Medical Use of Byproduct Material-Minor Corrections and Clarifications, 45181-45183 [E7-15762]

Download as PDF Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Proposed Rules (viii) Before leaving the premises of origin, the cases in which the eggs were packed were sealed with a seal of the national government of the region of origin by the salaried veterinarian of the national government of the region of origin who signed the certificate or, if exported from Mexico, by the veterinarian accredited by the national government of Mexico who signed the certificate. (ix) In addition, if the eggs were laid in any region where END is considered to exist (see paragraph (a) of this section), the certificate must also state: * * * * * (C) The eggs are from a flock of origin found free of END as follows: On the seventh and fourteenth days of the 21day period before the certificate is signed, at least 1 cull (sick or dead) bird for each 10,000 live birds occupying each poultry house certified for exporting table eggs was tested for END virus using a virus isolation test. The weekly cull rate of birds of every exporting poultry house within the exporting farm does not exceed 0.1 percent. The tests present no clinical or immunological evidence of END by either embryonated egg inoculation technique from tissues of dead birds or negative hemagglutination inhibition tests conducted on blood samples of sick birds collected by a salaried veterinary officer of the national government of the region of origin, or by an accredited veterinarian. All examinations and virus isolation tests were conducted in a laboratory located in the region of origin, and the laboratory was approved to conduct the examinations and tests by the veterinary services organization of the national government of that region. All results were negative for END. (D) The certificate must state that egg drop syndrome is notifiable in the region of origin and there have been no reports of egg drop syndrome in the flocks of origin of the eggs, or within a 50 kilometer radius of the flock of origin, for the 90 days prior to the issuance of the certificate. * * * * * sroberts on PROD1PC70 with PROPOSALS §§ 94.8 and 94.9 [Amended] 5. In §§ 94.8 and 94.9, footnotes 8 through 11 are redesignated as footnotes 7 through 10, respectively. 6. Section 94.12 is amended as follows: a. In paragraph (b)(1)(iii)(B), by redesignating footnote 12 as footnote 11. b. In paragraph (b)(3), by redesignating footnote 13 as footnote 12 and revising newly redesignated footnote 12 to read as set forth below. VerDate Aug<31>2005 17:02 Aug 10, 2007 Jkt 211001 § 94.12 Pork and pork products from regions where swine vesicular disease exists. * * * (b) * * * (3) * * * 12 12 See § 94.16 * * footnote 9 in § 94.9. [Amended] 7. In § 94.16, footnote 14 is redesignated as footnote 13. 8. Section 94.17 is amended as follows: a. In paragraph (e), by redesignating footnote 15 as footnote 14. b. In paragraph (p)(1)(i), by redesignating footnote 16 as footnote 15 and revising newly redesignated footnote 15 to read as set forth below. § 94.17 Dry-cured pork products from regions where foot-and-mouth disease, rinderpest, African swine fever, classical swine fever, or swine vesicular disease exists. * * * (p) * * * (1) * * * (i) * * * 15 * * 15 See footnote 14 in paragraph (e) of this section. §§ 94.18 and 94.24 [Amended] 9. In §§ 94.18 and 94.24, footnotes 17, 18, 20, and 21 are redesignated as footnotes 16 through 19, respectively. Done in Washington, DC, this 8th day of August 2007. Cindy Smith, Acting Administrator, Animal and Plant Health Inspection Service. [FR Doc. E7–15815 Filed 8–10–07; 8:45 am] BILLING CODE 3410–34–P NUCLEAR REGULATORY COMMISSION 10 CFR Parts 32 and 35 RIN 3150–AI14 Medical Use of Byproduct Material— Minor Corrections and Clarifications Nuclear Regulatory Commission. ACTION: Proposed rule. AGENCY: SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend 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 PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 45181 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: Comments on the proposed rule must be received on or before September 12, 2007. 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 for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including personal information such as social security numbers and birth dates in 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 website to Carol Gallagher (301) 415– 5905; email 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 am and 4:15 pm 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. E:\FR\FM\13AUP1.SGM 13AUP1 sroberts on PROD1PC70 with PROPOSALS 45182 Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Proposed Rules 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: For additional information see the Direct Final Rule published in the Final Rules section of this Federal Register. Because NRC considers this action noncontroversial and routine, we are publishing this proposed rule concurrently as a direct final rule. The direct final rule will become effective on October 29, 2007. However, if the NRC receives significant adverse comments on the proposed rule by September 12, 2007, then the NRC will publish a document to withdraw the direct final rule. If the direct final rule is withdrawn, the NRC will address the comments received in response to the proposed revisions in a subsequent final rule. Absent significant modifications to the proposed revisions requiring republication, the NRC will not initiate a second comment period for this action if the direct final rule is withdrawn. 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-andcomment 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 VerDate Aug<31>2005 19:04 Aug 10, 2007 Jkt 211001 (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. 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. 553; the NRC is proposing to adopt 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. No. 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 PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 (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 computergenerated 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: E:\FR\FM\13AUP1.SGM 13AUP1 Federal Register / Vol. 72, No. 155 / Monday, August 13, 2007 / Proposed Rules § 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-instorage 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. sroberts on PROD1PC70 with PROPOSALS * * * * * (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. VerDate Aug<31>2005 17:02 Aug 10, 2007 Jkt 211001 For the Nuclear Regulatory Commission. Martin J. Virgilio, Acting Executive Director for Operations. [FR Doc. E7–15762 Filed 8–10–07; 8:45 am] BILLING CODE 7590–01–P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 39 [Docket No. FAA–2006–26491; Directorate Identifier 2006–CE–76–AD] RIN 2120–AA64 Airworthiness Directives; Alpha Aviation Design Limited (Type Certificate No. A48EU Previously Held by APEX Aircraft and AVIONS PIERRE ROBIN) Model R2160 Airplanes Federal Aviation Administration (FAA), Department of Transportation (DOT). ACTION: Supplemental notice of proposed rulemaking (NPRM); reopening of the comment period. AGENCY: 45183 • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Examining the AD Docket You may examine the AD docket on the Internet at http://dms.dot.gov; or in person at the Docket Management Facility between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains this proposed AD, the regulatory evaluation, any comments received, and other information. The street address for the Docket Office (telephone (800) 647– 5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt. FOR FURTHER INFORMATION CONTACT: Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329–4146; fax: (816) 329–4090. SUPPLEMENTARY INFORMATION: The proposed AD would require actions that are intended to address the unsafe condition described in the MCAI. DATES: We must receive comments on this proposed AD by September 12, 2007. Comments Invited We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the ADDRESSES section. Include ‘‘Docket No. FAA–2006–26491; Directorate Identifier 2006–CE–76–AD’’ at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this proposed AD. We will consider all comments received by the closing date and may amend this proposed AD because of those comments. We will post all comments we receive, without change, to http:// dms.dot.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact we receive about this proposed AD. You may send comments by any of the following methods: • DOT Docket Web Site: Go to http:// dms.dot.gov and follow the instructions for sending your comments electronically. • Fax: (202) 493–2251. • Mail: U.S. Department of Transportation, Docket Operations, M– 30, West Building, Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590. • Hand Delivery: U.S. Department of Transportation, Docket Operations, M– 30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. Discussion We proposed to amend 14 CFR part 39 with an earlier NPRM for the specified products, which was published in the Federal Register on January 8, 2007 (72 FR 676). That earlier NPRM proposed to require actions intended to address the unsafe condition for the products listed above. Since that NPRM was issued, we determined that replacing any type 1 fuel fittings with type 2 fuel fittings, not just leaking type 1 fuel fittings, is needed in order to eliminate future fuel leaks. The Civil Aviation Authority of New Zealand, which is the airworthiness authority for New Zealand, has issued AD DCA/R2000/12, dated June 29, 2006 SUMMARY: We are revising an earlier NPRM for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as: To prevent fuel system leaks inspect the bronze/brass hollow threaded fuel line fittings for type and leaks, per Avions Pierre Robin Service Bulletin (SB) No. 86. ADDRESSES: PO 00000 Frm 00007 Fmt 4702 Sfmt 4702 E:\FR\FM\13AUP1.SGM 13AUP1

Agencies

[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Proposed Rules]
[Pages 45181-45183]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-15762]


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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: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend 
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: Comments on the proposed rule must be received on or before 
September 12, 2007.

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 for public inspection. Because 
your comments will not be edited to remove any identifying or contact 
information, the NRC cautions you against including personal 
information such as social security numbers and birth dates in 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 website to Carol Gallagher (301) 415-5905; email 
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 am and 4:15 pm 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.

[[Page 45182]]

    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: For additional information see the Direct 
Final Rule published in the Final Rules section of this Federal 
Register.
    Because NRC considers this action noncontroversial and routine, we 
are publishing this proposed rule concurrently as a direct final rule. 
The direct final rule will become effective on October 29, 2007. 
However, if the NRC receives significant adverse comments on the 
proposed rule by September 12, 2007, then the NRC will publish a 
document to withdraw the direct final rule. If the direct final rule is 
withdrawn, the NRC will address the comments received in response to 
the proposed revisions in a subsequent final rule. Absent significant 
modifications to the proposed revisions requiring republication, the 
NRC will not initiate a second comment period for this action if the 
direct final rule is withdrawn.
    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.

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. 553; the NRC is proposing to 
adopt 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. No. 109-58, 
119 Stat. 594 (2005).

    2. In Sec.  32.72, paragraph (b)(5) is revised to read as follows:


Sec.  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 Sec.  35.55(a) of this chapter with the written 
attestation signed by a preceptor as required by Sec.  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 Sec.  32.74, the introductory text of paragraph (a) is 
revised to read as follows:


Sec.  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 Sec. Sec.  
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 Sec.  35.2, the definition of Medium dose-rate remote 
afterloader is revised to read as follows:


Sec.  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 Sec.  35.41, paragraph (b)(4) is revised to read as follows:


Sec.  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 Sec. Sec.  35.600 or 35.1000.
* * * * *
    7. In Sec.  35.75, the text of paragraph (a) is republished and 
footnote 1 is revised to read as follows:

[[Page 45183]]

Sec.  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 Sec.  35.92, the introductory text of paragraph (a) is 
revised to read as follows:


Sec.  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 Sec.  35.190, paragraph (a)(1) is revised to read as follows:


Sec.  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 Sec.  35.290, paragraph (a)(1) is revised to read as 
follows:


Sec.  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. E7-15762 Filed 8-10-07; 8:45 am]
BILLING CODE 7590-01-P