[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