06-2856. Minor Amendments

AGENCY:

Nuclear Regulatory Commission.

ACTION:

Final rule.

SUMMARY:

The Nuclear Regulatory Commission (NRC) is amending its regulations to correct several miscellaneous errors in the Code of Federal Regulations (CFR), update the address for Region III, and remove all references to Subpart J in Parts 32 and 35. This document is necessary to inform the public of these minor changes to NRC regulations.

DATES:

Effective Date: March 27, 2006.

FOR FURTHER INFORMATION CONTACT:

Alzonia Shepard, Office of Administration, Rules and Directives Branch, Division of Administrative Services, Office of Administration, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, Telephone [phone]; e-mail [e-mail].

SUPPLEMENTARY INFORMATION:

Background

The Nuclear Regulatory Commission is amending the regulations in 10 CFR parts 1, 13, 20, 30, 32, 35, 40, 55, 70, 73, 110, and 140 to correct several miscellaneous errors in regulatory text, update the address for Region III, and remove all references to Subpart J in Parts 32 and 35. The miscellaneous errors in CFR text occurred in the process of preparing and printing several rulemaking documents.

Because these amendments constitute minor administrative corrections to the regulations, the notice and comment provisions of the Administrative Procedure Act do not apply pursuant to 5 U.S.C. 553(b)(B). The amendments are effective upon publication in the Federal Register. Good cause exists under 5 U.S.C 553(d) to dispense with the usual 30-day delay in the effective date of the final rule, because the amendments are of a minor and administrative nature dealing with corrections to certain CFR sections, which do not require action by any person or entity regulated by the NRC. Nor does the final rule change the substantive responsibilities of any person or entity regulated by the NRC.

Summary of Changes

Removing All References to Subpart J

Subpart J in 10 CFR Part 35 expired on October 24, 2005. Thus, Subject J is removed in its entirety. In addition, any references to Subpart J (i.e., §§ 35.900 through 35.981) are also removed. As an example, in current § 35.50(a)(2)(ii)(B), the phrase “or, before October 24, 2005, §§ 35.920, or 35.930” is removed.

The changes to remove references to Subpart J are made to the following sections: § 32.72(b)(2)(ii); § 35.2, the definitions of authorized medical physicist, authorized nuclear pharmacist, authorized user, and Radiation Safety Officer; § 35.8(b); § 35.10(a), (b), (c); § 35.13(b)(1), (2), (3); § 35.50(a)(2)(ii)(B); § 35.51(a)(2)(ii), (b)(2); § 35.59; § 35.100(b)(2); § 35.190(b), (c)(1)(ii), (c)(2); § 35.200(b)(2); § 35.290(b), (c)(1)(ii), (c)(2); § 35.300(b)(2); § 35.390(b)(1)(ii), (b)(2); § 35.392(b), (c)(2), (c)(3); § 35.394(b), (c)(2), (c)(3); § 35.396(a), (b), (c), (d)(2); (d)(3); § 35.490(b)(1)(ii), (b)(2), (b)(3); § 35.491(a), (b)(3); and § 35.690(b)(1)(ii), (b)(2), (b)(3).

Change Address of Region III, USNRC

The address of the NRC Region III office has been changed. The new address is incorporated in the following sections: § 1.5(b)(3), Appendix D to Part 20, § 30.6(b)(2)(iii), § 40.5(b)(2)(iii), § 55.5(b)(2)(iii), § 70.5(b)(2)(iii), and Appendix A to Part 73.

Additional Changes

1. Section 13.2 Definitions.

Definition of Statement: In paragraph (b)(1), replace “;” by “,” and in (b)(2), insert “(i)” in front of “The authority, or” and insert “(ii)” in front of “Any State, * * *” This change is to clarify this paragraph.

2. Section 13.3 Basis for civil penalties and assessments.

In current paragraph (a)(1)(iii), (B) and (C) are in the same subparagraph. In this final rule, (C) is separated from (B) to form a new subparagraph. This change is to clarify this paragraph.

3. Section 13.8 Service of complaint.

In paragraph (a), replace “under receipt” by “upon receipt.” This change is to clarify this paragraph.

4. Appendix B of Part 20.

In the Table of Elements, replace “Thalium” by “Thulium” for the element Tm with Atomic Number 69. This change is to correct a typographical error.

5. Section 32.74 Manufacture and distribution of sources or devices containing byproduct material for medical use.

In paragraph (a), add “transmission” after “calibration.” This change is being made to correct the inadvertent omission of “transmission” from this regulation and conform this regulation to the provisions in § 35.65, Authorization for calibration, transmission, and reference sources.

6. Section 35.2 Definitions.

Under the definition of Medical event, add “or (b)” after “§ 35.3045(a).” The words “or (b)” were inadvertently omitted.

7. Section 35.14 Notifications.

In current paragraph (b), a notification requirement was inadvertently omitted. In § 35.24, “Authority and responsibilities for the radiation protection program,” paragraph (c) states: “For up to 60 days each year, a licensee may permit an AU * * * to function as a temporary RSO * * *, if the licensee * * * notifies the Commission in accordance with 35.14(b).” However, current 35.14(b) does not contain this notification requirement. Thus, to correct this oversight, the notification requirement is added to § 35.14(b) to conform to § 35.24(c).

8. Section 35.49 Suppliers for sealed sources or devices for medical use. Section 35.65 Authorization for calibration, transmission, and reference sources.

In § 35.49(b), add “or an Agreement State medical use licensee” after “a Part 35 licensee.” This is to correct the inadvertent omission of the reference to Agreement State licensees in this paragraph.

Similarly, in § 35.65(b), add “or equivalent Agreement State regulations” after “under § 32.74 of this chapter.”

9. Section 35.290 Training for imaging and localization studies.

In paragraph (a)(1), replace “uptake, dilution, and excretion studies” by “imaging and localization studies.” This is to correct a typographical error and to conform this paragraph to the heading of this section. Training for “uptake, dilution, and excretion studies” is specified under § 35.190.

10. Section 35.390 Training for use of unsealed byproduct material for which a written directive is required.

Section 35.396 Training for parenteral administration of unsealed byproduct material requiring a written directive.

In paragraph 35.390(b)(1)(ii)(G)(3), add “,” after “any beta emitter.” The comma was inadvertently omitted. Addition of the comma clarifies that the phrase “with a photon energy less than 150 keV” applies only to photon-emitting radionuclides, not to any of the beta emitters.

Similarly, in § 35.696(d)(1), (d)(2), and (d)(2)(vi), add “,” after “any beta emitter.”

11. Section 70.14 Foreign military aircraft.

Replace “49 U.S.C. 1508(a)” by “49 U.S.C. 40103(d).” This change is to correct an error in citation to a statute.

12. Section 110.40 Commission review.

In paragraph 110.40(b)(7)(v), remove “1,000 curies of tritium” and add in its place “37 TBq (1,000 curies) of tritium.” This change is to correct a typographical error in a prior amendatory instruction. In a correction to a final rule entitled “Export and Import of Radioactive Materials: Security Policies: Correction,” published on August 9, 2005 (70 FR 46066), under § 110.40, the amendatory language stated: “In § 110.40, paragraph (b)(7)(iv) is amended by removing ‘1,000 curies of tritium’ and adding in its place ‘37 TBq (1,000 curies) of tritium.’ ” The reference to the paragraph was inadvertently entered as (b)(7)(iv), rather than (b)(7)(v). This change is being resubmitted to provide the correct amendatory instruction.

13. Section 140.21 License guarantees of payment of deferred premiums.

In the introductory text, replace “$10 million” by “$15 million.” This change is to correct an error. In the Federal Register notice published on October 27, 2005, regarding Price-Anderson Act Financial Protection Regulations and Elimination of Antitrust Reviews, “$10 million” was inadvertently allowed to remain in the rule text, rather than being changed to “$15 million” in conformity with the statute.

Environmental Impact: Categorical Exclusion

The NRC has determined that this final rule is the type of action described in categorical exclusion 10 CFR 51.22(c)(2). Therefore, neither an environmental impact statement nor an environmental assessment has been prepared for this final rule.

Paperwork Reduction Act Statement

This final rule does not contain new or amended information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Existing requirements were approved by the Office of Management and Budget, approval numbers 3150-0014, 3150-0017, 3150-0001, 3150-0010, 3150-0020, 3150-0018, 3150-0009, 3150-0002, 3150-0036, and 3150-0039.

Public Protection Notification

The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information of an information collection requirement unless the requesting document displays a currently valid OMB control number.

List of Subjects

10 CFR Part 1

• Organization and functions (Government Agencies)

10 CFR Part 13

• Claims
• Fraud
• Organization and function (government agencies)
• Penalties

10 CFR Part 20

• Byproduct material
• Criminal penalties
• Licensed material
• Nuclear materials
• Nuclear power plants and reactors
• Occupational safety and health
• Packaging and containers
• Radiation protection
• Reporting and recordkeeping requirements
• Source material
• Special nuclear material
• Waste treatment and disposal

10 CFR Part 30

• Byproduct material
• Criminal penalties
• Government contracts
• Intergovernmental relations
• Isotopes
• Nuclear materials
• Radiation protection
• Reporting and recordkeeping requirements

10 CFR Part 32

• Byproduct material
• Criminal penalties
• Labeling
• Nuclear materials
• Radiation protection
• Reporting and recordkeeping requirements

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

10 CFR Part 40

• Criminal penalties
• Government contracts
• Hazardous materials transportation
• Nuclear materials
• Reporting and recordkeeping requirements
• Source material
• Uranium

10 CFR Part 55

• Criminal penalties
• Manpower training programs
• Nuclear power plants and reactors
• Reporting and recordkeeping requirements

10 CFR Part 70

• Criminal penalties
• Hazardous materials transportation
• Material control and accounting
• Nuclear materials
• Packaging and containers
• Radiation protection
• Reporting and recordkeeping requirements
• Scientific equipment
• Security measures
• Special nuclear material

10 CFR Part 73

• Criminal penalties
• Export
• Hazardous materials transportation
• Import
• Nuclear materials
• Nuclear power plants and reactors
• Reporting and recordkeeping requirements
• Security measures

10 CFR Part 110

• Administrative practice and procedure
• Classified information
• Criminal penalties
• Export
• Import
• Intergovernmental relations
• Nuclear materials
• Nuclear power plants and reactors
• Reporting and recordkeeping requirements
• Scientific equipment

10 CFR Part 140

• Criminal penalties
• Extraordinary nuclear occurrence
• Insurance
• Intergovernmental relations
• Nuclear materials
• Nuclear power plants and reactors
• Reporting and recordkeeping requirements

For the reasons set forth in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553, the NRC is adopting the following amendments to 10 CFR parts 1, 13, 20, 30, 32, 35, 40, 55, 70, 73, 110 and 140.

PART 1—STATEMENT OF ORGANIZATION AND GENERAL INFORMATION

1. The authority citation for part 1 continues to read as follows:

Authority: Secs. 23, 161, 68 Stat. 925, 948, as amended (42 U.S.C. 2033, 2201); sec. 29, Pub. L. 85-256, 71 Stat. 579, Pub. L. 95-209, 91 Stat. 1483 (42 U.S.C. 2039); sec. 191, Pub. L. 87-615, 76 Stat. 409 (42 U.S.C. 2241); Secs. 201, 203, 204, 205, 209, 88 Stat. 1242, 1244, 1245, 1246, 1248, as amended (42 U.S.C. 5841, 5843, 5844, 5845, 5849); 5 U.S.C. 552, 553; Reorganization Plan No. 1 of 1980, 45 FR 40561, June 16, 1980.

2. In § 1.5, paragraph (b)(3) is revised to read as follows:

§ 1.5

Location of principal offices and Regional offices.

* * * * *

(b) * * *

(3) Region III, USNRC, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-4352.

* * * * *

PART 13—PROGRAM FRAUD CIVIL REMEDIES

3. The authority citation for part 13 continues to read as follows:

Authority: Public Law 99-509, sec. 6101-6104, 100 Stat. 1874 (31 U.S.C. 3801-3812). Sections 13.13 (a) and (b) also issued under section Pub. L. 101-410, 104 Stat. 890, as amended by section 31001(s), Pub. L. 104-134, 110 Stat. 1321-373 (28 U.S.C. 2461 note).

4. In § 13.2, the definition “Statement,” paragraphs (b)(1) and (b)(2) are revised to read as follows:

13.2

Definitions.

* * * * *

Statement means—* * *

(b) * * *

(1) A contract with, or a bid or proposal for a contract with, or

(2) A grant, loan, or benefit from,

(i) The authority, or

(ii) Any State, political subdivision of a State, or other party, if the United States government provides any portion of the money or property under such contract or for such grant, loan, or benefit, or if the Government will reimburse such State, political subdivision, or party for any portion of the money or property under such contract or for such grant, loan, or benefit.

5. In § 13.3, paragraphs (a)(1)(iii)(B) and (C) are revised to read as follows:

§ 13.3

Basis for civil penalties and assessments.

(a) * * *

(1) * * *

(iii) * * *

(B) Is false, fictitious, or fraudulent as a result of such omission; and

(C) Is a statement in which the person making such statement has a duty to include such material fact; or

* * * * *

6. In § 13.8, paragraph (a) is revised to read as follows:

§ 13.8

Service of complaint.

(a) Service of a complaint must be made by certified or registered mail or by delivery in any manner authorized by Rule 4(d) of the Federal Rules of Civil Procedure. Service is complete upon receipt.

* * * * *

PART 20—STANDARDS FOR PROTECTION AGAINST RADIATION

7. The authority citation for part 20 continues to read as follows:

Authority: Secs. 53, 63, 65, 81, 103, 104, 161, 182, 186,68 Stat. 930, 933, 935, 936, 937, 948, 953, 955, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 2073, 2093, 2095, 2111, 2133, 2134, 2201, 2232, 2236, 2297f), secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).

Appendix B to Part 20—Annual Limits on Intake (ALIs) and Derived Air Concentrations (DACs) of Radionuclides for Occupational Exposure; Effluent Concentrations; Concentrations for Release to Sewerage [Amended]

8. In Appendix B to Part 20, “List of Elements”, the Element “Thalium,” Atomic Number 69, should be changed to read as “Thulium.”

9. In the Appendix D to Part 20, second column, the address for Region III is revised to read as follows:

Appendix D to Part 20—United States Nuclear Regulatory Commission Regional Offices

* * * * *

USNRC, Region III, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-4352.

* * * * *

PART 30—RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF BYPRODUCT MATERIAL

10. The authority citation for part 30 continues to read as follows:

Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).

Section 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (42 U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 30.61 also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).

11. In § 30.6, paragraph (b)(2)(iii), is revised to read as follows:

§ 30.6

Communications.

* * * * *

(b) * * *

(2) * * *

(iii) Region III. The regional licensing program involves all Federal facilities in the region and non-Federal licensees in the following Region III non-Agreement States: Indiana, Michigan, Minnesota, Missouri, Ohio, and Wisconsin. All mailed or hand-delivered inquiries, communications, and applications for a new license or an amendment, renewal, or termination, request of an existing license specified in paragraph (b)(1) of this section must use the following address: U.S. Nuclear Regulatory Commission, Region III, Material Licensing Section, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-4352; where e-mail is appropriate it should be addressed to [e-mail].

* * * * *

PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT

12. The authority citation for part 32 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); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).

13. In § 32.72, paragraph (b)(2)(ii) is revised to read as follows:

§ 32.72

Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35.

* * * * *

(b) * * *

(2) * * *

(ii) This individual meets the requirements specified in 10 CFR 35.55(b) and 35.59 and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist, or

* * * * *

14. In § 32.74, the introductory text of paragraph (a) is revised to read as follows:

§ 32.74

Manufacture and distribution of sources or devices containing byproduct material for medical use.

(a) An application for a specific license to manufacture and distribute sources and devices containing byproduct material to persons licensed pursuant to part 35 of this chapter for use as a calibration, transmission, or reference source or for the uses listed in §§ 35.400, 35.500, and 35.600 of this chapter will be approved if:

* * * * *

PART 35—MEDICAL USE OF BYPRODUCT MATERIAL

15. 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); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).

16. In § 35.2, paragraph (1) of the definitions for the terms “Authorized medical physicist,” “Authorized nuclear pharmacist,” “Authorized user,” “Radiation Safety Officer” and for “Medical event” are revised to read as follows:

§ 35.2

Definitions.

* * * * *

Authorized medical physicist means an individual who—

(1) Meets the requirements in §§ 35.51(a) and 35.59; or

* * * * *

Authorized nuclear pharmacist means a pharmacist who—

(1) Meets the requirements in §§ 35.55(a) and 35.59; or

* * * * *

Authorized user means a physician, dentist, or podiatrist who—

(1) Meets the requirements in §§ 35.59 and 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), or 35.690(a); or

* * * * *

Medical event means an event that meets the criteria in § 35.3045(a) or (b).

* * * * *

Radiation Safety Officer means an individual who—

(1) Meets the requirements in §§ 35.50(a) or (c)(1) and 35.59; or

* * * * *

17. In § 35.8, paragraph (b) is revised to read as follows:

§ 35.8

Information collection requirements: OMB approval.

* * * * *

(b) The approved information collection requirements contained in this part appear in §§ 35.6, 35.12, 35.13, 35.14, 35.19, 35.24, 35.26, 35.27, 35.40, 35.41, 35.50, 35.51, 35.55, 35.60, 35.61, 35.63, 35.67, 35.69, 35.70, 35.75, 35.80, 35.92, 35.190, 35.204, 35.290, 35.310, 35.315, 35.390, 35.392, 35.394, 35.396, 35.404, 35.406, 35.410, 35.415, 35.432, 35.433, 35.490, 35.491, 35.590, 35.604, 35.605, 35.610, 35.615, 35.630, 35.632, 35.633, 35.635, 35.642, 35.643, 35.645, 35.647, 35.652, 35.655, 35.690, 35.1000, 35.2024, 35.2026, 35.2040, 35.2041, 35.2060, 35.2061, 35.2063, 35.2067, 35.2070, 35.2075, 35.2080, 35.2092, 35.2204, 35.2310, 35.2404, 35.2406, 35.2432, 35.2433, 35.2605, 35.2610, 35.2630, 35.2632, 35.2642, 35.2643, 35.2645, 35.2647, 35.2652, 35.2655, 35.3045, 35.3047 and 35.3067.

* * * * *

§ 35.10

[Amended]

18. In § 35.10, paragraphs (a), (b), and (c) are removed and reserved.

19. In § 35.13, paragraphs (b)(1), (b)(2), and (b)(3) are revised to read as follows:

§ 35.13

License amendments.

* * * * *

(b) * * *

(1) For an authorized user, an individual who meets the requirements in §§ 35.59 and 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), and 35.690(a);

(2) For an authorized nuclear pharmacist, an individual who meets the requirements in §§ 35.55(a) and 35.59;

(3) For an authorized medical physicist, an individual who meets the requirements in §§ 35.51(a) and (c) and 35.59;

* * * * *

20. In § 35.14, paragraphs (b)(2), (b)(3), and (b)(4), are redesignated as (b)(3), (b)(4) and (b)(5), and a new paragraph (b)(2) is added to read as follows:

§ 35.14

Notifications.

* * * * *

(b) * * *

(2) The licensee permits an authorized user or an individual qualified to be a Radiation Safety Officer, under §§ 35.50 and 35.59, to function as a temporary Radiation Safety Officer and to perform the functions of a Radiation Safety Officer in accordance with § 35.24(c).

* * * * *

21. In § 35.49, paragraph (b) is revised to read as follows:

§ 35.49

Suppliers for sealed sources or devices for medical use.

* * * * *

(b) Sealed sources or devices non-commercially transferred from a Part 35 licensee or an Agreement State medical use licensee.

* * * * *

22. In § 35.50, paragraph (a)(2)(ii)(B) is revised to read as follows:

§ 35.50

Training for Radiation Safety Officer.

* * * * *

(a) * * *

(2) * * *

(ii) * * *

(B) In clinical nuclear medicine facilities providing diagnostic and/or therapeutic services under the direction of physicians who meet the requirements for authorized users in §§ 35.290 or 35.390;

* * * * *

23. In § 35.51, paragraphs (a)(2)(ii) and (b)(2) are revised to read as follows:

§ 35.51

Training for an authorized medical physicist.

(a) * * *

(2) * * *

(ii) In clinical radiation facilities providing high-energy, external beam therapy (photons and electrons with energies greater than or equal to 1 million electron volts) and brachytherapy services under the direction of physicians who meet the requirements for authorized users in §§ 35.490 or 35.690; and

* * * * *

(b) * * *

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (c) and (a)(1) and (2), or (b)(1) and (c) of this section, and has achieved a level of competency sufficient to function independently as an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status. The written attestation must be signed by a preceptor authorized medical physicist who meets the requirements in § 35.51, or equivalent Agreement State requirements for an authorized medical physicist for each type of therapeutic medical unit for which the individual is requesting authorized medical physicist status; and

* * * * *

24. Section 35.59 is revised to read as follows:

§ 35.59

Recentness of training.

The training and experience specified in Subparts B, D, E, F, G, and H of this part must have been obtained within the 7 years preceding the date of application or the individual must have had related continuing education and experience since the required training and experience was completed.

25. In § 35.65, paragraph (b) is revised to read as follows:

§ 35.65

Authorization for calibration, transmission, and reference sources.

* * * * *

(b) Sealed sources, not exceeding 1.11 GBq (30 mCi) each, redistributed by a licensee authorized to redistribute the sealed sources manufactured and distributed by a person licensed under § 32.74 of this chapter or equivalent Agreement State regulations, providing the redistributed sealed sources are in the original packaging and shielding and are accompanied by the manufacturer's approved instructions.

* * * * *

26. In § 35.100, paragraph (b)(2) is revised to read as follows:

§ 35.100

Use of unsealed byproduct material for uptake, dilution, and excretion studies for which a written directive is not required.

* * * * *

(b) * * *

(2) A physician who is an authorized user and who meets the requirements specified in §§ 35.290, or 35.390 and 35.290(c)(1)(ii)(G); or

* * * * *

27. In § 35.190, paragraphs (b), (c)(1)(ii) and (c)(2) are revised to read as follows:

§ 35.190

Training for uptake, dilution, and excretion studies.

* * * * *

(b) Is an authorized user under §§ 35.290, 35.390, or equivalent Agreement State requirements; or (c)(1)* * *

(ii) Work experience, under the supervision of an authorized user who meets the requirements in §§ 35.190, 35.290, 35.390, or equivalent Agreement State requirements, involving—

* * * * *

(2) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in §§ 35.190, 35.290, or 35.390, or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (a)(1) or (c)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under § 35.100.

28. In § 35.200, paragraph (b)(2) is revised to read as follows:

§ 35.200

Use of unsealed byproduct material for imaging and localization studies for which a written directive is not required.

* * * * *

(b) * * *

(2) A physician who is an authorized user and who meets the requirements specified in § 35.290, or 35.390 and 35.290(c)(1)(ii)(G); or

* * * * *

29. In § 35.290, paragraphs (a)(1), (b), the introductory text of paragraph (c)(1)(ii) and paragraph (c)(2) are revised to read as follows:

§ 35.290

Training for imaging and localization studies.

(a) * * *

(1) Complete 700 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for imaging and localization studies that includes the topics listed in paragraphs (c)(1)(i) and (c)(1)(ii) of this section; and

* * * * *

(b) Is an authorized user under § 35.390 and meets the requirements in § 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements; or

(c)(1) * * *

(ii) Work experience, under the supervision of an authorized user, who meets the requirements in §§ 35.290, or 35.290(c)(1)(ii)(G), and 35.390, or equivalent Agreement State requirements, involving—

* * * * *

(2) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in §§ 35.290, or 35.390 and 35.290(c)(1)(ii)(G), or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraph (a)(1) or (c)(1) of this section and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under §§ 35.100 and 35.200.

30. In § 35.300, paragraph (b)(2) is revised to read as follows:

§ 35.300

Use of unsealed byproduct material for which a written directive is required.

* * * * *

(b) * * *

(2) A physician who is an authorized user and who meets the requirements specified in §§ 35.290, 35.390, or

* * * * *

31. In § 35.390, paragraphs (b)(1)(ii) introductory text, (b)(1)(ii)(G)( 3), and (b)(2) are revised to read as follows:

§ 35.390

Training for use of unsealed byproduct material for which a written directive is required.

* * * * *

(b)(1) * * *

(ii) Work experience, under the supervision of an authorized user who meets the requirements in § 35.390, or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in § 35.390(b), must also have experience in administering dosages in the same dosage category or categories (i.e., § 35.390(b)(1)(ii)(G)) as the individual requesting authorized user status. The work experience must involve—

* * * * *

(G) * * *

(3) Parenteral administration of any beta emitter, or a photon-emitting radionuclide with a photon energy less than 150 keV, for which a written directive is required; and/or

* * * * *

(2) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (a)(1) and (b)(1)(ii)(G) or (b)(1) of this section, and has achieved a level of competency sufficient to function independently as an authorized user for the medical uses authorized under § 35.300. The written attestation must be signed by a preceptor authorized user who meets the requirements in § 35.390 or equivalent Agreement State requirements. The preceptor authorized user, who meets the requirements in § 35.390(b) must have experience in administering dosages in the same dosage category or categories (i.e., § 35.390(b)(1)(ii)(G)) as the individual requesting authorized user status.

32. In § 35.392, paragraph (b), the introductory text of paragraph (c)(2) and paragraph (c)(3) are revised to read as follows:

§ 35.392

Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities less than or equal to 1.22 gigabecquerels (33 millicuries).

* * * * *

(b) Is an authorized user under § 35.390 for uses listed in § 35.390(b)(1)(ii)(G)(1) or (2), § 35.394, or equivalent Agreement State requirements; or

(c) * * *

(2) Has work experience, under the supervision of an authorized user who meets the requirements in §§ 35.390, 35.392, 35.394, or equivalent Agreement State requirements. A supervising authorized user who meets the requirements in § 35.390(b) must also have experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(1) or (2). The work experience must involve—

* * * * *

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (c)(1) and (c)(2) of this section, and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under § 35.300. The written attestation must be signed by a preceptor authorized user who meets the requirements in §§ 35.390, 35.392, 35.394, or equivalent Agreement State requirements. A preceptor authorized user, who meets the requirement in § 35.390(b), must also have experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(1) or (2).

33. In § 35.394, paragraph (b), the introductory text of paragraph (c)(2), and paragraph (c)(3) are revised to read as follows:

§ 35.394

Training for the oral administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22 gigabecquerels (33 millicuries).

* * * * *

(b) Is an authorized user under § 35.390 for uses listed in § 35.390(b)(1)(ii)(G)(2) or equivalent Agreement State requirements; or

(c) * * *

(2) Has work experience, under the supervision of an authorized user who meets the requirements in §§ 35.390, 35.394, or equivalent Agreement State requirements. A supervising authorized user, who meets the requirements in § 35.390(b), must also have experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(2). The work experience must involve—

* * * * *

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (c)(1) and (c)(2) of this section, and has achieved a level of competency sufficient to function independently as an authorized user for medical uses authorized under § 35.300. The written attestation must be signed by a preceptor authorized user who meets the requirements in §§ 35.390, 35.394, or equivalent Agreement State requirements. A preceptor authorized user, who meets the requirements in § 35.390(b), must also have experience in administering dosages as specified in § 35.390(b)(1)(ii)(G)(2).

34. In § 35.396, the introductory paragraph, paragraphs (a), (b), (c), the introductory text of paragraphs (d)(1) and (d)(2), paragraph (d)(2)(vi), and paragraph (d)(3) are revised to read as follows:

§ 35.396

Training for the parenteral administration of unsealed byproduct material requiring a written directive.

Except as provided in § 35.57, the licensee shall require an authorized user for the parenteral administration requiring a written directive, to be a physician who—

(a) Is an authorized user under § 35.390 for uses listed in §§ 35.390(b)(1)(ii)(G)(3) or 35.390(b)(1)(ii)(G)(4), or equivalent Agreement State requirements; or

(b) Is an authorized user under §§ 35.490, 35.690, or equivalent Agreement State requirements and who meets the requirements in paragraph (d) of this section; or

(c) Is certified by a medical specialty board whose certification process has been recognized by the Commission or an Agreement State under §§ 35.490 or 35.690, and who meets the requirements in paragraph (d) of this section.

(d)(1) Has successfully completed 80 hours of classroom and laboratory training, applicable to parenteral administrations, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. The training must include—

* * * * *

(2) Has work experience, under the supervision of an authorized user who meets the requirements in §§ 35.390, 35.396, or equivalent Agreement State requirements, in the parenteral administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV, and/or parenteral administration of any other radionuclide for which a written directive is required. A supervising authorized user who meets the requirements in § 35.390 must have experience in administering dosages as specified in §§ 35.390(b)(1)(ii)(G)(3) and/or 35.390(b)(1)(ii)(G)(4). The work experience must involve—

* * * * *

(vi) Administering dosages to patients or human research subjects, that include at least 3 cases involving the parenteral administration, for which a written directive is required, of any beta emitter, or any photon-emitting radionuclide with a photon energy less than 150 keV and/or at least 3 cases involving the parenteral administration of any other radionuclide, for which a written directive is required; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraph (b) or (c) of this section, and has achieved a level of competency sufficient to function independently as an authorized user for the parenteral administration of unsealed byproduct material requiring a written directive. The written attestation must be signed by a preceptor authorized user who meets the requirements in §§ 35.390, 35.396, or equivalent Agreement State requirements. A preceptor authorized user, who meets the requirements in § 35.390, must have experience in administering dosages as specified in §§ 35.390(b)(1)(ii)(G)(3) and/or 35.390(b)(1)(ii)(G)(4).

35. In § 35.490, the introductory text of paragraph (b)(1)(ii), and paragraphs (b)(2), and (b)(3) are revised to read as follows:

§ 35.490

Training for use of manual brachytherapy sources.

* * * * *

(b)(1) * * *

(ii) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in § 35.490 or equivalent Agreement State requirements at a medical institution, involving—

* * * * *

(2) Has completed 3 years of supervised clinical experience in radiation oncology, under an authorized user who meets the requirements in § 35.490 or equivalent Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by paragraph (b)(1)(ii) of this section; and

(3) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in § 35.490 or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraphs (a)(1), or (b)(1) and (b)(2) of this section and has achieved a level of competency sufficient to function independently as an authorized user of manual brachytherapy sources for the medical uses authorized under § 35.400.

36. In § 35.491, paragraphs (a) and (b)(3) are revised to read as follows:

§ 35.491

Training for ophthalmic use of strontium-90.

* * * * *

(a) Is an authorized user under § 35.490 or equivalent Agreement State requirements; or

(b) * * *

(3) Has obtained written attestation, signed by a preceptor authorized user who meets the requirements in §§ 35.490, 35.491, or equivalent Agreement State requirements, that the individual has satisfactorily completed the requirements in paragraphs (a) and (b) of this section and has achieved a level of competency sufficient to function independently as an authorized user of strontium-90 for ophthalmic use.

37. In § 35.690, the introductory text of paragraph (b)(1)(ii), and paragraphs (b)(2), and (b)(3) are revised to read as follows:

§ 35.690

Training for use of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units.

* * * * *

(b)(1) * * *

(ii) 500 hours of work experience, under the supervision of an authorized user who meets the requirements in § 35.690 or, equivalent Agreement State requirements at a medical institution, involving—

* * * * *

(2) Has completed 3 years of supervised clinical experience in radiation therapy, under an authorized user who meets the requirements in § 35.690 or equivalent Agreement State requirements, as part of a formal training program approved by the Residency Review Committee for Radiation Oncology of the Accreditation Council for Graduate Medical Education or the Royal College of Physicians and Surgeons of Canada or the Committee on Postdoctoral Training of the American Osteopathic Association. This experience may be obtained concurrently with the supervised work experience required by paragraph (b)(1)(ii) of this section; and

(3) Has obtained written attestation that the individual has satisfactorily completed the requirements in paragraphs (a)(1) or (b)(1) and (b)(2), and (c) of this section, and has achieved a level of competency sufficient to function independently as an authorized user of each type of therapeutic medical unit for which the individual is requesting authorized user status. The written attestation must be signed by a preceptor authorized user who meets the requirements in § 35.690 or equivalent Agreement State requirements for an authorized user for each type of therapeutic medical unit for which the individual is requesting authorized user status; and

* * * * *

Subpart J—[Removed and Reserved]

38. Subpart J is removed and reserved.

PART 40—DOMESTIC LICENSING OF SOURCE MATERIAL

39. The authority citation for part 40 continues to read as follows:

Authority: Secs. 62, 63, 64, 65, 81, 161, 182, 183, 186, 68 Stat. 932, 933, 935, 948, 953, 954, 955, as amended, secs. 11e(2), 83, 84, Pub. L. 95-604, 92 Stat. 3033, as amended, 3039, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2014(e)(2), 2092, 2093, 2094, 2095, 2111, 2113, 2114, 2201, 2232, 2233, 2236, 2282); sec. 274, Pub. L. 86-373, 73 Stat. 688 (42 U.S.C. 2021); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 275, 92 Stat. 3021, as amended by Pub. L. 97-415, 96 Stat. 2067 (42 U.S.C. 2022); sec. 193, 104 Stat. 2835, as amended by Pub. L. 104-134, 110 Stat. 1321, 1321-349 (42 U.S.C. 2243); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).

Section 40.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5851). Section 40.31(g) also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Section 40.46 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 40.71 also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).

40. In § 40.5, paragraph (b)(2)(iii), is revised to read as follows:

§ 40.5

Communications.

* * * * *

(b) * * *

(2) * * *

(iii) Region III. The regional licensing program involves all Federal facilities in the region and non-Federal licensees in the following Region III non-Agreement States: Indiana, Michigan, Minnesota, Missouri, Ohio, and Wisconsin. All mailed or hand-delivered inquiries, communications, and applications for a new license or an amendment, or renewal of an existing license specified in paragraph (b)(1) of this section must use the following address: U.S. Nuclear Regulatory Commission, Region III, Material Licensing Section, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-4352; where e-mail is appropriate it should be addressed to [e-mail].

* * * * *

PART 55—OPERATORS' LICENSES

41. The authority citation for Part 55 continues to read as follows:

Authority: Secs. 107, 161, 182, 68 Stat. 939, 948, 953, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2137, 2201, 2232, 2282); secs. 201, as amended, 202, 88 Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).

Sections 55.41, 55.43, 55.45, and 55.59 also issued under sec. 306, Pub. L. 97-425, 96 Stat. 2262 (42 U.S.C. 10226). Section 55.61 also issued under secs. 186, 187, 68 Stat. 955 (42 U.S.C. 2236, 2237).

42. In § 55.5, paragraph (b)(2)(iii), is revised to read as follows:

§ 55.5

Communications.

* * * * *

(b) * * *

(2) * * *

(iii) If the nuclear power reactor is located in Region III, submissions must be made to the Regional Administrator of Region III. Submissions by mail or hand delivery must be addressed to the Administrator at U.S. Nuclear Regulatory Commission, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-4352; where e-mail is appropriate it should be addressed to [e-mail].

* * * * *

PART 70—DOMESTIC LICENSING OF SPECIAL NUCLEAR MATERIAL

43. The authority citation for part 70 continues to read as follows:

Authority: Secs. 51, 53, 161, 182, 183, 68 Stat. 929, 930, 948, 953, 954, as amended, sec. 234, 83 Stat. 444, as amended, (42 U.S.C. 2071, 2073, 2201, 2232, 2233, 2282, 2297f); secs. 201, as amended, 202, 204, 206, 88 Stat. 1242, as amended, 1244, 1245, 1246 (42 U.S.C. 5841, 5842, 5845, 5846). Sec. 193, 104 Stat. 2835 as amended by Pub. L. 104-134, 110 Stat. 1321, 1321-349 (42 U.S.C. 2243); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).

Sections 70.1(c) and 70.20a(b) also issued under secs. 135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Section 70.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951 (42 U.S.C. 5851). Section 70.21(g) also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Section 70.31 also issued under sec. 57d, Pub. L. 93-377, 88 Stat. 475 (42 U.S.C. 2077). Sections 70.36 and 70.44 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 70.81 also issued under secs. 186, 187, 68 Stat. 955 (42 U.S.C. 2236, 2237). Section 70.82 also issued under sec. 108, 68 Stat. 939, as amended (42 U.S.C. 2138).

44. In § 70.5, paragraph (b)(2)(iii) is revised to read as follows:

§ 70.5

Communications.

* * * * *

(b) * * *

(2) * * *

(iii) Region III. The regional licensing program involves all Federal facilities in the region and non-Federal licensees in the following Region III non-Agreement States: Indiana, Michigan, Minnesota, Missouri, Ohio, and Wisconsin. All mailed or hand-delivered inquiries, communications, and applications for a new license or an amendment, or renewal of an existing license specified in paragraph (b)(1) of this section must use the following address: U.S. Nuclear Regulatory Commission, Region III, Material Licensing Section, 2443 Warrenville Road, Suite 210, Lisle, IL 60532-4352; where e-mail is appropriate it should be addressed to [e-mail].

* * * * *

45. Section 70.14 is revised to read as follows:

§ 70.14

Foreign military aircraft.

The regulations in this part do not apply to persons who carry special nuclear material (other than plutonium) in aircraft of the armed forces of foreign nations subject to 49 U.S.C. 40103(d).

PART 73—PHYSICAL PROTECTION OF PLANTS AND MATERIALS

46. The authority citation for part 73 continues to read as follows:

Authority: Secs. 53, 161, 68 Stat. 930, 948, as amended, sec. 147, 94 Stat. 780 (42 U.S.C. 2073, 2167, 2201); sec. 201, as amended, 204, 88 Stat. 1242, as amended, 1245, sec. 1701, 106 Stat. 2951, 2952, 2953 (42 U.S.C. 5841, 5844, 2297f); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note). Section 73.1 also issued under secs. 135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C, 10155, 10161). Section 73.37(f) also issued under sec. 301, Pub. L. 96-295, 94 Stat. 789 (42 U.S.C. 5841 note). Section 73.57 is issued under sec. 606, Pub. L. 99-399, 100 Stat. 876 (42 U.S.C. 2169).

47. In the Table, second column, in the table entitled “Classified Mailing Addresses” the address for Region III is revised to read as follows:

Appendix A to Part 73—U.S. Nuclear Regulatory Commission Offices and Classified Mailing Addresses

* * * * *

USNRC, Region III, 2443 Warrenville, Road, Suite 210, Lisle, IL 60532-4352.

* * * * *

CLASSIFIED MAILING ADDRESSES

* * * * *

USNRC, Region III, 2443 Warrenville, Road, Suite 210, Lisle, IL 60532-4352.

* * * * *

PART 110—EXPORT AND IMPORT OF NUCLEAR EQUIPMENT AND MATERIAL

48. The authority citation for part 110 continues to read as follows:

Authority: Secs. 51, 53, 54, 57, 63, 64, 65, 81, 82, 103, 104, 109, 111, 126, 127, 128, 129, 161, 181, 182, 183, 187, 189, 68 Stat. 929, 930, 931, 932, 933, 936, 937, 948, 953, 954, 955, 956, as amended (42 U.S.C. 2071, 2073, 2074, 2077, 2092-2095, 2111, 2112, 2133, 2134, 2139, 2139a, 2141, 2154-2158, 2201, 2231-2233, 2237, 2239); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841; sec. 5, Pub. L. 101-575, 104 Stat 2835 (42 U.S.C. 2243); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).

Sections 110.1(b)(2) and 110.1(b)(3) also issued under Pub. L. 96-92, 93 Stat. 710 (22 U.S.C. 2403). Section 110.11 also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152) and secs. 54c and 57d., 88 Stat. 473, 475 (42 U.S.C. 2074). Section 110.27 also issued under sec. 309(a), Pub. L. 99-440. Section 110.50(b)(3) also issued under sec. 123, 92 Stat. 142 (42 U.S.C. 2153). Section 110.51 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 110.52 also issued under sec. 186, 68 Stat. 955 (42 U.S.C. 2236). Sections 110.80-110.113 also issued under 5 U.S.C. 552, 554. Sections 110.130-110.135 also issued under 5 U.S.C. 553. Sections 110.2 and 110.42 (a)(9) also issued under sec. 903, Pub. L. 102-496 (42 U.S.C. 2151 et seq.).

§ 110.40

[Amended]

49. In § 110.40, paragraph (b)(7)(v) is amended by removing “1,000 curies of tritium” and adding in its place “37 TBq (1,000 curies) of tritium.”

PART 140—FINANCIAL PROTECTION REQUIREMENTS AND INDEMNITY AGREEMENTS

50. The authority citation for Part 140 continues to read as follows:

Authority: Secs. 161, 170, 68 Stat. 948, 71 Stat. 576 as amended (42 U.S.C. 2201, 2210); secs. 201, as amended, 202, 88 Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); Pub. L. 109-58.

51. In § 140.21, the introductory paragraph is revised to read as follows:

§ 140.21

Licensee guarantees of payment of deferred premiums.

Each licensee required to have and maintain financial protection for each nuclear reactor as determined in § 140.11(a)(4) shall at the issuance of the license and annually, on the anniversary of the date on which the indemnity agreement is effective, provide evidence to the Commission that it maintains one of the following types of guarantee of payment of deferred premium in an amount of $15 million for each reactor he is licensed to operate:

* * * * *

Dated at Rockville, Maryland, this 20th day of March, 2006.

For the Nuclear Regulatory Commission.

Michael T. Lesar,

Chief, Rules and Directives Branch, Division of Administrative Services, Office of Administration.