ML20011F490
| ML20011F490 | |
| Person / Time | |
|---|---|
| Issue date: | 02/14/1990 |
| From: | Taylor J NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | |
| References | |
| TASK-PII, TASK-SE SECY-90-047, SECY-90-47, NUDOCS 9003060112 | |
| Download: ML20011F490 (29) | |
Text
,
..p f.,,
1
\\
i..,,
i,:
1 RELEASED TO THE PDR l
....................o.....
\\
./
Jh/lPo.
k 1
n osa ines
%,.....,o POLICY ISSUE February 14, 1990 SECY-90-047 The Comissi(onersInformation)
For:
From:
James M. Taylor Executive Director for Operations
Subject:
ANNUAL REPORT ON MEDICAL USE PROGRAM, 1989 i
Purpose:
To provide an annual report on the Medical. Use Program.
Sumary:
In response to the Comission's request dated August 4, 1988, the staff is providing an annual report on the Medical Use Program.
This report discusses the implementation of the Five-Point Program previously described in SECY-88-77, special-interest topics in the medical use of byproduct materials, and the Medical Use Program's staffing and budget allocations.
Discussion:
Background
In 1988, the staff provided the Comission a Five-Point Program for improving the Nuclear Regulatory Comission's I
(NRC's) oversight of the medical use of byproduct material.
The program, described-in SECY-88-77 (Enclosure 1), provided an integrated regulatory framework to improve the regulatory.
oversight of medical use of byproduct material. The program maximizes the_use of existing voluntary programs to attain improvements in the qualit Voluntary quality assurance (QA) y of Medical Use Programs.
programs have been developed by organizations such as the American Association of Physicists in Medicine (AAPM), the American College of Radiology (ACR), the American College of Medical Physics ACMP, and the. American College of Nuclear Physicians
.l ACNP.
The Five Point Program addresses:
- 1. Program Development;
- 2. Inter-Organization Cooperation;
- 3. Staff Development;
- 4. Oversight; and
[/
- 5. Information.
ce$o(oo l '
XA N TE:
TO BE MADE PUBLICLY AVAILABLE IN 10 WORKING
~
t:
DAYS FROM THE DATE OF James.H. Myers,fiftSS THIS PAPER 492-0637 A
.,e La',,.
l o,
y The Comissioners 2-The staff's first report to the Comission, SECY-89-006, i
describing the start of the program, special-interest-i areas, and the budget was presented to the Comissioners on January 12, 1989. This paper describes the Medical UseL Program experience since the last report.
Industry Characterization l
~ NRC regulates medical use of byproduct material in approximately 2,200 hospitals and 400 private-practice..
t clinics. Agreement States account for an' additional 5,000 medical use licenses. Medical use includes using radiopharmaceuticals to evaluate the presence and. extent of disease, or to treat disease, and using of sealed sources-for cancer therapy. Approximately seven million diagnostic procedures and 150,000 therapy procedures are performed nationwide each year.
Five-Point Program The Five-Point Program was designed to optimize the use of.
agency resources by working with other organizations.
SECY-88-77 described a general program allowing the staff to t
identify fundamental needs and issuese The details of the continuing implementation are described next.
Program Development QA~ Rule. A proposed QA rule wat sent to the Comission and-
~
was published for comment on January.16, '1990. This rule will help medical licensees to detect misadministrations and to reduce-the chance of misadministrations.
NRC will test the proposed rule in a pilot program, to gain practical experience in its effectiveness, before developing a final
-rule.
In January 1990, letters were sent to 142 NRC and agreement state licensees _ requesting their voluntary participation in the pilot program. The pilot program will.
run at least through August.
. Medical Training.
In 1988, a-contract was executed to study training and experience-criteria, credentialing programs, and State licensure of physicians, technologists and
-l ancillary medical personnel. The results, due in early 1990, i
may indicate a need for rulemaking in this area, to enhance medical use regulations or to recognize changes in medical j
use training programs.
i
c l
D,,:
m t
-, t, The Commissioners 3
l
-QA Questionnaire.
The staff developed a questionnaire on n
medical use quality that is based on guidance found in
" Radiation Oncology in' Integrated Cancer Management." The latter is a QA guidance document authored by voluntary u
organizations interested in QA in radiation-therapy. The l
questionnaire, which is being used in a trial program during unannounced inspections, includes-questions covering performance evaluation factors -in teletherapy, brachytherapy, and nuclear medicine, which will provide a basis for trends analysis. - In addition, the questionnaire will provide a basic measure of current levels of use.of voluntary standards, and licensee management support for QA.
The information collected in the QA quest'ionaire will be l
evaluated under the QA Contract.
The QA Contract Request l-for Proposal (RFP) was-issued in December 1989. The 3
L Contract is expected to be awarded in May 1990. The duration of the contract.is one year.
c Price-Anderson.
In Section 19 of the Price-Anderson i
Amendments Act of 1988, Congress directed NRC to conduct a j
negotiated rulemaking to determine whether to enter into
~
indemnity agreements with persons licensed by the Comission or an Agreement State for the manufactu'e, production, r
possession, or use of radiopharmaceuticals for medical use.
The NRC staff began the negotiated rulemaking in October 1988.
In addition to the NRC staff, two parties representing manufacturers or radiopharmacies were involved in the proceedings. These parties sought government indemnification-because-of their assumption that certain radiation releases would not-be covered by their existing comprehensive general liability insurance, because of the attachment of nuclear and pollution exclusions to their insurance policies, and because they could not find adequate special nuclear liability insurance to fill this gap in s
coverage. The NRC staff asserted that these operations did not pose a significant risk to the public health and safety.
Furthermore, a number of issues related to NRC's legal authority to indemnify Agreement State licensees or to protect against releases of naturally occurring or
+
accelerator produced radioactive material (NARM) would need to be resolved before government indemnification could be found to be appropriate. The NRC staff received the convenor's report recommending against indemnification of radiopharmaceutical licensees in March 1989.
In SECY-89-105, April 3, 1989, the staff forwarded to the Commission the w
w
w F..
l, [4-y,e.s The Commissioners 4
i convenor's and staff's recommendation that i,he negotiated rulemaking be terminated. On Ma the Commission 1
published a notice (54 FR 22444)y 24,1989, sunnarizing the convenor's recommendation and terminating the rulemaking required by Section 19 of the Price-Anderson-Amendments Act.
n Human Factors. The staff believes that h' man error is a u
large contributor to mistakes-in medical use.
The staff's plan for. identifying and addressing human factors concerns in the medical environment has been given high priority.
l The plan will eventually include human factors input to all 4
medical use program activities, with coordination between the Offices of Nuclear Material Safety and Safeguards-(HMSS),
Nuclear Regulatory Research (RES), and Analysis and Evaluation.ofOperationalData(AEOD),aswellasoutside organizations.
Currently, in response to NMSS-identified needs, RES is contracting.for human factors evaluations of teletherapy, brachytherapy, and-treatment-planning computers.
These issues were assigned the highest priority because of-the relative significance of e ror-consequences. These=
i projects are expected to identify elements contributing to human _ errors, to evaluate the impact of those elements on performance, to prioritize performance problems in terms of i
safety significance, and to identify and to evaluate -
alternative approaches for resolving safety-significant problems. This initiative supplements the general performance evaluation factors program applicable to all materials. licensees.
-Proposals for the Teletherapy Human. Factors Evaluation have been received and are being reviewed by Research (RES). The contract is expected-to be awarded in April 1990. The a
Brachytherapy-Human Factors. Evaluation RFP is presently in contracting. The award date is August 1990. _ Initial discussions on the Treatment Plan Human Factors Evaluation Project are. continuing with RES.
Radiopharmacy Petition. A petition for rulemaking from the ACNP and the Society of. Nuclear Medicine (SNM) was received.
in June 1989.
The petitioners requested that NRC change certain requirements regarding the preparation and use of radiopharmaceuticals.
A notice of receipt has been published in the Federal Register on September 15, 1989 (Enclosure 2).
The staff has met with represent'atives of the petitioners and the Food and Drug Administration (FDA).
Initial staff work 9
5
-w-
p
?!
?
L m-
- w,
- J.,
j t
. The Commissioners 5
l i
has'been directed toward'providing relief from certain-i restrictions on:the preparation of radiopharmaceuticals, pending complete resolution of the request.
l Inter-Organization Cooperation The other key Federal agency tha' t' regulates-safety in medical care is the FDA.
It regulates drugs and medical 1
devices.that are placed in interstate commerce. The staff-t initiated and has conducted office-level and day-to-day-staff-level comunications designed to ensure NRC and FDA.
cooperation and coordination.
Interagency staff meetings were held with FDA's Center for Drug Evaluation and Research (CDER), to discuss and resolve, issues of common interest that were addressed in the petition for rulemaking on the practice of pharmacy ano medicine that-was-submitted by the ACNP and SNM. Many of the requests a
in that petition concern NRC's interpretation'of and reliance on FDA's radioactive drug regulations. Additionally, staff contacts were made with the FDA's Center for Biologics Evaluation and Research (CBER), to address radioactive-biologics regulations.
1 The staff also organized a seminar on "FDA's Regulation of Radioactive Drugs," given by CDER members at NRC Headquarters, in-January 1989, to describe the FDA regulatory program for pharmaceuticals. '. Representatives from ten different NRC offices and four regions attended.
The seminar was also broadcast-to the regions and in One White' Flint North.
The seminar provided an overview of FDA's mission and resources, and an explanation of its regulatory approval and inspection policies.=
The FDA's Center for Devices and Radiological' Health (CDRH) has. assisted NRC in identifying reported incidents i
with teletherapy units, and NRC provided the CDRH with information about devices involved in misadministrations and other incidents. The staff has already developed contacts at FDA who have helped resolve several technical questions that NRC licensees posed.
In return, NRC helped
- the CDRH locate some teletherapy units that required a special inspection for mechanical safety, l."
NMSS and the Office of Government and Public Affairs (GPA) o-sponsored a specia7-topics workshop on emerging medical 1
',C
,y L,.,
j y
- The Commissioners 6
technologies, in November 1989, in Illinois.
Staff from Agreement States, all five regions, and Headquarters i
participated.
i z
y During the year, staff has initiated contact with the AmericanPharmaceuticalAssociation(APA) the American Association of Colleges of Pharmacy. (AACP},(and the National Association of Boards of Pharmacy NABP). These organizations have been added to NRC's mailing list for
- information notices and the NMSS Licensee Newsivtter.
The staff assists and obtains constructive connents from organizations (Association _for:theAdvancementofMedical Instrumentation, Human Factors Special Interest Groups on Medical Systems and the Functionally Impaired, ano United States Pharmacopeial Convention) by participating in committee activities of these organizations.
Liaisons for information flow are established with the ACNP, ACR, and the ACMP. All of these organizations are on a mailing list-
.for regional and Headquarters Information Notices and GPA press releases.
Over the past two years, the NRC staff'has helped the-Department of Veterans Affairs (VA) design and begin implementation of a Radiation Safety Audit Program.
VA has committed to using its Regional Industrial Hygienists as a " force multiplier," to provide aooitional internal audits of its hospital-based programs. This will provide early correction of self-identified deficiencies without -
increasing staff at individual Veterans Affairs Medical Centers (VAMCs). To further this project,-VA allocated training funds for approximately 25 industrial hygienists in FY89. The NRC staff provided five two-day training sessions specifically tailored to VA's needs.
This initiative is discussed in depth in Enclosure 3.
3 Staff Development Headquarters and the regions have successfully completed a plan to recruit individuals with extensive medical use experience to work in the licensing and inspection programs in 1989. Personnel losses in 1989 were managed by hiring individuals with training and experience in nuclear medicine technology, dosimetry and medical health physics consulting.
e w
,l l,,
The Comissioners 7
I I
To ensure that Headquarters staff retains its expertise 1
in medical use, the staff has arranged for annual one-week refresher visits at a local Federal hospital that provides both diagnostic and therapy services.. Both Headquarters and regional. staff members have participated in the NRC rotational assignment program, to develop a broader understanding of programs and procedures.
Staff members j
have also participated in courses given by the Technical TrainingCenter(TTC).
The staff is'in the administrative portion of rotating membership on the Advisory Committee on the Medical 1Jses ofIsotopes(ACMUI).
The staff is also examining the membership of the ACMUI to determine if the comittee's '
composition adequately reflects the perspective of States and other interested parties.
The staff requested the Commission's approval to pursue implementing a Visiting Fellows Program under the Intergovernmental Personal Act (IPA) in Secy-89-295.
The staff will soon submit' options on implementing a Visiting-Fel, lows program as a separate Comission Paper.
Oversight The licensing and. inspection furctions are conducted by the regional offices, with guidance and oversight from Headquarters. Additional staff. resources were used to increase the inspection frequency for medical use licensees in 1989. Most medical use licensees will be inspected every three years; broad scope, nuclear pharmacy and teletherapy licensees will continue to be inspected annually. hRC now conducts over 1000 inspections of medical use licensees annually. The staff continues to use Notices of Violation, L
Civil Penaltics, and Orders, as appropriate, to ensure
='r compliance with regulations and license conditions.
The Headquarters staff continues to audit-licensing actions for uniformity, and has partially implemented a computer program to log and sort licensing and licensing-related I.
actions.
Based on this information, the staff may also l
identify licensee actions that may not require NRC approval, thus reducing NRC's caseload. Changes would probably, require minor amendments to the medical use regulations.
1 L
l 1.
g.' l i~
- . { v e,.,,.
y, h
The Comissioners 8
~
e
'The staff continues to prepare a contract for FD0 that
.incluces a review of other required and voluntary QA programs that NRC may rely on to provide adequate assurance of.public health and safety.in the medical use of< byproduct material.
Reliance on such programs may-provide the potential for reducing NRC's. inspection caseload and may allow reallocation of NRC resources'on cases of special-i interest and initiatives with nationwide impact.
AEOD continues to examine misadministration reports, looking r
for opportunities to improve the quality of medical use programs and to identify trends.
In 1989, the AE00 staff assessed the problems that have occurred in.the use of-iodine in seldom-used clinical procedures..
The staff has. initiated two studies to identify the causes of misadministrations in response to several events e
involving brachytherapy sources. A third study of therapy misadministrations involving multiple patients and the use of computer treatment-planning programs vas also performed.
Information The staff has used a variety of comunication. methods to inform licensees of NRC's medical use program and potential safety problems. These have included:
pre)aring and distributing the NMSS Licensee' Newsletter W11ch includes information about misadministrations and enforcement actions; providing background information for newsletter articles published by medical organizations; increasing the distribution of Information Notices; and participating in scientific meetings.
Staff members in all regions developed workshops for..
licensees, to clarify the meoical use regulatory program.
Each workshop was designed to respond to medical use issues specific to the region.
The workshop program has been well-received by licensees and regional staff members, and will be continued.
Additionally, the Comission's demonstrated interest in the Medical Use Program, as indicated by its participation in NRC workshops and visits to licensees, has' been beneficial..
Future regional workshops will provide continuing opportunities for Comission participation.
L L
L l:
t
.+-
. v.-
t
- The Commissioners 9-(
c
- A summary'of the Staff Workshops and outside meetings held,in 1989 can~be found in Enclosure 4..A. listing of.
Federal Registe_r Notices'and staff papers, regarding:the nedical use program,- issued in 1989 (and in some previous years) can be found in Enclosure 5.
. Budget ana Full-time Equivalent Unit,s_ (FTE) i The budget and FTE for-the' medical use program are described-in Table 1.
The staff believes that this allocation of resources best neets the needs of the medical use program and emphasizes inspection activities.
Table 1.
Resources For Medical Use Program,b a
FY89 FY90 FY91 FY92 Functional Areas 5
FTE 5
PlE 5
FTE 5
pit Program Developnent &
2 8
1 7
2 7
1 7
EventEvaluation(HQ)
Inspection:and Event 19 19 22 23 Evaluation (Regions)
' Licensing (Regions) 7 8
9 8
Supervision (HQ &
'5 5
5 5
Regions)-
TOTALS 2
39 1
39 2 '43 1
43 a Headquarters and regional staff resources are rounded and do not include overhead.
b Most of the program support funds are for improving medical QA. Dollar resources'are rounded in millions of dollars.
l
1
' j fo
-+
The Commissioners 10 1
I Areas of Concern i
The staff believes that developments in the medical workforce, reimbursement by public and third-party carriers for medical services, and new medical technolo most significant potential areas of concern.. gy pose the=
j Workforce.
It appears that the body of fully qualified nuclear physicians and nuclear medicine and radiation' therapy technologists will continue to decline _ because of a
[
high attrition rate of better-trained and more-experienced personnel. Able candidates for physician and technologist training programs continue-to perceive the profession as, being a less attiactive career alternative, despite the f
increasing need for radiation-medicine specialists. This deteriorating situation creates the need for continued monitoring of radiation-medicine training programs, to help' l
ensure the continued safe medical use of byproduct material.
Health Care Reimbursement.
Both public and private-sector third-party carriers have implemented stringent cost-control 1
programs, effectively reducing resources.and options throughout all facets of health care delivery, including-radiation medicine. The staff-expects that licensees, being forced to reduce costs, will find it harder to implement the Comission's objective of safer medical use of byproduct material.
Medical Technology. The staff anticipates that the key _
change in radiopharmaceutical uses will be the development and widespread use of radiolabeled monoclonal-antibodies, coupled with the use:of curie amounts of I-131.
Radiopharmacy practices may also expand, depending on the Commission's resolution of the ACNP/SNM petition.
In radiation oncology, there will be an increased use of high-dose-rate brachytherapy, stereotactic therapy, and computerized treatment planning and administration. The chance of error caused by. misunderstood parameter definitions, unvalidated computer codes, code limitations or faulty treatment-plan software is likely to increase.
x The staff is keeping abreast of the new' developments in radiation oncology by recruiting experienced medical use i
personnel, by developing an enhanced awareness of the new technology, and by interacting with cognizant professional organizations.
4,.
,1
.V.
+-
.s The : Consiissioners' 11 N
Coordination:
.This paper has been' coordinated with tii. Office of the g
General Counsel, and that office has no le:41 objection.
Note:
- The staff will continue the implementation of the Medical q
Use Program, as discussed in this paper, Ja es M. Ta or.
ecutive Director for Operations i
Enclosures:
1.
SRN's-dtd 08/4/88 and 02/14/89 2.
54 FR'36239'(09/15/89);
4
. 3.
Assistance to Dept. of Veterans Affairs 4.
. Staff Workshops and Participation in Outside Mtgs 5.
Other NRC Documents Related to the Medical Use Program
- DISTRIBUTION:
Cormnissioners OGC-OIG LSS
. GPA REGIONAI, OFFICES i
~. ACRS-ACNW ASLBP ASLAP SECY-I l
1
yp+
esm, wens,
,#e--:-v
.~~-m
~~m o r,,:.
9 - i 4
l'
,\\
T
?
s-zj
-i 0
1 I
U
,e f
s j
1 Qn
.!r
(
Y t'a
- li:-
j r
?
,p
(:ly
. t vt b
1 kW '
l r
fp o.
are j
q y' v.
- k
(
ENCLOSURE 1-
.1 4
4 e.
N'
-L ii
- j R'
L vy
),
[
4:
1-
[>
-[
ti-1.
p t
7 h
I g.
.x
'C 7s Y
- p a
t-y y
7,
. f.
t L
6; iV (e. '
k, r
4 1
w 4
p:
s f,
n
. 6+h w '
m.-.<
~
j
,e y
.,/p** ***g'g o.7 j
.o UNITIO STA788 i
Qg.
NUCLEAR MEGULATORY COMMIS810N Ag7}gN
- ogson, N 4
cys:
*'a u=
g..
4.
AuSust 4, 1984 Jordan,'AE0 Mcdonald.-A secastany N&.L1.cox L-
.R.gions, N;E
]
I 1
l MEMORANDUM FOR:
L Victor Stallo, Jr., Executive Director for operations l=
FRON:
amuel J. Chilk, Secretary SUR.ECT:
T SECY-88 MEDICAL USE PROGRAM This is to. advise you that the commission (with all Commissioners E
agreeing) has approved proceeding with the staff's plan to provfde_laproved regulatory oversight of the medical use of l
by-product material as revised in-the June 7, 1988 memerandum frca 4
H. Thompson to S. J. Chilk subject to the following p
modifications:
{
1.
The section titled "Requiation at h ASEY.igga in
, should be removed; j
l-i 2.
, press releases for escalated enforcement actions should he sent to professional society newsletters _(if this is not already done); and 3.
.the staff shoul'd provide the commission with an annual briefing on the Medical Use Program.
1
}
(NMSS) t,20Q (SECT SUSPENSE:
12/88) i Commissioner Rogers noted.that he believes that the medical misadministration of by-product material deserves further i
attention by the medical community.
The current estimated rate-of' medical-misadministrations, while small in comparison with other modalities of exposure to the public from by-product material employed in the commercial sector and from NARM, can be improved by a more effective and strengthened agency program.
Therefore, he agrees with the objective of providing improved
. regulatory oversight of the medical use of by-product material.
j Commissioner Rogers also noted-that the staff's Five-Point i
Program could contain more specificity and diversity as.to implementation.
In particular he believes a resource allocation j
for regulating medical use of by-product material other than that.
proposed in Table 1 may be more effective in achieving these Rec'd Off. ED0 Eulosure 1 S.4 c1 Nte 2!
~.
1 j
1,
, objections.
A continuing emphasis on Regional inspection activities as proposed to Regional licensing activities will be
-necessary to achieve the oversight element of the Five-Poi'nt-Program.
t
~-
Examples of additional actions the staff should consider in the Inter-organization cooperation and Information Feedback elements of the Progras' includes Encourage rotational assignments.of Needquarters NM3s a.
statf to the-Regions for periods of several sonths, and i
shorter assignments by Region Inspectors to NMss Headquarters staff for orientation and Program overview l
purposes.
i-
\\
~
i b.\\
Increased utilization of AE00 staff resources for L
3 periodic analyses.of medical community performance and L
.AE00 consideration of appropriate indicators of trends 1
. in performance.
l t
l Exploration of further institutional ties to the i
c.
l medical community through establishment of a one year medical Visiting Fellows program within NMSS Headquarters.
Budgetary support for'an NRC Medical Fellow Program, selected by HMas staff and the-Advisory committee on Nuclear Medicine might be possible through L
Health and Human services and National Institutes of Health.
d.
Active' involvement of commission offices, the EDO and senior NRC statf members in communicating directly with the medical community (hospital. administrators, L
physicians, medical schools, professional groups) as commission representatives.
Commissioner Rogers requests that the staff add more flesh to the skeleton of the Five-Point Program, review the examples above and consider additional opportunities for achieving greater leverage L.
in Program implementation.
The staff should report on these at L
its next briefing of the commission.
i copies:
?
Chairman Zech Commissioner Roberts Commissioner Carr Commissioner Rogers i.
OGC l
P i L.*
UNITED STATES
. : g.
p g'J NUCLEAR REGULATORY COMMISSION IN RESPONSU,:PLi
' j ' ' g 4 'f REFER To:
Hw90{
WASMINGTON, D.C. 20848 jf t
I I
opres or twe February 14, 1989~
secnavAny -
r REVIEED' d
\\
MEMORANDUM FOR:
Victer Stallo, Jr.
Executive Director for Operations
' t l
i:
{-
Harold R. Danten. Director k
_ Offica of Governmental and Public Affaira
^
FROM:
y( Samuel J. Chilk, Secretary SUETECT:
7 STAFF REQUIREMENTS - BRIEFING ON MEDICA L
USE OF BY-PRODUCT MATERIALS, 10:00 A.M.,
i THURSDAY, JANUARY 19, 1989, COMMISSIONERS' CONFERENCE ROOM, ONE WHITE FLINT NORTH, ROCKVILLE, MARYLAND (OPEN TO PUBLIC ATTENDANCE)
(
The Commission
- was briefed by the staff on current and future activities for monitoring and improving public health and safety in the medical uses of nuclear by-product materials.
i The Commission requested the staff to:
Review the need for increasing the inspection frequency of community hospitals.
-of inspection guidelines and review the program which exceed. staff's goal of a minimum of one inspection every three years greater frequency o(f inspection). including their rationale and n (GPA)
(SECY Suspense:
3/3/89)
Retain the rigor of reporting requirements for misadministrations in any proposed redefinition of this term.
The rationale for.any such redefinition should be provided in the staff paper accompanying the proposed rule on quality assurance and reporting requirements of misadministrations, unless statf believes the issue t.c..=t be resolved on a higher priority basis.
(EDO)
(SECY Suspense:
4/28/89) 4
- Commissianers Rogers and Curtiss were not present.
,a--
7___ _ _ _._. _
..y,;
2-i submit an information paper which outlines s'taff's-activities in the following' areas (as previously requested;!
-by Commissioner Rogers):
(1)
Efforts in monitoring medical community performance.
and the development of indicators of trends in i
performance.
(2)
Discussions with the medical community on establishing a visiting-fellows program with NMSS, including the associated costs of such a program.
(
l (EDo)
.SECY-Suspense: '4/14/89)z Provide a status briefing on NRC activities for. improving.
t oversight of medical.use licensees.
(EDo)'
(SECY suspense:
7/89)
^
Interact with the Advisory Committee on the Medical Uses of Isotopes in developing the performance evaluation factors.which the staff proposes to submit to the Commission in September 1989.
l l
(EDo)
(SECY Suspense 9/89)
(
l Review the U.S. Food and Drug Administration's (FDA's) quality assurance requirement and regulatory experiences l
for possible application by-the NRC.
Ensure highly qualified NRC inspectors and professional.
L inspection programs.
L l
Propose, in~the Commission's Five Year Plan, the necessary-.
resource adjustaants believed appropriate to respond to l-the concerns outlined in the Commission briefing (e.g.,
i computerized treatment planning, availability of trained l
technologists, sonoclonal antibodies, etc.).
Work closaly with the Agreement. States-to ensure that Ehtn 1
the staff in eenmidarina any medical users which will b=rmanro--r=ad NRe reauir===nta foy a mattar-of com atibilitv for the Asr_r==it Statam, the Stataa# ' a=&rience in thia ~
area and their'vi== ara-factered in..
Commissioner carr noted that the staff has shown good initiative in activities intended to improve oversight of the medical use of by-product. material.
He urged the staff to continue making progress in this important area.
cc:
Chairman Zech.
Commissioner Roberts Commissioner Carr Commissioner Rogers Commissioner Curtiss OGC i
t b
i
+..,.
c
- i..
.e.
- +,..
!1..
r f
'b p
i.
3 j,...
t'
[ ~1 t-t.e 4
u e, <
.[.
f t-6-.
ENCLOSURE:2.
f-I E
i 1
1 e
4 1
.$kl j
1 l
l.
9 4
I k
g..
I i
i 1
s
1
.' kroposed Rules-38239 i
' *da' " + =
Vol. 54. No. t*8 i
Friday. September 15. ts09 inis sect.on of tne FEDLHAt. EsEUISTEH contaes nouces to tne putHic of tne comments to the Secretary of the proposso istwance of rules and Commission. U.S. Nuclear Regulatory patient care even though they are repetions. Tne purpose of insse notices Commission. Wdshmston, DC 20555.
permitted to du so by the Food and Drug ts to gwe eteresteo persons an Attention. Dockenng and Service Admmistrahon (FDA) and by their state ocportunity to participate m tre rue
- Branch, medicallicenses. Accordmg to the a g enor to the scophon of tne final Del ver comments to the One White petiticmers. nuclear pharmacists have Flint North Building.11555 Rockville -
been disent'ranchized as a professional Pike. Rockville. Maryland between 7.30 entity because activities that are-NUCLEAR REGULATORY a.m. and 4.15 p.m.. Federal workdays.
permitted by the FDA and the states are i
COtstelSSION For a copy of the petition, wnte the not allowed under NRC regulations. The~
Regulatory Publications Branch.
petitioners state that although a nuclear l
10 CPR Parts 30,33, and 35 Divtsion of Freedom ofInformation and harmacist is authorized by state Publications Services. Office of cense to prepm radiopharmaceuticals tw No. Pnes-H Administration. U.S. Nuclear Regulatory. for patient admirustration 'upon recei Amortsen Comoge ofliustoer Commission. Washinston. DC 20555.
of a prescription by an authonzed user Phystatene and sie sostoey of Nuotear The petition and copies of comments physician, current NRC regulations agedleenes Receipt of Peteen for received may be inspected and copied severely restrict their activity to rigid Rutomateng for a fee at the NRC Public Document
. reconstitution of standard kite sad to Room. 2120 L Street NW. (Lower Level).
dispensing doses of
- Commission.asseecv
- Nuclear Regulatory Washmgton. DC.
radiopharmaceuticals distributed by manufacturers. Nuclear medicine con pusmesa moomssaisoes cosetacTt technologists reconstitute actices: Petition for rulemaking: notice Michael T, Lesar. Acting Chief. Rules radiopharmaceuticals and perform of receipt.
Review Section. Regulatory Publications clinical procedures under the Branch. Division of Freedom of supervision of an authorized user eusessaav:The Commission is Information and Publications Services, physician. The petitioners believe that publishing for public comment a notice Office of Administrabon U.S. Nuclear their refessional activities are curtailed
- iP
'p1 fo 18 g
Regulatory Commission. Washington, by th limitations imposed on nuclear DC 20555. Telephone:301492-7758 or u Li e
- the Commission by the Amencan Toll Fne 800-366-5642.
physicians and pharmacists.
College of Nuclear Physicians and the sueet.sasserraay seeponesafiose
Background
Society of Nuclear Medicine. The petition was docketed by the Petitionere Commission on June 3.1900, and has The American College of Nuclear a recitation of the following:
At the ume the Atomic Energy Act of1954 The petitioners) request that thebeen assigned ! peket No. PRM-35-O' Physicians (ACNP) and the Soctety of
- Pas **d. the FDA did not regulate Nuclear Medicine (SNM) are comprised radioactive drugs (although they had the Commission revise its regulations to of over 12.000 M&Wduals do mandate to do sol. ft)A began regulaung give cognizance to the appropriate scope anicipate in the medcal use of acevlerator-produced radiopharmaceuticals of their practice of medicine and Yproduct material. Members include in 1968 and began regulaung byproduct pharmacy and thereby allow nuclear physicians. technologists and nuclear radiopharmaceuticals m 1974. Until that time.
physicians and nuclear pharmacists to pharmacists. The physicians supervise the preparation and use of reconstitute non radioactive kits the preparation and administration of radiopharmaceuncais triade from byproduct differently from the method radiopharmaceuticals to diagnose and matenat had been reguladd solely by the tecommended by the manufacture:
treat patients. Technologists administer Atomic Energy Commission (now the Nuclear allow nuclear physicians and nuclear radiopharmaceuticals and perform Regulatory Commission). As years passed.
pharmacists to prepare clinical procedures under the direction FDA conunued to refine its role m reviewing, approung. and regulaung radiopharmaceuticals whose and supervision of an authonzed user radephannaceuucals for mearch and manufacture and distribution are not physician. Nuclear pnarmacists re%ulated by FDA: and permit nuclear reconstitute radiopharmaceutical kits, FDA now regulates all physicians to deterrnine appropriate compound radiopharmaceuticals. and diagnostic and therspeutic applications dispense radiopharmaceuticals for radiopharmaceuucals whether made by of radiopharmaceuticals.
medical purposes.
manufacturers, nuclear pharmacists or their designees in medical institutions or Datast Submit comments by December Petitioner,s Interest in centralized radiopharmacies, or 14.1989.
Comments received after this date The petitioners are interested in the nuclear physicians or their designees.
will be considered if it is practical to do recuested action because under current FDA has the Federal authonty to so. but the Commission is able to assure WC regulations. members of the resulate all research and c!!nical use o r
ra' ioactive drugs directly or indirectly.
d consideration only for comments
- -t;tiunmg organizations believe they received on or before this date.
=snnot approortately practice their Because of the exemption from atomasses: All persons who desire to
- rviessions. The pennoners state that r snufactunng and distnbution submit wntten comments concernmg the athorized user physicians cannot requirements of the FDA for pharmaceuticals (including pstition for rulemaking should send their presente certain radiopharmaceuticals radiopharmaceuticals) prepared under er routes of sdmmistration for optimal State laws regulatmg the pract
- ce of
i 38240 Tcderal Registir / Vol. 54. No.178 / Fridav. September 15. 1989 / Proposed Rules
,- e medicine and pharmacy. commeretal New Drug Applications are not granted compounded. or proceued under en desenbed in the sections for which it is c
exempt category of section 510(g) of the foe these drug preparatfor:s. These drugs Federal Food. Drug and Cosmete Act.
licensed.This authonzation supersedes are suit recosmzed and regulated by any license condition issued before (b) A medicalinstitution licensee may (insert effective date).
FDA.
use for medicalresearch une any The practices of medicine and byproduct matenalin a
- 7. With regard to suppliers, the PWmecy are esempt f;om,FD.W manufactunng and distribution P:d:';:hstmaceutical at:d !ct : " :
petitioners recommend msertma a new involvmg measurements of uptake, paragraph to 10 CFR 454 and rename regulations by congressional mandate, dilutlor er excretion if its use has been paragraph (c) as paragraph (d).
but they are t'ot exempt from FDA s approved by the Radiation Safety (c) Byproduct matenal in ragulations forbidding misbrandmg,and Committee (RSC) and the Institutional radiopharmaceuticals compounded by adulteration. The FDA is the ecforcement arm of the drug quality Review Board (IRB) chartered in or under the supervision of a state, standards published in the 1.'ntted States a;;cerdance with 45 CFR part 4tl.licensed nuclear pharmacist or nuclear Section J5.200 medicine physician if such radiopharmaceuticals are manufactured.
Petitioner's Proposal (a) A licensee may use for medical use prepared, propagated. compounded, or any byproduct materialin a processed under an exempt category of The petitioners propose the following radiopharmaceutical and for a
- 1. Define " medical research use" in to diagnostic use myolving imaging in yti{5
) f the Federal Food. Drug, amendments, CFR 30.4 as follows:
^
which:
Medico /Research f/se means the (1) The radiopharmaceuticalls
- 8. With regard to free.standmg radiopharmacies the pentioners request intentionalinternal or extemal manufactured and distnbuted in that NRC revise the regulations to allow administration of byproduct material, or. accordance with the Federal Food. Drug. free. standing radiopharmacies lic and Cosmetic Act and the Public Health the radiation therefrom, to human Service Act,or:
under 10 CFR 32.?2 and to CFR 32.73 to subjects for research purposes.
(2) The radiopharmaceuticalis also compound radiopharmaceuticals.
- 2. Define "radiopharmaceutical" in 10 manufactured. prepared. propagated, The petitioners believe that this must be accomplished by licensing action CFR 35.2 as follows:
compounded or processed under an because those licenses have a clause Radiopharmaceuticalmeans any drug exempt category of section 510(g) of the or biologic that contama byproduct Federal Food. Drug. and Cosmette Act.
that states that if the license document (b) A medicalinstitution heensee may is more restrictive than the regulation.
matenal.
1
- 3. Define,' medical research une., in 10 use for medical research use any the license document takes precedence.
byproduct materialin a According to petitioners, those licenses sho~ ld be amended by NRC. without u
M e Use means the radiopharmaceutical and for a use intentions; internal or external involving imagmg ifits use has been charge to the licensee to remove the administration of byproduct matenal, or approved by the RSC and the IRB requirement to reconstitute the radiation therefrom, to human chartered in accordance with 45 CFR radiopharmaceuticals in accordance part 46.
with the manufacturer's instruction.
4R afine "medi i ti ution"in to Section J5.J00 Petitioners believe that in the event of a
is iplina a n by N the CFR 35.2 as follows:
(a) Alicensee may use for medical use Medics /*retitution means a single any byproduct matenalin a should be alerted.
health care facility or a health care radiopharmaceutical and for a
- 9. With regard to specific licenses of organisation which may physically exist therapeutic use in which:
broad scope for medical research use.
In multiple separate locations but la integrated through economic and/or (1) The radiopharmaceuticalis the petitioners request 10 CFR 33.11(a)
I management agreements. Several manufactured and distnbuted in be amended as follows:
accordance with the Federal Food. Drug.
(a) A " Type A specific license of j
medical discipimes may be practiced in and Cosmetic Act and the Public Health broad scope"is a specific license a medicalinstitution..
Service Act,or:
l.
authorizing receipt, acquisition.
- 5. With regard to Practice of (3) The radiopharmaceuticalis ownership, possession. use, and transfer Pharmacy. Practite of Medicme. and manufactured, prepared. propaga ted.
of any chemical or physical farm of the htedical Research. the petitioners compounded. or processed under an byproduct material specified in the recommend the followmg amendments exempt category of Section $10(g) of the license. but not exceedmg quantities I
to il 35.100. 35.200, and 35.300:
Federal Food. Drug, and Cosmetic Act.
Section J5. 00 (b) A medicalinstitution licensee may specified in the license, for purposes authonzed by the Act.The quantmes use for medical research use any specified are usually in the multicune (a) A licensee may use for medical use byproduct materialin a i
r.riy byproduct matenalin a radiopharmaceutical for a therapeutic mstitutions may conduct medical range. Applicants that are medical radiopharmaceutical and fur a use if its use has been approved by the research use m addition to conductmg diagnostic use involving measurements RSC and the IRB chartered in research and development as defined m of uptake. dilution, or excretion m accordance with 45 CFR part 46.
which:
(1)The radiopharmaceutical is
- 6. With regard to NRC licenses, the manufactured and distributed m petitioners tecnmmend the addition of a 10.The petitioners recommend that to accordance with the Federal Food. Drug. new paragraph to 10 CFR 35.11.
CFR 33.13(c)(3) be amended by aodmg a and Cosmetic Act and the Public 1feanh (c) Any medicalinstitution licensed to new paragraph (ivi as follows:
(ivl Review, approval, and recordeg Service Act.or:
use byproduct matenal for medical use (2) The radiopharmaceuticalis as desenbed in i 35.100. I 35.200 or by the Radiation Safety Committee and the Institutional Review Board of the martufactured. prepared. propaga ted.
i 35.300 may also use byproduct Safety and ethics of proposed.ises material for medical research use involvmg medical research use prepa ed
b rcderal Register / Vol. SU No.178 / TrM8V. 53Dternber 15. 1989 / Propossd Rules 38241 t
et b
in accordance mth paragraph (c)t:)tiO
- of this section pnor to use of the pharmacy and medicine laws is causing rom Puntwest easeosissatiow coettact:
H b
byproduct material.
senous problems m the opumal delivery Mr. Greg Holt. Standardtzauon Branch, of quality nuclear medicite care and the ANM-113 telephone (206) 431 1918,
- 11. Finally. the peutioners recommend implementation of nuclear medicine M4timg address: FAA. Northwest
- that 10 Cnt 3317ta)(4) be amended to research.
. &c<l as inlinwm Mountain Repon.17900 Pacific Highway t
, Fj (4) Add or cause the addattJn of o..g. noeN stup..a +. em.t.y South. C-o8966. Scattie. Washmaton j
og s,pterrAer. nes.
9t168.
!L
_ byproduct material to any food-i beverage. cosmetic, dr'.:g. c oter he the Nuclear Ryulaitory Corrmours.
speecansawrany eNponesariow:
pmduct designed for ir;estion or Samuel J.Chilk.
Interested persons are ms tted to -
inhalation by. or application to. a human 3,
, g g.,,,,,,,,3,
participate in :he making of the 3
bems unless penmtted by the license IFR Doc' es-ncer ble&-144 Ba airl proposed rule by submittmt such l
document to conduct medical research
'** C # "*
wntten data, views. or arguments as they may desire. Communicanons use.
.1
-heuld identify the regulatory docket Gmunds foe otidos m
- The peutioners request that the NRC DEPARTMENT OF TRANSPORTATION. number and be submitted in du licate to the address specified above. At revise its regulations to give cognizance Federal Aviation Administration communications received on or before
~
to the appropnate scope of the practice
.the clesm date for comments specified tf medicine and pharmacy. The '
CFR PM 39 above wi be considered by the
_ peutioners beheve that to CFR part 35 Administrator before taking action on sh uld be revised to recognise all the go,,,,,n,,,uas.333.ag; the proposed rule. The proposals rnschamams that FDA uses to authon.
contained in this Notice may be changed ze the use of radiopharmaceuticals.
Airworttilness Directives; Airbus in light of the comments received.
According to the petitioners, granting of Industrie Model A300 Series Airplanes Comments are specifically invited on this petition would allow nuclear physictans and nuclear pharmacists to acaNCYt Federal AVlation the overall regulatory. economic, reconstitute non-radioactive kits Admmistration (FAA). DOT.
environmental, and energy aspects of the proposed rule. All comments differently from the method actions: Notice of Proposed Rulemaking submitted will be available, both before recommended by the manufacturer:
(NPRM).
and after the closing date for comments.
dow nuclear physicians and nuclear pharmacists to prepare suesssaavt This notice proposes to adopt in the Rules Docket for examination by radiopharmaceuticals whose a new airworthiness directive (AD).
nterested persons. A te ott manufacture and distnbution are,
applicable to Airbus Industne Model summanzms each FAA public contact.
purposefully not regulated by FDA: and A300 senes airplanes, which would concerned with the substance of this permit nuclear physiciana to determine require repetiuve inspections for cracks proposal, will be filed in the Rules and damage of vanous structural Docket appropetate dia ostic and therapeutic applications of diopharmaceuticals, as components associated with the wing Comrnenters wishing the FAA to
_ is their professional obilgation-center box and repair,if necessary.This acknowledge receipt of their comments proposalis prompted by full. scale s
P Statement lapppoet fatigue testmg by the manufacturer, mu mi l.ad d.
ped The etit oners state that NRC which idenufied cenain significant post card on which the following
' prone statement is made:" Comments to mentions only two FDA cornpliance
- $'* " Th 1
dit i ot Docket Number 89-NM-131-AD." The mechanisms. The two mechanisms cited [o$ted coul resultin du ed p st card will be date/ time stamped and are the approved Investigational New structuralintegrity of the fuselage and returned to the commenter.
pp o ed e Dg pl cat on (NDA).
Petitioners state that there are other 8 FP 8D'-
mechanisms to achieve FDA cortp!iance oatss: Comments must be received no The Direcuon Ge,nerale de 1/Aviatica
- which the petitioness believe should be later than November 7.1989-Civile (DGACl. in accordance with existing provisions of a bilateral added to NRC's re ulaticns. According aoonesses: Send comments on the airworthmess agreement. has notif;ed to petitioners. me anisms are approval proposalin duplicate to the Federal the FAA of an unsafe condition which via Product 1.lcense Applic.ation(Pt.A).
Aviation Administration. Northwest may exist on Airbus Industrie Model Radioactive Drug Research Committee Mountam Region. Transport Airplane A300 senes airplanes. Full. scale fatvue approval (RDRC). Insututional Peview Directorate, AN%103. Attention:
testma by the manufacturer has Bottd approval (IRB).
Airworthiness Rules Docket No. 89-NM-
. dent:fied certain sigmficant structural
~ The petitioners believe that to CFR 131-AD 17000 Pacific Highway South, components associated with the wma ptrt 35 directly conflicts with FDA's C-68966. Seattle. Washington 98168. The center box which are prone to crad ins.
regulatory framework. The petitioners state that except fur physician applicable service information may be These structures are fatigue sensita e.
obramed from Airbus Industne. Airbus sponsored " Notice of Cleimed Support Division. Avenue Didier Daurat. and extensive repairs may be req =Nd :f inves tigational f.xemptions" (IND), :D 31700 Blagnac. France. This informanon correente action is not taken m a tm.Wv CFR part 35 only allows the use of may be exammed at the FAA.
could result in reduced structural manner. This condition,if not corre radiopharmaceuticals prepared under Northwest Mountain Region. Transport intesnry of the fuselage and sub+
the portion of FDA regulations devoted to manufacturers with nationwide Airplane Directorate.17900 Pacific decompression of the airplane Highway South. Seattle. Washmston. or distnbution.The petitioners belies e that the Standardization Branch. 9010 East Airbus Industrie has issued So regul tory Incompatibility between NRC regulations. FDA regulations. and state Marginal Way South. Seattle, Metin A300 53-245, dated Mar ' >
Wa shmston.
1989. which desenbes procedure -
utrasome or rotatmg probe mm m
n =>,
,er-,ene w
~
~m'="
1;.,',
s
.7, r
m.
w 0
r
. z
(
5 i
)
1 s..
4
\\it t
3
.F b
. k s
-b
- i s.,r 1.
.~ p s
4 4
ENCLOSURE 3 J
t.
- 1 g.
a 4
m F.
}
p.
y
?
Q'
{5.'.
t s
e
{:;
' k l;
,k.
(.
p.
p.
I fr s
l 3
ie,
.s
- k. -
'(
h 1.
P.
s r
e-I;~
v7 g
u (l'
v.
fr;.,
r-
.c.
M c.
g; p
s e
t hI h4 e-
,i b-b-f.-
r.
+
,f t.
).
k F.
h n'i
).'-
E-h fu:,.
- ) ';;
pQvT&r%. ks -
u
Assistance to Department of-Veterans Affairs (VA)
The Nuclear Regulatory Commission (NRC) Headquarters staff developed a two-day l
training program specifically tailored to the needs of VA Regional Industr_ial Hygienists.
Each two-day session consisted of eight hours of classroom and laboratory instruction and four hours of auditing experience, under realistic.
conditions, in the host Nuclear Medicine Department.
The information presented du~ ring the instruction phase was taken from relevant NRC regulations, licensing policies, Regulatory Guides, NUREGs, and VA inspection data.
l The goal of the program was to familiarize Industrial Hygienists with the source I
documents for medical use radiation-safety requirements.
Emphasis was placed on locating specific requirements in the source documents.
Once located, the auditor can review the particular section to determine a requirement.
3 The syllabus used for each two-day session is attached.
The staff conducted five two-day sessions at VA Medical Centers (VAMCs) near NRC's five regional offices (see Table 1).
The number of participants at each session was kept small, to maximize the training experience.
This also allowed an opportunity for students to_ observe nuclear medicine equipment and clinical procedures closely, and to conduct a mock audit of the Nuclear Medicine Department, using the VA-developed checklist.
Table 1.
'NRC/VA Training Sessions.
Session VAMC Location NRC Presenters a
July 18-19 Decator, Ga.
James Myers, IMAB Robert Brown, RGN 2 1-July 31 -
Hines, II.
James Myers,-IMAB Aug 1 John Madera, RGN 3 Aug 3-4 Dallas, Tx.
James Myers, IMAB Blair Spitzberg, RGN 4 l
Aug 9-10 San Francisco, Ca.
James Myers, IMAB L
Jim Montgomery, RGN 5 l
l Aug 21-22 Philadelphia, Pa.
James Myers, IMAB l.
Josie Piccone, RGN 1 l
'IMAB stands for Medical, Academic, and Commercial Use Safety Branch.
o I
Each NRC region provided an individual with inspection experience to teach some of the lecture material and to assist in the audit portion of the program.
The Veterans Affairs Central Office (VACO) provided the necessary coordination and logistical support for the program at each of the designated training sites.
A l3 list of the VA staff who participated in the development of the training program is included in Table 2.
l
3,.
e.
-2'
(
Table 2. VA Planning Committee James W. Fletcher, MD Director.
1 Nuclear Medicine Service
=VACO, Washington, DC.
1 Francis K. Herbig, MS Program Director
. Nuclear Medicine Network VAMC, St. Louis, M0 Helen Malaskiewicz Program Analyst Nuclear Medicine Service VACO, Washington, DC Frank J.: Denney.
Industrial Hygienist Office 'of. Occupational Safety and Health Nuclear Medicine Service VACO, Washington, DC s
Rick Coger, PhD Assistant Director of Instructional Design St. Louis Continuing Education Center VAC0, St. Louis, M0-Under this program, the staff provided training for 34 VA Regional Industrial Hygienists and 11 VA radiation users (representatives from VAC0 Nuclear Medicine Service, Radiation Safety Officers, and Chief Technologists). The attendas, and VACO personnel auditing the course, considered the program
~
~
informative and beneficial.
Neither the VA nor the NRC staff plans that these audits will replace the
-traditional NRC safety inspection.
However,-the training the NRC staff has-
~
provided will bolster. VA's existing radiation safety programs, help identify areas of non-compliance, and lead to licensee self-correction of these items.
VACO and the NRC staff are currently forming plans to continue the development of the audit program for 1990.
To reinforce the training conducted this year, VA has requested.that its Industrial Hygienists be permitted to join NRC inspectors during an NRC safety inspection.
NRC staff will present an update-on NRC's Medical Use Program during the VA's annual Industrial Hygienists meeting.
The Industrial Hygienists have been placed on a mailing list for the i
NMSS Licensee Newsletter and other information pertinent to the medical use program.
9 t'
1 t
- g,.
e;
'~ *
,'I. :
E
- j.-
tg.
~'.O,-
4
- 3
- t,,
.e-.
- 4
, < r:
r e,
9 6
4 5
1
. +
ENCLOSURE 4 G
9 0
e
e o
i Staff Workshops and Participation in Outside Meetings JANUARY Headquarters, Workshop on Performance-Based Quality Assurance Rule, Rockville, Maryland Headquarters, Public Meeting on Rcdiophatmacy Issues, Washington, D.C.
Region II, W3rkshop, San Juan, Puerto Rico FEBRUARY Region I, Presentation to Pennsylvania Department of Environmental Resources, Norristown, Pennsylvania MARCH Region II, Presentation to Society of Nuclear Medicine Technologists, Charleston, West Virginia Headquarters,-Presentation at College of Nuclear Physicians Annual Meeting, San Diego, California Region II, Presentation to Southeastern Chapter, American Association of Physicists in Medicine, Atlanta, Georgia APRIL Region I, Society of Nuclear Medicine, Philadelphia, Pennsylvania MAY Headquarters, Participation in Advisory Gaoup on Radiation Safety Aspects of Industrial and Medical Radiation Sources, International Atomic Energy Association, Vienna, Austria Headquarters, Presentation to Conference of Radiation Control Program Directors Meeting, Baton Rouge, Louisiana Headquarters, Meeting with the Chief, Nuclear Medicine Service, Department of Veterans Affairs, Washington, D.C.
Region I, Workshop, Boston, Massachusetts Region I, Presentation to Delaware Valley Chapter, Society of Nuclear Medicine Technologists, Philadelphia, Pennsylvania Region II, Workshop, Charleston, West Virginic Region II, Presentation to International Atomic Energy Association, Argonne National Laboratory, Illinois Region III, Presentation to International Atomic Energy Association, Argonne National Laboratory, Illinois Region III, Meeting on Low Level Waste with the State of Minnesota, St. Paul, Minnesota Region III, Presentation at Perdue University by Chairmon Zach, West i
Lafayette, Indiana Region III, Mallinckrodt Emergency Response Exercise, St. Louis p
Missouri l
i j.
l i
L
<>g o s,.,
o
.g.
JUNE Headquarters, Presentation to American College of Medical Physicists Meeting, San Diego, California Region I, Workshop Hartford, Connecticut Region III, Workshop on Radiopharmacy and Quality Assurance, Chicago, Illinois Region III, Meeting on Low Level Waste with the State of Wisconsin,
. Madison, Wisconsin JULY Region I, Workshop New Brunswick, New Jersey Headduarters - Region II, Department of Veterans Affairs Training i
Program, Decator, Georgia Region V, Workshop, Oakland, California AUGUST Headquarters - Region I, Department of Veterans Affairs Training Program, Philadelphia, Pennsylvania deadquarters - Region III, Department of Veterans Affairs Training Program, Hines, Illinois Headquarters - Region IV, Department of Veterans Affairs Training Program, Dallas, Texas Headquarters - Region V, Department of Veterans Affairs Training Program, San Francisco, California Region I, Workshop, BalMmore, Maryland Region III, Presentat ue to Chicago Area High School Teachers, Oakbrook, Illinois Region III, Presentation to Health Physics Society Meeting, Santa Fe, New Mexico i
SEPTEMBER Headquarters, Orientation Visit to Washington Veterans Affairs Medical Center (VAMC), Washington, D.C.
Region I, Workshop, Harrisburg, Pennsylvania Region I, Workshop, Philadelphia, Pennsylvania Region I, Workshop, Pittsburgh, Pennsylvanie Region I, Annual Symposium Health Care Financing Administration, Ocean City, Maryland Region III, Presentation at Oakton College, Des Plaines, Illinois Region III, Presentation on Teletherapy and Brachytherapy Inspection Techniques, Cleveland, Ohio L
Region IV, Workshop, Oklahoma City, Oklahoma j
Region V, Presentation on Teletherapy and Brachytherapy Inspection Techniques, Cleveland, Ohio i
e m
m.-
--m
r o
s
?
4
&o o.,.
g OCTOBER Headquarters, Presentation on Medical Licensing and Inspection American College of Cardiology, Bethesda, Maryland Headquarters, Army Industrial Hygiene Annual Meeting, Aberdeen. Maryland Region I, Workshop, Rockport, Maine Region III, Presentation at Annual Agreement State Meeting, Kansas City, Missouri NOVEMBER Region I, Presentation to Technologist Section,'Mid-Eastern Chapter, Society of Nuclear Medicine, Philadelphia, Pennsylvania Region III, Presentation at NRC Agreement States Sponsored Course, Emmitsburg, Maryland Region V, Meeting with Hawaii Department of Health Officials on Quality Assurance and Workshop Honolulu, Hawaii Region V, Workshop, Oakland, California DECEMBER Headquarters, Presentation to Mid-Atlantic Chapter, American Association of Physicists in Medicine, Annapolis, Maryland Region II, Workshop, Richmond, Virginia i
e
pr 4
, e s.s (
- s e.
g f7i.
6 I
?
r i..
ENCLOSURE 5 k
I e
I h
4 k.
4 O
e e
F,
. a, p
, i (* n t.
r OTHER NRC DOCUMENTS RELATED TO THE MEDICAL USE PROGRAM Federal Register Notices 44 FR 8242, " Regulation of the Medical Use of Radioisotopes; Statement of General Policy," February 9, 1979.
51 FR 36932, " Medical Use of Byproduct Material; Final Rule," October 16, 1986.
53 FR 18845, " Medical Use of Byproduct Material; Training and Experience l
Criteria," May 25, 1988.
52 FR 36942, " Basic Quality Assurance in Radiation Therapy," and 52 FR 36949,
" Comprehensive Quality Assurance in Medical Use and a Standard of Care,"
October 2, 1987.
54 FR 22444, " Indemnification of Licensees that Manufacture, Produce, Possess, or Use Radiopharmaceuticals or Radioisotopes for Medical Purposes," May 24, 1989.
54 FR 36239, " Petition for Rulemaking; Notice of Receipt," September 15, 1989.
j Staff Papers I
SECY-88-77, " Medical Use Program," March la, 1988.
SECY-89-006, " Annual Report on Medical Use Program," January 12, 1989.
l SECY-89-105, " Price-Anderson Negotiated Rulemaking," April 3, 1989.
-SECY-89-171, " Proposed Amendments to 10 CFR Part 35 to Require a Basic Quality Assurance Program and to Modify Reporting and Recordkeeping Requirements,"
l June 7, 1989.
SECY-89-269, " Proposed Amendments to 10 CFR Part 35 to Require a Basic Quality i
Assurance Program and to Modify Reporting and Recordkeeping Requirements,"
August 30, 1989.
l SECY-89-295, " Medical Community Performance and Visiting Fellows Programs,"
September 21, 1989.
t l-1
'