Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Notices 68799 

We base our projections for CY 2011 

on— (1) current historical data; and (2) 

projection assumptions derived from 

current law and the Mid-Session Review 

of the President’s Fiscal Year 2011 

Budget. 

We estimate that in CY 2011, 

39,315,092 people aged 65 years and 

over will be entitled to benefits (without 

premium payment) and that they will 

incur about $212.435 billion in benefits 

and related administrative costs. Thus, 

the estimated monthly average per 

capita amount is $450.28 and the 

monthly premium is $450. The full 

monthly premium reduced by 45 

percent is $248. 

IV. Costs to Beneficiaries 

The CY 2011 premium of $450 is 

approximately 2 percent lower than the 

CY 2010 premium of $461. 

We estimate that approximately 

571,000 enrollees will voluntarily enroll 

in Medicare Part A by paying the full 

premium. We estimate an additional 

40,000 enrollees will pay the reduced 

premium. We estimate that the aggregate 

savings to enrollees paying these 

premiums in CY 2011, compared to the 

amount that they paid in CY 2010, will 

be about $78 million. 

V. Waiver of Proposed Notice and 

Comment Period 

We are not using notice and comment 

rulemaking in this notification of 

Medicare Part A premiums for CY 2011 

as that procedure is unnecessary 

because of the lack of discretion in the 

statutory formula that is used to 

calculate the premium and the solely 

ministerial function that this notice 

serves. The Administrative Procedure 

Act (APA) permits agencies to waive 

notice and comment rulemaking when 

notice and public comment thereon are 

unnecessary. On this basis, we waive 

publication of a proposed notice and a 

solicitation of public comments. 

VI. 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. 35). 

VII. Regulatory Impact Statement 

We have examined the impacts of this 

final rule as required by Executive 

Order 12866 on Regulatory Planning 

and Review (September 30, 1993), 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 Order 12866 directs 

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). As stated in section IV 

of this notice, we estimate that the 

overall effect of these changes in the 

Part A premium will be a savings to 

voluntary enrollees (section 1818 and 

section 1818A of the Act) of about $78 

million. Therefore, this notice is a not 

a major rule as defined in Title 5, 

United States Code, section 804(2) and 

is not an economically significant rule 

under Executive Order 12866. 

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 

government agencies. Most hospitals 

and most other providers and suppliers 

are small entities, either by nonprofit 

status or by having revenues of $7 

million to $34.5 million in any 1 year. 

Individuals and States are not included 

in the definition of a small entity. We 

have determined that this notice will 

not have a significant economic impact 

on a substantial number of small 

entities. Therefore, we are not preparing 

an analysis under the RFA. 

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 and has 

fewer than 100 beds. The Secretary has 

determined that this notice will not 

have a significant impact on the 

operations of a substantial number of 

small rural hospitals. Therefore, we are 

not preparing an analysis under section 

1102(b) of the Act. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

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 2010, that threshold is approximately 

$135 million. This notice has no 

consequential effect on State, local, or 

tribal governments or on the private 

sector. However, States are required to 

pay the premiums for dually-eligible 

beneficiaries. 

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 or local governments. 

In accordance with the provisions of 

Executive Order 12866, this notice was 

reviewed by the Office of Management 

and Budget. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance) 

Dated: September 9, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: October 29, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–28250 Filed 11–4–10; 2:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–8040–N] 

RIN 0938–AP86 

Medicare Program; Inpatient Hospital 

Deductible and Hospital and Extended 

Care Services Coinsurance Amounts 

for CY 2011 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

inpatient hospital deductible and the 

hospital and extended care services 

coinsurance amounts for services 

furnished in calendar year (CY) 2011 

under Medicare’s Hospital Insurance 

Program (Medicare Part A). The 

Medicare statute specifies the formulae 

used to determine these amounts. For 

CY 2011, the inpatient hospital 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
68800 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Notices 

deductible will be $1132. The daily 

coinsurance amounts for CY 2011 will 

be—(a) $283 for the 61st through 90th 

day of hospitalization in a benefit 

period; (b) $566 for lifetime reserve 

days; and (c) $141.50 for the 21st 

through 100th day of extended care 

services in a skilled nursing facility in 

a benefit period. 

DATES: Effective Date: This notice is 

effective on January 1, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Clare McFarland, (410) 786–6390 for 

general information. Gregory J. Savord, 

(410) 786–1521 for case-mix analysis. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 1813 of the Social Security 

Act (the Act) provides for an inpatient 

hospital deductible to be subtracted 

from the amount payable by Medicare 

for inpatient hospital services furnished 

to a beneficiary. It also provides for 

certain coinsurance amounts to be 

subtracted from the amounts payable by 

Medicare for inpatient hospital and 

extended care services. Section 

1813(b)(2) of the Act requires us to 

determine and publish each year the 

amount of the inpatient hospital 

deductible and the hospital and 

extended care services coinsurance 

amounts applicable for services 

furnished in the following CY. 

II. Computing the Inpatient Hospital 

Deductible for CY 2011 

Section 1813(b) of the Act prescribes 

the method for computing the amount of 

the inpatient hospital deductible. The 

inpatient hospital deductible is an 

amount equal to the inpatient hospital 

deductible for the preceding CY, 

adjusted by our best estimate of the 

payment-weighted average of the 

applicable percentage increases (as 

defined in section 1886(b)(3)(B) of the 

Act) used for updating the payment 

rates to hospitals for discharges in the 

fiscal year (FY) that begins on October 

1 of the same preceding CY, and 

adjusted to reflect changes in real casemix. The adjustment to reflect real casemix is determined on the basis of the 

most recent case-mix data available. The 

amount determined under this formula 

is rounded to the nearest multiple of $4 

(or, if midway between two multiples of 

$4, to the next higher multiple of $4). 

Under section 1886(b)(3)(B)(i)(XX) of 

the Act, the percentage increase used to 

update the payment rates for FY 2011 

for hospitals paid under the inpatient 

prospective payment system is the 

market basket percentage increase, 

otherwise known as the market basket 

update, reduced by .25 percentage 

points. Under section 1886(b)(3)(B)(viii) 

of the Act, hospitals will receive this 

update only if they submit quality data 

as specified by the Secretary. The 

update for hospitals that do not submit 

this data is reduced by 2.0 percentage 

points. We are estimating that after 

accounting for those hospitals receiving 

the lower market basket update in the 

payment-weighted average update, the 

calculated deductible will remain the 

same. 

Under section 1886(b)(3)(B)(ii)(VIII) of 

the Act, the percentage increase used to 

update the payment rates for FY 2011 

for hospitals excluded from the 

inpatient prospective payment system is 

the market basket percentage increase 

reduced by .5 percentage points for 

Long Term Care Hospitals and reduced 

by .25 percentage points for Inpatient 

Rehabilitation facilities and Psychiatric 

Hospitals, defined according to section 

1886(b)(3)(B)(iii) of the Act. 

The market basket percentage increase 

for 2011 is 2.6 percent, as announced in 

the final rule with comment period 

published in the Federal Register on 

August 16, 2010 entitled, ‘‘Medicare 

Program; Changes to the Hospital 

Inpatient Prospective Payment Systems 

for Acute Care Hospitals and Fiscal Year 

2011 Rates; and Changes to the LongTerm Care Hospital Prospective 

Payment System and Rate Years 2011 

and 2010 Rates (IPPS/RY 2011 LTCH 

PPS) (75 FR 50042–50677).’’ Therefore, 

the percentage increase for hospitals 

paid under the inpatient prospective 

payment system is 2.35 percent. The 

average payment percentage increase for 

hospitals excluded from the inpatient 

prospective payment system is 2.73 

percent. Weighting these percentages in 

accordance with payment volume, our 

best estimate of the payment-weighted 

average of the increases in the payment 

rates for FY 2011 is 2.40 percent. 

To develop the adjustment to reflect 

changes in real case-mix, we first 

calculated for each hospital an average 

case-mix that reflects the relative 

costliness of that hospital’s mix of cases 

compared to those of other hospitals. 

We then computed the change in 

average case-mix for hospitals paid 

under the Medicare prospective 

payment system in FY 2010 compared 

to FY 2009. (We excluded from this 

calculation hospitals whose payments 

are not based on the inpatient 

prospective payment system because 

their payments are based on alternate 

prospective payment systems or 

reasonable costs.) We used Medicare 

bills from prospective payment 

hospitals that we received as of July 

2010. These bills represent a total of 

about 8.5 million Medicare discharges 

for FY 2010 and provide the most recent 

case-mix data available at this time. 

Based on these bills, the change in 

average case-mix in FY 2010 is 0.3 

percent. Based on these bills and past 

experience, we expect the overall case 

mix change to be 0.5 percent as the year 

progresses and more FY 2010 data 

become available. 

Section 1813 of the Act requires that 

the inpatient hospital deductible be 

adjusted only by that portion of the 

case-mix change that is determined to 

be real. In the FY 2011 IPPS/RY 2011 

LTCH PPS final rule with comment 

period, we indicated that we believe the 

adoption of the Medicare severity-based 

diagnosis-related groups (MS–DRGs) led 

to increases in aggregate payments 

without a corresponding increase in 

actual patient severity of illness due to 

the incentives for improved 

documentation and coding. In that final 

rule with comment period, we estimated 

that changes in coding or classification 

that do not reflect real change in casemix would be 0.0 percent for FY 2010. 

Therefore, since we are expecting 

overall case mix to increase by 0.5 

percent and 0.0 percent of that to be 

caused by coding changes, real case mix 

changes resulted in an increase of 0.5 

percent for FY 2010. 

Thus, the estimate of the paymentweighted average of the applicable 

percentage increases used for updating 

the payment rates is 2.40 percent, and 

the real case-mix adjustment factor for 

the deductible is 0.5 percent. Therefore, 

under the statutory formula, the 

inpatient hospital deductible for 

services furnished in CY 2011 is $1132. 

This deductible amount is determined 

by multiplying $1100 (the inpatient 

hospital deductible for CY 2010) by the 

payment-weighted average increase in 

the payment rates of 1.0240 multiplied 

by the increase in real case-mix of 1.005, 

which equals $1132.03 and is rounded 

to $1132. 

III. Computing the Inpatient Hospital 

and Extended Care Services 

Coinsurance Amounts for CY 2011 

The coinsurance amounts provided 

for in section 1813 of the Act are 

defined as fixed percentages of the 

inpatient hospital deductible for 

services furnished in the same CY. The 

increase in the deductible generates 

increases in the coinsurance amounts. 

For inpatient hospital and extended care 

services furnished in CY 2011, in 

accordance with the fixed percentages 

defined in the law, the daily 

coinsurance for the 61st through 90th 

day of hospitalization in a benefit 

period will be $283 (one-fourth of the 

inpatient hospital deductible); the daily 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Notices 68801 

coinsurance for lifetime reserve days 

will be $566 (one-half of the inpatient 

hospital deductible); and the daily 

coinsurance for the 21st through 100th 

day of extended care services in a 

skilled nursing facility in a benefit 

period will be $141.50 (one-eighth of 

the inpatient hospital deductible). 

IV. Cost to Medicare Beneficiaries 

Table 1 below summarizes the 

deductible and coinsurance amounts for 

CYs 2010 and 2011, as well as the 

number of each that is estimated to be 

paid. 

TABLE 1—PART A DEDUCTIBLE AND COINSURANCE AMOUNTS FOR CALENDAR YEARS 2010 AND 2011 

Type of cost sharing 

Value Number paid (in millions) 

2010 2011 2010 2011 

Inpatient hospital deductible ........................................................................................ $1100 $1132 8.40 8.59 

Daily coinsurance for 61st–90th Day .......................................................................... $275 $283 2.25 2.30 

Daily coinsurance for lifetime reserve days ................................................................ $550 $566 1.13 1.16 

SNF coinsurance ......................................................................................................... $137 .50 $141 .50 42.41 43.66 

The estimated total increase in costs 

to beneficiaries is about $900 million 

(rounded to the nearest $10 million) due 

to— (1) the increase in the deductible 

and coinsurance amounts; and (2) the 

change in the number of deductibles 

and daily coinsurance amounts paid. 

V. Waiver of Proposed Notice and 

Comment Period 

The Medicare statute, as discussed 

previously, requires publication of the 

Medicare Part A inpatient hospital 

deductible and the hospital and 

extended care services coinsurance 

amounts for services for each CY. The 

amounts are determined according to 

the statute. As has been our custom, we 

use general notices, rather than notice 

and comment rulemaking procedures, to 

make the announcements. In doing so, 

we acknowledge that, under the 

Administrative Procedure Act (APA), 

interpretive rules, general statements of 

policy, and rules of agency organization, 

procedure, or practice are excepted from 

the requirements of notice and comment 

rulemaking. 

We considered publishing a proposed 

notice to provide a period for public 

comment. However, we may waive that 

procedure if we find good cause that 

prior notice and comment are 

impracticable, unnecessary, or contrary 

to the public interest. We find that the 

procedure for notice and comment is 

unnecessary because the formulae used 

to calculate the inpatient hospital 

deductible and hospital and extended 

care services coinsurance amounts are 

statutorily directed, and we can exercise 

no discretion in following the formulae. 

Moreover, the statute establishes the 

time period for which the deductible 

and coinsurance amounts will apply 

and delaying publication would be 

contrary to the public interest. 

Therefore, we find good cause to waive 

publication of a proposed notice and 

solicitation of public comments. 

VI. 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. 35). 

VII. Regulatory Impact Statement 

We have examined the impacts of this 

final rule as required by Executive 

Order 12866 on Regulatory Planning 

and Review (September 30, 1993), 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 Order 12866 directs 

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). As stated in section IV 

of this notice, we estimate that the total 

increase in costs to beneficiaries 

associated with this notice is about $900 

million due to— (1) The increase in the 

deductible and coinsurance amounts; 

and (2) the change in the number of 

deductibles and daily coinsurance 

amounts paid. Therefore, this notice is 

a major rule as defined in Title 5, 

United States Code, section 804(2), and 

is an economically significant rule 

under Executive Order 12866. 

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 

government agencies. 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 

have determined that this notice will 

not have a significant economic impact 

on a substantial number of small 

entities. Therefore, we are not preparing 

an analysis under the RFA. 

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 and has 

fewer than 100 beds. The Secretary has 

determined that this notice will not 

have a significant impact on the 

operations of a substantial number of 

small rural hospitals. Therefore, we are 

not preparing an analysis under section 

1102(b) of the Act. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 (UMRA) 

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 2010, that threshold is approximately 

$135 million. This notice has no 

consequential effect on State, local, or 

Tribal governments or on the private 

sector. However, States may be required 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
68802 Federal Register / Vol. 75, No. 216 / Tuesday, November 9, 2010 / Notices 

to pay the deductibles and coinsurance 

for dually-eligible beneficiaries. 

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 or local governments. 

In accordance with the provisions of 

Executive Order 12866, this notice was 

reviewed by the Office of Management 

and Budget. 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance) 

Dated: September 9, 2010. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Dated: October 29, 2010. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. 2010–28251 Filed 11–4–10; 2:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Secretary’s Advisory Committee on 

Heritable Disorders in Newborns and 

Children; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: Secretary’s Advisory Committee on 

Heritable Disorders in Newborns and 

Children. 

Dates and Times: January 27, 2011, 8:30 

a.m. to 5 p.m. January 28, 2011, 8:30 a.m. to 

3:30 p.m. 

Place: Renaissance Washington, DC 

Dupont Circle Hotel, 1143 New Hampshire 

Avenue, NW., Washington, DC 20037. 

Status: The meeting will be open to the 

public with attendance limited to space 

availability. Participants are asked to register 

for the meeting by going to the registration 

Web site at http://altarum.cvent.com/event/ 

SACHDNC012011. The registration deadline 

is Tuesday, January 25, 2011. Individuals 

who need special assistance, such as sign 

language interpretation or other reasonable 

accommodations should indicate their needs 

on the registration Web site. The deadline for 

special accommodation requests is Friday, 

January 21, 2011. If there are technical 

problems gaining access to the Web site, 

please contact Maureen Ball, Meetings 

Coordinator at conferences@altarum.org. 

Purpose: The Secretary’s Advisory 

Committee on Heritable Disorders in 

Newborns and Children (Advisory 

Committee) was established to advise and 

guide the Secretary regarding the most 

appropriate application of universal newborn 

screening tests, technologies, policies, 

guidelines and programs for effectively 

reducing morbidity and mortality in 

newborns and children having or at risk for 

heritable disorders. The Advisory Committee 

also provides advice and recommendations 

concerning the grants and projects authorized 

under the Public Health Service Act, 42 

U.S.C. 300b–10, (Heritable Disorders 

Program) as amended in the Newborn 

Screening Saves Lives Act of 2008. 

Agenda: The meeting will include: (1) 

Presentations from the following Advisory 

Committee workgroups: Communications, 

Health Information Technology, and 

Evidence Review; (2) a report from a National 

Survey of Recent and Prospective Mothers 

about Newborn Screening; and (3) 

presentations on the continued work and 

reports of the Advisory Committee’s 

subcommittees on laboratory standards and 

procedures, follow-up and treatment, and 

education and training. Proposed Agenda 

items are subject to change as priorities 

dictate. You can locate the Agenda, 

Committee Roster and Charter, presentations, 

and meeting materials at the home page of 

the Advisory Committee’s Web site at 

http://www.hrsa.gov/ 

heritabledisorderscommittee/. 

Public Comments: Members of the public 

can present oral comments during the public 

comment periods of the meeting, which are 

scheduled for both days of the meeting. 

Those individuals who want to make a 

comment are requested to register online by 

Tuesday, January 25, 2011, at http:// 

altarum.cvent.com/event/SACHDNC012011. 

Requests will contain the name, address, 

telephone number, and any professional or 

business affiliation of the person desiring to 

make an oral presentation. Groups having 

similar interests are requested to combine 

their comments and present them through a 

single representative. The list of public 

comment participants will be posted on the 

Web site. Written comments should be emailed via e-mail no later than Tuesday, 

January 25, 2011, for consideration. 

Comments should be submitted to Maureen 

Ball, Meetings Coordinator, Conference and 

Meetings Management, Altarum Institute, 

1200 18th Street, NW., Suite 700, 

Washington, DC 20036, telephone: 202 828– 

5100; fax: 202 785–3083, or e-mail: 

conferences@altarum.org. 

Contact Person: Anyone interested in 

obtaining other relevant information should 

write or contact Alaina M. Harris, Maternal 

and Child Health Bureau, Health Resources 

and Services Administration, Room 18A–19, 

Parklawn Building, 5600 Fishers Lane, 

Rockville, Maryland 20857, Telephone (301) 

443–0721, aharris@hrsa.gov. More 

information on the Advisory Committee is 

available at http://mchb.hrsa.gov/ 

heritabledisorderscommittee. 

Dated: November 2, 2010. 

Robert Hendricks, 

Director, Division of Policy and Information 

Coordination. 

[FR Doc. 2010–28188 Filed 11–8–10; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0369] 

Report on the Performance of Drug 

and Biologics Firms in Conducting 

Postmarketing Requirements and 

Commitments; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: Under the Food and Drug 

Administration Modernization Act of 

1997 (Modernization Act), the Food and 

Drug Administration (FDA) is required 

to report annually in the Federal 

Register on the status of postmarketing 

requirements and commitments 

required of, or agreed upon by, holders 

of approved drug and biological 

products. This notice is the Agency’s 

report on the status of the studies and 

clinical trials that applicants have 

agreed to or are required to conduct. 

FOR FURTHER INFORMATION CONTACT: 

Cathryn C. Lee, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 6464, 

Silver Spring, MD 20993–0002, 301– 

796–0700; or 

Robert Yetter, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 1400 

Rockville Pike, Rockville, MD 20852, 

301–827–0373. 

SUPPLEMENTARY INFORMATION: 

I. Background 

A. The Modernization Act 

Section 130(a) of the Modernization 

Act (Pub. L. 105–115) amended the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) by adding a new 

provision requiring reports of certain 

postmarketing studies, including 

clinical trials, for human drug and 

biological products (section 506B of the 

FD&C Act (21 U.S.C. 356b)). Section 

506B of the FD&C Act provides FDA 

with additional authority to monitor the 

progress of a postmarketing study or 

clinical trial that an applicant has been 

required to or has agreed to conduct by 

requiring the applicant to submit a 

report annually providing information 


wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1