Office of Planning, Research and Evaluation; Notice of Secretary's Advisory Committee Meeting, 60535-60536 [05-20758]
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Federal Register / Vol. 70, No. 200 / Tuesday, October 18, 2005 / Notices
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:
Computer diskette and on magnetic
storage media.
RETRIEVABILITY:
Information can be retrieved by name
and health insurance claim number of
the beneficiary.
CMS has safeguards in place for
authorized users and monitors such
users to ensure against excessive or
unauthorized use. Personnel having
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17:22 Oct 17, 2005
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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:
STORAGE:
SAFEGUARDS:
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.
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
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60535
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
OPRE, ACF, HHS.
Notice of Meeting—Advisory
Committee on Head Start Accountability
and Educational Performance Measures.
AGENCY:
ACTION:
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
E:\FR\FM\18OCN1.SGM
18OCN1
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.
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
https://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.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0410]
Prescription Drug User Fee Act; Public
Meeting
AGENCY:
ACTION:
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.
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 https://www.fda.gov/dockets/
ecomments.
DATES:
FOR FURTHER INFORMATION CONTACT:
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17:22 Oct 17, 2005
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Notice of public meeting.
SUMMARY:
Naomi Goldstein,
Director, Office of Planning, Research and
Evaluation.
[FR Doc. 05–20758 Filed 10–17–05; 8:45 am]
VerDate Aug<31>2005
Food and Drug Administration,
HHS.
PO 00000
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
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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
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Agencies
[Federal Register Volume 70, Number 200 (Tuesday, October 18, 2005)]
[Notices]
[Pages 60535-60536]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-20758]
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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
[[Page 60536]]
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 e-mail 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 https://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