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Fwd: MEDHP-SEC: Part 35 Information to NRC Stakeholders
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>Date: Mon, 04 Nov 2002 12:17:16 -0500
>From: "Linda Psyk" <LMP1@nrc.gov>
>To: <medhp-sec@hps1.org>
>Subject: MEDHP-SEC: Part 35 Information to NRC Stakeholders
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>Dear Stakeholder,
>
>Thank you for participating in one of the NRC Part 35 Workshops. As
>promised, I am sending this email to all workshop attendee's to inform you
>of the most current information on Part 35 now available on the NRC website.
>I apologize for not getting this out to you sooner, but it took some time
>to enter over 1000 email addresses and to work with IT getting information
>on the web page.
>
>The following web address will bring you to the Part 35 informational page.
>http://www.nrc.gov/materials/miau/miau-reg-initiatives/by-product.html
>
>The page is organized as follows:
>
>Background
>includes links to
>1. Revised NRC Medical Policy Statement
>2. New Part 35 Final Rule
>3. Federal Register Notice for Corrections to the Final Rule (10/9/02)
>
>Related Documents and Other Resources
>includes links to
>1. Final NUREG 1556, Vol. 9 (October 2002)
>2. NRC Form 313A
>3. Questions and Answers About Licensing Under Revised 10 CFR Part 35
>**These are the Q&As from the stakeholder workshops. Not all of the
>questions are posted yet because we are still working on some answers.***
>4. Part 35 Stakeholder Workshop Presentations
>** These are all of the slide presentations from the workshop in a
>downloadable format.**
>5. Specialty Board Certifications Recognized by NRC
>** List of Board Certifications recognized for NEW users under Subparts B,
>D, E, F, G, H. These are NOT the Boards listed under Subpart J!! At this
>time, only one Board has been recognized for NEW User status under the
>requirements in Subparts B, D, E, F, G, H. The Certification Board of
>Cardiology has been recognized for uses under 35. 200. **
>6. Sealed Source and Device Registry
>**This is the link to sources and devices approved for uses under Part 35.**
>7. Licensing Guidance For:
> A. TheraSphere and SIRSphere Yttrium-90 Microspheres
> B. Proxima I-125 GilaSite Liquid Brachytherapy Source
> Radiation
> Therapy System
> C. Cordis, Novoste, and Guidant IVB Systems
>
>
>Also:
>The Society of Nuclear Medicine has generated a licensing guidance
>document for diagnostic uses. Currently, this document can be obtained
>through the SNM website (see below) for a fee.
>
>http://www.snm.org/about/news_102402_1.html
>
>In the near future, NRC will be posting this document in a downloadable
>format on the NRC web page for free.
>
>Additional Documents and web addresses Related to Part 35:
>
>NRC Regulatory Issue Summary 2002-19:New Modalities to be Regulated under
>10 CFR 35.1000
>http://www.nrc.gov/reading-rm/doc-collections/gen-comm/reg-issues/2002/ri200219.pdf
>
>Appointment of Radiation Safety Officers and Authorized Users Under 10 CFR
>Part 35
>http://www.nrc.gov/reading-rm/doc-collections/gen-comm/info-notices/2002/in200228.pdf
>
>
>Medical use of Strontium-90 Eye Applicators: New Requirements for
>Calibration and Decay Correction
>http://www.nrc.gov/reading-rm/doc-collections/gen-comm/info-notices/2002/in02017.pdf
>
>
>As additional information becomes available, I will continue to send out
>information emails.
>Please feel free to contact me with any questions.
>
>
>
>Linda M. Psyk
>Health Physicist
>Nuclear Regulatory Commission
>Division of Industrial and Nuclear Safety
>(301) 415-0215
>lmp1@nrc.gov
>
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