83_FR_49573 83 FR 49383 - Human Studies Review Board; Notification of Public Meetings

83 FR 49383 - Human Studies Review Board; Notification of Public Meetings

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 190 (October 1, 2018)

Page Range49383-49384
FR Document2018-21331

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 83 Issue 190 (Monday, October 1, 2018) 
[Federal Register Volume 83, Number 190 (Monday, October 1, 2018)]
[Notices]
[Pages 49383-49384]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-21331]


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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9984-60-ORD]


Human Studies Review Board; Notification of Public Meetings

AGENCY: Environmental Protection Agency.

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 virtual public meeting will be held on Tuesday, October 23, 
2018, from 1:00 p.m. to approximately 5:30 p.m. Eastern Time. A 
separate, subsequent teleconference meeting is planned for Thursday, 
December 13th, 2018, from 2 p.m. to approximately 3:30 p.m. Eastern 
Time for the HSRB to finalize its Report of the October 23, 2018 
meeting and review other possible topics.

ADDRESSES: All of these meetings will be conducted entirely by 
telephone and on the internet using Adobe Connect. For detailed access 
information visit the HSRB website: 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), Thomas O'Farrell on telephone number (202) 564-8451; 
fax number: (202) 564-2070; email address: ofarrell.thomas@epa.gov; or 
mailing address: Environmental Protection Agency, Office of the Science 
Advisor, Mail code 8105R, 1200 Pennsylvania Avenue NW, Washington, DC 
20460.

SUPPLEMENTARY INFORMATION: Meeting access. These meetings will be open 
to the public. The full Agenda and meeting materials will be available 
at the HSRB website: 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, Thomas O'Farrell, 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. To pre-register to make oral comments, please 
contact the DFO, Thomas O'Farrell, listed under FOR FURTHER INFORMATION 
CONTACT. Requests to present oral comments during the meeting will be 
accepted up to Noon Eastern Time on Tuesday, October 16, 2018, for the 
October 23, 2018 meeting and up to Noon Eastern Time on Thursday, 
December 6, 2018 for the December 13, 2018 meeting. 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 
meeting 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 via email or Fax by Noon Eastern Time on Tuesday, October 16, 
2018, for the October 23, 2018 meeting and by Noon Eastern Time on 
Thursday, December 6, 2018 for the

[[Page 49384]]

December 13, 2018 meeting. 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, Thomas O'Farrell 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 section 9. The 
HSRB provides advice, information, and recommendations on issues 
related to scientific and ethical aspects of third-party human subjects 
research that are submitted to the Office of Pesticide Programs (OPP) 
to be used for regulatory purposes.
    Topic for discussion. On October 23, 2018, the Human Studies Review 
Board will consider a protocol titled ``A Study for Measurement of 
Potential Dermal and Inhalation Exposure During Antimicrobial 
Applications Involving Immersion, Dip, and Soak'' submitted by the 
Antimicrobial Exposure Assessment Task Force.
    The Agenda and meeting materials for this topic will be available 
in advance of the meeting at http://www2.epa.gov/osa/human-studies-review-board.
    On December 13, 2018, the HSRB will review and finalize their draft 
Final Report from the October 23, 2018 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 meeting 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 
Thomas O'Farrell listed under FOR FURTHER INFORMATION CONTACT.

    Dated: September 19, 2018.
 Jennifer Orme-Zavaleta,
EPA Science Advisor.
[FR Doc. 2018-21331 Filed 9-28-18; 8:45 am]
 BILLING CODE 6560-50-P

Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices 49383 name and other contact information in Act-compliant government-issued photo FOR FURTHER INFORMATION CONTACT: Any the body of your comment and with any identification to enter the building. member of the public who wishes to disk or CD–ROM you submit. If the EPA Attendees are encouraged to arrive at receive further information should cannot read your comment due to least 15 minutes prior to the start of the contact the HSRB Designated Federal technical difficulties and cannot contact meeting to allow sufficient time for Official (DFO), Thomas O’Farrell on you for clarification, the EPA may not security screening. Proposed agenda telephone number (202) 564–8451; fax be able to consider your comment. items for the meeting include, but are number: (202) 564–2070; email address: Electronic files should avoid the use of not limited to, the following: Overview ofarrell.thomas@epa.gov; or mailing special characters, any form of of materials provided to the address: Environmental Protection encryption, and be free of any defects or subcommittee; Update on ORD’s Air Agency, Office of the Science Advisor, viruses. For additional information and Energy Research Program and the Mail code 8105R, 1200 Pennsylvania about the EPA’s public docket visit the draft Strategic Research Action Plan; Avenue NW, Washington, DC 20460. EPA Docket Center homepage at http:// Review of charge questions; and SUPPLEMENTARY INFORMATION: Meeting www.epa.gov/dockets/. Subcommittee discussion. access. These meetings will be open to Docket: All documents in the docket Information on services for the public. The full Agenda and meeting are listed in the www.regulations.gov individuals with disabilities: For materials will be available at the HSRB index. Although listed in the index, information on access or services for website: http://www2.epa.gov/osa/ some information is not publicly individuals with disabilities, please human-studies-review-board . For available, e.g., CBI or other information contact Tim Benner at (202) 564–6769 questions on document availability, or if whose disclosure is restricted by statute. or benner.tim@epa.gov. To request you do not have access to the internet, Certain other material, such as accommodation of a disability, please consult with the DFO, Thomas copyrighted material, will be publicly contact Tim Benner, preferably at least O’Farrell, listed under FOR FURTHER available only in hard copy. Publicly ten days prior to the meeting, to give the INFORMATION CONTACT. available docket materials are available EPA as much time as possible to process Special accommodations. For either electronically in your request. information on access or services for www.regulations.gov or in hard copy at individuals with disabilities, or to Dated: September 21, 2018. the Board of Scientific Counselors request accommodation of a disability, Fred S. Hauchman, please contact the DFO listed under FOR (BOSC) Air and Energy Subcommittee Director, Office of Science Policy. FURTHER INFORMATION CONTACT at least Docket, EPA/DC, William Jefferson Clinton West Building, Room 3334, [FR Doc. 2018–21332 Filed 9–28–18; 8:45 am] 10 days prior to the meeting to give EPA 1301 Constitution Ave. NW, BILLING CODE 6560–50–P as much time as possible to process Washington, DC. The Public Reading your request. Room is open from 8:30 a.m. to 4:30 How may I participate in this meeting? p.m., Monday through Friday, excluding ENVIRONMENTAL PROTECTION legal holidays. The telephone number AGENCY The HSRB encourages the public’s for the Public Reading Room is (202) input. You may participate in these 566–1744, and the telephone number for [FRL–9984–60–ORD] meetings by following the instructions the ORD Docket is (202) 566–1752. in this section. Human Studies Review Board; 1. Oral comments. To pre-register to FOR FURTHER INFORMATION CONTACT: The Notification of Public Meetings make oral comments, please contact the Designated Federal Officer via mail at: DFO, Thomas O’Farrell, listed under Tim Benner, Mail Code 8104R, Office of AGENCY: Environmental Protection FOR FURTHER INFORMATION CONTACT. Science Policy, Office of Research and Agency. Requests to present oral comments Development, U.S. Environmental ACTION: Notice. during the meeting will be accepted up Protection Agency, 1200 Pennsylvania to Noon Eastern Time on Tuesday, Ave. NW, Washington, DC 20460; via SUMMARY: The Environmental Protection Agency (EPA), Office of the Science October 16, 2018, for the October 23, phone/voice mail at: (202) 564–6769; 2018 meeting and up to Noon Eastern via fax at: (202) 565–2911; or via email Advisor announces two separate public meetings of the Human Studies Review Time on Thursday, December 6, 2018 at: benner.tim@epa.gov. for the December 13, 2018 meeting. To Board (HSRB) to advise the Agency on SUPPLEMENTARY INFORMATION: the extent that time permits, interested General information: The meeting is the ethical and scientific review of persons who have not pre-registered open to the public. Any member of the research involving human subjects. may be permitted by the HSRB Chair to public interested in receiving a draft DATES: A virtual public meeting will be present oral comments during either agenda, attending the meeting, or held on Tuesday, October 23, 2018, meeting at the designated time on the making a presentation at the meeting from 1:00 p.m. to approximately 5:30 agenda. Oral comments before the HSRB may contact Tim Benner, the Designated p.m. Eastern Time. A separate, are generally limited to five minutes per Federal Officer, via any of the contact subsequent teleconference meeting is individual or organization. If additional methods listed in the FOR FURTHER planned for Thursday, December 13th, time is available, further public INFORMATION CONTACT section above. In 2018, from 2 p.m. to approximately 3:30 comments may be possible. general, each individual making an oral p.m. Eastern Time for the HSRB to 2. Written comments. Submit your presentation will be limited to a total of finalize its Report of the October 23, written comments prior to the meetings. three minutes. For security purposes, all 2018 meeting and review other possible For the Board to have the best amozie on DSK3GDR082PROD with NOTICES attendees must provide their names to topics. opportunity to review and consider your the Designated Federal Officer or ADDRESSES: All of these meetings will be comments as it deliberates, you should register online at https://epa-bosc- conducted entirely by telephone and on submit your comments via email or Fax airenergy-subcommittee.eventbrite.com the internet using Adobe Connect. For by Noon Eastern Time on Tuesday, by November 6, 2018, and must go detailed access information visit the October 16, 2018, for the October 23, through a metal detector, sign in with HSRB website: http://www2.epa.gov/ 2018 meeting and by Noon Eastern Time the security desk, and show REAL ID osa/human-studies-review-board. on Thursday, December 6, 2018 for the VerDate Sep<11>2014 17:50 Sep 28, 2018 Jkt 247001 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\01OCN1.SGM 01OCN1

49384 Federal Register / Vol. 83, No. 190 / Monday, October 1, 2018 / Notices December 13, 2018 meeting. If you GENERAL SERVICES ACTION: Notice of request for agency and submit comments after these dates, ADMINISTRATION public comments. those comments will be provided to the [Notice–MA–2018–09; Docket No. 2018– SUMMARY: After publication of this HSRB members, but you should 0002, Sequence No. 22] recognize that the HSRB members may second round notice, the Office of not have adequate time to consider your Government Ethics (OGE) plans to Federal Travel Regulation: Calculating comments prior to their discussion. You submit a modified OGE Form 450 Actual Expense Reimbursement should submit your comments to the Executive Branch Confidential Financial DFO, Thomas O’Farrell listed under FOR AGENCY: Office of Government-wide Disclosure Report to the Office of FURTHER INFORMATION CONTACT. There is Policy (OGP), General Services Management and Budget (OMB) for no limit on the length of written Administration (GSA). review and approval under the comments for consideration by the ACTION: Notice of Federal Travel Paperwork Reduction Act of 1995. HSRB. Regulation (FTR) Bulletin 18–09, DATES: Written comments by the public calculating actual expense and the agencies on this proposed Background reimbursement. modification are invited and must be The HSRB is a Federal advisory received by October 31, 2018. committee operating in accordance with SUMMARY: The FTR allows agencies to ADDRESSES: You may submit comments the Federal Advisory Committee Act 5 reimburse employees up to 300 percent on this paperwork notice to the Office U.S.C. App. 2 section 9. The HSRB of the applicable maximum per diem of Management and Budget, Attn: Desk provides advice, information, and rate under various circumstances Officer for OGE, via fax at 202–395– recommendations on issues related to including, but not limited to, when 6974 or email at OIRA_Submission@ scientific and ethical aspects of third- lodging and/or meals are not available omb.eop.gov. (Include reference to party human subjects research that are within the prescribed allowances for a ‘‘OGE Form 450 paperwork comment’’ submitted to the Office of Pesticide given temporary duty location. The in the subject line of the message.) Programs (OPP) to be used for regulatory General Services Administration is FOR FURTHER INFORMATION CONTACT: Sara purposes. notifying agencies that the FTR permits two methods of calculating actual Nekou at the U.S. Office of Government Topic for discussion. On October 23, expense reimbursement. The Ethics; telephone: 202–482–9229; TTY: 2018, the Human Studies Review Board information outlined in FTR Bulletin 800–877–8339; FAX: 202–482–9237; will consider a protocol titled ‘‘A Study 18–09 demonstrates how agencies may Email: snekou@oge.gov. An electronic for Measurement of Potential Dermal calculate actual expense reimbursement copy of the OGE Form 450 is available and Inhalation Exposure During under each method while staying within in the Forms Library section of OGE’s Antimicrobial Applications Involving the bounds of the current 300 percent website at http://www.oge.gov. A paper Immersion, Dip, and Soak’’ submitted actual expense ceiling. This Bulletin copy may also be obtained, without by the Antimicrobial Exposure also provides clarity and promotes charge, by contacting Ms. Nekou. Assessment Task Force. The Agenda and meeting materials for consistency across the Government. SUPPLEMENTARY INFORMATION: this topic will be available in advance This Bulletin is located at www.gsa.gov/ Title: Executive Branch Confidential of the meeting at http://www2.epa.gov/ ftr under the ‘‘FTR & Related Files’’ tab. Financial Disclosure Report. osa/human-studies-review-board. DATES: Applicable Date: October 1, Agency Form Number: OGE Form On December 13, 2018, the HSRB will 2018. 450. review and finalize their draft Final OMB Control Number: 3209–0006. Report from the October 23, 2018 FOR FURTHER INFORMATION CONTACT: For Type of Information Collection: meeting, in addition to other topics that clarification of content, please contact Revision of a currently approved may come before the Board. The HSRB Mr. Cy Greenidge, Program Analyst, collection. may also discuss planning for future Office of Government-wide Policy, Type of Review Request: Regular. HSRB meetings. The agenda and the Office of Asset and Transportation Respondents: Prospective draft report will be available prior to the Management, at 202–219–2349, or by Government employees, including meeting at http://www2.epa.gov/osa/ email at travelpolicy@gsa.gov. Please special Government employees, whose human-studies-review-board. cite Notice of FTR Bulletin 18–09. positions are designated for confidential Meeting minutes and final reports. Dated: August 24, 2018. disclosure filing and whose agencies Minutes of these meetings, summarizing Jessica Salmoiraghi, require that they file new entrant the matters discussed and Associate Administrator, Office of confidential disclosure reports prior to recommendations made by the HSRB, Government-wide Policy. assuming Government responsibilities. will be released within 90 calendar days [FR Doc. 2018–21156 Filed 9–28–18; 8:45 am] Estimated Annual Number of of the meeting. These minutes will be Respondents: 24,640. BILLING CODE 6820–14–P available at http://www2.epa.gov/osa/ Estimated Time per Response: 3 human-studies-review-board. In hours. addition, information regarding the Estimated Total Annual Burden: OFFICE OF GOVERNMENT ETHICS 73,920 hours. HSRB’s Final Report, will be found at http://www2.epa.gov/osa/human- Agency Information Collection Abstract: The OGE Form 450 collects studies-review-board or from Thomas Activities; Submission for OMB information from covered department O’Farrell listed under FOR FURTHER Review; Proposed Collection; and agency employees as required amozie on DSK3GDR082PROD with NOTICES INFORMATION CONTACT. Comment Request for a Modified OGE under OGE’s executive branch wide Form 450 Executive Branch regulatory provisions in subpart I of 5 Dated: September 19, 2018. CFR part 2634. The basis for the OGE Jennifer Orme-Zavaleta, Confidential Financial Disclosure Report reporting regulation is section 201(d) of EPA Science Advisor. Executive Order 12674 of April 12, 1989 [FR Doc. 2018–21331 Filed 9–28–18; 8:45 am] AGENCY: Office of Government Ethics (as modified by Executive Order 12731 BILLING CODE 6560–50–P (OGE). of October 17, 1990) and section 107(a) VerDate Sep<11>2014 17:50 Sep 28, 2018 Jkt 247001 PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 E:\FR\FM\01OCN1.SGM 01OCN1


Document Created: 2018-09-29 04:26:06
Document Modified: 2018-09-29 04:26:06
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 virtual public meeting will be held on Tuesday, October 23, 2018, from 1:00 p.m. to approximately 5:30 p.m. Eastern Time. A separate, subsequent teleconference meeting is planned for Thursday, December 13th, 2018, from 2 p.m. to approximately 3:30 p.m. Eastern Time for the HSRB to finalize its Report of the October 23, 2018 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), Thomas O'Farrell on telephone number (202) 564-8451;
FR Citation83 FR 49383 
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