Text

Request for OMB Review & Supporting Statement Re 10CFR35, Medical Use of Byproduct Material.Estimated Response Burden Is 1,294,681 H
	ML20210H959
Person / Time
Issue date:	07/21/1999
From:	Shelton B; NRC
To:	;
Shared Package
ML20210H965	List: ML20210H959; ML20210H976;
References
	OMB-3150-0010, NUDOCS 9908040150
	Download: ML20210H959 (28)
	v • d • e

PAPERWORK REDUCTION ACT SU2 MISSION Ple:se read the instructions before eting this form. For additional forms or Essistance in completing this form, contict

your s Pcperwork CII:r:nce cer. Sind two is of this form, ths coll:ction instrument to be reviswid, ths Supporting atoment, and any additional documentation Office of Information and Regulatory Affairs, Office of Management and Budget Docket Library, Room 10102,72517th Street NW, Washington, DC 20503.

1. Agency /Subegency onginating request 2. OMB control number U.S. Nuclear Regulatory Commission y a. 31$0-0010 b.None

3. Type of mformaton collecten (check one) 4. Type of review requested (check one)

a. New collection J a. Regular c. Delegated

b. Revision of a currently approved collection b. Emergency - Approval requested by (date):

g c. Extension of a currently approved collection 5. Wlit this information collection have a significant economic impact on a a.Yes

d. Reinstatement, without c , of a previously approved substantial number of small entites?

collecten for which approval as expired Y b NO J a. Three years from approval date c r app h a eh Requested

f. Existing collection in use without an OMB control number

'#**"d#* b. Other (Specify): j

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

8. Agency form number (s) (if apphcabJe)

Not applicable ,

g. Keywords Nuclear Materials, Occd]Ihtional safety and health, Radiation protection, Reporting and recordkeeping requirements

10. Abstract 10 CFR 35 contains requirements for licensees authorized to administer byproduct material or its radiation to humans for medin use. The information in the required reports and records is used b NRC to ensure that the health and safety orthe public is protected and that the licensee's possession and use of yproduct materialis in compliance with ths license and regulatory requirements.

11. Affected publiC (Mvh pnmey nth *P* aM bo"t,M thet apply mth "X*) 12. ObhgatQn to respond (Mark pnmary oth *P'and aR others thst apply mth *X')

a. Individuals or households d. Farms a. Voluntary T t . Business or other for-profit T e. Federai Govemment b. Required to obtain or retain benefits T c. Not-for-profit institutions T f. State, Local or Tribal GovemmentT c. Mandatory

13. Annual reporting and recordkeeping hour burden 14, Annual reporting and recordkeeping cost burden (en %Ei s orootiersi 6,619 a. Total annualized capital /startup costs 0

s. Number of respondente 6,676,254 b. Total annual costs (O&M) 0

b. Total annual responses

1. Percentage of these responses c Total annualized cost requested 0 collected electronically 0.0 % d. Current OMB inventory 0

c. Totalannualhc rs requested 1,294,681 e. Difference 0 d Current OMB inventory 1,336,353

f. Expianation of difference

e. Difference (41,672)

1. Program change

f. Explanation of difference

1. Program change 17,076 2. Adjustment O

2. Adjustment (59,344) /

15. Purpose of information collecten 16. Frequency of recordkeeping or reporting (check all that apply)

(Mars prtinary mth *P" and sli others that apply with M a. Recordkeeping b. Third-party disclosure

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a. Application for benefits f e. Program planning or management c. Reporting

] b. Program evaluation T

f. Research

g. Regulatory or comphance

] sion

4. Quarterly

2. Weekly

5. Semi-annually

] 3. Monthly

6. Annually

c. General purpose statistics -

d. Audit 7. Bennially 7 8 Other(describe)llenewals-10 yrs

17. Statistical methods 18. Agency contact tverson who can best answer questoons regarcang the Does this information collection employ statistical methods?

Name: Jayne McCausland -

Yes % No Phone. 301-415-6219 one su won ==aw=au=w ms /95 9909040150 990721 (1 A C 4 PDR ORC EUSOMB UI PDR ( ) p.]f

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' OMB SUPPORTING STATEMENT FOR 10 CFR PART 35 MEDICAL USE OF BYPRODUCT MATERIAL (3150-0010)

EXTENSION WITH REVISIONS l

l 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 protectiorfUf 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.

l This clearance extension incorporates the informetion collections contained in the final rule, ;

" Criteria for the Release of Individuals Administered Radioactive Material." OMB approved the )

burden increase for the final rule on January 6,1997.

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i NRC is currently developing a complete revision of 10 CFR Part 35, including Q 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 af ter 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 im[.'.ementation 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. i Sections 35.12(b) and (c) of 10 CFR Part 35 require that applicants subm;t 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 j may be submitted in a letter format. This report is needed to assure the NRC that applicants' i 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 authorized by the license, before adding or changing key individuals, before receiving more material than authorized by the license, or before changing the area or l

1 I 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 i 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 i 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 orde.

to maintain the licensee's file with a current record of individuals authorized to use or prepare radioactive material. The report for char.ges in " key" workers is required because if the l licensee no longer has a complete staff, the collective training and experience of the remaining staff may no longer be sufficient to ensure the cafety 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 changeslo ensure that the licensee continues receiving correspondence such as information noticeerbulletins, 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 safety.

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

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 is required to docurnent continuing management oversight of the radiation safety program.

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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 committee. The statement is needed so that managers and key users know their responsibilities. The statement must be retained for the duration of the license.

Sect lcn 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

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1 the client's management has permitted this work.

i 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 tactors 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 incorporated into the license when renewed.

Section 35.32 contains requirements for a quality management program.

t Section 35.32(a) requires that each applicant or licensee establish and maintain a written 4 quality management program. l 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 modifications 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 licensee adequate time to review and analyze the event and to provide NRC with a complete history of the event. NRC requires submission of the report within 3

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e 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 purpo,ses only.

Section 35.50(b)(9 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 j equipment performance, and to show compliance with regulatory requirements. ]

l 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 licenree can check the survey instrument for proper 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.

l Section 35.52(b) requires that licensees have procedures for use of instrumentation used to measure the radioactivity of alpha- or beta-emitting radionuclides for other than unit dosages. l 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 l 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 reccrdkeeping burden may be expected, although licensees who currently use alpha- or beta-emitting radionuclides already have procedures for using this instrumentation.

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

1e measurement. This record is required for licensees to show that they are maintaining control of the use of radiopharmaceuticals.

l Section 35.59(a) requires that licensees maintain the manufacturer's written instructicos 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.

Sect;on 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 'icensees file a report with the NRC within 5 days if leakage of 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.

NRC allows the licensee 5 days to submit the report so that the licensee can review and analyze the source and the leak test result. 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. !

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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 j to assure continued control over sources that are only occasionally used. I Section 35.59(i) requires that licensees mcke 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 condguous areas are within allowed levels.

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.

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Section 35.70(h) requires that licensees retain a record of radiatior 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 l j

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 specialinstructions to the released individualif the dose to a breast- 1 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 tha' requirements for release in 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 administered 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. 1 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 levels, and that a proper survey of each waste container was made prior to disposal.

i 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 concentratior, 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 neded to show that the training was given.

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1 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 re ord of the thyroid burden measurement of each individual who helped prepare or administer a toerapeutic 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 radiophannaceutical therapy patient dies or has a medical amergency. This notification is )

required so that trie rediation safety officer can take whatever actions are necessary to prevent l l a spread of radiometive contamination or loss of brachytherapy sources. The radiation safety j 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 l who was treated with temporary implant sources. The record is required to show that the l survey was performed.

Section 35.406(b) requires that licensees make a record of brachytherapy source use. This j record is required so that, if a brachytherapy source is misplaced or rnissing, 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 af ter 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(bLrequires that licensees retain a record of training for personnel who care for implant patients. This record is required to show that the trairling 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.

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l Section 35.415(a)(4) requires that, after an implant of radioactive material, licensees record the I 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 radiat;on safety officer immediately if the patient dies or has a medical emergency. This notification is required so that the radiation i

safety officer can take whatever action is necessary to prevent a spread of radioactive l 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(aJ requires that licensees post written instructions for individuals who operate teletherapy units 4hese 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)(4) requires that licensees retain a record of the teletherapy room radiation monitoring device function check. This record is needed to show that the check was made, and for trend analysis by the licensee.

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.

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

l Section 35.641(c) requires that licensees retain a record of radiation measurements after l 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 teletherapy 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 Part 20. The additional information in the report will facilitate a determination by the !

NRC that dose rates in restricted and unrestricted areas are within permissible limits. The 30 day submission requirement is contained in Section 35.645. l l

Section 35.643(b) requires that licensees request a license amendment if the licensee wants l authorization for fadiation levels in unrestricted areas which are above permitted levels. This '

report will trigger.am in depth NRC review of safety considerations before it allows a licensee to I operate the unit. The burden for the license amendment is included in OMB Clearance I I

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 must be made within 30 days after the !

completion of the action that initiated the record requirement. The 30-day requirement is imposed because of the especiaily high dose rates that can be found around te etherapy units.

Section 35.647(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 signed 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 of competency sufficient to independently operate a nuclear pharmacy.

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 l qualified nuclear pharmacist on site.

2. Acency Use of the informatic' 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.

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! 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 j to radiation or releases of radioactive materials that could impact public health and safety and the environment.

1 l 3. Reduction of Burden Throuah information Technoloav

There are no current information technology applications that would reduce the burden of these information collection requirements. The NRC encourages applicants and licensees to use new automated information technology 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. J

4. Effort to identify Duplication and Use Similar Information The Information IWquirements Control Automated System was searched to determine duplication. None was found. In general. information required 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 informatico 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 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 while maintaining the required level of safety.

6. Conseauences to Federal Proaram or Policy Activities if the Collection is Not Conducted or is Conducted Less Frecuentiv If the information1s not collected, NRC will have no way to assess whether this category of licensee is operating within the radiation safety requirements applicable to the possession, use, l

or transfer of byproduct material.

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

l Applications for new licenses and amendments are submitted only once. Applications for renewal of licenses are submitted every 10 years. Information submitted in previous applications may be referenced without being resubmitted. The schedule for co!!ecting the 10 i

7 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 OMB 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 l 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 individuai 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 regulations for protection of public health and safety.

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. Retention of the records for the duration of the license is required to 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, responsibilities, and radiation safety activities for the radiation safety officer and radiation safety committee. Retention 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 incorporatea 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

q.

l Section 35.33(a) requires:

(1) that the licensee notify by telephone the NRC Operations Center in case of a l 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 licensee 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 cf the radiation safety program.

Sections 35.33(afand (b) are cleared separately under OMB Clearance No. 3150-017t 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 configurations 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 source!, 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

I; l Section 35.205(d) requires that the licensee retain, for the duration of use of the area, a record of the calculations used to deterrnine 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 tirne cair handling equipment needs to reduce the air concentration to permissible limits. Retention beyond 3 years is necessary 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. j 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 to permit the radiation safety officer to ensure that safety requirements are met for removal or disposal of the I implanted radioactive material.

Section 35.630(cWequires 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.

Section 30.632(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 inadvertently administer incorrect radiation doses 5 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 permissible limits. They would also be necessary in reconstruction following an incident involving the unit.

Section 35.645 requires that licensees mail a copy of the teletherapy source installation records 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 throughout the period of licensed activity to show that the required work was done and to establish a service history

! which may be used in incident investigations and evaluation of generic equipment problems.

t i

13 l

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, .8. . Consultations Outside the NRC

: Notice of opportunity to comment on the proposed rule for the complete revision of 10 CFR Part

! 35 was published in the Federal Reaister on August 13,1998 (63 FR 43516-43580). Those l comments were considered in the preparation of the final rule. Notice of opportunity to comment on the clearance extension for the current rule was published in the Federal Reaister on May 3,1999 (64 FR 23686), and no comments were received.

9. Pavment or Gift to Respondents Not Applicable l

10. Confidentiality of the Information Reports submitted are generally 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 sebmittal of the report, the requirements for withholding the information are met (refer to 10 CFR 2.790(b)). Also, there are provisions in f0 CFR Part 9 for the NRC to withhold from public disclosure documents such j as reports of radiauon exp .sure to individuals and other personal records. j l

11. Justification for Sensitive Questions No sensitive information is requested under these regulations. l I

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.

I 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 estimated 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.

J Aareement State Licensees: J Most of the requirements in 10 CFR Part 35 have been designated a Compatibility Category D for Agreement Stajes. When an NRC requirement is designated a Compatibility Category D, the requirement does not have to be adopted 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 1

licensee) for the estimated 4,728 licensees covered by equivalent regulations. The details are 14 l.

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

$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 collection, (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 Govemment Application review activities are attributable to and reported under NRC Form 313, " Application for Material Licensee," OMB Clearance No. 3150-0120.

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

Annual Cost of NEC 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 assessments to NRC licensees pursuant to 10 CFR Parts 170 and/or 171.

15. Reasons for Chanaes in Burden and Cost

((RQ Licensees:

The revision % 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 Admir:istered 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 .

I Aaregment Stata 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.

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

17. Begson for Not Displayino the Expiration Date The ranuirement will be contained in a regulation. Amending the Code of Federal Regulations

, JW information that, in an annual publication, could become obsolete would be unduly Fy ome and too difficult to keep current.

15

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