Availability of Draft Toxicological Profile; Glutaraldehyde, 5756 [2016-01972]

Download as PDF 5756 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the profile development process, this Federal Register notice solicits any relevant, additional studies, particularly unpublished data.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 http:// 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.

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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 
http://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