ML20198J157

Submits Changes on Proposed Rule, Exempt Distribution of Radioactive Drug Containing One Uci of C-14 Urea (Parts 30 & 32). OMB Clearance Package for Compliance W/Paperwork Reduction Act of 1995 Encl

ML20198J157
Person / Time
Issue date:	03/20/1997
From:	Shelton B NRC OFFICE OF INFORMATION RESOURCES MANAGEMENT (IRM)
To:	Tse A NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
Shared Package
ML20013E023	List: ML20198H571 ML20198H672 ML20198H718 ML20198H780 ML20198H830 ML20198H875 ML20198H887 ML20198H907 ML20198J119 ML20198J157 ML20198J188 ML20198J224 ML20198J252 ML20198J270 ML20198J298 ML20198J324 ML20198J404 ML20198J418 ML20198J664 ML20198J741 ML20198J766 ML20198J793 ML20198J830 ML20198J869 ML20198J932 ML20198J978 ML20198J988 ML20198J995 ML20198K019 ML20198K055 ML20198K065 ML20198K118 ML20198K151 ML20198K202 ML20198K217
References
FRN-62FR32552, RULE-PR-30, RULE-PR-32 AF70-1-036, AF70-1-36, NUDOCS 9801140051
Download: ML20198J157 (19)

Text

'; .

d jf " * %, AF p o_ , ,

pe -4 UNITED STATES I

g j NUCLEAR REGULATORY COMMISSION W ASHINGToN. D.C. 20MMo01 N(

n t 0 ,o8 March 20, 1997 4)

MEMORANDUM TO: Anthony N. Tse, Section Chief Health Physics Section Radiation Protection and Health Effects Dranch

- Division of Regulatory Applications Office of Nuclear Regulato Research FROM: Bre h 7 i6R I[

Information and Records Management Branch Office of Information Resources Management

SUBJECT:

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

We have reviewed the subject proposed rule and the OMB clearance package for compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) and recommend that changes be made as follows:

Changes to the Rule: /

/

l /

Change the Papefwork Reduction Act Statement to Attachment 1. V Q  :% l Add sections 30.8 and,32.8, In(Tormation collection OMB requirement approval," and insert new sections 30.21 and 32.21, respectively (see Attachment 2). k-Incorporate a retention period of three, five, or ten years or life for the recordkeeping requirement identified at section 32.21a(a), "Same: Conditions of license."

Changes to the Supporting Statement:

Address section 30.21 under, " Description of information Collection," and in paragraph A.," JUSTIFICATION." The Supporting Statement as written only addresses Part 32, in section 30.21, we suggest that you use the same sequence of terms for handling carbon 14 urea as cited in ',he proposed rule. (See annotation on page 1 of the Supporting Statement.)

Add paragrap'h30.21(c) and identify '.he information collection as follows:

Paragraph 30.21(c) requires that an applicant obtain a specific license to manufacture, process, produce, package, repackage, or transfer for commercial distribution such capeules.

9001140051 900109

PDR PR 30 62FR32552 PDR

,t wit w v 0% j

"o,* ~,

2 in section 32.21a, include the retention period that you establish for the rule as requested above. ,

include section 30.21 under " Agency Use of Information." .

See additional minor changes annotated on the attached Supporting Statement.

Changes to the Commission memo:

On page 2, COORDINATION. replace the last sentence with, "The Office of /

Chief Information Officer has reviewed the proposed rule for information /

technology and information manag6 ment implications and concurs in it."

On page 2 RECOMMENDATION. add item "g" under " Note," "This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This rule is being sent to the Office of Management and Budget for review and approval of the information collection requirements."

We have placed publication of the proposed rule on hold with the Office of Administration pending IRM's approval of the OMB clearance package and your incorporating the above changes into the rule. Please refer to the annotations on the attached pages from your submittal for additional editorial comments. Should you require further assistance, please contact Doris Foster-Curseen at 415-5976 or e-mail DJF3.

Attachments: As stated, cc: M. Lesar, ADM i

l l

i

PAPERWORK REDUCTION ACT STATEMENTS Replace the last two paragraphs with the following: {

INFORMATION COLLECTION REQUIREMENTS

- t Send comments on any aspect of this proposed information-collection, . including suggestions for reducing the burden, to the l Information and Records Management Branch (T 6 F33), U.S. Nuclear  ;

Regulatory Commission, Washington, DC 20555 0001, or by Internet (

electronic mail at BJS19NRC.G0V: and to the Desk Officer, Office of Information and Regulatory Affairs, NE08 10202, (3150 0001 and 3150-  ;

0017), Office of Management and Budget Washington, DC 20503. ,

Comments to OM8 on the information enllections or on the above issues should be submitted by (insert aate 30 days after publication i the Federal Reaister). Comments received after this date will be  ;

considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date. '

i; L i Attachment 1 o-

- , _ - _ . - , . , . . . _ .. .,.~._...-.,.-_,-_.m._.... .

l PART 30 RULES OF GENERAL APPLICABILITY.TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL l S30.8 Information collection requirements: OMB approval.

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

appear in 5530.9, 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 end C to this part, PART 32 SPECIFIC DOESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS C0KfAINING BYPRODUCT MATERIAL S32.8 Information collection requirements: OMB approval.

(b) The appear in op roved information collection requirements l, containe 32.20, 32.22, 32.23, 32.25, 32.26, 32.27, 32.29, 32.51, 32.51a, 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, Attachment 2

{

=.

l 5

. i t

i i

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

SUBJECT:

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

PURPOSf,:

To obtain the Commission's approval for the publication of the proposed ru!c.

BACKGROUND:

By negative consent, the Commission approved a rule plan to amend Parts 30 and 32 to p the exempt distribution and use of one micro Curie (pCi) capsules of carbon 14 urea for in vivo  ;

diagnostic use. This rule plan was submitted to the Commission on February 7,1997. as SE 97 031. r

. DISCUSSION:

Part 32 would be amended to add a new section (9 32.21) to establish requirements for the manuf acture and distribution of carbon 14 urea capsules to persons exempt from licensing.

Currently, NRC' requires licensees who manufacture, prepare, or commercially distribute radioactive drugs to meet the requirements in 9 32.72(a)(2) (e.g., be registered or licensed with the FDA as a drug manufacturer or be licensed as pharmacy by a State Board of Pharms.cy)

The proposed amendment would require licensees distributing these capsules under an exempt ,

distribution license to meet this same requirement because the capsules will have wide,npread distribution for "in vivo" diagnostic use by persons who will be exempt from licensing. Also, this

' would provide high confidence that the carbon-14 urea capsules contain only one microcurie of .

cart >on-14 and do not contain other radioactive contaminants.

j mended to add a new section ($ 30.21), to permit any person to receive, Part 30 would b possess, use own, transfer, or acquire cartion-14 urea capsulas, not to exceed one microcurie CONTACT: .

Sam Jones, RES, 415-6198 / -

[

5 W , - + - - - , - , - - w w -

v y . &. w,-- - n- , - -, . - -.< -' , -- c

,4 -

The Commissioners 2 of carbon 14, for *in vivo diagnostic use, without a license. As a result, NRC regulations would permit the drug to be distributed to any person. The proposed amendment would include a reminder that persons would not be relieved from comolying with applicable FDA, other Federal, -

and State require;nents goveming drugs. Also, any person who desires to use the capsules for research involving hurnan subjects would be required to apply for and receive a specific license pursuant to Part 35.

COORDINATION:

t The Office of the General Counsel has no legal objection to the proposed rulemaking of the Chief Financial Officer has no resource-related objection to this rulemaking. The the Chief information Officer concurs that there will be no information techt,olog impe is.

_Jpgr#

RFCOMMFNDATioN: [

That the Commission:

1. Approve for publication in the Federal Renister the proposed amendments to 10 CFR Parts 30 and 32 (Enclosure 1).

2 Note:

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

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

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

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

c. The appropriate Congressional committees will be informed of this action (Enciasure 4). .

That a public announcement will be issued the Office of Pub!ic Affairs when the f.

proposed mjemaking is filed with tha Offic of the Federal Register (Enclosure 5),

m ~

' h(MC i

1

i AmendmentandkationaleforExempting"AnyPerson"fromLicensing l Requirements to Receive the Drug ,

Proposed Amendment to 10 CFR Part 30 f

f l

The regulations in 10 CFR Part 30 would be amended to add a_ new i 30.21, to perheit any person to receive, possess, usektransfMor acquire.forl .

f f

"in vivo"-diagnostic use, capsules containing one microcurie of carbon-14 urea without a license. The exemption would prohibit research involving humans

' subjects. NRC regulations would include a reminder that persons receiving the ,

drug would not be relieved from other Federal or State law governing drugs,

)

Rationale

.Tha Commission has determined that the capsules present no significant l radiological safety or environmental risk, and it is not- necessary to regulate  :

t the use.of this drug for its radioactive component. Therefore, the Commission 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 drug should be ,

distributed to any. person who is permitted to receive and use the drug under .

?

..the' appropriate Federal or Statt law governing drugs. ,

The phrase;"'in vivo' dia: #:. tic use" is being used in 5 30.21 instead of

" medical- use" for two reasons, iirst, the term " medical use" has a specific meaning-.and is defined in i 35.2 to mean "the intentional internal or external administration of byproduct material or the radiation therefrom to patients or 9-

~

)- <

m m g e yg- m*mg- e & mme 4 v

)

.. y n:cessary, it is expected'that this proposed rule, if adopted, would not.  ;

cause any-significant increase in-radiation exporare to the public or .

radiation release to the environment beyond toe exposures or releases q

resulting from the use of the Carbon-14 capsules under the current  !

regulations. Also, it is expected that thfre would be no non-radiological impacts if the proposed rule is adopted.

The draft environmental-assessment and' finding of no significant impact on.which this determination is based is available for inspection at the NRC t Single Public1 Document Room, 2120 L Street NW. (Lower level), Washington, DC. i copies of the draft environmental assessment and the finding of no significant ,

impact are :available .from Sam Jones, Office of Nuclear Regulatory _Research,  ;

U.S. Nuclear Regulatory Commission, Washington, OC 20555-0001, telephone (301) g

.415-6198 or e-mail at SZJ0nrc. gov. i i

VI. Paperwork Reduction Act Statement

/ <

This proposed rule amends information collection requirements that are

subject to the_ Paper Work Reduction Act of 1995 (44 U.S.C. 3501 et seq.). C .

w This rule-has been submitted to the Office of Management and Budget for revi and: approval of the inf The public repo

' matto collection reqwirements.

in rde for this colle: tion of information is ( J' L

,7

' estimated.to averase ours per response, including the time for

• - I reviewing instruct arching existing data sources, gathering and maintaining the data nee ded, and completing and reviewing the collection of information.- The U.S. Nuclear Regulatory Commission is seeking public comment 17 _

N n

x

&&,M

{& ],3 _ _ . . .

,. l i

d -

on the potential impact of the collection of information contained in the-l i

proposed rule and on the following issues:

. 1. Is the proposed collection of information necessary for the proper-

-performance of the functions'of the NRC, including whether the information 10111 have practical utility?

2. Is the estimate of the burden correct?.

3, is there a way to enhance the qunlity, utility, and the clarity of the information to be collected?

4. How can the burden of the collection of information be minimized,

' . including the use of-automated collection techniques?

Se' comments of any aspect of this proposed collection of information, .

including ggestions for reducing the burden, to the Information and Records ,

Management Bra ch (1-6 F33), U.S. Nuclear Regulatory Commission.-Washington, l

DC 20555-0001, or y Internet Electronic mail at BJSl@NRC. GOV; and to the Desk i

Officer, Office of 1 formation and Regulatory Affairs, NE08-10202, (3150-0017,

-0020 -0011, -0009, an -01320, Office of Management and Budget, Washington, DC 20503.

(

Comments to OMB on the. 11ections of information or on the above issues L*

i should be: submitted by (insert ate 30 days after publication in the Federal Reaister). : Comments received aft this date will be considered if it is ,

practical to do so, but assurance o consideration cannot be given to comments (

3 received after thisLdate.

1

( l t

18 4 q :, \

i

ta  ;

1

,a. . ; .. - - . -- _ _ , ,;_.,.._,,.2, _ . . . . _ - _ , _ , ._,_,_m,,-._. ., - ._ _.

. _ . ~ . _ _ _

a, 5 i 10 CFR Part;32 ,

s Byproduct material, Criminal penalties. . Labeling, Nuclear materials, l Radiation protection, Reporting and recordkeeping requirements.

For the reaFons set out in the preamble and under the authority of the l

-Atomic energy Act of 1954, as amended; the Energy Reorganization Act of 1974

.as amended and 5 U.S.C. 552 and 553;-the NRC is adopting the following -

' amendment to 10 CFR Parts 30 and 32. L PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING Of BYPRODUCT MATERIAL

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

• • • TO BE ADDED*** g g#g g g [Q/#~ /

L, kerie o D'b i i

^0 #

2@ map m.

h . A new section is added to read:

)

'l 30,21 Radioactive druo: Capsules contairling one microcurie of carbon-14 urea for "in vivo" diagnostic use.

-(a)-Except as provided in paragraphs (b) and (c) of this section, any person is: exempt from the requirements for a license set forth in Section 81 y

of the Act and from the regulations in this part and Part 35 of this chapter ,

proEidedthatsuchpersonreceives, possesses,uses, transfers, owns,or I

acquires carbon-14 urea capsules, not exceeding one microcurie each, for "in vivo" diagnostic use;

/-

> 23. 1

,j- t

_jy t

g.  ;

i 1

(b) Any person who desires to use the capsules for research involving j  ;

human subjects chall agy,.for and receive a specific license pursuant t .

Part 35 of this chapter. p T\ l (c) Any person who desires to. manufacture, process, produce, package,

- repackage, or transfer for commercial distribution such capsules shall app) , g, [ j p

for a sgific license pursuant to 6 32.Il of this chapter.

[% y4 l (d) Nothing in this section relieves persons from complying with applicable FDA, other Federal, and State requirements governing use of drugs. ,

PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRT.NSFER ,

ITEMS CONTAINING BYPRODUCT MATERIAL  :

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

• • • TO BE ADDED*** []hl4 Ak

).. s Mg Gsth% Mi

%. A new section is added to read:

6 32.21 Radioactive drua: Manufacture. distribution, and transfer of carbon- >

14 urea capsules not exceedina one microcurie each for "in yivo" diaanostic-use: Reauirements for a license.

kd? .' P'

(a) An application for a specific license to manufacture, process,

. produce, package, repackage, or transfer for commercial distribution carbon urea capsules not exceeding one microcurie each for "in vivo" diagnostic use, tof persons' exempt from. licensing under l-30.21 or the equivalent regulations of an~ Agreement State'wil.1_be approved if:

k-h a

h' ,

24 ,

s .~w. . . . . . _ . , .- _ . . . , . , , - , , - . . _ . . _ - , - , , _ . _ -

, 1 C

(1) The applicant satisfies the general requirements specified in-

/, i: t

' [.

paragraphs i 30,33 of this chapter: 'rovided, however, that the requirements f' of 6 30,33(a)(2) and (3) of this chapter do not apply to an application for a- l j license to transfer byproduct material manufactured, processed, produced, f

packaged, or repackaged pursuant to a license issued by an Agreement State. ,

(2) The applicant meets the requirements under 5 22.72-( )(2); /\ O (3) The applicant provides evidence that each carbon-14 urea capsule will 4 not exceed one microcurie; $p (4) The carbon-14 urea is not contained in any food, beverage, cosmetili,\>

drug (except as described in this section) or other commodity designed for j ingestion, or inhalation by or application to a human being; [

b '1 (5) The carbon-14 urea is in the form of a capsule, identified as

• \ :'

radioactive, and to be used for its radioactive properties, but is not k5

\ '

t

' V j incorporated into any manufactured or assembled commodity, product, or device -

' \ \

intended for commercial distribution; and (6) The applicant submits copies of prototype labels and brochures and the Commission approves such labels and brochures, #

Y j

(b) Nothing in this section relieves the licensee from complying with N -

anplicable FDA, other federal, and State requirements governing drugs, Ni V[

6 32.21a Same: Conditions of license.

Each' license issued under i 32.21 is subject to the following conditions: -

(a) The immediate container of the capsule (s) shall bear a durable, /

I  !

legible label which: L(1) . identifies the radioisotope, the physical and _

._ v <

chemical form, the quantity of radioactivity of each capsuleTa't a specific g

}-

date, and (2) bears the words " Radioactive Material " /4ddPC

. cw -

b L g 25 g r ndnD+

y k

h .

e %Yw.n.m.

I'

,: l' l a

(b) In addition to the labeling information: required by paragraph (a)=of_ll .

l this section, the labelf affixed.to the immediate container, or an ac, companying

~b rochure, shall also:. --

-s (1). state that the contents are exempt from NRC.or Agreement State' I

licensing requirements;

-fo. "In Vivo" Diagr:ostic Use (2) bear the words

• Radioactive Mate 1.1 i On'y Not!fer Research Involving Human Subjects - Introduction into Foods,. -

j Beverages,l Cosmetics, Other Drugs or Medicinals, or into Products Manufactured 1.  ;

for' Comercial Distribution =is Prohibited."

4< . ?;y,7 ,

N Dated at Rockvtile, Mary 1 cod this day of _ , 1997. l

'l For the Nuclear Regulatory Commission.

i John C. Hoyle.

Secretary of the Commission.

I i

?

_i l

e

't i J; 1

.f t 26 ,

m

~g

4. Impact on the Public and the Environment The proposed amendments would 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 view is predicated on the belief that each physician's primary motivation is to provide the best possible care to his or her patients, if the breath test is judged preferable to endoscopy, or olh'er procedure, any physician not authorized to use the test will refer his or her patient to authorized users who could perform the test under existing NRC regulations. Under this assumption, there would be no change in radiation exposures to the workers and Similarly, patients when compared the status quo to the proposed action.

there would be no change in impact to the environment and no non-radiological im,nacts because the Commission assumes that the same number of tests will be administered regardless which alternative is adopted.

5. List of Agencies and Persons Consulted and Identification of Sources Used ,

n following the receipt of the petition for rulemaking, a " Notice of receipt of (~ h petition for rulemaking" was published for public comment in thc Federal 4 Register on December 2. 1994 (59 FR 61831). A total of 315 public comment \/ I letters, 313 supporting (mostly form letters) and 2 opposing letters, were received. This petition was discussed with NRC's Advisory Committee on the Medical uses of Isotopes ACHUI) at the October 1995 meeting. Furthermore, a draft rulemaking plan has been forwarded to 29 Agreement States for comments.

6. Finding of No Significant Impacts The Commission has determined under the National Environmental Policy Act of 1969, ar amended, and the Commission's regulations in Subpart A of 10 CFR Part'51, that the proposed amendments, if adopted, would not be a major Federal action significantly affecting the quality of the human enviro ment, Th proposed and therefore an environment 1TTpait statement'leno(rego4 red.

rule would it-t[manufactureandinitialdistribution" of "C-u ea capsule $ mpt material andMpermit any person,df re eiv he capsules. }f

( n '-

(s_

2

,s * ,,

~~.m____

e s

__ . _ _ . _ _ _ _._m.__ . _ . . _ _ _ _ _ _ _ _ . _ . _ _ _ _ _ _ _ _ _ _ _ . _ . -

l

. . m. .

N^' 0 ( ( (+ l '

j N

u add unnecessary ,

l the same as Alternative 2. However, the adoption of Alternative 3)in States that assess g, ,

burden to those Agreement States and Agreement State licensees licensing or registration fees for generallic nyc.hdda ^3

'tive 2 also imposes - f, U> .

r initial distrijbutor % psules because P' jf incremental cost burden for manuf I they would need obtain an exe t stribut n license.'Each' nitial apj3Tio iconsdenewal 'once in every iv yebts) _ Ig

'on vyould p/ be'k'b .

estimated to take about 40 h urs and each would take about 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br />, husif the fi< at f year p iod, the aver ge# b den por '

r hour, the licensee would be about 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> per ear. Assum ngv aboriste o $12 j g g

r yea per licen e.

total burden would be about($1,280 p p ( v"" ' >

(b) Health and Safety Effects R t/ ,

f For the purposes of this regu a ory analysis, :he N C assumes that the sarne r.umbe breath testr. (i.e., 600,000 tests) will be adn .inis red regardless of the level of NRC regulatory control. This view is predicated c n e belief that each physician's primary j

/

motivation is to provide the best possible care to his or her patients. In addition, the routine and accidental exposures per carbon-14 urea breath test is not expected to be y affected by the level of NRC regulatory control. Thus, radiation exposures to the workers 1 ( '

and members of tne public would be the same regardless of which attemative is adopted.

The NRC has concluded that the human use of these capsules results ip.insig fic t exposures as depicted below: gg'gy .< &

Maximum Exposed

\ \ N. 5 r <

Routine Expbsufe .

D

--)

Scenario Individual L-y Worker administering "C- Full time worker, 8,000 1. css than 0.7 mrom/yr < %,

[ patients /yr urea breath tests Patient tests negative 0.38 mrem / capsule Routine exposure of patients from "C-urea breath tests Patient tests positive 0.18 mrem / capsule Release of 150 vCi of "CO, Member of public in the Less than 0.0002 mrem into administration area administration area Rupture of a capsule Skin (100 cm') exposed for 5.8 mrad skib dose causing skin contamin- one hour prior to washing 0.075 Ci sk n abs ption ation of worker or patient 0.029 mrem :ED Furthermore the NRC concluded that the impacts associated with any relee se of "C to the surrounding environment are expected to be very small and the expecte :1 sks are minimal. The carth's atmosphere contains an inventory of naturally occurri "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

~

6

fhs* * % UNITED STATES -

.y'.

't

.j j NUCLEAR REGULATORY COMMISSION WASHINGT oN. o.C. 305 4 0001 O '#

%,,,,,/ .

I' The Honorable James M. Inhefe, Chairman  !

. Subcommittee on Clean Air, Wetlands, Private Property and Nucleer Safety Committee on Environment and Public Works United States Senate Washington, DC 20510 Dear Mr. Chairmtm Enclosed for the information of the Subcommittee are copies of a public announcement and a Federal Register notice concerning a proposed amendment to 10 CFR Parts 30 and 32. This rulemaking is being taken in response to a petition for rulemaking submitt

' by Tri Med Specialties, Inc.

The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to allow NRC licensees to distribute a radioactive drug containing one rnicrocurie of carbon 14 urea .: .

to any person for "in vivo" diagnostic use. The NRC has determined that the radioac '

component of such capsules presents a minimal radiation risk ands therefore, regulato control of the drug for radiation safety is not necessary, if adopted, this amendment

-would make the drug more wideiy available, thus reducing costs to patients.-

Sirscerely; Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosures:

1. Public Announcert, int

2. Federal Register Notice cc: Senator Bob Graham

l':

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 'o ,information of the Subcommittee are copies of a public announcement and a Fet'arai degister notice conceming a proposed amendment to 10 CFR Parts 30 and 32. This rulemaking is being taken in response to a petition for rulemaking submitted by Tri Med Specialties, Inc.

The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to allow NRC licensees to distribute a radioactive drug containing one microcurie of carbon-14 urea to any person for *in vivo

• diagnostic use. The NRC has determined that the radioactive component of such r:apsules presents a minimal radiation risk and, therefore, regulatory control of the drug for radiation safety is not necessary. If adopted, this amendment would make the drug more widely available, thus reducing costs to patients.

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

Enclosures:

1. Public Announcement

2. Federal Hegister Notice cc: Senator Bob Graham Distribution: CTrottier/RPHEB rf File Center NCostanzi ATse IDOC NAME: 0:\JONE8\C14-PR.CLI I

RPHEB:DRA- D:DRA:RES _ D:p(p, D:OCA ,

Office RPHEB:DRA '

Name SJones A % CTrottier([ Morrisb Dhh- DKRathbun Date t lo /97 2/:797- n/$97 M 97 / /97 Yes/No Yes/No Yes/No Yes/Na Dietribution Yes/No OFFICIAL RECORD COPY (F ES File Code No.) 3A-3 4

1 w

I

• $[qpsn:g S UNITEJ STATES NUCLEAR REGULATORY COMMISSION l

L i! WASHINGTON. o.C. 70%!M001

%,,.....f .

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 for the information of the Subcommittee are copies of a public announcement and a Federal Register notice concernine a proposed amendment to 10 CFR Parts 30 and 32. This rulemaking is being taker; n response to a petition for rulemaking submitted-

-by Tri Med Specialties, Inc.

The Nuclear Regulatory Commission (NRC)is proposing to amend its regulations to allow NRC licensees to d'istribute a radioactive drug containing one microcurie of carbon 14 urea to any person for 'in vivo" diagnostic use. The NRC has determined that the radioactive component of such capsules presents a minimal radiation risk and, therefore, regulatory control of the drug for radiation safety is not necessary, if adopted, this amendment would make the drug more widely available, thus reducing costs to patients.

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

Enclosures:

1. Public Announcement

2. Federal Register Notice cc: Representative Ralph Hall

- . . m. . . . _ -._ _ ._ _

4- . -

. s .. -

i' t

The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power  !'

. Committee on Commerce

. United States House of Representative. -

Washington, DC 20515 l

Dear Mr. Chairman:

~

. i Enclosed for the information of the Subcommittee are copies of a public announcement

' ' and a Federal Register notice concerning a proposed amendment to 10 CFR Parts 30 i i

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

i

- The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to allow 3 NRC licensees to distribute a radioactive drug containing one microcurie of carbon 14 urea '

to any person for *in vivo

• diagnostic use. The NRC has determined that the radioactive component of such capsules presents a minimal radiaticin risk and, therefore, regulatory .

control of the drug for radiation safety is not necessary. If adopted, the. .'mendment 3 would make the drug rnore widely available, thes reducing costs to patiem.s.  ;

2: Sincerely, t 4

Dennis K. Rathbun, Director Office of Congressional Affairs

Enclosures:

1. Public Announcement *

- 2. Federal Register Notice cc:s Representative Ralph Hall Distribution: CTrottier/RPHEB rf File Center NCostanzi ATsc

. [ DOC NAME: 0:blONES\C14-PR.CL]

Cffice RPHEB:DRA RPHEB:DRA D:DRA:RES F DiRES / D:OCA '

Name SJones p - CTrottierCI BMorris 0" DLMorrisonM DKRathbun -

Date : 2/o /97' ,1/J 797 - < C //j'/97 ,

1. 1. J/97. / /97 Distributhm ' Yes/No i Yes/No ' Yes/No Yes/No Yes/No ^

- OFFICIAL RECORD COPY (RES.Filo Code No.) 3A 3 -

r t

~

. - . __ . .,s - --, -.

. . . . 1)Cb(SPC.2) HL8' S, l u l e O l U 1 B El F"'-

DEPARTMENT OF ENVIRONMENTAL QUALITY 000 DIVISION OF RADIATION CONTROL Id , bh' Macieelo taevkt 0""'**

168 North 1950 West AOd P.O.Itos 144850 Dianns R. Nelson. Ph D. sah LAe Cay. Utah 84114-4850 8 " "'* *

• Wdharni. sanciair (801) $36-4250 Voece [p"--]g_/

(801)$33-4097 Fax

• (801) $%-4414 T.D.D.

[D March 17,1997 Paul H. Lohaus, Deputy Director Office of State Programs U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001

Dear Mr. Lohaus:

We have received and reviewed the information contained in All Agreement S'ates letter SP-97-015.

The information concerned a proposed rule which will allow the exempt distribution of capsules containing one microcurie of C-14 urea to any person for uiagnostic testing of H. pylori.

The posation of the Utah Division of Radiation Control is that the proposed action is an acceptable replacement for the original proposal recommending distribution and use the capsules under a general license. You asked if there are requirements in Utah, other than radiation control program regulations, that might be of conecm. I can report that Utah Department of Commerce, Division of Occupational and Pmfessional Licensing, has advised us that they do not anticipate problems if the capsules are authorized under an exempt distribution license.

If you have questions concerning this response, please contact Craig W. Jones at (801) 536-4250.

Sincerely, rl WilliamJ.Sinelai!rector Utah Division of Radiation Control SF AG G=re+rt ios79 Ir ayy/ w ha es,.

. t .7)C3)(:,PCs) llL d '

,PN t -

g e5 C D rAB MARYLAND DEPARTMENT OF THE ENVIRONMENT d f# 0

'MDE 25m aroening Highway e Baltimore, Maryland 21224 (410) 631-3000 Parris N. Olendening Jane T. Nishida Governor . Secretary AF20-/

March 17,1997 g Mr. Paul Lohaus, Deputy Director Office of State Programs U.S. Nuclear Regulatory Commission Washington D.C. 20555 0001

Dear Mr. Lohaus:

In r6gards to your March 7,1997 correspondence concerning NRC's Rulemaking Plan - 10 CFR Parts 30 and 32 C 14 Urea H.I Pylori Diagnostic Test, Maryland's response to the two questions is as follows:

OUESTION 1: What is the position of your State on the NRC's plan not to limit receipt of the drug to physicians, but to rely on FDA and State Boards of Pharmacy to decide who should administer the drug?

C_QWIENT: Following c review of NRC's safety analysis, Maryland concurs that human use or the C 14 Urea H. Pylori diagnostic tes; would result in insignificant exposures to members of the general public. Given that radiation safety is a factor only in the manufacturer and distribution of the C-14 as an exempt quantity under an NRC license, it should be the responsibility of FDA and State Boards of Pharmacy to evaluate the ovsrall efficacy of the drug in relation to patient care and the methodologies of administration. NRC should not limit receipt of this drug to physicians.

QUESTION 2: Are there requirements in your State, that are mandated by regulations other than the radiation control program regulations, that might be of concem if the capsules are authorized under an exempt distribtition license, with a divis;on 1 level of compatibility for users?

COMMENT: According to Mr. Neil Thompson of the Maryland Department of the Environment's Waste Management Administration (MDE WAS), the provisions, of Title 7 of the Annotated Code of Maryland-Environment Article dealing with hazardous and solid waste and WAS regulations

~

6 I) P - 4 s P- tm -

hecyc P,.w

-17o og a o fTDD FOR THE DEAF (4bDe3009 9W/ Cd/ nnQ

• Mr. Paul Lohaus Page 2 of 2 (cont'd): have provisions which do not automatically exempt low-level radioactive waste (LLRW) generatdd as a result of usir.g exempt quantities recognized by the federal govemment. There is also some question about NRC's reasoning in makira this regulation a Division I item of compatibility, in any case, Maryland LLRW tc?ulations appear to be in cor.flict with this decision.

Thank you for the opportunity to comment on this matter. If you should have any questions concoming this letter, please feel free to contact me or Raymond Manley at (410) 63i 3300.

Sine rely, W/] '

I RU Roland G. Fletcher, Manager Radiological Health Program RGF/ REM /dpn

pa %i) d 24 8-AF7o PA STM. D ;S 'P M 64 DEPARTMENyDF~NU LEAR SAFETY LA6 1035 WTER PARK , IVE dJ M r SPRING IEfgJL12NOJS 62704 Jim Edgar *I17D85-99p' Thomas W. Onciper Governor Director ,

217 782f1S3fTDD)

N g h March 14,1997 d /

h '

,b;e Paul H. us, Deputy Director Office State Programs Mail Stop 3D23 U.S. Nuclear Regulatory Commission Washington, D.C. 20555-0001 Re: Rulemaking Plan - 10 CFR 30 & 32 C-14 Urea H. Pylori Diagnostic Test

Dear Mr. Lohaus:

The above referenced document asked for each Agreement State's position on two questions and requested response within two weeks. The questions with our responses follow:

1. What is the position of your State on the NRC's plan not to limit receipt of the drug to physicians, but to rely on FDA and State Boards of Pharmacy to decide who should administer the drug? (See page 6 of the fmal rulemaking plan)

We agree with the NRC's plar., however, the NRC should very clearly specify '

to FDA that there is no reason based on the presence of carbon-14 to limit who can administer the drug. The NRC should furnish a copy of such advisory statement to all the states to assist them in preparing a notice for each State Board of Pharmacy or other appropriate entities.

2. Are there requirements in your State, that are mandated by regulations other than the radiation control program regulations, that might be of concern if the capsules are authorized under an exempt distribution license, with a Division I level of compatibility for the users? (See page 10 of the final rulemaking plan)

None known. The. Illinois' Pharmacy Practice Act refers such matters to the Department of Nuclear Safety when radiopharmaceuticals are involved.

Q,~ s p. p . +

A m 2 m m a ,.p. g.p,4 et GP-%- 9 c .,,

l$

l ,. .'. v l

Paul H. Iohaus March 14,1997 Page 2 On page 5 of the Final Rulemaking Plan in the section entitled Arreement State Comments on Draft Rulemaking Phn, the third paragraph contains the following statement by NRC: " Illinois seems to imply that they could avoid rulemaking if the NRC were to adopt the exemption approach. However, as Georgia correctly observed, the exemption approach would require States to make conforming changes in their regulations as well."

The third paragraph of Illinois' October 28,1996, comment letter states:

" Implementation of Alternative 3 would require the NRC and each of the 29 Agreement States to have costly rulemaking proceedings to add a general license to the regulations of each agency. General licenses should be used only when some level of control is desired for the product. The NRC's technical analysis indicates that no controls are warranted, so Alternative 2 is appropriate and the least costly approach."

Contrary to the NRC's interpretation, Illinois did not imply that rulemaking could be avoided. Rulemaking would be required regardless of the approach. Under the NRC's current plan, Illinois agrees with Georgia's observation. The rulemaking for Illinois will be less costly for adding an exemption than for adding a new General License. In the exemption rulemaking, there would be no added requirement being imposed as there would be with the General License approach, therefore, the exemption rulemaking in Illinois will be a rather minor administrative change without the necessity of widespread distribution of proposed rule language for comment that would be necessary for a proposed new General License rule.

If NRC staff had contacted the Department regarding its comments, we would i have been pleased to explain. If any doubt exists regarding the meaning of comments h made by representatives of this agency, we prefer that you contact us to determine p[

I what of we meant rather than making interpretations that may lead to our views.

Sincerely, d.GAA54 Steven C. Collins, Chief Division of Radioactive Materials

. cc: James L. Lynch, State Agreements Officer NRC Region III

.. MV- -

}

Tf1 F@lCLC61CfL HEALTH fe :615-532-79?e tbr 21 '97 :M f'. 02 Q

DU(GPS fg 1 pp 704 3d l 9DL m  :

(). $^.J4% 0 l

STATE OF TENNESSEE DEPARTM' INT OF ENVIRONMENT AND CONSERVATION Q J Division of Radiological Health 7 l Third Floor. L & C Annes 401 Church Street

[ ,  ; {.p

-L 1

Nashville,TN 37243-1532 March 13,1997 Office of State Programs U.S. Nucimr Regulatory Commission Washington, D.C. 20555 Attention: Paul IAmus, Deputy Director Gentlemen:

We arc in receipt of your March 7,1997, All Agreement States letter (SP-97-015) concerning the Rulemaking Plan - 10CFR Parts 30 & 32 C.14 Urea H. Py.ori Diagnostic Test. This letter requested a response to two questions conccming the rulemaking plan. We are happy to provide our response to these questions:

1. What is the position of your State on the NRC's plan not to limit receipt of the drug to physicians, but to rely on FDA and State Boards of Pharmacy to decide who should administer the drug 7 The State of Tennessee concurs with not limiting the use of this drug to physicians as long as the U.S. Nuclear Regulatory Commission (NRC) requires the distribution to and use by "any pcroon who is permitted to receive and use the drug under an appropriate Federal or State law govcming the distribution and use of the drug."

2. Are there requirements in your State, that are mandated by regulations other than the radiation control program regulations, that might be of concern if the capsules are authorized under an exempt distribution license, with a Division I level of compatibility for the users?

The State of Tennossoc is unaware of any requirements mandated by regulations other than radiation control program regulations that would aEct the compatibility requirements for users However, we encourage the NRC, as it proposes and accomplishes the necessary ruicmaking, to recognize that an Agreement State such as Tennessee must follow a parallel course in order to make the nocessary changes in its Regulations to accommodate u item of this significance. States may not be able to accomplish the rule change as expeditiously as NRC. Therefore, NRC should share the specifics ofits intentions at cach stcp of the process with the States as soon as the text of the Proposed Rule is availabic. This information sharing will hcip reduce the impact that potential delays in rule changes may have in the exempt distribution of this radioactive material to the public.

@A1 no-su.o m a g sm i e > t z'I m y.-R F M

114 Fi#dCLO31CfL KitTH Fa. :615-532-79?4 tt4r 21 '# < :41 F' 03 -!

. Mr. Peu! Idans l March 13.- 1997,  ;

Page 2 The Division appreciates the opportunny to' address these questions on this final rulemaking plan, and looks forward to commmiing on future topics.

Sincerely, _

A

] k',/vP/ ll Michael 11. Mobley, Director Division of Radiological llcalth I

i