Federal Register / Vol. 76, No. 203 / Thursday, October 20, 2011 / Notices 65197 

statistical and research purposes related 

to evaluating and studying the operation 

and effectiveness of the Medicare 

program. 

2. ‘‘Medicare Drug Data Processing 

System (DDPS),’’ System No. 09–70– 

0553, last published at 73 FR 30943 

(May 29, 2008). The primary purpose of 

this system is to collect, maintain, and 

process information on all Medicare 

covered, and as many non-covered drug 

events as possible, for people with 

Medicare who have enrolled into a 

Medicare Part D plan. 

3. ‘‘Medicare Integrated Data 

Repository (IDR),’’ System No. 09–70– 

0571, published at 71 FR 74915 

(December 13, 2006). The primary 

purpose of this system is to establish an 

enterprise resource that provides one 

integrated view of all CMS data to 

administer the Medicare and Medicaid 

programs. 

4. ‘‘Chronic Condition Data 

Repository (CCDR),’’ System No. 09–70– 

0573, published at 71 FR 54495 

(September 15, 2006). The purpose of 

this system is to collect and maintain a 

person-level view of identifiable data to 

establish a data repository to study 

chronically ill Medicare beneficiaries. 

This system utilizes data extraction 

tools to support accessing data by 

chronic conditions and processes 

complex customized research data 

requests related to chronic illnesses. 

DATES: The Centers for Medicare & 

Medicaid Services (CMS) invites 

interested parties to submit written 

comments on the proposed system until 

November 16, 2011. As required by the 

Privacy Act (5 U.S.C. 552a(r)), CMS on 

October 17, 2011 sent a report of a new 

system of records to the Committee on 

Homeland Security and Governmental 

Affairs of the Senate, the Committee on 

Oversight and Government Reform of 

the House of Representatives, and the 

Office of Information and Regulatory 

Affairs of the Office of Management and 

Budget (OMB). The proposed action 

described in this notice is effective on 

November 26, 2011, unless CMS 

receives comments which result in a 

republication of the notice. 

ADDRESSES: The public should address 

comments to: CMS Privacy Officer, 

Division of Information Security & 

Privacy Management, Enterprise 

Architecture and Strategy Group, Office 

of Information Services, CMS, Room 

N1–24–08, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

Comments received will be available for 

review at this location, by appointment, 

during regular business hours, Monday 

through Friday from 9 a.m.–3 p.m., 

Eastern Time zone. 

FOR FURTHER INFORMATION CONTACT: 

Chris Haffer, Ph.D., Program Manager, 

Data Development and Services Group, 

Center for Strategic Planning, Centers 

for Medicare and Medicaid Services, 

7500 Security Boulevard, Mail-stop: 

C3–24–07, Baltimore, MD 21244–1850. 

Office: 410–786–8764, Facsimile: (410) 

786–5515, E-mail address: 

chris.haffer@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

statute defines QEs as public or private 

entities that are determined by the 

Secretary to be qualified to use 

Medicare claims data to make such 

evaluations of provider/supplier 

performance, and that agree to meet 

specific requirements regarding the 

transparency of their methods and their 

use and protection of Medicare data. 

The statute requires that Medicare 

claims extracts be combined with other 

claims data, although the statute is not 

specific on what, or how much, other 

claims data should be combined with 

Medicare claims data. The statute 

requires that the only use of such data 

and the derived performance 

information about providers and 

suppliers be in reports in an aggregate 

form, released and made available to the 

public, after first making such reports 

available to any identified provider or 

supplier and affording an opportunity to 

appeal and correct errors. The statute 

also instructs the Secretary to take such 

actions as she deems necessary to 

protect the identity of individual 

beneficiaries, and authorizes her to 

establish additional requirements that 

she may specify for QEs to meet, such 

as ensuring the security of data. The 

Medicare claims extracts are to be made 

available to QEs at a fee equal to the cost 

of making such data available (the fees 

will be deposited into the Part B Trust 

Fund). 

Dated: October 12, 2011. 

Michelle Snyder, 

Deputy Chief Operating Officer, Centers for 

Medicare & Medicaid Services. 

[FR Doc. 2011–27149 Filed 10–19–11; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Statement of Organization, Functions, 

and Delegations of Authority 

Part F of the Statement of 

Organization, Functions, and 

Delegations of Authority for the 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services (CMS), (Federal 

Register, Vol. 70, No. 249, pp. 77160– 

77161, dated December 29, 2005; Vol. 

75, No. 56, pp. 14176—14178, dated 

March 24, 2010; and Vol. 76, No. 144, 

pp. 44933–44934, dated July 27, 2011) 

are amended to: (1) Realign the survey 

and certification function from the 

Center for Medicaid, CHIP and Survey 

& Certification to the Office of Clinical 

Standards and Quality (OCSQ) and to 

change the organizational title for the 

Center for Medicaid, CHIP and Survey 

& Certification to the Center for 

Medicaid and CHIP Services (CMCS), 

and (2) realign the governmental 

relations function from the Office of 

Legislation (OL) to CMCS. Part F, 

Sections FC.10 (Organization) and FC.20 

(Functions) is revised as follows: 

• Section FC. 10 (Organization): 

Office of the Administrator (FC) 

Office of Equal Opportunity and Civil 

Rights (FCA) 

Office of Legislation (FCC) 

Office of the Actuary (FCE) 

Office of Strategic Operations and 

Regulatory Affairs (FCF) 

Office of Clinical Standards and Quality 

(FCG) 

Center for Medicare (FCH) 

Center for Medicaid and CHIP Services 

(FCJ) 

Center for Strategic Planning (FCK) 

Center for Program Integrity (FCL) 

Chief Operating Officer (FCM) 

Office of Minority Health (FCN) 

Center for Medicare and Medicaid 

Innovation (FCP) 

Federal Coordinated Health Care Office 

(FCQ) 

Center for Consumer Information and 

Insurance Oversight (FCR) 

Office of Public Engagement (FCS) 

Office of Communications (FCT) 

• Section FC.20 (Functions): 

Center for Medicaid and CHIP Services 

(FCJ) 

• Serves as CMS’ focal point for the 

formulation, coordination, integration, 

implementation, and evaluation of all 

national program policies and 

operations relating to the Medicaid and 

Children’s Health Insurance Program 

(CHIP). 

• In partnership with States, 

evaluates the success of State agencies 

in carrying out their responsibilities for 

effective State program administration 

and beneficiary protection, and, as 

necessary, assists States in correcting 

problems and improving the quality of 

their operations. 

• Identifies and proposes 

modifications to Medicaid and CHIP 

program measures, regulations, laws 

and policies to reflect changes or trends 


sroberts on DSK5SPTVN1PROD with NOTICES
65198 Federal Register / Vol. 76, No. 203 / Thursday, October 20, 2011 / Notices 

in the health care industry, program 

objectives, and the needs of Medicaid 

beneficiaries. Collaborates with OL on 

the development and advancement of 

new legislative initiatives and 

improvements. 

• Serves as CMS’ lead for 

management, oversight, budget and 

performance issues relating to Medicaid, 

CHIP, and the related interactions with 

the States. 

• Coordinates with the Center for 

Program Integrity on the identification 

of program vulnerabilities and 

implementation of strategies to 

eliminate fraud, waste, and abuse. 

• In conjunction with the Office of 

Public Engagement, oversees all CMS 

interactions and collaboration relating 

to Medicaid and CHIP with 

beneficiaries, States and territories and 

key stakeholders (e.g., health facilities 

and other health care providers, other 

Federal government entities, local 

governments) and communication and 

dissemination of policies, guidance and 

materials to same to understand their 

perspectives, support their efforts, and 

to drive best practices for beneficiaries, 

in States and throughout the health care 

industry. 

• Develops and implements a 

comprehensive strategic plan, objectives 

and measures to carry out CMS’ 

Medicaid and CHIP mission and goals 

and position the organization to meet 

future challenges with the Medicaid and 

CHIP programs. 

Office of Clinical Standards and 

Quality (FCG) 

• Serves as the focal point for all 

quality, clinical, medical science issues, 

survey and certification, and policies for 

CMS’ programs. Provides leadership 

and coordination for the development 

and implementation of a cohesive, CMSwide approach to measuring and 

promoting quality and leads CMS’ 

priority-setting process for clinical 

quality improvement. Coordinates 

quality-related activities with outside 

organizations. Monitors quality of 

Medicare, Medicaid, and the Clinical 

Laboratory and Improvement 

Amendments (CLIA). Evaluates the 

success of interventions. 

• Identifies and develops best 

practices and techniques in quality 

improvement; implementation of these 

techniques will be overseen by 

appropriate components. Develops and 

collaborates on demonstration projects 

to test and promote quality 

measurement and improvement. 

• Develops, tests, evaluates, adopts 

and supports performance measurement 

systems (i.e., quality measures) to 

evaluate care provided to CMS 

beneficiaries except for demonstration 

projects residing in other components. 

• Assures that CMS’ quality-related 

activities (survey and certification, 

technical assistance, beneficiary 

information, payment policies and 

provider/plan incentives) are fully and 

effectively integrated. Carries out the 

Health Care Quality Improvement 

Program for the Medicare, Medicaid, 

and CLIA programs. 

• Oversees the planning, policy, 

coordination and implementation of the 

survey, certification and enforcement 

programs for all Medicare and Medicaid 

providers and suppliers, and for 

laboratories under the auspices of CLIA. 

• Serves as CMS’ lead for 

management, oversight, budget, and 

performance issues relating to the 

survey and certification program and 

the related interactions with the States. 

• Leads in the specification and 

operational refinement of an integrated 

CMS quality information system, which 

includes tools for measuring the 

coordination of care between health care 

settings; analyzes data supplied by that 

system to identify opportunities to 

improve care and assess success of 

improvement interventions. 

• Develops requirements of 

participation for providers and plans in 

the Medicare, Medicaid, and CLIA 

programs. Revises requirements based 

on statutory change and input from 

other components. 

• Operates the Quality Improvement 

Organization and End-Stage Renal 

Disease Network program in 

conjunction with Regional Offices, 

providing policies and procedures, 

contract design, program coordination, 

and leadership in selected projects. 

• Identifies, prioritizes and develops 

content for clinical and health related 

aspects of CMS’ Consumer Information 

Strategy; collaborates with other 

components to develop comparative 

provider and plan performance 

information for consumer choices. 

• Prepares the scientific, clinical, and 

procedural basis for coverage of new 

and established technologies and 

services and provides coverage 

recommendations to the CMS 

Administrator. Coordinates activities of 

CMS’ Technology Advisory Committee 

and maintains liaison with other 

departmental components regarding the 

safety and effectiveness of technologies 

and services; prepares the scientific and 

clinical basis for, and recommends 

approaches to, quality-related medical 

review activities of carriers and 

payment policies. 

Office of Legislation (FCC) 

• Provides leadership and executive 

direction within CMS for legislative 

planning to address the 

Administration’s agenda. 

• Tracks, evaluates and develops 

provisions of annual legislative 

proposals for Medicare, Medicaid, CHIP, 

private health insurance programs, 

CLIA, Health Insurance Portability and 

Accountability Act and related statutes 

affecting health care financing, health 

insurance, quality, and access in concert 

with CMS components, the Department 

and the Office of Management and 

Budget. 

• Advances the legislative policy 

process through analysis, review and 

development of health care initiatives 

and issues. 

• Develops the long-range legislative 

plans for CMS in collaboration with the 

CMS Centers, Offices, and the Chief 

Operating Officer (COO). 

• Participates with other CMS 

components in the development of CMS 

policy, including implementing 

regulations and administrative actions. 

• Manages pro-actively CMS’ 

response in times of heightened 

congressional oversight of CMS in 

collaboration with the Centers, Offices, 

and COO. Manages, coordinates and 

develops policies for responding to 

congressional inquiries. 

• Coordinates activities with the 

Office of the Assistant Secretary for 

Legislation (ASL) and serves as the 

ASL’s principal contact point on 

legislative and congressional relations. 

• In collaboration with CMS Centers, 

Offices, and the COO, provides 

technical assistance, consultation and 

information services to congressional 

committees and individual members of 

Congress on the Medicare, Medicaid, 

CHIP, and private health insurance 

programs, new CMS initiatives, and 

pertinent legislation. 

• In collaboration with the CMS 

Centers, Offices, and COO, provides 

technical, analytical, advisory, and 

information services to CMS’ 

components, the Department, the White 

House, OMB, other government 

agencies, private organizations and the 

general public on CMS legislation. 

• Tracks and reports on legislation 

relating to CMS programs and maintains 

legislative reference library. 

• Coordinates CMS’ participation in 

congressional hearings, including 

preparation of testimony and briefing 

materials, and covers all other 

congressional hearings on matters of 

interest to CMS except Appropriations 

Committee hearings specifically on the 

appropriation budget. 


sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 76, No. 203 / Thursday, October 20, 2011 / Notices 65199 

Authority: 44 U.S.C. 3101. 

Dated: October 13, 2011. 

Michelle Snyder, 

Deputy Chief Operating Officer, Centers for 

Medicare & Medicaid Services. 

[FR Doc. 2011–27169 Filed 10–19–11; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–D–0720] 

International Conference on 

Harmonisation; E2B(R3) Electronic 

Transmission of Individual Case Safety 

Reports; Draft Guidance on 

Implementation; Data Elements and 

Message Specification; Appendix on 

Backwards and Forwards 

Compatibility; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance entitled 

‘‘E2B(R3) Electronic Transmission of 

Individual Case Safety Reports (ICSRs): 

Implementation Guide—Data Elements 

and Message Specification’’ (the draft 

E2B(R3) implementation guidance) and 

an appendix to the draft guidance 

entitled ‘‘ICSRs: Appendix to the 

Implementation Guide—Backwards and 

Forwards Compatibility’’ (the draft BFC 

appendix). The draft E2B(R3) 

implementation guidance and draft BFC 

appendix were prepared under the 

auspices of the International Conference 

on Harmonisation of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

The draft E2B(R3) implementation 

guidance is intended to revise the 

standards for submission of ICSRs and 

improve the inherent quality of the data, 

enabling improved handling and 

analysis of ICSR reports. The draft BFC 

appendix describes the relationship 

between data elements from the 2001 

ICH E2B guidance and draft E2B(R3) 

implementation guidance. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on these draft 

documents before it begins work on the 

final versions of the documents, submit 

either electronic or written comments 

on the draft documents by January 18, 

2011. 

ADDRESSES: Submit written requests for 

single copies of the draft documents to 

the Division of Drug Information (HFD– 

240), Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, rm. 2201, Silver Spring, 

MD 20993–0002, or the Office of 

Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

1401 Rockville Pike, Rockville, MD 

20852–1448. Send one self-addressed 

adhesive label to assist the office in 

processing your requests. The draft 

documents may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft documents. 

Submit electronic comments on the 

draft documents to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: 

Krishna K. Chary, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 8201 Corporate 

Dr., suite 540, Landover, MD 20785, 

240–487–7377, fax: 301–459–2285, email: krishna.Chary@fda.hhs.gov; or 

Deborah F. Yaplee, Center for Biologics 

Evaluation and Research (HFM–25), 

Food and Drug Administration, 1401 

Rockville Pike, Rockville, MD 20852, 

301–827–3288, fax: 301–827–9434, email: deborah.yaplee@fda.hhs.gov. 

Regarding the ICH: 

Michelle Limoli, Office of International 

Programs, Food and Drug 

Administration, 10903 New 

Hampshire Ave., Bldg. 31, rm. 3506, 

Silver Spring, MD 20993, 301–796– 

4600. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, many important 

initiatives have been undertaken by 

regulatory authorities and industry 

associations to promote international 

harmonization of regulatory 

requirements. FDA has participated in 

many meetings designed to enhance 

harmonization and is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and then 

reduce differences in technical 

requirements for drug development 

among regulatory Agencies. 

The ICH was organized to provide an 

opportunity for tripartite harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products among three 

regions: The European Union, Japan, 

and the United States. The six ICH 

sponsors are the European Commission; 

the European Federation of 

Pharmaceutical Industries Associations; 

the Japanese Ministry of Health, Labor, 

and Welfare; the Japanese 

Pharmaceutical Manufacturers 

Association; the Centers for Drug 

Evaluation and Research and Biologics 

Evaluation and Research, FDA; and the 

Pharmaceutical Research and 

Manufacturers of America. The ICH 

Secretariat, which coordinates the 

preparation of documentation, is 

provided by the International 

Federation of Pharmaceutical 

Manufacturers Associations (IFPMA). 

The ICH Steering Committee includes 

representatives from each of the ICH 

sponsors and the IFPMA, as well as 

observers from the World Health 

Organization, Health Canada, and the 

European Free Trade Area. 

In June and July 2011, the ICH 

Steering Committee agreed that a draft 

guidance entitled ‘‘E2B(R3) Electronic 

Transmission of Individual Case Safety 

Reports (ICSRs): Implementation 

Guide—Data Elements and Message 

Specification’’ and a draft appendix 

entitled ‘‘ICSRs: Appendix to the 

Implementation Guide—Backwards and 

Forwards Compatibility’’ should be 

made available for public comment. The 

documents are the product of the 

E2B(R3) Expert Working Group of the 

ICH. Comments about these documents 

will be considered by FDA and the 

E2B(R3) Expert Working Group. 

The key intention of the draft E2B(R3) 

implementation guidance is to revise 

the standards for submission of ICSRs 

and improve the inherent quality of the 

data, enabling improved handling and 

analysis of ICSRs. The draft E2B(R3) 

implementation guidance provides 

support for the implementation of 

software tools for creating, editing, 

sending, and receiving electronic ICSR 

messages. The draft E2B(R3) 

implementation guidance provides 

instruction for how pharmaceutical 

industries and regulatory authorities 

should use Part 2 of the International 

Organization for Standardization (ISO) 

ICSR standard to construct messages for 

exchanging pharmacovigilance 

information among themselves in ICH 

regions, and in other countries adopting 

ICH guidelines. The draft BFC appendix 

describes the relationship between data 


sroberts on DSK5SPTVN1PROD with NOTICES