Meeting of the Advisory Committee on Blood Safety and Availability, 68192-68193 [2011-28489]
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68192
Federal Register / Vol. 76, No. 213 / Thursday, November 3, 2011 / Notices
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[FR Doc. 2011–28457 Filed 11–2–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Temporary Certification Program;
Notice of Extension
Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice.
AGENCY:
This notice announces the
decision made by the National
Coordinator for Health Information
Technology (the National Coordinator)
to extend the Temporary Certification
Program.
SUMMARY:
Authority: Section 3001(c)(5) of the Public
Health Service Act (PHSA) as added by the
Health Information Technology for Economic
and Clinical Health (HITECH) Act.
srobinson on DSK4SPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Steve Posnack, Director, Federal Policy
Division, Office of Policy and Planning,
Office of the National Coordinator for
Health Information Technology.
SUPPLEMENTARY INFORMATION: On June
24, 2010, the Office of the National
Coordinator for Health Information
Technology (ONC) published a final
rule (75 FR 36158) to establish a
temporary certification program for
health information technology. The
temporary certification program would
ensure that Certified EHR Technology
was available for adoption and use by
eligible professionals (EPs), eligible
hospitals, and critical access hospitals
(CAHs) for the Medicare and Medicaid
EHR Incentive Programs beginning in
2011. On January 7, 2011, ONC
published a final rule (76 FR 1262) to
establish a permanent certification
program for health information
technology, which would eventually
replace the temporary certification
program. Under 45 CFR 170.490 and as
discussed in the temporary certification
program final rule (75 FR 36184), the
temporary certification program will
sunset on December 31, 2011, or if the
permanent certification program is not
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fully constituted at that time, then upon
a subsequent date that is determined to
be appropriate by the National
Coordinator. As we explained in the
temporary certification program final
rule (75 FR 36185), to determine
whether the permanent certification
program is fully constituted, the
National Coordinator will consider
whether there are a sufficient number of
ONC–Authorized Certification Bodies
(ONC–ACBs) and accredited testing
laboratories to address current market
demand. We refer readers to the final
rule (76 FR 1262) for more information
about accreditation, testing, and
certification activities under the
permanent certification program.
After consulting with the current
ONC–Approved Accreditor (ONC–AA)
for the permanent certification program
(the American National Standards
Institute (ANSI)) and the National
Institute of Standards and Technology
(NIST), which administers the National
Voluntary Laboratory Accreditation
Program (NVLAP) for health
information technology, we do not
anticipate that there will be a sufficient
number of accredited testing
laboratories or ONC–ACBs until
summer 2012. We base this conclusion
on ANSI and NVLAP’s estimations of
the amount of time needed to complete
the accreditation of certification bodies
and testing laboratories, as well as our
estimation of the time period for the
National Coordinator to review the
applications of accredited certification
bodies and subsequently authorize them
as ONC–ACBs.
On this basis, the National
Coordinator has determined it is
necessary to extend the temporary
certification program past the
established sunset date of December 31,
2011. If the National Coordinator were
to take no action, the temporary
certification program would end on that
date without a replacement program
fully in place to ensure the continued
availability of Certified EHR Technology
for EPs and hospitals that seek to
achieve meaningful use and participate
in the EHR Incentive Programs. We
believe that the sunset of the temporary
certification program should be tied to
the effective date of the final rule that
we intend to issue in summer 2012,
which is expected to adopt new and
revised standards, implementation
specifications, and certification criteria
for EHR technology in support of the
next stage of meaningful use under the
Medicare and Medicaid EHR Incentive
Programs. We believe aligning the
sunset of the temporary certification
program with the effective date of this
forthcoming final rule would provide
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certainty to health care providers, EHR
technology developers, and other
stakeholders, while also ensuring a
sufficient number of accredited testing
laboratories and ONC–ACBs exist to
meet market demand. Although we
believe this timeline is feasible based on
current expectations as discussed above,
we recognize unanticipated events may
make it necessary to reconsider the
sunset date for the temporary
certification program. We will publish
another Federal Register notice to
inform the public of any changes to our
expected sunset date for the temporary
certification program.
As stated in the temporary
certification program final rule (75 FR
36184), when the temporary
certification program sunsets, ONC–
Authorized Testing and Certification
Bodies (ONC–ATCBs) will be prohibited
from accepting new requests to test and
certify EHR technology and will be
permitted up to six months after the
sunset date to complete all testing and
certification activities associated with
requests received prior to the sunset
date. If these activities are not
completed within the 6-month period,
the EHR technology would have to be
resubmitted for testing and certification
under the permanent certification
program.
Dated: October 28, 2011.
Farzad Mostashari,
National Coordinator for Health Information
Technology.
[FR Doc. 2011–28492 Filed 11–2–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Advisory Committee on
Blood Safety and Availability
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
ACTION: Notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Services is hereby giving notice that the
Advisory Committee on Blood Safety
and Availability (ACBSA) will hold a
meeting. The meeting will be open to
the public.
DATES: The meeting will take place
Monday, December 5, and Tuesday
December 6, 2011, from 9 a.m. to 5 p.m.
ADDRESSES: National Institutes of Health
Conference Room, 5635 Fishers Lane,
Terrace Level, Rockville, MD 20852.
SUMMARY:
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Federal Register / Vol. 76, No. 213 / Thursday, November 3, 2011 / Notices
Mr.
James Berger, Acting Executive
Secretary, ACBSA, Office of the
Assistant Secretary for Health,
Department of Health and Human
Services, 1101 Wootton Parkway, Suite
250, Rockville, MD 20852, (240) 453–
8809, FAX (240) 453–8456, email
ACBSA@hhs.gov.
FOR FURTHER INFORMATION CONTACT:
The
ACBSA provides advice to the
Secretary, through the Assistant
Secretary for Health, on a broad range of
issues involving the safety and
availability of blood and blood
products. The agenda for the meeting
includes discussion by the Committee
on the current informed consent laws
for blood, organ, cells, and tissues. The
Committee will examine the informed
consent laws and consider making
recommendations about legal reform. In
keeping with established mission, the
ACBSA also will be asked to review and
comment on previous ACBSA
recommendations.
The public will have the opportunity
to present their views to the Committee
during a public comment session
scheduled for December 6, 2011.
Comments will be limited to five
minutes per speaker and must be
pertinent to the discussion. Preregistration is required for participation
in the public comment session. Any
member of the public who would like to
participate in this session is encouraged
to contact the Acting Executive
Secretary at his/her earliest convenience
to register for time (limited to 5
minutes) and registration must be prior
to close of business on December 1,
2011. If it is not possible to provide 30
copies of the material to be distributed,
then individuals are requested to
provide a minimum of one (1) copy of
the document(s) to the Acting Executive
Secretary to be distributed prior to the
close of business on December 5, 2011.
It is also requested that any member of
the public who wishes to provide
comments to the Committee utilizing
electronic data projection to submit the
necessary material to the Acting
Executive Secretary prior to the close of
business on December 1, 2011.
Electronic comments must adhere to
disability accessibility guidelines
(Section 508 compliance).
srobinson on DSK4SPTVN1PROD with NOTICES
SUPPLEMENTARY INFORMATION:
Dated: October 27, 2011.
James J. Berger,
Acting Executive Secretary, Advisory
Committee on Blood Safety and Availability.
[FR Doc. 2011–28489 Filed 11–2–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Toxic Substances and
Disease Registry
[ATSDR–271]
Notice of the Revised Priority List of
Hazardous Substances That Will Be
the Subject of Toxicological Profiles
Agency for Toxic Substances
and Disease Registry (ATSDR),
Department of Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Comprehensive
Environmental Response,
Compensation, and Liability Act of 1980
(CERCLA or Superfund), as amended by
the Superfund Amendments and
Reauthorization Act of 1986 (SARA),
requires that ATSDR and the
Environmental Protection Agency (EPA)
prepare a Priority List of Hazardous
Substances commonly found at facilities
on the CERCLA National Priorities List
(NPL). The Priority List of Hazardous
Substances includes substances that
have been determined to be of greatest
public health concern to persons at or
near NPL sites. CERCLA as amended
also requires that the Priority List of
Hazardous Substances be revised
periodically.
This announcement provides notice
that a revised Priority List of 275
Hazardous Substances has been
developed and is now available for
download. CERCLA as amended also
requires ATSDR to prepare and to
periodically revise toxicological profiles
on hazardous substances included in
the priority list. Thus, each priority list
substance is a potential toxicological
profile subject, as well as a candidate for
identification of priority data needs.
In addition to the Priority List of
Hazardous Substances, ATSDR has
developed a Completed Exposure
Pathway Site Count Report. This report
lists the number of sites or events at
which ATSDR is involved and wherein
a substance has been found in a
completed exposure pathway (CEP).
ADDRESSES: Requests for a printed copy
of the 2011 Priority List of Hazardous
Substances That Will Be the Subject of
Toxicological Profiles and Support
Document, including the CEP report
should be submitted to Ms. Nickolette
Roney, Division of Toxicology and
Environmental Medicine, ATSDR, Mail
Stop F–62, 1600 Clifton Road NE.,
Atlanta, GA 30333.
Electronic Availability: The 2011
Priority List of Hazardous Substances
and Support Document is posted on
SUMMARY:
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68193
ATSDR’s Web site located at https://
www.atsdr.cdc.gov/SPL. The CEP Report
is also posted at https://www.atsdr.cdc.
gov/CEP.
FOR FURTHER INFORMATION CONTACT: Ms.
Nickolette Roney, Division of
Toxicology and Environmental
Medicine, ATSDR, 1600 Clifton Road
NE., Mail Stop F–62, Atlanta, GA 30333,
telephone (800) 232–4636, ET.
This is an informational notice only;
no comments are solicited at this time.
SUPPLEMENTARY INFORMATION: CERCLA
establishes certain requirements for
ATSDR and EPA with regard to
hazardous substances most commonly
found at facilities on the CERCLA NPL.
Section 104(i)(2)(A) of CERCLA, as
amended,1 requires that ATSDR and
EPA prepare a list, in order of priority,
of at least 100 hazardous substances
most commonly found at facilities on
the NPL and which, in the agencies’ sole
discretion, pose the most significant
potential threats to human health (see
also 52 FR 12866, April 17, 1987).
CERCLA section 104(i)(2)(B) 2 also
requires the agencies to revise the
priority list to include 100 or more
additional hazardous substances (see
also 53 FR 41280, October 20, 1988),
and to include at least 25 additional
hazardous substances in each of the
three successive years following the
1988 revision (see 54 FR 43615, October
26, 1989; 55 FR 42067, October 17,
1990; and 56 FR 52166, October 17,
1991). CERCLA section 104(i)(2)(B)
further requires ATSDR and EPA at least
annually to revise the list to include any
additional hazardous substances that
have been determined to pose the most
significant potential threat to human
health.
In 1995, the agencies, recognizing the
stability of this listing activity, altered
the priority list publication schedule (60
FR 16478, March 30, 1995). As a result,
the substance priority list is now on a
2-year publication schedule, with
annual informal review and revision.
However, after the publication of the
2007 substance priority list, ATSDR
transitioned to a new science database.
This transition caused a delay in the
publication of the revised priority list.
Thus, the 2011 priority list is the first
publication of the list since the 2007
priority list. Each substance on the
Priority List of Hazardous Substances is
a potential subject of a toxicological
profile prepared by ATSDR and,
subsequently, a candidate for the
identification of priority data needs.
The ranking of substances on the
priority list is based on an algorithm
1 42
2 42
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U.S.C. 9604(i)(2)(A).
U.S.C. 9604(i)(2)(B).
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]]>Agencies
[Federal Register Volume 76, Number 213 (Thursday, November 3, 2011)]
[Notices]
[Pages 68192-68193]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-28489]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Advisory Committee on Blood Safety and
Availability
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of the Assistant Secretary for Health.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S.
Department of Health and Human Services is hereby giving notice that
the Advisory Committee on Blood Safety and Availability (ACBSA) will
hold a meeting. The meeting will be open to the public.
DATES: The meeting will take place Monday, December 5, and Tuesday
December 6, 2011, from 9 a.m. to 5 p.m.
ADDRESSES: National Institutes of Health Conference Room, 5635 Fishers
Lane, Terrace Level, Rockville, MD 20852.
[[Page 68193]]
FOR FURTHER INFORMATION CONTACT: Mr. James Berger, Acting Executive
Secretary, ACBSA, Office of the Assistant Secretary for Health,
Department of Health and Human Services, 1101 Wootton Parkway, Suite
250, Rockville, MD 20852, (240) 453-8809, FAX (240) 453-8456, email
ACBSA@hhs.gov.
SUPPLEMENTARY INFORMATION: The ACBSA provides advice to the Secretary,
through the Assistant Secretary for Health, on a broad range of issues
involving the safety and availability of blood and blood products. The
agenda for the meeting includes discussion by the Committee on the
current informed consent laws for blood, organ, cells, and tissues. The
Committee will examine the informed consent laws and consider making
recommendations about legal reform. In keeping with established
mission, the ACBSA also will be asked to review and comment on previous
ACBSA recommendations.
The public will have the opportunity to present their views to the
Committee during a public comment session scheduled for December 6,
2011. Comments will be limited to five minutes per speaker and must be
pertinent to the discussion. Pre-registration is required for
participation in the public comment session. Any member of the public
who would like to participate in this session is encouraged to contact
the Acting Executive Secretary at his/her earliest convenience to
register for time (limited to 5 minutes) and registration must be prior
to close of business on December 1, 2011. If it is not possible to
provide 30 copies of the material to be distributed, then individuals
are requested to provide a minimum of one (1) copy of the document(s)
to the Acting Executive Secretary to be distributed prior to the close
of business on December 5, 2011. It is also requested that any member
of the public who wishes to provide comments to the Committee utilizing
electronic data projection to submit the necessary material to the
Acting Executive Secretary prior to the close of business on December
1, 2011. Electronic comments must adhere to disability accessibility
guidelines (Section 508 compliance).
Dated: October 27, 2011.
James J. Berger,
Acting Executive Secretary, Advisory Committee on Blood Safety and
Availability.
[FR Doc. 2011-28489 Filed 11-2-11; 8:45 am]
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