54570 Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Notices 

TRANSACTION GRANTED EARLY TERMINATION—Continued 

ET date Trans No. ET req 

status Party name 

G Tilton Energy LLC. 

G Griffith Energy LLC. 

G Dynegy Arlington Valley, LLC. 

G Rocky Road Power, LLC. 

20090690 G General Motors Company. 

G Delphi Corporation. 

G DIP Holdco LLP. 

03–SEP–09 ............................................................ 20090401 G Fidelity National Information Services, Inc. 

G Metavante Technologies, Inc. 

G Metavante Technologies, Inc. 

04–SEP–09 ............................................................ 20090697 G Electric Power Development Co., Ltd. 

G General Electric Company. 

G Birchwood Power Partners, L.P. 

20090702 G Joe and Marlene Ricketts Grandchildren’s Trust. 

G Tribune Company. 

G Chicago Baseball Holdings, LLC. 

20090704 G STG III, L.P. 

G MSC.Software Corporation. 

G MSC.Software Corporation. 

FOR FURTHER INFORMATION CONTACT: 

Sandra M. Peay, Contact Representative, 

or Renee Hallman, Contact 

Representative, Federal Trade 

Commission, Premerger Notification 

Office, Bureau of Competition, Room H– 

303, Washington, DC 20580, (202) 326– 

3100. 

By direction of the Commission. 

Donald S. Clark, 

Secretary. 

[FR Doc. E9–25377 Filed 10–21–09; 8:45 am] 

BILLING CODE 6750–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0474] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Inspection by 

Accredited Persons Program Under 

the Medical Device User Fee and 

Modernization Act of 2002 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the publication of the criteria FDA 

intends to use to accredit third parties 

to conduct inspections of eligible 

manufacturers of class II or class III 

medical devices. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 21, 2009. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3793. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Inspection by Accredited Persons 

Program Under the Medical Device 

User Fee and Modernization Act of 

2002; FD&C Act, Section 704(g) (OMB 

Control Number 0910–0510)—Extension 

The Medical Device User Fee and 

Modernization Act of 2002 (MDUFMA) 

(Public Law 107–250) was signed into 

law on October 26, 2002. Section 201 of 

MDUFMA adds a new paragraph ‘‘g’’ to 

section 704 of the Federal, Food, Drug, 

and Cosmetic Act (the FD&C Act) (21 

U.S.C. 374), directing FDA to accredit 

third parties (accredited persons (APs) 

to conduct inspections of eligible 

manufacturers of class II or class III 

devices. This is a voluntary program. 


dcolon on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 74, No. 203 / Thursday, October 22, 2009 / Notices 54571 

FDA has a guidance document that 

provides information for those 

interested in participating in this 

program. The guidance is entitled 

‘‘Implementation of the Inspection by 

Accredited Persons Program Under the 

Medical Device User Fee and 

Modernization Act of 2002; 

Accreditation Criteria.’’ 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

FD&C Act 

Section: 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

704(g) 3 1 3 80 240 

1There are no capital costs or operating and maintenance costs associated with this collection of information 

FDA based these estimates on 

conversations with industry, trade 

association representatives, and internal 

FDA estimates. Once an organization is 

accredited, it will not be required to 

reapply. 

Dated: October 7, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–25395 Filed 10–21–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Notice of Establishment 

Pursuant to the Federal Advisory 

Committee Act, as amended (5 U.S.C. 

Appendix 2), the Director, National 

Institutes of Health (NIH), announces 

the establishment of the 

Interdisciplinary Molecular Sciences 

and Training Integrated Review Group, 

(IRG). 

The IRG shall advise the Director, 

National Institutes of Health (NIH), and 

the Director, Center for Scientific 

Review (CSR), on the scientific and 

technical merit of applications for 

grants-in-aid for research, research 

training or research-related grants and 

cooperative agreements, or contract 

proposals relating to scientific areas 

relevant to biological chemistry, 

biophysics and cell biology, drug 

discovery and development, devices 

and detection systems, biomaterials, 

delivery systems and nanotechnology, 

computational biology, imaging and 

data mining, genes, genomes and 

genetics, environmental monitoring, and 

basic translational oncology. 

Duration of this committee will be 

continuing with no specified end date. 

Dated: October 9, 2009. 

Francis S. Collins, 

Director, National Institutes of Health. 

[FR Doc. E9–25374 Filed 10–21–09; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[CMS–8039–N] 

RIN 0938–AP48 

Medicare Program; Medicare Part B 

Monthly Actuarial Rates, Premium 

Rate, and Annual Deductible 

Beginning January 1, 2010 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

monthly actuarial rates for aged (age 65 

and over) and disabled (under age 65) 

beneficiaries enrolled in Part B of the 

Medicare Supplementary Medical 

Insurance (SMI) program beginning 

January 1, 2010. In addition, this notice 

announces the monthly premium for 

aged and disabled beneficiaries as well 

as the income-related monthly 

adjustment amounts to be paid by 

beneficiaries with modified adjusted 

gross income above certain threshold 

amounts. The monthly actuarial rates 

for 2010 are $221.00 for aged enrollees 

and $270.40 for disabled enrollees. The 

standard monthly Part B premium rate 

for 2010 is $110.50, which is equal to 

50 percent of the monthly actuarial rate 

for aged enrollees or roughly 25 percent 

of the expected average total cost of Part 

B coverage for aged enrollees. (The 2009 

standard premium rate was $96.40.) The 

Part B deductible for 2010 is $155.00 for 

all Part B beneficiaries. A beneficiary 

who has to pay an income-related 

monthly adjustment may have to pay a 

total monthly premium of roughly 35, 

50, 65 or 80 percent of the total cost of 

Part B coverage. 

DATES: Effective Date: January 1, 2010. 

FOR FURTHER INFORMATION CONTACT: M. 

Kent Clemens, (410) 786–6391. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Part B is the voluntary portion of the 

Medicare program that pays all or part 

of the costs for physicians’ services, 

outpatient hospital services, certain 

home health services, services furnished 

by rural health clinics, ambulatory 

surgical centers, comprehensive 

outpatient rehabilitation facilities, and 

certain other medical and health 

services not covered by Medicare Part 

A, Hospital Insurance. Medicare Part B 

is available to individuals who are 

entitled to Medicare Part A, as well as 

to U.S. residents who have attained age 

65 and are citizens, and aliens who were 

lawfully admitted for permanent 

residence and have resided in the 

United States for 5 consecutive years. 

Part B requires enrollment and payment 

of monthly premiums, as provided for 

in 42 CFR part 407, subpart B, and part 

408, respectively. Part B costs are met 

by payments from the Part B account of 

the Supplementary Medical Insurance 

Trust Fund, which is funded by the 

premiums paid by all enrollees and 

general revenues of the Federal 

Government. 

The Secretary of the Department of 

Health and Human Services (the 

Secretary) is required by section 1839 of 

the Social Security Act (the Act) to 

announce the Part B monthly actuarial 

rates for aged and disabled beneficiaries 

as well as the monthly Part B premium. 

The Part B annual deductible is 

included because its determination is 

directly linked to the aged actuarial rate. 

The monthly actuarial rates for aged 

and disabled enrollees are used to 

determine the correct amount of general 

revenue financing per beneficiary each 

month. These rates, according to 

actuarial estimates, will initially equal, 

respectively, one-half the expected 

average monthly cost of Part B for each 

aged enrollee (age 65 or over) and onehalf the expected average monthly cost 

of Part B for each disabled enrollee 

(under age 65). The actuarial rates are 

then adjusted to include any margin 

necessary to maintain an adequate 

contingency reserve in the Part B 

account of the Supplementary Medical 

Insurance Trust Fund. 

The Part B deductible to be paid by 

enrollees is also announced. Prior to the 


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