ML20198K217
| ML20198K217 | |
| Person / Time | |
|---|---|
| Issue date: | 11/02/1994 |
| From: | Beckjord E NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Norry P NRC OFFICE OF ADMINISTRATION (ADM) |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-094, AF70-1-94, NUDOCS 9801140348 | |
| Download: ML20198K217 (13) | |
Text
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November 2, 1994 M 90-/
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-MEMORANDUM T0: Patricia G. Norry, Director Office of Administration FRON: Eric S. Beckjord, Director /s/ Eric S. Beckjord Office of Nuclear Regulatory Research
SUBJECT:
PETITION FOR RULEMAKING (PRM-35-12)
FILED BY TRI-MED SPECIALTIES, INC.
As requested, we have reviewed the subject petition for rulemaking and have determined that this petition does not qualify for special handling as a fast-track petition for rulemaking, as specified in 10 CFR 2.802(e) of the Commission's regulations.
This petition does not meet the criteria for the fast-track' process because:
(1) Since the effect of granting this petition would be for RC'to permit in vivo (i.e.; human use) diagnostic testing with C14 under a general license or to be exempted from licensing, the petition raises policy issues regarding the " human use" of byproduct material by an individual who may not be an " authorized user," as defined in 10 CFR 35.2; and (2) An environmental assessment would be needed to evaluate airborne releases and the disposal of waste.
The task leader for this petition is Samuel Z. Jones. Attached are our comments on the draft Federal Register Notice which will announce receipt of the petition and requests public comment on the petition.
Attachment:
- 1. Comments on Draft Federal Register Notice RPHEB/Rdg/Subj/ central
[PRM3512N.0RY]
SMcGuire s ,ran e . (RES-940295)
CRaddatz SSchneider JGlenn, NHSS LCamper, NMSS f3
[ Document Name: G:\ Jones \PRM] *see previous concurrences \ /
OFFC RPHEB:DRA kPHEB:DRA RPHEB DRA DD:DRA D:DRA DD ES D:RES d
20 0 10 0 / ,,A NW .)
NAME Jones: KDrSgYnette DCO FboNn'zi BNiY R er EBeckjord jw A.W P DATE 10/2r/94 10/d/94 10/;27/94 /// i /94 // / / /94 0 /g /@ b / ( /94 COPY Yn - No - No .
h-No Yes-h Yes - @ Yes - Yes @
OFFICIAL RECORD COPY (RES File Code) RES 9
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pg11g348980109 .,
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[7590-01-P]
NOCLEAR REGULATORY Co m ISSION 10 CFR Part 35
[ Docket No. PRM-35-12]
Tri-Med Specialties, Inc.; Filing of Petition for Rulemaking
-AGENCY: Nuclear Regulatory Commission.
ACTION: Notice of receipt of petition for rulemaking.
SUMMARY
The Nuclear Regulatory Commission (NRC) is publishing for public comment a notice of receipt of petition for rulemaking that was filed with the Commission by Tri-Mod Specialties, Inc. The petition was assigned Docket No.
PRM-35-12 on October 6, 1994. The petitioner requests that the Commission amend its regulations to permit licensed pharmaceutical manufacturers he toaa e ;sse v '
Av2E distribute / capsule #containing one micro-curie of carbon-14 (Cl4)'for diagnostic testing.
DATES:
Submit comments (75 days after publication in the Federal Reaister). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given except as to comments received on or before this date.
ADDRESS:
Submit comments to the Secretary, U.S. Nuclear Regulatory For Commission,- Attention: Docketing and Service Branch, Washington DC 20555.
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. l a copy;of the petition,~. write to the' Rules Review Section, Rules Review and-Directives Branch Division of Freedom of Information and Publications
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Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555.-
FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Ch'ief, Rules Review Section, Rules Review and Directives Branch, Division of Freedom of
- , Information and Publications Services, Office of Administration, U.S. . Nuclear l
Regulatory Commission, Washington,-DC 20555. Telephone: 301-415-7163 or Toll l Free:.1-800-368-5642.
SUPPLEMENTARY INFORMATION:
Background ,
i PETITIONER Tri-Med Specialties, Inc., headquartered in Overland-Park, Kansas, maintains a~ licensed pharmaceutical manufacturing site in Charlottesville Virginia. The petitioner also is licensed by the NRC (#^5-25215-01) to perform research using Cl4. This.research involves manufacture of capsules containing 1 micro-curie (yCi) of C14-urea and production of diagnostic breath
~
test kits. The test kits are currently transferred 1only'to facilities !
licensed by the Food and Drug Administration (FDA) (IND#42294) and the NRC.
~
PETITIONER'S REQUEST Tri-Med Specialties requests that the NRC amend its regulations to allow for the; general licensing and/or exemption for the commercial distribution by
' licensed pharmaceutical manufacturers of a capsule containing 1 #C1. of 2
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Cl4-urea-for_in vivo diagnostic testing. .The petitioner states thatLthe capsules would be used:to test _for-the' presence of Helicobacter pylori, a
~ bacterium that causes peptic ulcers in the stomach. According to_the petitioner, the capsules would be distributed separately or as part of a diagnostic kit that contains supplies to perform the test._The petitioner suggests the maximum number of capsules allowed in inventory at an unlicensed facility at any time be 150-(150 pCi).
GROUNDS FOR RE0 VEST The petitioner states that recent medical research has found peptic ulcers are commonly caused by the H. pylori bacterium that lives in the stomach of most ulcer sufferers. According to the petitioner, in the past, doctors used the endoscopy and biopsy procedure to detect the stomach ulcers. This procedure was uncomfortable and expensive at a cost of $1000. The petitioner states that by using a C14-urea tr- .r, H. pylori can be detected noninvasively
'~
by having the patient swallow a capsule with 30 milliliters of water. Cl4-urea is broken down by H. pylori to form labeled CO 2 , which is expired in the breath. The petitioner asserts that the C14-urea test could be performed by most doctors for less than a $100 cost to the patient.
PUBLIC IMPACT The petitioner notes that the risks from the C14-urea test would be very low because the 1-pCi of C14-urea consumed by the. patient is rapidly excreted as urea in the--urine or C0 2 in the breath. The. petitioner states that the fradiation dose received by the patient would be 0.3 millirem (an amount equal tob5ckgroundradiationreceivedin24 hours). The risk for persons 3
. a
C administering the test would be unmeasureably low and risk to the public would be close to zero. l The petitioner indicates that the Commission's regulations currently contain provisions for a general license whereby physicians and veterinarians can receive, use, and dispose of byproduct material for in vitro clinical or laboratory testing without applying for a specific license. According to the petitioner, these recipients are required only to be registered with the NRC.
The petitioner further notes that the Commission's regulations permit other general licenses that have a greater likelihood of affecting the public than the proposed C14-urea test.
BENEFITS OF THE TEST The petitioner states that under the current regulations, the test is 95-percent accurate and quite inexpensive because of its simplicity. The test would permit doctors to determine easily whether ulcer patients have been cured of their infection. The benefits to the public, according to the petitioner, would be a curative therapy for ulcers that can be made available to all people, thus saving the United States an estimated $500 million per annum aver conventional therapy.
CP .tVSION The petitioner states that the test may be supplied currently only to facilities licensed to receive C14. According to the petitioner, this requirement makes the test prohibitively expensive for the great majority of doctors. The petitioner states that the test is currently being studied at four sites under a Notice of Claimed Investigational Exemption for a New Drug 4
2
i (IND) application accepted by the FDA and is also being used at other sites under approved research protocols. The petitioner states that all-of these sites _are using the test under the petitioner's IND and are also licensed by the NRC to administer C14 to patients for diagnostic testing. The petitioner
- states that more than 200= tests have been performed at these additional sites and that no adverse events from the tests performed as of this date have. been reported. Therefore, the petitioner believes that licensed pharmaceutical manufacturers should be permitted to distribute the capsule containing_1 gCi
. of C14-urea for in vivo diagnostic-testing.
.@DITIONAt. DOCUMEi!Tji The petition includes additional justification and support for the requested amendment not ir.cluded in this Federal Reaister notice. Members of
'tne public interested in filing comments on PRM-35-12 can obtain a copy of the-petition and supporting documentation by writing to the address noted above.
Dated at Rockville, Maryland, this day of 1994.
i' For the Nuclear Regulatory Commission.
John C. Hoyle, Acting Secretary of the Commission.
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11.7 Petitions eligible fr /ast-track" processing.
4 (a) Occasionally, NRC receives a petition for rulemaking that requests an amendment to the regulations that is obviously meritorious.
In order to expedite the rulemaking process, these petitions for rulemaking may be published initially for public coment as a proposed rule. This " fast-track" procedure eliminates the usual step of publishing a notice of receipt of a petition for rulemaking and inviting public comment on the petition when the additional procedural step is unnecessary. " Fast-track" petitions are processed by the staff according to the procedures specified in this section and 11.9 of this handbook. The " fast-track" procedure may not be used for the expedi-tious denial of a petition for rulemaking.
(b) Following a determination that a petition for rulemaking meets the threshold-requirements for a petition, RPB assigns the petition to the appropriate staff office to determine whether the petition is eligible for "f ast-track" processing. The assigned staff office assigns a contact person to handle the petition. The contact person then makes the
" fast-track" determination within 10 working days.
(c) The NRC may consider a petition eligible for " fast-track" processing.if it --
" (1) Proposes action granting or recognizing an exemption from requirements in 10 CFR Chapter I or granting relief from restrictions while not imposing' additional burdens upon or increasing the risks to
-the health- and safety of any segment of industry or the public; 231 MARCH 1991 PETITIONS FOR RULEMAKING l
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(2) Proposes action involving interpretive rules, rules of l agency organization, procedure, or practice, and rules for the orderly conduct of Commission business;
< (3) Proposes sction involving an amendment to 10 CFR Clm 1er I that is corrective or of a minor or nonpolicy nature and that does not substantially modify existing regulations; (4) Proposes action involving --
(1) A minor safety, safeguards, or environmental e sue.,
(ii) An increase in NRC efficiency; or (iii) A reduction in the regulatory burden on licensees.
(5) Proposes action involving a request already under consideration in an ongoing rulemaking proceeding (Note, however, that NRC consideration of a request already included in an ongoing rulemaking depends on the ;
status of the rulemaking proceeding);
(6) Proposes other action that is clearly meritorious and will not adversely affect the rights of other licensees or persons. )
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(d) The NRC normally will not consider a petition eligbile for
" fast-track" processing if the proposed action will --
(1) nequire the preparation of an Environmental Impact Statement; (2) Impose new or increased reporting, application, or recordkeeping requirements subject to clearance by the Office of Management and Budget; )
(3) Have a significant economic impact on a substantial number of l l
small entities (see discussion of Regulatory Flexibility Act requirements l in sections 3.19 and 5.19 of this handbook),
1 PETITIONS FOR RULEMAKING 232 MARCH 1991 l
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l(4) Have a significant impact on NRC-. staff ~and resource:
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commitments; or ,
- (5)- Result' in denial of the. petition for rulemaking, ].
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PETITIONS FOR RULEMAKING- '233' MARCH 1991
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~94 OE -5 All :44 1500 AVON STREET EXT'D CHARLOTTESVILLE, VA 22902 - ' e R L !.iR Y PHONE (804) 977-8711 FAX (804) 977-8hp.;g 7,CKNic m fJ,CE hk M:li November 30,1994 00CKET NUMBER PETITION BULE PRM 3 5-12 Secretary ( 54 F8 6 /J'30 U.S. Nuclear Regulatory Commission Attention: Docketing and Seivice 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 TES_T 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 p 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, W (A L William A. Fry President, Tri-Med Specialties, Inc.
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05280 k Proposed Rules *d-'"+'"
Vol 59, No. 242 Monday, December 19, 1994 This section of the FCDERN. REGISTER Quarantine, APillS USDA, P.O. Drawer comments received between November contains notaces to the putAc of tte propsed 810. Riverdale, MD,20738. The 15.1994, and January 3,1995, issuance of rules anj regulations. The telephone number for the agency Authority: 7 U.S C.150dd.150ee,150ff.
purpose of these notaces la to give interested contact will change when agency offices 15s.167,450: 21 U.SC 136 and 13rsa; 7 CFR persons an opponundy to paWe in the in liyattsville, MD, move to Riverdale, 2.17,2.51, and 371.2(cl.
'g*'* *' *W P'*' " ** *d P'*" d MD, during January. Telephone: (301) Done in Washington. DC, this 14th, day of 436-8645 (llyattsville); (301) 734-8645 December 1994.
(Riverdale). Alea B.Thiermann, DEPARTMENTOF AGRICULTURE SUPPLEMENTARY INFORMATtON:
Acting Administmtor, Animolandflant Health Inspection Service.
Animal and Plant Health inspection Background IFR Doc. 94-3M51 Filed 17-16-94: 8:45 cml On November 15,1994, the Animal asmo cm som 7 CFR Part 319 and Plant Ilealth inspection Service (APlilS) published in the Federal (Docket No. 941116-2] Register (59 FR 59070-59071. Docket NUC1. EAR REGULATORY No. 94-116-1) an advance notice of COMMISSION Importation of Fresh Hass Avocado Fruit Crown in Michoacan, Mexico PmPosed rulemaking and a notice of pubhc meetings concerning the possible 10 CFR Part 35 AGENCY: Animal and Plant Ilealth importation of fresh liass avocado 'ruit pocket No. PRMS-12]
- Inspection Service, USDA. grown in approved orchards in ACTION: Advance notice of proposed approved municipalities in Michoacan, Tri-Med Spectattles, Inc.I Filing of rulemaking and public meetings; Mexico,into certain areas in the United Petition for Rulemaking, Correction reopening and extension of comment States. The two public meetings were held on November 28 and 29. Interested AGENCY: Nuclear Regulatory period. Commission.
persons were invited to present either suuuARY:The Animal and Plant Health written or oral comments at the public ACTION: Notice of receipt of petition for inspection Service is reopening and meetings on the Mexican proposal.The nitemaking; correction.
extending the time period for the public notice stated that copies of the Mexican to comment on an advance notice of proposal were available by calling of
SUMMARY
- This document clarifies a proposed rulemaking regarding the writing Mr. Victor Harabin. All written portion of the notice of receipt for a possible importation of fresh flass comments on the advance notice and petitmn for rulemaking filed by Tri-Med avocado fruit grown in approved Mexican proposal were required 'n b. Specialties,Inc., and docketed as PRM-erchards in approved municipahties in received on or before Decen/oer u, 35 12. The notice of receipt for this Michoacan, Mexico, into certain areas in 1994. petition was published on December 2, the United States. Reopening and At the public meetings, copies of the im (59 FR m34 DATES: Submit comments by February ntodding the comment period will gl*e Mexican proposal were also made 15,1995. Comments received after this interested persons additional time to available. A number of persons in prepare and submit comments on the date will be considered if it is practical attendance at both public meetings to do so, but assurance of consideration Mexican proposal. stated that this was their first cannot be given except as to comments DATES: Consideration will bu given only opportunity to review the Mexican to comments received on or before received n r before this date.
proposal and that the copies of the january 3,1995, proposal provided were incomplete ADDRESSES: Submit comments to the AoORESSES: Please send an original and because Appendices I,11, and 111 were Secretary, U.S. Nuclear Regulatory three copies of your comments to Chief. not included. They requested that the Commission, Attentione Docketing and Regulatory Analysis and Development. Appendices be provided and that the Service Branch, Washington, DC 20535.
PPD, APills, USDA, P.O. Drawer 810 comment period closing date he For 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. Di ectives Branch. Division of Freedom 116-2. Comments received may be APills has forwarded copies of these of Information and Publications inspected at USDA, room 1141, South Services, Office of Administration. U.S.
Appendices to those interested persons Building,14th Street and independenco who requested copies of the Mexican Nuclear Regulatory Commission.
Avenue SW., Washington, DC, between proposal pursuant to the November 15, Washington, DC 20555.
8 a.m. and 4:30 p.m., Monday through 1994 Federal Register notice or who FOR FURTHER INFORMATION CONT ACT:
Friday, except holidays. Persons received copies 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 requested to call ahead on (202) 690- persons may have additional time to Branch, Division of Freedom of 2317 to facilitate entry into the prepare and submit comments on the Information and Pu'alica' :ns Services, comment reading room. Mexican proposal. APillS is reopening Office of Administration, U.S. Nuclear FOR FURTHER INFORMATION CONT ACT: Mr. and extending the public comment Regulatory Commission Washington, -
Victor liarabin, llead. Permit Unit. Port period on Docket No. 94-116-1 until DC 20555. Telephone: 301-415-7103 or Operations, Plant Protection und January 3,1995. APillS uill wusider all toll free: 1-800-363-5642.
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Fed:rCI Registrr / Vol. .. No. 242 / Monday December 19,199 Proposed Rules 65281 l
cent tuunARY snFonuAfrON: In the to superseding that AD. The actions ruust submit a self. addressed, stamped notics of receipt for PRM-35-12 speciDed by this proposed AD are postcard on which the following published on December 2.1994 (59 FR intended to prevent uncontained statement is made: "Cornments to 61831), the paragraph under the fractures of 9th through 12th stage llPC Docket Number 81-ANF-03." The heading. **Henefits of the Test.** revised disks and engine falhare. postcard wili be date stamped and to read as follows: OATEs: Comments must be received by returned to the commenter.
The petidoner states that under the February 17.1995.
current regulatjons, the test is 95 Availability of NPRMs ADoRESSES: Submit comments in rcent accurate and quite inexpensive tri licate to the Federal Aviation ^"Y "" **I *I" *
- PY "I' '
use ofits simpilcity. The test would A ministration.New England Region. GPRM y submitting a request to the
. permit doctors to determine easily F AA.New England Regbn. Office of the Office of the Assistant Chief Counsel. Asdstant Wef Counsel. A,Muom whether or not ulcer patients have been Attention: Rules Docket No. 81-ANE-cured of their infection. By providing 03 12 New England Executive Park.
Rules Docket No. 81-AM,12 New the public with an inexpensive, casily Durlington MA 01B03-5299. Comments England Executive Park. Burlington, MA accessible diagnostic test, more 01603 -52E may be inspected at this location between 8'00 a.m. and 4:30 p.m.. Discussion Individuals would I[Y be g axuratel[g8 gd i nday through Friday, except Federal On February 7,1984, the Federal ,
St tes an estimated $500 m:11 ton per
- m tra The sIrvion information referenced in g le annum over conwntloaal therapy- the proposed rule may be obtained from 3, 2 Deted at Rockville. Maryland, ibis 13th day Pratt & Whitney. Technical Publications R2. Amendment No. 39-4817 (49 FR of December,1994. Department. M/S 132-30,400 Main 7361: February 29,1984). to require For the Nuclear Regulatory Commission. Street. East llartford. Connecticut, initial and repetitive inspections of 9th .
through 12th stage high pressure Michael T. imsar. 06108. This information may be compressor OlPC) disks at the tierod Chief. Rules ReviewSedlon Rules Heriew examined at the FAA New England Region. Office of Assistant Chief holes in Pratt & Whliney 0*W) fT8D and Dirediese Brunch. Division of rindorn o/informouon andPublisations Services. Counsel.12 New England Executive series turbofan engines. That action wes Offica o/Administrotson. Park. Durlington. MA. prompted by cracks in the tierod holes IFR Doc 94-31069 Filed 12-14M4; 8.45 aml FOR FURTHER INFORMATION CONTACT: In !!PC disks that resulted in engine aumo cour ross ew failures.That condition,if not corrected, Mark A. Rumimon. Aerospace Engineer can result in uncontained fractures of Engine Certification Office. FAA. Engine 9th through 12th stage HPC disks and and Propeller Directorute.12 New ine failure.
DEPARTMENT OF TRANSPORTATION England Executive Park. Durlbgton, MA enbn August 30,1984 the FAA issued Federal Aviation Administration 01603-5299; telephone (617) 238-7137; a correction to AD 81-08-02 R2 fax (617) 238-7199. Amendment 39-4817 (49 FR 35618:
14 CFR Part 39 SUPPLEMENTARY INFORMATION: September it.1984), to include an engine model that had been (Docket No. 81-ANE-03) Comments invited inadvertently omitted from the AD.
Interested persons are invited to Since issuance of AD 81-08-02 R2 h tne D s Tu n Engines padici Pate in ille ma ng DN2e & FAAyceW a repM of an prop %cd .o!e by submitting such uncontamed fracture of a 10th stage AGENCY: Federal Aviatlon wratten data views, or arguments as llPC disk. This disk had been subjected Administration. DOT. they may desire Communications to three previous on wing ultrasonic ACTION:Su plemental notice of should identify the Rules Docket inspections prior to fracture. This proposed r lemaking; reopenind of number and be submitted in triplicate to method has since neen determined as comment period. the address specified above. All inadequate for detecting tierod hole communications received on or before cracking.
supuARY:This notice revises an earlier the closing date for comments, specified On May 8.1989, the FAA issued on proposed airworthiness directive (AD). above, will be considered before taking NPRM that was published in the applicable to Pratt & Whitney JT8D action on the proposed rule.The Federal Register (54 FR 22306; May 23 senea turbofan engines, that would have proposals contained in this notice may 1989), that would have amended the amended an existing AD bycliminating be changed in light of the comments ' existing AD by eliminating the optional en optional on wing ultrasonic received. on wing ultrasonic inspection of the inspection of the 10th stage high Comments are specifically invited on 10th stage HPC disk, and by including pressure compressor DIPCI disk, and by the overall regulatory, economic, an engine model inadvertently omitted.
Including an engine model environmental, and energy aspects of Since the issuance of that NPRM.the intdvertently omitted, That proposal the proposed rule All comments FA A has determined that the reference was prompted by a report of an submitted will be available, both before to the inadvertently omitted engine uncontahied failure of a loth stage llPC and after the closing date for comments, model was unnecessary, as the FA A had disk that was prevlously inspected in the Rules Docket for examination by remedied this discrepancy in the August
- using the on. wing ultrasonic inspection interested persons. A report 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 reference concerned with the substance of this existing AD s by publishing a complete to the inadsertently omitted engine proposal will be filed in the Rules document rsther than only amending model, as the FAA has remedied this Docket, applicable paragraphs of the compliance discrepancy in an earlier cmvection to Commenters wishing the FAA to section. This document, therefore.
the AD, and changing the proposed acknowledge receipt of their comments reprints the corrected AD compliance action from amending AD 81-08-02 R2 submitted in response to this notice section test in its entirety for clarity.
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Vol. 59. No. 231 Fridy, Decemler 2,1994 This seckon of the FEDtHAt. REGISTER Regulatory Commission, Washington, performed by most doctors for less than contaarts nobces to tre potAc of the proposed DC 20555. Telephone: 301-415-7163 or . 5100 cost to the patient.
65suance os r*s arms re9utat.ons. The purpose of these nonces is to give interested toil free: 1-400-3G8-5642.
Public Impact persons an opportsty to portrapate in the SUPPt.EMENTARY D4FORMAflON:
rule mahng pnor t) tre adoption of tre W The petitioner' notes that the rists res. Petitioner I om the C14 urea test would be very Tri Med Specialties,Inc., low because the 1 pCi of C14-urea headquartered in Overland park, consumed by the patient is rapidly NUCt. EAR REGtJ1.ATORY Kansas, maintains a licensed excreted as urea in the urine or coa in COMMISSION the breath. The petitioner states that the pharmaceutical manufacturisig site in Charlottesville, Virginia. The petiuoner radiation dose received by the patient 10 CFR Part 35 also is licensed by the NRC (#45-25215- would bo 0/: millirem (an amount equal (Docket No. PRM-35-12] 01) to perfonn researth using C14. This to backgrc .md radiation received in 24 research involves manufacture of hours).Tl e risk for persons TrkMed Spectattles,Inc.; Filing of capsules containing 1 micro-curie (pCi) admir% ring the test would bo Petition for Rulemaking of C14 uma and production of immcasurably low and risk to the public diagnostic breath test kits. The test kits would be close to zero.
AGENCY: Nuclear Regulatory The petitioner indicater. that the -
g m mg g on- are currently transferred only to ACTtON: Notice of receipt of petition for facilities licensed by the Food and Drud Commission's regulations currently miemaking. Administration (FDA) (LNDs42294) and contain provisions for a general license the NRC- whereby physicians and veterinarians can receive, use, and dispose of suMMAny:'Ihe Nuclear Regulatory Petitioner's Request Commission (NRC)is publishing for byproduct material for in vitro clin,ical public comment a notice of receipt of a Tri Med Specialties requests that the or laboratory testing without applymg NRC amend its regulations to allow for for a specific license. According to the petition for rulemaking, dated August 23,1994, that was filed with the the general licensing and/or exemption petitioner, these recipients are required only to be registertwl with die NRC, The Ct>mmission by Tri-Med Specialties, f r the commercial dis *ribution by Inc. The petition was assigned Docket limnsed pharmaceutical manufactr rs petitioner further asserts that the No. PRM-35-12 on October 6,1994. of a C8Ps,ule containing 1 pCI of C14* Commission's regulations permit other The petitioner mquests that the uma for m vivo diagnostic testing. The generallicenses that have a greater likelihood of affecting the public than Cornmission amend its regulations to [titi ner states that the capsules would the proposed C14 urea test, permit licensed pharmaceutical used to test for the
, manufacturers to commercially 11elicobacter pylori, acterium a bresence that of Benefits of the Test distribute, under general licensing ar. */ eptic ulcers in the stomach. The petitioner states that under the
- causes Accord fng to the petitioner, the capsules current regulations, the t+ st is 95-micro eo'fcar a 14 1 w old be dis'ributed separately or as . .rcent accurate md quite inexpensive administration to humans for in vivo Part of a diagnostic kit that contains ause of its simplicity. The test would diaSnostic testin8' SuPPli es to perform the test.The pet tioner suggests the snaximum permit doctors to determine easily DATES: Sulimit comments by February whether or not ulcer patients have been 15,1995. Comments received after this number of capsules allowed in cured of their infection.The benefits to date will be considered if it is practical inventory at an unlicensed facility at the public, according to the petitioner, to do so, but assurance of consideration any time be 150 (150 pCi). would be a curative therapy for ulcers cannot be given except as to comments Grounds for Request that can be made available to all people, realved on or before this date- thus saving the United States an The petitioner states that recent ADDRESSES: Submit mmments to the estimated 5500 million medical research has found peptic conventional therapy. per annum over Secretary, U.S. Nuclear Regulatory ulcers are commonly caused by the Commission Attention: Docketing and li. pylori bacterium that lives in the Conclusion Service Branch, Washington DC 20555.
For a copy of the petition, write to the stomach of most ulcer sufferers. The petitioner states that the test may Rules Review Section, Rules Review According to the petitioner, in the past, be supplied currently only to facilities
, and Directives Branch, Division of doctors used the endoscopy and biopsy licensed to receive C14. According to procedure to detect the stomach ulcers. the petitioner, this requirement makes Freedom ofInformation and This procedure was uncomfortable and publications Services, Office of the test prohibitively expensive for the expensive at a cost of $1000. no great majority of doctors.The petitiones Administration U.S. Nuclear Regulatory petitioner states that by using a C14- states that the test is currently being Commission, Washington, DC 20555.
urea tracer, II. pylori can be detected studied at four sites under a~ Notice of FOR FURT) ten INFORMATION CONTACT: noninvasively by having the patient Ntichael T. Lesar, Chief, Rules Review Claimed Investigational Exemption for a '
Section, Rules Review and Directives swalmw a capsule with 30 milliliters of New Drug (INF1 application a,:cepted by water. C14. urea is broken down by the FDA and is also being used at other Branch, Division of Freedom of it pylori to form labeled CDs which is Information and Publications Services, sites under approved research protocols.
expired in the breath.ne petitlener The petitioner states that all of these Office of Administration. U.S. Nuclear asserts that the Ct 4-urra test could be sitc5 are using the test under the t
1
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C1C32 Federal Register / Vol. 59. No. 231 / Friday, Decernber 2.1994 / Proposed Rules petitioner's IND and are also licensed by to William W. Wales. Secretary. Board of following six months after the final the NRC to administer C14 to patisnts Governors of the Federal Reserve regulation is issuod.
for diagnostic testing. The petitioner System,20th Street and Constitution ne Daard is proposing regulations for st;tes that more than 200 tests have Avenue N.W., Washington, DC 20551. comment. and expects to adopt final been performed at these additional sites Comments also may be delivered to implementing regulations in March cnd that no adverse events from the Room B-2222 of the Eccles Building 1995. Compliance with the law would -
tests performed as of this date have been between 8:45 a.m. and 5:15 p.m. be mandatory by October 1.1995.
reported. Therefore. the pe'itioner weekdays, or to the guard station in the Section 156 of the Equitypmtection Act believes that licensed pharmaceutical Fccles Building courtyard on 20th states that the final rule govems all
- manufacturers should De perm;tted to Street. N.W. (between Constitution high rate, high-fee mortgage transactions distribute the capsule containing 1 pCi Avenue and C Struct) et any time. consummated after the mandatory cf C14 urea for in vivo diagnostic Comments may be inspected in Room effective date. The Board believes that testing. MP-500 of the Martin Building between the same r, .1pliance rule would apply 9:00 a.m. and 5 00 p.m. weekdays. to reverse mortgage transactions Addits.onalikx:uments except as provided in 12 CFR 261.8 of consummated after the mandatory "Ihe petition includes additional the Board's rules regarding the effective date.
justification and support for the availability of information. . . .
requested amendment not included in mn wn a sts FOR FURTHER INFORMATION CONTACT: Jane this Federal Register notice. Members of Ahrens. Senior Attomey, or Kyung Cho- Section 226.2-Definitions and Rules of the public interested in filing comments Miller or Sheilah Goodman. Staff Construction '
on PRM-35-12 can obtain a copy of the Attomeys. Division of Consumer and petition and supporting documentation Community Affairs, Board of Govemors 2(a) Definitions by writing to the address noted above. of the Federal Reserve System, at (202) 2(a)(17) Creditor Dated at Rodville. Maryland, tus 28th day 452-3667 or 452-2412; for the hearing Section 152(c) s.!:he Equity of Movember 1994. impaired only, Dorothea Thompson, Protection Act states the number of For the Nuclear Regulatory Commission. Telecommunications Device for the high rate, high fee mortgage transactions John C. Itoyl, Deaf, at (202) 452-3544. a lender may make before becoming a Actir2 ecretaryof S theCommission SUPPLEMENTARY INFORMATION:
cmdior for purposes of the TILA. The li R Doc. 94-2%54 Filed 12-1-94: 8 45 ami propo# regulation parallels ti.e m a coog 73, w L Dackground statute. "1 Pe regulation provides that The purpose of the Truth in tending persons making occasional home-Act (15 U.S.C.1601 et seq.) is to secured loans hss tha.n five during a FEDERAL RESERVE SYSTEM promote the informed use of consumer calendar year--are not subject to the act.
credit by requiring disclosures about its The proposed regulation provides that a 12 CFR Part 226 terms and cost. The act requires creditor includes a psrson originating (Regulation Z; Docket No. R-0858]
cn s s om sand M M N @m. bMW the cost of credit as an annual loans, or one or more su i 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 AGENCY: Doard of Governors of the by a consumer's home, and permits example, a person originating one high.
Federal Reserve Systern. 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 Limitati ns are imposed on some credit loans, one of which was a high rate,
SUMMARY
- The Board is Publishii.6 for line plans sec ired by a consumer s high fee loan, would be required to principal dwelling. The act is comply with TILA for both transactions.
I tl i n ndin e U ard's Regulation Subpart B--Open End Credit cmendments implement recent changes k" "N m da to the Truth in Lending Act by the P ht '
.. Section 226.5b--Hequirements for Home Riegla Community Development and II. Proposed Regulatory Provismns Equity Plons Regulatory improvement Act of 1994. The llorae Ownership and Equity . .
Tha 1:.w imposes new disclosure Protection Act of 1994 (Equity Sb(f) Limitations on llome Equ.ty i Plans.
requirements and substantive Protection Act), contained in the Riegle The TILA allows creditors to limitttions on mortgages bearing high Community Development and terminate open-end plans and demand rates or fees.The amendments would Regulatory improvement Act of 1994 repayment in narrowly drawn pmvide greater protections to (Community Development Act). Pub. L circumstances such as when the consumers entenng into high rate, high- 103-325,108 Stat. 2160, amends the consumer fails to make payments or fee mortgages. The law also impeses Truth in tending Act (TILA). Section takes actions that affect the creditor's n:w 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
, provide periodic payments to primarily new section 138 dealing with reverse substantive limitations. The legislative elderly homeowners and rely mortgage transactions. The Equity history states that the amendment is principally on the home,s value for Protection 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 en open-end reverse or before January 18,1995, days. It provides that the statutory mortgage loan in accordance with the ADDRESSES: Comments should refer to provisions and rules adopted by the credit contract.The proposed 11ocket No. R-0858, and may be mailed floard shall apply on the October 1 amendment reflects that intent.