Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Notices 54581 

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 $730 

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 2009, that threshold is approximately 

$133 million. This notice has no 

consequential effect on State, local, or 

Tribal governments or on the private 

sector. However, States may be required 

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 1, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Dated: September 17, 2009. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. E9–25372 Filed 10–16–09; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–8038–N] 

RIN 0938–AP43 

Medicare Program; Part A Premium for 

Calendar Year 2010 for the Uninsured 

Aged and for Certain Disabled 

Individuals Who Have Exhausted Other 

Entitlement 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This annual notice announces 

Medicare’s Hospital Insurance (Part A) 

premium for uninsured enrollees in 

calendar year (CY) 2010. This premium 

is paid by enrollees age 65 and over who 

are not otherwise eligible for benefits 

under Medicare Part A (hereafter known 

as the ‘‘uninsured aged’’) and by certain 

disabled individuals who have 

exhausted other entitlement. The 

monthly Part A premium for the 12 

months beginning January 1, 2010 for 

these individuals will be $461. The 

reduced premium for certain other 

individuals as described in this notice 

will be $254. 

DATES: Effective Date: This notice is 

effective on January 1, 2010. 

FOR FURTHER INFORMATION CONTACT: 

Clare McFarland, (410) 786–6390. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Section 1818 of the Social Security 

Act (the Act) provides for voluntary 

enrollment in the Medicare Hospital 

Insurance Program (Medicare Part A), 

subject to payment of a monthly 

premium, of certain persons aged 65 

and older who are uninsured under the 

Old-Age, Survivors, and Disability 

Insurance (OASDI) program or the 

Railroad Retirement Act and do not 

otherwise meet the requirements for 

entitlement to Medicare Part A. (Persons 

insured under the OASDI program or 

the Railroad Retirement Act and certain 

others do not have to pay premiums for 

Medicare Part A.) 

Section 1818A of the Act provides for 

voluntary enrollment in Medicare Part 

A, subject to payment of a monthly 

premium of certain disabled individuals 

who have exhausted other entitlement. 

These are individuals who were entitled 

to coverage due to a disabling 

impairment under section 226(b) of the 

Act, but are no longer entitled to 

disability benefits and free Medicare 

Part A coverage because they have gone 

back to work and their earnings exceed 

the statutorily defined ‘‘substantial 

gainful activity’’ amount (section 

223(d)(4) of the Act). 

Section 1818A(d)(2) of the Act 

specifies that the provisions relating to 

premiums under section 1818(d) 

through section 1818(f) of the Act for 

the aged will also apply to certain 

disabled individuals as described above. 

Section 1818(d) of the Act requires us 

to estimate, on an average per capita 

basis, the amount to be paid from the 

Federal Hospital Insurance Trust Fund 

for services incurred in the following 

calendar year (CY) (including the 

associated administrative costs) on 

behalf of individuals aged 65 and over 

who will be entitled to benefits under 

Medicare Part A. We must then 

determine, during September of each 

year, the monthly actuarial rate for the 

following year (the per capita amount 

estimated above divided by 12) and 

publish the dollar amount for the 

monthly premium in the succeeding CY. 

If the premium is not a multiple of $1, 

the premium is rounded to the nearest 

multiple of $1 (or, if it is a multiple of 


dcolon on DSK2BSOYB1PROD with NOTICES
54582 Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Notices 

50 cents but not of $1, it is rounded to 

the next highest $1). 

Section 13508 of the Omnibus Budget 

Reconciliation Act of 1993 (Pub. L. 103– 

66) amended section 1818(d) of the Act 

to provide for a reduction in the 

premium amount for certain voluntary 

enrollees (section 1818 and section 

1818A of the Act). The reduction 

applies to an individual who is eligible 

to buy into the Medicare Part A program 

and who, as of the last day of the 

previous month— 

• Had at least 30 quarters of coverage 

under Title II of the Act; 

• Was married, and had been married 

for the previous 1-year period, to a 

person who had at least 30 quarters of 

coverage; 

• Had been married to a person for at 

least 1 year at the time of the person’s 

death if, at the time of death, the person 

had at least 30 quarters of coverage; or 

• Is divorced from a person and had 

been married to the person for at least 

10 years at the time of the divorce if, at 

the time of the divorce, the person had 

at least 30 quarters of coverage. 

Section 1818(d)(4)(A) of the Act 

specifies that the premium that these 

individuals will pay for CY 2010 will be 

equal to the premium for uninsured 

aged enrollees reduced by 45 percent. 

II. Monthly Premium Amount for CY 

2010 

The monthly premium for the 

uninsured aged and certain disabled 

individuals who have exhausted other 

entitlement for the 12 months beginning 

January 1, 2010, is $461. 

The monthly premium for those 

individuals subject to the 45 percent 

reduction in the monthly premium is 

$254. 

III. Monthly Premium Rate Calculation 

As discussed in section I of this 

notice, the monthly Medicare Part A 

premium is equal to the estimated 

monthly actuarial rate for CY 2010 

rounded to the nearest multiple of $1 

and equals one-twelfth of the average 

per capita amount, which is determined 

by projecting the number of Part A 

enrollees aged 65 years and over as well 

as the benefits and administrative costs 

that will be incurred on their behalf. 

The steps involved in projecting these 

future costs to the Federal Hospital 

Insurance Trust Fund are: 

• Establishing the present cost of 

services furnished to beneficiaries, by 

type of service, to serve as a projection 

base; 

• Projecting increases in payment 

amounts for each of the service types; 

and 

• Projecting increases in 

administrative costs. 

We base our projections for CY 2010 

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

projection assumptions derived from 

current law and the Mid-Session Review 

of the President’s Fiscal Year 2010 

Budget. 

We estimate that in CY 2010, 

38,086,139 people aged 65 years and 

over will be entitled to benefits (without 

premium payment) and that they will 

incur about $210.795 billion in benefits 

and related administrative costs. Thus, 

the estimated monthly average per 

capita amount is $461.22 and the 

monthly premium is $461. The full 

monthly premium reduced by 45 

percent is $254. 

IV. Costs to Beneficiaries 

The CY 2010 premium of $461 is 

approximately 4 percent higher than the 

CY 2009 premium of $443. 

We estimate that approximately 

558,000 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 

cost to enrollees paying these premiums 

will be about $125 million in CY 2010 

more than the amount that they paid in 

CY 2009. 

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 2010, 

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. 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 an increased 

cost to voluntary enrollees (section 1818 

and section 1818A of the Act) of about 

$125 million. 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 

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 2009, that threshold is approximately 

$133 million. This notice has no 

consequential effect on State, local, or 

tribal governments or on the private 

sector. However, States are required to 


dcolon on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Notices 54583 

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 1, 2009. 

Charlene Frizzera, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Dated: September 17, 2009. 

Kathleen Sebelius, 

Secretary. 

[FR Doc. E9–25371 Filed 10–16–09; 4:15 pm] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Radiological Devices Panel of the 

Medical Devices Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Radiological Devices 

Panel of the Medical Devices Advisory 

Committee. 

General Function of the Committee: To 

provide advice and recommendations to the 

agency on FDA’s regulatory issues. 

Date and Time: The meeting will be held 

on November 17 and 18, 2009, from 8 a.m. 

to 5:30 p.m. 

Location: Holiday Inn, Ballroom, Two 

Montgomery Village Ave., Gaithersburg, MD. 

Contact Person: Toby Lowe, Center for 

Devices and Radiological Health, Food and 

Drug Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993, 301–796– 

6512, or FDA Advisory Committee 

Information Line, 1–800–741–8138 (301– 

443–0572 in the Washington, DC area), code 

3014512526. Please call the Information Line 

for up-to-date information on this meeting. A 

notice in the Federal Register about last 

minute modifications that impact a 

previously announced advisory committee 

meeting cannot always be published quickly 

enough to provide timely notice. Therefore, 

you should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn about 

possible modifications before coming to the 

meeting. 

Agenda: On November 17, 2009, the 

committee will discuss and make 

recommendations regarding the agency’s 

regulatory strategy for Full Field Digital 

Mammography (FFDM) Devices. The 

committee will discuss the public comments 

received in response to the publication of the 

draft guidance document entitled ‘‘Class II 

Special Controls Guidance Document: Full 

Field Digital Mammography System.’’ This 

guidance document can be found on the FDA 

Web site at http://www.fda.gov/ 

MedicalDevices/DeviceRegulation

andGuidance/GuidanceDocuments/ 

ucm107552.htm. 

On November 18, 2009, the committee will 

discuss and make recommendations 

regarding the agency’s regulatory strategy for 

computer-assisted detection (CADe) devices 

for radiological devices. CADe devices are 

devices intended to identify, mark, highlight 

or in any other manner direct attention to 

potential abnormalities revealed in 

radiological data of the human body or 

imaging device data during interpretation of 

patient images or patient imaging data by a 

physician or other health care professional. 

The committee will discuss two draft 

guidance documents entitled ‘‘ComputerAssisted Detection Devices Applied to 

Radiology Images and Radiology Device 

Data—Premarket Notification [510(k)] 

Submissions’’ and ‘‘Clinical Performance 

Assessment: Considerations for ComputerAssisted Detection Devices Applied to 

Radiology Images and Radiology Device 

Data—Premarket Approval (PMA) and 

Premarket Notification [510(k)] 

Submissions.’’ These guidance documents 

can be found on the FDA Web site at http:// 

www.fda.gov/MedicalDevices/ 

DeviceRegulationandGuidance/Guidance

Documents. Type in the title of the guidance 

document included in this notice. The 

guidance documents will also be available as 

background materials. 

FDA intends to make background material 

available to the public no later than 2 

business days before the meeting. If FDA is 

unable to post the background material on its 

Web site prior to the meeting, the background 

material will be made publicly available at 

the location of the advisory committee 

meeting, and the background material will be 

posted on FDA’s Web site after the meeting. 

Background material is available at http:// 

www.fda.gov/AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the appropriate 

advisory committee link. 

Procedure: Interested persons may present 

data, information, or views, orally or in 

writing, on issues pending before the 

committee. Written submissions may be 

made to the contact person on or before 

November 12, 2009. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. and 2 p.m. on both 

days. Those desiring to make formal oral 

presentations should notify the contact 

person and submit a brief statement of the 

general nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and an 

indication of the approximate time requested 

to make their presentation on or before 

November 6, 2009. Time allotted for each 

presentation may be limited. If the number of 

registrants requesting to speak is greater than 

can be reasonably accommodated during the 

scheduled open public hearing session, FDA 

may conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by November 9, 2009. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee meetings 

and will make every effort to accommodate 

persons with physical disabilities or special 

needs. If you require special accommodations 

due to a disability, please contact AnnMarie 

Williams, Conference Management Staff, 

301–796–5966, at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly conduct 

of its advisory committee meetings. Please 

visit our Web site at http://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for procedures 

on public conduct during advisory 

committee meetings. 

Notice of this meeting is given under the 

Federal Advisory Committee Act (5 U.S.C. 

app. 2). 

Dated: October 16, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25406 Filed 10–21–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

Scientific Management Review Board. 

The NIH Reform Act of 2006 (Pub. 

L.109–482) provides organizational 

authorities to HHS and NIH officials to: 

(1) Establish or abolish national research 

institutes; (2) reorganize the offices 

within the Office of the Director, NIH 

including adding, removing, or 

transferring the functions of such offices 

or establishing or terminating such 

offices; and (3) reorganize, divisions, 

centers, or other administrative units 

within an NIH national research 


dcolon on DSK2BSOYB1PROD with NOTICES