Availability of Draft Toxicological Profile; Glutaraldehyde, 5756 [2016-01972]
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Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices
It is not intended to constitute an
official interpretation of the complaint
or proposed order, or to modify in any
way the proposed order’s terms.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2016–01944 Filed 2–2–16; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[Docket No. ATSDR–2016–0001]
Availability of Draft Toxicological
Profile; Glutaraldehyde
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (DHHS).
ACTION: Notice of availability and
request for comment.
AGENCY:
This notice, prepared by the
Agency for Toxic Substances and
Disease Registry (ATSDR), announces
the availability of the Toxicological
Profile for Glutaraldehyde for review
and comment. All toxicological profiles
issued as ‘‘Drafts for Public Comment’’
represent ATSDR’s best efforts to
provide important toxicological
information on priority hazardous
substances. We are seeking public
comments and additional information or
reports on studies about the health
effects of glutaraldehyde for review and
potential inclusion in the profile.
Comments can include additional
information or reports on studies about
the health effects of glutaraldehyde.
Although ATSDR will consider key
studies for this substance during the
profile development process, this
Federal Register notice solicits any
relevant, additional studies, particularly
unpublished data. ATSDR will evaluate
the quality and relevance of such data
or studies for possible inclusion into the
profile. ATSDR is providing a public
comment period for this document as a
means to best serve public health and
our clients.
DATES: Written comments on this draft
Toxicological Profile must be received
on or before May 3, 2016.
ADDRESSES: You may submit comments,
identified by docket number ATSDR–
2016–0001, by any of the following
methods:
• Federal eRulemaking Portal:
www.regulations.gov. Follow the
instructions for submitting comments.
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
19:14 Feb 02, 2016
Jkt 238001
• Mail: Division of Toxicology and
Human Health Sciences, Agency for
Toxic Substances and Disease Registry,
1600 Clifton Rd. NE., MS F–57, Atlanta,
GA, 30329. Attn: Docket No. ATSDR–
2016–0001.
Instructions: All submissions received
must include the agency name and
docket number for this notice. All
relevant comments will be posted
without change. Because all public
comments regarding ATSDR
Toxicological Profiles are available for
public inspection, no confidential
business information or other
confidential information should be
submitted in response to this notice.
FOR FURTHER INFORMATION CONTACT: Ms.
Delores Grant, Division of Toxicology
and Human Health Sciences, Agency for
Toxic Substances and Disease Registry,
1600 Clifton Rd. NE., MS F–57, Atlanta,
GA, 30329. Phone: (800) 232–4636 or
770–488–3351.
SUPPLEMENTARY INFORMATION: The
Superfund Amendments and
Reauthorization Act of 1986 (SARA) (42
U.S.C. 9601 et seq.) amended the
Comprehensive Environmental
Response, Compensation, and Liability
Act of 1980 (CERCLA or Superfund) (42
U.S.C. 9601 et seq.) by establishing
certain requirements for ATSDR and the
U.S. Environmental Protection Agency
(U.S. EPA) regarding hazardous
substances that are most commonly
found at facilities on the CERCLA
National Priorities List (NPL). Among
these statutory requirements is a
mandate for the Administrator of
ATSDR to prepare toxicological profiles
for each substance included on the
priority list of hazardous substances
[also called the Substance Priority List
(SPL)]. This list identifies 275
hazardous substances that ATSDR (in
cooperation with EPA) has determined
pose the most significant potential
threat to human health. The 2015 SPL
is available online at
www.atsdr.cdc.gov/spl.
In addition, ATSDR has the authority
to prepare toxicological profiles for
substances not found at sites on the
National Priorities List, in an effort to
‘‘establish and maintain inventory of
literature, research, and studies on the
health effects of toxic substances’’ under
CERCLA Section 104(i)(1)(B), to respond
to requests for consultation under
section 104(i)(4), and as otherwise
necessary to support the site-specific
response actions conducted by ATSDR.
The public comments and other data
submitted in response to the Federal
Register notices are available for public
inspection at ATSDR. Comments are
available for public inspection from
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
Monday through Friday, except for legal
holidays, from 9 a.m. until 5 p.m.,
Eastern Time, at 4770 Buford Hwy NE.,
Atlanta, Georgia 30341. Please call
ahead to 1–800–232–4636 and ask for a
representative in the Division of
Toxicology and Human Health Sciences
to schedule your visit.
Availability
The Glutaraldehyde Toxicological
Profile is available online at https://
www.atsdr.cdc.gov/toxprofiles/
index.asp and www.regulations.gov,
Docket No. ATSDR–2016–0001.
Donna B. Knutson,
Acting Director, Office of Policy, Planning
and Evaluation, National Center for
Environmental Health and Agency for Toxic
Substances and Disease Registry.
[FR Doc. 2016–01972 Filed 2–2–16; 8:45 am]
BILLING CODE 4163–70–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–4599]
List of Highest Priority Devices for
Human Factors Review; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘List of Highest
Priority Devices for Human Factors
Review.’’ FDA is issuing this draft
guidance document in order to inform
medical device manufacturers which
device types should have human factors
data included in premarket
submissions. FDA believes these device
types have clear potential for serious
harm resulting from use error and that
review of human factors data in
premarket submissions will help FDA
evaluate the safety and effectiveness and
substantial equivalence of these devices.
This draft guidance is not final nor is it
in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 3, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
E:\FR\FM\03FEN1.SGM
03FEN1
]]>Agencies
[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)]
[Notices]
[Page 5756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-01972]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry
[Docket No. ATSDR-2016-0001]
Availability of Draft Toxicological Profile; Glutaraldehyde
AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR),
Department of Health and Human Services (DHHS).
ACTION: Notice of availability and request for comment.
-----------------------------------------------------------------------
SUMMARY: This notice, prepared by the Agency for Toxic Substances and
Disease Registry (ATSDR), announces the availability of the
Toxicological Profile for Glutaraldehyde for review and comment. All
toxicological profiles issued as ``Drafts for Public Comment''
represent ATSDR's best efforts to provide important toxicological
information on priority hazardous substances. We are seeking public
comments and additional information or reports on studies about the
health effects of glutaraldehyde for review and potential inclusion in
the profile.
Comments can include additional information or reports on studies
about the health effects of glutaraldehyde. Although ATSDR will
consider key studies for this substance during the profile development
process, this Federal Register notice solicits any relevant, additional
studies, particularly unpublished data. ATSDR will evaluate the quality
and relevance of such data or studies for possible inclusion into the
profile. ATSDR is providing a public comment period for this document
as a means to best serve public health and our clients.
DATES: Written comments on this draft Toxicological Profile must be
received on or before May 3, 2016.
ADDRESSES: You may submit comments, identified by docket number ATSDR-
2016-0001, by any of the following methods:
Federal eRulemaking Portal: www.regulations.gov. Follow
the instructions for submitting comments.
Mail: Division of Toxicology and Human Health Sciences,
Agency for Toxic Substances and Disease Registry, 1600 Clifton Rd. NE.,
MS F-57, Atlanta, GA, 30329. Attn: Docket No. ATSDR-2016-0001.
Instructions: All submissions received must include the agency name
and docket number for this notice. All relevant comments will be posted
without change. Because all public comments regarding ATSDR
Toxicological Profiles are available for public inspection, no
confidential business information or other confidential information
should be submitted in response to this notice.
FOR FURTHER INFORMATION CONTACT: Ms. Delores Grant, Division of
Toxicology and Human Health Sciences, Agency for Toxic Substances and
Disease Registry, 1600 Clifton Rd. NE., MS F-57, Atlanta, GA, 30329.
Phone: (800) 232-4636 or 770-488-3351.
SUPPLEMENTARY INFORMATION: The Superfund Amendments and Reauthorization
Act of 1986 (SARA) (42 U.S.C. 9601 et seq.) amended the Comprehensive
Environmental Response, Compensation, and Liability Act of 1980 (CERCLA
or Superfund) (42 U.S.C. 9601 et seq.) by establishing certain
requirements for ATSDR and the U.S. Environmental Protection Agency
(U.S. EPA) regarding hazardous substances that are most commonly found
at facilities on the CERCLA National Priorities List (NPL). Among these
statutory requirements is a mandate for the Administrator of ATSDR to
prepare toxicological profiles for each substance included on the
priority list of hazardous substances [also called the Substance
Priority List (SPL)]. This list identifies 275 hazardous substances
that ATSDR (in cooperation with EPA) has determined pose the most
significant potential threat to human health. The 2015 SPL is available
online at www.atsdr.cdc.gov/spl.
In addition, ATSDR has the authority to prepare toxicological
profiles for substances not found at sites on the National Priorities
List, in an effort to ``establish and maintain inventory of literature,
research, and studies on the health effects of toxic substances'' under
CERCLA Section 104(i)(1)(B), to respond to requests for consultation
under section 104(i)(4), and as otherwise necessary to support the
site-specific response actions conducted by ATSDR.
The public comments and other data submitted in response to the
Federal Register notices are available for public inspection at ATSDR.
Comments are available for public inspection from Monday through
Friday, except for legal holidays, from 9 a.m. until 5 p.m., Eastern
Time, at 4770 Buford Hwy NE., Atlanta, Georgia 30341. Please call ahead
to 1-800-232-4636 and ask for a representative in the Division of
Toxicology and Human Health Sciences to schedule your visit.
Availability
The Glutaraldehyde Toxicological Profile is available online at
https://www.atsdr.cdc.gov/toxprofiles/index.asp and www.regulations.gov,
Docket No. ATSDR-2016-0001.
Donna B. Knutson,
Acting Director, Office of Policy, Planning and Evaluation, National
Center for Environmental Health and Agency for Toxic Substances and
Disease Registry.
[FR Doc. 2016-01972 Filed 2-2-16; 8:45 am]
BILLING CODE 4163-70-P
