270 Federal Register / Vol. 76, No. 2 / Tuesday, January 4, 2011 / Rules and Regulations 

i. American College of Radiology Imaging 

Network, Protocol Development & Regulatory 

Resources, ‘‘Informed Consent Template & 

Checklist,’’ available at: http://www.acrin.org/ 

Portals/0/Administration/Regulatory/ICF_

Template.doc, accessed July 8, 2010; 

j. National Cancer Institute, ‘‘Simplification 

of Informed Consent Documents,’’ available 

at: http://www.cancer.gov/clinicaltrials/ 

education/simplification-of-informedconsent-docs/allpages, accessed July 7, 2010. 

10. Institutional Review Board: 

Management and Function (edited by 

Bankert, E. A. and R. J. Amdur), 2d Ed., 2006 

(Chapter 6–1, The Institutional Review 

Board’s Role in Editing Consent Documents, 

Pensha, R. L., pp. 199–201 and Chapter 6–2, 

The Consent Documents, Brown, A., pp 202– 

204). 

11. Flesch-Kincaid Reading Scale 

Information, Rudolf Flesch, ‘‘A New 

Readability Yardstick,’’ Journal of Applied 

Psychology, vol. 32, pp. 221–233, 1948. 

12. FDA, Office of Planning, Risk 

Communication Staff, ANALYSIS NOTE: 

Note No. 2010–001, July 30, 2010. 

13. FDA: A Guide to Informed Consent— 

Information Sheet, available at: http://

www.fda.gov/RegulatoryInformation/

Guidances/ucm126431.htm#nonenglish, 

accessed August 8, 2010. 

14. NIH: ClinicalTrials.gov: Protocol 

Registration System: PRS and U.S. Public 

Law 110–85: ‘‘Applicable Clinical Trials,’’ 

available at: http://prsinfo.clinicaltrials.gov/

fdaaa.html and http://

prsinfo.clinicaltrials.gov/Elaborations

OnDefinitions.pdf, accessed August 8, 2010. 

15. ‘‘Guidance for Sponsors, Institutional 

Review Boards, Clinical Investigators and 

FDA Staff: Guidance on Informed Consent for 

In Vitro Diagnostic Device Studies Using 

Leftover Human Specimens That Are Not 

Individually Identifiable,’’ available at: http://

www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/ucm078384.htm, 

accessed August 8, 2010. 

16. NIH: ClinicalTrials.gov ‘‘Basic Results 

Data Element Definitions (DRAFT),’’ available 

at: http://prsinfo.clinicaltrials.gov/results_

definitions.html, accessed August 8, 2010. 

List of Subjects in 21 CFR Part 50 

Human research subjects, Prisoners, 

Reporting and recordkeeping 

requirements, Safety. 

■ Therefore, under the Federal Food, 

Drug, and Cosmetic Act, the Public 

Health Service Act, and under authority 

delegated to the Commissioner of Food 

and Drugs, 21 CFR part 50 is amended 

as follows: 

PART 50—PROTECTION OF HUMAN 

SUBJECTS 

■ 1. The authority citation for 21 CFR 

part 50 continues to read as follows: 

Authority: 21 U.S.C. 321, 343, 346, 346a, 

348, 350a, 350b, 352, 353, 355, 360, 360c360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 

216, 241, 262, 263b-263n. 

■ 2. Section 50.25 is amended by 

redesignating paragraphs (c) and (d) as 

paragraphs (d) and (e), and by adding 

new paragraph (c) to read as follows: 

§ 50.25 Elements of informed consent. 

* * * * * 

(c) When seeking informed consent 

for applicable clinical trials, as defined 

in 42 U.S.C. 282(j)(1)(A), the following 

statement shall be provided to each 

clinical trial subject in informed consent 

documents and processes. This will 

notify the clinical trial subject that 

clinical trial information has been or 

will be submitted for inclusion in the 

clinical trial registry databank under 

paragraph (j) of section 402 of the Public 

Health Service Act. The statement is: ‘‘A 

description of this clinical trial will be 

available on http://

www.ClinicalTrials.gov, as required by 

U.S. Law. This Web site will not include 

information that can identify you. At 

most, the Web site will include a 

summary of the results. You can search 

this Web site at any time.’’ 

* * * * * 

Dated: December 28, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–33193 Filed 1–3–11; 8:45 am] 

BILLING CODE 4160–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 239 and 258 

[EPA–R10–RCRA–2010–0953; FRL–9247–6] 

Alaska: Adequacy of Alaska Municipal 

Solid Waste Landfill Permit Program 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: This action approves a 

modification to Alaska’s approved 

Municipal Solid Waste Landfill 

(MSWLF) permit program. The 

approved modification allows the State 

to issue Research, Development, and 

Demonstration (RD&D) permits to 

owners and operators of MSWLFs in 

accordance with its State law. On March 

22, 2004, EPA issued final regulations 

allowing RD&D permits to be issued to 

certain MSWLFs by approved States. On 

September 7, 2010, the State of Alaska 

submitted an application to EPA Region 

10 seeking Federal approval of its RD&D 

requirements. After thorough review, 

EPA Region 10 has determined that 

Alaska’s RD&D permit requirements are 

adequate through this direct final 

action. 

DATES: This direct final rule will 

become effective March 7, 2011 without 

further notice unless EPA receives 

adverse comments on or before February 

3, 2011. If adverse comments are 

received, EPA will publish a timely 

withdrawal of this direct final rule in 

the Federal Register informing the 

public that the rule will not take effect. 

EPA will then review the comments and 

then will publish a final rule in the 

Federal Register responding to the 

comments and affirming or revising its 

initial decision. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R10– 

RCRA–2010–0953, by one of the 

following methods: 

• http://www.regulations.gov: Follow 

the on-line instructions for submitting 

comments. 

• E-mail: calabro.domenic@epa.gov. 

• Fax: (206) 553–8509, to the 

attention of Domenic Calabro. 

• Mail: Domenic Calabro, Office of 

Air, Waste and Toxics, U.S. EPA, Region 

10, 1200 Sixth Avenue, Suite 900, 

Mailstop: AWT–122, Seattle, WA 98101. 

• Hand Delivery or Courier: Deliver 

your comments to Domenic Calabro, 

Office of Air, Waste and Toxics, U.S. 

EPA, Region 10, 1200 Sixth Avenue, 

Suite 900, Mailstop: AWT–122, Seattle, 

WA 98101. Such deliveries are only 

accepted during the Office’s normal 

hours of operation. 

Instructions: Identify your comments 

as relating to Docket ID No. EPA–R10– 

RCRA–2010–0953. 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 claimed to be other 

information whose disclosure 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 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
Federal Register / Vol. 76, No. 2 / Tuesday, January 4, 2011 / Rules and Regulations 271 

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. For additional information 

about EPA’s public docket visit the EPA 

Docket Center homepage at http://

www.epa.gov/epahome/dockets.htm. 

Docket: EPA has established a docket 

for this action under Docket ID No. 

EPA–R10–RCRA–2010–0953. All 

documents in the docket are listed on 

the http://www.regulations.gov Web 

site. Although it may be listed in the 

index, some information might not be 

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 

electronically through http://

www.regulations.gov or in hard copy at 

the U.S. Region 10 Library, 1200 Sixth 

Avenue, Seattle, WA 98101 by 

appointment only; telephone: (206) 

553–1289. 

FOR FURTHER INFORMATION CONTACT: 

Domenic Calabro, Office of Air, Waste 

and Toxics, U.S. EPA, Region 10, 1200 

Sixth Avenue, Suite 900, Mailstop: 

AWT–122, Seattle, WA 98101, 

telephone: (206) 553–6640, 

calabro.domenic@epa.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On March 22, 2004, EPA issued a 

final rule (69 FR 13242) amending the 

Municipal Solid Waste Landfill 

(MSWLF) criteria in 40 CFR part 258 to 

allow for Research, Development and 

Demonstration (RD&D) permits (69 FR 

13242). That rule allows for variances 

from specified criteria for a limited 

period of time, to be implemented 

through State-issued RD&D permits. 

RD&D permits are available only in 

States with approved MSWLF permit 

programs that have been modified to 

incorporate RD&D permit authority. 

While States are not required to seek 

approval to allow permits under this 

new provision, those States that are 

interested in providing RD&D permits to 

owners and operators of MSWLFs must 

seek approval from EPA before issuing 

such permits. Approval procedures for 

new provisions of 40 CFR Part 258 are 

outlined in 40 CFR 239.12. 

On March 15, 2000, EPA published a 

final rule (65 FR 453) approving the 

State of Alaska’s MSWLF permit 

program. On September 7, 2010, Alaska 

applied for approval of its RD&D permit 

provisions which are included as part of 

a broader revision package and is 

codified as 18 AAC 60.213. The final 

package was adopted by the ADEC, 

signed and officially filed by the Lt. 

Governor, and took effect on September 

5, 2010. 

II. Decision 

After a thorough review of Alaska’s 

revision package, EPA has determined 

that the Alaska Research, Development 

and Demonstration (RD&D) permit 

provisions as set out in 18 AAC 60.213 

are adequate to comply with the Federal 

criteria as set out in 40 CFR 258.4. The 

State regulations regarding RD&D 

permits incorporate by reference all of 

the requirements of 40 CFR 258.4, while 

specifying particular requirements 

which are either equivalent to or more 

stringent than the requirements of 40 

CFR 258.4. 

III. Statutory and Executive Order 

Reviews 

This action approves State solid waste 

requirements pursuant to Resource 

Conversation and Recovery Act (RCRA) 

Section 4005 and imposes no Federal 

requirements. Therefore, this rule 

complies with applicable executive 

orders and statutory provisions as 

follows: 

1. Executive Order 12866 

This action is not a ‘‘significant 

regulatory action’’ under the terms of 

Executive Order (EO) 12866 (58 FR 

51735, October 4, 1993) and is therefore 

not subject to review under the EO. 

2. Paperwork Reduction Act 

This action does not impose an 

information collection burden under the 

provisions of the Paperwork Reduction 

Act, 44 U.S.C. 3501 et seq. Burden is 

defined at 5 CFR 1320.3(b). This direct 

final rule does not establish or modify 

any information or recordkeeping 

requirements for the regulated 

community. EPA has determined that it 

is not subject to the provisions of the 

Paperwork Reduction Act. 

3. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA), 

as amended by the Small Business 

Regulatory Enforcement Fairness Act 

(SBREFA), 5 U.S.C. 601 et seq., 

generally requires Federal agencies to 

prepare a regulatory flexibility analysis 

of any rule subject to notice and 

comment rulemaking requirements 

under the Administrative Procedure Act 

or any other statute unless the agency 

certifies that the rule will not have a 

significant economic impact on a 

substantial number of small entities. 

Small entities include small businesses, 

small organizations, and small 

governmental jurisdictions. For 

purposes of assessing the impacts of this 

direct final rule on small entities, small 

entity is defined as: (1) A small 

business, as codified in the Small 

Business Size Regulations at 13 CFR 

part 121; (2) a small governmental 

jurisdiction that is a government of a 

city, county, town, school district or 

special district with a population of less 

than 50,000; and (3) a small 

organization that is any not-for-profit 

enterprise which is independently 

owned and operated and is not 

dominant in its field. EPA has 

determined that this direct final action 

will not have a significant impact on 

small entities because the action will 

only have the effect of modifying preexisting authorized requirements under 

State law. I certify that this action will 

not have a significant economic impact 

on a substantial number of small 

entities. 

4. Unfunded Mandates Reform Act 

This action contains no Federal 

mandates under the provisions of Title 

II of the Unfunded Mandates Reform 

Act of 1995 (UMRA), 2 U.S.C. 1531– 

1538 for State, local, or Tribal 

governments or the private sector. This 

action imposes no new enforceable duty 

on any State, local or Tribal 

governments or the private sector. This 

action contains no regulatory 

requirements that might significantly or 

uniquely affect small government 

entities. Thus, EPA has determined that 

the requirements of section 203 of the 

UMRA do not apply to this action. 

5. Executive Order 13132: Federalism 

This action addresses a modification 

to Alaska’s approved MSWLF permit 

program, which has been modified by 

State law to incorporate RD&D 

permitting authority. There are no 

substantial direct effects on the States, 

on the relationship between Federal and 

State governments, or on the 

distribution of power between among 

the various levels of government, as 

specified in Executive Order 13132. 

Therefore, Executive Order 13132 does 

not apply to this action. 

6. Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

This action does not have Tribal 

implications, as specified in Executive 

Order 13175. This action addresses a 

modification to Alaska’s approved 


wwoods2 on DSK1DXX6B1PROD with RULES_PART 1
272 Federal Register / Vol. 76, No. 2 / Tuesday, January 4, 2011 / Rules and Regulations 

MSWLF permit program, which has 

been modified by State law to 

incorporate RD&D permitting authority. 

Thus, EPA has determined that 

Executive Order 13175 does not apply 

to this rule. 

7. Executive Order 13045: Protection of 

Children From Environmental Health 

and Safety Risks 

This action is not subject to Executive 

Order 13045 because it is not 

economically significant and it is not 

based on health or safety risks. 

8. Executive Order 13211: Actions That 

Significantly Affect Energy Supply, 

Distribution, or Use 

This action is not subject to Executive 

Order 13211 (66 FR 28355, May 22, 

2001), because it is not a ‘‘significant 

regulatory action’’ as defined under 

Executive Order 12866. 

9. National Technology Transfer and 

Advancement Act 

Section 12(d) of the National 

Technology Transfer and Advancement 

Act of 1995 (‘‘NTTAA’’), Public Law 

104–113, section 12(d) (15 U.S.C. 272) 

directs EPA to use voluntary consensus 

standards bodies in its regulatory 

activities unless to do so would be 

inconsistent with applicable law or 

otherwise impractical. Voluntary 

consensus standards are technical 

standards (e.g., materials specifications, 

test methods, sampling procedures, and 

business practices) that are developed or 

adopted by voluntary consensus bodies. 

The NTTAA directs EPA to provide 

Congress, through the OMB, 

explanations when the Agency decides 

not to use available and applicable 

voluntary consensus standards. EPA has 

determined that this action does not 

involve ‘‘technical standards’’ as defined 

by the NTTAA. Therefore EPA is not 

considering the use of any voluntary 

consensus standards. 

10. Executive Order 12898: Federal 

Actions To Address Environmental 

Justice in Minority Populations and 

Low-Income Populations 

Executive Order (EO) 12898 (59 FR 

7629 (Feb. 16, 1994)) establishes Federal 

executive policy on environmental 

justice. Its main provision directs 

Federal agencies, to the greatest extent 

practicable and permitted by law, to 

make environmental justice part of their 

mission by identifying and addressing, 

as appropriate, disproportionately high 

and adverse human health or 

environmental effects of their programs, 

policies, and activities on minority 

populations and low-income 

populations in the United States. 

EPA has determined that this action 

will not have disproportionately high 

and adverse human health or 

environmental effects on minority or 

low-income populations because it does 

not affect the level of protection 

provided to human health or the 

environment. This action addresses a 

modification to Alaska’s approved 

MSWLF permit program, which has 

been modified by State law to 

incorporate RD&D permitting authority. 

EPA has determined that the action is 

not subject to Executive Order 12898. 

11. Congressional Review Act 

The Congressional Review Act, 5 

U.S.C. 801 et seq., as amended by the 

Small Business Regulatory Enforcement 

Fairness Act of 1996, generally provides 

that before a rule may take effect, the 

agency promulgating the rule must 

submit a rule report, which includes a 

copy of the rule, to each House of the 

Congress and to the Comptroller General 

of the United States. EPA will submit a 

report containing this document and 

other required information to the U.S. 

Senate, the U.S. House of 

Representatives, and the Comptroller 

General of the United States prior to 

publication in the Federal Register. A 

major rule cannot take effect until 60 

days after it is published in the Federal 

Register. This action is not a ‘‘major 

rule’’ as defined by 5 U.S.C. 804(2). This 

action will be effective March 7, 2011. 

List of Subjects 

40 CFR Part 239 

Environmental protection, 

Administrative practice and procedure, 

Intergovernmental relations, Waste 

treatment and disposal. 

40 CFR Part 258 

Reporting and recordkeeping 

requirements, Waste treatment disposal, 

Water pollution control. 

Authority: This action is issued under the 

authority of section 2002, 4005 and 4010(c) 

of the Solid Waste Disposal Act, as amended, 

42 U.S.C. 6912, 6945 and 6949(a). 

Dated: December 22, 2010. 

Dennis J. McLerran, 

Regional Administrator, EPA Region 10. 

[FR Doc. 2010–33196 Filed 1–3–11; 8:45 am] 

BILLING CODE 6560–50–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Federal Emergency Management 

Agency 

44 CFR Part 67 

[Docket ID FEMA–2010–0003] 

Final Flood Elevation Determinations 

AGENCY: Federal Emergency 

Management Agency, DHS. 

ACTION: Final rule. 

SUMMARY: Base (1% annual-chance) 

Flood Elevations (BFEs) and modified 

BFEs are made final for the 

communities listed below. The BFEs 

and modified BFEs are the basis for the 

floodplain management measures that 

each community is required either to 

adopt or to show evidence of being 

already in effect in order to qualify or 

remain qualified for participation in the 

National Flood Insurance Program 

(NFIP). 

DATES: The date of issuance of the Flood 

Insurance Rate Map (FIRM) showing 

BFEs and modified BFEs for each 

community. This date may be obtained 

by contacting the office where the maps 

are available for inspection as indicated 

in the table below. 

ADDRESSES: The final BFEs for each 

community are available for inspection 

at the office of the Chief Executive 

Officer of each community. The 

respective addresses are listed in the 

table below. 

FOR FURTHER INFORMATION CONTACT: Luis 

Rodriguez, Chief, Engineering 

Management Branch, Federal Insurance 

and Mitigation Administration, Federal 

Emergency Management Agency, 500 C 

Street, SW., Washington, DC 20472, 

(202) 646–4064, or (e-mail) 

luis.rodriguez1@dhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Federal Emergency Management Agency 

(FEMA) makes the final determinations 

listed below for the modified BFEs for 

each community listed. These modified 

elevations have been published in 

newspapers of local circulation and 

ninety (90) days have elapsed since that 

publication. The Deputy Federal 

Insurance and Mitigation Administrator 

has resolved any appeals resulting from 

this notification. 

This final rule is issued in accordance 

with section 110 of the Flood Disaster 

Protection Act of 1973, 42 U.S.C. 4104, 

and 44 CFR part 67. FEMA has 

developed criteria for floodplain 

management in flood prone areas in 

accordance with 44 CFR part 60. 


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