38208 Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices 

400. (For policy questions regarding this 

collection contact JoAnn Cerne at 410– 

786–4530. For all other issues call 410– 

786–1326.) 

4. Type of Information Collection 

Request: Revision of a currently 

approved Collection; Title of 

Information Collection: Home Health 

Advance Beneficiary Notice (HHABN); 

Use: Home health agencies (HHAs) are 

required to provide written notice to 

Medicare beneficiaries under various 

circumstances involving the initiation, 

reduction, or termination of services. 

The vehicle used in these situations is 

the Home Health Advance Beneficiary 

Notice (HHABN). The notice is designed 

to ensure that beneficiaries receive 

complete and useful information 

regarding potential financial liability or 

any changes made to their plan of care 

(POC) to enable them to make informed 

consumer decisions. The notice must 

provide clear and accurate information 

about the specified services and, when 

applicable, the cost of services when 

Medicare denial of payment is expected 

by the HHA. Form Number: CMS–R–296 

(OMB#: 0938–0781); Frequency: 

Reporting—Hourly, Daily, Weekly, 

Monthly, Yearly, Quarterly, Semiannually, Biennially, Once and 

Occasionally; Affected Public: Business 

or other for-profits and Not-for-profit 

institutions; Number of Respondents: 

9024; Total Annual Responses: 

12,349,787; Total Annual Hours: 

1,028,737. (For policy questions 

regarding this collection contact Evelyn 

Blaemire at 410–786–1803. 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 August 31, 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: July 23, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–18379 Filed 7–30–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10191] 

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: Medicare Parts 

C and D Universal Audit Guide; Use: 

Under the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 and implementing regulations at 

42 CFR Parts 422 and 423 Medicare Part 

D plan sponsors and Medicare 

Advantage organizations are required to 

comply with all Medicare Parts C and D 

program requirements. 42 CFR 422.502 

describes CMS’ regulatory authority to 

evaluate, through inspection or other 

means, Medicare Advantage Part C 

organizations. These records include 

books, contracts, medical records, 

patient care documentation and other 

records that pertain to any aspect of 

services performed, reconciliation of 

benefit liabilities, and determination of 

amounts payable. 42 CFR 423.503 states 

that CMS must oversee a Part D plan 

sponsor’s continued compliance with 

the requirements for a Part D plan 

sponsor. § 423.514 states that the Part D 

plan sponsor must have an effective 

procedure to develop, compile, 

evaluate, and report to CMS, to its 

enrollees, and to the general public, at 

the times and in the manner that CMS 

requires, statistics regarding areas such 

as cost of operations, patterns of 

utilization availability, accessibility, 

and acceptability of services. 

The explosive growth of these 

sponsoring organizations has forced 

CMS to update its current auditing 

strategy to ensure we continue to obtain 

meaningful audit results. As a result, 

CMS’ audit strategy will reflect a move 

away from routine audits to more 

targeted, data-driven and risk-based 

audits. CMS will also focus on high-risk 

areas that have the greatest potential for 

beneficiary harm. The goal of the audits 

will be the earliest possible detection 

and correction of issues and 

improvement in quality and 

performance of Part D sponsors and 

Medicare Advantage organizations. 

To accomplish these goals, we have 

combined all Part C and Part D audit 

elements into one universal guide 

which will also promote consistency, 

effectiveness and reduce financial and 

time burdens for both CMS and 

Medicare-contracting entities. Please 

refer to the crosswalk document for a 

list of changes. Form Number: CMS– 

10191 (OMB#: 0938–1000); Frequency: 

Reporting—Yearly; Affected Public: 

Business or other for-profits and Notfor-profit institutions; Number of 

Respondents: 195; Total Annual 

Responses: 195; Total Annual Hours: 

24,180. (For policy questions regarding 

this collection contact Laura Dash at 

410–786–8623. 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 September 29, 2009: 

1. Electronically. You may submit 

your comments electronically to http:// 

www.regulations.gov. Follow the 


PWALKER on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 74, No. 146 / Friday, July 31, 2009 / Notices 38209 

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 (CMS–10078), Room 

C4–26–05, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Dated: July 23, 2009. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–18378 Filed 7–30–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0352] 

Preparation for International 

Cooperation on Cosmetics 

Regulations Meetings in Tokyo, Japan; 

Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting entitled ‘‘International 

Cooperation on Cosmetics Regulations 

(ICCR)—Preparation for ICCR—3 

Meetings in Tokyo, Japan’’ to provide 

information and receive comments on 

the International Cooperation on 

Cosmetics Regulations (ICCR) as well as 

the upcoming meetings in Tokyo, Japan. 

The topics to be discussed are the topics 

for discussion at the forthcoming ICCR 

steering committee meeting. The 

purpose of the meeting is to solicit 

public input prior to the next steering 

committee and expert working group 

meetings in Tokyo, Japan, scheduled for 

the week of September 7, 2009. 

Date and Time: The meeting will be 

held on September 2, 2009, from 1:30 

p.m. to 3 p.m. 

Location: The meeting will be held in 

University Station, rm. 2073, 4300 River 

Rd., College Park, MD 20740. 

Contact Person: All participants must 

register with Mary Morrison, Office of 

the Commissioner (HFG–1), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, e-mail: 

mary.morrison@fda.hhs.gov, FAX: 301– 

827–0003. 

Registration and Requests for Oral 

Presentations: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number), written material and requests 

to make oral presentation, to the contact 

person by August 30, 2009. 

If you need special accommodations 

due to a disability, please contact Mary 

Morrison (see Contact Person) at least 7 

days in advance. 

Transcripts: Please be advised that as 

soon as a transcript is available, it will 

be accessible at http:// 

www.regulations.gov. It may be viewed 

at the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD. A transcript will 

also be available in either hardcopy or 

on CD–ROM, after submission of a 

Freedom of Information request. Written 

requests are to be sent to the Division 

of Freedom of Information (HFI–35), 

Office of Management Programs, Food 

and Drug Administration, 5600 Fishers 

Lane, rm. 6–30, Rockville, MD 20857. 

SUPPLEMENTARY INFORMATION: The 

purpose of the multilateral framework 

on the ICCR is to pave the way for the 

removal of regulatory obstacles to 

international trade while maintaining 

global consumer protection. 

ICCR is a voluntary international 

group of cosmetics regulatory 

authorities from the United States, 

Japan, the European Union, and Canada. 

These regulatory authority members 

will enter into constructive dialogue 

with their relevant cosmetics’ industry 

trade associations. Currently, the ICCR 

members are Health Canada; the 

European Directorate General for 

Enterprise and Industry; the Ministry of 

Health, Labor and Welfare of Japan; and 

the U.S. Food and Drug Administration. 

All decisions made by the consensus 

will be compatible with the laws, 

policies, rules, regulations, and 

directives of the respective 

administrations and governments. 

Members will implement and/or 

promote actions or documents within 

their own jurisdictions and seek 

convergence of regulatory policies and 

practices. Successful implementation 

will require input from stakeholders. 

Interested persons may present data, 

information, or views orally or in 

writing, on issues pending at the public 

meeting. Time allotted for oral 

presentations may be limited to 10 

minutes. Those desiring to make oral 

presentations should notify the contact 

person by August 30, 2009, and submit 

a brief statement of the general nature of 

the evidence or arguments they wish to 

present, the names and addresses, 

telephone number, fax, and e-mail of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation. 

The agenda for the public meeting 

will be made available on the Internet 

at http://www.fda.gov/Cosmetics/ 

InternationalActivities/ 

ConferencesMeetingsWorkshops/ 

InternationalCooperationonCosmetics

RegulationsICCR/default.htm. 

Dated: July 27, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–18321 Filed 7–30–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

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

hereby given of the following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Insulin Binding and 

Signaling. 

Date: August 20, 2009. 

Time: 1:30 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892, (Telephone 

Conference Call) 

Contact Person: Lakshmanan Sankaran, 

PhD, Scientific Review Officer, Review 

Branch, DEA, NIDDK, National Institutes of 

Health, Room 755, 6707 Democracy 

Boulevard, Bethesda, MD 20892–5452, (301) 

594–7799, ls38z@nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Immunology in 

Liver Disease. 


PWALKER on DSK8KYBLC1PROD with NOTICES