HIT Standards Committee Advisory Meeting; Notice of Meeting, 28782-28783 [2011-12107]
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Federal Register / Vol. 76, No. 96 / Wednesday, May 18, 2011 / Notices
considered a high priority for
interlaboratory studies based upon the
lack of adequately validated test
methods and the regulatory and public
health need for such test methods.
Based on this evaluation, ICCVAM
recommended that:
• The BG1Luc ER TA test method
should be considered a high priority for
interlaboratory validation studies as an
in vitro test method for the detection of
test substances with ER agonist and
antagonist activity.
• Validation studies should include
coordination and collaboration with the
European Centre for the Validation of
Alternative Methods (ECVAM) and the
Japanese Center for the Validation of
Alternative Methods (JaCVAM) and
include one laboratory in each of the
three respective geographic regions
(United States, Europe, and Japan).
• In preparation for the
interlaboratory validation study, XDS
should conduct protocol
standardization studies with an
emphasis on filling data gaps in the
antagonist protocol for the BG1Luc ER
TA.
The NIEHS subsequently agreed to
support the validation study in light of
its role as one of the three NTP agencies,
whose mission includes the
development and validation of
improved testing methods. Based on the
results of this study, ICCVAM is now
reviewing the validation status of this
test method for identification of
substances with in vitro ER agonist or
antagonist activity. NICEATM and the
ICCVAM Interagency Endocrine
Disruptors Working Group prepared a
draft BRD that provides a
comprehensive description and the data
from the validation study used to assess
the accuracy and reliability of the
BG1Luc ER TA test method. ICCVAM
also developed draft recommendations
for its use.
srobinson on DSKHWCL6B1PROD with NOTICES
Availability of the Peer Panel Report
The Panel’s conclusions and
recommendations are detailed in the
Independent Scientific Peer Review
Panel Report: Evaluation of the
Validation Status of the BG1Luc4E2 ER
TA (LUMICELL), an In Vitro
Transcriptional Activation Assay Used
to Identify Chemicals That Can Interact
with Human Estrogen Receptors which
is available along with the draft
documents reviewed by the Panel and
the draft ICCVAM test method
recommendations at https://
iccvam.niehs.nih.gov/methods/
endocrine/PeerPanel11.htm.
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Request for Public Comments
NICEATM invites the submission of
written comments on the Panel report.
When submitting written comments,
please refer to this Federal Register
notice and include appropriate contact
information (name, affiliation, mailing
address, phone, fax, e-mail, and
sponsoring organization, if applicable).
All comments received will be made
publicly available via the NICEATM–
ICCVAM Web site at https://
iccvam.niehs.nih.gov/methods/
endocrine/PeerPanel11.htm. ICCVAM
will consider the Panel report along
with public comments and comments
made by SACATM at their June 16–17,
2011 meeting (67 FR 23323) when
finalizing test method
recommendations. Final ICCVAM
recommendations will be published in
an ICCVAM test method evaluation
report, which will be forwarded to
relevant Federal agencies for their
consideration. The evaluation report
will also be available to the public on
the NICEATM–ICCVAM Web site at
https://iccvam.niehs.nih.gov/methods/
endocrine/ERTA–TMER.htm and by
request from NICEATM (see ADDRESSES
above).
Background Information on ICCVAM,
NICEATM, and SACATM
ICCVAM is an interagency committee
composed of representatives from 15
Federal regulatory and research agencies
that require, use, generate, or
disseminate toxicological and safety
testing information. ICCVAM conducts
technical evaluations of new, revised,
and alternative safety testing methods
with regulatory applicability and
promotes the scientific validation and
regulatory acceptance of toxicological
and safety testing test methods that
more accurately assess the safety and
hazards of chemicals and products and
that refine (decrease or eliminate pain
and distress), reduce, and replace
animal use. The ICCVAM Authorization
Act of 2000 (42 U.S.C. 285l–3)
established ICCVAM as a permanent
interagency committee of the NIEHS
under NICEATM. NICEATM
administers ICCVAM and provides
scientific and operational support for
ICCVAM-related activities and conducts
independent validation studies to assess
the usefulness and limitations of new,
revised, and alternative test methods
and strategies. NICEATM and ICCVAM
welcome the public nomination of new,
revised, and alternative test methods
and strategies applicable to the needs of
U.S. Federal agencies. Additional
information about ICCVAM and
NICEATM can be found on the
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NICEATM–ICCVAM Web site (https://
iccvam.niehs.nih.gov).
SACATM was established in response
to the ICCVAM Authorization Act
[Section 285l-3(d)] and is composed of
scientists from the public and private
sectors. SACATM advises ICCVAM,
NICEATM, and the Director of the
NIEHS and NTP regarding statutorily
mandated duties of ICCVAM and
activities of NICEATM. SACATM
provides advice on priorities and
activities related to the development,
validation, scientific review, regulatory
acceptance, implementation, and
national and international
harmonization of new, revised, and
alternative toxicological test methods.
Additional information about SACATM,
including the charter, roster, and
records of past meetings, can be found
at https://ntp.niehs.nih.gov/go/167.
References
Denison MS, Heath-Pagliuso S. 1998. The
Ah receptor: A regulator of the biochemical
and toxicological actions of structurally
diverse chemicals. Bull Environ Contam
Toxicol 61(5): 557–568.
ICCVAM. 2003a. ICCVAM Guidelines for
the Nomination and Submission of New,
Revised, and Alternative Test Methods. NIH
Publication No. 03–4508. Research Triangle
Park, NC.
ICCVAM. 2003b. ICCVAM Evaluation of In
Vitro Test Methods For Detecting Potential
Endocrine Disruptors: Estrogen Receptor and
Androgen Receptor Binding and
Transcriptional Activation Assays.
Dated: May 11, 2011.
John R. Bucher,
Associate Director, National Toxicology
Program.
[FR Doc. 2011–12264 Filed 5–17–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
HIT Standards Committee Advisory
Meeting; Notice of Meeting
Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces a forthcoming
meeting of a public advisory committee
of the Office of the National Coordinator
for Health Information Technology
(ONC). The meeting will be open to the
public.
Name of Committee: HIT Standards
Committee.
General Function of the Committee:
To provide recommendations to the
National Coordinator on standards,
implementation specifications, and
E:\FR\FM\18MYN1.SGM
18MYN1
srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 96 / Wednesday, May 18, 2011 / Notices
certification criteria for the electronic
exchange and use of health information
for purposes of adoption, consistent
with the implementation of the Federal
Health IT Strategic Plan, and in
accordance with policies developed by
the HIT Policy Committee.
Date and Time: The meeting will be
held on June 22, 2011, from 9 a.m. to 3
p.m./Eastern Time.
Location: To Be Determined. For upto-date information, go to the ONC Web
site, https://healthit.hhs.gov.
Contact Person: Judy Sparrow, Office
of the National Coordinator, HHS, 330 C
Street, SW., Washington, DC 20201,
202–205–4528, Fax: 202–690–6079, email: judy.sparrow@hhs.gov. Please call
the contact person 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.
Agenda: The committee will hear
reports from its workgroups, including
the Clinical Operations, Vocabulary
Task Force, Clinical Quality,
Implementation, and Enrollment
Workgroups. ONC intends to make
background material available to the
public no later than two (2) business
days prior to the meeting. If ONC is
unable to post the background material
on its Web site prior to the meeting, it
will be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on ONC’s Web site after
the meeting, at https://healthit.hhs.gov.
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 June 25, 2011. Oral
comments from the public will be
scheduled between approximately 2 and
3 p.m./Eastern Time. Time allotted for
each presentation will be limited to
three minutes each. If the number of
speakers requesting to comment is
greater than can be reasonably
accommodated during the scheduled
open public hearing session, ONC will
take written comments after the meeting
until close of business.
Persons attending ONC’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
ONC welcomes the attendance of the
public at its advisory committee
meetings. Seating is limited at the
location, and ONC will make every
effort to accommodate persons with
physical disabilities or special needs. If
you require special accommodations
VerDate Mar<15>2010
16:31 May 17, 2011
Jkt 223001
due to a disability, please contact Judy
Sparrow at least seven (7) days in
advance of the meeting.
ONC is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://healthit.hhs.gov for procedures
on public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act
(Pub. L. 92–463, 5 U.S.C., App. 2).
Dated: May 9, 2011.
Judith Sparrow,
Office of Programs and Coordination, Office
of the National Coordinator for Health
Information Technology.
[FR Doc. 2011–12107 Filed 5–17–11; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
HIT Policy Committee Advisory
Meeting; Notice of Meeting
Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces a forthcoming
meeting of a public advisory committee
of the Office of the National Coordinator
for Health Information Technology
(ONC). The meeting will be open to the
public.
Name of Committee: HIT Policy
Committee.
General Function of the Committee:
To provide recommendations to the
National Coordinator on a policy
framework for the development and
adoption of a nationwide health
information technology infrastructure
that permits the electronic exchange and
use of health information as is
consistent with the Federal Health IT
Strategic Plan and that includes
recommendations on the areas in which
standards, implementation
specifications, and certification criteria
are needed.
Date and Time: The meeting will be
held on June 8, 2011, from 10 a.m. to 4
p.m./Eastern Time.
Location: Renaissance Dupont Circle
Hotel, 1143 New Hampshire Ave., NW.,
Washington, DC. For up-to-date
information, go to the ONC Web site,
https://healthit.hhs.gov.
Contact Person: Judy Sparrow, Office
of the National Coordinator, HHS, 330 C
Street, SW., Washington, DC 20201,
202–205–4528, Fax: 202–690–6079, email: judy.sparrow@hhs.gov. Please call
the contact person for up-to-date
information on this meeting. A notice in
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28783
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.
Agenda: The committee will hear
reports from its workgroups, including
the Meaningful Use Workgroup, the
Privacy & Security Tiger Team, the
Information Exchange Workgroup, and
the Quality Measures Workgroup. ONC
intends to make background material
available to the public no later than two
(2) business days prior to the meeting.
If ONC is unable to post the background
material on its Web site prior to the
meeting, it will be made publicly
available at the location of the advisory
committee meeting, and the background
material will be posted on ONC’s Web
site after the meeting, at https://
healthit.hhs.gov.
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 June 2, 2011. Oral
comments from the public will be
scheduled between approximately 3 and
4 p.m. Time allotted for each
presentation is limited to three minutes.
If the number of speakers requesting to
comment is greater than can be
reasonably accommodated during the
scheduled open public hearing session,
ONC will take written comments after
the meeting until close of business.
Persons attending ONC’s advisory
committee meetings are advised that the
agency is not responsible for providing
access to electrical outlets.
ONC welcomes the attendance of the
public at its advisory committee
meetings. Seating is limited at the
location, and ONC will make every
effort to accommodate persons with
physical disabilities or special needs. If
you require special accommodations
due to a disability, please contact Judy
Sparrow at least seven (7) days in
advance of the meeting.
ONC is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://healthit.hhs.gov for procedures
on public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act
(Pub. L. 92–463, 5 U.S.C., App. 2).
Dated: May 9, 2011.
Judith Sparrow,
Office of Programs and Coordination, Office
of the National Coordinator for Health
Information Technology.
[FR Doc. 2011–12112 Filed 5–17–11; 8:45 am]
BILLING CODE 4150–28–P
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]]>Agencies
[Federal Register Volume 76, Number 96 (Wednesday, May 18, 2011)]
[Notices]
[Pages 28782-28783]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12107]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
HIT Standards Committee Advisory Meeting; Notice of Meeting
AGENCY: Office of the National Coordinator for Health Information
Technology, HHS.
ACTION: Notice of meeting.
-----------------------------------------------------------------------
This notice announces a forthcoming meeting of a public advisory
committee of the Office of the National Coordinator for Health
Information Technology (ONC). The meeting will be open to the public.
Name of Committee: HIT Standards Committee.
General Function of the Committee: To provide recommendations to
the National Coordinator on standards, implementation specifications,
and
[[Page 28783]]
certification criteria for the electronic exchange and use of health
information for purposes of adoption, consistent with the
implementation of the Federal Health IT Strategic Plan, and in
accordance with policies developed by the HIT Policy Committee.
Date and Time: The meeting will be held on June 22, 2011, from 9
a.m. to 3 p.m./Eastern Time.
Location: To Be Determined. For up-to-date information, go to the
ONC Web site, https://healthit.hhs.gov.
Contact Person: Judy Sparrow, Office of the National Coordinator,
HHS, 330 C Street, SW., Washington, DC 20201, 202-205-4528, Fax: 202-
690-6079, e-mail: judy.sparrow@hhs.gov. Please call the contact person
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.
Agenda: The committee will hear reports from its workgroups,
including the Clinical Operations, Vocabulary Task Force, Clinical
Quality, Implementation, and Enrollment Workgroups. ONC intends to make
background material available to the public no later than two (2)
business days prior to the meeting. If ONC is unable to post the
background material on its Web site prior to the meeting, it will be
made publicly available at the location of the advisory committee
meeting, and the background material will be posted on ONC's Web site
after the meeting, at https://healthit.hhs.gov.
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 June
25, 2011. Oral comments from the public will be scheduled between
approximately 2 and 3 p.m./Eastern Time. Time allotted for each
presentation will be limited to three minutes each. If the number of
speakers requesting to comment is greater than can be reasonably
accommodated during the scheduled open public hearing session, ONC will
take written comments after the meeting until close of business.
Persons attending ONC's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
ONC welcomes the attendance of the public at its advisory committee
meetings. Seating is limited at the location, and ONC will make every
effort to accommodate persons with physical disabilities or special
needs. If you require special accommodations due to a disability,
please contact Judy Sparrow at least seven (7) days in advance of the
meeting.
ONC is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://healthit.hhs.gov for
procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory
Committee Act (Pub. L. 92-463, 5 U.S.C., App. 2).
Dated: May 9, 2011.
Judith Sparrow,
Office of Programs and Coordination, Office of the National Coordinator
for Health Information Technology.
[FR Doc. 2011-12107 Filed 5-17-11; 8:45 am]
BILLING CODE 4150-45-P
