Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices 54823 

allowed for presentation by on-site 

registrants may be less than that for preregistered speakers and will be 

determined by the number of persons 

who register at the meeting. 

Persons registering to make oral 

comments are asked, if possible, to send 

a copy of their statement to the 

Executive Secretary for the BSC (see 

ADDRESSES above) by December 2, 2009, 

to enable review by the BSC prior to the 

meeting. Written statements can 

supplement and may expand the oral 

presentation. If registering on-site and 

reading from written text, please bring 

40 copies of the statement for 

distribution to the BSC and NTP staff 

and to supplement the record. 

Background Information on the NTP 

Board of Scientific Counselors 

The BSC is a technical advisory body 

comprised of scientists from the public 

and private sectors that provides 

primary scientific oversight to the NTP. 

Specifically, the BSC advises the NTP 

on matters of scientific program content, 

both present and future, and conducts 

periodic review of the program for the 

purpose of determining and advising on 

the scientific merit of its activities and 

their overall scientific quality. Its 

members are selected from recognized 

authorities knowledgeable in fields such 

as toxicology, pharmacology, pathology, 

biochemistry, epidemiology, risk 

assessment, carcinogenesis, 

mutagenesis, molecular biology, 

behavioral toxicology, neurotoxicology, 

immunotoxicology, reproductive 

toxicology or teratology, and 

biostatistics. Members serve overlapping 

terms of up to four years. BSC meetings 

are held annually or biannually. 

Dated: October 16, 2009. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. E9–25587 Filed 10–22–09; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–284 and 

CMS–10190] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS), Department of Health 

and Human Services, is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the Agency’s function; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension without change of a 

currently approved collection; Title of 

Information Collection: Medicaid 

Statistical Information System; Use: 

State data are reported by the Federally 

mandated electronic process, known as 

(MSIS) Medical Statistical Information 

System. These data are the basis of 

actuarial forecasts for Medicaid service 

utilization and costs; of analysis and 

cost savings estimates required for 

legislative initiatives relating to 

Medicaid and for responding to requests 

for information from CMS components, 

the Department, Congress and other 

customers; Form Number: CMS–R–284 

(OMB#: 0938–0345); Frequency: 

Reporting—Quarterly; Affected Public: 

State, Local, or Tribal Governments; 

Number of Respondents: 51; Total 

Annual Responses: 204; Total Annual 

Hours: 2,040. (For policy questions 

regarding this collection contact Denise 

Franz 410–786–6117. For all other 

issues call 410–786–1326.) 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: State Plan 

Preprints to Implement Sections 6083, 

6036, 6041, 6042, 6043 and 6044 of the 

Deficit Reduction Act (DRA) of 1995; 

Use: These preprints allow States the 

opportunity and flexibility to request 

changes in benefit packages, cost 

sharing, non-emergency medical 

transportation services, etc.; Form 

Number: CMS–10190 (OMB#: 0938– 

0993); Frequency: Reporting—Once and 

Occasionally; Affected Public: State, 

Local, or Tribal Governments; Number 

of Respondents: 56; Total Annual 

Responses: 16; Total Annual Hours: 

699. (For policy questions regarding this 

collection contact Fran Crystal at 410– 

786–1195. For all other issues call 410– 

786–1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS Web Site 

address at http://www.cms.hhs.gov/ 

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

To be assured consideration, 

comments and recommendations for the 

proposed information collections must 

be received by the OMB desk officer at 

the address below, no later than 5 p.m. 

on November 23, 2009. 

OMB, Office of Information and 

Regulatory Affairs, Attention: CMS 

Desk Officer, Fax Number: (202) 395– 

6974, E-mail: 

OIRA_submission@omb.eop.gov. 

Dated: October 16, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–25573 Filed 10–22–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–R–64] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

In compliance with the requirement 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Centers for Medicare & Medicaid 

Services (CMS) is publishing the 

following summary of proposed 

collections for public comment. 

Interested persons are invited to send 

comments regarding this burden 

estimate or any other aspect of this 

collection of information, including any 

of the following subjects: (1) The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

(2) the accuracy of the estimated 

burden; (3) ways to enhance the quality, 

utility, and clarity of the information to 

be collected; and (4) the use of 

automated collection techniques or 

other forms of information technology to 


CPrice-Sewell on DSKGBLS3C1PROD with NOTICES
54824 Federal Register / Vol. 74, No. 204 / Friday, October 23, 2009 / Notices 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Extension of the currently 

approved collection; Title of 

Information Collection: Indirect Medical 

Education (IME) and Supporting 

Regulations at 42 CFR 412.105; Direct 

Graduate Medical Education (GME) and 

Supporting Regulations at 42 CFR 

413.75 through 413.83; Use: The 

information collected on interns and 

residents (IRs) is used by the Medicare 

Part A fiscal intermediaries (FI) and Part 

A Medicare Administrative Contractors 

(MAC) to verify the number of IRs used 

in the calculation of Medicare program 

payments for indirect medical education 

(IME) as well as direct graduate medical 

education (GME). The IR data collected 

from the hospitals is processed through 

computers at FIs/MACs to identify any 

duplicated time based upon the 

accumulated time of each individual 

that worked at one or more hospitals. 

The identification of duplicate IRs is 

necessary to ensure that no IR is 

counted more than once. 

The FIs/MACs use the information 

collected on IRs to help ensure that all 

program payments for IME and GME are 

based upon an accurate number of FTE– 

IRs, determined in accordance with 

Medicare regulations. The IR data 

submitted by the hospitals are used by 

the FIs/MACs during their audits of the 

providers’ cost reports. The audit 

procedures help assure that the 

information reported was correct, and 

that IRs who should not have been 

reported by the hospitals (or portions of 

the IRs’ time) are not included in the 

FTE count. The FIs/MACs also use 

reports of duplicate IRs to prevent 

improper payment for IME and GME. 

Form Number: CMS–R–64 (OMB#: 

0938–0456); Frequency: Reporting— 

Yearly; Affected Public: Business or 

other for-profit and Not-for-profit 

institutions; Number of Respondents: 

1,190; Total Annual Responses: 1,190; 

Total Annual Hours: 2,380. (For policy 

questions regarding this collection 

contact Milton Jacobson at 410–786– 

7553. For all other issues call 410–786– 

1326.) 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’ Web Site 

at http://www.cms.hhs.gov/

PaperworkReductionActof1995, or Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov, or call the 

Reports Clearance Office on (410) 786– 

1326. 

In commenting on the proposed 

information collections please reference 

the document identifier or OMB control 

number. To be assured consideration, 

comments and recommendations must 

be submitted in one of the following 

ways by December 22, 2009: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 

instructions for ‘‘Comment or 

Submission’’ or ‘‘More Search Options’’ 

to find the information collection 

document(s) accepting comments. 

2. By regular mail. You may mail 

written comments to the following 

address: CMS, Office of Strategic 

Operations and Regulatory Affairs, 

Division of Regulations Development, 

Attention: Document Identifier/OMB 

Control Number, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: October 16, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–25572 Filed 10–22–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0480] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Investigational 

Device Exemptions Reports and 

Records 

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 

Investigational Device Exemptions 

Reports and Records. 

DATES: Submit written or electronic 

comments on the collection of 

information by December 22, 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. 

Investigational Device Exemptions 

Reports and Records—21 CFR Part 812 

(OMB Control Number 0910–0078)— 

Extension 

Section 520(g) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 360j(g)) establishes the statutory 

authority to collect information 


CPrice-Sewell on DSKGBLS3C1PROD with NOTICES