[Federal Register Volume 62, Number 115 (Monday, June 16, 1997)]
[Proposed Rules]
[Pages 32552-32558]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-15697]
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 30 and 32
RIN 3150-AF70
Exempt Distribution of a Radioactive Drug Containing One
Microcurie of Carbon-14 Urea
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule; request for comments.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing an
amendment to its regulations that would permit NRC licensees to
distribute a radioactive drug containing one microcurie of carbon-14
urea to any person for ``in vivo'' diagnostic use. The NRC has
determined that the radioactive component of such a drug in capsule
form presents a minimal radiation risk and, therefore, regulatory
control of the drug for radiation safety is not necessary. If adopted,
this amendment would make the drug more widely available, and reduce
costs to patients, insurers, and the health care industry. This action
is being taken in response to a petition for rulemaking (PRM-35-12)
submitted by Tri-Med Specialties, Inc.
DATES: Submit comments by July 16, 1997. Comments received after this
date will be considered if it is practicable to do so, but the
Commission is able to assure consideration only for comments received
on or before this date.
ADDRESSES: Send comments to: Secretary, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, Attention: Rulemakings and
Adjudications Staff.
Hand deliver comments to: 11555 Rockville Pike, Rockville,
Maryland, between 7:30 am and 4:15 pm on Federal workdays.
The public may examine comments received, the environmental
assessment and finding of no significant impact, and the regulatory
analysis at the NRC Public Document Room, 2120 L Street NW., (Lower
Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT: Dr. Anthony N. Tse, Office of Nuclear
Regulatory Research, U.S. Nuclear Regulatory Commission, Washington, DC
20555-0001, telephone (301) 415-6233 or e-mail at [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
II. Discussion
III. Summary of Proposed Amendments
IV. Agreement State Compatibility
V. Electronic Access
VI. Finding of No Significant Environmental Impact: Availability
VII. Paperwork Reduction Act Statement
VIII. Regulatory Analysis
IX. Regulatory Flexibility Certification
X. Backfit Analysis
XI. List of Subjects
I. Background
The Petition for Rulemaking
On October 6, 1994, the Commission docketed a petition for
rulemaking (Docket No. PRM-35-12) from Tri-Med Specialties, Inc (Tri-
Med). In a letter dated August 23, 1994, Tri-Med petitioned the NRC to
amend its regulations ``to allow for the general licensing and/or
exemption for the commercial distribution by licensed pharmaceutical
manufacturers of a capsule containing one micro-Curie (Ci) of
14C-urea for in vivo diagnostic testing.'' The purpose of
this diagnostic test is to detect the presence of the bacterium
Helicobacter pylori (H. pylori), a cause of peptic ulcers.
``Peptic ulcer disease is a chronic inflammatory condition of the
stomach and duodenum that affects as many as 10 percent of people in
the United States at some time in their lives. The disease has
relatively low mortality, but it results in substantial human suffering
and high economic costs.'' (Source: Article included as an appendix to
the petition, from JAMA, July 6, 1994, Vol-272, No. 1, ``H. pylori in
Peptic Ulcer Disease--NIH Consensus Conference'').
In the petition, the petitioner stated the following:
Recent medical research has found that peptic ulcers are commonly
caused by a bacterium called H. pylori. This
[[Page 32553]]
bacterium lives in the stomach of most ulcer sufferers. By treating
ulcer patients with antibiotics, doctors can now cure most ulcer
problems.
It is therefore necessary to detect the presence of H. pylori
bacteria in ulcer patients so that the new treatment can be given
appropriately. In the past, this was done by a gastroenterologist who
took biopsy samples of the stomach lining at endoscopy, a procedure
which was uncomfortable and expensive ($1,000).
With the new test, H. pylori can be detected non-invasively using a
14C-urea tracer. 14C-urea is broken down by H.
pylori to form labeled CO2 which is expired in the breath.
To do the test, a doctor asks the patient to swallow the capsule with
30 mls of water. After 15 minutes the patient blows 2 liters of breath
into a collection bag (a mylar balloon) which is mailed to a testing
laboratory. If 14C--CO2 more than twice
background is present in the breath sample, then the patient must be
infected with H. pylori.
This proposed rule, should it become final, would grant the
petition for rulemaking (PRM-35-12) from Tri-Med and complete action on
the petition.
Public Comments on the Petition
Following the receipt of the petition, the NRC published for public
comment a notice of receipt of petition for rulemaking in the Federal
Register on December 2, 1994 (59 FR 61831). The comment period closed
on February 15, 1995. The NRC received 315 public comment letters, of
which 313 support the petition (they were mostly form letters) and 2
letters opposed the petition. The two letters opposing the petition
stated that the product should not receive an exempt status because the
uncontrolled distribution and application of this product could lead to
significant risk to the public and that the medical uses should be
restricted to short-lived isotopes because of disposal problems
presented by long-lived isotopes.
The NRC has considered the two opposing comments and has determined
the following:
(1) The resulting radiation dose from the capsules to workers,
patients, and the public is very low (see Regulatory Analysis).
(2) The impacts associated with any releases of 14C to
the surrounding environment are expected to be very small and the
expected risks are minimal (see Environmental Assessment). Similarly,
the small doses from naturally occurring 14C are of little
significance to human health and the environment. Also, the Commission
concludes that the potential long-term impacts from widespread releases
of the long-lived 14C (5,730-year radiological half-life)
from breath tests are insignificant.
Comments From Advisory Committee on the Medical Uses of Isotopes
This petition was discussed with NRC's Advisory Committee on the
Medical Uses of Isotopes (ACMUI) at its October 1995 meeting. The ACMUI
indicated that it endorsed the wide availability of this diagnostic
test and that the radioactive drug could be used under a general
license or an exemption, whichever the NRC may determine to be
procedurally easier.
II. Discussion
Regulatory Issue
The regulatory issue is whether capsules containing one microcurie
of carbon-14 urea present a sufficiently small radiation risk that they
can be safely distributed to any person (including physicians who are
not ``authorized users'' under Part 35).
Current NRC Regulations for the Manufacture and Commercial Distribution
of Radioactive Drugs Containing Byproduct Material
NRC regulations in 10 CFR 32.72 address the manufacture,
preparation, or transfer for commercial distribution of radioactive
drugs containing byproduct material. This regulation requires
manufacturers or preparers of radioactive drugs for commercial
distribution to be:
(1) Registered or licensed with the U.S. Food and Drug
Administration (FDA) as a drug manufacturer;
(2) Registered or licensed with a State agency as a drug
manufacturer;
(3) Licensed as a pharmacy by a State Board of Pharmacy; or
(4) Operating as a nuclear pharmacy within a Federal medical
institution.
These facilities have a specific license with the NRC. Under the
specific license, the manufacturer or pharmacy can distribute
radioactive drugs only to persons authorized pursuant to Part 35,
``Medical Use of Byproduct Material.''
Current NRC Regulations for the Medical Use of Radioactive Drugs
Containing Byproduct Material
Currently, 10 CFR Part 35 only permits physicians who are
authorized users (e.g., physicians who meet certain training and
experience criteria regarding the safe use of radioactive drugs) or
persons working under the supervision of an authorized user to
administer radioactive drugs for medical use. The Agreement States have
similar requirements.
Current NRC Regulations on Exemptions From Licensing
Existing exemptions from licensing requirements for the use of
byproduct material include exemptions for specific products (e.g., time
pieces), exemption for classes of products (e.g., gas and aerosol
detectors) and broader materials exemptions in Sec. 30.14, ``Exempt
concentrations,'' and Sec. 30.18, ``Exempt quantities.'' These two
broad materials exemptions specifically exclude the transfer of
byproduct material contained in any food, beverage, cosmetic, drug, or
any product designed for ingestion or inhalation by, or application to,
a human being. (In the case of exempt quantities, this prohibition is
contained in Sec. 32.18, ``Manufacture, distribution and transfer of
exempt quantities of byproduct material; Requirements for a license,''
Sec. 32.18(b)).
Capsules containing one microcurie of carbon-14 urea would not
qualify as an ``exempt quantity'' in accordance with Sec. 30.18 because
of their intended use (as a drug) even though they contain a smaller
quantity than that set forth in Sec. 30.71, Schedule B. This use is
outside the intent of the exemption currently in Sec. 30.18. It would
introduce needless complexity to the regulations and confusion to
accommodate this unique use under the aforementioned sections.
However, because the capsules present an insignificant radiological
risk to the public and the environment, the NRC believes they could be
distributed to persons exempt from licensing for ``in vivo'' diagnostic
use.
Proposed Amendments for Permitting the Distribution of the Capsules to
Persons Exempt From Licensing
Proposed Amendment to 10 CFR Part 32
The regulations in 10 CFR Part 32 would be amended to add a new
Sec. 32.21, to provide requirements for a specific license to
manufacture, prepare, process, produce, package, repackage, or transfer
for commercial distribution capsules containing one microcurie of
carbon-14 urea, as a radioactive drug, to be distributed to any person
for ``in vivo'' diagnostic use. These requirements are consistent with
the existing requirements on other items under the heading
``Exemptions'' in 10 CFR Part 30. The proposed regulation would include
a reminder that licensees distributing the radioactive drug to persons
exempt from licensing would not be relieved from other applicable
Federal (e.g., FDA) or State
[[Page 32554]]
requirements governing the manufacture and distribution of drugs.
The NRC has decided that the manufacture or preparation of capsules
containing one microcurie of carbon-14 urea should continue to be
prepared by persons who meet the current NRC regulations to manufacture
and commercially distribute radioactive drugs. The NRC believes
regulatory control is needed to provide high confidence that the drug
contains only one microcurie of carbon-14 urea and does not contain any
other radioactive contaminants.
Proposed Amendment for Exempting ``Any Person'' From Licensing
Requirements To Receive the Drug
Proposed Amendment to 10 CFR Part 30
The NRC has determined that the drug in capsule form presents no
significant radiological safety or environmental risk, and that it is
not necessary to regulate the use of this drug for its radioactive
component. Therefore, the NRC can not justify requiring physicians, or
any other person, to meet NRC training and experience criteria directed
at the safe use of radioactive drugs, or to become an ``authorized
user.'' Hence, the capsules can be distributed to any person. However,
other Federal or State agencies may limit the receipt and use of the
capsules in accordance with their own requirements.
The regulations in 10 CFR Part 30 would be amended to add a new
Sec. 30.21, to permit any person to receive, possess, use, transfer,
own, or acquire for ``in vivo'' diagnostic use, capsules containing one
microcurie of carbon-14 urea without a license. The proposed regulation
would include a reminder that persons receiving the capsules would not
be relieved from other Federal or State law governing drugs. Further,
in accordance with the NRC's provisions for research involving human
subjects (10 CFR 35.6), the exemption permitting receipt and use of the
capsules for ``in vivo'' diagnostic use does not extend to use of the
capsules for research involving human subjects. Any person desiring to
use the capsules for human research would still be required to submit
an application for a specific license under Part 35 in order to protect
human subjects.
The phrase ``in vivo diagnostic use'' is being used in Sec. 30.21
instead of ``medical use'' for two reasons. First, the term ``medical
use'' has a specific meaning and is defined in Sec. 35.2 to mean ``the
intentional internal or external administration of byproduct material
or the radiation therefrom to patients or human research subjects under
the supervision of an authorized user.'' This term would be
inappropriate because:
(1) ``Medical use'' limits administration to authorized users; use
of this drug would not be so limited; and
(2) ``Medical use'' includes the administration of the drug to a
human research subject, which would be prohibited by this rulemaking.
Effects of the Proposed Amendments
The effect of these proposed amendments would be to make the drug
available to any person, for ``in vivo'' diagnostic use, without need
for an NRC or Agreement State license. Because the receipt and use of
the drug would be exempt from NRC licensing, Agreement States would
need to make appropriate provisions in their regulations to recognize
the exempt distribution of the drug, for ``in vivo'' diagnostic use.
Thus, after the manufacture and distribution of the drug, the NRC and
the Agreement States would not regulate the use of the drug as long as
its use was for ``in vivo'' diagnostic use. This means that, under NRC
and Agreement State regulations, primary-care physicians would not need
to be ``authorized users'' in order to administer the drug, and would
not necessarily need to refer their patients to nuclear medicine
physicians. This should result in cost savings to patients. Other
Federal and State organizations with responsibilities for regulating
drugs would be left to determine and regulate who could receive and use
the drug for ``in vivo'' diagnostic use. NRC would regulate the use of
the drug for research involving human subjects under a specific Part 35
license.
III. Summary of Proposed Amendments
Manufacturer and Distributors
A new section would be added to 10 CFR Part 32 to permit the
distribution of the capsules to persons who are exempt from licensing.
Section 32.21 Radioactive Drug: Manufacture, Preparation, or Transfer
for Commercial Distribution of Carbon-14 Urea Capsules Not Exceeding
One Microcurie Each for ``In Vivo'' Diagnostic Use for Humans to
Persons Exempt From Licensing; Requirements for a License
Paragraph (a)
This paragraph would establish the requirements for approval of a
license application to manufacture, prepare, process, produce, package,
repackage, or transfer for commercial distribution carbon-14 urea
capsules not exceeding one microcurie each for ``in vivo'' diagnostic
use, to persons exempt from licensing.
Paragraph (a)(1)
This paragraph would limit issuance of an ``exempt distribution
license'' for distribution of the capsules to persons exempt from
licensing to only those who possess either a NRC or Agreement State
``specific license'' for possession and use of byproduct material.
Paragraph (a)(2)
To assure that the capsules contain no more than one microcurie of
carbon-14 and present no other radiological risks, this paragraph would
require that the persons manufacturing and/or commercially distributing
the capsules for ``in vivo'' diagnostic use must also meet the
requirements of Sec. 32.72(a)(2). Specifically, these persons must be:
(1) Registered with or licensed by the FDA as a drug manufacturer;
or
(2) Registered with or licensed by a state agency as a drug
manufacturer; or
(3) Licensed as a pharmacy by a State Board of Pharmacy; or
(4) Operating as a nuclear pharmacy within a Federal medical
institution.
Paragraph (a)(3)
This paragraph would require applicants to provide evidence that
each carbon-14 urea capsule will not exceed one microcurie. The NRC's
evaluation that the capsules would not result in significant radiation
risks was based on the capsules containing one microcurie of carbon-14
urea. Therefore, applicants must demonstrate that the activity of each
carbon-14 capsule will not exceed one microcurie.
Paragraph (a)(4)
This paragraph would prohibit carbon-14 urea from being contained
in any food, beverage, cosmetic, drug or other commodity designed for
ingestion or inhalation by, or topical application to, a human being
except for the capsules as described in this section, because exempt
distribution of this drug has only been evaluated for ``in vivo''
diagnostic use in the form of a capsule containing one microcurie of
carbon-14 urea. Because of the capsule's ``in vivo'' diagnostic use,
there is no prohibition against the capsule being combined with food or
beverage at the time of administration so that the capsule can be
ingested by the patient.
Paragraph (a)(5)
Because the exempt distribution of this drug has only been
evaluated for ``in vivo'' diagnostic use in the form of a capsule
containing one microcurie of
[[Page 32555]]
carbon-14 urea, this paragraph would prohibit incorporation of the
capsules into any manufactured or assembled commodity, product, or
device intended for commercial distribution. Further, although the drug
is being distributed to persons exempt from licensing, this paragraph
would require the carbon-14 urea to be identified as radioactive
because the drug is being used for its radioactive content; therefore,
the end user must be provided with information that the drug contains a
radioactive material.
Paragraph (a)(6)
As with any product approved for distribution to persons exempt
from licensing, this paragraph would require persons who apply for a
license to manufacture or commercially distribute these capsules to
submit copies of prototype labels or brochures for NRC approval. This
will allow the NRC to confirm that the labels or brochures meet the
requirements of Sec. 32.21a (a) and (b).
Paragraph (b)
This paragraph declares that the regulations do not relieve
licensees or license applicants from complying with applicable FDA,
other Federal, and State requirements governing the manufacture and
distribution of drugs.
Section 32.21a Same: Conditions of License
This section would establish the conditions required for a license
to commercially distribute the capsules to persons exempt from
licensing.
Paragraph (a)
To inform the end user of the identity of the radioisotope, the
physical and chemical form, and the dosage of radioactivity, this
paragraph would establish that the immediate container of each capsule
or capsules must bear a durable, legible label that:
(1) Identifies the radioisotope, the physical and chemical form of
the radioisotope, the quantity of radioactivity contained in each
container at a specific date; and
(2) Bears the words ``Radioactive Material.''
The date requirement is consistent with labeling requirements for
other radioactive drugs with a half life of greater than 100 days.
Paragraph (b)
This paragraph would establish that, consistent with the intended
use of the capsules, the label affixed to the immediate container, or
an accompanying brochure, must:
(1) State that the contents are exempt from NRC or Agreement State
licensing requirements;
(2) Bear the words ``Radioactive Material. For ``In Vivo''
Diagnostic Use Only. This Material Is Not To Be Used for Research
Involving Human Subjects, and Must Not Be Introduced into Foods,
Beverages, Cosmetics, or Other Drugs or Medicinals, or into Products
Manufactured for Commercial Distribution.''
The intent of the requirement set out in (b)(2) is to make clear
that the capsule must remain in the form of a capsule and is not to be
combined with one of the listed items such as food or beverages which
would result in a radioactive product other than in the form of a
capsule for commercial distribution. Because of the capsule's ``in
vivo'' diagnostic use, there is no prohibition against the capsule
being combined with food or beverage at the time of administration so
that the capsule can be ingested by the patient.
``In Vivo'' Diagnostic Use by Persons Exempt From Licensing
A new section would be added to 10 CFR Part 30 to exempt any person
from NRC or the Agreement State regulations to receive the drug for
``in vivo'' diagnostic use for humans.
Section 30.21 Radioactive Drug: Capsules Containing One Microcurie of
Carbon-14 Urea for ``In Vivo'' Diagnostic Use for Humans Would Be Added
To Permit any Person To Receive the Capsules
Paragraph (a)
This paragraph would provide an exemption to any person from the
requirements for a license to receive, possess, use, transfer, own, or
acquire capsules containing one microcurie of carbon-14 urea for ``in
vivo'' diagnostic purposes. It should be noted that the ``transfer'' in
this paragraph does not include ``transfer for commercial
distribution,'' which is covered in paragraph (c) below.
Paragraph (b)
This paragraph would establish that persons exempt from licensing
would be prohibited from using the drug for research involving humans
subjects. A specific Part 35 license would be needed to use the drug in
any research involving human subjects.
Paragraph (c)
This paragraph would specify that a specific license is needed to
manufacture, prepare, process, produce, package, repackage or transfer
such capsules for commercial distribution.
Paragraph (d)
This paragraph declares that the regulations do not relieve end
users from complying with applicable FDA, other Federal, or State
requirements governing the receipt, administration, and use of drugs.
IV. Agreement State Compatibility
Under the Atomic Energy Act, certain regulatory functions are
reserved to the NRC. Among these are the distribution of products to
persons exempt from licensing, as discussed in 10 CFR Part 150. Hence,
the proposed rule, if adopted, would be a Division 4 item of
compatibility, with regard to the manufacture and commercial
distribution of the capsules (10 CFR Part 32). Because of the need for
nationwide consistency in the use of products which are widely
distributed, the proposed rule, if adopted, would be a Division 1 item
of compatibility with regard to possession and use (10 CFR Part 30).
Therefore, the Agreement States will need to make appropriate
provisions in their regulations to allow any person to receive capsules
containing one microcurie of carbon-14 urea for ``in vivo'' diagnostic
use without need for a license.
V. Electronic Access
Comments may be submitted electronically, in either ASCII text or
WordPerfect format (version 5.1 or later), by calling the NRC
Electronic Bulletin Board on FedWorld or connecting to the NRC
interactive rulemaking web site, ``Rulemaking Forum.'' The bulletin
board may be accessed using a personal computer, a modem, and one of
the commonly available communications software packages, or directly
via Internet.
If using a personal computer and modem, the NRC subsystem on
FedWorld can be accessed directly by dialing the toll free number: 1-
800-303-9672. Communication software parameters should be set as
follows: parity to none, data bits to 8, and stop bits to 1 (N,8,1).
Using ANSI or VT-100 terminal emulation, the NRC NUREGs and Reg Guides
for Comment subsystem can then be accessed by selecting the ``Rules
Menu'' option from the ``NRC Main Menu.'' For further information about
options available for NRC at FedWorld, consult the ``Help/Information
Center'' from the ``NRC Main Menu.'' Users will find the ``FedWorld
Online User's Guides'' particularly helpful. Many NRC subsystems and
databases also have a ``Help/Information Center'' option that is
tailored to the particular subsystem.
[[Page 32556]]
The NRC subsystem on FedWorld can also be accessed by a direct-dial
telephone number for the main FedWorld BBS, 703-321-3339, or by using
Telnet via Internet, fedworld.gov. If using 703-321-3339 to contact
FedWorld, the NRC subsystem will be accessed from the main FedWorld
menu by selecting the ``Regulatory, Government Administration and State
Systems,'' then selecting ``Regulatory Information Mall.'' At that
point, a menu will be displayed that has an option ``U.S. Nuclear
Regulatory Commission'' that will take you to the NRC Online main menu.
The NRC Online area also can be accessed directly by typing ``/go nrc''
at a FedWorld command line. If you access NRC from FedWorld's main
menu, you may return to FedWorld by selecting the ``Return to
FedWorld'' option from the NRC Online Main Menu. However, if you access
NRC at FedWorld by using NRC's toll-free number, you will have full
access to all NRC systems but you will not have access to the main
FedWorld system.
If you contact FedWorld using Telnet, you will see the NRC area and
menus, including the Rules menu. Although you will be able to download
documents and leave messages, you will not be able to write comments or
upload files (comments). If you contact FedWorld using FTP, all files
can be accessed and downloaded but uploads are not allowed; all you
will see is a list of files without descriptions (normal Gopher look).
An index file listing all files within a subdirectory, with
descriptions, is included. There is a 15-minute time limit for FTP
access.
Although FedWorld can be accessed through the World Wide Web, like
FTP that mode only provides access for downloading files and does not
display the NRC Rules menu.
You may also access the NRC's interactive rulemaking web site
through the NRC home page (http://www.nrc.gov). This site provides the
same access as the FedWorld bulletin board, including the facility to
upload comments as files (any format), if your web browser supports
that function.
For more information on NRC bulletin boards call Mr. Arthur Davis,
Systems Integration and Development Branch, U.S. Nuclear Regulatory
Commission, Washington, DC 20555, telephone (301) 415-5780; e-mail
AXD[email protected]. For information about the interactive rulemaking site,
contact Ms. Carol Gallagher, (301) 415-6215; e-mail [email protected].
VI. Finding of No Significant Environmental Impact: Availability
The Commission has determined under the National Environmental
Policy Act of 1969, as amended, and the Commission's regulations in
Subpart A of 10 CFR Part 51, that the proposed amendments, if adopted,
would not be a major Federal action significantly affecting the quality
of the human environment; therefore, an environmental impact statement
is not required. The proposed rule would establish requirements for the
manufacture and commercial distribution of 14 C-urea
capsules to persons exempt from licensing and establish regulations to
permit any person to receive the capsules without an NRC license. The
Commission believes that the radioactive component of this drug
presents no significant radiation risk and, therefore, regulatory
control of the ``in vivo'' diagnostic use of the capsules for radiation
safety is not necessary. It is expected that this proposed rule, if
adopted, would not cause any significant increase in radiation exposure
to the public or radiation release to the environment beyond the
exposures or releases resulting from the use of the Carbon-14 capsules
under the current regulations. Also, it is expected that there would be
no non-radiological impacts if the proposed rule is adopted.
The draft environmental assessment and finding of no significant
impact on which this determination is based is available for inspection
at the NRC Public Document Room, 2120 L Street NW., (Lower Level),
Washington, DC. Single copies of the draft environmental assessment and
the finding of no significant impact are available from Dr. Anthony N.
Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, telephone (301) 415-6233 or e-
mail at [email protected].
VII. Paperwork Reduction Act Statement
This proposed rule amends information collection requirements that
are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et
seq.). This rule has been submitted to the Office of Management and
Budget for review and approval of the information collection
requirements.
The public reporting burden for this collection of information is
estimated to average 16 hours per response, including the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. The Nuclear Regulatory Commission is seeking
public comment on the potential impact of the collection of information
contained in the proposed rule and on the following issues:
1. Is the proposed collection of information necessary for the
proper performance of the functions of the NRC, including whether the
information will have practical utility?
2. Is the estimate of the burden correct?
3. Is there a way to enhance the quality, utility, and the clarity
of the information to be collected?
4. How can the burden of the collection of information be
minimized, including the use of automated collection techniques?
Send comments on any aspect of this proposed information
collection, including suggestions for reducing the burden, to the
Information and Records Management Branch (T-6 F33), U.S. Nuclear
Regulatory Commission, Washington, DC 20555-0001, or by Internet
electronic mail at [email protected]; and to the Desk Officer, Office of
Information and Regulatory Affairs, NEOB-10202, (3150-0001, 3150-0017,
and 3150-0120), Office of Management and Budget, Washington, DC 20503.
Comments to OMB on the information collections or on the above
issues should be submitted by July 16, 1997. Comments received after
this date will be considered if it is practical to do so, but assurance
of consideration cannot be given to comments received after this date.
Public Protection Notification
The NRC may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number.
VIII. Regulatory Analysis
The NRC has prepared a regulatory analysis for the proposed rule.
The analysis examines the benefits and impacts considered by the NRC.
The regulatory analysis is available for inspection at the NRC Public
Document Room, 2120 L Street NW. (Lower Level), Washington, DC. Single
copies of the regulatory analysis are available from Dr. Anthony N.
Tse, Office of Nuclear Regulatory Research, U.S. Nuclear Regulatory
Commission, Washington, DC 20555-0001, telephone (301) 415-6233 or e-
mail at [email protected].
IX. Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b),
[[Page 32557]]
the Commission certifies that this rule does not have a significant
economic impact upon a substantial number of small entities. The
proposed rule would permit physicians and other health care providers
to use an additional diagnostic test without having to obtain an NRC
license, thus, would provide cost savings to patients, insurers, and
the health care industry. Any small entity subject to this regulation
which determines that, because of its size, it is likely to bear a
disproportionate adverse economic impact should notify the Commission
of this in a comment that indicates the following:
(a) The licensee's size and how the regulation would result in a
significant economic burden upon the licensee as compared to the
economic burden on a larger licensee.
(b) How the regulations could be modified to take into account the
licensee's differing needs or capabilities.
(c) The benefits that would accrue, or the detriments that would be
avoided, if the regulations were modified as suggested by the licensee.
(d) How the regulation, as modified, would more closely equalize
the impact of regulations or create more equal access to the benefits
of Federal programs as opposed to providing special advantages to any
individual or group.
(e) How the regulation, as modified, would still adequately protect
public health and safety.
X. Backfit Analysis
The NRC has determined that the backfit rule, 10 CFR 50.109, does
not apply to this 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 50.109(a)(1).
List of Subjects
10 CFR Part 30
Byproduct material, Criminal penalties, Government contracts,
Intergovernmental relations, Isotopes, Nuclear materials, Radiation
protection, Reporting and record keeping requirements.
10 CFR Part 32
Byproduct material, Criminal penalties, Labeling, Nuclear
materials, 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 30 and 32.
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF
BYPRODUCT MATERIAL
1. The authority citation for Part 30 continues to read as follows:
Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948,
953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42
U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C.
5841, 5842, 5846).
Section 30.7 also issued under Pub. L. 95-601, sec.10, 92 Stat.
2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123, (42
U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 68 Stat.
954, as amended (42 U.S.C. 2234). Section 30.61 also issued under
sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
2. In Sec. 30.8, paragraph (b) is revised to read as follows:
Sec. 30.8 Information collection requirements: OMB approval.
* * * * *
(b) The approved information collection requirements contained in
this part appear in Secs. 30.9, 30.11, 30.15, 30.18, 30.19, 30.20,
30.21, 30.32, 30.34, 30.35, 30.36, 30.37, 30.38, 30.41, 30.50, 30.51,
30.55, appendices A and C to this part.
* * * * *
3. A new Sec. 30.21 is added under the undesignated center heading
``Exemptions'' to read as follows:
Sec. 30.21 Radioactive drug: Capsules containing one microcurie of
carbon-14 urea for ``in vivo'' diagnostic use for humans.
(a) Except as provided in paragraphs (b) and (c) of this section,
any person is exempt from the requirements for a license set forth in
Section 81 of the Act and from the regulations in this part and part 35
of this chapter provided that such person receives, possesses, uses,
transfers, owns, or acquires carbon-14 urea capsules, not exceeding one
microcurie each, for ``in vivo'' diagnostic use for humans.
(b) Any person who desires to use the capsules for research
involving human subjects shall apply for and receive a specific license
pursuant to part 35 of this chapter.
(c) Any person who desires to manufacture, prepare, process,
produce, package, repackage, or transfer for commercial distribution
such capsules shall apply for and receive a specific license pursuant
to Sec. 32.21 of this chapter.
(d) Nothing in this section relieves persons from complying with
applicable FDA, other Federal, and State requirements governing
receipt, administration, and use of drugs.
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
4. 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).
5. In Sec. 32.8, paragraph (b) is revised to read as follows:
Sec. 32.8 Information collection requirements: OMB approval.
* * * * *
(b) The approved information collection requirements contained in
this part appear in Secs. 32.11, 32.12, 32.14, 32.15, 32.16, 32.17,
32.18, 32.19, 32.20, 32.21, 32.21a, 32.22, 32.23, 32.25, 32.26, 32.27,
32.29, 32.51, 32.51a, 32.52, 32.53, 32.54, 32.55, 32.56, 32.57, 32.58,
32.61, 32.62, 32.71, 32.72, 32.74, and 32.210.
* * * * *
6. A new Sec. 32.21 is added to read as follows:
Sec. 32.21 Radioactive drug: Manufacture, preparation, or transfer for
commercial distribution of carbon-14 urea capsules not exceeding one
microcurie each for ``in vivo'' diagnostic use for humans to persons
exempt from licensing; Requirements for a license.
(a) An application for a specific license to manufacture, prepare,
process, produce, package, repackage, or transfer for commercial
distribution carbon-14 urea capsules not exceeding one microcurie each
for ``in vivo'' diagnostic use, to persons exempt from licensing under
Sec. 30.21 or the equivalent regulations of an Agreement State will be
approved if:
(1) The applicant satisfies the general requirements specified in
Sec. 30.33 of this chapter, provided that the requirements of
Sec. 30.33(a) (2) and (3) of this chapter do not apply to an
application for a license to transfer byproduct material manufactured,
prepared, processed, produced, packaged, or repackaged pursuant to a
license issued by an Agreement State;
(2) The applicant meets the requirements under Sec. 32.72(a)(2);
(3) The applicant provides evidence that each carbon-14 urea
capsule will not exceed one microcurie;
(4) The carbon-14 urea is not contained in any food, beverage,
cosmetic, drug (except as described in this section) or other commodity
designed for ingestion or inhalation by, or topical application to, a
human being;
(5) The carbon-14 urea is in the form of a capsule, identified as
radioactive,
[[Page 32558]]
and to be used for its radioactive properties, but is not incorporated
into any manufactured or assembled commodity, product, or device
intended for commercial distribution; and
(6) The applicant submits copies of prototype labels and brochures
and the NRC approves these labels and brochures.
(b) Nothing in this section relieves the licensee from complying
with applicable FDA, other Federal, and State requirements governing
drugs.
7. A new Sec. 32.21a is added to read as follows:
Sec. 32.21a Same: Conditions of license.
Each license issued under Sec. 32.21 is subject to the following
conditions:
(a) The immediate container of the capsule(s) must bear a durable,
legible label which:
(1) Identifies the radioisotope, the physical and chemical form,
the quantity of radioactivity of each capsule at a specific date; and
(2) Bears the words ``Radioactive Material.''
(b) In addition to the labeling information required by paragraph
(a) of this section, the label affixed to the immediate container, or
an accompanying brochure also must:
(1) State that the contents are exempt from NRC or Agreement State
licensing requirements; and
(2) Bear the words ``Radioactive Material. For `In Vivo' Diagnostic
Use Only. This Material Is Not To Be Used for Research Involving Human
Subjects and Must Not Be Introduced into Foods, Beverages, Cosmetics,
or Other Drugs or Medicinals, or into Products Manufactured for
Commercial Distribution.''
Dated at Rockville, Maryland this 10th day of June, 1997.
For the Nuclear Regulatory Commission.
John C. Hoyle,
Secretary of the Commission.
[FR Doc. 97-15697 Filed 6-13-97; 8:45 am]
BILLING CODE 7590-01-P