Text

Notice of Pending NRC Action to Submit Info Collection Request to OMB & Solicitation of Public Comment Re 10CFR35, Medical Use of Byproduct Matl
	ML20206E459
Person / Time
Issue date:	04/27/1999
From:	Shelton B; NRC
To:	;
References
	OMB-3150-0010, OMB-3150-10, NUDOCS 9905050134
	Download: ML20206E459 (30)
	v • d • e

-

l d

e,n ;

'h e (7590-01-P]

l U. S. NUCLEAR REGULATORY COMMISSION I Agency information Collection Activities: Proposed Collection; Comment request i

AGENCY: U. S. Nuclear Regulatory Commission (NRC)

ACTION: Notice of pending NRC action to submit an intormation collection request to OMB and solicitation of public comment.

SUMMARY

The NRC is preparing a submittal to OMB for review of continued approval of information collections under the provis!ons of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35).

Information pertaining to the requirement to be submitted:

1. Tne title of the information collection: 10 CFR Part 35," Medical Use of Byproduct Material."

2. Current OMB approval number. 3150-0010

3. How often the collection is required: Required reports are collected and evaluated on a continuing basis P* needed due to a change in programs ,

or as events occur.

28' 88s

E8sE PDR

@9 A F -y 4

/

/0M m

1 ff/24

a

4. Who is required or asked to report: Physicians and medical institutions who are applicants for, or hold, an NRC license authorizing the 1

administration of byproduct material, or its radiation to humans for medical use.

5. The number of annual respondents: 1,891 NRC licensees and 4,728 Agreement State licensees.

6. The number of hours needed annually to complete the requirement or request 369,916 hours0.0106 days 0.254 hours 0.00151 weeks 3.48538e-4 months for NRC licensees and 924,765 hours0.00885 days 0.213 hours 0.00126 weeks 2.910825e-4 months for Agreement State licensees, for a total burden of 1,294,681 hours0.00788 days 0.189 hours 0.00113 weeks 2.591205e-4 months (196 l

hours perlicensee).

7. Abstract 10 CFR Part 35, " Medical Use of Byproduct Material,"

contains requirements that apply to NRC licensees who are authorized 1

to administer byproduct material or its radiation to humans for medical use. The information in the required reports and records is used by the NRC to ensure that the health and safety of the public is protected, and that the licensee's possession and use of byproduct material is in compliance with the license and regulatory requirements. The revision is a not decrease adjustment in burden resulting from a decrease in the number of affected licensees.

J

_ - - - . ~ _ _ . _ _ _. ___ _ _ _ _ ._

Submit, by (insert date 60 days after publication in the Federal Reaister), comments that l

address the following questions:

1

1. la the proposed collection of information necessary for the NRC to property perform its functions? Does the information have practical utility?

2. Is the burden est5 ate accurate?

3. Is there a way to enhance the quality, utility, and clarity of the information 1

to be collected? l 1

4. How can the burden of the information collecton be minimized, including the use of automated collection techniques or other forms of information technology?

A copy of the draft supporting statement may be viewed free of charge at the NRC Public Document Room,2120 L Street, NW (lower level), Washington, DC. OMB clearance requests are available at the NRC woridwide web site (http://www.nrc. gov /NRC/PUBLIC/OMB/index.html).

The document wil; be available on the NRC home page site for 60 days after the signature date of this notice.

J

0 Comments and questions about the information collection requirements may be directed to the NRC Clearance Officer, Brenda Jo. Shelton, U.S. Nuclear Regulatory Commission, T-6 E6, Washington, DC 20555-0001, by telephone at 301-415 7233, or by Intemet electronic mail at BJS1@NRC. GOV. l l

Dated at Rockville, Maryland, this J 7 day of )N J' 1999. ,

' f l i

For the Nuclear Regulatory Commission. !

(

Yo i AJ l

'/Brenda Jo.VtoWiearance Officer Office of the Chief Information Officer l l

1

1 SUPPORTING STATEMENT FOR 10 CFR PART 35 MEDICAL USE OF DYPRODUCT MATERIAL (3150-0010)

EXTENSION WITH REVISIONS DESCRIPTION OF THE INFORMATION COLLECTION Part 35 of Title 10 of the Code of Federal Regulations contains requirements that apply to the Nuclear Regulatory Commission's licensees who are authorized to administer byproduct material or its radiation to humans for medical use.

A. JUSTIFICATION

1. Need for and Practical Utility of the Collection of Information Part of the NRC's function is to license and regulate the use of byproduct materialin order to assure protection of public health and safety. The NRC requires licensees to perform certain tasks to ensure fulfillment of their obligations. The records required in this part are the least burdensome way for licensees to demonstrate compliance. Occasionally, safety matters are of such significance that personnel need to be aware of the information in order to perform their jobs or work in a safe manner In such cases reports are required This clearance extension incorporates the information collections contained in the final rule,

" Criteria for the Rel ease of Individuals Administered Radioactive Material." OMB approved the burden increase for the final rule on January 6,1997.

NRC is currently developing a complete revision of 10 CFR Part 35, including $$ 35.32 and 35.33, which are cleared under OMB No. 3150-0171. The schedule provides for the revised rule to be implemented 6 months after the rule becomes final (projected to be in the first half of CY 2000), except for the training and experience requirements which will be fully implemented 2 years after the rule becomes final. In order for this OMB extension to cover the entire implementation period, NRC requests that the full 3 year clearance period be granted. At that time, the recordkeeping and reporting burdens should be decreased because the new Part 35 requirements are more risk-informed and performance-based.

Sections 35.12(b) and (c) of 10 CFR Part 35 require that applicants submit a completed NRC Form 313, " Application for Materials License." The form elicits an orderly description of the applicant's complete radiation safety program. Requests for amendments and license renewals may be submitted in a letter format. This report is needed to assure the NRC that applicants' programs are adequate to protect health and minimize danger to life and property before the NRC can authorize receipt of radioactive material. NRC Form 313 has previously been cleared under OMB Clearance No. 3150-0120, which should be referred to for additional supporting information, burden and cost data.

Section 35.13 requires that licensees apply for and receive a license amendment before using material not author!2ed by the license, before adding or changing key individuals, before receiving more matodal than authorized by the license, or before changing the area or

addresses of authorized places of use. The triggering events are criticalindicators of a potential for change in the licensee's ability to control radiation dose to workers and the public, or the NRC's ability to contact the licensee or conduct an inspection of the licensee's program.

The information is required so that the staff can determine whether the licensee has individuals with adequate training and experience to safely use radioactive material, and the facilities and equipment necessary or required to assure protection of public health and safety.

Section 35.14 requires that licensees: 1) provide certain information for each individual no later than 30 days after the date the licensee permits the individual to work as an authorized user, or as an authorized nuclear pharmacist,2) notify the NRC within 30 days if a key worker ends his association with the licensee or has a name change, or 3) when the licensee's mailing address changes. The report for authorized user or authorized nuclear pharmacist is required in order to maintain the licensee's file with a current record of individuals authorized to use or prepare radioactive material. The report for changes in " key" workers is required because if the licensee no longer has a complete staff, the collective training and experience of the remaining staff may no longer be sufficient to ensure the safety of alllicensed users. This report will trigger a check of the licensee's file to determine whether the licensee's remaining users are qualified to receive and use radioactive material safely. The NRC needs to be aware of mailing address changes to ensure that the licensee continues receiving correspondence such as )

information notices, bulletins, and other safety related documents. '

Section 35.20 requires licensees to have a written program to keep radiation doses as low as reasonably achievable (ALARA). The program must be written to provide clear statements of authority, responsibility, and technical requirements. The written program is used by the licensee, the radiation safety officer, and authorized users. Its purpose is to ensure that licensees comply with the requirement to make a reasonable effort to maintain individual and collective occupational radiation doses ALARA.

Section 35.21(b)(2) requires that the licensee establish and implement the written policy and procedures that were submitted as part of the application. The written policy and procedures are needed so that NRC can review them and make a determination that the applicant can meet the requirements of the Atomic Energy Act and the Commission's regulations. The procedures must be implemented in order to provide for protection of public health and cafety.

The burden is included ' the burden for the application, NRC Form 313, OMB Clearance No. 3150-0120. i l

Sections 35.22(a)(4) and (5) require that medical institution licensees retain a copy of radiation safety committee meeting minutes for the duration of the license, and prescribe the information required in the minutes. A copy of the minutes must be provided to each member. The record f is required to document continuing management oversight of the radiation safety program. j Section 35.23(b) requires that licensees provide a written statement of authority, duties, responsibilities, and radiation safety activities for the radiation safety officer and radiation safety i committee. The statement is needed so that managers and key users know their I responsibilities. The statement must be retained for the duration of the license.

Section 35.29(b) requires that mobile nuclear medicine service licensees keep a letter of permission signed by the management of each client. This record is necessary to show that 2

the client's management has permitted this work.

Section 35.31(b) requires that licensees make a record of minor radiation safety program changes. This record is needed to document what radiation safety factors were considered before implementing the minor change. This permits the NRC to evaluate the nature and appropriateness of the minor changes during inspections prior to renewal and will provide the licensee with a complete record of the radiation safety program until the changes are l incorporated into the license when renewed. l Section 35.32 contains requirements for a quality management program.

Section 35.32(a) requires that each applicant or licensee establish and maintain a written quality management program.

Section 35.32(b) requires that the licensee develop audit procedures, revise the quality management program when necessary, and retain records of each audit and management evaluation of the quality management program for 3 years.

Section 35.32(c) requires that the licensee retain records of the relevant facts of recordable events for 3 years.

Section 35.32(d) requires that the licensee retain records of written directives and administered radiation dose or radiopharmaceutical dosage for 3 years.

Section 35.32(e) allows the licensee to make modihcations to the quality management program to increase the program's efficiency and requires that the modification be submitted to the NRC regional office within 30 days.

Section 35.32(f)(1) requires that an applicant for a new license submit a quality management program to the NRC regional office as part of the license application.

Sections 35.32(a), (b), (c), (d), (e), and (f)(1) are cleared separately under OMB Clearance No.

3150-0171. They are described here for information purposes only.

Section 35.33(a) requires:

(1) that the licensee notify by telephone the NRC Operations Center in case of a therapy misadministration within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after discovering the misadministration.

This prompt notification is necessary because a therapy misadministration may present a clear and present radiation hazard to a member of the public that may be mitigated by NRC assistance.

(2) that a licensee file a written report to the NRC within 15 days after discovery of a misadministration. This report is required so that the NRC can determine whether there might be generic implications in the incident which indicate a need to notify all licensees. NRC allows the licensee 15 days to submit the report to give the e licensee adequate time to review and analyze the event and to provide NRC with a complete history of the event. NRC requires submiss!on of the report within 3

l l

15 days so that NRC can promptly notify other licensees if it appears the precipitating event might be generic.

(3) that the licensee notify the referring physician and the patient, or human research subject, unless the referring physician informs the licensee that he will notify the patient, or unless contraindicated by factors known to the referring physician.

These reports are needed so that the patient can ensure adequate follow-up care, if applicable.

Section 35.33(a) is cleared separately under OMB Clearance No. 3150-0171. It is described here for information purposes only.

Section 35.33(b) requires that the licensee retain a record of each misadministration for 5 years. The written records are required to determine what kinds of actions precipitate misadministrations, to provide input for enhancements and/or revisions to procedures, and provide an indicator of the licensee's management control of the radiation safety program. This section is cleared separately under OMB Clearance No. 3150-0171. It is described here for information purposes only.

Section 35.50(b)(4) requires that licensees make a record of a geometry dependence test for the dose calibrator. This record is required to demonstrate the relationship between volume configurations of the radiopharmaceutical and the accuracy of the reading given by the dose calibrator, so correction factors, if applicable, can be applied.

Section 35.50(e) requires that licensees retain a record of checks and tests of dose calibrator performance. The record is required to show that the dose calibrator is functioning correctly and is capable of accurately measuring radiopharmaceutical dosages, to establish trends in equipment performance, and to show compliance with regulatory requirements.

Section 35.51(a)(3) requires that the licensee note on a survey instrument the apparent exposure rate from a dedicated check source at the time of instrument calibration. This information is required so that the licensee can check the survey instrument for proper i operation before making measurements. The burden is included in the burden estimate for Section 35.51(d).

Section 35.51(d) requires that licensees retain a record of survey instrument calibrations. This record is required to show that survey instruments were calibrated and operational. !

Section 35.52(b) requires that licensees have procedures for use of instrumentation used to measure the radioactivity of alpha- or beta-emitting radionuclidos for other than unit dosages.

In particular, this section does not apply to unit dosages of alpha- or beta-emitting radionuclides from a manufacturer or a nuclear pharmacy licensed under 10 CFR Part 32. Part 35 licensees may use procedures provided by the manufacturer of the instrumentation. These procedures are necessary to. ensure that licensees use the instrumentation correctly. Thus, an additional recordkeeping burden may be expected, although licensees who currently use alpha- or beta-omitting radionuclides already have procedures for using this instrumentation.

, Section 35.53(c) requires that licensees retain a record of each radiopharmaceutical dosage 4

i 1

1

- . . - . . , , . . _ _ . - . - . . . . g

measurement. This record is required for licensees to show that they are maintaining control of the use of radiopharmaceuticals.

Section 35.59(a) requires that licensees maintain the manufacturer's written instructions for the safe use of sealed sources and brachytherapy sources. These instructions are required so that individuals who handle sources can determine the specific safety measures appropriate for each kind of source used.

Section 35.59(d) requires that licensees retain a record of sealed source leak tests. This record is required to show that the leak test was done at the appropriate time, and that the source was not leaking.

Section 35.59(e)(2) requires that licensees file a report with the NRC within 5 days if leakage of i a sealed source is detected. This report is needed so that NRC can make a determination as ;

to whether other licensees who have similar sealed sources should take special precautions. 1 NRC allows the licensee 5 days to submit the report so that the licensee can review and l

analyze the source and the leak test result. NRC requires submission of the report within 5 1 days so that NRC can promptly notify other licensees if it appears there may be a generic problem. '

Section 35.59(g) requires that licensees make a record of sealed source and brachytherapy source inventory. This inventory is required to show that possession of sealed sources did not exceed the amount authorized by the license. The 5 year recordkeeping requirement will help to assure continued control over sources that are only occasionally used.

Section 35.59(i) requires that licensees make a record of radiation surveys of areas where sealed sources and brachytherapy sources are stored. This record is necessary to document that adequate radiation shielding has been provided for such sources, and that dose rates in contiguous areas are within allowed levels.

1 Section 35.60(b) requires that licensees label each syringe or syringe radiation shield as to its contents. This labelis needed because review of misadministration reports has indicated that in many cases misadministrations are caused by inadvertent transposition of syringes.

Section 35.61(b) requires that licensees label vial radiation shields with the identity of the radiopharmaceutical contained. NRC review of several misadministration reports indicates that many misadministrations occur when technicians draw a dosage from the wrong vial of radioactive material. Labels will help to reduce the chance of this happening.

Sections 35.70(d) and (g) require that the licensee establish action levels for radiation surveys.

The action levels provide the individual who makes a radiation survey with information on what levels are expected and what levels require investigation. The sections also require that the licensee immediately notify the radiation safety officer if excessive levels are detected during a survey. This notification is needed so that the radiation safety officer can take appropriate remedial action. The radiation safety officer is the primary individual onsite who is qualified to determine what action is needed to ensure worker and public health and safety, and whether that action is needed immediately or can be delayed.

5

Section 35.70(h) requires that licensees retain a record of radiation surveys. The record is needed to show that the required surveys were made.

Section 35.75(b) requires that licensees provide an individual who has been administered radiopharmaceuticals or implants containing radioactive material and who is being released from the licensee's control in accordance with $ 35.75(a) with instructions on recommended actions to maintain doses to other individuals as low as reasonably achievable (ALARA) if the total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem). The licensee must provide special instructions to the released individual if the dose to a breast-feeding infant or child could exceed 1 mSv (0.1 rem), assuming there is no interruption of breast feeding. These instructions are needed to ensure that the released individual is aware of the recommended actions to maintain doses ALARA. The written instructions serve as a ready reference after the patient is released, in case the individual has later questions on the oral instructions that were provided prior to his/her release.

Section 35.75(c) requires that licensees maintain, for 3 years after the release, a record of the basis for the release of an individual, if the release is authorized using other than standard assumptions. The record is needed to demonstrate that the basis for authorizing release of the individual met the requirements for release in 6 35.75(a).

Section 35.75(d) requires that licensees maintain, for 3 years after the release, a record that instructions were provided to a breast-feeding woman if the ad ninistered activity could result in a total effective dose equivalent to the breast-feeding infant that exceeds 5 mSv (0.5 rem), if the woman does not interrupt or discontinue breast feeding. The records are needed to verify that instructions were given to the breast-feeding woman to inform her of the need to interrupt or discontinue breast feeding.

Section 35.80(f) requires that mobile nuclear medicine service licensees make a record of radiation surveys. The record is needed to show that the required surveys were made.

Section 35.92(b) requires that licensees make a record of disposal of waste that was decayed in storage. The record is needed to show that the material was decayed for the required length of time, that its radioactivity cannot be distinguished from background radiation leveis, and that a proper survey of each waste container was made prior to disposal.

Section 35.204(c) requires that licensees retain a record of molybdenum-99 concentration in radiopharmaceuticals. This record is needed to show that the concentration measurement was made and that the maximum molybdenum 99 concentration level was not exceeded.

Section 35.205(d) requires that the licensee post a time period of evacuation in areas where radioactive gases are used. In case of a spill, this provides notice to workers of how much time air handling equipment needs to reduce the air concentration to permissible limits. The licensee must retain a record of the calculations used to determine the evacuation time for the duration of use of the area.

Section 35.310(b) requires that licensees retain a record of radiation safety instruction given to personnel who care for radiopharmaceutical therapy patients. This record is needed to show that the training was given.

6

= . + , c.. ew . ~we 4, m .--e- -

V, Sections 35.315(a)(2) requires that the licensee post radiopharmaceutical therapy patient room doors with a " Radioactive Materials" sign. This provides notice to hospital workers and the public that there is radioactivity in the room. The section also requires that the licensee note in the patient's chart how long visitors may stay in the patient's room. This is the most convenient way to provide this information to nurses, who are usually responsible for enforcing visiting rules.

Section 35.315(a)(4) requires that licensees make a record of dose rates around radiopharmaceutical treatment rooms after administration of the dosage. This record is required to show that members of the public are not exposed to excessive levels of radiation.

Section 35.315(a)(8) requires that licensees make a record of the thyroid burden measurement of each individual who helped prepare or administer a therapeutic dosage of iodine-131. This record is required to show that the measurement was performed and that workers were not exposed to excessive levels of iodine-131.

Section 35.315(b) requires that the licensee promptly notify the radiation safety officer if the radiopharmaceutical therapy patient dies or has a medical emergency. This notification is required so that the radiation safety officer can take whatever actions are necessary to prevent

. a spread of radioactive contamination or loss of brachytherapy sources. The radiation safety officer is the primary individual onsite who is qualified to determine what action is required to ensure worker and public health and safety, and whether action is needed immediately or can be delayed.

Section 35.404(b) requires that licensees retain a record of the radiation survey of each patient who was treated with temporary implant sources. The record is required to show that the survey was performed.

Section 35.406(b) requires that licensees make a record of brachytherapy source use. This record is required so that, if a brachytherapy source is misplaced or missing, the licensee is immediately alerted and can take appropriate action.

Section 35.406(c) requires that licensees make a record of radiation surveys of patients after implanting sources. This record is required to show that the survey was performed.

Section 35.406(d) requires that the licensee retain a record of the use of brachytherapy sources and special safety surveys. This record is needed to show that the licensee is providing adequate control for these sources. The record burden is included in the burden estimate for Sections 35.406(b) and (c).

Section 35.410(b) requires that licensees retain a record of training for personnel who care for implant patients. This record is required to show that the training was given.

Section 35.415(a)(2) requires that a licensee post the patient's door with a " Radioactive Materials" sign and note on the door or in the patient's chart where and how long visitors may stay in the patient's room. This posting is required to help protect against excessive radiation exposure to visitors.

7

. ~ . _ ._ _ _ _ _

Section 35.415(a)(4) requires that, after an implant of radioactive material, licensees record the results of a survey of the contiguous restricted and unrestricted areas and retain the record for 3 years. The record is used to demonstrate compliance with 10 CFR Part 20 requirements and to show that members of the public are not exposed to excessive levels of radiation.

Section 35.415(b) requires that the licensee notify the radiation safety officer immediately if the patient dies or has a medical emergency. This notification is required so that the radiation safety officer can take whatever action is necessary to prevent a spread of radioactive contamination or loss of sources. The radiation safety officer is the primary individual onsite who is qualified to determine what action is necessary to ensure worker public health and safety, and whether that action is required immediately or can be delayed.

Section 35.606 requires that licensees apply for and receive a license amendment before making certain changes in the teletherapy program. This license amendment process is necessary because the licensee may consider making changes that would cause radiation levels in restricted and unrestricted areas to exceed permissible levels. The burden is included in OMB Clearance No. 3150-0120.

Section 35.610(a) requires that licensees post written instructions for individuals who operate teletherapy units. These instructions are necessary to remind workers of proper operating procedures and to serve as a quick reference in case of emergencies or equipment malfunction.

Section 35.610(c) requires that licensees make a record of training for individuals who operate teletherapy units. This record is needed to show that the training was given.

Section 35.615(d)W rupires that licensees retain a record of the teletherapy room radiation monitoring device Mdm check. Tnis record is needed to show that the check was made, and for trend analysis by the x.ensee.

Section 35.615(d)(5) requires that licensees retain a record of the functional check of the instrument or dosimeter used when the radiation monitor is inoperable. The burden is included in Section 35.615(d)(4) as this record is required only when the radiation monitor is inoperable.

Section 35.630(c) requires that licensees retain a record of each calibration, intercomparison, and comparison of teletherapy dosimetry equipment. These records are needed to show that measurements of radiation teletherapy doses were made with instruments capable of making accurate measurements.

Section 35.632(g) requires that licensees retain a record of teletherapy unit calibration. This record is needed to show that the calibrations were done and that licensees did not inadvertently administer incorrect radiation doses to patients.

Section 35.634(c) requires that the qualified teletherapy physicist report the results of teletherapy unit spot-checks promptly to the licensee. This assures the licensee that the results of each spot-check have been reviewed by an expert. The licensee must keep a copy of each report to assure that the review has been made.

8

I l

Section 35.634(f) requires that licensees retain a record of spot-( V .s. This record is needed to show that the required checks were made.

Section 35.636(c) requires that licensees retain a record of safety checks for teletherapy facilities. This record is needed to show that the checks were made.

Section 35.641(c) requires that licensees retain a record of radiation measurements after installing a source in a teletherapy unit. These records provide assurance that the source is properly installed within the teletherapy unit, and that dose rates outside the telethrapy room are within permissible limits.

Section 35.643(a)(3) requires that licensees include additional survey and facility description information if changes in an NRC approved installation were necessary for compliance with 10 CFR Port 20. The additional information in the report will facilitate a determination by the NRC that t.ase rates in restricted and unrestricted areas are within permissible limits. The 30 day submission requirement is contained in Section 35.645.

Section 35.643(b) requires that licensees request a license amendment if the licensee wants authorization for radiation levols in unrestn tM areas which are above permitted levels. This report will trigger an in depth N AC review c.< safety considerations before it allows a licensee tc {

cpernte the unit. The burden for the license amendment is included in OMB Clearance ,

No. 3150-0120.

Section 35.645 requires that licensees mail a copy of teletherapy source installation records to the NRC. These records are needed to show that dose rates in restricted and unrestricted areas are within permissible levels. The submission roust be made within 30 days after the completion of the acthn that initiated the record requirement. The 30-day requirement is '

imposed because of the especially high doso rates that can be found around teletherapy units.

Section 35.347(c) requires that licensees keep a record of teletherapy unit inspection and servicing. This record is needed to show that the required work was done.

Section 35.980(b)(2) requires an individual to obtain a written certification sirned by a preceptor before the individual can be qualified as an authorized nuclear pharmacist. This is necessary to ensure that the individual has achieved a level o. competency sufficient to independently operate a nuclear pharmacy.

I Section 35.981 requires a licensee to receive an amendment identifying an experienced nuclear pharmacist as an authorized nuclear pharmacist before it allows this individual to work as an authorized nuclear pharmacist. This amendment is necessary to ensure that facilities have a qualified nuclear pharmacist on site.

2. Aaency Use of the Information The records that 10 CFR Part 35 requires the licensees to maintain are reviewed during inspections, license renewals, and license amendment reviews to evaluate compliance with NRC radiation safety requirements for possession and use of byproduct material.

9

The records of receipt, transfer, and disposal of byproduct material are reviewed by the NRC inspectors to determine that licensees have confined their possession and use of byproduct material to the locations, purposes, receipt, and quantities authorized in their licenses.

Reports are used by the agency in evaluating the protective actions required to avoid exposures to radiation or releases of radioactive materials that could impact public health and safety and the environment.

3. Reduction of Burden Throuah Information Technoloav There are no current information technology applications that would reduce the burden of these information collection requhements. The NRC encourages applicants and licer.. es to use new automated information tech *. ology when it would be beneficial to them. However, because of the types of information and the infrequency of submission, the applications and reports may not lend themselves readily to the use of automated information technology for their submission. Consequently, no submissions are currently submitted electronically.

4. Effort to identify Duolication and Use Similar Information The information Requirements Control Automated System was searched to determine duplication. None was found. In general,information requirrd by the NRC in applications, reports, or records concerning the transfer, receipt, possession, or use of byproduct material does not 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 the NRC or other Federal agencies. However, duplication, if any, is 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.

5. Effort to Reduce Small Business Burden While a number of licensees are considered small businesses, under the NRC's current definitions, the health and safety consequences of improper use of radioactive material are the same for large end 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 while maintaining the required level of safety.

6. Consecuences to Federal Proaram or Policy Activities if the Collection is Not Conducted or is Conducted Less Freauentiv If the information is not collected, NRC will have no way to assess whether this category of

!!cansee is operating within the radiation safety requirements app!icable to the possession, use, er iransfer of byproduct material.

The required reports are collected and evaluated on a continuing basis as events occur.

Applications for new licenses and amendments are subtrhted only once Applications for renewal of licenses are submitted every 10 years. Information sohmit'.ed in previous applications may be referenced without being resubmitted. The schedule for collecting the 10

4 .

l l

information is the minimum frequency necessary to assure that licensees will continue to !

conduct programs in a manner that will assure adequate protection of public health and safety.

7. Circumstances Which Justifv Variation from OMB Guidelines Contrary to the OMD Guidelines in 5 CFR 1320.5(d), Section 35.14 requires that licensees notify the NRC within 30 days if a key worker ends his association with the licensee. This prompt report is required because if the licensee no longer has a complete staff, the collective training and experience of the remaining staff may no longer be sufficient to ensure safety.

This report will trigger a check of the licensee's file to determine whether the remaining key users are qualified to receive and use material safely.

Section 35.20 requires licensees to retain, for the duration of the license, a written program to keep radiation dose as low as reasonably achievable. The written program must be retained so that it can be used by the licensee, the radiation safety officer, and authorized users throughout the period of the license to ensure that a reasonable effort is made to maintain individual and collective occupational radiation doses as low as reasonably achievable.

Section 35.21(b)(2) requires that the licensee establish and implement the written policy and procedures that were submitted as part of the application. It is necessary that the policy and procedures be retained for the duration of the license so that they will be available to the licensee's staff for implementation and so that the NRC staff can review them to ensure that the applicant can meet the requirements of the Atomic Energy Act and the Commission's

egulations for protection of publi tealth and safety.

I Sections 35 22(a)(4) and (5) r are that medicalinstitution licensees retain a copy of radiation I safety committee meeting miues for the duration of the license, and prescribe the information required in the minutes. Retention of the records for the duration of the license Ls required to

)

j show continuing management oversight of the radiation safety program.

Section 35.23(b) requires that licensees retain, for the duration of the license, a written statement of authority, duties, respchsibilities, and radiation safety activities for the radiation 4 safety officer and radiation safety committee. Retantion of the statement for the period of the license is necessary so that managers and key users know their responsibilities.

Section 35.31(b) requires that licensees retain a record of minor radiation safety program changes until license renewal or termination. This permits NRC to evaluate the nature and appropriateness of the minor changes during inspections prior to renewal and provides the licensee with a complete record of the radiation safety program until the changes are incorporated into the license at renewal.

Section 35.32(a) requires that each applicant or licensee establish and maintain a written quality management program for the duration of the licensed activity. Section 35.32(a)is cleared separately under OMB No. Clearance 3150-0171.

11

Section 35.33(a) requires:

(1) that the licensee notify by telephone the NRC Operations Center in case of a therapy misadministration within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after discovering the misadministration.

This prompt notification is necessary because a therapy misadministration may present a clear and present radiation hazard to a member of the public that might be mitigated by NRC assistance.

(2) that a licer:see file a written report to NRC within 15 days after discovery of a misadministration. NRC requires submission of the report within 15 days so that it can promptly notify other licensees if it appears the precipitating event might be )

generic.

Section 35.33(b) requires that the licensee retain a record of each misadministration for 5 years. These written records are needed to determine what kinds of actions precipitate :

misadministrations, and also provide an indicator of the licensee's management control of the J radiation safety program. {

Sections 35.33(a) and (b) are cleared separately under OMB Clearance No. 3150-0171.

i Section 35.50(b)(4) requires that licensees retain a record of a geometry dependence test for the dose calibrator for the duration of use of the dose calibrator. This record is necessary throughout the duration of use of the equipment to demonstrate the relationship between volume configuretions of the radiopharmaceutical and the accuracy of the reading given by the dose calibrator, and would be necessary for subsequent reconstruction in the event of an incident involving questions of dose calibration.

Section 35.50(e) requires that licensees retain a record of checks and tests of dose calibrator performance for the duration of use of the equipment. This record is needed throughout the duration of use of the equipment to show that the dose calibrator is functioning correctly and is capable of accurately measuring radiopharmaceutical dosages, and to establish trends in equipment performance.

Section 35.59(a) requires that licensees maintain, for the duration of source use, the manufacturer's written instructions for the safe use of sealed sources and brachytherapy sources. These instructions are needed so that, at any time during the duration of use, individuals who are handling sources can determine the specific safety measures appropriate for each kind of source used.

Section 35.59(e)(2) requires that licensees file a report with the NRC within 5 days if leakage of a sealed source is detected. NRC requires submission of the report within 5 days so that NRC can promptly notify other licensees if it appears there may be a generic problem.

Section 35.59(g) requires that licensees retain a record of sealed source and brachytherapy source inventory for 5 years. The 5 year recordkeeping requirement is necessary to assure continued control over sources that are only occasionally used, and to ensure that the records will be available for periodic inspections, which may exceed a 3 year interval.

12

Section 35.205(d) requires that the licensee retain, for the duration of use of the area, a record of the calculations used to determine the evacuation time for areas where radioactive gases are used. In case of a spill, the record of the calculations, which is required to be posted, provides notice to workers of how much time air handling equipment needs to reduce the air concentration to permissible limits. Retention beyond 3 years is necessaly to provide notice of evacuation time to workers and to ensure that records of calculations are available to the NRC for periodic inspections, which may exceed 3 year intervals.

Section 35.315(a)(8) requires that licensees retain a record of the thyroid burden measurement of each individual who helped prepare or administer a therapeutic dosage of iodine-131 until the Commission authorizes their disposition. Retention beyond 3 years is necessary to ensure that complete records of exposure of each individual are available to the individual and to the licensee so that the licensee can avoid accumulation of excessive exposures by individuals.

Section 35.415(b) requires that the licensee notify the radiation safety officer immediately if the patient dies or has a medical emergency. This immediate notification is necessary 4 permit the radiation safety officer to ensure that safety requirements are met for removal or disposal of the implanted radioactive material.

Section 35.630(c) requires that licensees retain a record of each calibration, intercomparison, and comparison of teletherapy dosimetry equipment for the duration of use of the teletherapy unit source. These records are necessary to show throughout the period of use of the equipment that measurements of radiation teletherapy doses were made with instruments capable of making accurate measurements, and for use in reconstruction in case of an incident.

1 Section 35.632(g) requires that licensees retain, for the duration of the license, a record of teletherapy unit calibration. This record is required to show that the calibrations were done and that licensees did not inadverter t!y administer incorrect radiation doses to patients, it would also be necessary in the case of reconstruction of an incident.

Section 35.641(c) requires that licensees retain, for the duration of the license, a record of radiation measurements after installing a source in a teletherapy unit. These records are required throughout the period of the license to provide assurance that the source was properly installed within the teletherapy unit, and that dose rates outside the teletherapy room are within i permissible limits. They would also be necessary in reconstruction following an incident j involving the unit. t Section 35.645 requires that licensees mail a copy of the teletherapy source installation records l i

to the NRC. The submission must be made within 30 days after completion of the action that initiated the record requirement. The 30 day requirement is imposed because of the especially high dose rates that can be found around teletherapy units.

Section 35.647(c) requires that licensees keep a record of teletherapy unit inspection and servicing for the duration of the license. This record is required throu@out the period of licensed activity to show that the required work was done and to estab:ish a service history which may be used in incident investigations and evaluation of generic equipment problerne 13 l

8. Consultations Outside the NRC Notice of opportunity to comment on the proposed rule for the complete revision of 10 CFR Part I 35 was published in the Federal Reaister on August 13,1998 (63 FR 43516-43580). Those comments are being considered in the preparation of the final rule. Notice of opportunity to comment on the clearance extension for the current rule has been published in the Federal Reaister. )

9. Payment or Gift to Respondents Not Applicable !

I

10. Confidentiality of the Information Reports submitted are gerierally subject to public disclosure in accordance with 10 CFR 2.790 and 10 CFR Part 9. Section 2.790 allows the NRC to withhold certain proprietary information (information of commercial value or " trade secrets") if, at the time of submittal of the report, the requirements for withholding the information are met (refer to 10 CFR 2.790(b)). Also, there are provisions in 10 CFR Part 9 for the NRC to withhold from public disclosure documents such as reports of radiation exposure to individuals and other personal records.

11. Justification for Sensitive Ouestions :

No sensitive information is requested under these regulations.

12. Estimated Burden and Burden Hour Cost NRC Licensees:

These requirements will affect approximately 1891 licensees and applicants, of which 1188 of the licensees are hospitals, and 463 of the licensees are physicians in private practice.

The total annual burden is estimated to be about 369,916 hours0.0106 days 0.254 hours 0.00151 weeks 3.48538e-4 months per year (about 196 hours0.00227 days 0.0544 hours 3.240741e-4 weeks 7.4578e-5 months per licensee) for the 1,891 licensees covered by 10 CFR Part 35. The details are shown in Tables ,

1 and 2. The total cost for the NRC licensees is estinuted at $44,759,836 (369,916 hours0.0106 days 0.254 hours 0.00151 weeks 3.48538e-4 months x

{

$121/ hour). The $121 per hour rate is based on NRC's fee recovery rate. I Aoreement State Licensees:

Most of the requirements in 10 CFR Part 35 have been designated a Compatibility Category D for Agreement States. When an NRC requirement is designated a Compatibility Category D, the requirement does not have to be adepted by the Agreement States, but Agreement States are encouraged to adopt similar regulations. The burden for Agreement State licensees in this OMB submittalis calculated on the basis of Agreement States having similar regulations for medical use programs.

The total annual burden is estimated to be about 924,765 hours0.00885 days 0.213 hours 0.00126 weeks 2.910825e-4 months per year (about 196 hours0.00227 days 0.0544 hours 3.240741e-4 weeks 7.4578e-5 months per licensee) for the estimated 4,728 licensees covered by equivalent regulations. The details are 14

shown in Tables 3 and 4. The total cost for the Agreement State licensees is estimated at l

$111,896,565 (924,765 hours0.00885 days 0.213 hours 0.00126 weeks 2.910825e-4 months x $121.00).

13. Estimate of Other Additional Costs None. For licensees under 10 CFR Part 35. It is most likely that purchases of equipment and services were made (1) prior to October 1,1995, (2) to achieve regulatory compliance with requirements not associated with the information collectior, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.

14. Estimated Annualized Cost to the Federal Government Application review activities are attributable to and reported under NRC Form 313, " Application for Material Licensee," OMB Clearance No. 3150-0120.

The " Quality Management Program and Misadministrations" information collection requirements are cleared under OMB Clearance No. 3150-0171.

Annual Cost of NRC staff review for activities other than application review (Professional effort is 761 hours0.00881 days 0.211 hours 0.00126 weeks 2.895605e-4 months @ $121.00 per hour) = $92,081. This cost is fully recovered through fee 4 assessments to NRC licensees pursuant to 10 CFR Parts 170 and/or 171. )

15. Reasons for Chanaes in Burden and Cost NRC Licensees: I The revision is a net decrease adjustment in total burden as a result of a decrease in the number of 10 CFR Part 35 licensees from 1,982 to 1,891 and minor adjustments to the previously incorporated burden for the final rule " Criteria for the Release of Individuals Administered Radioactive Material." The result is a net burden decrease of 6,491 hours0.00568 days 0.136 hours 8.118386e-4 weeks 1.868255e-4 months .

Aareement State Licensees: The revision is a net decrease in total burden as a result of a re-estimation of the number of Agreement State licensees and minor adjustments to the previously incorporated burden for the final rule " Criteria for the Release of Individuals Administered Radioactive Material." The result is a net burden decrease of 18,055 hours6.365741e-4 days 0.0153 hours 9.093915e-5 weeks 2.09275e-5 months because of the current estimate of 4,728 licensees, compared to the previous estimate of 4,955 licensees.

I

16. Publication for Statistical U_gg There is no application to statistics in the information collected. There are no plans for publication of this information.

17. Reason for Not Disolavina the Exoiration Date The requirement will be contained in a regulation. Amending the Code of Federal Regulations to display information that, in an annual publication, could become nbsolete would be unduly burdensome and too difficult to keep current.

15

I. .

]

18. Exceptions to the Certification Statem,arj There are no exceptions.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS Not applicable i

16

~ ~ _ . _ . . . . . . . . . . . .

f f

t l

S e

e s

n e

c _

U _

C _

R Nsr 0 9 0 3 0 0 4 lau 4 4 5 5 4 0 0 6 4 7 3 8 uo 5 2

2 2 4 4 3,

4 6

0 1 7, 1 nH n 2 7, 5, 1 1 4

8 1

9 7 _

An e i

1 1 _

td t r ou TB _

s r

s u e

e o -

s H _

n e

c f

f t

a -

U S _

C e R ela st 2 2 8 8 7 5 N ni t 5 0 0 0 0 1 2 2 2 5 5

- em cb 0 2 0 0 0 0 0 0 0 1 0 1 0 0 4 _

s Uu t

n -

e C Sr _

m e

Re Np r 7 iuq 1

e R y g l l

n a _

it u r

o p

n n 0 0 0 1 1 1 0 e A 2 2 2 7 7 7 2 R s 1 0-1 0-1 0-1 0-1 0

1 0

1 e 0-

s 0 0 0 0 0 0

0 1 n 5 5 5 5 5 5 5 e o p 1 1 1 1 1 1 1 l

3 3 3 3 3 3 3 _

b s a e o o

o o

o T R N N N N N N N e e e e e e e e e c c c c c c c s n n n n n n n n a a a a a a a e r r r r r r r c a a a a a a a U le le l e 9 le le le 0 0

0 0 0 0 4 0 0 6 0 3 le 0 0 C C C C 4 C C C 2 0, 2, 1 1 8 0 0 1 0 7 C 6 6 3 1 R 4 8, 8, 5, 2, 2, 7, B B B B B B 6 6 1 5 3 3 8 B N M M M M M M 8 9

7 8

1 2 M f

o O O O O O O O o

. e e e e e e e e e e e e e e N S S S S S S S

) ) ) )

) ) ) 2

(

6

(

2

(

3 _

1 2 2

( ) ) ) ) ) ) )

{

)

) ) (

)

(

)

) ) ) ) ) ) ) a a b a b a c a n b c f f a e b b d g b ( ( ( ( ( ( ( (

it o (

2

(

2 3 4

(

2

(

2

(

3

(

9

(

0

(

1

(

0

(

0

(

5 5

1 5

1 6

0 0

1 4

3 3

4 c 1 1 1 1 3 3 3 5 6 6 7 7 7 3 3 3 4 4 6 6 6 6 e 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 S 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3_ _

l < ' l

f f

t a

S o

e s

n e

i c

L C

R N s l r au 0 uo 5 0 3 nH n

1 2 6, 5

An e l

4 ad t r ou d

e TB u

n i

t 4 n

o r c e p

s s e r e u s

n o

_ e H ic f f

a L t C S R e N e s

- n 5 s el 2 t

n i ctta 0 1 1

e Li m

e Cm Ru b

r 8 iu NS 1 q

e R

g n

i t

r l y

o p la e u n

R n 0 0

A 2 2 1 s 1 0-1 0-le e -

s 0 0 b n 5 -

5 a o 1 1 T p s 3 3 e o o

R N N e e e e

s c c n n n e a r

a r

ic a a 5 L le le 1 5

C C 0 3

0 2 C 7 H B B 0 N M M 9, f

o O O 1

. e e o e e N S S

)

2

(

) )

b b :

n (

3 5

(

0 L it o 4 4 8 1

8 A c 6 6 9 9 T e 5 5 5 5 O S 3 3 3 3 T

d e

d u

lc i

n is dr o

c n e r

o e it _

a h t _

d e n g i

o c im n r

e iv r e

i k

n a r

P e t n n s r o o o m n

o t s

o it it it t it n n n n la a a a n n o io o o la r u

r u u e r

e it t it it r w p t a a a a e e d d d s e r u

r u

r u t n t t n e t

R d d d d f

a e n n r e e e m dr e e e e s r e m s r

s r

s r m s r m it o s s s s a s ip a a a p a p e c n n n n e n u e e e iu e iu h e e e e e y e q y y y q y q T R ic c c c ic s l i

l il i l 3 l e 3 3 3 e 3 e .

e e e c s n n e e r c g e U n f

e r

C ip r e 6 0 1 o

A e 5 4 9 0 3 4

0 4

8 7

5 3

1 f

N k 2, 8 8, 1

8, 5 2, 9 1

e

- dr 1 1 e s l ors 1 1 7 s t

n t a cu n e

e oeo ic m TRH l e

r e

h iu q

t y 9 e b 1 _

R r d g e e n p n r

a i

ip e

se r

up *

t e

e oe '0 0 0 1 1 1 1 1 1 r k

dr Hek 2 1

2 1

7 1

7 e 1

b o

l ard 0- 0- 0- 0- 0 0- 0- 0 0 3 5 2 t 8 0 - - -

0 4 0 0 s c uo 0 0 0 2 1 0 0 0 0 0 0 1 1 u

e nc 5 5 5 5 5 5 5 5 5 R ne 1 1 1 1 1 1 1 1 1 m AR 3 3 3 3 3 3 3 3 3 d 2 o o

o o

o n

N N N N N N N N N a le t r

b e e e e e e e e e o a c c c c c c c c c p T n n n n n n n n n e a

r a

r a r

a r )

r s

r a a a a a a a a a 4 n e le le le e le le le le le

(

) t e

p C C C l

C C C C C C e t Ce Re

(

0 i

r B B 7 B 1 B B B B B B 5 0 0 0 0 w Nkd M M 0 M 2 9 M M M M M M 5 1 1 1 8 7 5 a f

oo r

O O 4 O 4 8, O O O O O O 3 8, 8, 8, 7 8, 5 s

.c e e 1

e 1 e e e e e e e 1 1 1 1 a oe e e e e e e e e e e d NR S S S S S S S S S S e r .

an po eit r

pe c e

r sg a n

) ) t sitr 5

(

d

( no ep

)

) ) ) ) ) )

)

me u r 2 4 4 1 2 3 4 3 cd

(

)

(

) ) ) ) ) ) ) ) ) )

(

)

(

)

(

)

(

)

(

)

e

(

) ) oe n b a b b b a b c d e b b e e e a b do t

o 0

(

1

(

2

(

3

(

9

(

1

(

2

(

2

(

2

(

2

(

2

(

3

(

0

(

0

(

0

(

0

(

0

(

1

(

2 en it c 2 2 - 2 2 2 3 3 3 3 3 3 3 5 5 5 5 5 3 5 se eh e 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 ht S 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 Tn

i

d d ior a e e e z P

e e r i r

s s a o n a a f h e e o t io n le le e u _

t n o r r s a _

e it r r l t a e e u a s

e r u

t f

f o o R d a a p dr s s s s s s s s s s n s s is s s s s s s r e r r r r r r r r r o r r r r r r r r o a e

c r a a a a a a a a a it a a a d a a a a a a c y u e y

e y

e r e e l it e e e e e e _

e o y u y y y y y y y y _

R n _

s 3 3 5 3 3 3 3 3 3 3 d 3 3 u 3 3 3 3 3 3 d _

e -

u .

n _

it n s o r u

c o s H e g e

s i n

n p e e c e i k 2 3 2 2 0 L dr 0 6 1 5 8 0 3 0 0 0 6 5 2 5 3 6 9 2 9 9 6 9 3 7 6 3 2 6 4 3 0 5 9 6 4 C o 7 4 9 8, 1, 3 6, 5 3 4, 3, 8, 9 4, 2, 8 8 6, 4 6, 6, R c 0, 1 1 1 N e 5 1 1 5 5 5 7 3 1 R 8 5 2

- l 1

t s t a

n o e T 0 m 2 e

r 4,

iuq e

R r g e p

n r ip s r e e up e oe k

dr Hek 5 6 2 5 3 0 5 5 d 7 6 0 0 o

c lar uo 4 0 1 0 0 8 3 4 1

2 1 0 4 1 1 2 4 1

)

c 4 4 1 1 (

e nc _

R ne d n

AR a 2 )

e b

(

lb 6 0

a s 4 T r e 5 _

p 3 Ce Re i n _

Nkd 0 1 1 1 1 0 6 6 2 0 3 0 3 3 3 3 3 3 d 3 3 0 f r 1 9 9 9 9 1 6 6 4 1 5 1 6 6 6 2 2 2 e 2 2 6 ooc 8, 8, 8, 3, 8, 8, 0, 0, 8, 6 8, 8 8 8 4 4 4 d u 4 4

. 1 1 1 1 1 1 1 1 1 1 l oe c n

NR i

) ) )

4

(

8

(

4

(

) ) ) ) ) ) ) ) ) ) ) ) _

) ) f )

g )

) ) )

) ) c d b a a b b c d b a c _

n c a d i h c d f b (

4

(

5

(

0

(

5

(

5

(

4

(

6

( ( (

0

(

5

(

0 it o (

3

(

9

(

9

(

9

(

9

(

0

(

5

(

5

(

0

(

2 0 0 1 1 1 0 0 6

0 6

0 1 1 1 c 5 5 5 5 5 7 7 7 8 9 2 2 3 3 3 4 4 4 4 4 4 6 e 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 S 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3

e c

r u

d o s

i o y r p e a P r n e it o n h

t n n n o le o o e it e it it t a r

t a

r a r

e u f

o u u R d n d d d dr s s s s e r e s o r a r r e s

e s

u o a it e a a n c e n a e e n n it e y e r u Y y y e e n R ic ic ic o

c 3 l d 3 3 3 l l s 6 e 1 e

s 9,

n g 9 e n 6 c ip 3

- i L e :

s C e r k u R dr o

N o 6 h

- c 0 0 0 0 0 3 8 s e 8 3 4 2 2 2, n t R s 4 2 7 7 4 e n 2 dr e l t au r 3 u 1 m

e oo b 2 r TH e iuq I

e s

e n R e g i c

l n

ip r e C e p R e sr er N k

dr oue n l a

o c Hek 5 t

o e 5 0 T _

ard l

R 2

uo nc ne 8 0 4 2 1

2 1 0 l

e AR b ) _

a 4

(

T )

d

(

)

f

(

)

f

(

5 4 4 1 3 3 s 6 6 6 r

e 5 5 5 n 3 3 3 Ce Re Nkd i

d n in d

i d

n f r 0 e 0 0 0 0 e e 0 oo 6 d 6 6 6 6 d d 6

.c u u u lc lc l

oe c NR i n i n I n _

)

5

(

) ) ) ) ) ) )

g )

d

( (

0 ( (

c f

(

c (

c :

n 5 5 0 2

(

6 7 L i

o 1 1 3 3 4

3 4

3 3 1

4 4 A t

c 6 6 6 6 6 6 6 6 6 T -

e 5 5 5 5 5 5 5 5 5 O S 3 3 3 3 3 3 3 3 3 T

e ars t .

t u _

So t

nH en me edr e

r u gB Af f lat a 0 0 2 2 3 0 0 0 0 3 5 0 2 2 0 5 8 7 5 1 uS 6 1 0 1 6 3

6 3

7 0 0 4 3, 1 4 n e 5 3, 8, 8, 6, 0, n 4 Asen 9 3 0 1 2 4 4 1 la t e oi c TL s

e f e f a

s n t S

e c e U e a s n

t r e S

t icla t

Lt t n t ei c e t abr m Su e S 2 2 8 8 7 5 e

r t

nr 5 0 0 0 0 1 2 2 2 5 5 g ee 0 2 0 0 0 0 0 0 0 0 0 0 4 A mp 1 1

- es s er r u t

n go 2 e

m AH 2 e

iu r s e

q s e n R op g s n e 0 0 0 i

t R

1 1 1 0 r 2 2 2 7 7 7 2

_ o p e 1 1 1 1 1 1 1 e 0- 0- 0- 0- 0- 0- 0-e s 0 0 R n 0 0 0 0 0 e 5 5 5 5 5 5 5 1 1 1 1 1 1 3

ic 3 3 3 3 3 3 1

3 e L . . . .

o o o o o o lb e o t

N N N N N N N T

a S

t a

e c

n e

c n

e c

n e

c n

e c

n e

c n

e c

n t

n e

a r

a r a r

m a a a 3

a a a 0 0 a le le le le le le 0 0 5 5 0 0 0 0 0 3 le 0 0 3 e 2 5 G, 5, 5 8 5 0 e

r C C C 1 O C C 5 0 2

5, 2

5, 6

9, 0

0, 0 4 7, 1 C 1 9 0,

g y B B B 1 B B B 6 9 4 4 3 8 8 1 B Al l M M M M M M 4, 1, 6 2 M _

f a O O O O O O 2 2 ou O _

.n e e e e e e e on e e e e e e e NA S S S S S S S

) ) ) )

) )

) 2

(

6

(

2

(

3

(

1 2 2

( ) ) ) ) ) ) ) )

) ) ( ( ) ) ) ) ) ) ) a a b a b a c a n b c )

f

)

f a e b b d g b (

5

(

5

(

5

(

5

(

5 6

(

0

(

4

(

3 it o (

2

(

2 3 4

(

2

(

2

(

3

(

9

(

0

(

1

(

0

(

0

(

5 1 1 1 1 1 0 1 3 4 c 1 1 1 1 3 3 3 5 6 6 7 7 7 3 3 3 4 4 6 6 6 6 e 5 5 5 5 5 5 5 5 5 5 5 5 5 3 5 5 5 5 5 5 5 5 S 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3

e ars t

Sou t

t nH en me edr e

r u gB Aff lat a 7 2

uS 8 0, n 3 n ee 4 1

d As 1 e

u la en t

n oc it n

TU o

c 4

f s f a

e t e S le le s e u u r

n e r

e s f

o f

o c n U e t e t e

e cl a a t

a Uta d d t

ei t

e e S t m v v t

n t ab it c

i t

c e SuS f e f e

t m nr 5 f e

f e

e ee 0 r r 1

A e

r g

mn es er r u t

f e

a f

t e

a 1

3 2

- go s r

s r

t s AH a a n e y

e y 1 e

m 3 3 e

r l

it l

it iu 0 n n q 2 u u e e 1 0- d d R e e e s 0 ir r g n 5 u iu n e c 1 q q it 3 e e r

o U r r n

p e o n o

e t a N io it R t y e t

a a Sl l c lu l

u 3 t a n g g

> u r

en a r e e _

le a r r 9 b

T a mn eA es l

C e

5 t

n e

t n

e 3

7, r l a la 8 _

gse B 7 v v 6 An M iu iu 7, f o O q q 4 oo.s e e e oe e o o NR S N N

)

2

(

) )

b b :

n (

3 5

(

0 L o

it 4 4 8 1

8 A c 6 6 9 9 T e 6 5 5 5 O S 3 3 3 3 T t

, l t 6 6

d e

d u

lc in is dr o

c e

r n e o h it t a g d e n n ior ic im ik e v r

r e a P e t n n n m n s r io o o t t o it it n io n n n n s l t

a a a e t

o o o o a r r r p n

e it it it it l

r a

- u u u s t a r

a r

a r a r e e d d d e e u u u u t n t t t R d d d d f

a e n n n m s r e e e it e dr e e e e s r e m s r

s r

sr m sr m e e o s s s s a s ip a a a p a ip h s

n c n n n n e n u e e e u i

e u T e e e e e e y e q y y y q y q c R ic l

ic l

ic l 3 ic l e 3 3 3 e 3 e e iL c a n t

e r

t c e f

S e r

t g n n r o

e ip f m e e e e 4 0 8 5 8 0 5 8 8 e e

r k 4 0 2 2 5 0 9 3 2 s g d 1, 1, 7, 5, 3, 1, 1 3, n r s e A a or 8 2 l

cu 4 4 1 8 2 c t 2 1 i s

oeo l e

t TRH h n t e y 4 m r b 2 e

r e d p e iuq s r

e n r

e up * *

ia R oe 0 2

0 2

1 7

t e

g Hen 1 0-1 0

1 0-1 0-1 3

1 0-1 0-1 0-1 0-r e

n lar d - - 3 5 2 b ip uo 0 0 8 0 0 1 0 0 0 0 0 0 1 0 4 1 0 0 t e nc 5 5 5 2 5 5 5 5 5 5 s e ne 1 1 1 1 1 1 1 1 1 u k AR 3 3 3 3 3 3 3 3 3 dr . . . . . . . . . m o o o o o o o o o o d c N N N N N N N N N n e sr e e e e e e e e e a R e c c c c c c c c c t r

t p n n n n n n n n n o 4

n e e a

r a

r a r

a r

a r )

p e

e mkeC a a a a a a a a a 4

( r l

b edR r le C

le C

)

e n e

a e r oN.) (

0 t T g c os B B B B B B B B B it e 5 8 5 5 5 5 8 r

A R Nee M M 8 1

M 0 2 M M M M M M 5 5

2 2 5

2 9 7 3 w f

oe xsn O O 5, O 1 7, O O O O O O 3 5, 5, 5, 1 6, 1 a

.ta 5. e e e 3 e 4 e e e e e e e 4 4 4 4 s ot e e e e e e e e e e a N S (2 c i l S S S S S S S S S S d e

r .

an po ei t r

pec e

r sg

) )

a n 5 d si t

( ( t r no ep

)

2

)

4

)

4

)

1

)

2

)

3

)

4

)

3 me u r

( ( ( ( ( ( ( (

) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) cd n b

( (

a b(

b

(

b

( (

a b

( (

c d

( (

e b

( (

b (

e (

a b

(

oe t o 0 1 2 3 9 1 2 2 2 2 2 3 0 0 0 0 0 1 2 d o it c 2 2 2 2 2 3 3 3 3 3 3 3 5 5 5 5 5 5 5 en e 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 s eh e

S 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 ht _

Tn

i

d o d i

r a e e e e z P e r ir s s a o n a a f h o e e o t u

i n le le e t

n o r r s a t

e it a

r e

r e u l

a e r t t f s R d u f a

f a o o p

d n e dr s r e s r

s r s s s r

s r

s s s o s s is s s s s u o a c a a r

a r

a a a r

a r

a it r

a r

a d r a

r a

n c e r e e e e e e e e e a e e l e e e e it e y u y y y y y y y y y r y y it y y y y n R o u n o

c 3 s 3 5 3 3 3 3 3 3 3 d 3 3 u 3 3 3 3 _

s e

e s s r n u e o c H iL g t

a n I

t ip S e t

e 5 4 8 7 6 0 3 0 0 0 6 3 2 7 8 6 2 8 2 n k 5 3 5 5 9 6 3 3 5 1 3 5 3 e dr 7 6 2 3 4 0 6, 3, 7, 8, 9 1, 3, 8 6, 3, 5, 2, 6, 2, 1, 1, 2, 0, 2, m o 2 2 4 2 9 1 3 3 9 2 8 3 2 2 4 1 4 e c 8 1 6 1 e e 1 2 3 r

g R l

A t a

- o 5 2

t s T n

e m

e r

iuq r

e e p r

R sup r e g

n oe ip Hek 5 6 2 5 3 5 5 e l ard 7 6 0 0 0 4 2 e 4 0 1 0 0 3 0 4 1 1 2 4 1 )

c 4 k uo nc 8 1 1 1

(

dr ne d o AR n c

e a

)

R b

(

t n 6 4 0 e e s 4 r

l b

m e 5 a e p 3 e e n T r g e i A k 5 8 8 8 8 5 5 5 5 5 3 5 8 8 8 8 8 8 d 8 dr 2 2 2 2 2 2 6 6 0 2 3 2 5 e 5 f

6, 6, 5 5 5 5 5 0 _

oeo c t

5, 7, 7, 7, 7, 5, 2 2 1 5, 6, 5, 1, 1, 1, 0, 0, 0, d u _

ot ae 1

4 4 4 4 4 4 4 1 4 2 2 2 1 1 1 lc NSR '

i n

) )

4

(

8

(

) ) ) ) ) ) ) ) ) )

) ) ) )

g

) ) ) ) ) c d b a a b b c d b n (

c (

a d

( (

)

i( h

( (

c d

(

f

(

b

(

4

(

5

(

0

(

5

(

5

(

4

(

6

(

6

(

6

(

0 io t

3 9 9 9 9 0 5 5 0 2 0 0 1 1 1 0 0 0 0 1 c 5 5 5 5 5 7 7 7 8 9 2 2 3 3 3 4 4 4 4 4 -

e 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 5 _

S 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 .

j' ,

lll j .t 1lll L

e cr u

d s o

i o

r y

e p P a r

n e d o h e i n t e n n u t n io l o io i

n t e t a t e it a

t a

t n e r u

f o

r u

o R d d d c s s s n s s s dr r r r e io r r r e e o a a a s t a a a s s s c e e e n a e e e n n e e y y y e r u y y y e e e

s R 3 3 3 ic l d 3 3 3 i l

c ic l

n e

c i

L t

a _

t a s r _

S u 1 t o 8 n H 6, _

e g 4 9 _

m n -

e ip 2, e

r e 1 g e 2 0 0 :

A k dr 3 5 0 5 s r 6 2, 1 2, 6 u

t s

n o

c e

4 1 5 7

0 0

6 0

0 8,

0 0

8, 8 8 3

7, 7,

4 2 h o

2 e R 1 1 0 9 n m l a

1 8 :

e e t s dr i

r u o r u u q T o b e !

h e R r n e s

g e e n i

n p r

dr e p c e se r

up b u i e l k oe e e dr Hek 5 e s

t a

o c

l ard 4 1 8 5 0 n t

S _

uo 2 2 e e nc 0 4 1 1 0 c

t n _

R ne i l e

AR )

4 e m -

4 ( t e

e )

d )

f

)

f t a e l

( ( (

S r b 5 4 4 g .

a t n 1 3 3 t A

T e 6 6 6 n m

s r e d e e 5 3

5 3

5 3 m n e o e a r e n in n e C g e 8 0 0 i i r _

A k 5 5 5 d 0 0 0 0 d e

d e 0 g R dr e 5 5 5 5 5 A N f

oeo 0, 1 1 d 1 1 1 1 d d 1 -

.t c 1 u u u l a

l a

ot ae l

c lc lc t o

t o

NSR n n n i i I T T

) ) )

4

(

4

(

5

(

) ) ) ) ) ) )

) ) ) .

(

a (

c d

(

d

( (

c G

( (

c )

f

( (

c (

c :

n 5 0 5 5 0 2 4 4 6 1 7 L o 1 1 1 1 3 3 3 3 3 4 4 A -

it 4 6 6 6 6 6 6 6 6 6 6 T c

e 5 5 5 5 5 5 5 5 5 5 5 O S 3 3 3 3 3 3 3 3 3 3 3 T _

e !i I{ !!

,I (j

ML20206E459

Text

SUMMARY

Navigation menu

Search