ML20211E018
| ML20211E018 | |
| Person / Time | |
|---|---|
| Issue date: | 09/26/1997 |
| From: | Mace M NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | Alers P ICF, INC. |
| References | |
| CON-FIN-W-6295, CON-NRC-04-95-065, CON-NRC-4-95-65 NUDOCS 9709300019 | |
| Download: ML20211E018 (6) | |
Text
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UNITED STATES y
B NUCLEAR REGULATORY COMMISSION f
WASHINGTON, D.C. 2M.55 0001
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SCP 2 4 DS7 ICF Incorporated ATTN: Mr. Perry Alers Project Administrator 9300 Lee Highway ^
Fairfax, Virginia 22031-1207
Dear Mr. Alers:
Subject:
Task Order No. 15 entitled, " Revision of 10 CFR Part 35 - Medical Use of Byproduct Material," under Contract No. NRC-04-95-065 In accordance with Section G.5(c) of the subject contract, thh letter definitizes the subject task order. This effort shall be performed in i
accordance with the enclosed Statement of Work and the contractor's technical proposal dated September 8, 1997, which is hereby incorporated by reference I
and made a part of the subject task order.
Task Order No. 15 shall be in effect from September 29, 1997 through October 31, 1999. The total estimated ceiling for this task order is
$125,528.
The Accounting Data for this task order is as follows:
B&R No..
76015224010 Job Code No.:
W6295 APPN No.:
31X0200.760 BOC No.:
252A Obligated Amt.-
$50,000,00 The following individuals are considered to be essential to the successful performance of the work hereunder:
Paul Bailey, Craig Dean Walter Gawlak, John Collier, Steve Wyngarden, Jeffrey Pirkl, Kevin Blake, Kevin Greiner and Marci Catlett.
The contractor agrees that such personnel shall not be removed from the effort under this task order without compliance with Contract Clause H.2, Key Personnel.
Your contacts during the course of this task order are:
Technical Matters:
Samuel Jones Project Officer l]lllllllllll[llllll]gjg (301) 415-6198 Contractual Matters:
Amy Siller Contract Specialist 9'
(301) 415-6747 b
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NRC-04-95-065 PDR
. NRC-04-95 065 Task Order No. 15 The contractor shall not exceed the ceiling amount under this' task order-unless a formal modification is issued by the Contracting Officer.
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The issuance of this task order does not amend any terms or conditions of the subject contract.
Please indicate your acceptance of this task order by having an official, authorized to bind your organization, execute three copies of this document in the space provided and return two copies to the U.S. Nuclear Regulatory Comission, ATTN:
Ms.'Amy Siller,. Division of Contracts and Property
-Management, Contract Management Branc.h 1, M/S T-7-I-2 Washington, D.C. 20555.
You..should retain the third copy for your records.
Since we are rapidly approaching September 30, our fiscal year ending date.
you should expedite the execution and return of this document, Unless the signed documents are returned to me prior to that date, I cannot assure you of the continued availability of these funds.
Should you have any questions concerning the letter, please contact Ms. Siller on (301) 415-6747, Sincerely.
by Mar
, CoTC cting Officer Con rac anagemen Branch 1
'Divisio af Contracts and Property Management Office Administration
Enclosure:
As stated L
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.NAME
- 6c VicE Pc cs i oc or THLE -
Scar 7 t, 14 G DATE
STATEMENT OF WORK TECHNICAL ASSISTANCE FOR RULEMAKING SUPPORT REVISION OF 10 CFR PART 35 - MEDICAL USE OF BYPRODUCT MATERIAL TASK ORDER #15 NRC-04-95-065
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1.0 BACKGROUND
NRC has examined the issues surrounding its medical use program in great detail during the last four years. This process started with NRC's 1993 internal senior management review report: continued with the 1996 independent external review report by the National Academy of Sciences. Institute of Medicine; and culminated in NRC's Strategic Assessment and Rebaselining Project (SA).
In particular, medical oversight was addressed in the SA Direction-Setting Issue Pa)er Number 7 (DSI 7) (released September 16. 1996).
In its " Staff Requirements iemorandum (SRM) - COMSECY-96-057. Materials / Medical Oversight (DSI 7)." dated March 20,1997. the Commission directed staff to revise Part 35 associated guidance documents, and. if necessary. the Commission's 1979 " Medical Policy l
Statement." The Commission SRM specifically directed the restructuring of Part l
35 into a risk-informed, more performance-based regulation.
l A June 30, 1997. SRM informed the staff of the Commission's approval, with
- coments, of the staff's proposed program in SECY-97-131.
Supplemental Information on SECY-97-115. " Program for Revision of 10 CFR Part 35
' Medical Uses of Byproduct Material.' and associated Federal Reaister Notice." dated June 20.1997. After this approval, the NRC staff initiated development of draft rule language, using an entirely modality-based approach. The modality approach places all requirements for a given type of treatment into a single section of the regulation, including: (a) who or what organization is licensed! (b) what type of license is issued: (c) the necessary technical requirements, such as surveys and calibration; (d) the training and experience requirements: (e) the event recording and reporting requirements: and (f) the quahty improvement and management objectives.
Per NRC Management Directive 6.3. "The Rulemaking Process." the rulemaking, for this rule, is being conducted using a group approach. Governmental working and steering groups are developing rule text alternatives, including draft guidance documents.
State aarticipants have been identified for both the working and steering groups anc will enhance State participation in this process.
The NRC staff plans to solicit public input on the revision to Part 35.
associated guidance and the 1979 Medical Policy Statement on an informal and formal basis during the rulemaking process. During the development process. the NRC staff will make drafts publicly available on the NRC Technical Conference Forum and through the NRC Public Document Room.
The NRC staff is also planning a series of meetings in fall 1997 to discuss the major regulatory issues associated with the medical use of byproduct material and to obtain input on alternative rule language.
The NRC staff plans to interact with professional societies on an ongoing basis to solicit input.
Discussions will also be held in meetings with the Advisory Committee on the Medical Uses of Isotopes and the Organization of Agreement States in the fall of 1997.
In addition, the NRC staff will conduct public meetings, to be facilitated by NRC staff, in the fall of 1997. tentatively scheduled for October 28-30 in Chicago
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O Statement of Work, con't. and November 12-14 in Philadelphia.
These meetings will be used to focus discussion on specific rule text proposals.
Af ter Commission approval of the proposed rule language and associated documents, the proposed rule and associated draft documents will be published in theTederal Reaister for public comment for 75 days.
The NRC staff will also make these documents available on the NRC rulemaking website. The NRC staff plans to hold two public meetings during the formal comment period, planned for July 1 to September 15. 1998, to facilitate comment submittal.
2.0 OBJECTIVE Provide technical support to the NRC for revising the regulations in 10 CFR Part 35 - Medical Use of Byproduct Material.
3.0 WORKSCOPE The scope of work includes: (1) categorizing and summarizing public comments; (2) preparing a regulatory analysis; and (3) preparing of an environmental assessment.
Task 1 As directed by the technical monitor, the contractor shall categorize and summarize public comments made at the two public meetings tentatively scheduled for October 28-30 in Chicago and November 12-14 in Philadelphia.
The NRC will provide the contractor with a transcript of each meeting.
Task 2 The contractor shall provide the NRC with an Environmental Assessment for the proposed rule. The Environmental Assessment will be updated if needed after the public comments are received and analyzed.
Task 3 The contractor shall provide the NRC with a Regulatory Analysis for the proposed rule.
The Regulatory Analysis will be updated if needed after the public comments are received and analyzed.
The Regulatory Analysis shall include a Paperwork Reduction Act Statement and a Regulatory Flexibility Act Statement. The documents shall be prepared in accordance with the most recent guidance e.g..
" Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission. "NUREG l
BR-0058. Revision 2.
I Task 4 As directed by the technical monitor, the contractor shall categorize and summarize all public comments received on the proposed rule to include: (1) the public comments made during the two public meetings the NRC plans to conduct. in the July 1 to September 15. 1998 time period, after publication of the proposed rule; and (2) written comments received by the NRC in response to the Federal Reaister Notice announcing the proposed rule.
The NRC will provide the I.
Q Statement of Work, con't. contractor with a transcript of each public meeting, as well as the written comments received in response to the Federal Reaister Notice.
4.0-DELIVERABLES AND SCHEDULES Product Due Draft Final Task 1 l
Categorize and Sumarize Comments from the Public Meetings Held in the Fall of 1997
- First public meeting (planned for 10/28-30/97 in Chicago) 2 weeks
- Second public meeting
()lanned for 11/12-14/97 in Phil.)
2 weeks NUREG/CR Document combining the public coments of both meetings 2 weeks 2 weeks Task 2 Environmental Assessment 9 weeks after 2 weeks after 2nd public mtg.
contractor is (01/16/98) provided coments on draft Task 3 Regulatory Analysis 9 weeks after 2 weeks after 2nd public mtg.
contractor is (01/16/98) provided coments on draft Task 4 Categorize and Summarize Public Coments on the Proposed Rule 4a. Coments received at public meetings.
- First public meeting (planned between 7/1 and 9/15/98) 2 weeks
- Second public meeting (planned between 7/1 and 9/15/98) 2 weeks NUREG/CR Document combining the public coments of both meetings 2 weeks 2 weeks 4b.
NUREG/CR document that 2 weeks after 2 weeks after
' categorizes and sumarizes the close of public contractor is written comments received in-coment period provided coments response to the Federal Register on draft Notice announcing the proposed rule
7, - -- 7 Statement of Work, con't. Product Due praft Final
- 4c. Document combining:
(a) the 3 weeks after 2 weeks after written comments received in close of public contractor,is response to the Federal Reaister comment period provided comments Notice announcing the proposed on draft rule and (b) the public comments of the two meetings planned between July 1 and September 1. 1998
- Due date will be 2 weeks after the contractor receives the transcript of the i
meeting from the NRC.
l Note: NRC staff will provide reviews and comments on drafts within two weeks of l
receipt of drafts from the contractor.
5.0 PERIOD OF PERFORMANCE Two years from the effective date of this task order.
6.0 LEVEL OF EFFORT Approximately 1814 hours0.021 days <br />0.504 hours <br />0.003 weeks <br />6.90227e-4 months <br /> a
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