ML20216C919

Informs That Dr Glenn Wanted to Know If Recipient or Member of Staff Would Like to Make Presentation to ACMUI,941118 on Patient Release Criteria

ML20216C919
Person / Time
Issue date:	10/12/1994
From:	Thomas Taylor NRC
To:	Cool D NRC
Shared Package
ML20013H248	List: ML20216C904 ML20216C919 ML20216D019 ML20216D034 ML20216D075 ML20216D086 ML20216D113 ML20216D128 ML20216D163
References
FRN-62FR4120, RULE-PR-20, RULE-PR-35 AE41-2-083, AE41-2-83, NUDOCS 9804150103
Download: ML20216C919 (3)

Text

.

l Sk 19 E 4 I- >

From: Torre M. Taylor (TMT) l O(,/

To: _

DAC. W

• L , b,8 l

Date: Wednesday, October 12,1994 3:33 pm j

& Seddectiv.'SACMUI Meeting l

.m ni Dr. Glenn wanted me to contact you to see if you, or a member of your staff, would like to make the presentation to the ACMUI, Nov. 18,1994, on the Patient Release Criteria. l The status and issues need to be addressed. Also, the individual needs to be prepared for a " working discussion" of the criteria - to discuss specific issues on which the Committee has comments.

~ The session begins on Nov.18 from 8:00 - 10:00 a.m. The meeting is in TWFN, T2B3.

The meeting itselfis on Thursday from 8:00 to 5:00 and on Friday from 8:00 to 1:00. I will forward an agenda once I know who will be making all presentations.

. eIf possible, I need a brief summary for the briefing book., However, we need to get the book to reproduction by' Mon. or Tues; next' week, s'o I! understand if you can't get something to me by then. If not, I'll put a short statement as to presentation on status / issues.

I am cc'ing this message to Kitty since you are out ill. # g WGN l

Thanks, Torre (504-1062, TMT) fs i

'k> CC: KSD l

l l

V 9804150103 980402 PDR PR 20 62FR4120 PDR .

L

.~ ,iav/v"  ;

i ' >-

V (n, M ,V, !

. / M, i H -

51458 Federal Register / Vol. 59, No.195 / Tuesday, October 11, 1994 / Notices g 8. An Indication whether Section the study of the ved; cal use program by members, NRC consultants, and NRC ,

j504(h) Public Law 96-511 applies: the National Acade ry of Science;(4) staff will be permitted at the discretion

' Applicable. brachytherapy fracti,m. !on issum : {5) of the Chairman.

9. Abstract:In response to a petition Abnonnal Occurrence Criter 4. The transcript, minutes of the for rulemaking submitted by the  % i in3, ,r,) rulemaking - ' iease of meeting, and writte.i . m i.wr i . u " ' c I American College of Nuclear Phys.cuns Patients Contaming available for inspecd.it., and u p)i% .

and the Society of Nuclear Medicine, h for a fee, at the NRC Public De nm' Udir1 vnar oticals or Permanent Room,2120 L Street NW., Lor or b , -1.

the NRC is amending its regulations for Implants 10 CFR 3' 73";(7) discussion l the medical use of byproduct material ot t - # Notica 'f P oposed Washington, DC 20555, on or al,' a g Thu rule is necessary to provide greater Rum.miing fur 10 M Pact . ,; (d, December 9,1994.

flexibility by eliminating current issues involving misuministrations- 5. Seating for the public will be on a  ;

regulatory restrictions and allowing follow up of patiem , NRC use of fir,st-come, first served basis.

This meetmg will be held in properly qualified nuclear pharmacists - consultants; (9) review and approval of ,

accordance with the Atomic Energy Au and authorized users who are the bylaws for the Committee; and (10) of 1954, as amended (primarily Section physicians greater discretion in report on the Commission briefing held on October 20,1994. 161al: the Federal Advisory Committee preparing radioactive drugs containing byproduct material for medical use. DATES:The meeting will being 8 a m. on

.w D MC. App.); and th,e m ss n,s quMmns m M m.

This rule will also allow the use of November 17 and 18 1994 " "

byproduct materialin both research ADDRESSES: U.S. Nuclear Regulatory Dated. Oct ber 4,1994.

involving human subjects and the . Commission Two White Flint North, medical use of rediolabeled biologics. In Room T283,11545 Rockville Pike. Andrew L. Bates, eddition, this rule also contams other Rockville, MD. Adusory committee Management offu cr.

miscellaneous and conforming IFR Doc. 94-25033 Filed 10-7-94; 8.4 s aml FOR FURTHER INFORMATtON CONTACT:

amendments necessary to clarify or Larry W. Camper, Office of Nuclear stumo coor neo-esw Material Safety and Safeguards MS Co e of ubrn a a) be 'I 8FS, U.S. Nuclear, Regulatory inspected or obtained for a fee from the n n DC 20555, NRC Public Document Room 2120 L Street NW (Lower Levell. Washington.

"l ye 5- -

p DC. Conduct of the Meeting Meeting of the President's Committee Comments and questions can be of Advisors on Science and Barry Siegel, M.D. will chair the directed by mail to the OMB reviewer: Technology meeting. Dr. Siegel will conduct the meeting in a manner that will facilitate ACTION: Notice of meeting.

lat dr (315 01, 0, t 0 e "

Q/and -0120), NEOB-10202, Office of g }9 n d $" "to Ic

SUMMARY

This notice sets forth the Management and Budget. Washm, gton, participation in the meeting: schedule and proposed agenda for the DC 20503. 1. Persons who wish to provide a first meeting of the President's Comments can also be submitted by Committee of Advisors on Science and written statement should submit a Technology (PCAST), and describes the N C Clea ce Of c is Brenda f* Producible copy to Larry W. Camper functions of the Committee. Notice of (address listed above). Comments must J. Shelton' (301) 415-7233~ be received by November 10,1994, in this meeting is required under the Dated at Rockville Maryland. this 29th day order to ensure consideration at the Federal Advisory Committee Act.

I September 1994. meeting. The transcript of the meeting DATES AND PLACE: October 25 and 26.

For the Nuclear Regulatory Commasinn' w 11 be kept open until November 28. t 994. The White llouse Conference Gerald F.Cranford, 1994, for inclusion of written Center. Truman Room, Third Floor. 726 Designated Senior Official for Inform 9tmn comments. bckson Place NW, Washington, DC Resources Management- 2. Persons who wish to make oral 20500.

IFR Doc. 94-25032 Filed to-7-94 a 45 ami statements should inform Mr. Camper. TYPE OF MEETING:Open.

a:Luwo coot rson.et* in writing, by November 3,1994. PROPOSED SCHEDULE AND AGENDA:The Statements must pertain to the topics on President's Committee of Advisors on the agenda for the meeting The Science and Technology (PCAST) will Advisory Committee on Medical Uses Chairman will rule on requests to make meet in open session on Tuesday, of Isotepes: Meeting Notice oral statements. Members of the public October 25,1994, at approximately 9 00 AcENCY: W ! ear Regulatory will be permitted to make oral AM to be briefed on current activities of statements if time permits. Pennission the Office of Science and Tec.hnology Commimen. to make oral statements will be based on Pohcy (OSTP). This session will end at ACTION: Nmu e of meeting.

the order in which requests are approximately 12 00 Noon. The supua$vhe U.S. Nuclear Regulatory received. In general, oral statements will Committee will reconvene in open be limited to approximately 5 minutes. session at approximately 1:30 PM to j Commission will convene its next regular meeting of the Advisory Oral statements must be supplemented discuss possible long-term agenda items i Committee on Medical Uses of isotopes by detailed written statements, for the for the next year. This session will end (ACMUI) on November 17 and 18,1994. record. Rulings on who may speak, the at approximately 5:00 PM. Either of l Topics of discussion will include: (1) order of presentation, and time these sessions may be interrupted for Rulemaking on " Preparation. Transfer, allotments may be obtained by calling the PCAST to gather at the White llouse and Use of Byproduct Material for Mr. Camper. 301-415-7269, between 9 to be introduced to the President of the Medical Use";(2) status of a.m. and 5 EST, on November 14,1994. United States.

implementation of the Quality 3. At the meeting, questions from The Committee will meet again in Management rule: (3) progress report on attendees other than committee open session on Wednesday, October

a SuNm aa-y pop _ ACnun i O

t RULEMAKING ON PATIENT RELEASE CRITERIA, Status: Proposed rule published June 15,1994 (59 FR 30724). Comment period for the proposed rule, draft regulatory guide, NUREG-1492 expired August 29,1994. 58 comments were received.

Midor Issues:

1. Exclusion of patient release from 10 CFR 20.1301(a):

Almost all commenters approved deletion from Part 20

2. Activity-based vs. dose-base release limit:

A majority of commenters approved of the 500 mrem dose limit. A number of commenters preferred maintaining the status quo of 10 CFR 35.75. Some ,

commenters were concerned that a dose-based limit would cause confusion and potential problems. A few commenters said that a calculational approach requires the doctor to ask many personal questions. One commenter said dose  ;

estimates would be inaccurate because there is no reliable method of predicting the time and proximity to others. Some commenters were concerned about increased cost of treatment due to calculations and recordkeeping. Some

( commenters said that there probably would be no significant decrease in radiation exposure.

3. Release quantities Some commenters did not think release should be permitted with quantities > 30 mci.

4. Recordkeeping (summing dose) for administrations > 0.1 rem i i

This issue generated the strongest opposition to the proposed rule. Many 4 I

commenters said the requirement would cause excessive costs in time, effort, and money to find previous administration records and that the NRC underestimated the cost of record generation.

5. Written instructions to patients Many commenters said that instructions do not need to be written and that oral instructions alone should be permissible. However, a major health maintenance organization strongly supported the requirement that the instructions be written.

Several commenters said that a sizable fraction of patients will not behave as instructed.

C