ML20148H628
| ML20148H628 | |
| Person / Time | |
|---|---|
| Issue date: | 05/07/1997 |
| From: | Mcgaffigan E NRC COMMISSION (OCM) |
| To: | Hoyle J NRC OFFICE OF THE SECRETARY (SECY) |
| Shared Package | |
| ML20148H596 | List: |
| References | |
| FRN-62FR32552 AF70-1-013, AF70-1-13, SECY-97-090-C, SECY-97-90-C, NUDOCS 9706100461 | |
| Download: ML20148H628 (7) | |
Text
_ . . . . . - . _ . . . _ . _ - _ _ _ _
I l
l N O T'A'T I O N VOTE 4
RESPONSE SHEET TO:- John C. Hoyle, Secretary l
< l FROM: COMMISSIONER MCGAFFIGAN l l
i
SUBJECT:
SECY-97-090 - PROPOSED RULE:' EXEMPT i l
-DISTRIBUTION AND USE OF A RADIOACTIVE DEUG CONTAINING ONE MICROCPRIE. OF CARBON 14 UREA l (PARTS 30 AND 39.)
Approve.d . Y Disapproved Absta!o Not Participating Request Discussion l COMMENTS:
I approve of the-staff's plen to publish the proposed rule for comment and suggest edits to the Federal Reaister notice, public announcement, and letters to Congress as indicateo on the att' ached.
l
.p p
u, k .
/I
- /w/, \
SIGNATURE U i i
l Release Vote / ><' / h!7T7 !
'DXTE l
Withhold vote /_
t Entered on "AS" Yes A No I
I l
~
W 9706100461 970530 PDR COMMS NRCC l- CORRESFb.DENCE PDR
- - _ . .~ -. . . - . . -. . . - - .. - . - .. . .-. .-
~
[7590-01-PJ ;
NUCLEAR REGULATORY COMMISSION ?
10 CFR Parts 30 and 32
?
RIN: AF70, -
i Exempt Distribution of a Radioactive Drug Containing One Microcur; of Carbon-14 Urea ;
AGENCY: Nuclear Regulatory Commission, j ACTION: Proposed rule. l, l
SUMMARY
- The Nuclear Regulatory Commission (NRC)is proposing an amendment to its - ,
regulations that would ne mit NHC licensees to distribute a radioactive drug containing one r microcurie of carbon-14 uses 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 i
minimal radiation risk and, therefore, regulatory control of the drug for radiation safety is not necessery. If adopted, this amendment would coake the drug more widely available, i nkr!!J b) h. $4plll we s o. d.} ry ,
Y and reduce costs to patientsj 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.
-+ h- -
n
l j
Current NRC Regulations for the Medical Use of Radioactive Drugs
- l. .
Containing Byproduct Material i
Currently,10 CFR Part 35 only permits phys,icians 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 tousaI, A w. i ..
radioactive drugs for medical use. The Agreement States have similar requirements.
a 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 5 30.18, " Exempt quantities." These two broad materials j 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 i 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 1
byproduct material: Requirements for a license," 6 32.18(b)). l Capsules containing one microcurie of carbon-14 urea would not qualify as an
" exempt quantity" in accordance with 6 30.18 because of their interided use (as a drug) ~
even though they contain a smaller quantity than that set forth in 5 30.71, Schedule B.
This use is outside the intent of the exemption currently in 5 30.18. It would introduce i
l '
i 7
a
- l. -
l* i
?
. o i Public Protection Notification j l !
t +
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 .
I r
The NRC has prepared a regulatory analysis for the proposed rule. The analysis j i
examines the benefits and impacts considered by the NRC. The regulatory analysis is l t
available for inspection at the NRC Public Document Room,2120 L Street NW. (Lower l Level), Washington, DC. Single copies'of the regulatory analysis are available from Sam i t
Jones, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, l 1
Washington, DC 20555-0001, telephone (301) 415-6198 or e-mail at SZJ@nrc. gov. {
IX. Regulatory Flexibility Certification !
1 t
I As required by the Regulatory Flexibility Act of 1980,5 U.S.C. 605(b), the l Cornnussion certifies that this rule does not have a significant economic impact upon a , !
,,,) 44,, k . ,{ H. co a w o t'"' ~\
l substantial number of small entities. The proposed rule would permit physiciengto use an additional diagnostic test without having to obtain an NRC license, thus, would provide g :,,.h , % ,no y u A & b o,' 4 esr- . '. . s ' .s
. l cost savings to 94 w.straan :nd p;ticrt . Any small entity subject to this regulation which ,
determines that, because of its size, it is likely to bear a disproportionate adverse j 8
r economic impact should notify the Coi..niccion of this in a comment that indicates the 4
following: >
a e
22 ;
._. -. = , _
i
uq
[pe ne t UNITED STATES
<- o NUCLEAR HedulATORY COMMISSION f WASHINGTON, D.C. 20555 0001
% . . . . . j$ ;
' The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, i Private Property and Nuclear Safety Committee on Environment and Public Works !
United States Senate Washington, DC 20510 l Dear Mr. Chairman; i 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. .
i 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 i 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.alf adopted, this amendment would make the drug more widely available,/thus reducing costs to patients 2 inswers M fe c
~~- h., 3 >9 , , , , a ,, ,, _
- r Sincerely, ;
Te v e. , v(c r. , t 4 r 4 A 3 r . > d ..s "
,,7 m . y d.s c 1 e&#~ + 0' l,. .,.
- f,r . b , ,
e ; ,, , ._ u ta u. ! . t. ,e. .
')
5 Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
- 1. Public Announcement
- 2. Federal Register Notice cc: Senator Bob Graham i
i
Draft press release -- 4/23/97, 3:30 p.m.
NRC CONSIDERS CHANGING REGULATIONS TO PERMIT EXEMPT DISTRIBUTION OF RADIOACTIVE DIAGNOSTIC DRUG The Nucle e Regulatory Commission is considering amending its regulations to allow a specific radioactive drugg h:t :: b:}
used to diagnose stomach ulcersgto be distributed to any person [ b v 3
dw a %.
Currentlgonly -lisii ed ::10:e physicians may receive and-use- gt ,3, oan;r det the drug. c>>Mm u d 'cg tM 6 or b"'**' # !
The proposed change would not relieve persons from the requirement to comply with applicable Food and Drug Administration or other federal and,mI. ate requirements governing x 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, I
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 therefors believes that regulatory control of the drug for l
radiation safety is not necessary.
Under the proposed revisions to NRC regulations, .
manufacturers of the capsules and commercial pharmacies that l
preparethecapsuleswouldcontinuetoneedanNRClicense[andh, (*A' l
< w.m ,
l e containers of the capsules would have to bear the words k.
"radioactivemterialh"AInaddition, only those persons who were 7
licensed would be permitt d to use the capsules for research involving h Ian subjects.
u\ ch ye dc. E hm m b (dmh 'k Y re^h W# '
. j l
l The Tri-Med petition stated that Carbon-14 urea can ba used i I
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 theu- lives. Accordinrto a July 1994 article itt 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 Medical Uses of Isotopes discussed the petition at its October 1995 meeting. The committee endorsed making this diacnostic test widely available.
K Part 35 of the Commission's regulations permits Currentl{7 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 co administer radioactive drugu
- 'p < 5 for medical purposes. , y,ju ce< a c<
Under the proposed amendments, physiciansA" "ld " ' "**d t Si ysm be authorized usara in order to administer the drug, and would not need to refer their patients to nuclear medicine physicians.
This should result in cost savings to patientsj "" " i '* wJ Ns - L s~7 sc <y.
f 1
Interested persons are invited to submit comments on the
/g AR fif OgS UNITED STATES p'$
~
y'. NUCLE AR REGULATORY COMMISSION
{ /,j w AsHINGT ON. D.C. 20555-0001
( [ May 30, 1997 SECRETARY MEMORANDUM TO: L. Joseph Callan Executiv Direct r for Operations
- k. k k FROM: John C. oyle. Se retary
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 Reaister with incorporation of the changes to the Federal Recister notice, Congressional letters, and press release noted in tile attachments.
(EDO) (SECY Suspense: 6/30/97)
Attachment:
As stated 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 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 OHE DATE OF THIS SRM.
$!ll &f, 1
. o
[7590-01 -PJ NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30 and 32 PIN: 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 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 minimal radiation rist : nd, therefore, regulatory control of the drug for radiation safety is not necessary. . If adopted, this amendment would make tha drug more widely available, and reduce costs to patients / insurers and the health)are; industry. This action is being
.taken in response to a petition for rulemaking (PRM-35-12) submitted by Tri-Med Specialties, Ir:c.
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 cornments received on or before this date.
I l
Current NRC Regulations for the Medical Use of Radioactive Drugs Containing Byproduct Material Currently,10 CFR Part 35 only permits physicians who are authorized users (e.g., .
physicians who meet certain training and experience criteria regarding the sare use of radioactive drugs) or persons working under the supervision of an authorized user to use administer radioactive drugs for medical use. The Agreement States have similar requirements.
Current NRC Regulations on Exemptions from Licensing e 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 H 30.14,
" Exempt concentrations," and 9 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 ;
i application to, a human being. (in the case of exempt quantities, this prohibition is contained in i 32.18, "Manuf acture, distribution and transfer of exempt quantities of byproduct material; Requirernents for a license," l 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)
I 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 ,
1 I
l I !
l l' I l l
person desiring to use the capsules for human research would still be required to submit an applicdtion for a specific license under Part 35 in order to protect human subjects.
The phrase "in vivo diagnostic use" is being used in 6 30.21 instead of " medical use" for two reasons. First, the term " medical use" has a specific meaning and is defined in 9 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 administration to authorized users; use of this drug would not be so limited; and (2) " Medical use" includes the adrninistration 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 f 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, l
I Agreement States would need to make appropriate provisions in their regulations to l
l recognize the exempt distribution of the drug, for "in vivo" diagnostic use. Thus, after the manuf acture and distribution of the drug, the NRC and the Agreement States would not o ~
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 administer the drug, and would not l necessarily need to refer their patients to nuclear medicine physicians. This should result 10
Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a collection of informat::n unless it displays a currently valid OMB control number. .
+
l 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 l Level), Washington, DC. Single copies of the regulatory analysis are available from Sam Jones, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6198 cr e-mail at SZJ@nrc. gov. 3 e
t IX. Regulatory Flexibility Certification 1
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 rulo would permit physicians and other l
health' care providers to use an additional diagnostic test without having to obtain an NRC license, thus, would provide cost savings to phy !cian and patients, insurers, and the health care industry. Any sma'l 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 Commission of this in a comment that indicates the following:
22 i
e
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 Washington, 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 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 urea 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 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.
[make same changes to the Schaefer letter)
Sincerely, f
Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosures:
1 Public Announcement
- 2. Federal Register Notice l
cc: Senator Bob Graham i
1 1
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 drug, that can be used to diagnose stomach ulcers, to be distributed to any person for1administrationJto? humans. Currentlyt only licenacd nuclear ,
. physicians suthorized!byENRC or[AgreementlStates may receive and use administer the drug.
The proposed change would not relieve persons from the requirement to comply with applicable Food and Drug Administration or other EFederal 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.
Under the proposed revisions to NRC regulations, i manufacturers of the capsules and commercial pharmacies that prepare the capsules would continue to need an NRC license--and tojrovideVhigh7 confidence _oficapsulefc~ontenta; eThe containers of the capsules would have to bear the words " radioactive~
material- " andLotheri specific 7information onithel content'sl'6f ? the ,
containes. In addition, only those persons who were licensed would be permitted to use the capsules for research involving human subjects.
1 1
The Tri-Med petition stated that Carbon-14 urea can be used to detect the presence of a bacterium that causes peptic ulcers, e 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 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 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 drugs for medical purposes.
Under the proposed amendments, physicians criotherihealth careiworkers would not need to be authorized users in order to administer the drug, and physicians would not need to refer their patients to nuclear medicine physicians. This should result in cost savings to patients,Linsure'rs,;andLthelhealthJcare" industry.
Interested persons are invited to submit comments on the i
l l
i l
l l
l
f (M 30 days proposed rule change by 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 submitted electronically as described in the Federal Register notice.
l l
)
l i
i i
1 1