or processing radioactive material with the generator kit.

l

-l Section 32.73(a)(4) of 10 CFR Part 32 requires that the label affixed to the generator or reagent kit contains information on the radionuclide, quantity, 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.

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

f

o l

1

. Section 32.73(a)(5) of 10 CFR Part 32 requires that the label 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 approvedLfor use by persons licensed by the NRC pursuant to Sections 35.14'and 35.100 Group III of 10 CFR Part 35 or-equivalent licensees of Agreement States.

This information is.for the safety.

and use of the general licensee and his' employees.

Section 32.74(a)(2) of 10 CFR Part 22 establishes:the requirements 1for an:

application for a specific license to manufacture and' distribute-sources and-devices containing byproduct material to persons licensed' pursuant toLSection.

35.14 of 10 CFR Part 35 to use such sources and devices.

The sources and devices would be used as calibration'or reference 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 14 it, the chemical' and physical-form,- amount, details of design and construction, procedures 'for. andLresults' of-o prototype tests, radiation profile for a device,: quality control-procedures,.

calibration, labels, and instructions to users.

This.information is needed so--

' l that the NRC may determine the adequacy of the source or device design, arid that the source or device.will maintain its integrity under stresses likely to be L 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 storage are adequate from a radiation-safety standpoint.

1 1

q

. Section 32.74(a)(2)(viii) of 10 CFR Part 32-requires that instructions.for handling and storing the source or device from a radiation' safety standpoint' be-1

= attached.on a durable label, or where the instructions are too' lengthy,;they

^may be summarized, on the label:and printed in detail on an accompanying bro-chure.

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

~

his employees.

Section 32.74(a)(3) of 10 CFR Part 32. lists the information required to be.

placed on the label to include the name of the radionuclide, quantity,;and,date.

of assay as well as a statement that the source or deviceLis licensed.for' dis-tribution by NRC pursuant to Sections 35.14 and 35.100 Group VI of.10 CFR Part-35 or under equivalent licensees of Agreement States.

The NRC normally requires testing of sources or devices containing byproduct material.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 pn 1.es sufficient justification for granting an extended leak test interval, u

i

23-Section 32.210 of 10 CFR Part 32 specifies that a manufacturer or initial distributor of a sealed source or a device containing a sealed' source may l

submit a request to NRC for evaluation of radiation. safety information about 1

l l

its product and for registration of the product.

The request must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, l

additionally, in the case of a device, sufficient information about l

installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property.

This information is needed and used by NRC to determine the adequacy of the radiation safety properties of_the source l

or device under the expected conditions of use.

Reduction of Burden Through Information Technology l

There are no legal obstacles to reducing the burden associated with this information collection.

However, because of.the types of information and the infrequency of submission, the application and reports do not lend themselves readily to the use of automated information technology for submission.

1 Effort to Identify Duplication l

The Information Requirements Control Automated System (IRCAS) was searched to i

i determine duplication.

None was found.

l l

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

.gg.-

Effort to Reduce Small' Business Burden' The majority of licensees who use byproduct material are small businesses.

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 businesses by less frequent or less complete' reporting, recordkeeping, or accounting and control procedures.-

Consequences of less Frequent Collection Required. reports are collected and evaluated on a continuing basis as events-Applications for new licenses und amendments are submitted.only once.

occur.

Applications for renewal of licenses are submitted every five years.

Information submitted in previous applications may be' referenced without being resubmitted.

The schedule for collecting the information is the minimum frequency necessary to assure that licensees will continue to conduct programs in a manner that will assure adequate protection of. the public health and' safety.

Circumstances Which Jbstify Variation from OMB Guidelines i

Contrary to the OMB Guidelines in 5 CFR 1320.6(f), Section 32.52(c) requires i

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-I 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.

g 3.

.m.

7..,-

--- t 7

':?'

" 4 1

--LConsultations'OutsidetheNhency-

~

i There.have been no consultations-outside the agency-since"the previous, clearance of these information collection! requirements..

x Confidentia)ityof'Information-

- None, except.for' proprietary information..

s i-l:

- Sensitive Questions None.

l.

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2)

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, - -, =.,,

m 3.

=.-

4-c

. 26 '

s

. Estimate o'f Compliance Burden =

Rep'orting Requirements' Licensee

Total Annual-

,No. of Licensee'-

Staff-Hours.

l. ice'nsee. Burden s

'Section-

~ Responses Annually, -Per Submittal.

-(Hrs) 32.11

- - ~See OMB Clearance No.---3150-0120' l-32.~12

200

0. 6.-

s120

'See OMB Clearance'No.- '3150-0120 132.14 See OMB Clearanc'e No.I3150-01'20 32.15(b) 32,15(d) 75.

O.5

'38-32.16 2001 Oi6 120 32.17(c)

See OMB Clearance.No. 3150-0120 c-32.17(d)

See OMB Clearance No. 3150-0120' 32.18(d)

- - 'See OMB Clearance'No. 3150-0120 32.19(c) 47 0.5-24 32.19(d) 47 L 0. 5 7 24 -'

32.20(b)

~ 20' '

O. 6.

120-0 32.22 See OMB Clearance No.'3150-0120 32.25(D) 7-0.4

'3-32,25(c) 200 0.6 120 32.26

- -.See OMB Clearance No. 3150-0120 32.29(b).

200-.

O. 5 -

100 32.29(c)

'200

0. 6 '

120 See OMB Clearance No. 3150-6120!

32.51(a)(2) 32.51(a)(3) 5000

0. 5 2,500 1

32.51 a 5000

0. 5 2,500 32.'52(a) 15 24.0 360 l

1

+'.

s 4 t

' Reporting Requirements (continued)

Licensee Total-Annual.

No. of Licensee Staff: Hours-

. Licensee Burden 1

- Section Responses Annually Per Submittal (Hrs)-

32.52(b) 15-l24.0 360; 32.53(b).

- See CAB Clearance No.- 3150-0120 32.54(a) 75

0. 5-38 32.54(b) 12-0.5

'6 32.56 200

0. 5

'100 32.57(b)'

See OMB Clearance No.- 3150-0120 32.58 6-0.5 3

32.61(b)

- See OMB Clearance No. 3150-0120-32.61(d) 0 N/A'

_0, 32.70(b)

--See OMB Clearance 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)

=s 32.72(a)(2).

- See OMB Clearance No. 3150-0120 32;72(a)(4)(1)

-JSee 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) 32.210 100 22.0

'2,200' i Total 11,825 8,870

I

4

.28 n

'Recor'dkeeping Requirements Annual Hours Total-Record No. of peri Recordkeeping.

' Retention

Section, Recordkeepers Recordkeeper Hours-Period =

32.20(a)-

200

0. 6.

120 1 Yeara 1

32.52(c) 15=

166.0 2,490-5 Years L Total' Number of Recordkeepere:

215~

Total Record Keeping Hours Annually;'

2,610 Total Annual Burden Hours:

11,480 Estimated Cost to Public to Respond.

Scction Annual' Cost to-Respond-32.11

- See OMB Clearance No. 3150-0120 32.12

.$11,400-32.14

- See OMB Clearance.No. 3150-0120' j

32.15(b)

- See OMB Clearance No. 3150-0120L 32.15(d)

$3,610 32.16

$11,400-32.17(c)

- See OMB Clearance No;-3150-0120

.c 32.17(d)

- See OMB' Clearance No. 3150-0120.

32.18(d)

--See OMB Clearance No. 3150-0120 32.19(c)

.$2,280:

32.19(d)

$2,280' 32.20(a)

$11,400 32.20(b)

$11,400

' 32.22

- See OMB Clearance No. 3150-0120-32.25(b)

$ 285

' 32.25(c)

$11,400-1 1

. ~.

g Estimated Cost'to Public to Respond Section Annual Cost to Respond -

l

~

32.26

.See OMB Clearance No.. 3150-0120-l 32,29(b)

-~9 500:-

32.29(c):

$ 11,400' a

32.51(a)(2):

- See OMB Clearance.No.l3150-0120 32,51(a)(3)

~$237;500-32.51 a

$237,500.:

32.52(a)

$ 34,~200-

'd

-: e 32.52(b)

=$ 34',200

~

y 32.52(c)

.$236,550=

i

[

32.53(b)

See.0MB - Clearance 'N'o. ---3150-0120 -

i 32,54(a)

-$7 3,610-32.54(b) 570'

-32.56

$: 9,5007

.32.57(b)

See OMB Clearance No.- 3150-0120 32.58

285

-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) 12851 32.71(c)

'2851 32.71(d)

--Included in 31.71(c)J 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 11 4

=;

-l 1

)

4 '

I 1

j 30--

l Estimated Cost to Public to Respond'(contihued)

[

o

--Section

~ Annual' Cost'to Respond-ti

[

13150-0120..

1 I

32.73(a)(2)-

- See OMB Clearance No.

7

' 32.73(a)(4) 380-1 i

l;

. 32.73(a)(5)'

- Included;in 32.73(a)(4)

L

.~'32.74(a)(2)

' - See OMB Clearance No.- 3150-0120 L

i l.

.$~

380 l

32.74(a)(2)(viii).

]

32.74(a)(3)

- Included,in 32.74(a)(2)(viii) j 32.210.

.$209,000 l

Total-

$1,110,600

'j t

Source of Burden and Cost fita-and Method'of Estimating and Cost.

.The estimates are based on submittals to-NRC in past years.. Cost,to=

i-

-licensees and applicants is calculated atia rate of $95.00 per' hour.. Thi s '-

figure includes-both salaries and overhead.

' I 1

s i

Estimate of' Cost to the Federal' Government Annual Cost - NRC Staff Review-i (Professional effort.- 2,856, hours @$95/hr)

= $271,320'

+

f for activities other than-application. review.

Application review

~

p activities are attributab1e-to andireported under NRC' Form 313,.-

I L

p OMB Clearance No. 3150-0120.

1 r

f p..

t iv