Text

Requests Concurrence on Encl Commission Paper Final Rule: Exempt Distribution of Radioactive Drug Containing 1 Uci of C-14 Urea (Parts 30 & 32). W/Encl,Including FRN
	ML20198L521
Person / Time
Issue date:	08/25/1997
From:	Knapp M; NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:	Galante A, Olmstead W, Paperiello C; NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM), NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS), NRC OFFICE OF THE GENERAL COUNSEL (OGC)
Shared Package
ML20198K526	List: ML20198K525; ML20198K534; ML20198K567; ML20198K576; ML20198K638; ML20198L375; ML20198L385; ML20198L432; ML20198L463; ML20198L477; ML20198L495; ML20198L514; ML20198L521;
References
	FRN-62FR63634, RULE-PR-30, RULE-PR-32 AF70-2-020, AF70-2-20, NUDOCS 9801160050
	Download: ML20198L521 (63)
	v • d • e

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I O o- -- l'. UNITED STATES j [

f NUCLEAR REGULATORY COMMISSION -

-WASHINGTON, D.C. 20661K201 ggg a

%*.....! August 25, 1997 GDI t

MEMORANDUM TO: Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards v

. William J. Olmstead, Associate General Counsol for Ucensing and Regulation Office of the General Counsel AnthonyI Galante Chief Information Officer Jesse L. Funches Chief Finaricial Officer

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Richard L Bangart, Director Office of State Programs Jarnes Lieberman, Director Office of Enforcement Brenda J. Shelton, Chief Information and Records Management Branch Offi:e of Information Resources Mariagement David L. Meyer, Chief Rules rnd Directives Branch

. Divi / on of Administrative Services Office of Administration O ice

SUBJECT:

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

Your concurrence is requested on the attached Commission paper with enclosures, including a Federal Register notice on suoject final rule, This rulemaking action has been taken in response to a petition for rulemaking submitted by Tri-Med Specialties, Inc.

It is requested that NMSS coordinate with the Regions on this final rule.

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- C. Paperiella et al' 2 The following is a summary of this request:

1.

Title:

Fi nal Rule:. Exempt Distribution of a Radioactive Drug Containing One Microcurie of C;rbon 14 Urea

2. RES Tajk Leader: , Anthony Tse (415-6233)

3. Agg.izpnt n Individual: NMSS D. B. Howe

. OSP _ - Lloyd Bolling OGC Stuart Treby .

4. gpmoatibility for Aareement States: Yes .

5l Ep_qv_gsted Action:- Concurrence (Due to EDO 9/30/97)

-6; Reguested Camoletion Date: Two weeks after the date of this memorandum

7. Resoyrces and Coordination: Estimated resources to develop this rule is 0.2 FTE. Copies of.

this concurrence package have been forwarded to ACRS, ACNW, and the IG for information.

Attachment:

Commission paper w/encts.

cc: w/att.-

H. T. Bell, IG J. Larkins, ACRS & ACNW Regions Cognizant Individuals a

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f_QB:; iThe Commissioners -

f_RQJW ; L. Joseph Callani Executive Director for Operaticms -

FINAL RULE ON EXEMPT DISTRIBUTION AND USE OF A RADIOACTNE 4 6UBJECT:i DRUG CONTAINING ONE MICROCURIE OF CARBON 14 UREA (PARTS 30 '

jz , ~'AND 32) 4

~ PURPOSE:-

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

BACKGROUND.

g , On May 30, _1997, the Commission approved the publication of a proposed rule to amend Parts

30 and 32 that would permR :he exempt distribution and use of capsules containing one microcurie carbon-14 urea for *in vivo" diagnostic use. On June 16,1997; the proposed rule was t c

published in the Federal Reaister (62 FR 32552) for a 30 day public comment period. This action-

= is being taken in response to a petition for rulemaking (PRM.35-12) submitted by Tri-Med Specialties, Inc.

DISCUSSION:

t in response to a request for comment on the proposed rule, the NRC received seven public

- comment letters. Four commenters supported the rule, one opposed the rule, and two provided comments without explicitly stating whether they support or oppose the rule. A summary of public comments and staff's responses are presented in the preamble of the enclosed Federal

Register noticeL Except for a minor change in wording, the final amendments are the same as the proposed amendments; The Commissicn should note that'one commenter suggested that research use should be also L permitted under this exemption because the radiological risk is insignificant. The staff did not '

change the fina! rule in response to this comment.- A common rule entitled " Federal Policy for the -

' L Protection of Human Subjects; Notices and Rules" was promulgeted by 16 Federal agencies on -

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June,18, s1991 (50 F.R 28002) and was intended to ensure the protection of human research

. (subjectsn While this common rule provides for the exemption of certain research, such as

- 4 educational tests; surve*/, interviews', or observation of public behaviors; collection of existing

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data; it did not provide for an exemption of research activities involving minimal risk. However, the common rule permits that department or agency heads retain final judgment as to whether a particular activity is covered by this policy. In lieu of padicipating in the promulgation of the common rule, the NRC adopted S 35.6 that requires a licensee who conducts research involving human subjects using byproduct material to obtain informed consent from the human subjects and obtain prior approval by an " Institutional review board"(IRB). Because use of the capsules in conducting human research without following these provirions could erode public confidence in the NRC, even though the capsules present minimal risk, the staff recommends that such research use not be exempt from 9 35.6.

This final rule amends Part 30 to add a new semion (S 30.21) to permit any person to receive, possess, use, transfer, own, or acquire capsules containing one microcurie carbon-14 ures for "in vivo" diagnostic use without a incense. The final amendments include a reminder that persons will not be relieved from complying with applicable FDA, other Federal, and State requirements goveming drugs.

This final rule also amends Part 32 to add a new section (S 32.21) to est91ish requirements for the manufacture and distribution of carbon 14 urea capsules to persons exempt from licensing.

Currently, NRC requires licensees who reanufacture, prepare, or commercially distribute radioactive drugs to meet the requirements in S 32.72(a)(2) (e g., be registered or licensed with the FDA or a State as a drug manufacturer or be licensed as pharmacy by a State Board of Pharmacy). Licensees distributing these capsules under an exempt distribution license will need to meet this same requirement. This provides high confidence that the carbon-14 urea capsules contain one microcurie of carbon-14 and do not contain other radioactive contaminants.

RESOURCES:

Resources to complete and implement this rulemaking are included in the current budget.

COORDINATION:

The Office of the General Counsel has no legal obj(ction to the final 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.

RECOMMENDATION:

That the Commission:

1. Aporove the Notice of Final Rulemaking for publication (Enclosure 1).

2. Certify that this rule, if promulgated, will not have a negative economic impact on a substantial number of small entities in order to satisfy the requirements of the Regulatory Flexibility Act,5 U.S.C. 605(b).

3. Note:

a. Tne final rule will be published in the Federal Reoister.

The Commissioners- 3 s

b. - That the Chief Counsel for Advocacy of the Small Business Administration will be informed of the certification regarding economic impact on small entities and the reasons for it as required by the Regulatory Flexibility Act.

c. A regulatory analysis has been prepared (Enclosure 2);

?- d. An Environmental Assessment has been prepared (Enclosure 3);

e. The apprcpriate Congressional committees will be informed (Enclosurr i);

f. Congressional review letters for Small Business Regulatory Enforcement Faimcss Act will be sent (Enclosure 5);

g. A public anno.ancement will be issued (Enclosure 6); and

h. This final rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S C. 3501 et seq.). This rule has been approved by Office of Management and Budget.

i. All Agreement States will be sent a copy of the final rule upon approval for publication; J. The petitioner will be notified of this action and will be sent a copy of the Federal Register notice;

k. Copies of the Federal Register notice of final rulemaking will be distributed to affected licensees and commenters on the proposed rule. The notice will also be sent to other interested parties upon request.

L. Joseph Callan Executive Director for Operations

Enclosures:

As stated (6)

The Commissioners 3

b. That the Chief Counsel for Advocacy of the Small Business Administration will be informed of the certificatior, regarding economic impact on small entities and the reasons for it as required by the Regulatory Flexibility Act.

c. A regulatory analysis has been prepared (Enclosure 2);

d. An Environmental Assessment has been prepared (Enclosure 3);

e. The appropriate Congressional committees will be informed (Enclosure 4);

f. . Congressional review letters for Small Business Regul atory Enforcement Faimess Act will be sent (Enclosure 5);

g. A public announcement wii: be issued (Enclosure 6); and

h. This final rule amendr !nformation collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This rule has been approved by Office of Management and Budget.

i. All Agreement States will be sent a copy of the final rule upon approval for publication; J. The petitionerwill be notified of this action and will be sent a copy of the Federal Register notice; k, Copies of the Federal Register notice of final rulemaking will be distributed to affected licensees and commenters on the proposed rulc. The notice will also be sent to other interested parties upon request.

L Joseph Ca!!an Executive Director for Operations

Enclosures:

As stated (6)

Distribution:

RPHEB r/b LRiani AThadani, DEDE EDO rif, DMendiola ASummerour CGaliagher RECORD NOTC: A draft copy of the proposed rule was sent to OlG for information on Auaust 'M ,1997, DOCUMENT NAME: o:\tse\c14fr-cp.wpd "See previous conc To rec *we a copy of this document, indicate in the box: "C*

Copy wlo attach /enci *E* = Copy wt attach /enci "N* = No copy l DlDRA l I NMSS l oGP l OFFICE DRA/RPHED l l DRA/RPHEB l JMurphy" CJPaperiello l RLBangart NAME ATse* CTrottler*

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[DATE Blif 8/5197 OGC l ADM l ClO l IRM l OFFICE DE l NAME JLieberman WJOlmstead DMeyer AJGalante < ( BShelton DATE Cl 19 7 31 19 7 s/ 19 7 al /97 l BI 19 7 OCEFO l EDO l l l UUiCE l DIRES NAME- JFunches l MKnapp JLCallan DATE 8/ 19 7 sf /97 19 7 _ 31 OFFICIAL RECORD COPY (RES Fit] Code) RES: 3A-3 GOO 4t$- 19MdJw/J AonuAnw% +

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- h. This final rule amends information collection requireme that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 eq.). This rule has been approved by Office of Management and Budget

i. All Agreement States will be sent a copy o,f a final rule upon approval for publication; /

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j. The petitioner will be notified of th' action and will be sent a copy of the Federal Register notice;

k. Coples of the Federal Re ster notice of final rulemaking will be distributed to affected licensees an mmenters on the proposed rule. The notice will also be sent to other intere d parties upon request.

4 L. Joseph Callan Executive Director for Operations

Enclosures:

At stated (6)

Distribution:

RPHEBr/b LRiani AThadani, DEDE 3

EDO rif, DMendiola ASummerour CGallagher RECORD NOTE: A draft copy of the proposed rule was sent to OlG for information on Auaust .1997.

DOCUMENT NAME: c.\tse\c14fr-cp.wpd "See previous conc To rec *ive a copy of this doci.T. .- .t, indicate in the box: %" = copy wto attacNenci "E" = Copy w/ attach /enci "N" = No copy OFFICE DRA/RPHEa IG- DRA/RPHEa DORA @.a l NMS3 l- OSP l ATee* CTrottier* JMMl CJPaperiello l Rt.Bangart NAME DATE Stilt? 8!8107 8/ 8/ /97 - 8/ ... . _. ./. 9 7 .

NAME Juebevman WJOtmstead DMeyer AJGalante l SShelton 8/ 19 7 31 19 7 Ol 19 7 DATE S/ 19 7 31 19 7

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NAME- JFunches 1 MKnapp JLCallan DATE S/ 47 W M7 31 47 OFFICIAL RECORD COPY (RES Flie Code) REs: 3A-3

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ENCLOSURE 1 FEDERAL REGISTAR NOT!CE

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NUCLEAR REGULATORY COMMISSION 10 CFR Parts 30 and 32 -

. RIN: AD70 Exempt Distribution of a Radioactive Drug Containing One Microcurie of Carbon-14 Urea

' AGENCY: - Nuclear Regulatory Commission.

ACTION: Final rule.

SUMMARY

The Nuclear Regulatory Commission (NRC) is amending its regulations to permit NRC licensees to distribute a radioactive drug containing one microcurie of carbon-14 urea to a.4y 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. This amendment makes the drug more widely available and reduces costs to patients, insurers, and the health care industry. This action is being taken in response to a petition for rulemaking (PRM-35-12) submitted by Tri-Med Specialties, Inc.

EFFECTIVE DATE: (30 days from date of publication in the Federal Register).

-ADDRESP: Copies of the public record, including the final regulatory analysis and any public .

comments received on the proposed rule, may be examined and copied for a fee in the ,

J Ccmmission's Public Document Room at 2120 L Street, NW. (Lower Level), Washington, DC.

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+ ' FOR FURTHER INFORMATION CONTACT:;Dr. Anthony N. Tso, office of Nuclear Regulatory i _

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Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) L 1

- 415-6233 or e-mail at ANT @n c. gov, y

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SUPPLEMENTARY INFORMATION: -

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I. , The Petitlen for Rulemaking.

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-lL Proposed Rule, Public Comments, and NRC Responses.

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~ 111; Summary of the Final Amendments.

IV. - Description of_the Final Amendments V' _ Agreement State Compatibility.

_ VI.. Finding of No Significant Environmentalimpact: Availability.

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Vil! - Paperwor'.* Reduction Act Statement,

-Vill! I Regulatory Analysis.

IX. Regulatory Flexibility Certification.

X. Backfit Analysis.

. %I. List of Subjects - ,

I. The Petition for Rulemaking 1

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On October 6,1994, the Commission docketed a petition for rulemaking (Docket No.

PRM-35-12) from Tri-Med Specialties,' lac (Tri-Med). In a letter _ dated August 23,1994, Tri-Med -

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i 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

.x Lone micro-Curie'('pCI) of.C-14-urea for in vivo diagnostic testing." The purpose of this diagnostic -

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test is to detect the presence of the bacterium Helicobacter pylori (rt, pylori), a cause of peptic -

ulcers, ;

j Following the receipt of the petition, the NRC published for public com,rient a notice of .

receipt of petition for rulemaking in the Federal Register on _ December 2,1994 (59 FR 61831);

The corEment period closed on February 15,' 19951 The NRC received 315 oublic comment letters, of_which 313 support the petition (they were mostly form letters) and 2 letters opposed the petition.

II. Proposed Rule, Public Comments, and NRC Responses A proposed rule was published on June 16,- 1997 (62 FR 32552) that would permit NRC licensees to distribute capsules containing one microcurie C 14 urea to any person for "in vivo" diagnostic use. The peblic comment period closed on July 16,199*,,

In the preamble of the proposed rule, the NRC stated that, because the capsules present ~

an insignificant radiological risk to the public and the environment, the NRC believes the capsules could be distributed to persons exempt from licensing for"in vivo" diagnostic use. This

. change makes the drug more widely available and reduces costs to patients, insurers, and the health care industry,-

The NRC received seven public comment letters: three from industry, three from State agencies, and one from a university. Four commenters supported the rule, one opposed the rule, and two provided comments but did not explicitly state whether they support or oppose the

- rule. Public comments and NRC's responses are presented below, Comment 1: Under the proposed distribution, the NRC should not be forbidding research use of this drug b'y the same ' physicians who may use it clinically. Research use should be also 3

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' permitted under this exemption because the radiological risk for using C 1_4 capsules is -

insignificant.-

Response: The Commission did not change the final rule in response to this comment, I f.

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A common rule eniitled " Federal Policy for the Protection of Human Subjects; Notiews and Rules" was promulgated by 16 Federal agencies on June 18,1991 (56 FR 28002) and was intended to...

- ensure the protecti on of human research subjects. This rule was adopted to implement a

- recommendation of the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behovloral Research which was established on November 9,1978, by Pubiic Law 95 622. The Federal Policy requires that Federal agencies that conduct, fund, support, or

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- regulate research involving human subjects ensure adequate protection of the rights of the human subjects. During the public comment period of the common rule, a commenter suggested that all minimal risk research be exempt from the regulations. However, the final rule did not adopt this comment, in lieu of participating in the promulgation of the common rule, the NRC adopted S 35.6 4

that requires a licensee who conducts research involving human subjects using byproduct material to obtain informed cmsent from the human subjects and obtain prior approval by an

" Institutional review board" (IRB). Although the Commission did not adopt the common rule, the intention is to follow the essential requirements of the common rule, Because the common rule does not provide an exemption for research involving minimal risk, the Commission detennines that such research use not be exempt from $ 35.6, Comment 2: Two commenters expressed concems that the proposed rule language, *not iexceeding one microcurie," appeared to indicate the upper limit of the radioactivity in a capsule is exactly one' microcurie of C-14. Both stated that it is not possible to make the capsules to exactly one microcurie'due 't o statistical deviations during the manufacturing process.

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I Response: The NRC agrees with the commenters. The proposed rule did not intend to limit the radioactivity of C-14 to exactly one microcurie. The final rule language has been modified to read " capsule containing one microcurie C-14 urea (ellowing for nominal variation n that may occur during the manufacturing process)."

C_o,,mment 3: One commenter stated ti,at, when the total amount of energy released from complete decay of a radionuclide is considered, one microcurie of C-14 has the largest energy release because of its long half-life when compared to one microcurie of Tc-99m or 1-131. The commenter concluded that, given the insignificant radiation risk from the diagnostic use of C-14 urea, the radiation risk from the diagnostic use of Tc-99m or 1131 would also be insignificant.

j Bgsponse: The radiation risks from a radicisotope depends on the types of radiation omitted (e.g., a, Q, Y radiation) and their energy. Since C-14 emits low energy Q radiation with no Y radiation, low energy D radiation cannot penetrate very far into the tissue. Thus, the radiation risk to an individual from one microcurie C-14 would te insignificant. On the other hand, both Tc-99m and 1131 emit y radiation, which is more penetrating than the weak p radiation. Therefore, 1

Tc-99m and 1-131 are more hazardous than C-14 even though C 14 has the largest total energy released from complete decay per microcurie.

Comment 4: Due to the small quantity of radioactive materialin C-14 capsules, this product may be disposed of in the general trash. To avoid unnecessary concem for health risks in the disposal of the product, labels should contain a statement that the product may be disposed of in the general tras.i.

Response: In the final rule, the label requirements include a statement that the product may be disposed of in ordinary trash.

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1, Comment 5: The Commenter agrees that the widespread use of this product will require'-

' uniform regulations and that Agreement States will need to make appropriate regulatory : ;

provisions to enable persons to receive the drug for 'in vivo" diagnostic use. To' avoid confusing

-licensees and users, these changes to NRC and Agreement State regulations should be made simultaneously.. The commenter urges that the NRC take action to expedite the Agreement State regulatory changes.

Response: The NRC has urged the Agreement States to adopt the changes in their segulations expeditiously. However, under NRC's Adequacy and Compatibility Policy, Agreement

Sictes have up to three years to change their regulations for amendments or program requirements that are iteras of compatibility.

I Comment 6: The NRC should address this rule in the ongoing effort of overall Part 35 revision.. The commenter believes that (1) this rule represents a piecemeal effort to respond to a narrow issue and (2) the issue of reduced regulation for medical use of C-14 capsules is applicable to the same extent for virtually the entire range of diagnostic radioisotopes.

Response: If this rule is combined with the overall Part 35 revision, the C-14 capsules would not be available to primary care physicians until the overali revision is completed (the rule is scheduled to be completed in 1999). Thus, the NRC decided to proceed with this rule now because the benefits of making this capsule available to all physicians outweigh the benefits of addressing this issue in the overall revision of Part 35.

Comment 7: An appropriate function of the regulatory regime is to assure that personnel handling and administering radioactive drugs meet certain basic training and qualification requirements. The proposed exemption would impose no training or qualification requirements on users.

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Reapese:lThe etnount sf radiation' safety iraining needed for personnel depends on the I

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insignificant ' radiation risk, radiation safety training for personnel handling and administering the . j 4

capsule is not necessary..

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Commenty.lf the_NRC promulgutes the proposed rule in its present form, the exemption -

z will divest the Agreemerit States of any authority to regulate this product under a general or specific license. Had the NRC instead simply proposed a generallicense, Agreement State

agencies would retain the authority to adopt the generallicense or continue to require specific i

licensing.

Response: In the draft rulemaking plan, the NRC suggested using the generallicense - ,

= approach. The NRC received nine comment letters from Agreement States on the draft rulemaking plan; three suggested that an exemption approach wouid be more appropriate i

because it would be less costly to the Agreement States and their licensees than the general -

license approach.

' Based on these commentr, the NRC chose the exemption approach in tiie final rule plan as more cost-effective than a generallicense approach. The final rulemaking plan was revised

- accordingly and was provided to the Agreement States. No Agreement states expressed opposition to the NRC en the exemption approach. ;

Among the seven public comment letters received on the proposed rule, two were from

? Agreement States and one from a non Agreement State. All three supported the proposed rule.

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- Comment 9f The environmental assessment fails to consider the fact that another 4

equally _noninvasive, bui nonradiological, diagnostic procedure (such as C-13 test) is available x end prov; des a comparable altamative to the C-14 test. The apparent assumpticn undertying the

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o 1 environmental assessment is that in the absence of the C-14 test, the only altemative for the detection of H. pyloriis invasive gastroendoscopy.

Egggof_gg: The only regulatory issue in this rulemaking is whether the C-14 method should be made available to physicians who are not authorized users. The purpose of the environmental assessment is to document that the subject rule is expected to have no significant impact to the environment. In this environment assessment, the NRC has determined that the ,

environmentalimpact is expected to be insignificant because of the extremely low radiological (

hazards associated with the use of capsules containing one microcurie C-14 urea.

Comment 10: NRC's policy in the past has been not to exempt byproduct material that is ingested. Any change in this policy would be a significant departure from existing NRC regulations.

Response: In the statement of consideration for the proposed rule, under the heading

" Current NRC Regulations on Exemptions From Licensing," the NRC stated that although two broad material exemptions ($ 30.14, " Exempt concentrations," and $ 30.18, " Exempt quantities")

exclude the transfer of byproduct material contained in any product designed for ingestion or inhalation by a human being, that the C-14 capsules could be distnbuted to persons exempt from licensing for _"in vivo" diagnostic use because the capsules present an insignificant radiological risk to the public and the environment. This exemption only applies to the diagnostic use of capsules containing one microcurie C-14.

Comment 11: Although the Advisory Committee on Medical Uses of Radioisotopes (ACMUli has concluded that either an exemption or generallicense is appropriate for the C-14 product, its jvJgment was based partially on the assumptions: '{1) the product may only be dispensed by prescription, (2) the product is approved by the Food and Drug Administration, and 8

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- (3) the office / facility using _the' product will be sebloct to Clinical Laboratory improvement --

E Amendment (CLIA) regulation? These . assumptions do not address fundamental aspects of -

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_ nuclear safetf.-:

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Response: A3 stNod in the proposed rule, there are no nuclest safety issues associated; with the use of the C 14' capsules for clinical diagnostic testing.1Therefore, use of either an g-exemption or general license is' appropriate.-

Comment 12: The exemption approach does not' provide the NRC with flexibility to "m . impose a limitation on the amount of C-14 capsules any physician can possess in an office.Eln i the event there is a recall of the product, or a large amount of product becomes unusable, the

- NRC will have no control over the disposal of the product.

Resoorise: . It is not necessary to impose a possession limit on the amount of C 14

- capsules because the radiation risk is insignificant. The earth's atmosphere contains an inventory of naturally occurring C-14 of about 3.8 million curies which is in addition to the huge inventory of about 240 million curies in the world's oceans. The small amount of C-14 released

' into the atmosphere from ine use of this test would mix with the globalinventory and would have

no' impact on public health.- The current world inventory of naturalty. occurring C-14 results in an 7

: average dose to the public of about 1.25 mrem per year, and the release of 0.6 curies of C-14 from the total of 600,000 tests assumed to be administered annually would result in an additional-iaverage annual dose of 2 X 103 r,nem. In the event that a recallis necessary, the manufacturer may use the same process for recalling ary other non' radioactive drugs.

Comment 1.% lt is essential that end users be adequately informed of the product's radioactive characteristics, so that some form of storage, use, and disposal precautions can be c' .

n followed. Thus, the labeling must be conspicuously and prominently placed. The commenter K _

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suggested the following: (1) the phrase " conspicuously and prominently"in front of the proposed labeling " bears the words Radioactive Material" should be added, and (2) the NRC should require

- that the radioactive material legend, " Radioactive Material," be included on promotional brochures.

Response: Because the radiation risk from C-14 capsules is insignificant, regulatory control of the use, storage, and disposal of the drug for purpose of radiation safety is not necessary. Paragraph (a)(6) of $ 32.21 requires that applicants submit copies of prototype labels and brochures for NRC approval, The NRC will ensure that the labels meet $ 32.21a before they are approved. Since paragraph (a) of 5 32.21a specifies that the label must be durable and logible, the use of an additional phrase such as " conspicuously and prominently"is unnecessary.

Promotional brochures are for information only; nothing will prevent manufacturers from indicating on the promotional brochures that C-14 is a radioactive material.

lit. Summary of the Final Amendments Final Amendment to 10 CFR Par 132 The regulations in 10 CFR Part 32 are amended to add a new $ 32.21, to provide requirements for a specific license to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution capsules containing one microcurie of C-14 urea, as a radioactive drug, to be distributed to any person for "in vivo" diagnostic use. These requirements are consistent with the existing requirements on other items under the heading

" Exemptions"in 10 CFR Part 30. The amendment includes a reminder that licensees distributing

- , radioactive drug to persons exempt from licensing would not be relieved from other 10

f applicable Federal (e.g., FDA) or State requirements goveming the manufacture and distribution of drugs.

The amendment requires that the manufacture or preparation of capsules containing one microcurie of C-14 urea be prepared by persons who meet the current NRC regulations to manufacture and commercially distribute radioactive drugs. The NRC believes regulatory control (

is needed to provide high confidence that the drug contains one microcurie of C-14 urea and does not contain any other radioactive contaminants.

Final 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 are amended to add a new $ 30.21, to permit any

person to receive, possess, use, transfer, own, or acquire for "in vivo" diagnostic use, capsules containing one microcurie of C-14 urea without a license. The final regulation includes a reminder that persons receiving the capsules would not be refieved from other Federal or State law goveming drugs. Further, in accordance with the NRC's provisions for research involving human subjects (10 CFR 35.6), the exemption permitting receipt and use of the capsules for "in vivo" diagnostic use does not extend to use of the capsules for research hvolving human subjects. Any person desiring to use the capsules for human research would still be required to 11

4 submit an application for a specific license under Pa135 in order to ensure that human subjects

- are adequately protected.

The phrase "in vivo diagnostic use"is being used in 9 30.21 instead of " medical use" for two reasons. First, the tenn " medical use" has a specific meaning and is defined in S 35.2 to mean "the intentional intemal or external administration of byproduct material or the radiation therefrom to patier s or human research subjects under the supervision of an authorized user,"

This term would be inappropriate because:

(1) " Medical use" limits administration to authorized users; use of this drug would not be so limited; and (2)" Medical use" includes the administration of the drug to a human research subject, which would be prohibited by this rulemaking.

Effects of the Final Amendments The final amendments 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 are exempt from NRC licensing, Agreement States 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 will not .

regulate the use of the drug as long as its use is for "in vivo" diagnostic use. This means that, under NRC and Agreement State rc.utations, primary-care physicians do not need to be

" authorized users'in order to administer the drug, and do not need to refer their patients to nuclear medicine physicians This should result in cost savings to patients. Other Federal and State organizations with responsibilities for regulating drugs will determine and regulate who can 12 1

1o receive and use the drug for"in vivo" diagnostic use. NRC will continue to regulate the use of the drug for research involving human subjects under a specific Part 35 license.

IV. Description of the Final Amendments The final amendments are the same as the proposed amendments except for a minor wording change with respect to the radioactivity limit of C-14. Public comments suggested that the phrase " carbon 14 urea capsules not exceeding one microcurie" used in the proposed rule may be interpreted as an exact limit of one microcurie per capsule (See Comment 2 under the

- heading "Public Comment and NrtC Responses). The final rule has been modified and the phrase " capsules containing one microcurie carbon-14 urea (allowing for nominal variation that may occur during the manufacturing process)"is used.

Manufacturer and Distributors A new section is added to 10 CFR Part 32 to permit the distribution of the capsules to persons who are exempt from licensing A 32.21 Radioactive drua: Manufacture. preparation. or transfer for commercial distribution of capsules containina one microcurie carbon-14 urea each for "in vivo" disanostic use for humans to persons exempt from licensino: Recuirements for a license Paraaraoh fa)

(-This parsgraph establishes the requirements for approval of a license application to manufacture, prepare, process, produce, package, repackage, or transfer for commercial 13 f _ _ _

distribution capsules containing one microcurie carbcn-14 uros each for "in vivo" diagnostic use,

. to persons exempt from licensing.

. r;- .

Paraaraoh (a)(1)

L This paragraph limits 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._ .

Earsaraoh fan 2)

To assure that the capsules contain one microcurie of carbon-14 and present no other-

- radiological risks, this paragraph requires that the persons manufacturing and/or commercially

. distributing the capsules for"in vivo" diagnostic use must also meet the requirements of

-$ 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 1

(3) Licensed as a pharmacy by a State Board of Pharmacy; cr

- (4) Operating as a nuclear pharmacy within a Federal medical institution.

Parmoraoh (a)(3)

.This paragraph requires applicants to provide evidence that each carbon-14 urea capsule contains one micre, curie. The NRC's evaluation that the capsules would not result in significant radiation risks was based on the capsules containing one microcurie of carbon-14 urea.-

- Therefore, applicants must demonstrate that the activity of each carbon-14 capsule contains one

- microcurie, allowing for nominal variation that may occur during the manufacturing process.

/

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. _ . .. _.-___d_______________._.._.m.___ _ _ _ _ _ _ . _ _ _ _ _ -.__'

o Paraaraoh (aif4)-

A This paragraph prohibits 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. There is no prohibition against the capsule being combined with food or beverage at the time of administration so that the capsule can be ingested by the patient.

Paraaraoh (a)(5)

Because the exempt distribution of this drug has only bec evaluated for"in vivo" diagnostic use in the form of a capsule containing one microcurie of carbon-14 urea, this paragraph prohibits incorporation of the capsules into any manufactured or assembled commodity, product, or device intended for commercial distribution. Further, although the drug ts being distributed to persons exempt from licensing, this paragraph requires the carbon-14 urea to be identified as radioactive because the drug is being used for its radioactive content; therefore, the end user must be provided with information that the drug contains a radioactive material.

Paraaraoh (a)(6)

As with any product approved for distribution to persons exempt from licensing, this paragraph requires persons who apply for a license to manufacture or commercially distribute these capsules to submit copies of prototype labels or brochures for NRC approval. This will allow the NRC to confirm that the labels or brochures meet the requirements of $ 32.21a(a) and (b).

15 l

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4 h Estaaraoh(b)

This paragraph declares thabhe regulations do not relieve licensees or applicants from >

n.

' complyidg w ' ith applicable FDA, other Federal, and State requirements goveming _the

{ ^ manufacture and distribution of drugs.

Section 32.21a Sam,e;; Conditions of license u This section establisnes the conditions required for a licensee to commercially distribute;

- the c.apsules to persons exempt from licensing, LParenraoh (si-To inform the end user of the identity of the radioisotope, the physical and chemical form, and the dosage of radioactivity, this paragraph establishes that the immediate container 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 requirementls consistent with labeling requirements for other radioactive drugs -

with a half life of greater than 100 days.

= Parsaraoh (b)

This paragraph establishes that, consistent witt. the intended use of the capsules, the -

label affixed to the immediate container, or an accompanying brochure, must: <

(1) State that the contents are exempt from NRC or_ Agreement State licensing =

4 requirements:

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16

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(2) Bear the words " Radioactive Material. For 'en Vivo" Diagnostic Use onS This Material 1s Not To Be Used for Research involving Human Subjects, and Must Not Be introduced f t

into Foods, Beverages, Cosmodes, or Other Drugs er Medicinals, or into Products Menufactured for Commercial Distribution." l The intent of the requirement set out in (b)(2)is to make clear that the capsule must {

1 remain in the form of a capsule and !s not to be combined with one of the listed items such as .l food or beverages which would result in a radioactive pro 6W other than in ths form of a capsule ;

, ?

for commercial distribution. There is no prohibition against the capsule being combined with food or beverage at the time of administration so that the capsule can be ingested by the patient. [

i s i "In vivo" disonostic use by corsons exemot from licensino !

i A new section is added to 10 CFR Part 30 to exempt any person from NRC or the Agreement State regulaticas to receive the drug for "in vivo" diagnostic use for humans.

Section 30,21 Radioactive drua: QApsules gatainina one microcurie of carbon 14 ures t

for "in vivo" disonostic use for humans ,

i 1

-F i

Parsaraoh (a)

This paragraph provides an exemption to any person from the requirements for a license i to receive, possess, use, transfer, own, or acquire capsules containing one microcurie of carbon. >

14 urea for 'in vivo" diagnostic purposes, it should be noted that the " transfer"in this paragraph ,

does not include " transfer for commercial distribution," which is covered in paragraph (c) below, i

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' Paranraph (b) j This parag*aph establishes that persons exempt from licensing would be prohibited from . ,

using the drug for research involving humans subjects. A specific Part 35 license would be I

needed to use the' drug in any research involving human subjects in order to ensure the protection the rights of the human subjects, I ls f

Paranraoh (c)

-1 This paragraph specifies that a specific license is needed to manufacture, .

. prepare, process, produce l package, repac k age or trans f er such capsu l es for commercial' i

- distribution,-

i Parentaph Id) !

This paragraph declares that the regulations do not relieve end users from complying with applicable FDA, other Federal, or State requirements goveming the receipt, administration, and use of drugs.

V. Agreement State Compatibility i

Under the Atomic Energy Act, certalh regulatory functions are reserved to the NRC, Among these are the distribution of products to persons exempt from licensing, as discussed in f 10 CFR Part 150. . Hence,- amendments related to the manufacture and commercial distribution of the csosules (10 CFR Part 32)is a Division 4 item of comostibility. However, amendments

= related to possession and use (10 CFR Part 30)is a Division 1 item of compatibility because of the need for nationwide consistency in the use of products which are widely distributed, Ether & fore, the Agreement States will need to make appropriate provisions in their regulations to 5

18 t

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e allow any person to receive capsules containing one microcurie of carbon 14 ures for "in vivo" diagnostic ute without need for a license. The NRC has urged the Agreement Ststes to adopt i

the amendment expeditiously, VI. Finding of No Significant Environmentalimpact: Availability The Commiss!on 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 fins! ,

amendments is not a major Federal action significantly affectir:g the qustity of the human environment; therefore, an environmentalimpact statement is not required. The final rule establishes requirements for the manufacture and commercial distribution of carbon.14 urea capsules to persons exempt from licensing and establishes regulations to permit any person to receive the capsules without an NRC license. Tne Commission believes that the radioactive component of this drug presents no signincant radiation risk and, inerefore, regulatory control of the "in vivo" diagnostic use of the capsules for radiation safety is not necessary, it is expected that this final rule will not cause any significant in:rease in radiation exposure to the public or radiation release to the environment beyond the exposures or releases resulting from the use of the carbon.14 capsules under the current regulations. Also,it is expected that there will be no non-radiologicalimpacts. One public comment on the draft environmental assessment has been received (See Comment 9 under the heading ' Proposed Rule, Public Comments, and NRC Responces").

The environmental assessment and finding of no significant impact on which this determination is based is available for inspection at the NRC Public Document Rom,2120 L Street NW (Lower Level), Washington, DC. Single copies of the environmental assessment and the finding of no significant impact are available from Dr. Anthony N.1se, Office of Nuclear 19

o i

Regulatory Research, U.S. Nuclear Regulatory con mission, Washington, DC 20555-0001, telephone (301) 415 6233 or e mail at ANT @nre. gov.

Vll. Paperwork Reduction Act Statement This final rule amends information coliection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). These requirements were approved by the Office of Management and Budget, approvai ntmbers 3150-0001 and 3150-0017.

The public reporting burden for this collection of information is estimated to average 16 hours1.851852e-4 days 0.00444 hours 2.645503e-5 weeks 6.088e-6 months per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Send comments on any aspecs of this collection ofinformation, incluJing suggest:ns for reducing the burden, to the Infomation and Records Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Intemet electronic mail at BJS1@NRC. GOV; and to the Desk Officer, Office of Information and Regulatory Affairs, NEOB 10202, (3150-0001,3150-0017, and 3150-0120), Office of Management and Budget, Washington. DC 20503.

Public Protection Notification The NRC may not c'nduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.

20

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

Vllt. Regulatory Analysis i

The NRC has prepared a regulatory analysis for the final rule. The analysis examines the benefits and impacts considered by the NRC. No public comments on the draft regulatory analysis have been received during public comment period. The regulatory analysis is avallable

for inspection at th 6 NRC Public Document Room,2120 L Street NW. (Lower Level),

Washington, DC. Uingle copies of the regulatory analysic ve available from Dr. Anthony N. Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555 0001, telephone (301) 415-6233 or e mail at ANT @nrc. gov. ,

IX. Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980,5 U.S.C. 605(b), the Commission certifies that this rule does not have a significant economic impact upon a substantial number of small entities. The final rule permits phvsicians and o qer health care providers to use an additional diagnostic test without having to obtain an NRC license, thus, would provide cost savings to patients, insurers, and the health care industry. The final rule does not impose any

~

additional obligations on entities that may fall within the definition of "small entities" as set forth in Section 601(3) of the Regulatory Flexibility Act; or within the definition of "small business' as i

found in Section 3 of the Small Business Act,15 U.S.C. 632; or within the size standards adopteo by the NRC on April 11,1995 (60 FR 18344). .

L 21

Small Business Regulatory En,*orcement Falmess Act In accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not 'a major" rule and has verified this determination with the Office of Information and Regulatory Affairs, Office of Management and Budget. !

i X. Backfit Analysis The NRC has determined that the backfit rule, 40 CFR 50.109, does not apply to this rule, and therefore, a backfit analysis is not required because these amendments do not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1).

XI. List of Subjects 10 CFR Part 30 ,

Byproduct material, Criminal penalties, Govemment contracts, intergovemmental relations, Isotopes, Nuclear materials, Radiation protection, Reporting and record keeping requirements.

10 CFR Part 32 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.-

For the reasons set out in the preanible and under the authority of the Atomic energy Act of 1964, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the NRC is adopting the following amendments to 10 CFR Parts 30 and 32.

22 1

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PART 30-RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL

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

AUTHORITY: Secs. 81,82,161,182,183,186,68 Stat. 935,948,953,954,955, as amended, sec. 234,83 Stat. 444, as amended (42 U.S.C. 2111,2112,2201,2232,2233,2236, 2282); secs. 201, as amended,202,206,88 Stat.1242, as amended, 1244,1246 (42 U.S.C.

5841,5842, 5846).

Section 30.7 also issued under Pub. L.95-601, sec.10,92 Stat. 2951 as amended by Pub. L.102 486, sec. 2002,106 Stat. 3123, (42 U.S.C. 5851). Section 30.34(b) afso issued unde,'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).

4 4

2. In S 30.8, paragraph (b)is revised to read as follows:

6 30 8 Information collec. tion reauirements: OMB approval.

(b) The approved information collection requirements contained in this part appear in

$$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.

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

23

$ 30 21 Radioactive drua' Caosules containina one microcurie of cart >on 14 ures for"in vivo" l

iaanostic use for humans.

(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, i

transfers, owns, or acquires capsules containing one microcurie carbon 14 ures (allo ving for .

I nominal variation that inay occur during the manufacturing process) each, for "in vivo" diagnostic use for humans, (b) Any person who desires to use the capsules for research involv.ng human subjects shall apply for and receive a specific license pursuant to Part 35 of this chapter.

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

(d) Nothing in this section relieves persons from complying with applicable FDA, other Federal, and State requiremeats governing receipt, 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: Secs. 81,161,182,183,68 Stat. 935,948,953,954, as annended (42 U.S.C. 2111,2201,2232,2233); sec. 201,88 Stat.1242, as amended (42 U.S.C. 5841).

24

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5. In 5 32.8, paragraph (b)is revised to read as follows:

$_.3 2 8 information collection reau%ments:_OMB approval.

(b) The approved information collection requiremerds contained in this part appsar in

$$ 32.11, 32.12, 32.14, 32.15, 32.16, 32.17, 32.18, 32.19, 32.20, 32.21, 32.21 a, 32.22, 32.23, 32.2 5, 32.26, 32.27, 32.29, 32.51, 32.51 a, 32.52, 32.53, 32.54, 32.55, 32.56, 32.57, 32.58, 32.61, 32.62, 32.71, 32.72, 32.74, and 32.210.

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

A 32 21 Radioactive drua: Manufacture, preparation. of transfer for commercial distribution of papsules containina one microcurie carbon-14 urea each for "in vivo" disonostic use for humans to persons exemp1from licensina: Reauirements for a license.

(a) An applicstion for a specific license to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution capsules containing one microcurie carbon 14 urea (allowing for nominal variation that may occur during the manufacturing process) each for "in vivo" diagnostic use, to oersons exempt from licensing under $ 30.21 or the equivalent regulations of an Agreement State will be approved if:

(1) The applicant satisfies the general requirements specified in $ 30.33 of this chapter, provided that the requirements of S 30.33(a)(2) and (3) of this chapter do not apply to an application for a license to transfer byproduct material manufactured. prepared, processed, prodeced, packaged, or repackaged pursuant to a license issued by an Agreement State; (2) The applicant meets thc requirements under 9 32.72(a)(2);

(3) The applicant provides evidence that each capsule contains one microcurie carbon 14 uru ', allowing for nominal variation that may occur during the manufacturing process);

25

e l 1

5 (4) The cart >on 14 urea is not contained in any food, beverage, cosmetic, drug (except as -

described in this section) or other commodity designed for ingestion or Inhalanon by, or topical application to, a human being; f i

(5) The carbon 14 urea is in the form of a capsule, id4ntified as radioactive, and to be i

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[ used for its radioactive properties, but is not incorporated into any manufactured or assembled !

commodity, product, er device intended for commercial distribution; and (6) The applicant submits copies of prototype labels and brochures and the NRC .

j approves these labels and brochures.

(b) Nothing in this section relieves the licensee from complying with applicable FDA, other I I

Federal, and State requirements goveming drugs.

i i

7, A new $ 32.21a is added to lead as follows: l 3 32.21a Same Conditions of license.

Each license issued under $ 32.21 is subject to the following conditions: i (a) The immediate container of the capsule (s) must bear a durable, legible label which:

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

(b) In addition to the labeling information required by paragraph (a) of this section, the label effixed to the immediate container, or an accompanying brochure also must:

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

(2) Bear the words

Radioactive Material, For "in Vivo" Diagnostic Use only. This ,

Material is Not To Be Used for Research involving Human Subjects and Must Not Be introduced - l

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l Into Foods, Severages, Cosmetics, or._other Drugs or Medicinals, or into Products Manufactured _ ;

l for Commercial Distribution." ;

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e Dated at Rockville, Maryland this day of .1997. ;

For the Nuclear Regulatory Commission. j i

i i

John C. Hoyle, !

Secretary of the Comrnission. [

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ENCLOSURE 2 l

_1 REGULATORY ANALYSIS :

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Q REGULATORY ANAL.YSIS FOR FINAL RULEMAKING

" EXEMPT DISTRIBUTION AND USE OF A RADIOACTIVE DRUG CONTAINING CNE YlCROCURIE OF CARBON 14 UREA" 10 CFR PARTS 30 AND 32 ;

1. Backaround r i

Statement of the Probicm 1.1 h

On Ortober 6,1994, the Commission docketed a pet: tion for rulemaking (Docket No. PRM 35-

12) from Tr' Med Specicules, Inc (Tri-Med). In a letter dated August 23,1994, Tri Med petitioned the NRC to amend its regulations "to allow for the Denerallicensing and/or exemption for the commercial distribution by licensed pharmaceutical manufacturers of a capsule containing one micro-Curie (pCl) d "C-ures for in vivo diagnostic testing." The purpose of tW 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 condition of tne stomach and duodenum that affects as many as 10 percent of people in the United States et some time in their lives. The ,

disease has relatively low mortality, but it results in substanlial human suffering and high economic costs." (Source: Article included as an appendix to the petition, from JAMA, July 3, 1994 Vol 272, No.1,"H. pylori in Peptic Ulcer Disease NIH Consensus Conference").

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

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 prob!sms.

llIs therefore necessary to detect the presence of H. pylori bactsria in ulcer patients so that the new treatment can be given appropriately. In the past, 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 noninvasively using a "C urea tracer.

"C-urea is broksn down by H. pylori to form labeled CO2 which is expired in the breath. To do the test, a doctor asks the patient to swallow the capsule with 30 mis of water. After 15 minutes the patient blows 2 liters cf breath into a collection bag (a mylar balloon) which is mailed to a testing laboratory. h "C-CO2 more than twice background is present in the breath sample, then the patient must t,e infected with H. pylori, 1.2 Current NRC Reaulations in 10 CFR Part 32," Specific Domestic 1.icenses To Manufacture or Transfer Certain items Containing Byproduct Materiais," $ 32.72, " Manufacture, preparation, or transfer for commercial distribution ci radioactive drugs containing byproduct material for medical use under Part 35,"

. provides for commercial distribution of radioactive drugs containing byproduct material for use by l

L

persons authertzod pursuant to Part 35. Thus, the r;oulations corrently would permit Part 3' licensees to commercially distribute capsules containing i pCl of "C-ures to persons authorized -

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 drugs conta;ning byproduct material. .

Existing exemptions for use of byproduct materialin $ 30.14,

Exemption concentrations" $

32.18," Manufacture, distribution and transfer of exempt quantitles of byproduct material:

Requirements for license," do not permit the exempt transfer of byproduct materia! contained in any food, beverage, cosmetic, drug, or any product designed for ingestion or inhalation by, or application to, a human being.

. Therefore, under current regulations, the "C-uren capsules must be used under a Part 35 license.

1.3 Eartier NRC Actions Following the receipt of the petition, a " Notice of receipt of petition for rulemaking" was published for public comment in the Federal Rgaister on December 2: 1994 (59 FR 61831). A total of 315 public comment letters were received. Of these,313 supported the petition phey were mostly form letters) and 2 letters opposed the petulon. The two letters opposing the petition stated that (1) the product should not receive an exempt status because the uncontrolled distribution and 3 application of thin product could lead to significant risk to the public and (2) medical uses should be restricted to short lived isotupos becawe of disposal problems presented by long-lived isotopes. ,

This petition was discussed with NRC's Advisory Committee on the Medic 91 Uses of isotopes (ACMUI) at the October 1995 meeting. The ACMUlindicated 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 essler.

A rulemaking plan was prepared. After receiving comments from Agreer ent States on the draft 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.

1.4 Ergposed r Rule and Public Commente The proposed rule was published in the FederaLRegister (62 FR 32552, June 16,1997) for a 30 day public cornment period. The NRC received seven public comment letters. Four commenters supported the rule, one opposed the rule, and two providrsd comments without explicitly stating whether they support or oppose the rule. A summary of public comments and NRC's responses are presentec in the preamble of the Federal Register notice. Except a minor change in wording, the final amendments are the same as the proposed amendments. No comments related to the draft Regulatory Guide has been received.

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2. Objective The objective of the rulemaking is to amend 10 CFR Part 32 to permit the manufacture and commercial distnbution of "C-urea capsules to any person (including physicians who are not

" authorized users' under Part 35) and to amend 10 CFR Pcrt 30 to permit any person, without an NRC license, to receive and use the capsules for in vivo diagnostic use for humans.

3. Attematiytt Three eller66tivoi have imen consiered in the reguisiviy inatyilb: dsay t'is pat ltlon, i.s.,

maintain 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 altemative, only physicians who are authurized users under Part 35 would be allowed to possess and administer the "C-ures test. Any physician could apply to become an authorized user. However, the NRC expects few physicians would apply for a Part 35 lice us 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. Attematively, physicians who are not authorized users can continue to refer their patients to physicians who are authorized users to undergo tha *ggnostic test. However this would not relinve the current ,

expense, inconvenience, and ;% encountered in an otherwise straight forward procedure.

Under the second allemative,10 C"9 Puts 32 and 30 would be amended.10 CFR Part 32 would be amended to permit the manufacture and commercial distribution of "C-urea capsules to any person (including physicians who are not " authorized users" under Part 35): 10 CFR Part 30 would be amended to permit the raanufacture and commercial distribution of the capsule: 'o any person, for in vivo diagnostic use for humans. The NRC has determined that the radioactive component of this drug presents a minimal radiation risk and, therefore, regulatory control of the capsules is not necessary.

Urider the third allemative,10 CFR Part 35 would be amended tu permit any physician to receive and use the capsules under a generallicense. The health and safety concems for this attemative are the same as the Attemative 2. However,if this attemative were adopted, there could be a burden to those Agreement States that normally require registration of generallicense holders. An additional burden could also be imposed on generallicensees located in the Agreement State if the State charges a license or registration fee.

4. Value-impaq1Analvgig 4.1 The Petitioner's Assessment 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 3

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 ures breath tests / year, at an average cost of $100, in lieu of '

performing endoscopy at an average cost of $1000!!est. It assumes that the lower cost and greater availability of an unre0ulated breath test would result in a complete subst tution for endoscopy, Tri Mod's benefit analysis provides a measure of the total benefits associated with the test and does not focus on the incremental benefits of administering the test pursuant to iO CFR h100 regulation (status quo) versus releasing the test to all physicians (NRC licensed and non licensed alike). Implicit in Tri-Med's estimated annual benefits is the presumption that none of these "C tests and corresponding savings would accrue if the petition were dontd. In reality, under the status quo, the test would be available and administered by physicians or clinics hekiing a license under NRC's Par *. 35 or an equivalent Agreement State regulations.

Further, Yn Med's estimate did not allow for the substitution of other non invasive tests (e.g.,

serologic.al test for igg antibodies to H. py'ori antigens) for both endoscopy and "C-urea tasts.

4.2 The NRC's Assessment (a) Gost Savings Associated with Amendments to 10 CFR Part 30 The value irnpact analysis kuses on the incremental benefits of granting relief consistent with Attemative 2 or 3, as specified in Section 3 above. The analysis looks solely at changes relative to the base case or status quo. In this analysis, the comparison is between regulated and unregulated"C urea breath tests, not unregulated "C-urea breath tests and endoscopies or other noninvasive tests. For the purposes of this regulatory analysis, the NRC assumes that the same number of breath tests (i.e.,600,000 tests) will be administered regardless of the level of NRC regulatory control. This view is predicated on tne 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 endoscepy, or other procedure, 2ny 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 phys;cian who is not an authorized user (e.g., gastrointestinal specialist). There wauld riso 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 fe: use of this one product.

The benefit calculation is based on the assumption that as a result of this rulemaking action, a significant portion of the 600,000 patients would receive the "C breath test from physicians who are not authorized users (e.g., gastrointestinal specialists), The actual savings would be '

dependent on the number of tests ultimately administered by physicians who are r.ot authorized users, thereby eliminating the need for a referral to physicians who are authorized users (e.g.,

nuclear medicine specialists).

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

The basis for this estimate is as follows.

Assuming adoption of the petition eliminates the need for up to 600,000 referrals, patient savings in averted travel expenses (transportation and personal time incurred w:th 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 milliorfyear Health Care Savings in averted administrative expenses (administrative costs incurred wRh medical referral) would be:

600,000 patients / year x $19,00/ patient = $11.4 million/ year Assuming $19.00 (administrative cost / patient) as the differential between the cost of an office visit to a general 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, maintcining 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.

Total Savings:

$10.5 million/ year + $11.4 million/ year = $ 21.9 million/ year Alternatively, if only 200,000 or 400,000 of the 600,000 tests were performed by a physician who is not an authorized user, the annual cost savings would be approximately $7 mihlon per year and $1E million per year, respectively.

If Altemative 3 were adopted, it would permit any physician to receive and use capsules containing i pCi"C-urea for human use under a generallicense. The health ar'd tafety concems for this attemative are the same as Attemative 2. However, the adoption of Altemative 3 could add unnecessarf urdenb to those Agreement States and Agreement State licensees in States th9 assess licensing or registration fees for geiter:llicense holders. Attemative 2 also imposes incremental cost burden for manufacturers or commercial distributors of the capsules because they would need to obtain an exempt distribution license Each application is estimated to take up to 16 hours1.851852e-4 days 0.00444 hours 2.645503e-5 weeks 6.088e-6 months to prepare. Assuming 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 applicantJ in a year would need 2 hours2.314815e-5 days 5.555556e-4 hours 3.306878e-6 weeks 7.61e-7 months te reprogram its computer to print additional words on the label or brochure, the one time tot::I 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.

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a There would be costs for the Federal and State governments if Attemative 2 or 3 is adopted.

Under both Allematives 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) lipptth and Safety Effects For the purposes of this regulatory analysis, the NRC assumes that the same number of breath tests (i.e.,600,000 tests) will be administered regardless of the level of NRC regulater/ control.

This viewis 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 reutine and occidental exposures per carbon 14 urea breath test is not expectsd to be affected by the level of NRC regulatory control.

Thus, radiation exposures to the workers and members of the public would bv the same regardless of which attemative is adoptod. ,

The NRC has concluded that the human use of these capsules results in insignificant exposures as depicted below:

Scenario Maximum Exposed Routine Exposure individual Worker adm:nistering "C- Full-time worker, 8,000 Less than 0.7 mremlyr urea breath tests patients /yr Routine exposure of patients Patient tests negative 0.38 rnrem/ capsule from "C-urea breath tests Patient tests positive 0.18 mrem / capsule Release of 150 pCl of "CO, Member of public in the Less than 0.0002 mrem into administration administration area facility from fire Rupture of a capsule Skin (100 cm2 ) exposed fu 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 as ,ociated 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 environment to "C intakes from Inhalation, drinking water, '.nd 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 4

would result in an additional average annuti dose of 2 X 10 mrem. This is far below the EPA reporting level of 1 mrem / year required under the Clean Air Act for routine exposures to a member of the public, or the 4 mrem / year EPA limit for public drinking water. In a total population of about 260 mittion 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 6

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because tLe concentrstion 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. would increase over a period of time to an average of a million tests per

- year for 50 years, the collective annual dose to the U.S. population would be about 5 person rem

. over the next 50 years. This dose is vety small when compared to the annual collective dose to

= the U.S. population from naturally occumng "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 ihese exposures, and thus there is no expected impact from the widespread use of the breath test en the entire U.S. population.

As a result of this analysis, the NRC concludes that Attematives 2 and 3 are clear 1y preferable to the no action attemative. This is because either of the two attematives will result in significant cost savings with no measurable adverse effect on health and safety. Furthermore, the NRC's recommended option is Altemative 't because it would avoid the unnecessary cost burden to some Agreement States and their generallicensees.

- Therefore, by promulgating the final rule, the cost savings would be maximized without any measurable adverse effect on public health and safety.

5. Qtcis!on Rptionale Basert on the above analysis, the NRC is amending its regulations to permit th) manufactuie and commercial distribution of Carbon 14 urea capsules to any person (including physicians who are not " authorized users" under Part 35) and purmit any person, without an NRC license, to receive and use the capsules for in vivo diagnostic use for humans because the radiological risk from such distribution would be negligible and the savings to patients could be significant.

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4 ENVIRONMENTAL ASSESSMENT 3

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Environmental Assessment For Final Amendments to 10 CFR Parts 30 and 32

Distribution of a Radioactive Drug Containing One Microcurie of Carbon 14 Urea as Exempt Material for "!n Vivo" Diagnostic Testing" Statement of the Final Actia The Nucisar Regulatory Commission (NRC)is amending its regulations to allow NRC licensees to distribute a radioactive drug containing one microcurie of carbon 14 urea to any persc.1 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 fpr radiation safety is not necessary. This amendment makes the drug more widely available, thus reducing costs to patients, insurers, and the health care industry. This action is being taken in response to a petition for rulemaking (PRM-3512) submitted by Tri Med Specian:es, Inc.

M000 for the Amendments The amendments have been developed to grant the petition for rulemaking. The final rule permits manufacturers or commercial distributors to distribute Carbon-14 urea capsules ss exempt material to any person The Commission is promulgating thl4 rulemaking because it beliens that the radiological risk from such distribution would be negligible and the savings to patients could be signifim.t. In addition, the Commission recognizes that other Federal and State agencies (e g., Food and Drug Administration and the State Boards of Pharmacy) are responsible for the ref,. @t and use of drugs that do not contain byproduct materials, and would provide necessary oversight for the safe use of these Carbon 14 urea capsules as drugs.

6ILqmatives Considered Three attematives have been considered regarding the petition: deny the petition, i.e.,

maintain the status quo, permit the distribution of the capsules as exempt material, and permit the distribution of the capsules to generallicensees.

Under the first attemative, the current situation would continue: only physicians who are authorized users under Part 35 would be allowed to possess and administer the C-14 urea test.

Any physician could apply to become an authorized user. However, the NRC expects few physicians would apply for a Part 25 license for the sole purpose of using such capsules because

of the requirement for training and experience and it.e associated costs of obtaining and maintaining a Part 35 license. Alternatively, physicians who are not authorized users can !

continue to refer their patients to physicians who are authorized users to undergo the diagnostic test. However this would not relieve the current expense, inconvenience, and delay encountered in an otherwise straight forward procedure.

Under the second alternative,10 CFR Parts 32 and 30 would be amended. Part 32 would be amended to establish requirements for the manufacture and distribution of C-14 urea capsules to persons exempt from licensing, i.e., any person (including physicians who are not

" authorized users" under Part 35); Part 30 would be amended to permit any person to receive, possess, use, transfe*, own, Or acquire the capsules for "in vivo" diagnostic use for humans without a license. The NRC has determined that tha radioactive component of this drug presents a minimal radiation risk and, therefore, regulatory control of the capsules is not necessary.

Under the third attemative,10 CFR Part 35 would be amended to permit any physician to receive and use the capsules under a generallicense. The health and safety concems for this allemative are the same as the Attemative 2. However,if this attemative were adopted, there could be a burden to those Agreement States that normally require registration of generallicense holders. An additional burden could also be imposed on generallicensees located in the Agreement State if the State charges a license or registration fee.

Based on the Draft Regulatory Analysis prepared for this proposed rule, the Commission conciudes that Altematives 2 and 3 are clearly prcferable to the no action altemative. This is because either of the two attematives will result in significant cost savings with no measurable adverse effect on health and safety. Furthermore, the NRC's recommenciad option is Altemative 2 because it avoids the unnecessary cost burden to some Agreement States and their licensees, impact on the Public and the Environment The amendments are expected to have no significant impact 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 viewis 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 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, this rulemaking action is expected to result in no change in radiation exposures to the workers and patients when compared with the status 2

quo. Similarly, it is expected that there will be no change in impact to the environment because the Commission assumes that the same number of tests will be administered regardless of which alternative is adopted.

l.ist of Acencies and Persons Consulted and Identification of Sources Used Following the receipt of the petition for rulemaking, a " Notice of receipt of petition for rulemaking" was published for public comment in the Federal Reaister 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 discussod with NRC's Advisory Committee on the Medical Uses of isotopes ACMUI) at me October 1995 meeting. Furthermore, the droft rulemaking plan was forwarded to 29 Agreement States for comments.

A proposed rule was published in the Federal Reaister (62 FR 32552, June 16,1997) for a 30-day public comment period. The NRC received seven public comment letters. Four commenters supported the rule, one opposed the rule, and two provided comments without explicitly stating support or oppose the rule. A summary of public comments and NRC's responses are presented in the preamble of the Federal Register notice. Except a minor change in wording, the final amendments are the same as the proposed amendments.

One commenter adJressed the draft environmental Assessment. The commenter stated that the environmental Assessment fails to consider the fact that another equally noninvasive, but nonradiological, diagnostic procedure (such as C-13 test) is available and provides a comparable attemative to the C 14 test. The apparent assumption underlying the environmental assessreent is that in the absence of the C 14 test, the only altemative for the detection of H.

pylorlis invas;ve gastroendoscopy.

The only regr., 1ry issue in this rulemaking is whether the C 14 method should be made available to physicians who are not authorized users. The purpose of the environmental assessment is to document that the subject rule is expected to have no significant impact to the environment. As presented in the regulatory analysis prepared for this rule, the NRC has determinud that the environrnentalimpact is expected to be insignificant because of the extremely low radiological hazards associated with the use of capsules containing one microcurie C-14 urea. The earth's atmosphere contains an inventory of naturally occurring C-14 of about 3.8 million curies which is in addition to the huge inventory of about 240 million curies in the world's oceans. The steall amount of C-14 released into the atmosphere from the use of this test would mix with the globalinventory and would have no impact on public health. The current world inventory of naturally occurring C 14 results in an average dose to the public of about 3

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I sdministered annually would result in an additional average annual dose of 2 X 10 mrom.

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ELndina of No Sionificant impacts f 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 amendments will not be a major Federal action significantly affecting the quality of the human environment, and therefore an environmentalimpact statement is not required. The final rule amends 10 CFR Part 32 to permit the manufacture and commercial distilbution of C 14 urea -

capsules to any person (including physicians who are not " authorized users" under Part 35) and f

. 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 l

- capsules for "in vivo" diagnostic use is not necessary, it is expected that this final rule will not cause any significant increase in radiation exposure to the public or radiation release tc the environment beyond the exposures or releases resulting from the use of the carbon 14 capsules under the current regulations, i

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ENCLOSURE 4 CONGRESSIONAL LETTERS a

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.j NUCLEAR REGe. ATORY COMMISSION WAsHINGT oN, o.C. 2065 Hoot 9 . . . . . ,o The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power Committee on Commerce t

United States House of Representatives Washington, DC 20515

Dear Mr. Chairman:

Enclosed for the information of the Subcommittee are copies of a public announcement ar'd a Federal Register notice conceming a final amendment to 10 CFR Parts 30 and 32. This rulemaking is being taken in response to a petition for rulemaking submitted by Tn Med Specialties, Inc.

The Nuclear Regulatory Commission (NRC)is amending its regulations to allow NRC licensees to distribute a radioactive drug containing one microcurie of carbon-14 urea to any person for "in vivo diaDnostic use. The purpose of this diagnostic test is to detect the presence of the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers. The NRC has determined that the radioactive component of such capsules presents a minimal radiation risk at.d, therefore, regulatory control of the drug for radiation safety is not r.ecessary. The manufacture end distribution of the capsules will continue to .*equire an NRC license. This amendment makes the drug more widely available, thus reduces costs to patients, insurers, and the health care industry.

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

Enclosures:

1. Public Announcement

2. Federal Register Notice cc: Representative Ralph Hall

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The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power Committee on Commerce United States House of Representatives Washington, DC 20515

Dear Mr. Chairman:

Enclosed far the information of the Subcommittee are copies of a public announcement and a federal Register notice concoming a final 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 amending 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 purpose of this diagnostic test is to detect the presence of the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers. 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 wi!! continua to require an NRC licansa. This amendment makes the

' drug more widely available, thus reduces costs to patients, insurers, and the health care industry.

Sincerely,

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Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosures:

1. Public Announcement

2. Federal Register Notice cc: Representative Ralph Hall Distribution:

CTrottier/RPHEB rf File Center NCostanzi DOCUMENT NAME: o \tse\c14fr-cl.wpd To receive a copy of this document, indicate in the bo:t "c" = copy without ottachment/ enclosure, "B" = cop:r with attachment / enclosure, "N" = No copy OFFICE: DRA/RPHEB C DRA/RPHEB QlDR#RES D/RES D/OCA NAME: ATse;nb [W CTrottierl b JMb MKnapp DRathbun DATE: 8/1/97 8/ 0 97 h f8/97 8/ 197 8/ l97 OFFICIAL RECORD COPY (RES File Code No.) 3A 3

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NUCLEAR REGULATORY COMMISSION WASHINGTON, D,0. 30164001

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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 notica concerning a final 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 amending 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 purpose of this diagnostic test is to detect the presence of the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers. 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 will continue to require an NRC license. This amendment makes the drug more widely available, thus reduces costs to patients, insurers, and the health care industry.

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

Enclosures:

1. Public Announcement

2. Federal Register Notice cc: Senator Bob Graham

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A The Honorable James M. Inhofe, Chairman

^ubcommittee on Clean Air, Wetlands,.

Private Property and Nuclear Safety

- Committee on Environment and Public Wort

- United States Senate Washington, DC 20510

Dear Mr. Chairman:

Enclosed for the information of the Subcommittee are copies of a public announcen.ent and a Federal Register notice conceming a final amendment to 10 CFR Parts 30 and 32. This rulemaking is being taken in response to a petition for rulemaking submitted by Tri-Med Gpecialties, Inc.

The Nuclear Regulatory Commission (NRC) is amending I's regulations to allow NRC licensees to distribute a radioactive dru t containing one microcurie of carbon-14 urea t; any person for 'in vivo" diagnostic use. The purpose of this diagnostic tost is to detect the presence of the

. bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers. The NRC has determined that the rad;oactive component of such capsules presents a minimal radiation risk and, therefore, regulatory control ^f the drug for radiation safety is not necessary. The manufacture and distribution of the s ipsules will continue to require an NRC license. This amendment makes the drug more widely available, thus reduces costs to patients, insurers, and the health care industry.

Sincerely, i

Denni L Rathbun, I.

Office of Congressionm . ,uairs

Enclosures:

=

1. Public Announcement

- 2. Federal Register Notice cc: Senator Bob Graham G.stribunon:

CTrottier/RPHEB rf File Center

' NCostanzi DOCUMENT NA'etEt ot\tse\c14fr-cl.'pd d To receive a copy of this 6ocument, indicate in the bex "C" = copy without attachment / enclosure, "B" = copy with attachment / enclosure, "N" = No copy OFFICE: DRA/Fi2HEB C DRA/RPHEB D/DRA/REES D/RES D/OCA NAME: ATss;nb lh ' CTrottier U y[ MKnapp DRathbun 8/ ! 17 DATE: 8/1/97 / /h/97 8/ /97 8/ /97 _

OFFICIAL MECORD COPY (RES File Code No.) 3A-3

7 ENCLOSURE 5 SBREF LETTERS

[ f**0: 0 ye ?t UN'.TED STATES

- O E NUCLEAR REGblATORY COMMISSION if WASHINGTON. D.C. 7055 % 0001

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' Mr. Robert P. Murphy General Counsel

~ General Accounting Off;ce 2 Room 7175 441 G. St., NW -

} Washington, DC 20548'

Dear Mr. Murphy:

Pursuant to Subtitle E of the Small Business Regulatory Enforcement Falmess Act of 1996,5

\ U.S.C. 801, the Nuclear Regulatory Commis ion (NRC) is submitting a final rule regarding distribution of a radioactive drug containing one microcurie of carbon-14 urea to any person for "in vivo' diagnostic use for humans. The purpose of this diagnostic test is to detect the presence L - of the bacterium He!!cobacter pylori (H. pylori), a cause of peptic ulects. The final rule makes the drug more widely available, and reduces costs to patients, insurers, and health care industry.

The distribution of the drug in capsule form presents a minimal radiation risk and, therefore, regulatory control of the drug for radiation safety is not necessary. This action is being taken in I response to a petition for rulemaking (PRM 35-12) submitted by Tri-Med Specialties, Inc.

We have determined that tnis rule is not a " major rule" as cefined in 5 U.S.C. 804(2). We have confirmed this determination with the Office of Management and Budget.

Enclosed is a copy of the final rule that is being transmitted to the Office of the Federal Register for publication. The Regulatory Flaxibility Certification and a statement of the availability of the Regulatory Analysis are included in the final rule.

S incerely, Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosure:

Final Rule

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l Mr. Robert P. Murphy.

General Counsel General Accour. ting Office Room 7175 :

441 G. St., NW Washington, DC 20548 '

Dear Mr. Murphy:

Pursuant to Suutitle E of the Small Business Regulatory Enforcement Falmess Act of 1996,5 U.S.C. 801, the Nuclear Regulatory Commission (NRC) is submitting a fina! rule legarding distribution of a radioactive drug containing one microcurie of carbon-14 urea to any person for "in vivo" diagnastic use for humans. The purpose of this diagnostic test is to detect the presence of the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers. The final rule makes the drug more widely available, and reduces costs to patients, insurers, and health care industry.

The distribution of the drug in capsule form presents a minimal radiation risk and, therefore, re0ulatory control of the drug for radiation safety is not necesssty. This action is being then in response to a petition for ru!emaking (PRM-3512) submitted by Tri-Med Specialties, Inc.

We have determined that this rule is not a " major rule" as defined in 5 U.S.C. 804(2). We have confirmed this determination with the Office of Management and Budget.

Enclosed is a copy of the final rule that is being transmitted to the Office of the Federal Register for publication. The Regula.ory Flexibility Certification and a statement of the availability of the Regulatory Analysis are included in the final rule.

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

Enclosure:

Final Rule

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R?HEB R/F RES File OC R/F DOCUMENT NAME: o \tse\c14fr-si To receive a copy of this document, indicate in the box "C" =

copy without attachment / enclosure, "B" = copy with attachment / enclosure r "N" ='No copy OFFICEi DRA/RPHEB C DRA/RPHEB D/DRA/R,ES D/RES D/OCA NAME: ATse:nb k- CTrotter -

J MKnapp DRathbun t /

DATE: 8/1/97 8/ 6 /97 8 [//197 8/ /97 8/ /97 ~

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0-t The Honormale Al Gore:

President of the United < '

States Senate--- -

(Washington,' DC . 20510; q- ,- .

? Dear Mr. Presiderith

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Pursuant to Subtitle E of the Small Business R$gu!atory Enforcement Faimess Act of 1996[5 LU.S.C. 801, the Nuclear Regulatory Commission (NRC) is submitting a final rule regardingi distribution of a radioactive drug containing one microcurie of carbon-14 urea to any person for-1"in vivo" diagnostic uL for humans. The purpose of this diagnostic test is to_ detect the presence ;

lyof the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers. The final rule makes the -

% drug'~more wiooly available, and reduces corts to patients, insurers, and health care in_dustry.-

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9 The distribution of the drug in capsule form presents a minimal radiation risk and, thereforei-regulatory sn!,ol of the drug for radiation safety is not necessary.' This actior,is being taken in-respcnse to a petition for rulemaking (PRM-35-12) submitted by Tri-Med Specialties; inc.-

-We have determined that this rule is not a " major rule" as defined in 5 'l.S.C. 804(2).: We have

' confirmed this determination with the Ofiice of Management and Budget.-

Enclosed is's copy of the final rule that is being transmitted to the Office of the Federal Register y

. for publication. The Regulatory Flexibility Certification and a statement of the availability of the Regulatory Analysis are included in the final rule.

Sincerely,-

6G. - -

Dennis K.' Rathbun, Director Office of Congressional Affairs

Enclosure:

~ Final Rule ;

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1The Honorable Al Gors '-

W- President of the United --

. . - States Senate nWashington, DC 20510l 4 '

Dear Mr. President:

t Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996,5;

..U.S.C. 801, the Nuclear Regulatory Commission (NRC) is submitting a final rule regarding -

- distribution of a radioactive drug containing one microcurie of cart >on-14 urea to any person for?

' "in vivo" diagnostic use for humans.' The purpose of this diagnostic test is to detect the presence of the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers. The final rule makes the

+ drug more widely available, and reduces costs to patients, insurers, and health care industry.-

' The distribution of the drug in capsule form presents a minimal radiation risk and, therefore,

regulatory contel of the rirug for radiation safety is not necessarv This action is being taken in

-- response to a petition for rulemaking (PRM-35-_12) submitted by Tri-Med Specialties, Inc.

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L We have determined that this rule is not a " major ruls" su defined in 5 U.S.C. 804(2). We have iconfirmed this determination with the Off;ce of Management and Budget.-

Enclosed is a copy of the final rule that is being transmitted to the Office of the Federal Register.

for publication.? The Regulatory Flexibility Certit! cation and a statement of the availability of the

Regulatory Analysis are included in the final rule.

Sincerely, _

Dennis K. Rathbun, Director h Office of Congressional Affairs

Enclosure:

Final Rule

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OFFICE RPHEB:DRA'- N RPHEB:DRA, / D:QBA ) D:RES' D:OCA NAME ATse' ' CATrottieb' y. MKnapp DRathbun DATE " 8/1/97 : iI 8/ [/97 [M- '

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-t WASHINGTON, D.C 2c656-o001 A...../

The Honorable Newt Gingrich Speaker of the United States House of Representatives Washington, DC 20515

- Daar Mr. Speakr Pursuant to Subtitle E of the Small Business Regulatory Enforcement Faimess Act of 1996,5 U.S.C. 801, the Nuclear Regulatory Commission (NRC)is submitting a final rule regarding distribution of a radioactive drug containing one microcurie of carbon-14 urea to any person for "in vivo" dia3nostic use for humans. The purpose of this diagnostic test is to detect the presence of the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers. The final rule makes the drug more widely available, and reduces costs to patients, insurere, and health care industry.

The distribution of the drug in capsule form presents a minimal radiation risk and, therefore, regulatory control of the drug for radiation safety is not necessary. This action ,s being taken in response to a petition for rulemaking (PRM 35-12) submitted by Tri-Med Specialtios, Inc.

We have determined that this rule is not a " major rule" as defined in 5 U.S.C. 804(2). We have confirmed this determination with the Office of Management and Budget.

Enclosed is a copy of the final rule that is being transmitted to the Office of the Federal Register for publication. The hegulatory Flexibility Certification and a statement of the availability of the Regulatory Analysis are included in the final rule.

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

Enclosure:

Final Rule i

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O )The Honorable Newt Gingrich ~

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d Speaker of the United States? ,

, ._ - House of Representatives - -

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. ! Washington, DC 20515 w ,

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Dear Mr. Speaker:

Pursuant tc ' Subtitle E of the Small Business Regulatory Enforcement Faimess Act of 1996,5 - 4

U.S.C.' 801l the Nuclear Regulatory Commission (NRC) is submitting's final rule regarding -

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distribution of a radioactive drug containing one microcurie of carbon-14 ures to any person for .

"in vivo" diagnostic use for humans. The purpose of this diagnostic test is to detect the presence !

of the bacterium Helicobacter pylori (H. pylori), a cause of peptic ulcers.= T:ie final rule makes the .

~I drug more widely available, ar;d reduces costs to patients, Insurers, and health care industry. '

The distributio:) of the drug in capsule form presents a minimal radiation risk and, therefore,-

regulatory control of the drug for radiation safety is not necessary. This action is being taken in -

response to a_ petition for rulemaking (PRM-35-12) submitted by Tri-Med Specialties, Inc. .

We have determined that this rule is not a " major rule" as defined in 5 U.S.C. 804(2). .We_have d

, : confirmed this. determination with the Office of Management arid Budget. l Enclosed is's copy of the final rule that is being transmitted to the Office of the Federal Register j

'- for publication. The Regulatory Flexibility Certification and a statement of the availab!!ity of the Regulatory Analysis are included in the final rule.

mcorely, p

Dennis K. Rathbun,-Director s Office of Congressional Affairs

Enclosure:

FinalRule 7

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' OFFICE - RPHEB:DRA u RPHEB:DRA Q:0J% D:REF D:OCA -s NAME ATse k CATrottier ( MKnapp DRathbun DATE ~ 8/1/97 I 8/ /97 - [8//M7- 8/ 19 7 - /i /97 OFFICIAL RECORD COPY.

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ENCLOSURE 6- -!

PUBLIC ANNOUNCEMENT

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Draft press release -- 8/7/97

. NRC CHANGES REGULATIONS TO PERMIT EXEMPT DISThlBUTION OF RADIOACTIVE DIAGNOSTIC DRUG The Nuclear Regulatory Commission is amending its regulations to allow a specific radioactive drug used to diagnose stomach ulcers to be distributed to any person for administration to humans. Before this change, only physicians authorized by the NRC or Agreement States could receive and administer the drug. ?

The change does not relieve persons from the requirement to comply with aoplicable Food and Drug Administration or other Federal and State requirements governing receipt, administration and use of drugs.

.The change is in response to a 1994 petition from Tri Med Specialties, Inc.

It allcws any person to receive, possess, use and transfer capsules containing one microcurie carbon 14 urea each for diagnostic use in pat'- .ts. The NRC has determined that the capsules r. resent a minimal radiatiot risk, and therefore believes that &gulato.*y control of the drug for radiation safety is not necessary.

Under the amendments, manufacturers of the capsules and commercial pharmacies that prepare the capsules will continue to need an NRC license to

' provide high confidence of capsule contents. The containers of the capsules must bear the words " radioactive material" and other specific information on the contents of the container. In addition, only those persons who are licensed will be I

permitted to use the capsules for research involving human subjects.

The Tri-Med petition stated that Carbon-14 urea can be used to detect the presence of a bacter:Jm that causes peptic ulcers, a chronic inflammatory 1

condition of the stomach and duoder.um that affects as many as 10 percent of people in the United States at some time in their lives. According to a July 1994

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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 tect using Carbon-14 urea is non-invasive. A doctor asks the patient tr swallow the capsule with water After 15 minutes the patient blows into a collection bag, which is mailed to a testing laboratory for analysis.

Before the change, only physicians who were authorized users (e.g.,

physicians who met certain training and experience criteria regarding the safe use of ladioactive drugs) or persons working under the supervision of an authorized user could administer radioactive drugs for medical purposes.

I Under the amendments, physicians or other health care workers will not J l

need to be authorized users in order to administer the drug, and physicians will not need to refer their patients to nuclear medicine physicians. This should result in I

cost savings to patients, insurers, and the health care industry, A proposed rule on this subject was published in the Federal Register for public comment on June 16. Minor changes made to the rule as a result of comme..ts received are discussed in a Federal Register notice that will be published shortly.

J __ . ____ _ _ _ _

ML20198L521

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Enclosures:

Enclosures:

Enclosures:

SUMMARY

Dear Mr. Chairman:

Enclosures:

Dear Mr. Chairman:

Enclosures:

Dear Mr. Chairman:

Enclosures:

Dear Mr. Chairman:

Enclosures:

Dear Mr. Murphy:

Enclosure:

Dear Mr. Murphy:

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Enclosure:

Dear Mr. President:

Enclosure:

Enclosure:

Dear Mr. Speaker:

Enclosure:

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ML20198L521

Text

SUBJECT:

Title:

Attachment:

Contact:

Enclosures:

Enclosures:

Enclosures:

SUMMARY

Dear Mr. Chairman:

Enclosures:

Dear Mr. Chairman:

Enclosures:

Dear Mr. Chairman:

Enclosures:

Dear Mr. Chairman:

Enclosures:

Dear Mr. Murphy:

Enclosure:

Dear Mr. Murphy:

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Enclosure:

Dear Mr. President:

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Dear Mr. Speaker:

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