Federal Register / Vol. 75, No. 105 / Wednesday, June 2, 2010 / Notices 30839 

III. Marketing Policy 

Under § 330.14(h), any sunscreen 

product containing drometrizole 

trisiloxane may not be marketed as an 

OTC drug in the United States at this 

time unless it is the subject of an 

approved new drug application or 

abbreviated new drug application. 

IV. References 

The following references are on 

display in the Division of Dockets 

Management (see ADDRESSES) under 

Docket No. FDA–2003–N–0196 and may 

be seen by interested persons between 9 

a.m. and 4 p.m., Monday through 

Friday. 

1. Redacted TEA for drometrizole 

trisiloxane submitted by L’Oreal USA 

Products, Inc., dated January 21, 2009. 

2. FDA’s evaluation of the TEA for 

drometrizole trisiloxane. 

Dated: May 25, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–13001 Filed 6–1–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Cardiovascular and Renal Drugs 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Cardiovascular 

and Renal Drugs Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on July 28, 2010, from 8 a.m. to 5 

p.m. 

Location: The Marriott Inn and 

Conference Center, University of 

Maryland University College, 3501 

University Blvd. East, Adelphi, MD. The 

conference center telephone number is 

301–985–7300. 

Contact Person: Elaine Ferguson, c/o 

Christine Shipe, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, rm. 2419, Silver Spring, 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8532, e-mail: 

elaine.ferguson@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512533. Please call the Information 

Line for up-to-date information on this 

meeting. A notice in the Federal 

Register about last minute modifications 

that impact a previously announced 

advisory committee meeting cannot 

always be published quickly enough to 

provide timely notice. Therefore, you 

should always check the agency’s Web 

site and call the appropriate advisory 

committee hot line/phone line to learn 

about possible modifications before 

coming to the meeting. 

Agenda: On July 28, 2010, the 

committee will discuss new drug 

application (NDA) 22–433, ticagrelor 

tablets, 90 milligrams, manufactured by 

AstraZeneca LP, for the proposed 

indication for use in acute coronary 

syndrome (including heart attacks and 

any of a group of signs and symptoms, 

such as chest pain or shortness of 

breath, that are consistent with 

blockages in the blood vessels that 

supply the heart). 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before July 14, 2010. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before July 6, 2010. Time allotted for 

each presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by July 7, 2010. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Elaine 

Ferguson at least 7 days in advance of 

the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: May 27, 2010. 

Jill Hartzler Warner, 

Acting Associate Commissioner for Special 

Medical Programs. 

[FR Doc. 2010–13141 Filed 6–1–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

Privacy Act of 1974; CMS Computer 

Match No. 2010–03, HHS Computer 

Match No. 1003, SSA Computer Match 

No. 1048, IRS Project No. 241 

AGENCY: Department of Health and 

Human Services (HHS), Centers for 

Medicare & Medicaid Services (CMS). 

ACTION: Notice of renewal of an existing 

computer matching program (CMP) that 

has an expiration date of June 30, 2010. 

SUMMARY: In accordance with the 

requirements of the Privacy Act of 1974, 

as amended, this notice announces the 

renewal of an existing CMP between 

CMS, the Internal Revenue Service 

(IRS), and the Social Security 

Administration (SSA). We have 

provided information about the 

matching program in the 

SUPPLEMENTARY INFORMATION section 

below. The Privacy Act provides an 

opportunity for interested persons to 

comment on the matching program. We 

may defer implementation of this 

matching program if we receive 

comments that persuade us to defer 


sroberts on DSKD5P82C1PROD with NOTICES
30840 Federal Register / Vol. 75, No. 105 / Wednesday, June 2, 2010 / Notices 

implementation. See ‘‘Effective Dates’’ 

section below for comment period. 

DATES: Effective Dates: CMS filed a 

report of the Computer Matching 

Program (CMP) with the Chair of the 

House Committee on Oversight and 

Government Reform, the Chair of the 

Senate Committee on Homeland 

Security and Governmental Affairs, and 

the Acting Administrator, Office of 

Information and Regulatory Affairs, 

Office of Management and Budget 

(OMB) on May 19, 2010. We will not 

disclose any information under a 

matching agreement until 40 days after 

filing a report to OMB and Congress or 

30 days after publication in the Federal 

Register whichever is later. 

ADDRESSES: The public should address 

comments to: Walter Stone, CMS 

Privacy Officer, Division of Information 

Security & Privacy Management, 

Enterprise Architecture and Strategy 

Group, Office of Information Services 

(OIS), CMS, Mail stop 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. to 3 p.m., eastern 

daylight time. 

FOR FURTHER INFORMATION CONTACT: John 

Albert, Technical Advisor, Division of 

Medicare Benefits Coordination, 

Financial Services Group, Office of 

Financial Management, CMS, Mail stop 

C3–14–16, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. The 

telephone number is (410) 786–7457, or 

e-mail at John.Albert@cms.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Description of the Matching Program 

A. General 

The Computer Matching and Privacy 

Protection Act of 1988 (Pub. L. 100–503) 

amended the Privacy Act (5 U.S.C. 552a) 

by describing the manner in which 

computer matching involving Federal 

agencies could be performed and adding 

certain protections for individuals 

applying for and receiving Federal 

benefits. Section 7201 of the Omnibus 

Budget Reconciliation Act of 1990 (Pub. 

L. 101–508) further amended the 

Privacy Act regarding protections for 

such individuals. The Privacy Act, as 

amended, regulates the use of computer 

matching by Federal agencies when 

records in a system of records are 

matched with other Federal, State, or 

local government records. It requires 

Federal agencies involved in computer 

matching programs to: 

Negotiate written agreements with the 

other agencies participating in the 

matching programs; 

Obtain the Data Integrity Board approval 

of the match agreements; 

Furnish detailed reports about matching 

programs to Congress and OMB; 

Notify applicants and beneficiaries that 

the records are subject to matching; 

and 

Verify match findings before reducing, 

suspending, terminating, or denying 

an individual’s benefits or payments. 

B. CMS Computer Matches Subject to 

the Privacy Act 

CMS has taken action to ensure that 

all CMPs that this Agency participates 

in comply with the requirements of the 

Privacy Act of 1974, as amended. 

Dated: May 21, 2010. 

Michelle Snyder, 

Deputy Chief Operating Officer, Centers for 

Medicare & Medicaid Services. 

CMS Computer Match No. 2010–03 

HHS Computer Match No. 1003 

SSA Computer Match No. 1048 

IRS Project No. 241 

NAME: 

‘‘Medicare Secondary Payer (MSP) 

Program’’. 

SECURITY CLASSIFICATION: 

Level Three Privacy Act Sensitive. 

PARTICIPATING AGENCIES: 

Internal Revenue Service (IRS), Social 

Security Administration (SSA), and the 

Centers for Medicare & Medicaid 

Services (CMS). 

AUTHORITY FOR CONDUCTING MATCHING

PROGRAM: 

This Matching Agreement between 

IRS, SSA and CMS is executed pursuant 

to the Privacy Act of 1974 (5 U.S.C. 

552a), as amended, (as amended by Pub. 

L. 100–503, the Computer Matching and 

Privacy Protection Act (CMPPA) of 

1988), the Office of Management and 

Budget (OMB) Circular A–130, titled 

‘‘Management of Federal Information 

Resources’’ at 61 FR 6428–6435 

(February 20, 1996), and OMB 

guidelines pertaining to computer 

matching at 54 FR 25818 (June 19, 

1989). 

This agreement implements the 

information matching provisions of 

§ 6103(l)(12) of the Internal Revenue 

Code (IRC) (26 U.S.C 6103(1)(12)), and 

1862(b)(5) of the Social Security Act (42 

U.S.C. 1395y(b)(5)). 

PURPOSE(S) OF THE MATCHING PROGRAM: 

The purpose of this agreement is to 

establish the conditions under which: 

(1) IRS agrees to disclose return 

information relating to taxpayer identity 

to SSA, and (2) SSA agrees to disclose 

return information relating to 

beneficiary and employer identity, 

commingled with information disclosed 

by the IRS, to CMS. These disclosures 

will provide CMS with information to 

determine the extent to which any 

Medicare beneficiary is covered under 

any Group Health Plan (GHP). 

CATEGORIES OF RECORDS AND INDIVIDUALS

COVERED BY THE MATCH: 

IRS will disclose taxpayer identity 

information from the CADE (Customer 

Account Data Engine) Individual Master 

File (IMF), Treasury/IRS 24.030, 

published at 73 FR 13304 (March 12, 

2008), and maintained at the 

Martinsburg Computing Center in 

Martinsburg, West Virginia. This file 

includes millions of records of 

taxpayers who have filed Federal 

Individual Income Tax Returns. IRS 

established Project 241, IMF/Medicare 

Beneficiary Match to facilitate this 

matching program. 

SSA will extract identifying 

information of Medicare beneficiaries 

from the Master Beneficiary Record 

(MBR), SSA/OSR 60–0090, published at 

71 FR. 1826 (January 11, 2006) and 

maintained at the National Computer 

Center (NCC) in Baltimore, MD. This file 

includes records of individuals who 

have received and are receiving benefits 

under the Social Security Act. SSA will 

extract employer identity information 

from the Earnings Recording and Selfemployment Income System, SSA/0SR 

60–0059, referred to as the Master 

Earnings File (MEF) published at 71 FR. 

1819 (January 11, 2006) and maintained 

at the NCC. This file contains earnings 

records of individuals including 

identifying information of their 

employees. SSA will also extract 

employer name and address from the 

Employer Identification File (EIF). 

CMS will utilize a database, Medicare 

Advantage Prescription Drug System 

(MARx) CMS System No. 09–70–4001, 

published at 70 FR 60530 (October 18, 

2005), maintained at the CMS Data 

Center, located in Baltimore, Maryland, 

of the GHP information received from 

employers containing verified instances 

of employment and GHP coverage for 

Medicare beneficiaries and Medicareeligible spouses identified from the IMF, 

EIF, and MEF extracts. 

CMS will match GHP information 

against the Medicare Multi Carrier 

Claims System (MCS) (formerly known 

as Carrier Medicare Claims Records), 

CMS System No. 09–70–0501, 

published at 71 FR. 64968 (November 6, 

2006), maintained at the CMS Data 

Center, located in Baltimore, Maryland. 


sroberts on DSKD5P82C1PROD with NOTICES
Federal Register / Vol. 75, No. 105 / Wednesday, June 2, 2010 / Notices 30841 

These files contain information received 

from employers containing verified 

instances of employment and GHP 

coverage for Medicare beneficiaries and 

Medicare-eligible spouses identified 

from the IMF, EIF, and MEF extracts. 

CMS will match GHP information 

against the Fiscal Intermediary Shared 

System (FISS) (formerly known as 

Intermediary Medicare Claims Records), 

CMS System No. 09–70–0503, 

published at 71 FR 64961 (November 6, 

2006), maintained at the CMS Data 

Center, located in Baltimore, Maryland. 

This file contains information or records 

needed to properly process and pay 

Medicare benefits to, or on behalf of, 

eligible individuals. CMS accesses this 

file upon receiving a claim for payment. 

CMS will match GHP information 

against the Common Working File 

(CWF), CMS System No. 09–70–0526, 

published at 71 FR 64955 (November 6, 

2006), which is the repository data base 

for all current hospital and medical 

coverage MSP information, maintained 

at the CMS Data Center, located in 

Baltimore, Maryland. These files 

contain information or records needed 

to properly process and pay medical 

insurance benefits to, or on behalf of, 

entitled beneficiaries who have 

submitted claims for Supplementary 

Medical Insurance Benefits (Medicare 

Part B). CMS accesses this file upon 

receiving a claim for payment. 

CMS will match GHP information 

against the National Claims History 

(NCH), which is contained in the 

National Claims History File, CMS 

System No. 09–70–0558, published at 

71 FR 67137 (November 20, 2006), 

maintained at the CMS Data Center, 

located in Baltimore, Maryland. NCH 

contains records needed to facilitate 

obtaining Medicare utilization review 

data that will be useful for studies of the 

operation and effectiveness of the 

Medicare program. 

INCLUSIVE DATES OF THE MATCH: 

The Matching Program shall become 

effective 40 days after the report of the 

Matching Program is sent to OMB and 

Congress, or 30 days after publication in 

the Federal Register, which ever is later. 

The matching program will continue for 

18 months from the effective date and 

may be extended for an additional 12 

months thereafter, if certain conditions 

are met. 

[FR Doc. 2010–13000 Filed 6–1–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Advisory Commission on Childhood 

Vaccines; Request for Nominations for 

Voting Members 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

requesting nominations to fill three 

vacancies on the Advisory Commission 

on Childhood Vaccines (ACCV). The 

ACCV was established by Title XXI of 

the Public Health Service Act (the Act), 

as enacted by Public Law (Pub. L.) 99– 

660 and as subsequently amended, 

advises the Secretary of Health and 

Human Services (the Secretary) on 

issues related to implementation of the 

National Vaccine Injury Compensation 

Program (VICP). 

DATES: The agency must receive 

nominations on or before July 2, 2010. 

ADDRESSES: All nominations are to be 

submitted to the Director, Division of 

Vaccine Injury Compensation, 

Healthcare Systems Bureau (HSB), 

HRSA, Parklawn Building, Room 11C– 

26, 5600 Fishers Lane, Rockville, 

Maryland 20857. 

FOR FURTHER INFORMATION CONTACT: Ms. 

Andrea Herzog, Principal Staff Liaison, 

Policy Analysis Branch, Division of 

Vaccine Injury Compensation, HSB, 

HRSA at (301) 443–6634 or e-mail: 

aherzog@hrsa.gov. 

SUPPLEMENTARY INFORMATION: Under the 

authorities that established the ACCV, 

the Federal Advisory Committee Act of 

October 6, 1972 (Pub. L. 92–463) and 

section 2119 of the Act, 42 U.S.C. 

300aa–19, as added by Pub. L. 99–660 

and amended, HRSA is requesting 

nominations for three voting members 

of the ACCV. 

The ACCV advises the Secretary on 

the implementation of the VICP. The 

activities of the ACCV include: 

Recommending changes in the Vaccine 

Injury Table at its own initiative or as 

the result of the filing of a petition; 

advising the Secretary in implementing 

section 2127 regarding the need for 

childhood vaccination products that 

result in fewer or no significant adverse 

reactions; surveying Federal, State, and 

local programs and activities related to 

gathering information on injuries 

associated with the administration of 

childhood vaccines, including the 

adverse reaction reporting requirements 

of section 2125(b); advising the 

Secretary on the methods of obtaining, 

compiling, publishing, and using 

credible data related to the frequency 

and severity of adverse reactions 

associated with childhood vaccines; 

consulting on the development or 

revision of the Vaccine Information 

Statements and recommending to the 

Director of the National Vaccine 

Program that vaccine safety research be 

conducted on various vaccine injuries. 

The ACCV consists of nine voting 

members appointed by the Secretary as 

follows: (1) Three health professionals, 

who are not employees of the United 

States Government and have expertise 

in the health care of children, and the 

epidemiology, etiology, and prevention 

of childhood diseases, and the adverse 

reactions associated with vaccines, at 

least two shall be pediatricians; (2) three 

members from the general public, at 

least two shall be legal representatives 

(parents or guardians) of children who 

have suffered a vaccine-related injury or 

death; and (3) three attorneys, at least 

one shall be an attorney whose specialty 

includes representation of persons who 

have suffered a vaccine-related injury or 

death, and one shall be an attorney 

whose specialty includes representation 

of vaccine manufacturers. In addition, 

the Director of the National Institutes of 

Health, the Assistant Secretary for 

Health, the Director of the Centers for 

Disease Control and Prevention, and the 

Commissioner of the Food and Drug 

Administration (or the designees of such 

officials) serve as nonvoting ex officio 

members. 

Specifically, HRSA is requesting 

nominations for three voting members 

of the ACCV representing: (1) A health 

professional, who has expertise in the 

health care of children; and the 

epidemiology, etiology, and prevention 

of childhood diseases; (2) an attorney 

whose specialty includes representation 

of persons who have suffered a vaccinerelated injury or death; and (3) a 

member of the general public who is the 

legal representative (parents or 

guardians) of a child who has suffered 

a vaccine related injury or death. 

Nominees will be invited to serve a 3- 

year term beginning January 1, 2011, 

and ending December 31, 2014. 

Interested persons may nominate one 

or more qualified persons for 

membership on the ACCV. Nominations 

shall state that the nominee is willing to 

serve as a member of the ACCV and 

appears to have no conflict of interest 

that would preclude ACCV 

membership. Potential candidates will 

be asked to provide detailed information 

concerning consultancies, research 

grants, or contracts to permit evaluation 


sroberts on DSKD5P82C1PROD with NOTICES