ML20236R095
| ML20236R095 | |
| Person / Time | |
|---|---|
| Issue date: | 04/09/1998 |
| From: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Bangart R, Funches J, Gray J, Lieberman J, Meyer D NRC OFFICE OF ADMINISTRATION (ADM), NRC OFFICE OF ENFORCEMENT (OE), NRC OFFICE OF STATE PROGRAMS (OSP), NRC OFFICE OF THE CONTROLLER, NRC OFFICE OF THE GENERAL COUNSEL (OGC) |
| Shared Package | |
| ML20236R069 | List: |
| References | |
| FRN-63FR31604, RULE-PR-35 AF77-2-007, AF77-2-7, NUDOCS 9807210237 | |
| Download: ML20236R095 (32) | |
Text
- - _ _ - _ - _ - _ - _ _ _ - _ _ - _ _ _ - _ _ - - _ _ _ - _ _ - - _ -
.1' pe urq g4 % UNITED STATES pn()
'Y s* j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20665-0001 l ulL
\,,,,,,/ April 9, 1998 AF7P >
MEMORANDUM TO: Richard L. Bangart, Director Office of State Programs Jesse L. Funches Chief Financial Officer Joseph R. Gray, Associate General Counsel for Licensing and Regulation, OGC James Lieberman, Director Office of Enforcement !
David L. Meyer, Chief Rules and Directives Branch, ADM l
Brenda Jo Shelton, Chief I Information and Records
. Management Branch, IRM FROM: Donald A. Cool, Director o
,s Division of Industrial and Medical Nuclear Safety, NMSS Tf7 t
SUBJECT:
OFFICE REVIEW AND CONCURRENCE: FINAL RULE TO AMEND 10 CFR 35.18 TO REMOVE THE REFERENCE TO A 5-YEAR LICENSE TERM FOR MED! CAL USE LICENSES ;
Your concurrence is request'd on the attached Federal Reaister notice for the subject final rule.
The following is a summary of this request: !
- 1. Illig: License Term for Medical Use Licenses - 10 CFR Part 35
- 2. Reauested Action: Office concurrence.
- 3. NMSS Task Leader Jayne M. McCausland,415-6219 CONTACT: Jayne McCausland, NMSS/IMNS 301-415-6210 9807210237 900715 PDR PR
R. L. Bingirt (.t al.
f 4. Coanizant Individuals M rioris Rothschild, OGC 415-1633 l[ L. Rakovan, OSP 415-2589 L M. Lesar, ADM 415-7163
- 5. Backaround: On July 31,1997 (62 FR 40975), the NRC published for public comment a
- proposed rule revising 10 CFR 35.18 to eliminate the 5-year term limit for medical use i
licenses. Five letters of comment were received from interested members of the public, l and all commenters fully supported the proposed revision. This final rule makes the/
. fo l change3remove 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 shoder terms, if warranted by the individual circumstances of 1 license applicants. In addition, this revision will reduce the administrative burden of l
license renewals for both NRC and licensees and also support NRC's goal of streamlining the licensing process.
- 6. Reauested Comoletion Date: Twenty working days from date of memorandum. To meet the EDO deadline, a meeting will be scheduled during the week of April 20,1998, 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.
1
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, Ril/ ORA A. Beach, Rill / ORA E. W. Merschoff, RIV/ ORA W. Beecher, OPA Distribution:(Name of Document) Enter in PDR Yes a Noa
, RGon$on/RF LRiani IMNs/ Central File DMendiola NMss R/F CGallagher NRc Central File NJensen PHolahan
- see previous concurrences.
To niceive e rev v twes e,c.ent $.vt,cate in en tm c - rm, ethout attannent renrimure v - emy etw attaowat /enewee v - ein copy
!0FFICE: RGB/IMNS RGB/IMNS RGB/IMNS D/IMNS/NM4V' [
lNAME: *JMcCausland *PHolahan *JPiccone '
y IDATE: 03/30/98 03/31/98 04/03/98 I/
f T /98 l /gfA. orriciat accoao coer
-r-,--------- 4m-...--------.
?
ATTACHMENT MEMORANDUM TO EDO
s-M *%
, y* 4 UNITED STATES g ,g NUCLEAR REGULATORY COMMISSION t WASHINGTON, D.C. 20565 0001
'+9 . . . . . ,o MEMORANDUM TO: L. Joseph Callan Executive Director for Operations FROM: Carl J. Paperiello, Director Office of Nuclear Material Safety and Safeguards
SUBJECT:
LICENSE TERM FOR MEDICAL USE LICENSES - 10 CFR PART 35 Attached for your signature is a final rule (Attachment 1), to be published in the Federal Register, that amends 10 CFR Part 35 to remove the reference to the 5-year term limit for medical use licenses. This action makes the license terms for licenses issued pursuant to 10 CFR Part 35 consistent with the license terms for other material licenses.
Backaround: On July 31,1997, the proposed rule revising 10 CFR 35.18 to eliminate the 5-year term limit for medical use licenses was published for comment in the Federal Reaister (62 FR 40975). The Nuclear Regulatory Commission (NRC) received five letters of comment addressing the proposed rule. The " Statement of Considerations" for the final rule contains a discussio f t' e mments received.
-- statumtk Noti s: The appropriate ngressional committees will be notified (Attachments 2 and 3). A noti to the Commissio hat the Executive Director for Operations has signed the attached F ral Reaister notice ' attached for inclusion in the " Daily Staff Notes" (Attachment 4). The .
Y y 6^ ' m o coordination: The Offices Administration, Enforcement, and State Programs concur in t e amendments. The Offi of the General Counsel has no legal objection. Th f Financial Officer has r- rnew.m 4Ge,, to Se mlom.L 4. Th i
ie n rmation Jef
-'--""'---2'--'t-^^'-'--"'--^^- -
- Officer Q ---~ ~'&~dG E 'Eli' "IR.'/1.". 4. rt '#
Attachments: _ 1. Federal Reaister Notice of Final Rulemaking and disk '
' cyv
- 2. Congressional Letters 3.
4.
SBREFA Letters Daily Staff Notes item M M
- 5. Approval for Publication # -
'g. :t .
.h % od.oG M W m lay & skanaA% b
Ie ATTACHMENT 1 FEDERAL REGISTER NOTICE
{
l l
l; i
[7590-01-P]
I l NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 RIN 3150-AF77 License Term for Medical Use Licenses l
AGENCY: Nuclear Regulatory Commission.
l ACTION: Final rule. ,
'M AQ Wp
SUMMARY
- The Nuclear Regulatory Commission is amending 10 CIR Pen 05 to eliminate the 5-year term limit for medical use licenses i: 10 CFP,25.10.-- License terms for licenses issued
&r:= ;t ;e Ped M 35 wil %#
set by policya , . _ years, as are the license terms for other materials licenses. The NRC will issue some licenses for shorter termsgif warranted by the individual circumstances of license applicants. The amendment reduces the administrative l burden of license renewals for both NRC and licensees and supports NRC's goal of streamlining the licensing process.
EFFECTIVE DATE: This regulation becomes effective on (30 days following publication in the l
Federal Register).
t- 1 1
FOR FURTHER INFORMATION CONTACT: Jayne M. McCausland, Office of Nuclear Material l t
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6219, e-mail JMM2 @ nrc. gov. i I
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.
- l. Background in 1995, the NR ffice of Nuclear Material Safety and Safeguards (NMSS) initiated a review to determine t Mther the license term for material licenses could be increased so that NftC's licensing resources could be redirected to other areas of the materials program. The resources devcaed to renewals constituted over 50 percent of the total resources expended for
, licensii.g. NMSS undertook this review as a part of NRC's business process redesign efforts.
The license renewal process has been used as an opportunity for the Commission to review the history of the licensee's operating performance (e.g., the record on compliance
, 2 l
with regulatory requirements and the licensee's program. This review is performed to ascertain if the licensee employs up-to-date techrNogy and practices in the protection of health, safety, and the environment, and complies with any new or amended regulations. As part cf a license renewal, the licensee is asked to provide information on the current status of 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 amendments 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 materiallicenses. 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, 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 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
i 1 .
In March 1978, NMSS conducted a study (SECY-78-284, "The License Renewal Study for parts 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 propoaed 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 that 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 j l
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
i A . _ _ _ . _ _ _ _ - _ _ _ _ _ _ . ___
\ .
term reduces the administrative burden associated with the license renewal process for both the NRC sts:1 and the uranium recovery licensees. Also, the extension reduces the licensee 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.
On February 6,1997 (62 FR 5656), the Commission gave notice of the policy that the license term for material licenses issued pursuant to 10 CFR Parts 30,40, or 70 would be 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 was set by this policy, the term 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 iscue a license for a shorter term, depending on the individual circumstance, of the license applicant.
The public comment period closed on October 14,1997. A summary of 7he public comments is covered in Section IV, below.
II. Discussion
[
The change in policy, under which the license term for materials licenses is up to 10 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 5
in the unintentional abandonment of licensed material or decreases in the licensees' attention to l
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 medical inspection program are being proposed; (3) NRC would continue to be in the position to identify, by inspection or other means, violations that affect public health and safety, and to take appropriate enforcement actions; (4) Cases of abandonment of NRC licenses would be identified tNough nonpayment of the annual licensing fees and regional follow up; AS-(5) Th taff would 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 efforts are 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 medical use licenses so that the term for medical use licenses can be set by policy for up tc 10 as m as IO years.
6 l
l l _ _ _ _ _ _ _ _ _ - _ _ - -
IV. Discussion of Public Comments Five letters of public comment were received on the proposed rule. Comments were received from National Physics Consultants, Ltd., the American Association of Clinical Endocrinologists, the Mayo Clinic, the University of Cincinnati, and the American Hospital Association.
All commenters fully supported the proposed amendment to eliminate the reference to the 5-year term limit for medical use licenses in 10 CFR 35.18. In addition, the commenters endorsed the change in license terms for licenses issued pursuant to Part 35, set by policy for CLS MO
.-egado 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 NRC's proposal to eliminate this requirement citing a reduction of staff time and costs for both the NRC and individual licensees with no decrease in public health and safety. It was recognized that the NRC may issue some licenses for shorter terms if warranted by the individual circumstances of license applicants.
One commenter stated that routinr: license reviews by the local Radiation Safety Committee will ensure operation of a radiation safety program that assures public health and safety.
Another commenter indicated thapecause the NRC is in contact with the licensees on an ongoing t; asis, any changes in operations, personnel, facility, equipment, or applicable procedures are identified during the inspection and license amendment process.
7
l L One of the commentertexpre:::d agreeme6t 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.
i Another commenter recommended that NRC extend the license term for medical use licenses from 5 years to 10 years as soon as pose le to reduce the license fees and achieve further cost savings. This commenter expressed support for the NRC's business process redesign efforts citing that the reduction in the administrative burden of license renewals and reduced license fees will allow the organization's members to redirect their resources to support and implement NRC's initiative to move to a more performance-based regulatory approach.
I V. Compatibility for Agreement States This rulemaking will be a matter of compatibility between the NRC and the Agreement States,thareby pr~dding cen !:tency em^ag c'a*= ead C-d- 2!::fety rqdremeate.
Compatibilitybegory D has been assigned to the changes in 10 CFR 35.18. Category D means the provisions are not required for purposes of compatibility [hawa"^r :f;depted by the St:te, they chedd be ovmpaiivie mii NRC. No problems have been identified regarding I
l ( Agreement State compatibility implementation of this rule change.
l t
i 8
i L__-_---_----_-----------__--------------- - - - - - - -- - - - - --
Id l
VI. Finding of No Significant Environmentalimpact: Availability No Environmental Assessment will be needed because the rulemaking is covered by the categorical exclusion in 10 CFR 51.22(c)(3)(i) for amendmer,ts % Part 35 that relate to renewals of licenses.
Vll. Paperwork Reduction Act Statement W .]2.fAAU This final rule reduces the burden for both medical licensee @nqNRC becaus(terms L5 ma-M1 M could be established by policy, for upie 10 years, as is the case for other material licensees.
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 licensesdid ;;;re 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. 3150-0120 and expires on July 31, data on reduced burden from extension of the license term for all material licensesse .;;" 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 gin 1999. This is appropriate because the next OMB clearance extension will M
cover 1999-2002 f it;; ;.t;;l. L.,E the medical licenses currently under the 5-year extension will expire and be affected by this rulemaking. Send comments on any aspect of this information collection, including suggestions for further reducing the burden, to the Information 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 9
Desk Officer, Office of Information and Regulatory Affairs, NEOB-10202 (3150-0014), Office of Management and Budget, Washington, DC 20503.
Public Protection Notification if a document used to impose an information collection does not display a currently valid 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 medhal licenses, is codified in
.LOccticn 35.18 and states that "The Commission shall issue a license for the medica byproduct materia! 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 i
duration and manner of determination of the license terr (of medical use licenses and a materials licenses. Based on the above, the following options were considered.
Allemative Approaches
- 1. Take no action: Maintain the requirement that licenses issued pursuant to Part 35 would be issued for 5 years.
This option would continue the inconsistency between how license terms for medical licenses A/and all other materials licensesi /are established. Terms for medical use licenses are l established in codified regulations, whereas the term for other materials licenses are set by 10 1
i -
~.
l l policy. Also, this option would result in disparities in the duration of the term for rnaterial l licenses because medical use licenses would continue to be issued for 5-year terms whereas the duration of the term for other materials licenses would be up to 10 years l 2. Revise 70 CFR 35.18: Revise the regulations to delete any ref erene to the license term for licenses issued pursuant to Part 35.
This option would result in consistency between how license terris for medicallicenses 1:) &
and all other material licenses are established and in the duration ofeuehlicenses.
Commission decisions regarding the duration of a materials license could therefore apply uniformly to all types of material licenses. After final rulemaking action '.o n tvise 10 CFR 35.18, the license term for licenses issued pursuant to Part 35 would be set by Meady-established as m2 uf a S policy for.up4o 10 years.
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 does 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 g m p GS W Commission'Mpprovayebruary 199pxtending the license term tvio 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 procedues. Estimated savings are based on the assumption that these licensees would only 11
be required to submit a renewal application every 10 years as opposed to every 5 years, resulting, on average, in a savings of 190 applications per year. However, offsetting these savings, medicallicensees may need to submit an average of one additional amendment during the 10-year period to account for changes in operations that would have routinely been addressed when the license was renewed on a 5-year _ cycle. Assuming that a typical license (R) W V-renewal application and typical amendment involves'10~ hours anr&) hours _o professional effort, respectively, there would be a net savings per licensee o ours. Based on an industry professional labor rate of per hour, the annual industry-wide savings would n, ,
approximate $4 . Over a 30-year time frame, based on 7 rcent real discount rate, the O-3 1 000 1 . g ,qo, av pa& > au / 2 . q ..
present worth savings to industry would approximat
-- y- .
"W*"j Similarly, this rulemaking is also cost effective for the NRC because fewer resources would be required to review and process renewal applications. On average, it takes -
/ '
/
approximately 14 hours1.62037e-4 days <br />0.00389 hours <br />2.314815e-5 weeks <br />5.327e-6 months <br /> of NRC professional time to renew a medical license and 4 hours4.62963e-5 days <br />0.00111 hours <br />6.613757e-6 weeks <br />1.522e-6 months <br /> to r review an amendment. This translates to a net savings to the NRC of 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> per licensee. -
IDS Assuming an NRC labor rate of $ Japer ho r, and on average,190 applications per year, the Wh ' l J 0, annual NRC savings would equal $93;000 The 30-year present worth savings.t the NRC y 2 would approximate I hC a0gQ g ,
- 1Q9W jW iriifd5.[h mh
- I
[]
Jg Conclusion ) y\ ] g ,0 This rulemaking, to remove the 5-year es rm for medical use of bfpj?o ct kl, l material, is promulgated so the term for medi i licenses will be consistent with that of oth 'N ,
/
GS At&ruf M '
materials licenses (set by policy to be epio40 yeafs). The extension will reduce the administrative burden of license renewals for both NRC and the licensee and will support NRC's i
goal of streamlining the licensing process without any reduction in health and safety. NRC may 2
'i' pk t
'- ; 40 > s%
$ _ 19 d U
g 12 7 -
4o o. abgoo oo 70 q t e 3 7
- bS ) M _ _____ _ __
issue some licenses for shorier terms rif 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 AS W O
@ 10 years, the NRC is amending 10 CFR Part 35 to eliminate the 5-year term limit for a.S nO' medical use licenses and allow the license term to be set by the established policy a for opt 'y Q years.
IX. Regulatory Flexibility Certification As required by the Regulatory Flexibility Act of 1980,5 U.S.C. 605(b), the Commission certifies that this rule will not have a significant impact on a substantial number of small entities.
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 10 CFR 50.109(a)(1).
l
)
13 !
(
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 the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amendedrand 5 U.S.C.
552 and 5537the NRC is adopting the following amendment to 10 CFR Part 35.
e 1 PART 35 - MEDICAL USE OF BYPRODUCT MATERIAL g spaA.4* W 1.Nhhe 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).
14 l
)
l 2.## he introductory text of 9 35.18 is revised to read as follows:
6 35.18 License issuance. l
)
The Commission shall issue a license for the medical use of byproduct material if:
. . 1 p Dated at Rockville, Maryland, this day of 1998.
For the Nuclear Regulatory Commission.
1 l
I L. Joseph Callan, Executive Director for Operations.
15 L _ _ ____.---- __ __- - - - - - - - - - - - -
A
- 2. The introductory text of S 35.18 is revised to read as follows:
6 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.
RECORD NOTE: A copy of this final rule was sent to OlG for information on .
Distribution: (0.WICC AU SLA\ FINAL _35.FRN)
Ta receive a co w of this document, Indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure "N" = No copy OFFICE RGB:lRANS q l RG8:llANS l RGB:lAANS l TECH ED l D:IMNS:NAASS l NAaE: JMcCausland M PHolahan JPiccone EKraus DCool DATE: its F 1 19e t 198 i 198 1 198 OFFICE: D:OSP l OE R NARE: RBangert JLloberman JGrey Dtesyer BJShelton DATE: 1 198 1 198 i its i 198 1 198 OFFICE: E NARIE: JLFonches CPapertello HThompson LJCallan DATE: # 198 1 190 i 198 f 198 OFFICIAL RECORD COPY l (NMSS Flie Code) _
l 4
15 l
\. . .. . . . . .. .
6 ATTACHMENT 2 CONGRESSIONAL LETTERS
. [ pac %k.
UNITED STATES g j 2
NUCLEAR REGULATORY COMMISSION l WASHINGTON, D.C. 2055H001
\...../
The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
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 of license renewals for both NRC and the 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.
Sacerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Reaister Notice l'
cc: Senator Bob Graham i
l l
p cecoq bq y'-)
7 E UNITED STATES NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 2055% 4001
\..<...j!
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 Register 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 ament.iment reduces the administrative burden of license renewals for both NRC and the licensee and nupports NRC's goal of streamlining the licensing process without any adverse impact on the health and safety of workers or the pub!ic.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc: Representative Ralph Hall
O e
O l
l ATTACHMENT 3 SBREFA LETTERS 1
l
. k psuco
. ye & UNITED STATES s* g NUCLEAR REGULATORY COMMISSION 2 WASHINGTON, D.C. 20555 0001 l l % /
I Mr. Robert P. Murphy General Counsel General Accounting Office Room 7175 441 G. St., NW l
Washington, DC 20548 l 1
Dear Mr. Murphy:
l 1
Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996, f 5 U.S.C. 801, the U.S. Nuclear Regulatory Commission is submitting a final rule to remove the 5-year license term for medical use licenses in NRC's 10 CFR Part 35. 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 of license renewals for l 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.
1 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 ;
i
)
l l
___- _ _Y
gerog
,- p-.. ~t UNITED STATES j j NUCLEAR REGULATORY COMMISSION o WASHINGTON, D.C. 206edHm01 i-
- s. ...../
The Honorable Al Gore President of the United States Senate Washington, DC 20510
Dear Mr. President:
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 final rule to remove the
' 5-year license term for tuedical'we licenses in NRC's 10 CFR Part 35. 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 oflicense renewals 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 Register.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs I
Enclosure:
Final Rule I
a na uq 3 & UNITED STATES g g NUCLEAR REGULATORY COMMISSION o f WASHINGTON, D.C. 20065-0001 4 * * * , + ,&
The Honorable Newt Gingrich Speaker of the United States House of Representatives Washington, DC 20515
Dear Mr. Speaker:
1 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 final rule to remove the 5-year license term for medical use licenses in NRC's 10 CFR Part 35. 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 of license renewals 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 Register.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Final Rule l
4 9
i ATTACHMENT 4 DAILY STAFF NOTES ITEM
e l DAILY STAFF NOTES OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS L
Final Rule Sianed by EDO On .1998, the Executive Director for Operations approved a final 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.
This notice informs the Commission that, in accordance with the rulemaking authority delegated to the EDO, the EDO has signed this final rule and proposes to forward it on
.1998, to the Office of the Federal Register for publication, unless otbrwise directed by the Commission.
1 l
O h
a f
l ATTACHMENT 5 APPROVAL FOR PUBLICATION t
i i
i t
l l
)
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 Management Directive 9.17, Organization and Functions, Office of the Executive Director for Operations, paragraphs 0213,038,039, and 0310.
i l The enclosed final rule, " License Term for Medical Use Licenses" amends 10 CFR 35.18 to l remove the reference to a 5-year license term for medical use licenses. This rule makes the I term for medicallicenses consistent with that of other materials licenses which has t,een set l
by policy to up to 10 years. The extension reduces the administrative burden of license renewals for both NRC and the licensee and supports NRC's goal of streamlining 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 not constitute a significant question of policy, nor does it amend regulations contained in 10 CFR Parts 7, 6, or 9 Subpart C concerning matters of policy. I, therefore, find that this rule is within the scope of my rulemaking authority and am proceeding to issue it.
l l
Date L. Joseph Callan, l
Executive Director for Operations.
l l
i t- _ _ - _ _ _ _
5