Patient Safety Organizations: Voluntary Relinquishment From QAISys, Inc., 60003-60004 [2016-20912]
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Federal Register / Vol. 81, No. 169 / Wednesday, August 31, 2016 / Notices
Estimated labor costs: $21,570.
Commission staff derived labor costs
by applying appropriate hourly cost
figures to the burden hours described
above. Staff further assumes that office
support file clerks will handle the
Rule’s record retention requirements at
an hourly rate of $14.38.13 Based upon
the above estimates and assumptions,
the total annual labor cost to retain and
file documents, for the FTC’s allotted
burden, is $21,570 (1,500 hours × $14.38
per hour).
Absent information to the contrary,
staff anticipates that existing storage
media and equipment that covered
persons use in the ordinary course of
business will satisfactorily
accommodate incremental
recordkeeping under the Rule.
Accordingly, staff does not anticipate
that the Rule will require any new
capital or other non-labor expenditures.
Request for Comments
mstockstill on DSK3G9T082PROD with NOTICES
You can file a comment online or on
paper. Write ‘‘Regulation N: FTC File
No. P134811; K05’’ on your comment.
Your comment—including your name
and your state—will be placed on the
public record of this proceeding,
including, to the extent practicable, on
the public Commission Web site, at
https://www.ftc.gov/os/
publiccomments.shtm. As a matter of
discretion, the Commission tries to
remove individuals’ home contact
information from comments before
placing them on the Commission Web
site.
Because your comment will be made
public, you are solely responsible for
making sure that your comment does
not include any sensitive personal
information, such as a Social Security
number, date of birth, driver’s license
number or other state identification
number or foreign country equivalent,
entities can be indirectly covered by state
recordkeeping requirements for mortgage
advertisements and/or retain ads to demonstrate
compliance with state law, as discussed above. See
supra note 6. The FTC notes that the CFPB’s recent
information collection filing with OMB for
Regulation N also reflects the view that, in large
part, most entities either retain records in the
ordinary course of business or to demonstrate
compliance with other laws. See generally Bureau
of Consumer Financial Protection, Agency
Information Collection Activities: Submission for
OMB Review; Comment Review, 80 FR 45645 (July
31, 2015), available at https://www.gpo.gov/fdsys/
pkg/FR-2015-07-31/pdf/2015-18809.pdf.
13 This estimate is based on mean hourly wages
for office support file clerks provided by the Bureau
of Labor Statistics. See U.S. Bureau of Labor
Statistics, Occupational Employment and Wages—
May 2015, table 1 (‘‘National employment and wage
data from the Occupational Employment Statistics
survey by occupation’’), released Mar. 30, 2016,
available at https://www.bls.gov/news.release/pdf/
ocwage.pdf.
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passport number, financial account
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You are also solely responsible for
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in section 6(f) of the FTC Act, 15 U.S.C.
46(f), and FTC Rule 4.10(a)(2), 16 CFR
4.10(a)(2). In particular, do not include
competitively sensitive information
such as costs, sales statistics,
inventories, formulas, patterns, devices,
manufacturing processes, or customer
names.
If you want the Commission to give
your comment confidential treatment,
you must file it in paper form, with a
request for confidential treatment, and
you must follow the procedure
explained in FTC Rule 4.9(c), 16 CFR
4.9(c). Your comment will be kept
confidential only if the FTC General
Counsel, in his or her sole discretion,
grants your request in accordance with
the law and the public interest. Postal
mail addressed to the Commission is
subject to delay due to heightened
security screening. As a result, the
Commission encourages you to submit
your comments online. To make sure
that the Commission considers your
online comment, you must file it at
https://ftcpublic.commentworks.com/
ftc/regulationnpra by following the
instructions on the web-based form. If
this Notice appears at https://
www.regulations.gov, you also may file
a comment through that Web site.
If you file your comment on paper,
write ‘‘Regulation N: FTC File No.
P134811; K05’’ on your comment and
on the envelope, and mail it to the
following address: Federal Trade
Commission, Office of the Secretary,
600 Pennsylvania Avenue NW., Suite
CC–5610, (Annex J), Washington, DC
20580, or deliver your comment to the
following address: Federal Trade
Commission, Office of the Secretary,
Constitution Center, 400 7th Street SW.,
5th Floor, Suite 5610, (Annex J),
Washington, DC 20024. If possible,
submit your paper comment to the
Commission by courier or overnight
service.
The FTC Act and other laws that the
Commission administers permit the
collection of public comments to
consider and use in this proceeding as
appropriate. The Commission will
consider all timely and responsive
public comments that it receives on or
before October 31, 2016. You can find
more information, including routine
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uses permitted by the Privacy Act, in
the Commission’s privacy policy, at
https://www.ftc.gov/ftc/privacy.htm.
David C. Shonka,
Acting General Counsel.
[FR Doc. 2016–20933 Filed 8–30–16; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Patient Safety Organizations:
Voluntary Relinquishment From
QAISys, Inc.
Agency for Healthcare Research
and Quality (AHRQ), Department of
Health and Human Services (HHS).
ACTION: Notice of delisting.
AGENCY:
The Patient Safety and
Quality Improvement Act of 2005, 42
U.S.C. 299b–21 to b–26, (Patient Safety
Act) and the related Patient Safety and
Quality Improvement Final Rule, 42
CFR part 3 (Patient Safety Rule),
published in the Federal Register on
November 21, 2008, 73 FR 70732–
70814, provide for the formation of
Patient Safety Organizations (PSOs),
which collect, aggregate, and analyze
confidential information regarding the
quality and safety of health care
delivery. The Patient Safety Rule
authorizes AHRQ, on behalf of the
Secretary of HHS, to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ by
the Secretary if it is found to no longer
meet the requirements of the Patient
Safety Act and Patient Safety Rule,
when a PSO chooses to voluntarily
relinquish its status as a PSO for any
reason, or when a PSO’s listing expires.
AHRQ has accepted a notification of
voluntary relinquishment from QAISys,
Inc. of its status as a PSO, and has
delisted the PSO accordingly. QAISys,
Inc. submitted this request for voluntary
relinquishment after receiving a Notice
of Preliminary Finding of Deficiency.
DATES: The directories for both listed
and delisted PSOs are ongoing and
reviewed weekly by AHRQ. The
delisting was effective at 12:00 Midnight
ET (2400) on August 10, 2016.
ADDRESSES: Both directories can be
accessed electronically at the following
HHS Web site: https://
www.pso.ahrq.gov/listed.
FOR FURTHER INFORMATION CONTACT:
Eileen Hogan, Center for Quality
Improvement and Patient Safety, AHRQ,
SUMMARY:
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Federal Register / Vol. 81, No. 169 / Wednesday, August 31, 2016 / Notices
5600 Fishers Lane, Room 06N94B,
Rockville, MD 20857; Telephone (toll
free): (866) 403–3697; Telephone (local):
(301) 427–1111; TTY (toll free): (866)
438–7231; TTY (local): (301) 427–1130;
Email: PSO@AHRQ.hhs.gov.
Background
The Patient Safety Act authorizes the
listing of PSOs, which are entities or
component organizations whose
mission and primary activity are to
conduct activities to improve patient
safety and the quality of health care
delivery.
HHS issued the Patient Safety Rule to
implement the Patient Safety Act.
AHRQ administers the provisions of the
Patient Safety Act and Patient Safety
Rule relating to the listing and operation
of PSOs. The Patient Safety Rule
authorizes AHRQ to list as a PSO an
entity that attests that it meets the
statutory and regulatory requirements
for listing. A PSO can be ‘‘delisted’’ if
it is found to no longer meet the
requirements of the Patient Safety Act
and Patient Safety Rule, when a PSO
chooses to voluntarily relinquish its
status as a PSO for any reason, or when
a PSO’s listing expires. Section 3.108(d)
of the Patient Safety Rule requires
AHRQ to provide public notice when it
removes an organization from the list of
federally approved PSOs.
AHRQ has accepted a notification
from the QAISys, Inc., PSO number
P0161, to voluntarily relinquish its
status as a PSO. Accordingly, QAISys,
Inc. was delisted effective at 12:00
Midnight ET (2400) on August 10, 2016.
AHRQ notes that that QAISys, Inc.
submitted this request for voluntary
relinquishment following receipt of the
Notice of Preliminary Finding of
Deficiency sent on July 28, 2016. In
addition, QAISys, Inc., P0046, was
previously listed as a PSO in 2009;
AHRQ accepted its request for voluntary
relinquishment in 2013.
More information on PSOs can be
obtained through AHRQ’s PSO Web site
at https://www.pso.AHRQ.gov.
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[FR Doc. 2016–20912 Filed 8–30–16; 8:45 am]
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Food and Drug Administration
[Docket No. FDA–2016–D–2495]
Submission of Warning Plans for
Cigars; Draft Guidance for Industry;
Availability
SUPPLEMENTARY INFORMATION:
Sharon B. Arnold,
Deputy Director.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Submission of
Warning Plans for Cigars.’’ The draft
guidance, when finalized, will help
those involved in the manufacture,
distribution, and sale of cigars in the
United States understand the new cigar
warning plan requirements under FDA’s
final rule deeming these products to be
subject to the tobacco product
authorities in the Federal Food, Drug,
and Cosmetic Act (the FD&C Act). The
draft guidance reiterates the required
health warning statements and the
requirements for random display and
distribution that should be provided in
cigar warning plans, and, when
finalized, will help persons determine
who should submit a warning plan,
when a plan must be submitted, and
what information should be included
when submitting a plan.
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
either electronic or written comments
on the draft guidance by September 29,
2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
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that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–2495 for ‘‘Submission of
Warning Plans for Cigars.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
E:\FR\FM\31AUN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 169 (Wednesday, August 31, 2016)]
[Notices]
[Pages 60003-60004]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20912]
=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Patient Safety Organizations: Voluntary Relinquishment From
QAISys, Inc.
AGENCY: Agency for Healthcare Research and Quality (AHRQ), Department
of Health and Human Services (HHS).
ACTION: Notice of delisting.
-----------------------------------------------------------------------
SUMMARY: The Patient Safety and Quality Improvement Act of 2005, 42
U.S.C. 299b-21 to b-26, (Patient Safety Act) and the related Patient
Safety and Quality Improvement Final Rule, 42 CFR part 3 (Patient
Safety Rule), published in the Federal Register on November 21, 2008,
73 FR 70732-70814, provide for the formation of Patient Safety
Organizations (PSOs), which collect, aggregate, and analyze
confidential information regarding the quality and safety of health
care delivery. The Patient Safety Rule authorizes AHRQ, on behalf of
the Secretary of HHS, to list as a PSO an entity that attests that it
meets the statutory and regulatory requirements for listing. A PSO can
be ``delisted'' by the Secretary if it is found to no longer meet the
requirements of the Patient Safety Act and Patient Safety Rule, when a
PSO chooses to voluntarily relinquish its status as a PSO for any
reason, or when a PSO's listing expires. AHRQ has accepted a
notification of voluntary relinquishment from QAISys, Inc. of its
status as a PSO, and has delisted the PSO accordingly. QAISys, Inc.
submitted this request for voluntary relinquishment after receiving a
Notice of Preliminary Finding of Deficiency.
DATES: The directories for both listed and delisted PSOs are ongoing
and reviewed weekly by AHRQ. The delisting was effective at 12:00
Midnight ET (2400) on August 10, 2016.
ADDRESSES: Both directories can be accessed electronically at the
following HHS Web site: https://www.pso.ahrq.gov/listed.
FOR FURTHER INFORMATION CONTACT: Eileen Hogan, Center for Quality
Improvement and Patient Safety, AHRQ,
[[Page 60004]]
5600 Fishers Lane, Room 06N94B, Rockville, MD 20857; Telephone (toll
free): (866) 403-3697; Telephone (local): (301) 427-1111; TTY (toll
free): (866) 438-7231; TTY (local): (301) 427-1130; Email:
PSO@AHRQ.hhs.gov.
SUPPLEMENTARY INFORMATION:
Background
The Patient Safety Act authorizes the listing of PSOs, which are
entities or component organizations whose mission and primary activity
are to conduct activities to improve patient safety and the quality of
health care delivery.
HHS issued the Patient Safety Rule to implement the Patient Safety
Act. AHRQ administers the provisions of the Patient Safety Act and
Patient Safety Rule relating to the listing and operation of PSOs. The
Patient Safety Rule authorizes AHRQ to list as a PSO an entity that
attests that it meets the statutory and regulatory requirements for
listing. A PSO can be ``delisted'' if it is found to no longer meet the
requirements of the Patient Safety Act and Patient Safety Rule, when a
PSO chooses to voluntarily relinquish its status as a PSO for any
reason, or when a PSO's listing expires. Section 3.108(d) of the
Patient Safety Rule requires AHRQ to provide public notice when it
removes an organization from the list of federally approved PSOs.
AHRQ has accepted a notification from the QAISys, Inc., PSO number
P0161, to voluntarily relinquish its status as a PSO. Accordingly,
QAISys, Inc. was delisted effective at 12:00 Midnight ET (2400) on
August 10, 2016. AHRQ notes that that QAISys, Inc. submitted this
request for voluntary relinquishment following receipt of the Notice of
Preliminary Finding of Deficiency sent on July 28, 2016. In addition,
QAISys, Inc., P0046, was previously listed as a PSO in 2009; AHRQ
accepted its request for voluntary relinquishment in 2013.
More information on PSOs can be obtained through AHRQ's PSO Web
site at https://www.pso.AHRQ.gov.
Sharon B. Arnold,
Deputy Director.
[FR Doc. 2016-20912 Filed 8-30-16; 8:45 am]
BILLING CODE 4160-90-P
