Text

Notice of Pending NRC Action to Submit an Info Collection Request to OMB for & Solicitation of Public Comment
	ML20128H637
Person / Time
Issue date:	10/18/1996
From:	Cranford G; NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:	;
References
	OMB-3150-0171, OMB-3150-171, NUDOCS 9610100016
	Download: ML20128H637 (26)
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[7590-01-P]

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U. S. NUCLEAR REGULATORY C0ttilSSION Agency Information Collection Activities:

Proposed Collection; Comment request AGENCY:

U. S. fWclear //gulatory Commission (!!RC)

ACTION:

Notice of pending NRC action to submit an information collection request to OM8 and solicitation of public comment.

SUMMARY

The NRC is preparing a submittal to OMB for review of continued approval of information collections under the provisions of the Paperwork Reduction Act of 1995 (44 81.S.C. Chapter 35).

Information pertaining to the requirement to be submitted:

1.

The title of the information collection:

10 CFR 35.32 and 35.33 " Quality Management Program and Misadministrations" 2.

Current OMB approval number: 3150-0171 3.

How often the collection is required:

For quality management program (QMP):

i 0D0103 9610100016 961018 h

((g-(

PDR ORO NIRC 1

Reportina: One time submittal of a quality management program (QMP) for each existing and new licensee, when the QMP is modified, or when new modalities (uses) are added to an existing license.

Ten Agreement States, who should have adopted the rule by January 1995, have not done so. Therefore, this estimate includes the one-time burden for the development of QHPs by these ten Agreement State licensees.

Recordkeepina: Records of written directives, administered dose or dosage, annual review, and recordable events, for 3 years.

For Misadministrations:

Reportina: Whenever a misadministration occurs.

Recordkeepino: Records of misadministrations for 5 years.

4.

Who is required or asked to report: NRC Part 35 licensees who use byproduct material in limited diagncstic and therapeutic ranges and similar type of licensees regulated by Agreement States.

5.

The number of respondents:

6300 licensees

6.

The number of hours needed annually to complete the requirement or request: 34,743 hours0.0086 days 0.206 hours 0.00123 weeks 2.827115e-4 months for applicable licensees (24,400 hrs /yr for reporting and 10,343 hrs /yr for recordkeeping).

7.

Abstract:

In the medical use of byproduct material, there j

have been instances where byproduct material was nc administered as intended or was administered to a

'ong individual, which resulted in unnecessary expor or inadequate diagnostic or therapeutic procedures. The most frequent causes of these incidents were: insufficient supervision, deficient procedures, failure to follow procedures, and inattention to detail.

In an effort to reduce the frequency of such events, the NRC requires licensees to implement a quality management program (f 35.32) to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by an authorized user physician.

Collection of this information enables the NRC to ascertain whether misadministrations are properly identified, evaluated, and investigated by the licensee and that corrective action is taken. Additionally, NRC has a responsibility to inform the medical community of generic issues identified in the NRC review of misadministrations.

'O Submit, by (insert date 60 days after publication in the Federal Reaister),

comments that address the following questions:

1.

Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility?

2.

Is the burden estimate accurate?

3.

Is there a way to enhance the quality, utility, and clarity of the information to be collected?

4.

How can the burden of the information collection 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.

Members of the public who are in the Washington, DC, area can access this document via modem on the Public Document Room Bulletin Board (NRC's Advanced Copy Document Library), NRC subsystem at FedWorld, 703-321-3339. Members of the public who are located outside of the Washington, DC, area can dial FedWorld, 1-800-303-9672, or use the FedWorld Internet address:

fedworld. gov (Telnet). The document will be available on the bulletin board for 30 days after the signature date of this notice.

If assistance is needed in accessing the document, please contact the FedWorld help desk at 703-487-4608.

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d Additional assistance in locating the document is available from the NRC Public Document Room, nationally at 1-800-397-4209, or within the Washington, DC, area at 202-634-3273.

Comments and questions about the information collection requirements may be l

directed to the NRC Clearance Officer, Brenda Jo. Shelton, U.S. Nuclear Regulatory Commission, T-6 F33, Washington, DC, 20555-0001, er by telephone at (391) 415-7233, or by Internet electronic mail at BJS19NRC.G0V.

Dated at Rockville, Maryland, this day of

, 1996.

For the Nuclear Regulatory Commission.

GeraldF.Cranford,Designat'4dSenioK j

Official for Information Resources Management i

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1 i

I SUPPORTING STATENENT FOR i

10 CFR 35.32 and 35.33 i

" QUALITY NANAGEMENT PROGRAN AIS NISADMINISTRATIONS" i

(3150-4171)

REVISED CLEARANCE EXTENSION i

l INTRODUCTION AN OVERVIEW NRC regulations in 10 CFR Part 35 establish requirements for the medical use l-of byproduct material. The regulations are issued pursuant to the Atomic j

Energy Act of 1954, as amended, and the Energy Reorganization Act of 1974, as amended. This clearance extension addresses two provisions of 10 CFR Part 35:

(1) a requirement that licensees establish and maintain a quality management program (QMP)(i 35.32) and (2) requirements for notifications, records, and reports of misadministrations (i 35.33).

On December 24, 1991, the NRC submitted an information collection requirements (ICR) approval request to the Office of Management and Budget (OMB) for the Quality Management (QM) and Misadministrations rule which would be effective in January 1992.

In communications with OMB, the American College of Nuclear Physicians and Society of Nuclear Medicine (ACNP/SNM) expressed strong opposition to the rule.

In June 1992, OM8 disapproved the record collection requirements of the rule. The NRC Commissioners, finding that public health and safety warranted institution of the ICR, overrode the OM8 determination.

In addition, the ACNP/SINI took the NRC to court, in American Co11eae of Nuclear Physicians and Society of Nuclear Medicine v. U.S. Nuclear Reaulatory Consission. Only ten days after hearing arguments in the case, the court ruled in favor of the NRC, declaring that it saw "no need for a published opinion." 976 F.2d 45 (D.C. Cir.1992)(Table). The court stated:

on the record before us, we find no basis to overturn the QM rule; i

accordingly, the petition for review is hereby denied, substantially for the reasons stated by the NRC in its rulemaking. The NRC, in promulgating the QM rule, acted within the bounds of its broad statutory mandate to establish "such standards... as the Commission may deem necessary or desirable to... protect health or to minimize danger to life and property." 42 U.S.C. I 2201(b) (West Supp. 1992) (emphasis added). Moreover, the substantive requirements imposed by the QM Rule are not " arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law." 5 U.S.C. I 706(A) (1988).

In 1993, the NRC contracted with the National Academy of Sciences (NAS),

Institute of Medicine (IOM) to conduct an external review of the NRC's medical regulatory program. The goal of the external review was to develop an assessment of the adequacy and appropriateness of the current framework for the medical use of byproduct material. The quality management program (QMP)

(135.32) and requirements for notifications, records, and reports of misadministrations (f 35.33) were included in that study.

2 In a letter to CM8, dated November 28, 1995, the ACNP/SNM again requested that OM8 disapprove the ICR associated with 10 CFR 35.32 and 35.33 as they relate to diagnostic and therapeutic applications of byproduct material.

In December 1995, the 10M submitted its report to the NRC. The majority report (there was a dissenting opinion as well) was highly critical of NRC regulation in the medical area, and of the QM rule in particular. The ION findings have been and are being considered within the agency-wide Strategic Assessment and Re-baselining initiative. The staff is awaiting the Commission's direction on the medical use regulatory program.

In February 1996, the OM8 approved a one-year extension of the information collection provisions of NRC's QM rule rather than the three-year approval that is customary. The one-year extension necessitated that NRC begin preparation of the 1997 OM8 submittal within four-conths of the previous approval. The elapsed time was not sufficient to resolve the issues associated with the prospective changes to NRC's medical use program.

The Cossiission is seeking OM8 approval of a three-year clearance extension to allow sufficient time to consider what legislative and/or regulatory changes are appropriate for NRC's medical use program.

DESCRIPTION OF THE INFORMATION COLLECTION In the medical use of byproduct material, there have been instances where byproduct material was not administered as intended or administered to a wrong individual which resulted in unnecessary exposures to radiation, or inadequate, or incorrect diagnostic or therapeutic procedures. The most frequent causes of these incidents were:

insufficient supervision, deficient procedures, failure to follow procedures, and inattention to detail.

In an effort to reduce the frequency of such events, the NRC requires licensees to implement a QMP (f 35.32) to provide high confidence that byproduct material or radiation from byproduct material will be administered as directed by an authorized user physician.

In response to comments, the final rulemaking that established these new requirements, which the agency believes are essential to adequately protect the health and safety of the public, also minimized the reporting burden.

In the rulemaking, NRC also revised the definition for

" misadministration" in i 35.2, " Definitions," and distinguished between the "misadministrations" and lesser " recordable events" for which reporting to NRC is not necessary. These revisions considerably reduced the number of incidents that must be reported to the NRC or the Agreement States. Nhen compared to the previous definition, the number of incidents that meet the revised definition of misadministration has resulted in a greater than 10 fold reduction in the reporting burden. There has been a corresponding reduction in the regulatory effort.

The cost for this rule was ' front loaded," in that, all affected licensees were required to submit a QMP to be reviewed by the applicable regulatory agency. This implementation burden has been completed by current NRC licensees and 19 of the 29 States who have agreements with the NRC that allow them to regulate the use of byproduct material as Agreement States. However,

3 ten Agreement States have not completed their adoption of the rule.

Therefore, this ICR cost estimate reflects the one-time cost for the development and submission of QMPs for approximately 2000 Agreement States licensees in those ten Agreement States.

It should be noted that the Ccmission is currently reviewing the issue of compatibility relative to the QM rule for the Agreement States.

If relief is granted to the Agreement States from certain QM rule compatibility requireuents, the staff will submit a modification of the burden estimate that reflects the changes.

A.

JUSTIFICATION 1.

Need for and Practical Utility of the Collection of Information In order to obtain a license issued pursuant to 10 CFR Part 35, medical applicants, who plan to use byproduct material in certain diagnostic and therapeutic rar.ges, must submit a QMP to provide high confidence that byproduct matr.rfal will be administered as directed by an authorized user physician (6 35.32). The rulemaking and related regulatory guide were developed to include generally accepted good practices in the medical uses of byproduct material for therapy, and include specific measures intended to prevent many of the kinds of human errors observed and reported to the NRC over a number of years.

In comments provided during rulemaking, members of the Society of Nuclear Medicine and NRC's Advisory Committee on the Medical Uses of Isotopes indicated a belief that NRC medical use licensees already had procedures in place to assure that the administration of byproduct material was as directed by an authorized user physician. However, when reviewed, 72 percent of the licensee-submitted QMPs did not contain such procedures. The unexpected number of licensees that did not submit (nor apparently have) procedures to assure that byproduct material is administered as directed by an authorized user is an indication of the need for a Quality Management Rule.

The recordkeeping and reporting requirements of the quality management rule serve a number of valuable functions.

First, they provide assurance both to the licensees and to the NRC that sound safety practices are being followed, and that licensees are taking appropriate followup actions if and when mishaps occur. Second, they provide a basis for enforcement action by the NRC to correct safety deficiencies and take appropriate action against licensees and/or individuals if public health and safety is being endangered. Third, they furnish data that can be used to adjust NRC regulatory standards generically to ensure that they are sufficient to protect health and safety, but at the same time not more burdensome than necessary. Fourth, they can reveal generic problems of which the medical community can then be made aware by NRC.

For the calculations required in this justification, the staff estimates that 30 therapeutic misadministrations per year will be reported by NRC

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f f

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licensees over the next 3 years. The staff ba,;es this on the number of i

such misadministrations reported by NRC licensees for years 1993, 1994, j

and 1995. Assuming that Agreement State licensees and NRC licensees i

have similar medical use programs, and the Agreement States license 2.5 times as many licensees, the staff estimates that 105 (30+75) misadministrations per year will be reported nationwide.

Information on the recordkeeping and reporting requirements is described by specific j

section below.

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l Section 35.32(M requires that medical use licensees, who use byproduct i

material for limited diagnostic and therapy procedures, establish, i

implement, and maintain a QMP to provide high confidence that byproduct 1

material will be administered as directed by an authorized user j

physician. The QMP must include written policies and procedures which require that prior to certain administrations, a written directive is prepared, that the individual's identity is verified by more than one i

method, that final treatment plans, doses, and administrations are in i

accordance with the written directive, and that any unintended deviation from the directive is identified, evaluated, and acted upon. At this j

time, all affected NRC licensees have submitted a QMP which has j

undergone an initial NRC review, or have provided a negative declaration

~

that they will not utilize byproduct materials affected by the QMP requirements prior to the submission of a QMP. New licensees, subject to the requirements, must submit a written QMP with their application.

Additionally, 2000 Agreement State licensees are expected to submit a QMP to the appropriate Agreement State within the next 3 years.

Licensee implementation and maintenance of their QMP is reviewed during an NRC or Agreement State inspection.

Section 35.32(b)(1) requires licensees to develop procedures for and i

conduct a review of the QMP including, since the last review, an evaluation of a representative sample of administrations, all recordable events, and all misadministrations.

Reviews must be conducted at intervals no greater than 12 months. This is necessary to evaluate the effectiveness of the QMP and identify issues that may lead to i

modifications of the QMP.

2 Section 35.32(b)(2) requires licensees to evaluate QMP reviews and make modifications, if required, to ensure their effectiveness.

l Section 35.32(b)(3) requires licensees to retain records of each annual review of the QMP, including the evaluations and findings of the review,

)

in an auditable form for 3 years. The existence of these reviews is confirmed during NRC inspection.

Jection 35.32(c)(3) requires licensees to evaluate and respond to each

]

" recordable event" by retaining a record of the relevant facts and corrective action, in an auditable form for 3 years. This enables the i

licensee to identify error trends.

It enables the inspector to evaluate t

the licensee's response to such errors.

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5 Section 35.32fd) requires licensees to retain each written directive and a record of each administration for 3 years after the date of the administration, to ensure that each administration was in accordance with the written directive. A sample of the licensee's written directives is reviewed during an NRC inspection.

Section 35.32fe) requires the licensee to submit any voluntary modifications to the QMP to NRC within 30 days after the modification is made, to ensure that the modification does not decrease the effectiveness of the program.

Section 35.32(f)(1) requires each applicant for a new license to submit a QMP to NRC as part of a license application to ensure that the new licensee will implement a QMP that will provide high confidence that byproduct material will be administered as directed by the authorized user physician.

Section 35.32(f)(2) required licensees in existence on January 27, 1992, to submit certification that a QMP had been implemented as well as a copy of the QMP to assure NRC that a QMP had been implemented. This requirement has been satisfied.

Jection 35.33(a)(1) requires licensees to notify NRC by telephone no later than the next calendar day after discovery of a misadministration.

This will enable NRC to promptly take any necessary actions based on the circumstances.

Section 35.33(a)(2) requires licensees to submit a written report to NRC within 15 days of the discovery of a misadministration to provide NRC a synopsis of the event, its cause(s), and corrective actions taken, and to assure that all notifications were made.

Section 35.33(a)(3J requires licensees to notify the referring physician and the individual subject to the misadministration no later than 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after discovery, or as soon as possible, if the patient or the referring physician can not be reached within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months .

Patients and their referring physician (s) need this information to make timely decisions regarding possible health care needs.

Section 35.33(aif4) requires the licensee to furnish a written report of the misadministration to the patient, if the patient has been notified orally of the misadministration, within 15 days of the discovery of the misadministration. To satisfy this requirement, the licensee may provide the patient with either a copy of the report that was submitted to NRC, or a description of both the event and any consequences that may affect him/her. The description of the event must include a statement that the report submitted to NRC can be obtained from the licensee.

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section 35.33(b) requires the licensee to retain a record of the misadministration for ? years to ensure that the record is available for i

the next NkC inspection so that NRC can ascertain whether misadministrations have been investigated by the licensee and that corrective action has been taken.

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2.

Agency Use of Information Quality Manacement Procram (OMP) Recuirements: The reporting and record keeping requirements related to the QMP allow license reviewers to determine if licensees have developed a systematic approach to providing high confidence that byproduct material or the radiation therefrom will i

be administered as requested by authorized users. In addition, it enables inspectors to determine compliance with the requirement to implement the QMP.

Notifications. Reports. and Records of Misadministrations: The notification, reporting and recordkeeping requirements ensure that the

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NRC is notified of significant events and that the patient and referring physician are notified of the event.

In addition, it allows the NRC to j

determine whether to take any immediate actions, such as to conduct a special inspection of a licensee's facility or to alert other medical i

use licensees, to prevent similar events which may have generic implications. The recordkeeping requirements allow NRC inspectors to review misdainistrations and other events that have occurred, including 4

any correct.ve action taken by the licensee.

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3.

Reduction of Burden Throuah Information Technolony The NRC has not received any electronic submittals of QMPs. However, i

licensees have submitted parts of misadministration reports i

electronically. There is no legal obstacle to the use of information technology, and the NRC is developing processes that will soon assist l

licensees in doing so.

l 4.

Effort to Identify Duplication and Use Similar Information There is no source for the information other than from the medical use i

licensees. The Information Requirements Control Automated System has been searched. There is no duplication with other collections of l

information.

5.

Effort to. Reduce Small Business Burden In 1990, prior to the rulemaking, the NRC conducted a pilot program (OMB Clearance No. 3150-0145) to determine the impact and efficacy of the proposed " Basic Quality Assurance Program, Records and Reports of Misadministrations or Events Relating to the Medical Use of Byproduct 9

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Material." Several participants of the pilot program were licensees in i

private practices. Following the 60-day test, they indicated that, with certain modifications, they could incorporate the proposed rule into j

their procedures of medical practice and that the impact would be minimal. The NRC will re-address this issue in the planned revision of 10 CFR Part 35.

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6.

Consecuences to Federal Procram or Policy Activities if the Collection Is Not Conducted or is Conducted Less Frecuentiv If the collcction is not conducted, there would be no assurance that j

circumstances resulting in misadministrations, that endanger the health and safety of the general public, would be corrected. Under the current requirements, less frequent reporting is not possible for the following reasons:

i 10 CFR 35.32: The requirement to develop and submit a QMP is a one-time j

effort which has been completed by all affected NRC licensees and approximately one-half of Agreement States licensees. Additionally, once a QMP that meets the rule is submitted, the frequency that licensees' QMPs are modified is determined by the licensee's need to modify the QMP to correct deficiencies in their own QMP program.

i Therefore, the stated frequencies are at the minimum level.

i 10 CFR 35.33: Licensees are required to report misadministrations, by telephone, within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after discovery, followed by a written t'eport within 15 days after discovery. The requirement for one telephone call followed by a written report is the minimum frequency to inform the NRC about a misadministration so that any follow-up action can be taken.

i 7.

Circumstances Which Justify Variation from 0f5 Guidelines Contrary to the OM8 Guidelines in 5 CFR 1320.6(b), Section 35.33 requires licensees to report misadministrations, by telephone, within 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after discovery, followed by a written report within 15 days after discovery. Since a misadministration may have health and safety implications for patients or research subjects, the NRC believes that 24-hour notification is important to assure that appropriate follow-up action is immediately taken. The submittal of a report within 15 days assures that the licensee has adequately investigated the event, identified appropriate corrective actions to prevent recurrence, and met applicable notification, recordkeeping, and reporting requirements.

8.

Consultations Outside IRC The QM rule has been reviewed as part of the NRC-sponsored independent review of the NRC's medical use program by the National Academy of Sciences. Additionally, a Congressional appropriations committee

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8 recommended that NRC reconsider the ICR associated with this regulation.

The NRC believes this concern will be satisfied through the ongoing review of the NRC medical use program which may include a revision of 10 CFR Part 35, including 10 CFR 35.32 and 33. This effort is expected to begin in Igg 7.

Consultations and meetings with the medical community are planned as part of that rulemaking.

9.

Payment or Gift to Respondents Not applicable.

10.

Confidentiality of Information None, except for proprietary information.

11.

Justification for Sensitive Questions There are no sensitive questions.

12.

Estimated Burden and Burden Hour Cost There are two primary considerations in the calculation of this burden:

First, the current number of medical use licensees in the United States is approximately 2000 for the NRC and 5000 for the Agreement States. Of those licensees that require submission of a QMP (approximately 90 percent or 6300 licensees), all of the applicable NRC licensees (1800) and an estimated 2500 of the Agreement State licensees have submitted a QMP to the appropriate regulatory agency. Therefore, it is estimated that 2000 Agreement State licensees will submit a QMP within the next 3 years, i

second, based on findings from a pilot program and discussions with medical licensees in multiple public meetings during promulgation of the rule, it was assumed that go percent of licensees, who must implement a QMP, kill have policies and procedures (e.g., prepared to meet professional audit programs or Joint Commission on Accreditation of Healthcare Organization requirements) that could be adjusted, prepared, 4

and submitted to the NRC to comply with the requirements. However, based on the NRC's experience in reviewing the 1800 QMPs submitted by NRC licensees, 72 percent of the submittals did not meet the requirements, and modifications were required. The NRC has included this unexpected'and additional burden in this estimate for the development of the 2000 QMPs to be submitted by the Agreement State licensees to the appropriate Agreement State.

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9 These public burden estimates are based on NRC data, collected during j

the past 4 years and on staff projections of new applications and amendment requests expected to be received during the next 3 years.

1 The estimates assume that the Agreement States w'11 implement the rule i

exactly as has the NRC. Differences in Agreement State adoption or implementation would result in either greater or lesser burden. The average burden is calculated at the NRC labor cost rate of $120 per hour, which includes overhead. A burden breakout is included in Tables i

1 through 3.

The followine will be the estimated ICR burden and burden hour cost for l

the implemented rule:

BURDEN FOR 95tC LICENSEES:

l Each year, the NRC receives approximately 63 new license applications, and approximately 100 applications to amend existing licenses to add a modality, that require the establishment and submittal of a QMP.

Since the modification of an existing QMP to add a modality may range from a i

minor change to a major effort, the average burden is estimated to be 10 hours1.157407e-4 days 0.00278 hours 1.653439e-5 weeks 3.805e-6 months . Therefore:

1 63 licensees X 40 hrs (new licensees-develop QMP) =

2,520 hrs /yr 100 licensees X 10 hrs (add modality-modify QMP) 1,000 hrs /yr

=

i 63 licensees X 4 hrs (develop review procedures) =

252 hrs /yr 163 licensees X 72% (require modification) =

l 117 X 3 hrs (modify) =

351 hrs /yr l

Burden and cost for new applicants and new modalities i

added in NRC States =

4.123 hrs /yr X $120 = 1494.760

{

An estimated 15 percent of the 1800 licensees who have previously submitted QMPs, will modify their existing QMP each year to increase the program's efficiency. This does not include the burden for modification of new applications and applications to add a modality to an existing license that does not meet the requirements.

1800 submitted QMPs X 15% = 270 modifications per yr 270 modifications X 3 hrs per licensee - 810 hrs /yr i

Burden for IEtc licensees to modify QRPs = 810 hrs /yr X $120 = 197.200

)

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l l-10 Burden Associated with Notifications. Reports. and Records of Misadministration:

NRC licensees reported an average of 30 misadministrations per year for years 1993 through 1995. The definitions for misadministrations focus on therapy events in which NRC frequently requests the. services of a medical consultant to review the event, and conducts reactive inspections.

In calculating the burden for 10 CFR 35.33, the time commitment for licensees to interact with these consultants and NRC inspectors has been considered. Therefore, this burden has been estimated to average 16 hours1.851852e-4 days 0.00444 hours 2.645503e-5 weeks 6.088e-6 months per licensee, per event. Additionally, 1

NRC estimates 15 minutes for notification of event discovery, 30 minutes for notification of referring physician and individual who received the l

misadministration, and 15 minutes for furnishing the report.

30 misadministrations reported /yr X 17 hrs / event = 510 hrs /yr Licensees must retain a record of a misadministration for 5 yrs:

30 misadministrations X 10 minutes (to file record) =

5 hrs /yr Based upon inspections of implemented QMPs to date,15 percent of NRC licensees were found to have records of " recordable events" (i 35.32(c)(3)) during inspection. Therefore, 1800 X 15% = 270 " recordable events"/yr X 30 minutes (to record) =

135 hrs /yr Each of the 1800 NRC licensees must retain the records of the annual QMP review for 3 years:

1800 X 1 hr/yr =

1,800 hrs /yr l

Burden associated with notifications, reports, and records of misadministration =

2.450 hrs /yr X $120 = 1294.000 TOTAL BUltDEM FOR IEtt LICENSEES = 7383 hrslyr X 1120 =

1885.960/yr BURDEN FOR AGREEMENf STATE LICENSEES:

In order to estimate the burden to the Agreement State licensees, the following assumptions were made:

1.

Ninety percent of the 2000 Agreement State licensees will have existing policies and procedures that could be adjusted, prepared, and submitted to the Agreement State to comply with the requirements of the rule. An average burden of 5 hours5.787037e-5 days 0.00139 hours 8.267196e-6 weeks 1.9025e-6 months is estimated for preparation and submittal of a modified QMP.

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2.

Ten percent of the 2000 licensees will have to develop and submit a QMP. This will be a one-time burden of approximately 40 hours4.62963e-4 days 0.0111 hours 6.613757e-5 weeks 1.522e-5 months for l

each of the 200 licensees.

l 3.

Based on the NRC's experience, 72 percent of the 2000 QMPs initially i

submitted to the Agreement States will require modifications to meet the requirements of the rule. This will result in a burden of l

3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months each to modify the QMP for approximately 1440 licensees.

4 One time %urden to Aereement State Licensees for Initial Development.

Submittal istates who will adont the rule within next 3 years):

Development of QMP by 10% of 2000 licensees = 200 licensees X 40 hrs 8000 hrs annualized over 3 yrs = 2667 hrs /yr Preparation and submittal of existing procedures:

90% X 2000 licensees = 1800, annualized over 3 yrs =

l 600 submittals X 5 hrs each for preparation and submittal - 3,000 hrs /yr l

Based on the NRC's experience, 72 percent of the QMP 1

submittals will require modification:

i 2000 licensees X 72% (require modification)= 1440 annualized over 3 yrs = 480 QMPs/yr that require modification.

]

480 submittals/yr X 3 hrs / submittal to make modification = 1,440 hrs /yr Each of the 2000 licensees must also develop procedures for an annual j

review of the QMP (4 hrs).

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2000 licensees annualized over 3 yrs = 667 licensees /yr 667 licensees /yr X 4 hrs to develop procedures l

for QMP review =

2,668 hrs /yr Agreement State licensees

burden =

9.775 hrshr X 1120 -

11.173.000 l

Burden to New Apo11 cants - Aareement State:

Each year, the NRC receives approximately 63 new license applications, and approximately 100 applications to amend existing licenses to add a j

modality, that require the establishment and submittal of a QMP.

Because the Agreement States have 2.5 times the number of licensees as the NRC, it is estimated that an average of 158 applications for new licenses and 250 applications to add new modalities to existing licenses will be received each year. Since the modification of an existing QMP to add a modality may range from a minor change to a major effort, the a

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12 average burden is estimated to be 10 hours1.157407e-4 days 0.00278 hours 1.653439e-5 weeks 3.805e-6 months . Therefore:

158 licensees X 40 hrs (now licensees-develop QMP) =

6,320 hrs /yr 1

250 licensees X 10 hrs (add modality - modify QMP) =

2,500 hrs /yr 158 licensees X 4 hrs i

(new licenseos-develop review procedures) =

632 hrs /yr i

408 licensees X 72% require modification =

j 294 licensees X 3 hrs (modify) =

882 hrs /yr i

Burden for new applicants and modalities added in Agreement States = 10.334 hrs /yr X $120 = $1.240.080 l

Burden for makina modifications to previously submitted OMP:

An estimated 15 percent of the 2500 licensees who have previously submitted QMPs, will modify their existing QMP each year to increase the i

program's efficiency. This does not include the burden for modification 1

of new applications and applications to add a modality to an existing

{

license that do not meet the requirements.

2500 submitted QMPs X 15% (mod./yr)= 375 modifications /yr i

375 mod./yr X 3 hrs (to make modification) 1,125 hrs /yr

=

Burden for Agreement State licensees to modify QMPs = 1,125 hrs /yr l

Burden Associated with Notifications. Reports. and Records of

)

Misadministration:

The Agreement States have approximately 2.5 times the number of licensees as the NRC. Additionally, the NRC has no information to demonstrate that the frequency of incidents at Agreement State licensees is different than that of the NRC licensees. Therefore, for purposes of estimating the burden, based on an average of 30 misadministrations per year for NRC licensees, the NRC estimates 75 misadministrations per year for Agreement Stata licensees.

The estimated burden to report a misadministration is 16 hours1.851852e-4 days 0.00444 hours 2.645503e-5 weeks 6.088e-6 months per event. Additionally, NRC estimates 15 minutes for notification of event discovery, 30 minutes for notification of referring physician and individual who received the misadministration, and 15 minutes for furnishing the report.

1,275 hrs /yr 75 misadministrations reported /yr X 17 hrs / event

=

75 misadministrations X 10 minutes (to file reccrd) = 13 hrs /yr

i l

l f

13 4

l To date, based on inspection of NRC licensees, 15 percent of Agreement 4

State licensees, per year, will have records of recordable events

{

($ 35.32(c)(3)) during inspection:

I 4500 X 15% = 675

)

675 records /yr X 30 minutes to make the record =

338 hrs /yr Each of the 4500 Agreement State licensees must evaluate and retain 1

records of an annual QMP review for 3 years:

4500 X 1 hr/yr 4,500 hrs /yr Burden associated with notifications, reports, and records of misadministration - 6,126 hrs /yr X $120 = $735.120 TOTAL BURDEN FOR Aisittatmi STATE LICENSEES =

27.360 hrs /yr X 1120 =

13.283.200 Additional details on the reporting and recordkeeping burden are found in Tables 1 through 3 (attached)

The total compliance burden estimate, for IstC and Agreement State licensees is sisunarized below-i Number of Total Annual Cost.

Licensees Burden (hrs):

($120/hr) who will respond:

Reporting:

6300 24,400 hrs /yr

$2,928,000 Recordkeeping:

10,343 hrs /yr 1,241,160 Total Burden:

34.743 hrs /yr 14.169.160 13.

Estimate of Other Additional Costs Not applicable.

14.

Estimate of Annualized Cost to the Federal Government cuality Management Program (OMP)

All initial QMPs for NRC licensees have been submitted and reviewed.

Therefore, the continuing cost will be for the review of QMPs submitted as part of new license applications, when additional therapy modalities (e.g., brachytherapy, teletherapy) are added to an existing NRC license,

j i

14 and within 30 days of modifying existing QMPs. The QMPs are reviewed as part of the license application for new and amended licenses, and modifications are reviewed at the time of inspection. The NRC receives approximately 63 new applications per year and approximately 100 requests to amend existing licenses to add a modality. Additionally, based on the number of QMP modifications submitted to the NRC in the past year, it is estimated that 15 percent of licensees will modify their QMPs each year.

Assuming 3 hours3.472222e-5 days 8.333333e-4 hours 4.960317e-6 weeks 1.1415e-6 months would be needed for the QMP review for 63 new licenses and 100 amendments to add therapy modalities per year:

3 hrs X 163 licensing actions /yr = 489 hrs /yr X $120 =

1 58.680/yr Assuming 2 hours2.314815e-5 days 5.555556e-4 hours 3.306878e-6 weeks 7.61e-7 months would be needed to review a modification made to a previously reviewed QMP and 270 (estimated 15 percent) modifications are submitted by NRC licensees per year:

2 hrs X 270 modifications /yr = 540 hrs /yr X $120

$ 64.800/yr

=

The ongoing cost to the IstC for review of QMPs =

1029 hrs /yr X $120

$123.480/yr

=

Motifications. Reports. and Records of Misadministrations Based on statistical data, the staff estimates that 30 misadministrations per year will occur in NRC States over the next 3 years. Assuming that an average of 80 hours9.259259e-4 days 0.0222 hours 1.322751e-4 weeks 3.044e-5 months of NRC staff effort will be required to respond to each event, the cost to the NRC will be

$288,000 per year.

80 hrs / misadministration X 30 misadministrations/yr = 2400 hrs /yr.

2400 hrs /yr X $120/hr 1288.000/yr

=

The estimate includes time for the NRC Operations Center to respond to the original call, for the NRC staff to follow up with the action appropriate to the event (e.g., if needed, conduct an inspection, secure medical consultant services, etc.), and review the written report (submitted 15 days after the event was reported).

Total annualized cost to the NRC for all activities is estimated to be:

1029 hrs + 2400 hrs = 3429 hrs X $120 = 1411.480/Yr These costs are fully recovered through fee assessments to NRC licensees, pursuant to 10 CFR Parts 170 and 171.

l a

j 15 1

l 15.

Reasons for Change in Burden or Cost I

The following are the reasons for the most significant changes in the j

burden estimate:

1.

The increase in the cost from $116/hr in the previous submission to i

$120/hr for the 1997 submission.

i 2.

This estimate includes the one-time burden of the submission and review of the QMPs submitted by the approximately 2000 Agreement State licensees in the 10 States that have not yet adopted the rule.

In the initial submission, it was assumed that the Agreement States would implement the QM rule by January 1995. However, at the time of the 1996 submittal,13 of the 29 Agreement States had not as yet adopted the rule. Since the earlier submission, an additional three States, representing approximately 1000 licensees, have adopted the i

QM rule.

l 3.

The estimated burden on the Agreement States' regulatory agencies, previously included in this ICR, is now included in OMB Clearance i

3150-0183 " Office of State Programs Requests to Agreement States for Information."

4.

At the time of the 1996 submittal, the best data the NRC possessed estimated the number of licensee reported events that met the misadministration criteria as 25 misadministrations per year. Since that time, an improvement in data collection and analysis has increased that number to an average of 30 misadministrations per year. The Agreement States have approximately 2.5 times as many licensees. Therefore, we estimate approximately 105 misadministrations per year nationwide.

16.

Publication for Statistical Use The NRC tabulates and publishes an annual summary of misadministrations and other events.

17.

Reason for Not Display 1na the Expiration Date The requirement will be contained in a tegulation. Amending the Code of Federal Regulations to display information that, in an annual publication, could become obsolete would be unduly burdensome and too difficult to keep current.

16 18.

Exceptions to the Certification Statement There are no exceptions.

B.

Collection of Information Employina Statistical Methods Statistical methods are not used in this collection of information.

i t

1

4 1

Table 1 (Annualized)

Reportino Reauirements (4 35.32): (Assuming 6300 licensees) j l

Hours Total Per Burden Cost at Section Item Event hrs /yr

$120/hr

?

35.32(a)

Licensees.

Aareement State (one time):

Develop and maintain a written QMP (includes submittal),

Approximately 67 licensees 40 hrs

2,667

$320,040 r

(200 licensees /3 yrs)

Submission of QMP (Submit existing procedures, 600 (90%) licensees (1800 licensees /3 years) 5 hrs

3,000

$360,000 NRC & Aareement State:

221 new application QMPs 40 hrs 8,840

$1,060,800 350 amending license to 10 hrs 3,500

$420,000 add modality (submit QMP)

I e

Table 1 2

35.32(e)

Submit modification of QMP within 30 days after modification is made:

(72% initial failure rate for first time submittals)

Aareement State Licensees fone time):

72% of initial submittals -

3 hrs

1,440

$172,800 480 QMPs NRC Licensees:

Modify 72% of new and added modality applications -117 3 hrs 351

$42,120 15% existing QMPS-270 3 hrs 810

$97,200 Aareement State Licensees:

Modify 72% of new and added modality applications = 294 3 hrs 882

$105,840 15% of existing QMPs - 375 3 hrs 1125

$135,000 35.32(f)(1)

Submit a QMP to appropriate Included in agency 6 35.32(a) 35.32(f)(2)

Submit written certification Requirement complete

One time burden for Agreement States that have yet to adopt the rule:

7,107 hrs /yr Reporting Burden (f 35.32) per yr:

22.615 hrs /yr X $ 120 = $2.713.800

Table 2 (Annualized)

Reoortine Reauirements fl 35.33):

(Assuming 105 misadministrations per yr)

Hours Total Per Burden Cost Section Item Event hrs /yr at $120/hr

-_-.__==---------------------------_

==______

35.33(a)(1)

Notify NRC or Agreement State 15 min 26 hrs

$3,150 by phone no later than the next calendar day after discovery of misadministration.

35.33(a)(2)

Licensee written report to 16 hrs 1,680 hrs

$201,600 regulatory agency within 15 days after discovery of misadministration.

35.33(a)(3)

Licensee notification to 30 min 53 hrs

$6,300 referring physician and individual who received the misadministration no later than 24 hours2.777778e-4 days 0.00667 hours 3.968254e-5 weeks 9.132e-6 months after discovery.

35.33(a)(4)

Licensee written report to 15 min 26 hrs

$3,150 patient within 15 days of May be same misadministration.

report as 35.33(a)(2) above Reporting Burden (f 35.33) per yr:

1785 hrs /yr X $120 = $LlijL00

Table 3.(Annualized)

Recordkeepina burden (E 35.32):

(Assuming 6300 licensees)

Hours Total Per Burden Cost at Section Item Event hrs /yr

$120/hr 35.32(b)(1)

Licensees:

Develop procedures for review:

Aareement State (one-time):

667 initial development 4 hrs

2,668

$320,160 NRC and Aareement State:

221 New licensees /yr 4 hrs 884

$106,080 35.32(b)(2)

Licensees (6300 total):

Evaluate QMP reviews and make modifications, if needed:

50 min.

5,250

$630,000 35.32(b)(3)

Retain records of each 10 min.

1,050

$126,000 audit and management evaluation of the QMP for 3 years.

35.32(c)(3)

Retain record of relevant facts and corrective action relative to recordable event, for 3 years. (945 30 min.

473

$56,760 records /yr) 35.32(d)

Retain each written directive Historically, and a record of each part of patient's administration for 3 years.

medical record.

Recordkeeping burden (f 35.32) per yr:

10.325 hrs /vr X $120 = 11.239.000

0ne-time burden for licenses of Agreement States that have yet to adopt the rule:

2,668 hrs /yr

Table 4 (Annualizedl

'l Recordkeeoina burden (6 35.33):

(Assuming 105 misadministrations per yr)

Assumed Hours Total No. of Per Burden Cost at Section Item Events /yr Event hrs /yr

$120/hr

= = - - - -

==

_ = = _ _ _ _ _ _ _ _ - - - - - - - -

35.33(b)

Licensee shall retain 105 10 min 18 hours2.083333e-4 days 0.005 hours 2.97619e-5 weeks 6.849e-6 months

$2160 a record of the misadministration for 5 years.

Recordkeeping burden (f 35.33) per yr:

18 hrs /_vr X $120 -12]f_0 i

l

- -

ML20128H637

Text

SUMMARY

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