ML20217M577
| ML20217M577 | |
| Person / Time | |
|---|---|
| Issue date: | 03/20/1997 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| Shared Package | |
| ML20217M555 | List: |
| References | |
| REF-10CFR9.7 NUDOCS 9708250039 | |
| Download: ML20217M577 (43) | |
Text
. .
/ UNITED STATts f ;
NUCLE AR REQULATORY COMMISSION
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% ,,,,, March 20, 1997 M entTARY MEMORANDUM TO: L. Joseph Callan Exe ut ye D rector for Operations FROM: Jo1 C.
b oy e, Secretary I
SUBJECT:
S AFF REQUIREMENTS - COMSECY-96-057 MATERIALS / MEDICAL OVERSIGHT (DSI 7) l With respect to the overall materials program, the Commission continues to-support its preliminary views on this issue which were"aprovements with a combination of two options -- Continue the Ongoing Program (Option 2) and Decrease Oversight of Low Risk Activities with Continued Emphasis in High-Risk Activities
-(Option 3). For the longer term, the Commission also believes that consideration should be given to broadening NRC's regulatory oversight to include one or more of the higher-risk activities identified in Option 1.
With respect to the medical program, the Commission was not persuaded by the National Academy of Sciences, Institute of Medicine (IOM) report that recommends that NRC should not be the Federal agency involved in the regulation of ionizing radiation in medicine. The Commission continues to believe that the conclusions in the report were not substantiated and that the recommendations should not be pursued.
The Commission continues to support the use of ACMUI and professional medical organizations and societies in developing regulatory guides and standards as was proposed in the Commission's preliminary views. In the longer term, the commission would be willing to cot. sider-taking on broader regulatory responsibilities for higher risk activities involving other sources of ionizing radiation but such efforts should not divert resources from the 10 CFR Part 35 rulemaking discussed below.
i In lieu of a rulemaking plan in the context of Management Directive 6.3 the staff should submit a program for Commission approval for revising 10 CFR Part 35, and associated guidance documents, and the Commission's 1979 Medical Policy Statement, if necessary.- The program should describe how 10 CFR Part 35 can be restructured into a risk-informed,_more performance-based J regulation by a suspense date of 6/30/99. In developing the program the staff should consider the following:
9708250039 970812 PDR COMMS NRCC CDRRESPONDENCE PDR ,
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(1) Focusing Part 35 on those procedures : hat pose the highest risk.
(2) For diagnostic pr.cedures, staff should consider regulatory oversight alternatives consistent with the lower overall risk of these procedures.
(3) The staff should address how best to capture not only i relevant safety-significant events, but also precursor l events.
(4) Changing the nomenclature from " misadministration" to
" medical event" or comparable terminology.
(5) Part 35 should be redesigned so that it can i.. corporate necessary regulatory requirements for new treatment modalities in a timely rsnner, (6) The Quality Management Program provisions (10 CFR Part 35.32) should be re. evaluated and revised to focus on those requirements that are essential for patient safety, e.g., confirming patient identity, requiring written prescriptions and verifying dose. To the maximum extent possible, the requirements should be revised to be risk-informed. Given-this objective, a mixed approach of performance-based rules and otherwise prescriptive regulations should be pursued.
(7) The staff should consider the viability of using or referencing available industry guidance and standards within Part 35 and related guidance to the extent that they meet NRC needs.
(8) The staff should consider a rulemaking process that provides more opportunity for input from potentially affected parties than is provided by the normal notice and comment rulemaking_ process but would be less consumptive of resources and time than the process
-recently used in the development of NRC's rule on radiological criteria for license termination.
The staff's program to implement the above should be submitted to the Commission for its consideration no later than June 6, 1997.
The program should target June 30, 1999 as the date for completing tha rulemaking process. This rulemaking and associated guidance development is a very high priority for the Commission. The Commission is prepared to provide additional resources to the extent necessary to complete the rulemaking process on this schedule.
(NMSS/RES) (EDG - Program) (SECY Suspenset 6/6/97) 970006E (NMSS/RES) (EDO - Complete Rulemaking) (SECY Suspense: 6/30/99) 970006!
3-cc: Chairman Jackson Commissioner Rogers Commissioner Dieus Commissioner McGaffigan Commissioner Diaz K. Cyr D. Rathbun H. Bell A. Galante l
R.-Scroggins W. Beecher i
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4 e Enclosure 3 SECY.97-115
,p ~s RULEMAKING ISSUE (Notation Vote)
June 5. 1997 SECY-97-115_
EQB: The Commissioners FROM L. Joseph Calian Executive Director for Operations
SUBJECT:
PROGRAM FOR REVISION OF 10 CFR PART 35,
- MEDICAL USES OF BYPRODUCT MATERIAL' AND ASSOCIATED FEDERAL REGISTER NOTICE P_UBPOSE-To obtain Commission approval of: (1) the staffs proposed program for revising 10 CFR Part 35, associated guidance documents, and the Commission's 1979 Medical Policy Statement, if necessary; and (2) a Federal Reaister notice (FRN) of proposed rulemaking for pub!ication to solicit public comments regarding 10 CFR Part 35 restructuring into a risk-informed, more oerformance based regulation.
CATEGORY:
This paper addresses significant rulemaking issues requiring Commission consideration and epproval.
EtACKGROUND:
The, Commission, in l's " Staff Requirements Memorandum (SRM) COMSECY 96-057, Materials / Medical Oversight (DSI 7)," directed the staff to submit a program, for Commission approval, for revising Part 35, associated guidance documents, and, as necessary, the Commission's 1979 Medical Policy Statement (Attachment 1).
CONTACTS: Catherine Haney, NMSS/IMNS SECY NOTE: TO BE MADE PUBLICLY AVAILABLE AT CON 41SSION BRIEFING (301) 415-6825 ON JUNE 13, 1997 Susanne Woods, NMSS/IMNS (301) 415 7267 4,4-: : 3 3,L hf*
The Commissioners 2 The staff was also directed to desenbe how Part 35 could be restructured into a risk informed, more performance based regulation, in addition, a listing ofissues was provided for ctaff consideration during development of the program. The staff reviewed the Commission's direction and is prepared to move forward with the revision to Part 35 and associattsd guidance documents.
- DISCUSSION:
The staff plans to establish a steering group and a working group. This approach is desenbed in Management Directive 0.3,"The Rulemaking Prr<ess." The steering group will be comprised of representatives, at the Division Director level or higher, from the following offices: Office of Nuclear Materisi Safety and Safeguards (NMSS); Office of Nuclear Regulatory Research (RES); Office of the General Counsel (OGC); Office of Enforcement !
(OE); and Office of State Programs (OSP). The Director, Division of Industrial and Medical Nuclear Safety, NMSS, will chair the steering group. In addition, the steering group will include an Agreement State Program representative. The working group will be comprised of l Nuclear Regulatory Commission staff and representatives from both an Agreement State and a non Agreement State.' Representation willinclude NMSS, RES, OGC, and OSP. The nominated Agreement State representative is also a member of the Conference of Radiation
! Control Program Directors (CRCPD), Inc., Suggested State Regulation Committee (SSR) on Medical Regulation, The staff plans to work toward parallel development of the NRC rule and the CRCPD suggested state regulations to facilitate state development of their corresponding rules.
Attachment 2 describes the staffs proposed program for the revision to Part 35 and associated documents. 'la staff plans to use a fresh start approach, soliciting initial ideas and suggestions from the medical community and the public. Previously identified issues will also be factored mio the revision, including: recommendations of the Indiana, Pennsylvania, incident investigation Team; recommendations from intemal staff audits; open rulemakings and results of analyses in medicalissues papers.
The staff plans to use a process for revising Part 35 and associated guidance documents that provides more opportunity for input from potentially affected parties than is provided for by the typical notice and comment rutomaking process. This process includes solicitation of public comment on several occasions. The first opportunity begins with the publication of an FRN (Attachment 3) that solicits initial input into the development of Medical Policy Statement optirins and regulatory attematives. To the extent possible, commentors will be asked to provide specific examples of draft rule language. During this period, two public meetings are planned to further solicit the initial public input. The second opportunity for public input will ,
include a public comment period and a set of facilitated public meetings based upon draft rulemaking attematives. The staff plans to provide the draft rule attematives to the Cummission prior to soliciting comment. During these meetings the staff will. work with participants to review and refine the details of the proposed rule. Based upon the results of these public interactions, a proposed rutt, regulatory analysis, and environmental assessment
'The Organization of Agreemsat States recommended that the non Agreement States be reoresented on this working group.
The Commissioners 3 I
will be prepared, along with draft guidance documents. Following Commission approval, the l proposed rule will be published for comment, and a second set of facilitated public meetings would be completed. The meetings are expected to be focussed upon areas of cor,troversy, and upon tho draft guidance, as a mechanism to refine the rule and guidance into final form.
The revision of the medical regulations will be a complex and controversial process, because of the diversity of activites, modalities and risk that fall within the umbrella of medical use, l the corresponding diversity in medical community positions, and the varied availability of professional codes and standards. . Given these facts, the proposed program represents an L aggressive schedule. The staff emphasizos that the proposed plan does not account for any possible requests for extensiont, on public comment periods associated with the initial FRN, the notice requesting comment on the rulemaking attematives, or on the proposed rule.
Requests for comment extensions cannot be granted without causing a change to the end l-dates for the final rulemaking. The staff projects that the final rule will be published in April 2000 (Attachment 2).
Tne staff plans to provide NRC's medical licensees, professional medical societies, and the Agreement States (for distribution to their licensees) with copies of the initial FRN of proposed rulemaking. The staff plans to meet with and snlicit comments from several professional societies, including, among others: (1) Society of Nuclear Medicine; (2) American College of Nuclear Physicians; (3) Health Physics Society; (4) American Association of Physicists in Medicine; (5) the American College of Cardiology; and (6) the American College of Radiology. The staff will also attempt to identify patient's rights groups and forward them copies of both the FRN and applicable documents for their comment. To this end, the staff arranged for a two-hour discussion with the American College of Nuclear Physicians and Society of Nuclear Medicine at their combined meeting in San Antonio, Texas, on June 4,1997. The staff intends to make documents pertaining to this rulemaking and electronic comment submittal available on the Intemet, using a separate page within the current RES rulemaking bulletin board.
Contractors and consultants are expected to assist the staff during the rulemaking process.
Contractors, in particular, will be used to consolidate public comments and prepare the regulatory analyses for the revised rule, in addition, the staff will pursue the use of technical medical experts as consultants to the working group. Specifically, the project is expected to enlist experts for diagnostic and therapeutic uses of radioactive material. Further, the use of contracted facilitators for public meetings is being considered, in addition to the support of ~
the OGC Special Counsel for Public Liason and Agreement State Programs.
The staff believes that, at this time, providing the Commission with a description of how Part 35.can be tastructured, without the benefit of public comment, is premature and that it may lead stakeholder groups to believe that the staff has already decided on a particular approach, ideas generated at the first stages of comment will be validated and tested during the subsequent facilitated public meetings planned for spring 1998 and earty 1999. --The result will he the staff's proposed rule and associated guidance for Commission consideration
- in December 1998.
The staff used the guidance in the Strategic Assessment Direction Setting issues Papers Number 7, " Materials / Medical Regulations," and Number 12, " Risk Informed, Performance-
The Commissioners 4 Based Regulations," as well as the SRM (COMSECY 96-057) to prepare a preposed FRN and associated press release (Attachments 3 and 4). The FRN of proposed rulemaking contains a list of issues, presented in the form of questions, for consideration by the public.
The staff recognizes that the questions are to assist with the formulation of comments and that the commentary received need not be limited as response to the questions presented.
Rather, the overriding issues are both the identification of necessary changes (additions and deletions) to Part 35 requirements and the assessment of risk for a risk-informed, more performance based regulation with sufficient oversight of public health and safety. The staff also poses the question of whether quantitative or qualitative criteria should be considered in determining the " risk" for each modality. Public comments, the Commission SRM issues, and the staff reports on medical issues (as previously noted) will be used for developing the framework and associated text of the proposed rule.
The staff discussed revision of Part 35 with the Advisory Committee on the Medical Uses of Isotopes (ACMUI) at the April 1997 Committee meeting. As a mechanism for generating
_. discussion during the last two publi; meetings of the ACMUI, the staff identified a possible approach for restrucNring Part 35 by modality (e.g., teletherapy, radiopharmaceutical therapy), based upon risk. ACMUI comments addressing the Part 35 revision are t
summarized in the proposed FRN (Attachment 3). The ACMUI's discussion will be available l as additional backgrcrnd information for public commentors, and will be considered by the l working group in preparing rulemaking proposals. The staff intends to continue active l involvement of the ACMUI in the ongoing development process, including Committee meetings, additional reviews of guidance documents deveioped during the Part 35 revision process, and possible supplemental technicalinput from ACMUI subcommittees.
RESOURCES:
The Offices of Nuclear Material Safety and Safeguards, Research, General Counsel, and State Programs have identified the following resource requirements for this effort in their recent budget submissions. These resource levels will be considered in the FY 1999 budget review process.
FY 1998 FY 1999 FY 2000 Office M _ETE M FTE E FTE NMSS 39 3.0 GO 3.0 0 0.3 RES 150 1.9 50 1.0 OGC* O 0.3-0.6 0 0.3-0.6 OSP O 0.5 0 0.5
- OGC effort includes any process design and the possible option of faciHtation support for the public meetings from the Special Counsel for Public Liaison and Agreement State Programs.
NMSS management will monitor resource use closely for this rulemaking.
.. c.
'. 5 The Commissioners RECOMMENDATION:
That the Ccmmission approve the following: (1) the proposed Part 35 revision program; (2) issuance of the attached FRN; and (3) the attached press release.-
COORDINATION: ,
OGC reviewed this paper and has no legal objection. The Chief Financial Officer has no objection to this paper. The Office of Chief Information Officer has reviewed the plan for information management implications and concurs in it; however, since the revision to 10 CFR Part 35 contains information collection requirements, it must be submitted to the Office of Management and Budget for review no later than the date the proposed rule is published in the Federal Reaister.
hk L. Jo! ph Callan Executive Director for Operations
. Attachments: 1. SRM dated March 20,1997
- 2. Program for Revising '
10 CFR Part 35 and Associated Documents
- 3. Proposed Federal Reaister notice
- 4. Press Release DISTRIBUTION:
Commissioners
-OGC" OCAA-OIG-OPA OCA-CIO CFO
'EDO
'SECY-Commissioners' comments or consent-should be-provided directly to the Office of the Secretary by COB Friday, June 20, 1997. _
Commission staff office = comments, if any, should be submitted to the Commissioners NLT June 13, 1997, with an;information-copy to the Office of the Secretary. If the paper is of such a nature-that-it requires additional review and comment, the Commissioners
.and the-Secretariat should be apprised of when comments may be expected,
- ti:r: D va oe" ti ' : "iv i
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- js: Callan
[,, ,,% UNITED STATES NUCLE AR REGULATORY COMMISSION Thompsor fortan f $ .Norry i wasMINGT04.0 e 70$5ko001 5 t Slana e F 33.ch 20, 1997 Bangart, SP k*****./ Ross, AEOD MCstifAny l
MEMORA?T0UM TO: L. Joseph Callan Exe ut ve D rector for Operations b Secretary FROM: Job, C. oy e,
SUBJECT:
S AFF REQUIREMENTa COMSECY-96-057 MATERIALS / MEDICAL OVERSIGHT (DSI 7)
With respect to the overall materials program, the Commission continues to support its pre iminary views on this issue which were a combination of two options -- Continue the Ongoing Program with Improvements (Option 2) and Decrease Oversight of Low-Risk Activities with Continued Emphasis in High-Risk Activities (Option 3). For the longer term, the Commission also believes that consideration should be given to broadening NRC's regulatory I oversight to include one or more of the higher-risk activities identified in Option 1.
With respect to the medical p::-"a.. the Commission was not Institute of persuaded by the National Academy of Sciences,NRC should not be the Medicine (IOM) report that recommends that Federal agency involved in the regulat'.on of ionizing radiation in medicine. .The Commission continues to oelieve that the conclusions in the report were not substantiated and that the recommendations should not be pursued.
The Commission continues to support the use of ACMUI and professional medical organizations and societies in developing regulatory guides and standards asInwas the proposed in the longer term, the Commission's preliminary views.
Commission would be willing to consider taking on broader regulatory responsibilities for higher risk activities involving other sources of ionizing radiation but such efforts should not divert resources from the 10 CFR Part 35 rulemaking discussed below.
In lieu of a rulemaking plan in the context of Management Directive 6.3 the staff should submit a program for Commission approval for revising 10 CFR Part 35, and associated guidance if documents, and the Commission's 1979 Medical Policy Statement, 35 can be necessary. The program should describe how 10 CFR Part restructured into a risk-informed, more performance-based regulation by a suspense date of 6/30/99. In developing the program the staff should consider the following:
- se :ne M Focusing Fart 25 :n :n:se .:r::+d.res tna: .
h:ghest r:sk.
(2) For diagnostic procedures, staff should cenrider with the regulatory oversigl.c alternatives censistent lower overall risk of these procedures.
to capture not only (3) The staff should address how bestevents, but also precursor relevant safety-significant l events.
-(4) Changing the nomenclature from " misadministration" to "mectical event" or comparable terminology.
it can incorporate (5) Part 35 should be redesigned so that necessary regulatory requirements for new treatment j modalities in a timely mannu..
Preg 7am provisions (10 CFR Fart
.fi The Ouality Manage:..entshould be re-evaluated and revised to focus en 35.32) those requirements that are essential for patient identity, requiring safety, e.g., confirming patient To the written prescriptions and verifying dose.the requirements should be maximum extent possible, Given this objective, a revised to be risk-informed.
mixed approach of performance based rules and otherwi.se prescriptive regulad ans shoeld be pursued.
(7)
The staff should consider the viability of using or referencing within Part available indust y. guidance and standards 35 they meet NRC needs.
(8) The staff should consider a rulemaking process thatfrom potentially ,
provides more opportunity fer inputaffected parties than.is provide and comment rulemaking process but would be less consumptive of resources and time than the process recently used in the development of NRC's rule on radiological criteria for license termination.
The staff's program to implement the above should be submitted 1997. to the Commission for its cons,ideration no later 1999 as thethan dateJune for 6, The program abould target June 30, This rulemaking and
. completing the rulemaking process.is a very high priority for the associated guidance developmentThe Commission is prepared to provide additional Commission.
resources to the extent necessary to complete the rulemaking process on this schedule. 970006!
(SECY Suspense: 6/6/97) 970006!
(NMSS/RES) (EDG - Program) (SECY Suspense: 6/30/99)
(NMSS/RES)- (EDG - Complete Rulemaking) h ,
. . )
PROGRAM FOR REVISBNG 10 CFR PART 35. ASSOCIATED GUIDANCE DOCUMENTS. AND 1979 MEDICAL POUCY I 7/97 Pubbsh Ende_ral Ryg nobce for earty input wth 90 day commert pened ACMUI input, professional socety meetegs, and two putdic meetings Pubhc input Working group, Steenng Commdtee, and consutant develop documents with 2 gg7 review and approval from Steermg Commatee Staff Develops
- 1. Meecal Pohey Statemert Recommendaten
- 2. Rule Anernattves 3 Associated Comrression Paper Commessaan review and approval of Medical Pokey Statemert recommendataans and
' N rule aRemahves for pubhc refease and pubhcahon in Federal Reester Commission Review and Approval I Proposed rule anemstrves puthshed in fEh9f flenegg for 904ay comment penod g
O '2 Two faciliated pubhc meetings to examne enemahves in detad Pubhc input Wortung Group, Steenng Commatee, and consutants develop documents, with review p and approvat of Steenng Comrnatee r*
d 7/98 Preparahon of OMB cleanmce and supporting docume ts y Review with ACMUI and Agreemert States 0 Acetional coordnahon as necessary k.
Staff Deve6 ops :s r'
- 1. Proposed Rule. OMB Clearance.
Regidatory Ar@, Environmental n Assessment
- 2. Draft Gtadance Documerts 3 Associated Commission Paper I
1 _ _ _ _ _ _ _ - _ _ -
PROGRAM FOR REVISING 10 CFR PART 35. ASSOCIATED GUIDANCE DOCUMENTS. AND 1979 MEDICAL POUCY .
O4 12s6 Comnission review and appnwal for Endtral Le putihcation and > %
C......A Review and Approval of Proposed Rule and Guidance PutAsh prW rule and announce avadat#y of draft gudence in FM g
() a 299 encluding 90 day commerd perxxf Two facWed putAc mee*ings focm e tugh nsk activdies. cartroverstat issues and f' ou dance Pubhc input Workng Group, Steenng Commdtee, and consdtants develop documents, wdh review l
2 g and approval of Steenng Commatee
' Preparation cf OMB clearance and supportng documents Review wdh ACMUt and Agreement States Additional coordnahon as necessary Staff Develops
- 1. Final Rule, OMB Cleerence, coordneten for Rule Approval
- 2. Final Guidance Documents
- 3. Associated Commissaan Paper
'11/99 Commessaan review and approval of final rule and rnal guidance for release to the putte
() C Commission Review and Approval of Final Rule and Final Guidance 4f2000 PutAsh Fanal Rule O d
- The program presented represents ongoing efforts of the Working Group. Steering Committee, and project consultants including extensive NRC Offee coordination. ACMUI consultation. Agreement and non-Agreement State interaction, and numerous meetings with professional organizations, stakeholders, and the public.
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ATTACHMENT 3
[7590-01 P)
NUCLEAR REGULATORY COMMISSION RIN-3150-AF74 Medical Use of Byproduct Material:
Issues and Request for Public Comment AGENCY: Nuclear Regulatory Commission ACTION: Notice of Proposed Rulemaking
SUMMARY
- The U. S. Nuclear Regulatory Commission (NRC) is developing a program for revision of 10 CFR Part 35," Medical Use of Byproduct Material." The decision to revise Part 35 resulted from the NRC Strategic Assessment and Rebaselining Initiative (SA), a process involving identification of the direction-setting issues and associated options for the future of NRC activities. Specifically, the SA effort included medical use regulation. With this notice, the Commission is initiating a proposed rulemaking action which will culminate in the developement of a final rule for approval in late 1999. This notice describes issues proposed to be included in this rulemaking. The Commission plans to further propose specific rulemaking text for public comment during 1999 (approximately February 1999).
In order to provide the public the most effective opportunity to participate in developing the rule text, the Commission is requesting public comment on the issues identified by the questions in this notice within 90 days of the issuance of this notice. Comments received after this initial 90 day period will be considered along with the comments received on the proposed text artc , pated for publication in 1999. However, because of schedule requirements, it may not be practicable for the Commission to consider those comments received after the 90 day period in preparing the detailed proposed rulemaking text.
The comment period expires (90 days after the FRN is issued).
DATES:
ADDRESSES: Send wntten comments and suggestions to Secretary, Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Docketing and Service Branch. - Hand-Deliver comments to 11555 Rockville Pike, Rockville, MD, between 8:00 a.m. and 4:00 p.m. on Federal workdays.
Written comments may also be submitted electronically on the Intemet via NRC's interactive rulemaking web site, through the NRC home page (http://www.nrc. gov). This site provides the ability to upload comments as files (any format), if your web browser supports this function. For information about the interactive rulemaking site, contact Ms. Carol
- Gallagher, (301) 415-5905, e-mail CAG@nrc gov.
l L
l 4
4 .:
i
- FOR FURTHER INFORMATION REGARDING THIS NOTICE CONTACT:
Catherine Haney, Office of Nuclear Material Safety and Safeguards, Nuclear :;
L 1 i' Regulatory Commission, Washington, DC 20555 0001,~ telephone (301) I 415-6825 or Susanne Woods, Office of Nuclear Material Safety and C Safeguards, Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415 7267, '
c ' SUPPLEMENTAL INFORMATlON:
! Backaround NRC examined the issue of its medical use program in great detail during the last four years.
s This process started with NRC's 1993 intemal senior management review report; continued
[-
- with the 1996 independent extemal review report by the National Academy of Sciences, Institute of Medicine; and culminated in NRC's SA process, in particular, medical oversight was addressed in the Strategic Assessment Direction-Setting issue Paper Number 7 (DSI 7)
- (released September 16,1996).
! In their " Staff Requirements Memorandum (SRM) - COMSECY-96-057, Materials / Medical Oversight (DSI 7)," dated March 20,1997, the Commission directed staff to revise Part 35,-
associated guidance documents, and, if necessary, the Commission's 1979 Medical Policy Statement. Further, the SRM stated, 'Wth respect to the medical program, the Commission was not persuaded by the National Academy of Sciences, Institute of Medicine (IOM) report that recommends that NRC should not be the Federal agency involved in the regulation of ionizing radiation in medicine. The Commission continues to believe that the conclusions in the report were not substantiated and that the recommendations should not be pursued."
The Commission SRM.specifically directed the restructuring of Part 35 into a risk-informed, more performance-based regulation. Further, during development of the rule and .ssociated guidance, as well as during review of the Medical Policy Statement, the NRC staff was directed to consider the following issues:
- 1. Focusing Part 35 on those procedures that pose the highest risk.
- 2, Regulatory oversight attematives, for diagnostic procedures, that are consistent with the lower overall risk of these procedures.
- 3. The best way to capture not only relevant safety-significant events, but also precursor events:
- 4. The need to change from the term " misadministration", to " medical event" or other comparable terminology.
- 5. Redesigning Part 35 so that regulatory requirements for new treatment modalities can be incorporated in a timely manner.
- 6. Revising the requirement for a quality management program (10 CFR 35.32) to focus on those requirements that are essential for patient safety.
- 7. The viability of using or referencing available industry guidance and standards, within Part 35 and related guidance, to the extent that they meet NRC needs.
The NRC staff discussed items 1-7 and solicited preliminary views from the Advisory Committee on the Medical Uses of Isotopes (ACMUI) at the April 1997 Committee meeting.
[ Transcripts of this meeting are available by contacting the NRC Public Document Room and
,._ _ . - - - - .. . ___a . . - - . _ _ _ __ , , ,
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i .
" on the'Internet (as specified in the reference information provided).) ,
4 The ACMUI discussed their views and recommendations during a briefing of the Commission
[ on May 8,1997. The ACMUI concurred with NRC's position to continue the ongoing medical
- program with improvements, and to decrease oversight of low-risk activities with continued 4
, emphasis of high risk activities. The committee supported the use of professional medical organizations and societies in developing a performance based regulation. The ACMUI recommended consideration'of a quality improvement approach as an attemative to the
!_ present Quality Management Program. Further, the committee recommended, to the
' Commission, that the 1979 Medical Policy Statement be revised to reflect that NRC will l regulate radiation safety of patients only where pstified by the risk to the patients and only where voluntary standards or compliance with the standards are inadequate. The ACMUI i believed that the assessment of the risks justifying regulations should reference comparable i risks and comparable modes of regulation for other types of medical practice. In addition, they believed that the NRC should not intrude into medical judgments affecting patients and
' into other areas that the ACMUI considered to be traditionally a part of the practice of medicine.
This notice initiates a proposed rulemaking action which will culminate in the developmem of a final rule for approval in 1999. In order to provide the public the most effective opportumty to participate in developing the rule text, the Commission is requesting public comment on the issues identified by the questions in this notice and on the ACMUl recommendations within 90 days of the issuance of this notice. Comments received after this initial 90 day period wit! be considered along with the comments received on the proposed text that is anticipated for publication in 1999. However, because of schedule requirements, it may not be practicable for the Commission to consider those comments received after the 90 day period in preparing the detailed proposed rulemaking text. Further, the staff recognizes that the questions are to assist with the formulation of comments and that the commentary received need not be limited as response to the questions presented Rather, the overriding issues are both the identification of necessary changes (additions and deletions) to Part 35 requirements and the assessment of risk for a risk-informed, more performance-based regulation with sufficient oversight of public health and safety. The NRC staff is interested in ideas, proposals, and tomments on the structure and content of a revised Part 35, given the Commission guidance and direction as described above. To the extent possible, commentors are asked to provide specific examples of draft rule language.
Reauests for Comments on General Considerations -
. NRC has identified the following areas of Part 35 for consideration and is seeking comments on these issues, as well as any others, offered for consideration during the revision to Part 35:
- 1. How should the Part 35 requirements be revised to be risk-informed and more performance-based? How should performance be measured to provide both ,
NRC licensees and NRC with an objective basis for determining regulatory !
compliance?
i How should risk be assessed for medical uses and the regulation be modified -l 2.
to focus on procedures posing the highest risk? What quantitative or l l
l
- O qualitative enteria should be considered in determining the " risk" for each modality?
- 3. What oversight should exist for diagnostic procedures that is commensurate with the associated risks?
- 4. What specific events or incidents should be reported to NRC7
[e.g., machine failure, leaking source, software failure, hardware failure) What criteria should be used for determining if the event is reportable (e.g.,
threshold)? Are there modality-specific events that should be reported?
Should the term " misadministration" be changed to " medical event" or comparable terminology?
- 5. How should the regulation be redesigned to incorporate necessary regulatory requirements for new modalities? Should Part 35 be structured such that requirements for a particular modality are grouped together?
- 6. Which Quality Management Program provisions should be re-evaluated and revised to focus on requirements that are essential for patient safety? Are different provisions appropriate for each of the different modalities?
- 7. Which standards and guidance developed by professional societies and other organizations are applicable to NRC-regulated medical uses of radioactive material and how could they be incorporated within the regulatory framework of 4
Part 35 and/or associated guidance?
- 8. How should the issues of training and experience be addressed? What individuals or groups should be subject to such requirements?
- 9. Which new issues / modalities should be incorporated into Part 357
- 10. Should the 1979 Medical Policy Act Statement (44 FR 8242) be modified to n
increase flexibility for a risk-informed, more performance-based approach to medical regulation?
Reference Information
- 1. Strategic Assessment Direction-Setting issues Paper Number 7 is available by writing to the U S. Nuclear Regulatory Commasion, Attention: NRC Public Document Room, Washington, DC 20555-001. [ Telephone: (202) 634-3273; fax: (202) 634-3343).
- 2. The memorandum " Management Review of Existing Medical Use Regulatory Program (COMIS-92-026)" (dated June 16,1993) is available by writing to the U.S. Nuclear Regulatory Commission, Attention. NRC Public Document Room, Washington, DC 20555-001. [ Telephone: (202) 634-3273; fax: (202) 634-3343).
- 3. Radiation in Medicine: A Need for Regulatory Reform (1996) is available from
the National Academy P ess at 2101 Constitution Avenue, N.W., Dox 285, Washington, DC 20055.
- 4. Summary minutes and transcripts of the ACMUI April 1997 meeting or transcripts o'the May 8,1997, Commission briefing are available by writing to the U.S. Nuclear Regulatory Commission, Attention: NRC Public Document Room, Washington, DC 20555-001. [ Telephone: (202) 634-3273; fax: (202) 634-3343].
Transcripts of the May 8,1997 briefing are also available by intemet at http://www.nre. gov.
- 5. The NRC Medical Policy Act Statement of 1979 was published in the Federal Reaister, Volume 44, page 8242, on February 9,1979.
Dated at Rockville, Maryland, this day of May,1997.
For the U. S. Nuclear Regulatory Commission John C. Hoyle, Secretary of the Commission
t I
Enclosure 4 SECY-97-131
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RULEMAKING ISSUE (Information)
June 20, 1997 SECY-97-131 FOR: The Commissioners FROM: L. Joseph Callan Executive Director for Operations
SUBJECT:
CUPPLEMENTAL INFORMATION ON SECY-97115, " PROGRAM FOR REVISION OF 10 CFR PART 35,' MEDICAL USES OF BYPRODUCT MATERIAL,' AND ASSOCIATED FEDERAL REGISTER NOTICE" PURPOSE:
! To provide the Commission with supplemental information and an alternative program for the revision of 10 CFR Part 35.
CATEGORY:
This paper addresses significant rulemaking issues requiring Commission consideration and approval.
BACKGROUND:
On June 5,1997, in SECY-97-115, the staff requested Commission approval of; (1) its proposed program for revising 10 CFR Part 35, associated guidance documents, and the Commission's 1979 Medical Policy Statement, if necessary; and (2) a Federal Reaister notice (FRN) of proposed rulemaking, for publication, to solicit public comments about restructuring Part 35 into a risk-informed, more performance-based regulation.
CONTACTS: Diane S. Flack, IMNS/NMSS NOTE: TO BE MADE PUBLICLY AVAILABLE (301) 415-5681 IN 5 WORKING DAYS FROM THE DATE OF THIS PAPER Susanne Woods, IMNS/NMSS (301) 415-7267 k %f.1 b & D~5 5 ~ '[/P
The Commissioners 2 On June 13,1997, the staff briefed the Commission on its proposed program for revising Part 35 as described in SECY-97-115. In addition, the staff and the Commission discussed an aitemative approach to revising the regulation. The Commission requested that the staff supplement SECY-97115 with a desenption of the attemative approach, as well as with the estimated resources.to complete the rul; making, if this attemative were implemented.
DISCUSSION:
Attachment i describes the staff's attemative approach for revising Part 35 and the associated guidance documents. Under the attemative, the staff would immediately begin preparing proposed rule language and altematives using a ' modality
- approach (Attachment 2). The attemative differs from the program recommended in SECY 97-115 in several respects. First, there would be no formal public opportunity for comment at the beginning of the process. The staff would consider comments and rule language attematives beginning immedia'ely, but the first more formal opportunity for public interactions would be during facilitated public meetings in the fall of 1997. The staff would, under the attemative, provide a proposed rule; associated documents such as the regulatory analysis, environmental assessment, and finding of no significant environmental impact; and the Office I
of Management and Budget clearance package to the Commission in May 1998'. At that l same time, the staff would expect to provide the Commission with draft guidance documents i for each of the proposed rule modaltties, and its recommendations regarding the need for any changes to the 1979 Medical Policy Statement. Following Commission approval, the proposed rule and draft documents would be published for public comment. The legal minimum time for public comment on a proposed rulemaking is 75 days. The staff would expect to provide a final rule, associated documents, and final guidance documents for Commission approvalin May 1999.
Under the attemative, there would be more public interactions than the usual rulemaking and comment process of the Administrative Procedure Act,in the following respects. First, public input would begin immediately and continue throughout the development of the rule attematives and facilited public meetings in the fall of 1997, Consideration of comments would be cut off at a point approximately two-three months before providing the material to the Commission for approval. Rulemaking attematives and drafts would be made publicly available on an ongoing basis, including posting them on an INTERNET page, and the staff would make available the comments received, both in the PDR, and to the extent possible, electronically in the INTERNET. If the attemative revision program described in this supplemental information is approved, staff would revise the Enderal Reaister notice in SECY-97-115 to notify the public of the approved program and the availability of documents on the INTERNET. The staff would continue, as proposed in the original program outlined in SECY-97-115, to solicit commerts and specific rule text proposals from various professional societies. The staff would also continue its proposal to use both consultants, and a working group and steering group approach to the development of the documents. The staff would particularly look into obtaining consultants or other information sources that can provide an indication of the current trends in medical practice, in addition to vigorously using the
'As the staff proceeds with this rulemaking, the staff will be alert to issues or areas where more immediate rulemaking is appropriate.
. -- = .. . .. . _ - _ - , - . . _ - .. . _ _ .
.l I
l i
The Commissioners 3 Advisory Committee on the Medical Uses of Isotopes, RESOURCES:
Resource projection,s associated with revising Part 35 and associated documents for fiscal 1 years (FY) 1998, FY 1999, and FY 2000 were >rovided to the Commission in SECY 97115.
Staff does not anticipate any change in the resources needed, in FY 1998 and FY 1999, to complete the rulemaking effort by May 1999. The primary resource needs are based upon j development of the rule, associated documents, and corresponding guidance. Since this task is unchanged, the resource estimates are unchanged. Since the rulemaking effort would be completed in FY 1999, the resources identified in SECY-97115 for FY 2000 would be used in other areas of the medical program.
RECOMMdNDATION:
That the Commission approve the Part 35 revision program described in the attachment to this document, COORDINATION:
The Office of the General Counsel reviewed this paper and has no legal objection. The Chief Financial Officer and Chief Information Officer have no objection to this paper.
4
, seph Callan
, Ex cutive Director for Operations Attachments:
- 1. Attemative Program for Medical Revision
, 2. Modality Outline for 10 CFR Part 35 DISTRIBUTION:
Connaissioners l MC OCAA OIG OPA
ALTERNATIVE PROGRAM FOR MEDICAL REVISION The following is an attemative program for the revision of 10 Ci'R Part 35, as discussed with the Commission on June 13,1997 The attemative consists of the following program elements.
- 1. The staff would immediately initiate developrnent of draft language and rule attematives, and make these materials publicly available on an ongoing basis, including posting them on an INTERNET page, and would consider comments, suggestions, and other attematives that result from these interactions. Public input would begin immediately and continue throughout the development of rule attematives, facilitated public meetings in the fall of 1997, and development of the proposed rule. The staff would interact with professional societies and the public to solicit, on an informal basis, cornments and rule text. In addition, staff would prepare a Federal Reoister notice to notify the public of the approved Part 35 program and the availability of documents on the INTERNET,
- 2. Per Management Directive 6.3, the staff proposes to conduct this rulemaking using a group approach. Development of rule text attematives, including draft guidance documents, would use a working group (or groups) and steering group approach. The staff proposes to enhance the State participation in the process through the inclusion of State individuals in both the working group and the steering group, This participation would facilitate the Conference of Radiation Control Program Directors' (CRCPD's) development of corresponding rules in its suggested State regulations, and would allow the State staff to focus on potentialimpacts of Nuclear Regulatory Commission draft language on the regulation of non-Atomic Energy Act materials used in medical diagnosis, treatment, or research in the States.
- 3. Facilitaied pubHc round table meetings in the fall of 1997 would be used to focus discussion on specific rule text and attematives. Discussions would also be held in meetings with the Advisory Committee on the Medical Uses of isotopes (ACMUI), and with the Organization of Agreement States. The exact timing of the meetings would depend on the process to convene and facilitate these meetings, but it is expected that the meetings could be conducted in the late September to November 1997 timeh ame.
- 4. Based on the informal and formal public interactions, the staff, using the working group and steering group approach, would develop the proposed rule and associated documents including the regulatory analysis, environmental assessment, finding of no significant environmental impact, and Office of Management ar'd Budget clearance for Commission review and approval. The staff would also develop draft guidance documents for each medical modality of the proposed rule, for publication as drafts for comment, in parallel with the proposed rule, and would provide for Commission consideration, any recommendations regarding citanges to the 1979 Medical Policy Statement. During the development process, the staff would continue to make drafts publicly available, but would need to cut off consideration of comments at a point approximately two-three months before providing the material to the Commission for approval. Comments received after that time would be considered as part of the ATTACHMENT 1 I
~
s
2 ongoing interaction process, and as part of the comments received during the formal public comment period on the proposed rule after Commission approval.
S. Following Commission approval, the proposed rule and draft documents would be published for public comment. The legal minimum time for public comment on a proposed rulemaking is 75 days. The staff would make the drafts available on the INTERNET, and would accept comments electronically. The staff would also hold two public meetings, during the formal comment period, to facilitate comments.
- 6. Development of the final rule, associated documents, and final guidance would be through the working group and steering group. The staff would continue to make draft documents available, but would not be able to consider further extemal input -
beginning approximately four months before the submission of the final documents for i Commission approval. The staff would discuss the final documents with the ACMUI, and wi* the Agreement States, prior to submission to the Commission. The staff would expect to provide the final documents for Commission approval in May 1999.
ATTACHMENT 1
ALTERNATIVE PROGRAM FOR REVISING 10 CFR PART 35.
ASSOCIATED GUIDANCE DOCUMENTS , AND THE 1979 MEDICAL POLICY STATEMENT ,
3Q98 i 4Q98 SQ99 2099 4Q97 1Q98 2098 2Q91 3Q97 Jul l Aug l Sep Oct l Nov l Dec Jan l Feb l Mar Apr l May Jan l Feb l Mar Apr l May l Jun May l Jun Jul l Aug l Sep Oct l Nov l Dec Tash Name y Staff Development of Proposed Rule and Draft Guidance Documents Staff Development of .
Y .
Proposed Rufe and Draft j Informal Pubtle Interactions y informalPublicinteractions Facilitated Pubtle Meetings Facilitated Public IWieetings r
Commission Review' Approval Commhslon RehAmt Dran Rule Draft Rule . .___
Public Comment-Proposed Pube.c Comment-Proposed Rufe Rule -- - -- -
y Staff Development of Final Staff Development of Final Rule and Guidance Documents y Rule and Gutdance _ _ _ .
Submit to Commisske for Approval 5 Submit toCommission for Approval--
d MODALITY OUTLINE FOR 10 CFR PART 35 in developing the revisions to 10 CFR Part 35, the staff proposes to move the rule to an entirely modality based approach, as discussed with the Commission on June 13,1997. This approach is described briefly below.
Part 35 is currently a mixture of modality specific requirements, and generally applicable requiraments. The sta.1 proposes to mexamine the current divisions, and, based on risk, develop a set of requirements that are spet,$c to each modality. At this time, the staff anticipates that the following modalities would be addressed:
- 1. Iow-dose unsealed materials (diagnostic nuclear medicine);
- 2. high-dose unsealed materials (nuclear medicine therapy);
- 3. Icw-dose sealed source applications;
- 4. teletherapy;
- 5. high-dose-rate remote afterloaders;
- 6. gamma stereotactic surgery; and
- 7. emerging technologies.
The above list is not viewed as aff-inclusive. Additional categories may be developed, depending on the breadth of the areas to be covereo. and the similanty of requirements in a given area.
The modality approach envisioned would place all requirements for a given type of treatment into a single section of the regulation, including who or what organization is licensed; what type of license is issued; the necessary technical requirements, such as surveys and calibration; the training and experience requirements; the event recording and reporting recuirements; and the quality improvement and management objectives. Thus, requirements can be tailored more specifically for each modality (as listed above), with those posing lower risks having fewer or simpler requirements, and those posing higher risks having correspondingly more stringent requirements.
The advantage of organizing Part 35 to be entirely modality-driven is that the rule can be modified to incorporate new modalities by simply adding a new subpart to address the activity. The staff envisions that new approaches would initially be licensed under the emerging technologies modaiity, where the rule requirements would be generalin nature, and the specifics would be contained in license conditions. As experience was gained in the regulation of that modality, a rulemaking to add a new subpart to address the specific modality could then be undertaken, and there would be no need to revise the regulations for the other modalities.
The downside of the modality approach ls that there would need to be some repetition between the subparts, since some of the requirements would be similar for at least some of the modalities. However, the staff believes at this time that this type of organization would make for a more flexible and usable regulation.
ATTACHMENT 2
2 The following is a set of questions that have been developed for determining the contents of each modahty section. This list is not intended to be all-inclusive.
- 1. Who and/or what (e.g., facility) should be licensed?
- 2. What type of license (e.g., is registration a possibility)? -
3.' -What terms sihould be defined?
- 4. Should there be an operations 1 definition of ' adequate protection,'such as performance criteria or a " safety goal *?
- 5. What are the " technical issues
- that should be addressed (e.g., surveys, calibration, access controls, etc.)?
- 6. What training and experience (T&E) is necessary for what types cf personnel involved in the modality?.
- a. Should T&E include not only physicians and radiation safety officers, but associated professional personnel (e.g., medical physicists)?
- b. Should the focus of T&E be radiation safety or extend to rnedical or other l credentials? Is it sufficient to simply require the requisite licensure and credentials required by the State, for the medical specipity being practiced?
- c. Are there needs to maintain qualifications and undertake periodic requalifications?
- 7. What duties and responsibilities should be set forth, and for which personnel?
- 8. What reports of ' safety significant" medical events or ' precursor" events should be required?
- 9. What should be the necessary Quality Managemt.nt ot,jectives that are essential for patient safety? Are there any additional specifications needed in addition to the basic objectives?
- 10. What records should be kept?
- 11. - What provisions relative to enforcement should there be?
- 12. - What provisions for amendments, renewals, exemptions, etc., should be included in the rule?
- 13. What, if any, provisions are needed for the protection of human research subjects?--
- 14. Are there industry guides and standards available that either the regulation or guidance can rely on?
' 15. What interactions are there with other regulations, particularly 10 CFR Parts 20,30, 32, and 33?
ATTACHMENT 2
ea,-
0 4 l
l Enclosure 5 SR-SECY-97-115 i
_ Action: Paperiello,NM1S_
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[ -
1., -
UNITED STATES NUCLE AR REGULATORY COMMISSION Cys: Callan
- f. o on y wAssiNotON, D C 20555-0001 g
Norry
/ June 30, 1997 Blaha Thadani, RES OFFICE OF THE g3nggpg, gp s(cast ^" Shelton, CIO Meyer, ADM CHaney, NMSS SWoods. NMSS MEMORANDUM TO: L. Joseph Callan Exec 'v VD e tor for Operations FROM: JohW . Huy e, Secretary
SUBJECT:
STAFF REQUIREMENTS - SECY-97-115 - PROGRAM l FOR REVISION OF 10 CFR PART 35, " MEDICAL USES j OF' BYPRODUCT MATERIAL" AND ASSOCIATEO FEDERAL REGISTER NOTICE f
The Commission has approved the staff proposal to revise 10 CFR Part 35 consistent with the alternative program proposed in SECY-97-131 and subject to the following comments. ,
- 1. The staff should not only consider what regulations will be affected by the change to Part 35, but should also take a close look at existing guidance and draft guidance to determine what changes would be needed. To. ensure that all regulatory rulemaking and guidance development potentially affecting medical uses will be consistent with the Commission's direction in DSI 7, the staff should identify in the public meetings and Federal'Reoister notices all regulatory actions and proposed actions relating.to or affecting Part 35 licensed' activities. When appropriate,.
public comment-should be invited.
- 2. The staff should continue to solicit input from members of the pealic to' ensure, to the degree possible, that all inter sts are represented. The staff should include grcups representing radiopharmacists and medical technologists, and other experts,-as appropriate.
- 3. The staff should prepare alternatives with specific rule textLto help focus the discussion during the first-round of facilitated meetings and assist the staff in developing draft rule language for publication and comment.
-SECY NOTE: SECY-97-115 WAS RELEASED TO THE PUBLIC ON JUNE 17, 1997. THIS SRM, SECY-97-131, AND THE COMMISSION VOTING RECORD CONTAINING THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.
, Nf
2-
- 4. The staff should look for potential resource savings (FTE, consultants, and funds) that can be achieved through use of the internet, teleconferencing, etc. In making documents available over the internet, some caution should be exercised to ensure that the number of and versions of available documents for comment are not so large and varied that they will overwhelm commenters and lead to confusion on the part of the staff and management responsible for the rulemaking.
A Federal Recister notice and press release should be issued reflecting the approach outlined in SECY-97-131, attachments 1 and 2, and published in time to support the facilitated public meetings.
-(4994- (NMSS) (SECY Suspense: S 45/SIL) 9700065 8/29/9/
cc: Chairman Jackson Commissioner Rogers f Commissioner Dicus Commissioner Dia:
Commissioner McGaffigan OGC CIO CFO OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
no naoo y
/ 'g UNITED STATED
, NUCLEAR REGULATORY COMMISSION
? g WASHINGTON. D C. 20655-0001
% * * * * * ,o June 30, 1997 ,
ore Cs or THE !
SECRETARY COMMISSION VOTING RECORD DECISION ITEM: SECY-97-115 TITLE: PROGRAM FOR REVISION OF 10 CFR PART i 35, " MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED EEDERAL REGISTER NOTICE The Commission (with all Commissioners agreeing) disapproved the staff proposal as contained in this paper, but instead approved the alternative approach provided in SECY-97-131,.as recorded in the Staff Requirements Memorandum (SRM) of June 30, 1997.
This Record contains a summary of voting on this matter together with the individual vote sheets, views and comments of the Commissioners, and the SRM of June 30, 1997.
[ s g4hn C. Hoylb Secreftary of the Commission attachments:
- 1. Voting Summary
- 2. Commissioner Vote Sheets
- 3. Final SRM cc: Chairman Jackson Commissioner Rogers Commissioner Dicus Commissioner Diaz Commissioner McGaffigan OGC EDO PDR DCS
{) h
-a s.
VOTING
SUMMARY
- SECY-97-115 RECORDED VOTES NOT APRVD DISAPRVD ABSTAIN PARTICIP COMMENTS DATE CHRM. JACKSON X X 6/27/97 L'
COMR. ROGERS X X X 6/25/97 COMR. DICUS X X 6/30/97 6/26/97 i
COMR. DIAZ X X COMR. McGAFFIGAN X X 6/26/97 f0MMENT RESOLUTION In their vote sheets, all Commissioners approved alternative.
approach provided in SECY-97-131 with some additional comments.
Subsequently, the comments of the Commission were incorporated
~
-into the guidance to staff as reflected in the-SRM issued on June 30, 1997.
k I
NOT ATION VOTE ,
. RESPONSE SHEET TO: John C. Hoyle, Secretary FROM: CHAIRMAN JACKSON
SUBJECT:
SECY 97-115 - PROGRAM FOR REVISION OF 10 CFR PART 35," MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL REGISTER NOTICE Approved Disapproved xx Abstain Not Participating Request Discussion COMMENTS:
I disapprove the original program to revise 10 CFR Part 35,' Medical Uses of Byproduct Material' proposed in SECY 97-115; however, I approve the attemative program proposed in SECY 97131.
b '
SIGRATGRE June 27, 1997 Release Vote /XX /
DATE Withhold Vote / /
Q Q y Q O ,$.1 j f ", "-
l 3
l NOT ATION VOTE I
BFJPONSE SHEET TO: John C. Hoyle, Secretary FROM: COMMISSIONER ROGERS SECY 97115 PROGRAM FOR REVISION OF l
SUBJECT:
l 10 CFR PART 35," MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL BJgl STER NOTICE w
Approved" sh'ME' Disapproved"r%" Abstain Not Participating Request Discussion i
COMMENTS: rec ,+ rre s t< u e"7 k-SIGNATURE Q Release Vote / x / b '2 f. U P 7 DATEL)
Withhold Vote / /
x No Entered on"AS" Yes
)WLOD&R ? v i
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Commissioner Rogers' con.;aents on SECY-97-115 and SECY 97 131:
l 35 I approve the staff's program for revision of 10 CFR Part l
l as described in the attachment to SECY 97-131 and subject to the following comments The facilitated meetings should be focussed not so much on alternative rule text as on concrete, alternative approaches for ,
I resolving discrete, specific, long standing areas of controversy related to Part The meetings should be preceded by distribution of a35.
paper which identifies and, in an even-handed way, discusses these issues and alternatives for resolving them in a rulemaking context. The paper should convey the sense that the NRC is open to alternstives that may develop during workshop discussions.
To 111ust:ste my thinking, I would appeal to the same example that I mentioned in my ccmments on SECY-97-054.
Specifically, It seems clear that an essential aspect of a OM program is a set of procedures to assu., that the patient is given the 'right' dose. What is not so clear and has been an area of contention is how close tae delivered dose must be to the prescribed dose for it to be the 'right' dose. I believe that we might learn some important considerations from a full airing of this issue in a facilitated meeting.
I would expect that actual rule text could be developed quite quickly af ter the meetings and I would hope that the meetings could be moved forward in time by focussing them ontext.
issue resolution rather than the detailed wording of draft In any case, I believe the discussions would be more fruitful for NRC.
I disapprove publication of the Federal Register notice.
$C0--
/ sr/t7
NOTATION VOTE RESPONSE SHEET T0: John C. Hoyle Secretary of the Comission FROM: COMMISSIONER DICUS
SUBJECT:
SECY 97 115 PROGRAM FOR REVISION OF 10 CFR PART 35, l "HEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL REGIIIEB NOTICE l
Approved XX Disapproved Abstain l Not Participating Request Discussion COMMENTS:
SEE ATTACHED
.l k -
f *
,JIEN_ATURE
/
Release Vote /J 7 d/M l7 DATE Withhold Vote / /
Entered on "AS" Yes L No
"-f1N, LOD awe'
ROMMENTS OF COMMISSIONER DICUS ON SECY 97115 l
l approve staffs program to revise Part 35 as modified by the supplemental information in SECY 97131 subject to the following actions:
- 1) The staff should not only consider what regulations would be affected by the revised Part 35, but shouH also take a close look at existing guidance and draft guidance to determine what changes would be needed. To ensure that All regulatory rulemaking and guidance development potentially affecting medical usea will be consistent with the Commission's SRM on DSI 7, the staff should identify in their public meetings and Federal Register notices all regulatory practices end proposed actions relating to or affecting Part 35 licensed activities. For example, draft Regulatory Guides for licensing of the production and distribution of radioactive materials used in mealcine may need revision. When appropriate, public comment should be invited.
- 2) When soliciting comments, the staff should include groups representing radiopharmacists and medical technologists.
I
NOT ATION VOTE RESPONSE SHEET TO: John C. Hoyle, Secretary FROM: COMMISSIONER DIAZ
SUBJECT:
SECY 97115 - PROGRAM FOR REVISION OF 10 CFR PART 35," MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL REGISTER NOTICE Disapproved Abstain Approved \,~
Not Participating Request Discussion COMMENTS:
I concur with the approaches presented in SECY:97-131 with the proviso that staff should look for resource savings (FTE. consultants, and funds) that can be achieved through the use of the internet, teleconferencing, ect.
J l$
SIGNATOR'E' V
}
ReleaseVote / V / C-2b'97 DATE Withhold Vote / /
Entered on "AS" Yes No M}@S T
, e N OT ATIO N VO~ E RESPONSE SHEET TO: John C. Hoyle, Secretary FROM: COMMISSIONER MCGAFFIGAN
SUBJECT:
SECY 97-115 PROGRAM FOR REVISION OF 10 CFR PART 35," MEDICAL USES OF BYPRODUCT MATERIAL" AND ASSOCIATED FEDERAL REGISTER NOTICE
(,jg sicV- 17-f 3h Approved i Disapproved Abstain Not Participating Request Discussion COMMENTS: g g/J ,
SIGNATURE h f/n ,, .
lvu V ReleaseVote /x / C !)G f 9 7 DATE j Withhold Vote / /
Entered on"AS" Yes x No
~
i }Q}.i. DO ( 3}
X MilSS10NER McGAFFIGAN'S COMMENTS ON SECY 97 115 AS SUPPLEMENTED 3Y SECY-97-131:
L 1 approve of the staff's plan (including the modality a time line for revising Part 35 as described in SECY 97131 pproach) since itand proposed meets the time line and goals established by the Comission in the SRM on DS! 7 while providing enhanced opportunities for participation by licensees, professional organizations. the Agreement and non Agreement Ststes, the public, and the ACMUI, indeed, the new staff plan provides more meaningful opportunities for public coments than the previous plan despite saving n1ne months because it will focus the process earlier on real issues as opposed to general discussion which has already gone on for years, I agree with Comissioner Dicus' coments, but I disagree with those of Comissioner Rogers. During the facilitated public meetings. I believe that specific rule text and alternatives, couched to encourage a free flow of
-ideas, will help focus the discussion and assist the staff in developing draft rule language. We should not postpone rule language options until after these meetings.
I also believe that we need to go forward with a Federal leaister notice and press release modified to reflect the SECY 97131 approac1. The heart of these documents would be attachments 1 and 2 to SECY 97 131.
The staff should continue to try and to identify sources of input from members of the public to ensure, to the degree possible, that all interests are represented. As I have noted previously, I found the candid remarks of Robert Adler, a member of the National Academy of Sciences comittee that conducted the medical )rogram study, useful and worthwhile for the Comission as it .
considered tie NAS findings. I suggest that we include Mr. Adler among the individuals from whom we will specifically solicit comments, I comend the staff for identifying non traditional methods to solicit public comments such as making documents available over the Internet. However, some caution should be exercised to ensure that-the number of, and versions of, available documen+.s for coment are not so large and varied that they vill overwheln comenters and lead to confusion on the part of staff and management responsible for tl.e iulemaking.
e .
ja Asg
/ UNITED STATES
/ '
n NUCLEAR REGULATORY COMMISSION WASHINGTON O C. 20$$b-0001 o,,,,,e June 30, 1997 opriC orth
$f CRtTARY MEMORANDUM TO: L. Joseph Callan Exec 'v D e tor for Operations FROM: Jo / . Hoy e, ry
SUBJECT:
STAFF REQUIREMENTS - SECY-97-115 - PROGRAM FOR REVISION OF 10 CFR PART 35, " MEDICAL USES OF BYPRODUCT MATERIAL AND ASSOC".TED FEDERAL REGISTER NOTICE The Commission has approved the statf proposal to revise 10 CFR Part 35 consistent with the alternative program proposed in SECY-97-131 and subject to the following comments.
- 1. The staff should not only consider what regulations will be affected by the change to Part 35, but should also take a close look at existing guidance and dre.ft guidance to uwtermine what changes would be needed. To ensure that all regulatory rulemaking and guidance development potentially affecting medical uses will be consistent with the Commission's direction in DSI 7, the staff should identify in the public meetings and Federal'Reciater notices all
, regulatory actions and proposed actions relating to or j affecting Part 35 licensed activities. When appropriate, public comment should be invited.
- 2. The staff should continue to solicit input from members of the pablic to ensure, to the degree possible, that all interests are represented. The staff should include groups representing radiophamacists and medical techncicgicts, and other experts, as appropriate.
- 3. The staff should prepare alternatives with specific rule text to help focus the discussion during the first-round of facilitated meetings and assist the staff in developing draf t rule language for publication and cottunent.
SECY NOTE: SECY-97-115 WAS RELEASED TO THE PUBLIC ON JUNE 17, 1997. THIS SRM, SECY-97-131, AND THE COMMISSION VOTING RECORD CONTAINING THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE. PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.
t}l-0-P f N N
o s 2
- 4. The staff abould look for potential resource savings (FTE, consultants, and funds) that can be achieved through use of
-the internet, teleconferencing, etc. In making documents available over the -internet, some caution should be exercised to ensure that the number of and versions of available documents for comment are not so large and varied that they will overwhelm commenters and lead to confusion on the part of the staff and management responsible for the rulemaking.
A Federal Reciater notice and press release should be issued reflecting the approach outlined in SRCY-97-131, attachments 2 and 2, and published in time to support the facilitated public l meetings.
(EDO) (SECY Suspense 9/5/F7) cc Chairman Jackson Commissioner Rogers Commissioner Dieus Commissioner Diaz Commissioner McGaffigan OGC CIO CFO OCA OIG.