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Forwards documents & index for regulatory history file of proposed rule entitled, "Exempt Distribution of Radioactive Drug Containing One Microcurie of Carbon-14 Urea," 10CFR30 & 32.

Accession Number: ML20013E023

Date Released: Thursday, October 24, 2024

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• ML20198H571 - Forwards documents & index for regulatory history file of proposed rule entitled, "Exempt Distribution of Radioactive Drug Containing One Microcurie of Carbon-14 Urea," 10CFR30 & 32. (5 page(s), 1/9/1998)
• ML20198K055 - "Analysis of Costs & Benefits for Use of C-14 Urea Breath Test," Tri-Med Specialties,Inc,Charlottesville,VA.Draft 960325. (12 page(s), 4/30/1996)
• ML20198J119 - Forwards comments in response to 970228 memo requesting concurrence on Commission paper responding to Tri-Med Specialties,Inc Petition for rulemaking.Concur w/Commission paper. (6 page(s), 3/24/1997)
• ML20198K118 - "Environ Assessment for Use of C-14 Urea Breath Test," for Tri-Med Specialties,Inc,Charlottesville,VA.Draft 960325. (13 page(s), 4/30/1996)
• ML20198J917 - Requests assistance in matter re Tri-Med Specialties request for rule change or exemption from licensing for C-14 urea16 Breath Test.Expresses concern over inordinate length of time taken for decision to be made. (2 page(s), 9/3/1996)
• ML20198J224 - Informs that OCFO reviewed & concurs w/draft Commission paper on proposed rule, "Exempt Distribution & Use of Radioactive Drug Containing one uCi of C-14 Urea (parts 30 & 32)." (1 page(s), 3/12/1997)
• ML20198H907 - Forwards for action FR notice & supporting statement to be submitted to OMB for approval re proposed rule, "Exempt Distribution of Radioactive Drug Containing One uCi of Carbon-14 urea," (parts 30 & 32). (14 page(s), 4/1/1997)
• ML20198J766 - Forwards draft rulemaking plan entitled, "Medical Use of Capsules Containing One uCi of Carbon-14," for Agreement State input. (23 page(s), 9/30/1996)
• ML20198H634 - Lists action taken on request for approval of rev of info collection received on 970606 in accordance w/Paperwork Reduction Act.Regulatory analysis for proposed rulemaking & supporting documentation encl. (22 page(s), 8/13/1997)
• ML20198J649 - Confirms 960927 telcon.Discusses proposed schedule sent to Congressman D Burton.Notes points re worst case schedule NRC can commit to.Also,statement "Assuming staff wil start work" should be changed to "staff will start work." (2 page(s), 10/4/1996)
• ML20198J138 - Informs that Kentucky has no objection to C-14 urea capsule being distributed as exempt. (1 page(s), 3/20/1997)
• ML20198H875 - Forwards for signature,SECY paper transmitting proposed rule to Commission to amend parts 30 & 32 to permit exempt distribution & use of one uCi capsules of carbon-14 urea for in vivo diagnostic use. (58 page(s), 4/17/1997)
• ML20198K013 - "Analysis of Costs & Benefits for Use of C-14 Urea Breath Test." (8 page(s), 5/31/1996)
• ML20198J605 - Concurs w/daft rulemaking plan (10CFR35) & concurs w/ Alternative 3. (1 page(s), 10/17/1996)
• ML20198K065 - Discusses initiation of rulemaking plan on C-14 for in vivo diagnostic testing,10CFR35 (PRM-35-12) in response to petition filed by Tri-Med Specialties,Inc. (1 page(s), 4/11/1996)
• ML20198J157 - Submits changes on proposed rule, "Exempt Distribution of Radioactive Drug Containing one uCi of C-14 Urea (Parts 30 & 32)." OMB clearance package for compliance w/Paperwork Reduction Act of 1995 encl. (19 page(s), 3/20/1997)
• ML20198J404 - Forwards Commission paper w/enclosures,on proposed rule, "Exempt Distribution of Radioactive Drug Containing One uCi of C-14 Urea (Parts 30 & 32)," for concurrence. (53 page(s), 2/28/1997)
• ML20198J539 - Submits comments on draft rulemaking plan 10CFR35 in predecisional form concerning "Medical User of Capsules containing 1 uCi of C-14" & based on PRM-35-12.Support Alternative 3 which would establish general license. (1 page(s), 10/22/1996)
• ML20198J493 - Supports Option 3 of draft rulemaking plan for medical use of capsules containing C-14 as outlined in predecisional rulemaking plan.W/B Spell comments. (2 page(s), 10/24/1996)
• ML20198J418 - Forwards memo to Commission w/encls,including final rulemaking plan, "Exempt Distribution & Use of Radioactive Drug Containing One uCi of C-14 Urea (Parts 30 & 32)," for review. (52 page(s), 1/30/1997)
• ML20198K151 - Responds to 951019 ltr to J Piccone re personal experience w/C-14 breath test.NRC evaluating comments along w/over 300 public comments received on petition for rulemaking. (1 page(s), 11/22/1995)
• ML20198J997 - Forwards final deliverable repts which address/incorporate 960517 comments of NRC staff.Safety rept for use of C-14 urea capsules for detection of helicobacter pylori bacteria in human alimentary tract,encl. (1 page(s), 5/30/1996)
• ML20198J830 - Offers no legal objection to rulemaking plan for amend of 10CFR35 to provide general license for physicians to use capsules containing one uCi of diagnostic.Submits two paragraphs to be added as separate section. (15 page(s), 9/20/1996)
• ML20198K202 - Forwards for further action docket file on petition for rulemaking filed by Tri-Med Specialties,Inc,(PRM-35-12). (1 page(s), 4/12/1995)
• ML20198J103 - Responds to SP-97-015.North Dakota does not have any problem w/exempt distribution of capsules containing one microcurie of C-14 Urea for diagnostic testing. (1 page(s), 3/24/1997)
• ML20198K042 - Forwards revised "Analysis of Costs & Benefits for Use of C-14 Urea Breath Test" prepared under task 4 of NRC contract NRC-04-95-065.Version incorporates comments from NRC on first draft delivered on 960329. (1 page(s), 5/9/1996)
• ML20198J076 - Submits addl comments re SP-97-015 on proposed exemption for 1 microCi C-14 drug issue.North Dakota has same restrictions as many other states w/regard to not allowing licensing exemptions to apply to RAM that goes into drugs. (1 page(s), 3/25/1997)
• ML20198H913 - Submits comments on two specific questions asked in SP-97-015 ltr.State of WA position on "not limiting receipt of physicians," either alternative 2 or 3 (exempt of general license distribution) could be handled as stated. (1 page(s), 4/1/1997)
• ML20198H794 - Informs that Carbon 14 Urea Breath Test from Tri-Med Specialties,Inc,received final NDA approval from FDA on 970509. (1 page(s), 5/19/1997)
• ML20198H887 - Informs that ltr being sent at request of S Hoffman who expressed concern during telcon re Tri-Med petition not tracking draft schedule that NRC provided to Congressman Burton in fall of 1996. (1 page(s), 4/4/1997)
• ML20198K217 - Informs that petition for rulemaking (PRM-35-12) filed by Tri-Med Specialties,Inc does not qualify for special handling as fast-track petition for rulemaking as specified in 10CFR2.802(e) of Commission regulations. (13 page(s), 11/2/1994)
• ML20198J869 - Concurs w/rulemaking package,10CFR35, "Medical Use of Capsules Containing One uCi of C-14 (PRM-35-12)," subj to consideration of attached comments,in response to rulemaking plan,received 960916. (16 page(s), 9/19/1996)
• ML20198H860 - Forwards info on behalf of Tri-Med Specialties,Inc, in effort to receive rule change for 14C-urea Breath Test petition submitted to NRC in 1994 & expresses concern w/ increasingly inordinate amount of time taken for approval. (2 page(s), 4/18/1997)
• ML20198J932 - Concurs on rulemaking plan, "Medical Use of Capsules Containing One uCi of C-14 (PRM-35-12)," w/comments. (1 page(s), 8/27/1996)
• ML20198J188 - Informs that Ofc of Admin concurs in proposed rule & accompanying documents that would permit NRC licensees to distribute capsules containing 1 uCi C-14 urea for "in vivo" diagnostic use.Marked-up proposed rule includes changes. (44 page(s), 3/13/1997)
• ML20198K080 - Forwards draft safety rept,draft environ assessment,draft analysis of public comments & draft analysis of costs & benefits prepared under task 4 of contract NRC-04-95-065, addressing petition for rulemaking by Tri-Med Specialties. (1 page(s), 3/29/1996)
• ML20198J252 - Informs that review of proposed rule, "Exempt Distribution of Radioactive Drug Containing One uCi of C-14 Urea (Parts 30 & 32)," completed.No comments.Copies of comments received in response to FR notice to proposed rule requested. (1 page(s), 3/11/1997)
• ML20198K101 - Draft safety rept for, "C-14 Urea Capsules for Detection of Helicobacter Pylori Bacteria in Human Alimentary Tract." (31 page(s), 3/31/1996)
• ML20198H672 - Request for OMB review & supporting statement re application for matl license.Estimated respondent burden is 72,987 h. (12 page(s), 6/5/1997)
• ML20198J988 - Concurs on final rulemaking plan entitled, "Medical Use of Capsules Containing One uCi of C-14," that amends part 35. (10 page(s), 8/20/1996)
• ML20198H718 - Forwards marked-up copies of FRN,congressional ltrs & public announcement re proposed rule revising 10CFR30 & 32, "Exempt Distribution & Use of Radioactive Drug Containing One Microcurie of Carbon Urea," encl. (72 page(s), 6/4/1997)
• ML20198J793 - Responds to 960903 ltr re petition for rulemaking from Tri-Med Specialties,Inc.NRC staff working to resolve petition as soon as possible.Safety analysis & other evaluations that form technical bases completed. (2 page(s), 9/25/1996)
• ML20198J995 - Forwards rulemaking plan, "Medical Use of Capsules Containing One uCi of C-14 (PRM 35-12)," for concurrence. (11 page(s), 8/14/1996)
• ML20198K197 - Requests that NRC give serious consideration to petition that allows C-14 breath test to be distributed to physicians w/o NRC or Agreement State license. (3 page(s), 10/19/1995)
• ML20198J577 - Informs that proposed rule re "Medical Use of Capsules Containing One uCi of C-14", PRM-35-12,appears appropriate & should go forward. (1 page(s), 10/21/1996)
• ML20198J978 - Informs that OC reviewed rulemaking plan, "Medical Use of Capsules Containing One uCi of C-14 (PRM-35-12)," to issue direct final rule amending 10CFR35 (adding Subpart D). Review of budget shows resources available to proceed. (2 page(s), 8/23/1996)
• ML20198J298 - Informs that OE,J Lieberman,concurs on proposed rule, "Exempt Distribution of Radioactive Drug...." (1 page(s), 3/5/1997)
• ML20198H830 - Forwards comments on SECY-97-090 which presents proposed rule on exempt distribution of radioactive drug containing one microcurie of Carbon-14 urea. (30 page(s), 5/2/1997)
• ML20198J324 - Requests ltr explaining why rulemaking being further delayed re Tri-Med proposed rule. (1 page(s), 3/5/1997)
• ML20198J741 - Forwards,for transmittal to Commission,for info draft rulemaking plan entitled, "Medical Use of Capsules Containing One uCi of C-14," in accordance w/SRM COMSECY 96-035,dtd 960611. (1 page(s), 9/30/1996)
• ML20198J449 - Informs that state of OR does not intend to authorize in vivo diagnostic procedures under general license.Diagnostic procedure must be specifically authorized under 35.100 or equivalent regulations. (1 page(s), 12/6/1996)
• ML20198J270 - Concurs w/proposed rule 10CFR30 & 32, "Exempt Distribution of Radioactive Drug Containing 1 uCi C-14 Urea." Offers revs to Section IV Agreement State Compatibility. (1 page(s), 3/7/1997)
• ML20198J664 - Advises that draft rulemaking plan, "Medical Use of Capsules Containing One uCi of C-14," forwarded to Agreement States for input,per 960611 SRM.Two 960919 wire svc articles encl.W/o encls. (1 page(s), 10/2/1996)
• ML20198K019 - Submits comments on draft safety rept,environ assessment & cost benefits analysis associated w/Tri-Med petition for rulemaking. (2 page(s), 5/10/1996)
• ML20198H883 - Informs that State of MS would probally be willing to allow FDA & Pharmacy Board decide question of administration of C-14 urea.State of MS not aware of any other regulations concerning use & distribution of test. (1 page(s), 4/8/1997)
• ML20198H780 - Responds to 970418 ltr re petition for rulemaking submitted by Tri-Med Specialties,Inc.Specifically,concerns regarding, why NRC changed process & decided to proceed w/publication of proposed rule instead of direct final rule. (2 page(s), 5/20/1997)