Agency Information Collection Activities: Submission for OMB Review; Comment Request, 58282-58283 [2011-24121]
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Federal Register / Vol. 76, No. 182 / Tuesday, September 20, 2011 / Notices
hazard reduction strategies that
minimize risk in the MRI environment.
Through this effort, FDA and
stakeholder groups will take steps to
promote the safe use of MRI by
increasing awareness of safety issues
that may occur in the MRI environment
and by identifying regulatory, policy
and system-oriented solutions to
mitigate risk. FDA can advance these
goals by collaborating with medical
device and health care industries, and
the healthcare provider and consumer
communities.
II. Topics for Discussion at the Public
Workshop
The public workshop will be
organized to discuss the following topic
areas:
A. General MRI Safety
• Multiple professional organizations,
patient safety groups and accrediting
bodies, i.e. the American College of
Radiology (ACR), the International
Society for Magnetic Resonance in
Medicine (ISMRM), Emergency Care
Research Institute (ECRI Institute), and
the Joint Commission (TJC), have
sponsored MRI safety conferences and
published recommendations and
strategies for MRI safe practices. FDA
would like public comment on the
extent these practices have been
adopted, and if they have not, what are
the reasons for not adopting/
implementing these practices, and given
that FDA does not regulate the practice
of medicine, what can FDA do to
improve adoption.
• FDA would like public comment on
the policies and procedures individual
sites have in place governing the use of
non-implanted medical devices entering
the MRI suite.
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B. Ferromagnetic Detectors (FD)
• FDA would like public comment on
the user experience with ferromagnetic
detectors (FD) and to gather information
on whether these devices improve MRI
safety. FDA would also like to
understand any drawbacks to the use of
FD and other risk/benefit/cost
considerations by sites that are
considering adopting the technology.
• FDA would also like public
comment on the reasons for not
adopting/implementing use of FD.
C. Scanning Subjects Known To Have
Medical Implants
• FDA would like public comment on
the clinical scenario and the challenges
(technical and otherwise) involved in
the scanning of patients with implanted
medical devices. FDA is particularly
interested in hearing how individual
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sites make the decision of whether or
not to scan a patient with an implanted
medical device, or any special
monitoring of the patient’s condition or
the implanted medical device’s
performance.
• Safely scanning patients with
implanted medical devices requires
coordination between any MRI system
and the implanted medical device, as
not all implants can be safely scanned
in all MRI systems. Current FDA
labeling requirements for ‘‘MR
Conditional’’ implants include the static
magnetic field, maximum spatial
gradient, and maximum specific
absorption rate (SAR) under which the
device can be safely scanned. FDA
would like public comment on whether
this information is or is not sufficient to
make an informed decision about
whether it is safe or is not safe to scan
a patient.
• FDA would like public comment on
the challenges sites face in obtaining the
specific conditions of use (i.e. the ‘‘MR
Conditional’’ labeling) for medical
implants and what is done when
information about MRI compatibility is
unavailable. For example, when
presented with a patient with an
implanted medical device, how is the
identity of the implant definitively
determined and how is MR labeling
information obtained to make a decision
of whether or not to scan the patient? If
‘‘MR Conditional’’ labeling cannot be
found or the device cannot be
identified, how is the decision of
whether or not to scan a patient
determined?
D. The Impact of Innovation on MRI
Safety Concerns
• FDA would like comment from
stakeholders on future technical
developments and changing clinical
practice scenarios that may affect the
safety profile of MRI.
III. Transcripts
As soon as the transcript is available,
it will be accessible at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD. A transcript will
also be available in either hardcopy or
on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to the Division
of Freedom of Information (HFI–35),
Office of Management Programs, Food
and Drug Administration, 5600 Fishers
Lane, rm. 6–30, Rockville, MD 20857. A
link to the transcripts will also be
available on the Internet at https://
www.fda.gov/MedicalDevices/
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NewsEvents/WorkshopsConferences/
default.htm (select this public workshop
from the posted events list),
approximately 45 days after the public
workshop.
Dated: September 13, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–24030 Filed 9–19–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources
and Services Administration (HRSA)
publishes abstracts of information
collection requests under review by the
Office of Management and Budget
(OMB), in compliance with the
Paperwork Reduction Act of 1995 (44
U.S.C. Chapter 35). To request a copy of
the clearance requests submitted to
OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA
Reports Clearance Office on (301) 443–
1129.
The following request has been
submitted to the Office of Management
and Budget for review under the
Paperwork Reduction Act of 1995:
Proposed Project: National Survey of
Organ Donation Attitudes and Practices
(OMB No. 0915–New)
The Division of Transplantation
(DoT), Healthcare Systems Bureau,
Health Resources and Services
Administration (HRSA), is planning to
conduct a telephone survey of public
knowledge, perceptions, opinion, and
behaviors related to organ donation.
Two key missions of the DoT are (1) to
provide oversight for the Organ
Procurement and Transplantation
Network and policy development
related to organ donation and
transplantation, and (2) to implement
efforts to increase public knowledge,
attitudes, and behaviors related to organ
donation. With a constantly growing
deficit between the number of
Americans needing donor organs
(currently nearly 112,000) and the
annual number of donors (14,505 in
2010), increasing the American public’s
willingness to donate becomes
increasingly critical. Effective education
and outreach campaigns need to be
based on knowledge of the public’s
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58283
Federal Register / Vol. 76, No. 182 / Tuesday, September 20, 2011 / Notices
attitudes and perceptions about, and
perceived impediments to, organ
donation. Two national surveys using
nearly identical survey instruments to
identify public views and behaviors
related to organ donation were
conducted in 1993 and 2005.
The proposed study will identify
current organ donation views and
practices of the American public and
various population subgroups using a
survey instrument similar to the two
earlier studies in order to track changes
over time. It will measure issues such as
public knowledge about and attitudes
toward organ donation, public
commitment to or willingness to donate,
impediments to public willingness to
donate, and attitudes toward living
donation, donation practices, policy
issues, allocation policy, presumed
consent, and financial incentives for
donation. Demographic information also
will be collected. The randomly drawn
sample will consist of 3,250 adults (age
18 and over), including an oversample
of Asians, Hispanics, African
Americans, and Native Americans, and
will be geographically representative of
the United States. The survey
instrument will be administered in
English and Spanish languages through
computer-assisted telephone interviews.
In addition to being useful to the DoT,
especially in its donation outreach
initiatives, results of this survey also
Number of
respondents
Instrument
Responses
per
respondent
will be of assistance to the donation and
transplant community, DoT grantees
and other research efforts, and to the
Secretary’s Advisory Committee on
Organ Transplantation (ACOT) as it
fulfills its charge to advise the Secretary
of Health and Human Services on the
numerous and often controversial issues
related to donation and transplantation.
In its first meeting, the ACOT suggested
such a survey to gather information to
inform both public education efforts and
policy decisions on the issue of organ
donation.
The annual estimate of burden is as
follows:
Total
responses
Hours per
response
Total burden
hours
Telephone survey ................................................................
3,250
1
3,250
0.3
975
Total ..............................................................................
3,250
1
3,250
0.3
975
Written comments and
recommendations concerning the
proposed information collection should
be sent within 30 days of this notice to
the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov
or by fax to 202–395–6974. Please direct
all correspondence to the ‘‘attention of
the desk officer for HRSA.’’
Dated: September 13, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–24121 Filed 9–19–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Council on Migrant
Health; Notice of Meeting
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In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), notice is hereby given
of the following meeting:
Name: National Advisory Council on
Migrant Health.
Dates and Times: November 8, 2011, 8:30
a.m. to 5 p.m. November 9, 2011, 8:30 a.m.
to 5 p.m.
Place: Hotel Albuquerque at Old Town,
800 Rio Grande Boulevard, Northwest,
Albuquerque, New Mexico 87104,
Telephone: 505–843–6300, Fax: 505–842–
8426.
Status: The meeting will be open to the
public.
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Purpose: The purpose of the meeting is to
discuss services and issues related to the
health of migrant and seasonal farmworkers
and their families and to formulate
recommendations for the Secretary of Health
and Human Services.
Agenda: The agenda includes an overview
of the Council’s general business activities.
The Council will also hear presentations
from experts on farmworker issues, including
the status of farmworker health at the local
and national levels.
In addition, the Council will be holding a
public hearing at which migrant
farmworkers, community leaders, and
providers will have the opportunity to testify
before the Council regarding matters that
affect the health of migrant farmworkers. The
hearing is scheduled for Tuesday, November
8, 2011, from 1 p.m. to 4 p.m., at the Hotel
Albuquerque at Old Town.
The Council meeting is being held in
conjunction with the Midwest Stream
Farmworker Health Forum sponsored by the
National Center for Farmworker Health,
which is being held in Albuquerque, New
Mexico, November 10–12, 2011.
Agenda items are subject to change as
priorities indicate.
For Further Information Contact: Gladys
Cate, Office of Special Population Health,
Bureau of Primary Health Care, Health
Resources and Services Administration, 5600
Fishers Lane, Room 15–62, Maryland 20857;
telephone (301) 594–0367.
Dated: September 13, 2011.
Reva Harris,
Acting Director, Division of Policy and
Information Coordination.
[FR Doc. 2011–24127 Filed 9–19–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Child Health and Human Development
Special Emphasis Panel; Transition to
Fatherhood: Fatherhood Trajectories and
Consequences for Men.
Date: October 6, 2011.
Time: 1 p.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6100
Executive Boulevard,Rockville, MD 20852
(Telephone Conference Call).
Contact Person: Carla T. Walls, PhD,
Scientific Review Officer, Division of
Scientific Review, Eunice Kennedy Shriver
National Institute of Child Health And
Human Development, NIH, 6100 Executive
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[Federal Register Volume 76, Number 182 (Tuesday, September 20, 2011)]
[Notices]
[Pages 58282-58283]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-24121]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission for OMB
Review; Comment Request
Periodically, the Health Resources and Services Administration
(HRSA) publishes abstracts of information collection requests under
review by the Office of Management and Budget (OMB), in compliance with
the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request
a copy of the clearance requests submitted to OMB for review, e-mail
paperwork@hrsa.gov or call the HRSA Reports Clearance Office on (301)
443-1129.
The following request has been submitted to the Office of
Management and Budget for review under the Paperwork Reduction Act of
1995:
Proposed Project: National Survey of Organ Donation Attitudes and
Practices (OMB No. 0915-New)
The Division of Transplantation (DoT), Healthcare Systems Bureau,
Health Resources and Services Administration (HRSA), is planning to
conduct a telephone survey of public knowledge, perceptions, opinion,
and behaviors related to organ donation. Two key missions of the DoT
are (1) to provide oversight for the Organ Procurement and
Transplantation Network and policy development related to organ
donation and transplantation, and (2) to implement efforts to increase
public knowledge, attitudes, and behaviors related to organ donation.
With a constantly growing deficit between the number of Americans
needing donor organs (currently nearly 112,000) and the annual number
of donors (14,505 in 2010), increasing the American public's
willingness to donate becomes increasingly critical. Effective
education and outreach campaigns need to be based on knowledge of the
public's
[[Page 58283]]
attitudes and perceptions about, and perceived impediments to, organ
donation. Two national surveys using nearly identical survey
instruments to identify public views and behaviors related to organ
donation were conducted in 1993 and 2005.
The proposed study will identify current organ donation views and
practices of the American public and various population subgroups using
a survey instrument similar to the two earlier studies in order to
track changes over time. It will measure issues such as public
knowledge about and attitudes toward organ donation, public commitment
to or willingness to donate, impediments to public willingness to
donate, and attitudes toward living donation, donation practices,
policy issues, allocation policy, presumed consent, and financial
incentives for donation. Demographic information also will be
collected. The randomly drawn sample will consist of 3,250 adults (age
18 and over), including an oversample of Asians, Hispanics, African
Americans, and Native Americans, and will be geographically
representative of the United States. The survey instrument will be
administered in English and Spanish languages through computer-assisted
telephone interviews.
In addition to being useful to the DoT, especially in its donation
outreach initiatives, results of this survey also will be of assistance
to the donation and transplant community, DoT grantees and other
research efforts, and to the Secretary's Advisory Committee on Organ
Transplantation (ACOT) as it fulfills its charge to advise the
Secretary of Health and Human Services on the numerous and often
controversial issues related to donation and transplantation. In its
first meeting, the ACOT suggested such a survey to gather information
to inform both public education efforts and policy decisions on the
issue of organ donation.
The annual estimate of burden is as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses per Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Telephone survey................ 3,250 1 3,250 0.3 975
-------------------------------------------------------------------------------
Total....................... 3,250 1 3,250 0.3 975
----------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent within 30 days of this notice to
the desk officer for HRSA, either by e-mail to OIRA_submission@omb.eop.gov or by fax to 202-395-6974. Please direct all
correspondence to the ``attention of the desk officer for HRSA.''
Dated: September 13, 2011.
Reva Harris,
Acting Director, Division of Policy and Information Coordination.
[FR Doc. 2011-24121 Filed 9-19-11; 8:45 am]
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