William Stein III, M.D.; Receipt of Petition for Rulemaking, 34285-34288 [E6-9246]
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(B) Written notice from the Social
Security Administration that the
combination of name and social security
account number submitted for the
employee does not match Social
Security Administration records; or
(C) Written notice from the
Department of Homeland Security that
the immigration status document or
employment authorization document
presented or referenced by the employee
in completing Form I–9 was assigned to
another person, or that there is no
agency record that the document was
assigned to any person.
(2)(i) An employer who receives the
notice from SSA described in paragraph
(l)(1)(iii)(B) of this section will not be
deemed to have constructive knowledge
that the employee is an unauthorized
alien if—
(A) The employer takes reasonable
steps, within 14 days, to attempt to
resolve the discrepancy; such steps may
include:
(1) Checking the employer’s records
promptly after receiving the notice, to
determine whether the discrepancy
results from a typographical,
transcribing, or similar clerical error,
and if so, correcting the error(s),
informing the Social Security
Administration of the correct
information (in accordance with the
letter’s instructions, if any; otherwise in
any reasonable way), verifying with the
Social Security Administration that the
employee’s name and social security
account number, as corrected, match in
Social Security Administration records,
and making a record of the manner,
date, and time of such verification; and
(2) If no such error is found, promptly
requesting the employee to confirm that
the name and social security account
number in the employer’s records are
correct—and, if they are correct
according to the employee, requesting
the employee to resolve the discrepancy
with the Social Security Administration,
such as by visiting a Social Security
Administration office, bringing original
documents or certified copies required
by SSA, which might include
documents that prove age, identity, and
citizenship or alien status, and other
documents that may be relevant, such as
those that prove a name change, or, if
the employee states that the employer’s
records are in error, taking the actions
to correct, inform, verify, and make a
record described in paragraph
(l)(2)(i)(A)(1) of this section; and
(B) In the event that, within 60 days
of receiving the notice, the employer
does not verify with the Social Security
Administration that the employee’s
name matches in the Social Security
Administration’s records a number
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assigned to that name and that the
number is valid for work or is valid for
work with DHS authorization (and, with
respect to the latter, verify the
authorization with DHS), the employer
takes reasonable steps, within an
additional 3 days, to verify the
employee’s employment authorization
and identity, such as by following the
verification procedure specified in
paragraph (l)(2)(iii) of this section.
(ii) An employer who receives the
notice from DHS described in paragraph
(l)(1)(iii)(C) of this section will not be
deemed to have constructive knowledge
that the employee is an unauthorized
alien if—
(A) The employer takes reasonable
steps, within 14 days of receiving the
notice, to attempt to resolve the
question raised by DHS about the
immigration status document or the
employment authorization document;
and
(B) In the event that, within 60 days
of receiving the notice, the employer
does not verify with DHS that the
document was assigned to the
employee, the employer takes
reasonable steps, within an additional 3
days, to verify the employee’s
employment authorization and identity,
such as by following the verification
procedure specified in paragraph
(l)(2)(iii) of this section.
(iii) The verification procedure
referenced in paragraphs (l)(2)(i)(B) and
(l)(2)(ii)(B) of this section is as follows:
(A) The employer completes a new
Form I–9 for the employee, using the
same procedures as if the employee
were newly hired, as described in
§ 274a.2(a) and (b) of this part, except
that—
(1) Both Section 1—‘‘Employee
Information and Verification’’—and
Section 2—‘‘Employer Review and
Verification’’—of the new Form I–9
should be completed within 63 days of
receiving the notice referred to in
paragraph (l)(1)(iii)(B) or (C) of this
section;
(2) No document containing the social
security account number or alien
number that is the subject of a written
notice referred to in paragraph
(l)(1)(iii)(B) or (C) of this section, and no
receipt for an application for a
replacement of such document, may be
used to establish employment
authorization or identity or both; and
(3) No document without a
photograph may be used to establish
identity or both identity and
employment authorization; and
(B) The employer retains the new
Form I–9 with the prior Form(s) I–9 for
the same period and in the same manner
as if the employee were newly hired at
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34285
the time the new Form I–9 is completed,
as described in § 274a.2(b) of this part.
(3) Knowledge that an employee is
unauthorized may not be inferred from
an employee’s foreign appearance or
accent. Nothing in this definition
should be interpreted as permitting an
employer to request more or different
documents than are required under
section 274A(b) of the Act or to refuse
to honor documents tendered that on
their face reasonably appear to be
genuine and to relate to the individual,
except a document about which the
employer has received a notice
described in paragraph (l)(1)(iii) of this
section and with respect to which the
employer has received no verification as
described in paragraph (l)(2)(i)(B) or
(l)(2)(ii)(B) of this section.
Dated: June 8, 2006.
Michael Chertoff,
Secretary.
[FR Doc. E6–9303 Filed 6–13–06; 8:45 am]
BILLING CODE 4410–10–P
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 35
[Docket No. PRM–35–19]
William Stein III, M.D.; Receipt of
Petition for Rulemaking
Nuclear Regulatory
Commission.
ACTION: Petition for rulemaking; Notice
of receipt.
AGENCY:
SUMMARY: The Nuclear Regulatory
Commission (NRC) has received and
requests public comment on a petition
for rulemaking filed by William Stein
III, M.D. (petitioner). The petition has
been docketed by the NRC and has been
assigned Docket No. PRM–35–19. The
petitioner is requesting that the NRC
amend the regulations that govern
medical use of byproduct material
concerning training for parenteral
administration of certain radioactive
drugs used to treat cancer. The
petitioner believes that these regulations
do not adequately consider the training
necessary for a class of physicians,
namely medical oncologists and
hemotologists, to qualify as an
Authorized User (AU) physician to
administer these drugs. The petitioner
requests that the regulations be
amended to clearly codify an 80-hour
training and experience requirement as
appropriate and sufficient for
physicians desiring to attain AU status
for these unsealed byproduct materials.
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Submit comments by August 28,
2006. Comments received after this date
will be considered if it is practical to do
so, but assurance of consideration
cannot be given except as to comments
received on or before this date.
ADDRESSES: You may submit comments
by any one of the following methods.
Please include the following number
(PRM–35–19) in the subject line of your
comments. Comments on petitions
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. Attention:
Rulemaking 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 https://ruleforum.llnl.gov.
Address comments about our
rulemaking website to Carol Gallagher,
(301) 415–5905; (e-mail cag@nrc.gov).
Comments can also be submitted via the
Federal eRulemaking Portal https://
www.regulations.gov.
Hand deliver comments to 11555
Rockville Pike, Rockville, Maryland,
between 7:30 am and 4:15 pm on
Federal workdays.
Publicly available documents related
to this petition may be viewed
electronically on the public computers
located at the NRC 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 website at https://
ruleforum.llnl.gov.
Publically available documents
created or received at the NRC after
November 1, 1999 are also available
electronically at the NRC’s Electronic
Reading Room at https://www.nrc.gov/
reading-rm/adams.html. From this site,
the public can gain entry into the NRC’s
Agencywide Documents 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
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PDR Reference staff at 1–800–397–4209,
301–415–4737 or by e-mail to
pdr@nrc.gov.
For a copy of the petition, write to
Michael T. Lesar, Chief, Rules and
Directives Branch, Division of
Administrative Services, Office of
Administration, U.S. Nuclear Regulatory
Commission, Washington, DC 20555–
0001.
FOR FURTHER INFORMATION CONTACT:
Michael T. Lesar, Office of
Administration, U.S. Nuclear Regulatory
Commission, Washington, DC 20555.
Telephone: 301–415–7163 or Toll-Free:
1–800–368–5642 or E-mail:
MTL@NRC.Gov.
SUPPLEMENTARY INFORMATION:
Background
The NRC has received a petition for
rulemaking dated March 20, 2006,
submitted by William Stein III, M.D.
(petitioner). The petitioner requests that
the NRC amend 10 CFR part 35,
‘‘Medical Use of Byproduct Material.’’
Specifically, the petitioner requests that
a requirement be added to 10 CFR part
35 or that 10 CFR 35.396 be revised to
define and specify the number of
classroom and laboratory training hours
appropriate and sufficient for
physicians who seek AU status limited
to parenteral administrations of Sm-153lexidronam (Quadramet), I-131tositumomab (Bexxar), and Y-90ibritumomab tiuxetan (Zevalin).
The petitioner believes the current
regulations are burdensome and
deficient. The NRC has determined that
the petition meets the threshold
sufficiency requirements for a petition
for rulemaking under 10 CFR 2.802. The
petition has been docketed as PRM–35–
19. The NRC is soliciting public
comment on the petition for rulemaking.
Discussion of the Petition
The petitioner states that the training
and experience requirements for
physicians who seek AU status for
parenteral administration of Quadramet,
Bexxar, and Zevalin to treat certain
cancers should reflect current
requirements in 10 CFR 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),’’ and
not those currently in 10 CFR 35.396,
‘‘Training for the parenteral
administration of unsealed byproduct
material requiring a written directive.’’
The petitioner believes that the
requirements in 10 CFR 35.396 are too
restrictive and unnecessarily
burdensome because they require 700
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hours of training and board-certification
in radiation oncology.
Quadramet is approved by the Food
and Drug Administration (FDA) for pain
relief in bone cancer patients and is
administered intravenously. The
petitioner states that the average dosage
is 70 mCi and that the main route of
elimination is urinary excretion which
is usually complete within the first six
hours of administration. Less than one
percent of the administered dosage
remains in the blood five hours after
administration. Any remaining activity
will be retained in the skeleton for the
physical half-life of Sm-153 and results
in minimal risk of radiation exposure to
health care workers, family members, or
other individuals who have contact with
the patient. The petitioner believes that
the patient can be released under the
provisions specified in NUREG 1556,
Vol. 9. The petitioner also states that
patients can be released immediately if
the administered activity of Sm-153 is
less than 700 mCi and that no
instructions are required if the
administered activity is less than 140
mCi.
Bexxar has been approved by the FDA
for intravenous treatment of nonHodgkin’s lymphoma. The petitioner
indicates that the average dosage
administered ranges from 33 to 161 mCi,
averaging about 84 mCi, generally less
than the dosage used for oral treatment
of thyroid cancer with Na I-131. The
petitioner states that a patient who
receives an oral dosage of 30 mCi of
I-131 for hyperthyroidism presents more
of a radiation exposure hazard than a
patient who is treated with an average
dosage of Bexxar, for which the dose to
other persons is usually less than the
500 mrem limit. The petitioner believes
an oral dosage of I-131 remains in the
body much longer than the typical
Bexxar dosage. The petitioner also states
that the I-131 present in Bexxar is firmly
attached to the protein antibody and
therefore, represents a much lower
contamination hazard than from oral
I-131 administration.
Zevalin has also been approved by the
FDA for intravenous treatment of nonHodgkin’s lymphoma and is
administered according to the patients
body weight up to a maximum dosage
of 32 mCi. The petitioner states that the
Y-90 radionuclide presents a minimal
risk to individuals who may come in
contact with the patient and that the
patient can be released after treatment
under the provisions specified in
NUREG 1556, Vol. 9.
The petitioner notes that all
administrations of Quadramet, Bexxar,
and Zevalin require written directives
and believes that these drugs are
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generally less hazardous than oral
dosages of I-131. The petitioner
therefore believes that the training and
experience requirements should not
exceed the 80 hours specified for an
endocrinologist who treats thyroid
disorders with oral dosages of I-131.
(See, 10 CFR 35.392 and 35.394.) The
petitioner has concluded that the
training and experience requirement for
parenteral administrations under 10
CFR 35.396 is unnecessarily
burdensome because it requires board
certification in radiation oncology.
The petitioner notes that 10 CFR
35.390 requires 200 hours of classroom
training and laboratory experience for
oral administration of I-131 and all
parenteral administrations, §§ 35.392
and 35.394 require 80 hours of training
for oral administration of I-131, and
§ 35.396 requires 80 hours for all
parenteral administrations, but only
applies to board-certified radiation
oncologists. The petitioner also notes
that in SECY–05–0020, ‘‘Final Rule:
Medical Use of Byproduct MaterialRecognition of Specialty Boards’’
(January 19, 2005), the NRC justified the
200-hour classroom training
requirement in § 35.390 by stating that
these physicians are authorized to
prepare radioactive drugs and
administer many types of radionuclides
that require written directives and that
pose a greater risk of exposure to
radiation.
The petitioner states that § 35.396 was
published in the Federal Register on
March 30, 2005 (70 FR 16335), as part
of the final rule that amended training
and experience requirements for
administration of radiopharmaceuticals.
The petitioner believes that the NRC’s
rationale for the training and experience
requirements in § 35.396 is not known
and that an opportunity for public
comment period was not provided for
this provision before it appeared in the
final rule. The petitioner also states that
preparation of Quadramet, Bexxar, and
Zevalin does not require use of
generators and reagent kits. These
radiopharmaceuticals are usually
prepared at a commercial facility and
then supplied to medical facilities as a
unit dosage that the petitioner believes
is much less than the dosage used for
oral administration of I-131 for thyroid
cancer treatment. The petitioner has
concluded that because the parenteral
administration of Quadramet, Bexxar,
and Zevalin poses no greater potential
risk than oral administration of I-131,
use of these drugs should be considered
a medical issue, not a radiation safety
issue.
The petitioner believes that
physicians who seek AU status for the
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limited authorization of parenteral
administration of Quadramet, Bexxar,
and Zevalin should only be subject to an
80-hour training and experience
requirement, plus supervised work
experience and written attestation,
similar to the current requirement for
oral I-131 administrations at 10 CFR
35.394. The petitioner states that,
moreover, the NRC has not considered
codification of new drugs that require
written directives as they become
available for medical use and that there
is an unmet regulatory need to address
the ability of physicians to qualify for
medical use authorization for certain
unsealed byproduct materials that are
currently commercially available and
for which written directives are
required. The petitioner also states that
under 10 CFR 35.390(b)(1)(ii)(G)(3) and
(4) and § 35.396 (d)(2)(iv), only two
generic types of parenteral
administrations for which written
directives have been considered:
Parenteral administration of any beta
emitter, or photon-emitting radionuclide
with a photon energy of less than 150
keV; and parenteral administrations of
any other radionuclide.
The petitioner states that the current
training and experience requirements
governing all parenteral administrations
do not adequately consider the training
necessary to attain AU status for
Quadramet, Bexxar, and Zevalin. The
petitioner recognizes that other more
hazardous parenterally-administered
drugs may become commercially
available that require the increased
training specified in §§ 35.390 and
35.396. However, the petitioner believes
that radiopharmaceuticals should be
subjected to training requirements
according to potential radiation risk as
is the case for oral administrations of
I-131, rather than being lumped into a
collective group, which the petitioner
characterizes as being the NRC’s current
practice. The petitioner believes that the
current requirements are burdensome
and deficient in this regard and that,
without regulatory relief, physicians
would be discouraged from providing
these FDA-approved and commercially
available treatments resulting in an
adverse impact on their ability to
practice medicine. Under the current
requirements, the petitioner believes
that physicians would be required to
become board-certified radiation
oncologists under § 35.396 or complete
700 hours of training (including 200
hours of classroom and laboratory
training) under § 35.390 to attain AU
status to parenterally administer
Quadramet, Bexxar, or Zevalin.
The petitioner also states that to be
able to conclude that parenteral
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administration of Quadramet, Bexxar,
and Zevalin requires more than 80
hours of training, the NRC would have
to assert that each of these drugs
presents more potential radiation hazard
than oral administration of I-131. The
petitioner believes this is more of a
practice of medicine issue than a
radiation safety issue. The petitioner
also states that the NRC would be
intruding into the practice of medicine
if it did not conclude that medical
oncologists/hematologists who have
completed 80 hours of classroom and
laboratory training, appropriate work
experience, and obtained written
attestation could be granted AU status
for these drugs. The petitioner also
believes that such a prohibition would
prevent physicians from administering
these radiopharmaceuticals and limit
patients’ access to treatments for life
threatening diseases. The petitioner
therefore requests that the NRC
recognize as adequate and sufficient the
80-hour classroom and laboratory
training requirement for physicians to
attain AU status to administer
Quadramet, Bexxar, and Zevalin as is
required for oral Na I-131
administrations to treat thyroid cancer.
The petitioner states that the
additional training required under
§§ 35.390 and 35.396 is justified because
these physicians prepare radioactive
drugs and handle unsealed source
material in quantities that can involve
increased radiation exposure risks.
However, the petitioner notes that
physicians who administer parenteral
doses of Quadramet, Bexxar, and
Zevalin do not need to prepare
radioactive drugs.
The Petitioner’s Conclusion
The petitioner has concluded that the
current 700-hour training and
experience requirement (that includes a
minimum of 200 hours of classroom and
laboratory training) governing parenteral
administrations of radiopharmaceuticals
in 10 CFR part 35 with regard to
administration of Quadramet, Bexxar,
and Zevalin is unnecessarily
burdensome. The petitioner therefore
requests that the NRC recognize that 80
hours of classroom and laboratory
training, supervised work experience,
and a written attestation for physicians
is adequate and sufficient to attain AU
status for parenteral administrations of
Quadramet, Bexxar, and Zevalin, all
requiring written directives. The
petitioner offers the following options
for addressing this issue:
(1) A specific requirement should be
added to 10 CFR part 35 essentially
equivalent to the language in § 35.394
that governs oral administration of I-131
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particularly with regard to the alternate
pathway. An important language change
should be made as specified in
§ 35.394(c)(2)(vi) to require
administering dosages to patients or
human research subjects that includes at
least three cases involving each of these
parenteral administrations.
(2) A separate requirement should be
added for Quadramet, Bexxar, and
Zevalin similar to the training and
experience codification for
administration of I-131 to allow the NRC
to evaluate each substance individually
so all radioactive drugs can be handled
appropriately from a radiation safety
perspective.
(3) 10 CFR 35.396 should be revised
to specify an 80-hour classroom and
laboratory training period, appropriate
work experience, and a written
attestation to apply to the alternate
pathway for any physician, not limited
to board-certified radiation oncologists.
Specifically, the petitioner recommends
removing the current § 35.396(c) and
redesignating §§ 35.396(d)(1), (d)(2), and
(d)(3) as §§ 35.396(c)(1), (c)(2), and
(c)(3). However, the petitioner
recognizes that the Commission may not
agree with this change if other more
hazardous parenterally-administered
radiopharmaceuticals become available,
necessitating the increased training
currently specified in this requirement.
Dated at Rockville, Maryland, this 8th day
of June, 2006.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. E6–9246 Filed 6–13–06; 8:45 am]
BILLING CODE 7590–01–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 23
[Docket No. CE248; Notice No. 23–06–03–
SC]
Special Conditions: Thielert Aircraft
Engines GmbH, Piper PA 28–161
Cadet, Warrior II and Warrior III Series
Airplanes; Diesel Cycle Engine Using
Turbine (Jet) Fuel
Federal Aviation
Administration (FAA), DOT.
ACTION: Notice of proposed special
conditions.
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AGENCY:
This notice proposes special
conditions for the Piper PA 28–161
Cadet, Warrior II and Warrior III series
airplanes. These airplanes, as modified
by Thielert Aircraft Engines GmbH, will
SUMMARY:
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have a novel or unusual design
feature(s) associated with the
installation of a diesel cycle engine
utilizing turbine (jet) fuel. The
applicable airworthiness regulations do
not contain adequate or appropriate
safety standards for installation of this
new technology engine. These proposed
special conditions contain the
additional safety standards that the
Administrator considers necessary to
establish a level of safety equivalent to
that established by the existing
airworthiness standards.
DATES: Comments must be received on
or before July 14, 2006.
ADDRESSES: Comments on this proposal
may be mailed in duplicate to: Federal
Aviation Administration, Regional
Counsel, ACE–7, Attention: Rules
Docket, Docket No. CE248, 901 Locust,
Room 506, Kansas City, Missouri 64106,
or delivered in duplicate to the Regional
Counsel at the above address.
Comments must be marked: CE248.
Comments may be inspected in the
Rules Docket weekdays, except Federal
holidays, between 7:30 a.m. and 4 p.m.
FOR FURTHER INFORMATION CONTACT:
Peter L. Rouse, Federal Aviation
Administration, Aircraft Certification
Service, Small Airplane Directorate,
ACE–111, 901 Locust, Kansas City,
Missouri, 816–329–4135, fax 816–329–
4090.
SUPPLEMENTARY INFORMATION:
Comments Invited
Interested persons are invited to
participate in the making of these
proposed special conditions by
submitting such written data, views, or
arguments, as they may desire.
Communications should identify the
regulatory docket or notice number and
be submitted in duplicate to the address
specified above. All communications
received on or before the closing date
for comments will be considered by the
Administrator. The proposals described
in this notice may be changed in light
of the comments received. All
comments received will be available in
the Rules Docket for examination by
interested persons, both before and after
the closing date for comments. A report
summarizing each substantive public
contact with FAA personnel concerning
this rulemaking will be filed in the
docket. Persons wishing the FAA to
acknowledge receipt of their comments
submitted in response to this notice
must include with those comments a
self-addressed, stamped postcard on
which the following statement is made:
‘‘Comments to CE248.’’ The postcard
will be date stamped and returned to the
commenter.
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Background
On February 11, 2002, Thielert
Aircraft Engines GmbH, of Lichtenstein,
Germany applied for a supplemental
type certificate to install a diesel cycle
engine utilizing turbine (jet) fuel in
Piper PA 28–161 Cadet, Warrior II and
Warrior III series airplanes. The Piper
PA 28–161 Cadet, Warrior II and
Warrior III series airplanes, currently
approved under Type Certificate No.
2A13, is a four-place, low wing, fixed
tricycle landing gear, conventional
planform airplane. The Piper PA 28–161
Cadet, Warrior II and Warrior III series
airplanes to be modified have gross
weights in the range of 2325 to 2440
pounds in the normal category. The
affected series of airplanes have been
equipped with various gasoline
reciprocating engines of 160
horsepower.
Expecting industry to reintroduce
diesel engine technology into the small
airplane fleet, the FAA issued Policy
Statement PS–ACE100–2002–004 on
May 15, 2004, which identified areas of
technological concern involving
introduction of new technology diesel
engines into small airplanes. For a more
detailed summary of the FAA’s
development of diesel engine
requirements, refer to this policy.
The general areas of concern involved
the power characteristics of the diesel
engines, the use of turbine fuel in an
airplane class that has typically been
powered by gasoline fueled engines, the
vibration characteristics and failure
modes of diesel engines. These concerns
were identified after review of the
historical record of diesel engine use in
aircraft and a review of the 14 CFR part
23 regulations, which identified specific
regulatory areas that needed to be
evaluated for applicability to diesel
engine installations. These concerns are
not considered universally applicable to
all types of possible diesel engines and
diesel engine installations. However,
after review of the Thielert installation,
the Thielert engine type, and the
requirements applied by the Lufthart
Bundesamt, and applying the provisions
of the diesel policy, the FAA proposed
these fuel system and engine related
special conditions. Other special
conditions issued in a separate notice
included special conditions for HIRF
and application of § 23.1309 provisions
to the Full Authority Digital Engine
Control (FADEC).
Type Certification Basis
Under the provisions of § 21.101,
Thielert Aircraft Engines GmbH must
show that the Piper PA 28–161 Cadet,
Warrior II and Warrior III series
E:\FR\FM\14JNP1.SGM
14JNP1
]]>Agencies
[Federal Register Volume 71, Number 114 (Wednesday, June 14, 2006)]
[Proposed Rules]
[Pages 34285-34288]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9246]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 35
[Docket No. PRM-35-19]
William Stein III, M.D.; Receipt of Petition for Rulemaking
AGENCY: Nuclear Regulatory Commission.
ACTION: Petition for rulemaking; Notice of receipt.
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SUMMARY: The Nuclear Regulatory Commission (NRC) has received and
requests public comment on a petition for rulemaking filed by William
Stein III, M.D. (petitioner). The petition has been docketed by the NRC
and has been assigned Docket No. PRM-35-19. The petitioner is
requesting that the NRC amend the regulations that govern medical use
of byproduct material concerning training for parenteral administration
of certain radioactive drugs used to treat cancer. The petitioner
believes that these regulations do not adequately consider the training
necessary for a class of physicians, namely medical oncologists and
hemotologists, to qualify as an Authorized User (AU) physician to
administer these drugs. The petitioner requests that the regulations be
amended to clearly codify an 80-hour training and experience
requirement as appropriate and sufficient for physicians desiring to
attain AU status for these unsealed byproduct materials.
[[Page 34286]]
DATES: Submit comments by August 28, 2006. Comments received after this
date will be considered if it is practical to do so, but assurance of
consideration cannot be given except as to comments received on or
before this date.
ADDRESSES: You may submit comments by any one of the following methods.
Please include the following number (PRM-35-19) in the subject line of
your comments. Comments on petitions 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. Attention: Rulemaking 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 https://ruleforum.llnl.gov. Address comments
about our rulemaking website to Carol Gallagher, (301) 415-5905; (e-
mail cag@nrc.gov). Comments can also be submitted via the Federal
eRulemaking Portal https://www.regulations.gov.
Hand deliver comments to 11555 Rockville Pike, Rockville, Maryland,
between 7:30 am and 4:15 pm on Federal workdays.
Publicly available documents related to this petition may be viewed
electronically on the public computers located at the NRC 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 website at
https://ruleforum.llnl.gov.
Publically available documents created or received at the NRC after
November 1, 1999 are also available electronically at the NRC's
Electronic Reading Room at https://www.nrc.gov/reading-rm/adams.html.
From this site, the public can gain entry into the NRC's Agencywide
Documents 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 PDR Reference staff at 1-800-397-4209, 301-415-
4737 or by e-mail to pdr@nrc.gov.
For a copy of the petition, write to Michael T. Lesar, Chief, Rules
and Directives Branch, Division of Administrative Services, Office of
Administration, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001.
FOR FURTHER INFORMATION CONTACT: Michael T. Lesar, Office of
Administration, U.S. Nuclear Regulatory Commission, Washington, DC
20555. Telephone: 301-415-7163 or Toll-Free: 1-800-368-5642 or E-mail:
MTL@NRC.Gov.
SUPPLEMENTARY INFORMATION:
Background
The NRC has received a petition for rulemaking dated March 20,
2006, submitted by William Stein III, M.D. (petitioner). The petitioner
requests that the NRC amend 10 CFR part 35, ``Medical Use of Byproduct
Material.'' Specifically, the petitioner requests that a requirement be
added to 10 CFR part 35 or that 10 CFR 35.396 be revised to define and
specify the number of classroom and laboratory training hours
appropriate and sufficient for physicians who seek AU status limited to
parenteral administrations of Sm-153-lexidronam (Quadramet), I-131-
tositumomab (Bexxar), and Y-90-ibritumomab tiuxetan (Zevalin).
The petitioner believes the current regulations are burdensome and
deficient. The NRC has determined that the petition meets the threshold
sufficiency requirements for a petition for rulemaking under 10 CFR
2.802. The petition has been docketed as PRM-35-19. The NRC is
soliciting public comment on the petition for rulemaking.
Discussion of the Petition
The petitioner states that the training and experience requirements
for physicians who seek AU status for parenteral administration of
Quadramet, Bexxar, and Zevalin to treat certain cancers should reflect
current requirements in 10 CFR 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),'' and not
those currently in 10 CFR 35.396, ``Training for the parenteral
administration of unsealed byproduct material requiring a written
directive.'' The petitioner believes that the requirements in 10 CFR
35.396 are too restrictive and unnecessarily burdensome because they
require 700 hours of training and board-certification in radiation
oncology.
Quadramet is approved by the Food and Drug Administration (FDA) for
pain relief in bone cancer patients and is administered intravenously.
The petitioner states that the average dosage is 70 mCi and that the
main route of elimination is urinary excretion which is usually
complete within the first six hours of administration. Less than one
percent of the administered dosage remains in the blood five hours
after administration. Any remaining activity will be retained in the
skeleton for the physical half-life of Sm-153 and results in minimal
risk of radiation exposure to health care workers, family members, or
other individuals who have contact with the patient. The petitioner
believes that the patient can be released under the provisions
specified in NUREG 1556, Vol. 9. The petitioner also states that
patients can be released immediately if the administered activity of
Sm-153 is less than 700 mCi and that no instructions are required if
the administered activity is less than 140 mCi.
Bexxar has been approved by the FDA for intravenous treatment of
non-Hodgkin's lymphoma. The petitioner indicates that the average
dosage administered ranges from 33 to 161 mCi, averaging about 84 mCi,
generally less than the dosage used for oral treatment of thyroid
cancer with Na I-131. The petitioner states that a patient who receives
an oral dosage of 30 mCi of I-131 for hyperthyroidism presents more of
a radiation exposure hazard than a patient who is treated with an
average dosage of Bexxar, for which the dose to other persons is
usually less than the 500 mrem limit. The petitioner believes an oral
dosage of I-131 remains in the body much longer than the typical Bexxar
dosage. The petitioner also states that the I-131 present in Bexxar is
firmly attached to the protein antibody and therefore, represents a
much lower contamination hazard than from oral I-131 administration.
Zevalin has also been approved by the FDA for intravenous treatment
of non-Hodgkin's lymphoma and is administered according to the patients
body weight up to a maximum dosage of 32 mCi. The petitioner states
that the Y-90 radionuclide presents a minimal risk to individuals who
may come in contact with the patient and that the patient can be
released after treatment under the provisions specified in NUREG 1556,
Vol. 9.
The petitioner notes that all administrations of Quadramet, Bexxar,
and Zevalin require written directives and believes that these drugs
are
[[Page 34287]]
generally less hazardous than oral dosages of I-131. The petitioner
therefore believes that the training and experience requirements should
not exceed the 80 hours specified for an endocrinologist who treats
thyroid disorders with oral dosages of I-131. (See, 10 CFR 35.392 and
35.394.) The petitioner has concluded that the training and experience
requirement for parenteral administrations under 10 CFR 35.396 is
unnecessarily burdensome because it requires board certification in
radiation oncology.
The petitioner notes that 10 CFR 35.390 requires 200 hours of
classroom training and laboratory experience for oral administration of
I-131 and all parenteral administrations, Sec. Sec. 35.392 and 35.394
require 80 hours of training for oral administration of I-131, and
Sec. 35.396 requires 80 hours for all parenteral administrations, but
only applies to board-certified radiation oncologists. The petitioner
also notes that in SECY-05-0020, ``Final Rule: Medical Use of Byproduct
Material-Recognition of Specialty Boards'' (January 19, 2005), the NRC
justified the 200-hour classroom training requirement in Sec. 35.390
by stating that these physicians are authorized to prepare radioactive
drugs and administer many types of radionuclides that require written
directives and that pose a greater risk of exposure to radiation.
The petitioner states that Sec. 35.396 was published in the
Federal Register on March 30, 2005 (70 FR 16335), as part of the final
rule that amended training and experience requirements for
administration of radiopharmaceuticals. The petitioner believes that
the NRC's rationale for the training and experience requirements in
Sec. 35.396 is not known and that an opportunity for public comment
period was not provided for this provision before it appeared in the
final rule. The petitioner also states that preparation of Quadramet,
Bexxar, and Zevalin does not require use of generators and reagent
kits. These radiopharmaceuticals are usually prepared at a commercial
facility and then supplied to medical facilities as a unit dosage that
the petitioner believes is much less than the dosage used for oral
administration of I-131 for thyroid cancer treatment. The petitioner
has concluded that because the parenteral administration of Quadramet,
Bexxar, and Zevalin poses no greater potential risk than oral
administration of I-131, use of these drugs should be considered a
medical issue, not a radiation safety issue.
The petitioner believes that physicians who seek AU status for the
limited authorization of parenteral administration of Quadramet,
Bexxar, and Zevalin should only be subject to an 80-hour training and
experience requirement, plus supervised work experience and written
attestation, similar to the current requirement for oral I-131
administrations at 10 CFR 35.394. The petitioner states that, moreover,
the NRC has not considered codification of new drugs that require
written directives as they become available for medical use and that
there is an unmet regulatory need to address the ability of physicians
to qualify for medical use authorization for certain unsealed byproduct
materials that are currently commercially available and for which
written directives are required. The petitioner also states that under
10 CFR 35.390(b)(1)(ii)(G)(3) and (4) and Sec. 35.396 (d)(2)(iv), only
two generic types of parenteral administrations for which written
directives have been considered: Parenteral administration of any beta
emitter, or photon-emitting radionuclide with a photon energy of less
than 150 keV; and parenteral administrations of any other radionuclide.
The petitioner states that the current training and experience
requirements governing all parenteral administrations do not adequately
consider the training necessary to attain AU status for Quadramet,
Bexxar, and Zevalin. The petitioner recognizes that other more
hazardous parenterally-administered drugs may become commercially
available that require the increased training specified in Sec. Sec.
35.390 and 35.396. However, the petitioner believes that
radiopharmaceuticals should be subjected to training requirements
according to potential radiation risk as is the case for oral
administrations of I-131, rather than being lumped into a collective
group, which the petitioner characterizes as being the NRC's current
practice. The petitioner believes that the current requirements are
burdensome and deficient in this regard and that, without regulatory
relief, physicians would be discouraged from providing these FDA-
approved and commercially available treatments resulting in an adverse
impact on their ability to practice medicine. Under the current
requirements, the petitioner believes that physicians would be required
to become board-certified radiation oncologists under Sec. 35.396 or
complete 700 hours of training (including 200 hours of classroom and
laboratory training) under Sec. 35.390 to attain AU status to
parenterally administer Quadramet, Bexxar, or Zevalin.
The petitioner also states that to be able to conclude that
parenteral administration of Quadramet, Bexxar, and Zevalin requires
more than 80 hours of training, the NRC would have to assert that each
of these drugs presents more potential radiation hazard than oral
administration of I-131. The petitioner believes this is more of a
practice of medicine issue than a radiation safety issue. The
petitioner also states that the NRC would be intruding into the
practice of medicine if it did not conclude that medical oncologists/
hematologists who have completed 80 hours of classroom and laboratory
training, appropriate work experience, and obtained written attestation
could be granted AU status for these drugs. The petitioner also
believes that such a prohibition would prevent physicians from
administering these radiopharmaceuticals and limit patients' access to
treatments for life threatening diseases. The petitioner therefore
requests that the NRC recognize as adequate and sufficient the 80-hour
classroom and laboratory training requirement for physicians to attain
AU status to administer Quadramet, Bexxar, and Zevalin as is required
for oral Na I-131 administrations to treat thyroid cancer.
The petitioner states that the additional training required under
Sec. Sec. 35.390 and 35.396 is justified because these physicians
prepare radioactive drugs and handle unsealed source material in
quantities that can involve increased radiation exposure risks.
However, the petitioner notes that physicians who administer parenteral
doses of Quadramet, Bexxar, and Zevalin do not need to prepare
radioactive drugs.
The Petitioner's Conclusion
The petitioner has concluded that the current 700-hour training and
experience requirement (that includes a minimum of 200 hours of
classroom and laboratory training) governing parenteral administrations
of radiopharmaceuticals in 10 CFR part 35 with regard to administration
of Quadramet, Bexxar, and Zevalin is unnecessarily burdensome. The
petitioner therefore requests that the NRC recognize that 80 hours of
classroom and laboratory training, supervised work experience, and a
written attestation for physicians is adequate and sufficient to attain
AU status for parenteral administrations of Quadramet, Bexxar, and
Zevalin, all requiring written directives. The petitioner offers the
following options for addressing this issue:
(1) A specific requirement should be added to 10 CFR part 35
essentially equivalent to the language in Sec. 35.394 that governs
oral administration of I-131
[[Page 34288]]
particularly with regard to the alternate pathway. An important
language change should be made as specified in Sec. 35.394(c)(2)(vi)
to require administering dosages to patients or human research subjects
that includes at least three cases involving each of these parenteral
administrations.
(2) A separate requirement should be added for Quadramet, Bexxar,
and Zevalin similar to the training and experience codification for
administration of I-131 to allow the NRC to evaluate each substance
individually so all radioactive drugs can be handled appropriately from
a radiation safety perspective.
(3) 10 CFR 35.396 should be revised to specify an 80-hour classroom
and laboratory training period, appropriate work experience, and a
written attestation to apply to the alternate pathway for any
physician, not limited to board-certified radiation oncologists.
Specifically, the petitioner recommends removing the current Sec.
35.396(c) and redesignating Sec. Sec. 35.396(d)(1), (d)(2), and (d)(3)
as Sec. Sec. 35.396(c)(1), (c)(2), and (c)(3). However, the petitioner
recognizes that the Commission may not agree with this change if other
more hazardous parenterally-administered radiopharmaceuticals become
available, necessitating the increased training currently specified in
this requirement.
Dated at Rockville, Maryland, this 8th day of June, 2006.
For the Nuclear Regulatory Commission.
Annette L. Vietti-Cook,
Secretary of the Commission.
[FR Doc. E6-9246 Filed 6-13-06; 8:45 am]
BILLING CODE 7590-01-P
