ML20236R176
| ML20236R176 | |
| Person / Time | |
|---|---|
| Issue date: | 04/27/1998 |
| From: | Halman E NRC OFFICE OF ADMINISTRATION (ADM) |
| To: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20236R069 | List: |
| References | |
| FRN-63FR31604, RULE-PR-35 AF77-2-010, AF77-2-10, NUDOCS 9807210283 | |
| Download: ML20236R176 (24) | |
Text
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Q Clay
. [ \ UNITED STATES Q
g NUCLEAR REGULATORY COMMISSION 7 t WASHINGTON. D.C. 20526 0001
- g, + . + ,/ April 27. 1998
$#774 MEMORANDUM TO: Donald A. Cool, Director l Division of Industrial and Medical Nuclear Safety !
Office of Nuclear Material Safety and Safeguards FROM: Edward L. Halman, Diregge /
Office of Administration -
SUBJECT:
OFFICE CONCURRENCE ON FINAL RULE PACKAGE ENTITLED,
- LICENSE TERM FOR MEDICAL USE LICENSES" l
The Office of Administration concurs on the final rule that ame.nds Part 35 to eliminate the 5-year term limit for medical use licenses. We have attached a copy of the package that presents our comments.
When this document is forwarded for publication, please include a 3.5 inch diskette that contains a copy of the document in Wordperfect as part of the transmittal package. The diskette will be forwarded to the OFR and the Govemment Printing Office for their use in typesetting the document.- 1 i
ln order to assist you in preparing the list of documents centrally relevant to this final rule that is required by NRC's regulatory history procedures, you should place the designator "AF77-2"in the upper right-hand comer of each document concerning the final rule that you forward to the Nuclear Documents System.
I If you have any questions, please contact Michcel Harrison,415-6865, or t wid Meyer, 415-7162, of the Office of Administration.
Attachmeat: As stated l
t 9807210283 980715 PDR PR
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49 o l y- -c4 UNITED STATES l 7o j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 2056 5 0001 1
%, *s+s*y MEMORANDUM TO: L. Joseph Callan Executive Director for Operations
( 30M: Carl J. Paperiello, Direebr 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 Reaister. that amends 10 CFR Part 35 te 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 Endatal 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 discussion of the comments received.
Notices 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 approva(for publication is also attached (Attachment 5).
{Cl LssS_,
Coordination: The Offices of Administration, Enforcement, and Stste Programs concur in these amendments. The Office of the General Counsel has no legal 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 Reaister Notice of Final Rulemaking and disk
- 2. Congressional Letters
- 3. SBREFA Letters
- 4. Daily Staff Notes item
- 5. Approval for Publication i
[7590-01-P)
NUCLEAR REGULATORY COMMISSION 10 CFR Part 35 RIN 3150-AF77 License Term for Medical Use Licenses i
AGENCY: Nuclear Regulatory Commission. \o{ / jf f Y *( h (9 y' 0;p SY pP ACTION: Final rule. GS 9 l,ebc
{g j f pf*dd d
SUMMARY
- The' Nuclear Regulatory Commission is amending 1MFR-PM-3d to eliminate the
^ ^~ " License terms for licensee issued 5-year term limit for un/n medical use licenseg ^/sn
/ Jeu se9a4 purmuiiv P" ill be set by policy, upig 10 years, as are the license terms for other b fox e.1 m u s,y aj materials licenses. The NRC will issue some licenses for shorter terms warranted by the individual circumstances of license applicants. The amendment reduces the administrative 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 Federal Register).
FOR FURTHER INFORMATION CONTACT: Jayne M. McCausland, Office of Nuclear Material l
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555, telephone (301) 415-6219, e-mail JMM2 @ nrc. gov.
i O. . _ _ _ _ _ _ _ _ _ _ _ _ . _ _ _ _ _ _ _ _ _ _ _ _ . __
SUPPLEMENTARY INFORMATION:
- 1. Background.
II. Discussion.
111. 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 Antalysis.
I. Background in 1995, the NRC Office of Nuclear Material Safety and Safeguards (NMSS) initiated a review to determine whether the license term for material licenses could be increased so that NRC's licensing resources could be redirected to other areas of the materials program. The 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.
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
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- A with regulatory requirements) and the licensee's 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 its program as well as any proposed changes in operations (types and quantities of authorized materials), personnel (authorized users and radiation safety officers), facility, equipmer,t, 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 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, I licenses would be issued for 5-year terms, except when the nature of the applicant's prci. ed )
I 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.
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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 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 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 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 heensees 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_________________
l l term reduces the administrative burden associated with the license renewal process for both 1
the NRC staff 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 1
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 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 is covered in Section IV, below. -
1 L W p ' 11. 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 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 acuons; (4) Cases of abandonment of NRC licenses would be identified through nonpayment of the annual licensing fees and regional follow up; b
(5) Thej(staff would continue to make licensees aware of health and safety issues through the issuance of generic communications (ruch 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.
111. Statement of Regulatory Action The NRC is revising Part 35 to eliminate the 5-year term limit in 10 CFR 35.18 for y mAK M medical use licenses so that the term for medical use licenses can be set by policy for.ppW 0 years.
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IV. Discussion of Public Comments l
l Five letters of public comment were received on the proposed rule. Comments were I
received from National Physics Consultants, Ltd., the American Association of Clinical l
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 l
l 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 gNMf4
.mp%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 routine license reviews by the local Radiation Safety Committee will ensure operation of a radiation safety program that assures public health and safety.
because the NRC is in contact with the licensees on #
Another commenter indicated th an ongoing basis, any changes in operations, personnel, facility, equipment, or applicable procedures are identified during the inspection and license amendment process.
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t One of the commenters.=; ce;;{agretyhthat 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 I; cense 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'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.
V. Compatibility for Agreement States This rulemaking will be a matter of compatibility between the NRC and the Agreement States, thereby providing consistency among State and Federal safety requirements.
Compatibility category D has been assigned to the changes in 10 CFR 35.18. Category D means the provisions are not required for purposes of compatibility; however, if adopted by ti'e State, they should be compatible with NRC. No problems have been identified regarding Agreement State compatibility implementation of this rule change.
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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 amendments to Part 35 that relate to renewals of licenses.
Vll. Paperwork Reduction Act Statement I
hL Y44%
This final rule reduces 01 madthe 81 7burden for both medical licensees an{NRC beca could be established by policy, fo 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 gcurrent licenses W9 ;;rgranted 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 31,1999. The data on reduced burden from extension of the license end term for all material licensesM from other actions taken to streamline the licensing proceg will be included in the request for renewal of the information collection requirements on NRC Form 313j in 1999. This is appropriate because the next OMB clearance extension will cover 1999-200 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, j l
Washington, DC 20555-0001, or by intemet 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 medical licenses, is codified in -
l0.-(,M
_Sedhm 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 isyn inconsistency as to duration and manner of determination of the license te of medical use licenses and all other materials licenses. Based on the above, the following options were considered.
Altemative 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 licensyeand all other materials licensye are established. Terms for medical use licenses are established in codified regulations, whereas the term for other materials licenses are set by 10 l
policy. Also, this option would result in disparities in the duration of the term for material j licens 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.
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- 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 IFense terms for medical licenses
$1$lf I
and all other material licenses are established and in the duration ofartidb licenses.
Commission decisions regarding the duration of a materials license could therefore apply uniformly to all types of material licenses. After final rulemaking action to revise 10 CFR 35.18, l-the license term for licenses issued pursuant to Part 35 would be set by established a PWI 43 policy for.ppia{10 years.
l Value andImpact The license renewal process is resource-intensive for both the licensee and NRC. At l
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 j amendment process. Therefore, the rulemaking to remove the 5-year license term for medicai
! 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
{ o f M it W 14 4 5 Commission'bpprova[ February 199kextending the license term pp% 10 years for a j 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 oyproduct material for medical procedures. Estimated savings are based on the assumption that these licensees would only 11 4
l 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 renewal application and typical amendment involves 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> and 2 hours2.314815e-5 days <br />5.555556e-4 hours <br />3.306878e-6 weeks <br />7.61e-7 months <br /> of licensee l
professional effort, respectively, there would be a 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 1
on an industry professional labor rate of $70 per hour, the annual industry-wide savings would approximate $106,000. Over a 30-year time frame, based on a ercent real discount rate, the present worth savings to industry would approximate $1.3 million.
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 review an arnendment. 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.
Assuming an NRC labor rate of $70 per 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 $1.6 million.
Conclusion This rulemaking, to remove the 5-year license term for medical use of byproduct material, is promulgated so the term for medical licenses will be consistent with that of other M M4M Al materials licenses (set by policy to bex$k10 years). The extension will reduce the administrative burden of license renewals for both NRC and the licensee and will support NRC's goal of streamlining the licensing process without any reduction in health and safety. NRC may 12
issue some licenses for shorter term if warranted by the individual circumstances of license y 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 /
g pAus At '
10 years, the NRC is amending 10 CFR Part 35 to eliminate the 5-year term limit for i medical use licenses and allow the license term to be set by the established policy formfte 10 AS *4h 43 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).
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Small Business Regulatory Enforcement Fairness Act in accordance with the Small Business Regulatory Enforcement Faimess 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 amendehthe Energy Reorganization Act of 1974, as amendehand 5 U.S.C.
552 and 55kthe NRC is adopting the following amendment to 10 CFR Part 35.
PART 35 - MEDICAL USE OF BYPRODUCT MATERIAL i
1l[40l V
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).
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- 2. i The introductory text of 9 35.18 is revised to read as follows:
v
$ 35.18 License issuance The Commission shall issue a license for the medical use of byproduct material if:
h Dated at Rockville, Maryland,' this - day of 1998, For the Nuclear Regulatory Commission. ,
L. Joseph Callan, l Executive Director for Operations.
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uro 3* 4 UNITED STATES g g NUCLEAR REGULATORY COMMISSION o # WASHINGTON, D.C. 2055!Km01 Y+9. . . . ,o 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.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Reaister Notice cc: Senator Bob Graham l
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O ceco y -4 UNITED STATES
- } NUCLEAR REGULATORY COMMISSION
- WASHINGT ON, D.C. 205f4 4001
'+9 . . . . . ,d 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 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.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Eederal Reaister Notice cc: Representative Ralph Hall 1
.________________-___-_______--______a
p ela p*' 4 UNITED STATES g
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' 1" NUCLEAR REGULATORY COMMISSION WA8HINGToN, D.C. 20065 4001 k*****,d Mr. Robert P Murphy General Counsel General Accounting Office Room 7175 441 G. St., NW Washington, DC 20548
Dear Mr. Murphy:
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 . :t 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 Endacal Reaister.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Final Rule
s@ WEOc, y Ji UNITED STATES
- g NUCLEAR REGULATORY COMMISSION t WASHINGTON, D.C. 2066H001
.c f.
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 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 Reaister.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
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Enclosure:
Final Rule I
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[gs@ M2 $% UNITED STATES s* j NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555 4001
\ . . . . . /*
The Honorable Newt Gingrich Speaker of the United States House of Representatives Washington, DC 20515
Dear Mr. Speaker,
Pursuant to Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996, I 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 Reaister.
Sincerely, Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Final Rule -l l
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- e. _ _ . _ ____.___..__.____..______ ________ _ ___ _ _
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DAILY STAFF NOTES OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS Final Rule Sione>1 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 rulernaking authority delegated to the EDO, the ECO has signed this final rule and proposes to forward it on
.1998, to the Office of the Federal Register for publication, unless otherwise directed by the Commission.
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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 Di,ector for Operations, paragraphs 0213, 038, 039, and 0310.
The enclosed final rule, License Term for Medical Use Licenses" amends 10 CFR 35.18 to remove the reference to a 5-year license term for medical use licenses. This rale makes the term for medical licenses consistent with that of other materia!s licenses which has been set by policy to up to 10 years. The extension reduces the soministrative burden of license renewals for both NRC and the licensee and supports NRC's goal of streamlining the licensing process without any reduction h 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 7,8, 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.
Date L. Joseph Callan, Executive Director for Operations.
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