Text

Forwards for Signature,Secy Paper Transmitting Proposed Rule to Commission to Amend Parts 30 & 32 to Permit Exempt Distribution & Use of One Uci Capsules of carbon-14 Urea for in Vivo Diagnostic Use
	ML20198H875
Person / Time
Issue date:	04/17/1997
From:	Morrison D; NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:	Callan L; NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
Shared Package
ML20013E023	List: ML20198H571; ML20198H672; ML20198H718; ML20198H780; ML20198H830; ML20198H875; ML20198H887; ML20198H907; ML20198J119; ML20198J157; ML20198J188; ML20198J224; ML20198J252; ML20198J270; ML20198J298; ML20198J324; ML20198J404; ML20198J418; ML20198J664; ML20198J741; ML20198J766; ML20198J793; ML20198J830; ML20198J869; ML20198J932; ML20198J978; ML20198J988; ML20198J995; ML20198K019; ML20198K055; ML20198K065; ML20198K118; ML20198K151; ML20198K202; ML20198K217;
References
	FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-019, AF70-1-19, NUDOCS 9801130414
	Download: ML20198H875 (58)
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~ April 17, 1997 p MEMORANDUM TO: L. Joseph Callan Executive Director for Operations FROM: David L. Morrison, Director /s/ David L. Morrison Office of Nuclear Regulatory Research

SUBJECT:

PROPOSED RULE: EXEMPT DISTRIBUTION AND USE OF A RADIOACTIVE DRUG CONTA!NING ONE MICROCURIE OF CARBON 14 UREA (PARTS 30 AND 32)

Attached for your signature is the SECY Paper transmitting a proposed rule to the Coramission to amend Parts 30 and 32 to permit the exempt distribution and use of one micro-Curie ( Ci) capsules of carbon-14-urea for in vivo diagnostic use. This proposed rule was developed in response to a petition for rulemaking submitted by Tri-Med Specialties, Inc.

A final rulemaking plan was approved by the Commission in a Staff Requirements Memorandum dated March 3,1997 (SECY 97-031). This proposed rule is consistent with the final rulemaking plan, if you have any questions, please contact Sam Jones (415-61981.

Attachment:

Commission Paper w/encts.

Distribution:

RPHEB RF Central File CGallagher DMendiola FCostanzi LRiani ATu LBolling, OSP LCamper, NMSS MRothschild, OGC DBHowe, NMSS DOCUMENT NAME: o:\ jones \c14pr.tm To receive a copy of this document, indicate in the box "C" = copy without attachment / enclosure, "B" = copy with attachment / enclosure, "N" = No copy OFFICE: DRA/R'PHEB DRA/RPHEB , D/D$f]hS D/RES Jy NAME: SJones:nb47e CTrottir;r [l[ DMorrison DATE: 04/a /97

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COMMISSION PAPER

EQB: The Commissioners FROM: L. Joseph Callan, Executive Director for Operations

SUBJECT:

PROPOSED RULE: EXEMPT DISTRIBUTION AND USE OF A RADIOACTIVE DRUG CONTAINING ONE MICROCURIE OF CARBON 14 UREA (PARTS 30 AND 32)

PURPOSE:

To obtain the Commission's approval for the publication of the proposed rule.

BACKGROUND:

By negative consent, the Commission approved a rule.naking plan to amend Parts 30 and 32 to permit the exempt distribution and use of one micro Cune (pCi) capsules of carbon-14 urea for in vivo diagnostic use. This rulemaking plan was submitted to the Commission on February 7,1997 as SECY-97-031.

DISCUSSION:

Part 30 would be amended to add a new section (5 30.21), to permit any person to receive, possess, use, transfer, own, or acquire carbon-14 urea capsules, not to exceed one microcurie of carbon-14, for "in vivo" diagnostic use, without a license. The proposed amendment would include a reminder that persons would not be relieved from complying with applicable FDA, other Federal, and State requirements governing drugs. Also, any person who desires to use the capsules for research involving human subjects still would be required to apply for and receive a specific I?:ense pursuant to Part 35.

Part 32 would be amer'ded to add a new section (5 32.21) to establish requirements for the manufacture and distribution of carbon-14 urea capsules to persons exempt from CONTACT:

Sam Jones, RES/DRA (301) 415 6198

The Commiss;or.ers 2 1

licensings Currently, NRC requires licensees who manufacture, piepare, or commercially distribute radioactive drugs to meet the requirements in 5 32.72(a)(2) (e.g., be registered or licensed with the FDA or a State as a drug manuf acturer or be licensed as pharmacy by a State Board of Pharmacy). The proposed amendment would require licensees distributing these capsules under an exempt distribution license to meet this same requirement because the capsules will have widespread distribution for "in vivo" diagnostic use by persons who will be exempt from licensing. Also', this would provide high confidence that the carbon 14 ures capsules contain only cne microcurie of carbon-14 and do not contain other radioactive contaminants.

COORDINATION:

The Office of the General Counsel has no legal objection to the proposed rulemaking. The Office of the Chief Financial Officer concurs in the resource impacts of this rulemaking.

The Office of the Chief Information Officer concurs that there will be no information technology or management impacts.

HE_QDMMENDATION:

That the Commission:

1. Anorove for publication in the Federal Reaister the proposed amendments to 10 CFR Parts 30 ar.d 32 (Enclosure 1). .

2. Noin:

a. That the proposed amendments will be published in the Fedcral Reaister allowing 75 days for public comment.

b. That the Chief Counsel for Advocacy of the Small Business Administration will be informed of the certification and the reasons for it, as required by the Regulttory Flexibnity Act, 5 U.S.C. 605(b).

c. A regulatory analysis has been prepared for this rulemaking (Enclosure 2).

d. An Environmental Assessment has been prepared for this rulemaking (Enclosure 3).

e. The appropriate Congressional committees will be informed of this action (Enclosure 4).

f. That a public announcement will be issued by the Office of Public Affairs when the proposed rulemaking is filed with the Office of the Federal Register (Enclosure 5).

. . . _ . . . .-. - -. ..- . - . - ... . . - . - - . -.- - -..- . ~ . . .- -

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The Commissioners- - 3 .;

g. This proposed rule amends information collection requirements that are: 2

- subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). -;

Tliis rule is being sent to the Office of Management and Budget for review and approval of the information collection requirements, l

h. That resources to complete and implement this ulemaking are includeri in the current budget.- ,

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- L. Joseph Callan-Execut!ve Director

.for Operations

Enclosures:

As stated (5)

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g. This proposed rule amends informate > collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.).

This rule is being sent to the Office of Management and Budget for review and approval of the information collection requirements.

h. That resources to complete and implement this ulemaking are included in th s- ::urrent budget.

Original Signed by Hugh L. Thompson,Jr. g L. Joseph Callan -

Executive Director for Operations

Enclosures:

As stated (5)

Distribution:

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' The Commissioners - 3-g .- This proposed rule amends information collection requirements that are

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This rule is being s' ent to the Office of Management.and Budget for review and approval of the information collection requirements.

h. .That resources to complete and implement this rulemaking are included in the current budget.

L. Joseph Callan Executive Director-for Operations

Enclosures:

As stated (5)

Distribution:

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ENCLOSURE 1 FEDERAL REGISTER NOTICE l

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[7590-01 -P)

- NUCLEAR PEGULATORY 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 licensees to distribute a radioactive drug containing one microcurie of carbon 14 urr' ' 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. This action is being taken in response to a petition for rulemaking (PRM-3512) submitted by Tri-Med Specialties, Inc.

DATES: Submit comments by (Insert date 75 days after publication aate). Comments received after this date will be c nsidered if it is practicable to do so, but the Commission is able to assure consideration only for comments receivnd on or before this date.

I

ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention: Docketing and Service Branch.

Hand deliver commen;s to: 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 findir.g of no significant impact, and the regulatory analysis at the NRC Public Document

' Room, 2120 L Street NW. (Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT: Sam Jones, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commisslor., Washington, DC 20555-0001, telephone (301) 415-6198 or e-mail at SZJ@nrc. gov.

SUPPLEMENTARY INFORMATION:

1. Background.

II. Discussion.

Ill. Summary of Proposed Amendn.onts.

-IV. Agreement State Compatibility.

V. Electronic Access.

VI. Finding of No Significant Environmental Impact: Availability.

Vll. Paperwork Reduction Act Statement.

Vill. Regulatory Analysis.

IX. Regulatory Flexibility Certification.

X. Backfit Analysis.

2

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l. Background The Petition for Rulemaking On October 6,1994, the Commission docketed a petition for rulemaking (Docket No. PRM 35-12) from Tri-Med Specialties, Inc (Tri-Med). In a lettsr dated August 23, 1994, Tri-Med petitioned the NRC to amend its regulations "to allow for the general licensing andlor exemption for the commercial distribution by licensed pharmaceutical manuf acturers of a capsule containing one micro-Curie ( Ci) of "C-urea for in vivo diagnostic testing." The purpose of this diagnostic test is to detect the presence of the bacterium Helicobact 2 d (H. c,1o'ri), a cause of peptic ulcers.

" Peptic ulcer du vase is a chronic inflammatory condition of the stomach and duodenum that effects as many as 10 percent of people in the United States at ccme time in their lives. The disease has relatively low mortality, but it results in cubstantial human suffering and high economic costs." (Sourco: Article included as an appendix to the petition, from JAMA, July 6,1994, Vol-272, No.1, "H. pylori in Peptic Ulcer Disease-NIH Consensus Conference"),

in the petition, 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 proolems, 3

i

It is therefore necessary to detect the presence of H. pylori bacteria in ulcer-patients so that the new treatment can be given appro'priately, in the past, 4

this was done by a gastroenterologist who took biopsy samples of the stomach lining at endoscopy, a procedure which was uncomfortable and expensive ($1000).

With the new test, H. pylori can be detected non-invasively using a "C urea-tracer. "C-urea is broken down by H. pylori to form labeled CO, which is

>axpired in the breath. To do the test, a doctor asks the patient to swallow the capsule with 30 mis of water. After 15 minutes the patient blows 2 liters of breath into a collection bag (a mylar balloon) which is mailed to a testing laboratory. ll "C CO more than twice background is present in the breath sample, then the patient must be infected with H. pylori.

Public Comments on the Petition FoKt; wing 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. The NRC received 315 -

public comment letters, of which 313 support the petition (they were mostly form lettars) and ? letters opposed the petition. The two letters opposing the petition stated that the

- product should not ' receive an exempt status because the uncontrolled distribution and application of this product could lead to significant risk to the public and that the medical 4

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a uses should be restricted to short lived isotopes because of disposal problems presented -

by.long-liv'ed isotopes.

.The NRC has considered the two opposing comments and has determined the following:

2 (1) The resulting radiation dose from the capsules to workers, patients, and the public 13 very low (see Regulatory Analysis).

(2) The impacts associated with any seleases of "C to the surrounding environment are expected to be very small and th'e expected risks are minimal (see Environmental'

' Assessment). Similarly, the small doses from naturally 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 radiological 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 meeting. The ACMUI indicated that it endorsed

the wide availability of this diagnostic test and that the radioactive drug could be used under a general license or an exemption, whichever the NRC may determine to be procedurally easier.-

S i i

e ll. rescussion Regulatory issue The regulatory issue is whether capsules containing one microcurie of carbon 14 urea present a sufficiently'small radiation risk that they can be safely distributed to any person (including physicians who are not " authorized users" under Part 35).

Current NRC Regulations for the Manufacture and Commercial Distribution of Radioactive Drugs Containing Byproduct Material NRC regulations in 10 CFR 32.72 address the manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material. This regulation requires manufacturers or preparers of radioactive drugs for commercial distribution to be:

(1) Registered or licensed with the U.S. Food and Drug Administration (FDA) as a drt.g manufacturer; (2) Registered or licensed with a state agency as a drug manuf acturer; (3) Licensed as a pharmacy by a State Board of Pharmacy; or (4) Operating as a nuclear pharmacy within a Federal medical institution.

These facilities have a specific license with the NRC. Under the specific license, the manuf acturer or pharmacy can distribute radioactive drugs only to persons authorized

. pursuant to Part 35, " Medical Use of Byproduct Material."

6

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 safe use of radioactive drugs) or persons work.:ng under the supervision of an authorized user to use 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 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 application to, a human being. (in the case of exempt quantities, this prohibition is contained in 5 32.18, " Manufacture, 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 9 30.18 because of their intended 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 6 30.18. It would introduce 7

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_need! ass complexity to the regulations and confusion to accommodate this unique use t

' under the aforementioned sections.

However, because the capsules present an insignificant radiological risk to the_

public'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 4

of the Capsules to Persons Exempt from Licensing 2 Proposed Amendment to 10 CFR Part 32 The regulations in 10 CFR Part 32 would be amended to add a new I 32.21, to -

- provide requirements for a specific license to manufacture, process, produce, package,-

repackage, or transfer capsules containing one microcurie of carbon-14 urea, as a e

radionctive drug, to be distributed to any person for "in vivo" diagnostic use. These reauirements are consistent with the existing requirements on other items under the -

4-

heeding " 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 manufacture and distribution of drugs.

The NRC has decided that the manufacture 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 manufacture and commercially distribute radioactive drugs.

) <

lThe NRC believes regulatory control is needed to provide high confidence that the drug g .

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contains only one microcurie of carbon 14 urea and does not contain any other radioactive contaminants.

4 Proposed Amendment for Exempting "Any Person" from Licensing Requirements to Receive the Drug . .

Proposed Amendment 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 the use of this drug for its radioactive component. Therefore, the NRC can not justify requiring physicians, or any other person, to meet NRC training and-experience criteria directed at

' the safe use of radioactive drugs, or to become an " authorized user." Hence, the capsules can be distributed to any person. However, other Federal or State agencies may limit the 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 i 30.21, to permit any person to receive, possess, use, transfer, own, or acquire for "in vivo" diagnostic 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, the exemption would prohibit research involving human subjects. Any 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.

9

The phrase "in vivo diagnostic use" is being used in 5 30.21 instead of " medical use" for two reasons. First, the term " medical use" has a specific meaning and is defined in 6 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) The drug could be administered to patients by physicians or other persons who are not authorized users; 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 offect 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 administer the drug, and would not necessarily need to refer their patients to nuclear medicine physicians. TW should result in cost savings to patients. Other Federal and State organizations with responsibilities for regulating drugs would be lef t to determine and regulate who could receive and use the 10

t drug for "in vivo" diagnostic use. NRC would regulate the use of the drug for research

' involving human subjects under a specific Part 35 license.

Ill. Summary of Proposed Amendments Manufacturer and Distributors A new section would be added to 10 CFR Part 32 to permit the oistribution of the capsules to persons who are exempt from licensing.

5 32.21 Radioactive drua: Manufacture, distribution, and transfer of carbon-14 urea caosules not exceedina one microcurie each for "in vivo" diaanostic use for humans:

Reauirements for a license -

Paraaraoh (a)

This paragraph would allow the drug in capsule form to be distributed to persons without the need for an NRC or Agreement State license.

s Paracraoh (a)(1)

The NRC would limit issuance of an " exempt distribution license" for distribution of the capsules to persons exempt from licensing to only those who possess either a NRC or Agreement State " specific license" for possession and use of byproduct material.

11 Lh - y

Paraaraoh (a)(21' To assure that the capsules contain no more than one microcurie of carbon 14 and present no other radiological risks, the NRC would require that the persons manufacturing and/or distributing the capsules for "in vivo" diagnostic use must also meet the requiren ants of 5 32.72(a)(2). Specifically, these persons must be:

(1) Registered with or licensed by the FDA as a drug manufacturer; or (2) Registered with or licensed by a state agency as a drug manufacturer; or -

(3) Licensed as a pharmacy by a State Board of Pharmepy; or (4) Operating as a nuclear pharmacy within a Federal medicalinstitution.

Paraaraoh' (a)(3')

Applicants would be required to provide evidence that each carbon-14 urea capsule will not exceed one microcurie, lhe 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 varbon-14 capsule will not exceed one microcurie.

Peraarar,h (a)(4)

The NRC 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, because exempt distribution of this drug has only been evaluated for "in vivo" diagnostic use in the form of a capsule containing one microcurie of carbon 14 urea.

12 --

. r Paraaranh (a)(5J Because the exempt distribution of this drug has only been evaluated for "in vivo" .

diagnostic use in the form o. 9 capsule containing one microcurie of carbon-14 urea, the

- NRC would prohit,it incorporation of the capsules into any manufactured or assembled commodity, product. or deyice intended for commercial distribution. Further, although the -

drug is being distributed to persons exempt from licensing, the NRC will require the carbon-14 urea U be identified as radioactive because the drug is being userf for its radioactive content; therefore, the end user must be provided with information that the e

drug contains a radioactive material.

- Paraaraoh (all6)

As with any product approved for distribution to persons exempt from licensing, the NRC would require persons who apply for a license to manufacture or distribute these capsules to submit copies of prototype labels or brocheres 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).

Paraaranh (b)

This paragraph declares that the regulations do not relieve licensees or license applicants from complying with applicable FDA, other Federal, and State requirements E

governing the manufacture and distribution of drugs, t

13

- Section 32.213 Same: Conditions of licengg

= In this section, the NRC states the conditions required for a license to distribute the capsules to persons exempt from licensing.

.- l

brporpoh fal .

^

To inform the end user of the identity of the radioisotope, the physical and chemica! j form, and the dosage of radioactivity, the NRC would require that the immed! ate container

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I of each capsule'or capsules'must bear a durable, legible label that:

(1) Identifies the radioisotope, the physical and' chemical form of the radioisotope, the quantity of radioactivity contained in each container at a specific date; and (2) Bears the words " Radioactive Material."

The date requirement is consistent with labeling requirements for other radioactive )

' drugs with a half life of greater that 100 days.

brooraoh (b)

Consistent with the intended use of the capsules, the label aff ed to the immediate L container, or en accompanying brochure, must:

(1) State that the contents are exempt from NRC or Agreement State licensing requirementc; i

(2) Bear the words " Radioactive Material. For "In Vivo" Diagnostic Use Only. This ;

Materialis Not to be Used for Research involving Human Subjects, and Must Not be

Introduced into Foods, Beverages, Cosmetics, Other Drugs or Madicinals, or into Products

' Manufactured for Commercial Distribution." ,

14; '

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1 1 - .

"In vivo" disopostic use by persons exemot from licensina

;i

~ I 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 use for ~

. humans.-

d

=,,_.

' Section 30.21 Radioactive'druai Caosules containina one microcurie of ca! bon-14~

- urea for "in vivo" diaonostic use would be added to permit any person to receive the

capsules.

Paraormoh (al The NRC would exempt'any person from the requiroments for a license to receive, possess, use, transfer, own, or acquire capsules containing one microcurie of carbon 14 urea for "in vivo" diagnostic purposes.

Parauraoh (b)

% Persons exempt from licensing would be prohibited from using the drug for research

- involving humans subjects. A specific Part 35 license would be needed to use the drug in-I any research involving human subjects.

r-

~

Paraaraoh ic)-

This paragraph would specify th'at a specific license is needed to manufacture, process, produce, package, repackage or transfer such capsules for commercial i distribution.

r f M 15 1

s , ,- . ~ . - , . -- - , . . , .

4 fWo.numh.1d1 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.

IV. Agreement State Compatibility Under the Atomic Energy Act, certain regulatory functions are reserved to the NRC.

Among these are the distribution of products to persons exempt from licensing, as discussed in 10 CFR Part 150. Hence, the proposed rule, if adopted would be a Division 4 item of compatibility, with regard to the manufacture and distribution of the capsules (10 CFR Part 32). Due to the need for nationwide consistency in the use of products which are widely distributed, the proposed rule if adopted would be a Division 1 item of compatibility with regard to possession and use (10 CFR Part 30). Therefore, the Agreement States will need to make appropriate provisions in their regulations to allow any person to receive capsules containing one microcurie of carbon 14 urea for "in vivo" diagnostic use without need for a license.

V. Electronic Access Comments may be submitted electronically, in either ASCil text or WoroPerfect format (version 5.1 or later), by calling the NRC Elect .-nic Bulletin Board on FedWorld or connecting to the NRC interactive rutomaking web site, *Rulemaking Forum." Trie bulletin 16

board may be accessed using a personal computer, a modem, and one of the commonly available communications sof tware packages, or directly via Internet.

If using a personal computer and modem, the NRC subsystem on FedWorld can be accessed directly by dialing the toll frue number: 1 800 303 9672. Communication sof tware parameters should be set as follows: parity to none, data bits to 8, and stop bits to 1 (N,8,1). Using ANSI or VT 100 terminal emulation, the'NRC NUREGs arid Reg Guldes for Comment subsyctem cun 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 Centar" from the "NRC Main Menu." Users will find the " Fed'Norld Online User's Guides" particularly helpful. Many NRC subsystems and databases also have e " Help /Information Center" option tbst 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 'aternet, fedworld. gov. If using 703 3213339 to contact FedWorld, the NRC suosystem will be '

t accessed from the main FedWorld menu by select *ng the " Regulatory, Government Administration and 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 r"enu. The NRC Online area also can be Laccessed 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 toll free number, you will have full access to all NRC systems

< but you will not have access to the main FedWorld system.

-17 k

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If you contact FedWorld using Telnet, you wint see the NRC area and menus, - l l

including the Rules menu. Although you will be able to download documents and leave !

t 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 ,

index file listing all files within a subdirectory, with descriptions, is included. There is a 15 minute time limit for FTP access. [

t Although FedWorld can be accessed through the World Wide Web, like FTP that ;

mode only provides access for downloading files and does not display the NRC Rules i menu.

You may also access the NRC's interactive rulemaking web site through the NRC home page (http://www.ntc. gov). This site provides ,e access as the FedWorld .

bulletin board, including the facility to upload comments as files (any format), if your web i

browser supports that function.

For more information on NRC bulletin boa'rds call Mr. Arthur Davis, Systems Integration and Development Branch, U.S. Nuclear Regulatory Commission Washington, {

DC 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. - ,

VI. Finding of No Significant'Envirorimental Impact: Availability

. The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, 18

. l l

.. 1 I

that the proposed amendments,if adopted, would not b9 a major Federal action significantly af fecting the quality of the human environment; therefore, an environmental impact sta'.ement is not required. The proposed rule would establish requirements for the manuf acture and commercial distribution of "C-urea capsules to persons exempt from licensing and establish regulations to permit any person to receive the capsules without an NRC license. 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 cspsules for radiation safety is not necessa.ry, 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 resultir.g 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 environmentel assessment and finding of no significant impact on which this determination is based is available for 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 Sam Jones, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6198 or e mail at SZJ@nrc. gov.

Vll. Paperwork Reduction Act Statement This proposed rule amends information co!iection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This rule has been 19

submitted to the Office of Management and Budget for review and approval of the information collection requirements.

The public reporting burden for this collection of information is estimated to average 10 hours1.157407e-4 days 0.00278 hours 1.653439e-5 weeks 3.805e-6 months per response, including the time for reviewing instructions, searching existing cata sources, gather;ng and maintaining the data needed, and completing and reviewing the collection of information. The Nuclear Regulatory Commission is seeking public comment on the potentialimpact of the collection of informction contained in the proposed rule and on the 'ollowing issues:

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?

3. (s there a way to enhance the quality, utility, and the clarity of the information to be collectsd? '

4. How can the burden of the collection of information be minimized, including the use of automated , ection techniques?

Send comments on Ony aspect 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 Internet electronic mail at BJS1@NRC. GOV: and to the Dask Officer, Office of Information and Regulatory Affairs, NEOB 10202, (3150 0001 and 3150-0017), Office of Management and Budget, Washington, DC 20503.

Comments to OMB on the information collections or cn the above issues should be submitted by (insert date 30 days after publication in the Federal Register). - Comments 20

.9 roceived af ter this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date,. ,

Public Protection Notification The NRC may not conduct or spensor, and a person is not required to respond to, a ,

collection of information unless it displays ' 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 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 Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555 0001, telephone (301) 415 6108 or e-mail at SZJ@nre. 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 to use an additional diagnostic test without having to obtain an NRC license, thus, would provide cost savings to physicians and patients. Any small entity subject to this regulation which 21

_ . . _ _ _ . . . - ~ _ -

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I f

l 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: l (a) The licensee's size and how the regulation would result in a significant

. economic burden upon the licensee as comhared to the economic burden on a larger , , .

licensee. !

(b) How the regulations could be modified to take into account the licensee's

<liffering 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 tho impact of regulations or create more equal access to the benefits of Federal programs as opposed to i

providing special advantages to any individual or group, (e) How the regulation, as modified, would still adequately protect public health - i and safety. - i 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 n'ot required because these amendments do not involve any provisions that would impose backfits sa defined in 10 CFR 50.109(a)(1).

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List of Subjects t 10 CFR Part 30 Byproduct material, Criminal pen @les, Government contracts, Intergovernmental !

relations, Isotopes, Nuclear materials, Radiation protection, Reportina and..renord keeping :

i requirements. :

c

-10 CFR Part 32

- 8yproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.

.1 1

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#'JLES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL .

1. The authority citation for Part 30 ' continues to read as follows: ,

AUTHORITY: Sacs. 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. 2111, 2112, 2201, 2232/ 2233, 2236, 2282); sacs. 201, as amended, 202, 206, 88 Stat.1242, as

~

amended, 1244,' 1240 (42 U.S.C. 5841, 5841, 5846).

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' Section 30.7 also issued unoer Pub. L. 95 601, sec.10,92 Stat. 2951 as amended by Pub. L. 102-486, sec. 2002,100 Stat. 3123, (42 U.S.C. 5851). Section 30.34(b) also i

issued under sec.184,' 68 Stat.' 954, as amended (42 U.S.C. 2234). Section 30.61 also issued under sec.187,68 Stat. 955 (42 U.S.C. 2237). [

. 2.130.8(b) is revised to read as follows: [

l 30.8 infonpation collection.reouirements: OM8 anoroval, '

-i (b) The approved infortnation collection requirements contained in this part appear f in i 5 30.9, 30.11, 30.15, 30.18, 30.19, 30.20, 30.21, 30.32, 30.34, 30.35, 30.36, 30.37, 30.38, 30.41, 30.50, 30.51, 30.55, appendices A and C to this part. l

3. A new i 30.21 is added under the undesignated center heading " Exemptions" to read as follows:

i 30.21 Radioactive drua: Caosules containina one microcurie of carbon-14 urt a for "in ' j vivo" d!aanostic use.

(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 regulations in this part and Part 35 of this chapter provided that such person receives, possesses, uses, transfers, owns, or acquires carbon 14 urea capsules, not exceeding one

- microcurie each, for "in vivo" diagnostic use. -

i (b) Any person who desires to use the capsules for research involving human subjects shall apply for and receive a specific license pursuant to Part 35 of this chapter.

-i 24 {

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(c) Any person who desires to manufacture, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license pursuant to 6 32.21 of this chapter.

(d) Nothing in this section relieves persons from complying with applicable FDA, other Federal, and State requirements coverning ter:elpt, administration, and use of drugs.

PART 32 SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL

4. The authority citation for Part 32 continues to read as follows:

AUTHORITY: Sacs. 81,101,182,183, 68 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. I 32.8(b) is revised to read as follows:

6 32.8 Information collection reauirements: OMR eDorov_gl.

(b) The approved information collection requirements contained in this part appear in 19 3 2.11, 3 2.12, 3 2.14, 32.15, 32.16, 32.17, 32.18, 3 2.19, 3 2.21, 3 2.20, 32.22, 3 2.23, 3 2.25, 3 2.26, 32.27, 32.29, 32.51, 3 2.51 a, 3 2.52, 32.53, 32.54, 32.5 5, 32.56, 32.57, 32.58, 32.61, 32.62, 32.71, 32.72, 32.74, and 32.210, 25

=- - . - - -. . . - . - -. - - -.

O

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6. A new 6 32.21 is added to read as follows: ;

i 32.21 Radioactive drua: Manufacture, distribution, and transfer of carbon 14 urea !

CdDsules not exceedina one microcurie each fo. "in vivo" diaanostic use: Reauirements for

~

a license.

(a) An application for a saecific license to manufacture, process, produce, package, repackage, of transfer for commercial distribution carbon 14 urea capsules not exceeding one microcurie sach for "in vivo" diagnostic use, to persons exempt from licensing under - ,

15 30.21 or the equivalent regulat!ons of an Agreement State will be approved if:

(1) The applicant satisfies the general requirements specified in i 30.33 of this I

chapter, provided that the requlrom.entJ of 5 30.33(a)(2) and (3) of this chapter do not apply to an application for a license to transfer byproduct material manufactured, processed, producedi packaged, or repackaged pursuant to a license issued by an Agreement State; (2) The applicant meets the requirements under i 32.72(a)(2);

-(3) The applicant provides evidence that each carbon 14 urea capsule will not exceed one microcurie; (4) The carbon 14 urea is not contained in any 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 for its radioactive properties, but is not incorporated into any manufactured or assembled commodity, product, c device intended for commercial distribution; and

-(6) The applicant submits copies of prototype labels and brochures and the NRC '

approves these labels and brochures, i

26

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^- (b) Nothing in this section relieves the licensee from complying with applicable FDA, !

I other Federal, and State requirements governing drugs. :

l P

7. A now i 32.21a is added to read as follows: l i 32.21a Same: Condit@Ds of license.

Each license issued under i 32.211s subject to the following conditions: I i

(a) The immediate container of the capsule (s) must bear a durable, legible label I

. which: . ;

(1) Identifies the radioisotope, the physical and chemical form, the quantity of -

{

radioactivity of each capsula at a specific date; and .l l

(2) Bears the words " Radioactive Material." ]

P (b) In addition' to the labeling information required by paragraph (a) of this section, -

~

the label affixed to'the immediate container, or an accompanying brochure also must:-

(1) State that the contents are exempt from NRC or Agreement State licensing ;

requirements; and i

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i (2) Bear the words " Radioactive Material. For "In Vivo" Diagnostic Use Only. This Materialis Not to be Used for Research involving Human Subjects and Must Not be i Introduced into Foods, Beverages, Cosmetics, Other Drugs or Medicinals, or into Products !

4 Manuf actured for Cornmercial Distribution."

?

1:

Dated at Rockville, Maryland this day of __ ,1997.

t

- For the Nuclesr Regulatory. Commission. !

John C. Hoyle, '

Secretary of the Comrnission.

4 i

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I ENCLOSURE 2 l

REGULATORY ANALYSIS ;

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REGULATORY ANALYSIS l 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. packaround 1.1 Statement of the Proh!am 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 regulations "to allow for the general licensing and/or exemption for the commercial distribution by licensed pharmaceutical manufacturers of a capsule containing one micro-Curie ( Cl) of "C-urea for in vivo diagnostic testing." The purpose of this diagnostic test is to detect the presence of the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers.

" Peptic ulcer disease is a chronic inflammatory conditien 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 Cordarence").

In the petition dated August 23,1994, the petitioner stated the following:

Recent medical research has found that peptic u'cers 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. ,

it is therefore necessary to detect the presence of H. pylori bacteria in ulcer-patients so that the new treatment can be given appropriately, in the past, this was done by a gistroenterologist who took biopsy samples of the

,. stomach lining at endoscopy, a procedure which was uncomfortable and expensive ($1000).

With the now test, H. pylori cen be detected non-invasively using a "C urea tracer "C-urea is broken down by H. pylori to form labeled CO: which is expired in the breath. Tp do the test, a doctor asks the patient to swallow the capsule with 30 mis of water. After 15 minutes the patient blows 2

-liters of breath into a collection bag (a mylar balloon) which is mailed to a .

. testing laboratory, if:"C-CO, more than twice background is present in the breath sample, then the patient hiust be infected with H. pylori.

I

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1.2 Current NRC Reaulations [

In 10 CFR Part 32, " Specific Domestic Licenses To Manufacture or Trarisfer Certain items ;

Containing Byproduct Matedals," l 32.72, "Manuf acture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under Part 35," provides for commercial distribution of radioactive drugs containing ;

byproduct material for use by persons authorized pursuar't to Part 35. Thus, the '

. . - regulations currently would permit Part 32 licensees to commercially distribute capsules ,

containing 1 pCi of "C-ures to persons authgri. red pursuant to Part 35. '

in 10 CFR Part 35, " Medical Use of Byproduct Material," sets forth radiation safety requirements, including requirements for the training and experience of authorized user physicians to assure the safe possession and use of radioactive dWs containing

' byproduct material.

Existing exemptions for use of byproduct materialin i 30.14, " Exemption concentrations" and i 32.18, " Manufacture, distribution and transfer of exempt quantities of byproduct rnatorial: Requirements for license," do not permit the.cxempt transfer of byproduct material contained in ary/ food, beverage, cosmetic, drug, or any product designed for ingestion or Inhalation by, or application to, a human being.

t Therefore, under current regulations, the "C-urea car, ules 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 for rulemaking" was published for public comment in the Federal Realster on December 2,1994 (59 FR 61831). A total of 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 because the uncontrolled distribution and application of this product could lead to significant risk to the public and (2) medical uses should be restdcted to short lived isotopes because of disposal problems presented by long lived isotopes. >

This petition was discussed with NRC's Advisory Committee on the Medical Uses of '

Isotopes (ACMUI) at the October 1995 meeting. The ACMUI indicated that it endorsed the wide availab!!ity 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. J A rulemaking plan was prepared. After receiving comments from Agreement States on the draf t rulemaking plan, the Commission approved a final rulemaking plan to develop a proposed rule to amend 10 CFR Parts 30 and 32 allowing the' distribution of the Carbon 14 capsules as an exempt material to any person, 2 1

. ~

2. Objective i

The objective of the rulemakiry is to amend 10 CFR Part 32 to permit the manuf acture and commercial distribution of "C urea copsules 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.

3. Alternatives Three alternatives have been considered in the regulatory analysis: deny the petition, i.e.,

' rr.aintain the status quo, permit the distribution of the capsules to persons exempt from licensing, and permit the distribution of the capsules to generallicensees.

Under the first altenative, 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 the capsules because of the requirement for training and experience and the associated costs of obtaining and maintaining a Part 35 license. Alternatively, physicians who are not authorized users can continue to refer their patients to physicians who are uuthorized 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 se end alternative,10 CFR Parts 32 and 30 would be amended.10 CFR Part 32 Gld be amended to permit the manufacture and commercial distribution of "C utea 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 c;ingnostic use for humans. The NRC has determined that the radioactive component of this drug presents a minimal radiation risk and, theiefore, 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

4. Value ImpJct Analysis 4.1 _Ibe Petitioner's Assessment 4

in the letters dated August 23,1994 and November 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

($ 1000).

... 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 been cured of their infection. By providing the public with an inexpensive, easily accessible diagnostic test, more individuals would be accurately diagnosed and treated for their H. pylori infection. This would save the United States an estimated

$500 million per annum over conventional therapy.

The petitioner estimates annual benefits to be on the order of $500 million/ year. This assumes approximately 600,000 "C urea breath tests / year, at an average cost of $100, in lieu of parforming endoscopy at an avei: a 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 beriefit analysis provides a measure of the total benefits associated with the test and does not focus on the incremental benefits of administering the test pursuant to 10 CFR 35.100 regula; ion (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 of 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 on equivalent Agreement State regulations. Further, Tri-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.

4.2 Il)e NRC's Assessment (a) Cost Savinas Associated with Amendments to 10 CFR Part 30 The value impact analysis focuses on the incremental benefitr of granting relief consistent with Alternative 2 or 3, a; 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 non-invasive tests. For the purposes of this regula;ory 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, if the breath test is judged preferable to endoscopy, or other 4

. = - - . ._

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 care cost resulting from the elimination of the need for referrals from a physician who is not an authorized user (e.g., gaat.vi.au=tioal specialist). There would

., also be some regulatory 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 actior.,

a significant portion of the 600,000 patients would receive the "C breath test from ph/sicians who are not authorized users (e.g., gastrointestinal speclafists). The actual savings would be dependent on the number of tests ultimately administered by physicians who are not authorized users, thereby eliminating the need for a referral to physicians who are authorized users (e.g., nuclear medicine specialists).

The annual savings could be as high as approximately $20 million if there was a complete shift of the administration of the tests from physicians who are authorized users (i.e., base case) to physicians who are not authorized users.

The basis for this estimate is as follows.

Assuming adoption of the petition climinates 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 hours5.787037e-5 days 0.00139 hours 8.267196e-6 weeks 1.9025e-6 months / trip x $25.00/ hour) =

$10.5 million/ year Health Care Savings in averted administrative expenses (administrative costs incurred with medical referral) would be:

600,000 patients / year x $19.00/ patient = $11.4 million/ year .

Assuming $19.00 (administrative cost / patient) as the differential between the cost of an office visit to a generel family 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 likely be a new patient for the authorized user.

5

3 Total Savings:

$10.5 million/ year + $11.4 million/ year = $ 21.9 million/ year Afternatively, if only 200,000 or 400,000 of the 600,000 tests vvere performed by a physician who is not an authorized user, the annual cost savings would be approximaQ l

$7 million per year and $15 million per year, respectively, i

. If Afternative 3 were adopted,it would permit any physician to receive and use capsules conte'ning 1 pCi "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 States that assess licensing or registration fees for generallicense holders. Alternative 2 also imposes incremental cost burden for manufacture cr commercial distributors of the capsules because they would need obtain an exempt distribution license. Each application would be estimated to take about 16 hours1.851852e-4 days 0.00444 hours 2.645503e-5 weeks 6.088e-6 months .

Asouming 3 applicants per year, the total reporting burden would be 48 hours5.555556e-4 days 0.0133 hours 7.936508e-5 weeks 1.8264e-5 months . For recordkeeping burden, assuming each of the 3 applicants in a year would need 2 hours2.314815e-5 days 5.555556e-4 hours 3.306878e-6 weeks 7.61e-7 months to reprogram its computer to print additional words on the label or brochure, the one time 1 recordkeeping burden would be 6 hours6.944444e-5 days 0.00167 hours 9.920635e-6 weeks 2.283e-6 months . 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 permit the use of the capsules by persons other than physician who are authorized users.

(b) Health and Safetv Effects For the purposes of this regulatory analysis, the NP.C 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 per 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 theso capsules results in insignificant exposures as dephted below:

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i Scena.. Maximum Exposed Routine Exposure Individual 4

Worker administering "C- Full time worker,8,000 Less than 0.7 mrem /yr urea breath tests patients /yr Routine exposure of Patient tests negative 0.38 mrem / capsule patients from "C-urea Patient tests positive 0.19 mr:m/ capsule breath tests Release of 150 Ci of " ,

Member of public in the Less than 0.0002 mrem into administration administration area facility from fire Rupture of a capsule Skin (100 cm') expc sed for 5.8 mrad skin dose, causing skin contamin- one hour prior to washing; 0.029 mrem (CEDE) ation of worker or patient 0.075 pCi skin 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 million curies (equivalent to the activity in 3.8 trillion breath tests), which is in addition to the huge inventory of about 240 million curies in the world's oceans. The "C released into the atmosphere from the use of this test would mix with the globalinventory and expose the public and other biotic components of the enviror. ment 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 far below the EPA reporting level of 1 mrem / year required under the Clean Air Act for routine exposures to a member of the public, or the 4 mrem / year EPA limit for public drinking water, in a total population of about 260 million people in the U.S., the collective annual dose from the breath tests would be about 0.051 person-rem, in addition, the doses from normal use of breath tests, or from any accidental release of "C to the environment also are expected to be very small because the concentration of 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 environment. 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. woe'

increase over a period of time to an average -

of a million tests per year for 50 years, the collective annual dose to the U.S. population would be about 5 person-rem over the next 50 years. This dose is very small when compared to the annual collective dose to the U.S. population from naturally occurring "C of over 300,000 person rem, and about 78,000.000 person-rem from all naturally occurring radiation. Clearly, an increase of a few person rem will not significantly change 7

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these exposures, and thus there is no expected impact from the widespread use of the i breath test on the entire U.S. population. i 4 ;

As a result of this analysis, the NRC concludes that Alternatives 2 and 3 are clearly '

preferable to the no action alternative. This is because either of the two alternatives will !

result in significant cost savings with no measurable adverse effect on health and safety.

Furthermore, the NRC's recommended option is Alternative 2 because it would avoid the .

- unnecessary cost burden to some Agreement States and their generallicensees. '

Therefore, by adopti og the proposed rule, the cost savings would be maximized without any measurable esven e effect on public health and safety. ' ;

5.- Decision 81 tilgar,n i.

Based on the above analysis, the NRC is proposing to permit the manufacture and commercial distribution of Carbon-14 urea capsules to any person (including physicians

~who are not " authorized users" under Part 35) and permit any person, without an NRC ,

license, to receive and use the capsules for in vivo diagnostic use for humans because the i

- radiological risk from such distribution would be negligible and the savings to patients could be significant.

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ENCLOS.URE 3 ,

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ENVIRONMENTAL ASSESSMENT 4

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Environmental Assessment For Proposed Amendments to 10 CFR Parts 30 and 32 i

" 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 Proposcd Action ,

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 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, if adopted, this amendment would make the dcug more widely available, thus reducing costs to patients. This action is being takeriin response to a petition for rulemaking (PRM 3512) submitted by Tri Med .

Specialties, Inc.

2. Need for the Amendment::

The proposed amandments have been developed to grant the petition for rulemaking. The proposed rule, if adopted, would permit manufacturers or commercial distributors to distribute Carbon 14 urea capsules as exempt material to any person. The Commission is proceeding with this rulemaking because it believes that the radiological risk from such distribution would be negligible and the savings to patients could be significant, in i addition, the Commission recognires that other Federal and State agencies (e.g., Food and Drug Administration and the State Boards of Pharmacy) are' responsible for the receipt and use of drugs that do not contain byproduct materials, end would provide necessary oversight for the safe use of these Carbon 14 urea capsules as drugs.

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3. Alternatives Considered Three alternatives have been cor.3idered regarding the petition: deny the petition, i.e.,

maintain the status quo, perrnit the distribution of the capsules as exempt material, and !

permit the distribution of the capsules to generallicensees.

Under the first alternative, tee ~ current situation would continue: only physicians who are authorizrd 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 becaun 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-forwaro procedure.

Under the second alternative,10 CFR Parts 32 and 30 would be amended. Part 32 would be amended to permit the manufacture and commercial distribution of "C-urea capsules to any person (including physicians who are r.ot " authorized users" under Part 35); Part 30 would be amended to permit the manufacture and commercial distribution of the capsules -

as an exempt any person, without an NRC license, to receive and use the capsules for in vivo diagnostic use for humans. The NRC has determined that the radioactive component of this drug presents a minirnal radiation risk and, therefore, regulatory control of the capsules is not necessary.

Under the third altemative,10 CFR Part 35 would be amended to permit any physician to re eive 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.

2

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Based on the Draf t Regulatory Analysis prepared for this proposed rule, the Commission concludes that Alternatives 2 and 3 are clearly preferable to the no action alternative. This is because either of the two alternatives will result in significant cost savings with no -

measurable adverse effect on health and safety. Furthermore, the NRC's recommended 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 The proposed amendments would have no significant irnpact on the public and the environment. The NRC assumes that the same number 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 provide the best possible care to h!s or her patients if the breath test is judged preferable to endoscopy, 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, there would be no change in radiation exposures to the workers and patients a when compared the status quo to the proposed action. Similarly, there would be no change in impact to the environment becausa the Commission assumes that the same number of tests will be administered regardless which alternative is adopted.

5. List of Agencies and Persons Consulted and identification of Sources Used Followin;, the receipt of the petition for rulemaking, a " Notice of receipt of petition for rulemaking" was published for public comment in the Federal Renister on December 2, 1994 (59 FR 61831). A total of 315 public comment letters,313 supporting (mostly form letters) and 2 opposing letters, were received. This petition was discus's ed with NRC's Advisory Committee on the Medical U'ses of Isotopes ACMUI) at '.he October 1995 meeting. Furthermore, the draf t rulemaking plan was forwarded to 29 Agreement States for comments.

3

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6. Finding of No Significant impacts 7

-The Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, that the 3 proposed amendments, if adopted, would not be a major Federal action significantly affecting the quality of the human environment, and therefore an environmental impact

itatement is not required. The proposed rule would a" cod 10 CFR Part 32 to permit the ,

manufacture and commercial distribution of "C-urea capsules to any person (including !

physicians who are not " authorized users" under Part 35) arid 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 Commission believes that the radioactive component of this drug presents a minimal radiation risk and, therefore, regulatory control of the capsules for "in vivo" diagnostic use is not necessary'. It is expet,ted 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. ;

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l ENCLOSURE 4 CONGRESSIONAL LETTERS ,

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UNITED STATES -

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NUCLEAR HEGULATORY COMMISSION c .

wAssiwoioN. o.c, nosss-oooi The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and i>ublic 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 notico concerning a proposed amendment t610 CFR Parts 30 and 32. This rulemaking is being taken in response to a petition for rulemaking submitted "by Tri-Mod 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 vivn" 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. If adopted, this amendment would make the drug more widely available, thus reducing costs to patients.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosures:

1. Public Announcement

, 2. Federal Register Notice cc: Serutor Bob Graham

.___-______.~.i__i_----

i i

e The Honorable James M. Inhofo, Chairman Subcommittee on Clean Air, Wetlands, - -

Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20S10

Dear Mr. Chairman:

. Enclosed for the information of the Subcommittee are copies of a public annouricement 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 Mod 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 tu 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. If adopted, this amendment would make the drug more wi<tely available, thus reducing costs to patients.

Sincerely, Dennis K. Rathbun, Director Offica of Congressional Affairs

Enclosures:

1. Public Announcement

2. Federal Register Notice cc: Senator Bob Graham pistribution: CTrottier/RPHEB rf File Center NCostanzi ATse (DOC NAME: O:\ JONES \C14-PR.CL]

Office RPHEB:DRA RPHEB:DRA . , .D:DRA:RES D:p{p, D:OCA Name Dato SJones Aq - CTrottierd MMorrisM_ DIhh DKRathbun 1/"/97 .'t At 797 g/697 97 / /97 Dionibution Yes/No Yes/No Yes/No Yes/No Yes/Nc ;

OFFlidlAL RECORD COPY (RES File Code No.) 3A-3

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UNITED STATES g-n I2.

~ NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20066 4001 4,

-The H6norable Dan Schaefer, Chairman

" Subcommittee on Energy and Power Committee on Commerce United States House of Representatives

. Washington, DC 20515 Dear Mr. Chairmam

' Enclosed for the 'nformation 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 Nucleer 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 capsule,s 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.

Sincerely, ,

Donnis K. Rathbun, Director Office of Congressional Affairs

Enclosures:

s

1. Public' Announcement

'2. Federal Register Notice cc: Representativo Ralph Hall

o' s

The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power

. Committee on Ccmmerce United States House of Representative. -

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 amendment to 10 CFR Parts 30 -

and 32. This rulemaking is being taken in response to.a petition for rulemaking submitted by Tri-Mod Specialties, Inc.

< The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations tc allow NRC licensees to distribute a radioactivo 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. If adopted, this amendment would make the drug more widely available, thus reducing costs to patients.

Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosures:

1. Public Announcement

2. Federal Register Notice cc: Representative Ralph Hall Disirjbutiori: CTrottier/RPHEB rf File Center NCostanzi ATse (DOC NAME: O:\ JONES \C16-PR.CLI Office RPHEB:DRA RPHEB: DRAY D:DRA:RES P D:RES / D:OCA Name SJones A%- CTrottioh BMorris V" DLMorrisonM DKRathbun Date 2 /" /07 ;t]2 797 - < f /j#/97

/ ,

c#/97 / /97 Distribution Yes/No Yes/No Yes/No Yes/No i Yes/No OFFICIAL RECORD COPY -

(RES File Code No.) 3A-3

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-e e ed e ENCLOSURE 5 PUBLIC ANNOUNCEMENT k _.

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es w te e PUBLIC ANN 0UNCEMENT (T0 BE PROVIDED BY THE OFFICE OF PUBLIC AFFAIRS) 6 h

ML20198H875

Contents

Text

SUBJECT:

Attachment:

SUBJECT:

Enclosures:

Enclosures:

Enclosures:

= = = = = =r--- T- m?"==

SUMMARY

Dear Mr. Chairman:

Enclosures:

Dear Mr. Chairman:

Enclosures:

Enclosures:

Dear Mr. Chairman:

Enclosures:

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Forwards for Signature,Secy Paper Transmitting Proposed Rule to Commission to Amend Parts 30 & 32 to Permit Exempt Distribution & Use of One Uci Capsules of carbon-14 Urea for in Vivo Diagnostic Use
Person / Time
ML20198H875
Issue date:	04/17/1997
From:	Morrison D NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:	Callan L NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO)
Shared Package
ML20013E023	List: ML20198H571 ML20198H672 ML20198H718 ML20198H780 ML20198H830 ML20198H875 ML20198H887 ML20198H907 ML20198J119 ML20198J157 ML20198J188 ML20198J224 ML20198J252 ML20198J270 ML20198J298 ML20198J324 ML20198J404 ML20198J418 ML20198J664 ML20198J741 ML20198J766 ML20198J793 ML20198J830 ML20198J869 ML20198J932 ML20198J978 ML20198J988 ML20198J995 ML20198K019 ML20198K055 ML20198K065 ML20198K118 ML20198K151 ML20198K202 ML20198K217
References
FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-019, AF70-1-19, NUDOCS 9801130414
Download: ML20198H875 (58)
v • d • e

ML20198H875

Text

SUBJECT:

Attachment:

SUBJECT:

Enclosures:

Enclosures:

Enclosures:

= = = = = =r--- T- m?"==

SUMMARY

Dear Mr. Chairman:

Enclosures:

Dear Mr. Chairman:

Enclosures:

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Dear Mr. Chairman:

Enclosures:

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