ML20198H718
| ML20198H718 | |
| Person / Time | |
|---|---|
| Issue date: | 06/04/1997 |
| From: | Trottier C NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| To: | Meyer D NRC OFFICE OF ADMINISTRATION (ADM) |
| Shared Package | |
| ML20013E023 | List:
|
| References | |
| FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-006, AF70-1-6, NUDOCS 9801130379 | |
| Download: ML20198H718 (72) | |
Text
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., ocero UNITED STATES
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% NUCLEAR REGULATORY COMMISSION 3 WASHINGTON o.C. P%$4001
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MEMORANDUM TO: David L. Meyer, Chief Rules Review and Directives Branch Division of Freedom of Informaticn and Publications Services Office of Administration FROM: Cheryl A. Trottier, Acting Chief 4 Radiation Protection and Health Effects Branch Division of Regulatory Applications Office of Nuclear Regulatory Research PROPOSED RULE REVISING 10 CFR PARTS 30 AND 32, .
/
SUBJECT:
EXEMPT DISTRIBUTION AND USE OF A RADIOACTIVE DRUG CONTAINING ONE MICROCURIE OF CARBON UREA l By memorandum dated M$y 30,1997, the Secretary of the Commission indicated that the Commission has approved the proposed rule on exempt distribution and use of a radioactive drug containing one microcurie of carbon urea as set out in SECY 97-090 and recommended that the proposed rule should be published in the Federal Reoister after making certain spe changes to the Federal Register Notice (FRN), the Congressional Letters, and the Public Announcement. The marked up copie of the FRN, the Congressional Letters, and the Public Announcement are attached. Also attached is a copy of the Staff Requirements Memorandum ' indicating where in the FRN the specified changes are located. Please implement the Commission's action by arranging for publication of the attached propos rule in the Federal Reoister. A copy of the Federal Register Notice is attached in both hard copy and diskette. Also attache is a Congressionalletter package for transmittal to OCA and copies of the public announcement for transmittal to OPA. In addition, copies of the draft Environmental Assessment and the draft Regulatory Analysis are attached for transmittal to the POR. Attachments:
- 1. GRM dated May 30,1997 w! attachments
- 2. FR Notice + 3 Copies & Diskette
- 3. Congressional Letter Package 4 Public Announcement + 2 Copies
- 5. Draft Environmental Assessment 6.' Draft Regulatory Analysis m MIFR32552 PDR 4u v v.u3v u y x
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1 I 4 1 ATTACHMENT- 1 , I i 6 l STAFF REQUIREMENTS MEMORANDUM ; WITH ATTACHMENTS l t i 1 8 T y I f l r
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a 't j NUCLEAR REGULATORY COMMISSION WASHINGTON D.C. 20M!@001 49 ,o May 30, I t 14 7 MEMORANDUM TO: L. Joseph Callan Executive Director for Operations FROM: John C. Hoyle, Secretary /s/
SUBJECT:
STAFF REQUIREMENTS - SECY-97-090 - PROPOSED RULE: EXEMPT DISTRIBUTION AND USE OF A RADIOACTIVE DRUG CONTAINING ONE MICROCURIE OF CARBON UREA (PARTS 30 AND 32)
'the Commission has approved publication of the proposed rule in the Rd3Jal_Reaister with incorpora* -- of the changes to the B doral Reaister notice, Congressior.a 2 letters, and press release noted in the attachments. (SECY Suspense: 6/30/97)
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Attachment:
As stated cc: Chairinan Jackson Commissioner Rogers Commissioner Dieus Commissioner Diaz Commisoloner McGaffigan OGC CIO CFO OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail) PDR DCS SECY NOTE: THIS SRM, SECY-97-090, AND THE COMMISSION VOTING RECORD CONTAINING THE VOTE SHEETS OF ALL COMMISSIONERS WILL dE hADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM. 4.QMODI k - { ( , -, y c DO?
[7590-01 P) NUCLEAR REGULAT'1RY COMMISSION 10 CFR Parts 30 and 32 - RIN: AF70 Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon 14 Urea AGENCY: Nuclear Regulatory Commission. ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC)is proposing an amendment to its regulations that would permit NRC ucensees to distribute a radioactive drug containing one microcurie of carbon 14 urea to any person for "in vivo" diagnostic use. The NRC has
-determined that the radioactive component of such a drug in capsule form presents a minimal radiation risk and, therefore, regulatory control of the drug for radiation safety is not necessary, if adoped, this amendment wou!d make the drug more widely available, and reduce costs to patients, insurers and 'the health care indus_try. This action is being .
taken in response to a petition for rulemaking (PRM 35121 submitted by Tri-Med Specialtics, Inc.
. DATES: Submit comments by (Insert date 30 days after publication date). Comments received af ter this date will be considered if it is practicable to do so, but the Commission is able to assure consideration only for commenta received on or before this date,
k Current NRC Regulations for the Medical Use of Radioactive Drugs Containing Byproduct Material t Currently,10 CFR Part 35 only permits physicians who are authorized users (e.g., physicians who rneet certain training and experience criteria regarding the safe use of radin~9tive drugs) or persons working under the supervision of an authorized user to use
/, h ster radioactive drugs for medical use. The Agreement States have similar requirements.
Current NRC Regulations on Exemptions from Licensing Existing exemptions from licensing requirements for the use of byproduct material include exemptions for specific products (e.g., time pieces), exemption for classes of products (e.g., gas and aerosol detectors) and broader materials exemptions in 6 30.14
" Exempt concentrations," and 6 30.18, " Exempt quantities." These two broad materials exemptions specifically exclude the transf er 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. (in the case of exempt quantities, this prohibition is contained in 6 32.18, "Manuf acture, distribution and transfer of exempt quantities of byproduct material; Requirements for a license," 6 32.18(b)).
Capsules containing one microcurie of carbon 14 urea would not qualify as an
" exert pt quantity" in accordance with 6 30.18 because of their intended use (as a drug) even though they contain a smaller quantity than that set forth in 6 30.71, Schedule B.
This use is outside the intent of the exemption currently in i 30.18. It would introduce 7
person desiring to use the capsules for human research would still be required to submit an application for a specific license under Part 35 in order to protect human subjects. The phrase "in vivo diagnostic use" is being used in i 30.21 instead of " medical use" for two reasons. First, th term " medical use" has a specific meaning and is defined i i 35.2 to mean "the intentional internal or external administration of byproduct material or the radiation therefrom to patients or human research subjects under the supervision of an authorized user." This term would be inappropriate because: (1) " Medical use" limits administrat.an o authorized users; use of this drug would not be so limited; and (2) " Medical use" includes the administration of the drug to a human research subject, which would be prohibited by this rulemaking. Effects of the Proposed Amendments The effect of these proposed amendments would be to make the drug available to any person, for "in vivo" diagnostic use, without need for an NRC or Agreement State license. Cecause the receipt and use of the drug would be exempt from NRC licensing, Agreement States would need to make appropriate provisions in their regulations to recognize the exempt distribution of the drug, for "in vivo" diagnostic use. Thus, af ter the manuf acture and distribution of the drug the NRC and the Agreement States would not regclate the use of the drug as long as its use was for "in vivo" diagnostic use. This ld
.means that, under NRC and Agreemente State regulations, primary-care physicians wou not need to be " authorized users" in order to administer the drug, and would not necessarily need to refer their patients to nuclear medicine physicians. This should result 10
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[ k Public Protection Notification i The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number, i Vill. Regulatory Analysis a
' The NRC has prepared a regulatory analy.3 for the proposed rule. The analysis examines the benefits and impacts considered by the NHC. The regulatory analysis is -- i
}
available for inspection at the NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the regulatory anslysis are available from Sam < Jones, uffice of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, s Washington, DC 20555 0001, telephone (301) 415 6198 or e-mail at SZJ@nrc. gov. IX. Regulatory Flexibility Certification
- As required by the Regulatory Flexibility Act of 1980,5 U.S.C. 605(b), the r Commission certifies that this rule does not have a significant economic impact upon a substantial number of small entities. The proposed rule would permit physicians and other health care providers to use an additional diagnostic test without having to obtain an NRC
-4 license, thus,-would provide cost savings to phy:! !:n: :nd patientsLinsurers,:and.the'
- he'althlcarolindustry.' ' Any small. entity subject to this regulation which determines that. .
- : because of its size, it is likely to bear a disproportionate adverse economic impact should I notify the Commission of this in a comment that indicates the following:
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q i e The Honorable James M. Inhofe, Chairman Oubcommittee inn Clean Air, Wetlands, : Private Property and Nuclear Safety -l Committee on Environment and Public. Works ' United States Senate ' Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee are copies ~of a public announcement and l l a Federal Register notice concerning a proposed amendment to 10 CFR Parts 30 and 32.'
= This rulemaking is being taken in respon e to a petition for ru lema king su mb itted by Trie j; Med Specialties, Inc.; I J
;The Nuclear Regulatory Commission (NkC)is proposing to amend its regulations to allow NRC licenseea to distribute a radioactive drug containing one inicrocurie of carbon 14 urea i
to any person for _"in vivo" diagnostic use. The NRC ha: determined that the radioactive component of such capst.les presents a minimal radiation risk and, therefore, regulatory control of the drug for radiation safety is not necessary. The'manuf ac'tureJand distribution. . of theicapsules'would continue'to require ~an NRC license; if adopted, this amendment would make the drug more widely available, thus reducing costs to patients! insurers, and the1 health l care; industry. f (make same changes t6 the Schaefefletter) 4 Sincerely, 5 Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
1.' Public Announcement 2.- Federal Register. Notice : i cc: Senator Bob Graham - t 4 3 4 I e y
' a , . ,, u , _ ,- _
Draft press release -- 4/23/97, 3:30 p.m. NRC CONSIDERS CHANGING REGULATIONS TO PERMIT EXEMPT DISTRIBUTION OF RADIOACTIVE DIAGNOSTIC DRUG The Nuclear Regulatory Commission is considering amending its regulations to allow a specific radioacti'fe drug,. that can be used to diagnose stomach ulcers, to be distributed to any person
,for administration to humans. Currently, only reensed- nuclear
-physicians authorized;byfNRC or"Agreem'ent Statec may receive and use administer the drug.
The proposed change would not relieve persons from the requirement to comply with applicabl: Food and Drug Administration or other 4 Federal ano estate requirements governing receipt, administration and use of drugs. The change is in response to a 1994 petition from Tri-Med Specialties, Inc. It would allow any person to receive,. possess, use and transfer carbon-14 urea capsules, not exceeding one microcurie each, for diagnostic use in patients. The NRC has determined that the capsules present a minimal radiation risk, and therefore believes that regulatory control of the drug for radiation safety is not necessary. Under the proposed revisions to NRC regulations, manufacturers of the capsules and commercial pharmacies that prepare the capsules would continue to need an NRC licenser-and to provide high confidence of capsule contents, dThe containers of the capsules would have to bear the words " radioactive materialv" and4 other. specific =information on-the contents of the
'co~ntainer. In addition, only those persons who were licensed would be permitted to use the_ capsules for research involving human subjects.
4 w w w , - - ~ ~ -
The Tri-Med petition stated that Carbon-14 urea can be used to detect the prose,cce_of a bacterium that-causes peptic ulcers, a ch.cnic inflammatory condition of the stomach and duodenum that af fects as many as 10 rercent of people in the United States at some time in their lives. According'to a July 1994 article in the Journal of the American Medical Association, the disease has relatively low mortality, but results in substantial human suffering and high economic costs. Doctor _ can now cure most ulcer problems with antibiotics. The test using carbon-14 urea is non-invasive. A doctor asl' the patient to swallow the
-capsulo with water. After 15 minutes the patient blows into a collection bag, which is mailed to a testing laboratory for-analysis.
The NRC's Advisory Committee on the Medical Uses of Isotopes discussed the petition at its October 1995 meeting. The committee endorsed making this diagnostic test widely available. Currently, Part 35 of the Commission's regulations permits only physicians who are authorized users (e.g., physicians who meet certain training and experience criteria regarding the safe use of radioactive drugs) or persone working under the supervision of an authorized user to administer radioactive drugs for medical purposes. Under the proposed amendments, physicians orJother; health care workers would not need to be authorized users in order to adninister the drug, and physicians would not need to refer their patients to nuclear medicine physicians. This should result in
-cost savings to patients, insurers, and:the' health care industry.
. Interested persons are invited to submit comments on the
~(4G 30 dayn-proposed rule change by after publication of a; Federal Regis.cr norice on t!.is subject on
). .They may.be mailei to the Secretary, 20555-0001, U.S. . Nuclear Regulatory Commission, Washington, DC Attention: Rulemakings and Adjudications Staff, or submitted electronically as described in the Federal Register notice.
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ATTACHMENT 2 FEDERAL REGISTEP NOTICE "6
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; [7590 01-P]1 3
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NUCL' EAR REGUL'ATORY COMMISSION W 4
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-10 CFR Parts 30 and 32 j RIN: AF70 ,-
Exempt Distribution of a Radioactive Drug ' 4 .. Containing One Microcurie of Carbon-14 Urea - , I AGENCY: . Nuclear Regulatory Commission. ACTION: 1Proposcu rule. 1
SUMMARY
- . The Nuclear Regulatory Commission (NRC)is proposing an amendment to its ii
. regulations that would permit NRC licensees to d i stribute a radioactive drug conta n ng one microcurie of carbon 14 urea to any person for "in vivo" diagnostic use. The NRC has
" determined that the radioactive component of such a drug in capsule form presents a
. minimal radiation risk and, therefore, regulatory control of the drug for radiation safety is ,
' not necessary, if adopted, this amendment would make the drug more widely available, and reduce costs to patients, insurers, and the health care industry. This action is being
' taken in response to a pet', tion for rulemaking (PRM 35-12) submitted by Tri-Med
- Specialties, Inc.
DATES: Submit comments by (Insert date 30 days af ter publication date). Comments
- received after this date will be considered if it is practicable to do so, but the Commission
-is able to' assure consideration only for comments received on or before this date. ' hq 6 4
y e. ,_ws. , .n4w .e c.e_, g..g y%. ,, 4 9..L41, .,iwp _..-.i s 9 ,_-p._ y
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- ADDRESSES: Send comments to: ~ Secretary, U.S. Nuclear Degulatory Commission,-
Washington,L DC '20555 0001, Attention:: bocketing and Service Branch.' Hand deliver comments toi -11555 Rockville Pike, Rockville, Maryland, between ,
- 7.30 am and 4:15 pm on Federal' workdays. .
The public may examine comments received /the environmental assessment and-fi M W3.af no significant im' pact, and the regulatory analysis at the NRC Public Document Room, 2120 L Street NW. (Lower Level),' Washington,- DC.
~ FOR FURTHER INFORMATION CONTACT O . Anthony N. Tse, Office of Nuclear-20555 0001, Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC telephone (3011415 6233 or e-mail at ANT @nrc. gov.
SUPPLEMENTARY INFORMATION:
- 1. Bac' kground. l
- 11. Discussion.
Ill. Summary _ of Proposed Amendments. IV. Agreement State Compatibility. V. Electronic Access. VI. Finding of No Significant Environmental impact: Availability. l
- Vll. Paperwork Reduction Act Statement.
Vill. - Regulatory Analysis. IX. Regulatory Flexibility Certification.
. X.
Backfit Analysis.
- .XI. - List of Subjects .
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1.' Background
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The Petition for RUlemaking On October 6,1994, ths Commission docketed a petition for rulemaking (Docket i No. PRM 3512) from Tri-Med Specialties, Inc (Tri Med). In a letter dated August 23, 1994,' Tri Med' petitioned the NRC to amend its regulations "to allow for the general - '
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1 l I -licensing and/or exemption for the commercial distribution by licensed pharmaceutica manuf acturers of a capsule containing one micro-rurie ( Ci) of "C-urea for in vivo diagnostic testing." The purpose of this diagnosti: test is to detect the presence of the: i. bacterium Helicobacter pylori (H. pylori), a cause oi#cptic uicers.
>" Peptic ulcer disease is a chronic inflammatory condition of the stomach and duodenum that affects as many as 10 percent 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").
4
-In the petition, the petitioner stated the following:
- 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 ulcer sufferers.- By. treating ulcer patients with antibiotics, doctors can now cure most ulcer problems, f
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it is therefore necessary to detect the presence of H, py' tori bacteria in ulcer--- patients so that the new treatment can be given appropriately. _In the pastr this was done by a gastroenterologist who' took biopsy. samples of the stomach lining at endoscopy, a procedure which was uncomfortable and expensive ($1000). 1
~
- 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
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expired in the breath. To do the 'est. a doator 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 2more than twice_ background is present in the F
< breath sample, then the patient must be infected with H. pylori.
This proposed rule, should it become final, would grant the petition for rulemaking (PRM-3512) from Tri Med and complete action on the petition. Public Comments on the Petition 4 s Following the receipt of the petition, the NRC published for public comment a notice- , of receipt of petition for rulemaking in the Federal Register on December 2,1994 (59 FR - 61831). The comment period closed on February 15,1995.1The NRC received 315 public com, ment letters. of which 313 support the' petition (they were mostly form letters) and 2 (letters _ opposed the petition. The two letters opposing the petition stated that the product 4 1 a -w-- u >w. , , <-
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TshouId not receive an exempt status because tie's uncontroll5d distribution and application of this product could lead to_significant risk to_ the public and that the medical uses should "
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be restricted to short lived isotopes because of disposal problems presented by'long lived
- t isotopes. .
- Thw NRC has considered the two opposing comments and has determined the ,
t l foliowing: . (1) The resulting radiation dose from the' capsules to workerst patients / and tiie public is very low (see Regulatory Analysis),
- (2)<The impacts associated with'any releases of "C to the wrrounding environment are expected to be very small and the expected risks are minimal (see Environmental .
- ; Assessment). Simiiarly, the small dosua from nawralay occurring "C are of little significance to human health and the environment. Also, the Commission concludes that
-the potential long term impacts from widespread releases of the long-lived "C (5,730-year
- radiologica! half life) from breath tests are insignificant.
- Comments from Advisory Committee on the Medical Uses of isotopes
~ This petition was discussed with NRC's Advisory Committee on the Medical Uses of
~
Isotopes (ACMUI) at its October 1995 rneeting. 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 may determine to be procedurally easier. I e W 5 --
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'11. - Discussion . t
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/ Regulatory Issue ' ;
iThe regu'latory issue is whether capsules containing one microcurie of l carbon 14-
-1 urea present a sufficiently small radiation risk that they can be safely distributed lto any F
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person (including physicians who are not " authorized users" under Part 35). I
.4
' Current NRC Regulations f" the Manuf acture and Commercial
' Distribution of Radioactive Drugs Containing Byproduct Material- }
'NRC regulations jn 10 CFR 32.~72 address the manuf acture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material. This- .;
. regulation requires manuf acturers or preparers of radioactive drugs for commercial -
distribution to be: .
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' (1) Registered or licensed with the U.S. Food and Drug Administration (FDA) as a drug manufacturer;
-(2) Registered or licensed with a state agency as a drug manufacturer; (3) Licensed as a pharmesy by a State Board of Pharmacy; or s
-.(4) Operating as a nuclear pharmacy within a Federal medicalinstitution.
' : These f acilities have a specific licenso with the NRC. Under the specific license, the
- I
-.manuf acturer or pharmacy.can distribute radioactive drugs only to persons authorized
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pursuant to Part 35, " Medical Use of Byproduct Material." t s 6-
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4 Current NRC Regulations for the Medical Use of Radioactive Drugs Containing Byproduct Material Currently,10 CFR Part 35 only permits phwicians who are authorized users (e.g., physicians who meet certain training and experience criteria regarding the safe use of radioactive drugs) or persons working under the supervision of an authorized user to administer radioactive drugs for medical use, The Agreement States have similar requirements. Current NRC Regulations on Exe.nptions from Licensing Existing exemptions from licensing requirements for the use of byproduct material include exemptions for specific products (e.g., time pieces), exemption for classes of products (e.g., gas and aerosol detectors) and broader materials exemptions in 6 30.14,
" Exempt concentrations," and 5 30.18, " Exempt quantities." These two broad materials exemptions specifically exclude the transfer of byproduct material contained in any food, beverage, cosmetic, drug, or any product designed for ingestion or inhalation by, or e
application to, a human being. (In the case of exempt quantities, this prohibition is contained in 6 32.18, "Manuf acture, distribution and transfer of exempt quantities of byproduct material: Requirements for a license," 6 32.18(b)). Capsules containing one microcurie of carbon.14 urea would not qualify as an
" exempt quantity" in accordance with 5 30,18 because of their intended use (as a drug) even though they contain a smaller quantity than that set forth in 6 30.71, Schedule B.
This use is outside the intent'of the exemption currently in 5 30.18. It would introduce 7
neec,ioss complexity to the regulations and confusion to acco'mmodate this unique use un' der the aforementioned sections. However, because the capsules present an insignificant radiological risk to the pJblic and the environment, the NRC believes they could be distributed to persons exempt from licensing for "in vivo" diagnostic use. . Proposed Amendments for Permitting the Distribution of the Capsules to Persons Exempt from Licensing Proposed Amendment to 10 CFR Part 32 The regulations in 10 CFR Part 32 would be amended to add a new t; 32.21, to p'rovide requirements for a specific license to manuf acture, prepare, process, produce, package, repackage, or transfer for commercial distribution capsules containing one microcurie of carbon-14 urea, as a radioactive drug, to be distributed to any person for "in vivo" diagnostic use. These requirements are consistent with the existing requirements on other items under the heading " Exemptions" in 10 CFR Part 30. The proposed regulation would include a reminder that licensees distributing the radioactive drug to persons exempt from licensing would not be relieved from other applicable Federal (e.g., FDA) or State requirements governing the manuf acture and distribution of drugs. The NRC has decided that the manuf acture or preparation of capsules containing one microcurie of carbon-14 urea should continue to be prepared by persons who meet the current NRC regulations to manuf acture and commercially distribute radioactive drugs. The NRC believes regulatory control is needed to provide high confidence that the drug 8 w
; contains only one microcurie of carbon-14 urea and does not contain any other radioacti contaminants.
Proposed Amendment for Exempting "Any Person" from Licensing Requirements to Receive the Drug I Proposed A.mendment to 10 CFR Part 30 , The NRC has determined that the drug in capsule form presents no significant radiological safety or environmental risk, and that it is not necessary to regulate t iherefore, the NRC can not justify requiring this drug f or its ramuactive component, physicians, or any other person, to meet NRC training and experience criteria direc the safe use of radioactive drugs, or to become an "authorizec, user." Hence, the capsu can be distributed to any person. However, other Federal or State agencies may limit th receipt and use of the capsules in accordance with their own requirements. The regulations in 10 CFR Part 30 would be amended to add a new 6 30.21, to permit any person to receive, possess, use, transfer, own, or acquits for "in vivo" diagncstic use, capsules containing one microcurie of carbon 14 urea without a license The proposed regulation would include a reminder that persons receiving the capsules would not be relieved from other Federal or State law governing drugs. Further, in accordance with the NRC's provisions for research involving human subjects (10 CFR 35.6), the exemption permitting receipt and use of the capsules for "in vivo" diagnostic use does not extend to use of the capsules for research involving human subjects. Any 9
. - . - - - - - .. .~. - ._ _.-. - - . . _ _ -- - - - -
person desiring to use the capsules for human research would 'still be required to submit an i _ app li ca ti on for a s pecific license under Part 35 in order to protect human subjects.
?
The phrase "in vivo diagnostic use" is being used in _t 30.21 instead of " medical - , u e" for two reasons. ' First, the term " medical use" has a specific meaning and is defined . ,
=
in i 35.2 to mean "the intentional internal or external administration of byproduct material - or the~ radiation therefrom to patients or. human research subjects e .dc. tb::tgervision of . an authorized user." This term would be inappropriate because: r e (1) " Medical use" limits administration to authorized users; use of this drug would I not'be so limited; and 7 (2) " Medical use" includes the administration.of the drug to a human research subject, which would be prohibited by this rulemakdig. c Effects of the Proposed Amendments ? The effect of these proposed amendments would be to make the drug avellable to > w any person, for "in vivo" diagnostic use, without need for an NRC or Agreement State license. Because the receipt and use of the drug would be exempt from NRC licensing, Agreement States would need to make appropriate provisions in their regulations to recognize the exempt distribution of the drug, for "in _ vivo" diagnostic use. Thus, af ter the manuf acture and' dis'tribution of the drug, the NRC and the Agreement States would not regulate the use of the drug as'long as its ese was for "in vivo" diagnostic use. This means that, under NRC and Agreements State regulations, primary-care physicians would not nesd to be " authorized users" in order to administer the drug, and would not necessarily need to refer their patients to nuclear medicine physicians. This should result- ,
' 10 j-
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g-e a 9-
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iri' cost savings'to patients.'.Other Federal and State organizations with responsibilities;for-
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- regulating drugs would. be.lef t _to determine and' regulate _who could receive and use the . >
--drug for "in vivo". diagnost ic use; NRC would regulate the use of the drug'for research ~
involving human subjects under a specific Part 35 iicense. _ t - 111. Summary of Proposed .^.m:ndm:nts
< Manufacturer and Distributors-A new section would be added to 10 CFR Dart 32 to permit the distribution of the -
- capsules to persons who are exempt from licensirig.
..6 32.21 Radioactive droo: Manuf acture, preparation, or transfer for commercial-
' distribution of carbon 14 urea capsules not exceedina one microcurie each for "in vivo"-
' diaanostic use for humans to oersons exemot from licensina: Reauirements for a license G . Paraarach (a)-
.This paragraph would estabt;sh the requirements for approval of a license- .
application to manuf acture, prepare, process, produce, package, repackage, or transfer for commercial distribution carbon-14 urea capsules not exceeding one microcurie each for "in - l vivo" diagnostic.use, to persons exempt from licensing.
- Erraoraoh la)(1)-
- -This paragraph would limit issuance of an " exempt distribution license". for -
Ldistribution of the_ capsules to persons exempt from licensing _to only those who possess
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* ,4 L either a.NRC_ or Agreement' State specific license" for possession and use of byproduct 4_- .
material. .
-r Faraoraoh (a!(2)
To assure that the capsules contain no more than one microcurie of carbon-14 and: ( present no other radiological risks, thi: p:r:;;?cph would require that the. persons : i manuf acturing and/or commercially distributing the capsules for "in vivo" diagnostic;use must also meet the requirements of 9 32.72(a)(2).._ Specifically, these persons must be: (1) Registered with or licensed by 'h'e FDA as a drug manufacturer; or i
-(2) Registered with or licensed by a state agency as a drug manuf acturer; or (3) Licenseo;as a pharmacy by a State Board of Pharmacy; or
. i
'(4) Operating a's a nuclear pharmacy within a Federal medicalinstitution.
- Paraoraoh (a)(3) This paragraph would require applicants to provide evidence that each carbon-14 urea capsule will not exceed one microcurie. The NRC's evaluation that the capsules would not result in significant radiation risks was based on the capsules containing one . microcurie of carbon-14 urea. Therefore, applicants must demonstrate that the activity of
.'each carbon 14 capsule will not exceed one microcurie.
' Paraoraoh (a)(4) ,
This paragraph would prohibit carbon 14 urea from being contained in any food, .
- beverage, cosmetic, drug or other commodity designed for ingestion or inhalation by, or topical application to, a human being except for the capsules as described in this section,..
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3 t because exempt distribution of this drug has only been evaluated for "in vivo" diagnostic use in the form of a capsule containing one rricrocurie of carbon-14 urea. Because of the capsule's "in vivo" diagnostic use, there is no prohibition against the capsule being - combined with food or beverage at the time of administration so that the capsule can be ingested by the patient. Paraaraoh (a)(5) Because the exem.pt distnbution of this drug has only been evaluated for_."in vivo" diagnostic use in the form of a capsule containing one microcurie of cafbon 14 urea, this , paragraph would prohibit incorporation of the capsules into any manufactured or assembled Further, although the commodity, product, or device intendeo ar commercial distribution. drug is being distributed to persons exempt from licensing, this paragraph would require the carbon-14 urea to be identified as radioactive because the drug is being used for its radioactive content; therefore, the end user must be provided with information that the drug contains a radioactive material. Paraaraoh (a)(6) As with any product approved for distribution to persons exempt from licensing, this paragraph would require persons who apply for a license to manuf acture or commercially distribute these capsules to submit copies of prototype labels or brochures for NRC approval. This will allow the NRC to confirm that the labels or brochures meet the requirements of 6 32.21a (a) and (b). 13
_ _ - _ . . ~__ -~. 3 p- - l
.; . Paraaraoh (bb This paragraph declares that the regulations do not relieve licensees or license
' applicants from complying with applicable FD A, other Federal,-and State requirements. ,
governing the manufacture and distribution of drugs.. , i
?
- Section 3?.21e Sm" - Conditions of license .1 This section would establish the conditions required for a license to commerciallyJ l distribute the c'apsules to persons exempt from licensing, e
f Paraaraoh (gl To inform tne end user of the ider.aty of the radioisotope, the physical and chemical form, and.the dosage of radioactivity, this paragraph would establish that the immediate - container of each capsule or capsules must bear a durable, legible label that:
- 11) Identifies the radioisotope, the physical and chemical form of the radioisotope, the quantity of radioactivity contained in each container at a specific date, and ' l (2) Bears the words " Radioactive Material."
The 'date requirement is consistent with labeling requirements for other radioactive drugs with a half life of greater than 100 days. Paraaranh (b)
'This paragraph would establish that, consistent with the intended use of the -
capsules, the label affixed to the immediate container, or an accompanying brochure, must: . 1 cc. .
(1) State that the contents are exempt from NRC or Agreement State licensing ' requirements; (2) Bear the words " Radioactive Material. For "In Vivo" Diagnostic use Only. This Materialis Not To Be Used for Research involving I;uman Subjects, and Must Not Be introduced into Foods, Beverages, Cosmetics, or Other Drugs or Medicinals, or into Pedes Manuf actured for Commercial Distribution." The intent of the requirement set out in (b)(2) is to make clear that the capsule must remain in the form of a capsule and is not to be combined with one of the listed items such as food or beverages which would result in a radt active product other than in the form of a capsula for commercial distribution. Because of the capsule's "in vivo" diarjnostic use, there is no prohibition against the capsule being cuinoined with food or beverage at tne time of administration so that the capsule can be ingested by the patient.
"In vivo" diaanostic use by norsons exemnt from licensina A new section would be added to 10 CFR Part 30 to exempt any person from NRC or the Agreement State regulations to receive the drug for "in vivo" diagnostic usa for
- humans.
Section 30.21 Radioactive drua: Caosules containino one microcurie of carbon 14 urea for "in vivo" diaanostic use for humans would be added to permit any person to receive the ca'psules. 15
. - . . - . ~.- - - ..- . - .- --- _._ , - -. . ~.- - - - -
7 '- _.v
- Paraorapf tal This paragraph would provide an exemption to any person from the requirements for -r a license to' receive, possess, use, transfer, own, or acquire capsules containing one renicrocurie of carbon-14. urea for "in vivo" diagnostic purposes, it should be noted that the - :
'"transfer" in this paragraph does not include _" transfer for commercial distribution," which =
. . .is covered in paragraphle) below. i i
i Paraaraoh (b) This. paragraph would establish that persons exempt from licensing would be l
~
p'r ohibited from using the drug for research involvinq humr-= subjects. A specific Part 35. . license would be needed to use the drug in ar./ research involving human subjects. Paraaraoh fe! This paragraph would specify that a specific license is needed to manufacture,. . prepare, process, produce, package, repackage or transfer such capsules for commercial 8 distribution. 1 Paraaraoh (d) This paragraph declares that the regulations do not relieve end users from complying with applicable FDA, other Federal, or State requirements governing the receipt, administration, and use of drugs.~ $1 4
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IVE Agreemert State Compatibility-5 Under the Atomic Energy Act, certain rsgulatory. functions are reserved to the NRC. < Among these are the distribution of products to persons e>empt from licensing,'as discussed in 10 CFR Part 150. Honce, the proposed rule,if adopted, wtauld be a Division 4 item of compatibility, with raard to the manuf acture and i:ommer.:ial distribution of the t
. esprules (10 CFR Part 32). Because of the need for natior wide consistency in the use of-productswhich are widely distributed, the proposed rule, if adopted, would be a Division 1 Litem of compatibility with regard to possession and use (10 CFR Part 30). Therefore, the
- -Agreement States will need to make appropr i ate prov i n their regulations to_ allow'any-ii s ons person to receive capsules containing os.J microco..a of carbon 14 urea for "in vivo
' diagnostic use without need for a license.
V. Electronic Access 8 Comments may be submitted electronically, in either ASCll text or Wordperfect i format (version 5.1 or later), by calling the NRC Electronic Bulletin Board on FedWorld or connecting to the NRC interactive rulemaking web site, "Rulemaking Forum." The bulletin
- board may be accessed using a personal computer, a modem, and one of the commonly available communications software packages, or directly via internet, le ~
11 using a personal computer.and modem, the NRC subsystem on FedWorld can be accesseo directly by dialing the toll free number: 1-800 303-9672. Communication software parameters should be set as follows: parity to none, data bits to 8, and stop bits
..to 1 (N,8,1).1Using ANSI or VT-100 terminal emulation, the NRC NUREGs and Reg Guides 17 o
E. O .- . . -.- . , . , - -
for Comment subsystem can then be accessed by selecting the " Rules Menu" option from the "NRC Main Menu," For_ further information about options available for NRC at FedWorld, _ consult the " Help /information Center" from the "NRC Main Menu." Users will
-find the "FedWorld Online User's Guides" particu arly helpful. Many NRC subsystems and databases also have a " Help /information Center" option that is tailored to the particular subsystem.
The NRC subsystem on FedWorld can also be accessed by a direct dial telephone number for the main FedWorld BBS, 703 321-3339. or by using Telnet via Internet, fedworld. gov _If using 703 321-3339 to ?rtact FedWorld, the NRC subsystem will be accessed from the main FedWorld menu by selecting the " Regulatory, Government Administration ano State Systems," then selecting ' Regulatory information Mall." At that point, a menu will be displayed that has an option "U.S. Nuclear Regulatory Commission" that will take you to the NRC Online main menu. The NRC Online area also can be accessed directly by typing "/go nrc" at a FedWorld command line. If you access NRC from FedWorld's main menu, you may return to FedWorld by selecting the " Return to FedWorld" option from the NRC Online Main Menu. However, if you access NRC at FedWorld by using NRC's tc,ll-free number, you will have full access to all NRC systems but you w41 not have access to the main FedWorld rystem. If you contact FedWorld using Telnet, you will see the NRC area and menus, including the Rules menu. Although you will be able to download documents and leave messages, you will not be able to write comments or upload files (comments), if you contact FedWorld using FTP, all files can be accessed and downloaded but uploads are not allowed; all you will see is a list of files without descriptions (normal Gopher look). An 18 Y
. . , - . . -- - - . ~ - . . . . - - .. - -- . - --
3 . q [
' ith .escriptions,- is included.) There is a 15; ,
'index file listing'all files ethin a subd i' roctory, w i a
-- minute' time limit for I TP access.1 ._
s
' - Although FedWorld can be' accessed through'the World Wide Webflike FTP that j
mode only provides access for downloading. files ar.d doesi.ot dt play the NRC Rules i
~
. menu.--
~
You may also access the NRC's interactive rulemaking web site through the_ NRC.
- home page (http://www.nrc. gov). This site provides the same access as the FedWorld bulletin' board, including the facility to upload comments as files (any format), if your web L-browser supports that function.
For more information on NRC bulletin boards call Mr. -Arthur Davis, Systems r integration ano Development Branch, U.S. Nuclea. hugulatory Cornmission, Washington, iDC 20555, telephone (301) 415 5780; e mail AXD3@nrc. gov. - For information about the
-interactive rulemaking site, contact Ms.- Carol Gallagher, (301) 415 6215; e mail ,
CAG@nrc. gov. , Availability VI.- Finding of No Significant Environmental Impact:
.The Commission has determined unde'r the National Environmental Policy Act of I1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, that 0
the proposed amendments, if adopted, would not be a major Federal action si nificantly
' affecting the quality of the human environment; therefore,'an environmental impact f
statement is.not required. The proposed rule would establish requirements for the -
~ manuf acture and commercial.diuribution of MC urea capsulos to persons exempt from licensing'and establish regulations to permit any person to receive the capsules without an 19
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NRC lsense.- The Commission believes that the radioactive component of this drug .
~
= presents.no significant radiation risk and, therefore, regulatory control.of the "in vivo" diagnostic use of the capsules for radiation safety is not necessary. It is expected that this proposed rule, if adopted,' would not cause any significant increase in radiation. exposure to
- the public or radiation release to the environment beyond the exposures or releases-resulting from the use of the Carbon 14 capsules under the current regulations. Also,it is -
expected that'there would be no non-radiological impacts if the proposed rule is' adopted. The draft environmental assessment and finding of no significant impact on which
~
this determination is based is available fs inspection at the'NRC Public Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single copies of the draft. environmental assessment and the finding of no significant impact are available from Dr.
- Anthony N. Tse, Office of Nuclear Regulatory Research, U.S. Nur., lear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6233 or e-mail at-ANT @nrc. gov. .
Vll. Foperwork Reduction Act Statement This proposed rule amends information col!ection requirements that are subject to the Paperwork Reduction Act of .1995 (44 U.S.C. 3501 et seq.). This rule has been i s submitted to the Office of Management and Budget for review and approval of the intormation collection requirements.
-The public reporting burden for this collection of information is estimated to average -
'16 hours per response,-including the time for reviewing-instructions,' searching existing .
.' data sources, gathering and maintaining the data needed, and completing and reviewing -
20
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.' (the collection of information. :The Nuclear Regulatory Commission is' seeking public -
j comment'on the potential impact of the collection'of information contained in the_ proposed-~ ;
- ~ rule and on the following issuesi e
.1. Is the proposed collection of information necessary for the proper. performance' of the functions of the NRC, including whether the information will have practical utility?
- 2. Is the estimate of the burden correct? ,
;f 3.' is there a way to enhance the quality, utility, and the clarity of the information to be collected?
-- 4. How can the burden of the collection of information be minimized, including' the -
-use of automated collection techniques?
Send comments on any nspect of this proposed information collection, including
- suggestions for reducing the burden, to the Information and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by r
-Internet electronic mail at BJS1@NRC. GOV; and to the Desk Officer, Office of Information Office of and Regulatory .Aff airs, NEOB-10202, (3150-0001, 3150-0017, and 3150-0120),
Management and Budget Washington, DC 20503.
' Comments to OMB on the information collections or on the above issues.should be
- submitted by (insert date 30 days after publication in the Federal Register). Comments ,
- - - received af ter this date will be considered if it is practical to do so, but assurance of-consideration cannot be given to comments received af ter this date.
21
~ . -. , .- - - - - .. .
~ . . .
- . j Public Protection Notification ;
The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of informat;on unless it displays a currently valid OMB control number. Vill. Regulatory Analysis The NRC has prepared a regulatory ant.lysia 'or the proposed rule. The analysis examines the benefits and impacts consi ci by the NRC. The regulatory analysis is available for inspection at the NRC Pub!ic Document Rnom, 2120 L Street NW. (Lower Level), Washingto.1, DC; Single copies of the reguiatory analysis are available from Dr. Anthony N. Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6233 or e-mail at ANT @nrc. gov. IX. Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605(b), the Commission certifies that this rule does not have a significant economic impact upon a-substantial number of small entities. The proposed rule would permit physicians and other health care providers to use an additional diagnostic test without having to obtain an NRC license, thus, would provide cost savings to patients, insurers, and the health care inductry. Any sma*.I entity subject to this regulation which determines that, because of its. size,it is likely to bear a disproportionate adverse economic impact should notify the 22
Commission of this in a comment that indicates the following: (a) -The licensee's size and how the regulation would result in a significant economic' burden upon the licensee as compare'd to the economic burden on a larger
- licensee.
-(b) How the regulations could be modified to take into account the licensee's differing needs or. capabilities.
(c) The benefits that would accrue, or the detriments that would be avoided, if the regulations were modified as suggested by the licensee. (d) How the regulation, as modified, would more closely equalize the impact of regulations or create more equal access to the beaefits of Federal programs as opposed to providing special advantages to any individual or ;,,vup.
.(e) How the regulation, as modified, would still adequately protect public health and safety.
X. Backfit Analysis The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to this rule, and therefore, a backfit analysis is not required because these amendments do not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1). 23 t
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; XI. ' List of Subjects-y, 4 - - 2 t
-10 CFR Part 30; Byproduct material, Criminal penalties, Government contracts, intergovernmental
- . relations, isotopes, Nuclear materials, Radiation protection, Reporting and record keeping _
requirements. 1 10 CFR Part 32 .
- Byproduct material, Criminal pene'+ies, Labeling, Nuclear materials, Radiation
.m .
protection,' Reporting and recordkeeping requirements. . For the reasons set out in the preamble and under the authority of the Atomic energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C.' 553,- the NRC is proposing to adopt the following amendments to 10 CFR
. Parts 30 and 32.
PART 30 -RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENS!NG OF BYPRODUCT MATERIAL .
-1. The authority citation for Part 30 continues to read as follows:
- AUTHORITY: Secs. 81, 82,161,182,183, .186,- 68 Stat. 935, 948, 953, 954,
~
955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 211.1, 2112, 2201, 2232,2233,~ 22M, 2282); secs. 201, as amended, 202,206,88 Stat.1242, as ,
- amended,'1244,- 1246 (42 U.S.C. 5841, 5842, 5846). '
24-J
31 A: .:c -
~
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- 7 .,Section 30.7 ! also issued under Pub. L. 95 601/se.c.10,L92 Stat. 2951 as amended by Pub; C:102 486,'sec. 2902/106 Stat? 3123,.(42 U.S;C.~ 5851). Section-30.34(b) alsoe
. t issue ~d under seen1'84[68 Stat. 954,'as amended (42 U.S. .-C 2234);Sec' tion 30.61 also
' issued under sec.187,68 Stat. 955 (42 U S.CT2237).-
2 Jin?l 30.8,'paragrap k.(5)ir>9 vised to read as follows: l'30.8Ilnformation collection reouirements: OMB aoorovcl.-
. a i.
?
(b) The approved information collection requirements contained in this part appear in: '
- i 5 30.9i 30.11, 30.15, 30d 8, 30.19, 30.20, 30.2'1, 30.32, 30.34, 30.35, 30.36, 30.37, -.
- 30.38, 30.41,-30.50,30.51,'30.55, op,.andices ,s and C to this part.
.'s . . . .. I .2
- 3. A new ' 30.21 l is added under the undesignated center heading " Exemptions" to e
2 - read as fcPows: 6 30.21 Radioactive drua: Caosules containino one microcurie of carbon 14 urea for "i - , vivo"'diaonostic use for humans. E -(a) Except as provided in paragraphs (b) and (c) of this section, any person is
- - . exempt from the requirements for a license set forth in Section 81 of the Act and from the r
E reg'ulations inlthis part and Part 35 of this chapter provided that such person receives, y possesses, uses, transfers, owns, or acquires carbon 14 urea capsules, not exceeding one microcurie each, for "in vivo" d; agnostic use for humans. .
~
(b) Any person who desires to use the capsules for research involving human Isubjects shall apply ,for and receive a specific license purwant to Part 35 of this chapter.
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(c) Any person who desires to manuf acture, prepare, nrocess, produce, package, repackoge, cr transfer for commercial distribution such capsules shall apply for and receive a specific license pursucnt to 6 32.21 of this chapter. (d) Nothing in this section relieves persons from complying with applicable FDA, other Federal, and State requirements governing receipt, administration, and use of drugs. PART 32 SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER C e ITEMS CONTAINING BYPRODUCT MATERIAL
- 4. The authority citation for Part 32 continues to read as follows:
AUTHORITY: Secs. 81,161,182,18 , 6L Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201,2232, 2233); sec. 201, 88 Stat.1242, as amended (42 U.S.C. 5841). 5, in 6 32.8, paragraph (b) is revised to read as follows: i 32.8 Information collection reuuirements: OM8 annroval. (b) The approved information cohection requirements contained in this part appear in ~ 5 6 32.11, 3 2.12, 32.14, 32.15, 32.16, 32,17, 3 2.18, 3 2.19, 32.20, 32.21, 3 2.21 a, 3 2.2 2, 32.23, 32.2 5, 32.26, 3 2.27, 3 2.29, 32.51, 3 2.51 rs, 32.52,32.53, 32.54,32.55, 32.56, 32.57, 32.58, 32.61, 32.62, 32.71. 32.72, 32.74, and 32.210. 26
- 6. A new i 32.21 is added to read as f ollous:
6 32.21 Radioactive drum Manuf acture, prepa9 tion, or transfer for commercia! , distnbution of carbon 14 urea caowules not exceedino nne microcurie each for *in vivo" diannostic use for humans to persons exempt frorr licensin;; Re:uirements for a license. (a) An application for a specific license to manuf acture, prepare, process, produce,
~
rachy,.*c. ackage, or transfer for commercial distribution ca' bon 14 urea capsules not a exceeding one microcurie each for "in vivo" diagnostic use, to persons exempt from licensing under i 30.21 or the equivalent regulations of an Agreement State will be approved if: P (1) The applicant satisfies the general reqLrements specified in 6 30.33 of this chapter, provided that the requirements of 5 30.A.o,12) arid (3) of this chapter do not apply to an application for a license to transfer byproduct material manuf actured, prepared, processed, produced, packaged, or repackaged pursuant to a license issued by an Agreement State; (2) The applicant mer,ts the requirements under i 32.72(a)(2); (3) The applicant provides evidence that each carbon 14 urea capsule will not exceed one microcurie; d) The carbon-14 urea is not contained in ariy food, beverage, cosmetic, drug (except as described in this section) or other commodity designed for ingestion or inhalation by, or topical application to, a human being; (5) The carbon 14 urea is in the form of a capsule, identified as radioactive, and to be used f or its radioactive properties, but is not incorporated into any menuf actured or assembled commodity, product, or device intended for commercial distribution; and 1 27
e , (6) The applicant submits copies of prototype labels and brochures and tiie NRC approves these labels and brochures. (b) Nothing in this section relieves the licensee from complying with applicable FDA,
- ther federal, and State requirements governing drugs.
- 7. A new i 32.21a is added to read as, follows:
< l 32.21a Same: Conditions of licg_rlig. Each license issued under i 32.21 is subject to the following conditions: (a) The immediate container of tha capsulMs) must bear a durable, legible label which: (1)Ide.itifies the radioisotope, the phy ical and chemical form, the quantity of radioactivity of each capsule at a specific date; and (2) Bears the words " Radioactive Material." (b) In addition to'the labeling information required by paragraph (a) of this section, the label affixed to the immediate c otainer, or an accompanying brochure also must: (1) State that the contents are exempt from NRC or Agreement State licensing requirernents; and n 28
-p w x b_ _;_' ~ w
(2) Bear the words " Radioactive Material. For "In Vivo" Dial;nostic Use Only. This Materialis Not To Be Used for Research involving Human Subjects and Must Not Be introduced into Foods, Beverages, Cosmetics, or Other Drugs or Medicinals, or into Products Manuf actured for Commercial Distributior.." - Dated at Rockville, Maryland this day of __ 1997. For the Nuclear Regulatory Commission. John C. Hoyle, Secretary of the Commission. 29
4 L ATTACHMENT 3 CONGRESSI'tML LETTERS V e
4- p pecny
/*
ft UNITED STATES
'}
t NUCLEAR REGULATORY COMMISSION WASHINGTON. D.C. 20MHm01
'4 9 .< . . . . ,d The Honorable Don Schaefer, Chairman
. Subcommittee on Energy and Power Committee on Commerce .-
United States House of Representatives Washington,- DC 20515
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee are copies of a public announcement and a Federal Register notice concerning a proposed ...tendment to 10 CFR Parts 30 and 32. t:This rulemakingInc. Med Specialties, is being taken in response to a pe'ition for rulemaking submitted by Tri-The Nuclear Regulatory Comrbission (NRC)is proposing to amend its regulations to allow
' NRC licensees to distribute.a radioactive drug containing one microcurie of carbon 14 urea to any person for "in vivo" diagnostic uso. The NRC has determined that the radioactive component of such capsules presents a minimal radiation risk and, therefore, regulatory control of the drug for radiation safety is not necessary. The manufacture and distribution of the capsules would continue to require an NRC license. 'If adopted, this amendment would make the drug more widely available, thus reducing costs to patients, insurers, and the health care industry.
Sincerely, Dennis K Rathbun, Director Office of Congressional Affairs
Enclosures:
- 1. Public Announcement
- 2. Federal Register Notice cc: . Representative Ralph Hall-
-m
e ,--
. Th'e Honorable Dab Schaefer, Chairman Subcoinmittee on Energy and Power Committee on Commerce
' United States House of Representatives Washington, DC 20515 Oear Mr.- Chairman:
Enclosed for the information of the Subcommittee are copies of a public announcement and a Federal Register notice concerning a proposed amendment to 10 CFR Parts 30 and 32. This mIwIr'ag is being taken in response to a petition for rulemaking submitted by Tri-Med Specialties, inc. The Nuclear Regulatory Commission (NRC)is proposing to amend its regulations to allow NRC licensees to distribute a radioactive drug containing one microcurie of carbon 14 urea to any person for "!n vivo" diagnostic use. The NRC has determined that the radioactive-component,of such capsules presents a . *inimal rwdiation risk and, therefore, regulatory control of the drug for radiation safety is not necessary. The manufacture and distribution
- of _the capsules would continue to require an NRC liaense. .lf adopted, this amendment-would make the drug more widely available, thus
- educing ccsts to patients, insurers,' and the health care industry.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs L
Enclosures:
- 1. Public Announcement
- 2. Federal Register Notice cc:- Representative Ralph Hall Distribution: CTrottier/RPHEB rf File Center NCostanzi ATse l
lDOC NAME: 0:\MCCAUSLA\ CARBON 14.Ct.)
*Sse previous concurrences.=
Office RPHEB:DRA - RPHEB:DRA D:DRA:RES D:RES D:OCA Name *SJones- ' 'CTrottier - 'BMorris
- DLMorrison DKRathbun Date 2/28/97-- 2/27/97 2/28/97- -2/28/97 / /97 Distribution " Yes/No Yes/No Yes/No - Yes/No Yes/No OFFICIAL RECORD COPY-(RES File Code No.) 3A 3, i
t fl. c
._ u
l
-i i
t The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power e Committee on Commerce United States House of Representatives j Washington, DC 20515 '
Dear Mr,
Chairman: -{ Enclosed for the informa 'on of the Gubcommittee are copies of a public announcement and a Federal Register no e concerning a propesad amendment to 10 CFR Parts 30
-and 32. This rulemaking is eing taken in response to a petition for rulemaking i,ubmitted j dy Tri Med Specialties, Inc. .
- The Nuclear Regulatory Commission (NRv, is propusing to amend its regulations to allow NRC licensees to distribute a radioactive drug containing one microcurie of carbon 14 urea to any person for 'in vivo" diagnost,1c use. The NRC has determined that the radioactive ,
i component of such capsules presents a minimal radiation risk and, therefore, regulatory control of the drug for radiation safet'y is not necessary, if adopted, this amendment would make the drug more widely avah ble, thus reducing costs to patients. ! incerely, ! Den K. Rathbun, Director i Office Congressional Af f airs
Enclosures:
\
- 1. Public Announcement \
- 2. Federal Register Notice
- cc: Representative Ralph Hall D;stribution: CTrottier/RPHEB rf File Center NCostanzi Tse '
\
' \ --
- l DOC NAME: 0:UONES\C14-PR.CL)-
Office RPHEB;DRA'-- RPHEB:DRA y D:DRA:RES F 'D:RES / D:OCA , Name. SJones Ah CTrottierd2 BMorris 7 DLMorrison/^ ' DKRathbun Date s/A/97' ;t/) 797 , C //j /97
#fM7 -/ /97 Yes/No- Yes/No Yes/No- Yes/No - Yes/No
[ Diottibution OFFICLAL RECORD COPY (RES File Code No.) 3A 3 t 4
._ y -
g_e.. .-E., me.' . , , , - - -
(
= .,
',=
The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands,
. Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washinnton, DC 20510 -
Dear Mr. Chairman:
Enclosed-for the information of the Subcommittee are copies of a public announcement and a Federal Register notice concerning a proposed am::ndm:mt tc 10 CFR Parts 30 and 32.
. This rulemaking is being taken in response to a petition for rulemaking submitted by Tri-Med Specialties, Inc.
The Nuclear Regulatory Commission (NRC)is proposing to amend its regulations to' allow _NRC licensees to distribute a radioactive drug containing one microcurie of carbon 14 urea to any person for "in vivo" diagnostic us The NRC has determined that the radioactive-component of such capsules presents a rmnimal radiation risk and, therefore, regulatory control _ of the drug for radiation safety is not necessarv. The manufacture and distribution of the capsules would continue to require an NRC license. If adopted, this amendment would make the drug more widely available, tnus ieducing costs to patients, insurers, and the health care industry. Sincerely, Dennis K.- Rathbun, Director Office of Congressional Aff airs
Enclosures:
- 1. Public Announcement 2, Federal Register Notice cc: Senator Bob Graham Qignbution: CTrottier/RPHEB rf File Center NCostanzl ATse
-(DOC NAME: 0:\MCCAUSLA\ CARBON 14.CL)
'See'pievious concurrences.
Office RPHEB:DRA RPHEB:DRA D:DRA:RES D:RES D:OCA 4
'Name~ 'SJones
- CTrottier
- BMorris
- DLMorrison DKRathbun Date ~ 2/27/97: -2/27/97 2/28/97 2/28/97- / /97 0.strit>ution -Yes/No Yes/No - Yes/No Yes/No Yes/No OFFICIAL RECORD COPY - (F,ES File Code No.) 3A 3 g -
- - . . . 1
The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Wo.Ls United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the ubcommittee iro copies of a public announcement ; and a Federal Register notice concer 'ng a proposed amendment to 10 CFR Parts 30
-and 32. This rulemaking is being take in response to a netition for rulemaking submitted
~ by Tri Med Specialties, Inc. i The Nuclear Regulatory Commission (NRC) i proposing to amend its regulations to allow NRC licensees to distribute a radioactive drug ontaining one microcurio of carbon 14 uros to any person for "in vivo" diagnostic use. The RC has determined that the radioactive component of such capsules presents a minimal r diation risk and, therefore, regulatory control of the drug for radiation safety is not necos ary. If adopted, this amendment
- would make the drug more widely available, thus to . icing costs to patients.
Sincerely, : i Dennis K. Rathbu Director Office of Congressi nal Affairs Enclosurest
- 1. Public Announcement
- 2. Federal Register Notico 1
cc: Senator Bob Graham Distribution: CTrottier/RPHEB ff Filo Center NCostanzi ATse IDOC NAME: 0:\ JONES \C14 PR.CL). D:p%$, D:OCA ; Office RPHEB:DRA RPHEB:DRA , . D:DRA:RES _ . Name? SJones-A9 - CTrottierd MMorrisM thhe DKRathbun ;
'Date. t /o /97 ,1/.1797 a g /gyg7 ggg7 'l j. jg7 Yes/No Yes/No Yes/No Distribution . Yes/No ' Yes/No OFFICIAL RECORD COPY (RES File Code No.L 3A-3 4
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ATTACHMENT 4 PUBLIC ANNOUNCEMENT
NRC CONSIDERS CHANGING REGULATIONS TO PERMIT EXEMPT DISTRIBUTION OF RADIOACTIVE DIAGNOSTIC DRUG The " Nuclear Regulatory Commission is considering amending its regulations to allow a specific radioactive drug, used to diagnose stomach uicers, to be distributed to any person for administration to humans.- Currently, only physicians authorized by the NRC or Agreement States may receive and administer the drug. The proposed change would not relieve persons from the requirement to comply with applicable Food and Drug Administration or other Federal and State requirements governing receipt, administration and use of drugs. The change is in response to a 1994 petition from Tri-Med specialties, Inc. It would allow any person to receive, possess, use and transfer carbon-14 urea capsules, not exceeding one microcurie each, for diagnostic use in patients. The NRC has determined that the capsules present a minimal radiation risk, and therefore believes that regulatory _ control of the drug for radiation safety is not necessary. Under the proposed revisions to NRC regulations, manufacturers-of the capsules and commercial pharmacies that prepare the capsules-would continue to need an NRC license to provide high confidence of capsule contents. The containers of the' capsules would have to bear the words " radioactive materiala and_other specific 1information on the. contents of the container. 4
i i In addition, only those persons who were licensed would be permitted to use the capsules for research involving human subjects. The Tri-Hed petition stated that Carbon-14 urea can be used ts -Jatect the presence of a bacterium that causes peptic ulcers, a chronic inflammatory condition of the stomach and duodenum that affects as many as 10 percent of people in the United States at some time in their lives. According to a July 1994 article in the Journal of the American Medical Association, the disease has relatively low morte.lity, but res Ite in substantial human suffering and high economic costs. Doctors can now cure most ulcer problems with antibiotics. The test using Carbon-14 urea is non-invasive. A doctor asks the patient to swallow the capsule with water. After 15 minutes the patient blows into a collection bag, which is mailed to a testing laboratory for analysis. The NRC's Advisory Committee on the Medical Uses of Isotopes discussed the petition at its October 1995 meeting. The committee endorsed making this diagnostic test widely available. Currently, Part 35 of the Commission's regulations permits only physicians who are authorized users (e.g., physicians who meet certain training and experience criteria regarding the safe une_of radioactive drugs) or persons working under the supervision-of an authorized user to administer radioactive drugs for medical purposes. Under the proposed amendments, physicians or other health care workers would not need to be authorized users in order to
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i administer the drug, and physicians would not.need to refer their patients to nuclear medicine physicians.- This should result in cost savings;to patients,-insurers, and the health care industry. Interested persons are invited to submit comments on the (30 days-after l
. proposed rule change by publication of a Federal Register notice on this subject on l
). They may be mailed to the-Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, f Attention: Rulemakings and Adjudicat3ons Staff, or submitted !
I electronieslly as described in the **' Jal Register notice. i i
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ATTACHMENT 5 DRAFT ENVIRON!iENTA!. ASSESSMENT
i 4 I Environmental Assessment For Proposed Amendments to 10 CFR Parts 30 and 32
" Distribution of a Radioactive Drug Containing One Microcurie of Carbon 14 Urea as Exempt Material for "In Vivo" Diagnostic Testing" '
- 1. Introduction and Statement of the Proposed Action r The Nuclear Regulatory Commission (NRC)is pro, osing to amend its regulations to allow NRC licensees to distribute a radioactive drug containing one microcurie of carbon-14 urea to any person for > vivo' diagnostic tra. The I 'O S3s determined that the radioactivo component of such capsules presents a minimal radiation risk and, therefore, regulatory control of the drug for radiation safety is not necessary, if adopted, this amendment would make the drug more widely available, thus reducing costs to patients. This action is being taken in response to a petition for rulemaking (PRM 3512) submitted by Tri Med Specialties, Inc.
- 2. Need for the Amendments The ptoposed amendments have been developed to gi ~ t the petition for rulemaking. The '
proposed rule, if adopted, would permit manuf acturers r commercial distributors to disttibute Carbon 14 urea capsules as exempt material to any person. The Commission is proceedin; with this rulemaking because it believes that the radiological risk from such In distribution would be negligible and the savings to patients could be significant. addition, the Commission recognizes that other Federal and State agencies fe.g., Food and Drug Administration and the State Boards of Pharmacy) are responsible int the receipt and use of drugs that do not contain byproduct materials, and would provide necessary oversight for the safe use of these Carbon 14 urea capsules as drugs,
4 3, Alternatives Considered i Three alternatives have been considered regarding the petition: deny the petition, i.e., maintain the status quo, permit the distribution of the capsules as exempt material, and permit the distribution of the capsules to generallicensees. Under the first alternative, the current situation would continue: 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 physicians would apply for a Part 35 license for the sole purpose of using such capsules because of the requiremen. fu tra ning and experience and the associated costs of obtaining and maintaining a Part 35 license. Alternatively, physicians who are not authorized users can continue to refer their putief *r. to physicians who are authorized users to undergo the diagnostic test. However ti.is would not relieve the current expense, inconvenience, and delay encountered in an otherwise straight forward procedure. Under the second alternative,10 CFR Parts 32 and 30 would be amended. Part 32 would be amended to establish requirements for the manuf acture and distribution of "C-urea capsules to persons exempt from licensing, i.e., any person (including physicians who are not " authorized users" under Part 35); Part 30 would be amended to permit any person to receive, possess, use, transfer, own, or acquire the capsules for "m vivo" diagnostic use for humans without a license. The NRC has determined that the radioactive component of thh. dn:D presents a minimal radiation risk and, therefore, regulatory control of the capsules is not necessary. Under the third alternative,10 CFR Part 35 would be amended to permit any physician to receive and use the capsules under a general license. The health and safety concerns for However, if this alternative were this alternative are the same as the Alternative 2. adopted, there could be a burden to those Agreement States that normally require registration of general license holders. A additional burden could also be imposed on general licensees locatad in the Agreement State if the State charges a license or registration fee. 2
~
Based on the Draft Regulatory Analysis prepared for this proposed rule, the Commission concludes that Alternatives 2 ana 3 are clearly preferable to the no action alternative. This I is because either of the two alternatives will result in significan. cost savings with no measurable adverse effect on health and safety. l~urthermore, toe NRC's recommended I option is Alternative 2 because it would avoid the unnecessary cost burden to some Agreement States and their licensees.
- 4. Impact on the Public and the Environment l The proposed amendments would have no significant impact on the public and the ;
j environment. The NRC assumes that the same .mber of breath 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 providt sst possible care to his or ber l patients, if the breath test is judged preferable to enjoscopy, or other procedure, any physician not authorized to use the test will refer his or her patient to authorized users who could perform the test under existing NRC regulations. Under this assumption, the proposed action would result in no chan;e in radiation exposures to the workers and patients when compared with the status quo. Similarly, there would be no change in impact to the environment because the Commission assumes that the same number of tests will be administered regardless of which alternative is adopted.
- 5. List of Agencies and Persons Corisulted and identification of Sources Used Following the receipt of the petition for rulemaking, a " Notice of receipt of petition for rulemaking" was published f or public comment in the Eederal Renister on December 2, 1994 (50 FR 61831). A total of 315 public comment letters,313 supporting (mostly form letters) and 2 opposing letters, were roccived. This petition was discussed with NRC's Advisory Committee on the Medical Uses of Isotopes ACMUI) at the October 1995 meeting. Furthermore, the draf t rulemaking plan was forwarded to 29 Agreement States for comments.
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- 6. Finding of No Significant impacts The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Suopart A of 10 CFR Part 51, that the proposed amendments, if adopted, would not be a major Federal action significantly affecting the quality of the human environment, and therefore an environmental impact statement is not required. The proposed rule would amend 10 CFR Part 32 to permit the manuf acture and commercial distribution of ."C-urea capsules to any person (including physicians who are not " authorized users" under Part 35) and to amend 10 CFR Part 30 to permit any person, without an NRC license, to receive and use the capsules for in vivo diagnostic use for humans. The Commit,.:k . bereves that the radioactive component of this drug presents a mirfnal radiation risk and, therefore, regulatory control of the capsules for "in vivo" efiagnostic use is not necessary. It '= expected tt.at this proposed rule, if adopted, would not cause any significant increase in radiation exposure to the public or radiation release to the environment beyond the exposures or releases resulting from the use of the Carbon 14 capsules under the current regulations.
4
0 t u ATTACHMENT 6 DRAFT REGULATORY ANALYSIS
REGULATORY ANALYSIS FOR PROPOSED RULEMAKING
" EXEMPT DISTRIBUTION AND USE OF A RADIOACTIVE DRUG CONTAINING ONE MICROCURIE OF CARBON 14 UREA" 10 CFR PARTS 30 AND 32
^'
- 1. Backoround 11 . Statement of the Problem 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 petitioned the NRC to amend its 4 laticns "to allow for the generallicensing and/or exemption for.the commercial distribution by licensed pharmaceutical manufacturers of a capsule containing one micro Curie ( Ci) .f "C urca for in vivo diagnostic testing."
The purpose of this diagnot, tic test is to detet t th crosence of the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers.
" Peptic ulcer disease is a chronic inflammatory condition of the stomach and duodenum
. that af fects as many as 10 percent of people in the United States at some time in their lives. The disease has relatively low mortality, but it results in substantial human suf fering 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 1.
In the petition datec' August 23,1994, the petitioner stated the following: ~ 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 ulcer suf ferers. By treating ulcer patients with antibiotics, doctors can now cure most ulcer problems, it is therefore necessary to detect the presence of H. pylori bacteria in ulcer patients so that the new troatment can be given ar yropriately. In the past, this W.-s done by a gastroenterologist who took biopsy samples of the stoma'ch lining at endoscopy, a procedure which was uncomfortable and
. expensive ($1000).
With the new test. H. pylori can be detected noninvasively using a "C urea tracer. "C urea is broken down by H. p/ lori to form labsled 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 mvlar balloon) which is mailed to a testing laboratory. If "C CO, more than twice background is present in the breath _ sample, then the patient _must be infected with H. pylori..
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1 1.2 Current NRC Renutations in-10 CFR Part 32, ' Specific Domestic Licenses To Manufacture or Transfer Certain items j Containing Byproduct Materials," l 32.72, "Manuf acture, preparation, or transfer for i commercial distribution of radioactive drugs conta .ng bypecow material for medical use- l under Part 35," provides for commercial distribution of radioactive ' drugs containing ! byproduct material for use by persons authorized pursuant to Part 35. Thus, the' regulations currently would permit Part 32 licensees to commercially distribute capsules-containing 1 Ci of "C urea to persons authorized pursuant to Part 35. - { j in 10 CFR Part 35," Medical Use of Byproduct Material," sets forth radiation safety n requirements, including requirements for the training and experience of authorized user
. physicians to assure the safe possession and use of radioactive drugs containing bypro -
material. , .l n i 30.14, " Exemption concentrations"~ j Existing exemptions for use of byproduct materi l
'and 6 32.18, "Manuf acture, distribution and transfer of exempt quantiti;s of byproduct ;
- material: Requirements for license " do not permit the ewnst transfer of byproduct 3
material conta:ned in any food, beverage, cosme';-
,s, ce any product designed for l
ingestion or inhalation by, or application to, a human being. ; i ) Therefore, under current regulations, the "C-urea capsules must be used under a Part 35 license. , i 1.3 Earlier NRC Actions Following the receipt of the petition, a " Notice of receipt of petition 2,1994 for(59 rulemaking" FR 61831). was published for public comment in the Federal Reaister on December A total ol 315 public comment letters were received. Of these,313 supported the petition (they were mostly form letters) and 2 letters opposed the petition. The two letters opposing the petition stated that (1) the product should not receive an exempt status 3 because the uncontrolled distribution and opplication 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 problems presented by long lived isotopes. ! f
.This petition was discussed with NRC's Advisory Committee on the Medical Uses o
.lsotopes (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, whichevor the NRC may determine to be procedurally easier.
A tutemaking plan was prepared. Af ter receiving comments from' Agreement States on the draf t rulemaking plan, the Commission approved a final rulemaking plan to deve_ lop a. proposed rule to amend 10 CFR Parts 30 and 32 allowing the distribution of the Carbon ,
- capsules as an exempt material to any person.
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t 2- Obi 2&lly.9 , The objective of the rufemaking is to amend 10 CFR Part 32 to permit the manuf acture and commercial distribution of "C-urea capsules to any person (including physicians who are
..ot %thorized users" under Part 35) and to amend to CFR Par'. 30 to permit any person, without an NRC license, to receive and use the capsules for in vivo diagnostic use for humans.
3, Afternatives Three alternatives have been considered in the regulatory analysis: deny the petition, i.e., maintain the status quo, permit the distribution of the capsules to persons exempt from licensing, and permit the distribution of the capsules to generallicensees. I Under the first alternative, only physiciar.c v So e, 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 expacts few physicians would apply for a Part 35 license for the sole purpose of using the teosules 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 can continue to refer their patients to physicians who are authorized users to undergo the diagnostic test. However this would not relieve the current expense, inconvenience, and delay encountered in an otherwise straight forward procedure. Under the second alternative,10 CFR Parts 32 and 30 would be amended.10 CFR Part 32 would be amended to permit the manuf acture and commercial distribution of "C-urea capsules to any person (including physicians who are not " authorized users" under Part 35); 10 CFR Part 30 would be amended to permit the manuf acture and commercial distribution of the capsules to any person, for in vivo diagnostic use for humans. The NRC has determined that the radioactive component of this drug presents a minimal radiation risk and, therefore, regulatory control of the capsules is not necessary. Under the third alternative,10 CFR Part 35 would be amended to permit any physician to receive and use the capsules under a generallicense. The health and safety concerns for this alternative are the same as the Alternative 2. However, if this alternative were adopted, there could be a burden to those Agreement States that normally require registration of generallicense holders. A additional burden could also be imposed on generallicensees located in the Agreement State if the State charges a license or registration fee. 3
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- 4. yalue impact Analysis
- 4.1 The Petitioner's Assessment ,
in the letters dated August 23,1994 and Novembre 30,1994, the petitioner stated, respectively: 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 , t ($1000). l
... The test is 95 percent accurate and quite inexpensive because of its simplicity. '
The test would permit doctors to determine easily whether or not ulcer patients have
-l 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 w ;ld save the United States an estimated -
$500 million per annum over conventional therapy.
The petitioner esthnates annual bene 4r to be on hc crder of $500 million/ year. This 8 assumes approximately 600,000 "C urea breath tests / year, at an average cost of $100, in lieu of performing endoscopy at an average cost of $1000/ test. It assumes that the lower ' cost 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
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administering the test pursuant to 10 CFR 35.100 regulation (status quo) versus releasing ; the test to all physicians (NRC licensed'and non licensed alike), implicit in Tri Med's ! estimated annual benefits is the presumption that none nf these "C tests and 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 license under NRC's Part 35 or an equivalent Agreement State regulations. Further Tri- i Med's estimate did not allow for the substitution of other non invasive tests (e.g., serological test for igg antibodies to H. pylori antigens) for both endoscopy and "C urea , tests. i
- 4.2 .The NRC's Assessment (a) Gost Spvinas Associated with Amendments to 10 CFR Part 3Q h
The value impact analysis focuses on the incremental benefits of granting relief consistent with Alternative 2 or 3, as specified in Section 3 above. 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, not unregulated "C urea breath '
- tests and endoscopies or other noninvasive tests. For the purposes of this regulatory '
- analysis, the'NRC assumes that the same number of breath tests (i.e., 600,000 tests) will be administered regardless of the level of NRC regulory control. This view is predicated on the belief that each physician's primary motivation is to provide the best possible care '
7 to his or her patients. lf the breath test is judged preferable to endoscopy, or other t 4 4 6 m: o- r
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procedure, any physician not authorized to use the test will refer 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 are referred routinely to laboratories and specialists for a wide array of tests and procedures. The benefits of adopting the petition accrue as a result of reduced patient cost and reduced health cere 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 rogulatory savings because the NRC would not have to expend resources reviewing new applications for specific medical use licenses. However, these savings would be small because the NRC expects that few physicians who are not authorized users would apply for a specific NRC license for use of this one product.
.The benefit calculation is based on the assumption that as a result of the proposed action, a significant portion of the 600,000 patients would receive the "C breath test from physicians wno are not authorized users 69., go.,trointestinal specialists). The actual savings would be dependent on the number of tests ultimately administered by physicians who are not authorized users, thereby elimina*i:.g the need for a referral to physicians who are authorized sers (e.g., nuclear medicine sps ci 'itts).
The annual savings could be as high as approximately $20 million if there were a complete shift of the administration of the tests from physicians who are authorized users (i.e., base case) to physicians who are not authorized users. The basis for this estimate is as follows. Assuming adoption of the petition eliminates the need for up to 600,000 referrals, patient savings in averted travel expenses (transportation and personal 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 hours / trip x $25.00/ hour) =
$10.5 million/ year Health Care Savings in everted 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 ;
an office visit to a general f amily practice physician by an established patient - ($45.90), and the cost to a new patient ($64.90 per visit) for completion of new
- patient paperwork, reviewing health history, maintaining medical records, etc. The patient who is referred to an authorized user (e.g., nuclear medicine specialist) for the "C-urea breath test would most I.kely be a new patient for the authorized user.
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Total Savings:
$10.5 million/ year + $11.4 million/ year = $ 21.9 million/ year Alternatively, if only 200,000 or 400,000 of the 6G,000 t-sts ..ere partormed by a physician who is not an authorized user, the annual cost savings would be approximately
$7 million por year and $15 million per year, respectively.
If Alternative 3 were adopted, it 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, the adoption of Alternative 3 could add unnecessary burden to those Agreement States and Agreement State licensees in Stt;tes that assess licensing or registration fees for generallicense holders. Alternative 2 also imposes incremental cost burden for manufacturers or , commercial distributors of the capsules because they would need to obtain an exempt distribution license. Each application is estimatt . a take up to 16 hours to prepare. Assuming 3 applicants per year, the total reporting burden would be 48 hours. For recordkeeping burden, assuming each of the 3 applicant: 5 a year would need 2 hourc to
- abel or brochure, the one. time reprogram its c,mputer to print additional words :
total recordkeeping burden would be 6 hours. Assuming a labor rate of $125 per hour, the total burden would be about $6,750 per year. There would be costs for the Federal and State governments if Alternative 2 or 3 is adopted. Under both Alternatives 2 or 3, the NRC and some Agreement States would need to amend their regulations to permi the use of the capsules by persons other than physician who are Luthorized users. (b) Health and Safetv Effects , For the purposes of this regulatory analysis, the NRC assumes that the same number of breath 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 provide the best possible care to his or her patients. In addition, the routine and accidental exposures por carbon 14 urea breath test is not expected to be affected by the level of NRC regulatory control. Thus, radiation exposures to the workers and members of the public would be the same regardless of which alternative is adopted. The NRC has concluded that the human use of these capsules results in insignificant exposures as depicted below: 6
Maximum Exposed Routine Exposure Scenario individual Full time worker, 8,000 Less than 0.7 mrem /yr Worker administering "C-urea breath tests patients /yr Patient tests negative 0.38 mrem / capsule Routine exposure of Patient tests positive 0.18 mrem / capsule patients from "C urea breath tests Reinase of 150 Ci of "CO, Member of public in the Less than 0.0002 mrom into administration administration area facility from fire Skin (100 cm') exposed for 5.8 mrad skin dose, Rupture of a capsula causing skin contamin- one hour orior to washing; 0.029 mrom (CEDEl ation of worker or patient 0.075 Ci sun absorption Furthermore, the NRC concluded that the impacts associated with any releases of "C to the surrounding environment are expected to be very small and the expected risks are minimal. The earth's atmosphere contains an inventory of naturally occurring "C of about 3.8 milHon curies (equivalent to the activity in 3.8 trillion breath tests), which is in addition to the huge insentory 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 the public of about 1.25 mrem / year, and the release of 0.6 curies of "C from the total of 600,000 tests assumed to be administered annually would result in an additional average annual dose of 2 X 104mrem. This is f ar below the EPA reporting level of 1 mrem / year required under the Clean Air Act for routino exposures to a member of the public, or the 4 mrem / year EFA limit for public drinking water. Iri 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 cavironment elso are expected to be very small because the concentration of CO, released is very low and it would mix immediately with the atmosphere. The small doses from naturally occurring "C are of little significance to human health and the enviionment. Potentiallong 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. would 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. papulation from naturally occurring "C of over 300,000 person-rem, and about 78,000,000 person-rem from all naturally occurring ra6ation. Clearly, an increase of a few person tem will not c;;;nificantly change 7
c these exposures, and thus there is no expected impact from the widespread use of the breath test on the entire U.S. population. l As a result of this analysis, the NRC concludes that Alternatives 2 and 3 are clearly preferat's to the no action a!ternative. This is becruse either of the two alternatives will i result in significant cost savings with no measurable adverse effect on health and safety. Furthermore, the NRC's recommended option is Alt:rnat!ve 2 because t would avoid the unnecessary cost burden to some Agreement States and their generallicenseet. Therefore, by adopting the propnsed rule, the cost savings would b3 maximized without any measurable adverse effect on public health and safety.
- 5. Decision Rationale Based on the above analysis, the NRC is proposir . to permit the manuf acture and commercial distribution of Carbon 14 urea capsulas to any person (including physicians '
who are not " authorized users" under Part 35) and armit any person, without an NRC
'icense, to receive nd use the capsulas for in viv "i' gnostic .2.c for humans because the radiologicbl risk from such distrittition would be negligible and the savings to patients -
could be significant. 8
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[7590 01 P] - NUC1. EAR REGULATORY COMMISSION - 10 CFR Pans 30 and 32 .: RIN: AF70 Exempt Distribution of a P'dioactive Diug ~ i Containing One Microcurie of Carbon-14 Ursa H A'GENCY: Nuclear Regulatory Commission. ACTION: Proposed rule. F
SUMMARY
The Nuclear Regulatory Commission (NRC) is proposing an amendment to its , regulations that would permit NRC !!censees to distribute a radioactive drug con microcurie of carbon-14 ures to any person for "in vivo" diagnostic use. The NRC has 4 3 ' determined that the tedioactive component of such a drug in capsule form presents a minina 'adiation risk and, therefore, regulatory control of the drug for radiation safety not necessary. If adopted, this amendment would make the drug more widely available, and reduce costs to patients)$j@iiltsj$$)i@tWiMalif[Wiej@l$$ijg. This action is being
' Men.in response to a petition for rulemaking (PRM-3512) submitted by Tri Med
( Sp6cialties, Inc.
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DATES: Submit comments by (Insert date 30 days after publication date). Comments
- received after this date will be considered if it is practicable to do so, but the Commission is able to assure consideration ontv for corriments received on or before t
)
t
w- - Current NRC Regulations for the Medical Use of Radioactive Drugs Containing Byproduct Material Currently,10 CFR Part 35 only permns physicians who are authorized users (e.g., physicians who meet certain training a .4 qxperlei(e criteria regarding the safe use radioactive drugs) or persons working under the supervision of an authorized user to use hdininistsi r6dioactive drugs for medical use. Thi Agreement States have similar requirements. Current NRC Regulations on Exemptions from Licensing Existing exemptions from licensing requirements for the use of byproduct materia include exemptions for specific products (e.g., time pieces), exemption for classes of products (e.g., gas and aerosol detectors) and broader materials exemptions in 5 30 i i
" Exempt concentrations," and 5 30.18," Exempt quantities." These two broad material exemptions specifically exclude the transfer of byproduct material contained in any foo beverage, cosmetic, drug, or any product designed for ingestion or inhalation by, or application to, a human being. (In the case of exempt quantities, this prohibition is contained in 5 32.18,"Manuf acture, distribution and transfer of exempt quantities of '
byproduct reatorial: Requirements for a license," 5 32.18(b)). Capsules containing one microcurie of carbon-14 urea would not qualify as an
" exempt quantity" in accordance with 6 30.18 because of their intended use (as a drug) even though they contain a smaller quantity than that set forth in i 30.71, Schedule B.
This use is outside the intent 6f the exemption currently in 5 30.18. It would introduce 7
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i d to submit'an .l
._ . person desiring to use the capsules for human research would still be requ re
;l Tapplication for a specific license under Part 35 in order to protect human sub -
di l
- The phrase _"in vivo diagnostic use"Is being used in i 30.21 instead of "me ca -
f ' Luse" for two reasons. First, the arm " medical use" has a specific meaning an . F in i 35.2 to mean "the'intentionaiiriternaI or external administration of byproduc or the radiat,lon therefrom to patients or human research subjects under the an authorized user." This term'would be inappropriate because:- 5 (1) " Medical use" limits ' administration to authorized users; use of this drug :
' not be so limited; and :
a (2) " Medical use" includes the administration of the drug to a human research. subject,~ which would be prohibited by this rulemaking. - l Effects of the Proposed Amendments
--i -
= The effect of these proposed amendments would be to make the' drug available
-i any person, for "in vivo" diagnostic use, without need for an NRC or Agreement S license. Because the receipt and use of the drug would be exempt from NRC licensin '
Agreement States would need to make appropriate orovisions in their regulations to ' recognize the exempt distribution of the drug, for "in vivo" diagnostic use. Thus i manuf acture and distribution of tne drug, the !JRC and the Agreement States would + regulate the use of the drug as long as its use was for "in vivo" diagnostic use. T j i ld 1
- means thatfunder NRC and Agreemente State regulations, primary care physic ans wou k
not need to be " authorized users"in order to administer the drug, and would not d l necessarily need fo refar their patients to' nuclear medicine physicians. This shoul resu
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Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Vill. Regulatory Analysis The NRC has prepared a regulatory analysis for the proposed rule. The analysis examines the benefits and impacts considered by the NRC. The regulatory analysis is j available for inspection at the NRC Public Document Room,2120 L Street NW. (Lower ! Level), Washington, DC. Single copies of the regulatory analysis are available from Sam Jones, Office of Nuclear Regulatory Resaarch, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001,telephono (301) 415 6198or e-mail at SZJ@nrc. gov. 1 IX. Regulatory Flexibility Certification i As required by the Regulatory Flexibility Act of 1980,5 U.S.C. 605(b), the Commission certifies that this rule does not have a significant economic impact upon a substantial number of small entities. The proposed rule would permit physicians sH{6ths health care providers to use an additional diagnostic test without having to obtain an NRC license, thus, would provide cost s6vings to ph;;!cL:n cad patients [frisUrbiQan(th5 health carelindustry. Any small entity subject to this regulation which determines that, because of its size, it is likely to bear a disproportionarc Wverse economic impact should notify the Commission of this in a comment that indicates the following: 22 1 Il
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.o The Honorable James M. Inhofe, Chairman ~
Subcommittee on Clean Air, Wetlands,
. Private Property and Nuclear Safety . .
f Committee on Environment and Public Works
. United States Senate '
Washjqaton, DC 20510 DeaIMr. Chairrnani Enclosed fo'r the information of the Subcommittee' are copies of a public announcement and - - Ta Federal R*egister notice concerning a proposed amendment to 10 CFR Parts 30 and 32. . LThis rulemakingi s being taken in response to a petition for rulemaking submitted by Tri-1Med Specialties,'inc. , l i t ll w 1 The Nuclear Regulatory Commission (NRC)is proposing to amend its regu at ons o a o NRC licensees to distribute a radioactive drug containing one microcurie of carbon-14 urea " to _any person for "in vivo" diagnostic use. ~ The NRC Sas determined that the radioactive component of such capsules presents a minimal radiation risk and, therefore, regulatory control of the drug for radiation safety is not necessary. Mj@wf6iiespiii@jistiniution, - KMJNitoM@ Dish $Q4@j(i$[sj If adopted, this amendment would make the drug more widely available, thus reducing costs to patientsE16ss[sfa[srid N#5ENMENWS. < [d@hDidMchshgpD4M$@E@) w
-i
' Sincerely, '
n Dennis K. Rathbun, Director Office of Congressional Affairs i i
Enclosures:
E1, Pubile Announcement-f 2.f Federal Register Notice
, cci Senator Bob Graham D
4 1-
4 Draft press release -- 4/23/97, 3:30 p.m. NRC CONSIDERS CHANGING ~ REGULATIONS TO PERMIT EXEMPT DISTRIBUTION OF RADIOACTIVE DIAGNOSTIG DRUG . The Nuclear Regulatory Commission is considering amending ^ itsregulationstoallowaspecificradioactivedrugjthatcanbc usedtodiagnosestomachulcers[tobedistributedtoany_ person fMMI.s hhp yjppi g tj[gu@ g Currently @ only liccn:cd nuclear physic.ians sGth6s{isdj g{ g g {Q @s @ @ {sjes may receive and use @ @ g((pey the drug. The proposed change would not relieve persons from the requirement to comply with applicable Food and Drug Administration or other Qederal and eytate requirements
- governing receipt, administration and use of drugs.
The change is in response to a 1994 petition from Tri-Med Specialties, Inc. It would allow any person to receive, possess, use and transfer carbon-14 urea capsules, not exceeding one microcurie each, for diagnostic use in patients. The NRC has determined that the capsules present a minimal radiation risk, i and therefore. believes that regulatory control of the drug for 5 radiation safety is not necessary. Under the proposed revisions to NRC regulations, manufacturers of the capsules and commercial pharmacies that prepare the capsules would continue to need an NRC license, and Is!NIN b$k$$195[M f ksfg{@jjg j{g gj g g @ jj (he containers of the capsules would have to bear the words " radioactive
-materia 1r" syd@@sgyshggij(osysg[ogofijtysjyyEspj{yfytihj y@ysijj] In addition,-only those persons who were licensed would be-permitted to use the capsules for research involving human subjects.
um
^
e The Tri-Med petition stated that Carbon-14 urea:can be'used to detectithe presence of a bacterium:that ' causes peptic ulcers, a< chronic-inflammatory conditionLof_the stomach and duodenum that affects as many as.10 percent of people in the United States at some time in their lives. . According to a July 1994 article in the Journal of the American Medical Association, the-disease-has
. relatively low mortality, but results in substantial human-suffering and high economic costs. Doctors can now cure most ulcer problems with antibiotics. The test using Carbon-14 urea is non-invasive. ~A doctor asks the patient to swallow.the
. capsule with water. After 15 minutes the patient blows into a collection bag, which is mailed to a testing laboratory for analysis.
The NRC's Advisory Committee on the Medica 1'Uses of Isotopes discussed the petition at its October 1995 meeting. The committee endorsed making this diagnostic test widely available. Currently @ Part 35 of the Commission's regulations permits . only physicians who are suthorized users (e.g., physicians who i meet certain training and experience criteria regarding the safe
- i use of radioactive drugs) or persons working under the supervision of'an-authorized user to administer radioactive drugs ,
for medical purposes. Under the proposed amendments, physicians pg @ @ H @ (($ C M yk@ @ yy would not need to be authorized users in order to
-administer the drug,.and $pf gpish# would not need to refer their
. patients to nuclear medicine physicians. This should result in cost- savings to.patientspf{6p6fEysy{ add 3tliMiM((pj[Qdi@j$2 Interested persons are invited to submit comments on the T -
O h
_ (76 30 days proposed rule change by ' after publication of a Federal Register notice on this subject on _). They may be mailed to the Secretary, 20555-0001, U.S.-Nuclear Regulatory Commission, Washington, DC Attention: Rulemakings and Adjudications Staff, or submitted electronically as described in the Federal Register notice. 5 1 6
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Action: 'MorirTson. RES h Cys: Callan
/g .,.'%. UNITED STATES Jordan p ,g NUCLEAR REGULATORY COUMISSION Thompson j W ASHINGTON. D.C. 705$5 000$ Norry
{ 9, 8 May 30, 1997 Blaha Funches CFO
%, * * * * ' / Galante..CIO secactiny Heyer, ADM Shelton, IRM '
Lieberman, OE
-Jones, RES MEMORANDUM TO: L. Joseph Callan .
Execut D rect r for Operations John oyle, S ( retary FROM: ,
SUBJECT:
STAFF REQUIREMENTS - SECY-97-090 - PROPOSED RULE: EXEMPT DISTRIBUTION AND USE OF A RADIOACTIVE DRUG CONTAINING ONE MICROCURIE OF CARBON UREA (PARTS 30 AND 32) The Commission has approved publication of the proposed rule in the Federal Register with incorporation of the changes to the Federal Reaister notice, Congressional letters, and press release noted in the attachments. (SECY Suspense: 6/30/97) 9700042 (B9&) (RES)
Attachment:
.i As stated i
cc: Chairman Jackson-Commissioner Rogers Commissioner Dicus
- Commissioner Dia:
Commissioner McGaffigan OGC CIO'
.CFO OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
PDR' DCS SECY NOTE: THIS SRM, SECY-97-090, AND THE COMMISSION VOTING RECORD CONTAINING'THE VOTE SHEETS OF ALL COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF'THIS SRM.
?lUbOpoli j 'l*- 007 a P- . .
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I , f0((lb& y UNITED STATES [ga asc.,,*'o
* NUCLE AR REGULATORY COMMISSION W ASHWCT ON ,0.C. 20555
! h q/ .f/, g p
' May 30, 1997 9,,,,
OFFICE OF THE
"*""*"" COMMISSION VOTING RECORD DECISION ITEM: SECY-97-090 EXEMPT DISTRIBUTION PROPOSED RULE:
TITLE: AND USE OF A RADIOACTIVE DRUG CONTAINING ONE MICROCURIE OF CARBON 14 UREA (PARTS 30 AND 32) Commissioners agreeing) approved the ndum The Commission subject paper as (with al: recorded in the Staff Requirements Memora (SRM) of May 30, 1997. together This Record contains a summary of voting on this matter f the with the individual vote sheets, views and 1997,comments o Commissioners, and the SRM of May 30, i s
'~ ohn C. I?6yle Se tary of the Commission Attachments:
- 1. Voting Summary
- 2. Commissioner Vote Sheets
- 3. Final SRM cc: Chairman Jackson Commissioner Rogers Commissioner Dieus Commissioner Diaz Commissioner McGaffigan
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OGC EDO PDR DCS 4
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V_OTING
SUMMARY
- SECY-97-090 "
),
i RECORDED VOTES-yo7
- - . . DATE APRVD DISAPRVD ABSTAIN PARTI,CIP COMMENTS X 5/13/97 X ,
CHRM._ JACKSON _5/16/97 X X-COMR. ROGERS
-X 5/19/97
. COMR. DICUS- X' 5/8/97 ,
X COMR.:DIAZ X 5/7/97 , COMR. McGAFFIGAN X _ COMMENT' RESOLUTION d the staff's In their vote sheets, all Commissioners approve Some'provided additional comments. d
- recommendation.
-Subsequently, the comments of-the Commission were 30,:1997.
b J e
, . - - - - .,-a e un, - - - - - - -- . ---e-,
i l 1 VOTE
-N__O T A-T I O N l t
R.ESPONSE SHEET John C.. Hoyle, Secretary TO: - - . .
-- FROM: CHAIRMAN JACKSON EXEMPT
SUBJECT:
SECY-97-090 - PROPOSED RULE: DISTRIBUTION AND USE OF A RADIOACTIVE D CONTAINING ONE MICROCURIE OF CARBON (PARTS 30 AND 32) Disapproved _ Abstain Approved _x Request Discussion Not Participating _ COMMENTS:
' I approve the staff's plan for the publication of the proposed ti t ith rule in
-5 however, it is noted that the public comment period each other to avoid confusion regarding acceptance of public comments.
I av
/ SIGNA'IDRE May 13, 1997_
Release Vote / N/ DATE
' Withhold Vote ./ /
Yes X No Entered on "AS"
- %4%$fjf. lp ,
OM
NOTATION VOTE RESPONSE SHEET TO: John C. Hoyle, Secretary FROM: COMMISSIONER ROGERS urRMPT .
SUBJECT:
. SECY-97-090 - PROPOSED RULE: DISTRIBUTION AND USE OF A RADIOACTIV CONTAINING ONE MICROCURIE OF CARB (PARTS 30 AND 32) Disapproved _ Abstain Approved yycR.w Request Discussion Not Participating _ A gg g COMENTS : Q $ Q (w.m a W .I<<? A K U< r 1 b. M SIGNATURE [0< Of7 _ Release Vote /1/ N DATE Withhold vote / / Yes X No . Entered on "AS" M M \ p. %g\ d){ , oIo
N O T A T IO N- VOTE RESPONSE SHEET
.TO:
John C. Hoyle,' Secretary FROM: COMMISSIONER DICUS EXEMPT
SUBJECT:
SECY-97-090 - PROPOSED RULE: DISTRIBUTION AND USE OF A RADIOACTIVE CONTAINING ONE MICROCURIE OF CARBON (PARTS 30 AND 32) Disapproved _ Abstain Approved X _ Request Discussion Not Participating _ COMMENTS: One edit, attached , u /V/ be .6 b'A C .<d {rn c<..us n a.cCd.
. CJ~n M mi N J: n u x vi7t&L k n NSe '
7 )'7,[ , #
- a. oM '5 MUs .
19hk. ou i bd] . _ . _ CldkGNATURE W m, )9 . J 9 9, Release Vote /~xx / DATE ' Withhold Vote / / Yes _X No - Entered on "AS" _ et J P D/t
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.. f i ed to submit an person desiring to use the capsules for human research would still be requ r
~
j application for a specific license under Part 35 in order itol protect huma) The phrase "in vivo diagnostic use" is being used in 5 30.21 instea! d is defined j use" for two reasons. First, the term " medical use" has a specific meaning 4 d t rial l in i 35.2 to mean "the intentional internal or external administraiion of by ! h vision of or the radiatioh therefrom to patients or human research subjects under t e s an authorized user." This term would be inappropriste because: ld 2 (1) " Medical use" limits admiriistration to authorized users; use of th not be so limited; and h (2) " Medical use" includes the administration of the drug to a human re subject, which would be prohibited by this rulemaking. Effects of the Proposed Amendments i 1 The effect of these proposed amendments would be to make the drug State any person, for "in vivo" diagnostic use, without need for an NRC or Agree license. Because the receipt and use of the drup would be exempt from Agreement States would need to make appropriate provisions in their re f the recognize the exempt distribution of the drug, for "in vivo" diagnostic use. ' ld not manuf acture and distribution of the drug, the NRC and the Agreement States w This regulate the use of the drug as long as its use was for "in vivo *' diagnostic tate regulations, primary-care physicians would g means that, under NRC and Agreement not need to be " authorized users" in order to administer the drug, and would n This shou!d result necessarily need to refer their patients to nuclear medicine physicians. 10 4 e r- - - -- e..-- . m - ,,r- y
l
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\
j
'- N O T A T I--0 N V O T-E R_-ESPONSE EMEET 4
TO: Jolin C. Hoyle, Secretary FROM: COMMISSIONER DIAZ -- EXEMPT
~-
SUBJECT:
SECY-97-090 - PROPOSED RULE:
. DISTRIBUTION AND USE OF A RADIOACTIVE D CONTAINING ONE MICROCURIE OF CARBON (PARTS 30 AND 32)
Disapproved _ Abstain Approved
/ Request Discussion Not Participating COMMENTS: 9 g w, .d J
t i Ai
# V W gIgATURE )
/
T D - 9 ~l Release Vote /g/ _ DATE Withhold' Vote /___ _/ Yes No , Entered on."AS"- _ _ , e - h on-
'< N O T A T I O N' V O T-E RESPONSE SHEET 4 '
John C. Hoyle, Se'cretary TO: FROM: COMMISSIGNOR MCGAFFIGAN . RTRMPT
SUBJECT:
SECY-97-090 - PROPOSED RULE:
. DISTRIBUTION AND USE OF A RADIOACTIVE DR CONTAINING ONE MICROCURIE OF CARBON 14 (PARTS 30 AND 32)
Disapproved Abstain Approved i Request Discussion Not Participating COMMENTS: I approve of the staff's plan to publish the proposed rule for commen suggest edits to the Fed '
-al Register _ notice, public announcement, the attached.
to Congress as indicatet i j .l fr SIGNA % d U Release. Vote /k/ b/7/T7
' DXTE Withhold vote / /
Entered on "AS" Yes A No . 9
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013
(-- , (7590-01-P] t NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30 and 32 RIN: AF70, Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Ursa
~
Nuclear Regulatory Commission. AGENCY: ACTION: Proposod rule. The Nuclear Rogulatory Commission (NRC)is proposing
SUMMARY
- drug containing one regulations that would permit NRC licensees to distribute a radioac The 14RC has microcurie of carbon 14 urea to any person for "in vivo" diagnostic use.
determined that the radioactive coreponent of such asafety drug is in cap di i minimal radiation risk and, thereforei regulatory control of the drug f id ly available, not necessary, if adopted, this amendment would eur o s.J.by . make the drug more i+na uJ +t kill to a petition for Y
- and reduce costs to patients j This action is being taken in response rulemaking (PRM-3512) submitted by Tri-Med Specialties, Inc.
Submit comments by (Insert date 30 days after publication date DATES: h Commission received after this date will be considered if it is practicable to do so, b is able to assure consideration only for comments received on or b a f
'w ,
s q 4 '
' Current NRC Regulations for.the Medical Use of Radioactive DrugI .
Containing Byproduct Material i d users (e.g.,-
- - Currently,-10 C"R Part 35 only permits physicians who are author ze -
i ie s of .> physicians who meet certain training and experiencercriteria todd-,6ig regardin ' ~~^ - . i d radioactive'. drugs) or persons working under tho' supervision of an au i ents. ., radioactive drugs for medical use._ The Agreement States have similar ' Current NRC Regulations on Exemptions from Licensing . b Existing exemptions from licensing requirements for t'.ie use f include exemptions for specific products (e.g., time pieces), exemp in i 30.14, i products (e.g., gas and aerosol detectors) and broader materials exe d materials , i
" Exempt concentrations," and 5 30.18, " Exempt quantities." These t
;_ i d in any food, l exemptions specif'ically exclude the transfer of byproduct matetial conta n ihli by, or oeverage, cosmetic, drug, or any product designed for ingestion or n a a i ii is application to, a human being. (in the case of exempt quantities, th tities of contained in i 32.18, " Manufacture, distribution and transfer of exempt q byproduct material: Requirements for a license,"'I 32.18(b)).
ld not qualify as an Capsules containing one microcurie of carbon 14 urea wou d )
" exempt quantity":in accordance with i 30.18 because of their int f th in i 30.71, Schedule B.
even though they contain a smaller quantity than that set or ' i i 30.18. It would introduce _ , _
- This use is outside the intent of the exemption currently. n 7
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Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to r '~ collection of information unless it displays a currently valid OM8 control numbe Vill. Regulatory Analysis The NRC has prepared a regulatory analysis for the proposed rule. The i examines the benefits and impacts considered by the NRC. The regulatory available f or inspection at the NRC Public Document Room, 2120 L Street N Level), Washington, DC. Single copies of the regulatory analysis are availa Jones, Office of Nuclear Regulatory Resea ch, U.S. Nuclear Regulatory Com or e-mail at SZJ@nrc. gov. Washington, DC 2055d OOO1, telephonc (301) 415-6198 i 1 IX. Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980,5 U.S.C. 60S(b), the I"' Commission certifies that this rule does not have a significant 4 ).. h .,{ K economic 91- wot impac substantial number of small entities. The proposed rule would permit physiciangto additional diagnostic test without having),to n S a,.' h ure 4.;jnobtain
. an NRC license, thu p.! ,,.h , k s ar> < < , ~
cost savings to had patients. Any small entity subject to this regulation whic x determines that, because of its size, it is likely to bear a disproportionate adverse economic impact should notify the Co'mmission of this in a comment that indica following: . 22
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. o UNITED STATES
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NUCLEAR REGULATORY COMMISSION W ASHINoToN. D.C. 30666-0001 o The Honorable Jarnes M. Inhofe, Chairman ' ~ ~ ' Subcommittee on Clean Air, Wetlands, Private Property and Nuvie. ~,.fot, - Committee on Environment and Public Works United Stat'es Senate Washington, DC 20510 4
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee are copies of a public announ and a Federal Register notice concoming a propose .
' by Tri-Med Specialties, Inc.
The Nuclear Reguletory Commission (NRC) is proposing to amend its regulatio NRC licensees to distribute a radioactive drug containing one microcurie of carb to any person for *in vivo" diagnostic use. The NRC has determined that the component of such capsules presents a minimal radiation risk and, therefore, re control of the drug for radiation safety is notmg necessary.4lf adopted, costs to patients this amendme j frsswers ceA (b e. would make the drug more widely available, thus r ,.r . ad> s %
~~~~~ hm Uh iI r
Sincerely, . h**#'"* T a. era ufce6..<_ v4 4.sh.o d k-in
,\ ik yde s e. .t e+ 6no V ' S' ' '
c n: ... s jyc. 1.< u s e . Dennis K. Rathbun. Director Office of Congressional Affairs 9
Enclosures:
1, Public Announcement
- 2. Federal Register Notice cc: Senator Bob Graham
~
e
r as . 3:30 p.m.
- Draft press release -- 4/23/97, JRC CONSIDERS CHANG'ING REGULATIONS TO PERMIT i i
EXEMPT DISTRIBUTION OF RADIOACTIkE DIAGNOSTIC D 4 Commissi n is considering amending The Nuclear Regulatory i: ? - - its regulations to allow a specific radioactive dru p h:t ::: g Ex . used to diagnose stomach ulcerag t o be distributed to any personatAm.nu e,_r u Currencly only 11c ..; 3 =:1: Nphysiciansmayreceiveand-use- gr g " oirt.eslet ths drug. UMbt'd h N6 b"' The proposed change would not relieve persons from the requirement to comply with applicable Food and Drug x Administration or other, federal and / tate requirements governing receipt, administration and use of drugs. The change is in response to a 1994 petition from Tri-Med It would allow any person to receive, possess,
' Specialties, Inc.
- use and transfer carbon-14 urea capsules, not exceeding one The NRC has t
microcurie each, for diagnostic use in patients. determined that the capsules present a minimal radiation risk, and therefore believen that regulatory control of the drug for radiation safety is not necessary. . Under the proposed revisions to NRC regulations, manuf acturers of the capcules and commercial pharmacies that [and {*^Et prepare the capsules would continue to need an NRC license s[pu.n. i qp , Mecontainersofthecapsuleswouldhavetobearthewords ~ In addition, only those persons who were
" radioactive materiah "
d to use the capsules for research licensed would be permit involving human subjects. cro643 kTL ceA ht oth ye.dc. d rec _+um en 16t
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The-Tri-Med petition-stated'that Carbon-14: urea can be use -I i ulcers, to detect the presence of a bacterius'that'causes.pept c_ h ' a chronic'infissmatory condition of thawtomach and duodenum t at f people in the United states at affects:as many as 10_ percent-o Accordingeto a July 1994. article!in , some time.in their lives. ' f I
~~
-the Journal of the Anerican Medical Association,;t e ,
h disease has l 4 relatively low mortality, but resulte in subr,tantial human " suffaring and high economic costs. Doctors can_now cure nost_ The test using carbon-14: urea l ulcer problems-.with antibiotics. ' A doctor asks the patient-to swallow the is non-invasive. After 15 minutes the patient blows into a capsule-with water. . collection bag, which is mailed to a testing laboratory for analysis. ' The NatC's Advisory Committee on the Medical Uses of Isotopes discussed the petition at its October 1995 meeting. The committee 5 endorsed making this diagnostic ' test widely available. CurrentigPart 35 of the Commission's regulations permit
'7C (e.g., physicians who
=only" physicians who are authorized users f
' meet certain training and experience criteria regarding the sa e .
-use of radioactive drugs) or persons working under the supervision of-an_ authorized user to administer radioactive drugs A
, y H t c6<* * *'y
.for medical purposes. o r* d to Under-the proposed amendments, physicians 4would not nee ps m .,
- )(, - ld
- be authorized users -in order. to administer the drug, and wou not need to refer their patients to nuclear medicine physicians.
N ' a This.should' result;in cost savings to patientaf *8vr*"i (.ve mL&y .
%x nts on the
. Interested persons are invited to submit comme
{.. _ _ . . _ _ _ __ -. . .
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