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Request for OMB Review & Supporting Statement Re NRC Form 473, Diagnostic Misadministration Rept. Estimated Total Annual Respondent Burden Is 500 H
	ML20154F185
Person / Time
Issue date:	05/12/1988
From:	Mcdonald W; NRC OFFICE OF ADMINISTRATION & RESOURCES MANAGEMENT (ARM)
To:	;
Shared Package
ML20154F171	List: ML20154F168; ML20154F185;
References
	OMB-3150-0140, OMB-3150-140, NUDOCS 8805230138
	Download: ML20154F185 (23)
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The information is used by NRC to determine what kinds of actions precipitate misadministrations, and also as a measure of the licensee's management control of_the radiation safet.y program, e.

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g SUPPORTING STATEMENT FOR 10 CFR PART 35 MEDICAL USE OF BYPRODUCT MATERIAL AND NRC FORM 473 DIAGNOSTIC MISADMINISTRATION REPORT

Background

10 CFR Part 35, Medical Use of Byproduct Material, contains requirements that apply to Nuclear Regulatory Commission (NRC) licensees who are authorized to administer byproduct material or its radiation to humans for medical care.

NRC Form 473 is used by NRC medical licensees to report diagnostic misadminis-trations of radiopharmaceuticals as required by 10 CFR Part 35.

Justification Part of NRC's function is to license and regulate the use of byproduct mate-rials in order to assure protection of the 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, safaty matters are of such significance that others need to be aware of information in order to perform their jobs or work in a safe manner.

In these cases, reports are required.

Need for and Practical Utility of the Information Collection Sections 35.12 (b) and (c) of 10 CFR Part 35 require that applicants submit a completed NRC Form 313.

The form elicits an orderly description of the appli-cant's complete radiation safety program.

Requests for amendments and license renewals may be submitted in letter format.

This report is needed to assure NRC that the applicant is able to protect health and minimize danger to iife

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and property before it can authorize receipt of radioactive material.

NRC l

Form 313 has previously been cleared under OMB No. 3150-0120, which should be 3

referred to for additional supporting information, as well as burden and cost data.

j Section 35.13 of 10 CFR Part 35 requires that licensees apply for and receive a license amendment before using material not allowed by the license, before i

adding to or changing key individuals, before receiving more material than allowed by the license, or before changing the location of use or mailing 3

address.

The identified trigger events are critical indicators of potential f

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.

The information is needed so that the staff can determine whether the licensee has the training and experience and facilities and equipment i

needed to assure protection of public health and safety.

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Section 35.14 of 10 CFR Part 35 requires that licensees notify the NRC within f

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30 days if a key worker ends his association with the licensee.

This prompt report is needed because if the licensee no longer has a complete staff, the I

collective training and experience of the remaining staf f may no longer be i

sufficient to ensure safety.

This report will trigger a check of the j

licensee's file to determine whether the remaining key users are qualified to

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receive and use material safely, i

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Section 35.20 requires licensees to have a written program to keep radiation i

dose as low as reasonably achievable.

The program must be written to provide clear statements of authority, responsibility, and internal requirements.

Section 35.21(b)(2) of 10 CFR Part 35 requires that the licensee establish and l

implement the written policy and procedures that were submitted as part of the I

application.

The policy and procedures are needed so that the staff can review j

them and make a determination that the applicant can meet the requirements of f

the Atomic Energy Act and the Commission's regulations.

The procedures must be j

implemented in order to provide for protection of the public health and safety.

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The burden is included in the burden for the application, NRC Form 313, OMB No.

3150-0120.

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t Sections 35.22(a)(4) and (5) of 10 CFR Part 35 require that medical institution licensees retain a copy of Radiation Safety Committee meeting minutes for the f

I duration of the license, and prescribe the information required in the minutes.

i This record is needed to show continuing management oversight of the radiation r

f safety program.

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l Section 35.23(b) of 10 CFR Part 35 requires that licensees provide a written t

statement of authority, duties, responsibilities, and radiation safety activi-ties for the Radiation Safety Officer and Radiation Safety Committee.

The record is needed so that managers and key users know their responsibilities.

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j The statement must be retained for the duration of the license.

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Section 35.27(a) of 10 CFR Part 35 requires that licensees provide written per-

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mission to visiting authorized users to work under the license.

Section

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j 35.27(c) requires licensees to retain a copy of the license that identifies the

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visitor as an authorized user.

This permission and record are needed to show i

k that licensee management has permitted this work, and that a regulatory agency i

has reviewed the visitor's training and experience.

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Section 35.29(b) of 10 CFR Part 35 requires that mobile nuclear medicine ser-I vice licensees keep a letter of permission signed by the management of each

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l client.

This record is needed to show that client management has permitted j

this work.

1 Section 35.31(b) of 10 CFR Pc.rt 35 requires that licensees make a record of 3

l radiation safety program changes.

This record is needed to show what radiation

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f safety problems were considered before implementing the change, and also pro-vides a record of where within the licensee's facility radioactive materials i

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were received, used, and stored, i

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Section 35.33(a) of 10 CFR Part 35 requires that the licensee notify by tele-

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phone the appropriate NRC regional of fice in case of a therapy misadministra-

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tion within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months af ter discovering the misadministration.

i This prompt j

l notification is necessary because a therapy misadministration may present a

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clear and present radiation hazard to a member of the public that might be mitigated by NRC assistance.-

The licensee is also required to notify the i,

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referring physician and the responsible relative or guardian of the patient, j

i These reports are needed so that those individuals can provide adequate care for the patient.

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Section 35.33(b) of 10 CFR Part 35 requires that a licensee file a written j

report to NRC within 15 days after telephoning an initial therapy misadmini-l j

stration report.

This report is needed so that NRC can determine whether there l

l might be generic implications in the incident which indicate a need to notify

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all licensees.

NRC all us the licensee 15 days to submit the report so that it-

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can review and analyze what has happened and provide NRC with a complete history of the event.

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.

1 Section 35.33(c) of 10 CFR Part 35 requires that the Radiation Safety Officer investigate the cause of diagnostic misadministrations and make a record for j

NRC review.

The licensee must also notify the referring physician and the NRC Regional Office in writing on NRC Form 473 within 15 days.

These written l

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records are needed to determine what kinds of actions precipitate misadminis-trations, and also provide a measure of the licensee's management control of i

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the radiation' safety program.

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Section 35.33(d) of 10 CFR Part 35 requires licensees to retain a record of i

each misadministration for 10 years.

The record is needed so that individual

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licensees can determine the causes of misadministrations within their respec-I tive facilities and take corrective action.

This record must be retained for I

i 10 years because misadministration events are infrequent and, if there is a l

common cause for them, it will take longer to manifest itself.

Section 35.50(b)(4) of 10 CFR Part 35 requires that licensees make a record of a geometry dependence test for the dose calibrator.

This record is needed to i

f show that the volume configuration of the radiopharmaceutical does not affect the reading given by the dose calibrator.

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Secti,n '35.50(e) of 10 CFR Part 35 requires that licensees retain a record of checks and tests of dose calibrator performance.

This record is needed to show 4

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that the dose calibrator is capable of accurately measuring radiopharmaceutical dosages.

Section 35 51(a)(3) requires that the licensee note on a survey instrument the apparent exposure rate from a dedicated check source.

This information is i

i needed so the licensee can check the survey instrument for proper operation before making measurements.

The burden is included in the burden estimate for

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Section 35.51(d).

Section 35.51(d) of 10 CFR Part 35 requires that licensees retain a record of survey instrument calibrations.

This record is needed to show that survey instruments were working properly.

Section 35.53(c) of 10 CFR Part 35 requires that licensees retain a record of each radiopharmaceutical dosage measurement.

This record is needed to show that licensees are maintaining control of the use of radiopharmaceuticals.

Section 35.59(a) of 10 CFR Part 35 requires that licensees maintain written instructions for the safe use of sealed sources and brachytherapy sources.

j These instructions are needed so that individuals v'io are handling sources can I

determine the specific safety measures appropriate for each kind of source used.

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Section 35.59(d) of 10 CFR Part 35 requires that licensees retain a record of j

1 sealed source leak tests.

This record is needed to show that the leak test was done at the appropriate time, and that the test showed that the source was not leaking.

i Section 35.59(e)(2) requires that licensees file a report with the NRC within five 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 it can review and analyze the source and the leakage measurement.

NRC requires submission of the report within 5 days so that it can promptly notify other licensees if it appears there may be a generic problem.

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Section 35.59(g) of 10 CFR Part 35 requires that licensees make a record of sealed source and brachytherapy source inventory.

This inventory is needed to show that possession of sealed sources did not exceed the amount authorized by the license.

The five year recordkeeping requirement will help to assure con-tinued control over these sources that are only occasionally used.

Section 35.59(i) of 10 CFR Part 35 requires that licensees make a record of radiation surveys of areas where sealed sources and brachytherapy sources are stored.

This record is needed to show that adequate radiation shielding has been provided for such sources, and that dose rates in contiguous areas are within allowed levels.

Section 35.60(b) of 10 CFR Part 35 requires that licensees label each syringe or syringe radiation shield as to its contents.

This label is needed because review of misadministration reports has indicated that in many cases misadmin-istrations are caused by inadvertent transposition of syringes.

Section 35.61(b) of 10 CFR Part 35 requires that licensees label vial radiation shields with the identity of the radiopharmaceutical contained.

NRC redew of several misadministration reports indicates that many mi$ administrations 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) of 10 CFR Part 35 require that the licensee establish action levels for radiation surveys.

The action levels provide the individual who makes a radiation survey with a record of 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 report is needed so that the Radiation Safety Officer can take appropriate remedial action.

The Radiation Safety officer is the one 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) of 10 CFR Part 35 requ' ires that licensees retain a record of j

radiation surveys.

The record is needed to show that the required surveys were

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j made.

5 Section 35.80(f) of 10 CFR Part 35 requires that mobile nuclear medicine

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i service licensees make a record of radiation surveys.

The record is needed to 4

show that the required surveys were made.

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Section 35.92(b) of 10 CFR Part 35 requires that licensees make a record of i

disposal of waste that was decayed in storage.

The record is needed to show l

i that materials were decayed for the proper length of time and that a proper i

survey of each waste container was made.

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Section 35.204(c) of 10 CFR Part 35 requires that licensees retain a record of molybdenum-99 concentration in radiopharmaceuticals.

This record is needed to show that the concentration measurement was made.

J Section 35.205(d) requires that the licensee post a time period of evacuation in areas where aerosols and gases are used.

In case of a spill, this provides notice to workers of how much time air handling equipment needs to reduce the

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air concentration to permissible limits.

The licensee must retain a record of i

the calculations used to determine the evacuation time for the duration of j

license, i

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Section 35.310(b) of 10 CFR Part 35 requires that licensees retain a record of j

radiation safety instruction given to personnel who care for radiopharma-j eeutical therapy patients.

This record is needed to show that the training was given.

,1 Sections 35.315(a)(2) and 35.415(a)(2) require that the licensee post

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radiopharmaceutical therapy and brachytherapy patient room doors with a

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"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 i

patient's room.

I This is the most convenient way to provide this information to i

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nurses, who are usually responsible for enforcing visiting rules, because the patient's chart provides all the information concerning the patient.

Section 35.315(a)(4) requires that licensees make a record of dose rates around treatment rooms.

This record is needed to show that members of the public are not exposed to excessive levels of radiation.

Section 35.315(a)(8) of 10 CFR Part 35 requires that licensees make a record of the thyroid burden measurement of each individual who helped prepare or admin-ister a therapeutic dosage of iodine-131.

This record is needed to show that workers were not exposed to excessive levels of iodine-131.

Sections 35.315(b) and 35.415(b) of 10 CFR Part 35 require that the licensee promptly notify the Radiation Safety Officer if the radiopharmaceutical therapy or brachytherapy patient dies or has a medical emergency.

This report is needed 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 one 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.

Section 35.404(b) of 10 CFR Part 35 requires that licensees retain a record of the radiation survey of each patient who was treated with temporary implant sources.

The record is needed to show that the survey was made.

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i Section 35.406(b) of 10 CFR Part 35 requires that licensees make a record of brachytherapy source use.

This record is needed so that, if a brachytherapy source is misplaced, the licensee knows where to look for it, i

l Section 35.406(c) of 10 CFR Part 35 requires that licensees make a record of radiation surveys of patients af ter implanting sources.

This record is needed to show that the survey was made.

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i Section 35.406(d) requires'that the licensee retain a record of the use of 4

r brachytherapy sources and special safety surveys.

This record is needed to j

show that the licensee is providing adequate control for these sources.

The record burden is included in the burden.fstimate for Sections 35.406(b) and i

(c).

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Section 35.410(a) of 10 CFR Part 35 requires that licensees provide written radiation safety instruction for personnel caring for implant therapy patients.

This instruction is needed so that these personnel may study and refer to it l

l while caring for the patient.

Section 35.410(b) of 10 CFR Part 35 requires that licensees retain a record of training for personnel who care for implant patients.

This record is needed to

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show that the training was given.

Section 35.606 of 10 CFR Part 35 requires that licensees apply for and receive a license amendment before making certain changes in the teletherapy program.

l This license amendment process is necessary because the licensee might consider l

making changes that would cause radiation levels in restricted and unrestricted areas to exceed permissible levels.

j Section 35.610(a) of 10 CFR Part 35 requires that licensees post written

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instructions for individuals who operate teletherapy units.

These instructions l

j are needed to remind workers of proper operating procedures.

Section 35.610(c) of 10 CFR Part 35 requires that licensees make a record of 3

training for individuals who operate teletherapy units.

This record is needed I

to show that the training was given.

l Section 35.615(d)(4) of 10 CFR Part 35 requires that licensees retain a record

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of the teletherapy room radiation monitoring device function check.

This j

record is needed to show that the check was made, i

1 Section 35.630(c) of 10 CFR Part 35 requires that licensees retain a record of j

each calibration, intercomparison, and comparison of teletherapy dosimetry i

equipment.

These records are needed to show that measurements of radiation i

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teletherapy doses were made with instruments capable of making accurate measurerents.

Section 35.632(g) of 10 CFR Part 35 requires that licensees retain a record of I

i teletherapy unit calibration. This record is needed to show that the calibra-

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tions were dore and that lictnsees did not inadvertently misaominister l

radiation doses to patitnts, i

Section 35.634(c) of 10 CFR Part 35 requires that the qualified teletherapy calibration expert report the results of teletherapy unit spot-check $ promptly I

to the licensee. This assures the licensee that the results of each spot-check j

have been reviewed by an expert.

The licensee must keep a copy of each report to assure that the review has been made.

Section 35.634(f) of 10 CFR Part 35 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) of 10 CFR Part 35 requires that licensees retain a record of safety checks for teletherapy facilities.

This record is needed to show that the checks were made.

1 Section 35.641(c) of 10 CFR Part 35 requires that licensees retain a record of

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radiation measurements after installing a source in a teletherapy unit.

These j

records provide assurance that the source is properly installed within the I

teletherapy unit, and that dose rates outside the teletherapy room are within permissible limitr.

Section 35.643(a)(3) of 10 CFR Part 35 requires that licensees amend a report made to NRC pursuant to Section 35.645 to include additional survey information if changes in an installation as approved by NRC were necessary.

The

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additional information in the report provides assurance to NRC that dose rates f

in restricted and unrestricted areas are within permissible limits.

The 30-day submission requirement is contained in Section 35.645.

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Section 35.643(b) of 10 CFR Part 35 requires that licensees request a license amer.dment if radiation levels in unrestricted areas are above permitted levels.

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This report will trigger an indepth NRC review of safety considerations before

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j it allows a licensee to operate the unit. The 30-day submission requirement is j

contained in Section 35.645.

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l Section 35.645 of 10 CFR Part 35 requires that licensees mail a copy of tela-l i

therapy source installation records to the NRC.

This record is needed to show that dose rates in restricted and unrestricted areas are within permissible i

levels.

The submission n.ust be made within 30 days after the completion of the l

action that initiated the record requirement.

The 30-day requirement is i

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

l Section 35.647(c) of 10 CFR part 35 requires that licensees keep a record of j

teletherapy unit inspection and servicing.

This record is needed to show that l

the required work was done, i

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o ac es rd ng h b rden associated with this inwrratien collection.

However, because of the types of information and the

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infrequency of submission, the applications and reports do oct lend themselves l

1 readily to the use of automated information technology for submission.

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Ef fort to Identify Duplication l

The Federal Information '.ocator System was searched to detemine hRC and other Federal agency duplication.

Nore was found.

In general, information required by NRC in applications, reports, or records concerning the transfer, receipt, possession, or use of byproduct material does not duplicate other Federal e

information collection requirements and is not available from any source other than applicants or licensees.

Portions of the needed inforration might 4150 be l

j contained in other information submittels to hRC or other Federal agencies.

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However, duplication, if any, is slight, and the collection of this information l

l by use of specified forms and other required reports and records is the most effective and least burdensore means of obtaining the information.

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

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

Since the health and safety consequences of improper handling or use of radioactive byproduct material are the same for large and small entities, it is not possible to reduce the burden on small businesses by less frequent or less complete reporting, recordkeeping, or accounting and control procedures.

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

occur.

Applications for renewal of licenses are submitted esery five years.

Information submitted in previous applications may be referenced without being resubmitted. The schedule for collecting the information is the minimum frequency necessary to assure that licensees will continue to conduct programs in a manner that will assure adequate protection of the public health and safety.

Circumstances Which Justify Variation from OMB Guidelines Contrary to the OMB Guidelines in 5 CFR 1320.6(f), 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 needed 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 35.33(a) requires that the licensee notify by telephone the appropriate NRC regional office 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.

The licensee is also required to notify the referring physician and the responsible relative or guardian of the patient. These reports are needed so that those individuals can provide adequate care for the patient.

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Section 35.33(b) requires that a licensee file a written report to NRC within 15 days after telephoning an initial therapy misadministration report.

This report is r.eeded so that NRC can determine whether there might be generic implications in the incident which indicate a need to notify all licensee;.

NRC allows the licensee 15 days to submit the report so that it can review and analyze what has happened and provide NRC with a complete history of the event.

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(c) requires that the Radiation Safety Officer investigate the cause of diagnostic misadministrations and make a record for NRC review. The licensee must also notify the referring physician and the NRC Regional Office in writing on NRC Form 473 within 15 days.

These written records are needed to determine what kinds of actions precipitate misadministrations, and also provide a measure of the licensee's management control of the radiation safety program.

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

Section 35.645 requires that licensees mail a copy of teletherapy source installation records to the NRC.

This record is 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 especially high dose rates that can be found around teletherapy units.

Consultations Outside the Agency 13 i

Several experts in the use of radioactive material for patient care were asked to conrnent on the technical content, including the infonnation collection requirements, of the proposed regulation.

They were representatives of:

Food and Drug Administration, American Association of Physicists in Medicine, Health Physics Society, Society of Nuclear Medicine, and the American College of Radiology. The conrnents received were considered in promulgating the final rule. There have been no consultations outside the agency since the promul-gation of the revised rule.

Confidentiality None, except for proprietary infonnation.

5ensitive Questions None.

Number and Type of Respondents These requir ements will affect approximately 2500 licensees and applicants. About 2200 c.f the licensees are hospitals, and about 300 of the licensees are physicians in private practice.

J

't 4

14

Estimate of Compliance Burden Reporting Requirements Licensee Total Annual No. of Licensee Staff Hours Licensee Burden Section Responses Ar.nually Per Submittal (Hours) 35.12(b)

See OMB Clearance No. 3150-0120 35.ic(c)

See OMB Clearance No. 3150-0120 35.13 1800 3

5400 35.14 500 0.5 250 35.27(a)(1) 2500 0.5 1250 35.27(a)(2) 2500

0. 5 1250 35.33(a) 5 1

5 35.33(b) 5 10 50 35.33(c)

See NRC Form 473 (below), OMB Clearance No. 3150-0140 35.59(e) 1 2

2 35.60(b) 2200

7. 5 14250 35.61(b) 400 0.5 200 35.70(d) 26400 0.02 528 35.70(g) 26400 0.02 528 35.315(b) 1 0.1 1

35.315(a)(2) 8400 0.2 1680 35.410(a) 4800 0.5 2400 35.415(b) 1 0.1 1

35.415(a)(2) 4800 0.2 960 35.606 40 1

40 35.610(a) 100 0.5 50 35.634(c) 4800 0.1 480 35.643(c) 1 2

2 35.643(d) 1 0

2 35.645 100 0.5 50 Total 85755 29379 NRC Form 473 500 1

500 15

Recordkeeping Requiracents Total No. of Record-Record-Annual Hours keeping Record Section keepers per Recordkeeper Hours Detention Period 35.20 see 35.12 (b) and license duration

'(c)*

35.21(b)(2) see 35.12 (b) and license duration (c)*

35.22(a)(4) and (a)(5) 2200 2

4400 license duration 35.23(b) see 35.12(b) and license duration (c)*

35.27(c) see 35.27(a)*

3 years after last use 35.29(b) 50 1

50 duration of service 35.31(b) 1200 1

1200 license duration 35.33(c) 500 2

1000 10 years 35.33(d) see 35.33 (b) and

-10 years (c)*

35.50(b)(4) see 35.50(e)(4) '

eqpt. duration 35.50(e)(1) 1900 5

9500 3 years 35.50(e)(2) 1900

0. 2 380 3 years 35.50(e)(3) 1900 2

3800 3 years 35.50(e)(4) 380 1

380 eqpt, duration 35.51(d) 2500 0.2 500 3 years and (a)(3) i 35.53(c) 2200 75 165000 3 years 35.59(a) 2500 0.1 250 eqpt. duration 35.59(d) 2500 2

5000 3 years 35.59(g) 2200 2

4400 5 years 35.59(i) 2200 2

4400 3 years 35.70(h) 2200 65 143000 3 years 35.80(f) 50 100 5000 3 years i

16

Recordkeeping Requirements (Continued)

Total No. of Record-Record-Annual Hours keeping Record Section keepers per Recordke.epe,a Hours Detention Period 35.92(b) 2200 6

9500 3 years 35.205(d) 400 0.1 40 3 years 35.310(b) 700 1

700 3 years 35.315(a)(4) 700 1

700 3 years 35.315(a)(8) 700 2

1400 until disposal auth'd 35.404(b) 400 1

400 3 years 35.406(b) 400 2

800 3 years 35.J06(c) 400 1

400 3 years 35.406(d) included in 35.406(b) and (c) 35.410(b) 400 1

400 3 years 35.610(c) 400 0.1 40 3 years 35.615(d)(4) 400 5

2000 3 years 35.630(c) 200 1

200 eqpt. duration 35.632(g) 400 16 6400 license duration 35.634(c) 400 1

400 3 years 35.634(f) 400 12 4800 3 years 35.636(c) 100 1

100 3 years 35.641(c) 100 8

800 license duration 35.647(c) 100 0.1 10 license duration Total Recordkeepers:

2,500 Total Recordkeeping Burden:

390,550 hours0.00637 days 0.153 hours 9.093915e-4 weeks 2.09275e-4 months TOTAL BURnEN, 10 CFR PART 35: 419,929 hours0.0108 days 0.258 hours 0.00154 weeks 3.534845e-4 months TOTAL BURDEN, NRC FORM 473:

500 hours0.00579 days 0.139 hours 8.267196e-4 weeks 1.9025e-4 months i

I

These documents are prepared as a written report and must be retained by the licensee for reference.

The time spent making the record is included in the i

noted reporting section.

17 l

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Estimated Cost to Public to Respond Section Annual Cost to Respond 35.12(b)

See OMB Clearance No. 3150-0120 35.12(c)

See OMB Clearance No. 3150-0120 35.13 324,000 35.14 15,000 35.20 included in 35.12(b) and (c) 35.21(b)(2) included in 35.12(b) and (c) 35.22(a)(4) and 264,000 (a)(5) 35.23(b) included in 35.12(b) and (c) 35.27(a)(1) 75,000 35.27(a)(2) 75,000 35.27(c) included in 35.27(a) 35.29(b) 3,000 35.31(b) 72,000 35.33(a) 300 35.33(b) 3,000 35,33(c) 60,000 35.33(d) included in 35.33(b) and (c) 35.50(b)(4) included in 35.50(e)(4) 35.50(e)(1) 570,000 35.50(e)(2) 22,800 35.50(e)(3) 228,000 35.50(e)(4) 22,800 35.51(d) & (a)(3) 30,000 35.53(c) 9,900,000 35.59(a) 15,000 35.59(d) 300,000 35.59(e) 120 35.59(g) 264,000 35.59(i) 264,000 35.60(b) 855,000 l

18

Section Annual Cost to Respond 35.61(b) 12,000 35.70(d) 31,680 35.70(g) 31,680 35.70(h) 8,580,000 35.80(f) 300,000 35.92(b) 792,000 35.204(c) 570,000 35.205(d) 2,400 35.310(b) 42,000 35.315(a)(2) 100,800 35.315(a)(4) 42,000 35.315(a)(8) 84,000 35.315(b) 60 35.404(b) 24,000 35.406(b) 48,000 35.406(c) 24,000 35.406(d) included in 35.406(b) and (c) 35.410(a) 144,000 35.410(b) 24,000 35.415(a)(2) 57,600 35.415(b) 60 35.606 2,400 35.610(a) 3,000 35.610(c) 2,400 35.615(d)(4) 120,000 35.630(c) 12,000 35.632(g) 384,000 35.634(c) 52,800 35.634(f) 288,000 35.636(c) 6,000 35.641(c) 48,000 35.643(c) 120 19

Section Annual Cost to Respond 35.643(d) 120 35.645 3,000 35.647(c) 600 Total

$25,195,740 NRC Form 473

$30,000 Source of Burden and Cost Data and Method of Estimating and Cost The estimates are based on submittals to NRC in past years.

Cost to licensees and applicants is calculated at a rate of $60.00 per hour.

This figure includes both salaries and overhead.

Estimate of Cost to the Federal Government Application review activities are attributable to and reported under NRC Form 313, OMB Clearance No. 3150-0120.

Annual Cost of NRC staff review for activities other ther. application review.

(Professional effort is 640 hours0.00741 days 0.178 hours 0.00106 weeks 2.4352e-4 months @ $60.00 (hr)). = $38,400 I

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