81 FR 5756 - Availability of Draft Toxicological Profile; Glutaraldehyde
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry Federal Register Volume 81, Issue 22 (February 3, 2016)
Agency for Toxic Substances and Disease Registry
Federal Register Volume 81, Issue 22 (February 3, 2016)
| Page Range | 5756-5756 | |
| FR Document | 2016-01972 |
[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)] [Notices] [Page 5756] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01972] ======================================================================= ----------------------------------------------------------------------- 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the profile development process, this Federal Register notice solicits any relevant, additional studies, particularly unpublished data.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 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
![5756 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices
It is not intended to constitute an • Mail: Division of Toxicology and Monday through Friday, except for legal
official interpretation of the complaint Human Health Sciences, Agency for holidays, from 9 a.m. until 5 p.m.,
or proposed order, or to modify in any Toxic Substances and Disease Registry, Eastern Time, at 4770 Buford Hwy NE.,
way the proposed order’s terms. 1600 Clifton Rd. NE., MS F–57, Atlanta, Atlanta, Georgia 30341. Please call
By direction of the Commission. GA, 30329. Attn: Docket No. ATSDR– ahead to 1–800–232–4636 and ask for a
Donald S. Clark,
2016–0001. representative in the Division of
Instructions: All submissions received Toxicology and Human Health Sciences
Secretary.
must include the agency name and to schedule your visit.
[FR Doc. 2016–01944 Filed 2–2–16; 8:45 am]
docket number for this notice. All
BILLING CODE 6750–01–P Availability
relevant comments will be posted
without change. Because all public The Glutaraldehyde Toxicological
comments regarding ATSDR Profile is available online at http://
DEPARTMENT OF HEALTH AND Toxicological Profiles are available for www.atsdr.cdc.gov/toxprofiles/
HUMAN SERVICES public inspection, no confidential index.asp and www.regulations.gov,
business information or other Docket No. ATSDR–2016–0001.
Agency for Toxic Substances and confidential information should be
Disease Registry Donna B. Knutson,
submitted in response to this notice.
Acting Director, Office of Policy, Planning
[Docket No. ATSDR–2016–0001] FOR FURTHER INFORMATION CONTACT: Ms. and Evaluation, National Center for
Delores Grant, Division of Toxicology Environmental Health and Agency for Toxic
Availability of Draft Toxicological and Human Health Sciences, Agency for Substances and Disease Registry.
Profile; Glutaraldehyde Toxic Substances and Disease Registry, [FR Doc. 2016–01972 Filed 2–2–16; 8:45 am]
AGENCY: Agency for Toxic Substances 1600 Clifton Rd. NE., MS F–57, Atlanta, BILLING CODE 4163–70–P
and Disease Registry (ATSDR), GA, 30329. Phone: (800) 232–4636 or
Department of Health and Human 770–488–3351.
Services (DHHS). SUPPLEMENTARY INFORMATION: The DEPARTMENT OF HEALTH AND
ACTION: Notice of availability and Superfund Amendments and HUMAN SERVICES
request for comment. Reauthorization Act of 1986 (SARA) (42
U.S.C. 9601 et seq.) amended the Food and Drug Administration
SUMMARY: This notice, prepared by the Comprehensive Environmental [Docket No. FDA–2015–D–4599]
Agency for Toxic Substances and Response, Compensation, and Liability
Disease Registry (ATSDR), announces Act of 1980 (CERCLA or Superfund) (42 List of Highest Priority Devices for
the availability of the Toxicological U.S.C. 9601 et seq.) by establishing Human Factors Review; Draft
Profile for Glutaraldehyde for review certain requirements for ATSDR and the Guidance for Industry and Food and
and comment. All toxicological profiles U.S. Environmental Protection Agency Drug Administration Staff; Availability
issued as ‘‘Drafts for Public Comment’’ (U.S. EPA) regarding hazardous
represent ATSDR’s best efforts to substances that are most commonly AGENCY: Food and Drug Administration,
provide important toxicological found at facilities on the CERCLA HHS.
information on priority hazardous National Priorities List (NPL). Among ACTION: Notice.
substances. We are seeking public these statutory requirements is a
comments and additional information or SUMMARY: The Food and Drug
mandate for the Administrator of
reports on studies about the health Administration (FDA or Agency) is
ATSDR to prepare toxicological profiles
effects of glutaraldehyde for review and announcing the availability of the draft
for each substance included on the
potential inclusion in the profile. guidance entitled ‘‘List of Highest
priority list of hazardous substances
Comments can include additional Priority Devices for Human Factors
[also called the Substance Priority List
information or reports on studies about Review.’’ FDA is issuing this draft
(SPL)]. This list identifies 275
the health effects of glutaraldehyde. guidance document in order to inform
hazardous substances that ATSDR (in
Although ATSDR will consider key medical device manufacturers which
cooperation with EPA) has determined
studies for this substance during the device types should have human factors
pose the most significant potential
profile development process, this data included in premarket
threat to human health. The 2015 SPL
Federal Register notice solicits any submissions. FDA believes these device
is available online at
relevant, additional studies, particularly types have clear potential for serious
www.atsdr.cdc.gov/spl.
unpublished data. ATSDR will evaluate In addition, ATSDR has the authority harm resulting from use error and that
the quality and relevance of such data to prepare toxicological profiles for review of human factors data in
or studies for possible inclusion into the substances not found at sites on the premarket submissions will help FDA
profile. ATSDR is providing a public National Priorities List, in an effort to evaluate the safety and effectiveness and
comment period for this document as a ‘‘establish and maintain inventory of substantial equivalence of these devices.
means to best serve public health and literature, research, and studies on the This draft guidance is not final nor is it
our clients. health effects of toxic substances’’ under in effect at this time.
DATES: Written comments on this draft CERCLA Section 104(i)(1)(B), to respond DATES: Although you can comment on
Toxicological Profile must be received to requests for consultation under any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
mstockstill on DSK4VPTVN1PROD with NOTICES
on or before May 3, 2016. section 104(i)(4), and as otherwise
ADDRESSES: You may submit comments, necessary to support the site-specific considers your comment of this draft
identified by docket number ATSDR– response actions conducted by ATSDR. guidance before it begins work on the
2016–0001, by any of the following The public comments and other data final version of the guidance, submit
methods: submitted in response to the Federal either electronic or written comments
• Federal eRulemaking Portal: Register notices are available for public on the draft guidance by May 3, 2016.
www.regulations.gov. Follow the inspection at ATSDR. Comments are ADDRESSES: You may submit comments
instructions for submitting comments. available for public inspection from as follows:
VerDate Sep<11>2014 19:14 Feb 02, 2016 Jkt 238001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\03FEN1.SGM 03FEN1](https://thefederalregister.org/doc/81_FR_5778/page/1.svg)
Document Created: 2016-02-03 00:40:05
Document Modified: 2016-02-03 00:40:05
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability and request for comment. | |
| Dates | Written comments on this draft Toxicological Profile must be received on or before May 3, 2016. | |
| 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. | |
| FR Citation | 81 FR 5756 |
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