Submission for OMB Review; 30-day Comment Request; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery (NICHD), 57561-57562 [2014-22867]
Download as PDF
<![CDATA[
Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Notices
57561
TABLE 1—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1,
2014, THROUGH MARCH 31, 2014—Continued
PMA No., Docket No.
Applicant
Trade name
Date of action
P090031, FDA–2014–M–0254 ..................
Anika Therapeutics, Inc .....
P130015, FDA–2013–M–0326 ..................
Roche Diagnostics Operations, Inc.
MONOVISCTM Injectable Intra-articular
Device.
Elecsys® HBeAg Immunoassay and
Elecsys® PreciControl HBeAg.
Approved February 25,
2014.
Approved March 14, 2014.
II. Electronic Access
Persons with access to the Internet
may obtain the documents at https://
www.fda.gov/MedicalDevices/
ProductsandMedicalProcedures/
DeviceApprovalsandClearances/
PMAApprovals/default.htm.
Dated: September 19, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–22807 Filed 9–24–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day
Comment Request; Generic Clearance
for the Collection of Qualitative
Feedback on Agency Service Delivery
(NICHD)
Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH), has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on Thursday, July
3, 2014, Vol. 79, No. 128, page 38047–
38049 and allowed 60-days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment. The Eunice Kennedy Shriver
National Institute of Child Health and
Human Development (NICHD), 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.
DATES: Comment 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.
ADDRESSES: Direct Comments to Omb:
Written comments and/or suggestions
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:25 Sep 24, 2014
Jkt 232001
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: NIH
Desk Officer.
FOR FURTHER INFORMATION CONTACT: 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. Sarah L. Glavin, Project
Clearance Liaison, Office of Science
Policy, Analysis and Communication,
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, National Institutes of
Health, 31 Center Drive, Room 2A18,
Bethesda, Maryland 20892, or call a
non-toll free number (301) 496–1877 or
Email your request, including your
address to glavins@mail.nih.gov. Formal
requests for additional plans and
instruments must be requested in
writing.
SUPPLEMENTARY INFORMATION:
Proposed Collection: Generic
Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery (NICHD), 0925–0643,
Expiration Date 10/31/2014,
EXTENSION, Eunice Kennedy Shriver
National Institute of Child Health and
Human Development (NICHD), National
Institutes of Health (NIH).
Need and Use of Information
Collection: There are no changes being
requested for this submission. The
proposed information collection activity
provides a means to 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,
but are not statistical surveys that yield
quantitative results that can be
generalized to the population of study.
This feedback will provide information
about the NICHD’s customer or
stakeholder perceptions, experiences
and expectations, provide an early
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
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
NICHD and its customers and
stakeholders. It will also allow feedback
to contribute directly to the
improvement of program management.
The solicitation of feedback will target
areas such as: timeliness,
appropriateness, accuracy of
information, courtesy, efficiency of
service delivery, and resolution of
issues with service delivery. Responses
will be assessed to plan and inform
efforts to improve or maintain the
quality of service offered to the public.
If this information is not collected, vital
feedback from customers and
stakeholders on the NICHD’s services
will be unavailable.
The NICHD will only submit a
collection for approval under this
generic clearance if it meets the
following conditions:
• The collections are voluntary;
• The collections are low-burden for
respondents (based on considerations of
total burden hours, total number of
respondents, or burden-hours per
respondent) and are low-cost for both
the respondents and the Federal
Government;
• The collections are noncontroversial and do not raise issues of
concern to other Federal agencies;
• Any collection is targeted to the
solicitation of opinions from
respondents who have experience with
the program or may have experience
with the program in the near future;
• Personally identifiable information
(PII) is collected only to the extent
necessary and is not retained;
• Information gathered will be used
only internally for general service
improvement and program management
purposes and is not intended for release
outside of the agency;
• Information gathered will not be
used for the purpose of substantially
informing influential policy decisions;
and
• Information gathered will yield
qualitative information; the collections
E:\FR\FM\25SEN1.SGM
25SEN1
57562
Federal Register / Vol. 79, No. 186 / Thursday, September 25, 2014 / Notices
will not be designed or expected to
yield statistically reliable results or used
as though the results are generalizable to
the population of study.
Feedback collected under this generic
clearance provides useful information,
but it does 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 to
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
maintenance, and purchase of services
to provide information. Burden means
the total time, effort, or financial
resources expended by persons to
generate, maintain, retain, disclose or
provide information to or for a Federal
agency. This includes the time needed
to review instructions; to develop,
acquire, install and utilize technology
and systems for the purpose of
collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
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.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours are
4,950.
mechanisms that are designed to yield
quantitative results.
As a general matter, information
collections will not result in any new
system of records containing privacy
information and will not ask questions
of a sensitive nature, such as sexual
behavior and attitudes, religious beliefs,
and other matters that are commonly
considered private.
Request for Comments: Comments
submitted in response to this notice will
be summarized and/or included in the
request for OMB approval. Comments
are invited on: (a) Whether the
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
collection of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology;
and (e) estimates of capital or start-up
costs and costs of operation,
ESTIMATED ANNUALIZED BURDEN HOURS
Estimated annual reporting burden
Annual
frequency per
response
Number of
respondents
Type of collection
Hours per
response
Total hours
Conference/Training—Pre and Post Surveys ..................................................
Usability Testing ..............................................................................................
Focus Groups ..................................................................................................
Customer Satisfaction Survey .........................................................................
In-depth Interviews or Small Discussion Group ..............................................
100
100
750
13,500
750
1
1
1
1
1
15/60
30/60
1
15/60
1
25
50
750
3,375
750
Total ..........................................................................................................
15,200
........................
........................
4,950
Dated: September 18, 2014.
Sarah L. Glavin,
Project Clearance Liaison, Office of Science
Policy, Analysis, and Communications,
Eunice Kennedy Shriver National Institute of
Child Health and Human Development,
National Institutes of Health.
[FR Doc. 2014–22867 Filed 9–24–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-day Comment
Request; Office of Minority Health
Research Coordination Research
Training and Mentor Program
Applications
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
National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK),
National Institutes of Health (NIH) will
publish periodic summaries of proposed
projects to be submitted to the Office of
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:25 Sep 24, 2014
Jkt 232001
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
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)
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,
E:\FR\FM\25SEN1.SGM
25SEN1
]]>Agencies
[Federal Register Volume 79, Number 186 (Thursday, September 25, 2014)]
[Notices]
[Pages 57561-57562]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-22867]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-day Comment Request; Generic
Clearance for the Collection of Qualitative Feedback on Agency Service
Delivery (NICHD)
SUMMARY: Under the provisions of Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National Institutes of Health (NIH), has
submitted to the Office of Management and Budget (OMB) a request for
review and approval of the information collection listed below. This
proposed information collection was previously published in the Federal
Register on Thursday, July 3, 2014, Vol. 79, No. 128, page 38047-38049
and allowed 60-days for public comment. No public comments were
received. The purpose of this notice is to allow an additional 30 days
for public comment. The Eunice Kennedy Shriver National Institute of
Child Health and Human Development (NICHD), 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.
DATES: Comment 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.
ADDRESSES: 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, OIRAsubmission@omb.eop.gov or by fax to 202-395-6974,
Attention: NIH Desk Officer.
FOR FURTHER INFORMATION CONTACT: 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. Sarah L.
Glavin, Project Clearance Liaison, Office of Science Policy, Analysis
and Communication, Eunice Kennedy Shriver National Institute of Child
Health and Human Development, National Institutes of Health, 31 Center
Drive, Room 2A18, Bethesda, Maryland 20892, or call a non-toll free
number (301) 496-1877 or Email your request, including your address to
glavins@mail.nih.gov. Formal requests for additional plans and
instruments must be requested in writing.
SUPPLEMENTARY INFORMATION:
Proposed Collection: Generic Clearance for the Collection of
Qualitative Feedback on Agency Service Delivery (NICHD), 0925-0643,
Expiration Date 10/31/2014, EXTENSION, Eunice Kennedy Shriver National
Institute of Child Health and Human Development (NICHD), National
Institutes of Health (NIH).
Need and Use of Information Collection: There are no changes being
requested for this submission. The proposed information collection
activity provides a means to 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, but are not statistical surveys that yield
quantitative results that can be generalized to the population of
study. This feedback will provide information about the NICHD's
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
NICHD and its customers and stakeholders. It will also allow feedback
to contribute directly to the improvement of program management.
The solicitation of feedback will target areas such as: timeliness,
appropriateness, accuracy of information, courtesy, efficiency of
service delivery, and resolution of issues with service delivery.
Responses will be assessed to plan and inform efforts to improve or
maintain the quality of service offered to the public. If this
information is not collected, vital feedback from customers and
stakeholders on the NICHD's services will be unavailable.
The NICHD will only submit a collection for approval under this
generic clearance if it meets the following conditions:
The collections are voluntary;
The collections are low-burden for respondents (based on
considerations of total burden hours, total number of respondents, or
burden-hours per respondent) and are low-cost for both the respondents
and the Federal Government;
The collections are non-controversial and do not raise
issues of concern to other Federal agencies;
Any collection is targeted to the solicitation of opinions
from respondents who have experience with the program or may have
experience with the program in the near future;
Personally identifiable information (PII) is collected
only to the extent necessary and is not retained;
Information gathered will be used only internally for
general service improvement and program management purposes and is not
intended for release outside of the agency;
Information gathered will not be used for the purpose of
substantially informing influential policy decisions; and
Information gathered will yield qualitative information;
the collections
[[Page 57562]]
will not be designed or expected to yield statistically reliable
results or used as though the results are generalizable to the
population of study.
Feedback collected under this generic clearance provides useful
information, but it does 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 to 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.
As a general matter, information collections will not result in any
new system of records containing privacy information and will not ask
questions of a sensitive nature, such as sexual behavior and attitudes,
religious beliefs, and other matters that are commonly considered
private.
Request for Comments: Comments submitted in response to this notice
will be summarized and/or included in the request for OMB approval.
Comments are invited on: (a) Whether the collection of information is
necessary for the proper performance of the functions of the agency,
including whether the information shall have practical utility; (b) the
accuracy of the agency's estimate of the burden of the collection of
information; (c) ways to enhance the quality, utility, and clarity of
the information to be collected; (d) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques or other forms of information
technology; and (e) estimates of capital or start-up costs and costs of
operation, maintenance, and purchase of services to provide
information. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, disclose
or provide information to or for a Federal agency. This includes the
time needed to review instructions; to develop, acquire, install and
utilize technology and systems for the purpose of collecting,
validating and verifying information, processing and maintaining
information, and disclosing and providing information; to train
personnel and to be able to respond to a collection of information, to
search data sources, to complete and review the collection of
information; and to transmit or otherwise disclose the information.
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.
OMB approval is requested for 3 years. There are no costs to
respondents other than their time. The total estimated annualized
burden hours are 4,950.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Estimated annual reporting burden
-----------------------------------------------------------------------------------------------------------------
Annual
Type of collection Number of frequency per Hours per Total hours
respondents response response
----------------------------------------------------------------------------------------------------------------
Conference/Training--Pre and Post Surveys....... 100 1 15/60 25
Usability Testing............................... 100 1 30/60 50
Focus Groups.................................... 750 1 1 750
Customer Satisfaction Survey.................... 13,500 1 15/60 3,375
In-depth Interviews or Small Discussion Group... 750 1 1 750
---------------------------------------------------------------
Total....................................... 15,200 .............. .............. 4,950
----------------------------------------------------------------------------------------------------------------
Dated: September 18, 2014.
Sarah L. Glavin,
Project Clearance Liaison, Office of Science Policy, Analysis, and
Communications, Eunice Kennedy Shriver National Institute of Child
Health and Human Development, National Institutes of Health.
[FR Doc. 2014-22867 Filed 9-24-14; 8:45 am]
BILLING CODE 4140-01-P
