1060 Federal Register / Vol. 75, No. 5 / Friday, January 8, 2010 / Notices 

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 

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

PaperworkReductionActof1995, or 

E-mail 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 February 8, 2010. 

OMB, Office of Information and 

Regulatory Affairs. Attention: CMS Desk 

Officer. Fax Number: 202–395–6974. Email: OIRA_submission@omb.eop.gov. 

Dated: December 24, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–31299 Filed 1–7–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–906] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

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 

minimize the information collection 

burden. 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: The Fiscal 

Soundness Reporting Requirements; 

Use: CMS is assigned responsibility for 

overseeing all Medicare Advantage 

Organizations (MAO), Prescription Drug 

Plan (PDP) sponsors, 1876 Cost Plans, 

Demonstration Plans and PACE 

organizations on-going financial 

performance. Specifically, CMS needs 

the requested collection of information 

to establish that contracting entities 

within those programs maintain fiscally 

sound organizations. Refer to the 

supporting documents for a list of 

changes to this collection. Form 

Number: CMS–906 (OMB#: 0938–0469); 

Frequency: Reporting—Yearly and 

Quarterly; Affected Public: Private 

Sector: Business or other for-profits and 

Not-for-profit institutions; Number of 

Respondents: 514; Total Annual 

Responses: 1039; Total Annual Hours: 

346. (For policy questions regarding this 

collection contact Robert Ahern at 410– 

786–0073. 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 

E-mail 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 March 9, 2010: 

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: December 24, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–31301 Filed 1–7–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0568] 

Draft Guidance for Industry on 

Planning for the Effects of High 

Absenteeism to Ensure Availability of 

Medically Necessary Drug Products; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Planning for the 

Effects of High Absenteeism to Ensure 

Availability of Medically Necessary 

Drug Products.’’ The draft guidance 

encourages manufacturers of medically 

necessary drug products (MNPs) and 

components to develop contingency 

production plans in the event of an 

emergency that results in high 

absenteeism at one or more production 


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