Agency Information Collection Activities; Proposed Collection; Comment Request: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, National Institute of Neurological Disorders and Stroke (NINDS), 33097-33098 [2013-13074]
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Federal Register / Vol. 78, No. 106 / Monday, June 3, 2013 / Notices
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2013–12978 Filed 5–31–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[CDC–2013–0007; NIOSH–233]
NIOSH List of Antineoplastic and Other
Hazardous Drugs in Healthcare
Settings 2014: Proposed Additions and
Deletions to the NIOSH Hazardous
Drug List
National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC),
Department of Health and Human
Services (HHS).
ACTION: Notice of Draft Document
Available for Public Comment.
AGENCY:
The National Institute for
Occupational Safety and Health
(NIOSH) of the Centers for Disease
Control and Prevention (CDC)
announces the availability of the
following draft document for public
comment entitled ‘‘NIOSH List of
Antineoplastic and Other Hazardous
Drugs in Healthcare Settings 2014:
Proposed Additions and Deletions to the
NIOSH Hazardous Drug List.’’ The
document and instructions for
submitting comments can be found at
https://www.regulations.gov.
This guidance document does not
have the force and effect of law.
Public Comment Period: Comments
must be received by August 2, 2013.
ADDRESSES: You may submit comments,
identified by CDC–2013–0007 and
Docket Number NIOSH–233, by either
of the two following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
• Mail: NIOSH Docket Office, Robert
A. Taft Laboratories, MS–C34, 4676
Columbia Parkway, Cincinnati, Ohio
45226.
Instructions: All information received
in response to this notice must include
the agency name and the docket number
(CDC–2003–0007; NIOSH–233). All
relevant comments received will be
posted without change to https://
www.regulations.gov, including any
personal information provided. All
electronic comments should be
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SUMMARY:
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formatted as Microsoft Word. Please
make reference to CDC–2013–0007 and
Docket Number NIOSH–233.
SUPPLEMENTARY INFORMATION:
Background: The NIOSH Alert:
Preventing Occupational Exposures to
Antineoplastic and Other Hazardous
Drugs in Health Care Settings was
published in September 2004 (https://
www.cdc.gov/niosh/docs/2004-165/).
This Alert contained Appendix A which
was a list of drugs that were deemed to
be hazardous and may require special
handling. This list of hazardous drugs
was updated in 2010 and 2012 and
covered all new approved drugs and
drugs with new warning up to
December 2009. (https://www.cdc.gov/
niosh/docs/2010-167/; https://
www.cdc.gov/niosh/docs/2012-150/).
Between January 2010 and December
2011, 48 new drugs received FDA
approval and 276 drugs received special
warnings (usually black box warnings)
based on reported adverse effects in
patients. From this list of 324 drugs, 42
drugs were identified by NIOSH as
candidate hazardous drugs. Four of
these drugs had safe handling
recommendations from the
manufacturer and NIOSH is following
the recommendations of the
manufacturers. Therefore, these four
drugs will be listed as hazardous
without requiring further review. A
panel consisting of peer reviewers and
stakeholders was asked to review and
comment on the remaining 38
potentially hazardous drugs. In
addition, the panel members were asked
to comment on the addition of one drug
requested by several stakeholders and
the removal of one drug from the 2012
Hazardous Drug List. Reviewers were
not asked to provide a consensus
opinion and NIOSH made the final
determination regarding additions and
deletions to the 2014 hazardous drug
list.
NIOSH reviewed the
recommendations of the peer reviewers
and stakeholders and determined that
24 drugs in addition to the 4 drugs with
manufacturer’s warnings, were
determined to have one or more
characteristics of a hazardous drug and
this list of 28 drugs is being published
for comment in CDC–2013–0007 and
NIOSH Docket Number 233. In addition,
1 drug from the 2012 Hazardous Drug
List is being considered for removal.
The complete list of these drugs can be
found at: https://www.regulations.gov as
a supporting document.
FOR FURTHER INFORMATION CONTACT:
Barbara MacKenzie, NIOSH, Robert A.
Taft Laboratories, 4676 Columbia
Parkway, MS–C26, Cincinnati, Ohio
PO 00000
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33097
45226, telephone (513) 533–8132, Email
hazardousdrugs@cdc.gov.
Dated: May 24, 2013.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2013–13043 Filed 5–31–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Agency Information Collection
Activities; Proposed Collection;
Comment Request: Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery,
National Institute of Neurological
Disorders and Stroke (NINDS)
As part of a Federal
Government-wide effort to streamline
the process to seek feedback from the
public on service delivery, the National
Institute of Neurological Disorders
(NINDS) has submitted a Generic
Information Collection Request (Generic
ICR): ‘‘Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery’’ to OMB for
approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et.
seq.).
DATES: Comments must be submitted
within 30 days after publication in the
Federal Register.
ADDRESSES: Written comments may be
submitted to the Office of Management
and Budget, Office of Information and
Regulatory Affairs, Attn: NIH Desk
Officer, by Email to
OIRA_submission@omb.eop.gov, or by
fax to 202–395–6974.
FOR FURTHER INFORMATION CONTACT: To
request additional information, please
contact: Paul Scott, Ph.D., Director,
Office of Science Policy and Planning,
NINDS, 31/8A03 Center Drive,
Bethesda, MD 20892–2178, or Email
your request, including your address to
scottp@ninds.nih.gov.
SUPPLEMENTARY INFORMATION:
Title: Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery.
Abstract: The information collection
activity will garner qualitative customer
and stakeholder feedback in an efficient,
timely manner, in accordance with the
Administration’s commitment to
improving service delivery. By
qualitative feedback we mean
information that provides useful
insights on perceptions and opinions,
SUMMARY:
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33098
Federal Register / Vol. 78, No. 106 / Monday, June 3, 2013 / Notices
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide insights into
customer or stakeholder perceptions,
experiences and expectations, provide
an early warning of issues with service,
or focus attention on areas where
communication, training or changes in
operations might improve delivery of
products or services. These collections
will allow for ongoing, collaborative and
actionable communications between the
Agency and its customers and
stakeholders. It will also allow feedback
to contribute directly to the
improvement of program management.
Feedback collected under this generic
clearance will provide useful
information, but it will not yield data
that can be generalized to the overall
population. This type of generic
clearance for qualitative information
will not be used for quantitative
information collections that are
designed to yield reliably actionable
results, such as monitoring trends over
time or documenting program
performance. Such data uses require
more rigorous designs that address: the
target population to which
generalizations will be made, the
sampling frame, the sample design
(including stratification and clustering),
the precision requirements or power
calculations that justify the proposed
sample size, the expected response rate,
methods for assessing potential nonresponse bias, the protocols for data
collection, and any testing procedures
that were or will be undertaken prior
fielding the study. Depending on the
degree of influence the results are likely
to have, such collections may still be
eligible for submission for other generic
mechanisms that are designed to yield
quantitative results.
No comments were received in
response to the 60-day notice published
in the Federal Register of December 22,
2010 (75 FR 80542).
Below we provide NINDS’s projected
average estimates for the next three
years:
Current Actions: New collection of
information.
Type of Review: New Collection.
Affected Public: Individuals and
Households, Businesses and
Organizations, State, Local or Tribal
Government.
Average Expected Annual Number of
activities: 6.
Respondents: 14,700.
Annual responses: 24,700.
Frequency of Response: Once per
request for 5 activities, twice per request
for 1 activity.
Average minutes per response: 57.
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Burden hours: 5750.
An agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a currently valid
Office of Management and Budget
control number.
Dated: May 24, 2013.
Story Landis,
Director, National Institute of Neurological
Disorders and Stroke, National Institutes of
Health.
[FR Doc. 2013–13074 Filed 5–31–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
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National Institutes of Health
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting hosted by the
NIH Scientific Management Review
Board (SMRB). Presentations and
discussions will address optimal
approach to assessing the value of
biomedical research supported by NIH.
The NIH Reform Act of 2006 (Pub.L.
109–482) provides organizational
authorities to HHS and NIH officials to:
(1) Establish or abolish national research
institutes; (2) reorganize the offices
within the Office of the Director, NIH
including adding, removing, or
transferring the functions of such offices
or establishing or terminating such
offices; and (3) reorganize, divisions,
centers, or other administrative units
within an NIH national research
institute or national center including
adding, removing, or transferring the
functions of such units, or establishing
or terminating such units. The purpose
of the SMRB is to advise appropriate
HHS and NIH officials on the use of
these organizational authorities and
identify the reasons underlying the
recommendations.
The meeting will be open to the
public, with attendance limited to space
available. Individuals who plan to
attend and need special assistance, such
as sign language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
Name of Committee: Scientific
Management Review Board (SMRB).
Date: June 4, 2013.
Time: 8:00 a.m. to 6:30 p.m.
Agenda: The meeting topics will include:
1) an update from the SMRB’s Value of
Biomedical Research Working Group, and 2)
PO 00000
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presentations that explore approaches to
studying the value of biomedical research.
Time will be allotted on the agenda for
public comment. Sign up for public
comments will begin approximately at 7:30
a.m. on June 4, 2013, and will be restricted
to one sign-in per person. In the event that
time does not allow for all those interested
to present oral comments, any interested
person may file written comments with the
committee by forwarding the statement to the
Contact Person listed on this notice. The
statement should include the name, address,
telephone number and when applicable, the
business or professional affiliation of the
interested person.
Place: National Institutes of Health,
Building 1, 3rd Floor, Wilson Hall, 1 Center
Drive, Bethesda, MD 20892.
Contact Person: Juanita Marner, Office of
Science Policy, Office of the Director, NIH,
National Institutes of Health, 6705 Rockledge
Drive, Suite 750, Bethesda, MD 20892.
smrb@mail.nih.gov, (301) 435–1770.
This notice is being published less than 15
days prior to the meeting due to scheduling
conflicts with the presenters.
The meeting will also be webcast. The draft
meeting agenda and other information about
the SMRB, including information about
access to the webcast, will be available at
https://smrb.od.nih.gov.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxis, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals From
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
Dated: May 30, 2013.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2013–13180 Filed 5–31–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
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Prospective Grant of Co-Exclusive
Licenses: Multi-Focal Structured
Illumination Microscopy Systems and
Methods
AGENCY:
National Institutes of Health,
HHS.
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[Federal Register Volume 78, Number 106 (Monday, June 3, 2013)]
[Notices]
[Pages 33097-33098]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13074]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Agency Information Collection Activities; Proposed Collection;
Comment Request: Generic Clearance for the Collection of Qualitative
Feedback on Agency Service Delivery, National Institute of Neurological
Disorders and Stroke (NINDS)
SUMMARY: As part of a Federal Government-wide effort to streamline the
process to seek feedback from the public on service delivery, the
National Institute of Neurological Disorders (NINDS) has submitted a
Generic Information Collection Request (Generic ICR): ``Generic
Clearance for the Collection of Qualitative Feedback on Agency Service
Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA)
(44 U.S.C. 3501 et. seq.).
DATES: Comments must be submitted within 30 days after publication in
the Federal Register.
ADDRESSES: Written comments may be submitted to the Office of
Management and Budget, Office of Information and Regulatory Affairs,
Attn: NIH Desk Officer, by Email to OIRA_submission@omb.eop.gov, or by
fax to 202-395-6974.
FOR FURTHER INFORMATION CONTACT: To request additional information,
please contact: Paul Scott, Ph.D., Director, Office of Science Policy
and Planning, NINDS, 31/8A03 Center Drive, Bethesda, MD 20892-2178, or
Email your request, including your address to scottp@ninds.nih.gov.
SUPPLEMENTARY INFORMATION:
Title: Generic Clearance for the Collection of Qualitative Feedback
on Agency Service Delivery.
Abstract: The information collection activity will garner
qualitative customer and stakeholder feedback in an efficient, timely
manner, in accordance with the Administration's commitment to improving
service delivery. By qualitative feedback we mean information that
provides useful insights on perceptions and opinions,
[[Page 33098]]
but are not statistical surveys that yield quantitative results that
can be generalized to the population of study. This feedback will
provide insights into customer or stakeholder perceptions, experiences
and expectations, provide an early warning of issues with service, or
focus attention on areas where communication, training or changes in
operations might improve delivery of products or services. These
collections will allow for ongoing, collaborative and actionable
communications between the Agency and its customers and stakeholders.
It will also allow feedback to contribute directly to the improvement
of program management.
Feedback collected under this generic clearance will provide useful
information, but it will not yield data that can be generalized to the
overall population. This type of generic clearance for qualitative
information will not be used for quantitative information collections
that are designed to yield reliably actionable results, such as
monitoring trends over time or documenting program performance. Such
data uses require more rigorous designs that address: the target
population to which generalizations will be made, the sampling frame,
the sample design (including stratification and clustering), the
precision requirements or power calculations that justify the proposed
sample size, the expected response rate, methods for assessing
potential non-response bias, the protocols for data collection, and any
testing procedures that were or will be undertaken prior fielding the
study. Depending on the degree of influence the results are likely to
have, such collections may still be eligible for submission for other
generic mechanisms that are designed to yield quantitative results.
No comments were received in response to the 60-day notice
published in the Federal Register of December 22, 2010 (75 FR 80542).
Below we provide NINDS's projected average estimates for the next
three years:
Current Actions: New collection of information.
Type of Review: New Collection.
Affected Public: Individuals and Households, Businesses and
Organizations, State, Local or Tribal Government.
Average Expected Annual Number of activities: 6.
Respondents: 14,700.
Annual responses: 24,700.
Frequency of Response: Once per request for 5 activities, twice per
request for 1 activity.
Average minutes per response: 57.
Burden hours: 5750.
An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information unless it displays a
currently valid Office of Management and Budget control number.
Dated: May 24, 2013.
Story Landis,
Director, National Institute of Neurological Disorders and Stroke,
National Institutes of Health.
[FR Doc. 2013-13074 Filed 5-31-13; 8:45 am]
BILLING CODE 4140-01-P