Federal Register / Vol. 76, No. 187 / Tuesday, September 27, 2011 / Notices 59697 

Respondents/Affected Entities: State, 

tribal, or territorial environmental 

government offices. 

Estimated Number of Respondents: 

300. 

Frequency of Response: Twice per 

year for progress reporting; annually for 

quality assurance reporting form. 

Estimated Total Annual Hour Burden: 

956. 

Estimated Total Annual Cost: $37,370 

in labor costs. There are no annualized 

capital or O&M costs. 

Changes in the Estimates: There is an 

increase of 223 hours in the total 

estimated burden currently identified in 

the OMB Inventory of Approved ICR 

Burdens. This increase is due to an 

increase in the number of grants that are 

currently active and the adjustments 

were made accordingly. 

Dated: September 21, 2011. 

John Moses, 

Director, Collection Strategies Division. 

[FR Doc. 2011–24814 Filed 9–26–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–ORD–2011–0693; FRL–9472–4] 

Human Studies Review Board (HSRB); 

Notification of a Public Meeting 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: The U.S. Environmental 

Protection Agency (EPA) Office of the 

Science Advisor (OSA) announces a 

public meeting of the Human Studies 

Review Board (HSRB) to advise the 

Agency on EPA’s scientific and ethical 

reviews of research with human 

subjects. 

DATES: This public meeting will be held 

on October 19–20, 2011, from 

approximately 9 a.m. to approximately 

5:30 p.m. Eastern Time. Comments may 

be submitted on or before Wednesday, 

October 12, 2011. 

ADDRESSES: Submit your written 

comments, identified by Docket ID No. 

EPA–HQ–ORD–2011–0693, by one of 

the following methods: 

Internet: http://www.regulations.gov: 

Follow the on-line instructions for 

submitting comments. 

E-mail: ORD.Docket@epa.gov. 

Mail: Environmental Protection 

Agency, EPA Docket Center (EPA/DC), 

ORD Docket, Mailcode: 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 West Building, located 

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 e-mail the ORD 

Docket at ord.docket@epa.gov for 

instructions. Updates to Public Reading 

Room access are available on the Web 

site (http://www.epa.gov/epahome/ 

dockets.htm). 

Instructions: Direct your comments to 

Docket ID No. EPA–HQ–ORD–2011– 

0693. EPA’s policy is that all comments 

received will be included in the public 

docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) 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 http:// 

www.regulations.gov or e-mail. The 

http://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 e-mail comment directly 

to EPA without going through http:// 

www.regulations.gov, your e-mail 

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, 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 

EPA cannot read your comment due to 

technical difficulties and cannot contact 

you for clarification, 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; e-mail address: 

downing.jim@epa.gov, or Lu-Ann 

Kleibacker at telephone number: (202) 

564–7189; fax: 202–564–2070; e-mail 

address: kleibacker.lu-ann@epa.gov; 

mailing address: Environmental 

Protection Agency, Office of the Science 

Advisor (8105R), 1200 Pennsylvania 

Avenue, NW., Washington, DC 20460. 

General information concerning the EPA 

HSRB can be found on the EPA Web site 

at http://www.epa.gov/osa/hsrb/. 

SUPPLEMENTARY INFORMATION: Location: 

The meeting will be held at the 

Environmental Protection Agency, 

Conference Center—Lobby Level, One 

Potomac Yard (South Bldg.) 2777 S. 

Crystal Drive, Arlington, VA 22202. 

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. 

I. Public Meeting 

A. Does this action apply to me? 

This action is directed to the public 

in general. This action may, however, be 

of particular interest to persons who 

conduct or assess human studies, 

especially studies on substances 

regulated by EPA, or to persons who are, 

or may be required to conduct testing of 

chemical substances under the Federal 

Food, Drug, and Cosmetic Act (FFDCA) 

or the Federal Insecticide, Fungicide, 

and Rodenticide Act (FIFRA). 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. Since many 

entities may also be interested, the 

Agency has not attempted to describe all 

the specific entities that may be affected 

by this action. If you have any questions 

regarding the applicability of this action 

to a particular entity, consult Jim 

Downing or Lu-Ann Kleibacker 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 http:// 

www.epa.gov/fedrgstr/. 

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59698 Federal Register / Vol. 76, No. 187 / Tuesday, September 27, 2011 / Notices 

Docket: All documents in the docket 

are listed in the http:// 

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 http:// 

www.regulations.gov or in hard copy at 

the ORD Docket, EPA/DC, Public 

Reading Room. The EPA/DC Public 

Reading Room is located in the EPA 

Headquarters Library, Room Number 

3334 in the EPA West Building, located 

at 1301 Constitution Avenue, NW., 

Washington, DC 20460. The hours of 

operation are 8:30 am 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 (http://www.epa.gov/epahome/ 

dockets.htm). 

EPA’s position paper(s), charge/ 

questions to the HSRB, and the meeting 

agenda will be available by the first of 

October 2011. In addition, the Agency 

may provide additional background 

documents as the materials become 

available. You may obtain electronic 

copies of these documents, and certain 

other related documents that might be 

available electronically, from the 

regulations.gov Web site and the EPA 

HSRB Web site at http://www.epa.gov/ 

osa/hsrb/. For questions on document 

availability, or if you do not have access 

to the Internet, consult either Jim 

Downing or Lu-Ann Kleibacker listed 

under FOR FURTHER INFORMATION

CONTACT. 

C. What should I consider as I prepare 

my comments for 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 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 

EPA, it is imperative that you identify 

docket ID number EPA–HQ–ORD–2011– 

0693 in the subject line on the first page 

of your request. 

1. Oral comments. Requests to present 

oral comments will be accepted up to 

Wednesday, October 12, 2011. 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 e-mail) to 

Jim Downing or Lu-Ann Kleibacker, 

under FOR FURTHER INFORMATION

CONTACT, no later than noon, Eastern 

Time, Wednesday, October 12, 2011, in 

order to be included on the meeting 

agenda and to provide sufficient time 

for the HSRB Chair and HSRB 

Designated Federal Official (DFO) 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 HSRB to have the best 

opportunity to review and consider your 

comments as it deliberates on its report, 

you should submit your comments at 

least five business days prior to the 

beginning of this meeting. If you submit 

comments after this date, those 

comments will be provided to the Board 

members, but you should recognize that 

the Board members may not have 

adequate time to consider those 

comments prior to making a decision. 

Thus, if you plan to submit written 

comments, the Agency strongly 

encourages you to submit such 

comments no later than noon, Eastern 

Time, Wednesday, October 12, 2011. 

You should submit your comments 

using the instructions in Section I., 

under subsection C., ‘‘What should I 

consider as I prepare my comments for 

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 or Lu-Ann Kleibacker 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 

(FACA) 5 U.S.C. App.2 9. The HSRB 

provides advice, information, and 

recommendations to 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 EPA’s Science 

Advisor. 

1. Topics for discussion. At its 

meeting on October 19 and 20, 2011, 

EPA’s Human Studies Review Board 

will consider scientific and ethical 

issues surrounding these topics: 

a. A new scenario design and 

associated protocol from the 

Antimicrobials Exposure Assessment 

Task Force II (AEATF–II), describing 

proposed research to monitor the 

dermal and inhalation of workers while 

pouring liquid antimicrobial pesticide 

products from both conventional and 

reduced-splash containers. EPA requests 

the advice of the HSRB concerning 

whether, if it is revised as suggested in 

EPA’s review and if it is performed as 

described, this research is likely to 

generate scientifically reliable data, 

useful for assessing the exposure of 

those who pour liquid antimicrobial 

pesticide products from conventional 

and reduced-splash containers, and to 

meet the applicable requirements of 40 

CFR part 26, subparts K and L. 

b. A new scenario design and 

associated protocol from the 

Agricultural Handler Exposure Task 

Force (AHETF) describing proposed 

research to measure dermal and 

inhalation exposure to workers who 

load liquid pesticides with closed 

system equipment. EPA requests the 

advice of the HSRB concerning whether, 

if it is revised as suggested in EPA’s 

review and if it is performed as 

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Federal Register / Vol. 76, No. 187 / Tuesday, September 27, 2011 / Notices 59699 

described, this research is likely to 

generate scientifically reliable data, 

useful for assessing the exposure of 

those who load liquid pesticides with 

closed system equipment, and to meet 

the applicable requirements of 40 CFR 

part 26, subparts K and L. 

c. The unpublished report of the 

completed Carroll-Loye Biological 

Research, Inc. study No. Mas-003 to 

evaluate in the field the repellent 

efficacy against mosquitoes of a product 

containing 16% para-methane-3,8-diol 

and 2% lemongrass oil. The protocol for 

this study was reviewed favorably by 

the HSRB at their meeting in October 

2010. EPA seeks the advice of the HSRB 

on the scientific soundness of this 

completed study for use to estimate the 

duration of complete protection against 

mosquitoes provided by the tested 

repellent, and on whether available 

information supports a determination 

that the study was conducted in 

substantial compliance with subparts K 

and L of 40 CFR part 26. 

d. A published report by Moiemen et 

al. (2010) of an intentional exposure 

human study measuring dermal 

absorption of silver from the use of 

nanosilver-containing wound dressings 

to treat major burns. EPA seeks the 

advice of the HSRB on the scientific 

soundness of this completed study for 

use in support of an assessment of the 

absorption of nanosilver particles 

through the skin, and on whether there 

is adequate information to determine 

that the study was conducted in 

substantial compliance with procedures 

at least as protective as those in subparts 

A–L of EPA’s regulation at 40 CFR part 

26. 

2. Meeting minutes and reports. 

Minutes of the meeting, summarizing 

the matters discussed and 

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 http:// 

www.epa.gov/osa/hsrb/ and http:// 

www.regulations.gov. In addition, 

information regarding the Board’s Final 

meeting report, will be found at 

http://www.epa.gov/osa/hsrb/ or from 

the person listed under FOR FURTHER

INFORMATION CONTACT. 

Dated: September 21, 2011. 

Paul T. Anastas, 

EPA Science Advisor. 

[FR Doc. 2011–24816 Filed 9–26–11; 8:45 am] 

BILLING CODE 6560–50–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

[EPA–HQ–OPPT–2011–0793; FRL–8890–4] 

Receipt of Request for Waiver from 

Testing 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Notice. 

SUMMARY: Regulations issued by EPA 

under section 4 of the Toxic Substances 

Control Act require that specified 

chemical substances be tested to 

determine if they are contaminated with 

halogenated dibenzo-p-dioxins (HDDs) 

or halogenated dibenzofurans (HDFs), 

and that results be reported to EPA. 

However, the regulations allow for 

exclusion and waiver from these 

requirements if an appropriate 

application is submitted to EPA and is 

approved. EPA has received a request 

for a waiver from these testing 

requirements from 3M and will accept 

comments on this request. EPA will 

publish another Federal Register notice 

on or before November 14, 2011, 

announcing its decisions on this 

request. 

DATES: Comments must be received on 

or before October 11, 2011. 

ADDRESSES: Submit your comments, 

identified by docket identification (ID) 

number EPA–HQ–OPPT–2011–0793, by 

one of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the online 

instructions for submitting comments. 

• Mail: Document Control Office 

(7407M), Office of Pollution Prevention 

and Toxics (OPPT), Environmental 

Protection Agency, 1200 Pennsylvania 

Ave., NW., Washington, DC 20460– 

0001. 

• Hand Delivery: OPPT Document 

Control Office (DCO), EPA East Bldg., 

Rm. 6428, 1201 Constitution Ave., NW., 

Washington, DC. Attention: Docket ID 

Number EPA–HQ–OPPT–2011–0793. 

The DCO is open from 8 a.m. to 4 p.m., 

Monday through Friday, excluding legal 

holidays. The telephone number for the 

DCO is (202) 564–8930. Such deliveries 

are only accepted during the DCO’s 

normal hours of operation, and special 

arrangements should be made for 

deliveries of boxed information. 

Instructions: Direct your comments to 

docket ID number EPA–HQ–OPPT– 

2011–0793. EPA’s policy is that all 

comments received will be included in 

the docket without change and may be 

made available online at http:// 

www.regulations.gov, including any 

personal information provided, unless 

the comment includes information 

claimed to be Confidential Business 

Information (CBI) or other information 

whose disclosure is restricted by statute. 

Do not submit information that you 

consider to be CBI or otherwise 

protected through regulations.gov or email. The 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 e-mail comment directly 

to EPA without going through 

regulations.gov, your e-mail address 

will be automatically captured and 

included as part of the comment that is 

placed in the docket and made available 

on the Internet. If you submit an 

electronic comment, EPA recommends 

that you include your name and other 

contact information in the body of your 

comment and with any disk or CD–ROM 

you submit. If EPA cannot read your 

comment due to technical difficulties 

and cannot contact you for clarification, 

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. 

Docket: All documents in the docket 

are listed in the docket index available 

at http://www.regulations.gov. 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, 

is not placed on the Internet and will be 

publicly available only in hard copy 

form. Publicly available docket 

materials are available either in the 

electronic docket at http:// 

www.regulations.gov, or, if only 

available in hard copy, at the OPPT 

Docket. The OPPT Docket is located in 

the EPA Docket Center (EPA/DC) at Rm. 

3334, EPA West Bldg., 1301 

Constitution Ave., NW., Washington, 

DC. The EPA/DC Public Reading Room 

hours of operation are 8:30 a.m. to 4:30 

p.m., Monday through Friday, excluding 

legal holidays. The telephone number of 

the EPA/DC Public Reading Room is 

(202) 566–1744, and the telephone 

number for the OPPT Docket is (202) 

566–0280. Docket visitors are required 

to show photographic identification, 

pass through a metal detector, and sign 

the EPA visitor log. All visitor bags are 

processed through an X-ray machine 

and subject to search. Visitors will be 

provided an EPA/DC badge that must be 

visible at all times in the building and 

returned upon departure. 

FOR FURTHER INFORMATION CONTACT: For 

technical information contact: Rebecca 

Edelstein, National Program Chemicals 

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