Request for the Technical Review of the Draft Current Intelligence Bulletin (CIB): Derivation of Immediately Dangerous to Life and Health (IDLH) Values, 4115-4116 [2011-1301]
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Federal Register / Vol. 76, No. 15 / Monday, January 24, 2011 / Notices
evaluate new and improved test
methods applicable to the needs of
Federal agencies. Additional
information about ICCVAM and
NICEATM is available on the
NICEATM–ICCVAM Web site at https://
iccvam.niehs.nih.gov.
Dated: January 13, 2011.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2011–1329 Filed 1–21–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Meeting of the Task Force on
Community Preventive Services
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice of meeting.
AGENCY:
The Centers for Disease
Control and Prevention (CDC)
announces the next meeting of the Task
Force on Community Preventive
Services (Task Force). The Task Force—
an independent, nonfederal body of
nationally known leaders in public
health practice, policy, and research
who are appointed by the CDC
Director—was convened in 1996 by the
Department of Health and Human
Services (HHS) to assess the
effectiveness of community,
environmental, population, and
healthcare system interventions in
public health and health promotion.
During this meeting the Task Force will
consider the findings of systematic
reviews and issue recommendations and
findings to help inform decision making
about policy, practice, and research in a
wide range of U.S. settings. The Task
Force’s recommendations, along with
the systematic reviews of the scientific
evidence on which they are based, are
compiled in the Guide to Community
Preventive Services (Community Guide).
DATES: The meeting will be held on
Wednesday, February, 16, 2011 from
8:30 a.m. to 5:30 p.m. EST and
Thursday, February 17, 2011 from 8:30
a.m. to 1 p.m. EST.
ADDRESSES: Atlanta Marriott Century
Center, 2000 Century Blvd., NE.,
Atlanta, GA.
FOR FURTHER INFORMATION CONTACT: Sara
Dodge, Division of Community
Preventive Services, Epidemiology and
Analysis Program Office, Office of
Surveillance, Epidemiology, and
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SUMMARY:
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Laboratory Services, Centers for Disease
Control and Prevention, 1600 Clifton
Road, Atlanta, Georgia 30333, phone:
(404) 498–0554, e-mail:
communityguide@cdc.gov.
Purpose:
The purpose of the meeting is for the
Task Force to consider the findings of
reviews and issue recommendations and
findings to help inform decision making
about policy, practice, and research in a
wide range of U.S. settings.
Matters To Be Discussed:
Effectiveness of small media clientoriented screening interventions to
decrease breast, cervical and colorectal
cancers; privatization of alcohol retail
sales; school dismissal policy to reduce
influenza transmission; client or family
incentives to reduce vaccine
preventable diseases; clinic based
education when used alone to reduce
vaccine preventable diseases; and
extended school hours to promote
health equity. New reviews on
cardiovascular disease and skin cancer
will also be discussed.
Meeting Accessibility: This meeting is
open to the public, limited only by
space available.
SUPPLEMENTARY INFORMATION:
Dated: January 7, 2011.
Tanja Popovic,
Deputy Associate Director for Science,
Centers for Disease Control and Prevention.
[FR Doc. 2011–1302 Filed 1–21–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket Number NIOSH–156]
Request for the Technical Review of
the Draft Current Intelligence Bulletin
(CIB): Derivation of Immediately
Dangerous to Life and Health (IDLH)
Values
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of public comment
period.
AGENCY:
The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC) is
conducting a public review of the draft,
Current Intelligence Bulletin (CIB):
Derivation of Immediately Dangerous to
Life and Health (IDLH) Values. NIOSH
SUMMARY:
PO 00000
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4115
is requesting technical review of the
draft CIB. The draft document and
instructions for submitting comments
can be found at https://www.cdc.gov/
niosh/docket/review/docket156/
default.html.
Public Comment Period: Comments
must be received by March 15, 2011.
A public meeting to be convened
either in Cincinnati, Ohio or via
Teleweb may be scheduled at a date and
time to be announced later if
determined to be necessary. This public
meeting will be announced via a
subsequent notice.
ADDRESSES: Written comments,
identified by docket number NIOSH–
156, may be submitted by any of the
following ways:
• Mail: NIOSH Docket Office, Robert
A. Taft Laboratories, MS–C34, 4676
Columbia Parkway, Cincinnati, OH
45226.
• Facsimile: (513) 533–8285.
• E-mail: nioshdocket@cdc.gov.
All information received in response
to this notice will be available for public
examination and copying at the NIOSH
Docket Office, 4676 Columbia Parkway,
Room 111, Cincinnati, Ohio 45226. A
complete electronic docket containing
all comments submitted will be
available on the NIOSH Web page at
https://www.cdc.gov/niosh/docket, and
comments will be available in writing
by request. NIOSH includes all
comments received without change in
the docket, including any personal
information provided. All electronic
comments should be formatted as
Microsoft Word. Please make reference
to docket number NIOSH 156.
FOR FURTHER INFORMATION CONTACT: G.
Scott Dotson, NIOSH, Robert A. Taft
Laboratories, MS–C32, 4676 Columbia
Parkway, Cincinnati, OH 45226,
telephone (513) 533–8540.
SUPPLEMENTARY INFORMATION: In 1974,
the National Institute for Occupational
Safety and Health (NIOSH) and the
Occupational Safety and Health
Administration (OSHA) jointly initiated
the development of occupational health
standards consistent with Section 6(b)
of the Occupational Safety and Health
Act of 1970 for substances with thenexisting OSHA permissible exposure
limits (PELs). This joint effort was
called the Standards Completion
Program (SCP). As part of the respirator
selection process for each draft
technical standard, Immediately
Dangerous to Life and Health (IDLH)
values were determined for each
chemical. The purpose of deriving an
IDLH value was to provide guidance on
respirator selection and to establish a
maximum exposure concentration in
E:\FR\FM\24JAN1.SGM
24JAN1
mstockstill on DSKH9S0YB1PROD with NOTICES
4116
Federal Register / Vol. 76, No. 15 / Monday, January 24, 2011 / Notices
which workers, in the event of
respiratory protection failure (e.g.,
contaminant breakthrough in a cartridge
respirator or stoppage of air flow in a
supplied-air respirator), could escape
safely when the exposure was below the
IDLH value.
Since the establishment of the original
IDLH values in 1974, NIOSH has
continued to review the available
scientific data to improve the protocol
used to derive the acute exposure
guidelines, in addition to the chemicalspecific IDLH values. This draft CIB
represents the most recent update of the
scientific rationale and process used to
derive IDLH values based on health
effects considerations determined
through a critical assessment of the
toxicology and human health effects
data.
The new process relies on a weightof-evidence approach based on
scientific judgment for establishing
IDLH values that allows for the critical
evaluation of the quality and
consistency of the scientific data, and in
extrapolation from the available data to
the IDLH value. The weight-of-evidence
approach refers to the critical
examination of all the available data
from diverse lines of evidence and the
derivation of a scientific interpretation
based on the collective body of data
including its relevance, quality and
reported results. Guidelines are
presented to aid in the selection of the
critical adverse effect, a point of
departure (POD) or the point on the
dose-response curve from which dose
extrapolation is initiated, and applying
default uncertainty factors (UFs) to
derive the IDLH value. Conceptually,
the derivation process presented in this
CIB is similar to that used in other risk
assessment applications including the
process steps of:
• Hazard characterization,
• Identification of critical adverse
effects,
• Identification of a POD,
• Application of an appropriate UF
based on the study and POD, and
• Determination of the final risk
value.
Supplemental information included
within this draft CIB includes (1) An
overview of the literature search strategy
used to identify relevant data, (2) the
scheme used to prioritize and select
chemicals for which an IDLH value will
be established and (3) an overview of
the analysis applied by NIOSH to
develop a scientifically-based approach
for the selection of the UF during the
derivation of IDLH values. In addition,
Appendix A of the draft CIB presents an
example of the derivation of an IDLH
VerDate Mar<15>2010
15:51 Jan 21, 2011
Jkt 223001
value for vinyl acetate (CAS #108–50–4)
based on the new process.
3794.
Jonnalynn.Capezzuto@fda.hhs.gov.
Dated: January 13, 2011.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2011–1301 Filed 1–21–11; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0044]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry and Food and Drug
Administration Staff; Section 905(j)
Reports: Demonstrating Substantial
Equivalence for Tobacco Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information request regarding the
Guidance for Industry and FDA Staff;
Section 905(j) Reports: Demonstrating
Substantial Equivalence for Tobacco
Products.
DATES: Submit either electronic or
written comments on the collection of
information by March 25, 2011.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr. PI50–
400B, Rockville, MD 20850. 301–796–
SUMMARY:
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Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined in
44 U.S.C. 3502(3) and 5 CFR 1320.3(c)
and includes Agency requests or
requirements that members of the public
submit reports, keep records, or provide
information to a third party. Section
3506(c)(2)(A) of the PRA (44 U.S.C.
3506(c)(2)(A)) requires Federal Agencies
to provide a 60-day notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Information Request Regarding
Guidance for Industry and FDA Staff;
Section 905(j) Reports: Demonstrating
Substantial Equivalence for Tobacco
Products (OMB Control Number 0910–
0673—Extension)
On June 22, 2009, the President
signed the Family Smoking Prevention
and Tobacco Control Act (the Tobacco
Control Act) (Pub. L. 111–31) into law.
The Tobacco Control Act amended the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) by adding a new chapter
granting FDA important new authority
to regulate the manufacture, marketing,
and distribution of tobacco products to
protect the public health generally and
to reduce tobacco use by minors.
Section 905(j) of the FD&C Act
authorizes FDA to establish the form for
the submission of information related to
E:\FR\FM\24JAN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 15 (Monday, January 24, 2011)]
[Notices]
[Pages 4115-4116]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-1301]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket Number NIOSH-156]
Request for the Technical Review of the Draft Current
Intelligence Bulletin (CIB): Derivation of Immediately Dangerous to
Life and Health (IDLH) Values
AGENCY: National Institute for Occupational Safety and Health (NIOSH)
of the Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Notice of public comment period.
-----------------------------------------------------------------------
SUMMARY: The National Institute for Occupational Safety and Health
(NIOSH) of the Centers for Disease Control and Prevention (CDC) is
conducting a public review of the draft, Current Intelligence Bulletin
(CIB): Derivation of Immediately Dangerous to Life and Health (IDLH)
Values. NIOSH is requesting technical review of the draft CIB. The
draft document and instructions for submitting comments can be found at
https://www.cdc.gov/niosh/docket/review/docket156/default.html.
Public Comment Period: Comments must be received by March 15, 2011.
A public meeting to be convened either in Cincinnati, Ohio or via
Teleweb may be scheduled at a date and time to be announced later if
determined to be necessary. This public meeting will be announced via a
subsequent notice.
ADDRESSES: Written comments, identified by docket number NIOSH-156, may
be submitted by any of the following ways:
Mail: NIOSH Docket Office, Robert A. Taft Laboratories,
MS-C34, 4676 Columbia Parkway, Cincinnati, OH 45226.
Facsimile: (513) 533-8285.
E-mail: nioshdocket@cdc.gov.
All information received in response to this notice will be
available for public examination and copying at the NIOSH Docket
Office, 4676 Columbia Parkway, Room 111, Cincinnati, Ohio 45226. A
complete electronic docket containing all comments submitted will be
available on the NIOSH Web page at https://www.cdc.gov/niosh/docket, and
comments will be available in writing by request. NIOSH includes all
comments received without change in the docket, including any personal
information provided. All electronic comments should be formatted as
Microsoft Word. Please make reference to docket number NIOSH 156.
FOR FURTHER INFORMATION CONTACT: G. Scott Dotson, NIOSH, Robert A. Taft
Laboratories, MS-C32, 4676 Columbia Parkway, Cincinnati, OH 45226,
telephone (513) 533-8540.
SUPPLEMENTARY INFORMATION: In 1974, the National Institute for
Occupational Safety and Health (NIOSH) and the Occupational Safety and
Health Administration (OSHA) jointly initiated the development of
occupational health standards consistent with Section 6(b) of the
Occupational Safety and Health Act of 1970 for substances with then-
existing OSHA permissible exposure limits (PELs). This joint effort was
called the Standards Completion Program (SCP). As part of the
respirator selection process for each draft technical standard,
Immediately Dangerous to Life and Health (IDLH) values were determined
for each chemical. The purpose of deriving an IDLH value was to provide
guidance on respirator selection and to establish a maximum exposure
concentration in
[[Page 4116]]
which workers, in the event of respiratory protection failure (e.g.,
contaminant breakthrough in a cartridge respirator or stoppage of air
flow in a supplied-air respirator), could escape safely when the
exposure was below the IDLH value.
Since the establishment of the original IDLH values in 1974, NIOSH
has continued to review the available scientific data to improve the
protocol used to derive the acute exposure guidelines, in addition to
the chemical-specific IDLH values. This draft CIB represents the most
recent update of the scientific rationale and process used to derive
IDLH values based on health effects considerations determined through a
critical assessment of the toxicology and human health effects data.
The new process relies on a weight-of-evidence approach based on
scientific judgment for establishing IDLH values that allows for the
critical evaluation of the quality and consistency of the scientific
data, and in extrapolation from the available data to the IDLH value.
The weight-of-evidence approach refers to the critical examination of
all the available data from diverse lines of evidence and the
derivation of a scientific interpretation based on the collective body
of data including its relevance, quality and reported results.
Guidelines are presented to aid in the selection of the critical
adverse effect, a point of departure (POD) or the point on the dose-
response curve from which dose extrapolation is initiated, and applying
default uncertainty factors (UFs) to derive the IDLH value.
Conceptually, the derivation process presented in this CIB is similar
to that used in other risk assessment applications including the
process steps of:
Hazard characterization,
Identification of critical adverse effects,
Identification of a POD,
Application of an appropriate UF based on the study and
POD, and
Determination of the final risk value.
Supplemental information included within this draft CIB includes
(1) An overview of the literature search strategy used to identify
relevant data, (2) the scheme used to prioritize and select chemicals
for which an IDLH value will be established and (3) an overview of the
analysis applied by NIOSH to develop a scientifically-based approach
for the selection of the UF during the derivation of IDLH values. In
addition, Appendix A of the draft CIB presents an example of the
derivation of an IDLH value for vinyl acetate (CAS 108-50-4)
based on the new process.
Dated: January 13, 2011.
John Howard,
Director, National Institute for Occupational Safety and Health,
Centers for Disease Control and Prevention.
[FR Doc. 2011-1301 Filed 1-21-11; 8:45 am]
BILLING CODE 4163-19-P
