ML20057B165

Extends Invitation to Participate in Workshop Re Compounding Radiopharm

ML20057B165
Person / Time
Issue date:	07/19/1991
From:	Bahadur S NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:	Kalman S External (Affiliation Not Assigned)
Shared Package
ML19342C263	List: ML20057B152 ML20057B165 ML20057B192 ML20057B208 ML20057B212
References
FRN-58FR33396, RULE-PR-30, RULE-PR-32, RULE-PR-35 AD69-1-002, AD69-1-2, NUDOCS 9309200101
Download: ML20057B165 (7)

Text

d'

' g p Rf C j'

UNITED STATES NUCLEAR REGULATORY COMMISSION i_

o, g 7[i g

WASHINGTON. D.C. 20555

~

k

,o' c>3g Jllt 1 S 1991 f

Mr. Sam Kalman, Board Secretary b

Board of Pharmaceutical Specialties 2215 Constitution Avenue, NW Washington, DC 20037 t

Dear Mr. Kalman:

I would like to invite your organization to participate in a forthcoming workshop on one of the issues related to compounding radiopharmaceuticals that was raised in a petition for rulemaking submitted to NRC by the American College of Nuclear Physicians and the Society of Nuclear Medicine. The i

objective of the workshop is to conduct a roundtablo discussion of the key issues related to establishing an " authorized radiopnarmacist" in NRC's regulations.

An agenda for the workshop is enclosed for your information (Enclosure 1). For each of the three key agenda topics, we will present a proposed "strawman," and during the discussions, would like the participants to critique our strawman, offer their best solution, and provide the rationale to support that solution.

We expect that a lively and fruitful discussion will arise on each topic from the various proposed solutions.

During our telephone conversations, your organization expressed an interest in participating in-the workshop.

In order to optimize the roundtable discussion, we would like to have two or three participants represent each of the five groups. A list of the five groups with a tentative list of participants is enclosed (Enclosure 2).

Please confirm that your participant (s) will attend the workshop or, if you wish to maPe a change, nominate the new participant (s) by July 31, 1991, in addition to myself, the NRC team will consist of John Telford, Section Chief, Rulemaking Section of my Branch, who will act as the moderator of the workshop, and Larry Camper, Section Chief, Medical and Academic Section of the Medical and Commercial Use Safety Brench.

A notice announcing the workshop will be published in the Federal Reaister. This workshop will be open to members of the public with seating for the public available on a first-come first-served basis. A transcript of the workshop will be taken by a court reporter so that the information collected will be part of the public record and, therefore, can be considered by the NRC staff in resolving the petition.

3100N((j/

9309200101 930908 PDR PR iJ 30 58FR33396 PDR

[

The workshop will be held from 9:00 am until 5:30 pm on August 7,1991 in the Sheraton International Hotel At O' Hare, Chicago, IL.

Please call the hotel (708-297-1234) to make your reservation and refer to the "NRC Workshop" to obtain our group rate of $67 plus tax per night.

To confirm participation by your organization, nominate your participant (s), or if you have any questions, please call Dr. Anthony Tse at (301) 492-3797.

I am pleased that your organization will participate and look forward to meeting you at the workshop.

Sincerely, Qiginal Sigacd 4 Sher Bahadur, Chief Regulation Development Branch Division of Regulatory Applications Office of Nuclear Regulatory Research

Enclosures:

1.

Agenda 2.

List of Participants 3.

DISTRIBUTION: (w/encls.)

IDENTICAL LETTERS SENT TO THOSE

< Subj-circ-chron ON ENCLOSED LIST.

RDB reading file (SBahadur)

- BMorris

-FCostanzi

' '~ c JTelford f.

ATse

~~~

WGlenn, NMSS

/ LCamper, NMSS

. LBolling, GPA l

OFF:

RDB/D%/RES RD DRA/RES RDB/D RS NAME:

ATse Q JT ford SBahadur DATE:

7/18/91 7/)[/91 7/R/91 0FFICIAL RECORD' COPY 2

Identical letters Sent To:

Mr. Sam Kalman, Board Secretary i

Board of Pharmaceutical Specialties 2215 Constitutions Avenue, NW Washington, DC 20037

r. Homer Hupf, President American Board of Science in Nuclear Medicine 3341 Cadencia Street i

Carlsbad, Ca 92009-Mr. Carmen A. Catizone, Executive Director National Association of Boards of Pharmacy i

1300 Higgins Road i

Park Ridge, IL 60068 l

Mr. Henry Kramer, Chairman Committee on Radionuclides and Radiopharmaceuticals US Council.for Energy Awareness 3911 Campolindo Drive oraga, CA 94556 Dr. Dennis Eshima College of Pharmacy Radiopharmacy University of New Mexico lbuquerque, NM 87131 Mr. Dennis Swanson School of Pharmacy 1111 Salk Hall University of Pittsburgh l

Pittsburgh, PA 15261 Ms. Anne Smith, Director i

Nuclear Pharmacy Program School of Pharmacy and Pharmacal Sciences Purdue University 6

Robert E. Heine Pharmacy Building West Lafayette, IN 47907 Mr. Brian Hyps Associate Director for Government Affairs American Pharmaceutical Association i

2215 Constitution Avenue, NW Washington, DC 20037 Ms. Beverly Black, Director Federal Regulatory Affairs American Society of Hospital Pharmacists 4630 Montgomery Avenue Bethesda, MD 20814 i

(

l ENCLOSURE 1 AGENDA i

NRC WORKSHOP TO DISCUSS ESTABLISHING AN AUTHORIZED RAD 10 PHARMACIST Chicago, IL August 7, 1991 Workshop Chairman: Sher Bahadur, NRC I

9:00 am Welcome - Sher Bahadur, NRC.

9:05 am o

Purpose of the meeting - John Telford, NRC.

o Regulatory oversight perspectives - Larry Camper, NRC.

9:15 am Opening remarks from the participants.

o Self introductions.

9:45 am Roundtable discussion of certifications to be accepted for an authorized radiopharmacist (Topic number 1).

o Proposed certifications.

o Certification examination.

10:15 am Break.

10:30 am Roundtable discussion of education and experience criteria ir lieu of certification (Topic number 2).

Proposed criteria.

c 12:00 noon Lunch.

1:00 pm Resume discussion.

2:00 pm Roundtable discussion of supervision provided by an authorized radiopharmacist to other pharmacists or personnel working as a pharmacist (Topic number 3).

o Sufficient supervision.

o Maximum number of pharmacists that an authorized radiopharmacist can supervise.

o Use of radiopharmaceutical procedures manuals.

3:15 pm Break.

3:30 pm Resume discussion.

4:30 pm Concluding remarks.

o From all participants.

5:00 pm Questions and comments from members of the public.

5:30 pm Adjourn.

i ENCLOSURE 2 TENTATIVE LIST OF WORKSHOP PARTICIPANTS (NOMINATED BY THE FIVE GROUPS)

GROUP ORGANIZATION PARTICIPANT

---

=

.=

t Certifying o American Board of Science in Nuclear Homer Hupf Group Medicine o Board of Pharmaceutical Specialties James Ponto k

State Boards o National Association of Boards of Carmen Catizone i

of Pharmacy Phanmacy Lester Hosto Group Frank Wickham x

6 Industry.

o Committee on Radionuclides and Michael Mosley Group Radiopharmaceuticals, US Council Janet Reuther for Energy Awareness Andrew Williams University o University of New Mexico Dennis Eshima Group o University of Pittsburgh Dennis Swanson o Purdue University Anne Smith i

l Pharmacist o American Pharmaceutical Association Clyde Cole Group o American Society of Hospital Pharmacists David Laven

}

}

l FederrI Regist:r /.Vol. 56. No.147 / Wednesday, July 31.-1991 / Proposed Rtilesi 21 Dated at P.ockville.MD this 15th dah

)N submission to the othergovernment with Credit Irivestigation or other for agency, a copy of the SF-60 that is dated personnel security action may be.

July 1991.

nl and bears an original signature together discontinued.-ne requestor shall For the Nuclear Regulatory Commiss6on.

v with a request form (NRC Form E37):

Identify the fall name and date of birth g

3,,,, g, y,y,,

finzi signed by a licensee or other contractor of the individual, the date of request.

g,gg g 4

official as the supporting documentation and the type of access authorization 1:

for an NRC access authorization

("Q" or "L") or access authorization

[nt Doc. pt-17895 Filed 7-30-91i s.45 am) renewal application. Failure to file a i.

renewaI originally requested.ne '

at m ocoot75 m renewal application concurrent with the requestor shall conFuta each telephone

' led submission of an individuars SF-60 to notification promptly in writing.

the other government agency pursuant -

7. In 25.27 paragraph (a)is revised to 10 CFR Part 35 to their reinvestigation requirements read as follows willresult in the expiration of the

, Reopening of cases in which "Authortzed etadiopharmacist" Workshop To Discuss Establishing an individual's NRC access authorization.

f 25.27

5. Section i 25.23 is revised to read as requests for eccess authorizations are cancet:ed. -

AGENCY: Nuclear Regulatory I N **#

(a)In conjunction with a new request Commission.

I 25.23 Notlfication of grant of access for access authorization or renewal of ACTION: Notice of meeting.

auth rtzati n.

d access authorization for individuals

, g,,

ne determination to grant or r'enew whose cases were previously cancelled.

SUMMARY

%e Nuclear Regulatory' access authorization will be furnished in new fingerprint cards in duplicate and a. Commission (NRC) staff plans to writing to the licensee or other person new Security Acknowledgment (for convene a public workshop with T,

that initiated the request. Upon receipt cases where no final access o

representatives of appropriate o

of the notification of original grant of authorization was previously issued) access authorization, the bcensee or.

must be furnished to the NRC Division organizations to discuss key issues -

other person shall obtain, as a condition of Security along with the request.

related to establishing an "stithorized radiopharmacist"in NRC's regulations, for grant of access authorization and access to classified information, en 8.In i 25.31 a new paragraph (d) is DATES-ne workshop will be held '

executed ** Classified Information added to read as follows:

Wednesday, August 7,1971, and will Nondisclosure Agreement" SF 312) from begin at 9 a.m. and end about 5:30 p.m.

[$

,'.the affected Individual. The individual i 25.31 ~ Extensions and transfers of P:

.dehall also be given a security orientation ADDRESSES:SheratonInterna'tional Al briefing in accordance with 5 95.33 of o liare 6810 North Mannheim Roa'd, this chapter.ne signed SF 312 must be (d) ne date of an extension or Rosemont. Illinois,

~ ' ~ promptly forwarded to the NRC Division -transfer of access authorization may not FOR FURTHEft INFORMATION CONTACT:

of Security. Reconis of access be used to determine when a request for Dr. AnthonyTse, Regulation authorization grant and renewal -

renewal of access authorization is Development Branch, NL/S-129. U.S.

~ notification must be maintained by the -

requhrd. Access authorization renewal Nuclear Regulatory Commission.

i i^

. licensee or other organization for three requests must be timely submitted in Washington, DC 20555, telephone (301) years after the access authorization has-accordance with 6 25.21(c).

492-3797.

been terminated by the NRC Division of 9 Appendix A to part 25 is revised to

'O Security.%Is information may also be read as follows:

SUPP11MENTARY INFORMATION: ne

- fumished toother representatives of the American College of Nuclear Physicians Commission, to licensees, contractors, APPENoix A To PART 25-FEES FOR NRC and the Society of Nuclear Medicine

, r or other Federal agencies. Notifications Access AMOREADON submitted a petition for rulemaking to.

tr

- of necess authorization will not be given NRC requesting that the NRC amend its

' ' ions pertaining to the use of in writing to the affected individual categoy

,ee n.

P yp. 21oct materialin medical q

- ( ) h gose cases in which the in,tus t access,e.atnortration ises epplications. One of the issues raised in' non,1,1,m.n,, t access astrana.

the petition is related to compounding

- etermination was niade as a result of a son us Personnel Security Hearing or by Extenaan or transfer or L access e*

radiopharmaceuticals containing Personnel Security Review Examiners, bydud maMaL s

y pr2aton i4s or Renewai or E aooess autnortzaten -

45 ne objective of the workshop is to

.' (b) When the indkidual also is the Y -U.Na*no"n te,.st.

22 e nduct a roundtable discussion of the a

y c ficial designated by the licensee to w proceans a mo 1 ey issues related to establishing an aj

.. trhom written NRC notifications are Reinstatment of -O" axess authmza.

"au'horized radiopharmacist"in NRC's ta

' forwarded.

om

= 2mo regulations.ne organizations that will

'l Hection i 25.25 is revised to read as oMe dproces*seng"'

• be represented at the worksho,p inclode:

..follows:

• 3.000 y' i "

Exten on or transrer or "o-s 2. coa Bosrd of Pharmaceutical Specialtics:

4 Extenson or transtar of -Q" (emedne American Board of Scienca in Nuclear I2L25 Cancetation of requesta for pmoessind

' 3N Medicine: National Association of

{

accews authortratforL Rmewat of -Q" preal fw year emnwres-Boards of pharmecy; Comndttee on V

en a request for an individur.l's

,1 40 cess authorization or renewal of of *O" (subsequent fnio year Radionuclides and R

7 remesugabons) 45 Radiopharmaceuticals of the U.S.

.Q4ooess authorization is withdrawn or.

f r

Council for Energy Awareness:

.$r lled, the requestor shall notify the

./,@[N% bag,a" d American Pharmaceutical Association.

Division of Security immediately 9

sary. a see or s2. coo we be assesseo pnar to the American Society of Hospital-hone ao that the full field Co"dg8h"7,'n",y%,,,,a, %,.,,,,, Pharmacists, and selected graduate

( %,. -

a on National Agency Check -

rarsed schools of pharmacy.

lr

.~

i.h* f g^s sf

7 36116 i

Federal Regist:r / Vol. 50. No.147 / Wednesday, July 31,1991 / Proposed Rules

[

Conduct of the Meeting proposes additional safety standards amendment to theirType CertiGeate b

He workshop will be chaired by the which the Administrator considers (TC) No. A49 Ell for their Model 140 '

undenigned and moderated by Mr. John necessary to ensure that the critical end Series airplance to indade the Phase U h

L Telford, Section Chief, Rulemaking essential functions that these systems Avionics package.*Ihe 14G-103A cad -

1 Section, Regulation Development pehn am mentained when the 200A were applied for on May 8.1909, a

Branch. Division of Regulatory

. airplane is exposed to lightning and and the 146-300A on January 6.1989.

i 4

Conunission.The workshop wiu be

!!IRF.

The Model146 series is a high wing E?

conducted in a manner that will OATES: Comments must be received on pressuriwd 94-108 passenger transport

{

facilitate the orderly conduct or or before September 16,1991, category airplane with a maximum

,M business.The transcript of the workshop ADDRESSES: Comments on this proposal takeoff gross weight of 84,000 to 95,003 will be available for inspection, and maybemailedinduplicate to Federal pounds (depending on mode?). maximum copying for a fee. at the NRC Public Aviation Administration.Officeof the cruise speed of 305 knots, and a

[,.'(j Document Room,2120 LStmet NW,,

Assistant Chief Counsel. Altn-Rules maximum operating altitude of 81,000 Washington. DC 20555 on or about Docket (ANM-7). Docket No. NM41, feet.The airplanes are powemd by four 1

August 27,1991.

2001 Lind Avenue SW., Renton, Arco Lycoming turbofan engines

\\

Tne following procedures apply to Washington 98055-4050; or delivered in mounted on the wing. The Phase II

!-f1 public attendance at the workshop:

duplicate to the Office of the Assistant avionics installation on the airplane

1. Questions or statements from Chief Counsel at the above address.

incorporates a number of novelor Ijd attendees other than participants {te,,

Comments must be marked: Docket No.

unusual design features, such as digital

?'a; representatives of the organizations NM-61. Comments may be inspectedin avionics including.but not necessarily L

listed above and participating NRC the Rules Docket weekdays,except limited to, an electronic liight Instrument

{

staff) will be entertained as time Federal holidays, between 7;.30 a.m. and system [EFIS) including primary L

permita.

4 p.m.

airspeed and vertical speed, dual fall

2. Scating for the public wiU be on a FOR FURTHER INFORMAMOsd CONTAen passive digital flight guidance system

.f*

first-come Erst-served basis.

William L Sdiroeder. FAA with Category HI autornaticlanding Dated at Rockvale. Maryland, this sah day Standardization Branch. ANM-113 system, dual digital air data computers.

of July 1991.

Transport Airplane Directorate, Aircraft and full authority digital engine control,3 For the Nuc1 car Regulatory Commission' Certification Earvloe,1801 Lind Avenue (FADEC) with auto throttle system y.>

Sher Bahad"

SW., Renton, Washington 98055-4040; whida am vulacrable to h#nMg and

.h> }?

Chief Regulation Dewfoptnent Dmnch.

telephone [200)2Z7-Et48.

high-intensity radiated fields ([lIIRF)

Wg{

Division ofRegulawry Applications. 0Fice of GUPPLEMENTARY CNFORMADON:

ex1ernal to the airplane

• j NuclecrRegulatoryResearch.

Comments lavited Type Ceducation Bas h'

IFR Ikx:. 91-18104 Tded T-SG-el: 6:45 am) h

• * * ~

Intemsted pmons eminvhed to I.t. der the provisions of { 21.101 of a participate in the making of the FAR British Aerospace must slu:>w tha

[5h!,

~~

proposed special conditions by the Model140 meets the applicable m 7}

DEPARTMENT OFTRANSPORTATION submitting such written data, views. or provaions of the regulations s

arguments as they may desire.

incorporated by reference in TC No. 4 Federal Aviatio4 Administration Communications should identify the A49EU, or the applicable regulations

• i regulatory docket or notice number and effect on the date of application for 14 CFR Parts 2I and 25 be submitted in duplicate to the address Model146 unless:(1)otherwlae q

r

}.

et No. HM-6 t; Notice No. SC-91 specified above. Allcom nunications specified by the Administratoc or {2)

I received on or before the closing date compliance withlater effective

?

m for comments will be considered by the amendmentsis electedormquimd a k.

SpecialConditionttBritish Aerospace Administrator before taking aetion on under i 21.1?; and (3) special condi

' p Model 146-403A.-200A and-300A this proposal. The proposal contained in am prescribed by the Administrator, Airplanes Equipped With Phase 41 this notice may be changed in light of The phase 11 avionics installation, Avionnes; Ughtning and High Intensity comments received. Allcomments the Model146 would be required to Radiated Helds (titRF) submitted will be available in the Rules comply with pan 25, as amended n s

'i j AcEwev: Federal Aviation Docket for examination by interested through Amendment 25-66. in ad p

Administration [FAA). DOT.

persons, both before and after the part 34 of the FAR through the latest closing date for comments. A report amendments in effect at the time of AcMox:Notiw of pmposed r.pecial summanizing each substantive pubhc awarding the type certihcate, and p

'y conditions.

contact with FAA persormel concerning 30 of the FAR through thelatest '

. ;(3

=

suuMARn This notice proposes special this rulemaking will be filed in the amendment in effect on the date the conditmns for the British Aerospace doclet. penons wishing the FAA to noise tests are performed, must be Model s46.-100A. -200A and -300A acknowledge receipt of their comments The special conditions whidimey Series a, planes. These tirplanes are submitted in response to this notice developed es a result of this notice n

I,9"ipped with British Aerospace 146 must submit with those comments a self. form an additionalpart of the type 8

hase U high-technology digital evionics addressed, stamped postcaid on which certification basis.

systems which perform critical or the following statement is made:

If the Administrator finds that i

essential functions. The applicable

" Comments to Docket No. NM-01." The applicable airworthiness regnisti regulations do not contam edequate or postcard will be date/tirne stamped, and (i.e.. part 25. a s amended) do not, appropriate safety standards for the returned to the commentor.

adequate or appropriate safety

protection of these systems Imm the Baclq;round standards for Model146 series effects oflightning and high-intensity On May 4.1939, and January 6.1989 novel or unusual design featcre, with Phase Il avionics becacse'c!

j radiated fields (lilRF). This notice British Aerospace applied for conditions are prescribed under 1

.