ML20210K620

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Requests Docket of Enclosed Six Documents Which Will Be Made Available at 970819-20 Meeting of Medical Use of Byproduct Material,Working Group for Revision
ML20210K620
Person / Time
Issue date: 08/18/1997
From: Flack D
NRC
To:
NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
Shared Package
ML20210K626 List:
References
FRN-62FR42219, FRN-62FR42707, RULE-PR-35 NUDOCS 9708190334
Download: ML20210K620 (3)


Text

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August 18,1997

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! DOCUMENT CONTROL DESK / 3f[ .

PUBLIC DOCUMENT ROOM M/((M$/9 PLEASE DOCKET THE ENCLOSED SIX DOCUMENTS WHICH WILL BE MADE '

AVAILABLE AT THE AUGUST 19-20,1997 MEETING OF THE " MEDICAL USE OF BYPRODUCT MATERIAL; WORKING GROUP FOR REVISION" ( see the er. closed 62 FR 42707).

d if you have any questions, please call me at 415-5681.

Thank you, Diane Flack (DSF1)

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' Federe : E egister / Vol. 62, No.153 / Friday, August 8,1997 / Proposed Rules ACTION: Establishment of working group " Medical Policy Statement." The Paperwork Reduction Act Commission SRM specifically directed and notice of meeting.

This prop sed rule contains no new the restructuring of Part 35 into a risk-information collection or recordkeepin8 sonensARyt A working group consisting of informed, more performance-based requirements under the Paperwork representauves from the U.S. Nuclear Regulatory Commission, the "I"lati*

Reduction Act of 1995 (44 U.S C. 3501 A June 30,1997, SRM informed the ff 889 l- OrEanization of Agreement States staff of the Commission's approval, with List of Subjecta in 9 CFR Pad 92 (OAS), and the Conference of Radiation comments, of the staffs proposed Control Program Directors (CRCPD) has Animal disease, imports, Livestock, been established in response to Program in SECY-97-131, Supplernental Informadon on SECY-Poultry and poultry products. Commission approval of the staffs97-115," Program for Revision of to Quarantine, Reporting and proposed plan for revising to CFR part CFR Part 35,' Medical Uses of recordkeeping requirements. 35faseociated guidance documents, and Byproduct Material,'and Associated Accordingly,9 CFR port 92 would be the Commission's 1979 " Medical Policy Statement," if neceuary. With this Federal Register Notice," dated June 20 stuended as follows: 1997. After this approval, the NRC staff 8PProval, the NRC staff has begun .

initiated development of draft rule PART 92--lMPORTATION OF CERTAIN developing draft rule language and ANIMALS, BIRDS, ANDBIRD'POULTRY'D alternadves, using an entirely modality. language, using an antirely modality-AND CERTAIN ANIMAL, Ah based approach, to help focus the public based approach. The modality approach POULTRY PRODUCTS *, input and the discussions during places all requirements for a given type REQUIREMENTS FOR MEANS OF facilitated public meetings. During this of treatment into a single section of the CONVEYANCE AND SHIPPING process, the staff is examining the regulation, including: (a) Who or what CONTAINERS applicability of risk infortaed, organlaation is licensed; (b) what type of performance-based regulations and less license is issued;(c) the necenary

1. The authority citation for part 92 would continue to read as follows: prescripuvo approaches to regulation of technical requimments, such as surveys nuclear material used for medical and calibration; (d) the training and Authority:7 U.S.C 1622; 19 U.S C 1306; experience requirements; (e) the event 21 U.S C 102-103, t u,1 tea,134e.134b. Purposes. The working group will meet at NRC lleadquarters in Rockville. recording and reporting requirements; 134c,134d 134f,135,138, and tasa; 31 U S C 9701; 7 CFR 2.22,2 80, and 371.2(dl. Maryland, on August 19 and August 20, and (f) the quality improvement and 1997, to review the early draft staff management objectives.

l 32.308 (Amomledl documents and to discuss the major Per NRC Management Directive 6.3,

2. In 5 92.30s, paragraph (a)(1) would regulatory issues associated with the ,,The Rulemaking Process, the be amended by removing the reference medical use of byproduct material. rulemaking will be conducted using a

'to "$ 92.317" and adding in its place the DATES: The Working Group will meet on SmuP 8Pproach. A governmental reference to "55 92.317 and 92.324" August to and 20,1997, from 9.00 a.m. working group consisting of

'o 5:00 p.m.

representatives of NRC, OAS, and

$ 92.224 (Amended] ADORESSEs: U.S. Nuclear Regulator 7 CRCPD has been established to develop

3. Section 92.324 would be amended Commission, One White Flint Norta, rule text alternatives, including draft by removing the words ", for not less Auditorium,11555 Rockville Pike' guidance documents. State participation than 7 days and" and by removing the Rockville, MD,20852-2738.

words " approved by the A dministrator in the proceu will enhance and constructed so as to prevent the FOR FURTHER INFOResAT10N CONTACT: development of corresponding rules in Cathy llaney, U.S. Nuclear Regulatory State regulations, and provide an entry of mosquitoes and other bematophagous insects" Commission. Office of Nuclear Material opportunity for early State Luput and Safety and Safeguards, MS T8F5, will allow the State staff to assess 5 92.326 (Amended) Washington, DC 20555, telephone (301) potential impacts of NRC draft language

4. In $ 92.326, the first sentence 415-6825, e-mail csh@nte gov. on tue regulation of non Atomic Energy would be amended by removing the SUPPt.EndENTARY INFORRAATION: NRC has Act materials used in medical diagnosis words "92.323, and 92.324" and adding examined the issues surrounding its treatment, or research, in the States.

in their place the words "and 92.323" medical use program in great detail At the initial meeting of the working Done to Washingtcu, DC, this 4th day of during the last four years. This process SmuP,on August 14-20,1997, the August 1997, started with NRC's 1993 internal senior grou will review the initial draft input management review report; continued d8v OPed by the NRC staff, focusing its Terry 1. Medley, with the 1996 independent external discussion ou the major regulatory Administmtor. Animal and Plant Health inspectmn Service.

review report by the National Academy es associated with the medical use of Sciences, institute of Medicine; and IFR Doc. 97-20994 Filed 6-7-97; 8:45 amt o YProduct material.

culminated in NRC's Strategic eu ,,,eco, u m Auessment and Rebaselining Pro}ect Committee Oganisatiop, and (S A), in particular, medical oversight Operations was addressed in the SA Direction-NUCLEAR REGULAT3RY Setting lasue Paper Number 7 (DSI 7) Cathy llaney, NRC, Office of Nuclear COMM6SSION (released September 16,1996). In its Material Safety and Safeguards, will

" taff Requirements Memorandum serve as chairman. Other members are 10 CFR PM M (SRM)-COMSECY-96-057, Materials / from the NRC's Office of Nuclear Medical Oversight (DSI 7)," dated Material Safety and Safeguards: Office Medical Use of Byproduct Motorial; March 20,1997, the Commission of Nuclear Regulatory Research: Office Wortdn0 Group for Hovision directed staff to revise Part 35, of the General Counsel, and Office of I '

a0ENCY: U.S. Nuclear Regulatory associated guidance documents, and, if State Programs; and from OAS and Commission. necessary, the Commission's 1979 CRCPD.

. _ . _ _ _ _ . . _ _ _ _ _ . . _ _ _ _ _ . _ _ _ _ _ _ . _ _ _ . _ . _ _ _ _ . _ _ _ _ _ _ _ . . - ~

4- 6 42700 Feeleral Register / Vol, 62, No.153 / Friday, August 8,1997 / Proposed Rules thanamanse Meetings security control room are accessible could choose either to designate one omos to hold a single account at one The working group will meet, as from b courtyard entrance on 20th needed, la the Washington, DC, area, or Street between Constitution Avenue and Reserve Bank or to continue to have

C Street, N.W. Comments may be separete accounts on a same state /same-et otherlocations agfood upon by the working smup members. Meetings will inspected in Ram MP-500 betwwn District basis as they do today, The be announced in advence, through b 9
00 a.m. nad 5:00 p.m. Board is also proposing champs to b NRC Public Meeting Notice System and, POR PURmen espoRa$ATION 00NTACTI pass-through account ruim in with some eaceptions, will be open for Oliver Ireland Associate General Regulation D to accommodate the public observsvon. Persons attending Counal, (202/452-3625) or Stephanl* s ngle-account option and to maka other working group meetings will be Martin, Senior Attorney (202/452- chanys appucable to allinsututions welcome to provide input to the 31981,1Agal Division. For the hearing that will simplify and clarify the pas,-

working group for its considwetion, im only, contact Diane Jenkins To acommnicatins Device for b D'eaf through rulm either in written form or orally at times The Board believes making a single speci6ed by the working smup' chair. (TDD)(202/452-3544), Board of Governors of the Federal Reserve account optional rather than required Dated at Rockville, Maryland, this 4th day System,20th and C Streets, N.W., for families of foreign bank branches is ,

Washington, D.C. 20551, reasonable in light of certain 1 For 11 lear Regulatory th=6 ton. OPwetional, legal, and su ry suppuessNTARY BdPoRIAATIOss: To l g,,,ig 4, c,,g' 5 facilitate laterstate hannring, the Federal di5moces between U.S. ches and Reserve Banks will begin to implement agencies of foreign banks and domestic ar' o N ,

e new account ettucture c,n January 2, banks.8 For example, certain foreign Safetyend sefsgi,wds.

1996, that will provide a single Federal hanha have historically manapd their (FR Dec. 97-30e74 Filed 6-7-e7; e.45 aml

,,,, , Reserve account for each domestic U.S. omces as independent entities timt depository institution. This structure do not necessarily coordinate lending will enable the Federal Reserve Banks to and investment decisions from a central establish a single debtor. creditor omce. Further, each omes of a foreign FEDERAL RESERVE SYSTEhd relauonship with each chartered entity, bank family must have a separate thereby lag an effective means for license, alther state or federal. The 12 CFR Part 304 cu (neptenen 0; Doekst No, M-40001 ment r po bi t es d will ",a [; ,, no 8

lasured and are thus would be Reesm Requimmente of DepceNory Inetnuuons a[matire I ry tutions.

liquida;ed separately based on b law

To determine the Federal Reserve Bank of each licensing state. In addition, U.Si i Acasecy
Board of Governors of the where a bank with interstate branches Federal Reserve System. will hold an account, the Board adopted bank supervisory authorities treat U.S.

amendments to its Regulation D (12 CFR branches of foreign banks as

. ACTIOes: Proposed rule. ind* Pendent units for ohr purposes,

  • part 204, Reserve Requirements of aussesARY:The Board la proposing to Depository lastitutions) and Regulation such as asset maintenance requirements, amend its Reguladon D. Reserve 1(12 CFR part 209,lasue and As a result of bee diffences, U.S.

- Requirements of.l. epository lastitutions, Cancellation of Capital Stock of Federal branches of foreign banks may be placed to allow U.S. branches and agencies of Reserve Banks)(62 FR 34613, June 27, at a disadvantage if they wm required, i foreign banks and Edge and Agreement 1997). These amendments define a in the short term, to adopt a single ,

1 corporations to choose whether to domestic depository institution's account structure. -

aggregate ruerves on a nationwide bests location for purposes of Fedml Reserve To ensure stability in account in a single account at one Reserve Bank membership and roame account relationships and to move the foreign or to contlaue to have separate accounts maintenance, banks and Edge corporations toward the

$ on a name-state /same. District basis as U.S. branches and agencies of the Preferred long-run account structure, they do today.The amendments would name foreign bank and Edge and l the optional single account, where j also update and clarify the pass through Agreement corporations 5 of b same Possible, would be a one-way election.

account rules in Regulation D for all parent bank were not included in the new single account structure or in the That is, once an entity selects a single

- lastitutions. These amendments would final amendments to Regulations D and account it would not be permitted to tacilitate interstate banking and eliminate certain restrictions applicable 1. pending further consideration of legal switch back to multiple accounts

' to pass-thmugh accounts. and operationalissues. The Board is without the Board's approval. The OAfga:Comunents must be submitted on now proporing amendments to single account would be available to

, or before September 12,1997. Regulation D under which the Federal U.S. branches of foreign banks and Edge 1 Anonsassa:Congneats, which should Reserve Bat ks will offer a single corporations effective January 2,1999.

refer to Docket No. R-0980, may be account to these insututions on an snelled to Mr. William W. Wiles, Optional beels. Under this proposal, a The distiseutehias chenecionetice of U.s.

foreign banks and Edge corporations t=*acim of imisa henke do met nece eerily apply Secretary, Board of Governors of b

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  • P " " ^** " " * 'I' l Federal Reserve System. 20th Street and Y

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' Constitution Avenue' N.W" 35^ *hh' Fd*I "***'n Act ti U.s.c ett.asu* W"m'm*ad l ofnok amemmonanimmt the nem Edge corposehoo d IbPeo Washington, D.C. 20551.Cornments and Asmeent corporatione have en agreement o,

""ffere di troen that of muluple U.S. opkm cir foreign addressed to Mr. Wiles also may be undenau,,s wuh m some unde, escuam as g the haaks. Unisse otherwise moned, the sosio.ies poimie .

delivered to b Board's inell room Federal F.easrw Act it U.S C sol-40sel. For *PPl y mainly to U.S. breaches of foreise beake.

Puryn m W tMs docW. the tem ** Edge Baum of the hinancel pueHet neulmory  !

Letween 8:45 a.m. and 5:15 p.m. and to tmuant W them mutus, howmr. b account the security control room outside of "'"***"d" ^8"*"t NPmuone, 1

""'" h those hours. Both the mall room and the N ' tenechmend M *'" "" $", ,,e ifam8Bbuk8* ppm e- e- < q ,-,,--,-+,,n,-- , , , - - - s- ,,n-, , , , , . . g - ...----m.-n----,---,--__-..--.--~------><-a Y