79174 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–9062–N] 

Medicare and Medicaid Programs; 

Quarterly Listing of Program 

Issuances—July Through September 

2010 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice lists CMS manual 

instructions, substantive and 

interpretive regulations, and other 

Federal Register notices that were 

published from July through September 

2010, relating to the Medicare and 

Medicaid programs. This notice 

provides information on national 

coverage determinations (NCDs) 

affecting specific medical and health 

care services under Medicare. 

Additionally, this notice identifies 

certain devices with investigational 

device exemption (IDE) numbers 

approved by the Food and Drug 

Administration (FDA) that potentially 

may be covered under Medicare. This 

notice also includes listings of all 

approval numbers from the Office of 

Management and Budget for collections 

of information in CMS regulations and 

a list of Medicare-approved carotid stent 

facilities. Included in this notice is a list 

of the American College of Cardiology’s 

National Cardiovascular Data registry 

sites, active CMS coverage-related 

guidance documents, and special onetime notices regarding national coverage 

provisions. Also included in this notice 

is a list of National Oncologic Positron 

Emissions Tomography Registry sites, a 

list of Medicare-approved ventricular 

assist device (destination therapy) 

facilities, a list of Medicare-approved 

lung volume reduction surgery facilities, 

a list of Medicare-approved clinical 

trials for fluorodeoxyglucose positron 

emissions tomography for dementia, 

and a list of Medicare-approved 

bariatric surgery facilities. 

Section 1871(c) of the Social Security 

Act requires that we publish a list of 

Medicare issuances in the Federal 

Register at least every 3 months. 

Although we are not mandated to do so 

by statute, for the sake of completeness 

of the listing, and to foster more open 

and transparent collaboration efforts, we 

are also including all Medicaid 

issuances and Medicaid substantive and 

interpretive regulations (proposed and 

final) published during this 3-month 

timeframe. 

FOR FURTHER INFORMATION CONTACT: It is 

possible that an interested party may 

need specific information and not be 

able to determine from the listed 

information whether the issuance or 

regulation would fulfill that need. 

Consequently, we are providing contact 

persons to answer general questions 

concerning these items. Copies are not 

available through the contact persons. 

(See Section III of this notice for how to 

obtain listed material.) 

Questions concerning CMS manual 

instructions in Addendum III may be 

addressed to Ismael Torres, Office of 

Strategic Operations and Regulatory 

Affairs, Centers for Medicare & 

Medicaid Services, C4–26–05, 7500 

Security Boulevard, Baltimore, MD 

21244–1850, or you can call (410) 786– 

1864. 

Questions concerning regulation 

documents published in the Federal 

Register in Addendum IV may be 

addressed to Terri Plumb, Office of 

Strategic Operations and Regulatory 

Affairs, Centers for Medicare & 

Medicaid Services, C4–26–05, 7500 

Security Boulevard, Baltimore, MD 

21244–1850, or you can call (410) 786– 

4481. 

Questions concerning Medicare NCDs 

in Addendum V may be addressed to 

Patricia Brocato-Simons, Office of 

Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services, C1– 

09–06, 7500 Security Boulevard, 

Baltimore, MD 21244–1850, or you can 

call (410) 786–0261. 

Questions concerning FDA-approved 

Category B IDE numbers listed in 

Addendum VI may be addressed to John 

Manlove, Office of Clinical Standards 

and Quality, Centers for Medicare & 

Medicaid Services, C1–13–04, 7500 

Security Boulevard, Baltimore, MD 

21244–1850, or you can call (410) 786– 

6877. 

Questions concerning approval 

numbers for collections of information 

in Addendum VII may be addressed to 

Eulanda Grigg, Office of Strategic 

Operations and Regulatory Affairs, 

Regulations Development and Issuances 

Group, Centers for Medicare & Medicaid 

Services, C5–11–16, 7500 Security 

Boulevard, Baltimore, MD 21244–1850, 

or you can call (410) 786–7202. 

Questions concerning Medicareapproved carotid stent facilities in 

Addendum VIII may be addressed to 

Sarah J. McClain, Office of Clinical 

Standards and Quality, Centers for 

Medicare & Medicaid Services, C1–09– 

06, 7500 Security Boulevard, Baltimore, 

MD 21244–1850, or you can call (410) 

786–2994. 

Questions concerning Medicare’s 

recognition of the American College of 

Cardiology-National Cardiovascular 

Data Registry sites in Addendum IX may 

be addressed to JoAnna Baldwin, MS, 

Office of Clinical Standards and 

Quality, Centers for Medicare & 

Medicaid Services, C1–09–06, 7500 

Security Boulevard, Baltimore, MD 

21244–1850, or you can call (410) 786– 

7205. 

Questions concerning Medicare’s 

active coverage-related guidance 

documents in Addendum X may be 

addressed to Beverly Lofton, Office of 

Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services, C1– 

09–06, 7500 Security Boulevard, 

Baltimore, MD 21244–1850, or you can 

call (410) 786–7136. 

Questions concerning one-time 

notices regarding national coverage 

provisions in Addendum XI may be 

addressed to Beverly Lofton, Office of 

Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services, C1– 

09–06, 7500 Security Boulevard, 

Baltimore, MD 21244–1850, or you can 

call (410) 786–7136. 

Questions concerning National 

Oncologic Positron Emission 

Tomography Registry sites in 

Addendum XII may be addressed to 

Stuart Caplan, RN, MAS, Office of 

Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services, C1– 

09–06, 7500 Security Boulevard, 

Baltimore, MD 21244–1850, or you can 

call (410) 786–8564. 

Questions concerning Medicareapproved ventricular assist device 

(destination therapy) facilities in 

Addendum XIII may be addressed to 

JoAnna Baldwin, MS, Office of Clinical 

Standards and Quality, Centers for 

Medicare & Medicaid Services, C1–09– 

06, 7500 Security Boulevard, Baltimore, 

MD 21244–1850, or you can call (410) 

786–7205. 

Questions concerning Medicareapproved lung volume reduction 

surgery facilities listed in Addendum 

XIV may be addressed to JoAnna 

Baldwin, MS, Office of Clinical 

Standards and Quality, Centers for 

Medicare & Medicaid Services, C1–09– 

06, 7500 Security Boulevard, Baltimore, 

MD 21244–1850, or you can call (410) 

786–7205. 

Questions concerning Medicareapproved bariatric surgery facilities 

listed in Addendum XV may be 

addressed to Kate Tillman, RN, MA, 

Office of Clinical Standards and 

Quality, Centers for Medicare & 

Medicaid Services, C1–09–06, 7500 

Security Boulevard, Baltimore, MD 

21244–1850, or you can call (410) 786– 

9252. 

Questions concerning 

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tomography for dementia trials listed in 

Addendum XVI may be addressed to 

Stuart Caplan, RN, MAS, Office of 

Clinical Standards and Quality, Centers 

for Medicare & Medicaid Services, C1– 

09–06, 7500 Security Boulevard, 

Baltimore, MD 21244–1850, or you can 

call (410) 786–8564. 

Questions concerning all other 

information may be addressed to 

Annette Brewer, Office of Strategic 

Operations and Regulatory Affairs, 

Regulations Development Group, 

Centers for Medicare & Medicaid 

Services, C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850, 

or you can call (410) 786–6580. 

SUPPLEMENTARY INFORMATION: 

I. Program Issuances 

The Centers for Medicare & Medicaid 

Services (CMS) is responsible for 

administering the Medicare and 

Medicaid programs. These programs pay 

for health care and related services for 

39 million Medicare beneficiaries and 

35 million Medicaid recipients. 

Administration of the two programs 

involves the following: (1) Furnishing 

information to Medicare beneficiaries 

and Medicaid recipients, health care 

providers, and the public; and (2) 

maintaining effective communications 

with regional offices, State governments, 

State Medicaid agencies, State survey 

agencies, various providers of health 

care, all Medicare contractors that 

process claims and pay bills, and others. 

To implement the various statutes on 

which the programs are based, we issue 

regulations under the authority granted 

to the Secretary of the Department of 

Health and Human Services under 

sections 1102, 1871, 1902, and related 

provisions of the Social Security Act 

(the Act). We also issue various 

manuals, memoranda, and statements 

necessary to administer the programs 

efficiently. 

Section 1871(c)(1) of the Act requires 

that we publish a list of all Medicare 

manual instructions, interpretive rules, 

statements of policy, and guidelines of 

general applicability not issued as 

regulations at least every 3 months in 

the Federal Register. We published our 

first notice June 9, 1988 (53 FR 21730). 

Although we are not mandated to do so 

by statute, for the sake of completeness 

of the listing of operational and policy 

statements, and to foster more open and 

transparent collaboration, we are 

continuing our practice of including 

Medicare substantive and interpretive 

regulations (proposed and final) 

published during the respective 3- 

month time frame. 

II. How To Use the Addenda 

This notice is organized so that a 

reader may review the subjects of 

manual issuances, memoranda, 

substantive and interpretive regulations, 

national coverage determinations (NCD), 

and FDA-approved investigational 

device exemptions (IDE) published 

during the subject quarter to determine 

whether any are of particular interest. 

We expect this notice to be used in 

concert with previously published 

notices. Those unfamiliar with a 

description of our Medicare manuals 

may wish to review Table I of our first 

three notices (53 FR 21730, 53 FR 

36891, and 53 FR 50577) published in 

1988, and the notice published March 

31, 1993 (58 FR 16837). Those desiring 

information on the Medicare NCD 

Manual (NCDM, formerly the Medicare 

Coverage Issues Manual (CIM)) may 

wish to review the August 21, 1989, 

publication (54 FR 34555). Those 

interested in the revised process used in 

making NCDs under the Medicare 

program may review the September 26, 

2003, publication (68 FR 55634). 

To aid the reader, we have organized 

and divided this current listing into 11 

addenda: 

• Addendum I lists the publication 

dates of the most recent quarterly 

listings of program issuances. 

• Addendum II identifies previous 

Federal Register documents that 

contain a description of all previously 

published CMS Medicare and Medicaid 

manuals and memoranda. 

• Addendum III lists a unique CMS 

transmittal number for each instruction 

in our manuals or Program Memoranda 

and its subject matter. A transmittal may 

consist of a single or multiple 

instruction(s). Often, it is necessary to 

use information in a transmittal in 

conjunction with information currently 

in the manuals. 

• Addendum IV lists all substantive 

and interpretive Medicare and Medicaid 

regulations and general notices 

published in the Federal Register 

during the quarter covered by this 

notice. For each item, we list the 

following: 

++ Date published; 

++ Federal Register citation; 

++ Parts of the Code of Federal 

Regulations (CFR) that have changed (if 

applicable); 

++ Agency file code number; and 

++ Title of the regulation. 

• Addendum V includes completed 

NCDs, or reconsiderations of completed 

NCDs, from the quarter covered by this 

notice. Completed decisions are 

identified by the section of the NCDM 

in which the decision appears, the title, 

the date the publication was issued, and 

the effective date of the decision. 

• Addendum VI includes listings of 

the FDA-approved IDE categorizations, 

using the IDE numbers the FDA assigns. 

The listings are organized according to 

the categories to which the device 

numbers are assigned (that is, Category 

A or Category B), and identified by the 

IDE number. 

• Addendum VII includes listings of 

all approval numbers from the Office of 

Management and Budget (OMB) for 

collections of information in CMS 

regulations in title 42; title 45, 

subchapter C; and title 20 of the CFR. 

• Addendum VIII includes listings of 

Medicare-approved carotid stent 

facilities. All facilities listed meet CMS 

standards for performing carotid artery 

stenting for high risk patients. 

• Addendum IX includes a list of the 

American College of Cardiology’s 

National Cardiovascular Data registry 

sites. We cover implantable cardioverter 

defibrillators (ICDs) for certain 

indications, as long as information 

about the procedures is reported to a 

central registry. 

• Addendum X includes a list of 

active CMS guidance documents. As 

required by section 731 of the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) (Pub. 

L. 108–173, enacted on December 8, 

2003), we will begin listing the current 

versions of our guidance documents in 

each quarterly listings notice. 

• Addendum XI includes a list of 

special one-time notices regarding 

national coverage provisions. We are 

publishing a list of issues that require 

public notification, such as a particular 

clinical trial or research study that 

qualifies for Medicare coverage. 

• Addendum XII includes a listing of 

National Oncologic Positron Emission 

Tomography Registry (NOPR) sites. We 

cover positron emission tomography 

(PET) scans for particular oncologic 

indications when they are performed in 

a facility that participates in the NOPR. 

• Addendum XIII includes a listing of 

Medicare-approved facilities that 

receive coverage for ventricular assist 

devices used as destination therapy. All 

facilities were required to meet our 

standards in order to receive coverage 

for ventricular assist devices implanted 

as destination therapy. 

• Addendum XIV includes a listing of 

Medicare-approved facilities that are 

eligible to receive coverage for lung 

volume reduction surgery. Until May 

17, 2007, facilities that participated in 

the National Emphysema Treatment 

Trial are also eligible to receive 

coverage. 


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• Addendum XV includes a listing of 

Medicare-approved facilities that meet 

minimum standards for facilities 

modeled in part on professional society 

statements on competency. All facilities 

must meet our standards in order to 

receive coverage for bariatric surgery 

procedures. 

• Addendum XVI includes a listing of 

Medicare-approved clinical trials for 

fluorodeoxyglucose positron emission 

tomography (FDG–PET) for dementia 

and neurodegenerative diseases. 

III. How To Obtain Listed Material 

A. Manuals 

Those wishing to subscribe to 

program manuals should contact either 

the Government Printing Office (GPO) 

or the National Technical Information 

Service (NTIS) at the following 

addresses: Superintendent of 

Documents, Government Printing 

Office, ATTN: New Orders, P.O. Box 

371954, Pittsburgh, PA 15250–7954, 

Telephone (202) 512–1800, Fax number 

(202) 512–2250 (for credit card orders); 

or National Technical Information 

Service, Department of Commerce, 5825 

Port Royal Road, Springfield, VA 22161, 

Telephone (703) 487–4630. 

In addition, individual manual 

transmittals and Program Memoranda 

listed in this notice can be purchased 

from NTIS. Interested parties should 

identify the transmittal(s) they want. 

GPO or NTIS can give complete details 

on how to obtain the publications they 

sell. Additionally, most manuals are 

available at the following Internet 

address: http://cms.hhs.gov/manuals/

default.asp. 

B. Regulations and Notices 

Regulations and notices are published 

in the daily Federal Register. Interested 

individuals may purchase individual 

copies or subscribe to the Federal 

Register by contacting the GPO at the 

address given above. When ordering 

individual copies, it is necessary to cite 

either the date of publication or the 

volume number and page number. 

The Federal Register is also available 

on 24x microfiche and as an online 

database through GPO Access. The 

online database is updated by 6 a.m. 

each day the Federal Register is 

published. The database includes both 

text and graphics from Volume 59, 

Number 1 (January 2, 1994) forward. 

Free public access is available on a 

Wide Area Information Server (WAIS) 

through the Internet and via 

asynchronous dial-in. Internet users can 

access the database by using the World 

Wide Web; the Superintendent of 

Documents home page address is http:// 

www.–gpoaccess.–gov/–fr/–index.–html, 

by using local WAIS client software, or 

by telnet to swais.gpoaccess.gov, then 

log in as guest (no password required). 

Dial-in users should use 

communications software and modem 

to call (202) 512–1661; type swais, then 

log in as guest (no password required). 

C. Rulings 

We publish rulings on an infrequent 

basis. CMS Rulings are decisions of the 

Administrator that serve as precedent 

final opinions and orders and 

statements of policy and interpretation. 

CMS Rulings provide clarification and 

interpretation of complex or ambiguous 

provisions of the law or regulations 

relating to Medicare, Medicaid, 

Utilization and Quality Control Peer 

Review, private health insurance, and 

related matters. Interested individuals 

can obtain copies from the nearest CMS 

Regional Office or review them at the 

nearest regional depository library. On 

occasion, we publish rulings in the 

Federal Register. Rulings, beginning 

with those released in 1995, are 

available online, through the CMS 

Home Page. The Internet address is 

http://www.cms.hhs.gov/rulings. 

D. CMS’ Compact Disk-Read Only 

Memory (CD–ROM) 

Our laws, regulations, and manuals 

are also available on CD–ROM and may 

be purchased from GPO or NTIS on a 

subscription or single copy basis. The 

Superintendent of Documents list ID is 

HCLRM, and the stock number is 717– 

139–00000–3. The following material is 

on the CD–ROM disk: 

• Titles XI, XVIII, and XIX of the Act. 

• CMS-related regulations. 

• CMS manuals and monthly 

revisions. 

• CMS program memoranda. 

The titles of the Compilation of the 

Social Security Laws are current as of 

January 1, 2005. (Updated titles of the 

Social Security Laws are available on 

the Internet at http://www.ssa.gov/OP_

Home/ssact/comp-toc.htm.) The 

remaining portions of CD–ROM are 

updated on a monthly basis. 

Because of complaints about the 

unreadability of the Appendices 

(Interpretive Guidelines) in the State 

Operations Manual (SOM), as of March 

1995, we deleted these appendices from 

CD–ROM. We intend to re-visit this 

issue in the near future and, with the 

aid of newer technology, we may again 

be able to include the appendices on 

CD–ROM. 

Any cost report forms incorporated in 

the manuals are included on the CD– 

ROM disk as LOTUS files. LOTUS 

software is needed to view the reports 

once the files have been copied to a 

personal computer disk. 

IV. How To Review Listed Material 

Transmittals or Program Memoranda 

can be reviewed at a local Federal 

Depository Library (FDL). Under the 

FDL program, government publications 

are sent to approximately 1,400 

designated libraries throughout the 

United States. Some FDLs may have 

arrangements to transfer material to a 

local library not designated as an FDL. 

Contact any library to locate the nearest 

FDL. 

In addition, individuals may contact 

regional depository libraries that receive 

and retain at least one copy of most 

Federal Government publications, either 

in printed or microfilm form, for use by 

the general public. These libraries 

provide reference services and 

interlibrary loans; however, they are not 

sales outlets. Individuals may obtain 

information about the location of the 

nearest regional depository library from 

any library. 

For each CMS publication listed in 

Addendum III, CMS publication and 

transmittal numbers are shown. To help 

FDLs locate the materials, use the CMS 

publication and transmittal numbers. 

For example, to find the Medicare 

National Coverage Determination 

publication titled ‘‘Positron Emission 

Tomography (FDG PET) for Initial 

Treatment Strategy (PI) in Solid Tumors 

and Myeloma,’’ use CMS–Pub. 100–03, 

Transmittal No. 124. 

Authority: (Catalog of Federal Domestic 

Assistance Program No. 93.773, Medicare— 

Hospital Insurance, Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program, and Program No. 93.714, 

Medical Assistance Program) 

Dated: December 10, 2010. 

Jacquelyn Y. White, 

Director, Office of Strategic Operations and 

Regulatory Affairs. 

BILLING CODE 4120–01–P 


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srobinson on DSKHWCL6B1PROD with NOTICES2EN17DE10.066</GPH>
Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79223 


srobinson on DSKHWCL6B1PROD with NOTICES2EN17DE10.067</GPH>
79224 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


srobinson on DSKHWCL6B1PROD with NOTICES2EN17DE10.068</GPH>
Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79225 


srobinson on DSKHWCL6B1PROD with NOTICES2EN17DE10.069</GPH>
79226 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79227 


srobinson on DSKHWCL6B1PROD with NOTICES2EN17DE10.071</GPH>
79228 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


srobinson on DSKHWCL6B1PROD with NOTICES2EN17DE10.072</GPH>
Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79229 


srobinson on DSKHWCL6B1PROD with NOTICES2EN17DE10.073</GPH>
79230 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79231 


srobinson on DSKHWCL6B1PROD with NOTICES2EN17DE10.075</GPH>
79232 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79233 


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79234 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79235 


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79236 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79237 


srobinson on DSKHWCL6B1PROD with NOTICES2EN17DE10.081</GPH>
79238 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79239 


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79240 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79241 


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79242 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79243 


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79244 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79245 


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79246 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79247 


srobinson on DSKHWCL6B1PROD with NOTICES2EN17DE10.091</GPH>
79248 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79249 


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79250 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79251 


srobinson on DSKHWCL6B1PROD with NOTICES2EN17DE10.095</GPH>
79252 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79253 


srobinson on DSKHWCL6B1PROD with NOTICES2EN17DE10.097</GPH>
79254 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79255 


srobinson on DSKHWCL6B1PROD with NOTICES2EN17DE10.099</GPH>
79256 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79257 


srobinson on DSKHWCL6B1PROD with NOTICES2EN17DE10.101</GPH>
79258 Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 


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Federal Register / Vol. 75, No. 242 / Friday, December 17, 2010 / Notices 79259 

[FR Doc. 2010–31543 Filed 12–16–10; 8:45 am] 

BILLING CODE 4120–01–C 


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