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Re: Reg guide 10.8
At 01:08 PM 7/1/97 -0500, you wrote:
>Hi, radsafers,
>I am looking for the newest version of NRC Regulatory Guide 10.8. Is there
>any one out there know when it was published and if it is available on the
>web site?
>
>Thanks.
>
>
>
Here is the revision history of the subject Reg Guide:
10.8 Guide for the Preparation of Applications for - 01/79
Medical Use Programs (Draft FC 415-4, Proposed 1 10/80
Revision 2, published 8/85) (Draft DG-0002, Proposed 2 08/87
Appendix X to Regulatory Guide 10.8, published 12/91)
(Appendix X published June 1992)
There is currently a proposed revision out for comment. This may be
downloaded
in Word Perfect format at
ftp://ftp.fedworld.gov/pub/nrc-rgin/6dg-0009
Best regards
U.S. NUCLEAR REGULATORY COMMISSION March 1997
OFFICE OF NUCLEAR REGULATORY RESEARCH Division 10
Task DG-0009
DRAFT REGULATORY GUIDE
Contact: D. Howe (301)415-7848
S. Jones (301)415-6198
DRAFT REGULATORY GUIDE DG-0009
PROPOSED SUPPLEMENT
To REGULATORY GUIDE 10.8, REVISION 2,
"GUIDE FOR THE PREPARATION OF APPLICATIONS
FOR MEDICAL USE PROGRAMS"
Regulatory Guide 10.8, "Guide for the Preparation of Applications for
Medical Use Programs," Revision 2, August 1987, provides directions for
completing NRC Form 313 for the preparation of applications for specific
medical use byproduct material licenses. The guide is based on major
revisions
to 10 CFR Part 35 that became effective April 1, 1987. On December 2, 1994,
the NRC published new medical use regulations (59 FR 61767) that affect
some of
the guidance provided in Revision 2 of Regulatory Guide 10.8, which remains
the
current guidance for the completion of applications for the medical use of
byproduct material. This supplement would provide additional guidance in
consideration of the new regulations and add Appendix Y, "Provisions for
Research Involving Human Subjects," to Revision 2 of Regulatory Guide 10.8.
The changes in the regulations (effective January 1, 1995) include:
Recognition of pharmacists with specific training and experience in
nuclear pharmacy as "authorized nuclear pharmacists,"
Deletion of previous restrictions on the sources of supply for
unsealed byproduct material to be used for medical use,
Deletion of previous restrictions on the preparation of unsealed
byproduct material for medical use,
Permission for some qualified physician authorized users to work as
authorized users without being listed on the license,
Clarification of circumstances under which holders of specific
licenses of broad scope are relieved from submitting amendments,
and
Authorization for the use of byproduct material in the conduct of
research involving human subjects as a part of "medical use," as
defined in 10 CFR 35.2.
In addition to this supplement, Draft Regulatory Guide DG-0006, "Guide
for
the Preparation of Applications for Commercial Nuclear Pharmacy Licenses," is
being developed to provide guidance to applicants and licensees who intend to
prepare unsealed byproduct material for medical use by or under the
supervision
of an "authorized nuclear pharmacist" or "authorized user," as defined in
10 CFR 35.2. This supplement should clarify for applicants and licensees the
use of the guidance proposed in Draft Regulatory Guide DG-0006 on completing
NRC Form 313, "Application for a Material License."
This supplement addresses the effects of the new medical use regulations
for each section and appendix in Revision 2 of Regulatory Guide 10.8 as
follows:
Section 1. INTRODUCTION -- Not affected.
Section 2. FILING AN APPLICATION -- Not affected.
Section 3. CONTENTS OF AN APPLICATION
ITEM 1 - License Information -- Not affected.
ITEM 2 - Applicant's Name and Mailing Address -- Not affected.
ITEM 3 - Locations of Use -- Not affected.
ITEM 4 - Persons to Be Contacted About Application -- Not affected.
ITEM 5 - Radioactive Material and ITEM 6 - Purpose
The regulations in 10 CFR Part 35 continue to divide byproduct material
for medical use into six types of use. The new regulations permit the use of
any unsealed byproduct material for the medical uses permitted by 10 CFR
35.100, 200, and 300. Therefore, applicants and licensees are no longer
limited to radioisotopes traditionally used in radiopharmaceuticals or the use
of radiopharmacuticals for which the U.S. Food and Drug Administration has
accepted a "Notice of Claimed Investigational Exemption for a New Drug" (IND)
or approved a "New Drug Application" (NDA). Further, the regulations in 10
CFR
Part 35 now specifically address research involving human subjects (10 CFR
35.6). Guidance being developed on this type of research is issued for public
comment in this draft guide in the proposed Appendix Y.
Table 1 on page 7 of Revision 2 of Regulatory Guide 10.8 has been used as
guidance to respond to Item 5 of NRC Form 313 for the uses described in 10 CFR
35.100, 35.200, and 35.300. This supplement would provide two new tables.
Table 1a would replace the first three entries in Table 1 of Revision 2 of
Regulatory Guide 10.8 for licensees who have either an authorized nuclear
pharmacist or a physician who is an authorized user and who meets the
requirements specified in 10 CFR 35.920. Table 1b would replace the same
first
three entries of Table 1 for licensees who do not have an authorized nuclear
pharmacist and the authorized user physician's training and experience is
limited to that specified in 10 CFR 35.910 or 35.930. Applicants and
licensees
would use the matrix format provided in Tables 1a and 1b to respond to Item 5
of NRC Form 313 for unsealed radioactive material. For Item 5a, you may state
"Any byproduct material" or "Any byproduct material initially distributed
pursuant to 10 CFR 32.72 or equivalent Agreement State requirements"
(depending
on whether you follow Table 1a or 1b). For Item 5b, you may state "Unsealed";
and for Item 5c, you should state the maximum activity you would like to
possess for each requested use (i.e., under 10 CFR 35.100, 35.200, or 35.300).
The maximum activities requested should be representative of current uses and
projected waste storage needs. For Item 6, the purpose for which the licensed
material will be used, you should state "Any use described in 35.100," "Any
use
described in 35.200," or "Any use described in 35.300."
Table 1a
Item 5a,
Elements
and mass
number
Item 5b,
Chemical
and/or
physical
form
Item 5c,
Maximum
amount that
will be
possessed at
any one time
Item 6,
Purpose for
which licensed
material will
be used
Any
byproduct
material
Unsealed
_____
Activity
Any use
described in
35.100
Any
byproduct
material
Unsealed
_____
Activity
Any use
described in
35.200
Any
byproduct
material
Unsealed
_____
Activity
Any use
described in
35.300
Table 1b
Item 5a,
Elements
and mass
number
Item 5b,
Chemical
and/or
physical
form
Item 5c,
Maximum
amount that
will be
possessed at
any one time
Item 6,
Purpose for
which licensed
material will
be used
Any
byproduct
material
initially
distributed pursuant
to 10 CFR
32.72 or
equiva-lent
Agreement
State
require-ments
Unsealed
_____
Activity
Any use
described in
35.100
Any
byproduct
material
initially
distri-buted
pursuant
to 10 CFR
32.72 or
equiva-lent
Agreement
State
requirements
Unsealed
_____
Activity
Any use
described in
35.300
Items 5.d, 5.e, 5.f, 6.d, 6.e, and 6.f in Table 1 of Revision 2 of
Regulatory Guide 10.8 would continue to be the format to be used in responding
to Item 5 of NRC Form 313 for the uses described in 10 CFR 35.400 and 10 CFR
35.500.
ITEM 7 -- Individuals Responsible for Radiation Safety Programs -- Their
Training and Experience
The regulations in 10 CFR 35.2, "Definitions," have been amended to add
the term "authorized nuclear pharmacist." In addition to the authorized user,
RSO, or teletherapy physicist, the authorized nuclear pharmacist may be
responsible for the radiation safety program.
The regulations in 10 CFR 30.33(a) state: "An application for a specific
license will be approved if: ... (3) The applicant is qualified by training
and
experience to use the material for the purpose requested in such manner as to
protect health and minimize danger to life or property." Therefore, for new
license applications and license renewals, applicants and licensees should
identify all authorized users, authorized nuclear pharmacists, the radiation
safety officer, and teletherapy physicists as well as provide documentation of
their training and experience. If documentation of an individual's
training or
experience was provided in an earlier notification, it does not have to be
resubmitted.
The regulations in 10 CFR 35.13(b) permit certain pharmacists and
physicians to work as authorized nuclear pharmacists or authorized users,
respectively, without requiring the licensee to apply for and receive a
license
amendment to identify them on the license. The regulations in 10 CFR 35.13(b)
require that these physicians and pharmacists are (1) certified by an
organization specified in 10 CFR 35.910(a), 35.920(a), 35.930(a), 35.940(a),
35.950(a), 35.960(a), or 35.980(a); (2) identified as an authorized user or an
authorized nuclear pharmacist on a Commission or Agreement State medical
use or
commercial nuclear pharmacy license; or (3) identified as an authorized
user or
an authorized nuclear pharmacist on a permit issued by a Commission or
Agreement State medical use license of broad scope. Licensees using this
provision, in accordance with 35.14(a), must provide NRC with a copy of each
individual's certification, the NRC or Agreement State license identifying the
individual as an authorized user or authorized nuclear pharmacist, or a permit
issued by a broad scope licensee identifying the individual as an authorized
user or authorized nuclear pharmacist. The regulations in 10 CFR 35.14(a)
require that this documentation be submitted to the NRC no later than 30 days
from the date the licensee allows the individual to work as an authorized user
or authorized nuclear pharmacist.
NOTE: You are still required to amend your license when adding a new
radiation safety officer or teletherapy physicist. Even though amendment
requests are not needed for some individuals to be listed on a license as
authorized users or authorized nuclear pharmacists prior to their working in
that capacity, it may be advantageous when updating the license for other
purposes to include these individuals for the following reasons: (1)
authorized
nuclear pharmacists who are currently board certified will no longer be
recognized as authorized nuclear pharmacists when their certification expires
unless they are listed on a license and (2) an authorized user or an
authorized
nuclear pharmacist may use this publicly available document to demonstrate
continuing experience to meet the criteria in 10 CFR 35.972, "Recentness of
Training."
The guidance that applicants and licensees should use regarding training
and experience for individuals identified on a license as "authorized
users" is
on pages 8 and 9 of Revision 2 of Regulatory Guide 10.8.
Applicants and licensees may use guidance that is proposed in Item 7 and
Appendix A in Draft Regulatory Guide DG-0006 regarding the training and
experience of individuals who must be identified on a license as "authorized
nuclear pharmacists." Applicants and licensees may find it convenient to
document the training and experience of these individuals using the format in
Figures A-1 and A-2 of Draft Regulatory Guide DG-0006.
ITEM 8 - Training for Individuals Working in or Frequenting Restricted
Areas
The regulations in 10 CFR 35.25 regarding supervision and instruction
must
be followed if the applicant or licensee permits the preparation of unsealed
byproduct material for medical use under the supervision of an authorized
nuclear pharmacist or authorized user as permitted by 10 CFR 35.11(c). Item 8
of Draft Regulatory Guide DG-0006 provides information, based on 10 CFR 35.25,
on the instruction, supervision, and review that would meet these supervision
and instruction requirements.
ITEM 9 - Facilities and Equipment, and ITEM 10 - Radiation Safety Program
The new regulations no longer restrict licensees to only the use of
specific isotopes or to the formulation and reformulation procedures for the
preparation of unsealed byproduct material for the uses described in 10 CFR
35.100, 35.200, and 35.300. Also, the new regulations no longer restrict
medical uses to diagnosis and therapy, but permit research involving human
subjects provided the research meets the criteria in 10 CFR 35.6.
On pages 11-13, Regulatory Guide 10.8 provides guidance for an acceptable
radiation safety program for the uses of isotopes approved prior to January 1,
1995. However, with the increased flexibility provided by the new
regulations,
the applicant or licensee is now responsible for determining whether (1) the
guidance in Revision 2 of Regulatory Guide 10.8 provides an adequate radiation
safety program for its operations or (2) additional facilities, equipment,
personnel, and radiation safety procedures are necessary.
If the applicant or licensee determines that the scope of its operations
is within the guidance provided in Revision 2 of Regulatory Guide 10.8, it
should continue to use that guidance in responding to Items 9, Facilities and
Equipment, and 10, Radiation Safety Program, of NRC Form 313.
An applicant or licensee who determines that the guidance provided in
Revision 2 of Regulatory Guide 10.8 is not adequate for the scope of its
operations (including radiation safety programs necessitated by or associated
with research or the use of alpha-, low-energy photon-, or low-energy beta-
emitters) should supplement the application with additional information to
demonstrate that its facilities, equipment, personnel, and radiation safety
program meet the requirements in 10 CFR Part 20 as well as the requirements in
10 CFR Part 35.
Licensees who will use only unit dosages of alpha- or beta-emitting
radionuclides obtained from a manufacturer or preparer licensed pursuant to
10 CFR Part 32 are not required to have instruments to measure the alpha- or
beta-emitter dosages (10 CFR 35.52). This does not relieve such licensees
from
applicable requirements to assay or measure effluent releases, fixed or
removable contamination, and doses to workers or the general public.
The guidance being developed in Draft Regulatory Guide DG-0006 (in
Items 9
and 10) may be helpful in describing the scope of your operations, facilities,
equipment, and associated radiation safety programs to handle uses of unsealed
alpha-, beta-, and low-energy photon-emitting radionuclides for medical use or
in the preparation of unsealed byproduct material for medical use.
Appendices B, C, D, I, J, M, N, O, and R of Regulatory Guide 10.8 were
developed primarily for photon-emitting radionuclides. Generally,
high-energy
beta-emitters can be measured or assayed with the same instruments, and these
appendices can be used provided energy dependence and geometric considerations
are taken in to account. Applicants and licensees should continue to use
these
appendices for photon- and high-energy beta-emitting radionuclides. Some of
the information in these appendices may not be appropriate and additional
changes may be needed to the model programs provided in these appendices to
reflect the decrease in prescriptive requirements and the removal of some
requirements from the regulations.
Therefore, if you use alpha-, low-energy photon-, or low-energy
beta-emitters, you should describe your program to demonstrate the safe use
of these
radionuclides. Regulatory Guide 10.8 was not specifically developed for the
use of alpha-, low-energy photon-, or low-energy beta-emitters.
ITEM 11 - Waste Management -- Not affected.
ITEM 12 - License Fees -- Not affected.
ITEM 13 - Certification -- Not affected.
ITEM 14 - Voluntary Economic Data -- Not affected.
Section 4. AMENDMENTS TO LICENSE
The regulations in 10 CFR 35.13, 35.14, and 35.15 are either new or
revised. Licensees should review the regulations regarding the need for
amendments, the regulations that now permit notification instead of
amendments,
and the amendment and notification exemptions granted to holders of medical
use
Type A Specific Licenses of Broad Scope.
Section 5. RENEWAL OF LICENSE -- Not affected.
Section 6. IMPLEMENTATION -- Not affected.
APPENDICES
Appendices A, E, G, H, K, P, Q, S, W, and X are not affected.
Appendices B, C, D, F, I, J, L, M, N, O, R, T, U, and V may be
affected as
described in Item 9.
Appendix Y is proposed in this Draft Regulatory Guide DG-0009 as a new
appendix to Revision 2 of Regulatory Guide 10.8.
If the applicant or licensee determines that its scope of operations is
within the guidance provided in the above appendices to Revision 2 of
Regulatory Guide 10.8, it should continue to use that guidance in
responding to
NRC Form 313.
All licensees and applicants may want to modify or remove certain
commitments in the appendices in response to regulatory changes to less
prescriptive requirements.
If the applicant or licensee determines that the guidance provided in
these appendices is not adequate for the scope of its operations, it should
supplement the application with additional information.
The appendices should be supplemented, as appropriate, to include:
(1) Information on alpha-, beta-, and low-energy photon-emitting
radionuclides,
(2) Additional responsibilities of the radiation safety committee to
review and approve or disapprove of individuals to work as or be listed as
authorized users, authorized nuclear pharmacists, teletherapy physicists, or
radiation safety officers in accordance with 10 CFR 35.22(b)(2);
(3) Additional radiation safety precautions, facilities, and equipment,
if any, associated with preparing unsealed byproduct material by or under the
supervision of an authorized nuclear pharmacist or appropriately trained
authorized user, and
(4) Radiation safety program changes that may be necessitated by or
associated with research involving human subjects.
EXHIBITS
EXHIBITS 1, 2, 3, 4, 5, 15, 17, 18, 19, 20, 21 are not affected.
EXHIBITS 6, 7, 8, 9, 10, 11, 12, 13, 14, 16 may be affected.
The applicant or licensee who determines that its scope of operation is
within the guidance provided in the above exhibits to Revision 2 to Regulatory
Guide 10.8 should continue to use that guidance in responding to NRC Form 313.
All licensees and applicants may also want to modify or remove certain
commitments in the exhibits in response to regulatory changes to less
prescriptive requirements.
If an applicant or licensee determines that the guidance provided in
these
exhibits is not adequate for the scope of the operations, the application
should be supplemented with additional information.
The exhibits may have to be supplemented, as appropriate, to include
information on alpha-, beta-, and low-energy photon-emitting radionuclides and
radiation safety programs associated with preparing unsealed byproduct
material
by or under the supervision of an authorized nuclear pharmacist or
appropriately trained authorized user.
APPENDIX Y
PROVISIONS FOR RESEARCH INVOLVING HUMAN SUBJECTS
The amendment to 10 CFR Part 35 (published December 2, 1994, 59 FR 61767)
changed a number of requirements for medical use programs. Among other
things,
the term "medical use" was amended and a new section was added to address
human
research. "Medical use" means the intentional internal or external
administra-tion of byproduct material or the radiation therefrom to
patients or human
research subjects under the supervision of an authorized user. Section 35.6,
"Provisions for Research Involving Human Subjects," specifically addresses
research and places research involving human subjects into the following two
categories:
Research covered by the Federal Policy for the Protection of Human
Subjects (Federal Policy) (published in the Federal Register on June
18, 1991, 56 FR 28003) and
Research not covered by the Federal Policy.
Table 1 provides a chart to assist applicants and licensees in categorizing
research projects.
1. Research Covered by the Federal Policy
The provisions in 10 CFR 35.6 state that licensees may conduct research
involving human subjects provided the research is conducted, funded,
supported,
or regulated by another Federal Agency that has implemented the Federal
Policy.
Therefore, a specific licensing authorization or amendment is not required if
the applicant or licensee meets this criterion. The applicant or licensee
must
obtain informed consent from the human subject and obtain, as a minimum, prior
review and approval of the research activities by an "Institutional Review
Board" in accordance with the meaning of these terms as defined and described
in the "Federal Policy for the Protection of Human Subjects."
NOTE: Fifteen Federal Agencies have adopted the "Federal Policy for the
Protection of Human Subjects": United States Department of Agriculture;
Department of Energy; National Aeronautics and Space Administration;
Department
of Commerce; Consumer Product Safety Commission; International Development
Cooperation Agency, Agency for International Development; Department of
Housing
and Urban Development; Department of Justice; Department of Defense;
Department
of Education; Department of Veterans Affairs; Environmental Protection Agency;
Department of Health and Human Services; National Science Foundation; and
Department of Transportation.
2. Research Not Covered by the Federal Policy
If the research involving human subjects is not conducted, funded,
supported, or regulated by a Federal Agency that has adopted the Federal
Policy, the applicant or licensee must apply, in accordance with 10 CFR 35.6,
for a specific amendment before conducting research involving human subjects.
When applying for this specific amendment, the applicant should submit an
affirmation (or other evidence) that:
(1) An Institutional Review Board (as defined and described in the
Federal Policy) will review and approve the research prior to the
conduct of the research, and
(2) Prior to the conduct of the research, the licensee will obtain
informed consent (as defined and described in the Federal Policy)
from the human subject.
If the licensee does not provide the affirmation described above or other
evidence, the amendment will not be approved.
If the radiation safety program necessitated by or associated with the
research goes beyond the applicant's previously described radiation safety
program, a revised radiation safety program should be submitted in the
amendment request.
NOTE: In the past, the NRC has authorized a few medical use licensees
with limited specific licenses and most medical use licensees with specific
licenses of broad scope to do research involving human subjects. Prior to
renewal of such licenses, these licensees may continue research that is not
conducted, funded, supported, or regulated by a Federal Agency that has
adopted
the Federal Policy, provided (as required in 10 CFR 35.6) their internal
procedures (1) require prior review and approval of the research by an
Institutional Review Board (IRB), (2) require informed consent by each
research
subject, and (3) use the terms "informed consent" and "Institutional Review
Board" as defined and described in the Federal Policy for the Protection of
Human Subjects. If the internal procedures of a limited specific licensee
or a
specific licensee of broad scope do not meet all three criteria, the licensee
must revise its internal procedures prior to continuation of the research
involving human subjects to ensure that the research conforms to all three
criteria as required by 10 CFR 35.6. If the licensee does not revise its
internal procedures to meet all three criteria, the licensee may no longer
conduct research involving human subjects and must apply for an amendment to
remove this authority from its license. TABLE 1
Is the licensee one of the
15 Federal Agencies that
adopted the Federal Policy? Yes
Research is covered
by Federal Policy.
No further
information is
needed.*
No
Is all human research
conducted, funded,
supported, or regulated by
one of the 15 Federal
Agencies that adopted the
Federal Policy?
Yes Research is covered
by Federal Policy.
No further
information is
needed.*
No or not sure
Does the licensee have a
valid "Multiple Project
Assurance" with the
Department of Health and
Human Services (or other
equivalent assurance with
one of the other 14 Federal
Agencies that adopted the
Federal Policy)? No Research not
specifically conducted,
funded, supported, or
regulated by one of
these Federal agencies
requires an amendment
request.*
Yes
Did the licensee voluntarily
state in the "Multiple
Project Assurance" (or other
equivalent assurance with one
of the other 14 Federal
Agencies that adopted the
Federal Policy) that all
human research would be
performed in accordance with
the assurance? No Research not
specifically under the
assurance is not
covered by Federal
Policy. An amendment
request is necessary
for this research.*
Yes
Research is covered by the
Department of Health and
Human Services or one of
the other 14 agencies that
adopted the Federal
Policy, and no further
information is needed.*
*If the radiation safety program necessitated by or associated with the
research goes beyond the applicant's previously described radiation safety
program, a revised radiation safety program should be submitted in an
amendment
request. DRAFT VALUE/IMPACT STATEMENT
A draft value/impact statement was published with the proposed
Revision 2 to Regulatory Guide 10.8 (Task FC 415-4) when the draft guide
was published for public comment in August 1985. No changes were
necessary, so a separate value/impact statement for the final guide, or
for this proposed supplement, has not been prepared. A copy of the draft
value/impact statement is available for inspection and copying for a fee
at the NRC's Public Document Room at 2120 L Street NW., Washington, DC;
the PDR's mailing address is Mail Stop LL-6, Washington, DC 20555;
telephone (202)634-3273; fax (202)634-3343.
Judd M. Sills, CHP | Office: (619)455-2049
General Atomics, Room 01-166C| Fax: (619)455-3181
3550 General Atomics Court | E-Mail: sillsj@gat.com
San Diego, CA 92121 |