16422 Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Notices 

License Number: 015590N. 

Name: Express Global Freight, Inc. 

Address: 20311 Valley Blvd., Walnut, 

CA 91789. 

Date Revoked: February 19, 2011. 

Reason: Failed to maintain a valid 

bond. 

License Number: 015847N. 

Name: Straightline Logistics, Inc. 

Address: One Cross Island Plaza, 

Suite 210, Rosedale, NY 11422. 

Date Revoked: February 13, 2011. 

Reason: Failed to maintain a valid 

bond. 

License Number: 017279F. 

Name: Unicom Trans, Inc. 

Address: 15500 S. Western Avenue, 

Gardena, CA 90249. 

Date Revoked: February 23, 2011. 

Reason: Failed to maintain a valid 

bond. 

License Number: 017330N. 

Name: Geomarine Shipping Inc. 

Address: 27 Cambridge Road, East 

Rockaway, NY 11518. 

Date Revoked: February 20, 2011. 

Reason: Failed to maintain a valid 

bond. 

License Number: 018125F. 

Name: Echo-Translink Systems (ETS) 

dba Echo Worldwide. 

Address: 14205 SE 36th Street, Suite 

100, Bellevue, WA 98006. 

Date Revoked: February 28, 2011. 

Reason: Failed to maintain a valid 

bond. 

License Number: 018977N. 

Name: Alas Cargo LLC. 

Address: 228–236 Star of India Lane, 

Main Street, Carson, CA 90746. 

Date Revoked: February 7, 2011. 

Reason: Failed to maintain a valid 

bond. 

License Number: 019156N. 

Name: La Primavera Cargo Express 

Corp. 

Address: 1388–92 Jesup Avenue, 

Bronx, NY 10452. 

Date Revoked: February 26, 2011. 

Reason: Failed to maintain a valid 

bond. 

License Number: 019277N. 

Name: Trans Freight (USA) Inc. 

Address: 317 W. Main Street, Unit 

419, Alhambra, CA 91801. 

Date Revoked: February 21, 2011. 

Reason: Failed to maintain a valid 

bond. 

License Number: 019288F. 

Name: Kairos Logistics LLC. 

Address: 1447 West 178th Street, 

Suite 305, Gardena, CA 90248. 

Date Revoked: February 15, 2011. 

Reason: Failed to maintain a valid 

bond. 

License Number: 019897N. 

Name: Pinoy Express Cargo, Inc. 

Address: 18800 Amar Road, Suite A– 

7, Walnut, CA 91789. 

Date Revoked: February 10, 2011. 

Reason: Failed to maintain a valid 

bond. 

License Number: 019908NF. 

Name: International Trade 

Management Group, LLC dba ITM 

Logistics dba Patriot Lines. 

Address: 611 Live Oak Drive, McLean, 

VA 22101. 

Date Revoked: February 21, 2011. 

Reason: Failed to maintain valid 

bonds. 

License Number: 020527NF. 

Name: Fast Logistics, Inc. 

Address: 3350 SW 3rd Avenue, Suite 

207, Fort Lauderdale, FL 33315. 

Date Revoked: February 28, 2011. 

Reason: Failed to maintain valid 

bonds. 

License Number: 021273NF. 

Name: Frontcargo Freight Services 

Inc. 

Address: 4729 NW 72nd Avenue, 

Miami, FL 33166. 

Date Revoked: February 12, 2011. 

Reason: Failed to maintain valid 

bonds. 

License Number: 021837F. 

Name: Cargo America, Inc. 

Address: 332 South Wayside Drive, 

Houston, TX 77011. 

Date Revoked: November 10, 2010. 

Reason: Failed to maintain a valid 

bond. 

License Number: 021901F. 

Name: Magusa Logistics, Corp. 

Address: 11222 NW. 53rd Lane, Doral, 

FL 33178. 

Date Revoked: February 28, 2011. 

Reason: Failed to maintain a valid 

bond. 

License Number: 021961N. 

Name: Miami Envios Express Inc. 

Address: 7468 SW 117th Avenue, 

Miami, FL 33183. 

Date Revoked: February 16, 2011. 

Reason: Surrendered license 

voluntarily. 

License Number: 022184F. 

Name: Santiago Cargo Express, Corp. 

Address: 9–16 37th Avenue, Long 

Island City, NY 11101. 

Date Revoked: February 25, 2011. 

Reason: Failed to maintain a valid 

bond. 

Sandra L. Kusumoto, 

Director, Bureau of Certification and 

Licensing. 

[FR Doc. 2011–6865 Filed 3–22–11; 8:45 am] 

BILLING CODE 6730–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–6029–N] 

RIN 0938–AQ99 

Medicare, Medicaid, and Children’s 

Health Insurance Programs; Provider 

Enrollment Application Fee Amount for 

2011 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

$505 calendar year (CY) 2011 

application fee for institutional 

providers that are: Initially enrolling in 

the Medicare, program; revalidating 

their Medicare enrollment; or adding a 

new Medicare practice location. These 

institutional providers and suppliers are 

required to submit the 2011 fee amount 

with any enrollment applications 

submitted on or after March 25, 2011 

and on or before December 31, 2011. 

Similarly, beginning March 25, 2011 

prospective or re-enrolling Medicaid or 

CHIP providers must submit the 

applicable application fee unless: 

(1) The provider is an individual 

physician or nonphysician practitioner; 

or (2) the provider is enrolled in Title 

XVIII of the Act or another State’s title 

XIX or XXI plan and has paid the 

application fee to a Medicare contractor 

or another State. 

DATES: Effective Date: This notice is 

effective on March 23, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Frank Whelan, (410) 786–1302 for 

Medicare enrollment issues. Claudia 

Simonson, (312) 353–2115 for Medicaid 

and CHIP enrollment issues. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the February 2, 2011 Federal 

Register (76 FR 5862) we published a 

final rule with comment period entitled: 

‘‘Medicare, Medicaid, and Children’s 

Health Insurance Programs; Additional 

Screening Requirements, Application 

Fees, Temporary Enrollment Moratoria, 

Payment Suspensions and Compliance 

Plans for Providers and Suppliers’’. This 

final rule with comment finalized, 

among other things, provisions related 

to the submission of application fees as 

part of the Medicare, Medicaid and 

Children’s Health Insurance Program 

(CHIP) provider enrollment processes. 

Specifically, and as stated in 42 CFR 

424.514, institutional providers and 

suppliers that are: Initially enrolling in 


jlentini on DSKJ8SOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Notices 16423 

the Medicare program; revalidating their 

Medicare enrollment; or adding a new 

Medicare practice location, will be 

required to submit an application fee 

beginning March 25, 2011 with any 

enrollment application. We will adjust 

the amount of the fee annually for 

inflation. Institutional providers are 

defined at § 424.502 as— 

Any provider or supplier that submits a 

paper Medicare enrollment application using 

the CMS–855A, CMS–855B (not including 

physician and non-physician practitioner 

organizations), CMS–855S or associated 

Internet-based PECOS enrollment 

application. 

Similarly, as stated in 42 CFR 455.460, 

beginning March 25, 2011 prospective 

or re-enrolling Medicaid or CHIP 

providers must submit the applicable 

application fee unless: (1) The provider 

is an individual physician or 

nonphysician practitioner; or (2) the 

provider is enrolled in Title XVIII of the 

Act or another State’s title XIX or XXI 

plan and has paid the application fee to 

a Medicare contractor or another State. 

The February 2, 2011 final rule with 

comment period contains additional 

information about the entities that must 

submit an application fee, the purpose 

of the fee, and the process of obtaining 

a hardship exception or a waiver for 

Medicaid providers. 

II. Provisions of the Notice 

The application fee amount for the 

period on or after March 25, 2011 and 

on or before December 31, 2011 will be 

$505. This figure was calculated in 

accordance with the following: 

• Section 1866(j)(2)(C)(i)(I) of the 

Social Security Act (the Act) established 

a $500 application fee for providers and 

suppliers in calendar year (CY) 2010. 

• In 42 CFR 424.514(d)(2) of our 

regulations, and consistent with 

section1866(j)(2)(C)(i)(II) of the Act, we 

stated that for CY 2011 and for 

subsequent years, the fee will be 

adjusted by the percentage change in the 

consumer price index (CPI) for all urban 

consumers (all items; United States city 

average) for the 12-month period ending 

with June of the previous year. 

• As stated in the Regulatory Impact 

Analysis section of the February 2, 2011 

final rule with comment period 

(76 FR 5955) the CPI–U increase for the 

12-month period ending with June of 

the previous year is1.0 percent, based 

on data obtained from the Bureau of 

Labor Statistics. This results in an 

application fee for the CY 2011 of $505 

(or, $500 × 1.01). 

We will provide additional 

information to institutional providers on 

how the application fee can be 

submitted. Institutional providers are 

reminded that they can submit a 

hardship exception request in the event 

they believe that it is appropriate; 

additional information on the hardship 

exception is available in the February 2, 

2011 final rule with comment period. 

The application fee for calendar year 

2012 will be published in the Federal 

Register later this year. 

III. Collection of Information 

Requirements 

This document does not impose 

information collection and 

recordkeeping requirements. 

Consequently, it need not be reviewed 

by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 

(44 U.S.C. chapter 35). However, it does 

reference previously approved 

information collections. As stated in 

Section I of this notice, the forms CMS– 

855(A and B) and the CMS–855(S) are 

approved under OMB control numbers 

0938–0685 and 0938–1057. 

IV. Regulatory Impact Statement 

We have examined the impact of this 

notice as required by Executive Order 

12866 on Regulatory Planning and 

Review (September 30, 1993), Executive 

Order 13563 on Improving Regulation 

and Regulatory Review (February 2, 

2011), the Regulatory Flexibility Act 

(RFA) (September 19, 1980, Pub. L. 96– 

354), section 1102(b) of the Social 

Security Act, section 202 of the 

Unfunded Mandates Reform Act of 1995 

(March 22, 1995; Pub. L. 104–4), 

Executive Order 13132 on Federalism 

(August 4, 1999) and the Congressional 

Review Act (5 U.S.C. 804(2)). Executive 

Orders 12866 and 13563 direct agencies 

to assess all costs and benefits of 

available regulatory alternatives and, if 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). A regulatory impact 

analysis (RIA) must be prepared for 

major rules with economically 

significant effects ($100 million or more 

in any 1 year). 

In the regulatory impact analysis 

section of the February 2, 2011 

published final rule with comment 

(76 FR 5862), we estimated the total 

costs for institutional providers and 

suppliers in application fees for each 

CYs from 2011 through 2015. For 

2011—and based on an application fee 

of $505—we projected in Tables 11 and 

12 (76 FR 5955 through 5956) a total 

cost of $46,160,030 for Medicare 

providers and suppliers (or 91,406 

providers and suppliers × $505). For 

Medicaid providers, the estimated total 

cost for 2011—as indicated in Tables 13 

and 14 (76 FR 5957)—was $9,519,755 

(or 18,851 providers × $505). 

We are retaining these estimates for 

purposes of this notice. Thus, we project 

the total cost in application fees for 

Medicare and Medicaid providers and 

suppliers in CY 2011 to be $55,679,785. 

This notice does not reach the 

economic threshold and thus is not 

considered a major rule. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

entities. For purposes of the RFA, small 

entities include small businesses, 

nonprofit organizations, and small 

governmental jurisdictions. Most 

hospitals and most other providers and 

suppliers are small entities, either by 

nonprofit status or by having revenues 

of $7.0 million to $34.5 million in any 

1 year. Individuals and States are not 

included in the definition of a small 

entity. We are not preparing an analysis 

for the RFA because we have 

determined, and the Secretary certifies, 

that this notice will not have a 

significant economic impact on a 

substantial number of small entities. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 604 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a Metropolitan Statistical Area for 

Medicare payment regulations and has 

fewer than 100 beds. We are not 

preparing an analysis for section 1102(b) 

of the Act because we have determined, 

and the Secretary certifies, that this 

notice will not have a significant impact 

on the operations of a substantial 

number of small rural hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 also 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates require spending 

in any 1 year of $100 million in 1995 

dollars, updated annually for inflation. 

In 2011, that threshold is approximately 

$136 million. This notice will have no 

consequential effect on State, local, or 

Tribal governments or on the private 

sector. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 


jlentini on DSKJ8SOYB1PROD with NOTICES
16424 Federal Register / Vol. 76, No. 56 / Wednesday, March 23, 2011 / Notices 

Since this regulation does not impose 

any costs on State or local governments, 

the requirements of Executive Order 

13132 are not applicable. 

In accordance with the provisions of 

Executive Order 12866, this notice was 

not reviewed by the Office of 

Management and Budget. 

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program and Catalog of Federal Domestic 

Assistance Program No. 93.773, Medicare— 

Hospital Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: March 16, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2011–6813 Filed 3–22–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–D–0277] 

Draft Guidance for Industry: 

Compliance With Regulations 

Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco To 

Protect Children and Adolescents; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised draft guidance 

for industry entitled ‘‘Draft Guidance for 

Industry: Compliance With Regulations 

Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco to 

Protect Children and Adolescents.’’ This 

revised draft guidance replaces the 

original draft guidance published in the 

Federal Register of June 9, 2010 (75 FR 

32791). The original draft guidance was 

revised to remove potential ambiguities 

and to address several issues not 

included in the original draft guidance. 

This revised draft guidance is intended 

to help small entities comply with the 

final rule entitled ‘‘Regulations 

Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco to 

Protect Children and Adolescents.’’ 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 23, 2011. 

ADDRESSES: The draft guidance for 

industry entitled ‘‘Draft Guidance for 

Industry: Compliance with Regulations 

Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco to 

Protect Children and Adolescents’’ is 

available on the Internet at http://

www.fda.gov/TobaccoProducts/

GuidanceComplianceRegulatory

Information/default.htm, or a paper 

copy may be ordered free of charge by 

calling 1–877–287–1373. 

Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Office of Compliance and Enforcement, 

Center for Tobacco Products, Food and 

Drug Administration, 9200 Corporate 

Blvd., Rockville, MD 20850–3229, 877– 

287–1373, ctpcompliance@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Family Smoking Prevention and 

Tobacco Control Act (Tobacco Control 

Act) (Pub. L. 111–31; 123 Stat. 1776) 

was enacted on June 22, 2009, amending 

the Federal Food, Drug, and Cosmetic 

Act and providing FDA with the 

authority to regulate tobacco products. 

Section 102 of the Tobacco Control Act 

requires FDA to publish final 

regulations regarding cigarettes and 

smokeless tobacco, which are identical 

in their provisions to the regulations 

issued by FDA on August 28, 1996 (61 

FR 44396), with certain specified 

exceptions. In the Federal Register of 

March 19, 2010 (75 FR 13225), FDA 

published a final rule entitled 

‘‘Regulations Restricting the Sale and 

Distribution of Cigarettes and Smokeless 

Tobacco to Protect Children and 

Adolescents.’’ The final regulations 

apply to manufacturers, distributors, 

and retailers who make, distribute, or 

sell cigarettes or smokeless tobacco 

products. 

As of June 22, 2010, these Federal 

regulations, among other things, 

prohibit retailers from selling cigarettes, 

cigarette tobacco, or smokeless tobacco 

to persons under the age of 18, and 

require retailers to verify the age of all 

customers under the age of 27 by 

checking a photographic identification 

that includes the bearer’s date of birth. 

FDA announced the publication of the 

original draft guidance document on 

June 9, 2010 (75 FR 32791). This revised 

draft guidance replaces the original draft 

guidance. The original draft guidance 

was revised to remove potential 

ambiguities and to address several 

issues not included in the original draft 

guidance. This revised draft guidance is 

intended to help small entities comply 

with the final rule entitled ‘‘Regulations 

Restricting the Sale and Distribution of 

Cigarettes and Smokeless Tobacco to 

Protect Children and Adolescents’’ 

published on March 19, 2010. FDA is 

soliciting comments on the revised draft 

guidance document which replaces the 

original draft guidance document. FDA 

may amend the guidance document 

periodically as a result of comments 

received. 

II. Significance of Guidance 

FDA is issuing this draft guidance 

document consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). The draft guidance, when 

finalized, will represent the Agency’s 

current thinking on ‘‘Compliance with 

Regulations Restricting the Sale and 

Distribution of Cigarettes and Smokeless 

Tobacco to Protect Children and 

Adolescents.’’ It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments 

regarding this document. It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of mailed comments. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/TobaccoProducts/

GuidanceComplianceRegulatory

Information/default.htm or http:// 

www.regulations.gov. 

Dated: March 17, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–6794 Filed 3–22–11; 8:45 am] 

BILLING CODE P 


jlentini on DSKJ8SOYB1PROD with NOTICES