2
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University
of Texas Health Science Center San Antonio
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This
e-mail is in response to IP GRAM 09/16/2013: Import Permit Forms
Submitted for Public Comment. In particular the changes to
Subpart F—Importations—contains provisions for the
importation of infectious biological agents, infectious
substances, and vectors (42 CFR 71.54); requiring persons that
import these materials to obtain a permit issued by the CDC. I
have no problem accepting the changes requested except the
following. It is not obvious to me how the CDC will verify “that
the permittee has implemented biosafety measures commensurate
with the hazard posed by the infectious biological agent,
infectious substance, and/or vector to be imported, and the level
of risk given its intended use”. If this is as simple as a
signature than that is OK. If it requires an inspection that
seems a bit too much. It seems to me the risk is already stated
in the Biological Handbook. For example, Schistosma sp which is
what I work with is a Class 2 agent. It seems redundant to ask
for what is already classified by CDC.
Thank you for
the opportunity to respond to the proposed changes.
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The
question being asked, “4. Has the permittee implemented
biosafety measures commensurate with the hazard posed by the
infectious biological agent, infectious substance, and/or vector
to be imported, and the level of risk given its intended use?”
is for the applicant to confirm if the facility has implement
these measures. The Program may verify this information by
requesting the entity’s biosafety plan or more information
regarding the implemented biosafety measures.
Depending
on the response and the program’s criteria, an inspection
may occur. The criteria used to determine those “high-risk”
entities to be inspected include facilities that applied to
import infectious biological agents which are capable of causing
serious or potentially lethal disease in humans via the aerosol
route. Facilities that has been inspected by either HHS/CDC or
the U.S. Department of Agriculture’s Animal and Plant
Health Inspection Service (USDA/APHIS) under the HHS or USDA
select agent regulations (42 CFR Part 73, 9 CFR Part 121, or 7
CFR Part 331) will probably not require an additional inspection.
Inspections are be conducted to ensure that the importer has
biosafety measures in place that are commensurate with the hazard
posed by the infectious biological agent, infectious substance,
and/or vector to be imported, and the level of risk given its
intended use.
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3
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Biologics
Clinical Pharmacology
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I
appreciate this opportunity to provide comments. Comments below
are directed to the EAIPP Application Form Only:
(a)
Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information shall have practical utility; New
Requirements:
• Name and Address of the person
responsible at location where the materials will be stored. No
comment.
• Verification that the permittee has
implemented the biosafety measures indicated on the form (e.g.
BSL2). Comment – see below
• A 2nd contact as
backup for the permittee would be required. No comment.
(b)
The accuracy of the agency’s estimate of the burden of the
proposed collection of information; Comment – current
estimate is 20 minutes per application. However, there is no
indication of what form of verification would be acceptable for
the BSL. Depending on the requirement for “verification”,
it could take more than 20 minutes to complete the
application.
(c) ways to enhance the quality, utility,
and clarity of the information to be collected; Comments –
• Clarify what would be acceptable as verification for
Biosafety measures. Would the requirement apply to the
permittee, their backup, the person responsible for the sample
storage area, and/or the storage facility?
• Simplify
what is required in section E.2. of the application. Instruction
on the form indicate: Detailed description of work to be
accomplished with the imported agents ( background, purpose,
objectives, methods, etc). We conduct multiple animal research
studies each year, with the same ex-U.S. in-life supplier, the
sample types are the same, and the purpose is essentially the
same, but the assay methodology might change. Per the above
requirement, and depending on what level of detail was required
in the previous application, that might necessitate a new CDC
permit just to change the methodology. The level of detail
appears to be dependent upon the CDC personnel reviewing the
application.
For example, in some applications, this
statement was sufficient in E.2:
Gain understanding of
relationship between Pharmacokinetics, Pharmacodynamics, or
Toxicokinetics for biologic compounds via various dosing regimens
with test articles in cynomolgus monkeys.
For others, we
had to provide more information:
To understand distribution
of these monoclonal antibodies to the sites of action, i.e.
synovial fluid, tissue homogenate and tissues, and their ability
to neutralize target at the sites of action. Immunoassays will be
used to quantify both monoclonal antibodies and PD biomarkers
from these samples.
(d) ways to minimize the burden of
the collection of information on respondents, including through
the use of automated collection techniques or other forms of
information technology. Comments – a system for knowing
where an application is in the process - at a minimum:
Received, In Progress, Pending Clarification, Approved.
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(a)
The accuracy of the agency’s estimate of the burden of the
proposed collection of information; Comment – current
estimate is 20 minutes per application. However, there is no
indication of what form of verification would be acceptable for
the BSL. Depending on the requirement for “verification”,
it could take more than 20 minutes to complete the application.
DSAT Response: The question being asked, “4.
Has the permittee implemented biosafety measures commensurate
with the hazard posed by the infectious biological agent,
infectious substance, and/or vector to be imported, and the level
of risk given its intended use?” is for the applicant to
confirm if the facility has implement these measures. Based on
our experience with previous import permit submissions that
addressed Section G (Receiving Laboratory Capabilities) of the
permit application, we confirmed that applicants already have
implemented biosafety measures in place (e.g., biosafety plan).
During the revision of the import permit regulations, we
specifically sought comment from the public concerning burden.
We did not receive any comments specifically addressing the
burden. As part of the revision of the forms, we determined that
applicants were able to complete the form within 20 minutes.
(c) ways to enhance the quality, utility, and clarity
of the information to be collected; Comments –
•
Clarify what would be acceptable as verification for Biosafety
measures. Would the requirement apply to the permittee, their
backup, the person responsible for the sample storage area,
and/or the storage facility?
DSAT Response: The
Program may verify this information by requesting the permittee
to provide the entity’s biosafety plan or more information
regarding the implemented biosafety measures.
Depending
on the response and the program’s criteria, an inspection
may occur. The criteria used to determine those “high-risk”
entities to be inspected include facilities that applied to
import infectious biological agents which are capable of causing
serious or potentially lethal disease in humans via the aerosol
route. Facilities that has been inspected by either HHS/CDC or
the U.S. Department of Agriculture’s Animal and Plant
Health Inspection Service (USDA/APHIS) under the HHS or USDA
select agent regulations (42 CFR Part 73, 9 CFR Part 121, or 7
CFR Part 331) will probably not require an additional inspection.
Inspections are be conducted to ensure that the importer has
biosafety measures in place that are commensurate with the hazard
posed by the infectious biological agent, infectious substance,
and/or vector to be imported, and the level of risk given its
intended use.
• Simplify what is required in
section E.2. of the application. Instruction on the form
indicate: Detailed description of work to be accomplished with
the imported agents ( background, purpose, objectives, methods,
etc). We conduct multiple animal research studies each year,
with the same ex-U.S. in-life supplier, the sample types are the
same, and the purpose is essentially the same, but the assay
methodology might change. Per the above requirement, and
depending on what level of detail was required in the previous
application, that might necessitate a new CDC permit just to
change the methodology. The level of detail appears to be
dependent upon the CDC personnel reviewing the application.
For
example, in some applications, this statement was sufficient in
E.2:
Gain understanding of relationship between
Pharmacokinetics, Pharmacodynamics, or Toxicokinetics for
biologic compounds via various dosing regimens with test articles
in cynomolgus monkeys.
For others, we had to provide more
information:
To understand distribution of these monoclonal
antibodies to the sites of action, i.e. synovial fluid, tissue
homogenate and tissues, and their ability to neutralize target at
the sites of action. Immunoassays will be used to quantify both
monoclonal antibodies and PD biomarkers from these samples.
DSAT
Response: The requested information is currently the same
information that we request on the currently approved form.
Guidance on the information needed to complete the form is
available at:
http://www.cdc.gov/od/eaipp/forms/Guidance_Document_for_Completion_Agents.pdf.
(d) ways to minimize the burden of the collection
of information on respondents, including through the use of
automated collection techniques or other forms of information
technology. Comments – a system for knowing where an
application is in the process - at a minimum: Received, In
Progress, Pending Clarification, Approved.
DSAT
Response: We appreciate the comment and will review if this type
of system is feasible.
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