Adverse Outcome Pathways: From Research to Regulation Workshop; Notice of Public Meeting and Registration Information, 36079-36080 [2014-14738]

Download as PDF mstockstill on DSK4VPTVN1PROD with NOTICES Federal Register / Vol. 79, No. 122 / Wednesday, June 25, 2014 / Notices Evidence Integration to Case Studies.’’ The OHAT, Division of the National Toxicology Program (DNTP), National Institute of Environmental Health Sciences (NIEHS) will host the webbased meeting and the public can register to participate at https:// ntp.niehs.nih.gov/go/41629. DATES: Webinar: July 31, 2014, 12:30 p.m. to approximately 3:30 p.m. Eastern Daylight Time (EDT). Registration for Webinar: June 17, 2014 through July 28, 2014. ADDRESSES: Webinar Web page: https:// ntp.niehs.nih.gov/go/41629. FOR FURTHER INFORMATION CONTACT: Dr. Andrew Rooney, Deputy Director, OHAT, Division of NTP, NIEHS, P.O. Box 12233, K2–04, Research Triangle Park, NC 27709. Phone: 919–541–2999, Fax: 301–480–3299, Email: Andrew.Rooney@nih.gov. Hand Delivery/Courier: 530 Davis Drive, Room K2154, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: Background: The OHAT has developed a systematic review framework, the OHAT Approach, to address environmental health questions by extending approaches developed for clinical medicine to address the greater range of data relevant to environmental health sciences (e.g., human, animal, and mechanistic studies) (available at https://ntp.niehs.nih.gov/go/38673). The OHAT adapted guidance from authorities on systematic review and sought advice during development of the OHAT Approach through consultation with technical experts in systematic review and human health assessment as well as scientific advisory groups and the public. The approach includes seven steps that provide a framework for incorporating systematic review and evidence integration into NTP literaturebased, non-cancer health assessments. The framework, released as the Draft OHAT Approach in February 2013 and published in April 2014 (https:// ehp.niehs.nih.gov/1307972/), was assessed and refined through application of the procedures to casestudy evaluations. The OHAT applied the approach to two case studies: (1) An evaluation of the association of bisphenol A (BPA) exposure with obesity and (2) an evaluation of the association of perflurooctanoic acid (PFOA) or perfluorooctane sulfonate (PFOS) exposure with immunotoxicity. The purpose of this webinar is to present lessons learned during the casestudy process. The meeting will be conducted in a presentation and discussion format. The first part of the VerDate Mar<15>2010 18:01 Jun 24, 2014 Jkt 232001 webinar will consist of a series of topic or ‘‘lesson’’ focused presentations, followed by a short question-andanswer period. The second part of the webinar will be a general discussion period when the public can make brief comments on or ask questions about the application of the OHAT Approach to the case studies and lessons learned. Webinar and Registration: The webinar is scheduled for July 31, 2014, 12:30 p.m. to 3:30 p.m. EDT and may end early if discussions are finished. Registration for the webinar is required and is open from June 17, 2014, through July 28, 2014, at https:// ntp.niehs.nih.gov/go/41629. Registrants will receive instructions by email on accessing the webinar on or before July 28, 2014. Registrants are encouraged to access the Web site to stay abreast of current information about this event. Public Participation: As noted above, the meeting format includes time after each lesson-presentation and during the general discussion session for the public to ask questions or make brief remarks. Individuals with disabilities who need accommodations to participate in this event should contact Dr. Andrew Rooney (See FOR FURTHER INFORMATION CONTACT). TTY users should contact the Federal TTY Relay Service at (800) 877– 8330. Requests should be made at least 5 business days in advance of the webbased meeting. Background Information on OHAT: The OHAT was established to serve as an environmental health resource to the public and regulatory and health agencies (https://www.ncbi.nlm.nih.gov/ pmc/articles/PMC3094430). This office conducts evaluations to assess the evidence that environmental chemicals, physical substances, or mixtures (collectively referred to as ‘‘substances’’) cause adverse health effects and provides opinions on whether these substances may be of concern given what is known about current human exposure levels. The OHAT also organizes workshops or state-of-thescience evaluations to address issues of importance in environmental health sciences. The OHAT assessments are published as NTP Monographs. Information about the OHAT is found at https://ntp.niehs.nih.gov/go/ohat. Dated: June 17, 2014. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2014–14740 Filed 6–24–14; 8:45 am] BILLING CODE 4140–01–P PO 00000 Frm 00092 Fmt 4703 Sfmt 4703 36079 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Adverse Outcome Pathways: From Research to Regulation Workshop; Notice of Public Meeting and Registration Information The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces a workshop on ‘‘Adverse Outcome Pathways: From Research to Regulation.’’ The workshop proposes to initiate stakeholder interaction and collaboration to enhance scientific development of the Adverse Outcome Pathway (AOP) concept with the goal of improving regulatory assessment of chemical toxicity. Registration is requested for attendance and required to access the webcast. Information about the meeting and registration is available at https://ntp.niehs.nih.gov/go/41374. DATES: Meeting: September 3–5, 2014, from 8:30 a.m. to approximately 5:30 p.m. Eastern Daylight Time (EDT) on September 3 and 4 and from 9:00 a.m. to approximately 4:00 p.m. EDT on September 5. A poster session will be held on September 4 from 6:30 p.m. to 8:30 p.m. Meeting Registration: Registration is open through August 15, 2014. Registration to view the plenary sessions of the workshop via webcast is required. ADDRESSES: Meeting Location: William H. Natcher Conference Center, National Institutes of Health, Bethesda, Maryland 20892. Meeting Web page: The preliminary agenda, registration, and other meeting materials are at https://ntp.niehs.nih.gov/ go/41374. FOR FURTHER INFORMATION CONTACT: Dr. Warren S. Casey, Director, NICEATM; email: warren.casey@nih.gov; telephone: (919) 316–4729. SUPPLEMENTARY INFORMATION: Background: Traditional toxicology test methods expose multiple animals to test substances and observe adverse outcomes; these methods may not efficiently serve future scientific and regulatory needs. To improve the regulatory assessment of chemical toxicity, NICEATM is evaluating the use of AOPs, a conceptual framework relating toxic exposures to illness or injury in an individual or a population through specific molecular and cellular changes. Through plenary presentations, case studies, and breakout sessions, the SUMMARY: E:\FR\FM\25JNN1.SGM 25JNN1 36080 Federal Register / Vol. 79, No. 122 / Wednesday, June 25, 2014 / Notices workshop will engage stakeholders in how the scientific development of AOPs could enhance regulatory assessment of chemical toxicity. The workshop steering committee is comprised of members from government and nongovernment stakeholders including the NTP, Physicians Committee for Responsible Medicine, European Union Reference Laboratory for Alternatives to Animal Testing, Consumer Product Safety Commission, Dow Chemical Company, U.S. Environmental Protection Agency, U.S. Food and Drug Administration, Health and Environmental Sciences Institute, and Proctor & Gamble. Meeting and Registration: This meeting is open to the public, free of charge, with attendance limited only by the space available. A preliminary agenda and additional information are available at https://ntp.niehs.nih.gov/go/ 41374. The plenary sessions of the workshop will be webcast. Registration is required to view the webcast; the URL for the webcast will be provided in an email prior to the meeting. Individuals who plan to attend in person should register at https://ntp.niehs.nih.gov/go/ 41374 by August 15, 2014, to facilitate planning for the workshop. Individuals interested in this workshop are encouraged to visit the Web page to stay abreast of the most current information. Information for visitors to the William H. Natcher Conference Center is available at https://www.orf.od.nih.gov/ AboutORF/BFM/Pages/45Beth.aspx. Individuals with disabilities who need accommodation to participate in this event should contact Dr. Elizabeth Maull at phone: (919) 316–4668 or email: maull@niehs.nih.gov. TTY users should contact the Federal TTY Relay Service at (800) 877–8339. Requests should be made at least five business days in advance of the event. Background Information on NICEATM: NICEATM conducts data analyses, workshops, independent validation studies, and other activities to assess new, revised, and alternative test methods and strategies. NICEATM also provides support for the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM). The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–3) provides authority for ICCVAM and NICEATM in the development and implementation of alternative test methods in regulatory safety testing. Information about NICEATM and ICCVAM is found at https://ntp.niehs.nih.gov/go/niceatm and https://ntp.niehs.nih.gov/go/iccvam. Dated: June 17, 2014. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2014–14738 Filed 6–24–14; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Substance Abuse and Mental Health Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276–1243. Project: Co-Location and Integration of HIV Prevention and Medical Care Into Behavioral Health Program—NEW The Substance Abuse and Mental Health Services Administration’s (SAMHSA) Center for Mental Health Services, (CMHS), Center for Substance Abuse Prevention (CSAP), Center for Substance Abuse Treatment (CSAT) are Number of respondents Instrument HIV/Hepatitis Testing Form .................................................. Number of responses per respondent 5,000 requesting approval from the Office of Management and Budget (OMB) for new data collection activities associated with their Co-location and Integration of HIV Prevention and Medical Care into Behavioral Health Program. The program is designed to support integrated behavioral health and physical health services for racial/ethnic populations at high risk for behavioral health disorders and at high risk for contracting HIV. This information collection is needed to provide SAMHSA with objective information to document the reach and impact of the Co-location and Integration of HIV Prevention and Medical Care into Behavioral Health program. The information will be used to monitor quality assurance and quality performance outcomes for organizations funded by this grant program. The information will also be used to assess the impact of services on behavioral health and physical health services for individuals served by this program. Collection of the information included in this request is authorized by Section 505 of the Public Health Service Act (42 U.S.C. 290aa–4)—Data Collection. Further support for the program was provided in the 2013 Senate Appropriations Report 113–71. The report urged SAMHSA to ‘‘focus its efforts on building capacity and outreach to individuals at risk or with a primary substance abuse disorder and to improve efforts to identify such individuals to prevent the spread of HIV.’’ Additional support for this data collection effort is provided by the 2013 National HIV/AIDS Strategy which instructed SAMHSA to ‘‘support and rigorously evaluate the development and implementation of new integrated behavioral health models to address the intersection of substance use, mental health, and HIV.’’ The table below reflects the annualized hourly burden. Total number of responses 1 Hours per response per respondent Total burden hours 5,000 0.13 650 200 1,000 0.58 0.12 117 120 120 0.58 69.6 mstockstill on DSK4VPTVN1PROD with NOTICES Co-Located and Integrated Care TRAC—Baseline Clients with HIV Receiving Integrated Medical Services .... Individuals only Receiving Prevention Services .................. 200 1,000 1 1 Co-Located and Integrated Care TRAC—Follow Up Clients with HIV Receiving Integrated Medical Services 2 .. VerDate Mar<15>2010 18:01 Jun 24, 2014 Jkt 232001 PO 00000 Frm 00093 120 Fmt 4703 Sfmt 4703 1 E:\FR\FM\25JNN1.SGM 25JNN1

Agencies

[Federal Register Volume 79, Number 122 (Wednesday, June 25, 2014)]
[Notices]
[Pages 36079-36080]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-14738]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Adverse Outcome Pathways: From Research to Regulation Workshop; 
Notice of Public Meeting and Registration Information

SUMMARY: The National Toxicology Program (NTP) Interagency Center for 
the Evaluation of Alternative Toxicological Methods (NICEATM) announces 
a workshop on ``Adverse Outcome Pathways: From Research to 
Regulation.'' The workshop proposes to initiate stakeholder interaction 
and collaboration to enhance scientific development of the Adverse 
Outcome Pathway (AOP) concept with the goal of improving regulatory 
assessment of chemical toxicity. Registration is requested for 
attendance and required to access the webcast. Information about the 
meeting and registration is available at https://ntp.niehs.nih.gov/go/41374.

DATES: 
    Meeting: September 3-5, 2014, from 8:30 a.m. to approximately 5:30 
p.m. Eastern Daylight Time (EDT) on September 3 and 4 and from 9:00 
a.m. to approximately 4:00 p.m. EDT on September 5. A poster session 
will be held on September 4 from 6:30 p.m. to 8:30 p.m.
    Meeting Registration: Registration is open through August 15, 2014. 
Registration to view the plenary sessions of the workshop via webcast 
is required.

ADDRESSES: 
    Meeting Location: William H. Natcher Conference Center, National 
Institutes of Health, Bethesda, Maryland 20892.
    Meeting Web page: The preliminary agenda, registration, and other 
meeting materials are at https://ntp.niehs.nih.gov/go/41374.

FOR FURTHER INFORMATION CONTACT: Dr. Warren S. Casey, Director, 
NICEATM; email: warren.casey@nih.gov; telephone: (919) 316-4729.

SUPPLEMENTARY INFORMATION: 
    Background: Traditional toxicology test methods expose multiple 
animals to test substances and observe adverse outcomes; these methods 
may not efficiently serve future scientific and regulatory needs. To 
improve the regulatory assessment of chemical toxicity, NICEATM is 
evaluating the use of AOPs, a conceptual framework relating toxic 
exposures to illness or injury in an individual or a population through 
specific molecular and cellular changes.
    Through plenary presentations, case studies, and breakout sessions, 
the

[[Page 36080]]

workshop will engage stakeholders in how the scientific development of 
AOPs could enhance regulatory assessment of chemical toxicity. The 
workshop steering committee is comprised of members from government and 
nongovernment stakeholders including the NTP, Physicians Committee for 
Responsible Medicine, European Union Reference Laboratory for 
Alternatives to Animal Testing, Consumer Product Safety Commission, Dow 
Chemical Company, U.S. Environmental Protection Agency, U.S. Food and 
Drug Administration, Health and Environmental Sciences Institute, and 
Proctor & Gamble.
    Meeting and Registration: This meeting is open to the public, free 
of charge, with attendance limited only by the space available. A 
preliminary agenda and additional information are available at https://ntp.niehs.nih.gov/go/41374. The plenary sessions of the workshop will 
be webcast. Registration is required to view the webcast; the URL for 
the webcast will be provided in an email prior to the meeting. 
Individuals who plan to attend in person should register at https://ntp.niehs.nih.gov/go/41374 by August 15, 2014, to facilitate planning 
for the workshop. Individuals interested in this workshop are 
encouraged to visit the Web page to stay abreast of the most current 
information.
    Information for visitors to the William H. Natcher Conference 
Center is available at https://www.orf.od.nih.gov/AboutORF/BFM/Pages/45Beth.aspx. Individuals with disabilities who need accommodation to 
participate in this event should contact Dr. Elizabeth Maull at phone: 
(919) 316-4668 or email: maull@niehs.nih.gov. TTY users should contact 
the Federal TTY Relay Service at (800) 877-8339. Requests should be 
made at least five business days in advance of the event.
    Background Information on NICEATM: NICEATM conducts data analyses, 
workshops, independent validation studies, and other activities to 
assess new, revised, and alternative test methods and strategies. 
NICEATM also provides support for the Interagency Coordinating 
Committee on the Validation of Alternative Methods (ICCVAM). The ICCVAM 
Authorization Act of 2000 (42 U.S.C. 285l-3) provides authority for 
ICCVAM and NICEATM in the development and implementation of alternative 
test methods in regulatory safety testing. Information about NICEATM 
and ICCVAM is found at https://ntp.niehs.nih.gov/go/niceatm and https://ntp.niehs.nih.gov/go/iccvam.

    Dated: June 17, 2014.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2014-14738 Filed 6-24-14; 8:45 am]
BILLING CODE 4140-01-P
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