ML20206E655
| ML20206E655 | |
| Person / Time | |
|---|---|
| Issue date: | 02/20/1985 |
| From: | Dircks W NRC OFFICE OF THE EXECUTIVE DIRECTOR FOR OPERATIONS (EDO) |
| To: | Jennifer Davis NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| NUDOCS 8606230481 | |
| Download: ML20206E655 (38) | |
Text
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f}c7 FEB 2 01985
! MEMORANDUM FOR: John G. Davis, Director .
Office of Nuclear Material Safety and Safeguards FROM: William J. Dircks Executive Director for Operations
SUBJECT:
CONTROL OF NRC RULEMAKING By memorandum of February 13, 1984, " Control of NRC Rulemaking by Offices Reporting to the EDO," Offices were directed that effective April 1, 1984, (1) all offices under ED0 purview must obtain my approval to begin and/or continue a specific rulemaking, (2) resources were not to be expended on rule-makings that have not been approved, and (3) RES would independently review rulemaking proposals fonvarded for my approval and make recommendations to me concerning whether or not and how to proceed with the rulemakings.
i In accordance with my directive, the following proposal concerning rulemaking
! has been forwarded for my approval.
Proposed revision of 10 CFR Part 35, " Human Uses of Byproduct Material," to add new methods of use for FDA approved radiopharmaceuticals. (Sponsored by NMSS - memorandum, Minogue to ED0 dated February 11,1985.)
I approve continuation of this rulemaking. The NRC Regulatory Agenda i (NUREG-0936) should be modified to reflect the status of this rulemaking.
2 (Signed) William J.Dircks William J. Dircks !
Executive Director for Operations !
V. Stello J. Roe H. R. Denton J. Taylor R. B. Minogue P. G. Norry Distribution WSchwink DEDROGR cf Jniezek Central File VStello WDircks EDO rf JPhilips EO 20 M PDR
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/ FEB 111985 MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: Robert B. Minogue, Director Office of Nuclear Regulatory Research
SUBJECT:
CONTROL 0F NRC RULEMAKING: RES INDEPENDENT REVIEW 0F ONG0ING RULEMAKING SPONSORED BY NMSS Based on our independent review of the proposed rulemaking, sponsored by NMSS, to modify 935.14(b)(7) of 10 CFR Part 35, " Human Uses of Byproduct Material," to add six new methods of use and the appropriate radiopharma-ceuticals, RES agrees with the recommendation of the Director, NMSS, that this rulemak'ing effort should continue.
The basis for our recommendation is as follows:
o This is a minor rulemaking implementing a policy, set out in a final rulemaking notice published February 4, 1983 (48 FR 5217) to add a new 10 CFR 35.14(b)(7), that the NRC would amend the specified para-graph to allow NRC-licensed physicians and hospitals to use radiophar-maceuticals for newly developed methods of use (that are not listed on their respective. FDA-approved package labels), without applying to the NRC for a license amendment.
o The proposed rule would modify 10 CFR 35.14(b)(7) to add six new methods of use and the appropriate technetium-99 radiopharmaceuticals for each method of use. With assistance from its Advisory Committee on the Medical Uses of Isotopes, NRC staff has determined that the proposed clinical procedures involving oral administration or injec-tion of the radiopharmaceuticals can be conducted with no unjustified radiation dose to the patient and with a demonstration of adequate occupational radiation protection measures.
The corrplete RES independent review package has been sent to OED0 (Atten-tion: DEDR0GR) and to the Direc or, NMSS.
, Ohb *U Robert B. Minogue, Director Office of Nuclear Regulatory Research
Enclosure:
As stated l
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JFoul ke WAMills FEB 111985 KGo11er Dross RMinogue MEMORA'iDUM FOR: William J. Dircks Executivo Director for Operations FROM: Robert B. Ilinogue, Director Offico of Nuclear Regulatorv Rosearch SUNECT: CONTROL OF NRC RULEU KING: RES INCEPERDENT REVIEt: OF ONGOIN", RULEMAKING SPO' SORED BY N'iSS Based or. nur independent review of the proposed rulemskina, sparsnred by N':SS , to mndify 935.14(b)(7) of 10 CFR P<trt 35, "Huvn !!ses of Pyproduct Hatorial," to add six new methods of use and tha appropriate radiopharma-ceuticals, RES ag*ces with ths recomendation of the Director, N'SS, that
, this ruler" kino affort shnuld cnntinue.
The basis for our recomendation is as follows:
3 o Thie if a miror rulmking implementing a policv. 50+ out in a final rulemcking notice published February 4, 1903 (49 FR 5217) tc add a naw 10 CFP 35.14(b)(7), that the NRC would amend the specified scra-oraph tc allow NRC-licensed physicians and hospitals to usc radiophar-macauticris for navly develop 9d methods of use (that are not listed er their respective FDA-approved pcckege labals), withsut applvino to th.' N.C for a license ar.endnant.
o Tha proposed rula would modify 10 CFR 35.14(b)(7) to add six new mth:,dc cf ute and the appropricte technatium-99 radiopharm?coutir.'1 t for e7ch mth,d of u':a. With assistMco from its Adviscry Cnm ittea cr- the .vadical Uses of isotopes, NRC staff has determined that tha prnpesed clinical procedures hvelvinc oral administratina or iniec-tion of tha radiophanricauticals can be conducMd with nc ur.instified ra t i., ti o n dase to the prti"t and with a danw trat ios of adequ:'o occupe ttor.cl radiatier nrottetion rm:.ures.
Th - c~ plete PES indapmden' reviax p.'chna hr. c b n srnt to OEM (Atton-tion: DE9PO^-R) and tc the Direcirr, NMSS.
Wh signed by:
810Butzs. Maosa Robert R. Minogue, Director Office of Nuclear Regulatory Rer,carch Enclosura: DRPES:DM As cta'.ed Os s e FRE W 005 C8"'"".RfMC85 KGoller f._ (BE t 3
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ROUTING AND TRANSMRTAL SUP JAN 8 1985 TO: (Name, o#1ce symbol. room number, Initials Date burnsng, Agencytrost) 3, O. E. Bassett, itember, RIRB g K. R. Goller, l1 ember, RIRB
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We are at step III.C.2, "RIR3 deliberations," of the ~
RES independent review procedures for the attached specific ongoing rulemaking sponsored by Please evaluate the attached dra'ft independent review package and provide RA!!RB with your voting sheet indicating your position on the rulemaking.
Your response by c.o.b. JAN 16'1125 .
will assist in RES' making independent recommendations to the EDO in a timely manner.
DO NOT use this form as a RECORD of approvels, concurrences, m ea=*
clearsaces, and similar actions FROM:(Name, org. symbol. Agency / Post) Room No.--Sids.
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4 RES INDEPENDENT REVIEW BOARD V0 TING SHEET T0: F. P. GILLESPIE, CHAIRMAN, RIRB FROM: G. A. Arlotto, RIRB flember TITLE OF RULEMAKING: "USE OF CERTAIN RADI0 PHARMACEUTICALS FOR PROCEDURES NOT LISTED ON FAD-APPROVED LABEL"
/ AGREE WITH DRAFT RES REQUEST RIRB ts/ INDEPENDENT RECOMMENDATIONS MEETING.
IN DRAFT INDEPENDENT REVIEW PACKAGE.
MODIFY DRAFT RES NOT PARTICIPATING.
INDEPENDENT RECOMMENDATIONS AS INDICATED BELOW.
COMMENTS AND SUGGESTIONS:
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MEMBER, RIRB i)
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RES INDEPENDENT REVIE',: EDAED VOTING SHEET TO: F. P. GILLESPIE, CHAIRMAN, RIRB FROM: 0. E. BASSETT, MEMBER, RIRB TITLE OF RULEMAKING: "USE OF CERTAIN RADI0 PHARMACEUTICALS FOR PROCEDURES NOT LISTED ON FAD-APPROVED LABEL" AGREE WITH DRAFT RES REQUEST RIRE INDEPENDENT RECOMMENDATIONS ,____ MEETING.
X IN DRAFT INDEPENDENT REVIEW PACKAGE.
MODIFY DRAFT RES NOT PARTICIPATING.
INDEPENDENT RECOMMENDATIONS AS INDICATED BELOW.
COMMENTS AND SUGGESTIONS:
Straight " approval" on this.
/O'${hbfWiA- 'rs1 ht O. E. BASSETT '
MEMBER, RIRB l
JANUARY 14, 1985 !
DATE
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UNITED STATES E( ), ( [ogg NUCLEAR REGULATORY COMMISSION
$ , c: E WASHINGTON, D. C. 20555 DEC 2 61994 ed #
a MEMORANDUM FOR: Frank P. Gilles /
RES Indepe view Board %
, FROM: Karl R. Goller, Director ,
Division of Radiation Programs and Earth Sciences, RES
SUBJECT:
CONTROL OF NRC RULEMAKING: RES INDEPENDENT REVIEW 0F PROPOSED RULEMAKING As requested by your December 11, 1984 memorandum, the NMSS package concerning modification of 10 CFR 35.14(b)(7) to add six new methods of use and the appropriate radiopharmaceuticals for each, was assigned to the Health Effects Branch for review.
The draft staff recommendation is that NRC should proceed with the proposed
- rulemaking.
1 Enclosed is our draft independent review package. The RES task leader is Judith D. Foulke, x74563.
v -
Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES
Enclosures:
A. Rulemaking Review Package received from NMSS .
B. Draft Staff Recommendation C. Results of RES Staff Review 4
JAN17 1985 '
[ o
~'g UNITED STATES NUCLEAR REGULATORY COMMISSION N g ;E WASHINGTON, D. C. 20555 J' V
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SUBJECT:
ADDENDUM TO RES INDEPENDENT REVIEW 0F PROPOSED RULEMAKING
! This is an addendum to our December 26, 1984 review package concerning NMSS's modification of 10 CFR 35.14(b)(7) to add six new methods of use and the appropriate radiopharmaceuticals for each. It should be noted that NMSS based its decision to include these new medical procedures on the criteria given in the February 28, 1983 Federal Register Notice entitled, " Physician's Use of Radioactive Drugs." These two criteria are:
o No unjustified radiation dose to the patient, and o Demonstration of adequate occupational radiation protection measures.
In addition to the staff evaluation, members of NRC's Advisory Committee on the Medical Uses of Isotopes were consulted for their recommendations. For the particular uses to be included, the health and safety considerations for the additional uses are no greater than for the uses specified in the i respective package labels. These considerations were implicit in the review, but we decided they should be transmitted in writing.
Karl R. Goller, Director Division of Radiation Programs and Earth Sciences, RES l
1 U
DRAFT STAFF RECOMMENDATION Based on the staff review, DRPES finds that the proposed rulemaking should continue.
_ _. , c . _ ,--. ---,. -.
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RESULTS OF RES STAFF REVIEW a) The issue to be addressed.
This proposed rulemaking will add the following Food and Drug Administration (FDA) - approved drugs for the following new methods of use to 635.14(b)(7):
technetium-99m labeled sulfur colloid for gastroesophageal imaging technetium-99m labeled sulfur colloid, pertechnetate, or '
macroaggregated human serum albumin for Le Veen, ventriculo-atrial, and ventriculo-peritoneal shunt imaging technetium-99m labled pertechnetate for cystography and dacryocystography.
As such, it is a specific implementation of NRC's policy for licensing radiopharmaceuticals as described in the Federal Register on February 3, 1983 (48 FR S217). The purpose of the policy change was to allow presently licensed physicians or hospitals to use certain radiopharmaceuticals for recently developed methods of use not listed on their respective package labels.
b) The necessity and urgency for addressing the issue.
A large number of physicians have been waiting for FDA to issue a list of new approved uses for already approved radiopharmaceuticals. It now appears FDA will not take this step, but rather continue to follow the established procedure of waiting for the manufacturers to request a label change. Because of the costs involved relative to the additional sales, the manufacturers have no incentive to do this.
These new methods of use are not only better than older ones, they may even result in' lower patient doses. In some cases, there is no other imaging method ava'ilable.
c) Alternatives to rulemaking.
The only alternative is to amend individual licenses to authorize the new methods of use, d) How the issue will be addressed through rulemaking.
The proposed rule would modify 10 CFR 35.14(b)(7) to add six new methods of use and the appropriate radiopharmaceuticals for each.
e) How the public, industry, and NRC will be affected.
Both the NRC and the licensees will benefit by eliminating costly and 2
time consuming license amendments. The patients will benefit from improved diagnostic methods.
f) NRC resources and scheduling.
NMSS estimates it will need about 0.1 staff-year to complete the proposed and final rulemaking. This seems reasonable.
3
Federal Regi:ter / Vd. 48, No. 25 / Frid:y, February 4,1983 / Rul:s cnd Regul:ti:ns 5217 List of Subjects in 7 CFR Part $10 of other diagnostic similar future exceptions. Copies of the radiopharmaceuticals. This final rule public comments received and the hg E
- na* 1 =n s' responds to the petition filed by the late Dr. George V.Taplin to approve the use Commission analysis of the comments may be examined in the Commission's of technetium-99m pentetate for lung Public Document Room at 1717 H Street, PART 910-{ AMENDED]
function studies (PRM 35-1). The final N.W., Washington, D.C.
- 1. Section 910.897 is added as follows: rule will relieve many of NRC's medical Two commenters opposed the licensees from applicable regulatory proposed rule because of their feeling 19t0.497 Lamon Regulation 397*
requirements. The final rule and the new that NRC would be authorizing the The quantity oflemons grown in exception procedures are intended to addition of non-FDA. approved California and Arizona which may be remove unnecessary restrictions on the procedures to its regulations, thereby handled dunng the period February 6, physician in patient treatment while starting a precedent for such procedures 1983 through February 12,1983, is continuing to provide an adequate level to be added without close evaluation.
established at 210.000 cartons. of radiation protection for the patient Careful consideration was given to the
- 2. Section 910.098 Lemon Regulation and the worker, questions raised by these commenters, 396 (48 FR 3935)is revised to read as EFFacTtyt DATs: March 7,1983. but the NRC does not believe that follows: patient protection is being compromised.
POR FusmtER MFORefATION CONTACT:
3 910.496 Lamon Regulation 396. Deborah A. Bozik, Office of Nuclear Technetium-99m penetetate gives Regulatory Research, U.S. Nuclear several times less radiation to the lung The quantity oflemons grown in
- California and Arizona which may be Regulatory Commission, Washington, than other radiopharmaceuticals which handled during the period January 30, DC,20555 (Phone 301-427-4566), are more slowly absorbed and thus are 1983, through February 5,1983, is SUPPLEssENTARY INFORstATioec On April retained longer in the lungs. Taplin and established at 200,000 cartons. 13,1982, the NRC published a proposed . Chopra, "Inhalatf og Lung Imaging with Radioactive Aerosols and Gases " Prog.
(sec 1 io. 4s stat. 31, as amended; 7 U.S.C. rule (47 FR 15796) to amend its
- regulations to provide an exception from Nucl. Med., Vol. 5, pp.119-143 (Karger.
b Basel1978), and Taplin and Chopra.
Dated: February 3.1983.
certain regulatory requirements for technetium-99m pentetate in i 35.14 of " Lung Perfusion-Inhalation. Scintigraphy D. S. Kurylookl. 10 CFR Part 35, which contains the in Obstructive Airway Disease and g
Y \ Deputy Director, Fruit and Vegetable specific license requirements for certain Pulmonary Embolism," Radiological Division, Agneulturo1Markermgservice. Clinics of North America, Vol.XVI No.
.. ( - irm om asus7 ra.a s_m sa.*3 groups of medical uses of byproduct material. In addition, this proposed rule 3, pp. 491-513. December 1978.
"""8******* also offered criteria and information for It is noteworthy that NRC and FDA
\
evaluation of similar future exceptions have sought a solution to the general
\ hUCLEAR REGULATORY
' to NRC regulations.
This rulemaking was developed in problem of drug labeling for unapproved uses, and FDA currently is considering a COMMISSION response to a petition filed by George V, program to add presently unapproved 10 CFR Part 35 Taplin, M.D. (deceased) for a rulemaking uses of approved radiopharmaceuticals.
to remove NRC restrictions that apply However, until such a program is when a physician uses an FDA. Implemented NRC believes that this Physician's Use of Radioactive Drugs rulemaking is the most appropriate way approved radioactive drug for a clinical AoENcV: Nuclear Regulatory procedure that does not have FDA to resolve the problem in this interim Commission. approval. Specifically, the petitioner period. Nine commenters either Action: Final rule. sought the nonrestricted use of addressed topics not specifically technetium pentetate as an aerosol for covered in this rulemaking or requested susentARY:The Nuclear Regulatory lung function studies (PRM-35-1; 44 FR that NRC consider other unapproved Commission (NRC)is amending its 26817; May 1,1979). The NRC grants that uses of FDA-approved regulations to provide sin exception from portion of the petition that requests a radiopharmaceuticals.The most certain regulatory requirements for specific exception for technetium-99m common requests centered on the uses technetium-99m pentetate (a Food and pentetate used for lung function studies, of technetium-99m pertechnetate for Drug Administration (FDA}-approved he NRC denies the petitioner's request voiding cystograms and technetium-99m drug) used for lung function studies that NRC remove all restrictions on the sulfur colloid for evaluation of14eVeen which is a use not yet approved by FDA. physican's use of an FDA-approved shunt patency. NRC developed criteria Prior to this fmal rule. NRC regulations radioactive drug for a clinical procedure and proceds for evaluating required that a physician using an that does not have FDA approval. exceptions to 135.14(b)(B). These approved drug for an unapproved However, the procedures and criteria procedures and criteria were published procedure follow FDA-approved established in this rulemaking create an in the April 13,1982 proposed rule and labeling for (1) physical form (2) route appropriate mechanism for addressing were open to the public for comment.
of administration, and (3) dosage range. future requests for exceptions to these They were very favorably received.ne Because in the lung function studies, restrictions and, as such, are an attempt Commission will use these criteria to technetium-99m pentetste is used as an to provide the greater flexibihty desired determine whether an exception from aerosol and administered by inhalation, by the petitioner. the requirements in i 35.14(b)(6) of to it does not meet the FDA. approved The public was invited to submit CFR Part 35 will result in an method for use of this written comments on the proposed rule unreasonable risk to the health and radiopharmaceutical, and an exception by June 14,1982, and 35 comment letters safety of the public or will mintmlre is necessary.ne preamble to this were received.nirty-one commenters danger to life or property, rulemaking also sets out the criteria and . supported the proposed rule, and 15 Any interested person should submit procedures that NRC will use to specifically noted their support of the a request for an exception to NRC's eval.uate similar requests for exceptions criteria and procedures for evaluating Office of Nuclear Material Safety and l
l y f f 4 C ol 7
5218 Federal Register / Vol. 48, No. 25 / Fridry. F;bru;ry 4,1983 / Rul;s cnd Rigulati:na l Safeguards detailing the following this rule will not have a significant the product labeling (package insert) economic impact upon a substantial .shall comply with tne product labeling information:
- Descriptien of the procedures, number of small entities. The rmal rule regarding:
- Justification for the exception affects about 2,000 specific licenses (i) Chemical and physical form:
(including an explanation of why the under il 35.11. 35.12, and 35.14 of 10 (ii) Route of administration; and procedure is not included in the product CFR Part 35.These licenses are issued (iii) Dosage range.
labelling), principally to medical institutions. Small (7) The following
- Purpose and benefits of the business entities, primarily physicians in radiopharmaceutical(s) when used for procedure, private practice, comprise about 275 of the listed clinical procedure (s), are not
- Analysis of the radiation dose, and the specific medicallicenses. subject to the restrictions in paragraph
- Supporting technical and scientific The final rule relieves NRC's medical (b)(6) of this section:
information, including any provisions licensees from regulatory requirements (i) Technetium-99m pentetate as an necessary to ensure occupational safety by relaxing restrictions on the physician aerosol forlung function studies.
and patient safety. concerning patient care. The final rule (8) Radioactive aerosols must be In order to reach a concl'usion has no significant economic impact on administered with a closed, shielded regarding the possible inclusion of these - these licensees. In the proposed rule, the system that either is vented to the radiopharmaceuticals in the regulations, NRC specifically requested comments outside atmosphere through an air NRC would expect that such requests on this conclusion as to impact on small exhaust or provides for collection and would provide evidence that the entities. No comments were received disposalof the aerosol.
following two criteria, upon which NRC that questioned this conclusion. . . . . . .
will conduct its assessment, would b Dated at Bethesda. MD, this 28th day of List of Subjects in to CFR Part 35 I*""**' #
- No unjustified radiation dose to the Byproduct material, Drugs, Health For the Nuclear Regulaton Commission.
patient. and
- facilities, Health professions, Medical William J. Dircks,
- Demonstration of adequate devices Nuclear materials.
occupational radiation protection Occupational safety and health. Penalty, Executive Directorfor Operations.i, measures. Radiation protection, Reporting and PR Da am M W1sh) \
The NRC staff would review a recordkeeping requirements. sumo coes tsecaw request, and based upon its findings as Under the Atomic Energy Act of 1954, well as the recocunendation ofits as amended, the Energy Reorganization Advisory Comm ttee on the Medical i
Act of 1974, as amended, and section DEPARTMENT OF ENERGY Uses of Isotopes (ACMUI), would 553 of Title 5 of the United States Code. 10 CFR Part 810 publish in the Federal Register a notice the following amendments to Title 10, Unclassified Activities in Foreign of rulemaking. He notice would provide Chapter I, Code of Federal Regulations, for a 30- to 45-day comment period. The Atomic Energy Programs part 35, are published as a document final rule establishing the exception subject to codification. AotNcy:Ene#8Y' /.
would be made immediately effective.
PART 35-HUMAN USES OF ACT om: Final rule. I EnvironmentalImpact: Negative BYPRODUCT MATERIAL.
Declaration sumuARY: Pursuant to the Nuclear Non-1.The authority citation of Part 35 Proliferation Act of 1978 (NNPA) and in ne Commission has determined under the National Environmental Policy continues to read as follows: accordance with the Executive Branch Authority: Secs. 81.161,182.183. 68 Stat. Procedures established and published Act of 1989, as amended, and the June 9,1978 (43 FR 25328), the Commission's regulations in 10 CFR Part 935. 948 953,954, as amended (42 U.S.C. 2111.
2201,2232. 2233); sec. 201, so Stat.1242, as Department of Energy (DOE)is 51, that promulgation of this regulation amending its regulations, to CFR Part amended (42 U.S.C. 5841).
is not a major Federal action For the purposes of sec. 223,68 Stat. 958, as 810 " Unclassified Activities in Foreign significantly affecting the quality of the ( ' Atomic Energy Programs." He amended human environment and therefore an (e[n 1(f). 35 3 . 3 d an'! 1 regulations reflect changes made by the environmentalimpact statement is not (b) and (c) are issued under sec.161b. 68 Stat. NNPA to Section 57.b. of the Atomic required.He environmentalimpact 948, as amended (42 U.S.C. 2201(b)); and Energy Act and incorporate the appraisal and negative declaration on il 35.14(b)(5) (li), (iii), and (v) and (f)(2), 35.27 and 35.31[d) are issued under sec.181o. 68 additional export criteria mandated by which this determination is based are the NNPA to govern the export of available for public inspection at the Stat. 950 as amended (42 U.S.C. 2201(o)).
sensitive nuclear technology for NRC Public Document Room,1717 H St. 2. Section 35.14 is amended by NW., Washington, D.C.
peaceful purposes.ne amended revising paragraph (b)(6) and adding regulations update the list of countries aphs (b)(7) and (b)(a) to read as to which the general authorization Paperwork Reduction Act Statement Pursuant to the provisions of the
{aa ' contained in i 810.7(a) does not apply.
Paperwork Reduction Act of 1980 (44 1 35.14 Specmc Nconees for certain . Added to the listed countries are all U.S.C. 3501, et seq.), the NRC has made groupe of mediceluees of byproduct non-nuclear weapon states that are not parties to the Trea'y on the Non-a determination that this rule would not impose new recordkeeping. application,
"*i*L
- * * *
- Proliferation of Nuclear Weapons (NFF) )
reporting, or other types of information (b)* * * (except for those that accept fullscope collection requirements. (6) Except for those safeguards or for which the Treaty of radiopharmaceuticals listed in Tlatelolco is currently in force) and Regulatory Flexlhility Cartification paragraph (b)(7) of this section, for certain countries in regions of particular in accordance with the Regulatory Groups I, II, and III any licensee using wolatility and sensitivity, Withdrawal of Flexibility Act of 1980,5 U.S.C. 805(b), byproduct material for clinical the general authorization to these the Commission hereby certifies that procedures other than those specified in countries will assure that authorizations
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1.DIRCKS REGULATORY AGENDA ENTRY INPULY:MinUGut
- 2. DRAFT REGULATORY ANALYSIS ROSS KELBER MARINO P000LAK OKLESSON a E =Aa=* GULLER/ CONT I MALARO J. HENRY FILE u s avCLEAm mEsutArony Commsession ronasanc nos MAIL CONTROL FORM M
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ME2ORNiDLN FOR: Willians J. Dircks Executive Director for Operations
'nDU: James J. Henry, Coordinator Research Independent Review Board FR34: John G. Davis, Director Office of Nuclear Material Safety and Safeguards SUtk7ECr: RDCOME:NDATICN '!O INITIA'!E MDOR IULDSKIN3 h e following inform tion is submitted in response to your directive of May 30, 1934 that the office sponsoring a rulernaking asser.t>1e a ruleunking revies package.
- 1. This rulemaking will allow NRC licensees to use Food and Drug Administration (FDA) asuval radiopharmaceuticals for some recently developed methods of use that are not listed m the respective package labels. his implements 1UC policy (48 FR 5217, February 4, 1983).
- 2. Althcugh not urgent, this will facilitate potentially beneficial new uses of approved drugs.
- 3. The only alternative to the rulemking would be to amend individual licenses to authorize the new methods of user that would consume an inordinate amount of staff time.
- 4. The proposed rule would modify 10 CrR 35.14(b)(7) to add six new methods of use and the appropriate radiopban=r=ticals for each.
- 5. Se proposed rule would make the new diagnostic methcxis of use available to NRC licensees and their patients. Were is no increase in cost or worker dose for licensees. W is is the nost efficient way for NIC to authorize the nort methods of use.
- 6. Inc would need abrut 0.1 staff year to cortplete the proposed rularaaking and final rulemaking. W e proposed rule e n be published in Jamary 1985 and the final rule in April 1905.
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wne ronu aie n0 s0) NRCM ONO OFFICIAL RECORD COPY _________
hilliau J. 91rcks 1 recowend tuat the ofiice proceed with tnis proposeu ruleanning.
John G. Davis, Director ufiice of nuclear haterial Satety suo bateguarus 1.nclosures
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- 4. brait begulatory Analysis cc: . John Clarke.. __.
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T Enclesure 1 I
DFAFT FEGULATOFY AGENDA ENTFY ABSTFACT +
As new uses for FDA-approved drugs are developed, NFC considers amending its regulations to provide physicians an exception from its requirement to only use a radiopharmaceutical for the methods of use listed on the i package label. Although not urgent, this will facilitate potentially beneficial new uses of approved drugs. The only alternative to the rulemaking would be to amend individual licenses to authorize these new methods of use; that would consume an inordinate amount of staff time.
i a The proposed rule would allow NFC-licensed physicians to use some currently availabl'e diagnostic radiopharmaceuticals for some recently i
developed methods of use that are not listed on the respective package ;
s labels. NFC will use about 0.1 staff year to complete the proposed rulemaking and final rulemaking.
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- T??4 NUCLEAR REGULATORY COMMISS10N 10 CFR PART 35 Physician's Use of Radioactive Drugs AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to allow physicians to use technetium-99m labeled sulfur colloid for gastroesophageal Imaging; technetium-99m labele'd sulfur colloid, pertechnetate, and macroaggregated human serum albumin for Leveen, ventriculo-atrial and ventriculo-peritoneal shunt Imaging; and technetium-99m labeled pertechnetate for cystography and dacryocystography. Without this amendment, each NRC licensee that wants to use these radioactive materials in these ways would have to apply to the NRC for permission to do so. The proposed rule will allow physicians or hospitals that are now licensed by NRC to use other similar materials to use these drugs without making an application to NRC.
DATE: Comment period expires [***30 days from date of publication ***]
Comments received after this date will be considered if it is practical to do so, bat assurance of consideration cannot be given except as to comments received on or before this date.
ADDRESSES: Send comments to: The Secretary of the Commission, U.S.
Nuclear Regulatory Commission, Washington, DC 20555, ATTN: Docketing and Service Branch. Hand deliver comments to: Room 1121,1717 H Street, NW, Washington, DC between 8:15 am and 5:00 pm. Examine comments received, environmental and regulatory analyses and the requests for exception at: The NRC Public Document Room, 1717 H Street, NW, Washington, DC.
FOR FURTHER INFORMATION CONTACT: Norman L. McElroy, Office of Nuclear Material Saf ety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, Telephone: (301) 427-4108.
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MC 11 paq SUPPLEMENTARY INFORMATION: Pnysicians who want to use certain radioactive materials in the practice of medicine may do so only in accordance with a license issued by the Nuclear Regulatory Commission (NRC) or by States which have an agreement with the NRC to lIcense the use of these materials instead of the NRC.
As new radiopharmaceuticals, radloactive sources, medical devices, and uses of radioisotopes are developed, the NRC considers adding them to one of the groups under which medical licenses are issued. The groups were designed to allow physicians and community hospitals wide access to nuclear medicine services. The groups In $35.100 contain only radiopharmaceuticals that are the subject of an FDA-approved "New Drug Application" (NDA), or a " Notice of Claimed Investigational Exemption for a New Drug" (IND) that has been accepted by FDA. A licensee authorized to use all the materials listed in a group is referred to as a " group medical licensee."
NRC regulations in $35.14(b)(6) that apply to the group medical IIcensees provide that when a physician uses byproduct material for clinical procedures other than those approved by FDA and specified in the product labeling or package insert, the physician must follow the product labeling regarding: (1) chemical and physical form, (2) route of administration, and (3) dosage range. The NRC has received requests to amend its regulations to provide an exception from the product labeling requirement for technetium-99m sulfur colloid when used for gastroesophageal Imaging; technetium-99m labeled sulfur colloid, pertechnetate, and macroaggregated human serum albumin when used for Leveen, ventriculo-atrial, and ventriculo-peritoneal shunt Imaging; and technetium-99m labeled pertechnetate for cystography and dacryocystography. These are clinical procedures that are not listed in the product labels.
it is noteworthy that NRC and FDA have sought a solution to the general problem of drug labeling, and FDA currently is considering a program to authorize additional clinical procedures that use approved radiopharmaceuticals. However, until such a program is implemented, NRC believes that this rulemaking is the most appropriate way to resolve the problem in this interim period. This policy was described in an NRC rulemaking published in the Federal Register on February 3, 1983 (48 FR 5217).
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The requests for exception that NRC received provided a description of I the clinical procedure, a justification for the exception, the purpose of the procedure, an analysis of the radiation dose, and additional technical and scientific information. (Each of the requests for exception is available for Inspection at the NRC Public Document Room, 1717 H Street, f4W, Washington, D.C. ) The NRC has reviewed the requests to determine whether the requested exception from the requirements in 535.14(b)(6) might result in an unreasonable risk to the health and safety of the public or might endanger life or property.
The NRC specifically considered two criteria:
o No unjustified radiation dose to the patient, and o Demonstration of adequacy of occupational radiation protection measures With assistance from its Advisory Committee on the Medical Uses of isotopbs (ACMul), the NRC has determined that the above criteria have been met for the proposed clinical procedures. f4any of the committee members believe that these clinical procedures are useful, and the risk / benefit ratio for these procedures is extremely low. They also noted that these techniques will probably become routine once approved by NRC.
Technetium-99m labeled sulfur colloid can be administered orally either as a solid or IIquid test meal. Following oral administration, technetium-99m sulf ur colloid goes from the esophagus to the stomach, small intestine, and the upper large intestine. This cilnical procedura permits external Imaging which is helpful in assessing gastric emptying, gastroesophageal reflux, and esophageal transit.
The gastric emptying procedure is useful in demonstrating the presence and the severity of gastric motor disorder; the gastroesophageal reflux study may demonstrate backward flow in the digestive tract.
The esophageal transit study may demonstrate obstructions or abnormal transit time. The radiation dose to an avercge adult patient from i millicurie of orally administered technetium-99m sulfur colloid as a liquid is: 0.1 rad to the stomach wall; 0.3 rad to the small Intestine; 0.5 rad to the upper large Intestine; 0.3 rad to the lower large intestine; 0.1 rad to the ovaries; 0.01 rad to the testes; and 0.02 red to the whole body. The estimated absorbed radiation dose to an average adult patient from 1 millicurie of orally administered technetium-99m sulfur colloid as a solid food is: 0.2 rad to the stomach wall; 0.2 rad to the small intestine; 0.4 rad to the upper large intestine; 0.3 rad to the lower large Intestine; 0.1 rad to the ovarios, 0.004 rad to the testes; and 0.02 rad to the whole body.
These estimated absorbed radiation doses and the following doses are similar to other absorbed doses received from diagnostic nuclear medicine and x-ray procedures.
REC 111334 4 .
A Leveen shunt is an implanted tube that drains built-up fluid from the peritoneal cavity to a large central vein. Technetium-99m labeled sulfur colloid, pertechnetate, or macroaggregated human serum albumin can be injected into the peritoneal cavity to diagnose shunt malfunction, such as blockage by clot or valve failure, by taking Images of the shunt. The normal dosage is 3 to 10 millicuries. The radiation dose f rom an intraperitoneal injection of a 3 millicurie dosage of technetium-99m sulfur colloid is: 0.02 rad to the whole body; 0.02 rad to the testes; 0.02 rad to the ovaries; 0.03 rad to the liver; 0.02 rad to the spleen and 0.03 rad to the red marrow.
A ventriculo-atrial shunt is a tube implanted in patients with hydrocephalus (fluid build-up in the head). It drains the fluid from the head to the atrial cavity. Technetium-99m labeled sulfur colloid,
, pertechnetate, or macroaggregated human serum albumin is injected into the shunt system of the patient to localize shunt blockage before surgical repair is performed. The normal dosage is i to 5 millicuries. The radiation dose from an injection of a 5 millicurle dosage of technetium-99m to a patient with a patent shunt is: 0.1 rad to the whole body and 0.1 rad to the brain.
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- A ventriculo-peritoneal' shunt is an implanted tube in patients with hydrocephalus (fluid build-up in the head). It drains the fluid from
- the head to the peritoneal cavity. Technetium-99m labeled sulfur l colloid, pertechnetate, or macroggregated human serum albumin is 3
injected into the shunt system of patients to localize shunt blockage 4 before performing surgical repairs. The normal dosage is 1 to 5 '
! millicuries. The radiation dose from an injection of a 5 millicurie J dosage cf technetium-99m to a patient with a patent shunt is: 0.1 rad to the whole body and 0.1 rad to the brain.
i Cystography is a procedure for patients with bladder problems. A tube is inserted into the bladder of a patient. Technetium-99m pertechnetate is instilled through the tube into the bladder. Images are taken during filling and voiding of the bladder to measure the i amount of reflux (backward flow) into the upper tracts, bladder volume
- at which reflux occurs, drainage time of reflux after voiding, and the i remaining urine volume. The normal dosage is i millicurie. The i radiation dose from a 1 millicurie dosage of technetium-99m !
pertechnetate is: 0.002 rad to the whole body, 0.006 rad to gonads, !
and 0.2 rad to the bladder.
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D C 11 1939 Dacryocystography is a procedure for patients whose eyes exhibit excessive teardrops (epiphora). This procedure is performed to assess tear production and drainage in patients, and for nasolacrimal system imaging. Technetium-99m labeled pertechnetate is administered as a sterile eye drop. The normal dosage is 100 to 250 microcuries. The radiation dose from a dosage of 100 to 150 microcuries of technetium-99m pertechr.etate per eye drop to the germinal epithelium of the lens is: 0.01 to 0.02 rad under normal physiological conditions. With blocked lacrimal drainage, the dose to the lens is 0.4 to 0.6 rad.
FINDING OF NO SIGNIFICANT ENVIRONMENTAL lMPACT: AVAILABILITY The Commission has determined under the National Environmental Policy Act of,1969, as amended, and the Commission's regulations in Subpart A of 10 CFR Part 51, that this is not a major Federal action significantly af fecting the quality of the human environment and therefore en environmental impact statement is not required. The assessment shows that any detectable ef fect on the environment is unlikely. The environmental assessment and finding of no significant impact on which this determination is based are available for
, inspection at the NRC Public Document Room, 1717 H Street, NW, Washington, DC. Single copies of the environmental assessment are available from Mr. McElroy (see "For Further Information Contact" heading).
Paperwork Reduction Act Statement This proposed rule contains no information collection requirements and therefore it is not subject to the requirements of the Paperwork Reduction Act of 1980 (44 U.S.C. 350I et. seq.).
Regulatory Analysis The NRC has prepared a draf t regulatory analysis for this proposed rule. The analysis examines the costs and benefits of the alternatives considered by the NRC. The draft analysis is available for inspection at the NRC Public Document Room,1717 H Street, NW, Washington DC. A single copy may be obtained from Mr. McElroy (see "For Further Information Contact" heading).
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_s- DEC.11 19A4 Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980, 5 U.S.C. 605 (b), the NRC certifies that this rule, if adopted, will not have a significant economic impact on a substantial number of small entities.
The NRC has prepared a draf t regulatory analysis for this proposed rule that examines the economic impact of this action. The analysis notes that approximately 1900 medical IIcensees may experience some beneficial Impact from the rule. The proposed rule would spare each medical licensee, desiring to use the radioactive material in the requested manner, the estimated 5230 cost of preparing a license amendment request, the $120 amendment foe, and the delay (length and cost undetermined) associated with the amendment of the license.
The Commission is seeking comment particularly from small entitles (i.e., 'small businesses, small organizations, and small jurisdictions i
as defined by the Regulatory Flexibility Act) about the ways the proposed rule will affect them and the ways it may be modified to impose less stringent requirements on them which will still adequately protect the public health and safety. Those small entitles that offer comments on how the regulations could be modified to take into account their differing needs,should specifically discuss:
(a) The size of their business and how the proposed regulations would result in a significant economic burden upon them as compared to larger organizations in the same business community; (b) How the proposed regulation could be modified to take into account their dif fering needs or capabilities; (c) The benefits that would accrue, or the detriments that would be avolded, if the proposed regulation were modified as suggested by the commenter; (d) How the proposed regulation, as modified, would more closely equalize the impact of NRC regulations or create more equal access to the benefits of Federal programs as opposed to providing special advantages to any Individuals or groups; and (e) How the proposed regulation, as modified, would still I adequately protect the public health and safety.
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_y_ C:( IT T??4 List of Subjects in 10 CFR Part 35 Syproduct material, Drugs, Health facilities, Health professions, incorporation by reference, Medical devices, Nuclear materials, Occupational safety and health, Penalty, Radiation protection, Reporting and recordkeeping requirements.
For the reasons set out In the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C. 553, the following amendment to 10 CFR Part 35 is being considered.
PART 35 - HUMAN USES OF BYPRODUCT MATERIAL
- 1. The authority citation for Part 35 continues to read as follows:
Authority: Secs. 81,161,182,183, 68 Stat. 935, 948, 953, 954, as amended (42 U.S.C. 2111, 2201, 2232, 2233); Sec. 201, 88 Stat. 1242, ,
as amended (42 U.S.C. 5841). '
For the purposes of sec. 223, 68 Stat. 958, as amended (42 U.S.C.
2273); 5535.2, 35.14(b), (e) and (f ), 35.21(a), 35.22(a), 35.24, and 35.31(b) and (c) are issued under sec.161(b), 68 Stat. 948, as amended 42 U.S.C. 2201(b); and 5535.14(b)(5)(ll), (Ill) and (v) and (f)(2), 35.25 and 35.31(d) are issued under sec.161o, 68 Stat. 950, as amended (42 U.S.C. 2201(o)).
, 2. In 535.14, paragraph (b)(7) is revised to read as follows:
535.14 Specific licenses for certain groups of medical uses of by-product material.
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(7) The following radiopharmaceuticals, when used for the listed clinical procedures, are not subject to the restrictions in paragraph (b)(6) of this section:
(I) Technetium-99m pentetate as an aerosol for lung f unction studies; (ll) Technetium-99m sulfur colloid as a solid or liquid for gastroesophageal Imaging;
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C2011 1934
-3 1 (Ill) Technetium-99m sulfur colloid, pertechnetate, or macroaggregated human serum albumin for Leveen shunt Imaging; (iv) Technetium-99m sulfur colloid, pertechnetate, or macroaggregated human serum albumin for ventriculo-atrial shunt Imaging; 4
(v) Technetium-99m sulf ur colloid, pertechnetate, or macroaggregated human serum albumin for ventriculo-peritoneal shunt Imaging; (vi) Technetium-99m pertechnetate for cystography; and (vil) Technetium-99m pertechnetate for dacryocystography. [
- , e n a f Qated at Bethesda, Maryland this day of , 1984.
For the Nuclear Regulatory Commission M
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" Wtlilam J. Olrcks, 4 Executive Ofrector for Operations. i l
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"*'i MEMORANDUM FOR: William J. Dircks Executive Director for Operations FROM: John G. Davis, Director i Office of Nuclear Material Safety and Safeguards
SUBJECT:
AMENDMENT TO 10 CFR 35.14(b)(7) TO ALLOW USE OF CERTAIN RADI0 PHARMACEUTICALS FOR PROCEDURES NOT LISTED ON THE i
FDA-APPROVED LABELS Attached for your signature is a proposed rulemaking that would amend 35.14(b)(7) of 10 CFR Part 35, " Human Uses Of Byproduct Material."
The purpose of this proposed amendment is to allow physicians or hospitals I
that are now permitted by NRC to use other radiopharmaceuticals to use certain
] radiopharmaceuticals for recently developed methods of use not listed on their
- respective package labels. The amendment will reduce NRC and licensee i
administrative costs by eliminating the need for-licensees to request a license amendment if they want to use a radiopharmaceutical for a new method of use.
Currently, if a physician uses a radiopharmaceutical approved by the Food and Drug Administration (FDA) for a method of use not listed on the pa.kage label, the physician is required by NRC regulation to follow the label instructions for (1) chemical and physical form, (2) route of administration, and (3) dosage range. Physicians who use radiopharmaceuticals for the methods of use listed in 135.14(b)(7) of 10 CFR Part 35, " Human Uses of Byproduct Material," are excepted from this requirement. This regulatory policy is described in an i NRC Federal Register notice published on February 3,1983(48FR5217).
I I This proposed rulemaking would amend 135.14(b)(7) to allow licensees to use
- the following FDA-approved drugs for the following new methods of use
technetium-99m labeled sulfur colloid for gastroesophageal imaging; j technetium-99m labeled sulfur colloid, pertechnetate, or macroaggregated i
j human serum albumin for Leveen, ventriculo-atrial, and ventriculo-peritoneal l4 Lil;/tLT w3
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- 1 111984
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shunt imaging; and technetium-99m labeled pertechnetate for cystography and dacryocystography.
The Office of the Executive Legal Director has no legal objection and the Offices of Administration and Nuclear Regulatory Research concur in the amendment to 10 CFR Part 35.14(b)(7).
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- John G. Davis, Director
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J Office of Nuclear Material Safety and Safeguards
Enclosures:
- 1. Federal Register Notice
- 2. Federal Register Notice (48 FR 5217) ,
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Approved For Publication In a final rule published March 19, 1982 (47 FR 11816), the Commission delegated to the Executive Director for Operations (10 CFR 1.40(c) and (d)) the authority to develop and romulgate rules as defined in the APA (5 U.S.C. 551(4)), subject to the limitations in NRC Manual Chapter 0103, Organization and Functions, Office of the Executive Director for Operations, paragraphs 0213, 038, 039, and 0310.
The proposed rule entitled " Physician's Use of Radioactive Drugs," would amend 10 CFR 35.14(b)(7) to allow licensees to use certain radiopharmaceuticals for recently developed methods of use not listed on their respective labels.
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, This final rule does not constitute a significant question of policy, nor does l it amend regulations contained in 10 CFR Parts 0, 2, 7, 8, 9 Subpart C or 110.
I, therefore, find that this rule is within the scope of my rulemaking authority and am proceeding to issue it.
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! Date WilliamJ.bircks Executive Director for Operations i
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b ilEiKLY REPORT TO THE Co.tilSSION OFFICE OF NUCLEAR t/ATERI AL SAFETY AND SAFEGUARDS Proposed Rule to be Sicned by EDO On , 1984, the Executive Director for Operations approved a proposec rule that would amend 10 CFR Part 35, "duman Uses of Byproduct i.iaterial," by allowing licensees to use the following FDA-approved drugs for the following clinical procedures: technetium-99m labeled sulf ur colloid for gastroesophageal imaging; technetium-99m labeled sulfur colloid, pertechnetate, or macroaggregated human serum albumin for Leveen, ventriculo-atrial, and ventriculo-pertioneal shunt imaging; and
! technetium-99m labeled pertechnetate for cystography and dacryocystography.
I This action is taken pursuant to NRC policy published in the Federal Register on February 4,1983 (48 FR 5217).
This notice constitutes notice to the Commission that, in accordance with the rulemaking authority delegated to the EDO, the EDO has received this proposed rule and proposes to forward it on to the Secretary for Federal Register publication.
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CEC 11 U54 EWVIRONENTAL IMPACT ASSESSMENT FOR NiENDVENT TO 35.14(b)(7) CF 10 CFR PART 35 TO PERMIT HEDICAL LICENSEES TO USE CERTAIN RADIO'HARMACEUTICALS FOR PROCEDURES NOT LISTE0 ON THE FDA-APPROVED LASEL introduction:
Physiciens who want to use certain radioactive materials in the practice of medicina may do so only in accordance with a license issued by the Nuclear Regulatory Commission (NRC) or an Agreement State.
Physicians are required by NRC regulation to use drugs in accordance with package label Instructions approved by the Food and Drug Administration (FDA). The NRC is proposing to avend its regulations to provide an exception that would allow physicians to use certain approved drugs f or methods of use not yet approved by FDA. 1 Procedure Descriptions:
- 1. Technetium-99m sulfur colloid is used as a diagnostic imaging agent for the liver, spleen, and bone marrow. It can also be used as proposed for gastroesophageal imaging. When administered orally either as solid or liquid test meal, technetium-99m sulf ur colloid permits external Imaging that is helpful in assessing gastric emptying, gastroesophageal reflux, and esophageal transit.
- 2. A Leveen shunt is an implanted tube that drains built-up fluid from the peritoneal cavity to a large central vein. Technetium-99m labeled sulfur colloid, pertechnetate, or macroaggregated human serum albumin can be injected into the peritoneal cavity to diagnose shunt malf unction, such as blockage by clot or valve f ailure, by taking Images of the shunt.
- 3. A ventriculo-atrial shunt is a tube implanted in patients with hydrocephalus (fluid build-up in the head). It drains the fluid from the head to the atrial cavity. Technetium-99m labeled sulfur colloid, pertechnetate, or macroaggregated human serum albumin is injected into the shunt system of the patient to localize shunt blockage before surgical repair is performed.
- 4. A ventriculo-peritoneal shunt is an implanted tube in patients with hydrocephalus (fluid build-up in the head). It drains the fluid from the head to the peritoneal cavity. Technetium-99m labeled sulf ur colloid, pertechnetate, or macroaggregated human serum albumin is injected into the shunt system of patients to localize shunt blockage before performing surgical repairs.
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- 5. Cystography is a procedure for patients with bladder problems. A tube is inserted into the bladder of a patient. Technetium-99m pertechnetate is instilled through the tube into the bladder. Images are taken during filling and voiding of the bladder to measure the actual amount of reflux (backward flow) into the upper tracts, to quantitate bladder volume at which reflux occurs, to calculate drainage tine of reflux
. after voiding, and the recalning urine volume.
- 6. Dacryocystography is a procedure for patients who exhibit excessive teardrop problems (epiphora). Technetium-99m labeled pertechnetate is administered as a sterile eye drop. This procedure is performed to assess tear production and drainage in patients, and for nasolacrimal system imaging.
Need for the Proposal:
,As new uses for FDA-approved drugs are developed, NRC considers amending its regulations to provide physicians an exception from its requirement to only use a radiopharmaceutical for the methods of use listed on the package label (see 48 FR 5212). This facilitates potentially beneficial new uses of approved drugs.
Alternatives:
Proposed Action: By amending the Commission's rules, provide an exception that would allow physicians to use the approved radiopharmaceuticals for the new uses.
Alternative: No action. (Licensees could Individually ask that these additional uses for approved drugs be specifically authorized on their respective licenses.)
Impact:
Without this exception, a licensee authorized to use these drugs for approved uses could not use them for the excepted procedures in patients who, in the physician's judgment, should receive them for diagnostic imaging. The NRC IIcensing process assures that appropriately trained physicians with adequate facilities, radiation safety training and program control will use these drugs safely in medical practice.
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E Concerning radiation exposure of the ecosystem, the Commission notes that a National Academy of Sciences-National Research Council Committee has found that " Evidence to cate indicates that probably no other living ,
organisms are very much more radiosensitive than man so that if man as an individual is protected, then other organisms and populations would be most unlikely to suffer harm." ("Tne Effects on Populations of Exposure to Los Levels of lonizing Radiation," National Academy of 1 Sciences-National Research Council, Washington, D.C. 20006, November 1972, p. 34). Because the radiopharmaceuticals will be used by persons with training and experience, f acilities and equipment, and radiation saf ety procedures found adequate to keep exposures within the limits of 10 CFR Part 20, the Commission has determined that significant human impact is unlikely. Similarly, any detectable ef f ect on other living organisms or the quality of the human environment is unlikely.
Summary and Conclusion The alternative and proposed action both permit use of the drugs by physicians adequately trained to use them safely. The proposed action is preferred over the alternative for reasons of administrative convenience which have no bearing on environmental impact. The proposed action
- will not have any significant environmental impact. ,
References:
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- 1. Revised Training and Experience Criteria f or Nuclear Medicine Physicians (47 FR 54367) dated December 2, 1982.
- 2. "The Ef fects on Populations to Exposure to Low Levels of lonizing Radiation," National Academy of Sciences-National Research Council, Washington, D.C. 20006, November, 1972.
0.F" 1 1 1994 RECULATORY ANALYSIS FOR A'dNDMENT OF 10 CFR 35.14(b)(7) TO ALL0n USE OF CERTAlh RAD 10 PHARMACEUTICALS FOR PROCEDURES NOT LISTED ON THE FDA-APPROVED LABEL
- 1. Statement of the Problem if a physician uses a radiopharmaceutical approved by the Food and Drug Administration (FDA) for a method of use not identified on the package labeling, the physician is required by NRC regulation to follow the labeling instructions for (1) chemical and physical form, (2) route of administration, and (3) dosage range. Physicians who use radio-pharmaceuticals for the methods of use listad in 535.14(b)(7) of 10 CFR Part 35, " Human Uses of Byproduct Naterial," are excepted from this requirement. The purpose of this proposed amendment is to add some recently developed methods of use to that section. This regulatory policy is described in an NRC Federal Register notice published on February 4, 1983 (48 FR 5217).
- 2. Objectives The proposed regulatory action is designed to allow physicians or hospitals that are now permitted by NRC to use other radio-pharmaceuticals to use these radiopharmaceuticals for methods of use not listed on their respective labels. The amendment will reduce administrative costs by eliminating the need for licensees to request a license amendment if they want to use a radiopharmaceutical for a listed method of use.
- 3. Alternatives Proposed Action: Add the drugs and methods of use to 535.14(b)(7) by amending the Commission's regulations.
Alternative 1: No action. (Licensees could individually ask that these additional uses be specifically authorized on their respective licenses.)
Alternative 2: Ask FDA to change the approved labeling to include the new method of use.
- 4. Consequences Proposed Action: This proposed rule would relleve a majority of HRC's medical licensees from certain regulatory requirements. All affected licensees would be able to use the radiopharmaceuticals for the listed methods of use without the cost and delay associated with a license amendment.
DE: 1 1 DS4 Alternative 1: Alternative 1 would require each of the approximately 1900 mecical licensees who c.ay want to use the radiopharmaceuticals for the listed eethods of use to request a license amendment. Each amendment would cost the licensee $230 of administrative and clerical ef fort (estimated at about 2 to 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> of licensee effort to prepare paperwork ) plus the 5120 NRC license amendment f ee. The total cost to each licensee would be approximately $350. A large number of amendment requests woulo create an unacceptable backlog in the licensing section.
Alternative 2: This alternative would default to the no action alternative because FDA will not initiate a label change of its own
- volition; a request for a change in approved labeling must be initiated by the manufacturer of the radiopharmaceutical. We assume the manuf acturers believe that the few additional sales that would result from the new methods of use would not be sufficient to cover the expense of preparing the requests for label change; otherwise, they would have requested the label changes.
- 5. Decision Rationale The proposed action is recommended because it requires no costs to
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licensees, and will not consume extensive NRC staff resources. In i addition, it provides an opportunity for public comment which would not be provided by Alternative 1.
Alternative 1 is not recommended because Individual licensing actions would involve considerable delay and unnecessary expense to licensees.
Also, hRC does not have the technical and clerical resources needed to promptly process the large number of amendment requests that might be received.
Alternative 2 is not recommended because manuf acturers have insuf ficient motive to shoulder the burden of preparing the necessary requests for label changes.
- 6. Imp lementation The staf f will prepare supporting documents and publish a proposed rule in the Federal Realster. The staff, with assistance from the Advisory Con.mittee on the Medical Uses of Isotopes, will analyze the public comments received and prepare a final rule. The Office of Administration will mail copies of the proposed and final rule to affected licensees.
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DEC 11 19M u :;.1 - r-
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The Honorable Alan K. Simpson Chairman, Subcommittee on Nuclear Regulation Committee on Environment and Public Works United States Senate Washington, D. C. 20510
Dear Mr. Chairman:
The Nuclear Regulatory Commission (NRC) has sent to the Office of the Federal Register for publication the enclosed proposed amendment to the Commission's rules in 10 CFR Part 35. The amendment, if adopted, would allow me, dical licensees to use technetium-99m labeled sulfur colloid for gastroesophageal imaging; technetium-99m labeled sulfur colloid, pertechnetate or macroaggregated human serum albumin for Leveen, ventriculo-atrial, and ventriculo-peritoneal shunt imaging; and technetium-99m labeled pertechnetate for cystography and dacryocystography.
Without this amendment, each NRC licensee that wants to use these FDA-approved radioactive drugs in the indicated ways would have to apply to the NRC for permission to do so. The proposed rule would allow licensees that are now licensed by NRC to use other similar radioactive drugs to use these drugs without making an application to NRC.
The Commission is issuing the proposed rule for public comment and has requested comments with respect to the implementation of the rule.
Sincerely, John G. Davis, Director Office of Nuclear Material Safety and Safeguards
Enclosure:
As stated ,_
c .. a -. y a cc: Senator Gary Hart 6jllh }
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