[Federal Register Volume 72, Number 155 (Monday, August 13, 2007)]
[Proposed Rules]
[Pages 45181-45183]
From the Federal Register Online via the Government Publishing 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.

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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: [email protected]. 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 
[email protected]. 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 [email protected].

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 [email protected].

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