Implementing the Patient Safety and Quality Improvement Act of 2005 Including How to Become a Patient Safety Organization: Interim Guidance Availability, 60705 [E8-24267]
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60705
Federal Register / Vol. 73, No. 199 / Tuesday, October 14, 2008 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Forms
Average
burden hours
per response
Total burden
hours
Recruit Letters .................................................................................................
Web Survey .....................................................................................................
10,754
10,754
1
1
15/60
20/60
2,689
3,585
Total ..........................................................................................................
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6,274
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. E8–24297 Filed 10–10–08; 8:45 am]
BILLING CODE 4150–31–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality (AHRQ), Office for Civil Rights
(OCR)
Implementing the Patient Safety and
Quality Improvement Act of 2005
Including How to Become a Patient
Safety Organization: Interim Guidance
Availability
October 14, 2008.
Agency for Healthcare Research
and Quality (AHRQ), Office for Civil
Rights (OCR), HHS.
ACTION: Notice of Availability.
jlentini on PROD1PC65 with NOTICES
AGENCY:
SUMMARY: AHRQ and OCR are
announcing the availability of the
guidance entitled ‘‘Implementing the
Patient Safety and Quality Improvement
Act of 2005 Including How to Become
a Patient Safety Organization.’’ The
Interim Guidance document explains
how the Department of Health and
Human Services (HHS) will begin
implementing the Patient Safety and
Quality Improvement Act of 2005
(Patient Safety Act), how an entity can
become a Patient Safety Organization
(PSO), and how information may be
protected as Patient Safety Work
Product (PSWP) in the interim period
prior to the promulgation of a final
regulation. To access the Interim
Guidance, visit AHRQ’s PSO Web site at
https://www.pso.ahrq.gov.
DATES: The Interim Guidance is effective
immediately with the publication of this
notice. The Interim Guidance will
remain effective until the effective date
of the final regulation, which is
expected to be promulgated before the
end of 2008.
SUPPLEMENTARY INFORMATION:
I. Background
The Interim Guidance document is
intended to inform private, public and
VerDate Aug<31>2005
15:37 Oct 10, 2008
Jkt 217001
nonprofit health care communities, the
legal community and others of HHS’s
policies and procedures for
implementing the Patient Safety Act,
prior to the promulgation of a final
regulation. This Interim Guidance
interprets the Patient Safety Act. The
Patient Safety Act (Pub. L. 109–41)
amended the Public Health Service Act
(42 U.S.C. 299 et seq.) by renumbering
existing sections and inserting new
sections 921 through 926 (42 U.S.C.
299b–21 through 299b–26). The Patient
Safety Act authorizes the listing by the
Secretary of statutorily defined PSOs.
PSOs are to carry out statutorily defined
patient safety activities on behalf of
providers in order to assist them to
improve patient safety. To encourage
providers to submit information to PSOs
and PSOs to conduct analyses regarding
patient safety, the statute establishes
privilege and confidentiality protections
to protect certain information, including
information collected by providers for
sharing with PSOs for analysis, analyses
performed by the providers and/or the
PSOs, and information shared between
the PSOs and the health care providers
they serve. This information is defined
in the statute as PSWP.
II. Significance of the Interim Guidance
The Interim Guidance establishes the
process by which the Secretary will list
PSOs. Once PSOs are listed by the
Secretary, providers can: (1) Voluntarily
submit information to PSOs, and (2)
seek PSOs’ analysis of patient safety
events. These activities should lead to
improvements in patient safety. The
protections established by the Patient
Safety Act will permit and encourage
numerous providers to submit pertinent
data to PSOs so that the PSOs will be
able to aggregate and analyze the data
from multiple providers, thus enabling
the identification of patterns that could
suggest underlying or systemic causes of
patient risks and hazards that then can
be addressed to improve patient safety
and quality.
III. Paperwork Reduction Act of 1995
The listing of PSOs under the Interim
Guidance involves collecting of
information that is subject to review by
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
the Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501–3520).
These collections of information have
been approved under OMB control
number 0935–0143.
Dated: October 7, 2008.
Ann C. Agnew,
Executive Secretary to the Department.
[FR Doc. E8–24267 Filed 10–8–08; 4:15 pm]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0448]
International Drug Scheduling;
Convention of Psychotropic
Substances; Single Convention on
Narcotic Drugs; Gammahydroxybutyric acid; Ketamine;
Dextromethorphan; Nbenzylpiperazine; 1-(3trifluoromethylphenyl) piperazine; 1-(3chlorophenyl) piperazine; 1-(4Methoxyphenyl) piperazine; 1-(3,4methylenedioxybenzyl) piperazine;
Gamma-butyrolactone; 1,4-Butanediol;
Reopening of Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; reopening of comment
period.
SUMMARY: The Food and Drug
Administration (FDA) is reopening until
October 20, 2008, the comment period
for the notice on ‘‘International Drug
Scheduling; Convention on
Psychotropic Substances; Single
Convention on Narcotic Drugs,’’
published in the Federal Register of
September 5, 2008 (73 FR 51823),
requesting comments on abuse
potential, actual abuse, medical
usefulness, trafficking, and impact of
scheduling changes on availability for
medical use of 10 drug substances. FDA
is taking this action in response to a
request for a reopening of the comment
period to allow interested persons
additional time to review the notice and
submit comments.
E:\FR\FM\14OCN1.SGM
14OCN1
]]>Agencies
[Federal Register Volume 73, Number 199 (Tuesday, October 14, 2008)]
[Notices]
[Page 60705]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-24267]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality (AHRQ), Office for Civil
Rights (OCR)
Implementing the Patient Safety and Quality Improvement Act of
2005 Including How to Become a Patient Safety Organization: Interim
Guidance Availability
October 14, 2008.
AGENCY: Agency for Healthcare Research and Quality (AHRQ), Office for
Civil Rights (OCR), HHS.
ACTION: Notice of Availability.
-----------------------------------------------------------------------
SUMMARY: AHRQ and OCR are announcing the availability of the guidance
entitled ``Implementing the Patient Safety and Quality Improvement Act
of 2005 Including How to Become a Patient Safety Organization.'' The
Interim Guidance document explains how the Department of Health and
Human Services (HHS) will begin implementing the Patient Safety and
Quality Improvement Act of 2005 (Patient Safety Act), how an entity can
become a Patient Safety Organization (PSO), and how information may be
protected as Patient Safety Work Product (PSWP) in the interim period
prior to the promulgation of a final regulation. To access the Interim
Guidance, visit AHRQ's PSO Web site at https://www.pso.ahrq.gov.
DATES: The Interim Guidance is effective immediately with the
publication of this notice. The Interim Guidance will remain effective
until the effective date of the final regulation, which is expected to
be promulgated before the end of 2008.
SUPPLEMENTARY INFORMATION:
I. Background
The Interim Guidance document is intended to inform private, public
and nonprofit health care communities, the legal community and others
of HHS's policies and procedures for implementing the Patient Safety
Act, prior to the promulgation of a final regulation. This Interim
Guidance interprets the Patient Safety Act. The Patient Safety Act
(Pub. L. 109-41) amended the Public Health Service Act (42 U.S.C. 299
et seq.) by renumbering existing sections and inserting new sections
921 through 926 (42 U.S.C. 299b-21 through 299b-26). The Patient Safety
Act authorizes the listing by the Secretary of statutorily defined
PSOs. PSOs are to carry out statutorily defined patient safety
activities on behalf of providers in order to assist them to improve
patient safety. To encourage providers to submit information to PSOs
and PSOs to conduct analyses regarding patient safety, the statute
establishes privilege and confidentiality protections to protect
certain information, including information collected by providers for
sharing with PSOs for analysis, analyses performed by the providers
and/or the PSOs, and information shared between the PSOs and the health
care providers they serve. This information is defined in the statute
as PSWP.
II. Significance of the Interim Guidance
The Interim Guidance establishes the process by which the Secretary
will list PSOs. Once PSOs are listed by the Secretary, providers can:
(1) Voluntarily submit information to PSOs, and (2) seek PSOs' analysis
of patient safety events. These activities should lead to improvements
in patient safety. The protections established by the Patient Safety
Act will permit and encourage numerous providers to submit pertinent
data to PSOs so that the PSOs will be able to aggregate and analyze the
data from multiple providers, thus enabling the identification of
patterns that could suggest underlying or systemic causes of patient
risks and hazards that then can be addressed to improve patient safety
and quality.
III. Paperwork Reduction Act of 1995
The listing of PSOs under the Interim Guidance involves collecting
of information that is subject to review by the Office of Management
and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520). These collections of information have been approved under
OMB control number 0935-0143.
Dated: October 7, 2008.
Ann C. Agnew,
Executive Secretary to the Department.
[FR Doc. E8-24267 Filed 10-8-08; 4:15 pm]
BILLING CODE 4153-01-P
