Availability of Draft Toxicological Profiles, 74093-74094 [2014-29258]

Download as PDF emcdonald on DSK67QTVN1PROD with NOTICES Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Notices • Figures 2D/E, 3G, and 7C in the Cell Metabolism paper • Figures 6B/C/E, Figure 8C, and Figure 9H in the Journal of Neuroscience paper; Figures 6B/C/E of the Journal of Neuroscience paper also were included as Figures 5A/C/B in grant application DK080427–06A1, and Figure 8C of the Journal of Neuroscience paper also was included as Figure 8C in grant application DK080427–06A1 • Figure 10B in grant application DK080427–06A1 2. Respondent fabricated graphs purported to represent the results of six (6) different quantitative polymerase chain reaction (Q–PCR) experiments measuring mRNA levels in mouse liver from wild-type or AGRP RNAi mice and controls that had received brain infusions of alpha-MPT, a tyrosine hydroxylase inhibitor or vehicle and leptin, AGRP knockout mice injected with ethanol, or wild-type mice injected with ethanol and caffeine in the following figures: • Figure 2F in the Cell Metabolism paper • Figures 5A, 6F, and 9A in the Journal of Neuroscience paper; Figure 5A of the Journal of Neuroscience paper also was included as Figure 4A in grant application DK080427–06A1, and Figure 6F of the Journal of Neuroscience paper also was included as Figure 7A in grant application DK080427–06A1 • Figure 3B in grant application AA022665–06A1 Dr. Warne has entered into a Voluntary Settlement Agreement (Agreement) and has voluntarily agreed: (1) to have his research supervised for a period of three (3) years, beginning on November 18, 2014; Respondent agrees that prior to the submission of an application for U.S. Public Health Service (PHS) support for a research project on which the Respondent’s participation is proposed and prior to Respondent’s participation in any capacity on PHS-supported research, Respondent shall ensure that a plan for supervision of his duties is submitted to ORI for approval; the supervision plan must be designed to ensure the scientific integrity of Respondent’s research contribution; Respondent agrees that he shall not participate in any PHS-supported research until such a supervision plan is submitted to and approved by ORI; Respondent agrees to maintain responsibility for compliance with the agreed upon supervision plan; (2) that for a period of three (3) years, beginning on November 18, 2014, any institution employing him shall submit, VerDate Sep<11>2014 02:54 Dec 13, 2014 Jkt 235001 in conjunction with each application for PHS funds, or report, manuscript, or abstract involving PHS-supported research in which Respondent is involved, a certification to ORI that the data provided by Respondent are based on actual experiments or are otherwise legitimately derived and that the data, procedures, and methodology are accurately reported in the application, report, manuscript, or abstract; (3) to exclude himself voluntarily from serving in any advisory capacity to PHS including, but not limited to, service on any PHS advisory committee, board, and/or peer review committee, or as a consultant for a period of three (3) years, beginning on November 18, 2014; and (4) that as a condition of the Agreement, the senior authors will request retraction or correction of the following papers: • Cell Metabolism 14:791–803, 2011 • Journal of Neuroscience 33(29):11972–85, 2013 FOR FURTHER INFORMATION CONTACT: Acting Director, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453– 8200. Donald Wright, Acting Director, Office of Research Integrity. [FR Doc. 2014–29337 Filed 12–12–14; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [Docket No. ATSDR–2014–0001] Availability of Draft Toxicological Profiles Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (DHHS). ACTION: Notice of availability, and request for comments. AGENCY: This notice announces the availability of Set 26 Toxicological Profiles for review and comment. Comments can include additional information or reports on studies about the health effects of Set 26 substances. Although ATSDR considered key studies for each of these substances 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 SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 74093 profile. ATSDR remains committed to providing a public comment period for this document as a means to best serve public health and our clients. The Set 26 Toxicological Profiles are available online at http://www.atsdr.cdc.gov/ toxprofiles/index.asp and http:// www.regulations.gov/#!home, docket ATSDR–2014–0001. The Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (CERCLA), as amended by the Superfund Amendments and Reauthorization Act of 1986 (SARA), § 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. DATES: To be considered, comments on the draft Toxicological Profiles must be received not later than March 16, 2015. Comments received after close of the public comment period will be considered solely at the discretion of ATSDR, based upon what is deemed to be in the best interest of the general public. ADDRESSES: You may submit comments, identified by docket number ATSDR– 2014–0001, by any of the following methods: • Federal eRulemaking Portal: http:// www.regulations.gov/#!home. Follow the instructions for submitting comments. • Mail: Division of Toxicology and Human Health Sciences, 1600 Clifton Rd., NE., MS F57, Atlanta, Ga., 30333. 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, 1600 Clifton Rd., NE., MS F–57, Atlanta, Ga., 30333. Phone: 770–488–3351. SUPPLEMENTARY INFORMATION: The Comprehensive Environmental Response, Compensation, and Liability Act, as amended (CERCLA or Superfund) (42 U.S.C. 9601 et seq.) establishes certain responsibilities for ATSDR and the U.S. Environmental Protection Agency (U.S. EPA) with regard to hazardous substances most commonly found at facilities on the CERCLA National Priorities List (NPL). As part of these responsibilities, the E:\FR\FM\15DEN1.SGM 15DEN1 74094 Federal Register / Vol. 79, No. 240 / Monday, December 15, 2014 / Notices emcdonald on DSK67QTVN1PROD with NOTICES 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 November 03, 2011 (76 FR 68193). 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 sitespecific 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 26 Toxicological Profiles: DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–15–0020] Proposed Data Collections Submitted for Public Comment and Recommendations The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. To request more information on the below proposed project or to obtain a copy of the information collection plan and instruments, call 404–639–7570 or send comments to Leroy A. Richardson, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an email to omb@cdc.gov. Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget (OMB) approval. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services Name CAS to provide information. Burden means 1 Trichlorothe total time, effort, or financial ethylene(UPDATE) ............ 79–01–6 resources expended by persons to 2 Tetrachloroethylene (UPgenerate, maintain, retain, disclose or DATE) ............................... 127–18–4 provide information to, or for, a Federal 3 Hydrogen Sulfide/Caragency. This includes the time needed bonyl Sulfide (UPDATE) ... 7783–06–4 463–58–1 to review instructions; to develop, 4 Parathion (NEW) ............. 56–38–2 acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying Sascha Chaney, information, processing and Acting Director, Office of Policy, Planning maintaining information, and disclosing and Evaluation, National Center for and providing information; to train Environmental Health/Agency for Toxic, personnel and to be able to respond to Substances and Disease Registry. a collection of information, to search [FR Doc. 2014–29258 Filed 12–12–14; 8:45 am] data sources, to complete and review BILLING CODE 4163–70–P the collection of information; and to VerDate Sep<11>2014 02:54 Dec 13, 2014 Jkt 235001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 transmit or otherwise disclose the information. Written comments should be received within 60 days of this notice. Proposed Project—Coal Workers’ Health Surveillance Program (CWHSP)(OMB Control No. 0920–0020, Expiration Date 2/28/2015)—Revision— National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention (CDC). Background and Brief Description NIOSH would like to submit an Information Collection Request (ICR) to revise the data collection instruments being utilized within the Coal Workers’ Health Surveillance Program (CWHSP). On May 1, 2014, the Mine Safety and Health Administration (MSHA) published final rule 30 CFR parts 70, 71, 72, 75, and 90. The new MSHA rule added surface coal miners, a respiratory health assessment, and spirometry testing for chronic obstructive pulmonary disease (COPD) to the previously mandated chest x-ray examination program. These additions are being referred to as the Expanded CWHSP (an additional component under the current CWHSP). This request incorporates all components that now fall under the CWHSP. Those components include: Coal Workers’ X-ray Surveillance Program (CWXSP), B Reader Program, Enhanced Coal Workers’ Health Surveillance Program (ECWHSP), Expanded Coal Workers’ Health Surveillance Program, and National Coal Workers’ Autopsy Study (NCWAS). The CWHSP is a congressionallymandated medical examination program for monitoring the health of coal miners and was originally established under the Federal Coal Mine Health and Safety Act of 1969 with all subsequent amendments (the Act). The Act provides the regulatory authority for the administration of the CWHSP. This Program, which operates in accordance with 42 CFR part 37, is useful in providing information for protecting the health of miners (whose participation is entirely voluntary), and also in documenting trends and patterns in the prevalence of coal workers’ pneumoconiosis (‘black lung’ disease) among miners employed in U.S. coal mines. The total estimated annualized burden hours of 13,471 is based on the following collection instruments: • Coal Mine Operator Plan (2.10) and Coal Contractor Plan (2.18)—Under 42 CFR part 37, every coal operator and coal contractor in the U.S. must submit a plan approximately every 4 years, providing information on how they plan to notify their miners of the opportunity E:\FR\FM\15DEN1.SGM 15DEN1

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[Federal Register Volume 79, Number 240 (Monday, December 15, 2014)]
[Notices]
[Pages 74093-74094]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-29258]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[Docket No. ATSDR-2014-0001]


Availability of Draft Toxicological Profiles

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

ACTION: Notice of availability, and request for comments.

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

SUMMARY: This notice announces the availability of Set 26 Toxicological 
Profiles for review and comment. Comments can include additional 
information or reports on studies about the health effects of Set 26 
substances. Although ATSDR considered key studies for each of these 
substances 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 remains 
committed to providing a public comment period for this document as a 
means to best serve public health and our clients. The Set 26 
Toxicological Profiles are available online at http://www.atsdr.cdc.gov/toxprofiles/index.asp and http://www.regulations.gov/#!home, docket ATSDR-2014-0001.
    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.

DATES: To be considered, comments on the draft Toxicological Profiles 
must be received not later than March 16, 2015. Comments received after 
close of the public comment period will be considered solely at the 
discretion of ATSDR, based upon what is deemed to be in the best 
interest of the general public.

ADDRESSES: You may submit comments, identified by docket number ATSDR-
2014-0001, by any of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov/#!home. Follow the instructions for submitting comments.
     Mail: Division of Toxicology and Human Health Sciences, 
1600 Clifton Rd., NE., MS F57, Atlanta, Ga., 30333.
    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, 1600 Clifton Rd., NE., MS F-57, 
Atlanta, Ga., 30333. Phone: 770-488-3351.

SUPPLEMENTARY INFORMATION: The Comprehensive Environmental Response, 
Compensation, and Liability Act, as amended (CERCLA or Superfund) (42 
U.S.C. 9601 et seq.) establishes certain responsibilities for ATSDR and 
the U.S. Environmental Protection Agency (U.S. EPA) with regard to 
hazardous substances most commonly found at facilities on the CERCLA 
National Priorities List (NPL). As part of these responsibilities, the

[[Page 74094]]

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 November 03, 2011 (76 FR 
68193). 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 26 Toxicological Profiles:

------------------------------------------------------------------------
                          Name                                  CAS
------------------------------------------------------------------------
1 Trichloroethylene(UPDATE).............................         79-01-6
2 Tetrachloroethylene (UPDATE)..........................        127-18-4
3 Hydrogen Sulfide/Carbonyl Sulfide (UPDATE)............       7783-06-4
                                                                463-58-1
4 Parathion (NEW).......................................         56-38-2
------------------------------------------------------------------------


Sascha Chaney,
Acting Director, Office of Policy, Planning and Evaluation, National 
Center for Environmental Health/Agency for Toxic, Substances and 
Disease Registry.
[FR Doc. 2014-29258 Filed 12-12-14; 8:45 am]
BILLING CODE 4163-70-P