ML20198K202
| ML20198K202 | |
| Person / Time | |
|---|---|
| Issue date: | 04/12/1995 |
| From: | Lesar M NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | Steve Jones NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-089, AF70-1-89, NUDOCS 9801140340 | |
| Download: ML20198K202 (1) | |
Text
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April 12, 1995 HEMORANDUM T0:
Samuel Z. Jones Of f Nuclear Re ul ry Research
/
FROM:
esar, Chi f Rules Review Section Regulatory Publications Branch Divisicn of Freedom of Information and Publications Services Office of Administration
SUBJECT:
PRM-35-12 DOCKET FILE Attached for further action is the docket file on the petition for rulemaking filed by Tri-Med Specialties, Inc. (PRM 35-12).
The docket consists of the petition filed, the Federal Register notice requesting comment on the petition, and the comments received on the petition as of April 7, 1995.
If you have any questions on this matter, please contact me on 415-7163.
Attachments:
As stated 4
9001140340 980109 PDR PR 30 62FR32552 PDR GW
x F;: !4?te %ne.
1500 AVON STREET EXT'D CHARLOTTESVILLE, VA 22902 PHONE (804) 977-8711 FAX (804) 977-8760 e
Director, Freedom of fnformation and Publication Services Omcc of Administration U.S. Nuclear Regulatory Commission Washington, DC 20555 August 23,1994 Attention: Chief, Hegulatory Publications Hranch in accordance with Title 10. Code of Federal Regulation, part 2, Subpart H.
Rulemaking Tri Med Specialties, Inc is petitioning the NRC to allow for the general licenring and/or exemption for the comniercial distribution by licensed pharmaceutical manufacturers of a capsule containing one micro-Curie (nCi) of Cl4-urea for in vivo diagnostic testing The suggested maximum number of capsules which could be in inventory at an unlicensed facility at any time would be 150 (ISO Ci)
Specifically, the Tri Med Specialties, Inc petition is to permit the distribution of the capsule containing lpCi Cl4 The capsules will be distributed separately or as part of a diagnostic kit which contains supplies to perform the test. The purpose of the kit is to detect the presence of the bacterium llelicobacter pylori, a cause of peptic ulcers (see below).
The pharmaceutical grade Cl4 urea is in a dry solid form The manufacturing process calls for one micro Curie of the Cl4 urea to be placed in a gelatin capsule. After insertion of the Cl4 into the capsule, the outside of the capsule is inspected for any contamination it is then placed into a commeieial blister pack and scaled The scaled package is then placed into another container which is also scaled. That package is then placed into a shipping container that is approximately 6" by 6" by 2" During the packaging processes, the capsule and external packaging are re-inspected to provide an airtight seal.
Because of the exceptionally low dose, the capsule presents minimal risk to the public Even if the shipping container should be damaged during the shipping process, exposure to such a small amount of Cl4 is minimal. We feel that this product should be exempted in much the same way as the possession and distribution of smoke detectors.
They are exempt from licensing requirements and also contain small amounts of radioactive material.
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4 Tri Med Specialties, Inc, corporate headquarters is located in Overland Park.
Kansas. Their omce in Charlottesville, Virginia is a licensed pharmaceutical manufacturing site It is also licensed by NRC # 45 25215 01 to perform research using Cl4 ; The research performed at this facility involves the manufacturing of the I pCi Cl4 urea capsule and the production of the diagnostic breath test kits These test kits are currently transferred only to facilities who are licensed by the FDA (IND # 42294) and the NRC to use them Reason for Use:
Recent medical research has found that peptic ulcers are commonly caused by a t,terium called 11 pylori. This bacterium lives in the stomach of most ulcer sufferers. By l
bl s (see treating ulcer patients with antibiotics, doctors can now cure most u cer pro em Appendix I).
It is therefore necessary to detect the presence ofil pylori bacteria in ulcer patients so that the new treatment can be given appropriately. In the past, this was done by a gast:0cnterologist wi.o took biopsy samples of the stomach lining at endo > copy; a procedure which was uncomfortable and expensive ($1000)
With the new test,11 pylori can be detected non invasively using a Cl4 urea tracer Cl4 urea is broken down by 11 pylori to form labeled CO: which is expired in the breath. To do the test, a doctor asks the patient to swallow the capsule with 30 mis of water. Aller 15 minutes the patient blows 2 liters of breath into a collection bag ( a mylar balloon) which is mailed to a testing laboratory If Cl4 CO: more than twice background is present in the breath sample, then the patient must be infected with li.
pylori.
Risks of the Test The lpCi of Cl4 urea consumed by the patient is rapidly excreted as urea in the urine or CO:in breath This means that even for persons taking the test, risk is very low.
The radiation dom received by the patient is 0 3 millirems (an amount equal to
- background receised in 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />) For persons administering the test the risk is unmeasurably low and rist. to the public is close to zero Public impact The impact on the public is minimal. This is especielly true when compared to unlicensed distribution that the NRC already approves - 10 CFR part 31.11 describes general license provisions whereby physicians and veterinarians can receive, use and
- dispose of byproduct material for in vitro clinical or laboratory testing without applying fo'r a specific license: They simply have to register with the NRC. Specifically part 31.11
- (a)(3), general licensing of Cl4 for in vivo uses as described above, would have less
- impact on the general public Other generallicenses permitted in part 31 would have
- much more likelihood ofimpacting the public than the proposed C14 urea test.
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Benefits of the Test The test is accurate (95%) and quite inexpensive because ofits simpF:ity. With
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the test, doctors can easily determine whether or not ulcer patientt, have been cured of j
their infection if exempted, the Cl4 urea breath test could be done by most doctors for l
less than $100 cost to the patient. This is a considerable cost savings over endoscopy and j
-l biopsy (51000) The benefits to the public are that curative therapy for ulcers will become available to all, saving the United States an estimated 5500 rnillion per annum over 4
conventional therapy (see Appendix l}
I Hensons for Lleensing Esemption Currently, the test must be supplied only to facilities licensed to receive Cl4. This requirement makes the test prohibitively expensive for the great majority of doctors.
i Present Usage of the Test I
The test is currently being studied at four sites under an IND application accepted by the FDA. Over 100 patients have been enrolled to this point The test is also being used at other sites under approved research protocols All of these sites are using the test under our IND and ari. also licensed by the NRC to administer Cl4 to patients for l
diagnostic testing More than 200 tests have been performed at these additional sites From the tests performed as of this date, no adverse events related to the test have been i
reported As outlined in 10 CFR part ?, paragraph 2 802(l) we are requesting assistance in filing this petition within the specified guidelines We understand that a " Fast Track" l
process whereby the NRC can expedite consideration of a mie change petition is poss We request that this petition receive this treatment The medical and (mancial reasons for this have been outlined above Any questions you have or advice that you can provide would be greatly appreciated Pl case direct questions to William A, Fry, President, Tri Med Specialties,Inc. (800 874-6331)
Barry J. Marshall, h1 D.. Direcior of Pharmaceutical Operations (804-977 8711)
James R. Gilchrist, Consulting Radiation Safety Omcer.(804 982 4901)
Matthew J. Combs, Ph D, Pharmaceutical Scientist (804 924 2843)
Susic R. Ilomnan RN, BSN, Product Development goordinator (804 977 8711)
Sincerely,-
p 3 y,,
J William A. Fry President '
Tri Med Specialties, Inc
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I Appendicesi 4
- 1. NIH Consensus Conference :llelicobacter pyloriin Peptic Ulcer Disease JAMA.
1994;272:65 69 2.- A 20 minute Breath Test for Helicobacter pylori. Am J. Gastro 1990,86:438-445
- 3. Radiation Dose Estimates for the Carbon 14 Labeled Urea Breath Test. J Nu 1993;34:821 825; i i
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G1831 Proposed Rules re" WL 59, No. 231 friday. December 2.1994 1his secton of pse FEDE rat. HLGSTEFI Reputatory Cornmission, Washington, performed by most doctors for less than cereanno nonces to the ptase of the sweposed DG 20555. Telephone: 301-415-7163 or 5100 cost to the patient.
leeuake of ndse md sqkesmans.1M i011 free: 1-800-368-5642.
gasposa of twee nasces is to gWe Iraerseted Public 1mpact persons an apparassy to pertwate m we suretrasserTAnyinesonesAfl0N:
The petitioner' notes that the ri&La nas mehene pnar w the aduseon et we Ivel y,titioner from the C14 ures test would be very ndse-Tel-Med Spcialties, lac.,
low because the 1 pCl of C14 urea headquartemd in Overland Park' consumed by the patient is rapidly NUCt. EAR REGULATORY Kansas,inalntains a licensed excreted as uros in the urine or coa in 00estatsst0N pharmaceutical manufacturing site in the breath. The peutioner states that the Charlottesville, Virginia. The poudoner radiation dose received by the patient would be 0.3 millirem (an amount equal 10 CFR Part 35 also is licensed by um NRC (445-25215-to background rediation received in 24 lDedet No.Pfts445-12]
- 01) to perform research using C14.%is hours). %e risk for persons research involves manuladurJ of TrHead Speclast6es,Inc.1 FWing of capsules containing 1 micro curie (pCl) administering the test would be immeasurably low and risk io the public Poetion for Rulemaking of C14 ures and producuon of would be close to sem.
Acteects Nuclear Regulatory diagnosuc treath test kits. The test kits The petitioner indicates that the gg' are currently transferred only to Commission's reg +alations cunently facilities licensed by the Food and Dru contein provisions for a general limnse Actions: Nouco of receipt of petition for Administration (FD A) (INDs 42294) en whereby physicians and vetorinarians mlernsking.
the NRC.
can receive, use, and dispose of euensa.s %e Nuclear Regulatory Petitioner's Request byproduct nr.aterial for in vitro clinical Commission (NRC)is ublishing for public comnant a not ce of receipt of a Tri.Med Specialues requ ests that the or laboratory testing without applying for a specific license. According to the NRC amend its ulations to allow for ptition for rulemaking, dated August petitioner, these recipients are mquired 23,1994, that was filed with the the generallicens ng and/or exemption Cbmmission by Tri.Med Specialties, for the commercial distribution by only to be registered with the NRC.%e petitioner further asserts that the Inc. The petition was assigned Docket 11 enned phannaceuncal manufacturers No. PRM-35-12 on October G 1994.
of a capsub cmtalning 1 pCl of C14*
Commission's regulations permit other ceneral licenses tnat have a greater The petitioner requests that the urea for in vivo diagnostic testing ne
]ilelihood of aHecting the public than Commission amend its regulations to (ettuoner states that the capsules would the proposed C14 urea test, l
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m ally distribute under general licensing nr. !/ causa reptic ulcers in the stomach.
The petitioner states that under the or exemption, capsules containing one According to the petitioner, the capsules current regulations, the t. st is 05-w uld be distributed sebarately or as rcent accurate end quite inexpensive fcarl C141 f
$cause of its simplicity. The test would part of a diagnmuc W at antains admin ra lon to I u ans forin ivo diaE'mr, tic testinE suppHes t pedonn Ge w. The permit doctors to determine easily patta: Submit comments by February petitioner suggests the maximum whether or not ulcer patients have been number of capsules allowed in cured of their infection. no benefits to 15,1995. Comments received after this date willis conaldered if it is practical inventory at an unlicensed facility at the public, acco ding to the petitioner, to do so, but assurance of conslderation any time be 150 (150 pCi).
would be a curative therapy for ulcers cannot tw given except as to comments Grounds for Request that can be made evallable to all people, received on or before this date.
thus saving the United States an The petitioner states that recent estimated 5500 million per armum over AconE9%S: Submit mmments to the medical research has found ic conventione) therapy.
Secretary, U.S. Nuclear Regulatory ulcers are commonly caused the Commission, Attentium Docketing and li. pylori bacterium that lives i the Conclusion
- Service Branch Washington DC 20555.
stomach of met uker sufferers.
The petitioner states that the test may For a copy of the petition, write to the According to the petitioner,in the past, he supplied curantly only to facilities Rules Review Section, Rules Review doctors used the endoscopy and biopsy licensed to receive C14. Amording to and Duectives Branch, Division on pmcedure to detect the stemach ulcers.
the petitioner, this requirement makes Freedom oflafonmation and This procedure was uncomfortable and the test prohibitively expensive for the puh!!cationsSirvices Office of expensive at a cost of $1000.ne great majority of doctors. ne petiuones Administration U.S.NuclearRegulatory petitioner states that by using a C14 states that the test is currently being Comminaiort Washington, DC 20555, urea tracer,11. lori can be detected studied at four sites under a~ Notice of 90M FWITNER psFCsesaT!ost 00stTACT:
noninvasively having the patient Claimed Investigational Exemption for a MichaelT,tasar ChieI,Rutes Review swallow a capsu e with 30 milliliters of New Drug (IND) application accepted by
' Section, Rules Review and Directives water. C14-ures is broken down by the FDA and is also being used at other 3 ranch, Division of Freedom of 11 pylori to fonn labeled CO2. which is sites under approved research protocols.
Inf irmation and publiations Services, expired in the breath.ne petitioner The petitioner states that all of these Office of Administration, U.S. Nuclear ass.rts that the C14-urea test could be sites are using the test under the L.........
r 61832 l'ederd Register / Vol. h9, No. 231 / Friday Ih cember 2,19(it / Proposed Itules peutioner's IND and are also licensed by 1o Williarn W. mies, Secrttary, Doard of following six months after the final e
the NRC 10 administer C14 to patients Governors of the i ederal iteserve regulation is issued.
for diagnostic testing. The petitioner System,20th Street and Constitution The Board is proposing regulations for states that more than 200 tests have Avenue, N.W.. Washington, DC 2055 L comment, and expocts to adopt final been perfortned at these additional sites Comments also may be delivered to implementing regulations in March and that no adverse events from the Room Il-2222 of the Eccles flullding 1995. Complianw with the law would -
tests perfonnni as of this date have imen between 8:45 a.m. and 5:15 p.m.
le mandatory by October 1,1995, reported. ~1herefore, the petitioner weekdays, or to the guard station in the Section 156 of the Equity Protection Act believes that liwnsed phannaceutical Eccios Hullding courtyard on 20th states that the final rule govems all '
manufacturers should te permitted to Street, N.W (hetween Constitution high rate, high. fee mortgage transactions distribute the capsule containing 1 pCi Avenue and C Street) at any time.
consummated after the mandatory of C14-urce for in vivo diagnostic Comments may be inspected in Room effective date. The Board believes that testing.
MP-500 of the Martin 11ullding between the same compliamn rule would apply 9.00 a.m. and 5:00 p.m. weekdays, to reverse mortgage transactions Additional Documents except as pmvided in 12 CFR 201.8 of consummated after the rnandatory The petition includes additional the Board s rules regarding the effective date.
justification and support for the availability of information, "L 8""' I' ' "" ^"*'I requested arnendment not included in FOR rvRTHER INFORMATION COM ACT: lane this Federal Itegister notice. Members of Ahrens, Senior Attorney, or Kyung Cho. Secflon 226 2-Definitions and Rules of tie public interested in filing comments Miller or Sheilah Goodman, Staff Construdion et i RM-35-12 can obtain a copy of the Attomeys, Division of Consumer and 2(a) Definitions petition and supporting documentation Cornmunity Affairs, Board of Governors tiy writing to the address noted above.
of the federal Reserve System, at (202) 2(a)(17) Creditor Datetl at Ndville, Maryland, this 28th day 452-3667 or 452-2412; for the hearing Section 152(c) J:he Equity of November,1994, impaired only, Dorethea Thompson, Protection Act states the number of for the Nuclear Regulatory Commiss6on.
Telecommunications Device for the high rate, high. fee rnortgage tranuctions John C Ileyle Deaf, at (202) 452-3544.
a lender may mrd e before becoming a creditor for purposes of the TILA.The Ading Scrireary of the Commissson.
SUPPMMMARY pdORMATM IFR Iloc. 94-2M4 Filed 12-t-94; a tw ami proposed regulation parallels the
- l. Barkground statute. The regulation provides that a con, y,,w The purpose of the Truth in tending persons making occasional home-Act (15 ll.SC 1001 et seq.) is to secured loans-less than five during a FEDERAL RESERVE SYST 1 pmrnote the informed use of consumer calendar yea;-are not subject to the act.
ctwlit by requiring disclosures about its The proposed regulation provides that a 12 CFR Part 226 terms and cost. The act requires creditor includes a person originating creditors to disclose credit tenns and two or more high rate, high fee mortgage (Regulauon Z: Docket No. H-0858) the cost of credit as an annual loans, or one or more such mortgage Truth in Lending percentage rate (APR). The act requires loans through a mortgage broker during additional disclosures for loans secured any 12 month period. Thus, for AGENCv! Iloard of Govemors of the by a consumer's home, and permits example, a person originating one high-Federal Reserve System-consumers to cancel certain transactions rate, high fee mortgage that soon ACTION: Proposed rule, that involve their principal dwelling.
thereafter enters into two home secured loans, one of which was a high rate, suuuARY:The Board is publishh., for Limitations are imbiosed on some credit high fee loan, would be requimd to line plans secured y a consumer's comment pmposed amendments to principal dwellie-The act is comply with TILA for both transactions.
Regulation Z(Truth in tending).The cmIndments implement recent changes "f2 ed b ;0 *e Bontd's Regu1ation Subpart B--Open End Credit made to the Truth in Lending Ad by the I
Section 226.5b-Requirements for Horne Riegle Community Development and II. Proposed Regulatory Provisions Equity Plans Regulatory improvement Act of 1994-The llome Ownership and Equity
- Ihe law imposes new disclosur' Pmtection Act of 1994 (Equity
$b(f) Limitations on llome Equity Plans-requirements omd substantive Protection Act), ccmtained in the Riegle The TILA allows creditors to lirnitations on mortgages bearing high Community Development and terminate open end plans and demand rates or foes. The amendments would Regulatory improvement Act of 1994 repayment in narmwly drawn provide greater pmtections to (Community Development Act), Pub. L circumstances such as when the consumers entering into high rate, high' 103-325,108 Stat. 2160, amends the consumer fails to make payments or fee mortgages. The law also imposes Truth in tending Act (TILA). Section takes actions that affect the creditor's new disclosure requirements to assist 152 of the Equity Protection Act adds a security. Section 154(c) of the Equity consumers in comparing the cost of new section 129 dealing with high rate. Protection Act excludes reverse reverse mortgage transactions, which high fee mortgages. Section 154 adds a mortgage transactions from these pmvide periodic payments to primarily new section 138 dealing with reverse substantive limitations. The legislative elderly homeowners and rely mortgage transactions. The Equity hietory states that the amendment is principally on the home's value for Pmtection Act was enacted in intended to codify the Board's repayment.
September 1994, and directs the Board interpretation regarding a creditor's DATES: Comments must be received on to issue final regulations within 180 ability to accelerate an open-end reverse or before January 18.1995.
days. It provides that the statutory mortgage loan in accordance with the ADontssts: Comments should re'er to provisions and rules adopted by the credit contract. The proposed Docket No. R4858, and may be nailed Board shall apply on the October 1 amendment reflects that intent.
, mss ='3 e.
F45280 Proposed Rules
>d-ine~
Vol. 59. No. 242 Monday, Ococmtwr 19, 1994 Ttwo sectson of the FEDERAL REGISTER Quarantine, APillS, USDA, P.O. Drawer comments received between November contaans notares to ttaa pec of the groposed 810. Riverdale, MD,20738. The 15,1994, and January 3,1995.
Issuance of rules and regulahons. Iha telephone number for the agency Authoriry: 7 U.S C.150dd,150ee,150ff.
gxrpose of these nouces ta to geve interested contact will change when agency offices 151-167,450. 21 U.SC 130 and 12a,7 CFR gersons an opportung to partaupate en the in Ilysttsville, MD, move to Riverdale, 217,2.51, and 371.2ic).
r makrig poor to tre adoptson of the final MD, during January. Telephone: (301)
Done in washington, DC, rhl: 14th, day of 43fh8045 (llyattsville); (3011734-8645 Decemler 1394.
- (IUverdale).
Alex B.Thiermann.
DEPARTMENT OF AGRICULTURE SUPPLEMENTARV INFORMATION:
Acting Administrator, Animof ond/'intil Health insperrion Service.
Animal and Plant Health inspection Ilackground p.x Doc. 94-31151 riled 12-tr,-94; a 45 aml On November 15,1994, the Animaj s w eacow w as 7 CFR Par 1310 and Plant llealth inspection Service (APillS) published in the Federal (Dott.et No. 94-i tik-2)
Register (59 FR 59070-59071 Doclet NUCLEAR REGULATORY Importation of Fresh Hass Avocado No. 94-116-1) an advance notice of COMMISSION Fruit Grown in Michoacan, Mealco pmposed rulemaking and a notice of iublic meetin a concerning the >ossible p
AGENOY: Animal and Pl3nt IIcalth mportation o fresh lies avoca o fruit
[ Docket No. PRM-35-12)
Inspection Service, USDA.
grown in approved orchards in Action: Advance notice of propo,cd approved municipalities in Michoacan, Trt.Med Specialties,Inc.! Filing of rulemaking and public rnectings, Mexico, into certain areas in the United Petition for Rulernaking, Correction reo sening and extension of comment States. The two public meetings were p;r od.
beld on November 28 and 29. Interested AGENCY: Nuclear Regulatory persons were invited to present either C,ommission, suwuARY:The Animal and Plant llcalth written or oral comments at the public ACTION: Notice of receipt of petition for inspection Service is reopening and meetings on the Mexican pr posal The rulemaking; correction.
cuending the time period for the public notice stated that copies of I ie Mexican suuuARY:This document clarifies a to comment on an advance notice of proposal were available by calling or proposed rulemaking regarding the writing Mr. Victor liarabin All written portion of the notice of receipt for a possible importation of fresh fless comments on the advance notice and petiti n for rulemaking filed by Tri Med avocado fruit grown in approved Mexitan proposal were required 'n tu Specialties, Inc., and docketed as PRM-orchards in appruved municipalities in tereived on or before Decendwr ia, 35 -12. Tim notice of mceipt for das Michonran, Mexico, into certain areas in 1994, petition uas published on December 2, 1994 (59 FR 61831).
the United States. Reopening and M ec blic Mm. Wies he estedding the comment period will give Mexican proposal were also made DATES: Submit comments by February interested persons additional time to 15,1995. Cmuments received after this Mable. A number of persons in a
repare and submit comments on the attendance at both public meetings date wdl be considered if it is practical t do so, but assurance of consideration texican proposal.
stated that this was their first tAlts: Consideration will tm given only opportunity to review the Mexican cann t be given except as to comments received on or before this date.
to comments received on or before proposal and that the copies of the
):nuary 3,1995.
imposal pmvided were incomplete ADDRESSES: Submit comments to the j
ADORES $[S: Please send an original and occause Appendices I,11, and 111 were Secretary, U.S. Nuclear Regulatoe three copics of your comments to Chief, not included.They te ucsted that the Commission, Attentiorv Docketing and Regulatory Analysis and Development, Appendices be rovid d and that the Service Branch, Washington, DC 20555, PPD, APillS, USDA, P.O. Drawer 810, comment perio closing date be Fcr a copy of the petition. write to the Riverdale, MD 20738. Please state that extended to allow time for review of the Rules Review Section Rule Review and your comments refer to Docket No. 94-complete pmposal and comment.
Directives llranch, Division of Freedom
]
11&-2. Comments received may be APills has forwarded copies of these of Information and Publications inspected at USDA, room 10.1, South Appendices to those interested persons Services. Office of Administration.U.S.
Buil ling,14th Street av 'ndependenca who requested copies of the Mexican Nucloat Regulatory Commission.
Avenue SW., Washingioi. 'X'., bet 7 proposal pursuant to the November 15 Washington, DC 20555.
8 a.m. and 4:30 p.m., Mong sy thrc 8 we, Federal Register notice or w ho FOR FURTHER INFORMATION CONTACT:
Friday, except holidays. Persons
,ccived copics of the proposal at the Michael T. lesar, Chief, Rules Review wishing to inspect comments are two public meetings. So that interested Section Rules Review and Directives wquested to call ahead on (20216no-persons may have additional time to Branch, Division of Free lom of 2817 to facilitate entry into the prepare and submit comments on the information and Publications Services, comment reading room-Mexican proposal. APillS is reopening Office of Administration, U.S. Nuclear FOR FURTHER INr0RMATION CONT ACT: Mr.
and extending the public comment Regulatory Commission, Washington, Victor linfabin, llead, Permit Unit. Port period on Docket No. 94-116-1 until DC 20555. Telephone: 301-415-7163 or Operations, Plant Protection and hnuary 3,1995. APl!!S will consider all toll free: 1-800-308-5642.
%***!a Feder:I Regider / Vol, ~. No. 242 / Monday December 19,199 Proposed Rules G5281 i
cuppttast NTARY mroRuATicN: In the to superseding that AD. The actions ruust submit a self. addressed, stamped notka of twelpt for PRM-35-12 spenfied by this proposed AD are postcard on which the following publisted on December 2,1994 (59 FR intended to prevent unmntained statement is inado:" Comments to sissl), the parayaph under the fractures of 9th through 12th stage llPC Docket Number 81-ANE-03." The heading. llenefits of the Test." revised disks and engine failure.
postcard willie date stamped and to read as follows:
DATES: Comments must be received by returned to the commenter.
The petluoner states that tmder the February 17,1995.
Availability of NPRMs current regulations, the test is 95 ADDRES&tSt Submit comments in Any person may obtain a mpy of this t accurate and quite inexpenshe tif licate to the Federal Avlation taae of its simplicity. The test would g[r.Cnististion, New England Region.
NPRM by submittbg a request to the FAA, New England Region. Office of the
. permit doctors to determine easily Office of the Assistant Chief Counsel.
i Assistant Chief Counsel, Attention:
l whether or not ulcer patients have been Attention: Rules Docket No. 81-ANU-Rules [kicket No. 81-ANE-03,12 New cured of their infection. By providjng 03 12 New England Exocutive park, England Exe*utive Park Durlington, MA the public with an inexpensive, casily Durlington. MA 01803-5299. Comments 01603-$ N acemealble diagnostic test rnore may be inspected at this location Individuals would be accuratel between 8:00 a.m. and 4:30 p m..
Discussion 6
trea Hy h
n[ay thr ugh Friday, except FederalOn February 7.1984, the Federal
,w
., e U lied States an estimated $500 million per meTrvloe information referenced in
^
,3 g
e 2
antum over conventional therapy.
the proposed rule may be obtained from R2 Amendment No. 39-4817 (49 FR Deted at Itockville, Meryland, this 13th day prett & Whitney. Techrdcal Publications 7361:I ebruary 29 1984), to require 3
1 of Deoseber,1994 Department M/S 132-30,400 Main initial and repetitive inspections of 9th.
1 For the Nuclear Regulatory Cummission.
Strent. East flattford. Connecticut' through 12th stage high pressure Mhamel T. laner.
06108. This information may be compressor O!PC) disks at the tierod Chief. blee Neview $wilan. Nies Neview examined at the FAA, New England holes in Pratt & Whitney (PW) JT8D sad Directhes 8 mach. Divisica c/rnedom Region Office of Assistant Chief series turbofan engines. 'ILt action was o/in/,onneslon and rubikations Services. Counsel,12 New England Executive rompted by cracks in the tierod holes DEk ofAdministmfion.
Park, Durlington, MA.
fn llPC disks that resulted in engine (FIL Duc,94-31069 Filed 12-8644,8.45 eml FOR FURTHER MFomeAATION CONTACT failures That condition,if not corrected, entaea cons rese**
Mark A. Rumizen. Aerospace Engineer can result in uncontained fractures of ens ne Certification Office, FAA, Engine 9th through 12th seage HPC disks and i
and Propeller Directorate.12 New ine failure.
DEPARTMENT OF TRANSPORTATION England Executive park, DurlinEton, MA e"hn August 30,1984, the FAA issued
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01803-5299; telephone (617) 238-7137: a correction to AD 81 02 R2, Federal Av6ation Administration fax (017) 238-7199.
Amendment 39-4817 (49 FR 35618; 14 CFR Part 39 suPPLtutNTARY MFORMATION:
September 11,1984), to inc.lude an engine model that had been (Dochet No. 81-ANE-43)
Comments invited inadvertently omitted from the AD.
Intested persons are invited to Since issuance of AD 81-08-02 R2.
Altworthiness Directives; Pratt &
participate in the making of the the FAA received a report of an Whitney JT8D Series Tuttiotan Engines proposmi e nie by submitting such uncontained fracture of a 10th stage ActNCV: Federal Aviation written unta views,or arguments as
!!PC disk. This disk had been subjected Administration, DOT, they may desire. Communications to three previous on. wing ultrasonic ACTION: Supplemental notice of should identify the Rules Docket inspor.tions prior to fracture. This proposed rulemaking: reoponing of number and be submitted in triplicate to method has since ocen determined as comment period.
the address specified above. All inadequate for detecting tierod hole communications roccived on or before cracking.
. suesuAmft This notice revises an earlier the closing date for comments, specified On May 8,1989, the FAA issued an proposed airworthiness directive (AD).
above, will be considered before taking NPRM that was published in the applicable to Pratt & Whitney,rT00 action on the proposed rule.The Federal Register (54 FR 22306; May 23, senes turbofan engines, that would have proposals contained in this notice may 1983). that wou!d have amended the amtnded an existing AD by eliminatin8 be changed in light of the comments existing AD by climinating the optional an optional on-wing ultrasonic received.
on wing ultrasonic inspection of the intpection of the 10th stage high Comments are specifically invited on 10th stage llPC disk, and by including
. pressure compressor OlPC) disk, and by the overall regulatory, economic, an engine model inadvertently omitted.
including an engine mcxtel environmental, and energy aspects of Since the issuance of that NPRM, the insdvertently omitted. ~itat proposal the pmposed rule. All comments FAA has determined that the reference w s prompted by a report of an submitted will be available, both before to the inadvertently omitted engine uncontained failure of a 10th stage llPC and after the closing date for comments, model was unnecessary, as the FAA had disk that was previously inspected in the Rules Docket for examination by remedied this discrepancy in the August using the on. wing ultrasonic inspection interested persons. A Mport 30,1984, correction. Also, the FAA now method.This action revises the summarizing each FAA public contact utilizes a revised format that supersedes proposed rule by removing the re!crence concerned with the substance of this existing AD's by publishing a complete to the inadvertently omitted engine proposal will be filed in the Rules document rather than only amending
- model, as the FAA has remedied this Doc ket, applicable paragraphs of the compliance discrepancy in an earlier correction to Commenters wishing the FAA to section. This document, therefore, the AD, and changing the proposed acknowhidge receipt of their comments reprints the corrected AD compliance action from amending AD 81-08-02 R2 submitted in response to this notice snction text in its entirety for clarity.
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[W. afli November 30,1994 L'OCKET NUMBER PETITION RULE PRM 3 5-I2 Secretary
(,54 F 8 6 /J'3 /)
U.S. Nuclear Regulatory Commission Attention: Docketing and Service Branch Washington, DC 20555 RE Docket No. PRM 3512
Dear Secretary,
I received your letter of November 23,1994, notifying us our petition will be published in the Federal Register. On page 4, under " Benefits of the Test" I think the third sentence could be misinterpreted. The sentence may'make it sound as if our
" diagnostic" test is actually a " curative therapy for ulcers" It might be helpful to amend this as follows:
BENEFITS OF THE TEST The petitioner states that under the current regulations, the test is 95% accurate and quite inexpensive because of its simplicity. The test would permit doctors to determine easily whether or not ulcer patients have been cured of their infection. By providing the public with an inexpensive, easily accessible diagnostic test, more individuals would be accurately diagnosed and treated for their H. pylori infection. This would save the United States an estimated $500 million per annum over conventional therapy.
Please call me at 1-88-874-6331 if you have any questions regarding my comment. Thank-you for your help in this matter.
- Sincerely, William A. Fry President, Tri Med Specialties, Inc.
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1500 AVON STREET EXT'D CHARLOTTESVILLE, VA 22902 PHONE (804) 977-8711 FAX (804) 977-8760 Director, Freedorn ofinformation and Publication Services OlTsce of Administration U.S. Nuclear Regulatory Commission Washington, DC 20555 August 23,1994 Attention: Chief, Regulatory Publications Hranch in accordance with Title 10. Code of Federal Regulation, pan 2, Subpart H-Rulemaking Tri-Med Specialties, Inc is petitioning the NRC to allow for the general licenting and/or exemption for the comn.ercial distribution by licensed pharmaceutical manufacturers of a capsule containing one micro Curie (pCi) of Cl4 urea for in vivo diagnostic testing The suggested maximum number of capsules which could be in inventory at an unlicensed facility at any time would be 150 ( 150pCi)'
Specifically, the Tri Med Specialties, Inc petition is to permit the distribution of the capsule containing lpCi Cl4. The capsules will be distribe'ed separately or as pan of a diagnostic kit which contains supplies to perform the test T he purpose of the kit is to detect the presence of the bacterium llelicobacter pylori. a cause of peptic ulcers (see below).
The pharmaceutical grade Cl4 urea is in a dry solid form The manufacturing process calls for one micro Curie of the Cl4 urea to be placed in a gelatin capsule. After insertion of the Cl4 into the capsule, the outside of the capsule is inspected for any contamination it is then placed into a commercial blister pack and sealed. The sealed package is then placed into another container which is also sealed. That package is then placed into a shipping container that is approximately 6" by 6" by 2" During the packaging processes, the capsule and external packaging are re inspected to provide an airtight seal.
Because of the exceptionally low dose, the capsule presents minimal risk to the public, Even if the shipping container should be damaged during the shipping process, exposure to such a small amount of Cl4 is minimal. We feel that this product should be exempted in much the same way as the possession and distribution of smoke detectors They are exempt from licensing requirements and also contain small amounts of radioactive material NRCM1940 IX)C p1 WhS%)A A
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k Tri Med Specialties, Inc. corporate headquarters is located in O Kansas Their omce in Charlottesville, Virginia is a licensed pharma f m research using to per or manufacturing site It is also licensed by NRC # 45 25215 01 Ci Cl4 urca capsule and the production of the di t kits are Cl4 A (IND # 42294) and currently transferred only to facilities who are licensed by the FD the NRC to use them.
d by a Reason for Use:
Recent medical research has found that peptic ulcers are common ff ers B y bacterium called Il pylori. This bacterium lives in the stomach of mo st ulcer problems (see treating ulcer patients with antibiotics, doctors can now cure mo ti ts It is therefore necessary to detect the presence of H pylori ba Appendix I).
his was done by a so that the new treatment can be given appropriately, in the past, t i
do> copy, a gastioenterologist wi o took biopsy samples of the stomach lin ng at procedure which was uncomfortable and expen f
h 30 mis of tracer. Cl4 ureais broken down by h pylori to orm a e e water. After 15 minutes the patient blows 2 liters of breat more than twice balloon) which is mailed to a testing laboratory if if d with II.
pylori.
i the Risks of the Test The lpCi of Cl4 urea consumed by the patient is rapidly excret ki urine or CO:in breath This means that even for persons ta ng t e(an amount i
The radiat on dose received by the patient is 0 3 mill remsFor persons i
background received in 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />) unmeasurably low and risk to the public is close to zero.
d to The impact on the public is minimal This is especially true wh Public impact unlicensed distribution that the NRC already approves eive, use and generallicense provisions whereby physicians and veterinarians c lying dispose of byproduct material for in vitro cl ll t 31.11 ould have less b
(a)(3), generallicensing of Cl4 for in vivo uses as described a ove, w i
t 31 would have impact on the general public Other generallicenses permitted n par Cl4-urea test.
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Henefits of the Test The test is accurate (95%) and quite inexpensive because ofits simplicity. With the test, doctors can easily determine whether or not ulcer patients have been cured of their infection. If exempted, the Cl4-urea breath test could be done by most doctors for less than $100 cost to the patient. This is a considerable cost savings over endoscopy and biopsy ($1000). The benefits to the public are that curative therapy for u!cers will becom avaihble to all, saving the United States an estimated $500 million per annum over conventional therapy (see Appendix 1).
Reasons for Licensing Exemption Currently, the test must be supplied only to facilities licensed to receive Cl4. This requirement makes the test prohibitively expensive for the great majority of doctors.
Present Usage of the Test The test is currently being studied at four sites under an IND application accepted The test is also being by the FDA - Over 100 patients have been enrolled to this point used at other sites under approved research protocols All of these sites are using the test under our IND and ars also licensed by the NRC to administer Cl4 to patients for diagnostic testing. More than 200 tests base been performed at these additional sites.
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ht t have been From the tests performed as of this date, no adverse events re ate to t e es reponed.
As outlined in 10 CFR pan 2, paragraph 2.802(1) we are requesting assistance in filing this petition within the specified guidelines We understand that a " Fast Track" process whereby the NRC can expedite consideration of a rule change petition is p We request that this petition receive this treatmert. The medical and financial reasons this have been outlined above Any questions you have or advice that you can provide would be greatly appreciated P case direct questions to.
William A. Fry, President, Tri Med Specialties,Inc. (800-874 5331)
Bany J Marshall, M.D.. Director of Pharmaceutical Operations (804 977-871 l)
James R. Gilchrist, Consulting Radiation Safety Ollicer.(804-982-4901)
Matthew J. Combs, Ph D., Pharmaceutical Scientist (804-924 2843)
Susic R 11oflinan RN, BSN, Product Development Coordinator (804-977-8711)
Sincerely,-
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AF70-January 30, 1995 g
The Honorable Dan Burton I
'N United Staten Hom;e.of Representatives Washington ~ DC 20515
Dear Congressman'3urton:
Thank you for your comment letter of January 5,1995, regarding the petition for rulemaking submitted by Tri-Med Specialties Inc., concerning a 14 C Urea Breath Test.
Currently, we are receiving comments on this petition.
Your comments will be considered as part of the resolution of the petitien, Sincerely.
Or!g!nal c!gnc6 by Jamt5 f,1. Taylor James M. Taylor Executive Director for Operations Distributipa:
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Docket No. PRM-35-12 0CA T2 rec:lva a copy of this document, indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure
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Jar tary 5, 1995 Mr. Ivan Selin Chairman Nuclear Regulatory Commission 11555 Rockville Pike Rockville, Maryland 20852-RE:
DOCKET No. PRM-35-12 Dear Mr. Chairmans I am a patient who has been treated for the H pylori bacteria by Dr. Barry Marshall.
I suffered with this bacteria for several years, and had it not been for this test and the treatment prescribed for me'by Dr. Marshall, I would still be suffering.
I have read the petition for rulemaking submitted by Trf
,9d Specialties, Inc.
At present, if a patie:
'oes not live in a city with a large medical center, they must travel great distances to have this test performed.
The other option is to have an endoscopy performed, which is-both inconvenient and expensive.
There are literally millions of people around the world who are suffering from the H pylori bacteria.
I, therefore, urge you to approve this petition, L
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1 thus. making the 14 C Urea Breath Test more accessible to patients throughout the country.
Thank you-for your consideration of this matter.
trely yours,
/ Al Wb Dan Burton l
Member of Congress
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