81_FR_96231 81 FR 95981 - Human Studies Review Board; Notification of Public Meetings

81 FR 95981 - Human Studies Review Board; Notification of Public Meetings

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 250 (December 29, 2016)

Page Range95981-95982
FR Document2016-31640

The Environmental Protection Agency (EPA) Office of the Science Advisor announces two separate public meetings of the Human Studies Review Board (HSRB) to advise the Agency on the ethical and scientific review of research involving human subjects.

Federal Register, Volume 81 Issue 250 (Thursday, December 29, 2016) 
[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 95981-95982]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-31640]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9957-50-ORD]


Human Studies Review Board; Notification of Public Meetings

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) Office of the 
Science Advisor announces two separate public meetings of the Human 
Studies Review Board (HSRB) to advise the Agency on the ethical and 
scientific review of research involving human subjects.

DATES: A public virtual meeting will be held on January 25-26, 2017, 
from 1:00 p.m. to approximately 5:00 p.m. Eastern Time each day. A 
separate, subsequent teleconference meeting is planned for Thursday, 
March 17, 2017, from 2:00 p.m. to approximately 3:30 p.m. for the HSRB 
to finalize its Final Report of the January 25-26, 2017 meeting and 
review other possible topics.

ADDRESSES: Both of these meetings will be conducted entirely by 
telephone and on the Internet using Adobe Connect. For detailed access 
information visit the HSRB Web site: http://www2.epa.gov/osa/human-studies-review-board.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to 
receive further information should contact the HSRB Designated Federal 
Official (DFO), Jim Downing on telephone number (202) 564-2468; fax 
number: (202) 564-2070; email address: [email protected]; or mailing 
address: Environmental Protection

[[Page 95982]]

Agency, Office of the Science Advisor, Mail Code 8105R, 1200 
Pennsylvania Avenue NW., Washington, DC 20460.

SUPPLEMENTARY INFORMATION: 
    Meeting access: These meetings are open to the public. The full 
Agenda and Meeting materials are available at the HSRB Web site: http://www2.epa.gov/osa/human-studies-review-board. For questions on document 
availability, or if you do not have access to the Internet, consult 
with the DFO, Jim Downing listed under FOR FURTHER INFORMATION CONTACT.
    Special accommodations. For information on access or services for 
individuals with disabilities, or to request accommodation of a 
disability, please contact the DFO listed under FOR FURTHER INFORMATION 
CONTACT at least 10 days prior to the meeting to give EPA as much time 
as possible to process your request.

How may I participate in this meeting?

    The HSRB encourages the public's input. You may participate in 
these meetings by following the instructions in this section.
    1. Oral comments. Requests to present oral comments during either 
conference call will be accepted up to Noon Eastern Time on Wednesday, 
January 18, 2017, for the January 25-26, 2017 meeting and up to Noon 
Eastern Time on Friday, March 10, 2017 for the March 17, 2017 
conference call. To the extent that time permits, interested persons 
who have not pre-registered may be permitted by the HSRB Chair to 
present oral comments during either call at the designated time on the 
agenda. Oral comments before the HSRB are generally limited to five 
minutes per individual or organization. If additional time is 
available, further public comments may be possible.
    2. Written comments. Submit your written comments prior to the 
meetings. For the Board to have the best opportunity to review and 
consider your comments as it deliberates, you should submit your 
comments by Noon Eastern Time on Wednesday, January 18, 2016, for the 
January 25-26, 2017 conference call, and by noon Eastern Time on 
Friday, March 10, 2017 for the March 17, 2017 teleconference. If you 
submit comments after these dates, those comments will be provided to 
the HSRB members, but you should recognize that the HSRB members may 
not have adequate time to consider your comments prior to their 
discussion. You should submit your comments to the DFO, Jim Downing 
listed under FOR FURTHER INFORMATION CONTACT. There is no limit on the 
length of written comments for consideration by the HSRB.

Background

    The HSRB is a Federal advisory committee operating in accordance 
with the Federal Advisory Committee Act 5 U.S.C. App. 2 Sec.  9. The 
HSRB provides advice, information, and recommendations on issues 
related to scientific and ethical aspects of human subjects research 
that are submitted to the Office of Pesticide Programs to be used for 
regulatory purposes. The major objectives of the HSRB are to provide 
advice and recommendations on: (1) Research proposals and protocols; 
(2) reports of completed research with human subjects; and (3) how to 
strengthen EPA's programs for protection of human subjects of research.
    Topics for discussion. On Wednesday, January 25, 2017, EPA's Human 
Studies Review Board will consider three published articles:
    1. Methylisothiazolinone contact allergy and dose-response 
relationships, authored by Michael D. Lundov, Claus Zachariae, and 
Jeanne D. Johansen. Contact Dermatitis (2011) 64, 330-336.
    2. Methylisothiazolinone in rinse-off products causes allergic 
contact dermatitis: A repeated open-application study, authored by K 
Yazar, M.D. Lundov, A. Faurschou, M. Matura, A. Boman, J.D. Johansen, 
and C. Lid[eacute]n. British Journal of Dermatology (2015) 173, 115-
122.
    3. An evaluation of dose/unit area and time as key factors 
influencing the elicitation capacity of methylchloroisothiazolinone/
methylisothiazolinone (MCI/MI) in MCI/MI-allergic patients, authored by 
Claus Zachariae, Anne Lerbaek, Pauline M. McNamee, John E. Gray, Mike 
Wooder, and Torkil Menn[eacute]. Contact Dermatitis (2006) 55, 160-166.
    Then on Thursday, January 26, 2017 the HSRB will consider:
    1. Published article: Cholinesterase Activity Resulting from 
Carbaryl Exposure.
    2. Unpublished article: A randomized double blind study with 
malathion to determine the residues of malathion dicarboxylic acid 
(DCA), malathion monocarboxylic acid (MCA), dimethyl phosphate (DMP), 
dimethyl thiophosphate (DMTP), and dimethyl dithiophosphate (DMDTP) in 
human urine.
    Meeting materials for these topics will be available in advance of 
the meeting at http://www2.epa.gov/osa/human-studies-review-board.
    On March 17, 2017, the Human Studies Review Board will review and 
finalize their draft Final Report from the January 25-26, 2017 meeting 
in addition to other topics that may come before the Board. The HSRB 
may also discuss planning for future HSRB meetings. The agenda and the 
draft report will be available prior to the conference call at http://www2.epa.gov/osa/human-studies-review-board.
    Meeting minutes and final reports. Minutes of these meetings, 
summarizing the matters discussed and recommendations made by the HSRB, 
will be released within 90 calendar days of the meeting. These minutes 
will be available at http://www2.epa.gov/osa/human-studies-review-board. In addition, information regarding the HSRB's Final Report, will 
be found at http://www2.epa.gov/osa/human-studies-review-board or from 
Jim Downing listed under FOR FURTHER INFORMATION CONTACT.

    Dated: December 19, 2016.
Thomas A. Burke,
EPA Science Advisor.
[FR Doc. 2016-31640 Filed 12-28-16; 8:45 am]
 BILLING CODE 6560-50-P

Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices 95981 assumptions of liability, is January 11, of pipeline facilities in Plaquemines and Commission’s Office of External Affairs 2017. St. Bernard Parishes, Louisiana. at (866) 208–FERC or on the FERC Web The Commission encourages On July 14, 2016, the Federal Energy site (www.ferc.gov). Using the electronic submission of protests and Regulatory Commission (Commission or ‘‘eLibrary’’ link, select ‘‘General Search’’ interventions in lieu of paper, using the FERC) issued its Notice of Application from the eLibrary menu, enter the FERC Online links at http:// for the Project. Among other things, that selected date range and ‘‘Docket www.ferc.gov. To facilitate electronic notice alerted agencies issuing federal Number’’ excluding the last three digits service, persons with Internet access authorizations of the requirement to (i.e., CP16–474), and follow the who will eFile a document and/or be complete all necessary reviews and to instructions. For assistance with access listed as a contact for an intervenor reach a final decision on a request for to eLibrary, the helpline can be reached must create and validate an a federal authorization within 90 days of at (866) 208–3676, TTY (202) 502–8659, eRegistration account using the the date of issuance of the Commission or at FERCOnlineSupport@ferc.gov. The eRegistration link. Select the eFiling staff’s Environmental Assessment (EA) eLibrary link on the FERC Web site also link to log on and submit the for the Project. This instant notice provides access to the texts of formal intervention or protests. identifies the FERC staff’s planned documents issued by the Commission, Persons unable to file electronically schedule for the completion of the EA such as orders, notices, and rule should submit an original and 5 copies for the Project. makings. of the intervention or protest to the Schedule for Environmental Review Dated: December 22, 2016. Federal Energy Regulatory Commission, Nathaniel J. Davis, Sr., Issuance of EA: February 3, 2017 888 First Street NE., Washington, DC 90-day Federal Authorization Decision Deputy Secretary. 20426. Deadline: May 4, 2017 [FR Doc. 2016–31535 Filed 12–28–16; 8:45 am] The filings in the above-referenced If a schedule change becomes BILLING CODE 6717–01–P proceeding are accessible in the necessary, additional notice will be Commission’s eLibrary system by provided so that the relevant agencies clicking on the appropriate link in the are kept informed of the Project’s ENVIRONMENTAL PROTECTION above list. They are also available for progress. AGENCY electronic review in the Commission’s Public Reference Room in Washington, Project Description [FRL–9957–50–ORD] DC. There is an eSubscription link on High Point would abandon by sale the Web site that enables subscribers to nine segments (totaling 61.3 miles) of Human Studies Review Board; receive email notification when a 12- to 22-inch-diameter natural gas Notification of Public Meetings document is added to a subscribed pipeline on its Venice to Toca AGENCY: Environmental Protection docket(s). For assistance with any FERC Transmission Pipeline. To continue use Agency (EPA). Online service, please email of the remainder of High Point’s system FERCOnlineSupport@ferc.gov. or call ACTION: Notice. and isolate it from the abandoned (866) 208–3676 (toll free). For TTY, call pipeline that Cayenne Pipeline, LLC SUMMARY: The Environmental Protection (202) 502–8659. plans to use for natural gas liquids, High Agency (EPA) Office of the Science Dated: December 22, 2016. Point would cut and cap the pipeline at Advisor announces two separate public Nathaniel J. Davis, Sr., nine locations and remove one meter. meetings of the Human Studies Review Deputy Secretary. All of the abandonment activities, Board (HSRB) to advise the Agency on [FR Doc. 2016–31538 Filed 12–28–16; 8:45 am] except for disconnecting cross-over and the ethical and scientific review of BILLING CODE 6717–01–P tie-in piping at the Venice, Toca, and research involving human subjects. Venice Gas Processing Plants and the DATES: A public virtual meeting will be use of three existing access roads, would held on January 25–26, 2017, from 1:00 DEPARTMENT OF ENERGY occur within High Point’s existing p.m. to approximately 5:00 p.m. Eastern permanent right-of-way. Most of the Time each day. A separate, subsequent Federal Energy Regulatory work would take place on existing teleconference meeting is planned for Commission platforms. The abandonment would also Thursday, March 17, 2017, from 2:00 include modifications of 15 associated p.m. to approximately 3:30 p.m. for the [Docket No. CP16–474–000] aboveground valves to isolate the line to HSRB to finalize its Final Report of the be abandoned from the rest of High January 25–26, 2017 meeting and review High Point Gas Transmission, LLC; Point’s pipeline system. other possible topics. Notice of Schedule for Environmental Additional Information ADDRESSES: Both of these meetings will Review of the Venice to Toca Pipeline In order to receive notification of the be conducted entirely by telephone and Abandonment Project issuance of the EA and to keep track of on the Internet using Adobe Connect. On July 1, 2016, High Point Gas all formal issuances and submittals in For detailed access information visit the Transmission, LLC (High Point) filed an specific dockets, the Commission offers HSRB Web site: http://www2.epa.gov/ application in Docket No. CP16–474– a free service called eSubscription. This osa/human-studies-review-board. 000 requesting a Certificate of Public can reduce the amount of time you FOR FURTHER INFORMATION CONTACT: Any asabaliauskas on DSK3SPTVN1PROD with NOTICES Convenience and Necessity pursuant to spend researching proceedings by member of the public who wishes to section 7(b) of the Natural Gas Act to automatically providing you with receive further information should abandon certain natural gas pipeline notification of these filings, document contact the HSRB Designated Federal facilities. The proposed project is summaries, and direct links to the Official (DFO), Jim Downing on known as the Venice to Toca Pipeline documents. Go to www.ferc.gov/docs- telephone number (202) 564–2468; fax Abandonment Project (Project). High filing/esubscription.asp. number: (202) 564–2070; email address: Point proposes to abandon by sale to Additional information about the downing.jim@epa.gov; or mailing Cayenne Pipeline, LLC about 61.3 miles Project is available from the address: Environmental Protection VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1

95982 Federal Register / Vol. 81, No. 250 / Thursday, December 29, 2016 / Notices Agency, Office of the Science Advisor, comments for consideration by the finalize their draft Final Report from the Mail Code 8105R, 1200 Pennsylvania HSRB. January 25–26, 2017 meeting in addition Avenue NW., Washington, DC 20460. to other topics that may come before the Background SUPPLEMENTARY INFORMATION: Board. The HSRB may also discuss Meeting access: These meetings are The HSRB is a Federal advisory planning for future HSRB meetings. The open to the public. The full Agenda and committee operating in accordance with agenda and the draft report will be Meeting materials are available at the the Federal Advisory Committee Act 5 available prior to the conference call at HSRB Web site: http://www2.epa.gov/ U.S.C. App. 2 § 9. The HSRB provides http://www2.epa.gov/osa/human- osa/human-studies-review-board. For advice, information, and studies-review-board. questions on document availability, or if recommendations on issues related to Meeting minutes and final reports. you do not have access to the Internet, scientific and ethical aspects of human Minutes of these meetings, summarizing consult with the DFO, Jim Downing subjects research that are submitted to the matters discussed and listed under FOR FURTHER INFORMATION the Office of Pesticide Programs to be recommendations made by the HSRB, CONTACT. used for regulatory purposes. The major will be released within 90 calendar days Special accommodations. For objectives of the HSRB are to provide of the meeting. These minutes will be information on access or services for advice and recommendations on: (1) available at http://www2.epa.gov/osa/ individuals with disabilities, or to Research proposals and protocols; (2) human-studies-review-board. In request accommodation of a disability, reports of completed research with addition, information regarding the please contact the DFO listed under FOR human subjects; and (3) how to HSRB’s Final Report, will be found at FURTHER INFORMATION CONTACT at least strengthen EPA’s programs for http://www2.epa.gov/osa/human- 10 days prior to the meeting to give EPA protection of human subjects of studies-review-board or from Jim as much time as possible to process research. Downing listed under FOR FURTHER Topics for discussion. On Wednesday, INFORMATION CONTACT. your request. January 25, 2017, EPA’s Human Studies Dated: December 19, 2016. How may I participate in this meeting? Review Board will consider three published articles: Thomas A. Burke, The HSRB encourages the public’s EPA Science Advisor. 1. Methylisothiazolinone contact input. You may participate in these allergy and dose-response relationships, [FR Doc. 2016–31640 Filed 12–28–16; 8:45 am] meetings by following the instructions authored by Michael D. Lundov, Claus BILLING CODE 6560–50–P in this section. Zachariae, and Jeanne D. Johansen. 1. Oral comments. Requests to present Contact Dermatitis (2011) 64, 330–336. oral comments during either conference 2. Methylisothiazolinone in rinse-off ENVIRONMENTAL PROTECTION call will be accepted up to Noon Eastern products causes allergic contact AGENCY Time on Wednesday, January 18, 2017, dermatitis: A repeated open-application for the January 25–26, 2017 meeting and [EPA–HQ–OAR–2016–0179; FRL–9957–70– study, authored by K Yazar, M.D. OAR] up to Noon Eastern Time on Friday, Lundov, A. Faurschou, M. Matura, A. March 10, 2017 for the March 17, 2017 Boman, J.D. Johansen, and C. Lidén. California State Motor Vehicle conference call. To the extent that time British Journal of Dermatology (2015) Pollution Control Standards; permits, interested persons who have 173, 115–122. Greenhouse Gas Emissions From 2014 not pre-registered may be permitted by 3. An evaluation of dose/unit area and and Subsequent Model Year Medium- the HSRB Chair to present oral time as key factors influencing the and Heavy-Duty Engines and Vehicles; comments during either call at the elicitation capacity of Notice of Decision designated time on the agenda. Oral methylchloroisothiazolinone/ comments before the HSRB are methylisothiazolinone (MCI/MI) in AGENCY: Environmental Protection generally limited to five minutes per MCI/MI-allergic patients, authored by Agency (EPA). individual or organization. If additional Claus Zachariae, Anne Lerbaek, Pauline ACTION: Notice of decision. time is available, further public M. McNamee, John E. Gray, Mike comments may be possible. Wooder, and Torkil Menné. Contact SUMMARY: The Environmental Protection 2. Written comments. Submit your Dermatitis (2006) 55, 160–166. Agency (EPA) is granting the California written comments prior to the meetings. Then on Thursday, January 26, 2017 Air Resources Board’s (‘‘CARB’s’’) For the Board to have the best the HSRB will consider: request for a waiver of Clean Air Act opportunity to review and consider your 1. Published article: Cholinesterase preemption for its greenhouse gas comments as it deliberates, you should Activity Resulting from Carbaryl (‘‘GHG’’) emission regulation for the submit your comments by Noon Eastern Exposure. new 2014 and subsequent model year Time on Wednesday, January 18, 2016, 2. Unpublished article: A randomized on-road medium- and heavy-duty for the January 25–26, 2017 conference double blind study with malathion to engines and vehicles (‘‘California Phase call, and by noon Eastern Time on determine the residues of malathion 1 GHG Regulation’’) adopted in 2011. Friday, March 10, 2017 for the March dicarboxylic acid (DCA), malathion This regulation establishes requirements 17, 2017 teleconference. If you submit monocarboxylic acid (MCA), dimethyl applicable to new motor vehicles with comments after these dates, those phosphate (DMP), dimethyl a gross vehicle weight rating exceeding comments will be provided to the HSRB 8,500 pounds and engines that power asabaliauskas on DSK3SPTVN1PROD with NOTICES thiophosphate (DMTP), and dimethyl members, but you should recognize that dithiophosphate (DMDTP) in human such motor vehicles, except for the HSRB members may not have urine. medium-duty passenger vehicles that adequate time to consider your Meeting materials for these topics will are subject to California’s Low Emission comments prior to their discussion. You be available in advance of the meeting Vehicle Program. This regulation should submit your comments to the at http://www2.epa.gov/osa/human- generally aligns California’s GHG DFO, Jim Downing listed under FOR studies-review-board. emission standards and test procedures FURTHER INFORMATION CONTACT. There is On March 17, 2017, the Human with the federal GHG emission no limit on the length of written Studies Review Board will review and standards and test procedures that EPA VerDate Sep<11>2014 18:41 Dec 28, 2016 Jkt 241001 PO 00000 Frm 00027 Fmt 4703 Sfmt 4703 E:\FR\FM\29DEN1.SGM 29DEN1


Document Created: 2016-12-29 01:58:13
Document Modified: 2016-12-29 01:58:13
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.
DatesA public virtual meeting will be held on January 25-26, 2017, from 1:00 p.m. to approximately 5:00 p.m. Eastern Time each day. A separate, subsequent teleconference meeting is planned for Thursday, March 17, 2017, from 2:00 p.m. to approximately 3:30 p.m. for the HSRB to finalize its Final Report of the January 25-26, 2017 meeting and review other possible topics.
ContactAny member of the public who wishes to receive further information should contact the HSRB Designated Federal Official (DFO), Jim Downing on telephone number (202) 564-2468; fax
FR Citation81 FR 95981 
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