ML20058M521
| ML20058M521 | |
| Person / Time | |
|---|---|
| Issue date: | 08/08/1990 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| TASK-PII, TASK-SE SECY-90-275, NUDOCS 9008100155 | |
| Download: ML20058M521 (10) | |
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r RELEASED TO THE PDR l
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f August 8, 1990 SECY-90-275 F_or:
The Commiss1 7
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James M. laylor Executive Director for Operations
Subject:
IMPLEMENTATION OF THE MEDICAL VISITING FELLOWS PROGRAM
Purpose:
This paper informs the Commission about the implementation and administration of the Medical Visiting Fellows Program (MVFP) described in SECY-89-295. is a Federal Register Notice dated June 7, 1990, outlining a number of program items designed to initiate implementation of the MVFP, and soliciting nominations. contains a summary of key milestones associated with the administration of the MVFP, their expected completion dates, and lead Offices.
This paper also responds to comments from the Commissioners contained in a memorandum from Samuel J. Chilk, of October 20, 1989, regarding the development of the MVFP.
The responses of the staff are found in Enclosure 3.
Discussion:
The U.5. Nuclear Regulatory Commission (NRC) intends to expand its understanding of the regulated community through a MVFP.
The objectives of this program are to improve NRC's knowledge of the medicel community; to keep abreast of new technology and oevelcoments in the diagnostic and therapeutic uses of isotopes; to develop an awareness of the socio-economic factors governing health care; to develop and sustain a base of experienced individuals familiar w';h the regulatory environment; to improve NRC's regulatory process; and to develop medical use regulations that minimally intrude into medical practice.
The program is primarily seeking physicians with expert backgrounds in nuclear medicine or radiation oncology.
Others, having expert qualifications in related fields such as diagnostic radiological physics, therapeutic radiological physics, or radiopharmecy are also invited to apply as Medical Visiting Fellows.
Contact; Janet Schlueter, Nii55 492-0633 A
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Nominees might be on sabbatical or interested in conducting.
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graduate, post graduate, or post-doctural research, or job 4
related work consistent with the needs and interests of'the;
'NRC.
A collateral NRC goal'is to create a cadre of individuals with knowledge and experience in the regulation of the.
medical use of isotopes.
As a result, the NRC will likely ask former Fellows to participate, from time to time, in meetings 1"
and sem.inars to provide advice and consultation about the regulated program, the.MVFP, or related areas of interest.
The staff will incorporate language into each individual's MVFP agreement indicating that the Fellow should be willing.to meet and confer with the NRC and other Fellows in future.
meetings and seminars at the request of the Commission.
Individuals participating in-the MVFP would join the NRC for approximately one year, to undertake activities consistent-with the interests and needs of the NRC and the individual's j
-professional experience. =Appointmenti, may be-lengthened upon mutual agreement by the NRC and the Fellow.
The key. elements associated'with administration of the MVFP.
r have'been designed to ensure that tht program is meaningful for both-the Fellows and the Commission.
The following'paragraphso describe the process that the staff will follow-to implement and administer the program:
Procedures for receipt of nomination peckets The NM',5 Project Manager will receive and log the nomination'
- pachts, The Project Manager will review'each packet for cc;apleteness and forward a letter acknowledging receipt of F
the packet to the' applicant'in a timely manner.
Evaluation panel The NMSS Office Director will' establish an evaluation panel and appoint its_ members.
The panel will consist of three to five individuals from higher-level NRC management representing several agency Offices, and the Project Manager.
The NMSS l
Office-Director will chair the panel.
As an early and integral part of the panel's evaluation, the Office of the General Counsel will be consulted and will provide advice on all prospective candidates with regard to conflict of interest i
issues.
Review of nomination packets by the panel Within 30 days of the close of the nomination period described I
in the Notice, the evaluation panel will complete a review of each applicant, primarily on the basis of the packet submitted.
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Coordination with the agency host Office-for the development of the work project or product Within 60 days of the close of the nomination period described in the Notice, the panel will identify prospective:
7 candidates,.if any.
As a resulti during initial negotiations with the appr'opriate host Office, the panel will identify each work project,' and if applicable, an' expected product. - The.
host Office is not limited to NMSS and might' include other Of fices, such as, the Office of Nuclear Regulatory Research.
The development of each work project will be based on the i
. individual applicant's professional experience and the i
needs of the Commission at that' time.~
For example, in one-t project a Fellow could investigate the emerging trends i.n'
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Nuclear Medicine, or Radiation Therapy and.related radiological safety considerations._ A few examples of new trends of-interest include the following: the use of monoclonal antibodies in diagnostic and therapeutic administrations; the j
use of high activity brachytherapy afterloaders; and the use of--
i the gamma knife device for the treatment of intracranial tumors.
An example of a work product, might be an analysis of the I
o status of monoclonal antibody research, research issues that
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need to be resolved before it achieves wide-spread use',
i projections as to when this might be achieved, identification of ' licensing issues for routine use that; nee'd to be resolved, and proposed special licensing requirements such as, training, radiation safety precautions, quality assurance requirements, etc.
i Negotiations with selected individual (s)
The development of a work project and product will include an interview-of candidates by the NMSS Office Director and others as deemed appropriate, and'an initial negotiation ~with each prospective candidate.
The host Office and the Office of Personnel will-submit' specific guidelinet which will be tailored to: incorporate expertise offered by each individual.
In addition, during the interview the~0ffice of Personnel i
1 will explain NRC procedural commitments (e.g. drug testing).,
Recommendations forwarded to EDO for approval
'The panel will submit to the EDO, for approval, those candidates it recommends within 90 days of the close'of the nomination period identified in the Federal Register Notice.
Candidate selection and notification process Upon ED0 approval, the staff will notify the candidate (s) in order to proceed with final negotiations with the host Office and the Office of Personnel.
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Commencement of term of appointment The Project Manager will: continue to participate by ensuring _
.that the Office of Personnel and the' host Office complete-c placement of each Fellow, handling the responsibility for all daily administrative matters, and identifying a host Office staff member to coordinate the work project and product, if appropriate.
3 Solicitation of' additional candidates The _ staf f will periodically publish Federal Register Notices announcing a call for nominations for the MVFP.
The timing of these Notices will be determined by the timing of the end date of each Fellow, the number of Fellows currently participating in the MVFP, the'needs of the Commission at that-time, and the availability of qualified applicants.
Actions ~Taken:
The Federal Register Notice published on June 7,1990, 3
-announcing a call for nominations of Fellows, described a1 number of program items designed to initiate implementation of the MVFP.
These items include the following:
Objectives of MVFP, Appointment Method, Term of Appointment, Compensation, Duty Location and Travel, Eligibility Requirements, How to s
Nominate, Where to Submit Nominations, and Date Nominations
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i Are Due.
The call for nominations closes August 31, 1990.
In addition to publication of the Federal Register Notice
~j on JuneL7,-1990, copies of the Notice have teen distributed to all medical use program licensees.
Copies have also been' given to_the Office of State Programs for distribution to Agreement States and Agreement State licensees.
To ensure t
wide distribution, the staff sent copies to=approximately 4
200 organizations and individuals who may have an interest in i
the.MVFP, and placed copies in: professional journals such as Scanner, published by the American' College of Nuclear Physicians and Newsline, published by the Society of Nuclear Medicine.
Copies of the Notice were also made available at the Society of Nuclear. Medicine's 37th Annual Meeting,' June 19 to 22, 1990, held in Washington, D.C.
1 As a result of this Federal Register Notice, the receipt of nomination packets has commenced.
Consequently, the program is underway with the staff focus primarily on administration of_the MVFP.
However, at present, the staff has no. indication of the kind or number of nominations it will receive.
Therefore, the number of candidates selected will depend on the:
range of disciplines involved, and the types of activities that L
can be assigned.
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,5 Coordination:
This paper'has been coordinated.with the Office of.the General Counsel,.and'that office has no legal objection.
,.w J.es M. Ta or xecutive Director for Operations
Enclosures:
. 1.1-FRN 2.: ' Key Milestones of program mgmt.
3.
Responses.to-comments'from the OCM contained-in a memo of 10/20/89.
DISTRIBUTION:
- Conunissioners OGC IG GPA-REGIONS
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- ASLBP ASLAP SECY
Fedesst Radster / Vol. 65, Ns.110 / Thursday. June F. teso / Notices 33321 1
' essentnadens far Ylstung Possue participate in puelic meetings and also be considered based on the needs Program seminars sponsored by NRC for of NRC and h individual's interests.
seassev: Nuclear Regulatory exchanging information and discussing Now to Nominate, Candidates ma Commisalon, issues, of mutual interest, that will nominated by professional groups. y be benefit h regulation of medical acviess Callfor nominations, practice. A collateral NRC goal is to medical societies, govemment agencies, create a cadre ofindividual with or may be self. nominated. Nominations must peovide the nominee's current susmaanyt he Nuclear Regulatory fu n'o'f address and telephon n and e
calus thfulon (NRC)is inviting nominations of physiciana, bevin6 lootopes: therefore, it is likely that I"
"8 expert qualifications la the medteal former FeDows may be asked to educational and professional specialty fields of Nuclear Madision or particpate. from time to time, in NRC.
qualifications of h nominee. A brief Radiation Oncology, to apply as Vlatting sponsored meetings and seminars after statement of the individual's Fellowe. Othere hastag expert their appointments end, to provide Profeestonal objectives should also qualificauons in related fields such as advice and consultauon about the included.
Diagnooltic *-M "' Phyelos, regulated program.
Whm to Subm/t Nom /not/ons.
nerapeutic Radiological Physica er herefore, NRC is primarily soliciting Submit nominations to: Secretary of the Radiopharmancy are also invited to nominations of physicians involved with Comminion. ATTN: Visiting Fellows
- apply, the medical use of todioisotopes, but Management Of!1cer U.S. Nuclear will be pleased to recelve nominations Regulatory Commission, Washington, supetassustrany esposumatsose of other radiation health professionals DC 20555.
Ob/ect/res. NRC le see to axpand and medical radiation specialists to its understanding of the ted serve in the VFP.
Date Nom / notions Are Due.
community by creating a program for Appointment Afethod. Appointments Nominations are due to the Secretary of Visiting FeDows,ne objectives of this will be made by means of the Commission by August 31.1990.
prograro are to treprove NRC's IntergovernmentalPersonnel Act
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knowledge of the medical community; to entsnment, reimbursable detail, or James H. Myers, Medical, Academic, keep abreast of new technology and professional term oppointment, and Commercial Use Safety Branch, developments in the diagnosuc and depending on the selectee e situation.
Mail, Stop: eH3, U.S. Nuclear Regulatory therapeutic sees of isotopes; to develop Term of Appointment he term of Commission, Washington, DC 20555.
an awareness of the socio oooncenic factore governing health caret to develop appcintment will be approximately one telephone (301) 492-0637, year, Appointments may be lengthened.
D*l'd At 88'hvilis, Maryland, tius 3tst day and sustain a base of experienced depending on the depth and scope of the oiM*Y 1884 Individual familar with h regulatory Fellow's pro}ect, to approximately two For the Wclear Regulatory Commission.
enytromment: to improve NRCs yeart.
regulatory process and to develop -
John g. Cleon, medical use regulations that misstaaDF Compensorion. Visiting Fellows will intrude tage modscal peactice. He receive compensauon commensurate c33,/. Medical. Academic andCommercial vu sof,ry proneA. piwsion o/lndustrroland peogram is open to physicians interested with their experience. salary history and in seeking an oppomtment for individual federal pay guidelinn while serving Mw -!welearSofery,NMSA their appointment. Visiting Fellows win pt Doc +1327t Filed e>.6.co: a as emi sebbetical pursuits. Other specialists on be reimbursed for official travel and a
,,,o w sabbatical. or those who wish to engage relocation expenses.
in post.doctroal research, will also be Duty Locotton ond Trovel. Visiting c:naldered. Individuals participating in Fellows may be assigned to any Office the Visiting Fellows Program (VFP) in NRC, including Office of the would join NRC, for approximately one Commissioners, consistent with the year, to undertake acuvities consistent Mtb the interests and needs of NRC and interests and needs of NRC and the with tne individual's training and individual's training and experience.
experience: and that wiu result in a The duty location is at NRC
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clearly defined assignment useful to lisadquarters One White Flint North, i-NRCs medical regulatory program.
11555 Rockville 1%e, Rockville, ne number of appointments made Maryland 20a52. It is anticipated that will depend on the range of skills there wiu be some trave associated with embodied in the nominations, individual g3, p,,ig,*
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interests and the needs of NRC Eligibih.tyRequirements. NRC is an in addition to a specific assignment or equal opportunf ry employer. Mominees research project, it is anticipated that must be U.S. citizens. Nomiees must also the Fellow would attend meetings of satisfy applicable NRC security, conflict NRCs Advisory Committee on the of interest, and drug. free work place i-Medical Use of Isotopes (ACMUT),
standards. Eligibility is open to Federal. State, and local agencies:
physicians specializing in Nuclear I
professional organizations: and groups, Medicine or Radiadon Oncology, l
to participate in discussions on issues Diagnosuc Radiological Physicists.
related to medical affairs and radiation Therapeutic Radiological Physicists and l
medicine.He selectee may also Radiopharmacists. Other nominees. will ENCLOSURE 1
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a KEY MILESTONES 0F MEDICAL VISITING-FELLOWSLPROGRAM (MVFP) AND-e c
RESPONSIBLE OFFICE y
Objective Office Completion Date*
Draft Federal-Register Notice NMSS May 1, 1990 and submit:to E00 Federal Register Notice approved-E00 M:y 30, 1990 Federal Register. Notice published Fed. Reg.
June 7, 1990 MVFP Commission Paper due NMSS NMSS July 19, 1990 t
MVFP Commission. Paper due EDO NMSS July 26~, 1990 I
MVFP Appointment Panel Identified NMSS/0P August 15, 1990 4
Nominations ~Cicse NMSS August 31, 1990-Nomination. Assessment Begiris NMSS/0P September 3, 1990 Interviews with selectee (s) and NMSS/0P October 31', 1990 initial negotiati'ns o
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Nomination Assessment' Closes NMSS/0P November 15, 1990
.. Panel recommendations forwarded to E00 November 30,11990 1
EDO for approval
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.Hotification:of selectee NMSS/E00 December 31,11990 i
Selectee acceptance, project-definition, NMSS/0P January 31, 1991 j
final 2 negotiation and_ clearance processing Fellow on Board OP To Be Determined E
- Note: All dates are representative and may change due to programmatic needs.
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-l ENCLOSURE 2 l
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l STAFF RESPONSES-TO COMMENTS FROM THE COMMISSIONERS CONTAINED IN A SECY MEMORANDUM DATED OCTOBER 20, 1989 Comment No. 1:
The staff is encouraged to pursue potential assignments for a Visiting Fellow in areas of emerging medical technologies and procedures where the Commission needs to concentrate efforts to ensure that the regulations are adequate for future medical applications.
STAFF-RESPONSE:
q As directed by the Commission, the staff has pursued potential assignments
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.for the MVFP, The staff has discussed the matter with representatives of professional societies, Federal agencies and services, and individual physicians.
The staff believes that there are several types of individuals willing to participate in the MVFP.
There are projects that may be undertaken that
,4 are consistent'with tne individual's training and experience and the interests and needs.of the NRC.
For example, the Commission could benefit from a nuclear medicine or radiation therapy physician's knowledge and experience in the area of quality assurance, monoclonal antibody therapy, gamma knife therapy, or high activity brachytherapy afterloaders.
A nuclear medicine physician, or a radi0 pharmacist, could work on a project related to physician-ordered modifications of the radiopharmaceutical manufacturer's instructions for the reconstitution of reagent kits or the use of radiopharmaceuticals.
These individuals could also address the issue of compounding radiopharmaceuticals.
The Commission could also benefit from the work of a medical radiation physicist for teletherapy units and/or brachytherapy devices.
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Comment No. 2:
The fellows program should contain language th.t states that it is the Commission's expectation that a fellowship retipient will be willing to participate in possible future meetings and seminars sponsored by the NRC for the purposes of maintaining contact with the alumni of the program and exchanging professional information of mutual interest.
Over time a group of past fellowship holders could be a very valuable information resource to the NRC and it seems appropriate to ask potential fellowship candidates to make a non-binding commitment to meet and confer, from time to time, with the NRC and other fellows.
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STAFF RESPONSE:
The staff has addressed this area of concern by establishing a collateral MVFP goal to create a cadre of individuals with knowledge and experience ir. C'e regulation of the medical use of isotopes.
Therefore, former Fellows wil! 5-asked to' participate, from time to time, in meetings and seminars, aftei 2he4r appointments end, to provide advice and consultation about the.'egulatcG p 'ogren..
The staf f will incorporate language into the MVFP agreement, indicating that the Fellow is willing to meet and conf er with the NRC, and other Fellows, in the
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Comment No. 3:
The U.S. Public Health Service should be included as one of the organizations participating in the program.
As a federally funded, non profit, service-oriented entity, their members could provide a unique perspective on
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the practice of medicine.
STAFF RESPONSE:
-The staff. contacted members of the U.S. Public Health Service (USPHS)'and discussed the concept of the MVFP.
Although the USPHS physicians could provide a: unique perspective on the practice of medicine, most USPHS physicians are not specialized in nuclear medicine or radiation oncology.
USPHS physicians
.may, however, be able to contribute to projects related to broad issues such as ~ industrial hygiene, referring physicians, Federal medical programs, and emergency medical response capabilities in incidents involving nuclear materials.
Comment No. 4:
.Since the paper mentions that the program costs are expected to be j
accommodated through reallocations of planned program support funs., the t
Commission should be informed on whether the " user-fee" concept applies and if so, how.
STAFF RESPONSE:
Most of the' costs for the MVFP are expected to be accommodated through reallocations of plannea program support funds.
Fellows will not work on fee-chargeable casework, but they may follow such work in parallel as part of their work activity.
Indiviouals participating in the MVFP would
' join the NRC, to undertake activities consistent with the interests and needs of
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the NRC and.the individual's training and experience.
Their participation'will; result in a clearly defined project, or assignment, useful'to the NRC's medical--
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. regulatory program.- ' Work assignments involving fee-chargeable casework would
' appear to be inconsistent with established goals of the MVFP.
' Comment No. 5:
The staff is encouraged' to pursue the offer of key medical use organizations to provide short-term sabbatical positions for NRC staff. in order.to provide.
j enhanced understanding of ~ the regulated industry as well as valuable current experience.
STAFF RESPONSE:
The~ staff believes that the offer of key medical organizations to proviae short-term sabbatical positions for NRC staff at the. facilities of NRC-medical licensees needsLfurther evaluation. The staff believes that the goals of' enhancing the NRC staff members' understanding of the regulated industry-and maintaining current knowledge of clinical practice can be partially achieved through selective recruiting, additional staff training, and-attendance at national or local medical society meetings and short, one-day to two-week, observation visits arranged with nearby medical institutions.
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benefits to NRC'of-establishing short-term rabbaticals for staff members, must
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be balanced-against the possibility of creating conflict-of-interest situations
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The staff recommends continued discussion with the medical organizations, participating. medical institutions, the Advisory Committee on the Medical Use of Isotopes (ACMUI), Office of Personnel (OP),
Office of the Generai Counsel (0GC), and NMSS to more fully develop this issue.
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