Human Studies Review Board; Notification of a Public Meeting, 30135-30137 [2014-12172]

Download as PDF Federal Register / Vol. 79, No. 101 / Tuesday, May 27, 2014 / Notices spanning from Manchester-By-The-Sea to Marshfield, a corridor in Vineyard Sound, and a corridor in Nantucket Sound. The state wide NDA will seamlessly integrate the 20 smaller NDAs that have been designated in Massachusetts since 1991. The boundaries for this statewide NDA encompass all Commonwealth of Massachusetts coastal waters: from mean low water along the coast of Massachusetts, seaward to the statefederal boundary, north to the border with New Hampshire, and south to the border with Rhode Island: https:// www.mass.gov/eea/agencies/czm/ program-areas/coastal-water-quality/ ndas/. Massachusetts has certified that there are a total of 132 pumpout facilities in coastal Massachusetts: https:// www.mass.gov/eea/agencies/czm/ program-areas/coastal-water-quality/ clean-boating/pumpout-list.html. Based on the examination of the petition and its supporting documentation, and information from site visits conducted by EPA New England staff, EPA has determined that adequate facilities for the safe and sanitary removal and treatment of sewage from all vessels are reasonably available for the area covered under this determination. This determination is made pursuant to Section 312 (f) (3) of Public Law 92–500, as amended by Public Laws 95–217 and 100–4. Dated: May 14, 2014. H. Curtis Spalding, Regional Administrator, New England Region. [FR Doc. 2014–12170 Filed 5–23–14; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–ORD–2014–0411; FRL 9911–45– OA] Human Studies Review Board; Notification of a Public Meeting U. S. Environmental Protection Agency. ACTION: Notice. AGENCY: The Environmental Protection Agency (EPA) Office of the Science Advisor announces a public meeting of the Human Studies Review Board to advise the Agency on the ethical and scientific reviews of EPA research with human subjects. DATES: This public meeting will be held on June 11, 2014, from approximately 10:30 a.m. to approximately 4:00 p.m. Eastern Time. Comments may be sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:12 May 23, 2014 Jkt 232001 submitted on or before noon (Eastern Time) on Friday, June 4, 2014. ADDRESSES: The meeting will be held at the Environmental Protection Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202. Comments: Submit your written comments, identified by Docket ID No. EPA–HQ–ORD–2014–0411, by one of the following methods: Internet: https://www.regulations.gov: Follow the online instructions for submitting comments. Email: ORD.Docket@epa.gov. Mail: The EPA Docket Center EPA/ DC, ORD Docket, Mail code: 28221T, 1200 Pennsylvania Avenue NW., Washington, DC 20460. Hand Delivery: The EPA/DC Public Reading Room is located in the EPA Headquarters Library, Room Number 3334 in the EPA WJC West, at 1301 Constitution Avenue NW., Washington, DC 20460. The hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday, excluding federal holidays. Please call (202) 566– 1744 or email the ORD Docket at ord.docket@epa.gov for instructions. Updates to Public Reading Room access are available on the Web site https:// www.epa.gov/epahome/dockets.htm. Instructions: The Agency’s policy is that all comments received will be included in the public docket without change and may be made available online at https://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information or other information the disclosure of which is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through https:// www.regulations.gov or email. The https://www.regulations.gov Web site is an ‘‘anonymous access’’ system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through https:// www.regulations.gov, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any electronic storage media you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 30135 comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to receive further information should contact Jim Downing at telephone number (202) 564–2468; fax: (202) 564– 2070; email address: downing.jim@ epa.gov; mailing address Environmental Protection Agency, Office of the Science Advisor, Mail code 8105R, 1200 Pennsylvania Avenue NW., Washington, DC 20460. General information concerning the EPA HSRB can be found on the EPA Web site at https:// www.epa.gov/hsrb. SUPPLEMENTARY INFORMATION: Meeting access: Seating at the meeting will be on a first-come basis. To request accommodation of a disability, please contact the persons listed under FOR FURTHER INFORMATION CONTACT at least ten business days prior to the meeting using the information under FOR FURTHER INFORMATION CONTACT, so that appropriate arrangements can be made. Procedures for providing public input: Interested members of the public may submit relevant written or oral comments for the HSRB to consider during the advisory process. Additional information concerning submission of relevant written or oral comments is provided in Section I, ‘‘Public Meeting’’ under subsection D. ‘‘How May I Participate in this Meeting?’’ of this notice. Web cast: This meeting may be webcast. Please refer to the HSRB Web site, https://www.epa.gov/hsrb/ for information on how to access the webcast. Please note that the webcast is a supplementary public process provided only for convenience. If difficulties arise resulting in webcasting outages, the meeting will continue as planned. I. Public Meeting A. Does this action apply to me? This action is directed to the public in general. This Notice may, however, be of particular interest to persons who conduct or assess human studies, especially studies on substances regulated by the EPA, or to persons who are, or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act or the Federal Insecticide, Fungicide, and Rodenticide Act. This notice might also be of special interest to participants of studies involving human subjects, or representatives of study participants or experts on community engagement. The Agency has not attempted to describe all E:\FR\FM\27MYN1.SGM 27MYN1 30136 Federal Register / Vol. 79, No. 101 / Tuesday, May 27, 2014 / Notices the specific entities that may have interest in human subjects research. If you have any questions regarding this notice, consult Jim Downing listed under FOR FURTHER INFORMATION CONTACT. sroberts on DSK5SPTVN1PROD with NOTICES B. How can I access electronic copies of this document and other related information? In addition to using regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at https:// www.epa.gov/fedrgstr/. Docket: All documents in the docket are listed in the https:// www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in https:// www.regulations.gov or in hard copy at the ORD Docket, EPA/DC, in the Public Reading Room. The EPA/DC Public Reading Room is located in the EPA Headquarters Library, Room Number 3334 in the EPA WJC West, at 1301 Constitution Avenue NW., Washington, DC 20460. The hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday, excluding federal holidays. Please call (202) 566–1744 or email the ORD Docket at ord.docket@epa.gov for instructions. Updates to Public Reading Room access are available on the Web site (https://www.epa.gov/epahome/ dockets.htm). The Agency’s position paper(s), charge/questions to the HSRB, and the meeting agenda will be available by the last week of May 2014. In addition, the Agency may provide additional background documents as the materials become available. You may obtain electronic copies of these documents, and other related documents that are available electronically, from the regulations.gov Web site and the EPA HSRB Web site at https://www.epa.gov/ hsrb/. For questions on document availability, or if you do not have access to the Internet, consult Jim Downing listed under FOR FURTHER INFORMATION CONTACT. C. What should I consider as I prepare my comments for the EPA? You may find the following suggestions helpful for preparing your comments: VerDate Mar<15>2010 19:12 May 23, 2014 Jkt 232001 1. Explain your views as clearly as possible. 2. Describe any assumptions that you used. 3. Provide copies of any technical information and/or data that you used to support your views. 4. Provide specific examples to illustrate your concerns and suggest alternatives. 5. To ensure proper receipt by the EPA, be sure to identify the Docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation. D. How may I participate in this meeting? You may participate in this meeting by following the instructions in this section. To ensure proper receipt by the EPA, it is imperative that you identify Docket ID number EPA–HQ–ORD– 2014–0411 in the subject line on the first page of your request. 1. Oral comments. Requests to present oral comments will be accepted up to Friday, June 6, 2014. To the extent that time permits, interested persons who have not pre-registered may be permitted by the Chair of the HSRB to present oral comments at the meeting. Each individual or group wishing to make brief oral comments to the HSRB is strongly advised to submit their request (preferably via email) to Jim Downing, under FOR FURTHER INFORMATION CONTACT no later than noon, Eastern Time, Friday, June 6, 2014, in order to be included on the meeting agenda and to provide sufficient time for the HSRB Chair and HSRB Designated Federal Official to review the meeting agenda to provide an appropriate public comment period. The request should identify the name of the individual making the presentation and the organization (if any) the individual will represent. Oral comments before the HSRB are generally limited to five minutes per individual or organization. Please note that this includes all individuals appearing either as part of, or on behalf of, an organization. While it is our intent to hear a full range of oral comments on the science and ethics issues under discussion, it is not our intent to permit organizations to expand the time limitations by having numerous individuals sign up separately to speak on their behalf. If additional time is available, further public comments may be possible. 2. Written comments. Submit your written comments prior to the meeting. For the Board to have the best PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 opportunity to review and consider your comments as it deliberates on its report, you should submit your comments by June 4, 2014. If you submit comments after this date, those comments will be provided to the Board members, but you should recognize that the HSRB members may not have adequate time to consider those comments prior to their discussion during the meeting. You should submit your comments using the instructions in Section I., under subsection C., ‘‘What Should I Consider as I Prepare My Comments for the EPA?’’ In addition, the agency also requests that persons submitting comments directly to the docket also provide a copy of their comments to Jim Downing listed under FOR FURTHER INFORMATION CONTACT. There is no limit on the length of written comments for consideration by the HSRB. E. Background The HSRB is a Federal advisory committee operating in accordance with the Federal Advisory Committee Act 5 U.S.C. App.2 § 9. The HSRB provides advice, information, and recommendations to the EPA on issues related to scientific and ethical aspects of human subjects research. 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. The HSRB reports to the EPA Administrator through the Agency’s Science Advisor. 1. Topics for discussion. At its meeting on June 11, 2014, EPA’s Human Studies Review Board will consider scientific and ethical issues surrounding these topics: a. Published report by Gardner et al (1988) of an intentional exposure human study measuring the effects of low dose oral iodide supplementation on thyroid function b. Published report by Paul et al (1988) of an intentional exposure human study measuring the effects of small increases of dietary iodine on thyroid function c. Published report by Lemar et al (1995) of an intentional exposure human study measuring the effects of chronic tetraglycine hydroperiodide water purification tablet use on thyroid function d. Discussion of a report from the HSRB Work Group of the Return of Individual Research Results. 2. Meeting minutes and reports. Minutes of the meeting, summarizing the matters discussed and E:\FR\FM\27MYN1.SGM 27MYN1 Federal Register / Vol. 79, No. 101 / Tuesday, May 27, 2014 / Notices recommendations, if any, made by the advisory committee regarding such matters, will be released within 90 calendar days of the meeting. Such minutes will be available at https:// www.epa.gov/osa/hsrb/and https:// www.regulations.gov. In addition, information regarding the Board’s final meeting report, will be found at https:// www.epa.gov/osa/hsrb/ or from the person listed under FOR FURTHER INFORMATION CONTACT. Dated: May 15, 2014. Robert Kavlock, Interim Agency Science Advisor. [FR Doc. 2014–12172 Filed 5–23–14; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [FRL–9911–39–OA] Notification of a Public Teleconference of the Clean Air Scientific Advisory Committee Augmented Sulfur Oxides Primary NAAQS Review Panel Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The Environmental Protection Agency (EPA) Science Advisory Board (SAB) Staff Office announces a public teleconference of the Clean Air Scientific Advisory Committee (CASAC) Augmented Sulfur Oxides Primary National Ambient Air Quality Standards (NAAQS) Review Panel to discuss its draft review of EPA’s Integrated Review Plan for the Primary National Ambient Air Quality Standard for Sulfur Dioxide (External Review Draft). DATES: The CASAC will hold a teleconference on Wednesday, June 11, 2014, from 1:00 p.m. to 4:00 p.m. (Eastern Time). ADDRESSES: The CASAC public teleconference will take place via telephone only. FOR FURTHER INFORMATION CONTACT: Any member of the public who wants further information concerning the CASAC’s public teleconference may contact Dr. Diana Wong, Designated Federal Officer (DFO) via telephone at (202) 564–2049 or email at wong.diana-M@epa.gov. General information concerning the CASAC can be found on the EPA Web site at https://www.epa.gov/casac. SUPPLEMENTARY INFORMATION: The CASAC was established pursuant to the Clean Air Act (CAA) Amendments of 1977, codified at 42 U.S.C. 7409D(d)(2), to review air quality criteria and NAAQS and recommend any new sroberts on DSK5SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 19:12 May 23, 2014 Jkt 232001 NAAQS and revisions of existing criteria and NAAQS as may be appropriate. The CASAC shall also provide advice, information, and recommendations to the Administrator on the scientific and technical aspects of issues related to the criteria for air quality standards, research related to air quality, sources of air pollution, and of adverse effects which may result from various strategies to attain and maintain air quality standards. The CASAC is a Federal Advisory Committee chartered under the Federal Advisory Committee Act (FACA), 5 U.S.C., App. 2. Section 109(d)(1) of the CAA requires that the Agency periodically review and revise, as appropriate, the air quality criteria and the NAAQS for the six ‘‘criteria’’ air pollutants, including oxides of sulfur. EPA is currently reviewing the primary (health-based) NAAQS for sulfur dioxide (SO2), as an indicator for health effects caused by the presence of oxides of sulfur in the ambient air and has requested CASAC advice. For purposes of the review of the sulfur oxides air quality criteria for health and the primary NAAQS for sulfur dioxide, the CASAC Augmented Sulfur Oxides Review Panel was formed following a request for public nominations of experts (78 FR 43880— 43881, July 22, 2013), and held a public teleconference on April 22, 2014 (as noticed in 79 FR 16325–16326) to peer review EPA’s Integrated Review Plan for the Primary National Ambient Air Quality Standard for Sulfur Dioxide (External Review Draft- March 2014). Information about this review activity may be found on the CASAC Web site at https://yosemite.epa.gov/sab/sab product.nsf/fedrgstr_activites/SO_2%20 Primary%20NAAQS%20Review?Open Document. Pursuant to FACA and EPA policy, notice is hereby given that the CASAC Augmented Sulfur Oxides Primary NAAQS Review Panel will hold a public teleconference to discuss CASAC’s draft review of this EPA document. The CASAC Augmented Sulfur Oxides Review Panel will comply with the provisions of FACA and all appropriate SAB Staff Office procedural policies. Technical Contacts: Any technical questions concerning the Integrated Review Plan for the Primary National Ambient Air Quality Standard for Sulfur Dioxide (External Review Draft—March 2014) should be directed to Dr. Michael Stewart (stewart.michael@epa.gov). Availability of Meeting Materials: Prior to the teleconference, the CASAC draft report, agenda and other materials will be accessible through the calendar PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 30137 link on the blue navigation bar at https:// www.epa.gov/casac/. Procedures for Providing Public Input: Public comment for consideration by EPA’s federal advisory committees and panels has a different purpose from public comment provided to EPA program offices. Therefore, the process for submitting comments to a federal advisory committee is different from the process used to submit comments to an EPA program office. Federal advisory committees and panels, including scientific advisory committees, provide independent advice to EPA. Members of the public can submit relevant comments for a federal advisory committee to consider as it develops advice for EPA. Interested members of the public may submit relevant written or oral information on the topic of this advisory activity, and/ or the group conducting the activity, for the CASAC to consider during the advisory process. Input from the public to the CASAC will have the most impact if it provides specific scientific or technical information or analysis for CASAC panels to consider or if it relates to the clarity or accuracy of the technical information. Members of the public wishing to provide comment should contact the DFO directly. Oral Statements: In general, individuals or groups requesting an oral presentation on a public teleconference will be limited to three minutes. Each person making an oral statement should consider providing written comments as well as their oral statement so that the points presented orally can be expanded upon in writing. Interested parties should contact Dr. Diana Wong, DFO, in writing (preferably via email) at the contact information noted above by June 4, 2014 to be placed on the list of public speakers. Written Statements: Written statements should be supplied to Dr. Diana Wong, DFO, via email at the contact information noted above by June 4, 2014 so that the information may be made available to the Panel members for their consideration. Written statements should be supplied in one of the following electronic formats: Adobe Acrobat PDF, MS Word, MS PowerPoint, or Rich Text files in IBM– PC/Windows 98/2000/XP format. It is the SAB Staff Office general policy to post written comments on the Web page for advisory meetings or teleconferences. Submitters are requested to provide an unsigned version of each document because the SAB Staff Office does not publish documents with signatures on its Web sites. Members of the public should be aware that their personal contact information, if included in any written E:\FR\FM\27MYN1.SGM 27MYN1

Agencies

[Federal Register Volume 79, Number 101 (Tuesday, May 27, 2014)]
[Notices]
[Pages 30135-30137]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12172]


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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2014-0411; FRL 9911-45-OA]


Human Studies Review Board; Notification of a Public Meeting

AGENCY: U. S. Environmental Protection Agency.

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) Office of the 
Science Advisor announces a public meeting of the Human Studies Review 
Board to advise the Agency on the ethical and scientific reviews of EPA 
research with human subjects.

DATES: This public meeting will be held on June 11, 2014, from 
approximately 10:30 a.m. to approximately 4:00 p.m. Eastern Time. 
Comments may be submitted on or before noon (Eastern Time) on Friday, 
June 4, 2014.

ADDRESSES: The meeting will be held at the Environmental Protection 
Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 
2777 S. Crystal Dr., Arlington, VA 22202.
    Comments: Submit your written comments, identified by Docket ID No. 
EPA-HQ-ORD-2014-0411, by one of the following methods:
    Internet: https://www.regulations.gov: Follow the online 
instructions for submitting comments.
    Email: ORD.Docket@epa.gov.
    Mail: The EPA Docket Center EPA/DC, ORD Docket, Mail code: 28221T, 
1200 Pennsylvania Avenue NW., Washington, DC 20460.
    Hand Delivery: The EPA/DC Public Reading Room is located in the EPA 
Headquarters Library, Room Number 3334 in the EPA WJC West, at 1301 
Constitution Avenue NW., Washington, DC 20460. The hours of operation 
are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday through Friday, 
excluding federal holidays. Please call (202) 566-1744 or email the ORD 
Docket at ord.docket@epa.gov for instructions. Updates to Public 
Reading Room access are available on the Web site https://www.epa.gov/epahome/dockets.htm.
    Instructions: The Agency's policy is that all comments received 
will be included in the public docket without change and may be made 
available online at https://www.regulations.gov, including any personal 
information provided, unless the comment includes information claimed 
to be Confidential Business Information or other information the 
disclosure of which is restricted by statute. Do not submit information 
that you consider to be CBI or otherwise protected through https://www.regulations.gov or email. The https://www.regulations.gov Web site 
is an ``anonymous access'' system, which means EPA will not know your 
identity or contact information unless you provide it in the body of 
your comment. If you send an email comment directly to the EPA without 
going through https://www.regulations.gov, your email address will be 
automatically captured and included as part of the comment that is 
placed in the public docket and made available on the Internet. If you 
submit an electronic comment, the EPA recommends that you include your 
name and other contact information in the body of your comment and with 
any electronic storage media you submit. If the EPA cannot read your 
comment due to technical difficulties and cannot contact you for 
clarification, the EPA may not be able to consider your comment. 
Electronic files should avoid the use of special characters, any form 
of encryption, and be free of any defects or viruses.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to 
receive further information should contact Jim Downing at telephone 
number (202) 564-2468; fax: (202) 564-2070; email address: 
downing.jim@epa.gov; mailing address Environmental Protection Agency, 
Office of the Science Advisor, Mail code 8105R, 1200 Pennsylvania 
Avenue NW., Washington, DC 20460. General information concerning the 
EPA HSRB can be found on the EPA Web site at https://www.epa.gov/hsrb.

SUPPLEMENTARY INFORMATION: 
    Meeting access: Seating at the meeting will be on a first-come 
basis. To request accommodation of a disability, please contact the 
persons listed under FOR FURTHER INFORMATION CONTACT at least ten 
business days prior to the meeting using the information under FOR 
FURTHER INFORMATION CONTACT, so that appropriate arrangements can be 
made.
    Procedures for providing public input: Interested members of the 
public may submit relevant written or oral comments for the HSRB to 
consider during the advisory process. Additional information concerning 
submission of relevant written or oral comments is provided in Section 
I, ``Public Meeting'' under subsection D. ``How May I Participate in 
this Meeting?'' of this notice.
    Web cast: This meeting may be webcast. Please refer to the HSRB Web 
site, https://www.epa.gov/hsrb/
    for information on how to access the webcast. Please note that the 
webcast is a supplementary public process provided only for 
convenience. If difficulties arise resulting in webcasting outages, the 
meeting will continue as planned.

I. Public Meeting

A. Does this action apply to me?

    This action is directed to the public in general. This Notice may, 
however, be of particular interest to persons who conduct or assess 
human studies, especially studies on substances regulated by the EPA, 
or to persons who are, or may be required to conduct testing of 
chemical substances under the Federal Food, Drug, and Cosmetic Act or 
the Federal Insecticide, Fungicide, and Rodenticide Act. This notice 
might also be of special interest to participants of studies involving 
human subjects, or representatives of study participants or experts on 
community engagement. The Agency has not attempted to describe all

[[Page 30136]]

the specific entities that may have interest in human subjects 
research. If you have any questions regarding this notice, consult Jim 
Downing listed under FOR FURTHER INFORMATION CONTACT.

B. How can I access electronic copies of this document and other 
related information?

    In addition to using regulations.gov, you may access this Federal 
Register document electronically through the EPA Internet under the 
``Federal Register'' listings at https://www.epa.gov/fedrgstr/.
    Docket: All documents in the docket are listed in the https://www.regulations.gov index. Although listed in the index, some 
information is not publicly available, e.g., CBI or other information 
whose disclosure is restricted by statute. Certain other material, such 
as copyrighted material, will be publicly available only in hard copy. 
Publicly available docket materials are available either electronically 
in https://www.regulations.gov or in hard copy at the ORD Docket, EPA/
DC, in the Public Reading Room.
    The EPA/DC Public Reading Room is located in the EPA Headquarters 
Library, Room Number 3334 in the EPA WJC West, at 1301 Constitution 
Avenue NW., Washington, DC 20460. The hours of operation are 8:30 a.m. 
to 4:30 p.m. Eastern Time, Monday through Friday, excluding federal 
holidays. Please call (202) 566-1744 or email the ORD Docket at 
ord.docket@epa.gov for instructions. Updates to Public Reading Room 
access are available on the Web site (https://www.epa.gov/epahome/dockets.htm).
    The Agency's position paper(s), charge/questions to the HSRB, and 
the meeting agenda will be available by the last week of May 2014. In 
addition, the Agency may provide additional background documents as the 
materials become available. You may obtain electronic copies of these 
documents, and other related documents that are available 
electronically, from the regulations.gov Web site and the EPA HSRB Web 
site at https://www.epa.gov/hsrb/. For questions on document 
availability, or if you do not have access to the Internet, consult Jim 
Downing listed under FOR FURTHER INFORMATION CONTACT.

C. What should I consider as I prepare my comments for the EPA?

    You may find the following suggestions helpful for preparing your 
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data that you 
used to support your views.
    4. Provide specific examples to illustrate your concerns and 
suggest alternatives.
    5. To ensure proper receipt by the EPA, be sure to identify the 
Docket ID number assigned to this action in the subject line on the 
first page of your response. You may also provide the name, date, and 
Federal Register citation.

D. How may I participate in this meeting?

    You may participate in this meeting by following the instructions 
in this section. To ensure proper receipt by the EPA, it is imperative 
that you identify Docket ID number EPA-HQ-ORD-2014-0411 in the subject 
line on the first page of your request.
    1. Oral comments. Requests to present oral comments will be 
accepted up to Friday, June 6, 2014. To the extent that time permits, 
interested persons who have not pre-registered may be permitted by the 
Chair of the HSRB to present oral comments at the meeting. Each 
individual or group wishing to make brief oral comments to the HSRB is 
strongly advised to submit their request (preferably via email) to Jim 
Downing, under FOR FURTHER INFORMATION CONTACT no later than noon, 
Eastern Time, Friday, June 6, 2014, in order to be included on the 
meeting agenda and to provide sufficient time for the HSRB Chair and 
HSRB Designated Federal Official to review the meeting agenda to 
provide an appropriate public comment period. The request should 
identify the name of the individual making the presentation and the 
organization (if any) the individual will represent. Oral comments 
before the HSRB are generally limited to five minutes per individual or 
organization. Please note that this includes all individuals appearing 
either as part of, or on behalf of, an organization. While it is our 
intent to hear a full range of oral comments on the science and ethics 
issues under discussion, it is not our intent to permit organizations 
to expand the time limitations by having numerous individuals sign up 
separately to speak on their behalf. If additional time is available, 
further public comments may be possible.
    2. Written comments. Submit your written comments prior to the 
meeting. For the Board to have the best opportunity to review and 
consider your comments as it deliberates on its report, you should 
submit your comments by June 4, 2014. If you submit comments after this 
date, those comments will be provided to the Board members, but you 
should recognize that the HSRB members may not have adequate time to 
consider those comments prior to their discussion during the meeting. 
You should submit your comments using the instructions in Section I., 
under subsection C., ``What Should I Consider as I Prepare My Comments 
for the EPA?'' In addition, the agency also requests that persons 
submitting comments directly to the docket also provide a copy of their 
comments to Jim Downing listed under FOR FURTHER INFORMATION CONTACT. 
There is no limit on the length of written comments for consideration 
by the HSRB.

E. 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 to the EPA on 
issues related to scientific and ethical aspects of human subjects 
research. 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. The HSRB 
reports to the EPA Administrator through the Agency's Science Advisor.
    1. Topics for discussion. At its meeting on June 11, 2014, EPA's 
Human Studies Review Board will consider scientific and ethical issues 
surrounding these topics:
    a. Published report by Gardner et al (1988) of an intentional 
exposure human study measuring the effects of low dose oral iodide 
supplementation on thyroid function
    b. Published report by Paul et al (1988) of an intentional exposure 
human study measuring the effects of small increases of dietary iodine 
on thyroid function
    c. Published report by Lemar et al (1995) of an intentional 
exposure human study measuring the effects of chronic tetraglycine 
hydroperiodide water purification tablet use on thyroid function
    d. Discussion of a report from the HSRB Work Group of the Return of 
Individual Research Results.
    2. Meeting minutes and reports. Minutes of the meeting, summarizing 
the matters discussed and

[[Page 30137]]

recommendations, if any, made by the advisory committee regarding such 
matters, will be released within 90 calendar days of the meeting. Such 
minutes will be available at https://www.epa.gov/osa/hsrb/and https://www.regulations.gov. In addition, information regarding the Board's 
final meeting report, will be found at https://www.epa.gov/osa/hsrb/ or 
from the person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: May 15, 2014.
Robert Kavlock,
Interim Agency Science Advisor.
[FR Doc. 2014-12172 Filed 5-23-14; 8:45 am]
BILLING CODE 6560-50-P
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