ML20238C728
| ML20238C728 | |
| Person / Time | |
|---|---|
| Issue date: | 09/04/1987 |
| From: | Grimsley D NRC OFFICE OF ADMINISTRATION & RESOURCES MANAGEMENT (ARM) |
| To: | Potter J NUCLEAR LICENSING REPORTS |
| Shared Package | |
| ML20238C730 | List: |
| References | |
| FOIA-87-403 NUDOCS 8709100332 | |
| Download: ML20238C728 (7) | |
Text
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INFORMATION ACT (FOlA) REQUEST SEP - 41987 see.
DOCKET NuMBEfit$t i# eppucew MOVESTER to O
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Y PART 1.-RECORDS RELEASED OR 900T LOCATED (See checked boxes)
No agency records magnet to the request have been located.
No additional agency escxeds subpoet to the request have been located, i
Agency records subsect as the request that are identified in Appendis are already eveitable for public inspection and copying in the NRC Public Document Roarm, 1717 H Street, N.W., Washington. DC-Agency records subenet to the request that are identrfied in Appendix h
are being made available for public inspection and copying in the NRC Public Document i
Rovi,1717 H Street. N W., Weshington DC, in a folder under this FOIA rer and requester name.
The nonproprietary wrsion of the proposalts) that you agreed to accept in a tenophone conversation wrth a member of my staff is now being made aveRabi6 f4 public inkW and coving at the NRC Public Document Room.1717 H Street. N W. Washrgton. DC, in a fo6 der under the FOIA number and requester name.
Enclosed is informatur on how you may obtain eccess to and the charges for copying records placed in the NRC Public Document Room.1717 H Street, N.W., Washing.w Ot Agency records subpect to the request are enclosed. Any applicable charge for copies of the records provided and payment procedures a o noted in the comments sectum.
Rscords subtect to the reo.sest have been referred to another Federal agencyram) for remew and direct response to you.
In view of NRC's renomme to this request, no further action a being taken on appeal lurtter dated PART ll.A-INFORMATION WITHHELD FROM PUBLIC DISCLOSURE I
Certain information e the mouested records is being withheld from public dadasure pursuant to the FOIA exemptions described in and for the reasons stated in Part 11. sec.
tions B. C. and D. Am renessed portions of the documents for which only part of the scord is being wrthheld are being made available for public inspection and copymg r the NRC Public Document Room.1717 H Street. N W. Washington, DC. in a folder under this FOIA number and requeMer name.
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POTTERB7-403 PDR.
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FhlEEDOM 0F INFORMATION ACT RESPONSE FOIA NUMBERt$L DATE:
PART 14 B-APPLICABLE FOIA EXEMPTIONS Rscords subject to the request that are described in the enclosed Appendices are beeig withheld in their entirety or in part under FOIA I
Essmptions and for the reasons set forth below pursuant to 5 U.S.C. 552(b) and 10 CFR 9.5(a) of NRC Regulations.
- 1. The wrthheld information is property classi6ed pursuant to Esecutive Order 12356 (EXEMPTION 11
- 2. The withheld information relates solely to the intamal personnel rules and procedures of NRC. (EXEMPTION 21
- 3. The withheld information is specifically enempted from puble disclosure by statute indicated: (EXEMPTION 3)
Section 141145 of the Atomic Energy Act whch grohibits the declosure of Restricted Data or Formerfy Restected Data 642 U S C. 21612166).
Secton 147 of the Atomic Energy Act which prohitets the declosure of Unclassified Safeguards information 642 U.S.C. 2167).
- 4. The withheld information lo a trade secret or commerenW or financial information that is being withheld for the reason (s) indcatect: (EXEMPTION 4)
The information is considered to be confidential tasuness (propnetary) information.
The informaton is consedered to be proprietary eformation pursuant to 10 CFR 2.790(dH1).
The information was submitted and received ir perdence from a foreign source pursuant to 10 CFR 2.790(d62).
- 5. The withheld information consats of interagency or mtraagency records that are not available through decovery maring litigation. Osclosure of predecisional informata:in would tend to inhibit the open and frank enchange of deas essential to the deliberative process. Where records are withheld in theer entirety, the facts are inextncably intertwined with the predecia.onal informaton. There also are no reasonat*Y segregable factual portions because the re4eese of the facts would permrt an indaract inquiry into the predeces onal process of the agency. (EXEMPTION 5)
- 6. The withheld information is enempted from public deciosure because its declosure would result in a clear 4y unwarranted invason of personal privacy. (EXEMPTION 61
- 7. The withheld informaton consats of investigatory recoros compiled for law enforcement purposes and is being withheld for the reason (si Indicated. (EXEMPTION 71 Disclosure would interfere with en enforcement proceeding because it could reveal the scope, direction, and fact n of enforcernant efforts. and thus could possibly allow them to take action to shield potentnas wrongdoing or a veolation of NRC requirements from invesagators. (EXEMPTION 7( A))
Disciosure would constrtte an unwarranted invason of personal privacy (EXEMPTION 7(C))
The information consats of names of individuals and other information the disclosure of which would reveal contities of confidential sources. (EXEMPTION 7(D))
h PART ll.C-DENYING OFFICIALS Pursuant to 10 CFR 9.9 and/or 9.15 of the U.S. Nuclear Regulatory Commisten regulatons, it has been determined that the rformation withheld is exempt from production or declosure, and that its production or declosure is contrary to the putec interest. The persons responsible for the denial are those oMcials identifed below as denying offe als and the Director, Deveion of Rules and Records, Office of Adminstration, for arvy denials that may be appealed to the Executtve Director for Operatons. Ecol-DENYING OFFICIAL TITtI/ OFFICE RECORDS DENIED APPELLATE OFFICIAL 1
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Sewe k a %k cJ 4e. Co missiat Lo PART 11 D-APPEAL RIGHTS The denial by each denying official identified in Part ll.C may be appealed to the Appellate Official identrfied in that section. Any such appeal must be in writing and must be made within 30 days of receipt of this response. Appeals must be addressed as appropnate to the Executive Director for Operations or to the Secretary of the Commission, U.S. Nuclear Regulatory Commission, Washington, DC 20555, and should clearly state on the envelope and in the letter that it is an " Appeal from an initial FOIA Decision."
etc solu 4e4 (Pert 21 U.S. NUCLEAR REGULATORY COMMISSION me>
FOIA RESPONSE CONTINUATION
Re:
F0!A-87-403 APPENDIX B
RECORDS MAINTAINED IN THE PDR UNDER THE ABOVE REQUEST NUMBER (UMBER DATE DESCRIPTION 1.
1/7/87 Memo fm Beckjord, RES, to Cunningham, NMSS, on DRAFT COMMISSION PAPER:
QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE 2.
9/30/8 Memo fm Alexander, RES, to Belote, RES, on CONTROL OF NRC RULEMAKING:
" QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE" 3.
10/15/86 Memo fm Alexander, RES, to Belote, RES, on CONTROL OF RULEMAKING:
- QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE" 4.
Staff Requirements Memorandum to Chairman and Commissioners dated 12/9/86 from Samuel Chilk (w/o attachments) 5.
Letter to Barry Wessels from Norman McElroy, 12/30/86, Request Permission for Cmr Carr and Other to Visit the Division of Radiation Oncology and Biophysics at the George Washington University Medical Center 6.
Margaret Federline's note to Car Carr and his staff, 6/1/87, re: Article Entitled, " Software' Bugs: A Matter of Life and Liability," by Ed Joyce Published in Datamation on May 15, 1987 i
Re: F01 A 87-403
~
~
~
APPEN0!X C
RECORDS TOTALLY WITHHELD (UNDER EXEMPT NUMBER DATE DESCRIPTION 1.
Chairman's vote sheet on SECY-84-485
" Proposed Revision of 10 CFR Part 35 ' Medical Use of Byproduct Material,'" dated 4/5/85 -g page.
2.
Chairman's response to Commissioner Bernthal's 3/14/86 memorands to 1
Commissioners, dated 4/3/86 - 1 page.
~
3.
Chairman's response to Commissioner Bernthal's 11/26/86 memorandum to Commissioners, dated 12/2/86 - 1 page. (CostLz-86-25) 4.
Handwritten note to Chairman from assistant dated 12/12/86 - 1 page.
5.
Internal note to Chairman from assistant on SECL-87-29 entitled "Misahinistration," dated 3/12/87 - 1 page.
6.
Chairman's vote sheet on SECY-87-29, dated 3/13/87.
7.
Internal note to Chairman from assistant on SECY-87-2SA entitled "SECY-87 Misadministration," dated 7/2/87 - 1 page.
8.
Chairman's vote on SECY-87-29A, dated 7/8/87 - 1 page.
9.
Memo from Frederick M. Bernthal to Commissioners dated November 26, 1986 with comment noted by Thomas M. Roberts dated 12/2/86.
10.
Memo from Lando W. Zech, Jr. to Commissioner Bernthal dated Decea6er 2,1986 with comments by Thomas M. Roberts dated 12/9/86.
11*
Mano to Commissioners from Cosa Bernthal dtd 3/14/86, subj: Medical Misakinistrations of Radiation Therapy, 2 pages 12.
Memo to Commissioners from Comm Bernthal dtd 11/26/86, subj: Medical Misa41nistrations: Need for Improved Oversight, I page 13.
Note to Come Bernthal from Janet dtd 11/13/86,subj: Medical i
Misadministration: Meed for Improved Regulation,1 page 14.
Come Bernthal's vote sheet on CR-87-29 dtd 2/25/87, subj: Ltr to Charles Howton, SSA, concerning the renewal of the charter for the Advisory Committee on Medical Uses of Isotopes,1 page 15.
Note to Come Bernthal from Janet dtd 12/3/86, subj:
C0pt.Z-85-25--Chairman Zech's Response to COMFB-86-8, 2 pages 16.
Handwritten notes with regard to Secy 87-49, no date (Secy subj:
Traintei and Experience Criteria for the Medical Use of Byproduct Materia' ) 2 pages 17.
Cons Bernthal's vote sheet on Secy 87-49 dtd 4/14/87, 2 pages 18.
Note to Cosm Bernthal from Janet did 4/9/87, subj: Secy 87-49-Training and Experience Criteria for the Medical Use of By-Prohet Material, 2 pages
Re:
FOI A 87 - 403 l
APPENDIX C
RECORDS TOTALLY WITHHELD (UNDER EXEMPTION 5) j NUMBER DATE DESCRIPTION & EXEMPTION I
86-168 dtd 7/15/86, (Secy subj:
Com Bernthal's vote sheet on Sec{ Medical Use of Byproduct Material"),
19.
j Final Revision of 10 CFR Part 35 3 pages 20.
Note for com Bernthal from Janet dtd 7/3/86, subj: Secy 86-168. Final Revision of 10 CFR.Part 35, " Medical Use of Syproduct Material", 3 pa9es 21.
Com Bernthal's vote sheet on Secy 84-485 dtd 4/24/85, (Secy subj:
Proposed Revision of 10 CFR Part 35 " Medical Use of Byproduct Material"). 2 pages 22.
Martaret Federline's note to Commissioner Carr and his staff, undated, i
REsAx0!NG SECY 87 MEDICAL MI$ ADMINISTRATIONS (2 pages) 23.
Commissioner Carr's Notation Vote Sheet. 3/2/87, SECY-87 MI$ ADMINISTRATIONS (9pages) 1 24.
Commissioner Carr's staff notes on SECY-87-29. MISADMINISTRATION (22 pages). Note: Only pages with connents are being forwarded.
25~
Commissioner Carr's 12/11/86 comments on the 12/9/86 DRAFT STAFF REQUIREMENTS MEMORANDUM REGARDING COMLZ-86-25/C0MF8-86-8. (4 pages) 26.
Commissioner Carr's staff 3/24/87 coments on 3/19/87 DRAFT STAFF REQUIREMENTS MEMORANDUM REGARDING SECV-87-29. (9 pages) 27.
Memorandum from Commissioner Carr to Chaiman Zech and Commissioner Bernthal.12/4/86 COMFB-86-8 AE COMLZ-86-25
. MEDICAL M!$ ADMINISTRATION:
NEED FOR DMt0VED OVERSIGHT Carr's itaff coments on the 12/4/86 memoran@m., and Commissioner (4pages) 28.
12/9/88 Memormadum from Chilk to Chairman Zech and Commissioners
Subject:
" Staff. Requirements Memorandum"(i page) w/ attachment: Undated Memorandum from Chilk to Chairman Eoch and Commissioner Bernthal, Subject; "CONFB-86-8/COHLZ-86-25 Medical Misadministration" (1 page), w/ attachment:
Undated draft SRM Memorandum from Chilk to V. Stello:
Subject:
" Medical Misadministration - Need For Improved Oversight" E3 pages).
29*
12/16/86 Memorandum from Chilk to V. Stello (SRM),
Subject:
" Medical Misadministration - Need For Improved i
Oversight" (3 pages).
I predecisional.
1
Re: FOI A-87-403 APPENDIX C
RECORDS TOTALLY WITHHELD (UNDER EXEMPTION 5) i NUMBER,
DATE DESCRIPTION & EXEMPTION 30.
2/5/87 SECY 87-29 'Misahinistrations" (71l pages).
31*
3/26/87 Memorandum, for V. Ste110 from J. Hoyle.
Subject:
Staff Requirements 5ECY-87-29-Misadministration (3 pages).
32.
6/18/87 SECY 87-29A ' Misadministration" (65 pages).
33.
12/2/86 Memorandum from Lando W. Zech, Jr. to Commissioner Bernthal,
Subject:
"COMFB-86 Medical Misadministration" (1 page),
34.
12/4/86 Memorandum from Kenneth M. Carr to Chairman Zech and Commissioner Bernthal,
Subject:
"COMFB-86-8 and COMLZ-86 Medical Misadministration: Need For Improved l
Oversight" (2 pages).
35.
12/9/86 Memorandum from Chilk to Chairman Zech and Commissioners,
Subject:
" Staff Requirements Memorandum"(1 page) l w/ attachment: Undated Memorandum from Chilk to Chairman Zech and j
Commissioner Bernthal, subject; "CONFB-88-8/COHL2-86-25 Medical y
Misadministration" (1 page), w/ attachment:
Undated draft SRM
{
Memorandum from Chilk to V. Stello:
Subject:
" Medical Misadministration - Need For Improved Oversight" (3 Pages).
36*
12/16/86 Memorandum from Chilk to V. Stello (SRM),
Subject:
" Medical Misadministration - Need For Improved Oversight" (3 pages).
j 37*
7/20/87 Memorandum from Crane to Malsch,
Subject:
" Draft Staf f Paper On Medical Quality Assurance Misadministration, ETC" (3 Pages).
4 f
1 i
)
Re:
F01A-87-403 APPENDIX B
RECORDS MAINTAINED IN THE PDR UNDER THE ABOVE REQUEST NUMBER NUMBER DATE DESCRIPTION 1,
1/7/87 Memo fm Beckjord, RES, to Cunningham, NMSS, on DRAFT COMMISSION PAPER:
QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE 2.
9/30/8 Memo fm Alexander, RES, to Belote, RES, on
.. CONTROL OF NRC RULEMAKING:
" QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE" 3.
10/15/86 Memo fm Alexander RES, to Belote RES, on CONTROL OF RULEMAKING:
" QUALITY ASSURANCE AND PENALTIES FOR NEGLIGENCE" 4.
Staff Requirements Memorandum to Chairman and Commissioners dated 12/9/86 from Samuel Chilk (w/o attachments) 5.
Letter to Barry Wessels from Norman McEiroy, 12/30/86, Request Permission for Cmr Carr and Other to Visit the Division of Radiation Oncology and Biophysics at the George Washington University Medical Center 6.
Margaret Federline's note to Cmr Carr and. his staff, 6/1/87, re: Article Entitled, "Sof tware Bugs: A Matter of Life and L1 ability," by Ed Joyce Published in Datamation on May 15, 1987
NOCLEAR LICENSING REPORTS Executive Offices:
Mail Order Address:
200.A Monroe Street. Suite 105 P.O. Box 10866 Rockville, Maryland 20850 Rockville. Maryland 20850 (301) 424-4132 JUN 2 6 1su Mr. Donnie H. Grimsley ffgDOW 0F INFORMATION
] QUEST [-/g RE Director, Division of Rules and Records Office of Administration and Resources Management U.S. Nuclear Regulatory Ccumission of hh-M M Washington, D.C.
20555
Dear Mr. Grimsley:
Pursuant to the Freeds of Information Act, I request copies of the records shown on the attachment. Should any records subject to this request be considered by the NRC to be personal records as distinguished frczn agency records, I request the identification of such records and the ciremstances leading to their creation in order that I might challenge, if appropriate, the NRC's determination through the administrative and judicial processes.
In accordance with the Freed s of Information Act of 1986 (Pub. L.99-570) and the Guidelines of the Office of Management and Budget, I request waiver of all search, review, and reproduction charges for records subject to this request for the reasons set forth in my letter to you dated June 25, 1987, which is incorporated herein by reference.
Please send any records subject to this request to the office address listed above. Please telephone me if you have any questions or require further information.
Sincerely, John Potter Editor
Enclosure:
As stated h-M[-
e-i j
Attachment to Letter from Nuclear Licensing Reports dated Records Requested Any records regarding NRC's consideration of a rulemaking that would strengthen NRC's oversight of medical licensees by requiring radiation therapy licensees, and licensees using large diagnostic dosages, to inplement caprehensive goality assurance programs to reduce the chance of misadministration, including the cost of such programs on affected licensees.
i For reference, this subject was referred to by Chairman Zech in his address at the Broad Scope Licensee Sympositam in Wakefield, Massachusetts on May 18, 1987, an excerpt of which appears below from NRC press release No.
S-8-87.
.l For some time, the Comission has been examining policy issues concerning the regulation of the medical use of byproduct material.
The Comission is considering rulemaking that would strengthen NRC oversight of medical f
licensees. The scope of this rule would require radiation therapy licensees, and licensees using large diagnostic dosages, to implement comprehensive quality assurance programs to reduce the chance of misadministration.
It would also provide for a regulatory standard in the medical use of byproduct material for radiation therapy. Although the number of misadministration annually in our country is very small, I believe there is room for improvement.
j