Availability of Draft Toxicological Profile, 23600-23601 [2011-10146]

Download as PDF 23600 Federal Register / Vol. 76, No. 81 / Wednesday, April 27, 2011 / Notices Guidelines to Agencies on Governmentwide Debarment and Suspension (2 CFR 376 et seq.); and (2) Dr. Bhrigu is prohibited from serving in any advisory capacity to the U.S. Public Health Service (PHS), including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as a consultant. FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453–8800. John Dahlberg, Director, Division of Investigative Oversight, Office of Research Integrity. [FR Doc. 2011–10150 Filed 4–26–11; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Findings of Research Misconduct Office of the Secretary, HHS. ACTION: Notice. AGENCY: Notice is hereby given that the Office of Research Integrity (ORI) has taken final action in the following case: Junghee J. Shin, PhD, New York Medical College: Based on the report of an investigation conducted by New York Medical College (NYMC) and additional analysis by the Office of Research Integrity (ORI) in its oversight review, the U.S. Public Health Service (PHS) found that Junghee J. Shin, PhD, former graduate student, NYMC, engaged in research misconduct in research supported by National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), grants R01 AI048856 and R01 AI043063. PHS found that the Respondent engaged in research misconduct by falsifying data in Figure 4 of a manuscript submitted to the journal Infection and Immunity (Shin, J.J., Godfrey, H.P., & Cabello, F.C. ‘‘Expression and localization of BmpC in Borrelia burgdorferi after growth under various environmental conditions.’’ Submitted to Infection and Immunity; hereafter referred to as the ‘‘manuscript’’) and Figure 5 of a paper published in Infection and Immunity (Shin, J.J. Bryksin, A.V., Godfrey, H.P., & Cabello, F.C. ‘‘Localization of BmpA on the exposed outer membrane of Borrelia burgdorferi by monospecific anti-recombinant BmpA rabbit WReier-Aviles on DSKGBLS3C1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 15:36 Apr 26, 2011 Jkt 223001 antibodies.’’ Infection and Immunity 72(4):2280–2287, April 2004; hereafter referred to as the ‘‘paper.’’ Retracted in: Infection and Immunity 76(10):4792, October 2008). Specifically, NYMC and ORI found that: • Dr. Shin falsified microscopic immunofluorescence blank images in Figure 4 of the manuscript (top row, 1st, 2nd, 4th, and 5th panels, and bottom row, 1st panel) and Figure 5 of the paper (top row, 1st and 5th panels, lower 1st panel) by using one blank image from an unknown experiment to falsely represent the preimmunization control conditions (intact cells and methanol fixation) as well as the negative staining of anti-BmpC and anti-FlaB in Figure 4 and anti-FlaB in Figure 5 on intact cells. • Dr. Shin falsified at least one of two images in Figure 4 of the manuscript and Figure 5 of the paper by using different portions of a green-red pair of microscopic immunofluorescence images (1230036.tif and 1230037.tif) because unfixed cells staining positive for BmpA in the top row, 4th panel, of Figure 5 were the same unfixed cells purportedly positive for OspA in the top row, 3rd panel, of Figure 4. • Dr. Shin falsified at least one of two images in Figure 4 of the manuscript and Figure 5 of the paper by using different photo cropping from a single microscopic immunofluorescence image (1230039.tif) to represent fixed cells positive for BmpA and labeled with anti-FlaB in the lower row, 5th panel, of Figure 5 and to also represent fixed cells positive for BmpC and stained with anti-FlaB in the lower row, 5th panel, of Figure 4. Dr. Shin has entered into a Voluntary Settlement Agreement in which she has voluntarily agreed, for a period of three (3) years, beginning on April 5, 2011: (1) That any institution that submits an application for PHS support for a research project on which the Respondent’s participation is proposed or that uses her in any capacity on PHSsupported research, or that submits a report of PHS-funded research in which she is involved, must concurrently submit a plan for supervision of her duties to ORI for approval; the supervisory plan must be designed to ensure the scientific integrity of her research contribution; Respondent agrees that she will not participate in any PHS-supported research until such a supervision plan is submitted to ORI; and (2) to exclude herself voluntarily from service 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. PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 FOR FURTHER INFORMATION CONTACT: Director, Division of Investigative Oversight, Office of Research Integrity, 1101 Wootton Parkway, Suite 750, Rockville, MD 20852, (240) 453–8800. John Dahlberg, Director, Division of Investigative Oversight, Office of Research Integrity. [FR Doc. 2011–10157 Filed 4–26–11; 8:45 am] BILLING CODE 4150–31–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Toxic Substances and Disease Registry [CDC–2011–0005] Availability of Draft Toxicological Profile Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (DHHS). ACTION: Notice of availability. AGENCY: This notice announces the availability of the Toxicological Profile for Uranium (Update) for review and comment. These comments can include additional information or reports on studies about the health effects of uranium. Although ATSDR considered key studies for uranium 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 addition to 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 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 this draft toxicological profile must be received not later than July 29th, 2011. Comments received after the close of the public comment period will be considered at the discretion of ATSDR, based upon what is deemed to be in the best interest of the general public. ADDRESSES: Requests for printed copies of the draft toxicological profile should be sent via e-mail to cdcinfo@cdc.gov, or SUMMARY: E:\FR\FM\27APN1.SGM 27APN1 WReier-Aviles on DSKGBLS3C1PROD with NOTICES Federal Register / Vol. 76, No. 81 / Wednesday, April 27, 2011 / Notices to Ms. Delores Grant, Division of Toxicology and Environmental Medicine, Agency for Toxic Substances and Disease Registry, Mailstop F–62, 1600 Clifton Road, NE., Atlanta, Georgia 30333. Electronic access to this document is also available at the ATSDR Web site: https:// www.atsdr.cdc.gov/toxprofiles/ index.asp. Electronic comments may be sent via https://www.regulations.gov, docket control number CDC–2011–0005. Please follow the directions on the site to submit comments. Comments may also be sent to the attention of Ms. Nickolette Roney, Division of Toxicology and Environmental Medicine, Agency for Toxic Substances and Disease Registry, Mailstop F–62, 1600 Clifton Road, NE., Atlanta, Georgia 30333, e-mail: tppubliccomment@cdc.gov. Send one copy of all comments and three copies of all supporting documents. 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 Environmental Medicine, Agency for Toxic Substances and Disease Registry, Mailstop F–62, 1600 Clifton Road, NE., Atlanta, Georgia 30333, telephone (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) with regard to 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 March 6, 2008 (73 FR 12178). 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 VerDate Mar<15>2010 15:36 Apr 26, 2011 Jkt 223001 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. 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 is in the process of development. If adequate information is not available, ATSDR, in cooperation with the National Toxicology Program (NTP), is required to ensure the initiation of research to determine such health effects. All toxicological profiles issued as ‘‘Drafts for Public Comment’’ represent ATSDR’s best efforts to provide important toxicological information on priority hazardous substances. The draft toxicological profile will be made available to the public on or about April 29th, 2011. Hazardous substance CAS No. Uranium (Update) ..................... 7440–61–1 Dated: April 21, 2011. Ken Rose, Director, Office of Policy, Planning and Evaluation, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry. [FR Doc. 2011–10146 Filed 4–26–11; 8:45 am] BILLING CODE 4163–70–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [60Day–11–11EQ] Proposed Data Collections Submitted for Public Comment and Recommendations In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the PO 00000 Frm 00066 Fmt 4703 Sfmt 4703 23601 proposed projects or to obtain a copy of the data collection plans and instruments, call 404–639–5960 and send comments to Daniel Holcomb, CDC Reports Clearance Officer, 1600 Clifton Road, MS–D74, Atlanta, GA 30333 or send an e-mail to omb@cdc.gov. 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 through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice. Proposed Project Environmental Health Specialists Network (EHS-Net) National Voluntary Environmental Assessment Information System (NVEAIS)—New—National Center for Environmental Health (NCEH), Centers for Disease Control and Prevention (CDC). Background and Brief Description The CDC is requesting OMB approval for the EHS-Net National Voluntary Environmental Assessment Information System (NVEAIS) to collect data from foodborne illness outbreak environmental assessments routinely conducted by local, state, territorial, or tribal food safety programs during outbreak investigations. Environmental assessment data are not currently collected at the national level. The data reported through this information system will provide timely data on the causes of outbreaks, including environmental factors associated with outbreaks, and are essential to environmental public health regulators’ efforts to respond more effectively to outbreaks and prevent future, similar outbreaks. This information system is specifically designed to link to CDC’s existing disease outbreak surveillance system (National Outbreak Reporting System). The information system was developed by the Environmental Health Specialists Network (EHS-Net), a collaborative project of CDC, the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and nine states (California, Connecticut, Georgia, Iowa, New York, Minnesota, Oregon, Rhode Island, and E:\FR\FM\27APN1.SGM 27APN1

Agencies

[Federal Register Volume 76, Number 81 (Wednesday, April 27, 2011)]
[Notices]
[Pages 23600-23601]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-10146]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Toxic Substances and Disease Registry

[CDC-2011-0005]


Availability of Draft Toxicological Profile

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

ACTION: Notice of availability.

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

SUMMARY: This notice announces the availability of the Toxicological 
Profile for Uranium (Update) for review and comment. These comments can 
include additional information or reports on studies about the health 
effects of uranium. Although ATSDR considered key studies for uranium 
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 addition to 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 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 this draft toxicological profile 
must be received not later than July 29th, 2011. Comments received 
after the close of the public comment period will be considered at the 
discretion of ATSDR, based upon what is deemed to be in the best 
interest of the general public.

ADDRESSES: Requests for printed copies of the draft toxicological 
profile should be sent via e-mail to cdcinfo@cdc.gov, or

[[Page 23601]]

to Ms. Delores Grant, Division of Toxicology and Environmental 
Medicine, Agency for Toxic Substances and Disease Registry, Mailstop F-
62, 1600 Clifton Road, NE., Atlanta, Georgia 30333. Electronic access 
to this document is also available at the ATSDR Web site: https://www.atsdr.cdc.gov/toxprofiles/index.asp.
    Electronic comments may be sent via https://www.regulations.gov, 
docket control number CDC-2011-0005. Please follow the directions on 
the site to submit comments. Comments may also be sent to the attention 
of Ms. Nickolette Roney, Division of Toxicology and Environmental 
Medicine, Agency for Toxic Substances and Disease Registry, Mailstop F-
62, 1600 Clifton Road, NE., Atlanta, Georgia 30333, e-mail: 
tppubliccomment@cdc.gov. Send one copy of all comments and three copies 
of all supporting documents. 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 Environmental Medicine, Agency for Toxic Substances and 
Disease Registry, Mailstop F-62, 1600 Clifton Road, NE., Atlanta, 
Georgia 30333, telephone (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) with regard to 
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 March 6, 2008 (73 FR 12178). 
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.
    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 is in the process of development. If 
adequate information is not available, ATSDR, in cooperation with the 
National Toxicology Program (NTP), is required to ensure the initiation 
of research to determine such health effects.
    All toxicological profiles issued as ``Drafts for Public Comment'' 
represent ATSDR's best efforts to provide important toxicological 
information on priority hazardous substances.
    The draft toxicological profile will be made available to the 
public on or about April 29th, 2011.

------------------------------------------------------------------------
                    Hazardous substance                        CAS No.
------------------------------------------------------------------------
Uranium (Update)...........................................    7440-61-1
------------------------------------------------------------------------


    Dated: April 21, 2011.
Ken Rose,
Director, Office of Policy, Planning and Evaluation, National Center 
for Environmental Health/Agency for Toxic Substances and Disease 
Registry.
[FR Doc. 2011-10146 Filed 4-26-11; 8:45 am]
BILLING CODE 4163-70-P
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