ML20236R222
| ML20236R222 | |
| Person / Time | |
|---|---|
| Issue date: | 04/29/1998 |
| From: | Abbott C NRC |
| To: | Mccausland J NRC |
| Shared Package | |
| ML20236R069 | List: |
| References | |
| FRN-63FR31604, RULE-PR-35 AF77-2-012, AF77-2-12, NUDOCS 9807210306 | |
| Download: ML20236R222 (1) | |
Text
_ _ _ _ - _ _ _ _ _ _ - _ _ _ _ _ _ _ - _ _ _ _ _ _ _ _ - _ _ _ _ _
l PD/2
~
Frosa: Carol Abbott To: TWP9.JMM2 Date: 4/29/98 2:00pm subject: OCFO review of rulemaking pkg: License Term for Medical Use Licenses -10 CFR Part 35 Jayne--
OCFO has reviewed the Federal Reoister notice for the final rule, " License Term for Medical Use Licenses - 10 CFR Part 35" which removes the reference to the 5-year term limit for medical use licenses in 10 CFR 35.18, and concurs in the package with the following changes to the transmittal memo to the EDO.
Please insert a Resources section after the Notices section as follows:
l l'
" Resources: No additional resources will be needed to imiplement this rule."
Also, replace the OCFO sentence in the Coordination section with the
' following:
"The office of the Chief Financial Officer has reviewed this paper for resource
( implications and has no objections."
l REF:
OC-98-158 l DBA-98-116 File: NML-2.7.1 CC: RRR, CFD, KLO, SLS, TWP8.EJB2, MDD, JRE, LSH1, WND...
9907210306 990715 PDR PR 35 63FR31604 PDR
( '
M ?dttch*IJ llb 9 5 0 "%q, n W 6td CGC
?
' f-. .J4 UNITED STATES Si/Flig v l #
5 l 'r ( 3 NUCLEAR REGULATORY COMMISSION l
" !- waswiwarow, o.c. sossscooi pp{
%, + April 9, 1998 MEMORANDUM TO: Richard L. Bangart, Director Office of State Programs ,
Jesse L. Funches
'q Chief Financial Officer O,
f ,
Joseph R. Gray, Associate General Counsel for Licensing
' Og# 6 and Regulation, OGC E cy James Lieberman, Director
()
Office of Enforcement David L. Meyer, Chief Rules and Directives Branch, ADM Brenda Jo Shelton, Chief information and Records Management Branch, IRM FROM: Donald A. Cool, Director Division of Industrial and Medical Nuclear Safety, NMSS
~~~
/r'ff(s i
SUBJECT:
OFFICE REVIEW AND CONCURRENCE: FINAL RULE TO AMEND 10 CFR 35.18 TO REMOVE THE REFERENCE TO A 5-YEAR LICENSE TERM FOR MEDICAL USE LICENSES l
Your concurrence is requested on the attached Federal Reaister notice for the subject final ruh. l The following is a summary of this request: '
- 1. Iltle: License Term for Medical Use Licenses - 10 CFR Part 35
- 2. Reauested Action: Office concurrence. i 1
- 3. NMSS Task Leader: Jayne M. McCausland,415-6219 )
l l
CONTACT: Jayne McCausland, NMSS/IMNS ;
301-415-6210 l
-wav/vtw 9p, j
R. L. B:ng:rt ct 1. , , [h . M r c b {d l l
- 4. Coanizant individuals: M:rjoria Rothschild, OGC 415-1633 /naAc/
g[9 lg CGC a #
% L. Rakovan, OSP 415-2589 M. Lesar, ADM 415-7163
- 5. Backaround: On July 31,1997 (62 FR 40975), the NRC published for public comment a l proposed rule revising 10 CFR 35.18 to eliminate the 5-year term limit for medical use licenses. Five letters of comment were received from interested members of the public, and all commenters fully supported the proposed revision. This final rule makes the to i
change remove the reference to the 5-year term limit for medical use licenses in 10 CFR 35.18, and making the license terms for licenses issued pursuant to Part 35 consistent with the license terms for other material licenses. The NRC will continue to issue some licenses for shorter terms, if warranted by the individual circumstances of license applicants. In addition, this revision will reduce the administrative burden of license renewals for both NRC and licensees and also support NRC's goal of streamlining the licensing process.
- 6. Reauested ComotetiQQHEC Twenty working days from date of memorandum. To meet the EDO deadlir.e, a meeting will be scheduled during the week of April 20,1998,L5llg) /
to discuss and resolve any remaining issues / concerns that are delaying concurrence.
Please plan on having an official who can concur for your office available for this meeting. If no issues are identified and all concurrences received, this meeting will be ;
cancelled.
- 7. Steerina Grouo: None
- 8. Enhanced Public Participation: No
- 9. Compatibility for Aareement States: Yes
- 10. Resources and Coordination No additional resources are anticipated to implement the rule. A copy of this concurrence package has been forwarded to the IG for information.
Attachment:
Memorandum to EDO, w/encls (5) cc w/att:
H. T. Bell, OlG C. Paperiello, NMSS W. Kane, NMSS H. Miller, Rl/ ORA L. Reyes, Rnl ORA A. Beach, Rlll/ ORA E. W. Merschoff, RIV/ ORA W. Beecher, OPA Distribution:(Name of Document) Enterin PDR Yes a Noa RGordon/RF LRiani IMNs/ Central File DMendiola NMss R/F CGallagher NRC Central File NJensen PHolahan
- See previous concurrences.
to rerew, e r<m, of this chiriene,it indicate in tn, tvu r - r,in, witnout attart,na,it <,nr i,wur, n con, witti atract,.mt ionctosu r , v - iso copy 0FFICE: RGB/IMNS RGB/IMNS RGB/IMNS D/IMNS/N G ' [
NAME: *JMcCausland *PHolahan *JPictone
,v OATE: 03/30/98 03/31/98 04/03/98 u! k /98 Agi' 0FFICIAL RECORD COPY
- 6 e
b ATTACHMENT MEMORANDUM TO EDO
2 Hop {
'~
5 h & UNITED STATES g ,g NUCLEAR REGULATORY COMMISSION
- WASHINGTON, D.C. 20066-0001
. \...../
! MEMORANDUM TO: L. Joseph Callan Executive Director for Operations l FROM: Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards
SUBJECT:
LICENSE TERM FOR MEDICAL USE LICENSES - 10 CFR PART 35 s
Attached for your signature is a final rule (Attachment 1), to be p blished in the Federal Register. that amends 10 CFR Part 35 to remove the reference a the 5-year term limit for medical use licenses. This action makes the license terms for li nses issued pursuant to 10 CFP Part 35 consistent with the license terms for other material licenses.
!. Background On July 31,1997, the proposed rule revising 10 CFR 35.18 to eliminate the l ' 5-year term limit for medical use licenses was published for comment in the Federal Register (62 FR 40975). The Nuclear Regulatory Commission (NRC) received five letters of comment addressing the proposed rule. The " Statement of Considerations" for the final ru!e contains a -
discussion of the comments received.
- Noboes
- The appropriate Congressional committees will be notified (Attachments 2 and 3). A
. notice to the Commission that the Executive Director for Operations has signed the attached Federal Register notice is attached for inclusion in the " Daily Staff Notes" (Attachment 4). The approval for publication is also attached (Attachment 5).
Coordinahon The Offices of Administration, Enforcement, and State Programs concur in these amendments. The Office of the General Counsel has no legel objection. The Office of the Chief Financial Officer has no resources-related objection to this rulemaking. The Chief Information
- Officer concurs that there will be no information technology impacts.
Attachments: 1. Federal Register Notice of Final Rulemaking and disk
- 2. Congressional Letters i
- 3. SBREFA Letters
- 4. Daily Staff Notes item
- 5. Approval for Publication e
3
i I
l i
i l
l i
- ATTACHMENT 1 l
! FEDERAL REGISTER NOTICE l
I l
l f
[7590-01-P]
NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 RIN 3150-AF77 License Term for Medical Use Licenses AGENCY: Nuclear Regulatory Commission.
l l- ACTION: Final rule.
SUMMARY
- The Nuclear Regulatory Commission is amending 10 CFR Part 35 to eliminate the 5-year term limit for medical use licenses in 10 CFR 35.18. License terms for licenses issued pursuant to Part 35 will be set by policy, up to 10 years, as are the license terms for other materials licenses. The NRC will issue some licenses for shorter terms, if warranted by the individual circumstances of iicense applicants. The amendment reduces the administrative oh a 5-Wcv C4 Cic burden of license renewalsp for both NRC and licensees and supports NRC's goal of streamlining the licensing process.
l EFFECTIVE DATE: This regulation becomes effective on (30 days following publication in the l Federal Register).
1 FOR FURTHER INFORMATION CONTACT: Jayne M. McCausland, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, 1
telephone (301) 415-6219, e-mail JMM2 @ nrc. gov.
1 l
l
SUPPLEMENTARY INFORMATION:
- 1. Background.
II. Discussion.
Ill. Statement of Regulatory Action.
IV. Summary of Public Comments.
V. Agreement State Compatibility.
VI. Finding of No Significant EnvironmentalImpact: Availability.
Vll. Paperwork Reduction Act Statement.
Vill. Regulatory Analysis.
IX. Regulatory Flexibility Certification.
X. Backfit Analysis.
- 1. Background V 'y lJad 6
, ,4g6 it h C?)
In 1995, the NRC Office of Nuclear Material Safety and Safeguards (NMSE ) initiated a (s l review to determine whether the license term for materiaflicenses rc;;;fso that could b NRC's licensing resources could be redirected to other areas of the materials program.j{he /
resources devoted to renewals constituted over 50 percent of the total resources expended for !
licensing. NMSS undertook this review as a part of NRC's" business process redesign" efforts. [
l The license renewal process has been used as an opportunity for the Commission to I review: (1) the history of the licensee's operating performance (e.g., the record on compliance 2 l l
l gen l1 raab'(4(I rcd 4 (N I with regulatory requirements); and (2) the licensee' program. This review is performed to /
ascertain if the licensee employs up-to-date technology and practices in the protection of health, safety, and the environment, and complies with any new or amended regulations. As
, part of a license renewal, the licensee is asked to provide information on the current status of l its program as well as any proposed changes in operations (types and quantities of authorized materials), personnel (authorized users and radiation safety officers), facility, equipment, or applicable procedures. The renewal process has been perceived to benefit both the licensee and NRC because it requires both to take a comprehensive look at the licensed operation.
However, in practice, comprehensive program reviews occur when proposed changes are identified and requested by licensees as aN[n*dhIents rather than during the license renewal process.
License terms have been reviewed on numerous occasions since 1967. On May 12, 1967 (32 FR 7172), the Commission amended 10 CFR Part 40 to eliminate a 3-year limit on the term of source material licenses. At that time, there was no restriction on the term of byproduct licenses under 10 CFR Part 30 or special nuclear material licenses under 10 CFR Part 70. In the notice of proposed rulemaking associated with this rule, dated December 22,1966, NRC indicated that if the proposed amendment to eliminate the 3-year restriction were adopted, l licenses would be issued for 5-year terms, except when the nature of the applicant's proposed activities indicated a need for a shorter license period. At that time, the Commission believed there was little justification for granting licenses under 10 CFR Parts 30,40, and 70 for terms of j less than 5 years, in view of the cumulative experience up to that time and the means available to NRC to suspend, revoke, or modify such licenses if public health and safety or environment so required.
3
In March 1978, NMSS conducted a study (SECY-78-284, "The License Renewal Study for arts 30,40, and 70 Licenses") to consider changing the 5-year renewal period for Parts 30, /
40, and 70 licenses. The study concluded, in part, that the NRC should continue its practice of issuing specific licenses for 5-year terms and should retain an option to write licenses for shorter terms, if deemed necessary, for new types of operations or if circumstances warranted.
On July 26,1985 (50 FR 30616), NRC proposed revising 10 CFR Part 35, " Medical Use of Byproduct Material." The proposed rulemaking indicated that the Commission had selected a term of five years for a license. It was believed that a term shorter than 5 years would not benefit health and safety because past experience indicated that medical programs did not generally change significantly over that period of time. The notice also indicated that a longer term may occasionally result in unintentional abandonment of the license. On October 16,1986 (51 FR 36932), NRC issued the final rule that consolidated and clarified radiation safety requirements related to the medical use of byproduct materials, and included a license term of 5 years.
On June 19,1990 (55 FR 24948), the Commission announced thot the license term for major operating fuel cycle licensees (i.e., licenses issued pursuant to 10 CFR Parts 40 or 70) would be increased from a 5-year term to a 10-year term at the next renewal of the affected licenses. This change enabled NRC resources to be used to improve the licensing and inspection programs. The bases for this change were that major operating fuel cycle facilities had become stable in terms of significant changes to their licenses and operations and that licensees would be required to update the safety demonstration sections of their licenses every 2 years.
On July 2,1996, the Commission approved the NRC staff's proposal to extend the license term for uranium recovery facilities from 5 years to 10 years. Extending the license 4
l
term reduces the administrative burden associated with the license renewal process for both the NRC staff and the uranium recovery licensees. Also, the extension reduces tdlicensee fees, makes the license term for these facilities more commensurate with the level of risk, and supports NRC's goal of streamlining the licensing process. Licensees were informed of the extensions in July 1996.
YN dh l
p ycno&.
On February 6,1997 (62 FR 5656), the Commission gave notice of the pelic/that the W[e%
license term for materiallicenses issued pursuant to 10 CFR Parts 30,40, or 70 would be mMt '
I increased from a 5-year term to up to a 10-year term at the next renewal of the affected licenses. However, whereas the 10-year term for other licenses w'as set by this policy, the term l for licenses issued pursuant to 10 CFR Part 35 was established by regulation at 5 years.
On July 31,1997 (62 FR 40975), the NRC published a proposed rule to revise 10 CFR Part 35 to eliminate the 5-year term limit in 10 CFR 35.18 for medical use licenses. The term for medical licenses could then be set by policy for up to 10 years. The NRC could issue a license for a shorter term. depending on the individual circumstances of the license applicant.
The public comment period closed on October 14,1997. A summary of the public comments trochlecl is soveredin Section IV, below. f II. Discussion Ylf iN The change in pch ,f un er which the license term for materials licenses is up to 10 l years, has created an inconsistency between the license terms for medical use and nonmedical use materials licenses. NRC believes that the license duration period for medical use licenses may also be extended without adverse impacts on public health and safety, such as increases l
l 5 'I l
~.
in the unintentional abandonment of licensed material or decreases in the licensees' attention to licensed activities, for the following reasons:
(1) Licensees would continue to be required to adhere to the regulations and their license conditions, and to apply for license amendments for certain proposed changes to their programs; (2) No changes in either the frequency or elements of the medicalinspection program are being proposed; (3 NRC would continue to be in thaposition to identify, by inspection or other means, v' pf th rc%{ch*6ha or % licwacondA sj /
violations,that aTettpubitctiesttfrandwieiy, and to take appropriate enforcement actions; 7 (4) Cases of abandonment of NRC licenses would be identified through nonpayment of the annuallicensing fees and reg /
(5) The staff weuld continue to make licensees aware of health and safety issues through the issuance of generic communications (such as information notices, generic letters, bulletins, and the NMSS Licensee Newsletter); and (6) NRC moving to a more performance-based regulatory approach, where emphasis is placed on the licensee's execution of commitments rather than on rereview of the details of the licensee's program.
Ill. Statement of Regulatory Action The NRC is revising Part 35 to eliminate the 5-year term limit in 10 CFR 35.18 for viil /
medical use licenses so that the term for medical use licenses ee6 be set by policy for up to 10 /
years.
6
J IV. Discussion of Public Comments .
J Five letters of public comment were received on the proposed rule. Comments were l
l received from National Physics Consultants, Ltd., the American Association of Clinical Endocrinologists, the Mayo Clinic, the University of Cincinnati, and the American Hospital I
Association. i All commenters fully supported the proposed amendment to eliminate the reference to l
the 5-year term limit for medical use iicenses in 10 CFR 35.18. In addition, the commenters 1 endorsed the change in license terms for licenses issued pursuant to Part 3 policy for /
up to 10 years, as are the license terms for other material licenses.
In general, commenters disparaged the license renewal process, on a 5-year frequency, as requiring a significant expenditure of time and fees with minimal benefit, and supported 4 NRC's proposal to eliminate this requireme iting a reduction of staff time and costs for both [
the NRC and individuallicensees with no decrease in public health and safety. Wwal Cobd /
i recognized that the NRC may issue some licenses for shorter terms if warranted by the individual circumstances of license applicants.
One commenter stated that routine license reviews by the local Radiation Safety Committee will ensure operation of a radiation safety program that aYsur public health and [
safety.
Another commenter indicated that, because the NRC is in contact with the licensees on an ongoing basis, any changes in operations, personnel, facility, equipment, or applicable ,
procedures are identified during the inspection and license amendment process.
l I 1
l l 7 l l l 1 j
9 One of the commenters expressed agreement that the radiation safety programs at most medical facilities are very stable and pointed out that significant changes in the radiation safety program require license amendments.
Another commenter recommended that NRC extend the license term for medical use licenses from 5 years to 10 years as soon as possible to reduce the license fees and achieve further cost savings. This commenter expressed support for the NRC'shusiness process [
redesign fforts pin Am ;/redu he administrative burden of license renewals and /
chnI Ilow organization's members to redirect their resources to support !
and implement NRC's initiative to move to a more performance-based regulatory approach.
V. Compatibility for Agreement States
- /
Thie .uloinannis m., uw a not;& c' wuip.icudity imi.._.i u ru 6C, im;;;.e .^ ;reem States,.thersty providing consstencpmong State andFederaLr *ty reiramerits., _-
Compatibility category D has been assigned to the changes in 10 CFR 35.18. Category D I
means the provisions are not required for purposes of compatibility; however, if adopted by the CSf
/ hey _should be compet% Mth NR No problems have been identified regarding 7 Agree ent State compatibility implementa ion of this rule change. b
\ ,
s%H r& g i 4 e,(.o a ld 'dy(u kuc s 4 tWf*N 8
I VI. Find;..; cf M: 0 gi,lf;ee.-(Environmental impact: Celegoricco Ave!!d!?yF f
Tk Wwsch e has, eMemna& At 4G %)rAir Ly A atfron dewke is i
No Env;rcamente! 2 eeeeemerl w!!Lbetneeded because the ru! cmc!Mg !: Ocvared by the categorical exclusion hf10 CFR 51.22(c)(3)(i) for amendments to Part 35 that relate to renewals oflicenses. Ik<e{we, nefflus y esaswm& &ChdnoV ae cm vCron g ia)
MEM mE h% bets f G.pwe.D $f 1E* {%cd rgleN6n.
Vll. Paperwork Reduction Act Statement
,-- This final rule reduces the burden for both medical licensees and NRC becaus t/
6 k 64 cow31kgtib 6 Wet is ed by policy, for up to 10 years, as is the scase for other ma _
However, the reduced burden from less frequent license renewal will not be realized in the near future because the affected licenses are operating under a 5-year extension of the current licenses which were granted in 1995. The impact of that one-time extension is addressed in the current supporting statement for NRC Form 313, " Application for Material License," which was approved by the Office of Management and Budget (OMB) under OMB Clearance No. 3150-Wh4h 0120 andg expires on July 31,1999. The data on reduced burden from extension of the license [
term for all material licenses, as well as from other actions taken to streamline the licensing process, will be included in the request for renewal of the information collection requirements on NRC Form 313, in 1999. This is appropriate because the next OMB clearance extension will cover 1999-2002, during which tim:, the medical licenses currently under the 5-year extension will expire and affected by this rulemaking. Send comments on any aspect of this information collection, including suggestions for further reducing the burden, to the information l and Records Management Branch (T-6F33), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail at BJS1@NRC. GOV; and to the I
{ 9 ,
l
i l'
Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202 (3150-0014), Office of Management and Budget, Washington, DC 20503.
l l Public Protection Notification l
l l
r If a document used to impose an information collection does not display a currently valid P OMB control number, the NRC may not conduct or sponsor, and a person is not required to '
respond to, the information collection.
Vill. Regulatory Analysis Problem The current rule requirement, regarding the term of medical licenses, is codified in Section 35.18 and states that "The Commission shall issue a license for the medical use of byproduct material for a term of five years." The license term of other materials licenses, as established by Commission policy, is up to 10 years. There is thus an inconsistency as to LOYseer r f duration anc erpt man)n(u
_ ss]etr%rth. the license term of medical use/license materials licenses. Based on the above, the following options were considered.
Attemative Approaches
- 1. Take no action: Maintain the requirement that licenses irosued pursuant to Part 35 would be issued for 5 years. -
o ,arpg6c4 m 4 This option would continue the inconsis&
, NQuMok"S MahW enoy betweer$p. y; S: 2.m:f( g V ses[and all other mathials licensesh 9'M Terms for medical use licenses are [
established in codified regulations, whereas the term for other materials licenses arekby /
10 l
policy. Also, this option would result in disparities in the duration of the term for material licensesw bec;= Medical use licenses would continue to be issued for 5-year terms whereas (5
the duration of the term for other materials licenses "fau!d b2up to 10 years.
/
- 2. Revise 10 CFR 35.18: Revise the regulations to delete any reference to the license term for licenses issued pursuant to Part 35.
This option would result in consistency between how license terms for medical licenses 1
and all other materia! licenses are established and in the duration of such licenses.
Commission decisions regarding the duration of a materials license could therefore apply 1
uniformly to all types of material licenses. After final rulemaking action to revise 10 CFR 35.18, tk the license term for licenses issued pursuant to Part 35 would be set by already established policy for up to 10 years.
I Value andImpact The license renewal process is resource-intensive for both the licensee and NRC. At the time of license renewal, licensees submit to NRC any changes in operations, personnel, facility, equipment, or applicable procedures. Because NRC is in contact with the licensees on an ongoing basis, many of these changes are identified during the inspection and license amendment process. Therefore, the rulemaking to remove the 5-year license term for medical use of byproduct material not change the health and safety requirements imposed on [
licensees.
By removing the reference to the 5-year term in 10 CFR 35.18 and, with the
.% A Commission's appFew((February 1997)(extendingth'e license term up to 10 years for all material licenses issued pursuant to Parts 30,40, and 70, there is a reduction in the regulatory burden for approximately 1,900 NRC licensees that use byproduct material for medical procedures. Estimated savings are based on the assumption that these licensees would only 11
l .
l ..
- hgd (Cur
- be required to submit a renewal application every 10 year as opposed to every 5 years, resulting, on average, in a savings of 190 applications pe7 year. However, offsetting these savings, medical licensees may need to submit an avera e of one additional amendment during I
the 10-year period to account for changes in operations hat would have routinely been D'
addressed when the license was renewed on a 5-year c/cle. Assuming that a typicallicense ([9 U
renewal application and typical amendment involve 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> nd 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> of licensee
(/ [
professional effort, respectively, there wouldp net savings per licensee of 8 hours9.259259e-5 days <br />0.00222 hours <br />1.322751e-5 weeks <br />3.044e-6 months <br />. Based on an industry professional labor rate o per hour, the annual industry-wide savings would pproximate $106,000. Over a 30-year time frame, based on a 7 percent real discount rate, the ,
esent worth savings to industry would approximate $1.3 million. M Similarly, this rulemaking is also cost effective for the NRC because fewer resources b 6 n -
wou be required to review and process renewal applications. On average, it takes hl #*zf4* -
6C .
approxima -14 hours f NRC professional time to renew a medicallicense and 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> t review uass kms.)was tnis 19neW te a net savings toV the NRC arg ancooment.1 -
Assuming an NRC labor rate of r hour, and on average,190 applications per year, the annual NRC savings would equal $133,000. The 30-year present worth savings to the NRC would approximate $1.6 million.
Conclusion This rulemaking, to remove the 5-year license term for medical use of byproduct material, is promulgated so the term for medical licenses will be consistent with that of other materials licenses (set by policy to be up to 10 years). The extension will reduce the administrative burden of license renewals for both NRC and thiiflicenseefand will support NRC goal of streamlining the licensing process without any reduction in health and safety. NRC may I 12
i L',
issue some licenses for shorter terms, if warranted by the individual circumstances of license applicants.
DecisionalRationale Based on the consistency which is created between license terms for medical licenses and all other material licenses by the rulemaking, and the cost effectiveness of a license term of up to 10 years, the NRC is amending 10 CFR Part 35 to eliminate the 5-year term limit for medical use licenses and allow the license term to be set by the established policy for up to 10 years.
IX. Regulatory Flexibility Certification 9 C&Ondm/G As required by the Regulatory Flexibilit) Act of 1980, 5 U.S.C. 605(b), the Comrnission l AY certifies that this rule will not have a,significan(impact on a substantial number of small entities. ,
SBygga,T'OtJ tJeX l' PAGC
- X. Backfit Analysis The NRC has determined that the backfit rule,10 CFR 50.109, does not apply to this final rule and, therefore, that a backfit analysis is not required for this final rule because the amendment does not involve any provision that would impose backfits as defined in l
13
4 INSERT By removing the reference to the 5-year license term in 10 CFR 35.18, the duration of medical use licenses will be consistent with the license term of up to 10 years for other materials licenses, resulting in a reduction in the regulatory burden for NRC medical use licensees.
l l
l
Small Business Regulatory Enforcement Fairness Act in accordance with the Small Business Regulatory Enforcement Fairness Act of 1996, the NRC has determined that this action is not a " major rule" and has verified this determination with the Office of Information and Regulatory Affairs, Office of Management and Budget.
List of Subjects in 10 CFR Part 35 Byproduct material, Criminal penalties, Drugs, Health facilities, Health professions, Medical devices, Nuclear materials, Occupational safety and health, Radiation protection, Reporting and recordkeeping requirements.
For the reasons set out in tne 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.
552 and 553, the NRC is adopting the following amendment to 10 CFR Part 35.
PART 35 - MEDICAL USE OF BYPRODUCT MATERIAL i
- 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 l U.S.C. 2111,2201,2232,2233); sec. 201,88 Stat.1242, as amended (42 U.S.C. 5841).
14 L_____-.-- _ _ - - - - - _ _
~.
- 2. : The introductory text of 9 35.18 is revised to read as follows:
$ 35.18 License issuance The Commission shall issue a license for the medical use of byproduct material if:
Dated at Rockville, Maryland, this day of 1998.
. For the Nuclear Regulatory Commission.
L. Joseph Callan, Executive Director for Operations.
l 15
4 e
ATTACHMENT 2 CONGRESSIONAL LETTERS
(
E_-_________.__._________.______._..______________._
sp uou y- +1 UNITED STATES j j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20n&o001 ,
g 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 g
Dear Mr. Chairman:
Ntft'. % wH4 nili k \ % ( m 'h Aphrato shAhlim w ,ggce,@c, The U.S. Nuclear Regulatory Commission intends soon t publish in the Federal Reaister the enclosed final amendment to the Commission's rules in 0 CFR Part 35. The amendment removes the 5-year license term for medical use licens License terms for licenses issued pursuant to Part 35 will be set by policy, as are the li for other materials licenses.
This amendment reduces the administrative burden o license for both NRC and the v licensee and supports NRC's goal of streamlining the icensing process without any adverse impact on the health and safety of workers or the public.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Reaister Notice cc: Senator Bob Graham l
acrag p 'a UNITED STATES g ,j NUCLEAR REGULATOP.Y COMMISSION
't WASHINGTON, D.C. 20555- @ 01 4 . . . . . ,&
The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power Committee on Commerce United States House of Representatives Washington, DC 20515
Dear Mr. Chairman:
The U.S. Nuclear Regulatory Commission intends soon to publish in the Federal Reaister the enclosed final amendment to the Commission's rules in 10 CFR Part 35. The amendment removes the 5-year license term for medical use licenses. License terms for licenses issued pursuant to Part 35 will be set by policy, as are the license terms for other materials licenses.
This amendment reduces the administrative burden A5 ot lice % hp.p,for both NRC and the v/
a nse Mr.c.....
licensee and supports NRC's goal of streamlining the licensing process without any adverse impact on the health and safety of workers or the public.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Reaister Notice -
cc: Representative Ralph Hall t
?
3-
! J
m a.
4 ATTACHMENT 3 SBREFA LETTERS
p Crag AP
-% UNITED STATES NUCLEAR REGULATORY COMMISSION if WASHINGTON, D.C. 2055!KD01
. . . . . p$
Mr. Robert P. Murphy General Counsel General Accounting Office Room 7175 441 G. St., NW Washington, DC 20548
Dear Mr. Murphy:
& li3w Pursuant to Subtitle E of the Small Business Regulatory Enforcement Faim ss Act of 1996, 5 U.S.C. 801, the U.S. Nuclear Regulatory Commission is submitting a fina rule to remove the
' 5-year license term for medical use licenses in NRC's 10 CFR Part 35. Li , nse terms for licenses issued pursuant to Part 35 will be set by policy, as are the license terms for otherpy materials licenses. This amendment reduces the administrative burden of license ren~-@or i both NRC and the licensee and supports NRC's goal of streamlining the li$enso process.
We have determined that this rule is not a " major rule," as defined in 5 U.S.C. 804(2). We have confirmed this determination with the Office of Management and Budget.
Enclosed is a copy of the final rule that is being transmitted to the Office of the Federal Register for publication. The " Regulatory Analysis" is included in the final rule. This final rule is scheduled to become effective 30 days after publication in the Federal Reaister.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Final Rule 1
- _ _ . - . - - _ _ _ . - _ - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - ~ -~----- -~ - -- - -
t@ EE 1 UNITED STATES j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 205!& 0001
\...../
The Honorable Al Gore President of the United States Senate Washington, DC 20510
Dear Mr. President:
p Pursuant to Subtitle E of the Small Business Regulatory Enforcement Faimess Act of 1996, 5 U.S.C. 801, the U.S. Nuclear Regulatory Commission is submitting a fin rule to remove the 5-year license term for medical use licenses in NRC's 10 CFR Part 35. Li nse terms for licenses issued pursuant to Part 35 will be set by policy, as are the license terms for othe materials licenses. This amendment reduces the administrativefor _- burden ofji both NRC and the licensee and supports NRC's goal of streamlining the license process.
We have determined that this rule is not a " major rule," as defined in 5 U.S.C. 804(2). We have confirmed this determination with the Office of Management and Budget.
Enclosed is a copy of the final rule that is being transmitted to the Office of the Federal Register for publication. The " Regulatory Analysis" is included in the final rule. This final rule is sc heduled to become effective 30 days after publication in the Federal Reaister.
~
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Final Rule
7__
sp reog p'-
~
i
. t UNITED STATES g uj NUCLEAR REGULATORY COMMISSION o S WASHINGTON, D.C. 20555-0001 4 o 9.....g The Honorable Newt Gingrich Speaker of the United States House of Representatives Washington, DC 20515
Dear Mr. Speaker:
s 5-cfuv Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairhss Act of 1996, 5 U.S.C. 801, the U.S. Nuclear Regulatory Commission is submitting a fingi rule to remove the 5-year license term for medical use licenses in NRC's 10 CFR Part 35. Lic. ense terms for licenses issued pursuant to Part 35 will be set by policy, as are the license terms for othe g materials licenses. This amendment reduces the administrative burden ofjicense rerrt._ for both NRC and the licensee and supports NRC's goal of streamlining the license process.
We have determined that this rule is not a " major rule," as defined in 5 U.S.C. 804(2). We have confirmed this determination with the Office of Management and Budget.
Enclosed is a copy of the final rule that is being transmitted to the Office of the Federal Register for publication. The " Regulatory Analysis" is included in the final rule. This final rule is scheduled to become effective 30 days after publication in the Federal Reaister.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Final Rule l
I 1
I 1
I J
4 I
I ATTACHMENT 4 DAILY STAFF NOTES ITEM
DAILY STAFF NOTES OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS Final Rule Sianed bv EDO
\
On 1998, the Executive Director for Operations approved a final I rule, " License Term for Medical Use Licenses," that amends 10 CFR 35.18 by removing the reference to a 5-year license term for medical use licenses. License terms for licenses issued pursuant to Part 35 will be set by policy, up to 10 years, as are the license terms for other -
materials licenses.
l This notice informs the Commission that, in accordance with the rulemaking authority delegated to the EDO, the EDO has signed tht=, final rule and proposes to forward it on 1998, to ti;9 Office of the Federal Register for publication, unless otherwise directed by the Commission.
l l
l l
t l
l l
l l
l L
O ATTACHMENT 5 APPROVAL FOR PUBLICATION
\
1 I
i l
l l
1
l Acoroved for Publication The Commission delegated to the EDO (10 CFR 1.31(c)) the authority to develop and promulgate rules as defined in the APA (5 U.S.C. 551 (4)) subject to the limitations in NRC Managernent Directive 9.17, Organization and Functions, Office of the Executive Director for Operations, paragraphs 0213,038 039, and 0310.
' 9 ccs 4
The enclosed final rule, " License Term for Medical Use Licenses" amends 10 CF 35.18 to remove the reference to a 5-year license term for medical use licenses. This rul makes the term for medical licenses consistent with that of other materials licenses which s been set by policy to up to 10 years. The extension reduces the administrative burden o licensep4rn !
renewah(for both NRC and the licensee and supports NRC's goal of streamlining'g the licensing process without any reduction in health and safety. NRC may issue some licenses for shorter terms, if warranted by the individual circumstances of license applicants.
This final rule does rot constitute a significant question of policy, nor does it amend regulations j contained in 10 CFR Parts 7,8, or 9(Subpart C)concerning matters of policy. I, therefore, find v that this rule is within the scope of my rulemaking authority and am proceeding to issue it.
Date i_. Joseph Callan, Executive Director for Operations.