Proposed Collection; Comment Request: “Ethical Dilemmas in Surgery and Utilization of Hospital Ethics Consultation Service: A Survey”, 72955-72956 [2011-30548]
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Federal Register / Vol. 76, No. 228 / Monday, November 28, 2011 / Notices
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This notice is issued under the
Federal Advisory Committee Act
(5 U.S.C. app. 2) and 21 CFR part 14
relating to advisory committees.
Dated: November 21, 2011.
Jill Hartzler Warner,
Acting Associate Commissioner for Special
Medical Programs.
[FR Doc. 2011–30415 Filed 11–25–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0828]
Wyeth Pharmaceuticals, Inc.;
Withdrawal of Approval of a New Drug
Application for MYLOTARG
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of a new drug application
(NDA) for MYLOTARG (gemtuzumab
ozogamicin) for Injection, held by
Wyeth Pharmaceuticals, Inc. (Wyeth),
500 Arcola Rd., Collegeville, PA 19426.
Wyeth, now a part of Pfizer, Inc., has
voluntarily requested that approval of
this application be withdrawn, thereby
waiving its opportunity for a hearing.
DATES: Effective November 28, 2011.
FOR FURTHER INFORMATION CONTACT:
David Joy, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6254, Silver Spring,
MD 20993–0002, (301) 796–3601.
SUPPLEMENTARY INFORMATION: FDA
approved MYLOTARG (gemtuzumab
ozogamicin) for Injection on May 17,
2000, under the Agency’s accelerated
approval regulations, 21 CFR part 314,
subpart H. MYLOTARG was indicated
for the treatment of patients with CD33positive acute myeloid leukemia in first
relapse who were 60 years of age or
older and who were not considered
candidates for other cytotoxic
chemotherapy. On May 21, 2010, FDA
requested that Wyeth voluntarily
withdraw MYLOTARG from the market,
after results of a required postapproval
clinical trial failed to verify clinical
benefit to patients and raised new
concerns about the drug’s safety. In a
letter dated October 25, 2010, Wyeth
requested that FDA withdraw approval
of NDA 21–174, MYLOTARG
(gemtuzumab ozogamicin) for Injection,
under § 314.150(d) (21 CFR 314.150(d)).
In that letter, Wyeth also waived its
SUMMARY:
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72955
opportunity for a hearing, provided
under 21 CFR 314.150 and 314.530. In
FDA’s acknowledgment letter of
November 2, 2010, the Agency stated
that a large prospective trial that tested
the addition of MYLOTARG to first-line
chemotherapy for patients with newly
diagnosed acute myelogenous leukemia
failed to verify clinical benefit of
MYLOTARG and raised safety concerns.
FDA also acknowledged that Wyeth
waived its opportunity for a hearing.
Therefore, under sections 505(e) and
506(b)(3) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(e) and 356(b)(3)) and § 314.150(d),
and under authority delegated by the
Commissioner to the Director, Center for
Drug Evaluation and Research, approval
of NDA 21–174, and all amendments
and supplements thereto, is withdrawn
(see DATES). Distribution of this product
in interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the FD&C Act (21
U.S.C. 355(a) and 331(d))).
Dated: November 22, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–30473 Filed 11–25–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment
Request: ‘‘Ethical Dilemmas in Surgery
and Utilization of Hospital Ethics
Consultation Service: A Survey’’
In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
for opportunity for public comment on
proposed data collection projects, the
Department of Bioethics, the Clinical
Center, the National Institutes of Health
(NIH) will publish periodic summaries
of proposed projects to be submitted to
the Office of Management and Budget
(OMB) for review and approval.
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
SUMMARY:
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72956
Federal Register / Vol. 76, No. 228 / Monday, November 28, 2011 / Notices
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: One
occasion. Affected Public: Individuals.
Type of Respondents: Surgeons
Estimated
number of
responses per
respondent
Estimated
number of
respondents
Type of
respondents
practicing in the US. The annual
reporting burden is as follows:
Estimated Number of Respondents:
3,156; Estimated Number of Responses
per Respondent: 29 items per
questionnaire; Average Burden Hours
Per Response: 0.00862; and Estimated
Total Annual Burden Hours Requested:
789. The annualized cost to respondents
is estimated at: $0. There are no Capital
Costs to report. There are no Operating
or Maintenance Costs to report.
Average burden
hours per
response
Estimated total
annual burden
hours requested
Surgeons ..........................................................................................
3156
29
0.00862
789
Total ..........................................................................................
............................
............................
............................
789
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.
To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact Dr. Marion Danis at
Department of Clinical Bioethics,
National Institutes of Health, Building
10, Room 1C118, Bethesda, MD 20892–
1156, Telephone: (301) 435–8727,
Facsimile: (301) 496–0760, or email
your request, including your address to:
mdanis@cc.nih.gov.
pmangrum on DSK3VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Comments Due Date
Comments regarding this information
collection are best assured of having
their full effect if received within 60
days of the date of this publication.
VerDate Mar<15>2010
15:34 Nov 25, 2011
Jkt 226001
Dated: November 6, 2011.
Laura M. Lee,
Special Assistant to the DDCC—Patient Safety
and Clinical Quality Project Clearance
Liaison, CC, National Institutes of Health.
[FR Doc. 2011–30548 Filed 11–25–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review;
Comment Request; Cancer Risk in U.S.
Radiologic Technologists: Fourth
Survey (NCI)
Summary: Under the provisions of
section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Cancer Institute, the National Institutes
of Health (NIH) 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 September 21, 2011 (76 FR
58520) and allowed 60 days for public
comment. One public comment was
received in which the individual
suggested asking the respondents to
report the number of procedures
performed per month rather than per
week because of the infrequency of
some procedures. The program staff will
assess this during the pre-test. 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
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on or after October 1, 1995, unless it
displays a currently valid OMB control
number.
Proposed Collection: Title: Cancer
Risk in U.S. Radiologic Technologists:
Fourth Survey (NCI). Type of
Information Collection Request:
Reinstatement with change of a
previously approved collection (OMB
No. 0925–0405, expiration 02/28/2011).
Need and Use of Information Collection:
By conducting a fourth cohort follow-up
survey in an ongoing cohort study of
U.S. Radiologic Technologists (USRT),
updated information will be collected
on cancer and other medical outcomes,
personal medical radiation procedures,
and other risk factors from all
participants, plus detailed employment
data from subgroups of participants who
performed or assisted with
fluoroscopically-guided or radioisotope
procedures. Researchers at the National
Cancer Institute and The University of
Minnesota have followed a nationwide
cohort of 146,000 radiologic
technologists since 1982, of whom
110,000 completed at least one of three
prior questionnaire surveys and 23,454
are deceased. This cohort is unique
because estimates of cumulative
radiation dose to specific organs (e.g.
breast) are available and the cohort is
largely female, offering a rare
opportunity to study effects of low-dose
radiation exposure on breast and
thyroid cancers, the two most sensitive
organ sites for radiation carcinogenesis
in women. The fourth survey will be
administered by mail to approximately
93,000 living and located cohort
members who completed at least one of
the three previous surveys to collect
information on new cancers and other
disease outcomes, detailed work
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]]>Agencies
[Federal Register Volume 76, Number 228 (Monday, November 28, 2011)]
[Notices]
[Pages 72955-72956]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-30548]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; Comment Request: ``Ethical Dilemmas in
Surgery and Utilization of Hospital Ethics Consultation Service: A
Survey''
SUMMARY: In compliance with the requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995, for opportunity for public comment
on proposed data collection projects, the Department of Bioethics, the
Clinical Center, the National Institutes of Health (NIH) will publish
periodic summaries of proposed projects to be submitted to the Office
of Management and Budget (OMB) for review and approval.
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
[[Page 72956]]
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: One occasion. Affected Public:
Individuals. Type of Respondents: Surgeons practicing in the US. The
annual reporting burden is as follows: Estimated Number of Respondents:
3,156; Estimated Number of Responses per Respondent: 29 items per
questionnaire; Average Burden Hours Per Response: 0.00862; and
Estimated Total Annual Burden Hours Requested: 789. The annualized cost
to respondents is estimated at: $0. There are no Capital Costs to
report. There are no Operating or Maintenance Costs to report.
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average burden Estimated total
Type of respondents number of responses per hours per annual burden
respondents respondent response hours requested
----------------------------------------------------------------------------------------------------------------
Surgeons................................ 3156 29 0.00862 789
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Total............................... ................ ................ ................ 789
----------------------------------------------------------------------------------------------------------------
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.
FOR FURTHER INFORMATION CONTACT: To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact Dr. Marion Danis at Department of Clinical
Bioethics, National Institutes of Health, Building 10, Room 1C118,
Bethesda, MD 20892-1156, Telephone: (301) 435-8727, Facsimile: (301)
496-0760, or email your request, including your address to:
mdanis@cc.nih.gov.
Comments Due Date
Comments regarding this information collection are best assured of
having their full effect if received within 60 days of the date of this
publication.
Dated: November 6, 2011.
Laura M. Lee,
Special Assistant to the DDCC--Patient Safety and Clinical Quality
Project Clearance Liaison, CC, National Institutes of Health.
[FR Doc. 2011-30548 Filed 11-25-11; 8:45 am]
BILLING CODE 4140-01-P
