Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19365 

Daniel Holcomb, 

Reports Clearance Officer, Centers for Disease 

Control and Prevention. 

[FR Doc. 2011–8272 Filed 4–6–11; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–1357–N] 

RIN 0938–AQ97 

Medicare Program; Hospital Inpatient 

Prospective Payment Systems for 

Acute Care Hospitals and Fiscal Year 

2011 Final Wage Indices Implementing 

the Medicare and Medicaid Extenders 

Act 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice contains the final 

fiscal year (FY) 2011 wage indices and 

hospital reclassifications and other 

related tables which reflect changes 

required by or resulting from the 

implementation of section 102 of the 

Medicare and Medicaid Extenders Act 

of 2010. MMEA requires the extension 

of the expiration date for certain 

geographic reclassifications and special 

exception wage indices through 

September 30, 2011. 

DATES: Applicability Date: The revised 

wage indices for section 508 and special 

exception providers published in this 

notice are applicable for discharges on 

or after October 1, 2010 and on or before 

September 30, 2011. Certain hospitals 

that are not section 508/special 

exception providers, but that are located 

in areas affected by section 102 of the 

MMEA, are also identified in this 

notice, and will be paid based on the 

revised wage index published in this 

notice for discharges on or after April 1, 

2011 and on or before September 30, 

2011. 

FOR FURTHER INFORMATION CONTACT: 

Brian Slater, (410) 786–5229. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The final rule setting forth the 

Medicare fiscal year (FY) 2011 hospital 

inpatient prospective payment systems 

(IPPS) for acute care hospitals and the 

long-term care hospital prospective 

payment system (LTCH PPS) 

(hereinafter referred to as the FY 2011 

IPPS/LTCHPPS final rule) appeared in 

the August 16, 2010 Federal Register 

(75 FR 50042) and we subsequently 

corrected this final rule in an October 1, 

2010 Federal Register notice (75 FR 

60640). 

On December 15, 2010, the Medicare 

and Medicaid Extenders Act (MMEA) of 

2010 (Pub. L. 111–309) was enacted. 

Section 102 of the MMEA extends 

section 508 of the Medicare Prescription 

Drug, Improvement, and Modernization 

Act of 2003 (MMA) (Pub. L. 108–173) 

reclassifications and certain additional 

special exceptions through September 

30, 2011. This notice addresses the 

provisions of the MMEA that impact the 

FY 2011 IPPS final wage index tables. 

II. Provisions of this Notice 

A. Section 508 Extension 

Section 102 of the MMEA of 2010, 

extends through the end of FY 2011 

wage index reclassifications under 

section 508 of the MMA and certain 

special exceptions (for example, those 

special exceptions contained in the final 

rule that appeared in the Federal 

Register (69 FR 49105 and 49107) 

extended under section 117 of the 

Medicare, Medicaid and SCHIP 

Extension Act (MMSEA) of 2007 (Pub. 

L. 110–173) and further extended under 

section 124 of the Medicare 

Improvements for Patients and 

Providers Act of 2008 (MIPPA)(Pub. L. 

110–275) and section 3137(a) of the 

Patient Protection and Affordable Care 

Act (PPACA) (Pub. L. 111–148) as 

amended by section 10317 of the Health 

Care and Education Reconciliation Act 

of 2010 (HCERA), (Pub. L. 111–152 

enacted on March 30, 2010). (These 

public laws are collectively known as 

the Affordable Care Act (ACA).) 

Under section 508 of MMA, a 

qualifying hospital could appeal the 

wage index classification otherwise 

applicable to the hospital and apply for 

reclassification to another area of the 

State in which the hospital is located or, 

at the discretion of the Secretary, to an 

area within a contiguous State. We 

implemented this process through 

notices published in the Federal 

Register on January 6, 2004 (69 FR 661), 

and February 13, 2004 (69 FR 7340). 

Such reclassifications were applicable 

to discharges occurring during the 3- 

year period beginning April 1, 2004, and 

ending March 31, 2007. Section 106(a) 

of the Medicare Improvements and 

Extension Act, Division B of the Tax 

Relief and Health Care Act of 2006 

(MIEA–TRHCA) extended the 

geographic reclassifications of hospitals 

that were made under section 508 of the 

MMA. In the March 23, 2007 Federal 

Register (72 FR 3799), we published a 

notice that indicated how we were 

implementing section 106(a) of the 

MIEA–TRHCA through September 30, 

2007. Section 117 of the MMSEA further 

extended section 508 reclassifications 

and certain special exceptions through 

September 30, 2008. On February 22, 

2008 in the Federal Register (73 FR 

9807), we published a notice regarding 

our implementation of section 117 of 

the MMSEA. In the October 3, 2008 

Federal Register (73 FR 57888), we 

published a notice regarding our 

implementation of section 124 of 

MIPPA, which extended section 508 

reclassifications and certain special 

exceptions through September 30, 2009. 

In the June 2, 2010 Federal Register (75 

FR 31118), we explained our 

implementation of section 3137(a) of the 

ACA, as amended by section 10317 of 

ACA, which further extended section 

508 reclassifications and certain special 

exceptions through the end of FY 2010. 

Section 102 of the MMEA has 

extended the hospital reclassifications 

originally received under section 508 

and certain special exceptions through 

September 30, 2011 (FY 2011). 

Furthermore, effective April 1, 2011, 

section 102 of the MMEA also requires 

that in determining the wage index 

applicable to hospitals that qualify for 

wage index reclassification, the 

Secretary shall remove the section 508 

and special exception hospitals’ wage 

data from the calculation of the 

reclassified wage index if doing so 

increases the reclassified wage index. If 

the section 508 or special exception 

hospital’s wage index applicable for the 

period beginning on October 1, 2010, 

and ending on March 30, 2011, is lower 

than for the period beginning on April 

1, 2011, and ending on September 30, 

2011, the Secretary shall pay the 

hospital an additional amount that 

reflects the difference between the wage 

indices for the two periods. As a result 

of these changes, we have recalculated 

certain wage index values to account for 

the new legislation. 

Hospitals receiving an extension of 

their section 508 reclassifications or 

special exceptions wage indices are 

shown in Table 9B of the Addendum to 

this notice. Please note we are not 

making reclassification decisions on 

behalf of hospitals in this extension as 

we did with the MIPPA provision. 

(Because MIPPA was enacted prior to 

the finalization of the FY 2009 rates, we 

were able to modify reclassifications 

that had not yet taken effect. In contrast, 

MMEA was enacted in the middle of the 

fiscal year, and reclassifications are 

already in effect). Also, as explained in 

this notice, in cases where we have 

removed section 508/special exception 

hospital data from the reclassification 

wage index (effective April 1), we have 

mstockstill on DSKH9S0YB1PROD with NOTICES

19366 Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 

done so only where the labor market 

area includes hospitals that have 508 

reclassifications/special exceptions 

extended, or where an extended 

hospital was reclassified to such area for 

FY 2011. 

When originally implementing 

section 508 of the MMA, we required 

each hospital to submit a request in 

writing by February 15, 2004, to the 

Medicare Geographic Classification 

Review Board (MGCRB), with a copy to 

CMS. We will neither require nor accept 

written requests for the extension 

required by MMEA, since that law 

simply provides a 1 year continuation 

through the end of FY 2011 for any 

section 508 reclassifications and special 

exceptions wage indices that expired 

September 30, 2010. 

B. FY 2011 Final Wage Indices 

The FY 2011 final wage index values 

and geographic adjustment factors 

(GAF) for hospitals affected by section 

102 of the MMEA are included in Tables 

2, 4C, and 9B of the Addendum to this 

notice, as well as in a Table showing the 

hospitals that have been removed from 

Table 9A. These tables also are posted 

on our Web site at http:// 

www.cms.hhs.gov/AcuteInpatientPPS/. 

Table 2 of the Addendum to this notice 

includes the final wage index values for: 

(1) Section 508 and special exception 

hospitals; and (2) other hospitals 

affected by the extension. Table 4C of 

the Addendum to this notice lists the 

revised final wage index and GAF 

values for certain hospitals that are 

reclassified, for hospitals that have not 

had their section 508 reclassifications or 

special exceptions extended, will be 

effective April 1, 2011. The revised 

Table 9A of the Addendum lists 

hospitals removed from the table due to 

the enactment of section 102 of MMEA. 

In addition, Table 9B of the Addendum 

to this notice lists hospitals that are 

section 508 and special exception 

providers that have been extended until 

September 30, 2011. Please note that 

some hospitals that might otherwise 

qualify for an extension of their section 

508 reclassification or special exception 

have not been so extended for FY 2011, 

because they are receiving a higher wage 

index as a result of maintaining their 

MGCRB reclassification or due to 

section 10324 of the ACA which 

provides for a floor (of 1.0) on the area 

wage index for hospitals in Frontier 

States. Therefore, in keeping with our 

historic practice, these providers 

continue to receive the wage index 

published in the FY 2011 IPPS/LTCH 

PPS final rule, or subsequent correction 

notice (published on October 1, 2010), 

and are neither removed from Table 9A 

nor listed in Table 9B. 

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). 

IV. Waiver of Proposed Rulemaking 

and Delay of Effective Date 

We ordinarily publish a notice of 

proposed rulemaking in the Federal 

Register and invite public comment 

prior to a rule taking effect in 

accordance with section 553(b) of the 

Administrative Procedure Act (APA) 

and section 1871 of the Act. In addition, 

in accordance with section 553(d) of the 

APA and section 1871(e)(1)(B)(i) of the 

Act, we ordinarily provide a 30-day 

delay to a substantive rule’s effective 

date. For substantive rules that 

constitute major rules, in accordance 

with 5 U.S.C. 801, we ordinarily provide 

a 60-day delay in the effective date. 

None of the above processes or 

effective date requirements apply, 

however, when the rule in question is 

interpretive, a general statement of 

policy, or a rule of agency organization, 

procedure or practice. They also do not 

apply when the Congress itself has 

created the rules that are to be applied, 

leaving no discretion or gaps for an 

agency to fill in through rulemaking. 

In addition, an agency may waive 

notice and comment rulemaking, as well 

as any delay in effective date, when the 

agency for good cause finds that notice 

and public comment on the rule as well 

the effective date delay are 

impracticable, unnecessary, or contrary 

to the public interest. In cases where an 

agency finds good cause, the agency 

must incorporate a statement of this 

finding and its reasons in the rule 

issued. 

The policies being publicized in this 

notice do not constitute agency 

rulemaking. Rather, the Congress, in the 

MMEA, has already required that the 

agency make these changes, and we are 

simply notifying the public of certain 

required revisions to wage index values 

that are effective either October 1, 2010 

(or for certain affected non-508 hospitals 

April 1, 2011). As this notice merely 

informs the public of these required 

modifications to the wage index values 

under the IPPS, it is not a rule and does 

not require any notice and comment 

rulemaking. To the extent any of the 

policies articulated in this notice 

constitute interpretations of the 

Congress’s requirements or procedures 

that will be used to implement the 

Congress’s directive; they are 

interpretive rules, general statements of 

policy, and/or rules of agency procedure 

or practice, which are not subject to 

notice-and-comment rulemaking or a 

delayed effective date. 

However, to the extent that notice and 

comment rulemaking or a delay in 

effective date or both would otherwise 

apply, we find good cause to waive such 

requirements. Specifically, we find it 

unnecessary to undertake notice and 

comment rulemaking in this instance as 

this notice does not propose to make 

any substantive changes to IPPS policies 

or methodologies already in effect as a 

matter of law, but simply applies rate 

adjustments required by MMEA to these 

existing policies and methodologies. 

Therefore, we would be unable to 

change any of the policies governing the 

IPPS for FY 2011 in response to public 

comment on this notice. Finally, even if 

any of the policies could be subject to 

change, as many of the changes outlined 

in this notice have already taken effect 

or must take effect within a very short 

period of time after enactment of the 

MMEA (that is, by April 1, 2011— 

approximately 3 months after 

enactment), it would also be 

impracticable to undertake notice and 

comment rulemaking. For these reasons, 

we also find that a waiver of any delay 

in effective date, if it were otherwise 

applicable, is necessary to comply with 

the requirements of the MMEA. 

Therefore, we find good cause to waive 

notice and comment procedures as well 

as any delay in effective date, if such 

procedures or delays are required at all. 

V. Regulatory Impact Analysis 

A. Introduction 

We have examined the impacts 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 (January 18, 

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 

(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 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19367 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. A 

regulatory impact analysis (RIA) must 

be prepared for regulatory actions with 

economically significant effects ($100 

million or more in any 1 year). This 

notice has been designated an 

‘‘economically’’ significant regulatory 

action, under section 3(f)(1) of Executive 

Order 12866. Therefore, although we do 

not consider this notice to constitute a 

substantive rule, we have prepared a 

RIA, that to the best of our ability, 

presents the costs and benefits of this 

notice. In accordance with Executive 

Order 12866, the notice has been 

reviewed by the Office of Management 

and Budget. 

The RFA requires agencies to analyze 

options for regulatory relief of small 

businesses, if a rule has a significant 

impact on a substantial number of small 

entities. For purposes of the RFA, small 

entities include small businesses, 

nonprofit organizations, and small 

government jurisdictions. We estimate 

that most hospitals and most other 

providers and suppliers are small 

entities as that term is used in the RFA. 

The great majority of hospitals and most 

other health care providers and 

suppliers are small entities, either by 

being nonprofit organizations or by 

meeting the SBA definition of a small 

business (having revenues of less than 

$7.5 to $34.5 million in any 1 year). (For 

details on the latest standard for health 

care providers, we refer readers to page 

33 of the Table of Small Business Size 

Standards at the Small Business 

Administration’s Web site at http:// 

www.sba.gov/services/ 

contractingopportunities/ 

sizestandardstopics/tableofsize/ 

index.html.) For purposes of the RFA, 

all hospitals and other providers and 

suppliers are considered to be small 

entities. Individuals and States are not 

included in the definition of a small 

entity. We believe that this notice will 

have a significant impact on small 

entities. Because we acknowledge that 

many of the affected entities are small 

entities, the analysis discussed in this 

section would fulfill any requirement 

for a final regulatory flexibility analysis. 

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. With the exception of hospitals 

located in certain New England 

counties, for purposes of section 1102(b) 

of the Act, we now define a small rural 

hospital as a hospital that is located 

outside of an urban area and has fewer 

than 100 beds. Section 601(g) of the 

Social Security Amendments of 1983 

(Pub. L. 98–21) designated hospitals in 

certain New England counties as 

belonging to the adjacent urban area. 

Thus, for purposes of the IPPS, we 

continue to classify these hospitals as 

urban hospitals. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

(Pub. L. 104–4) 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 not mandate 

any requirements for State, local, or 

Tribal governments, nor will it affect 

private sector costs. 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. This notice will not have 

a substantial effect on State and local 

governments. 

Although this notice merely reflects 

the implementation of provisions of the 

MMEA and does not constitute a 

substantive rule, we are nevertheless 

preparing this impact analysis in the 

interest of ensuring that the impacts of 

these changes are fully understood. The 

following analysis, in conjunction with 

the remainder of this document, 

demonstrates that this notice is 

consistent with the regulatory 

philosophy and principles identified in 

Executive Order 12866 and 13563, the 

RFA, and section 1102(b) of the Act. 

The notice will positively affect 

payments to a substantial number of 

small rural hospitals, as well as other 

classes of hospitals, and the effects on 

some hospitals may be significant. The 

impact analysis, which shows the effect 

on all payments to hospitals, is shown 

in Table I of this notice. 

B. Statement of Need 

This notice is necessary to update the 

final fiscal year (FY) 2011 wage indices 

and hospital reclassifications and other 

related tables to reflect changes required 

by or resulting from the implementation 

of section 102 of the MMEA. MMEA 

requires the extension of the expiration 

date for certain geographic 

reclassifications and special exception 

wage indices through September 30, 

2011. We note that the changes in this 

notice are already in effect with changes 

made to PRICER and announced 

through a Joint Signature Memorandum. 

C. Overall Impact 

The FY 2011 IPPS final rule included 

an impact analysis for the changes to the 

IPPS included in that rule. This notice 

updates those impacts to the IPPS 

operating payment system as to reflect 

certain changes required by the MMEA. 

Because provisions in the MMEA were 

not budget neutral, the overall estimates 

for hospitals have changed from our 

estimate that was published in the FY 

2011 IPPS final rule (75 FR 50042). We 

estimate that the changes in the FY 2011 

IPPS final rule, in conjunction with the 

final IPPS rates and wage index 

included in this notice, will result in an 

approximate $279 million decrease in 

total operating payments relative to FY 

2010. In the FY 2011 IPPS final rule (75 

FR 50042), we had projected that total 

operating payments would decrease by 

$440 million relative to FY 2010. 

However, the changes in this notice will 

increase operating payments by $162 

million relative to what was projected in 

the FY 2011 IPPS final rule, resulting in 

a net decrease of $279 million in total 

operating payments. Capital payments 

are estimated to increase by an 

additional $13.6 million in FY 2011 as 

a result of the changes in this notice. 

D. Anticipated Effects 

In Table I, we provide an impact 

analysis for changes to the IPPS 

operating payments in FY 2011 as a 

result of the changes required by the 

MMEA. The table categorizes hospitals 

by various geographic and special 

payment consideration groups to 

illustrate the varying impacts on 

different types of hospitals. The first 

row of Table I shows the overall impact 

on the 3,472 acute care hospitals 

included in the analysis. The impact 

analysis reflects the change in estimated 

operating payments in FY 2011 due to 

the provisions in the MMEA relative to 

estimated FY 2011 operating payments 

published in the FY 2011 IPPS final rule 

(75 FR 50042). Overall, all hospitals will 

experience an estimated 0.2 percent 

increase in operating payments in FY 

2011 due to the provisions in MMEA 

compared to the previous estimates of 

operating payments in FY 2011 

published in the FY 2011 IPPS final 

rule. Because the provisions in the 

MMEA were not budget neutral, all 

hospitals, depending on whether they 

were affected by the provisions in the 

MMEA, will either experience no 

mstockstill on DSKH9S0YB1PROD with NOTICES

19368 Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 

change or an increase in IPPS operating 

payments in FY 2011 in this notice 

relative to the previously published 

estimates. As such, hospitals located in 

urban areas will experience a 0.2 

percent increase in payments while 

hospitals located in rural areas will not 

experience any change in payments in 

FY 2011 due to the provisions in this 

notice as compared to the estimated 

payments provided in the FY 2011 IPPS 

final rule. Among the hospitals that are 

subject to the changes in this notice, 

hospitals will experience a net effect 

increase in payments ranging from 0.1 

percent to 0.4 percent where urban 

Middle Atlantic hospitals, urban East 

North Central hospitals and urban 

reclassified hospitals are expected to 

experience the largest net increase in 

operating payments of 0.4 percent in FY 

2011. 

TABLE I—IMPACT ANALYSIS OF CHANGES FOR FY 2011 ACUTE CARE HOSPITAL OPERATING PROSPECTIVE PAYMENT

SYSTEM

Number of 

hospitals 

Percent net 

effect of all 

changes for 

FY 2011 

All Hospitals ............................................................................................................................................................. 3472 0.2 

By Geographic Location: 

Urban hospitals ................................................................................................................................................. 2494 0.2 

Large urban areas ..................................................................................................................................... 1362 0.2 

Other urban areas ..................................................................................................................................... 1132 0.2 

Rural hospitals .................................................................................................................................................. 978 0 

Bed Size (Urban): 

0–99 beds ......................................................................................................................................................... 622 0.1 

100–199 beds ................................................................................................................................................... 785 0.2 

200–299 beds ................................................................................................................................................... 460 0.2 

300–499 beds ................................................................................................................................................... 430 0.2 

500 or more beds ............................................................................................................................................. 197 0.2 

Bed Size (Rural): 

0–49 beds ......................................................................................................................................................... 348 0 

50–99 beds ....................................................................................................................................................... 368 0 

100–149 beds ................................................................................................................................................... 156 0 

150–199 beds ................................................................................................................................................... 60 0 

200 or more beds ............................................................................................................................................. 46 0 

Urban by Region: 

New England .................................................................................................................................................... 121 0.3 

Middle Atlantic .................................................................................................................................................. 330 0.4 

South Atlantic ................................................................................................................................................... 382 0 

East North Central ............................................................................................................................................ 403 0.4 

East South Central ........................................................................................................................................... 155 0 

West North Central ........................................................................................................................................... 167 0 

West South Central .......................................................................................................................................... 336 0 

Mountain ........................................................................................................................................................... 161 0 

Pacific ............................................................................................................................................................... 389 0.1 

Puerto Rico ....................................................................................................................................................... 50 0 

Rural by Region: 

New England .................................................................................................................................................... 24 0 

Middle Atlantic .................................................................................................................................................. 70 0.1 

South Atlantic ................................................................................................................................................... 165 0 

East North Central ............................................................................................................................................ 121 0 

East South Central ........................................................................................................................................... 176 0 

West North Central ........................................................................................................................................... 100 0.1 

West South Central .......................................................................................................................................... 219 0 

Mountain ........................................................................................................................................................... 72 0 

Pacific ............................................................................................................................................................... 31 0 

By Payment Classification: 

Urban hospitals ................................................................................................................................................. 2551 0.2 

Large urban areas ............................................................................................................................................ 1404 0.2 

Other urban areas ............................................................................................................................................ 1147 0.2 

Rural areas ....................................................................................................................................................... 921 0 

Teaching Status: 

Nonteaching ...................................................................................................................................................... 2429 0.1 

Fewer than 100 residents ................................................................................................................................. 805 0.2 

100 or more residents ...................................................................................................................................... 238 0.3 

Urban DSH: 

Non-DSH .......................................................................................................................................................... 779 0.2 

100 or more beds ............................................................................................................................................. 1531 0.2 

Less than 100 beds .......................................................................................................................................... 356 0.1 

Rural DSH: 

SCH .................................................................................................................................................................. 423 0 

RRC .................................................................................................................................................................. 212 0 

100 or more beds ............................................................................................................................................. 30 0.2 

Less than 100 beds .......................................................................................................................................... 141 0.2 

Urban teaching and DSH: 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19369 

TABLE I—IMPACT ANALYSIS OF CHANGES FOR FY 2011 ACUTE CARE HOSPITAL OPERATING PROSPECTIVE PAYMENT

SYSTEM—Continued 

Number of 

hospitals 

Percent net 

effect of all 

changes for 

FY 2011 

Both teaching and DSH .................................................................................................................................... 818 0.2 

Teaching and no DSH ...................................................................................................................................... 161 0.3 

No teaching and DSH ...................................................................................................................................... 1069 0 

No teaching and no DSH ................................................................................................................................. 503 0.2 

Special Hospital Types: 

RRC .................................................................................................................................................................. 180 0.1 

SCH .................................................................................................................................................................. 332 0 

MDH .................................................................................................................................................................. 194 0 

SCH and RRC ........................................................................................................................................... 117 0 

MDH and RRC .......................................................................................................................................... 13 0 

Type of Ownership: 

Voluntary ........................................................................................................................................................... 1990 0.2 

Proprietary ........................................................................................................................................................ 859 0.1 

Government ...................................................................................................................................................... 586 0 

Medicare Utilization as a Percent of Inpatient Days: 

0–25 .................................................................................................................................................................. 353 0 

25–50 ................................................................................................................................................................ 1593 0.2 

50–65 ................................................................................................................................................................ 1203 0.2 

Over 65 ............................................................................................................................................................. 233 0.2 

FY 2011 Reclassifications by the Medicare Geographic Classification Review Board: 

All Reclassified Hospitals ................................................................................................................................. 773 0.3 

Non-Reclassified Hospitals ............................................................................................................................... 2699 0.1 

Urban Hospitals Reclassified ........................................................................................................................... 442 0.4 

Urban Nonreclassified Hospitals, FY 2011 ...................................................................................................... 2022 0.1 

All Rural Hospitals Reclassified FY 2011 ........................................................................................................ 331 0 

Rural Nonreclassified Hospitals FY 2011 ........................................................................................................ 585 0.1 

All Section 401 Reclassified Hospitals: ............................................................................................................ 37 0 

Other Reclassified Hospitals (Section 1886(d)(8)(B)) ...................................................................................... 63 0 

Specialty Hospitals: 

Cardiac Specialty Hospitals .............................................................................................................................. 19 0 

E. Alternatives Considered 

This notice provides descriptions of 

the statutory provisions that are 

addressed and identifies policies for 

implementing these provisions. Due to 

the prescriptive nature of the statutory 

provisions, no alternatives were 

considered. 

F. Accounting Statement and Table 

1. Acute Care Hospitals 

As required by OMB Circular A–4 

(available at http:// 

www.whitehouse.gov/omb/circulars/ 

a004/a-4.pdf), in Table II, we have 

prepared an accounting statement 

showing the classification of 

expenditures associated with the 

provisions of this notice as they relate 

to acute care hospitals. This table 

provides our best estimate of the change 

in Medicare payments to providers as a 

result of the changes to the IPPS 

presented in this notice. All 

expenditures are classified as transfers 

from the Federal government to 

Medicare providers. As previously 

discussed, relative to what was 

projected in the FY 2011 IPPS final rule, 

the changes in this notice will increase 

FY 2011 operating payments by $162 

million and capital payments by $14 

million. Thus, the total increase in 

Federal expenditures for FY 2011 is 

approximately $176 million. 

TABLE II—ACCOUNTING STATEMENT: 

CLASSIFICATION OF ESTIMATED EXPENDITURES UNDER THE IPPS 

FROM PUBLISHED FY 2011 TO REVISED FY 2011 

Category Transfers 

Annualized 

Monetized 

Transfers.

$176 million 

From Whom to 

Whom.

Federal Government to IPPS 

Medicare Providers 

Total ........ $176 million 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program) 

Dated: March 3, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: April 1, 2011. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

Addendum 

This addendum includes tables 

referred to throughout the notice which 

contain data relating to the final FY 

2010 wage indices and the hospital 

reclassifications and payment amounts 

for operating costs discussed in section 

II. of this notice. 

TABLE 2A—REVISED FY 2011 WAGE

INDEX VALUES FOR SECTION 508/ 

SPECIAL EXCEPTION HOSPITALS

(Effective October 1, 2010 through September 

30, 2011). 

CMS certification No. 

Revised FY 

2011 wage 

index 

010150 ...................................... 0.8567 

020008 ...................................... 1.2776 

050549 ...................................... 1.5477 

060075 ...................................... 1.1429 

mstockstill on DSKH9S0YB1PROD with NOTICES

19370 Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 

TABLE 2A—REVISED FY 2011 WAGE

INDEX VALUES FOR SECTION 508/ 

SPECIAL EXCEPTION HOSPITALS— 

Continued 

(Effective October 1, 2010 through September 

30, 2011). 

CMS certification No. 

Revised FY 

2011 wage 

index 

070005 ...................................... 1.2529 

070006 * .................................... 1.2867 

070010 ...................................... 1.2867 

070016 ...................................... 1.2529 

070017 ...................................... 1.2529 

070018 * .................................... 1.2867 

070019 ...................................... 1.2529 

070022 ...................................... 1.2529 

070028 ...................................... 1.2867 

070031 ...................................... 1.2529 

070034 * .................................... 1.2867 

070036 ...................................... 1.3329 

070039 ...................................... 1.2529 

150034 ...................................... 1.0386 

160040 ...................................... 0.8759 

160064 ...................................... 0.9501 

160067 ...................................... 0.8759 

160110 ...................................... 0.8759 

220046 ...................................... 1.1629 

230003 ...................................... 0.9930 

230004 ...................................... 0.9930 

230013 ...................................... 1.0781 

230019 ...................................... 1.0781 

230020 ...................................... 1.0057 

230024 ...................................... 1.0057 

230029 ...................................... 1.0781 

230036 ...................................... 1.0781 

230038 ...................................... 0.9930 

230053 ...................................... 1.0057 

230059 ...................................... 0.9930 

230066 ...................................... 0.9930 

230071 ...................................... 1.0781 

230072 ...................................... 0.9930 

230089 ...................................... 1.0057 

230097 ...................................... 0.9930 

230104 ...................................... 1.0057 

230106 ...................................... 0.9930 

230130 ...................................... 1.0781 

230135 ...................................... 1.0057 

230146 ...................................... 1.0057 

230151 ...................................... 1.0781 

230165 ...................................... 1.0057 

230174 ...................................... 0.9930 

230176 ...................................... 1.0057 

230207 ...................................... 1.0781 

230236 ...................................... 0.9930 

230254 ...................................... 1.0781 

230269 ...................................... 1.0781 

230270 ...................................... 1.0057 

230273 ...................................... 1.0057 

230277 ...................................... 1.0781 

250002 ...................................... 0.8443 

250078 * .................................... 0.8443 

TABLE 2A—REVISED FY 2011 WAGE

INDEX VALUES FOR SECTION 508/ 

SPECIAL EXCEPTION HOSPITALS— 

Continued 

(Effective October 1, 2010 through September 

30, 2011). 

CMS certification No. 

Revised FY 

2011 wage 

index 

250122 ...................................... 0.8443 

310021 ...................................... 1.2867 

310028 ...................................... 1.2867 

310050 ...................................... 1.2867 

310051 ...................................... 1.2867 

310060 ...................................... 1.2867 

310115 ...................................... 1.2867 

310120 ...................................... 1.2867 

330023 * .................................... 1.2867 

330049 ...................................... 1.2867 

330067 * .................................... 1.2867 

330106 ...................................... 1.4341 

330126 ...................................... 1.2867 

330135 ...................................... 1.2867 

330205 ...................................... 1.2867 

330264 ...................................... 1.2529 

340002 ...................................... 0.9087 

390001 ...................................... 0.9370 

390003 ...................................... 0.9370 

390045 ** .................................. 0.9370 

390072 ...................................... 0.9370 

390095 ...................................... 0.9370 

390119 ...................................... 0.9370 

390137 ...................................... 0.9370 

390169 ...................................... 0.9370 

390185 ...................................... 0.9852 

390192 ...................................... 0.9370 

390237 ...................................... 0.9370 

390270 ...................................... 0.9852 

430005 ...................................... 1.0934 

470003 ...................................... 1.1629 

490001 ...................................... 0.8514 

530015 ...................................... 1.0577 

* These hospitals are assigned a wage 

index value under a special exceptions policy 

(see the FY 2005 IPPS final rule, 69 FR 

49105). 

** This hospital has been assigned a wage 

index under a special exceptions policy (see 

the FY 2007 IPPS final rule, 71 FR 48070). 

TABLE 2B—REVISED FY 2011 WAGE

INDEX VALUES FOR OTHER AFFECTED HOSPITALS

(Effective April 1, 2011 through September 30, 

2011) 

CMS certification No. 

Revised FY 

2011 wage 

index 

070015 .................................. 1.2867 

TABLE 2B—REVISED FY 2011 WAGE

INDEX VALUES FOR OTHER AFFECTED HOSPITALS—Continued 

(Effective April 1, 2011 through September 30, 

2011) 

CMS certification No. 

Revised FY 

2011 wage 

index 

070033 .................................. 1.2867 

070038 .................................. 1.2529 

140012 .................................. 1.0386 

140110 .................................. 1.0386 

140161 .................................. 1.0386 

150002 .................................. 1.0386 

150004 .................................. 1.0386 

150008 .................................. 1.0386 

150090 .................................. 1.0386 

150125 .................................. 1.0386 

150126 .................................. 1.0386 

150165 .................................. 1.0386 

150166 .................................. 1.0386 

150170 .................................. 1.0386 

230002 .................................. 1.0057 

230037 .................................. 1.0057 

230069 .................................. 1.0781 

230077 .................................. 1.0781 

230099 .................................. 1.0057 

230142 .................................. 1.0057 

230244 .................................. 1.0057 

230279 .................................. 1.0781 

230297 .................................. 1.0057 

230301 .................................. 1.0781 

230302 .................................. 1.0781 

250023 .................................. 0.8443 

250040 .................................. 0.8443 

250094 .................................. 0.8443 

250117 .................................. 0.8443 

310002 .................................. 1.2867 

310009 .................................. 1.2867 

310015 .................................. 1.2867 

310017 .................................. 1.2867 

310038 .................................. 1.2867 

310039 .................................. 1.2867 

310054 .................................. 1.2867 

310070 .................................. 1.2867 

310076 .................................. 1.2867 

310083 .................................. 1.2867 

310096 .................................. 1.2867 

310108 .................................. 1.2867 

310119 .................................. 1.2867 

330027 .................................. 1.2867 

330167 .................................. 1.2867 

330181 .................................. 1.2867 

330182 .................................. 1.2867 

330198 .................................. 1.2867 

330225 .................................. 1.2867 

330259 .................................. 1.2867 

330331 .................................. 1.2867 

330332 .................................. 1.2867 

330372 .................................. 1.2867 

TABLE 4C.—REVISED WAGE INDEX AND CAPITAL GEOGRAPHIC ADJUSTMENT FACTORS (GAF) FOR ACUTE CARE

HOSPITALS THAT ARE RECLASSIFIED BY CBSA AND BY STATE—FY 2011 

[Wage index includes rural floor budget neutrality adjustment] 

CBSA code Area State Revised wage index Revised GAF 

11460 ........ Ann Arbor, MI .................................................... MI 1.0057 1.0039 

16974 ........ Chicago-Joliet-Naperville, IL .............................. IL 1.0386 1.0263 

22420 ........ Flint, MI .............................................................. MI 1.0781 1.0528 

25060 ........ Gulfport-Biloxi, MS ............................................. MS 0.8443 0.8906 

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19371 

TABLE 4C.—REVISED WAGE INDEX AND CAPITAL GEOGRAPHIC ADJUSTMENT FACTORS (GAF) FOR ACUTE CARE

HOSPITALS THAT ARE RECLASSIFIED BY CBSA AND BY STATE—FY 2011—Continued 

[Wage index includes rural floor budget neutrality adjustment] 

CBSA code Area State Revised wage index Revised GAF 

35004 ........ Nassau-Suffolk, NY ........................................... NY 1.2529 1.1670 

35644 ........ New York-White Plains-Wayne, CT .................. CT 1.2867 1.1884 

35644 ........ New York-White Plains-Wayne, NJ ................... NJ 1.2867 1.1884 

35644 ........ New York-White Plains-Wayne, NY .................. NY 1.2867 1.1884 

The following providers have been 

removed from Table 9A published in 

the FY 2011 IPPS/LTCH final rule (or in 

the October 1, 2010 correction notice to 

that final rule) due to the 

implementation of section 102 of the 

MMEA: 

TABLE 9A—HOSPITAL RECLASSIFICATIONS AND REDESIGNATIONS WITHDRAWN/TERMINATED DUE TO SECTION 102 OF THE

MMEA—FY 2011 

CCN Geographic CBSA Reclassified CBSA LUGAR 

020008 ........................................................... 02 11260 

060075 ........................................................... 06 24300 

070005 ........................................................... 35300 35004 

070006 ........................................................... 14860 35644 

070010 ........................................................... 14860 35644 

070016 ........................................................... 35300 35004 

070017 ........................................................... 35300 35004 

070018 ........................................................... 14860 35644 

070019 ........................................................... 35300 35004 

070022 ........................................................... 35300 35004 

070028 ........................................................... 14860 35644 

070031 ........................................................... 35300 35004 

070034 ........................................................... 14860 35644 

070036 ........................................................... 25540 35300 

070039 ........................................................... 35300 35004 

150034 ........................................................... 23844 16974 

160064 ........................................................... 16 24 

230003 ........................................................... 26100 34740 

230013 ........................................................... 47644 22420 

230019 ........................................................... 47644 22420 

230020 ........................................................... 19804 11460 

230024 ........................................................... 19804 11460 

230029 ........................................................... 47644 22420 

230036 ........................................................... 23 13020 

230038 ........................................................... 24340 34740 

230053 ........................................................... 19804 11460 

230071 ........................................................... 47644 22420 

230072 ........................................................... 26100 34740 

230089 ........................................................... 19804 11460 

230097 ........................................................... 23 24340 

230104 ........................................................... 19804 11460 

230106 ........................................................... 24340 34740 

230130 ........................................................... 47644 22420 

230135 ........................................................... 19804 11460 

230146 ........................................................... 19804 11460 

230151 ........................................................... 47644 22420 

230165 ........................................................... 19804 11460 

230174 ........................................................... 26100 34740 

230176 ........................................................... 19804 11460 

230207 ........................................................... 47644 22420 

230236 ........................................................... 24340 34740 

230254 ........................................................... 47644 22420 

230269 ........................................................... 47644 22420 

230270 ........................................................... 19804 11460 

230273 ........................................................... 19804 11460 

230277 ........................................................... 47644 22420 

250002 ........................................................... 25 22520 

250078 ........................................................... 25620 25060 

310050 ........................................................... 35084 35644 

330023 ........................................................... 39100 35644 

330106 ........................................................... 35004 35644 

330126 ........................................................... 39100 35644 

390185 ........................................................... 42540 10900 

mstockstill on DSKH9S0YB1PROD with NOTICES

19372 Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 

TABLE 9B.—HOSPITAL RECLASSIFICATIONS AND REDESIGNATIONS BY INDIVIDUAL HOSPITAL UNDER SECTION 508 OF

PUBLIC LAW 108–173—FY 2011 

CCN Note Geographic 

CBSA 

Wage index 

CBSA section 

508 reclassification 

Own wage 

index 

010150 ............................................................................................................. ........................ 17980 0.8567 ........................

020008 ............................................................................................................. ........................ 02 ........................ 1.2776 

050549 ............................................................................................................. ........................ 42220 1.5477 ........................

060075 ............................................................................................................. ........................ 06 ........................ 1.1429 

070005 ............................................................................................................. ........................ 35004 1.2529 ........................

070006 ............................................................................................................. * 35644 1.2867 ........................

070010 ............................................................................................................. ........................ 35644 1.2867 ........................

070016 ............................................................................................................. ........................ 35004 1.2529 ........................

070017 ............................................................................................................. ........................ 35004 1.2529 ........................

070018 ............................................................................................................. * 35644 1.2867 ........................

070019 ............................................................................................................. ........................ 35004 1.2529 ........................

070022 ............................................................................................................. ........................ 35004 1.2529 ........................

070028 ............................................................................................................. ........................ 35644 1.2867 ........................

070031 ............................................................................................................. ........................ 35004 1.2529 ........................

070034 ............................................................................................................. * 35644 1.2867 ........................

070036 ............................................................................................................. ........................ 25540 ........................ 1.3329 

070039 ............................................................................................................. ........................ 35004 1.2529 ........................

150034 ............................................................................................................. ........................ 16974 1.0386 ........................

160040 ............................................................................................................. ........................ 16300 0.8759 ........................

160064 ............................................................................................................. ........................ 16 ........................ 0.9501 

160067 ............................................................................................................. ........................ 16300 0.8759 ........................

160110 ............................................................................................................. ........................ 16300 0.8759 ........................

220046 ............................................................................................................. ........................ 14484 1.1629 ........................

230003 ............................................................................................................. ........................ 28020 0.9930 ........................

230004 ............................................................................................................. ........................ 28020 0.9930 ........................

230013 ............................................................................................................. ........................ 22420 1.0781 ........................

230019 ............................................................................................................. ........................ 22420 1.0781 ........................

230020 ............................................................................................................. ........................ 11460 1.0057 ........................

230024 ............................................................................................................. ........................ 11460 1.0057 ........................

230029 ............................................................................................................. ........................ 22420 1.0781 ........................

230036 ............................................................................................................. ........................ 22420 1.0781 ........................

230038 ............................................................................................................. ........................ 28020 0.9930 ........................

230053 ............................................................................................................. ........................ 11460 1.0057 ........................

230059 ............................................................................................................. ........................ 28020 0.9930 ........................

230066 ............................................................................................................. ........................ 28020 0.9930 ........................

230071 ............................................................................................................. ........................ 22420 1.0781 ........................

230072 ............................................................................................................. ........................ 28020 0.9930 ........................

230089 ............................................................................................................. ........................ 11460 1.0057 ........................

230097 ............................................................................................................. ........................ 28020 0.9930 ........................

230104 ............................................................................................................. ........................ 11460 1.0057 ........................

230106 ............................................................................................................. ........................ 28020 0.9930 ........................

230130 ............................................................................................................. ........................ 22420 1.0781 ........................

230135 ............................................................................................................. ........................ 11460 1.0057 ........................

230146 ............................................................................................................. ........................ 11460 1.0057 ........................

230151 ............................................................................................................. ........................ 22420 1.0781 ........................

230165 ............................................................................................................. ........................ 11460 1.0057 ........................

230174 ............................................................................................................. ........................ 28020 0.9930 ........................

230176 ............................................................................................................. ........................ 11460 1.0057 ........................

230207 ............................................................................................................. ........................ 22420 1.0781 ........................

230236 ............................................................................................................. ........................ 28020 0.9930 ........................

230254 ............................................................................................................. ........................ 22420 1.0781 ........................

230269 ............................................................................................................. ........................ 22420 1.0781 ........................

230270 ............................................................................................................. ........................ 11460 1.0057 ........................

230273 ............................................................................................................. ........................ 11460 1.0057 ........................

230277 ............................................................................................................. ........................ 22420 1.0781 ........................

250002 ............................................................................................................. ........................ 25060 0.8443 ........................

250078 ............................................................................................................. * 25060 0.8443 ........................

250122 ............................................................................................................. ........................ 25060 0.8443 ........................

310021 ............................................................................................................. ........................ 35644 1.2867 ........................

310028 ............................................................................................................. ........................ 35644 1.2867 ........................

310050 ............................................................................................................. ........................ 35644 1.2867 ........................

310051 ............................................................................................................. ........................ 35644 1.2867 ........................

310060 ............................................................................................................. ........................ 35644 1.2867 ........................

310115 ............................................................................................................. ........................ 35644 1.2867 ........................

310120 ............................................................................................................. ........................ 35644 1.2867 ........................

330023 ............................................................................................................. * 35644 1.2867 ........................

330049 ............................................................................................................. ........................ 35644 1.2867 ........................

330067 ............................................................................................................. * 35644 1.2867 ........................

mstockstill on DSKH9S0YB1PROD with NOTICES

Federal Register / Vol. 76, No. 67 / Thursday, April 7, 2011 / Notices 19373 

TABLE 9B.—HOSPITAL RECLASSIFICATIONS AND REDESIGNATIONS BY INDIVIDUAL HOSPITAL UNDER SECTION 508 OF

PUBLIC LAW 108–173—FY 2011—Continued 

CCN Note Geographic 

CBSA 

Wage index 

CBSA section 

508 reclassification 

Own wage 

index 

330106 ............................................................................................................. ........................ 35004 ........................ 1.4341 

330126 ............................................................................................................. ........................ 35644 1.2867 ........................

330135 ............................................................................................................. ........................ 35644 1.2867 ........................

330205 ............................................................................................................. ........................ 35644 1.2867 ........................

330264 ............................................................................................................. ........................ 35004 1.2529 ........................

340002 ............................................................................................................. ........................ 16740 0.9087 ........................

390001 ............................................................................................................. ........................ 10900 0.9370 ........................

390003 ............................................................................................................. ........................ 10900 0.9370 ........................

390045 ............................................................................................................. ** 10900 0.9370 ........................

390072 ............................................................................................................. ........................ 10900 0.9370 ........................

390095 ............................................................................................................. ........................ 10900 0.9370 ........................

390119 ............................................................................................................. ........................ 10900 0.9370 ........................

390137 ............................................................................................................. ........................ 10900 0.9370 ........................

390169 ............................................................................................................. ........................ 10900 0.9370 ........................

390185 ............................................................................................................. ........................ 29540 0.9852 ........................

390192 ............................................................................................................. ........................ 10900 0.9370 ........................

390237 ............................................................................................................. ........................ 10900 0.9370 ........................

390270 ............................................................................................................. ........................ 29540 0.9852 ........................

430005 ............................................................................................................. ........................ 39660 1.0934 ........................

470003 ............................................................................................................. ........................ 14484 1.1629 ........................

490001 ............................................................................................................. ........................ 31340 0.8514 ........................

530015 ............................................................................................................. ........................ 53 ........................ 1.0577 

* These hospitals are assigned a wage index value under a special exceptions policy (see FY 2005 IPPS final rule, 69 FR 49105). 

** This hospital has been assigned a wage index under a special exceptions policy (see FY 2007 IPPS final rule, 71 FR 48070). 

[FR Doc. 2011–8209 Filed 4–6–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

The 14th Annual Food and Drug 

Administration-Orange County 

Regulatory Affairs Educational 

Conference in Irvine, California: New 

Regulatory Challenges 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of conference. 

The Food and Drug Administration 

(FDA) is announcing the following 

conference: 14th Annual Educational 

Conference co-sponsored with the 

Orange County Regulatory Affairs 

Discussion Group (OCRA). The 

conference is intended to provide the 

drug, device, biologics, and dietary 

supplement industries with an 

opportunity to interact with FDA 

reviewers and compliance officers from 

the centers and District Offices, as well 

as from other industry experts. The 

main focus of this interactive conference 

will be product approval, compliance, 

and risk management in the three 

medical product areas. Industry 

speakers, interactive Q & A, and 

workshop sessions will also be included 

to assure open exchange and dialogue 

on the relevant regulatory issues. 

Date and Time: The conference will 

be held on June 8 and 9, 2011, from 7:30 

a.m. to 5 p.m. 

Location: The conference will be held 

at the Irvine Marriott Hotel, 18000 Von 

Karman Ave., Irvine, CA 92612. 

Contact: Linda Hartley, Office of 

Regulatory Affairs, Food and Drug 

Administration, 19701 Fairchild, Irvine, 

CA 92612, Voice: 949–608–4413, Fax: 

949–608–4417; or Orange County 

Regulatory Affairs Discussion Group, 

Attention to Detail, 5319 University Dr., 

suite 641, Irvine, CA 92612, Voice: 949– 

387–9046, Fax: 949–387–9047, Web site: 

http://www.ocra-dg.org. (FDA has 

verified the Web site address, but FDA 

is not responsible for any subsequent 

changes to the Web site after this 

document publishes in the Federal 

Register.) 

Registration and Meeting Information: 

See OCRA’s Web site at http:// 

www.ocra-dg.org. Contact Attention to 

Detail at 949–387–9046. 

Before May 1, 2011, registrations fees 

are as follows: $675.00 for members, 

$725.00 for non-members and $475.00 

for FDA/Government/Students.* After 

May 1, 2011, $725.00 for members, 

$775.00 for non-members, and $475.00 

for FDA/Government/Students.* 

* OCRA student rate applies to those 

individuals enrolled in a regulatory or 

quality-related academic program at an 

accredited institution. Proof of 

enrollment required. 

The registration fee will cover actual 

expenses including refreshments, lunch, 

materials, parking, and speaker 

expenses. 

If you need special accommodations 

due to a disability, please contact Linda 

Hartley (see Contact) at least 10 days in 

advance. 

Transcripts: Transcripts will not be 

available for the conference. 

Dated: April 1, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–8283 Filed 4–6–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0443] 

Cathryn Lyn Chatman (also known as 

Cathryn Lyn Garcia): Debarment Order 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is issuing an 

order under the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) debarring 

mstockstill on DSKH9S0YB1PROD with NOTICES