Board of Scientific Counselors, National Center for Health Statistics, (BSC, NCHS), 301-302 [E8-31340]
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Federal Register / Vol. 74, No. 2 / Monday, January 5, 2009 / Notices
environment; (9) provides application
software support; (10) serves as network
System Administrator for production
and development systems; and (11)
installs, configures, and maintains the
Internet software environment for
enterprise applications.
c. Quality Assurance and Support
Branch (PIH3). The Quality Assurance
and Support Branch (QASB) has the
following functions: (1) Provides
functional expertise and troubleshooting
support for PSC systems; (2) develops
system change requirements; (3)
provides interagency IT
communications support; (4) performs
functional testing of PSC systems; (5)
develops training materials for the HHS
human resources management system
and the HHS time and attendance
system; (6) develops and maintains the
HHS Time and Attendance Policy
Manual; (7) provides advice on
enhancement requests; (8) administers
the help desk function and tracks all
calls and e-mails for support for the
human resources and time & attendance
systems; (9) provides functional
expertise to the technical staff; (10)
provides system training including
regulations and procedures related to IT;
(11) assists in reviews of functional and
system requirements and performs
documentation testing to ensure the
accuracy and completeness of all system
enhancements; and (12) develops test
plans, test cases, and scenarios.
d. Application Development Branch
(PIH4). The Application Development
Branch (ADB) provides the following
functions: (1) Provides overall technical
support for PSC systems; (2) provides
software application management,
systems administration, and
configuration management; (3) provides
software development services; (4)
provides liaison services to other
Agency offices providing automated
interfaces; (5) evaluates and
recommends various software and
hardware products in support of the
PSC’s systems; (6) provides Tier 2 and
Tier 3 ‘‘break/fix’’ support contact for
users and help desk personnel for
problems with FAD applications; (7)
provides support for enterprise
reporting; (8) develops and delivers
current and/or historical personnel and
payroll reports; (9) maintains existing
reports, including periodic reports
generated for the Office of Personnel
Management and HHS internal and
external customers; and (10) performs
daily loading of HHS personnel data
and bi-weekly loading of payroll data
into the historical database.
5. Telecommunications Management
Division (PID). The Telecommunications
Management Division (TMD) provides
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the following services: (1) Plans,
engineers, and schedules program
implementation and management of
telecommunications networks and
services (such as ordering, installation,
and operational control of telephone
station equipment); (2) monitors
telecommunications billing for dialtone, voice mail, adds/moves/changes,
and telecommunications equipment; (3)
plans and administers
telecommunications budgets; (4)
maintains inventory files and cost data
of all installed telecommunications
equipment; (5) manages on-site support
for users of voice messaging; (6)
provides training for end users; and (7)
administers the Federal
Telecommunications Service contract,
and manages carriers, contractors and
vendors for PSC and its customers.
6. Freedom of Information Act and
Records Management Division (PIF).
The Freedom of Information Act (FOIA)
and Records Management Division
(FRMD): (1) Responds to all FOIA
requests for records generated by, and in
the custody and control of, all
components of the Office of Public
Health and Science (OPHS), and the
Program Support Center (PSC); (2)
responds to all requests for records that
involve more than one of the Public
Health Service components and the
PSC; (3) responds to all administrative
appeals; (4) coordinates with the Office
of the General Counsel to resolve the
administrative appeals which result in
litigation; and (5) provides FOIA
training and consultation.
III. Under AJ, ‘‘Office of Business
Transformation (AJJ)’’ make the
following change: Retitle the ‘‘Division
of Competitive Sourcing (AJJ2)’’ as the
‘‘Division of Commercial Services
Management (AJJ2).’’
IV. Delegations of Authority: All
delegations and re-delegations of
authority to officers and employees of
the Program Support Center, which
were in effect immediately prior to this
reorganization will be continued in
effect with them or their successors,
pending further redelegation, provided
they are consistent with this
reorganization.
Dated: December 20, 2008.
Segundo Pereira,
Acting, Assistant Secretary for
Administration and Management.
[FR Doc. E8–31257 Filed 1–2–09; 8:45 am]
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301
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Center for Health Statistics,
(BSC, NCHS)
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC),
announces the following meeting of the
aforementioned committee:
Times and Dates:
11 a.m.–5:30 p.m., January 22, 2009.
8:30 a.m.–2 p.m., January 23, 2009.
Place: NCHS Headquarters, 3311
Toledo Road, Hyattsville, Maryland
20782.
Status: This meeting is open to the
public; however, visitors must be
processed in accordance with
established federal policies and
procedures. For foreign nationals or
non-US citizens, pre-approval is
required (please contact Althelia Harris,
301–458–4261, adw1@cdc.gov or
Virginia Cain, vcain@cdc.gov at least 10
days in advance for requirements). All
visitors are required to present a valid
form of picture identification issued by
a state, federal or international
government. As required by the Federal
Property Management Regulations, Title
41, Code of Federal Regulation, Subpart
101–20.301, all persons entering in or
on Federal controlled property and their
packages, briefcases, and other
containers in their immediate
possession are subject to being x-rayed
and inspected. Federal law prohibits the
knowing possession or the causing to be
present of firearms, explosives and other
dangerous weapons and illegal
substances. The meeting room
accommodates approximately 100
people.
Purpose: This committee is charged
with providing advice and making
recommendations to the Secretary,
Department of Health and Human
Services; the Director, CDC; and the
Director, NCHS, regarding the scientific
and technical program goals and
objectives, strategies, and priorities of
NCHS.
Matters To Be Discussed: The agenda
will include welcome remarks by the
Director, NCHS; review of the NHANES
program; presentation of the ambulatory
and hospital care surveys program; and
an open session for comments from the
public.
Requests to make oral presentations
should be submitted in writing to the
contact person listed below. All requests
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302
Federal Register / Vol. 74, No. 2 / Monday, January 5, 2009 / Notices
must contain the name, address,
telephone number, and organizational
affiliation of the presenter.
Written comments should not exceed
five single-spaced typed pages in length
and must be received by January 8,
2009.
The agenda items are subject to
change as priorities dictate.
Contact Person for More Information:
Virginia S. Cain, PhD, Director of
Extramural Research, NCHS/CDC, 3311
Toledo Road, Room 7211, Hyattsville,
Maryland 20782, telephone (301) 458–
4500, fax (301) 458–4020.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities for both CDC and
the Agency for Toxic Substances and
Disease Registry.
Dated: December 24, 2008.
Elaine L. Baker,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. E8–31340 Filed 1–2–09; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0642]
Draft Guidance for Industry and Food
and Drug Administration Staff; Assay
Migration Studies for In Vitro
Diagnostic Devices; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of the draft guidance
entitled ‘‘Assay Migration Studies for In
Vitro Diagnostic Devices.’’ This draft
guidance presents a least burdensome
regulatory approach to gaining FDA
approval of Class III or certain licensed
in vitro diagnostic devices in cases
when a previously approved assay is
migrating (i.e., transitioning) to a New
System for which the assay has not been
previously approved or licensed.
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 this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by April 6, 2009.
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Submit written requests for
single copies of the draft guidance
document entitled ‘‘Assay Migration
Studies for In Vitro Diagnostic Devices’’
to the Division of Small Manufacturers,
International, and Consumer Assistance
(HFZ–220), Center for Devices and
Radiological Health, Food and Drug
Administration, 1350 Piccard Dr.,
Rockville, MD 20850 or to the Office of
Communication, Training, and
Manufacturers Assistance (HFM–40),
Center for Biologics Evaluation and
Research (CBER), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448.
Send one self-addressed adhesive
label to assist that office in processing
your request, or fax your request to
CDRH at 240–276–3151. The guidance
may also be obtained by mail by calling
CBER at 1–800–835–4709 or 301–827–
1800. See the SUPPLEMENTARY
INFORMATION section for information on
electronic access to the guidance.
Submit written comments concerning
this draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to either
https://www.regulations.gov. Identify
comments with the docket number
found in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Sally Hojvat, Center for Devices and
Radiological Health (HFZ–440),
Food and Drug Administration,
2098 Gaither Rd., Rockville, MD
20850, 240–276–0711.
For further information concerning
the guidance including statistical
content as it relates to devices
regulated by CBER: Stephen Ripley,
Center for Biologics Evaluation and
Research (HFM–17), Food and Drug
Administration, 1401 Rockville
Pike, suite 200N Rockville, MD
20852, 301–827–6210
For further information concerning
the statistical content in the
guidance: Marina V. Kondratovich,
Center for Devices and Radiological
Health (HFZ–550), Food and Drug
Administration, 1350 Piccard Drive,
Rockville, MD 20850, 240–276–
3126.
ADDRESSES:
SUPPLEMENTARY INFORMATION:
I. Background
This draft guidance presents a least
burdensome regulatory approach to gain
FDA’s approval of Class III or certain
licensed in vitro diagnostic devices,
when a previously approved assay is
migrating (i.e., transitioning) to a New
System, for which the assay has not
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been previously approved or licensed.
The regulatory approach in this
guidance is also applicable to some
510(k) cleared devices, when the device
transitioning to a new system presents
specific concerns, either because of the
nature of the analyte and indications, or
because of the specific technology used
(e.g., nucleic acid amplification tests).
The focus of this guidance is on the
study designs and performance criteria
that should be fulfilled, so that sponsors
can utilize the migration study approach
in support of the change. The FDA
believes that the assay migration study
paradigm proposed in this draft
guidance, provides a least burdensome
scientific and regulatory pathway for
manufacturers to transfer a previously
approved or licensed assay, with full
clinical data from an Old System to a
New System (previously not approved
or licensed). The paradigm is suitable in
cases when sufficient knowledge can be
derived from the documentation of
design controls, risk analyses, and prior
performance studies on an Old System.
II. Significance of Guidance
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized will
represent the agency’s current thinking
on assay migration studies for in vitro
diagnostic devices. It does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statute
and regulations.
III. Electronic Access
Persons interested in obtaining a copy
of the draft guidance may do so by using
the Internet. To receive ‘‘Assay
Migration Studies for In Vitro
Diagnostic Devices,’’ you may either
send an e-mail request to
dsmica@fda.hhs.gov to receive an
electronic copy of the document or send
a fax request to 240–276–3151 to receive
a hard copy. Please use the document
number 1660 to identify the guidance
you are requesting.
CDRH maintains an entry on the
Internet for easy access to information
including text, graphics, and files that
may be downloaded to a personal
computer with Internet access. Updated
on a regular basis, the CDRH home page
includes device safety alerts, Federal
Register reprints, information on
premarket submissions (including lists
of approved applications and
manufacturers’ addresses), small
manufacturer’s assistance, information
on video conferencing and electronic
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]]>Agencies
[Federal Register Volume 74, Number 2 (Monday, January 5, 2009)]
[Notices]
[Pages 301-302]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-31340]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Board of Scientific Counselors, National Center for Health
Statistics, (BSC, NCHS)
In accordance with section 10(a)(2) of the Federal Advisory
Committee Act (Pub. L. 92-463), the Centers for Disease Control and
Prevention (CDC), announces the following meeting of the aforementioned
committee:
Times and Dates:
11 a.m.-5:30 p.m., January 22, 2009.
8:30 a.m.-2 p.m., January 23, 2009.
Place: NCHS Headquarters, 3311 Toledo Road, Hyattsville, Maryland
20782.
Status: This meeting is open to the public; however, visitors must
be processed in accordance with established federal policies and
procedures. For foreign nationals or non-US citizens, pre-approval is
required (please contact Althelia Harris, 301-458-4261, adw1@cdc.gov or
Virginia Cain, vcain@cdc.gov at least 10 days in advance for
requirements). All visitors are required to present a valid form of
picture identification issued by a state, federal or international
government. As required by the Federal Property Management Regulations,
Title 41, Code of Federal Regulation, Subpart 101-20.301, all persons
entering in or on Federal controlled property and their packages,
briefcases, and other containers in their immediate possession are
subject to being x-rayed and inspected. Federal law prohibits the
knowing possession or the causing to be present of firearms, explosives
and other dangerous weapons and illegal substances. The meeting room
accommodates approximately 100 people.
Purpose: This committee is charged with providing advice and making
recommendations to the Secretary, Department of Health and Human
Services; the Director, CDC; and the Director, NCHS, regarding the
scientific and technical program goals and objectives, strategies, and
priorities of NCHS.
Matters To Be Discussed: The agenda will include welcome remarks by
the Director, NCHS; review of the NHANES program; presentation of the
ambulatory and hospital care surveys program; and an open session for
comments from the public.
Requests to make oral presentations should be submitted in writing
to the contact person listed below. All requests
[[Page 302]]
must contain the name, address, telephone number, and organizational
affiliation of the presenter.
Written comments should not exceed five single-spaced typed pages
in length and must be received by January 8, 2009.
The agenda items are subject to change as priorities dictate.
Contact Person for More Information: Virginia S. Cain, PhD,
Director of Extramural Research, NCHS/CDC, 3311 Toledo Road, Room 7211,
Hyattsville, Maryland 20782, telephone (301) 458-4500, fax (301) 458-
4020.
The Director, Management Analysis and Services Office, has been
delegated the authority to sign Federal Register notices pertaining to
announcements of meetings and other committee management activities for
both CDC and the Agency for Toxic Substances and Disease Registry.
Dated: December 24, 2008.
Elaine L. Baker,
Director, Management Analysis and Services Office, Centers for Disease
Control and Prevention.
[FR Doc. E8-31340 Filed 1-2-09; 8:45 am]
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