Federal Register / Vol. 70, No. 200 / Tuesday, October 18, 2005 / Notices 60535 

or to a grantee of a CMS-administered 

grant program, when disclosure is 

deemed reasonably necessary by CMS to 

prevent, deter, discover, detect, 

investigate, examine, prosecute, sue 

with respect to, defend against, correct, 

remedy, or otherwise combat fraud or 

abuse in such programs. 

10. To another Federal agency or to an 

instrumentality of any governmental 

jurisdiction within or under the control 

of the United States (including any state 

or local governmental agency), that 

administers, or that has the authority to 

investigate potential fraud or abuse in, 

a health benefits program funded in 

whole or in part by Federal funds, when 

disclosure is deemed reasonably 

necessary by CMS to prevent, deter, 

discover, detect, investigate, examine, 

prosecute, sue with respect to, defend 

against, correct, remedy, or otherwise 

combat fraud or abuse in such programs. 

B. Additional Circumstances 

Affecting Routine Use Disclosures. This 

system contains Protected Health 

Information as defined by the 

Department of Health and Human 

Services (HHS) regulation ‘‘Standards 

for Privacy of Individually Identifiable 

Health Information’’ (45 CFR Parts 160 

and 164, 65 Fed. Reg. 82462 (12–28–00), 

Subparts A and E. Disclosures of 

Protected Health Information authorized 

by these routine uses may only be made 

if, and as, permitted or required by the 

‘‘Standards for Privacy of Individually 

Identifiable Health Information.’’

In addition, our policy will be to 

prohibit release even of data not directly 

identifiable information, except 

pursuant to one of the routine uses or 

if required by law, if we determine there 

is a possibility that an individual can be 

identified through implicit deduction 

based on small cell sizes (instances 

where the patient population is so small 

that individuals who are familiar with 

the enrollees could, because of the small 

size, use this information to deduce the 

identity of the beneficiary). 

POLICIES AND PRACTICES FOR STORING, 

RETRIEVING, ACCESSING, RETAINING, AND

DISPOSING OF RECORDS IN THE SYSTEM: 

STORAGE: 

Computer diskette and on magnetic 

storage media. 

RETRIEVABILITY: 

Information can be retrieved by name 

and health insurance claim number of 

the beneficiary. 

SAFEGUARDS: 

CMS has safeguards in place for 

authorized users and monitors such 

users to ensure against excessive or 

unauthorized use. Personnel having 

access to the system have been trained 

in the Privacy Act and information 

security requirements. Employees who 

maintain records in this system are 

instructed not to release data until the 

intended recipient agrees to implement 

appropriate management, operational 

and technical safeguards sufficient to 

protect the confidentiality, integrity and 

availability of the information and 

information systems and to prevent 

unauthorized access. 

This system will conform to all 

applicable Federal laws and regulations 

and Federal, HHS, and CMS policies 

and standards as they relate to 

information security and data privacy. 

These laws and regulations include but 

are not limited to: the Privacy Act of 

1974; the Federal Information Security 

Management Act of 2002; the Computer 

Fraud and Abuse Act of 1986; the 

Health Insurance Portability and 

Accountability Act of 1996; the EGovernment Act of 2002, the ClingerCohen Act of 1996; the Medicare 

Modernization Act of 2003, and the 

corresponding implementing 

regulations. Office of Management and 

Budget Circular A–130, Management of 

Federal Resources, Appendix III, 

Security of Federal Automated 

Information Resources also applies. 

Federal, HHS, and CMS policies and 

standards include but are not limited to: 

all pertinent National Institute of 

Standards and Technology publications; 

the HHS Information Systems Program 

Handbook and the CMS Information 

Security Handbook. 

RETENTION AND DISPOSAL: 

Records are maintained with 

identifiers for all transactions after they 

are entered into the system for a period 

of 6 years and 3 months. Records are 

housed in both active and archival files. 

All claims-related records are 

encompassed by the document 

preservation order and will be retained 

until notification is received from the 

Department of Justice. 

SYSTEM MANAGER AND ADDRESS: 

Director, Division of Medicare 

Advantage Appeals and Payment 

Systems, Information Services 

Modernization Group, Office of 

Information Services, CMS, Room N3–

16–24, 7500 Security Boulevard, 

Baltimore, Maryland 21244–1850. 

NOTIFICATION PROCEDURE: 

For purpose of access, the subject 

individual should write to the systems 

manager who will require the system 

name, SSN, address, date of birth, sex, 

and for verification purposes, the 

subject individual’s name (woman’s 

maiden name, if applicable). Furnishing 

the SSN is voluntary, but it may make 

searching for a record easier and prevent 

delay. 

RECORD ACCESS PROCEDURE: 

For purpose of access, use the same 

procedures outlined in Notification 

Procedures above. Requestors should 

also reasonably specify the record 

contents being sought. (These 

procedures are in accordance with 

Department regulation 45 CFR 5b.5 

(a)(2)). 

CONTESTING RECORD PROCEDURES: 

The subject individual should contact 

the system manager named above, and 

reasonably identify the record and 

specify the information to be contested. 

State the corrective action sought and 

the reasons for the correction with 

supporting justification. (These 

procedures are in accordance with 

Department regulation 45 CFR 5b.7). 

RECORD SOURCE CATEGORIES: 

Data for this system is collected from 

MAs and MAPDs (which obtained the 

data from the individuals concerned), 

Social Security Administration, and the 

Medicare Beneficiary Database system 

of records. 

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS

OF THE ACT: 

None. 

[FR Doc. 05–20909 Filed 10–17–05; 8:45 am] 

BILLING CODE 4120–03–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Office of Planning, Research and 

Evaluation; Notice of Secretary’s 

Advisory Committee Meeting 

AGENCY: OPRE, ACF, HHS. 

ACTION: Notice of Meeting—Advisory 

Committee on Head Start Accountability 

and Educational Performance Measures. 

SUMMARY: The Secretary of Health and 

Human Services, by authority of 42 

U.S.C. 9836A, Section 641A(b) of the 

Head Start Act, as amended (5 U.S.C. 

Appendix 2), has formed the Advisory 

Committee on Head Start Accountability 

and Educational Performance Measures 

(the Committee). The Committee is 

governed by the provisions of Public 

Law 92–463, as amended (5 U.S.C. 

Appendix 2). 

The function of the Committee is to 

help assess the progress of HHS in 

developing and implementing 

60536 Federal Register / Vol. 70, No. 200 / Tuesday, October 18, 2005 / Notices 

educational measures in the Head Start 

Program. This includes the Head Start 

National Reporting System (NRS). The 

Committee is to provide 

recommendations for integrating NRS 

with other ongoing assessments of the 

effectiveness of the program. The 

Committee will make recommendations 

as to how NRS and other assessment 

data can be included in the broader 

Head Start measurement efforts found in 

the Family and Child Experiences 

Survey (FACES), the national Head Start 

Impact Study, Head Start’s Performance 

Based Outcome System and the ongoing 

evaluation of the Early Head Start 

program. 

Date: November 1, 2005, 8:30 a.m.–

5:30 p.m. (Dinner Recess). November 2, 

2005, 8:30 a.m.–4:30 p.m. 

Place: The Beacon Hotel, 1615 Rhode 

Island Ave, NW., Washington, DC 

20036. 

Agenda: The Committee will hear 

presentations related to existing Head 

Start evaluations and NRS 

implementation and will continue the 

discussions begun at the first meeting in 

June 2005. 

SUPPLEMENTARY INFORMATION: This, the 

second meeting of the Committee, is 

open to the public. Persons wishing to 

bring written statements or papers 

focused on relevant, existing research 

with Head Start populations or on 

measures appropriate for low-income 

four- and five-year-old children are 

welcome to do so. Individuals may email such documents to 

Secretaryadvisory-hs@esi-dc.com or 

mail to: ESI, ATTN: Xzavier Wright, 

Head Start Bureau—Secretary’s 

Advisory Committee, 7735 Old 

Georgetown Road, Suite 600, Bethesda, 

Maryland 20814. 

Documents received shall be 

presented to the Committee. 

The Committee meeting records shall 

be kept at the Aerospace Center located 

at 901 D Street, SW., Washington, DC 

20447. The Head Start Bureau will also 

make material related to this meeting 

available on the Head Start Web site 

http://www2.acf.dhhs.gov/programs/ 

hsb/. 

An interpreter for the deaf and hard 

of hearing will be available upon 

advance request by contacting 

xzavier@esi-dc.com. 

Naomi Goldstein, 

Director, Office of Planning, Research and 

Evaluation. 

[FR Doc. 05–20758 Filed 10–17–05; 8:45 am] 

BILLING CODE 4184–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2005N–0410] 

Prescription Drug User Fee Act; 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 on the Prescription Drug 

User Fee Act (PDUFA). The legislative 

authority for PDUFA expires in 

September 2007. Without further 

legislation, we will no longer be able to 

collect user fees for the prescription 

drug program and resources critical to 

running the program would become 

unavailable to us. We invite public 

comment on the PDUFA program and 

suggestions regarding what features we 

should propose for the next PDUFA 

program. 

DATES: The public meeting will be held 

on November 14, 2005, from 9 a.m. to 

5 p.m. Registration to attend the meeting 

must be received by October 31, 2005. 

You may register electronically at 

CBERTraningSuggestions@cber.fda.gov. 

Walk-in registration at the meeting site 

will also be accepted. Submit written 

comments by December 14, 2005. 

ADDRESSES: The meeting will be held at 

the Natcher Conference Center, National 

Institutes of Health, Bldg. 45, Center Dr., 

9000 Rockville Pike, Bethesda, MD 

20815. Parking is limited, and there may 

be delays entering the NIH campus due 

to increased security. All visitors’

vehicles will be inspected, and visitors 

must show one form of identification 

(ID) (such as a government-issued photo 

ID, driver’s license, passport, etc.) We 

recommend arriving by subway 

(Metrorail) if possible. NIH is accessible 

from the Metrorail’s ‘‘Red Line’’ at the 

Medical Center/NIH station. 

Submit written comments to the 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. Submit electronic comments 

to http://www.fda.gov/dockets/ 

ecomments. 

FOR FURTHER INFORMATION CONTACT: 

For information regarding this notice: 

Patricia A. Stewart, Office of Policy 

and Planning (HFP–1), Food and 

Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–

827–2647, FAX: 301–594–6777, email: Patricia.Stewart@oc.fda.gov. 

For information regarding 

registration: Melanie Whelan or 

Kathy Eberhart, Office of 

Communication, Training and 

Manufacturers Assistance (HFM–

49), Center for Biologics Evaluation 

and Research, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852, 

301–827–2000, FAX: 301–827–

3079. 

SUPPLEMENTARY INFORMATION: 

I. Introduction 

FDA is announcing its intention to 

hold a public meeting on PDUFA. The 

authority for PDUFA expires in 

September 2007. Without further 

legislation, FDA would no longer be 

able to collect user fees for the 

prescription drug program. Resources 

critical to running the program would 

become unavailable to FDA. We are now 

considering what features we should 

propose for the next PDUFA program. 

We are convening a public meeting to 

hear stakeholder views on this subject. 

We are offering the following two 

general questions for consideration, and 

we are interested in responses to these 

questions and any other pertinent 

information stakeholders would like to 

share: 

1. What is your assessment of the 

overall performance of the PDUFA 

program thus far? 

2. What aspects of PDUFA should be 

retained, or what should be changed to 

further strengthen and improve the 

program? 

We provide the following background 

on the PDUFA program so potential 

participants can better understand the 

history and evolution of the PDFUA 

program and its current status. 

II. What is PDUFA? What Does It Do? 

PDUFA, in broad terms, is a series of 

laws that have authorized us to collect 

fees from companies that produce 

certain human drug and biological 

products. The original PDUFA (PDUFA 

I) was enacted in 1992 (as the 

Prescription Drug User Fee Act, Public 

Law 102–571) and had a 5-year life. In 

1997, as PDUFA I expired, Congress 

passed the FDA Modernization Act 

(FDAMA, Public Law 105–115). 

FDAMA included, among other things, 

an extension of PDUFA (PDUFA II) for 

an additional 5 years. In 2002, Congress 

extended PDUFA again for 5 years 

(PDUFA III) through the Public Health 

Security and Bioterrorism Preparedness 

and Response Act (Public Law 107–

188). 

PDUFA’s original intent was to 

provide additional revenues to us so 

that we could hire more staff to improve 

the process for the review of human