ML20141L890
| ML20141L890 | |
| Person / Time | |
|---|---|
| Issue date: | 05/30/1997 |
| From: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| To: | Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| References | |
| FRN-62FR32552, REF-10CFR9.7 AF70-1-007, AF70-1-7, SECY-97-090-C, SECY-97-90-C, NUDOCS 9706030111 | |
| Download: ML20141L890 (9) | |
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, - [kR RfC UNITED STATES y ; NUCLEAR REGULATORY COMMISSION
-{ E WASHINGTON, D.C. 20555-0001 j8 May 30, 1997 SECRETARY MEMORANDUM TO: L. Joseph Callan
! Execut' D rec r for Operations
'FROM: John C. .oyle, S k
retary
SUBJECT:
STAFF REQUIREMENTS - SECY-97-090 - PROPOSED RULE: .. EXEMPT DISTRIBUTION AND USE OF A , RADIOACTIVE DRUG CONTAINING ONE MICROCURIE OF
- j. CARBON UREA (PARTS 30 AND 32) l The Commission has approved publication of the proposed rule in j the Federal Recister with incorporation of the changes to the l Federal Recister notice, Congressional letters, and press release noted in the attachments.
(EDO) (SECY Suspense: 6/30/97) i l
Attachment:
l As stated i cc: Chairman Jackson Commissioner Rogers Commissioner Dicus Commissioner Diaz Commissioner McGaffigan OGC CIO CFO OCA OIG Office Directors, Regions, ACRS, ACNW, ASLBP (via E-Mail)
'PDR DCS
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i j SECY NOTE: THIS SRM, SECY-97-090, AND THE COMMISSION VOTING
- i. RECORD CONTAINING THE VOTE SHEETS OF ALL
! COMMISSIONERS WILL BE MADE PUBLICLY AVAILABLE 5 WORKING DAYS FROM THE DATE OF THIS SRM. 1O-l l ' c'30014 MM lilElElBI.E E.R.NH. 9706030111 970530 . PDR 10CFR PT9.7 PDR m . . .
s v [7590 01-P] NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30 and 32 RIN: AF70 Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea I AGENCY: Nuclear Regulatory Commission. l l l l ACTION: Proposed rule. l l
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing an amendment to its I regulations that would permit NRC licensees 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 l
minimal radiation risk and, therefore, regulatory control of the drug for radiation safety is i not necessary. If adopted, this amendment would make the drug more widely available, and reduce costs to patients { insurers;and the he.althJaie'indUstr9. This action is being taken in response to a petition for rulemaking (PRM-35-12) submitted by Tri-Med Specialties, Inc. 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 only for comments received on or before this date. t
l i.. l A j \ j ( Current NRC' Regulations for the Medical Use of Radioactive Drugs ; Containing Byproduct Material i l Currently,10 CFR Part 35 only permits physicians who are authorized users (e.g., physicians who meet certain training and experience criteria regarding the safe use of i radioactive drugs) or persons working under the supervision of an authorized user to use l sdniihist6r radioactive drugs for medical use. The Agreement States have similar 1 requirements. ;
. Current NRC Regulations on Exemptions from Licensing i Existing exemptions from licensing requirements for the use of byproduct material j i
I 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 i 30.14,
" Exempt concentrations," and 6 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 application to, a human being. (in the case of exempt quantities, this prohibition is i
contained in 6 32.18, " Manufacture, distribution and transfer of exempt quantities of ; byproduct material: Requirements for a license," 5 32.18(b)). j i Capsules containing one microcurie of carbon-14 urea would not qualify as an l I
" exempt quantity" in accordance with 5 30.18 because of their intended use (as a drug) i even though they contain a smaller quantity than that set forth in 5 30.71, Schedule B.
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- This use is outside the intent of the exemption currently in i 30.18. It would introduce i
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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 s 30.21 instead of " medical use" for two reasons. First, the term " medical use" has a specific meaning and is defined ; 3 , i in 6 35.2 to mean "the intentional internal or external administration of byproduct material I l 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 administration to 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. l 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. 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, after the manufacture and distribution of the drug, the NRC and the Agreement States would not regulate the use of the drug as long as its use was for "in vivo" diagnostic use. This means that, under NRC and Agreements State regulations, primary-care physicians would not need to be " authorized users" in order to adrr.inister the drug, and would not necessarily need to refer their patients to nuclear medicino physicians. This should result 10 i i
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 l 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 j l Jones, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, l Washington, DC 20555-0001, telephone (301) 415-6198 or e-mail at SZJ@nrc. gov. l l IX. Regulatory Flexibility Certification l 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 and other
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health care providers to use an additional diagnostic test without having to obtain an NRC I I
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license, thus, would provide cost savings to physicians and patients [ insurers [and the ( l l
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health [ care.industr . Any small entity subject to this regulation which determines that, I i 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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1 l The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, i Private Property and Nuclear Safety l Committee on Environment and Public Works ! United States Senate ( Washington, DC 20510 I
Dear 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 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 urca to any person for "in vivo" diagnostic use. 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'manuisctureland distribution
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of theicapsuleLsiwo'uId continoef to req 6 ire ariNRC license? If adopted, this amendment would make the drug more widely available, thus reducing costs to patients? ins _UrersTand I
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the tiealthf care industry. l i [make .same changes to the1Schaef.er letter} , i Sincerely, ; 1 Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
- 1. Public Announcement
- 2. Federal Register Notice cc: Senator Bob Graham
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 radioactive drugh that ca:. be used to diagnose stomach ulcersi to be distributed to any person i f dr~ adthinis tra tioh7 tol;;; humans . Currently,j only licenced nucicar physicians hethorisiedlbp$NRCior/AyreementJStates may receive and use adsini'stbf the drug. The proposed change would not relieve persons from the requirement to comply with applicable Food and Drug Administration or other 4 Federal and 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. t i Under the proposed revisions to NRC regulations, l l manufacturers of the capsules and commercial pharmacies that prepare the capsules would continue to need an NRC licenser-and tolprovidb high confiderice 46f, espsule;[contedts. bThe containers of the capsules would have to bear the words " radioactive material- " And '6therfspscificJidformatiodionfthe?;costshts tbf s the condainsr; In addition, only those persons who were licensed l would be permitted to use the capsules for research involving human subjects. l 1
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The Tri-Med petition stated that Carbon-14 urea can be used to detect 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 I 1 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 f capsule with water. After 15 minutes the patient blows into a j collection bag, which is mailed to a testing laboratory for J ] analysis. 3 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 persons working under the supervision of an authorized user to administer radioactive druge for medical purposes. Under the proposed amendments, physicians or]othe~lheslthr carelsorkers would not need to be authorized users in order to administer the drug, and physicians would not need to refer their catients to nuclear medicine physicians. This should result in cost savings to patients;J. insurers,jande thelhealthicare^ industry. Interested persons are invited to submit comments on the i a j
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proposed rule change by (M 30 days after publication of a Federal Register notice on this subject on
). They may be mailed to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Rulemakings and Adjudications Staff, or surmitted I electronically as described in the Federal Register notice.
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