[Federal Register Volume 60, Number 2 (Wednesday, January 4, 1995)]
[Rules and Regulations]
[Pages 322-325]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-00124]
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NUCLEAR REGULATORY COMMISSION
10 CFR Part 32
RIN: 3150-AD69
Preparation, Transfer for Commercial Distribution, and Use of
Byproduct Material for Medical Use
AGENCY: Nuclear Regulatory Commission.
ACTION: Final rule; clarification.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is amending regulatory
text and the response to a public comment contained in a final rule
published in the Federal Register on Friday, December 2, 1994, entitled
``Preparation, Transfer for Commercial Distribution, and Use of
Byproduct Material for Medical Use.'' This action is necessary
following reconsideration by the NRC regarding the requirements for the
information to be included on labels for radioactive drugs to be
transferred for commercial distribution. The effect of this action is
to reduce regulatory burden and uncertainty for licensees that
manufacture and distribute radiopharmaceuticals that contain byproduct
material for medical use.
EFFECTIVE DATE: January 1, 1995.
ADDRESSES: Copies of the public record, including the final regulatory
analysis and any public comments received on the proposed rule, may be
examined and copied for a fee in the Commission's Public Document Room
at 2120 L Street, NW. (Lower Level), Washington, DC.
FOR FURTHER INFORMATION CONTACT: Mr. John L. Telford (301) 415-6229 or
Mr. Samuel Z. Jones (301) 415-6198, Office of Nuclear Regulatory
Research, U.S. Nuclear Regulatory Commission, Washington, DC 20555.
SUPPLEMENTARY INFORMATION:
I. Background
On Friday, December 2, 1994 (59 FR 61767), the NRC published in the
Federal Register a final rule regarding 10 CFR Parts 30, 32, and 35
(Preparation, Transfer for Commercial Distribution, and the Use of
Byproduct Material for Medical Use). On Thursday, November 17, 1994,
the NRC staff received comments on the regulatory guides associated
with this rulemaking action during a public meeting with the NRC's
Advisory Committee on the Medical Uses of Isotopes (ACMUI). Initially,
the NRC staff believed that these comments could be resolved through
appropriate regulatory guidance. However, these comments resulted in
the NRC staff concluding that the final published requirements in 10
CFR 32.72(a)(4)
(1) Contained an undue burden with regard to the information
required to be included on syringe labels; and
(2) Were not clear with regard to what was meant by a
``container.''
The NRC staff subsequently developed revised regulations to specify
the information to be included on each label. In this rulemaking, the
NRC is modifying the requirements of 10 CFR 32.72(a)(4) before the
published effective date of January 1, 1995. This rulemaking will
minimize intrusion into areas related to the practice of medicine in a
manner consistent with the Commission's policy as published on February
9, 1979 (44 FR 8242), entitled ``Regulation of the Medical Uses of
Radioisotopes; Statement of General Policy'' and minimize the
regulatory burden on licensees. The specific revised requirements and
response to the public comment are provided in this document.
[[Page 323]]
II. Discussion
A. Revised NRC Response to the Public Comment
The following comment, in regard to 10 CFR 32.72(a)(4), was
published in the Federal Register on Friday, December 2, 1994 (59 FR
61771):
``(3) Comment. The syringe label should not be limited to the
clinical procedure. On the other hand, it is unnecessary to require
that the label, or the leaflet or brochure that accompanies the
radioactive drug, contain all of the statements specified in the
proposed rule.''
The Commission agrees with the comment regarding syringe labels.
The revised response is:
On page 61771, in the first column, the second complete paragraph
and the first sentence of the third complete paragraph are withdrawn
and replaced by the following text:
Response. (a) The revised regulations in Sec. 32.72(a)(4)(ii)
require that labels for syringes, vials, or other containers used to
hold radioactive drugs to be transferred for commercial distribution
must include the radiation symbol and the words ``CAUTION, RADIOACTIVE
MATERIAL'' or ``DANGER, RADIOACTIVE MATERIAL'' and an identifier that
ensures that the syringe, vial, or other container can be correlated
with the information on the transport radiation shield label. The
radiation symbol has been included for the protection of public health
and safety. In the event that a syringe, vial, or other container
becomes separated from its transport radiation shield, it would be
readily identifiable as radioactive. The radiation symbol is currently
required by Sec. 20.1904 to be on containers of radioactive material
and that requirement is restated in Sec. 32.72 as a matter of
convenience for licensees. This radiation symbol will also need to be
the same as described in Sec. 20.1901. The identifier has been included
to provide a correlation between a syringe, vial, or other container
and the information on the label of its transport radiation shield. The
benefits of this correlation are: the transport radiation shield label
provides more information than the syringe, vial, or other container
label; it allows confirmation that the syringe, vial, or other
container is in the correct transport radiation shield; and this
additional information facilitates the radioactive drug being
administered as directed by a physician authorized user. Thus, this
correlation is necessary for both radiation safety and patient safety.
By not specifying the identifier, the NRC staff has provided maximum
flexibility for licensees to select the identifier that best suits
their operations. Acceptable identifiers may include prescription
number, name of the radioactive drug or its abbreviation, the patient's
name, or the clinical procedure.
The revised regulations do not require ``the clinical procedure to
be performed or the patient's or the human research subject's name'' to
be included on the syringe label since this information may or may not
be available to commercial nuclear pharmacies. However, this regulation
does not preclude other information from being included on the syringe
label, such as the clinical procedure when this information is
available and appropriate. Also, the phrase ``syringe radiation
shield'' has been deleted to eliminate any confusion between this
shield and the transport radiation shield. The phrases ``vial'' and
``other container'' have been added to make clear that the regulatory
requirements of Sec. 32.72(a)(4)(ii) are not limited to syringes but
apply to any container used to hold a radioactive drug to be
transferred for commercial distribution, e.g., generator or ampule.
In addition to these modifications, the revised regulations in
Sec. 32.72(a)(4)(i) replace the word ``container'' with the phrase
``transport radiation shield'' to make clear the placement of the label
containing the specified information. The transport radiation shield
could be constructed of lead, glass, plastic, or other material as is
appropriate for the isotope to be transferred for commercial
distribution. However, the phrase ``transport radiation shield'' does
not refer to the outer suitcase, package, packing, or other carrying
device, even though that barrier may provide some radiation shielding.
Also, there are two modifications to the information to be included on
this label. First, this label must now include the radiation symbol and
the words ``CAUTION, RADIOACTIVE MATERIAL'' or ``DANGER, RADIOACTIVE
MATERIAL.'' The radiation symbol has been included for the protection
of public health and safety so that this item can be readily identified
as radioactive. Second, the phrase ``date and time of assay'' has been
replaced with ``at a specified date and time.'' This new phrase
recognizes the current licensee practice of providing a date and time
on this label that is the specified date and time at which the syringe,
vial, or other container will hold the stated quantity of radioactivity
rather than the actual date and time of assay. In addition, if a
syringe, vial, or other container does not require a ``transport
radiation shield'' because the syringe, vial, or other container itself
provides sufficient radiation shielding, then the information on the
label of the syringe, vial, or other container must include the items
specified in Sec. 32.72(a)(4)(i). Furthermore, complying with these NRC
labeling requirements does not relieve licensees from complying with
other applicable requirements (e.g., U.S. Department of Transportation)
for labeling the outer suitcase or package.
(b) The Commission agrees with the comment that it is unnecessary
to require that the label, or the leaflet or brochure that accompanies
the radioactive drug, contain all of the statements specified in the
proposed rule. Therefore, the Commission is deleting the sentence in
Sec. 32.72(a)(4) reading: ``Furthermore, the label, or the leaflet or
brochure that accompanies the radioactive drug, must contain a
statement that the U.S. Nuclear Regulatory Commission has approved
distribution of the byproduct material to persons licensed to use
byproduct material pursuant to 10 CFR 35.100, 35.200, or 35.300, as
appropriate, and to persons who hold an equivalent license issued by an
Agreement State.'' This sentence was deleted because as revised, the
regulations provide greater flexibility and responsibility for
licensees. The licensees distributing radioactive drugs must confirm
that the recipients are licensed to receive the radioactive drugs and
the medical use recipients who can compound radioactive drugs are
responsible for ensuring the appropriate uses of those radioactive
drugs. Thus, licensees will need to continue to ensure pursuant to
Sec. 30.41(c) that radioactive drugs are only distributed to persons
authorized to receive such byproduct materials. The Commission is
removing from the text of the rule the last sentence of
Sec. 32.72(a)(4) reading: ``The Commission's labeling requirements are
independent of requirements of the U.S. Food and Drug Administration
(FDA); one label is acceptable to NRC provided that it contains all of
the information which NRC requires.'' This sentence is being placed in
the preamble because this statement is not a regulatory requirement and
simply provides factual information.
B. Justification
These modifications relieve a restriction and result in a
relaxation of the labeling requirements and are exempt from the
requirements for a 30-day delay in the effective date under 5 U.S.C.
553(d)(1). Therefore, this modification is being made effective on
January 1, 1995, to coincide with the effective date for the remainder
of the previously published final rule. Further, [[Page 324]] as
provided in 5 U.S.C. 553(d)(3), good cause exists for making the
modification effective on less than 30 days notice. As originally
written, the rule would have required that information be included on
syringe labels that might not be available to the commercial nuclear
pharmacy. This would have made compliance difficult or impossible in
some instances. Failure to make this modification effective on the same
date as the originally published final rule would run the risk of
either disrupting the availability of radiopharmaceuticals, if nuclear
pharmacies refused to ship materials without the information needed
under the originally published final rule, or shipments being made in
violation of the rule because of a medical need for the radioactive
drugs but a lack of needed information at the nuclear pharmacy
facility. Thus, even if this change did not involve a relaxation of a
regulatory requirement, meeting the criteria of 5 U.S.C. 553(d)(1) for
exception from the 30-day notice requirement, the Commission finds the
January 1, 1995, effective date justified under the ``good cause''
exception in 5 U.S.C. 553(d)(3).
III. Administrative Statements
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 this final amendment is not a major
Federal action significantly affecting the quality of the human
environment, and therefore an environmental impact statement is not
required. This final amendment clarifies the NRC's intent regarding the
information to be included on labels for radioactive drugs to be
transferred for commercial distribution. It is expected that there will
be no increase in radiation exposure to the public or to the
environment beyond the exposures currently resulting from transporting
radioactive drugs. The NRC prepared an environmental assessment and
finding of no significant impact for the final rule published December
2, 1994 (59 FR 61767), and it is available for inspection at the NRC
Public Document Room, 2120 L Street, NW. (Lower Level), Washington, DC.
This rulemaking action does not make any substantive changes that would
affect the conclusions reached in that assessment. Single copies of the
environmental assessment and finding of no significant impact are
available from John L. Telford or Samuel Z. Jones (see FOR FURTHER
INFORMATION CONTACT heading).
Paperwork Reduction Act Statement
This rulemaking action amends information collection requirements
that are subject to the Paperwork Reduction Act of 1980 (44 U.S.C. 3501
et seq). These requirements were approved by the Office of Management
and Budget, approval number 3150-0001 for amendments to 10 CFR Parts
32.
The public burden for this collection of information is estimated
to be no change from the current requirements, including the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information. Send comments regarding this burden estimate
or any other aspect of this collection of information, including
suggestions for reducing this burden, to the Information and Records
Management Branch (T-6 F33), U.S. Nuclear Regulatory Commission,
Washington, DC 20555, and to the Desk Officer, Office of Information
and Regulatory Affairs, NEOB-10202, (3150-0001, -0010, and -0120),
Office of Management and Budget, Washington, DC 20503.
Regulatory Analysis
The Commission prepared a regulatory analysis for the final rule
published December 2, 1994 (59 FR 61767). This rulemaking action does
not make any substantive changes that would change the conclusions
reached in that analysis. The regulatory analysis is available for
inspection at the NRC Public Document Room at 2120 L Street, NW. (Lower
Level), Washington, DC. Single copies of the regulatory analysis are
available from John L. Telford or Samuel Z. Jones (see FOR FURTHER
INFORMATION CONTACT heading).
Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act of 1980, 5 U.S.C.
605(b), the Commission certifies that this rule will not have a
significant economic impact on a substantial number of small entities.
This rule affects manufacturers and commercial nuclear pharmacies.
These licensees would not be considered small entities under the NRC's
size standards (56 FR 56671; November 6, 1991). This rulemaking action
clarifies the NRC's intent regarding the information to be included on
labels for radioactive drugs to be transferred for commercial
distribution and is expected to result in no change of burden for the
affected licensees.
Backfit Analysis
The Commission has determined that the backfit rule, 10 CFR 50.109,
does not apply to this amendment because this amendment does not
involve any provisions which would impose backfits as defined in 10 CFR
50.109(a)(1). Therefore, a backfit analysis is not required for this
amendment.
List of Subjects in 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. 552 and 553, the NRC is adopting
the following amendments to 10 CFR Part 32.
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
1. The authority citation for Part 32 continues to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841).
2. In Sec. 32.72 paragraph (a)(4) is revised to read as follows:
Sec. 32.72 Manufacture, preparation, or transfer for commercial
distribution of radioactive drugs containing byproduct material for
medical use under Part 35.
(a) * * *
(4) The applicant satisfies the following labeling requirements:
(i) A label is affixed to each transport radiation shield, whether
it is constructed of lead, glass, plastic, or other material, of a
radioactive drug to be transferred for commercial distribution. The
label must include the radiation symbol and the words ``CAUTION,
RADIOACTIVE MATERIAL'' or ``DANGER, RADIOACTIVE MATERIAL''; the name of
the radioactive drug or its abbreviation; and the quantity of
radioactivity at a specified date and time. For radioactive drugs with
a half life greater than 100 days, the time may be omitted.
(ii) A label is affixed to each syringe, vial, or other container
used to hold a radioactive drug to be transferred for commercial
distribution. The label must include the radiation symbol and the words
``CAUTION, RADIOACTIVE MATERIAL'' or ``DANGER, RADIOACTIVE MATERIAL''
and an identifier that ensures that the syringe, [[Page 325]] vial, or
other container can be correlated with the information on the transport
radiation shield label.
* * * * *
Dated at Rockville, Maryland, this 28th day of December, 1994.
For the Nuclear Regulatory Commission.
Hugh L. Thompson, Jr.,
Acting Executive Director for Operations.
[FR Doc. 95-00124 Filed 1-3-95; 8:45 am]
BILLING CODE 7590-01-P
