[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]


=======================================================================
-----------------------------------------------------------------------

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.

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

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