ML23284A132 (1) Final Supporting Statement 2023

FINAL SUPPORTING STATEMENT FOR
10 CFR PART 35
MEDICAL USE OF BYPRODUCT MATERIAL
(3150-0010)
EXTENSION
Title 10 of the Code of Federal Regulations (10 CFR) Part 35, “Medical Use of Byproduct
Material,” contains the U.S. Nuclear Regulatory Commission's (NRC) requirements and
provisions for the medical use of byproduct material and for issuance of specific licenses
authorizing the medical use of this material. These requirements and provisions provide for the
radiation safety of workers, the public, patients, and human research subjects.
The recordkeeping requirements of Part 35 are centralized into Subpart L - Records (§§
35.2024-2655). Cross references to the recordkeeping requirements in Subpart L appear in
other related portions of the Part 35 rule, but these cross references do not constitute
additional recordkeeping requirements. Reporting requirements are included in Subpart M –
Reports (§§ 35.3045-3204) as well as in multiple subsections throughout Part 35, according to
the specific medical use of the material.
In addition to the requirements for licensees, specialty board certification entities desiring to be
recognized by the NRC under the requirements of Subparts B and D-H must submit a request
for recognition, which is reviewed and accepted by the NRC staff if it is adequate. The NRCrecognized specialty boards infrequently submit letters to the NRC to revise the information in
their original application as changes to their processes occur. Every 5 years, the NRC sends
the NRC-recognized specialty boards a letter requesting confirmation that their certification
process continues to meet the NRC regulations and that no changes were made without
review by the NRC. In addition to this, the NRC also requests that specialty boards that are no
longer interested in having certifications recognized by the NRC or are becoming inactive to
submit a letter to allow the NRC to cease recognition.
The burden for the training and experience requirements for individuals in Subparts B and D-H
are related as appropriate to the clearance for NRC Form 313, "Application for Material
License," and to the NRC Form 313A series of forms for individuals seeking authorization for
recognition as authorized users (AU), authorized medical physicists (AMP), authorized nuclear
pharmacists (ANP), radiation safety officers (RSO) and associate radiation safety officers
(ARSO); which are cleared under the Office of Management and Budget (OMB)
Clearance No. 3150-0120. Subsequent references to "NRC Form 313" are intended to refer to
NRC Form 313 and to the NRC Form 313A series of forms for recognition as AU, AMP, ANP,
RSO and ARSO.
A.

JUSTIFICATION
The NRC regulates and licenses the medical use of byproduct materials, as provided by
the Atomic Energy Act as amended, and the Energy Reorganization Act of 1974, in order
to provide for the radiation safety of workers, the public, and patients. Licensees must
perform certain tasks, maintain records, and prepare reports to demonstrate their
fulfillment of regulatory requirements. Specialty boards may request NRC recognition of
their certifying processes so that individuals certified by the entity can provide
documentation of their board certification as evidence of training and experience. This
1

allows the licensees to demonstrate compliance with NRC training and experience
requirements using the NRC-recognized specialty board certification certificate received
by the individual; instead of maintaining records on the individual’s training and
experience. The records required by Part 35 are the least burdensome way for licensees
to demonstrate compliance with the NRC's requirements.
Safety-significant events must be reported to the NRC, to patients or human research
subjects, and to referring physicians. Collection of this information enables the NRC to
determine whether the licensee is within compliance with the NRC requirements, what steps
must be taken by other licensees to prevent such events, whether required notifications
have been made, and whether corrective actions have been taken. In addition, NRC has
the responsibility, pursuant to section 208 of the Energy Reorganization Act of 1974, as
amended, to inform Congress and the public of those events constituting "abnormal
occurrences" and to also inform NRC medical use licensees of generic issues identified by
the NRC review of medical events.
1.

Need for and Practical Utility of the Collection of Information
The NRC regulates the use of byproduct material in medicine as necessary to
provide for the radiation safety of workers and the general public in a risk-informed
and performance-based manner. 10 CFR Part 35 contains the requirements and
provisions for the medical use of byproduct material and for issuance of specific
licenses authorizing the medical use of this material. These requirements and
provisions provide for the radiation safety of workers, the public, patients, and human
research subjects.
The need for each specific requirement is described in Appendix A, “Description of
Information Collection Requirements.”

2. Agency Use of Information
The NRC uses the records and reports required in this part to ascertain that licensees'
medical use programs are adequate to protect public health and minimize danger to
life and property and that licensees' personnel are aware of and follow up on the
information and steps needed to perform licensed activities in a safe manner. The
NRC uses the specialty board application letter and supporting documentation to
determine if the specialty board certification process meets the NRC requirements for
recognition under the appropriate regulation. In addition, the specialty board submits
information on any change in their processes, to allow the NRC to verify that the
specialty board continues to meet the requirements. The staff makes use of the
specialty board letters and licensee records to determine whether the licensee has
individuals with adequate training and experience to safely use byproduct material or
radiation from byproduct material to be administered to patients or human research
subjects. The staff also makes use of the records and reports to determine whether
the licensee has the facilities and equipment necessary to assure protection of public
health and safety. The NRC also uses the information to develop reports to inform
Congress and the public about the measures taken to provide for the radiation safety
of workers, the public, and patients, and to alert licensees to issues of general
concern. Reports of medical events are required to ensure that NRC is notified of
significant events. These reports also allow NRC to determine whether to take
actions, such as to conduct inspections, or to alert other medical use licensees, to
2

prevent similar events that may have generic implications. In addition, collection of
this information enables the NRC to ascertain whether such events are evaluated by
the licensee, reported to patients or human research subjects, and referring
physicians and that corrective action is taken.
3. Reduction of Burden through Information Technology
The NRC has issued Guidance for Electronic Submissions to the NRC which
provides direction for the electronic transmission and submittal of documents to the
NRC. Electronic transmission and submittal of documents can be accomplished via
the following avenues: the Electronic Information Exchange (EIE) process, which is
available from the NRC's “Electronic Submittals” Web page, by Optical Storage
Media (OSM) (e.g. CD-ROM, DVD), by facsimile or by e-mail. It is estimated that
approximately 75% of the potential responses from NRC licensees are filed
electronically, and the percentage of submissions that are made electronically is
steadily increasing. Agreement State reporting may vary from state to state, but it is
estimated to be similar to NRC licensee reporting. Certain notifications are required
to be made via phone call or other non-electronic method (e.g., the requirement from
paragraph 35.3045(c) that a licensee must notify by telephone the NRC Operations
Center no later than the next calendar day after discovery of a medical event). These
notifications make up about 1% of total responses.
4. Effort to Identify Duplication and Use Similar Information
No sources of similar information are available. There is no duplication of
requirements.
5. Effort to Reduce Small Business Burden
While a number of medical licensees are considered small businesses under the
NRC's current definitions, the health and safety consequences of improper use of
byproduct material are the same for large and small entities. It is not possible to
reduce the burden on small businesses by less frequent or less complete reporting,
recordkeeping, or accounting and control procedures while maintaining the required
level of safety.
6. Consequences to Federal Program or Policy Activities if the Collection is Not
Conducted or is Conducted Less Frequently
If the information is not collected, NRC will not be in a position to assess whether this
category of licensee is operating within the specific radiation safety requirements
applicable to the medical use, possession, or transfer of byproduct material for
medical use. In addition, NRC will not be able to report to Congress and evaluate
those medical events constituting "abnormal occurrences" or to ensure that patients,
human research subjects, and referring physicians are informed of "medical events."
Applications are required to be submitted for the initial license, for amendments, and
for renewals. The review and submission of the information required for the
application is essential to NRC's determination of whether the applicant has adequate
training, experience, equipment, and facilities to protect the public health and safety.
Other reporting and recordkeeping requirements apply to specific actions or events
3

(e.g., inventories of licensed material, calibrations and checks of medical devices and
medical events). Collection of specific information at the required frequency from
licensees that administer byproduct material to patients or human research subjects
is essential to protect the health and safety of workers, patients and human research
subjects, and the public.
The paperwork submitted by specialty board certification entities desiring to be
recognized by the NRC under the requirements of Subparts B and D-H is already
limited. For the NRC to interact less frequently with the NRC-recognized specialty boards
would reduce our confidence that their certification processes continue to meet the NRC
regulations. If a specialty board certification process fails to ensure that individuals met
the NRC training and experience requirements, without the NRC’s awareness, then
licensees may incorrectly assume that individuals with the appropriate certifications
are appropriately trained for their job functions.
7.

Circumstances Which Justify Variation from OMB Guidelines
Contrary to OMB’s implementing regulation at 5 CFR 1320.5(d), some of the
provisions in the revision of Part 35 require licensees to maintain records for more
than 3 years or to report information to the NRC or to patients’ physicians within less
than 30 days following an occurrence.
Paragraph 35.67(e)(2) requires that, in accordance with § 35.3067, a licensee file a
report within 5 days if a leakage test reveals the presence of 185 Bq (0.005
microcuries) or more of removable contamination. This report is necessary so that
the NRC can make a determination as to whether other licensees who have similar
sealed sources should take special precautions and to promptly notify other
licensees if it appears there may be a generic problem. The NRC allows the licensee
up to 5 days to submit the report so that the licensee can review and analyze the
leak test result.
Paragraph 35.642(c) requires that an AMP review the results of each spot-check of a
teletherapy unit and notify the licensee as soon as possible in writing of the results of
each spot-check. The purpose of this requirement is to ensure that the AMP is aware
of any problems noted during the spot-check and that the licensee is aware of the
performance of the unit so that patients are not administered incorrect doses.
Paragraph 35.643(c) requires that an AMP review the results of each spot-check of a
remote afterloader unit and notify the licensee as soon as possible in writing of the
results of each spot-check. The purpose of this requirement is to ensure that the
AMP is aware of any problems noted during the spot-check and that the licensee is
aware of the performance of the unit so that patients are not administered incorrect
doses.
Paragraph 35.645(b)(2) requires licensees to have the AMP review the results of
each spot-check of a gamma stereotactic radiosurgery unit within 15 days of each
spot-check and to notify the licensee as soon as possible in writing of the results of
each spot check. The purpose of this requirement is to ensure that the AMP is aware
of any problems noted during the spot check and that the licensee is aware of the
performance of the unit so that patients are not administered incorrect doses.
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Paragraph 35.2024(a) requires that a record of actions taken by licensee's
management in accordance with § 35.24(a) be retained for 5 years to allow the NRC
to evaluate the nature and appropriateness of such actions during inspections.
Paragraph 35.2024(b) requires that a copy of the authority, duties, and
responsibilities of the RSO, and the RSO’s signed agreement to such
responsibilities, in accordance with § 35.24(e), be maintained by the licensee for the
duration of the license. The purpose of this requirement is to ensure that they remain
available for reference and to allow the NRC to evaluate the nature and
appropriateness of such actions during inspections.
Section 35.2026 requires that a record of radiation safety program changes in
accordance with § 35.26 be retained for 5 years to allow the NRC to evaluate the
nature and appropriateness of such changes during inspections.
Section 35.2041 requires that a copy of the procedures for administrations requiring
a written directive, required by § 35.41, be retained for the duration of the license.
Retention of these procedures for the duration of the license will allow NRC to
investigate medical events where an administered dose or dosage was not in
accordance with the written directive.
Section 35.2433 requires that records of the calculated activity of a strontium-90
source in accordance with § 35.433 be retained for the life of the source to ensure
that they remain available for reference by the licensee and the NRC and to show
throughout the life of the source that its activity was properly calculated.
Section 35.2610 requires that operating procedures and procedures for responding
to abnormal situations, required by § 35.610(a)(4) and (d)(2), be retained until the
licensee no longer possesses the remote afterloader, teletherapy unit, or gamma
stereotactic radiosurgery unit to ensure that these procedures remain available for
reference by the licensee and the NRC. These procedures are needed for as long as
the licensee possesses the unit because they are essential to safe operations.
Section 35.2630 requires that a record of each calibration, intercomparison, and
comparison of dosimetry equipment done in accordance with § 35.630 be retained
for the duration of the license to show throughout the period of use of the equipment
that calibrations of medical devices were made with properly calibrated equipment.
Paragraph 35.2642(c) requires that a copy of the written procedures for periodic
spot- checks for teletherapy units established by the AMP be retained until the
licensee no longer possesses the teletherapy unit to ensure that the procedures
remain available for reference by the licensee and the NRC.
Paragraph 35.2643(c) requires that a copy of the written procedures for periodic
spot- checks for remote afterloader units established by the AMP be retained until
the licensee no longer possesses the remote afterloader unit to ensure that the
procedures remain available for reference by the licensee and the NRC.
Paragraph 35.2645(c) requires that a copy of the written procedures for periodic
spot-checks for gamma stereotactic radiosurgery units established by the AMP be
retained until the licensee no longer possesses the gamma stereotactic radiosurgery
5

unit to ensure that the procedures remain available for reference by the licensee and
the NRC.
Section 35.2652 requires that a record of radiation surveys of treatment units made
in accordance with § 35.652 be retained for the duration of use of the unit to provide
assurance that the source was properly installed or repaired and that the unit did not
exceed occupational dose levels with the sources in the shielded position. These
records also would be necessary in reconstructing the contributing factors following
an incident involving the unit.
Section 35.2655 requires that a record of 5-year inspections for teletherapy and
gamma stereotactic radiosurgery units required by § 35.655 be retained for the
duration of use of the unit. This record is required throughout the period of use of the
unit to show that the required work was done and to establish a service history that
may be used in incident investigations and evaluation of generic equipment
problems.
Paragraph 35.3045(d) requires that licensees submit a written report to the
appropriate NRC Regional Office listed in § 30.6 within 15 calendar days after
discovery of a medical event. This requirement balances the time required for the
licensee to evaluate the event and prepare a written report against the needs of the
NRC to take timely action, as necessary, to address the medical event.
Paragraph 35.3045(e) requires that if an individual affected by a medical event has
been notified verbally about the medical event, the licensee must furnish a written
report of the medical event to the individual upon request. This requirement ensures
that complete written information will be furnished to an individual upon request so
that adequate follow-up medical care can be provided, if needed.
Paragraph 35.3045(g) requires a licensee to provide a copy of the annotated medical
event report to the referring physician, if other than the licensee, no later than 15 days
after the discovery of the event. This requirement balances the time required for the
licensee to evaluate the event and prepare a written report against the needs of the
referring physician to provide timely follow-up medical care, if needed.
Paragraph 35.3047(e) requires the licensee to provide notification of the event to the
referring physician and also notify the pregnant individual or mother (both hereafter
referred to as the mother) no later than 24 hours after discovery of an event that
would require reporting under paragraph (a) or (b) of § 35.3047, unless the referring
physician personally informs the licensee either that he or she will inform the mother
or that, based on medical judgment, telling the mother would be harmful. If the
referring physician or mother cannot be reached within 24 hours, the licensee shall
make the appropriate notifications as soon as possible thereafter. This requirement
ensures that verbal notice is supplied promptly to the referring physician and the
pregnant individual or mother so that adequate follow-up medical care can be
provided, if necessary.
Paragraph 35.3047(f) requires a licensee to provide a copy of the annotated event
report to the referring physician, if other than the licensee, no later than 15 days after
the discovery of the event. This requirement balances the time required for the
licensee to evaluate the event and prepare a written report against the needs of the
6

referring physician to provide timely follow-up medical care.
Section 35.3067 requires licensees to file a report with the NRC within 5 days if a
leakage test required by § 35.67 reveal the presence of 185 Bq (0.005 microcuries) or
more of removable contamination. This report is necessary so that the NRC can
make a determination as to whether other licensees who have similar sealed sources
should take special precautions and to promptly notify other licensees if it appears
there may be a generic problem. The NRC allows the licensee up to 5 days to submit
the report so that the licensee can review and analyze the leak test result.
8.

Consultations Outside the Agency
Opportunity for public comment on the information collection requirements for this
clearance package was published In the Federal Register on August 1, 2023 (88 FR
50182). Five licensees (two medical broad scope licensees and three medical
licensees requiring written directives) were contacted by email as part of the
consultation process. No comments were received in responses to these
consultations.

9.

Payment or Gift to Respondents
Not Applicable

10. Confidentiality of the Information
Confidential and proprietary information is protected in accordance with the NRC
regulations at 10 CFR 9.17(a) and 10 CFR 2.39(b). However, no information normally
considered confidential or proprietary is requested.
11. Justification for Sensitive Questions
No sensitive information is requested under these regulations.
12. Estimated Burden and Burden Hour Cost
This supporting statement provides an estimate of the reporting, recordkeeping, and
third- party disclosure burden for 10 CFR Part 35 NRC and Agreement States
licensees.
Section 274 of the Atomic Energy Act of 1954 provides a statutory basis under which
NRC relinquishes to the States portions of its regulatory authority to license and
regulate byproduct materials (radioisotopes); source materials (uranium and
thorium); and certain quantities of special nuclear materials. The mechanism for the
transfer of NRC’s authority to a State is an agreement signed by the Governor of the
State and the Chairman of the Commission, in accordance with section 274b of the
Act. Licensees operating in these “Agreement States” are referred to in this
supporting statement as “Agreement State Licensees.” A map of Agreement States
and non-Agreement states is located on NRC’s website at
https://scp.nrc.gov/rulemaking.html. The NRC has established compatibility
requirements for Agreement States to implement their own regulations in a manner
consistent with NRC regulations.
7

The NRC does not have data on the number of licensee’s subject to Part 35 who
operate in Agreement States; therefore, the number of these licensees must be
estimated. Annually, the Agreement States provide the NRC with an estimate of the
total number of radioactive materials licensees within their states. In the last survey,
there were 7.5 times more licensees in Agreement States as there were in states
regulated by the NRC. For this clearance, the total number of Agreement State
licensees subject to Part 35 was estimated using the ratio of the total number of
Agreement State materials licensees to the total of NRC materials licensees. The
current ratio is 7.5 (7.5 Agreement State licensees: 1 NRC licensee). Because there
are currently 862 known NRC materials licensees subject to Part 35, staff estimated
there are currently 6,465 Agreement States materials licensees subject to Part 35
(862 NRC licenses x 7.5 = 6,465).
The number of NRC record keepers (862) is taken from the NRC’s web based
licensing system (WBL) and master materials licensee database. The Agreement
State record keepers (6,465) is derived from multiplying the number of NRC medical
use licenses by the ratio of all NRC materials licenses and all Agreement State
material licenses. This ratio is 7.5. The NRC estimates 1 specialty certifying entities
provide updated information per year.
In addition to NRC licensee and Agreement State licensee respondents, the NRC
estimated the paperwork burden associated with specialty board certification entities.
In order to maintain an active, efficient, and effective program, the NRC anticipates
the following activities annually. Each year, the NRC anticipates one application letter
from a specialty board seeking NRC-recognition of specialty board certification
processes (80 hours per application letter) as well as 1 certificate (3 hours per
certificate). The NRC anticipates that two NRC-recognized specialty boards will
submit Notification of Change letters (4 hours per letter) each year. The NRC
currently recognizes eight specialty boards for various certifications. The NRC
anticipates eight specialty boards sending a response letter to an NRC confirmation
letter, as well as submitting any procedures or program documents that were
changed (8 hours per response). Finally, the NRC anticipates that one letter each
year will be submitted by a specialty board requesting the NRC to no longer
recognize it or to inform the NRC that it has become inactive or disbanded. The total
annual burden is 225 hours.
The total number of respondents is as follows:
Part 35 Respondents
NRC licensees
Agreement State licensees
Specialty board certifying entities
Total

862
6,465
13
7,340

The following table summarizes the burden for Part 35.
Part 35 Totals
Reporting

Burden

Responses

61,807

234,284
8

Cost @ $290/hr
$

17,923,885

Recordkeeping
Third Party Disclosure
Total

1,043,235
12,528
1,117,570

7,327
72,383
313,994

$
$
$

302,538,154
3,633,251
324,095,290

Detailed tables showing the burden for each information collection requirement in
10 CFR Part 35 are included as a supplementary document to this submission,
“Burden Spreadsheet for 10 CFR Part 35 information collections.
The $290 hourly rate used in the burden estimates is based on the Nuclear
Regulatory Commission’s fee for hourly rates as noted in 10 CFR 170.20 “Average
cost per professional staff-hour.” For more information on the basis of this rate, see
the Revision of Fee Schedules; Fee Recovery for Fiscal Year 2022 (87 FR 37214,
Jun. 22, 2022).
13. Estimate of Other Additional Costs
The NRC has determined that the quantity of records to be maintained is roughly
proportional to the recordkeeping burden and, therefore, can be used to calculate
approximate records storage costs. Based on the number of pages maintained for a
typical clearance, the records storage cost has been determined to be equal to 0.0004
times the recordkeeping burden cost. Because the recordkeeping burden is estimated
to be 1,043,235, the storage cost for this clearance is $121,016 (1,043,235 x 0.0004 x
$290 (overall hourly fee rate)).
14. Estimated Annualized Cost to the Federal Government
For the requested clearance period, the annualized burden and cost to NRC staff for
review of submittals made under Part 35 is estimated to be 300 hours and $87,000
($290 per hour x 300 hours).
15. Reasons for Changes in Burden
The burden for Part 35 decreased from 1,166,695 hours to 1,117,570 hours, a
decrease of 49,125 hours. 53,942 hours of this decrease is a decrease in
recordkeeping burden. There was a 12,401-hour increase in third party disclosure
burden. In previous clearances, the requirement to provide instructions to patients as
part of the release criteria pursuant to 35.75(b) was included in the reporting burden.
The current burden statement more accurately includes this burden as a third-party
disclosure, resulting in an increase to the third-party disclosure burden. Additionally,
the requirement limiting the aggregating of sealed sources in 35.65(b)(2) was
included in the previous clearance. However, 35.65(b)(2) does not constitute a
recordkeeping burden and has been removed from this clearance. The following
table summarizes the changes:

Part 35 Burden Totals
Reporting
Recordkeeping

Previous
submission
69,391
1,097,177
9

Current
Request
61,807
1,043,235

Change
(7,585)
(53,942)

Third Party Disclosure
Total

127
1,166,695

12,528
1,117,570

12,401
(49,125)

The number of estimated respondents increased slightly from 7,021 to 7,329. Data
on the number of NRC licensees is extracted from the Web-Based Licensing system
(WBL). NRC staff queried the database to determine the total number of NRC
licensees as well as the number of licensees holding licenses authorizing materials
used for specific medical purposes. Changes in industry are reflected in the
distribution of specific license types and authorizations included in the data collected
from WBL. The burden changes are in large part due to the change in the distribution
of specific license types with different license types having different reporting and
recordkeeping requirements. For example, the number of licensed HDR afterloader
units increased since the last clearance, signaling an ongoing increase in these types
of activities and their associated reporting and recordkeeping burdens that is likely to
continue over the next three years. The data were used to estimate respondents on
the NRC licensee burden tables. NRC staff anticipates that the number of licensees
will remain stable over the course of the clearance period.
The NRC does not have data on the number of licensees subject to Part 35 who
operate in Agreement States; therefore, the number of these licensees must be
estimated. Annually, the Agreement States provide the NRC with an estimate of the
total number of radioactive materials licensees within their states. In the last survey,
there were 7.5 times more licensees in Agreement States as there were in states
regulated by the NRC. This is an increase from the previous renewal, in which the
ratio was 7.2.
In states regulated by the NRC, data is available on both the number of licensees
and the particular applications of the material for which they are licensed. As a result,
the NRC can determine the specific requirements in the CFR and the specific
information collections applicable to each of the licensees regulated by the agency.
For AS, the NRC staff only knows the total number of licensees in each state - the
specific applications of the material for they are licensed is unknown.
As a result of the estimation method, the number of licensees in AS may show some
variability over time, particularly when states newly join the AS program. For
example, before they became AS, the number of licensees subject to each
requirement in 10 CFR Part 35 was known for licensees in Wyoming and Vermont,
because they were regulated by the NRC and the NRC had their data in the webbased licensing system. After these states became AS, the NRC did not have
complete data on these licensees. Instead, NRC staff must estimate the number of
licensees in WY and VT that are subject to each information collection requirement.
Further, the method used to estimate respondents assumes that all types of
licensees and applications of materials are equally distributed across states, and that
the distribution is similar in Agreement States when compared to non-Agreement
states. The NRC staff believes that the current method strikes the best balance
between accuracy in estimation and burden upon licensees. The current estimation
method is the most accurate available without burdening the AS with an annual,
comprehensive survey of the specific types of licensees in each Agreement State.
10

In addition, there was an increase in the overall hourly fee rate from $278/hr to
$290/hr.
The annual burden associated with the specialty board certification program has
increased significantly. While the past program had reflected the burden associated
with the application letter and the Notification of Change letters, the past estimates
was 2 hours. In fact, the staff re-evaluated the burden on the specialty boards as 80
hours for an application letter and 4 hours for each Notification of Change letter. In
addition, the NRC performed an evaluation of the NRC-recognized specialty boards
for the first time in 2022. The NRC will continue to conduct this on a 5 year basis. As
part of this process, the NRC ceased to recognize two specialty boards. In addition,
the NRC received a request from another NRC-recognized specialty board in 2022
seeking to discontinue recognition. This was the first communication of this type to be
received by the NRC and it had not been factored into earlier OMB clearances. Given
changes to the program, the NRC staff reviewed the entire process and provided new
estimates of burden that are based on the current program. The NRC anticipates
having more communication with specialty boards moving forward. In addition, the
Agreement States may review and approve specialty board application letters. As of
today, the Agreement States have not received an application to recognize a specialty
board’s certification process and have not yet participated in the specialty board
certification process review program. Regardless, the NRC staff conservatively
anticipated one application letter review (80 hours) annually, being conducted by the
Agreement State.
16. Publication for Statistical Use
There is no application to statistics in the information collected. There are no plans for
publication of this information.
17. Exceptions to the Certification Statement
Not Applicable
B.

COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS
Not Applicable

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10 CFR PART 35
MEDICAL USE OF BYPRODUCT MATERIAL (3150-0010)
APPENDIX A
DESCRIPTION OF INFORMATION COLLECTION REQUIREMENTS
§ 35.6 Provisions for the protection of human research subjects
This section requires a licensee whose research is conducted, funded, supported, or regulated
by another Federal Agency that has implemented the Federal Policy for the Protection of
Human Subjects, prior to conducting research, to obtain review and approval of the research
by an “Institutional Review Board (IRB),” as defined and described in the Federal Policy and
obtain “informed consent” from the human research subject. This review and approval is
needed to ensure the licensee’s compliance with the requirements for the protection of human
subjects. Informed consent is needed to ensure that the human research subject is informed of
any potential risks and voluntarily agrees to them.
This section also requires a licensee whose research is not conducted, funded, supported, or
regulated by another Federal Agency which has implemented the Federal Policy for the
Protection of Human Subjects to apply for and receive approval of a specific amendment to its
NRC medical use license before conducting such research. The amendment request must
include a written commitment that the licensee will, prior to conducting research: ( 1) obtain
review and approval of the research by an “Institutional Review Board,” as defined and
described in the Federal Policy; and (2) obtain “informed consent,” as defined and described in
the Federal Policy, from the human research subject. This information is needed to ensure the
licensee's compliance with the requirements for the protection of human subjects.
§ 35.12 Application for license, amendment, or renewal
Paragraph 35.12(b) requires that an application for a license for medical use of byproduct
material as described in §§ 35.100, 35.200, 35.300, 35.400, 35.500, 35.600, and 35.1000 must
be made by filing an original and one copy of NRC Form 313, "Application for Material
License." This includes the facility diagram, equipment, and training and experience
qualifications of the RSO, ARSO, AU(s), AMP(s), and ANP(s); and submitting procedures
required by §§ 35.610, 35.642, 35.643, and 35.645, as applicable. The NRC Form 313
requires a description of the applicant’s complete radiation safety program. Under § 35.12(c),
an application for license amendment or renewal must be made on NRC Form 313 or by a
letter requesting the amendment or renewal, and must include procedures required by §§
35.610, 35.642, 35.643, and 35.645, as applicable. An application must be signed by the
applicant’s or licensee’s management.
The burden for Paragraphs 35.12 (b) and (c) is cleared under OMB Clearance No. 3150-0120,
which should be referred to for additional supporting information, burden and cost data.
Paragraph 35.12(d), in addition to the requirements in paragraphs (b) and (c) of this section,
requires that an application for a license or amendment for medical use of byproduct material
as described in § 35.1000 must also include information regarding any radiation safety aspects
of the medical use of the material that is not addressed in the requirements of Subparts A
through C of this part. The applicant also is required to provide specific information on: (1)
radiation safety precautions and instructions; (2) methodology for measurement of dosages or
doses to be administered to patients or human research subjects; and (3) calibration,
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maintenance, and repair of instruments and equipment necessary for radiation safety. The
applicant or licensee also is required to provide any other information requested by the
Commission in its review of the application. This information is needed to enable the
Commission to evaluate a license application for a new medical use of byproduct material that
is not specifically addressed in subparts D through H of Part 35. The burden for new
modalities is submitted on NRC Form 313 (OMB Clearance No. 3150-0120).
§ 35.13 License amendments
This section requires that licensees apply for and receive a license amendment before
receiving, preparing, or using byproduct material for medical uses that are permitted under
Part 35, but are not authorized by the licensee's current license issued under this part; before
permitting anyone to work as an AU, ANP, or AMP under the license, except as provided in
§ 35.14(a); before changing RSOs or ARSOs, except as provided in § 35.24(c); before
receiving byproduct material in excess of the amount or in a different form than is authorized
on the license, or receiving a different radionuclide than is authorized on the license; before
adding or otherwise changing areas of use identified in the application or on the license
including areas used in accordance with §§ 35.100 and 35.200 if the change includes addition
or relocation of either an area where positron emission tomography (PET) radionuclides are
produced or a PET radioactive delivery line from a PET radionuclide/PET radioactive drug
production area (other areas of use where byproduct material is used only in accordance with
§§ 35.100 and 35.200 are exempt) before changing the address(es) of use identified in the
application or on the license, and before revising procedures required by §§ 35.610, 35.642,
35.643, and 35.645, as applicable, where such revision reduces radiation safety. The
information is necessary to determine the licensee's ability to control radiation dose to workers,
patients, and the public; and for NRC to contact the licensee or conduct an inspection of the
licensee's program. The information also is required so that the NRC can determine whether
the licensee has individuals with adequate training and experience to use byproduct material
safely and has the facilities and equipment necessary to ensure protection of public health and
safety.
Paragraph 35.13(d) requires a licensee to apply for and receive a license amendment prior to
permitting an individual to work as an ARSO or before the RSO assigns different tasks and
duties to an ARSO currently authorized on the license. The information is required so that the
NRC can determine whether the individual has adequate training and experience (T&E) to
serve as an ARSO. The burden for Section 35.13 is included in the information collection
burden for NRC Form 313 (OMB Clearance No. 3150-0120).
§ 35.14 Notifications
Paragraph 35.14(a) requires that licensees provide to the Commission a copy of the board
certification and written attestation, the Commission or Agreement State license, the permit
issued by an NRC master material licensee, the permit issued by a licensee of broad scope, or
the permit issued by an NRC master material license broad scope permit for each individual no
later than 30 days after the date the licensee permits the individual to work as an AU, as an
ANP, or as an AMP. The information is required so that the NRC can determine whether the
licensee has individuals with adequate training and experience to use byproduct material
safely.
Paragraph 35.14(b) requires that licensees notify the NRC by letter no later than 30 days after
an ANP, AU, AMP, RSO or ARSO permanently discontinues performance of duties under the
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license or has a name change; when a qualified individual functions as a temporary RSO;
when the licensee's mailing address changes; when the licensee has a name change that is
not a transfer of control of the license; or when licensees authorized for use of byproduct
material under §§ 35.100 and 35.200 have added to or changed the areas of use identified in
the application or on the license, if the change does not include addition or relocation of either
an area where PET radionuclides are produced or a PET radioactive drug delivery line from the
PET radionuclide/PET radioactive drug production area. The report for AU and ANP is
required in order to maintain the license file with a current record of individuals authorized to
use or prepare byproduct material. The report for changes in "key" workers and temporary
RSO is required because, if the licensee no longer has a complete staff, the collective training
and experience of the remaining staff may no longer be sufficient to ensure the safety of all
licensed uses. This report will trigger a check of the licensee's file to determine whether the
licensee's remaining users are qualified to receive and use byproduct material safely. The
NRC needs to be aware who is temporarily responsible for implementing the radiation safety
program. The NRC needs to be aware of name and mailing address changes to ensure that
the licensee continues receiving correspondence such as information notices, bulletins, and
other safety related documents. The NRC needs to be aware of changes of areas of use so
that NRC can determine if the facilities are adequate to assure protection of public health and
safety.
Section 35.14 (b)(1) requires a licensee to notify the Commission within 30 days of when an
ARSO discontinues performance of duties under the license or has a name change. The
report is required in order to maintain the license file with a current record of individuals
responsible for the safe use of byproduct material.
Section 35.14(b)(6) requires a licensee to notify the NRC if it receives certain sealed sources
without first obtaining a license amendment. Specifically, a licensee will have to notify the NRC
no later than 30 days after receiving a sealed source from a new manufacturer or a new model
number for a sealed source listed in the sealed source and device registry (SSDR) used for
manual brachytherapy for quantities and isotopes already authorized by the license. The
notification is used in lieu of a license amendment requirement which was removed under
§ 35.13(i). This notification is required in order for the NRC to have an accurate record of
sealed sources possessed by a licensee.
§ 35.19 Specific exemptions
Section 35.19 provides that upon application of any interested person or upon its own initiative,
the Commission may grant exemptions from the regulations in Part 35 that it determines are
authorized by law and will not endanger life or property or the common defense and security
and are otherwise in the public interest. Applications for and granting of specific exemptions
will allow NRC to make provision for special circumstances outside the purview of the
regulations.
§ 35.24 Authority and responsibilities for the radiation protection program
Paragraph 35.24(a) requires a licensee's management to approve in writing (1) requests for
license application, renewal, or amendment prior to submittal; (2) any individual, prior to
allowing that individual to work as an AU, ANP, or AMP; and (3) radiation protection program
changes that do not require an amendment and are permitted under § 35.26. Management
approval is necessary to ensure that actions affecting the radiation protection program have
been reviewed by responsible licensee officials.
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Paragraph 35.24(b) requires that a licensee's management appoint a RSO who agrees, in
writing, to be responsible for implementing the radiation protection program. The licensee,
through the RSO, shall ensure that radiation safety activities are being performed in
accordance with licensee-approved procedures and regulatory requirements. A licensee's
management may appoint, in writing, one or more ARSO to support the RSO. The RSO, with
written agreement of the licensee's management, must assign the specific duties and tasks to
each ARSO. These duties and tasks are restricted to the types of use for which the ARSO is
listed on a license. The RSO may delegate duties and tasks to the ARSO but shall not
delegate the authority or responsibilities for implementing the radiation protection program.
The recordkeeping burden is captured in § 35.2024(c).
Paragraph 35.24(c) allows a licensee to permit an individual qualified to be a Radiation Safety
Officer, under §§ 35.50 and 35.59, to function as a temporary Radiation Safety Officer and to
perform the functions of a Radiation Safety Officer, as provided in paragraph (g), if the
licensee takes the actions required in paragraphs (b), (e), (g), and (h) and notifies the
Commission in accordance with § 35.14(b).
Paragraph 35.24(e) requires a licensee to establish in writing the authority, duties, and
responsibilities of the RSO, so that the duties and responsibilities of the RSO are clearly
defined, and the RSO is provided sufficient authority to assure that the licensee's radiation
safety activities are being performed in accordance with regulatory requirements.
Paragraph 35.24(f) requires licensees who are authorized for two or more different types of
uses of byproduct material under Subparts E, F, and H, or two or more types of units under
Subpart H, to establish a Radiation Safety Committee to oversee all uses of byproduct material
permitted by the license. The requirement to establish a Radiation Safety Committee to
oversee the radiation protection program provides assurance both to the licensees and the
NRC that all of the different departments and diverse professional staff are aware of changes,
needs, and issues related to the licensee's radiation protection program.
Paragraph 35.24(h) requires that a record of actions taken pursuant to paragraphs (a), (b) and
(e) be retained in accordance with § 35.2024. A description of the contents of the record and
the need for the record is provided under § 35.2024.
§ 35.26 Radiation protection program changes
Paragraph 35.26(a) allows a licensee to revise its radiation protection program without
Commission approval if the revision does not require an amendment under § 35.13; the
revision is in compliance with the regulations and the license; the revision has been reviewed
and approved by the RSO and licensee management; and the affected individuals are
instructed on the revised program before the changes are implemented. Review and approval
by licensee management will allow a licensee to make some changes in their radiation safety
program, provided that the changes are in compliance with the regulations and the license.
Paragraph 35.26(b) requires a record of each change to be retained in accordance with
§ 35.2026. A description of the contents of the record and the need for the record is provided
under § 35.2026.
§ 35.27 Supervision
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Paragraph 35.27(a) requires a licensee that permits the receipt, possession, use, or transfer of
byproduct material by an individual under the supervision of an AU as allowed by § 35.11(b) to
instruct the supervised individual in the licensee's written radiation protection procedures,
written directive procedures, Part 35 regulations, and license conditions with respect to the use
of byproduct material. This instruction is necessary to provide high confidence that the
supervised individual knows and follows all of these procedures, regulations, and license
conditions.
Paragraph 35.27(b) requires a licensee that permits the preparation of byproduct material for
medical use by an individual under the supervision of an ANP or physician who is an AU as
allowed by § 35.11(b)(2) to instruct the supervised individual in the preparation of byproduct
material for medical use and require the supervised individual to follow the instructions of the
supervising AU or ANP regarding the preparation of byproduct material for medical use,
radiation protection procedures, Part 35 regulations, and license conditions. This instruction is
necessary to provide high confidence that the supervised individual properly prepares
byproduct material for medical use.
§ 35.40 Written directives
Paragraph 35.40(a) requires licensees that perform certain specified medical administrations
involving I-131 sodium iodide greater than 1.11 Megabequerels (MBq), any therapeutic dosage
of unsealed byproduct material, or any therapeutic dose of radiation from byproduct material, to
prepare a dated and signed written directive prior to performing the medical administration.
The regulatory text of § 35.40(b) requires:
(b)

The written directive must contain the patient or human research subject’s
name and the following information—
(1)
For any administration of quantities greater than 1.11 MBq (30
μCi) of sodium iodide I-131: the dosage;
(2)
For an administration of a therapeutic dosage of unsealed byproduct
material other than sodium iodide I-131: the radioactive drug,
dosage, and route of administration;
(3)
For gamma stereotactic radiosurgery: the total dose, treatment site,
and values for the target coordinate settings per treatment for each
anatomically distinct treatment site;
(4)
For teletherapy: the total dose, dose per fraction, number of
fractions, and treatment site;
(5)
For high dose-rate remote afterloading brachytherapy: the
radionuclide, treatment site, dose per fraction, number of fractions,
and total dose; or
(6)
For all other brachytherapy, including low, medium, and pulsed dose
rate remote afterloaders:
(i)
Before implantation: treatment site, the radionuclide, and
dose; and
(ii)
After implantation but before completion of the procedure:
the radionuclide, treatment site, number of sources, and total
source strength and exposure time (or the total dose).

If an oral directive is used because of the emergent nature of the patient’s condition,
subsection 35.40(a)(1) requires the information in the oral directive to be documented as soon
as possible in writing in the patient’s record and a written directive must be prepared within 48
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hours of the oral directive. Documenting an oral directive is needed to ensure that complete
record is made of the administration of byproduct material or radiation from byproduct material.
Paragraph 35.40(c) permits a written revision to an existing written directive if the revision is
dated and signed by an AU before the administration or the next fractional dose. If an oral
revision to an existing written directive is used because of the emergent nature of the patient’s
condition, the oral revision must be documented as soon as possible in the patient’s record and
a revised written directive must be signed by the AU within 48 hours of the oral revision.
Documenting an oral directive is needed to ensure that a complete record is made of the
administration of byproduct material or radiation from byproduct material.
Paragraph 35.40(d) requires the licensee to retain a copy of the written directive in accordance
with § 35.2040. A description of the record and the need for the record is provided under
§ 35.2040. Preparation of a written directive is necessary to provide high confidence that
byproduct material will be administered as directed by the AU physician.
§ 35.41 Procedures for administrations requiring a written directive
Paragraph 35.41(a) requires licensees to develop, implement and maintain written procedures
for any administration requiring a written directive to provide high confidence that the patient or
human research subject's identity is verified prior to each administration and that each
administration is in accordance with the written directive (WD). These procedures are
necessary to ensure that administrations that require a written directive are given as directed
by the AU physician.
Paragraph 35.41(b)(5) requires licensees to develop, implement, and maintain written
procedures for any administration requiring a WD to determine if a medical event, as defined
in § 35.3045, has occurred. A licensee will retain a copy of these procedures in accordance
with § 35.2041. These written procedures are necessary to provide high confidence that each
administration is in accordance with the WD to ensure patient safety.
Paragraph 35.41(b)(6) requires licensees to develop, implement, and maintain written
procedures for permanent implant brachytherapy. The procedures must include determining
within 60 calendar days from the date the implant was performed, the total source strength
administered outside of the treatment site compared to the total source strength documented
in the post-implantation WD. A licensee will retain a copy of these procedures in accordance
with § 35.2041. These written procedures are necessary to provide high confidence that each
administration is in accordance with the WD to ensure patient safety.
Paragraph 35.41(c) requires the licensee to retain a copy of the procedures required by
§ 35.41(a) in accordance with § 35.2041. A description of the record and the need for the
record is provided under § 35.2041.
§ 35.50 Training for Radiation Safety Officer and Associate Radiation Safety Officer
An individual fulfilling the responsibilities of the RSO or an individual assigned duties and tasks
as an ARSO, as provided in § 35.24, is an individual who must meet one of the following
requirements: 1) be certified by a specialty board that is recognized by the NRC or an
Agreement State; or 2) must complete a structured educational program; or 3) be currently
recognized as an AU, AMP, or ANP, who has experience with the radiation safety aspects of
similar types of byproduct material for which the individual has RSO responsibilities. In
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addition to meeting one of these requirements, the individual must also obtain written
attestation signed by a preceptor RSO or ARSO, which attests that the individual has
satisfactorily completed all applicable training and education requirements, and can function
independently as an RSO or ARSO.
The training and supervised experience and the preceptor statement required by § 35.50 is
submitted as part of a licensee's application as required under §§ 35.12 or 35.13, and is
cleared under OMB Clearance No. 3150-0120.
If a specialty boards certification process meets the requirements in § 35.50(a) and (c)(1), the
board may apply to NRC or an Agreement State to have its certification process recognized
and its certified diplomates can use their certification as documentation of training and
experience. The board applies once for recognition, submits a copy of their certificate, and
periodically updates information if there are changes to the name of the board, the certification
process, or certificate. NRC- recognized specialty boards should contact the NRC if the board
is going to become inactive or disband. NRC- recognized specialty boards will participate in a
periodic evaluation of continued compliance. The procedures for recognizing, monitoring, and
terminating the certification process of specialty boards is available at
https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.
§ 35.51 Training for an authorized medical physicist
An individual fulfilling the responsibilities of the AMP must meet one of the following
requirements: 1) be certified by a specialty board that is recognized by the NRC or an
Agreement State; or 2) meet the educational requirements outlined in § 35.51(b)(1). In
addition to meeting one of these requirements, the individual must also obtain written
attestation that he or she has satisfactorily completed all applicable training and education
requirements and can function independently as an AMP. This requirement is necessary to
ensure that the individual has achieved a level of competency sufficient to function
independently as an AMP.
The training and supervised experience and the preceptor statement required by § 35.51 is
submitted as part of a licensee's application as required under §§ 35.12 or 35.13, and is
cleared under OMB Clearance No. 3150-0120.
If a specialty boards certification process meets the requirements in § 35.51(a), the board may
apply to NRC or an Agreement State to have its certification process recognized and its
certified diplomates can use their certification as documentation of training and experience.
The board applies once for recognition, submits a copy of their certificate, and periodically
updates information if there are changes to the name of the board, the certification process, or
certificate. NRC- recognized specialty boards should contact the NRC if the board is going to
become inactive or disband. NRC- recognized specialty boards will participate in a periodic
evaluation of continued compliance. The procedures for recognizing, monitoring, and
terminating the certification process of specialty boards is available at
https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.
§ 35.55 Training for an authorized nuclear pharmacist
An individual fulfilling the responsibilities of the ANP must be a pharmacist who meets one of
the following requirements: 1) be certified by a specialty board that is recognized by the NRC
or an Agreement State; or 2) meet the educational requirements outlined in § 35.55(b)(1). In
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addition to meeting one of these requirements, the individual must also obtain written
attestation that he or she has satisfactorily completed all applicable training and education
requirements and can function independently as an ANP. This requirement is necessary to
ensure that the individual has achieved a level of competency sufficient to function
independently as an ANP.
The training and supervised experience and the preceptor statement required by § 35.55 is
submitted as part of a licensee's application as required under §§ 35.12 or 35.13 and is cleared
under OMB Clearance No. 3150-0120.
If a specialty boards certification process meets the requirements in § 35.55(a), the board may
apply to NRC or an Agreement State to have its certification process recognized and its
certified diplomates can use their certification as documentation of training and experience.
The board applies once for recognition, submits a copy of their certificate, and periodically
updates information if there are changes to the name of the board, the certification process, or
certificate. NRC- recognized specialty boards should contact the NRC if the board is going to
become inactive or disband. NRC- recognized specialty boards will participate in a periodic
evaluation of continued compliance. The procedures for recognizing, monitoring, and
terminating the certification process of specialty boards is available at
https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.
§ 35.60 Possession, use, and calibration of instruments used to measure the activity of
byproduct material
Paragraph 35.60(c) requires licensees to retain a record of each instrument calibration
required by §35.60(b) in accordance with § 35.2060. A description of the contents of the
record and the need for the record is provided under § 35.2060.
§ 35.61 Calibration of survey instruments
Paragraph 35.61(a) requires that the licensee conspicuously note on a survey instrument the
date that the instrument was calibrated. This information is necessary to show that survey
instruments are calibrated and operational.
Paragraph 35.61(c) requires that licensees retain a record of each survey instrument
calibration in accordance with § 35.2061. A description of the contents of the record and the
need for the record is provided under § 35.2061.
§ 35.63 Determination of dosages of unsealed byproduct material for medical use
Paragraph 35.63(a) requires licensees to determine and record the activity of each dosage
before medical use. Paragraph 35.63(e) requires licensees to retain a record of each
radiopharmaceutical dosage determination in accordance with § 35.2063. A description of the
contents of the record and the need for the record is provided under § 35.2063.
§ 35.67 Requirements for possession of sealed sources and brachytherapy sources
Paragraph 35.67(b) requires licensees in possession of certain sealed sources to test the
sources for leakage. Paragraph 35.67(d) requires licensees to retain a record of sealed source
leak tests in accordance with § 35.2067(a). A description of the contents of the record and the
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need for the record is provided under § 35.2067(a).
Paragraph 35.67(e) (2) requires licensees to file a report with the NRC within 5 days in
accordance with § 35.3067 if leakage of a sealed source is detected. A description of the
contents and need for the report is provided under § 35.3067.
Paragraph 35.67(g) requires licensees in possession of sealed sources or brachytherapy
sources, except for gamma stereotactic radiosurgery sources, to conduct a semi-annual
physical inventory of all such sources in its possession and retain the inventory record in
accordance with § 35.2067. A description of the contents and need for the record is provided
under § 35.2067(b).
§ 35.69 Labeling of vials and syringes
Paragraph 35.69 requires that each syringe and vial that contains unsealed byproduct material
must be labeled, and that each syringe shield and vial shield must also be labeled unless the
label on the syringe or vial is visible when shielded. Labeling is needed because review of
misadministration/medical event reports has indicated that in many cases
misadministrations/medical events are caused by inadvertent transposition of syringes or by
drawing a dosage from the wrong vial of byproduct material.
§ 35.70 Surveys for ambient radiation exposure rate
This section requires licensees to survey with a radiation detection survey instrument at the
end of each day of use all areas where unsealed byproduct material requiring a written
directive was prepared for use or administered. Licensees are required to retain a record of
each survey in accordance with § 35.2070. A description of the contents of the record and the
need for the record is provided under § 35.2070.
§ 35.75 Release of individuals containing unsealed byproduct material or implants containing
byproduct material
Paragraph 35.75(b) requires licensees to provide an individual who has been administered
unsealed byproduct material or implants containing byproduct material and who is being
released from the licensee's control in accordance with § 35.75(a) with instructions on actions
recommended to maintain doses to other individuals as low as is reasonably achievable if the
total effective dose equivalent to any other individual is likely to exceed 1 mSv (0.1 rem). The
licensee must provide special instructions to the released individual if the total effective dose
equivalent to a nursing infant or child could exceed 1 mSv (0.1 rem), assuming there is no
interruption of breast feeding. These instructions are needed to ensure that the released
individual is aware of the actions recommended to maintain doses to other persons as low as
reasonably achievable.
Paragraph 35.75(c) requires licensees to maintain a record of the basis for authorizing the
release of an individual, in accordance with § 35.2075(a). A description of the contents of the
records and a statement of need for the records is provided under § 35.2075.
Paragraph 35.75(d) requires licensees to maintain a record of the instructions that were
provided to breast-feeding women in accordance with § 35.2075(b). A description of the
contents of the record and a statement of need for the record is provided under § 35.2075.
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§ 35.80 Provision of mobile service
Paragraph 35.80(a)(1) requires a licensee providing mobile service to obtain a letter signed by
the management of each client that permits the use of byproduct material at the client's
address and delineates the authority and responsibility of the licensee and the client. This
record is necessary to show that the client's management has permitted this work and to
clearly delineate the authority and responsibilities of each entity. Paragraph 35.80(a)(4)
requires a mobile service licensee to survey all areas of use before leaving a client’s address to
ensure compliance with the requirements of Part 20.
Paragraph 35.80(c) requires that the letter required in § 35.80(a)(1) and a record of the surveys
required in § 35.80(a)(4) be retained in accordance with § 35.2080. A description of the
contents of the record and the need for the record is provided under § 35.2080 (a) and (b).
§ 35.92 Decay-in-storage
Paragraph 35.92(b) requires licensees to retain a record of disposal of waste that was decayed
in storage and retain the record in accordance with § 35.2092. A description of the contents of
the record and the need for the record is provided under § 35.2092.
§ 35.190 Training for uptake, dilution, and excretion studies
An individual fulfilling the responsibilities of an AU of unsealed byproduct material for uses
authorized under § 35.100 must be a physician who meets one of the following requirements:
1) be certified by a medical specialty board whose certification process includes all of the
requirements of § 35.190(a) and whose certification has been recognized by the Commission
or an Agreement State, or 2) be an AU under §§ 35.290 or 35.390, or equivalent Agreement
State requirements, or 3) meet the training and experience requirements specified in
§ 35.190(c)(1). In addition to meeting one of these requirements, the individual must also
obtain written attestation that he or she has satisfactorily completed all applicable training and
education requirements and can function independently as an AU of unsealed byproduct
material for use authorized under § 35.100. This requirement is necessary to ensure that the
individual has achieved a level of competency sufficient to function independently as an AU for
uses under § 35.100.
The training and supervised experience and the preceptor statement required by § 35.190 is
submitted as part of a licensee's application as required under §§ 35.12 or 35.13 and is cleared
under OMB Clearance No. 3150-0120.
If a specialty boards certification process meets the requirements in § 35.190(a), the board
may apply to NRC or an Agreement State to have its certification process recognized and its
certified diplomates can use their certification as documentation of training and experience.
The board applies once for recognition, submits a copy of their certificate, and periodically
updates information if there are changes to the name of the board, the certification process, or
certificate. NRC- recognized specialty boards should contact the NRC if the board is going to
become inactive or disband. NRC- recognized specialty boards will participate in a periodic
evaluation of continued compliance. The procedures for recognizing, monitoring, and
terminating the certification process of specialty boards is available at
https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.
§ 35.204 Permissible molybdenum-99 concentration
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Paragraph 35.204(d) requires that if a licensee is required to measure the molybdenum-99
concentration or strontium-82 and strontium-85 concentrations, the licensee shall retain a
record of each measurement in accordance with § 35.2204.
Section 35.204(e) requires licensees to report any measurement that exceeded the limits
specified in § 35.204(a) for Mo-99/Tc-99m and strontium-82 (Sr-82)/rubidium-82 (Rb-82)
generators. Although current regulations require licensees to measure Mo-99, Sr-82, and
strontium-85 (Sr-85) concentrations and record the results, there is no provision to report
when a result exceeds the regulatory limits. Reporting will be in accordance with the reporting
and notification requirements in § 35.3204. This reporting requirement will provide information
that will allow the NRC to respond to the potential patient safety issue in a timely manner.
§ 35.290 Training for imaging and localization studies
An individual fulfilling the responsibilities of an AU of unsealed byproduct material for uses
authorized under § 35.200 must be a physician who meets one of the following requirements:
1) be certified by a medical specialty board whose certification process has been recognized by
the Commission or an Agreement State; or 2) be an AU under §35.390 and meet the
requirements in § 35.290(c)(1)(ii)(G) or equivalent Agreement State requirements; or 3)
complete the training and experience requirements in § 35.290(c)(1). In addition to meeting
one of these requirements, the individual must also obtain written attestation that he or she has
satisfactorily completed all applicable training and education requirements and can function
independently as an AU of unsealed byproduct material for use authorized under § 35.200.
This requirement is necessary to ensure that the individual has achieved a level of competency
sufficient to function independently as an AU under § 35.200.
The training and supervised experience and the preceptor statement required by § 35.290 is
submitted as part of a licensee's application as required under §§ 35.12 or 35.13 and is cleared
under OMB Clearance No. 3150-0120.
If a specialty boards certification process meets the requirements in § 35.290(a), the board
may apply to NRC or an Agreement State to have its certification process recognized and its
certified diplomates can use their certification as documentation of training and experience.
The board applies once for recognition, submits a copy of their certificate, and periodically
updates information if there are changes to the name of the board, the certification process, or
certificate. NRC- recognized specialty boards should contact the NRC if the board is going to
become inactive or disband. NRC- recognized specialty boards will participate in a periodic
evaluation of continued compliance. The procedures for recognizing, monitoring, and
terminating the certification process of specialty boards is available at
https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.
§ 35.310 Safety instruction
Paragraph 35.310(a) requires that licensees provide safety instruction, initially and at least
annually, to personnel caring for patients or human research subjects that have received
therapy with unsealed byproduct material and cannot be released in accordance with § 35.75.
This instruction is needed to ensure that personnel receive instruction in (1) limiting radiation
exposure to the public and workers, and (2) the actions to be taken in the event of death or
medical emergency.
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Paragraph 35.310(b) requires licensees to retain a record of individuals receiving instruction
required by § 35.310(a) in accordance with § 35.2310. A description of the contents of the
record and the need for the record are provided under § 35.2310.
§ 35.315 Safety precautions
Paragraph 35.315(a) (2) requires that the licensee post the room of a patient or human
research subject who cannot be released in accordance with § 35.75 with a "Radioactive
Materials" sign. Paragraph 35.315(a) (3) requires a licensee to note on the door or in the
patient's chart indicating where and how long visitors may stay in the patient's room. This
posting and note are required so that employees and visitors receive information necessary for
radiation safety.

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Paragraph 35.315(b) requires that the licensee promptly notify the RSO, or his or her
designee, and the AU as soon as possible if the patient has a medical emergency or dies. This
notification is required so that the RSO, or his or her designee, or AU can take whatever
actions are necessary for radiation safety.
§ 35.390 Training for use of unsealed byproduct material for which a written directive is
required
An individual fulfilling the responsibilities of an AU of unsealed byproduct material for uses
authorized under § 35.300 must be a physician who meets one of the following requirements:
1) be certified by a medical specialty board whose certification process has been recognized
by the Commission or an Agreement State; or 2) complete all the training and supervised
experience requirements in § 35.390(b) (1). In addition to meeting one of these requirements,
the individual must also obtain written attestation that he or she has satisfactorily completed all
applicable training and education requirements and can function independently as an AU of
unsealed byproduct material for uses authorized under § 35.300. This requirement is
necessary to ensure that the individual has achieved a level of competency sufficient to
function independently as an AU under §35.300.
The training and supervised experience and the preceptor statement required by §35.390 is
submitted as part of a licensee's application as required under §§ 35.12 or 35.13 and is cleared
under OMB Clearance No. 3150-0120.
If a specialty boards certification process meets the requirements in § 35.390(a), the board
may apply to NRC or an Agreement State to have its certification process recognized and its
certified diplomates can use their certification as documentation of training and experience.
The board applies once for recognition, submits a copy of their certificate, and periodically
updates information if there are changes to the name of the board, the certification process, or
certificate. NRC- recognized specialty boards should contact the NRC if the board is going to
become inactive or disband. NRC- recognized specialty boards will participate in a periodic
evaluation of continued compliance. The procedures for recognizing, monitoring, and
terminating the certification process of specialty boards is available at
https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.
§ 35.392 Training for oral administration of sodium iodide I-131 requiring a written directive in
quantities less than or equal to 1.22 Gigabecquerels (33 millicuries)
An individual fulfilling the responsibilities of an AU of unsealed byproduct material for the oral
administration of sodium iodide I-131 requiring a written directive in quantities less than or
equal to 1.22 Gigabecquerels (33 millicuries) must be a physician who meets one of the
following requirements: 1) be certified by a medical specialty board whose certification process
has been recognized by the Commission or an Agreement State; or 2) be an AU in accordance
with § 35.392(b); or 3) has completed all the training and supervised experience requirements
in § 35.392(c)(1). In addition to meeting one of these requirements, the individual must also
obtain written attestation that he or she has satisfactorily completed all applicable training and
education requirements and can function independently as an AU of unsealed byproduct
material for the oral administration of sodium iodide I-131 requiring a written directive in
quantities less than or equal to 1.22 Gigabecquerels (33 millicuries). This requirement is
necessary to ensure that the individual has achieved a level of competency sufficient to
function independently as an AU for the administration of sodium iodide I-131.
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The training and supervised experience and the preceptor statement required by §35.392 is
submitted as part of a licensee's application as required under §§ 35.12 or 35.13 and is cleared
under OMB Clearance No. 3150-0120.
If a specialty boards certification process meets the requirements in § 35.392(a), the board
may apply to NRC or an Agreement State to have its certification process recognized and its
certified diplomates can use their certification as documentation of training and experience.
The board applies once for recognition, submits a copy of their certificate, and periodically
updates information if there are changes to the name of the board, the certification process, or
certificate. NRC- recognized specialty boards should contact the NRC if the board is going to
become inactive or disband. NRC- recognized specialty boards will participate in a periodic
evaluation of continued compliance. The procedures for recognizing, monitoring, and
terminating the certification process of specialty boards is available at
https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.
§ 35.394 Training for the oral administration of sodium iodide I-131 requiring a written directive
in quantities greater than 1.22 Gigabecquerels (33 millicuries)
An individual fulfilling the responsibilities of an AU of unsealed byproduct material for the oral
administration of sodium iodide I-131 requiring a written directive in quantities greater than 1.22
Gigabecquerels (33 millicuries) must be a physician who meets one of the following
requirements: 1) be certified by a medical specialty board whose certification process has
been recognized by the Commission or an Agreement State; or 2) be an AU in accordance with
§35.390 for uses listed under 35.390(b)(1)(ii)(G)(2); or 3) has completed all the training and
supervised experience requirements in § 35.394(c)(1). In addition to meeting one of these
requirements, the individual must also obtain written attestation that he or she has satisfactorily
completed all applicable training and education requirements and can function independently
as an AU of unsealed byproduct material for the oral administration of sodium iodide I-131
requiring a written directive in quantities greater than 1.22 Gigabecquerels (33 millicuries).
This requirement is necessary to ensure that the individual has achieved a level of competency
sufficient to function independently as an AU for the administration of sodium iodide I-131.
The training and supervised experience and the preceptor statement required by § 35.394 is
submitted as part of a licensee's application as required under §§ 35.12 or 35.13 and is cleared
under OMB Clearance No. 3150-0120.
If a specialty boards certification process meets the requirements in § 35.394(a), the board
may apply to NRC or an Agreement State to have its certification process recognized and its
certified diplomates can use their certification as documentation of training and experience.
The board applies once for recognition, submits a copy of their certificate, and periodically
updates information if there are changes to the name of the board, the certification process, or
certificate. NRC- recognized specialty boards should contact the NRC if the board is going to
become inactive or disband. NRC- recognized specialty boards will participate in a periodic
evaluation of continued compliance. The procedures for recognizing, monitoring, and
terminating the certification process of specialty boards is available at
https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.
§ 35.396 Training for the parenteral administration of unsealed byproduct material requiring a
written directive
An individual fulfilling the responsibilities of an AU of unsealed byproduct material for
parenteral administration requiring a written directive must be a physician who meets one of
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the following requirements: 1) be an AU under § 35.390 for uses listed in
§§ 35.390(b)(1)(ii)(G)(3), or equivalent Agreement State requirements; or 2) be an AU under §§
35.490, 35.690, or equivalent Agreement State requirements and who has completed all the
requirements in § 35.396 (d) of this section which includes obtaining a written attestation that
he or she has satisfactorily completed all applicable training and education requirements and
can function independently as an AU for parenteral administration of unsealed byproduct
material requiring a written directive. This requirement is necessary to ensure that the
individual has achieved a level of competency sufficient to function independently as an AU for
the parenteral administration of unsealed byproduct material requiring a written directive.
The training and supervised experience and the preceptor statement required by § 35.396 is
submitted as part of a licensee's application as required under §§ 35.12 or 35.13 and is cleared
under OMB Clearance No. 3150-0120.
§ 35.404 Surveys after source implant and removal
Paragraph 35.404(c) requires that, in accordance with § 35.2404, licensees retain a record of
surveys to locate and account for all sources that have not been implanted and, after implant
removal, to confirm that all sources have been removed. These surveys a r e required by
§§ 35.404(a) and (b). A description of the contents of the record and the need for the record is
provided under § 35.2404.
§ 35.406 Brachytherapy sources accountability
Paragraph 35.406(c) requires licensees to make a record of brachytherapy source
accountability in accordance with § 35.2406. A description of the contents of the record and
the need for the record is provided under § 35.2406.
§ 35.410 Safety instruction
Paragraph 35.410(a) requires licensees to provide safety instruction, initially and at least
annually, to personnel caring for patients or human research subjects that are receiving
brachytherapy and cannot be released in accordance with § 35.75. This instruction is needed
to ensure that personnel receive instruction in (1) limiting radiation exposure to the public and
workers and (2) the actions to be taken in the event of death or medical emergency.
Paragraph 35.410(b) requires licensees to retain a record of radiation safety instruction for
personnel who care for patients or human research subjects who are undergoing implant
therapy, in accordance with § 35.2310. A description of the contents of the record and the
need for the record is provided under § 35.2310.
§ 35.415 Safety precautions
Paragraph 35.415(a) requires that the licensee post the patient's or human research subject’s
room with a "Radioactive Materials" sign and note on the door or in the patient's or human
research subject’s chart where and how long visitors may stay in the room. This posting
provides notice to control radiation exposures to hospital workers and the public.
Paragraph 35.415(c) requires that the licensee notify the RSO, or his or her designee, and AU
as soon as possible if the patient or human research subject has a medical emergency or dies.
This notification is required so that the RSO, or his or her designee, or AU can take whatever
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actions are necessary for radiation safety.
§ 35.432 Calibration measurements of brachytherapy sources
Paragraph 35.432(d) requires licensees to retain a record of calibration measurements made
on brachytherapy sealed sources in accordance with § 35.2432. A description of the contents
of the record and the need for the record is provided under § 35.2432.
§ 35.433 Decay of strontium-90 sources for ophthalmic treatments
Paragraph 35.433 (b) requires licensees to retain a record of the activity of each strontium-90
source used for ophthalmic treatment in accordance with § 35.2433. A description of the
contents of the record and the need for the record is provided under § 35.2433.
§ 35.490 Training for use of manual brachytherapy sources
An individual fulfilling the responsibilities of an AU of a manual brachytherapy source for uses
under § 35.400 must be a physician who meets one of the following requirements: 1) be
certified by a medical specialty board whose certification process has been recognized by the
Commission or an Agreement State; or 2) meet all the supervised training and experience
requirements in § 35.490(b) (1). In addition to meeting one of these requirements, the
individual must also obtain written attestation that he or she has satisfactorily completed all
applicable training and education requirements and can function independently as an AU for
uses under § 35.400. This requirement is necessary to ensure that the individual has achieved
a level of competency sufficient to function independently as an AU for uses under § 35.400.
The training and supervised experience and the preceptor statement required by § 35.490 is
submitted as part of a licensee's application as required under §§ 35.12 or 35.13 and is cleared
under OMB Clearance No. 3150-0120.
If a specialty boards certification process meets the requirements in § 35.490(a), the board
may apply to NRC or an Agreement State to have its certification process recognized and its
certified diplomates can use their certification as documentation of training and experience.
The board applies once for recognition, submits a copy of their certificate, and periodically
updates information if there are changes to the name of the board, the certification process, or
certificate. NRC- recognized specialty boards should contact the NRC if the board is going to
become inactive or disband. NRC- recognized specialty boards will participate in a periodic
evaluation of continued compliance. The procedures for recognizing, monitoring, and
terminating the certification process of specialty boards is available at
https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.
§ 35.491 Training for ophthalmic use of strontium-90
An individual fulfilling the responsibilities of an AU of strontium-90 for ophthalmic radiotherapy
must be a physician who meets one of the following requirements: 1) is an AU in accordance
with § 35.491(a); or 2) meets all the supervised training and experience requirements in
§ 35.491(b) (1). In addition to meeting one of these requirements, the individual must also
obtain written attestation that he or she has satisfactorily completed all applicable training and
education requirements and can function independently as an AU of strontium-90 for
ophthalmic uses. This requirement is necessary to ensure that the individual has achieved a
level of competency sufficient to function independently as an AU of strontium-90 for
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ophthalmic uses.
The training and supervised experience and the preceptor statement required by § 35.491 is
submitted as part of a licensee's application as required under §§ 35.12 or 35.13 and is cleared
under OMB Clearance No. 3150-0120.
§ 35.590 Training for use of sealed sources for diagnosis
An individual fulfilling the responsibilities of an AU of diagnostic sealed sources for use in a
device authorized under § 35.500 must be a physician, dentist, or podiatrist who meets one of
the following requirements: 1) be certified by a medical specialty board whose certification
process has been recognized by the Commission or an Agreement State; or 1) meets all the
training and experience requirements in § 35.590(b). This requirement is necessary to ensure
that the individual has achieved a level of competency sufficient to function independently as
an AU of diagnostic sealed sources for use in a device authorized under § 35.500.

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The training and experience required by § 35.590 is submitted as part of a licensee's
application as required under §§ 35.12 or 35.13 and is cleared under OMB Clearance
No. 3150-0120.
If a specialty boards certification process meets the requirements in § 35.590(a), the board
may apply to NRC or an Agreement State to have its certification process recognized and its
certified diplomates can use their certification as documentation of training and experience.
The board applies once for recognition, submits a copy of their certificate, and periodically
updates information if there are changes to the name of the board, the certification process, or
certificate. NRC- recognized specialty boards should contact the NRC if the board is going to
become inactive or disband. NRC- recognized specialty boards will participate in a periodic
evaluation of continued compliance. The procedures for recognizing, monitoring, and
terminating the certification process of specialty boards is available at
https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.
§ 35.604 Surveys of patients and human research subjects treated with a remote afterloader
unit
Paragraph 35.604(a) requires licensees who use sealed sources in remote afterloader units,
before releasing a patient or human research subject from licensee control, to make a survey
of the patient or human research subject and the remote afterloader unit with a portable
radiation detection survey instrument to confirm that the source(s) has been removed from the
patient or human research subject and returned to the safe shielded position. Paragraph
35.604 (b) requires the licensee to retain a record of the survey required by paragraph
35.604(a) in accordance with § 35.2404. A description of the contents of the record and the
need for the record is provided under § 35.2404.
§ 35.605 Installation, maintenance, adjustment, and repair
Paragraph 35.605(d) requires licensees to retain a record of each installation, maintenance,
adjustment, and repair of remote afterloader units, teletherapy units, and gamma stereotactic
radiosurgery units in accordance with § 35.2605. A description of the contents of the record
and the need for the record is provided under § 35.2605.
§ 35.610 Safety procedures and instructions for remote afterloader units, teletherapy units, and
gamma stereotactic radiosurgery units
Paragraph 35.610(a) (4) requires licensees to develop, implement, and maintain written
procedures for responding to an abnormal situation. These procedures are necessary
because of the complexity and higher radiation risk associated with therapeutic treatment
devices.
Paragraph 35.610(b) requires licensees to physically locate a copy of the procedures at the
unit console. These safety procedures are necessary to ensure that workers at the console
have physical access to the procedures.
Paragraph 35.610(c) requires licensees to post instructions for individuals who operate the
devices at the device console providing the location of the procedures and emergency names
and telephone numbers. These instructions are necessary to inform workers of the procedures
and to serve as a quick reference in case of emergencies or equipment malfunction.
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Paragraph 35.610(d)(1) requires all individuals who will operate remote afterloader units,
teletherapy units, and gamma stereotactic radiosurgery units to receive vendor operational
and safety training prior to the first use for patient treatment of a new unit or an existing unit
with a manufacturer upgrade that affects the operation and safety of the unit. The training
must be provided by the device manufacturer or by individuals certified by the device
manufacturer to provide the training. This training is necessary to ensure that operators of
these devices have adequate training to protect patient safety.
Paragraph 35.610(d)(2) requires licensees to provide initial instruction and annual refresher
instruction to all individuals who operate the unit in the procedures identified in § 35.610(a)
and the operating procedures for the unit. The initial instruction and refresher instruction are
necessary due to the complexity of therapeutic treatment devices.
Paragraph 35.610(e) requires licensees to ensure that operators, AMPs, and AUs participate in
drills of the emergency procedures, initially and at least annually. The drills are necessary
because of the complexity and higher radiation risk associated with therapeutic treatment
devices.
Paragraph 35.610(f) requires licensees to make a record of initial instruction and refresher
training for individuals who operate the units and to retain the record in accordance with
§ 35.2310. A description of the contents of the record and the need for the record is provided
under § 35.2310.
Paragraph 35.610(g) requires licensees to retain a copy of the procedures required by
§ 35.610(a) (4) and (d) (2) in accordance with § 35.2610. A description of the need for the
record is provided under § 35.2610.
§ 35.615 Safety precautions for remote afterloader units, teletherapy units, and gamma
stereotactic radiosurgery units
Paragraph 35.615(f) (4) requires a licensee to notify the RSO, or his/her designee, and an AU
as soon as possible if the patient or human research subject has a medical emergency or dies.
This notification is required so that the RSO, or his/her designee, or AU can take whatever
actions are necessary for radiation safety.
§ 35.630 Dosimetry equipment
Paragraph 35.630(c) requires licensees to retain a record of each calibration, intercomparison,
and comparison of dosimetry equipment in accordance with § 35.2630. A description of the
contents of the record and the need for the record is provided under § 35.2630.
§ 35.632 Full calibration measurements on teletherapy units
Paragraph 35.632(g) requires licensees to retain a record of each calibration in accordance
with § 35.2632. A description of the contents of the record and the need for the record is
provided under § 35.2632.
§ 35.633 Full calibration measurements on remote afterloader units
Paragraph 35.633(i) requires licensees to retain a record of each calibration in accordance with
§ 35.2632. A description of the contents of the record and the need for the record is provided
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under §35.2632.
§ 35.635 Full calibration measurements on gamma stereotactic radiosurgery units
Paragraph 35.635(g) requires licensees to retain a record of each calibration in accordance
with § 35.2632. A description of the contents of the record and the need for the record is
provided under § 35.2632.
§ 35.642 Periodic spot-checks for teletherapy units
Paragraph 35.642(b) requires licensees to perform spot check measurements in accordance
with written procedures established by the AMP. Written procedures are necessary to ensure
that the spot-checks are performed correctly and consistently.
Paragraph 35.642(c) requires that the AMP review the results of each spot-check and notify
the licensee in writing of the results of each spot checks. The written notification is needed to
ensure that the licensee is aware of the results of each spot-check and aware of the
performance of the unit, so that patients are not administered incorrect doses.
Paragraph 35.642(f) requires licensees to retain a record of each spot-check required by
§ 35.642(a) and (d), and a copy of the spot-check procedures required by § 35.642(b), in
accordance with § 35.2642. A description of the contents of these records and the need for the
records is provided under § 35.2642.
§ 35.643 Periodic spot-checks for remote afterloader units
Paragraph 35.643(b) requires licensees to perform spot check measurements in accordance
with written procedures established by the AMP. Written procedures are necessary to ensure
that the spot-checks are performed correctly and consistently.
Paragraph 35.643(c) requires licensees to have the AMP review the results of each spot-check
required by paragraph (a) within 15 days of the check and to notify the licensee as soon as
possible in writing of the results of each spot check. The written notification is needed to
ensure that the licensee is aware of the results of each spot- check and aware of the
performance of the unit, so that patients are not administered incorrect doses.
Paragraph 35.643(f) requires licensees to retain a record of each spot-check required by
§ 35.643(d), and a copy of the spot-check procedures required by § 35.643(b), in accordance
with § 35.2643. A description of the contents of these records and the need for the records is
provided under § 35.2643.
§ 35.645 Periodic spot-checks for gamma stereotactic radiosurgery units
Paragraph 35.645(b) (1) requires licensees to perform spot-check measurements in
accordance with written procedures established by the AMP. The AMP is the most qualified
individual to ensure that the procedures are performed in accordance with published
recommendations of nationally recognized bodies. Written procedures are necessary to
ensure that spot-checks are performed correctly and consistently.
Paragraph 35.645(b) (2) requires licensees to have the AMP review the results of each spotcheck of a gamma stereotactic radiosurgery unit within 15 days of each spot-check and to
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notify the licensee as soon as possible in writing the results of each spot-check.
The written notification is needed to ensure that the licensee is aware of the results of each
spot-check and aware of the performance of the unit, so that patients are not administered
incorrect doses.
Paragraph 35.645(g) requires licensees to retain a record of each spot-check required by
§ 35.645(c) and (d), and a copy of the spot-check procedures required by § 35.645(b), in
accordance with § 35.2645. A description of the contents of these records and the need for the
records is provided under § 35.2645.
§ 35.647 Additional technical requirements for mobile remote afterloaders
Paragraph 35.647(e) requires licensees to retain a record of each check of mobile remote
afterloaders before use at each address of use, as required by § 35.647(b), in accordance with
§ 35.2547. A description of the contents of the record and the need for the record is provided
under § 35.2647.
§ 35.652 Radiation surveys
Paragraph 35.652(a) requires licensees to make radiation surveys to ensure that radiation
levels do not exceed levels stated in the Sealed Source and Device Registry. Paragraph
§ 35.652(c) requires licensees to retain a record of the radiation surveys in accordance with
§ 35.2652. A description of the contents of the record and the need for the record is provided
under § 35.2652.
§ 35.655 5-year inspection for teletherapy and gamma stereotactic radiosurgery units
Paragraph 35.655(c) requires licensees to keep a record of the teletherapy unit and gamma
stereotactic radiosurgery unit 5-year inspection and servicing required by § 35.655(a) in
accordance with § 35.2655. A description of the contents of the record and the need for the
record is provided under § 35.2655.
§ 35.690 Training for use of remote afterloader units, teletherapy units, and gamma
stereotactic radiosurgery units
An individual fulfilling the responsibilities of an AU of a remote afterloader unit, or teletherapy
unit, or gamma stereotactic radiosurgery unit must be a physician who meets one of the
following requirements: 1) be certified by a medical specialty board whose certification process
has been recognized by the Commission or an Agreement State; or) meet all the supervised
training and experience requirements in § 35.690(b) (1). In addition to meeting one of these
requirements, the individual must also obtain written attestation that he or she has satisfactorily
completed all applicable training and education requirements and can function independently
as an AU of a remote afterloader unit, or teletherapy unit, or gamma stereotactic radiosurgery
uniT. This requirement is necessary to ensure that the individual has achieved a level of
competency sufficient to function independently as an AU of a remote afterloader unit, or
teletherapy unit, or gamma stereotactic radiosurgery unit.
The training and experience required by § 35.690 is submitted as part of a licensee's
application as required under §§ 35.12 or 35.13 and is cleared under OMB Clearance
No. 3150-0120.
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If a specialty boards certification process meets the requirements in § 35.690(a), the board
may apply to the NRC or an Agreement State to have its certification process recognized and
its certified diplomates can use their certification as documentation of training and experience.
The board applies once for recognition, submits a copy of their certificate, and periodically
updates information if there are changes to the name of the board, the certification process, or
certificate. NRC- recognized specialty boards should contact the NRC if the board is going to
become inactive or disband. NRC- recognized specialty boards will participate in a periodic
evaluation of continued compliance. The procedures for recognizing, monitoring, and
terminating the certification process of specialty boards is available at
https://www.nrc.gov/materials/miau/med-use-toolkit/spec-board-cert.html.
§ 35.1000 Other medical uses of byproduct material or radiation from byproduct material
Paragraph 35.1000(a) provides that a licensee may use byproduct material or a radiation
source approved for medical use which is not specifically addressed in subparts D through H of
Part 35 if the applicant or licensee has submitted the information required by § 35.12(b)
through (d) and has received written approval from the Commission.
The burden for Paragraphs 35.12 (b) through (d) is cleared under OMB Clearance
No. 3150-0120, which should be referred to for additional supporting information, burden, and
cost data.
§ 35.2024 Records of authority and responsibilities for radiation protection programs
Paragraph 35.2024(a) requires licensees to retain a record of actions taken by the licensee’s
management in accordance with § 35.24(a) for 5 years. This record must include a summary
of actions taken and the signature of licensee management for requests for license application,
renewal, or amendment; approvals or disapprovals of requests to allow an individual to work as
an AU, ANP, or AMP; and approval or disapproval of radiation protection program changes that
do not require an amendment. This record is needed to establish a written record of these
actions and the basis for them because it is important to document the licensee’s management
review and approval of licensing actions and changes to the radiation protection program.
Paragraph 35.2024(b) requires licensees to retain a copy of both the authority, duties, and
responsibilities of the RSO as required by § 35.24(e), and a signed copy of each RSOs
agreement to be responsible for implementing the radiation safety program, as required by §
34.24(b), for the duration of the license. The records must include the signature of the RSO
and licensee management. These records are important to show that the RSO has sufficient
authority, time, resources, and management prerogative to ensure that radiation safety
activities are being performed in accordance with licensee- approved procedures and
regulatory requirements.
Section 35.2024(c) requires the licensee to keep the written documents signed by the
licensee’s management for each ARSO appointed under § 35.24(b) for 5 years after the
ARSO is removed from the license. These records are important to show that the ARSO had
sufficient authority, time, resources, and management prerogative to ensure that radiation
safety activities were being performed in accordance with licensee-approved procedures and
regulatory requirements.
§ 35.2026 Records of radiation protection program changes
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This section requires licensees to retain a record of each radiation protection program change
made in accordance with § 35.26(a) for 5 years. The record must include a copy of the old and
new procedures, the effective date of the change, and the signature of the licensee
management that reviewed and approved the change. This record facilitates the
Commission's evaluation of the nature and appropriateness of the minor changes during
inspections prior to renewal and provides the licensee with a complete record of the radiation
safety program changes until the changes are incorporated into the license when renewed.

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§ 35.2040 Records of written directives
This section requires licensees to retain a copy of each written directive as required by
§ 35.40 for 3 years. Retention of the written directives and records of each administration for 3
years after the date of the administration will allow NRC to ensure that administrations were in
accordance with the written directives by reviewing a sample of written directives and records
of administrations during an NRC inspection.
§ 35.2041 Records for procedures for administrations requiring a written directive
This section requires licensees to retain a copy of the procedures for administrations requiring
a written directive, required by § 35.41, for the duration of the license. Retention of these
procedures for the duration of the license will allow NRC to investigate events where an
administered dose or dosage was not in accordance with the written directive.
§ 35.2060 Records of calibrations of instruments to measure the activity of unsealed byproduct
material
This section requires licensees to maintain a record of instrument calibrations required by
§ 35.60 for 3 years. The records must include the model and serial number of the instrument,
the date of calibration, the results of the calibration, and the name of the individual who
performed the calibration. The records of the calibrations required in § 35.60 are necessary to
demonstrate that the instruments used to measure the activity of alpha-, beta-, and photonemitting radionuclides are functioning correctly and are capable of accurately measuring
dosages; to establish trends in equipment performance; and to show compliance with
regulatory requirements.
§ 35.2061 Records of radiation survey instrument calibrations
This section requires licensees to maintain a record of radiation survey instrument calibrations
required by § 35.61 for 3 years. The record must include the model and serial number of the
instrument, the date of calibration, the results of the calibration, and the name of the individual
who performed the calibration. This survey instrument calibration record is required to show
that survey instruments were calibrated and are functioning correctly.
§ 35.2063 Records of dosages of unsealed byproduct material for medical use
This section requires licensees to maintain a record of dosage determinations required by
§ 35.63 for 3 years. The record must contain: the radiopharmaceutical; the patient's or human
research subject's name, or identification number if one has been assigned; the prescribed
dosage, the determined dosage, or a notation that the total activity is less than 1.1
megabecquerels (30 microcuries); the date and time of the dosage determination; and the
name of the individual who determined the dosage. This record is required to demonstrate that
the prescribed dosage was obtained for administration to the patient or human research
subject.
§ 35.2067 Records of leak tests and inventory of sealed sources and brachytherapy sources
Paragraph 35.2067(a) requires licensees to retain records of leak tests required by
§ 35.67(b) for 3 years. The records must include the model number and serial number, if one
has been assigned, of each source tested; the identity of each source by radionuclide and its
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estimated activity; the results of the test; the date of the test; and the name of the individual
who performed the test. This record is required to demonstrate that the leak test was done as
required, and that the source was not leaking.
Paragraph 35.2067(b) requires that licensees retain records of the semi-annual physical
inventory of sealed sources and brachytherapy sources required by § 35.67(g) for 3 years.
The inventory records must contain the model number of each source, and serial number, if
one has been assigned; the identity of each source by radionuclide and its nominal activity; the
location of each source; and the name of the individual who performed the inventory. This
inventory record is needed to show that all sealed sources are accounted for.
§ 35.2070 Records of surveys for ambient radiation exposure rate
This section requires a licensee to retain a record of each survey required by § 35.70 for 3
years. The record must include the date of the survey, the results of the survey, the instrument
used to make the survey, and the name of the individual who performed the survey. The
records are needed to document that the surveys were performed, and that the ambient
radiation exposure rates are below the limits set for protection of workers and the public.
§ 35.2075 Records of the release of individuals containing unsealed byproduct material or
implants containing byproduct material
Paragraph 35.2075(a) requires licensees to retain a record of the basis for authorizing the
release of an individual in accordance with § 35.75, if the total effective dose equivalent is
calculated by: using the retained activity rather than the activity administered; using an
occupancy factor less than 0.25 at 1 meter; using the biological or effective half-life; or
considering the shielding by tissue. These records are necessary to document the basis for
releasing individuals containing radiopharmaceuticals or implants from the control of licensees,
and into situations where they could expose members of the general public.
Paragraph 35.2075(b) requires licensees to retain a record that the instructions required by
§ 35.75(b) were provided to a breast-feeding female if the radiation dose to the infant or child
from continued breast-feeding could result in a total effective dose equivalent exceeding 5
millisievert (0.5 rem). This record is necessary to show that nursing mothers have been
provided with necessary information for the protection of an infant or child.
Paragraph 35.2075(c) requires licensees to retain the records required by paragraphs (a) and
(b) of this section for 3 years after the date of release of the individual. Retention of the
release records for 3 years after the date of the release will allow the NRC to ensure that
releases were in accordance with the criteria for release by reviewing a sample of the records
during an NRC inspection.
§ 35.2080 Records of mobile medical services
Paragraph 35.2080(a) requires licensees providing mobile medical services to retain a copy of
each letter that permits the use of byproduct material at a client’s address, as required by
§ 35.80(a) (1). Each letter must clearly delineate the authority and responsibility of the licensee
and the client and must be retained for 3 years after the last provision of service. These
records are necessary to show that the licensees had permission to use byproduct material at
the client's address of use and to document the authority and responsibility of the licensee and
the client.
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Paragraph 35.2080(b) requires licensees to maintain a record of each survey required by
§ 35.80(a) (4) for 3 years. The record must include the date of the survey, the results of the
survey, the instrument used to make the survey, and the name of the individual who performed
the survey. These records are needed to show that the required surveys were made to ensure
compliance with the radiation protection requirements of 10 CFR Part 20.
§ 35.2092 Records of decay-in-storage
This section requires licensees to retain records of the disposal of licensed materials, as
required by § 35.92 for 3 years. The record must include the date of disposal, the survey
instrument used, the background radiation level, the radiation level measured at the surface of
each waste container, and the name of the individual who performed the survey. These
records are needed to show that the radioactivity of the materials that are disposed of as
ordinary waste cannot be distinguished from background radiation levels, and that a proper
survey was made at the surface of the byproduct material prior to disposal.
§ 35.2204 Records of molybdenum-99 concentrations
This section requires licensees to maintain records of molybdenum-99 concentration tests
required by § 35.204(b) for 3 years. The record must include, for each measured elution of
technetium-99m, the ratio of the measures expressed as kilobecquerel of molybdenum-99 per
megabecquerel of technetium-99m (or microcuries of molybdenum per millicurie of
technetium), the time and date of the measurement, and the name of the individual who made
the measurement. This record is needed to show that the concentration measurement was
made and that the maximum molybdenum-99 concentration level was not exceeded.
§ 35.2310 Records of safety instruction
This section requires licensees to maintain a record of safety instructions required by
§§ 35.310 and 35.410 and the operational and safety instructions required by § 35.610 for 3
years. The record must include a list of the topics covered, the date of the instruction, the
name(s) of the attendee(s), and the name(s) of the individual(s) who provided the instruction.
This record is needed to show that the required initial and refresher training was given and that
the drills were performed so that individuals are aware of the safety and emergency procedures
to be used in caring for patients and human research subjects treated with byproduct material
or radiation therefrom.
§ 35.2404 Records of surveys after source implant and removal
This section requires licensees to maintain a record of the surveys required by
§§ 35.404 and 35.604 for 3 years. Each record must include the date and results of the
survey, the survey instrument used, and the name of the individual who made the survey. This
record is used to show that all sources were removed from the patient or human research
subject, and that no sources have been misplaced.
§ 35.2406 Records of brachytherapy source accountability
This section requires licensees to maintain records of brachytherapy source accountability
required by § 35.406 for 3 years. For temporary implants, the record must include: the
number and activity of sources removed from and returned to storage; the time and dates they
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were removed from and returned to storage, the name of the individual(s) who removed them
from and returned them to storage, and the location of use. For permanent implants, the
record must include: the number and activity of sources removed from storage, the dates they
were removed from storage, and the name of the individual who removed them from storage;
the number and activity of sources not implanted, the date they were returned to storage, and
the name of the individual who returned them to storage; and the number and activity of
sources permanently implanted in the patient or human research subject. This record is
required to show that no brachytherapy source is misplaced or missing.
§ 35.2432 Records of calibration measurements of brachytherapy sources
This section requires licensees to maintain a record of calibrations of brachytherapy sources
required by § 35.432 for 3 years after the last use of the source. The record must include: the
date of calibration; the manufacturer's name, model number, and serial number for the source
and the instruments used to calibrate the source; the source output or activity; the source
positioning accuracy within the applicators; and the signature of the AMP. These records are
needed to document that the brachytherapy sources have been calibrated.
§ 35.2433 Records of decay of strontium-90 sources for ophthalmic treatments
This section requires licensees to maintain a record of the activity of a strontium-90 source
required by § 35.433 for the life of the source. The record must include: the initial activity of
the source and date; and for each decay calculation, the date and source activity as
determined under § 35.433. These records are needed to document that the activity of the
strontium-90 sources have been calculated accurately to ensure that adequate radiation safety
is maintained.
§ 35.2605 Records of installation, maintenance, adjustment, and repair of remote afterloader
units, teletherapy units, and gamma stereotactic radiosurgery units.
This section requires licensees to retain records of installation, maintenance, adjustment, and
repair of remote afterloader units, teletherapy units, and gamma stereotactic radiosurgery units
as required by § 35.605 for 3 years. For each installation, maintenance, adjustment, and
repair, the record must include the date, description of the service, and name(s) of the
individual(s) who performed the work. This record is necessary to show that the devices are
properly installed, maintained, and repaired, to establish trends in device performance, and to
establish a service history that may be used in evaluation of generic equipment problems.
§ 35.2610 Records of safety procedures
This section requires licensees to maintain records of procedures required by
§ 35.610(a) (4) and (d) (2) until the licensee no longer possesses the remote afterloader,
teletherapy unit, or gamma stereotactic radiosurgery unit. These procedures are needed for as
long as the licensee possesses the unit because they are essential to safe operations. These
records are needed to show that individuals are aware of the operating procedures for the unit
and the safety procedures to be used to respond to abnormal and emergency situations.
§ 35.2630 Records of dosimetry equipment used with remote afterloader units, teletherapy
units, and gamma stereotactic radiosurgery units.
This section requires licensees to retain a record of the calibration, intercomparison, and
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comparisons of its dosimetry equipment done in accordance with § 35.630 for the duration of
the license. For each calibration, intercomparison, or comparison, the record must include: the
date; the manufacturer’s name, model numbers and serial numbers of the instruments that
were calibrated, intercompared, or compared as required by paragraphs (a) and (b) of
§ 35.630; the correction factor that was determined from the calibration or the apparent
correction factor that was determined from an intercomparison; and the names of the
individuals who performed the calibration, intercomparison, or comparison. This record is
needed to show that calibrations of medical devices were made with properly calibrated
instruments.
§ 35.2632 Records of teletherapy, remote afterloader, and gamma stereotactic radiosurgery full
calibrations
This section requires licensees to maintain records of the teletherapy unit, remote afterloader
unit, and gamma stereotactic radiosurgery unit full calibrations required by §§ 35.632, 35.633,
and 35.635 for 3 years. The record must include: the date of the calibration; the
manufacturer's name, model number, and serial number of the teletherapy, remote afterloader,
and gamma stereotactic radiosurgery unit(s), the source(s), and the instruments used to
calibrate the unit(s); the results and an assessment of the full calibrations; the results of the
autoradiograph required for low dose-rate remote afterloader units; and the signature of the
AMP who performed the full calibration. This record is needed to show that the calibrations
were done so that licensees did not inadvertently administer incorrect radiation doses to
patients from the teletherapy unit, remote afterloader unit, or gamma stereotactic radiosurgery
unit.
§ 35.2642 Records of periodic spot-checks for teletherapy units
Paragraph 35.2642(a) requires licensees to retain a record of each periodic spot-check for
teletherapy units required by § 35.642 for 3 years. The record must include: the date of the
spot-check; the manufacturer's name, model number, and serial number of the teletherapy
unit, source, and instrument used to measure the output of the teletherapy unit; an assessment
of timer linearity and constancy; the calculated on-off error; a determination of the coincidence
of the radiation field and the field indicated by the light beam localizing device; the determined
accuracy of each distance measuring and localization device; the difference between the
anticipated output and the measured output; notations indicating the operability of each
entrance door electrical interlock, each electrical or mechanical stop, each source exposure
indicator light, and the viewing and intercom system and doors; and the name of the individual
who performed the periodic spot-check and the signature of the AMP who reviewed the record
of the spot check. This record is needed to show that the spot-checks were performed and that
the units and related safety equipment are operating correctly.
Paragraph 35.2642(c) requires licensees to retain a copy of the written procedures for periodic
spot-checks for teletherapy units established by the AMP. The procedures must be retained
until the licensee no longer possesses the teletherapy unit. This record is necessary to ensure
that the procedures remain available for reference by the licensee and the NRC.
§ 35.2643 Records of periodic spot-checks for remote afterloader units
Paragraph 35.2643(a) requires licensees to retain records of each spot-check for remote
afterloader units required by §§ 35.643 for 3 years. The record must include, as applicable:
the date of the spot-check; the manufacturer's name, model number, and serial number for the
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remote afterloader unit and source; an assessment of timer accuracy; notations indicating the
operability of each entrance door electrical interlock, radiation monitors, source exposure
indicator lights, viewing and intercom systems, and clock and decayed source activity in the
unit’s computer; and the name of the individual who performed the periodic spot-check and the
signature of the AMP who reviewed the record of the spot check. This record is necessary to
show that the spot-checks were performed and that the units and related safety equipment are
operating correctly.
Paragraph 35.2643(c) requires licensees to retain a copy of the written procedures for periodic
spot-checks for remote afterloader units established by the AMP. The procedures must be
retained until the licensee no longer possesses the remote afterloader unit. This record is
necessary to ensure that the procedures remain available for reference by the licensee and the
NRC.
§ 35.2645 Records of periodic spot-checks for gamma stereotactic radiosurgery units
Paragraph 35.2645(a) requires licensees to retain records of each spot-check for gamma
stereotactic radiosurgery units required by § 35.645 for 3 years. The record must include: the
date of the spot-check; the manufacturer's name, model number, and serial number for the
gamma stereotactic radiosurgery unit and the instrument used to measure the output of the
unit; an assessment of timer linearity and accuracy; the calculated on-off error; a determination
of trunnion centricity; the difference between the anticipated output and the measured output;
an assessment of source output against computer calculations; notations indicating the
operability of radiation monitors, helmet microswitches, emergency timing circuits, emergency
off buttons, electrical interlocks, source exposure indicator lights, viewing and intercom
systems, timer termination, treatment table retraction mechanism, and stereotactic frames and
localizing devices (trunnions); and the name of the individual who performed the periodic spotcheck and the signature of the AMP who reviewed the record of the spot check. This record is
necessary to show that the spot-checks were performed and that the units and related safety
equipment are operating correctly.
Paragraph 35.2645(c) requires licensees to retain a copy of the written procedures for periodic
spot-checks for gamma stereotactic radiosurgery units established by the AMP. The
procedures must be retained until the licensee no longer possesses the gamma stereotactic
radiosurgery unit. This record is necessary to ensure that the procedures remain available for
reference by the licensee and the NRC.
§ 35.2647 Records of additional technical requirements for mobile remote afterloader units
This section requires licensees to retain records of each check for mobile remote afterloader
units required by § 35.647 for 3 years. The record must include: the date of the check; the
manufacturer's name, model number, and serial number of the remote afterloader unit;
notations accounting for all sources before the licensee departs from a facility; notations
indicating the operability of each entrance door electrical interlock, radiation monitors, source
exposure indicator lights, viewing and intercom system, applicators, source transfer tubes and
transfer tube applicator interfaces, and source positioning accuracy; and the signature of the
individual who performed the check. This record is necessary to show that the checks were
performed and that the units and related safety equipment are operating correctly.

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§ 35.2652 Records of surveys of therapeutic treatment units
This section requires licensees to maintain records of radiation surveys of treatment units
made in accordance with § 35.652 for the duration of use of the unit. The record must include:
the date of the measurements; the manufacturer's name, model number, and serial number of
the treatment unit, source, and instrument used to measure radiation levels; each dose rate
measured around the source while the unit is in the off position and the average of all
measurements; and the signature of the person who performed the test. This record is
necessary to show that the surveys were performed and that the units do not exceed
occupational dose levels with the sources in the shielded position.
§ 35.2655 Records of 5-year inspection for teletherapy and gamma stereotactic radiosurgery
units
This section requires licensees to maintain a record of the 5-year inspections for teletherapy
and gamma stereotactic radiosurgery units required by § 35.655 for the duration of use of the
unit. The record must contain: the inspector's radioactive materials license number; the date
of inspection; the manufacturer's name and model number and serial number of both the
treatment unit and source; a list of components inspected and serviced, and the type of
service; and the signature of the inspector. This record is needed to document the type of
service that was performed and that any required work was done.
§ 35.3045 Reports and notification of a medical event
Paragraph 35.3045(a) requires licensees to report any event, except for an event that results
from patient intervention, in which the administration of byproduct material or radiation from
byproduct material results in a dose meeting or exceeding specified criteria. The burden
associated with this paragraph is addressed under paragraphs (c) and (d) of this section.
Paragraph 35.3045(b) requires licensees to report any event resulting from intervention of a
patient or human research subject in which the administration of byproduct material or radiation
from byproduct material results or will result in unintended permanent functional damage to an
organ or a physiological system, as determined by a physician. The burden associated with
this paragraph is addressed under paragraphs (c) and (d) of this section.
Paragraph 35.3045(c) requires licensees to notify the NRC by telephone no later than the next
calendar day after discovery of the medical event. This reporting requirement is needed to
ensure that NRC is aware of medical events and is able promptly to take any necessary actions
based on the circumstances.
Paragraph 35.3045(d) requires licensees to submit a written report to NRC within 15 days of
the discovery of the medical event. The report must include the licensee's name; the name of
the prescribing physician; a brief description of the event; why the event occurred; the effect, if
any, on the individual(s) who received the administration; what actions, if any, have been taken
or are planned to prevent recurrence; certification that the licensee notified the individual (or
the individual's responsible relative or guardian) and if not, why not. The report must not
contain the individual's name or any other information that could lead to identification of the
individual. This reporting requirement is needed to provide NRC a synopsis of the event, its
cause(s), and corrective actions taken, so that NRC can ensure that appropriate follow-up
actions are taken after medical events, and so that NRC can promptly notify other licensees if it
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appears the precipitating event might be generic.
Paragraph 35.3045(e) requires the licensee to notify the referring physician and the individual
who is the subject of the medical event, or that individual's responsible relative or guardian, no
later than 24 hours after its discovery, or as soon as possible, if the patient or the referring
physician cannot be reached within 24 hours. Patients and their referring physician(s) need
this information to make timely decisions regarding possible health care needs. If verbal
notification is made, the licensee is required to inform the individual or responsible relative or
guardian that a written description of the event may be obtained upon request. The licensee
shall provide such a written description, if requested.
Paragraph 35.3045(g) requires the licensee to: (1) annotate a copy of the medical event
report provided to the NRC with the: (a) name of the individual who is the subject of the event;
and (b) social security number or other identification number, if one has been assigned, of the
individual who is the subject of the event; and (2) provide a copy of the annotated report to the
referring physician, if other than the licensee, no later than 15 days after the discovery of the
event. It is necessary to annotate the report to the NRC because the report has no identifying
information regarding the patient. It is necessary to send a copy of the annotated report to the
referring physician because the referring physician is responsible for the medical care of the
patient and this information is needed for the physician to care for the patient.
§ 35.3047 Report and notification of a dose to an embryo/fetus or a nursing child
Paragraph 35.3047(a) requires the licensee to report any dose to an embryo/fetus that is
greater than 50 mSv (5 rem) dose equivalent that is the result of an administration of
byproduct material or radiation from byproduct material to a pregnant individual unless the
dose to the embryo/fetus was specifically approved, in advance, by the AU. The burden for
this requirement is addressed under paragraphs (c) and (d) of this section. This report is
needed so that NRC can comply with the legislative intent of section 208 of the Energy
Reorganization Act of 1974 (Public Law 93-438) as amended, which requires NRC to submit
reports to Congress of unintended radiation exposure.
Paragraph 35.3047(b) requires the licensee to report any dose to a nursing child that is greater
than 50 mSv (5 rem) total effective dose equivalent or has resulted in unintended permanent
functional damage to an organ or a physiological system of the child, as determined by a
physician, that is a result of an administration of byproduct material to a breast-feeding
individual. The burden for this requirement is addressed under paragraphs (c) and (d) of this
section. This report is needed so that NRC can comply with the legislative intent of section 208
of the Energy Reorganization Act of 1974 (Public Law 93-438) as amended, which requires
NRC to submit to Congress reports of unintended radiation exposure.
Paragraph 35.3047(c) requires the licensee to notify by telephone the NRC Operation Center
no later than the next calendar day after discovery of a dose to the embryo/fetus or nursing
child that requires a report under § 35.3047(a) or (b). This reporting requirement is needed to
ensure that NRC is aware of unintended radiation exposure to an embryo/fetus or nursing child
and can promptly take any necessary actions based on the circumstances.
Paragraph 35.3047(d) requires the licensee to submit a written report to the appropriate NRC
Regional Office no later than 15 days after discovery of a dose to the embryo/fetus or nursing
child that requires a report under § 35.3047(a) or (b). The written report must include the
licensee's name; the name of the prescribing physician; a brief description of the event; why
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the event occurred; the effect, if any, on the embryo/fetus or the nursing child; what actions, if
any, have been taken or are planned to prevent recurrence; and certification that the licensee
notified the pregnant individual or mother (or the mother’s or child’s responsible relative or
guardian, and if not, why not. The report must not contain the individual's or child’s name or
any other information that could lead to identification of the individual or child. This reporting
requirement is needed to provide information to NRC about the causes of the unintended
radiation exposure to an embryo/fetus or nursing child and methods to prevent recurrence.
Paragraph 35.3047(e) requires the licensee to notify the referring physician and also notify the
pregnant individual or mother (both hereafter referred to as the mother) no later than 24 hours
after discovery of an event that would require reporting under paragraph (a) or (b) of this
section, unless the referring physician personally informs the licensee either that he or she will
inform the mother or that, based on medical judgment, telling the mother would be harmful. If
the referring physician or mother cannot be reached within 24 hours, the licensee is required to
make the appropriate notifications as soon as possible thereafter. To meet the requirements of
this paragraph, the notification may be made to the mother’s or child’s responsible relative or
guardian instead of the mother, when appropriate. If a verbal notification is made, the licensee
shall inform the mother, or the mother’s or child’s responsible relative or guardian that a written
description of the event can be obtained from the licensee upon request. The licensee shall
provide such written description if requested. This reporting requirement is needed to provide
information about the event to the referring physician and the pregnant individual or mother, or
the mothers or child’s responsible relative or guardian, for appropriate medical care, if needed.
Paragraph 35.3047(f) requires the licensee to: (1) annotate a copy of the report provided to the
NRC with the: (a) name of the pregnant individual or the nursing child who is the subject of the
event; and (b) social security number or other identification number, if one has been assigned,
of the pregnant individual or the nursing child who is the subject of the event; and (2) provide a
copy of the annotated report to the referring physician, if other than the licensee, no later than
15 days after the discovery of the event.
§ 35.3067 Report of a leaking source
This section requires licensees to report detection of a leaking source by submitting a written
report within 5 days after a leakage test required by § 35.67 reveal the presence of 185 Bq
(0.005 microcurie) or more of removable contamination. The report must be filed with the
appropriate NRC Regional Office with a copy to the NRC Headquarters Office. The report
must include the model and serial number, if assigned, of the leaking source; the radionuclide
and its estimated activity; the results of the test, the date of the test, and the action taken. This
report is needed to ensure that the NRC is aware of the leaking source and is able promptly to
take any necessary actions based on the circumstances.
§ 35.3204 Report and notification for an eluate exceeding permissible molybdenum-99,
strontium-82, and strontium-85 concentrations
Paragraph 35.3204(a) requires radiopharmacy and medical use licensees to notify both the
NRC Operations Center and the distributor of the generator by telephone within 7 days after
discovery that an eluate exceeds the permissible concentration listed in § 35.204(a).
Breakthrough of Mo-99 and contamination of Sr-82 and Sr-85 can lead to unnecessary
exposure to radiation to patients. This notification requirement will allow the NRC to assess
the situation so that appropriate actions may be taken to avoid unwarranted radiation
exposure to patients.
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Paragraph 35.3204(b) requires radiopharmacy and medical use licensees to submit a written
report to the appropriate NRC Regional Office listed in § 30.6 within 30 days after discovery of
an eluate exceeding the permissible concentration listed in § 35.204(a). This report is a follow
up on the requirement under § 35.3204(a) to notify the NRC within 7 days after discovery that
an eluate exceeds the permissible concentration listed in § 35.204(a). This reporting
requirement will allow the NRC to determine appropriate actions to take to avoid unwarranted
radiation exposure to patients.

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GUIDANCE DOCUMENTS FOR INFORMATION COLLECTION REQUIREMENTS
CONTAINED IN
10 CFR PART 35
MEDICAL USE OF BYPRODUCT MATERIAL
3150-0010
Title
Consolidated Guidance About Materials
Licenses: Program-Specific Guidance About
Medical Use Licenses, Final Report (NUREG1556, Volume 9, Revision 3)
Regulatory Guide 8.39
Release of Patients Administered Radioactive
Materials
Procedures for Recognizing, Monitoring, and
Terminating the Certification Process of Specialty
Boards

Accession number
ML19256C219

ML083300045
ML20351A389

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