ML20147F149
| ML20147F149 | |
| Person / Time | |
|---|---|
| Issue date: | 03/07/1997 |
| From: | Lohaus P NRC OFFICE OF STATE PROGRAMS (OSP) |
| To: | GENERAL, MASSACHUSETTS, COMMONWEALTH OF, OHIO, STATE OF, OKLAHOMA, STATE OF, PENNSYLVANIA, COMMONWEALTH OF |
| Shared Package | |
| ML20147F155 | List: |
| References | |
| FRN-62FR32552 AF70-1-046, AF70-1-46, SP-97-015, SP-97-15, NUDOCS 9703200061 | |
| Download: ML20147F149 (20) | |
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UNITED STATES j j NUCLEAR REGULATORY COMMISSION WASHINGTON. D.C. 200664 201
....,/ March 7,1997 ALL AGREEMENT STATES .
MASSACHUSETTS, OHIO, OKLAHOMA, PENNSYLVANIA TRANSMITTAL OF STATE AGREEMENTS PROGRAM INFORMATION (SP-97-015 ) .
Ybur. attention is invited to the enclosed correspondence which contain~s: .
INCIDENT AND EVENT INFORMATION.............
PROGRAM MANAGEMENT INFORMATION.......
i TRAINING COURSE INFORMATION.................. l TECH NICAL INFO RM ATIO N..... ... . ............ ..... . ..
OTHER.........................................................XX. RULEMAKING PLAN -
10 CFR PARTS 30 & 32 C 14 UREA H. PYLORI DIAGNOSTIC TEST Supplementary information: Enclosed for your information is the final rulemaking plan regarding a proposed rule which will allow the exempt distribution of capsules containing one microcurie of C-14 Urea to any person for diagnostic testing. You will recall that a .
- draft of this rulemaking plan, which would have allowed general license distribution to any j physician, was sent to you for review and comment via All Agreement States letter !
SP-96-107 on October 1,1996. In considering the change from general license to exempt '
distribution, we would appreciate receiving your position on the following two questions i
_ within two weeks of the date_of this letter:
- 1. What is the position of your State on the NRC's plan not to limit receipt of I the drug to physicians, but to rely on FDA and State Boards of Pharmacy to i decide who~should administer the drug? (See page 6 of the final rulemaking plan) 2.' Are there requirements in your State, that are mandated by regulations other than the radiation control program regulations, that might be of concern if the capsules are authorized under an exempt distribution license, with a W
Division 1 level of compatibility for the users? -(See page 10 of the final l 190024 ruiemaking pian) i
- ElI5 9 C'2
- NBC HLE CENTEll COPY 4y i 9703200061 970307 PDR STPRG ESGGEN
? -
I l SP-97-015 1 I If you have any questions regarding this correspondence, please contact me or the individual named below.
! POINT OF CONTACT: Lloyd A. Bolling
! TELEPHONE: (301) 415-2327 FAX: (301) 415-3502
< INTERNET: LAB @NRC. GOV
- s 4 1
Paul H. Lohaus, Deputy Director Office of State Programs
Enclosures:
As stated
I SP 015 l 1
If you have any questions regarding this correspondence, please contact me or the l individual named below. !
1 POINT OF CONTACT: Llop r . ;..ag TELEPHONE: (3C l) 41 b-2327 FAX: (301)415-3502 INTERNET: LAB @NRC. GOV
'CriginalSigned By:
PAUL H. LOHAUS Paul H. Lohaus, Deputy Director Office of State Programs
Enclosures:
As stated I
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Distribution:
EDO RF DIR RF ' DCD '(SP03)' RSAOs) E-Mailed SDroggitis :PDR'(YESy NO_) RSLOs) 3/10/97 All A/S File FAXED TO STATES: 3/7/97 DOCUMENT NAME: G:\SP97015 Ta receive a copy of this document, indicate in the b , : ,
%f C,. Copy without a[hment/ enclosure "E" = Copy with attachment / enclosure "N* = No copy OFFICE OSP OSP.pl% OSP:IN jM RES l OGC DEDR NAME LBolling:nb/gd PLohais([,[l> RBange,rt~ BMorris FXCameron HLThompson DATE 03/06/97* 03/06/97* 03/f197 03/07/97* 03/07/97* 03/07/97*
- See Previous Concurrence. OSP, FILE COD.E:;. SP-A-y,
l, i
i FINAL RULEMAKING PLAN 10 CFR PARTS 30 AND 32 l
- EXEMPT DISTRIBUTION OF A RADIOACTIVE DRUG l' CONTAINING ONE MICROCURIE OF CARBON 14 UREA
- j. (PRM-35-12) -
l BACKGROUND On October 6,1994, the Commission docketed a petition for rulemaking (Docket No. PRM-3512) from Tri-Med Specialties, Inc (Tri-Med). In a letter dated August 23,1994, Tri-Med i
petitioned the NRC to amend its regulations "to allow for the generallicensing and/or
- exemption for the commercial distribution by licensed pharmaceutical manufacturers of a l capsule containing one micro-Curie (pCi) of "C-urea for in vivo diagnostic testing." The
- i. purpose of this diagnostic test is to detect the presence of the bacterium Helicobacter j pylori (H. pylori), a cause of peptic ulcers, j " Peptic ulcer disease is a chronic inflammatory condition of the stomach and duodenum l that affects as many as 10% of people in the United States at some time in their lives.
- , The disease has relatively low mortality, but it results in substantial human suffering and high economic costs." (Source: Article included as an appendix to the petition, from JAMA, July 6,1994-Vol 272, No.1, "H. pylori in Peptic Ulcer Disease-NIH Consensus
[ Conference").
In the petition dated August 23,1994, the petitioner stated the following:
a Recent medical research'has found that peptic ulcers are commonly caused by a bacterium called H. pylori. This bacterium lives in the stomach of most
- q. ulcer sufferers. By treating ulcer patients with antibiotics, doctors can now
- cure most ulcer problems.
i it is therefore necessary to detect the presence of H. pylori bacteria in ulcer j patients so that the new treatment can be.given appropriately, in the past, i this was done by a gastroenterologist who took biopsy samples of the j stomach lining at endoscopy, a procedure which was uncomfortable and
- expensive ($1000).
With the new test, H. pylori can be detected non-invasively using a "C-urea tracer. "C-urea is broken down by H. 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. After 15 minutes the patient blows 2 liters of breath into a collection bag (a Mylar balloon) which is mailed to a testing laboratory. If "C-CO more 2 than twice background is present in the breath sample, then the patient must be infected with H. pylori.
CURRENT REGULATIONS 10 CFR Part 32, " Specific Domestic Licenses To Manufacture or Transfer Certain Items Containing Byproduct Materials," 9 32.72, " Manufacture, preparation, or transfer for
h commercial distribution of radioactive drugs containing byproduct material for medical use
-under Part 35," provides for_ commercial distribution of radioactive drugs containing i byproduct material for use by persons authorized pursuant to Part 35. Thus, the
] regulations currently would permit Part 32 licensees to commercially distributo capsules
, containing 1 Ci of "C-urea to persons authorized pursuant to Part 35.
, 10 CFR Part 35, " Medical Use of Byproduct Material," sets forth radiation safety 4
requirements, including requirements for the training and experience of authorized user
- physicians to assure the safe possession and use of radioactive drugs containing byproduct l material.
Existing exemptions for use of byproduct materialin 6 30.14, " Exempt concentrations" and 5 32.18, "Manuf acture, distribution and transfer of exempt quantities of byproduct material: Requirements for license," do not permit the exempt transfer of byproduct material contained in any food, beverage, cosmetic, drug, or any product designed for ingestion or inhalation by, or application to, a human being.
REGULATORY ISSUE The regulatory issue is whether the "C-urea capsules present a sufficiently small radiation i risk that they can be safely distributed to and used by physicians who are not " authorized
, users" under 10 CFR Part 35.
l t
SAFETY ANALYSIS i
l Based on a safety anelysis conducted by an NRC contractor, the staff has concluded that j the human use of these capsules results in insignificant exposures as depicted below:
Scenario Maximum Exposed Routine Exposure l Individual 1
Worker administering "C- Full-time worker, 8,000 Less than 0.7 mrem /yr
, urea breath tests patients /yr j
Routine exposure of Patient tests negative 0.38 mrem / capsule patients from "C-urea breath tests l-Patient tests positive 0.18 mrem / capsule Release of 150 Ci of "CO 2 Member of public in the Less than 0.0002 mrem
, into administration area' administration area i
Rupture of a capsule Skin (100 cm ) exposed for 5.8 mrad skin dose
] causing skin contamination one hour prior to washing. 0.075 Ci skin absorption
, of worker or patient 0.029 mrerr CEDE 3
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d Pathways to the Environment 3 )
} Based on an environmental report prepared by an NRC contractor, the staff concluded that
- the impacts associated with any releases of "C to the surrounding environment are j
- expected to be very small and the expected risks are minimal. i l
l The earth's atmosphere contains an inventory of naturally occurring "C of about 3.8 l million curies (equivalent to the activity in 3.8 trillion breath tests), which is in addition to
- the huge inventory of about 240 million curies in the world's oceans. The "C released into
} the atmosphere from'the use of this test would mix with the global inventory and expose
' the public and other biotic components of the environment to "C intakes from inhalation, drinking water, and all possible food pathways in the same manner as naturally occurring
- "C. The current world inventory of naturally occurring "C results in an average dose to I- the public of about 1.25 mrom/ year, and the release of 0.6 curies of "C from the total of
- 600,000 tests assumed to be administered annually (see the REGULATORY ANALYSIS j section below) would result in an additional average annual dose of 2 X 104 mrem. This is
{ far below the EPA reporting level of 1 mrem / year required under the Clean Air Act for
- routine exposures to a member of the public, or the 4 mrem / year EPA limit for public drinking water. In a total population of about 260 million people in the U.S., the collective
- annual dose from the breath tests would be about 0.051 person-rem. In addition, the doses from normal use of breath tests, or from any accidental release of "C to the environment also are expected to be very small because the concentration of CO2released is very low and it would mix immediately with the atmosphere.
i l Collective Exoosures to Members of the Public The small doses from naturally occurring "C are of ittle significance tc human health and the environment. Potential long-term impacts from widespread releases of the long-lived "C (5,730-year radiological half-life) from breath tests were concluded to be insignificant.
Assuming that the testing in the U.S. wouk; increase over a period of time to an average of a million tests per year for 50 years, the collective annual dose to the U.S. population would be about 5 person-rem over the next 50 years. This dose is very small when compared to the annual collective dose to the U.S. population from naturally occurring "C l of over 300,000 person-rem, and about 78,000,000 person-rem from all naturally occurring radiation. Clearly, an increase of a few person-rem will not significantly change ;
these exposures, and thus there is no expected impact from the widespread use of the !
breath test on the entire U.S. population.
COMMENTS FROM THE ADVISORY COMMITTEE ON THE MEDICAL USES OF ISOTOPES (ACMUI)
This petition was discussed with the ACMUI at the October 1995 meeting. The ACMUI indicated that it endorsed the wide availability of this diagnostic test and that the radioactive drug could be used under a generallicense or an exemption, whichever the NRC thought to be procedurally easier.
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COMMENTS FROM THE PUBLIC The " Notice of receipt of petition for rulemaking" was published for public comment in the j Federal Reaister on December 2,1994 (59 FR 61831). A total of 315 public comment l Ictters,313 supporting (mostly form letters) and 2 opposing letters, were received.
The two letters opposing the petition made the following two comments:
(1) The product should not receive an exempt status because the uncontrolled distribution and application of this product could lead to significant risk to the public, and (2) Medical uses should be restricted to short-lived isotopes because of disposal I
problems presented by long-lived isotopes. l The staff disagrees with both comments.
(1) As shown in the " SAFETY ANALYSIS" section of this plan, the radiation dose to workers, patients, and the public is very low. ,
1 (2) As discussed in the " Pathways to the Environment" section of this plan, the impacts l associated with any releases of "C to the surrounding environment are expected to '
be very small and the expected risks are minimal. Also, as discussed in the l
" Collective Exposures to Members of the Public" section of this plan, the small doses from naturally occurring "C are of little significance to human health and the i environment. Potential long-term impacts from widespread releases of the long-lived l "C (5,730-year radiological half-life) from breath tests were concluded to be insignificant.
DRAFT RULEMAKING PLAN in accordance with Management Directive 6.3, "The Rulemaking Process," the staff drafted a rulemaking plan in response to a petition for rulemaking submitted by Tri-Med Specialties, Inc. Three alternatives were considered in the draft rulemaking plan:
Alternative 1 - Deny the petition.
Alternative 2 - Grant the petition via an exemption to permit physicians who are not " authorized users" to receive and use capsules containing 1 Ci of "C-urea. l Alternative 3 - Grant the petition via a general . license to permit physicians who are not " authorized users" to receive and use capsules containing 1 pCi of "C-urea 1
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i Under the draft plan, the staff would have developed a direct final rule amending 10 CFR Part 35 to permit, under a general license, any physician to administer to patients capsules l containing one microcurie of C-14 as a diagnostic tool for detecting peptic ulcers caused !
by the Helicobacter pylori bacterium (Alternative 3).
Distribution of byproduct material as exempt material requires an NRC license, even in an Agreement State. Hence, manuf acturers and distributors licensed by Agreement States would need to obtain and maintain both NRC and Agreement State licenses to distribute the "C capsules as exempt material. This is not the case for byproduct material to be possessed and used under a generallicense. The staff viewed this potential dual licensing as an unnecessary burden with no safety benefit. Therefore, the staff did not recommend distribution to and use as exempt materialin the draft rulemaking plan. In terms of public i health and safety, either Alternative 2 or 3 could be adopted because the radiological risk is negligible.
In accordance with COMSECY-96-035 dated June 11,1996, a copy of the draft rulemaking plan was provided to the Agreement States on October 1,1996, for a 30-day i period of review and comment. Comments were received from ten Agreement States.
AGREEMENT STATE COMMENTS ON DRAFT RULEMAKING PLAN Six States (Kentucky, Nebraska, Colorado, Washington, Utah, and Louisiana) supported the staff's recommended approach (i.e., grant the petition, and permit physicians who are not authorized users to receive and use capsules containing 1 Ci of "C-urea via a general license). Kentucky indicated they already have provisions for a generallicense for "in vivo" use in their regulations.
One State, Oregon indicated that it would not permit administration of the capsules under a generallicense, but would continue to require that all physicians who administer radioactive drugs, including the "C-urea capsules, be specifically licensed.
Three States, New York, Georgia and lilinois, opposed the generallicense approach recommended by the staff. Georgia and Illinois recommended that physicians who are not
" authorized users" he permitted to receive and use capsules containing 1 Ci of "C - urea as exempt materi . Georgia argued that their burden would be increased by distribution and use under a generallicense because of reports required from distributors, invoicing of physicians for generallicense fees, and possible amendment of all of their distribution licenses. Illinois stated that distribution of the capsules as exempt materialis consistent with the NRC's technical evaluation and would ensure that physicians could have access to the capsules without a specific or generallicense. Illinois further stated that if the NRC were to require distribution and administration under a generallicense, Agreement States would need to incur the expense of modifying their regulations. Illinois seems to imply that they could avoid rulemaking if the NRC were to adopt the exemption approach. However, as Georgia correctly observed, the exemption approach would require States to make conforming changes in their regulations as well. New York stated that they agreed that the widespread medicel use of the capsules would involve no risk to the public health and safety or the environment, and would provide significant medical benefits to the 5
population. New York also stated that using a risk-based regulatory approach, there is no need to regulate the capsules for their radioactivo content. Further, New York argued that a generallicense is an ineffective means of regulatory control in any case. New York also noted that the Food and Drug Administration will regulate the capsules as a drug.
RECOMMENDED APPROACH The staff has determined that the radiological risk of this drug presents such a small ,
radiation hazard that the capsules can be treated without regard to their radioactivity. '
Hence, no control of the capsules is necessary for radiation safety after they are manuf actured and distributed. In light of this, and in light of the comments from Illinois, I and Georgia, the staff has decided not to recommend distribution and use of the "C-urea capsules under a general license. Rather, the staff is now recommending that Part 30 be ,
amended to permit the "C-urea capsules to be distributed to and used by any person, l without need of an NRC (or Agreement State) license, who is permitted to receive and use I the drug under an appropriate Federal or State law governing the distribution and use of the drug. Thus regulation of receipt and use of the drug will be left to other Federal and State agencies with the responsibility and authority to regulate drugs (as is the case for other drugs that do not contain byproduct materials). The staff believes that permitting exempt receipt of the capsules by "any person who is permitted to receive and use the drug under an appropriate Federal or State law," rather than limiting receipt and use to ,
physicians only will provide any controls needed for regulation of the capsules as a drug, l
- and avoid the need for NRC to amend its regulations if other Federal or State agencies permit under their authority the distribution and use the radioactive drug to persons who are not physicians.
The staff believes that NRC should require the drug to be manufactured under a specific Part 32 license to ensure that capsules contain only one microcurie of carbon-14 and do not contain any other radioactive contaminants. Hence, conforming amendments would be made to Part 32 to provios requirements for a specific license to manuf acture, process, produce, package, repackage, or transfer capsules containing one microcurie of "C-urea, as a radioactive drug, to be distributed as an exempt material to any person for "in vivo" diagnostic testing. Licensees distributing the radioactive drug as an exempt material would not be relieved from other applicable Federal (e.g., FDA) or State drug manuf acturing and distribution requirements.
PRELIMINARY REGULATORY ANALYSIS In the letter dated August 23,1994, the petitioner stated, if exempted, the C-14 breath test could be done by most doctors for less than $100 cost to the patient. .This is a considerable savings over endoscopy and biopsy
($1000).
In a letter on November 30,1994, the petitioner stated:
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4 i ... The test is 95% accurate and quite inexpensive because of its simplicity. The test j would permit doctors to determine easily whether or not ulcer patients have been j cured of their infection. By providing the public with an inexpensive, easily i accessible diagnostic test, more individuals would be accurately diagnosed and J treated for their H. pylori infection. This would save the United States an estimated
- $500 million per annum over conventional therapy. !
! l 4 Tri-Med estimates annual benefits to be on the order of $500 million/ year. This assumes l - approximately 600,000 "C-urea breath tests / year, at an average cost of $100, in lieu of j performing endoscopy at an average cost of $1000/ test, it assumes that the lower cost i
and greater availability of an unregulated breath test would result in a complete substitution for endoscopy. Tri-Med's benefit analysis provides a measure of the total
- benefits associated with the test and does not focus on the incremental benefits of
. administering the test pursuant to 10 CFR 35.100 regulation (status quo) versus releasing j the test to all physicians (NRC licensed and non licensed alike). Implicit in Tri-Med's
, ' estimated annual benefits is the presumption that none of these "C tests and i
{- corresponding savings would accrue if the petition were denied. In reality, under the
! status quo, the test would be available and administered by physicians or clinics holding a j license under NRC's Part 35. Further, Tri-Med's estimate did not allow for the substitution i of other non-invasive tests'(e;g., serological test for igg antibodies to H. pylori antigens)
! for both endoscopy and "C-urea tests. In addition, wire service articles dated i j September 19,1996, stated that the FDA has approved a non-radiological diagnostic ')
l breath test using "C for detecting the presence of H. pylori infections. j The staff's benefit analysis focuses on the incremental benefits of granting relief based on i the petition. The analysis looks solely at changes relative to the base case or status quo.
! In this analysis, the comparison is between regulated and unregulated"C-urea breath tests, l not unregulated "C-urea breath tests and endoscopies or other non-invasive tests. For the
- ' purposes of this regulatory analysis the staff assumes that the same number of breath i tests (i.e., 600,000 tests) will be administered regardless of the level of NRC regulatory
. control. This view is predicated on the belief that each physician's primary motivation is to l provide the best possible care to his or her patients. If the breath test is judged preferable l to endoscopy, or other procedure, any physician not authorized to use the test will refer j' his or her patient to authorized users who could perform the test under existing NRC ,
! regulations. This appears fully consistent with standard medical practice, whereby patients i are referred routinely to laboratories and specialists for a wide array of tests and
- procedures.
1:
! In the NRC's analysis, the benefits of adopting the petition accrue as a result of reduced l patient cost and reduced health care cost resulting from the elimination of the need for
[ referrals from a physician who is not an authorized user (e.g., gastrointestinal specialist).
. There would also be some regulatory savings because the NRC would not have to expend l resources reviewing new applications for specific medical use licenses. However, the NRC i savings would be small because the staff expects that few physicians who are not
.. authorized users would apply for a specific NRC license for use of this one product.
! The staff's benefit calculation is based on the assumption that a significant portion of the 600,000 patients would receive the "C breath test from physicians who are not authorized j 7 i
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users (e.g., gastrointestinal specialists) instead of authorized users (e.g., nuclear medicine specialists). The actuel savings would be dependent on the number of tests ultimately administered by physicians who are not authorized users, thereby eliminating the need for a referral.
The annual savings could be as high as approximately $20 million if there was a complete shift of the administration of the tests from physicians who are authorized users (i.e., base cars) to physicians who are not authorized users.
The basis for this estimate is as follows.
Assuming adoption of the petition eliminates the need for 600,000 referrals, patient savings in averted travel expenses (transportation and vsonal time incurred with medical referral) would be:
Assuming round trip of 20 miles @ $0.25/ mile, and personal time of 0.5/ hours / trip valued at $25.00/ hour 600,000 trips / year x (20 miles / trip x $0.25/ mile + 0.5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> / trip x $25.00/ hour) =
$10.5 million/ year Health Care Savings in averted administrative expenses (administrative costs incurred with medical referral) would be:
600,000 patients / year x $19.00/ patient = $11,4 million/ year Assuming $19.00 (administrative cost / patient) as the differential between the cost of l an office visit to a general family practice physician by an established oatient l
($45.90), and the cost to a new patient ($64.90 per visit) for completion of new l patient paperwork, reviewing health history, maintaining medical recor' , etc. The ;
patient who is referred to an authorized user (e.g., nuclear medicine t c.cialist) for the "C-urea breath test would most likely be a new patient for the authorized user.
Total Savings:
$10.5 million/ year + $11.4 million/ year = $ 21.9 million/ year Alternatively, if only 200,000 or 400,000 of the 600,000 tests were performed by a physician who is not an authorized user, the annual cost savings would be approximately
$7 million/ year and $15 million/ year, respectively.
COMPARISON OF ALTERNATIVES Alternative 1 - Deny the Petition This alternative would maintain the status quo. Only physicians who are authorized users under Part 35 would be allowed to possess and administer the "C-urea test. Any physician could apply to become an authorized user. However, the NRC expects few 8
physicians would apply for a Part 35 license for the sole purpose of using such capsules because of the requirement for training and experience and the associated costs of obtaining and maintaining a Part 35 license. Alternatively, physicians who are not authorized users could refer their patients to physicians who are authorized users to undergo the diagnostic test, but this would add expente, inconvenience, and delay to an otherwise straight-forward procedure.
Alternative 2 - Grant the petition to permit the "C-urea capsules to be distributed to and used by any person, without need of an NRC (or Agreement State) license, who is permitted to receive and use the drug under an appropriate Federal or State law governing the distribution and use of ,
the drug. I Parts 30 and 32 would be amended to permit the manufacture and distribution of capsules l containing one microcurie of "C-urea as an exempt material to any person. The staff has I determined that the radioactive component of this drug presents a minimal radiation risk and, therefore, regulatory control of the human use of capsules for radiation safety is not necessary.
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Alternative 3 - Grant the petition via a generallicense to permit physicians who are not !
" authorized users" to receive and use capsules containing 1 Ci of "C-urea for in vivo diagnostic testing.
This alternative would permit any physician to receive and use capsules containing 1 Ci "C-urea for human use under a generallicense. The health and safety concerns for this ;
alternative are the same as Alternative 2. However, if this alternative were adopted, there could be a burden to those Agreement States and Agreement State licensees in States that assess licensing or registration fees for generallicense holders.
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RECOMMENDED COURSE OF ACTION l
The staff recommends proceeding with a rulemaking amending Parts 30 and 32 in conformance with Alternative 2 for the following reasons:
- Health and Safety Based upon the analysis of the radiological impacts discussed above, there dc not appear to be any safety or technical reasons why the capsules, breath test materials, counting fluids and vials, and urine from patients cannot be treated without regard to their radioactivity.
- Avoided Costs Under Alternative 1, physicians who are not authorized users would have to refer patients to authorized users to undergo the diagnostic test. These referrals and 9
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attendant expense could be avoided under either Alternatives 2 or Alternative 3.
However, compared with Alternative 3, Alternative 2 appears to be less burden for Agreement States and their licensees.
AGREEMENT STATE IMPLEMENTATION Rules pertaining to the distribution of products to persons exempt from NRC requirements fallinto the class of regulatory functions reserved to the NRC pursuant to the AEA and delineated in 10 CFR Part 150. Therefore, the staff's recommended amendment to Part 32 pertaining to the manufacture and distribution of capsules containing 1 Ci of "C - urea for "in vivo" diagnostic testing by persons exempt from licensing would be a Division 4 matter l of compatibility. The amendment to Part 30 would be a Division 1 matter of compatibility I since Agreement States would need to conform their regulations to recognize that l possession and use of "C-urea capsules is exempt from licensing. States (e.g., Oregon, and possibly others) would not be able to require that physicians administering radioactive drugs to humans be specifically or generally licensed.
l l
Q_GC LEGAL SUFFICIENCY ANALYSIS DEMONSTRATING THAT NO KNOWN BASIS EXISTS FOR LEGAL OBJECTION OGC has reviewed the rulemaking plan and has not identified any environmentalissues that would present significant difficulties in pursuing the proposed rule.
Since this rulemaking would address the resolution of PRM-35-12, the staff will need to ensure that appropriate procedural actions are taken to close the actions associated with that petition. These actions include specifically granting or denying the petition for rulemaking, either in the Federal Register notice associated with the rulemaking or in a separate Federal Register notice, and informing the petitioner of the Commission's decision. The detailed procedures for regonding to the rulemaking petition are contained in Part 11 of the Regulations Handbook (NUREG/BR-0053, Rev. 3).
ASSESSMENT OF LIKELY IMPACTS ON NRC AND AGREEMENT STATE LICENSEES This rulemaking would not result in any additional regulatory burden to NRC medical use licensees. Authorized users would continue to be authorized to receive and use this product for medical use.
SUPPORTING DOCUMENTS A regulatory analysis, an environmental assessment, and an OMB information collection approval package will be provided for this rulemaking.
RESOURCES 10
Resources to complete and implement this rule are included in the current budget.
LEAD OFFICE STAFF AND STAFF FROM SUPPORTING OFFICES Staff-Level Workino Grouo Concurrina Official RES - Sam Jones Bill M. Morris -
NMSS - Donna Beth Howe Donald A. Cool OGC - Marjorie Rothschild Stuart A. Treby OSP - Lloyd Bolling Richard L. Bangart ADM - Mike Lesar David L. Meyer 1
STEERING GROUPS / WORKING GROUP There is no need for a steering group for this rulemaking. The Working Group is identified I above.
ENHANCED PUBLIC PARTICIPATION This rulemaking will be placed on the electronic bulletin board at FedWorld and will also be published in the Federal Reoister.
EDO OR COMMISSION ISSUANCE Because the amendment involves a policy issue (i.e., the capsules would be distributed to any person who would be exempt from NRC regulations), it is recommended that the Commission issue the rule. i l
SCHEDULE i Proposed Rule: Weeks from the date EDO/Comm approves the Rulemaking plan Send proposed rule to office for 2 weeks concurrence .
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I Send proposed rule to EDO 6 weeks 1 Send proposed rule to Commission . 8 weeks l Receive Commission approval 10 weeks Publish in the Federal Reaister for a 75-day 13 weeks public comment period; and submit information collection approval package to OMB 4 5
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l U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF STATE PROGRAMS i
OFFICE OF STATE PROGRAMS FAX: (301) 415-3502 85
, NUMBER OF PAGES: 5% including this page DATE: MARCH 7,1997 4
TO: RADIATION CONTROL PROGRAM DIRECTORS IN
- AGREEMENT STATES I MASSACHUSETTS, OHIO, OKLAHOMA, PENNSYLVANIA l NRC REGIONAL STATE AGREEMENTS OFFICERS NRC REGIONAL STATE LIAISON OFFICERS j
- FROM
- PAUL H. LOHAUS, DEPltTY DIRECTOR OFFICE OF STATE PROGRAMS i
i i
SUBJECT:
SP-9h-015 RULEMAKING PLAN - 10 CFR PARTS 30 & 32 C-14 UREA H. PYLORI DIAGNOSTIC TEST i-a VERIFICATION - 415-3340 4
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Agreement State would similarly withhold this inform,ation from public disclosure. We ask
- that you confirm whether you will be able to withhold this pre-decisional information from i public disclosure under comparable State rules We would appreciate receiving your 4
response, on this issue, as soon as possible. Upo'n receipt of your confirmation that you can withhold this pre-decisional information, we' will provide you a copy of the draft
- proposed rule, via mail, prior to publishing it in' the Federal Reaister, for your early review.
- Staff plans to provide the proposed rule to the Commission for approval for publication in i the Federal Reaister for public comment by' April 18,1997.
4 If you have any questions regarding correthis/
spondence, please contact me or the i individual named below.
l POINT OF CONTACT.:/ Lloyd A. Bolling j TELEPHONE:
/ (301) 415-2327
- FAX
- / (301) 415-3502
- INTERNET: LAB @NRC. GOV Paul H. Lohaus, Deputy Director i Office of State Programs
Enclosures:
/
i As stated I
\1 \C N WS tNNsh(k k o
! / n4ap%w%% l
/
(\Sn b1A m bsm/h Distribution: [ \
EDO RF /
DIR RF DCD (SP03) RSAOs) E-Mailed ,
SDroggitis All A/S File PDR (YESf NO_) RSLOs) 3/ /97 S] 1
/ FAXED TO STATES: 3/ /97
/
'See previous concurrence j DOCUMENT NAME: G:\SP97CCC. LAB j i Ta receive a copy of this document,ind6cate in the box: *C" = Copy without attachment /h gh C py y(th attac ent/en losure "N* = No copy ,;
DE@f OFFICE OSP OSP:DD OSP:D 4'RES4,Q9' OGC NAME- LBolling:nb/gd PLohaus. RBangart BMorris FXCameron HLThorppsffn DATE 03/06/97* 03/06/97* 03/ /97 03f//97 03T//97 03/,f/97 OSP FILE CODE: SP-A L
k -
ROUTING AND TRANSMITTAL SLIP DATE: MARCH 6. 1997 PARALLEL CONCURRENCE REOUESTED' INITIALS DATE i
)
H. L. THOMPSON. DEDR 3/ /97 .
l pg/ 6 F>l $ F. X. CAMERON. 0GC 3/ /97 B. MORRIS, RES 3/ /97 l 4
MEMORANDUM T0: ALL AGREEMENT STATES MASSACHUSETTS, OHIO. OKLAHOMA, PENNSYLVANIA l
).
j FROM: PAUL H. LOHAUS. DEPUTY DIRECTOR OFFICE OF STATE PROGRAMS t- i
SUBJECT:
RULEMAKING PLAN - 10 CFR PARTS 30 & 32 C-14 UREA H. PYLORI DIAGNOSTIC TEST 1
4 i
4 i
YOUR CONCURRENCE IS REQUESTED BY 12:00 N00N MARCH 7, 1997.
gjwi65 o f
MNT 4 j (THIS DOCUMENT HAS TO BE FAXED TO THE STATES BY C.0.B.) gAI 1
. OSP CONTACT: LLOYD A. BGLLING 415 2327 Oh
@ti /
s JWsW' PLEASE-CALL KATHALEEN KERR (415-3340) FOR PICK UP.
1 1
1
, 1 SP :
information, we will provide you a copy of the draf t proposed rule, via mail, prior to publishing it in the Federal Register, for your early review. Staff plar$s to provide the proposed rule to ,
the Commission for approval for publication in the Federa} Register for public comment by April '
18,1997.
If you have any questions regarding this correspondence, please contact me or the individual named below.
4 POINT OF CONTACT: Lloyd A. Bolling TELEPHONE: (301) 415-2327 FAX: (301) 415 3502 INTERNET: LAB @NRC. GOV g
/ 1
/ !
/
/
, Paul H. Lohaus, Deputy Director j' Office of State Programs
/
,/
Enclosures:
j e!
As stated
/
Distribution: ,
DIR RF / DCD (SP03) RSAOs) E Mailed SDroggitis PDR (YESf NO_) RSLOs) 3/ /97 All A/S File FAXED TO STATES: 3/ /97 I
DOCUMENT NA E: G:\SP97CCC. LAB T2 reeme e esey of is. e coment. macete h the box: *C* = Copy trithout attachment / enclosure *f * = Copy with attachment / enclosure opy OFFICE / OSP j OSPp0y OSP;D RES * ' OGC-l NAME LBolling:nttpCfj+ PLohausi U\ RBangart BMorris FXCameron DATE 03F/97 036n17 03/ /97 03/ /97 03(d97 0FFICE DEDR l l l l l NAME HLThompson DATE 03/ /97 OSP FILE CODE: SP-A-4
) # G4ottSSiod
- w sof NW,gs+,M PWrA lWn
SP information, we will provide you a copy of the draft proposediule, via mail, prior to publishing it in the Federal Register, n,. your early review. Straff plans to provide the proposed rule to the Commission for approval for publication in the Federal Register for public comment by April 18,1997.
/
/
ondence, please contact me ar the individual j If youbelow.
named have any questions regarding this corresp/
$ POINT OF CONTACT: Lloyd A., Bolling TELEPHONE: (301) 415-2327 l FAX: (301) 415-3502
- INTERNET
- LAB @NRC. GOV
. i
/
l/ i
/
/ l
/ Paul H. Lohaus, Deputy Director l
/
/ Office of State Programs ,
/
/ l
/
Enclosures:
/ I As stated /
p Distribution:
DIR RF / DCD (SP03) RSAOs) E-Mailed SDroggitis PDR (YESf NO_) RSLOs) 3/ /97 All A/S' File FAXED TO STATES: 3/ /97
/
,/
/
DOCUMENT /NAME: G:\SP97CCC. LAB ,
To receive e copy'of this document, Indicate in the box: "C' - Copy writhout attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy )
OFFICE OSP j OSPpby OSP:D RES OGC NAME LBolling:nt1 pCg/- PLohau( V( RBangart BMorris FXCameron DATE 03F/97 034/97 03/ /97 03/ /97 03/ /97 0FFICE DEDR l l l NAME HLThompson
~
DATE 03/ /97 OSP FILE CODE: SP-A-4
{.52- Action: Morrison, RES
- Itrog*o f$.
. ,, UNITED STATES Cys: Callan p , h[.-9 NUCLEAR REGULATORY COMMISSION Jordan g y WASHINGTON, D.C. 20555-0001
" Thompson
! Norry v.,,*,/ March 3, 1997 Blaha Paperiello, NMSS OFFICE OF THE ' 0 '
SECRETARY Croggins, CF0 Galante. CIO MEMORANDUM TO: L. Joseph Callan Exe t've Director for Operations FROM: Jo C. oy e, Secretary
SUBJECT:
S AFF REQUIREMENTS - SECY-97-031 - FINAL RULEMAKING PLAN: EXEMPT DISTRIBUTION AND USE OF A RADIOACTIVE DRUG CONTAINING ONE !
MICROCURIE OF CARBON 14 UREA (PARTS 30 AND 32) i This is to advise you that the Commission has not object.ed to I implementation of the rulemaking plan and staff development of a proposed rule to permit the distribution of the radioactive drug as an exempt material.
(RES) (Suspense date: 4/18/97) 9700042 cc: Chairman Jackson Commissioner Rogers Commissioner Dicus Commissioner Diaz Commissioner McGaffigan OGC OCA $
OIG E Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail 4 PDR o
_.L DCS , M e
7
\P SECY NOTE: THIS SRM AND SECY-97-031 WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM.
,. 6fidbd Wh [