Submission for OMB Review; Comment Request: Ethical Dilemmas in Surgery and Utilization of Hospital Ethics Consultation Service: A Survey, 67380-67381 [2012-27445]
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Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices
Dated: October 31, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012–27340 Filed 11–8–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0001]
Anesthetic and Analgesic Drug
Products Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Anesthetic and
Analgesic Drug Products Advisory
Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
DATES: Date and Time: The meeting will
be held on December 7, 2012, from 8
a.m. to 5 p.m.
Location: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(rm. 1503), Silver Spring, MD 20992–
0002. Information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/default.htm; under
the heading ‘‘Resources for You,’’ click
on ‘‘Public Meetings at the FDA White
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to the White Oak Campus must enter
through Building 1.
Contact Person: Philip A. Bautista,
Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 31, rm. 2417, Silver Spring,
MD 20993–0002, 301–796–9001, FAX:
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default.htm and scroll down to the
appropriate advisory committee meeting
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modifications before coming to the
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Agenda: The committee will discuss
the risks and benefits of new drug
application (NDA) 202880, by Zogenix
Inc., for hydrocodone bitartrate
extended-release capsules (proposed
tradename ZOHYDRO ER), an opioid
analgesic medication for the
management of moderate to severe
chronic pain when a continuous,
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This formulation of hydrocodone
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containing no other active
pharmaceutical ingredients, such as
acetaminophen or ibuprofen)
hydrocodone-containing drug product.
It will be formulated in dose strengths
up to 50 milligrams, and administered
twice daily (i.e., every 12 hours). The
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whether the benefit-risk assessment of
this product favors its approval for
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material available to the public no later
than 2 business days before the meeting.
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meeting, the background material will
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location of the advisory committee
meeting, and the background material
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the meeting. Background material is
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AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
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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 November 23, 2012.
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interested in making formal oral
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the general nature of the evidence or
arguments they wish to present, the
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participants, and an indication of the
approximate time requested to make
their presentation on or before
November 14, 2012. Time allotted for
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number of registrants requesting to
speak is greater than can be reasonably
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accommodated during the scheduled
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require special accommodations due to
a disability, please contact Philip
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FDA is committed to the orderly
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AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: November 5, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2012–27368 Filed 11–8–12; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request: Ethical Dilemmas
in Surgery and Utilization of Hospital
Ethics Consultation Service: A Survey
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Clinical
Center Department of Bioethics, the
National Institutes of Health has
submitted to the Office of Management
and Budget (OMB) a request to review
and approve the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on November 28,
2011 on page 72955–72956 [FR DOC #
2011–30548] and allowed 60-days for
public comment. Two comments were
received by the NIH Department of
Bioethics. The comments we received
included one request from a survey firm
that was interested in possibly
administering the survey, and one
SUMMARY:
E:\FR\FM\09NON1.SGM
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67381
Federal Register / Vol. 77, No. 218 / Friday, November 9, 2012 / Notices
request from the American Association
of Medical Colleges (AAMC) that was
interested in knowing what items were
in the survey instrument. The purpose
of this notice is to allow an additional
30 days for public comment. The
National Institutes of Health may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection: Title: Ethical
Dilemmas in Surgery and Utilization of
Hospital Ethics Consultation Service: A
Survey. Type of Information Collection
Request: NEW. Need and Use of
Information Collection: This survey is
intended to collect information about
the ethical dilemmas that surgeons have
faced in their practices over the past
year, and assess their experiences, if
any, with their hospital consultation
services. Specifically, the information
gathered in this study will be valuable
in understanding the ethical dilemmas
that surgeons face, the utility of
institution ethics consultations services
for surgeons, and to identify what
barriers, if any, discourage surgeons
from utilizing these services. The results
of this study can be used by medical
professionals, hospitals, and bioethicists
in several important ways. First, they
will provide a better understanding the
ethical dilemmas that surgeons face in
Estimated
number of
respondents
Type of respondents
their practices. Second, they will
provide understanding of factors that
determine the current utilization of
hospital consultation services by
surgeons. Third, information collected
on the barriers to surgeons’ use of ethics
consultation services will provide better
insight into the perspective and culture
of surgery as it relates to ethical
dilemmas in their practices and how
ethics consultation services could better
support surgeons when faced with these
dilemmas. Frequency of Response:
Once. Affected Public: Individuals;
Businesses or other for-profit. Type of
Respondents: Individuals.
The annual reporting burden is as
follows:
Estimated
number of
responses per
respondent
Average
burden per
response
(in hours)
Estimated total
annual burden
hours
requested
598
1
15/60
150
Total ..........................................................................................................
tkelley on DSK3SPTVN1PROD with NOTICES
Surgeons ..........................................................................................................
598
........................
........................
150
There are no capital, operating, or
maintenance costs to report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the function of the
agency, including whether the
information will have practical utility;
(2) The accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
Ways to minimize the burden of the
collection of information on those who
are to respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact: Marion
VerDate Mar<15>2010
17:34 Nov 08, 2012
Jkt 229001
Danis, MD, Department of Clinical
Bioethics, National Institutes of Health,
Building 10, Room 1C118, Bethesda,
MD 20892–1156; Telephone: 301–435–
8727; Facsimile: 301–496–0760; Email:
mdanis@cc.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
this publication.
Dated: August 28, 2012.
Laura Lee,
Project Clearance Liason, CC, National
Institutes of Health.
[FR Doc. 2012–27445 Filed 11–8–12; 8:45 am]
inventions to extend market coverage
for companies and may also be available
for licensing.
FOR FURTHER INFORMATION CONTACT:
Licensing information and copies of the
U.S. patent applications listed below
may be obtained by writing to the
indicated licensing contact at the Office
of Technology Transfer, National
Institutes of Health, 6011 Executive
Boulevard, Suite 325, Rockville,
Maryland 20852–3804; telephone: 301–
496–7057; fax: 301–402–0220. A signed
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Cell Lines Expressing Nuclear and/or
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DEPARTMENT OF HEALTH AND
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Description of Technology: RNase H1
has been shown to remove RNA/DNA
hybrids and either too much or too little
enzyme can lead to undesirable effects
such as deletions of DNA. The gene
encoding RNase H1 in mammalian cells
produces two forms of the protein. One
is targeted to the nucleus of the cell and
the other to the mitochondrial organelle.
To study the effects of expression as
well as to understand the regulation of
the frequency with which each form is
made, NIH investigators constructed
cells derived from HEK293 cells where
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expressed only after addition of
doxycycline as a small molecule
inducer compound. The set of cell lines
could be important in the process of
analysis of RNA/DNA hybrids as each
National Institutes of Health
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ACTION: Notice.
AGENCY:
The inventions listed below
are owned by an agency of the U.S.
Government and are available for
licensing in the U.S. in accordance with
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development. Foreign patent
applications are filed on selected
SUMMARY:
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]]>Agencies
[Federal Register Volume 77, Number 218 (Friday, November 9, 2012)]
[Notices]
[Pages 67380-67381]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-27445]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request: Ethical Dilemmas in
Surgery and Utilization of Hospital Ethics Consultation Service: A
Survey
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the Clinical Center Department of Bioethics, the
National Institutes of Health has submitted to the Office of Management
and Budget (OMB) a request to review and approve the information
collection listed below. This proposed information collection was
previously published in the Federal Register on November 28, 2011 on
page 72955-72956 [FR DOC 2011-30548] and allowed 60-days for
public comment. Two comments were received by the NIH Department of
Bioethics. The comments we received included one request from a survey
firm that was interested in possibly administering the survey, and one
[[Page 67381]]
request from the American Association of Medical Colleges (AAMC) that
was interested in knowing what items were in the survey instrument. The
purpose of this notice is to allow an additional 30 days for public
comment. The National Institutes of Health may not conduct or sponsor,
and the respondent is not required to respond to, an information
collection that has been extended, revised, or implemented on or after
October 1, 1995, unless it displays a currently valid OMB control
number.
Proposed Collection: Title: Ethical Dilemmas in Surgery and
Utilization of Hospital Ethics Consultation Service: A Survey. Type of
Information Collection Request: NEW. Need and Use of Information
Collection: This survey is intended to collect information about the
ethical dilemmas that surgeons have faced in their practices over the
past year, and assess their experiences, if any, with their hospital
consultation services. Specifically, the information gathered in this
study will be valuable in understanding the ethical dilemmas that
surgeons face, the utility of institution ethics consultations services
for surgeons, and to identify what barriers, if any, discourage
surgeons from utilizing these services. The results of this study can
be used by medical professionals, hospitals, and bioethicists in
several important ways. First, they will provide a better understanding
the ethical dilemmas that surgeons face in their practices. Second,
they will provide understanding of factors that determine the current
utilization of hospital consultation services by surgeons. Third,
information collected on the barriers to surgeons' use of ethics
consultation services will provide better insight into the perspective
and culture of surgery as it relates to ethical dilemmas in their
practices and how ethics consultation services could better support
surgeons when faced with these dilemmas. Frequency of Response: Once.
Affected Public: Individuals; Businesses or other for-profit. Type of
Respondents: Individuals.
The annual reporting burden is as follows:
----------------------------------------------------------------------------------------------------------------
Estimated Average Estimated
Estimated number of burden per total annual
Type of respondents number of responses per response (in burden hours
respondents respondent hours) requested
----------------------------------------------------------------------------------------------------------------
Surgeons........................................ 598 1 15/60 150
---------------------------------------------------------------
Total....................................... 598 .............. .............. 150
----------------------------------------------------------------------------------------------------------------
There are no capital, operating, or maintenance costs to report.
Request for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the function of the agency,
including whether the information will have practical utility; (2) The
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) Ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) Ways to minimize
the burden of the collection of information on those who are to
respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov or by fax to 202-395-6974,
Attention: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact: Marion Danis, MD, Department of Clinical
Bioethics, National Institutes of Health, Building 10, Room 1C118,
Bethesda, MD 20892-1156; Telephone: 301-435-8727; Facsimile: 301-496-
0760; Email: mdanis@cc.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of this publication.
Dated: August 28, 2012.
Laura Lee,
Project Clearance Liason, CC, National Institutes of Health.
[FR Doc. 2012-27445 Filed 11-8-12; 8:45 am]
BILLING CODE 4140-01-P
