Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Biennial Review and Republication of the Select Agent and Toxin List, 42363-42364 [2010-17728]
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Federal Register / Vol. 75, No. 139 / Wednesday, July 21, 2010 / Proposed Rules
further enhanced for clarity in
protecting research integrity.
With regard to enforcement
authorities, the current regulations
include in 42 CFR 50.606 and 45 CFR
94.6 a description of remedies available
to HHS and a PHS Awarding
Component when identifying concerns
regarding FCOI or compliance with the
regulations. In addition, 42 CFR 50.607
identifies other HHS regulations that
apply, including uniform administrative
requirements, as well as debarment and
suspension procedures. The NPRM
includes proposed revisions to all three
of these sections. Among the proposed
changes, with regard to matters
determined to require corrective action
under the regulations, we proposed
revising paragraph 50.606(b) to
incorporate by reference 45 CFR 74.14
(special award conditions), and
proposed revising paragraph 94.6(b) to
reference ‘‘other enforcement action’’ in
addition to, or in lieu of, a Stop Work
Order by the Contracting Officer. In
section 50.607, we proposed minor
revisions to update the CFR location or
title of the existing references, but also
specifically requested comment with
regard to the necessity of this section.
In conjunction with the comment
period extension, we seek public
comment on whether the proposed
changes to the regulations’ references to
the enforcement authorities available to
the PHS, including those discussed
above, should be further revised and
clarified in the regulations. This
includes comment on whether the
regulations should include one or more
descriptions of specific measures that
the Department, including a PHS
Awarding Component, may initiate as a
result of particular types of identified
FCOI or non-compliance under the
regulations. As one example, the
regulations potentially could describe
situations in which an Investigator’s
identified FCOI or an Investigator’s
failure to comply with an Institution’s
FCOI policy or FCOI management plan
necessitates notification to other
Institutions (e.g., when the Investigator,
or the PHS-funded research project on
which he or she is working, transfers
from one Institution to another).
In addition to possible clarification of
enforcement authorities, the Department
also seeks comment as to whether it
should clarify how the regulations apply
in circumstances in which an
Investigator or a PHS-funded research
project transfers from one Institution to
another, or in which a new Institution,
and Investigators at the new Institution,
become involved in an ongoing PHSfunded research project (e.g., where the
new Institution becomes a subgrantee
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15:10 Jul 20, 2010
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on the project). As one example, we
proposed in the NPRM to revise
substantially 42 CFR 50.604(f) and 45
CFR 94.4(f) such that these paragraphs
would require an Institution, through its
designated officials, to determine
whether an Investigator’s SFI is related
to PHS-funded research and, if so
related, whether the SFI is a FCOI. We
request comment as to whether the
regulations should further clarify that,
as part of the Institution’s FCOI
determination process, institutional
officials must consider whether an
Investigator’s SFI was previously
determined to be a FCOI and subject to
a management plan with regard to other
PHS-funded research project(s). Such
consideration could be based on
information in the Institution’s own
records or from publicly accessible
sources (e.g., the Web site of an
Institution that previously employed the
Investigator). We welcome additional
public comment on alternative
approaches or additional clarifications
that may be incorporated into the
regulations to protect further the
objectivity of PHS-funded research in
situations involving a transfer of an
Investigator or PHS-funded project
between Institutions, or the introduction
of a new Institution and Investigators to
an existing PHS-funded project.
Dated: June 22, 2010.
Francis S. Collins,
Director, National Institutes of Health.
Approved: July 6, 2010.
Kathleen Sebelius,
Secretary.
[FR Doc. 2010–17739 Filed 7–20–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 73
RIN 0920–AA34
Public Health Security and
Bioterrorism Preparedness and
Response Act of 2002; Biennial Review
and Republication of the Select Agent
and Toxin List
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Advance notice of proposed
rulemaking and request for comments.
AGENCY:
The Public Health Security
and Bioterrorism Preparedness and
Response Act of 2002 (42 U.S.C. 262a)
(the Bioterrorism Act) requires the
biennial review and republication of the
HHS list of select agents and toxins.
SUMMARY:
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Fmt 4702
Sfmt 4702
42363
Accordingly, we are soliciting public
comment on the current HHS list of
select agents and toxins, including
whether any biological agent or toxin
should be added to or removed from the
list. We are also seeking comments as to
whether we should ‘‘tier’’ the HHS select
agent list based on the relative
bioterrorism risk of each agent or toxin
and possibly further ‘‘stratify’’ the
security requirements for agents in the
highest tier based on type of use or other
factors.
DATES: We will consider all comments
received on or before August 20, 2010.
ADDRESSES: Comments in response to
this notice should be marked
‘‘Comments on the changes to the list of
select agents and toxins’’ and mailed to:
Centers for Disease Control and
Prevention, Division of Select Agents
and Toxins, 1600 Clifton Road, MS A–
46, Atlanta, GA 30333. Comments may
be e-mailed to: SAPcomments@cdc.gov.
FOR FURTHER INFORMATION CONTACT:
Robbin Weyant, Director, Division of
Select Agents and Toxins, Centers for
Disease Control and Prevention, 1600
Clifton Rd., MS A–46, Atlanta, GA
30333. Telephone: (404) 718–2000.
SUPPLEMENTARY INFORMATION: The
Bioterrorism Act requires the HHS
Secretary to establish by regulation a list
of each biological agent and toxin that
has the potential to pose a severe threat
to public health and safety. In
determining whether to include an
agent or toxin on the list, the HHS
Secretary considers the effect on human
health upon exposure to the agent or
toxin; the degree of contagiousness of
the agent; the methods by which the
agent or toxin is transferred to humans;
the availability and effectiveness of
pharmacotherapies and immunizations
to treat and prevent illnesses resulting
from the agent or toxin; the potential for
the agent or toxin to be used as a
biological weapon; and the needs of
children and other vulnerable
populations. The current list of HHS
biological select agents and toxins can
be found at https://www.selectagents.
gov/Select%20Agents%20and%
20Toxins%20List.html. The
Bioterrorism Act requires that the HHS
Secretary review and republish the HHS
list of select agents and toxins on at
least a biennial basis.
Background
The HHS Secretary last republished
the HHS select agent and toxin list in
the Federal Register on October 16,
2008 (73 FR 61363). The HHS select
agent and toxin list, found in part 73 of
Title 42 of the Code of Federal
Regulations (42 CFR part 73), is divided
E:\FR\FM\21JYP1.SGM
21JYP1
erowe on DSK5CLS3C1PROD with PROPOSALS-1
42364
Federal Register / Vol. 75, No. 139 / Wednesday, July 21, 2010 / Proposed Rules
into two sections. The select agents and
toxins listed in § 73.3 (HHS select agents
and toxins) are those regulated only by
HHS under the authority of the
Bioterrorism Act. The select agents and
toxins listed in § 73.4 (Overlap select
agents and toxins) are those regulated by
HHS under the authority of the
Bioterrorism Act and regulated by
Secretary of Agriculture (USDA) under
the authority of the Agricultural
Bioterrorism Protection Act of 2002 (7
U.S.C. 8401).
To fulfill this statutory mandate,
CDC’s Division of Select Agents and
Toxins (DSAT) has initiated its biennial
review process which will include
consultation with subject matter experts
including the Intragovernmental Select
Agents and Toxins Technical Advisory
Committee (ISATTAC). The ISATTAC is
comprised of Federal government
employees from the CDC, the National
Institutes of Health (NIH), the Food and
Drug Administration (FDA), the USDA/
Animal and Plant Health Inspection
Service (APHIS), USDA/Agricultural
Research Service (ARS), USDA/Center
for Veterinary Biologics (CVB), the
Department of Homeland Security
(DHS), and the Department of Defense
(DOD).
The purpose of this advanced notice
of proposed rulemaking is to seek public
comment on (1) the appropriateness of
the current HHS list of select agents and
toxins, (2) whether there are other
agents or toxins that should be added to
the HHS list, (3) whether agents or
toxins currently on the HHS list should
be deleted from the list, (4) whether the
HHS select agent list should be tiered
based on the relative bioterrorism risk of
each agent or toxin, and (5) whether the
security requirements for agents in the
highest tier should be further stratified
based on type of use or other factors.
A recent report by the National
Research Council recommended that the
select agent list should be ordered based
on the potential of an agent to be used
as a biothreat, and a graded series of
security procedures should be applied
so that the greatest resources and
scrutiny go to securing agents that pose
a maximum risk (https://
www8.nationalacademies.org/
onpinews/
newsitem.aspx?RecordID=12774). As
noted above, we are also seeking public
comment on whether the HHS list
should be tiered based on the relative
bioterrorism risk of each agent or toxin
and whether the security requirements
for agents in the highest tier should be
further stratified based on type of use or
other factors. If a commenter believes
that the HHS list should be tiered and/
or stratified, we would also be
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15:10 Jul 20, 2010
Jkt 220001
interested in what criteria should be
used to designate higher-risk agents, and
what, if any, changes we should make
in security requirements for what would
be determined to be higher-risk agents.
If implemented, tiering of the HHS
select agent list could allow for the
application of more stringent security
measures for those select agents or
toxins which pose a higher risk to
public health and safety if stolen or
misused. If implemented, stratification
of the HHS select agent list could allow
for varying levels of security
requirements for entities that possess
the highest tier agents, based on use of
the agent or other factors. If a
commenter believes that tiering and/or
stratification of the HHS select agent list
is advisable, we would be interested in
comments as to what criteria should be
used to designate which agents and
toxins pose a higher bioterrorism risk
and what criteria should be used for
stratifying the highest risk agents. For
example, the tiering and/or stratification
of the HHS select agent list might
consider the relative ease with which a
particular agent or toxin might be
disseminated or transmitted between
humans or throughout the environment;
the potential for high mortality rates; the
potential for a major public health
impact; whether misuse of an agent or
toxin might result in public panic or
other social or economic disruption; and
whether the agent or toxin requires
Federal, State and local officials to take
special action in planning for major
public health disasters (quarantine
needs, eradicated agent or toxin).
Additionally, we would also be
interested in what corresponding
changes should be made to the security
requirements found in 42 CFR 73.11 to
increase protection for higher tier agents
or toxins; whether those security
requirements should be stratified based
on the use of the agent or other factors;
and whether such changes should be
prescriptive (the imposition of specific
restraints, restrictions, or requirements)
or risk-based (security requirement
based on a security risk assessment), or
a combination of prescriptive and riskbased.
Following the conclusion of CDC
review, we will publish another notice
in the Federal Register either proposing
that the select agent and toxin list
remain the same, or that specific
biological agents or toxins be added to
or deleted from the list. If appropriate,
we will also propose any changes to the
Select Agent regulations (42 CFR Part
73) to implement a tiering and/or
stratification schema along with any
corresponding amendments to the
current security requirements in the
PO 00000
Frm 00026
Fmt 4702
Sfmt 4702
Select Agent regulations that might be
required for higher-risk agents and
toxins.
This action has been determined to be
significant for the purposes of Executive
Order 12866 and, therefore, has been
reviewed by the Office of Management
and Budget.
Authority: 42 U.S.C. 262a.
Dated: January 8, 2010.
Kathleen Sebelius,
Secretary.
Editorial Note: This document was
received in the Office of the Federal Register
on July 15, 2010.
[FR Doc. 2010–17728 Filed 7–20–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF TRANSPORTATION
Pipeline and Hazardous Materials
Safety Administration
49 CFR Parts 171 and 173
[Docket No. PHMSA–2010–0017 (HM–245)]
RIN 2137–AE56
Hazardous Materials: Incorporation of
Certain Cargo Tank Special Permits
Into Regulations
Pipeline and Hazardous
Materials Safety Administration
(PHMSA), DOT.
ACTION: Notice of proposed rulemaking
(NPRM).
AGENCY:
The Pipeline and Hazardous
Materials Safety Administration is
proposing to amend the Hazardous
Materials Regulations to incorporate
provisions contained in certain widely
used or longstanding cargo tank special
permits that are granted to multiple
parties and have an established safety
record. Special permits allow a
company or individual to package or
ship a hazardous material in a manner
that varies from the regulations
provided an equivalent level of safety is
maintained. The proposed revisions are
intended to provide wider access to the
regulatory flexibility offered in the
special permits and eliminate the need
for numerous renewal requests, thereby,
facilitating commerce activity and
reducing paperwork burdens while
maintaining an appropriate level of
safety.
SUMMARY:
Comments must be received by
August 20, 2010. A 30 day comment
period is appropriate for this
rulemaking because it proposes to
incorporate long-standing, widely used
special permits into the HMR. These
DATES:
E:\FR\FM\21JYP1.SGM
21JYP1
]]>Agencies
[Federal Register Volume 75, Number 139 (Wednesday, July 21, 2010)]
[Proposed Rules]
[Pages 42363-42364]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-17728]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 73
RIN 0920-AA34
Public Health Security and Bioterrorism Preparedness and Response
Act of 2002; Biennial Review and Republication of the Select Agent and
Toxin List
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Advance notice of proposed rulemaking and request for comments.
-----------------------------------------------------------------------
SUMMARY: The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (42 U.S.C. 262a) (the Bioterrorism Act) requires
the biennial review and republication of the HHS list of select agents
and toxins. Accordingly, we are soliciting public comment on the
current HHS list of select agents and toxins, including whether any
biological agent or toxin should be added to or removed from the list.
We are also seeking comments as to whether we should ``tier'' the HHS
select agent list based on the relative bioterrorism risk of each agent
or toxin and possibly further ``stratify'' the security requirements
for agents in the highest tier based on type of use or other factors.
DATES: We will consider all comments received on or before August 20,
2010.
ADDRESSES: Comments in response to this notice should be marked
``Comments on the changes to the list of select agents and toxins'' and
mailed to: Centers for Disease Control and Prevention, Division of
Select Agents and Toxins, 1600 Clifton Road, MS A-46, Atlanta, GA
30333. Comments may be e-mailed to: SAPcomments@cdc.gov.
FOR FURTHER INFORMATION CONTACT: Robbin Weyant, Director, Division of
Select Agents and Toxins, Centers for Disease Control and Prevention,
1600 Clifton Rd., MS A-46, Atlanta, GA 30333. Telephone: (404) 718-
2000.
SUPPLEMENTARY INFORMATION: The Bioterrorism Act requires the HHS
Secretary to establish by regulation a list of each biological agent
and toxin that has the potential to pose a severe threat to public
health and safety. In determining whether to include an agent or toxin
on the list, the HHS Secretary considers the effect on human health
upon exposure to the agent or toxin; the degree of contagiousness of
the agent; the methods by which the agent or toxin is transferred to
humans; the availability and effectiveness of pharmacotherapies and
immunizations to treat and prevent illnesses resulting from the agent
or toxin; the potential for the agent or toxin to be used as a
biological weapon; and the needs of children and other vulnerable
populations. The current list of HHS biological select agents and
toxins can be found at https://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html. The Bioterrorism Act
requires that the HHS Secretary review and republish the HHS list of
select agents and toxins on at least a biennial basis.
Background
The HHS Secretary last republished the HHS select agent and toxin
list in the Federal Register on October 16, 2008 (73 FR 61363). The HHS
select agent and toxin list, found in part 73 of Title 42 of the Code
of Federal Regulations (42 CFR part 73), is divided
[[Page 42364]]
into two sections. The select agents and toxins listed in Sec. 73.3
(HHS select agents and toxins) are those regulated only by HHS under
the authority of the Bioterrorism Act. The select agents and toxins
listed in Sec. 73.4 (Overlap select agents and toxins) are those
regulated by HHS under the authority of the Bioterrorism Act and
regulated by Secretary of Agriculture (USDA) under the authority of the
Agricultural Bioterrorism Protection Act of 2002 (7 U.S.C. 8401).
To fulfill this statutory mandate, CDC's Division of Select Agents
and Toxins (DSAT) has initiated its biennial review process which will
include consultation with subject matter experts including the
Intragovernmental Select Agents and Toxins Technical Advisory Committee
(ISATTAC). The ISATTAC is comprised of Federal government employees
from the CDC, the National Institutes of Health (NIH), the Food and
Drug Administration (FDA), the USDA/Animal and Plant Health Inspection
Service (APHIS), USDA/Agricultural Research Service (ARS), USDA/Center
for Veterinary Biologics (CVB), the Department of Homeland Security
(DHS), and the Department of Defense (DOD).
The purpose of this advanced notice of proposed rulemaking is to
seek public comment on (1) the appropriateness of the current HHS list
of select agents and toxins, (2) whether there are other agents or
toxins that should be added to the HHS list, (3) whether agents or
toxins currently on the HHS list should be deleted from the list, (4)
whether the HHS select agent list should be tiered based on the
relative bioterrorism risk of each agent or toxin, and (5) whether the
security requirements for agents in the highest tier should be further
stratified based on type of use or other factors.
A recent report by the National Research Council recommended that
the select agent list should be ordered based on the potential of an
agent to be used as a biothreat, and a graded series of security
procedures should be applied so that the greatest resources and
scrutiny go to securing agents that pose a maximum risk (https://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=12774). As
noted above, we are also seeking public comment on whether the HHS list
should be tiered based on the relative bioterrorism risk of each agent
or toxin and whether the security requirements for agents in the
highest tier should be further stratified based on type of use or other
factors. If a commenter believes that the HHS list should be tiered
and/or stratified, we would also be interested in what criteria should
be used to designate higher-risk agents, and what, if any, changes we
should make in security requirements for what would be determined to be
higher-risk agents.
If implemented, tiering of the HHS select agent list could allow
for the application of more stringent security measures for those
select agents or toxins which pose a higher risk to public health and
safety if stolen or misused. If implemented, stratification of the HHS
select agent list could allow for varying levels of security
requirements for entities that possess the highest tier agents, based
on use of the agent or other factors. If a commenter believes that
tiering and/or stratification of the HHS select agent list is
advisable, we would be interested in comments as to what criteria
should be used to designate which agents and toxins pose a higher
bioterrorism risk and what criteria should be used for stratifying the
highest risk agents. For example, the tiering and/or stratification of
the HHS select agent list might consider the relative ease with which a
particular agent or toxin might be disseminated or transmitted between
humans or throughout the environment; the potential for high mortality
rates; the potential for a major public health impact; whether misuse
of an agent or toxin might result in public panic or other social or
economic disruption; and whether the agent or toxin requires Federal,
State and local officials to take special action in planning for major
public health disasters (quarantine needs, eradicated agent or toxin).
Additionally, we would also be interested in what corresponding changes
should be made to the security requirements found in 42 CFR 73.11 to
increase protection for higher tier agents or toxins; whether those
security requirements should be stratified based on the use of the
agent or other factors; and whether such changes should be prescriptive
(the imposition of specific restraints, restrictions, or requirements)
or risk-based (security requirement based on a security risk
assessment), or a combination of prescriptive and risk-based.
Following the conclusion of CDC review, we will publish another
notice in the Federal Register either proposing that the select agent
and toxin list remain the same, or that specific biological agents or
toxins be added to or deleted from the list. If appropriate, we will
also propose any changes to the Select Agent regulations (42 CFR Part
73) to implement a tiering and/or stratification schema along with any
corresponding amendments to the current security requirements in the
Select Agent regulations that might be required for higher-risk agents
and toxins.
This action has been determined to be significant for the purposes
of Executive Order 12866 and, therefore, has been reviewed by the
Office of Management and Budget.
Authority: 42 U.S.C. 262a.
Dated: January 8, 2010.
Kathleen Sebelius,
Secretary.
Editorial Note: This document was received in the Office of the
Federal Register on July 15, 2010.
[FR Doc. 2010-17728 Filed 7-20-10; 8:45 am]
BILLING CODE 4163-18-P
