Proposed Collection; 60-Day Comment Request; Customer and Other Partners Satisfaction Surveys, 66750-66751 [2013-26610]
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66750
Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Notices
Center for Drug Evaluation and
Research, by the Commissioner of Food
and Drugs.
Dated: October 30, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and
Research.
[FR Doc. 2013–26491 Filed 11–5–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Customer and Other Partners
Satisfaction Surveys
Summary: In compliance with the
requirement of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995
for the opportunity for public comment
on the proposed data collection projects,
the National Institutes of Health Clinical
Center (CC) will publish periodic
summaries of proposed projects to be
submitted to the Office of Management
and Budget (OMB) for review and
approval.
Written comments and/or suggestions
from the public and affected agencies
are invited to address 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)
The quality, utility, and clarity of the
information to be collected; and (4)
Whether the proposed collection
minimizes 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 Submit Comments and for Further
Information: To obtain a copy of the
data collection plans and instruments,
submit comments in writing, or request
more information on the proposed
project, contact: Dr. David K.
Henderson, Deputy Director for Clinical
Care, National Institutes of Health
Clinical Center, 10 Center Drive, Bldg.
10, Rm. 6–1480, Bethesda, MD 20892 or
call non-toll-free number (301) 496–
3515 or email your request, including
your address to: dkh@nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
Comment 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.
Proposed Collection: Title: Generic
Clearance for Surveys of Customers and
Other Partners, 0925–0458, Expiration
Date 12/31/2013, Type of Submission:
Extension, National Institutes of Health
Clinical Center (CC), National Institutes
of Health (NIH).
Need and Use of Information
Collection: The information collected in
these surveys will be used by Clinical
Center personnel: (1) To evaluate the
perceptions of various Clinical Center
customers and other partners of Clinical
Center services; (2) to assist with the
design of modifications of these
services, based on customer input; (3) to
develop new services, based on
customer need; (4) to evaluate the
perceptions of various Clinical Center
customers and other partners of
implemented service modifications, and
(5) for hospital accreditation. These
surveys are voluntary and necessary for
the proper performance of Clinical
Center functions and will almost
certainly lead to quality improvement
activities that will enhance and/or
streamline the Clinical Center’s
operations. The major mechanisms by
which the Clinical Center will request
customer input is through surveys and
focus groups. The surveys will be
tailored specifically to each class of
customer and to that class of customer’s
needs. Surveys will either be collected
as written documents, as faxed
documents, mailed electronically or
collected via the web or by telephone
from customers. Information gathered
from these surveys of Clinical Center
customers and other partners will be
presented to, and used directly by,
Clinical Center management to enhance
the services and operations of our
organization.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
4,900.
FY 2014
Type of respondent
Number of
respondents
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
hour burden
Clinical Center Patients ...................................................................................
Family Members of Patients ............................................................................
Visitors to the Clinical Center ..........................................................................
NIH Intramural Collaborators ...........................................................................
Vendors and Collaborating Commercial Enterprises ......................................
Professionals and Organizations Referring Patients .......................................
Regulators ........................................................................................................
Volunteers ........................................................................................................
5000
2000
500
2000
500
2000
30
275
1
1
1
1
1
1
1
1
30/60
30/60
10/60
10/60
20/60
20/60
20/60
30/60
2500
1000
84
334
167
667
10
138
Type of respondent
Number of
respondents
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
hour burden
Clinical Center Patients ...................................................................................
Family Members of Patients ............................................................................
Visitors to the Clinical Center ..........................................................................
NIH Intramural Collaborators ...........................................................................
Vendors and Collaborating Commercial Enterprises ......................................
Professionals and Organizations Referring Patients .......................................
Regulators ........................................................................................................
5000
2000
500
2000
500
2000
30
1
1
1
1
1
1
1
30/60
30/60
10/60
10/60
20/60
20/60
20/60
2500
1000
84
334
167
667
10
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FY 2015
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Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Notices
66751
FY 2015—Continued
Type of respondent
Number of
respondents
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
hour burden
Volunteers ........................................................................................................
275
1
30/60
138
Type of respondent
Number of
respondents
Number of
responses per
respondent
Average time
per response
(in hours)
Total annual
hour burden
Clinical Center Patients ...................................................................................
Family Members of Patients ............................................................................
Visitors to the Clinical Center ..........................................................................
NIH Intramural Collaborators ...........................................................................
Vendors and Collaborating Commercial Enterprises ......................................
Professionals and Organizations Referring Patients .......................................
Regulators ........................................................................................................
Volunteers ........................................................................................................
5000
2000
500
2000
500
2000
30
275
1
1
1
1
1
1
1
1
30/60
30/60
10/60
10/60
20/60
20/60
20/60
30/60
2500
1000
84
334
167
667
10
138
FY 2016
Dated: October 28. 2013.
David K. Henderson,
Deputy Director for Clinical Care, CC,
National Institutes of Health.
[FR Doc. 2013–26610 Filed 11–5–13; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Office of Science Policy, Office of
Biotechnology Activities; Recombinant
or Synthetic Nucleic Acid Molecule
Research: Action Under the NIH
Guidelines for Research Involving
Recombinant or Synthetic Nucleic Acid
Molecules (NIH Guidelines)
AGENCY:
NIH, Public Health Service,
HHS.
Notice of Final Action under the
NIH Guidelines.
ACTION:
The Office of Biotechnology
Activities (OBA) is updating Appendix
B (Classification of Human Etiologic
Agents on the Basis of Hazard) of the
NIH Guidelines by specifying the risk
group (RG) classification for two
organisms: Middle East Respiratory
Syndrome coronavirus (MERS-CoV) and
Pseudomonas aeruginosa.
Background: The NIH Guidelines
provide guidance to investigators and
local Institutional Biosafety Committees
(IBCs) for setting containment for
research involving recombinant or
synthetic nucleic acid molecules.
Section II–A, Risk Assessment, instructs
investigators and IBCs to make an initial
risk assessment based on the RG of the
agent that will be manipulated (see
Appendix B, Classification of Human
Etiologic Agents on the Basis of Hazard).
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
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17:25 Nov 05, 2013
Jkt 232001
The RG of the agent often correlates
with the minimum containment level
required for experiments subject to the
NIH Guidelines. Updating Appendix B
by revising the risk groups for certain
organisms, or adding new organisms,
leads to more uniform containment
recommendations that are
commensurate with the biosafety risk.
The resulting amendments are ‘‘Minor
Actions’’ under Section IV–C–1–(b)–2 of
the NIH Guidelines and, therefore, will
be implemented immediately upon
publication in the Federal Register.
However, the OBA welcomes public
comment to inform any future changes
to Appendix B.
DATES: Comments may be submitted to
the OBA in paper or electronic form at
the mailing, fax, and email addresses
shown below under the heading ‘‘FOR
FURTHER INFORMATION.’’ All comments
should be submitted by December 6,
2013. All written comments received in
response to this notice will be available
for public inspection in the NIH OBA
office, 6705 Rockledge Drive, Suite 750,
MSC 7985, Bethesda, MD 20892–7985,
weekdays between the hours of 8:30
a.m. and 5:00 p.m.
FOR FURTHER INFORMATION CONTACT: If
you have questions, or require
additional information about these
changes, please contact the OBA by
email at oba@od.nih.gov or by telephone
at 301–496–9838. Comments may be
submitted to the same email address or
by fax to 301–496–9839 or by mail to
the Office of Biotechnology Activities,
National Institutes of Health, 6705
Rockledge Drive, Suite 750, Bethesda,
Maryland 20892–7985. Background
information may be obtained by
contacting the NIH OBA by email at
oba@od.nih.gov.
PO 00000
Frm 00071
Fmt 4703
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Middle East Respiratory Syndrome
coronavirus (MERS-CoV)
MERS-CoV is an emerging infectious
disease agent that was originally
identified in 2012 in Saudi Arabia. The
virus is a member of the order
Nidovirales, family Coronaviridae, and
causes a severe pulmonary syndrome
that is similar to what was seen with
Severe Acute Respiratory Syndrome
coronavirus (SARS-CoV). MERS-CoV
has been identified as the cause of a
severe respiratory disease in 144
individuals, of which 62 have died (as
of October 25, 2013; source: Centers for
Disease Control and Prevention (CDC)—
https://www.cdc.gov/coronavirus/mers/).
The overall mortality rate of MERS-CoV
infection to date is about four times
higher than what was reported for
SARS-CoV; although it is of note, in
patients over 65 years of age, that
mortality from infection with SARS-CoV
was reported to exceed 50 percent
(based on World Health Organization
(WHO) data accessed September 9,
2013, https://www.who.int/csr/sars/
archive/2003_05_07a/en/print.html). As
was the case for SARS-CoV, there are no
proven preventive or therapeutic
measures against this new virus. In
addition, there are many unanswered
questions regarding this virus, including
questions about how the virus is
transmitted. Although the incidence of
viral infections caused by MERS-CoV
remains highest in, and largely localized
to the Arabian Peninsula (138 of 144
cases), the high mortality rate associated
with this agent and its epidemic
potential has led to close monitoring by
the WHO (https://www.who.int/csr/
disease/coronavirus_infections/faq/en/
index.html).
E:\FR\FM\06NON1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66750-66751]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26610]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment Request; Customer and Other
Partners Satisfaction Surveys
Summary: In compliance with the requirement of Section
3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for the
opportunity for public comment on the proposed data collection
projects, the National Institutes of Health Clinical Center (CC) will
publish periodic summaries of proposed projects to be submitted to the
Office of Management and Budget (OMB) for review and approval.
Written comments and/or suggestions from the public and affected
agencies are invited to address 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) The quality, utility, and clarity of the information to be
collected; and (4) Whether the proposed collection minimizes 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 Submit Comments and for Further Information: To obtain a copy of
the data collection plans and instruments, submit comments in writing,
or request more information on the proposed project, contact: Dr. David
K. Henderson, Deputy Director for Clinical Care, National Institutes of
Health Clinical Center, 10 Center Drive, Bldg. 10, Rm. 6-1480,
Bethesda, MD 20892 or call non-toll-free number (301) 496-3515 or email
your request, including your address to: dkh@nih.gov. Formal requests
for additional plans and instruments must be requested in writing.
Comment 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.
Proposed Collection: Title: Generic Clearance for Surveys of
Customers and Other Partners, 0925-0458, Expiration Date 12/31/2013,
Type of Submission: Extension, National Institutes of Health Clinical
Center (CC), National Institutes of Health (NIH).
Need and Use of Information Collection: The information collected
in these surveys will be used by Clinical Center personnel: (1) To
evaluate the perceptions of various Clinical Center customers and other
partners of Clinical Center services; (2) to assist with the design of
modifications of these services, based on customer input; (3) to
develop new services, based on customer need; (4) to evaluate the
perceptions of various Clinical Center customers and other partners of
implemented service modifications, and (5) for hospital accreditation.
These surveys are voluntary and necessary for the proper performance of
Clinical Center functions and will almost certainly lead to quality
improvement activities that will enhance and/or streamline the Clinical
Center's operations. The major mechanisms by which the Clinical Center
will request customer input is through surveys and focus groups. The
surveys will be tailored specifically to each class of customer and to
that class of customer's needs. Surveys will either be collected as
written documents, as faxed documents, mailed electronically or
collected via the web or by telephone from customers. Information
gathered from these surveys of Clinical Center customers and other
partners will be presented to, and used directly by, Clinical Center
management to enhance the services and operations of our organization.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 4,900.
FY 2014
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) hour burden
----------------------------------------------------------------------------------------------------------------
Clinical Center Patients.................... 5000 1 30/60 2500
Family Members of Patients.................. 2000 1 30/60 1000
Visitors to the Clinical Center............. 500 1 10/60 84
NIH Intramural Collaborators................ 2000 1 10/60 334
Vendors and Collaborating Commercial 500 1 20/60 167
Enterprises................................
Professionals and Organizations Referring 2000 1 20/60 667
Patients...................................
Regulators.................................. 30 1 20/60 10
Volunteers.................................. 275 1 30/60 138
----------------------------------------------------------------------------------------------------------------
FY 2015
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) hour burden
----------------------------------------------------------------------------------------------------------------
Clinical Center Patients.................... 5000 1 30/60 2500
Family Members of Patients.................. 2000 1 30/60 1000
Visitors to the Clinical Center............. 500 1 10/60 84
NIH Intramural Collaborators................ 2000 1 10/60 334
Vendors and Collaborating Commercial 500 1 20/60 167
Enterprises................................
Professionals and Organizations Referring 2000 1 20/60 667
Patients...................................
Regulators.................................. 30 1 20/60 10
[[Page 66751]]
Volunteers.................................. 275 1 30/60 138
----------------------------------------------------------------------------------------------------------------
FY 2016
----------------------------------------------------------------------------------------------------------------
Number of Average time
Type of respondent Number of responses per per response Total annual
respondents respondent (in hours) hour burden
----------------------------------------------------------------------------------------------------------------
Clinical Center Patients.................... 5000 1 30/60 2500
Family Members of Patients.................. 2000 1 30/60 1000
Visitors to the Clinical Center............. 500 1 10/60 84
NIH Intramural Collaborators................ 2000 1 10/60 334
Vendors and Collaborating Commercial 500 1 20/60 167
Enterprises................................
Professionals and Organizations Referring 2000 1 20/60 667
Patients...................................
Regulators.................................. 30 1 20/60 10
Volunteers.................................. 275 1 30/60 138
----------------------------------------------------------------------------------------------------------------
Dated: October 28. 2013.
David K. Henderson,
Deputy Director for Clinical Care, CC, National Institutes of Health.
[FR Doc. 2013-26610 Filed 11-5-13; 8:45 am]
BILLING CODE 4140-01-P
