ML20237A205

Request for OMB Review & Supporting Statement Re 10CFR35, Quality Mgt Program & Misadministrations

ML20237A205
Person / Time
Issue date:	08/05/1998
From:	Shelton B NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:
Shared Package
ML20237A200	List: ML20237A197 ML20237A205
References
OMB-3150-0171, OMB-3150-171, NUDOCS 9808130174
Download: ML20237A205 (33)

Text

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M PAPERWORK REDUCTION ACT SUBMISSION

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e' Please read the instructions before completin your agency's Paperwork Clearance Officer.g Sendthistwo form.

copiesFor of thisadditional form. theforms or assistance collection instrument to in be completing

. reviewed,this theform, contact

- Supporting Statement, and any additional documentation to: Office of information und Regulatory Affairs Office of Management and Budget, Docket Library, Room 10102,72517th Street NW, Washington, DC 20503.

1. Agency / Subagency onginating request 2. OMB contml number U.S. Nuclear Regulatory Commission g ac 3150-0171 b.None

3. Type of information collection fcheck one) 4. Type of review requested (check one)

a. New collection g a. Regular c. Delegated g b. Revision of a currently approved collection - b. Emergency Approval requested by (date): i

c. Extension of a currently approved collection 5. Will this information collection have a a Yes -

_ significant economic impact on a j

d. Reinstatement, without change. of a previously approved substantial number of small entities? ""g""b.No collection for which approval has expired Rei " y

coi c o or hc "a ro"va h s e e" g Requested '"*"

a. Three years from approval date expiration date

f. Existing collection in use without an OMB control number OtWW@

7. Title 10 CFR 35, Quality Management Rule

8. Agency form numberts) (if appiscable)

Not applicable

9. Keywords Byproduct Material, Reporting and Recordkeeping Requirements

10. Abstract The Quality Management Rule requires licensees to provide reports and keep records relating to medical pyproduct misadministration and requires the physician to provide written directives to patients treated with byproduct material, j j

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11. Affected public IMas pnmary eth v and an orners that apptr etn wp 12. Obligation to respond cuais onma y am y and an otners that apply orth =x')  !

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

13. Annual reporting anc recordkeeping hour burden 14. Annual reporting and recordkeeping cost burden f.n tnousands of donars;

a. Number of respondents 6,300 a. Total annualized capital /startup costs 0

b. Total annual responses 3,194 b. Total annual costs (O&M) 0

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

- c. Total annual hours requested 34,743 e. Difference O

d. Current OMB inventory 34,743

f. Explanation of difference

e. Difference O

1. Programchange

i. f. Explanation of difference

2. Adjustment i 1. Program change

2. Adjustment

15. Purpose of informaison collection 16. Frequency of recordkeeptng or reporting (check att that appiy)  !

[ (Mark 's mary with "P" and all others that appIy with *X") a. Recordkeeping

c. Rcporting

] b. Third-party disclosure l' a. Application for benefits e. Program planning or management

""""] h0n 2. Weekly 3. Monthly 1

b. Program evaluation f. Research , on _ _

c. General purpose statistics T g. Regulatory or compliance 4. Quarterly 5. Semi-annually 6. Annually  %

d. Audit 7. Bicr:nially 8. Other (describe)  %

17, $tatistical methods 18. Agency contact (person who can best answer questions regarding tru Content of this submisston) fj: 0 Dr *his information collection employ statistical methods?

eO3, j '

Name: Salty Merchant

]Yes  % No Phone: 301-415-7874 s- slo J.

Ous as-a a ronn .= aasn.o unma inranns 9 10/95 'M GISDR N O @l@l%S "

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19, Certification for Papsrwork Reduction Act Submiccions ,

On behalf of this Federal agency, I certify that the collection ofinformation encompassed by this request complies with 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8 (b)(3), appear at the erd of the F it..structions. The certification is to be made with reference to those regulatoryprosisions as setforth in the instructions.

The following is a summary of the topics, regarding the proposed collection ofinformation, that the certification covers:

(a) It is necessary for the proper performance of agency functions; (b) h avoids unnecessary duplication; (c) It reduces burden on small entities; (d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents; (e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices; (t) It indicates the retention periods for recordkeeping requirements; (g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3):

(i) Why the information is being collecud; (ii) Use ofinfomation; (iii) Burden estimate; (iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature of extent of confidentiality; and (vi) Need to display currently valid OMB control number; (h) It was deveioped by an office that has planned and al!ocated resources for the efficient and effective manage-(i) liiONEffE80ve$nhe"$$c'$"eShSt"at'0tkaiSNNhnkciso"d$fofy!,t an *d19 fIheinstructions);

(j) It makes appropriate use ofinfonnation technology, if you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in item 18 of the Supporting Statement.

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Sgrtature of Authortted Agar.cy OffMal Date s

Dato

{q atur of Senior C@ tv Ma o.herton lr r<c' tb _ig cer, ofnce of the enief information officer / g N-0 8 8 83-1 10/95

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~. k SUPPORTING STATEMENT FOR j 10 CFR 35.32 and 35.33

" QUALITY MANAGEMENT PROGRAM AND MISADMINISTRATION" (3150 0171)

REVISED CLEARANCE EXTENSION INIBODUCTLQN AND OVERVIEW j NRC regulations in 10 CFR Part 35 establish requirements for the medical use of byproduct material. The regulations are issued pursuant to the Atomic, 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: l (1) a requirement that licensees establish and maintain a quality management j program (QMP)(S 35.32) and (2) requirements for notifications, records and reports of misadministration (S 35.33).

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On December 24, 1991, the NRC submitted sn infonaation collection requirements (

(ICR) approval request to the Office of Management and Budget (OMB) for the  !

Quality Management (QM) and Misadminiscrations rule which would be efrective  !

in January 1992. In communications with OMB, the American College of Nuclear  !

Physicians and Society of Nuclear Medicine (ACNP/SNM) expressed strong j opposition to the rule. In June 1992, OMB disapproved the record collection l

requirements of tne rule. The NRC Commissioners, finding that public health and safety warronted institution of the ICR, overrode the OMB determination. l l

l In addition, the ACNP/SNM took the NRC to court, in estica1LCollege_of I Ruclear Phys 1cians and Society of Nuclear Medicine v. U.S. NuclRar Reculator.y  ;

ComiS110D. 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: 1 On the record before us, we find no basis to overturn the QM rule; 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. S 2201(b) (West Supp.1992) (emphasis l added). Moreovar, 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.L. S 706(A) (1988).

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2 In 1993, tne 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 end appropriateness of the current framework for the medical use of byproduct material. The quality management program (QMP) I (S 35.32) and requirements for notifications, records, ard reports of ,

misadministration (S 35.33) were included in that study. j In a letter to OMB, dated November 28, 1995, the ACNP/SNM again requested that OMB disapprove the ICR associated with 10 CFR 35.32 and 35.33 as they relate to diagnostic and therapeutic applications of byproduct material.

l In December 1995, the IOM submitted its report to the NRC. The majority of i the report (there was a dissenting opinioc, as well) was highly critical of NRC ,

regulation in the medical area, and of the QM rule in particular. The IOM fir.2 ngs were considered within the agency wide Strategic Assessment and Re-baselining initiative.

1 In February 1996, the OMB 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 OMB submittal within four months 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.

In March 1997, the OMB approved an eighteen month extension of the information collection provisions of NRC's QM rule rather than the three-year approval that is customary. This OMB approval included only NRC licensees and the 19 Agreement States that had adopted the requirements at that time.

Additionally, it required NRC to provide a written progress report on the status of NRC's reforms of the information collection at the time of the next renewal.

Since the March 1997 approval, the Commission has taken no action to enforce a compatibility requirement on the 10 Agreement States that have not adopted the QM rule. In addition, the State of Massachusetts became an Agreement State, and the State of Ohio is expected to become one by December 1998, bringing the nuaber of Agreement States to 31. However, the number of States that have not adopted the requirements remains at 10 because both the Massachusetts and the and Ohio programs have adopted the QM rule and the licensees had implemented the requirements before becoming Agreement State licensees. Therefore for this request, the number of Agreement States that have adopted, or will adopt.

the rule is now 21.

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Status _Repgrt On NRCs Medical Use Procram Reform i 10 CFR Part 35, Medical Use of Byproduct Materia', including 10 CFR 35.32 and )

35.33, is being revised to incorporate specific improvements in NRC's regulations governing the medical use of byproduct material.

Dur ing the last four years, NRC has examined the issues surrounding its medical use program in detail. The process started with NRC's 1993 internal j senior management review: continued with the 1996 independent external review j by the National Academy of Sciences, Institute of Medicine: and culminated in NRC's Strategic Assessment and Re baselining Project (SA). In particular,  ;

medical oversight was addressed in the SA Direction Setting Issue Paper Number l 7 (OSI 7), Materials / Medical Oversight.

In a Staff Requirements Memorandum COMSECY 96 057, the Commission directed )

the staff to submit a plan for revising 10 CFR Part 35, associated guidance documents, and, as necess6ry, the Commission's 1979 Medical Policy Statement.

With regard to the Quality Management provisions in 10 CFR 35.32, the l Commission specifically directed the staff to re-evaluate and revise the rule to focus ca those requirements that are essential for patient safety, e.g., j confirming patient identity, requiring written prescriptions, and verifying dose. The staff was directed to pursue a mixed approach of performance based and prescriptive regulations, and to the maximum extent possible, to revise the requirements to be risk informed.

The overall schedule provided to the Commission called for the staff to provide a proposed rule, associated documents (e.g. the regulatory analysis, environmental impact statement, and finding of no significant environmental impact), and the Office of Management and Budget clearance package to the Commission in May 1998. This schedale was met. At the same time, staff provided the Comission with draft guidance documents and its recommendations on the need for any changes to the 1979 Medical Policy Statement. Following Commission approval, the proposed rule and draft documents will be published in mid August in the Eetr31 Reaister for public comment. The staff expects to provide a final rule, associated documents, and final guidance documents for

Commission approval in May 1999.

l The NRC is using the rulemaking process to revise Part 35 into a risk-I informed, more performance-based regulation in order to focus regulatory oversight on those activities that pose the highest risk. The review and development of the Part 35 revision is being conducted using a group approach.

The Working and Steering Groups include representatives of the NRC, Organization of Agreement States, and the Conference of Radiation Control l

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Program Directors. In addition to developing the rule text as part of the l Working Group, the members are also overseeing the development of the associated documents in order to ensure consistency in the rulemaking package. 4 The program for revising Part 35 and the associated guidance documents provides greater opportunity for input from potentially affected parties (the ,

medical community and the public) than is provided by the typical notice and comment rulemaking process. Early public input was solicited through several .

dif ferent mechanisms: requesting public input through Federal Reaister i notices: holding open meetings of the government groups developing the revised rule language: meeting with medical professional societies and boards; putting background documents, options for the more sigr.ificant regulatory issues i associated with the rulemaking, and alternatives for revising the 1979 Medical l Policy Statement on the Internet; and convening public workshops. l Participants from the broad spectrum of interests that may be affected by the I rulemaking were invited to a."nd the public workshops in Philadelphia, PA and I Chicago, IL held in October and November 1997. The public was also welcome l to attend these workshops, as well as the Part 35 Workshop that was held in I conjunction with the All Agreement States Meeting in October 1997 and the l ACMUI meetings in September 1997 and March 1998.

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1 The staff has developed rule language alternatives, with specific rule text, for the major regulatory issues. In addition, alternatives have been developed for revising the Medical Policy Statement. These alternatives were discussed at: the Advisory Committee on the Medical Use of Isotopes (ACMUI) i meetings in September 1997 and March 1998: the All Agreement States meeting in l October 1997: and public meetings held in October 1997 in Philadelphia, PA and )

in November 1997 in Chicago, IL. The alternatives were also available for l comment on the Internet and were discussed with numerous medical groups.

Documents that summarize the comments at all four public meetings are being I prepared. l In January 1998, the NRC staff put the draft proposed rule on the Internet for I public comment. This provided the public an opportunity to comment on a "strawman" draft proposed text while the staff and coritractor continued to develop the guidance documents and the other rulemaking documents associated with the rulemaking, and to finalize the proposed rule.

The Commission recently approved publication of the proposed rule and associated documents. They will be published in the Eeden1 Reaister for public comment for 90 days. The NRC staff plans to hold three public meetings j during the formal comment period to facilitate public comment.

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Development of the final rule, associated documents, and final guidance will  !

also be done using a steering and working group, which will hold open meetings. In addition, staff plans to continue making draft documents i available on the Internet and to discuss the draft final documents with the l ACHUI and the Agreement States before submitting them to the Commission.

In view of this aggressive time schedule, the fact that the final Part 35 rule is not scheduled to be submitted to the Commission until June 1999, and the proposed implementation period is up to two years for certain sections, the i Commission is seeking OMB approval of a three year clearance extension to  !

allow NRC sufficient time to complete the 10 CFR Part 35 rulemaking.

l DESCRIPTION OF THE INFORMATION COLLECIl0N In the medical use of byproduct material, there have been instances where byproduct material was not administered as intended or administered to a wrong l 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 (S 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 S 35.2, " Definitions " ard distinguished between the

" misadministration" and lesser " recordable events" for which reporting to NRC is not necessary. These revisions considerably reduced the number of incidents that nust be reported to the NRC or the Agreement States. When 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 20 of the 30 States who have agreements with the NRC that allow I

them to regulate the use of byproduct material as Agreement States. However, ten Agreement States have not completed their adoption of the rule.

Therefore, this ICR cost estimate is inflated by the one time cost for the U-______-___ -_

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I development and submission of OMP.s for approximately 2000 Agreement State licensees in the ten Agreement States who have not adopted the rule. The NRC )

has chosen to continue to include the burden for these licenses, since there l 1.s a possibility that some, or all, of these Agreement States may choose to l adopt the rule, or some aspects of the rule, during this approval period.

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j. A. JUSTIFICATION l 1. Need for and Practical Utility of the Collection of Information i

L 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 ranges, must submit a OMP to provide high confidence that L byproduct material will be administered as directed by an authorized l l user physician (S 35.32). The rulemaking and related regulatory guide were developed to include generally accepted good practices in the l medical uses of byproduct material for therapy, and include specific l measures intended to prevent many of the kinds of human errors observed i and reported to the NRC over a number of years.

l In comments provided during rulemaking, members of the Society of l Nuclear Medicine and NRC's Advisory Committee on the Medical Uses of l 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 OMPs did not contain :>uch 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 l need for a Quality Management Rule.

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( The recordkeeping and reporting requirements of the quality management L rule serve a number of valuable functions. First, they provide l

assurance both to the licensees and to the NRC that sound safety practices are being followed, and that licensees are taking appropriate follow up 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 I

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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 misadministration per year will be reported by NRC licensees over the next 3 years. The staff bases this on the number of such misadministration reported by NRC licensees for years 1993 through 1997. Assuming that Agreement State licensees and NRC licensees have similar medical use programs, and the Agreement States license 2.5 times as many licensees, the staff estimates that 105 (30+75) misadministration per year will be reported nationwide. Information on the recordkeeping and reporting requirements is described by specific section below.

Section 35.32(a) requires that medical use licensees, who use byproduct material for limited diagnostic and therapy procedures, establish, implement, and maintain a OMP to provide high confidence that byproduct material will be administered as directed by an authorized user physician. The OMP 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 ,

nethod, that final treatment plans, doses, and administrations are in l accordance with the written directive, and that any unintended deviation l from the directive is identified, evaluated, and acted upon. At this {

time 611 affected NRC licensees have submitted a OMP which has {

undergone an initial NRC review, or have provided a negative declaration j that they will not utilize byproduct materials affected by the OMP j requirements prior to the submission of a QMP. New licensees, subject to the requirements, must submit a written OMP with their application.

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 conduct a review of the OMP including, since the last review, an j evaluation of a representative sample of administrations, all recordable ;

events, and all misadministration. Reviews must be conducted at j intervals no greater than 12 months. This is necessary to evaluate the

< effectiveness of the OMP and identify issues that may lead to modifications of the OMP.

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

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l 8 1 Section 35.32(b)(31 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.

Ee.c. tion 35.32(c)(31 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  ;

licensee to identify error trends. It enables the inspector to evaluate the licensee's response to such errors.

Section 35.32(d) 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 35.32(el 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 OMP that will provide high confidence that byproduct material will be administered as directed by the authorized user physician.

Section 35.32(f)(21 required licensees in existence on January 27. 1992, to submit certification that a QMP had been implemented as well as a cnpy of the OMP to assure NRC that a OMP had been implemented. This  ;

requirement has been satisfied. j j

Section 35.33(a)(1) requires licensees to notify NRC by telephone no l later than the next calendar day after discovery of a misadministration. l This will enable NRC to promptly take any necessary actions based on the I circumstances. l l Section 35.33(a)(2) recuires 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 i to assure that all notifications were made. l l <

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.Section 35.33(a)(3) requires licensees to notify the referring physician and the individual subject to the misadministration no later than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovery, or as soon as possible, if the patient or the referring physician can not % reached within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />. Patients and their referring physician (s) need this'information to make timely decisions regarding possible health care needs.

Sgetion 35.33(a)(4) 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 pattent 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.

Section 35.33(b) requires the licensee to retain a record of the misadministration for 5 years to ensure that the record is available for the next NRC inspection so that NRC can-ascertain whether misadministration have been investigated by the licensee and that corrective action has been taken.

2. Agencv_Use of Information Quality Manaaement Proaram (OMP) Requirements: 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 be administered as requested by authorized users. In addition, it enables inspectors to determine compliance with the requirement to implement the QMP.

Notifications. Reoorts. and Records of Misadministration: The notification, reporting and recordkeeping requirements ensure that the

NRC is riotified of significant events and that the patient and referring physician are notified of the event. In addition, it allows the NRC to determine whether to take any immediate actions, such as to conduct a special inspection of a licensee's facility or to alert other medical use licensees, to prevent similar events which may have generic implications. The recordkeeping requirements allow NRC inspectors to  ;

review misadministration and other events that have occurred, including any corrective action taken by the licensee.

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3. Raduction of Burden Throuah Information Technology The NRC has not received any electronic submittals of QMPs. However, licensees have submitted parts of misadministration reports electronically. There is no legal obstacle to the use of information technology, and the NRC is developing processes that will soon assist licensees in doing so.

4. Effort to Identify Duplication and Use Similar Information There is no source for the information other than from the medical use licensees. The Information Requirements Control Automated System has been searched. There is no duplication with other collections of information.

5. Effort _to Reduce Small Business Burden In 1990, priu 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 Misadministration or Events Relating to the Medical Use of Byproduct Material." Several participants of the pilot program were licensees in private practices. Following the 60 day test, they indicated that, with certain modifications, they could incorporate the proposed rule into their procedurcs of medical practice and that the impact would be minimal. The NRC is re addressing this issue in the planned revision of 10 CFR Part 35.

6. Consequences to Federal Proaram or Policy Activities if the Collection Is Not Conducted or is Conducted Less Freauently l

If the collection is not conducted, there would be no assurance that L circumstances resulting in misadministration, 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:

10 CFR 35.32: The requirement to develop and submit a QMP is a one-time effort which has been completed by all affected NRC licensees and

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11 approximately two-thirds of Agreement States licensees. Additionally, once a OMP that meets the rule is submitted, the frequency that licensees' QMPs are modified is determined by the licensee's need to modify the OMP to correct deficiencies in their own OMP program.

Therefore, the stated frequencies are at the minimum level.

10 CFR 35.33: Licensees are required to report misadministration, by telephone, within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after discovery, followed by a written report 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.

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7. Circumstances Which Justifv Variation from OMB Guidelines Contrary to the OMB Guidelines in 5 CFR 1320.6(b) Section 35.33 requires licensees to report misadministration, by telephone, within 4

24. hours 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 I 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 NRC An invitation to comment on the information collection requirements for 10 CFR 35.32 and 35.33 was published in the Federal Reaister on May 6, 1998 (63 FR 25098). NRC received the following two responses:

1. The Council on Radionuclides and Radiopharmaceuticals commented that "the NRC Quality Management Program and Misadministration program is a duplication of efforts that are under the authority of the Food and Drug l

Administration (FDA), and local Boards of Medicine. NRC's responsibility l to provide adequate radiation protection to the public does not require .

i the onerous reporting requirements imposed under S35.32 and S35.33."

2. The Nuclear Energy Institute (NEI) commented that "the NRC Quality Management Program and Misadministration program is a duplication of i efforts that are more properly administered under the authority of the Food and Drug Administration (FDA) and local pharmacy and medical' boards therefore a burden and not in keeping with the Paperwork Reduction Act i l

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1 of 1995." NEI further supplied comments on NRC's burden estimate and on I using the information collected by FDA or modifying it for NRC use in lieu of separately collecting the information.

A proposed rule, revising 10 CFR Part 35 in its entirety, will be published in August 1998. We anticipate publishing the final rule in August 1999. These comments, and others of a similar nature, will be considered as part of that rulemaking. The comments are not being addressed in this extension request because this OMB clearance approval will be discontinued when the revised 10 CFR Part 35 becomes effective.

On December 5,1996, comments were provided by the Department of Nuclear Safety, the State of Illinois, responding to NRC's Federal Reaister notice (October 7, 1996), announcing the submission of an ICR request to 0MB and solicitation of public comments. The comments expressed by the State of Illinois representative questioned the necessity for and utility of the ICR: were in opposition to the necessity for some of the reporting requirements: protested the burden to the Agreement States for their overview activities, including inspection effort., which is covered in a separate clearance package, 3150 0183, " Policy Statements, Criteria for Guidance of States and NRC in Discontinuance of NRC Regulatory i Authority and Assumption Thereof by States Through Agreement Programs and IMPEP Questionnaire:" addressed the burden of implementing Temporary Instruction 2800/025, Inspection of Quality Management Programs, which ,

has expired: and recommended excluding certain categories of i misadministration.

The OM 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 recommended that NRC reconsider the ICR associated with this regulation.

The NRC believes this concern will be satisfied through the revision of 10 CFR Part 35, including 10 CFR 35.32 and 33.

The program for revising Part 35 and the associated guidance documents has included soliciting early public input through several different l mechanisms: requesting public input through EE.deral Reaisigt notices, ,

holding open meetings of the government groups developing the revised l rule language; meeting with medical professional societies and boards:

I putting background documents, options for the more significant regulatory issues associated with the rulemaking, and alternatives for l revising the 1979 Medical Policy Statement on the Internet: and )

i t

13 convening public workshops. Participants from the broad spectrum of interests that may be affected by the rulemaking were invited to attend the public workshops in Philadelphia, PA and Chicago, IL, held in  !

October and November 1997. The public was also welcome to attend these workshops, as well as the Part 35 Workshop that was held in conjunction with the All Agreement States Meeting in October 1997 and the ACHUI 4 meetings in September 1997 and March 1998. I i

After Commission approval of the proposed rule language and associated I documents, they will be published in the Federal Reaister for public  !

comment for 75 days. The NRC staff plans to hold three public meetings during the formal comment period to facilitate public comment.

l 1

Development of the final rule, associated documents. and final guidance will also be done using a steering and working group, which will hold open meetings. In addition, staff plans to continue making draft documents available on the Internet and to discuss the draft final documents with the ACHUI and the Agreement States before submitting them to the Commission, j

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 i There are two primary cmiderations 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 rarcent or 6300 licensees), all or the applicable NRC licensees L

\

[ *.

I 14 (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 could possibly submit a OMP within the next 3 yeurs.

l Second, based on findings from a pilot program and discussions with l medical licensees in multiple public meetings during promulgation of the rule, it was assumed that 90 percent of licensees, who must implement a QMP, will 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, and submitted to the NRC to comply with the requirements. However, based on the NRC's experience in reviewing the 1800 QMPs originally 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 that could be submitted voluntarily by the Agreement State licensees to the appropriate Agreement State.

These public burden estimates are based on NRC data, collected during the past 5 years and on staff projections of new applications and amendment requests expected to be received during the next 3 years.

The estimates assume that the Agreement States will implement the rule 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 $121 per hour, which includes overhead. A burden breakout is included in Tables 1 through 3.

The followina will be the estimated ICR burden and burden hour cost for the imoi nanted rule:

BURDEN FOR NRC LICENSEES:

Each year, the NRC receives approximately 63 new license applications, and approximately 100 applications to amend existing licen.ses to add a modality, that require the establishment and submittal of a OMP. Since the modification of an existing QMP to add a modality may range from a

~'

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

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 63 licensees X 4 hrs (develop review procedures) = 252 hrs /yr 163 licensees X 72% (require modification) =

117 X 3 hrs (modify) = 351 hrs /yr Burden and cost for new applicants and new modalities added in NRC States = 4.123 hrs /vr X $121 = $498.883 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 Burden for NRC licensees to modify QMPs = 810 hrs /vr X $121 = .$98.010 Burden Associated with Notifications. Reoorts. and Records of Misadministration:

NRC licensees reported an average of 30 misadministration per year for years 1993 through 1997. The definitions for misadministration 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 <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br /> per licensee, 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.

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

30 misadministration X 10 minutes (to file record) = 5 hrs /yr

i 16 l l

Based upon inspections of implemented OMPs to date,15 percent of NRC licensees were found to have records of " recordable events" (S 35.32(c)(3)) during inspection. Therefore, i 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 Burden associated with notifications, reports, and records of misadministration = 2.450 hrs /vr X $121 = $296.450 TOTAL BURDEN FOR NRC LICENSEES = 7383 hrs /vr X $121 = $893.343/vr I

BURDEN FOR AGREEMENT 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 <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> is estimated for preparation and submittal of a modified QMP.

! 2. Although the NRC har taken no acticn to enforce a compatibility requirement on the 10 Agreement States who have not adopted the QM l

rule, the NRC has included the burden cost of ten percent of the i

2000 non-QM Agreement State . s who may develop and submit a OMP during this approval period. This will be a one time burden of approximately 40 hours4.62963e-4 days <br />0.0111 hours <br />6.613757e-5 weeks <br />1.522e-5 months <br /> for each of the 200 licensees.

]

3. Based on the NRC's experience, 72 percent of the 2000 QMPs initially 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 <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> each to modify the OMP for approximately 1440 licensees.

17 One time burden to Aareement State Licensees for Initial Development.

Submittal (States who may adoot the rule within next 3 vears):

l Development of QMP by 10% of 2000 licensees = 200 licensees X 40 hrs = 8000 hrs annualized over 3 yrs =

2,667 hrs /yr

, Preparation and submittal of existing procedures:

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

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 submittals will require modification: 1 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 review of the QMP (4 hrs). '

l 2000 licensees annualized over 3 yrs = 667 licensees /yr 667_ licensees /yr X 4 hrs to develop procedures for QMP review = 2.668 hrs /yr Aareement State licensees' burden = 9.775 hrs /vr X $121 = $1.182.775 Burden to New Acolicants - Aareement State:

Each year, the NRC receives approximately 63 new license applications, and approximately 100 applications to amend existing licenses to add a modality, thz.t 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 QHP to add a modality may range from a minor change to a major effort, the average burden is estimated to be 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />. Therefore:

158 licensees X 40 hrs (new licensees develop QMP) = 6,320 hrs /yr 250 licensees X 10 hrs (add modality modify QMP) = 2,500 hrs /yr

18 158 licensees X 4 hrs (new licensees develop review procedures) = 632 hrs /yr 408 licensees X 72% require modification =

294 licensees X 3 hrs (modify) = 882 hrs /yr Burden for new applicants and modalities added in Agreement States = 10.334 hrs /vr X 121 = $1.250.414 Burden for makina modifications to oreviousiv 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 .

program's efficiency. .This does not include the burden for modification I 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 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 Burden Associated with Notifications. Reoorts. and Records of Misadministration:

l l 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 misadministration per year for NRC licensees, the NRC estimates 75 misadmiristrations per year for Agreement State licensees.

The estimated burden to report a misadministration is 16 hours1.851852e-4 days <br />0.00444 hours <br />2.645503e-5 weeks <br />6.088e-6 months <br /> 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.

! i

r 19 75 misadministration reported /yr X 17 hrs / event = 1,275 brs/yr l

! 75 misadministration X 10 minutes (to file record) = 13 hrs /yr To date, based on inspection of NRC licensees,15 percent of Agreement

' State licensees, per_ year, will have records of recordable events (S 35.32(c)(3)) during inspection:

4500 X 15% = 675

( 675 records /yr X 30 minutes to make the record = 338 hrs /yr L

i Each of the 4500 Agreement State licensees must evaluate and retain records of an annual QMP review for 3 years:

4500 X 1 hr/yr = 4,500 hrs /yr l_ Burden associated with notifications, reports, and records of misadministration = 6,126 hrs /yr X 121 = $741.246 IDTAL BURDEN FOR AGREEMENT STATE LICENSEES =

27.360 hrs /vr X 121 = $3,310,560*

• Inflated by the 9,775 hrs /yr burden for those Agreement States who have not as yet adopted the QM rule, who may choose to develop and implement the rule during the next ICR approval period.

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

The total compliance burden estimate, for NRC and Agreement State licensees is summarized below:

Number of Total Annual Cost:

Licensees Burden (hrs): ($121/hr)

{ who will respond:

Reporting: 6300 24.400 hrs /yr $2,952,400 Recordkeeping: 10.343 hrs /vr $1.251.503 Total Burden: 34.743 hrs /vr $4.203.903

l .

l 20

13. Estimate of Other Additional Costs ,

Not applicable.

14. Estimate of Annualized Cost to the Federal Government Quality Manaaement Procram (0MP)

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, and within 30 days of modifying existing QMPs. The QMPs are reviewed ci "

part of the license application for new and amended licenses, and modifications are reviewed at' the time of inspection. The NRC receives i 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 <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> 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 $121 = $59.169/vr Assuming 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> 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 $121 = $65.340/vr The ongoing cost to the NRC for review of QMPs =

1029 hrs /yr X $121 = $124.509/yr Notifications. Reoorts. and Records of Misadministration Based on statistical data, the staff estimates that 30 misadministration per year will occur in NRC States over the next

21 l 3 years. Assuming that an average of 80 hours9.259259e-4 days <br />0.0222 hours <br />1.322751e-4 weeks <br />3.044e-5 months <br /> of NRC staff effort will l

be required to respond to each event, the cost to the NRC will be 1 l $288,000 per year.

80 hrs / misadministration X 30 misadministration /yr = 2400 hrs /yr 2400 hrs /yr X $121/hr = $290.400/vr l 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 $121 = 1414.909/vr These costs are fully recovered through fee assessments to NRC licensees, pursuant to 10 CFR Parts 170 and 171.

15. Reasons for Change in Burden or Cost The following are the reasons for the most significant changes in the burden estimate: i

1. The increase in the cost from $120/hr in the previous submission to

$121/hr for the 1998 submission.

2. The March 1997 OMB approval of the information collection provisions of the QM rule did not include the burden of the 10 Agreement States J who had not yet adopted the QM rule. To ensure that the voluntary l, implementation of the rule, by any or all of those states, is included in the ICR approval, this estimate is inflated by the one-time burden of the submission and review of the QMPs that could be submitted by the approximately 2000 Agreement State licensees in the 10 States that have not yet adopted the rule. Including these Agreement States licensees may result in an over-estimation of approximately 9,775 hours0.00897 days <br />0.215 hours <br />0.00128 weeks <br />2.948875e-4 months <br /> per year (28%).

l 3. There are two additional Agreement States. Therefore, although the total burden has not changed, the burden hours for licensees in i those Agreement States has moved from NRC licensee burden to Agreement State licensee burden.

i 22

16. Publication for Statistical Usg The NRC tabulates and publishes an annual summary of misadministration and other events. ,

17. Reason for Not Disolavina the Exoiration Date l The requirement will be contained in a regulation. Amending the Code of Federal Regulations to display information that, in an annual '

publication, could become obsolete would be unduly burden;ome and too difficult to keep current.

18. Exceotions to the Certification Statement There are no exceptions.

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

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I l: - July'6,1998 Ms. Brenda Jo. Shelton

, NRC Clearance Officer I. Office of the ChiefInformation Officer T-6 F33 j

! U.S. Nuclear Regulatory Commission l

Washington, DC 20555-0001 i

l

REFERENCE:

Request for Comments on NRC's submittal to OMB on I information collection: 10 CFR 35.32 and 35.33 " Quality J

Management Program and Misadministration" 03 Federal  !

Register 25098 (May 6,1998) l l

Dear Mi. Shelton:

!c - The Nuclear Energy Institute (NEI),1 is submitting the following comments in l

l response to the request for comments on the Nuclear Regulatory Commission's l .

(NRC) submittal to the Office of Management and Budget (OMB) on information

' collection

10 CFR 35.32 and 35.33 " Quality Management Program and l

Misadministration" 63 Federal Register 25098 (May 6,1998). NEI believes the  !

l 'NRC Quality Management Program and Misadministration Program is a duplication of efforts that are more properly administered under the authority of f

the Food and Drug Administration (FDA) and local pharn2acy and medical boards L therefore a burden and not in keeping with the Paper Work .Reduction Act of 1995.

l The following responses to the four questions asked by the NRC in its Federal l Register notice are based on this position. ]

i NEI is the organization responsible for establishing unified nuclear industry policy on matters

' affecting the nuclear energy industry, including the regulatory aspects of generic operational and i technical issues. NEI's members include all utilities licensed to operate commercial nuclear power l l

plants in the United States, nuclear plant designers, major architect / engineering firms, fuel fabrication facilities, materials licensees, and other organizations and individuals involved in the nu:: lear energy industry.

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Ms. Brenda Jo. Shelton July 6,1998 Page 2

1. Is the proposed collection ofinformation necessary for the NRC to properly perform its function? Does the information havepractical utihty?

The NRC does not need to collect this information to properly perform its function.

The FDA is already collecting this information. In accordance with 21 CFR 600 and 21 CFR 800 the health professional, user facility, distributor and/or manufacturer have an obligation to report " Adverse Events". This is FDA's term for misadministration and physiological reactions in FDA approved applications and devices. The FDA's program is more comprehensive than the NRC's and since it is covering all FDA approved applications and devices, not just radioactive materials, the health professionals more familiar with the forms and process. This makes it more likely that an adverse event will be reported, and reported correctly.

2. Is the burden estimate accurate?

The estimate is not accurate. Since the health professionals reporting to the FDA as well as local pharmacy and medical boards and the NRC, the NRC's estimate is underestimating the reporting requirements. To be accurate the NRC must also include the time that the health professional, user facility, distributor, and/or manufacturer spent in the duplicative effort reporting to FDA and the local boards.

Since the FDA requirements are more extensive than the NRC's, a simple doubling of the NRC estimate is not sufficient.

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

If the NRC deems it is important to have access to this information, the NRC should f review FDA Form 3500A and determine ifit meets NRC's needs. If the NRC identifies any short coming it can discuss this with the FDA to enhance the form.

The FDA could forward copies of FDA Form 3300A it receives or the licensee can send a copy of the form to the NRC.

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

l As discussed in the responses to the prior questions the NRC can substantially .

l l reduce the burden ifit would accept and use the FDA information and rely on the l

FDA to provide it. This would assure that both the NRC and FDA are receiving consistent information and it would reduce the burden on the health professional considerably..

i 1

j

4 Ms. Brenda Jo. Shelton July 6,1998 Page 3 We will respond to any questions or comments the NRC may have.

Sincerely,

/

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/ '

Felix M. Killar, Jr 1

as.

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'. uhr l OR L.. Council on Radionuclides and Radiopnannaceraicals, Inc.

3911 Campolendo Drwe Mors CA 9 H%1%1 ,

(925) 2341850 ]

Far (925) 283-lMO j E mail corardsitcon com I

Henry 11. Kramer. Ph.D., FACNP Ewa< om- I l

July 6,1998 j l

l l

1 Ms. Brenda Jo Shelton NRC Clearance Otlicer Office of the ChiefInformation Officer T-6 F33 U.S. Nuclear Regulatory Commission Washington, DC 20555-0001

REFERENCE:

Request for comments on NRC's submittal to OMB on ,

information collection: 10 CFR 35.32 and 35.33 " Quality l Management Piogram and Misadministration" 63 Federal Register 25098 (May 6,1998)

Dear Ms. Shelton:

The Council on Radionuclides and Radiopharmaceuticals (CORAR*)is submitting the following comments in response to the request for comments on the Nuclear Regulatory Commission's  ;

(NRC) submittal to the Office of Management and Budget (OMB) on information collection: 10 CFR 35.32 and 35.33 " Quality Management Program and Misadministration" 63 Federal Register 25098 (May 6,1998). CORAR believes the NRC Quality Management Program and Misadministration program is a duplication of etTorts that arc under the authority of the Food and l Drug Administration (FDA), and local Boards of Medicine. NRC's responsibility to provide l

• CORAR is a trade association of the manufacturers and distributors of radiopharmaceutica.1, life science research radionuclides and radiation sources used in medicine, research and industrial applications.

i

I a

.a i

i adequate radiation protection to the public does not require the onerous reporting requirements imposed under 35.32 and 35.33. CORAR holds this position for the follow'mg reasons:

• The administration of drugs to patients is properly regulated by the FDA, state medical boards and pharmacy regulations, and the hospital accreditation agencies.

• The additional prescriptive requirements of NRC for the use of byproduct materials in medicine adds no enhanced patient protection over that provided by these agencies which can regulate the administration of all drugs, irrespective of whether they are chemotherapeutic or non-byproduct radiopharmaceuticals.

• In the hands of qualified professionals, radiopharmaceuticals are no more hazardous to the l patient than other therapeutic drugs. By imposing the additional reporting requirements, the NRC creates the impression of extraordinary risk and establishes a disincentive to use a modality which may be particularly beneficial to the patient. ,

I

• The prescriptive notification requirements of 35.33, in particular, are an unwarranted l intrusion into the practice of medicine.

l CORAR also feels the NRC should be adhering to their Medical Pdicy Statement of 1979 that states "NRC will minimize intrusion into medical judgments affecting patients and into other areas traditionally considered to be a part of the practice of medicine." We feel the reporting l l

requirements of 10 CFR 35.32 and 35.33 cross over the threshold identified in the Medical Policy Statement as the practice of medicine, and should not be regulated by the NRC. NRC medical licensees should be left to conduct their practices in accordance with established standards for the j practice of medicme, j We would be happy to provide any additional information or detail required by the NRC. You ,

may contact me at (314)654-7914.

Sincerely, v

i Roy W. Brown, Chairman Committee on Health Care l

I

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