80_FR_62733 80 FR 62533 - Availability of Draft Toxicological Profile; Set 27 Toxicological Profiles

80 FR 62533 - Availability of Draft Toxicological Profile; Set 27 Toxicological Profiles

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Toxic Substances and Disease Registry

Federal Register Volume 80, Issue 200 (October 16, 2015)

Page Range62533-62534
FR Document2015-26321

The Agency for Toxic Substances and Disease Registry (ATSDR), located within the Department of Health and Human Services (HHS) announces the availability of Set 27 Toxicological Profiles for review and comment. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), Sec. 104(i)(3), (42 U.S.C. 9604(i)(3)), directs the ATSDR Administrator to prepare Toxicological Profiles of Priority hazardous substances and, as necessary, to revise and publish each updated toxicological profile. Comments can include additional information or reports on studies about the health effects of Set 27 substances. Although ATSDR considered key studies for each of these substances during the profile development process, the Federal Register notice solicits any relevant, additional studies, particularly unpublished data.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 remains committed to providing a public comment period for this document as a means to best serve public health and our clients.

Federal Register, Volume 80 Issue 200 (Friday, October 16, 2015)
[Federal Register Volume 80, Number 200 (Friday, October 16, 2015)]
[Notices]
[Pages 62533-62534]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-26321]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Docket No. ATSDR-2015-0002]


Availability of Draft Toxicological Profile; Set 27 Toxicological 
Profiles

AGENCY: Agency for Toxic Substances and Disease Registry (ATSDR), 
Department of Health and Human Services (HHS).

ACTION: Notice of availability and request for comment.

-----------------------------------------------------------------------

SUMMARY: The Agency for Toxic Substances and Disease Registry (ATSDR), 
located within the Department of Health and Human Services (HHS) 
announces the availability of Set 27 Toxicological Profiles for review 
and comment. The Comprehensive Environmental Response, Compensation, 
and Liability Act of 1980 (CERCLA), as amended by

[[Page 62534]]

the Superfund Amendments and Reauthorization Act of 1986 (SARA), Sec.  
104(i)(3), (42 U.S.C. 9604(i)(3)), directs the ATSDR Administrator to 
prepare Toxicological Profiles of Priority hazardous substances and, as 
necessary, to revise and publish each updated toxicological profile.
    Comments can include additional information or reports on studies 
about the health effects of Set 27 substances. Although ATSDR 
considered key studies for each of these substances during the profile 
development process, the 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 remains committed to 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 January 14, 2016.

ADDRESSES: You may submit comments, identified by docket number ATSDR-
2015-0002, 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-2015-0002.
    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 (SARA) (Pub. L. 99-499) amends the Comprehensive Environmental 
Response, Compensation, and Liability Act (CERCLA or Superfund) (42 
U.S.C. 9601 et seq.) by establishing certain responsibilities for ATSDR 
and the U.S. Environmental Protection Agency (U.S. EPA) regarding 
hazardous substances most commonly found at facilities on the CERCLA 
National Priorities List (NPL). As part of these responsibilities, the 
ATSDR Administrator must prepare Toxicological Profiles for substances 
enumerated on the priority list of hazardous substances. This list 
identifies 275 hazardous substances which, according to ATSDR and U.S. 
EPA, pose the most significant potential threat to human health. The 
availability of the revised priority list of 275 hazardous substances 
was announced in the Federal Register on May 28, 2014 (79 FR 30613). 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). ATSDR also prepares Toxicological Profiles 
in response to requests for consultation under section 104(i)(4), and 
as otherwise necessary to support the site-specific response actions 
conducted by ATSDR.
    Each profile will include an examination, a summary, and an 
interpretation of available toxicological information and 
epidemiological evaluations. This information and these data identify 
the levels of significant human exposure for the substance and for the 
associated health effects. The profiles must also include a 
determination of whether adequate information on the health effects of 
each substance is available (or in the process of development) in order 
to identify levels of significant human exposure. If adequate 
information is not available, ATSDR, in cooperation with the National 
Toxicology Program (NTP), is required to ensure the initiation of a 
program of research to provide such information.

                      Set 27 Toxicological Profiles
------------------------------------------------------------------------
                                                  Name
------------------------------------------------------------------------
1.............................  Polybrominated Biphenyl Ethers (PBDEs)
                                 UPDATE.
2.............................  N,N-Diethyl-meta-toluamide (DEET).
3.............................  Toluene Diisocyanates (mixture).
                                Methylenediphenyl Diisocyanates (NEW).
4.............................  Nitrates/Nitrites (NEW).
5.............................  Toluene (UPDATE).
------------------------------------------------------------------------

    The Set 27 Toxicological Profiles are available online at http://www.atsdr.cdc.gov/toxprofiles/index.asp and http://www.regulations.gov, 
Docket No. ATSDR-2015-0002.

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. 2015-26321 Filed 10-15-15; 8:45 am]
 BILLING CODE 4163-18-P



                                                                              Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices                                               62533

                                                inventories, formulas, patterns, devices,               DEPARTMENT OF HEALTH AND                              the Agency in light of private sector
                                                manufacturing processes, or customer                    HUMAN SERVICES                                        activity and opportunities for public
                                                names.                                                                                                        private partnerships.
                                                                                                        Agency for Healthcare Research and                      The Council is composed of members
                                                   If you want the Commission to give
                                                                                                        Quality                                               of the public, appointed by the
                                                your comment confidential treatment,
                                                                                                                                                              Secretary, and Federal ex-officio
                                                you must file it in paper form, with a                  Meeting of the National Advisory                      members specified in the authorizing
                                                request for confidential treatment, and                 Council for Healthcare Research and                   legislation.
                                                you must follow the procedure                           Quality
                                                explained in FTC Rule 4.9(c), 16 CFR                                                                          II. Agenda
                                                4.9(c). Your comment will be kept                       AGENCY: Agency for Healthcare Research
                                                                                                        and Quality (AHRQ).                                      On Tuesday, November 3, 2015, there
                                                confidential only if the FTC General                                                                          will be a subcommittee meeting for the
                                                                                                        ACTION: Notice of public meeting.
                                                Counsel, in his or her sole discretion,                                                                       National Healthcare Quality and
                                                grants your request in accordance with                  SUMMARY:     In accordance with section               Disparities Report scheduled to begin at
                                                the law and the public interest. Postal                 10(a) of the Federal Advisory Committee               7:30 a.m. The subcommittee meeting is
                                                mail addressed to the Commission is                     Act, 5 U.S.C. App. 2, this notice                     open the public. The Council meeting
                                                subject to delay due to heightened                      announces a meeting of the National                   will convene at 8:30 a.m., with the call
                                                security screening. As a result, the                    Advisory Council for Healthcare                       to order by the Council Chair and
                                                Commission encourages you to submit                     Research and Quality.                                 approval of previous Council summary
                                                your comments online. To make sure                      DATES: The meeting will be held on                    notes. The meeting is open to the public
                                                that the Commission considers your                      Tuesday, November 3, 2015, from 8:30                  and will be available via webcast at
                                                online comment, you must file it at                     a.m. to 2:45 p.m.                                     www.webconferences.com/ahrq. The
                                                https://ftcpublic.commentworks.com/                     ADDRESSES: The meeting will be held at                meeting will begin with the AHRQ
                                                ftc/healthbreachnotificationpra by                      the Hubert H. Humphrey Building,                      director presenting an update on current
                                                following the instructions on the web-                  Room 800, 200 Independence Avenue                     research, programs, and initiatives.
                                                based form. If this Notice appears at                   SW., Washington, DC 20201.                            Following the Director’s update, the
                                                http://www.regulations.gov, you also                    FOR FURTHER INFORMATION CONTACT:
                                                                                                                                                              agenda will include discussion of
                                                may file a comment through that Web                     Jaime Zimmerman, Designated                           AHRQ’s work on health information
                                                                                                        Management Official, at the Agency for                technology (Health IT), a presentation
                                                site.
                                                                                                        Healthcare Research and Quality, 540                  on the Medical Expenditure Panel
                                                   If you file your comment on paper,                                                                         Survey (MEPS), and discussion on the
                                                write ‘‘Health Breach Notification Rule,                Gaither Road, Rockville, Maryland,
                                                                                                        20850, (301) 427–1456. For press-related              recent IOM report on diagnostic errors.
                                                PRA Comments, P–125402’’ on your                                                                              The final agenda will be available on the
                                                                                                        information, please contact Alison Hunt
                                                comment and on the envelope, and mail                                                                         AHRQ Web site at www.AHRQ.gov no
                                                                                                        at (301) 427–1244.
                                                it to the following address: Federal                       If sign language interpretation or other           later than Friday, October 23, 2015.
                                                Trade Commission, Office of the                         reasonable accommodation for a                        Sharon B. Arnold,
                                                Secretary, 600 Pennsylvania Avenue                      disability is needed, please contact the              Deputy.
                                                NW., Suite CC–5610, (Annex J),                          Food and Drug Administration (FDA)                    [FR Doc. 2015–26319 Filed 10–15–15; 8:45 am]
                                                Washington, DC 20580, or deliver your                   Office of Equal Employment                            BILLING CODE 4160–90–P
                                                comment to the following address:                       Opportunity and Diversity Management
                                                Federal Trade Commission, Office of the                 on (301) 827–4840, no later than Friday,
                                                Secretary, Constitution Center, 400 7th                 October 23, 2015. The agenda, roster,                 DEPARTMENT OF HEALTH AND
                                                Street SW., 5th Floor, Suite 5610,                      and minutes are available from Ms.                    HUMAN SERVICES
                                                (Annex J), Washington, DC 20024. If                     Bonnie Campbell, Committee
                                                possible, submit your paper comment to                  Management Officer, Agency for                        Agency for Toxic Substances and
                                                the Commission by courier or overnight                  Healthcare Research and Quality, 540                  Disease Registry
                                                service.                                                Gaither Road, Rockville, Maryland,
                                                                                                        20850. Ms. Campbell’s phone number is                 [Docket No. ATSDR–2015–0002]
                                                   The FTC Act and other laws that the
                                                Commission administers permit the                       (301) 427–1554.                                       Availability of Draft Toxicological
                                                collection of public comments to                        SUPPLEMENTARY INFORMATION:                            Profile; Set 27 Toxicological Profiles
                                                consider and use in this proceeding as                  I. Purpose                                            AGENCY:  Agency for Toxic Substances
                                                appropriate. The Commission will                           The National Advisory Council for                  and Disease Registry (ATSDR),
                                                consider all timely and responsive                      Healthcare Research and Quality is                    Department of Health and Human
                                                public comments that it receives on or                  authorized by Section 941 of the Public               Services (HHS).
                                                before December 15, 2015. You can find                  Health Service Act, 42 U.S.C. 299c. In                ACTION: Notice of availability and
                                                more information, including routine                     accordance with its statutory mandate,                request for comment.
                                                uses permitted by the Privacy Act, in                   the Council is to advise the Secretary of
                                                the Commission’s privacy policy, at                     the Department of Health and Human                    SUMMARY:   The Agency for Toxic
                                                http://www.ftc.gov/ftc/privacy.htm.                     Services and the Director, Agency for                 Substances and Disease Registry
                                                                                                        Healthcare Research and Quality                       (ATSDR), located within the
srobinson on DSK5SPTVN1PROD with NOTICES




                                                David C. Shonka,
                                                                                                        (AHRQ), on matters related to AHRQ’s                  Department of Health and Human
                                                Principal Deputy General Counsel.                       conduct of its mission including                      Services (HHS) announces the
                                                [FR Doc. 2015–26362 Filed 10–15–15; 8:45 am]            providing guidance on (A) priorities for              availability of Set 27 Toxicological
                                                BILLING CODE 6750–01–P                                  health care research, (B) the field of                Profiles for review and comment. The
                                                                                                        health care research including training               Comprehensive Environmental
                                                                                                        needs and information dissemination on                Response, Compensation, and Liability
                                                                                                        health care quality and (C) the role of               Act of 1980 (CERCLA), as amended by


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                                                62534                         Federal Register / Vol. 80, No. 200 / Friday, October 16, 2015 / Notices

                                                the Superfund Amendments and                            most commonly found at facilities on                   www.regulations.gov, Docket No.
                                                Reauthorization Act of 1986 (SARA),                     the CERCLA National Priorities List                    ATSDR–2015–0002.
                                                § 104(i)(3), (42 U.S.C. 9604(i)(3)), directs            (NPL). As part of these responsibilities,              Donna B. Knutson,
                                                the ATSDR Administrator to prepare                      the ATSDR Administrator must prepare
                                                Toxicological Profiles of Priority                                                                             Acting Director, Office of Policy, Planning
                                                                                                        Toxicological Profiles for substances                  and Evaluation, National Center for
                                                hazardous substances and, as necessary,                 enumerated on the priority list of                     Environmental Health and Agency for Toxic
                                                to revise and publish each updated                      hazardous substances. This list                        Substances and Disease Registry.
                                                toxicological profile.                                  identifies 275 hazardous substances                    [FR Doc. 2015–26321 Filed 10–15–15; 8:45 am]
                                                   Comments can include additional                      which, according to ATSDR and U.S.                     BILLING CODE 4163–18–P
                                                information or reports on studies about                 EPA, pose the most significant potential
                                                the health effects of Set 27 substances.
                                                                                                        threat to human health. The availability
                                                Although ATSDR considered key                                                                                  DEPARTMENT OF HEALTH AND
                                                                                                        of the revised priority list of 275
                                                studies for each of these substances                                                                           HUMAN SERVICES
                                                during the profile development process,                 hazardous substances was announced in
                                                the Federal Register notice solicits any                the Federal Register on May 28, 2014
                                                                                                        (79 FR 30613). In addition, ATSDR has                  Centers for Medicare & Medicaid
                                                relevant, additional studies, particularly                                                                     Services
                                                unpublished data. ATSDR will evaluate                   the authority to prepare Toxicological
                                                the quality and relevance of such data                  Profiles for substances not found at sites             [Document Identifier: CMS–10003, CMS–
                                                                                                        on the National Priorities List, in an                 10467, CMS–1450(UB–04), CMS–1500(08–
                                                or studies for possible inclusion into the
                                                                                                        effort to ‘‘. . . establish and maintain               05)]
                                                profile. ATSDR remains committed to
                                                providing a public comment period for                   inventory of literature, research, and                 Agency Information Collection
                                                this document as a means to best serve                  studies on the health effects of toxic                 Activities: Proposed Collection;
                                                public health and our clients.                          substances’’ under CERCLA Section                      Comment Request
                                                DATES: Written comments on this draft                   104(i)(1)(B). ATSDR also prepares
                                                Toxicological Profile must be received                  Toxicological Profiles in response to                  AGENCY: Centers for Medicare &
                                                on or before January 14, 2016.                          requests for consultation under section                Medicaid Services, HHS.
                                                ADDRESSES: You may submit comments,                     104(i)(4), and as otherwise necessary to               ACTION: Notice.
                                                identified by docket number ATSDR–                      support the site-specific response
                                                                                                        actions conducted by ATSDR.                            SUMMARY:   The Centers for Medicare &
                                                2015–0002, by any of the following
                                                                                                                                                               Medicaid Services (CMS) is announcing
                                                methods:                                                   Each profile will include an
                                                   • Federal eRulemaking Portal:                                                                               an opportunity for the public to
                                                                                                        examination, a summary, and an                         comment on CMS’ intention to collect
                                                www.regulations.gov. Follow the                         interpretation of available toxicological
                                                instructions for submitting comments.                                                                          information from the public. Under the
                                                                                                        information and epidemiological                        Paperwork Reduction Act of 1995 (the
                                                   • Mail: Division of Toxicology and
                                                Human Health Sciences, Agency for                       evaluations. This information and these                PRA), federal agencies are required to
                                                Toxic Substances and Disease Registry,                  data identify the levels of significant                publish notice in the Federal Register
                                                1600 Clifton Rd. NE., MS F–57, Atlanta,                 human exposure for the substance and                   concerning each proposed collection of
                                                GA 30329. Attn: Docket No. ATSDR–                       for the associated health effects. The                 information (including each proposed
                                                2015–0002.                                              profiles must also include a                           extension or reinstatement of an existing
                                                   Instructions: All submissions received               determination of whether adequate                      collection of information) and to allow
                                                must include the agency name and                        information on the health effects of each              60 days for public comment on the
                                                docket number for this notice. All                      substance is available (or in the process              proposed action. Interested persons are
                                                relevant comments will be posted                        of development) in order to identify                   invited to send comments regarding our
                                                without change. Because all public                      levels of significant human exposure. If               burden estimates or any other aspect of
                                                comments regarding ATSDR                                adequate information is not available,                 this collection of information, including
                                                Toxicological Profiles are available for                ATSDR, in cooperation with the                         any of the following subjects: (1) The
                                                public inspection, no confidential                      National Toxicology Program (NTP), is                  necessity and utility of the proposed
                                                business information or other                                                                                  information collection for the proper
                                                                                                        required to ensure the initiation of a
                                                confidential information should be                                                                             performance of the agency’s functions;
                                                                                                        program of research to provide such
                                                submitted in response to this notice.                                                                          (2) the accuracy of the estimated
                                                                                                        information.
                                                FOR FURTHER INFORMATION CONTACT: Ms.
                                                                                                                                                               burden; (3) ways to enhance the quality,
                                                Delores Grant, Division of Toxicology                                                                          utility, and clarity of the information to
                                                                                                              SET 27 TOXICOLOGICAL PROFILES                    be collected; and (4) the use of
                                                and Human Health Sciences, Agency for
                                                Toxic Substances and Disease Registry,                                                                         automated collection techniques or
                                                                                                                                      Name
                                                1600 Clifton Rd. NE., MS F–57, Atlanta,                                                                        other forms of information technology to
                                                GA 30329. Phone: (800) 232–4636 or                      1 ..    Polybrominated       Biphenyl    Ethers        minimize the information collection
                                                770–488–3351.                                                     (PBDEs) UPDATE.                              burden.
                                                SUPPLEMENTARY INFORMATION: The                          2 ..    N,N-Diethyl-meta-toluamide (DEET).             DATES:  Comments must be received by
                                                Superfund Amendments and                                3 ..    Toluene Diisocyanates (mixture).               December 15, 2015.
                                                Reauthorization Act (SARA) (Pub. L.                             Methylenediphenyl         Diisocyanates        ADDRESSES: When commenting, please
                                                                                                                  (NEW).
                                                99–499) amends the Comprehensive                                                                               reference the document identifier or
srobinson on DSK5SPTVN1PROD with NOTICES




                                                                                                        4 ..    Nitrates/Nitrites (NEW).
                                                Environmental Response,                                                                                        OMB control number. To be assured
                                                                                                        5 ..    Toluene (UPDATE).
                                                Compensation, and Liability Act                                                                                consideration, comments and
                                                (CERCLA or Superfund) (42 U.S.C. 9601                                                                          recommendations must be submitted in
                                                et seq.) by establishing certain                          The Set 27 Toxicological Profiles are                any one of the following ways:
                                                responsibilities for ATSDR and the U.S.                 available online at http://                              1. Electronically. You may send your
                                                Environmental Protection Agency (U.S.                   www.atsdr.cdc.gov/toxprofiles/                         comments electronically to http://
                                                EPA) regarding hazardous substances                     index.asp and http://                                  www.regulations.gov. Follow the


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Document Created: 2015-12-14 15:23:47
Document Modified: 2015-12-14 15:23:47
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability and request for comment.
DatesWritten comments on this draft Toxicological Profile must be received on or before January 14, 2016.
ContactMs. 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 Citation80 FR 62533 

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