[Federal Register Volume 81, Number 250 (Thursday, December 29, 2016)]
[Notices]
[Pages 95981-95982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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