Unknown. Final rule

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A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

--- schema: federal-register doc_type: fedreg source_file: FR-2007-08-13.xml --- 72 155 Monday, August 13, 2007 Contents Administration Administration on Aging See Aging Administration Aging Aging Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 45249 E7-15820 Agriculture Agriculture Department See Animal and Plant Health Inspection Service See Forest Service Alcohol Alcohol, Tobacco, Firearms, and Explosives Bureau NOTICES Agency information collection activities; proposals, submissions, and approvals, 45270 E7-15730 Animal Animal and Plant Health Inspection Service PROPOSED RULES Exportation and importation of animals and animal products:

Table eggs from regions where exotic Newcastle disease exists, 45177-45181 E7-15815 NOTICES Agency information collection activities; proposals, submissions, and approvals, 45215-45216 E7-15804 Committees; establishment, renewal, termination, etc.: Foreign Animal and Poultry Diseases, Secretary's Advisory Committee, 45216 E7-15819 Pest risk assessments: Lemons from— Argentina, 45216-45217 E7-15816 Architectural Architectural and Transportation Barriers Compliance Board PROPOSED RULES Americans with Disabilities Act; implementation:

Accessibility guidelines— Passenger Vessel Emergency Alarms Advisory Committee; establishment, membership, and meeting, 45200 07-3934 Bonneville Bonneville Power Administration NOTICES Reports and guidance documents; availability, etc.: Pacific Northwest; long-term regional dialogue policy, 45238-45239 E7-15770 Centers Centers for Medicare & Medicaid Services PROPOSED RULES Medicaid: Rehabilitative services coverage, 45201-45213 07-3925 Coast Guard Coast Guard RULES Ports and waterways safety; regulated navigation areas, safety zones, security zones, etc.:

Lake Michigan, Petoskey, MI, 45160-45162 E7-15826 Tampa Bay, Rattlesnake, Big Bend, FL, 45162-45165 E7-15827 Commerce Commerce Department See Foreign-Trade Zones Board See International Trade Administration See National Oceanic and Atmospheric Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, E7-15786 45218-45219 E7-15788 Commodity Commodity Futures Trading Commission PROPOSED RULES Commodity Exchange Act: Registered entities and exempt commercial markets, 45185-45191 E7-15370 NOTICES Privacy Act; systems of records, 45225-45228 E7-15801 Defense Defense Department See Navy Department NOTICES Federal Acquisition Regulation (FAR):

Agency information collection activities; proposals, submissions, and approvals, 45228 07-3938 Privacy Act; systems of records, 45228-45235 E7-15771 E7-15773 E7-15774 E7-15775 E7-15776 E7-15777 Education Education Department NOTICES Agency information collection activities; proposals, submissions, and approvals, 45237 E7-15752 Postsecondary education: Federal Family Education Loan Program— Cohort default rate data for institutions located outside U.S.; electronic delivery, 45237-45238 E7-15806 Employment Employment and Training Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 45271-45272 E7-15731 Energy Energy Department See Bonneville Power Administration See Federal Energy Regulatory Commission NOTICES Committees; establishment, renewal, termination, etc.:

Fusion Energy Sciences Advisory Committee, 45238 E7-15772 EPA Environmental Protection Agency RULES Air quality implementation plans; approval and promulgation; various States; air quality planning purposes; designation of areas: Ohio, 45169-45172 E7-15604 Air quality implementation plans; approval and promulgation; various States: Virginia, 45165-45169 E7-15587 PROPOSED RULES Air quality implementation plans; approval and promulgation; various States: Virginia, 45200-45201 E7-15585 NOTICES Committees; establishment, renewal, termination, etc.:

Environmental Laboratory Advisory Board, 45243-45244 E7-15785 Meetings: Nanoscale materials; material characterization; scientific peer consultation, 45244-45246 E7-15780 Equal Equal Employment Opportunity Commission NOTICES Meetings; Sunshine Act, 45246 07-3950 FAA Federal Aviation Administration RULES Airworthiness directives: Boeing, 45151-45153 E7-15582 Taylorcraft, 45153-45156 E7-15581 Restricted areas, 45156-45157 E7-15747 PROPOSED RULES Airworthiness directives: Alpha Aviation Design Ltd., 45183-45185 E7-15794 NOTICES Aeronautical land-use assurance; waivers:

Leesburg Executive Airport; VA, 45293-45294 07-3919 Airport noise compatibility program: Noise exposure maps— Ronald Reagan Washington National Airport, VA, 45294-45295 07-3920 Federal Energy Federal Energy Regulatory Commission NOTICES Environmental statements; notice of intent: Golden Triangle Storage, Inc., 45239-45241 E7-15800 Hydroelectric applications, 45241-45243 E7-15797 E7-15798 Meetings: New York Independent System Operator, Inc; technical conference, 45243 E7-15796 *Applications, hearings, determinations, etc.:* East Tennessee Natural Gas, LLC, 45239 E7-15799 Egan Hub Storage, LLC, 45239 E7-15795 Federal Highway Federal Highway Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 45295 E7-15824 Federal Railroad Federal Railroad Administration NOTICES Exemption petitions, etc.:

Union Pacific Railroad Co., 45296-45297 E7-15738 E7-15760 Railroad safety program plans: Union Pacific Railroad Co., 45297 E7-15779 Federal Reserve Federal Reserve System NOTICES Banks and bank holding companies: Formations, acquisitions, and mergers, 45246-45247 E7-15697 E7-15737 Federal Transit Federal Transit Administration NOTICES Grants and cooperative agreements; availability, etc.: Environmental Management Systems training and assistance for State and local transit agencies, 45297-45298 E7-15754 Fish Fish and Wildlife Service NOTICES Reports and guidance documents; availability, etc.:

Endangered Species of Wild Fauna and Flora International Trade Convention; Appendices I and II; amendments, 45260-45264 E7-15828 Food Food and Drug Administration RULES Animal drugs, feeds, and related products: Ampicillin sodium, 45158-45159 E7-15761 Formalin, 45157-45158 E7-15763 NOTICES Agency information collection activities; proposals, submissions, and approvals, 45249-45250 E7-15740 Meetings: Harmonization International Conference— Yokohama, Japan; preparation, 45250 E7-15803 International Conference on Cosmetics Regulations— Brussels, Belgium; preparation, 45250-45251 07-3954 Foreign Foreign-Trade Zones Board NOTICES *Applications, hearings, determinations, etc.:* Louisiana M-I L.L.C.; barite grinding and milling facilities, 45219 E7-15808 Pennsylvania Souriau USA; aerospace, industrial, and R/F connectors manufacturing facility, 45221 07-3940 South Carolina Kittel Supplier USA, Inc.; automotive door trim components assembly plants, 45219-45220 E7-15813 Texas M-I L.L.C.; barite grinding and milling facilities, 45220-45221 E7-15807 Motorola Inc.; mobile phone kitting sites, 45221 E7-15811 Samsung Austin Semiconductor L.LC.; semiconductor manufacturing facilities, 45220 E7-15809 Forest Forest Service NOTICES Environmental statements; notice of intent:

Gallatin National Forest, MT, 45217-45218 07-3922 Meetings: Resource Advisory Committees— Crook County, 45218 07-3939 Davy Crocket National Forest, 45218 07-3936 GSA General Services Administration NOTICES Federal Acquisition Regulation (FAR): Agency information collection activities; proposals, submissions, and approvals, 45228 07-3938 Health Health and Human Services Department See Aging Administration See Centers for Medicare & Medicaid Services See Food and Drug Administration See National Institutes of Health See Substance Abuse and Mental Health Services Administration NOTICES Meetings:

American Health Information Community, 45247-45249 07-3927 07-3928 07-3929 07-3930 07-3931 07-3932 07-3933 Homeland Homeland Security Department See Coast Guard NOTICES Meetings: Homeland Security Science and Technology Advisory Committee, 45255 E7-15821 Reports and guidance documents; availability, etc.: Privacy impact assessments; web publication, 45255-45257 E7-15817 Housing Housing and Urban Development Department NOTICES Mortgage and loan insurance programs: Credit Watch Termination Initiative; mortgagees whose Origination Approval Agreements have been terminated; list, 45257-45258 E7-15745 Mortgagee Review Board; administrative actions, 45258-45260 E7-15742 Interior Interior Department See Fish and Wildlife Service See Minerals Management Service See National Park Service PROPOSED RULES Native American Graves Protection and Repatriation Review Act; implementation:

Unclaimed human remains, funerary objects, sacred objects, or objects of cultural patrimony; disposition; consultation and dialogue, 45213-45214 E7-15823 IRS Internal Revenue Service RULES Income taxes: Foreign corporations; gross income exclusions Correction, E7-15271 45159-45160 E7-15272 PROPOSED RULES Income taxes: Foreign corporations; gross income exclusions; cross-reference; hearing Correction, 45199-45200 E7-15273 NOTICES Meetings: Taxpayer Advocacy Panels, 45303-45304 E7-15751 E7-15755 International International Trade Administration NOTICES Antidumping:

Forged stainless steel flanges from— India, 45221-45223 E7-15810 Stainless steel bar from— Italy, 45223-45224 E7-15805 Meetings: President's Export Council, 45224 07-3946 Justice Justice Department See Alcohol, Tobacco, Firearms, and Explosives Bureau See Justice Programs Office NOTICES Privacy Act; systems of records, 45269-45270 E7-15729 Justice Justice Programs Office NOTICES Agency information collection activities; proposals, submissions, and approvals, 45270-45271 E7-15728 Labor Labor Department See Employment and Training Administration Maritime Maritime Administration NOTICES Voluntary Intermodal Sealift Agreement, 45298-45300 E7-15825 Minerals Minerals Management Service NOTICES Agency information collection activities; proposals, submissions, and approvals, 45264-45268 E7-15783 NASA National Aeronautics and Space Administration NOTICES Federal Acquisition Regulation (FAR):

Agency information collection activities; proposals, submissions, and approvals, 45228 07-3938 National Highway National Highway Traffic Safety Administration RULES Consumer information: New Car Assessment Program; safety labeling; response to reconsideration petitions, 45172-45176 E7-15743 NOTICES Agency information collection activities; proposals, submissions, and approvals, 45300-45301 E7-15739 NIH National Institutes of Health NOTICES Agency information collection activities; proposals, submissions, and approvals, 45251-45252 E7-15750 Inventions, Government-owned; availability for licensing, 45252-45253 E7-15749 Meetings:

Clinical Center, 45253-45254 07-3923 National Institute on Alcohol Abuse and Alcoholism, 45254 07-3924 NOAA National Oceanic and Atmospheric Administration NOTICES Agency information collection activities; proposals, submissions, and approvals; correction, 45224-45225 E7-15787 E7-15789 Meetings: National Sea Grant Review Panel, 45225 E7-15812 National Park National Park Service NOTICES National Register of Historic Places; pending nominations, 45268-45269 E7-15748 Native American human remains, funerary objects; inventory, repatriation, etc.:

Bishop Museum, Honolulu, HI, 45269 E7-15822 Navy Navy Department NOTICES Privacy Act; systems of records, 45235-45237 E7-15778 Nuclear Nuclear Regulatory Commission RULES Byproduct material; medical use: Corrections and clarifications, 45147-45151 07-3976 PROPOSED RULES Byproduct material; medical use: Corrections and clarifications, 45181-45183 E7-15762 NOTICES *Applications, hearings, determinations, etc.:* Duke Power Co. LLC, 45272-45276 E7-15766 E7-15767 Nuclear Nuclear Waste Technical Review Board NOTICES Meetings:

Yucca Mountain, NV— Repository development; technical and scientific issues, 45276-45277 07-3937 Personnel Personnel Management Office RULES Preference eligibles claims submission; representative recognition; CFR part removed, 45147 E7-15662 NOTICES Excepted service; positions placed or revoked, 45277-45279 E7-15802 Pipeline Pipeline and Hazardous Materials Safety Administration NOTICES Agency information collection activities; proposals, submissions, and approvals, 45301-45302 07-3941 Hazardous materials transportation:

Radioactive material; safe transport; International Atomic Energy Agency regulations; issues or problems, 45302-45303 E7-15741 SEC Securities and Exchange Commission NOTICES Agency information collection activities; proposals, submissions, and approvals, 45279-45282 E7-15722 E7-15733 E7-15735 E7-15736 E7-15764 Self-regulatory organizations; proposed rule changes: American Stock Exchange LLC, 45282-45283 E7-15725 Chicago Board Options Exchange, Inc., 45283-45284 E7-15756 Financial Industry Regulatory Authority, Inc, 45284-45287 E7-15723 International Securities Exchange, LLC, 45287-45288 E7-15758 NASDAQ Stock Market LLC, 45288-45290 E7-15757 New York Stock Exchange LLC, 45290-45293 E7-15724 SBA Small Business Administration NOTICES Disaster loan areas:

North Dakota, 45293 E7-15768 Oklahoma, 45293 E7-15769 Social Social Security Administration PROPOSED RULES Ticket to Work Self-Sufficiency Program; improvements, 45191-45199 E7-15715 Substance Substance Abuse and Mental Health Services Administration NOTICES Meetings: Mental Health Services Center National Advisory Council, 45254 E7-15791 Substance Abuse Prevention Center National Advisory Council, 45254-45255 E7-15792 Surface Surface Transportation Board NOTICES Railroad operation, acquisition, construction, etc.:

Peoria, IL, 45303 E7-15732 Transportation Transportation Department See Federal Aviation Administration See Federal Highway Administration See Federal Railroad Administration See Federal Transit Administration See Maritime Administration See National Highway Traffic Safety Administration See Pipeline and Hazardous Materials Safety Administration See Surface Transportation Board Treasury Treasury Department See Internal Revenue Service Reader Aids Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.

To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.gpo.gov and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions. 72 155 Monday, August 13, 2007 Rules and Regulations OFFICE OF PERSONNEL MANAGEMENT 5 CFR Part 990 RIN 3206-AJ97 General and Miscellaneous AGENCY: Office of Personnel Management. ACTION: Final rule. SUMMARY: The Office of Personnel Management

(OPM)is issuing final regulations to remove its regulation concerning the submission of claims by preference eligibles to OPM and the recognition of representatives by OPM. The purpose of this revision to part 990 is to eliminate the part because it is obsolete. OPM no longer adjudicates claims or appeals under sections 3502, 3503, or 7701 of title 5, United States Code. That appellate function was vested in the Merit Systems Protection Board, created by the Civil Service Reform Act of 1978. Accordingly, there is no basis to retain the provisions of part 990 in the Code of Federal Regulations. DATES: *Effective Date:* August 13, 2007. FOR FURTHER INFORMATION CONTACT: Hakeem Basheerud-Deen at

(202)606-1434, Fax:

(202)606-2329, TTY:

(202)418-3134, or e-mail: *hakeem.basheerud-deen@opm.gov.* SUPPLEMENTARY INFORMATION: On May 27, 2003, OPM issued proposed regulations at **Federal Register** 68 FR 28806 to remove and reserve part 990 from the Code of Federal Regulations. No comments were received and the proposed rule is adopted as a final rule without change. Regulatory Flexibility Act I certify that this regulation will not have a significant economic impact on a substantial number of small entities because it affects only certain Federal employees. Executive Order 12866, Regulatory Review This rule has been reviewed by the Office of Management and Budget in accordance with Executive Order 12866. List of Subjects in 5 CFR Part 990 Administrative practice and procedure, Claims, Government employees, Veterans. U.S. Office of Personnel Management. Linda M. Springer, Director. Under the authority of 5 CFR chapter I, OPM is removing and reserving 5 CFR part 990 as follows: PART 990—[REMOVED AND RESERVED] 1. Part 990 is removed and reserved. [FR Doc. E7-15662 Filed 8-10-07; 8:45 am] BILLING CODE 6325-39-P NUCLEAR REGULATORY COMMISSION 10 CFR Parts 32 and 35 RIN 3150-AI14 Medical Use of Byproduct Material—Minor Corrections and Clarifications AGENCY: Nuclear Regulatory Commission. ACTION: Direct final rule. SUMMARY: The Nuclear Regulatory Commission

(NRC)is amending its regulations to correct or clarify the rule language in several sections in the regulations that govern specific domestic licenses to manufacture or transfer certain items containing byproduct material and medical use of byproduct material. The regulations that govern medical use of byproduct materials were amended in their entirety on April 24, 2002 (67 FR 20249). Subsequently, these regulations were amended again to revise the training and experience requirements for the medical use of byproduct material on March 30, 2005 (70 FR 16336). Through implementation of these revised regulations, the NRC has identified additional changes that need to be made to these regulations. This action is necessary to clarify certain provisions and to make certain conforming changes to the regulations. DATES: The final rule is effective on October 29, 2007, unless significant adverse comments are received by September 12, 2007. A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. If the rule is withdrawn due to significant adverse comments, timely notice will be provided in the **Federal Register** . ADDRESSES: You may submit comments by any one of the following methods. Please include the following number (RIN 3150-AI14) in the subject line of your comments. Comments on rulemakings submitted in writing or in electronic form will be made available to the public in their entirety on the NRC rulemaking Web site. Personal information, such as name, address, phone, e-mail address, etc., will not be removed from your submission. *Mail comments to:* Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff. *E-mail comments to:* *SECY@nrc.gov.* If you do not receive a reply e-mail confirming that we have received your comments, contact us directly at

(301)415-1966. You may also submit comments via the NRC's rulemaking Web site at *http://ruleforum.llnl.gov.* Address questions about our rulemaking Web site to Carol Gallagher

(301)415-5905; e-mail *cag@nrc.gov.* Comments can also be submitted via the Federal eRulemaking Portal *http://www.regulations.gov.* *Hand deliver comments to:* 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4:15 p.m. Federal workdays. (Telephone

(301)415-1966.) Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at

(301)415-1101. Publicly available documents related to this rulemaking may be viewed electronically on the public computers located at the NRC's Public Document Room (PDR), O1 F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. The PDR reproduction contractor will copy documents for a fee. Selected documents, including comments, may be viewed and downloaded electronically via the NRC rulemaking Web site at *http://ruleforum.llnl.gov.* Publicly available documents created or received at the NRC after November 1, 1999, are available electronically at the NRC's Electronic Reading Room at *http://www.nrc.gov/reading-rm/adams.html.* From this site, the public can gain entry into the NRC's Agencywide Document Access and Management System (ADAMS), which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC Public Document Room

(PDR)Reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to *pdr@nrc.gov.* FOR FURTHER INFORMATION CONTACT: Edward M. Lohr, Office of Federal and State Materials and Environmental Management Programs, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone

(301)415-0253, e-mail *eml1@nrc.gov.* SUPPLEMENTARY INFORMATION: Background The purpose of these amendments is to amend 10 CFR Parts 32 and 35 to clarify and make certain conforming changes related to the NRC's requirements for the medical use of byproduct material. Discussion This direct final rule revises several sections in 10 CFR Parts 32 and 35 to correct or clarify rule language. It also includes conformatory changes that should have been incorporated in the regulations but were inadvertently left out. The changes and clarifications are minor in nature and noncontroversial. The following changes are being made to the regulations: Section by Section Analysis 1. Section 32.72 Manufacture, Preparation, or Transfer for Commercial Distribution of Radioactive Drugs Containing Byproduct Material for Medical Use Under Part 35 During the rulemaking completed in 2005, conforming changes to § 32.72, to reflect the changes made in § 35.55, were inadvertently omitted. The 2005 revision of the training and experience requirements for an authorized nuclear pharmacist

(ANP)in § 35.55 removed the requirement for a preceptor statement as a condition for recognition of a specialty board's certification process. Instead, an individual seeking ANP status on an NRC license must provide a preceptor statement, in addition to documentation of the board certification. This amendment makes the necessary conforming changes to § 32.72. Additionally, certification by the Board of Pharmaceutical Specialties is removed from § 32.72 because specialty boards recognized by the Commission or Agreement States are posted on the NRC's web page and are no longer listed in NRC regulations. 2. Section 32.74 Manufacture and Distribution of Sources or Devices Containing Byproduct Material for Medical Use Section 32.74(a) states that an application will be approved for a specific license to manufacture and distribute sources and devices containing byproduct material to persons licensed under Part 35 of this chapter for use as a calibration or reference source or for the uses listed in §§ 35.400, 35.500, and 35.600 if certain conditions are met. When Part 35 was amended on April 24, 2002 (67 FR 20249), a new section, § 35.1000, “Other medical uses of byproduct material or radiation from byproduct material,” was added to address radiation safety issues associated with new modalities. A conforming change should have been made in § 32.74(a) to reference § 35.1000, but was inadvertently left out. This change amends this section by adding § 35.1000 after §§ 35.400, 35.500, 35.600. 3. Section 35.2 Definitions The definitions in this section include both *medium-dose rate remote afterloader* and *high-dose rate remote afterloader.* The medium-dose rate remote afterloader is defined as a device that remotely delivers a dose rate of greater than 2 gray (200 rads), but less than 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed. The high-dose rate remote afterloader is defined as delivering a dose rate in excess of 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed. The dose rate of equal to 12 gray (1200 rads) per hour was inadvertently excluded. This section is being amended to revise the definition of *medium dose-rate remote afterloader* to include “equal to” 12 gray. In addition, for clarification, the phrase “per hour” will be added after the phrase “delivers a dose rate of greater than 2 gray (200 rads)” to read as “delivers a dose rate of greater than 2 gray (200 rads) per hour.” 4. Section 35.41 Procedures for Administrations Requiring a Written Directive Section 35.41(b)(4) requires a licensee to have procedures verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by § 35.600. When Part 35 was amended on April 24, 2002 (67 FR 20249), a new section, § 35.1000, “Other medical uses of byproduct material or radiation from byproduct material,” was added to address radiation safety issues associated with new modalities. A conforming change should have been made in § 35.41(b)(4) to reference § 35.1000, but was inadvertently left out. This changes this section by adding § 35.1000 after § 35.600. 5. Section 35.75 Release of Individuals Containing Unsealed Byproduct Material or Implants Containing Byproduct Material In § 35.75(a), the footnote states that NUREG-1556, Vol. 9, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Licenses,” describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 mSv (0.5 rem). NUREG-1556, Vol. 9, is not the current version of this NUREG. The current version, “Revision 1,” is expected to be revised. Thus, the footnote is revised to add the phrase “The current version of” before the phrase “NUREG-1556, Vol. 9.” 6. Section 35.92 Decay-in-Storage This section permits decay-in-storage by medical use licensees for radionuclides with half-lives of less than 120 days. This section inadvertently excluded radionuclides with half-lives equal to 120 days. This change revises this section to include “equal to” 120 days. 7. Section 35.190 Training for Uptake, Dilution, and Excretion Studies Section 35.190(a)(1) provides that in order for a specialty board's certification process to be recognized, the board must require all candidates for certification to complete 60 hours of training and experience “that includes the topics listed in paragraphs (c)(1)(i) and (c)(1)(ii) of this section.” The intent of the regulation is that candidates must obtain their work experience involving the topics listed in (c)(1)(ii) under the supervision of a specified authorized user. The change of the phrase to “as described in paragraphs (c)(1)(i) through (c)(1)(ii)(F) of this section,” clarifies that all of the requirements in § 35.190(c)(1)(ii), including that candidates must obtain their work experience under the supervision of a specified authorized user, are also applicable to the board certification pathway. 8. Section 35.290 Training for Imaging and Localization Studies Section 35.290(a)(1) provides that in order for a specialty board's certification process to be recognized, the board must require all candidates for certification to complete 700 hours of training and experience “that includes the topics listed in paragraphs (c)(1)(i) and (c)(1)(ii) of this section.” The intent of the regulation is that candidates must obtain their work experience involving the topics listed in (c)(1)(ii) under the supervision of a specified authorized user. The change of the phrase to “as described in paragraphs (c)(1)(i) through (c)(1)(ii)(G) of this section,” clarifies that all of the requirements in § 35.290(c)(1)(ii), including that candidates must obtain their work experience under the supervision of a specified authorized user, are also applicable to the board certification pathway. Procedural Background This rulemaking will become effective on October 29, 2007. However, if the NRC receives significant adverse comments by September 12, 2007, then the NRC will publish a document that withdraws the direct final rule and will address the comments received in a final rule as a response to the companion proposed rule published elsewhere in this issue of the **Federal Register** . Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period on this action. A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, including challenges to the rule's underlying premise or approach, or would be ineffective or unacceptable without a change. A comment is adverse and significant if:

(1)The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when:

(a)The comment causes the NRC staff to reevaluate (or reconsider) its position or conduct additional analysis;

(b)The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or

(c)The comment raises a relevant issue that was not previously addressed or considered by the NRC staff.

(2)The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition.

(3)The comment causes the staff to make a change (other than editorial) to the rule. Voluntary Consensus Standards The National Technology Transfer Act of 1995 (Pub. L. 104-113) requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this final rule, the NRC corrects and clarifies the rule language in several sections in 10 CFR Parts 32 and 35. This action does not constitute the establishment of a standard that contains generally applicable requirements. Issues of Compatibility for Agreement States Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” approved by the Commission on June 30, 1997 (62 FR 46517), specific requirements within this rule should be adopted by Agreement States for purposes of compatibility or because of health and safety significance. Implementing procedures for the Policy Statement establish specific categories which have been applied to categorize the requirements in Parts 32 and 35. A Compatibility Category “A” designation means the requirement is a basic radiation protection standard or deals with related definitions, signs, labels, or terms necessary for a common understanding of radiation protection principles. Compatibility Category “A” designated Agreement State requirements should be essentially identical to those of the NRC. A Compatibility Category “B” designation means the requirement has significant transboundary implications. Compatibility Category “B” designated Agreement State requirements should be essentially identical to those of the NRC. A Compatibility Category “C” designation means the essential objectives of the requirement should be adopted by the State to avoid conflicts, duplications, or gaps. The manner in which the essential objectives are addressed in the Agreement State requirement need not be the same as NRC provided the essential objectives are met. A Compatibility Category “D” designation means the requirement does not have to be adopted by an Agreement State for purposes of compatibility. The Compatibility Category Health and Safety (H&S) identifies requirements that are not required for compatibility, but which have particular health and safety significance. Agreement States should adopt the essential objectives of such requirements in order to maintain an adequate program. Summary of NRC Rules With Compatibility or Health and Safety Designations Under the Direct Final Rule Covering 10 CFR Parts 32 and 35 Section and paragraph Section title Category B § 32.72(b)(5) Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under Part 35. § 32.74(a) Manufacture and distribution of sources or devices containing byproduct material for medical use. § 35.190 Training for uptake, dilution, and excretion studies. § 35.290 Training for imaging and localization studies. Category C § 35.75(a) Release of individuals containing unsealed byproduct material or implants containing byproduct material. Category D § 35.2 Definitions—Medium dose-rate remote afterloader. § 35.41(b)(4) Procedures for administrations requiring a written directive. Category H&S § 35.92 Decay-in-storage is an “H&S” for States authorizing this activity and “D” for States that do not authorize this activity. Plain Language The Presidential Memorandum dated June 1, 1998, entitled, “Plain Language in Government Writing” directed that the Government's writing be in plain language. The NRC requests comments on this direct final rule specifically with respect to the clarity and effectiveness of the language used. Comments should be sent to the address listed under the heading ADDRESSES above. Environmental Impact: Categorical Exclusion The NRC has determined that this final rule is the type of action described in the categorical exclusion at 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 direct 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 3150-0001 and 3150-0010. Public Protection Notification The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number. Regulatory Analysis A regulatory analysis has not been prepared for this direct final rule because this rule is considered a minor nonsubstantive amendment and it has no economic impact on NRC licensees or the public. Regulatory Flexibility Certification Under the Regulatory Flexibility Act of 1980 (5 U.S.C. 605(b)), the Commission certifies that this rule does not have a significant economic impact on a substantial number of small entities. This rule merely corrects or clarifies the rule language in several sections in 10 CFR parts 32 and 35. Backfit Analysis The NRC has determined that the backfit rule (§§ 50.109, 70.76, 72.62, or 76.76) does not apply to this final rule and therefore, a backfit analysis is not required because these amendments do not involve any provisions that would impose backfits as defined in 10 CFR Chapter I. Congressional Review Act Under the Congressional Review 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 of OMB. List of Subjects 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. For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR parts 32 and 35. PART 32—SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL 1. 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), Energy Policy Act of 2005, Pub. L. 109-58, 119 Stat. 594 (2005). 2. In § 32.72, paragraph (b)(5) 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)* * *

(5)Shall provide to the Commission a copy of each individual's: (i)(A) Certification by a specialty board whose certification process has been recognized by the Commission or an Agreement State as specified in § 35.55(a) of this chapter with the written attestation signed by a preceptor as required by § 35.55(b)(2) of this chapter; or

(B)The Commission or Agreement State license; or

(C)The permit issued by a licensee of broad scope; and

(ii)State pharmacy licensure or registration, no later than 30 days after the date that the licensee allows, under paragraphs (b)(2)(i) and (b)(2)(iii) of this section, the individual to work as an authorized nuclear pharmacist. 3. 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 under part 35 of this chapter for use as a calibration, transmission, or reference source or for the uses listed in §§ 35.400, 35.500, 35.600, and 35.1000 of this chapter will be approved if: PART 35—MEDICAL USE OF BYPRODUCT MATERIAL 4. 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). 5. In § 35.2, the definition of *Medium dose-rate remote afterloader* is revised to read as follows: § 35.2 Definitions. *Medium dose-rate remote afterloader,* as used in this part, means a brachytherapy device that remotely delivers a dose rate of greater than 2 gray (200 rads) per hour, but less than or equal to 12 gray (1200 rads) per hour at the point or surface where the dose is prescribed. 6. In § 35.41, paragraph (b)(4) is revised to read as follows: § 35.41 Procedures for administrations requiring a written directive.

(b)* * *

(4)Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by §§ 35.600 or 35.1000. 7. In § 35.75, the text of paragraph

(a)is republished and footnote 1 is revised to read as follows: § 35.75 Release of individuals containing unsealed byproduct material or implants containing byproduct material.

(a)A licensee may authorize the release from its control of any individual who has been administered unsealed byproduct material or implants containing byproduct material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 mSv (0.5 rem). 1 1 The current revision of NUREG-1556, Vol. 9, “Consolidated Guidance About Materials Licenses: Program-Specific Guidance About Medical Licenses” describes methods for calculating doses to other individuals and contains tables of activities not likely to cause doses exceeding 5 mSv (0.5 rem). 8. In § 35.92, the introductory text of paragraph

(a)is revised to read as follows: § 35.92 Decay-in-storage.

(a)A licensee may hold byproduct material with a physical half-life of less than or equal to 120 days for decay-in-storage before disposal without regard to its radioactivity if it— 9. In § 35.190, paragraph (a)(1) is revised to read as follows: § 35.190 Training for uptake, dilution, and excretion studies.

(a)* * *

(1)Complete 60 hours of training and experience in basic radionuclide handling techniques and radiation safety applicable to the medical use of unsealed byproduct material for uptake, dilution, and excretion studies as described in paragraphs (c)(1)(i) through (c)(1)(ii)(F) of this section; and 10. In § 35.290, paragraph (a)(1) is 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 as described in paragraphs (c)(1)(i) through (c)(1)(ii)(G) of this section; and Dated at Rockville, Maryland, this 31st day of July, 2007. For the Nuclear Regulatory Commission. Martin J. Virgilio, Acting Executive Director for Operations. [FR Doc. 07-3976 Filed 8-10-07; 8:45 am]

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