Submission for OMB Review; General Services Administration Acquisition Regulation; Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery, 39926-39927 [2016-14509]
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Federal Register / Vol. 81, No. 118 / Monday, June 20, 2016 / Notices
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Dated: June 16, 2016.
Megan Grumbine,
General Counsel, Federal Retirement Thrift
Investment Board.
[FR Doc. 2016–14591 Filed 6–16–16; 11:15 am]
BILLING CODE 6760–01–P
GENERAL SERVICES
ADMINISTRATION
[OMB Control No. 3090–0297; Docket No.
2016–0001; Sequence 3]
Submission for OMB Review; General
Services Administration Acquisition
Regulation; Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery
General Services
Administration (GSA).
ACTION: Notice of request for an
extension to an existing OMB clearance.
AGENCY:
Under the provisions of the
Paperwork Reduction Act, the
Regulatory Secretariat Division will be
submitting to the Office of Management
and Budget (OMB) a request to review
and approve an extension of a
previously approved information
collection requirement regarding the
Generic Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery.
DATES: Submit comments on or before
July 20, 2016.
ADDRESSES: Submit comments regarding
this burden estimate or any other aspect
of this collection of information,
including suggestions for reducing this
burden to: Office of Information and
Regulatory Affairs of OMB, Attention:
Desk Officer for GSA, Room 10236,
NEOB, Washington, DC 20503.
Additionally submit a copy to GSA by
any of the following methods:
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SUMMARY:
VerDate Sep<11>2014
17:05 Jun 17, 2016
Jkt 238001
• Regulations.gov: https://
www.regulations.gov. Submit comments
via the Federal eRulemaking portal by
searching for ‘‘Information Collection
3090–0297, Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery.’’ Select the
link ‘‘Submit a Comment’’ that
corresponds with ‘‘Information
Collection 3090–0297, Generic
Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery.’’ Follow the instructions
provided at the ‘‘Submit a Comment’’
screen. Please include your name,
company name (if any), and
‘‘Information Collection 3090–0297’’ on
your attached document.
• Mail: General Services
Administration, Regulatory Secretariat
Division (MVCB), 1800 F Street NW.,
Washington, DC 20405. Attn: Ms.
Flowers/IC 3090–0297, Generic
Clearance.
Instructions: Please submit comments
only and cite Information Collection
3090–0297, Generic Clearance for the
Collection of Qualitative Feedback on
Agency Service Delivery, in all
correspondence related to this
collection. Comments received generally
will be posted without change to https://
www.regulations.gov, including any
personal and/or business confidential
information provided. To confirm
receipt of your comment(s), please
check www.regulations.gov,
approximately two to three days after
submission to verify posting (except
allow 30 days for posting of comments
submitted by mail).
FOR FURTHER INFORMATION CONTACT: Ms.
Hada Flowers, Office of
Governmentwide Policy, GSA, at 202–
501–4755, or email hada.flowers@
gsa.gov.
SUPPLEMENTARY INFORMATION:
A. Purpose
A notice was published in the Federal
Register at 81 FR 20638 on April 8,
2016. No comments were received. 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,
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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
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. The Digital
Government Strategy released by the
White House in May, 2012 drives
agencies to have a more customercentric focus. Because of this, GSA
anticipates an increase in requests to
use this generic clearance, as the plan
states that: A customer-centric principle
charges us to do several things: Conduct
research to understand the customer’s
business, needs and desires; ‘‘make
content more broadly available and
accessible and present it through
multiple channels in a program- and
device-agnostic way; make content more
accurate and understandable by
maintaining plain language and content
freshness standards; and offer easy
paths for feedback to ensure we
continually improve service delivery.
The customer-centric principle holds
true whether our customers are internal
(e.g., the civilian and military federal
workforce in both classified and
unclassified environments) or external
(e.g., individual citizens, businesses,
research organizations, and state, local,
and tribal governments).’’
E:\FR\FM\20JNN1.SGM
20JNN1
Federal Register / Vol. 81, No. 118 / Monday, June 20, 2016 / Notices
B. Annual Reporting Burden
Respondents: 160,082.
Responses per Respondent: 1.
Total Annual Responses: 160,082.
Hours per response: 3.8386 minutes.
Total Burden hours: 10,241.
C. Public Comments
Public comments are particularly
invited on: Whether this collection of
information is necessary and whether it
will have practical utility; whether our
estimate of the public burden of this
collection of information is accurate,
and based on valid assumptions and
methodology; ways to enhance the
quality, utility, and clarity of the
information to be collected.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat Division (MVCB),
1800 F Street NW., Washington, DC
20405, telephone 202–501–4755. Please
cite OMB Control No. 3090–0297,
Generic Clearance for the Collection of
Qualitative Feedback on Agency Service
Delivery, in all correspondence.
Dated: June 14, 2016.
David A. Shive,
Chief Information Officer.
[FR Doc. 2016–14509 Filed 6–17–16; 8:45 am]
BILLING CODE 6820–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–0734]
Evaluation and Reporting of Age,
Race, and Ethnicity Data in Medical
Device Clinical Studies; Draft
Guidance for Industry and Food and
Drug Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of the draft
guidance entitled ‘‘Evaluation and
Reporting of Age, Race, and Ethnicity
Data in Medical Device Clinical
Studies.’’ The purpose of this document
is to outline FDA’s proposed
recommendations and expectations for
the evaluation and reporting of age,
race, and ethnicity data in medical
device clinical studies. The primary
intent of these recommendations is to
improve the quality, consistency, and
transparency of data regarding the
performance of medical devices within
asabaliauskas on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:05 Jun 17, 2016
Jkt 238001
specific age, race, and ethnic groups.
This draft guidance is not final nor is it
in effect at this time.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment of this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by September 19,
2016.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–D–0734 for ‘‘Evaluation and
Reporting of Age, Race, and Ethnicity
Data in Medical Device Clinical
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39927
Studies.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
An electronic copy of the guidance
document is available for download
from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the draft guidance
document entitled ‘‘Evaluation and
Reporting of Age, Race, and Ethnicity
Data in Medical Device Clinical
Studies’’ to the Office of the Center
Director, Guidance and Policy
Development, Center for Devices and
E:\FR\FM\20JNN1.SGM
20JNN1
Agencies
[Federal Register Volume 81, Number 118 (Monday, June 20, 2016)]
[Notices]
[Pages 39926-39927]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14509]
=======================================================================
-----------------------------------------------------------------------
GENERAL SERVICES ADMINISTRATION
[OMB Control No. 3090-0297; Docket No. 2016-0001; Sequence 3]
Submission for OMB Review; General Services Administration
Acquisition Regulation; Generic Clearance for the Collection of
Qualitative Feedback on Agency Service Delivery
AGENCY: General Services Administration (GSA).
ACTION: Notice of request for an extension to an existing OMB
clearance.
-----------------------------------------------------------------------
SUMMARY: Under the provisions of the Paperwork Reduction Act, the
Regulatory Secretariat Division will be submitting to the Office of
Management and Budget (OMB) a request to review and approve an
extension of a previously approved information collection requirement
regarding the Generic Clearance for the Collection of Qualitative
Feedback on Agency Service Delivery.
DATES: Submit comments on or before July 20, 2016.
ADDRESSES: Submit comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for
reducing this burden to: Office of Information and Regulatory Affairs
of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington,
DC 20503. Additionally submit a copy to GSA by any of the following
methods:
Regulations.gov: https://www.regulations.gov. Submit
comments via the Federal eRulemaking portal by searching for
``Information Collection 3090-0297, Generic Clearance for the
Collection of Qualitative Feedback on Agency Service Delivery.'' Select
the link ``Submit a Comment'' that corresponds with ``Information
Collection 3090-0297, Generic Clearance for the Collection of
Qualitative Feedback on Agency Service Delivery.'' Follow the
instructions provided at the ``Submit a Comment'' screen. Please
include your name, company name (if any), and ``Information Collection
3090-0297'' on your attached document.
Mail: General Services Administration, Regulatory
Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405.
Attn: Ms. Flowers/IC 3090-0297, Generic Clearance.
Instructions: Please submit comments only and cite Information
Collection 3090-0297, Generic Clearance for the Collection of
Qualitative Feedback on Agency Service Delivery, in all correspondence
related to this collection. Comments received generally will be posted
without change to https://www.regulations.gov, including any personal
and/or business confidential information provided. To confirm receipt
of your comment(s), please check www.regulations.gov, approximately two
to three days after submission to verify posting (except allow 30 days
for posting of comments submitted by mail).
FOR FURTHER INFORMATION CONTACT: Ms. Hada Flowers, Office of
Governmentwide Policy, GSA, at 202-501-4755, or email
hada.flowers@gsa.gov.
SUPPLEMENTARY INFORMATION:
A. Purpose
A notice was published in the Federal Register at 81 FR 20638 on
April 8, 2016. No comments were received. 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, 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. The
Digital Government Strategy released by the White House in May, 2012
drives agencies to have a more customer-centric focus. Because of this,
GSA anticipates an increase in requests to use this generic clearance,
as the plan states that: A customer-centric principle charges us to do
several things: Conduct research to understand the customer's business,
needs and desires; ``make content more broadly available and accessible
and present it through multiple channels in a program- and device-
agnostic way; make content more accurate and understandable by
maintaining plain language and content freshness standards; and offer
easy paths for feedback to ensure we continually improve service
delivery.
The customer-centric principle holds true whether our customers are
internal (e.g., the civilian and military federal workforce in both
classified and unclassified environments) or external (e.g., individual
citizens, businesses, research organizations, and state, local, and
tribal governments).''
[[Page 39927]]
B. Annual Reporting Burden
Respondents: 160,082.
Responses per Respondent: 1.
Total Annual Responses: 160,082.
Hours per response: 3.8386 minutes.
Total Burden hours: 10,241.
C. Public Comments
Public comments are particularly invited on: Whether this
collection of information is necessary and whether it will have
practical utility; whether our estimate of the public burden of this
collection of information is accurate, and based on valid assumptions
and methodology; ways to enhance the quality, utility, and clarity of
the information to be collected.
Obtaining Copies of Proposals: Requesters may obtain a copy of the
information collection documents from the General Services
Administration, Regulatory Secretariat Division (MVCB), 1800 F Street
NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB
Control No. 3090-0297, Generic Clearance for the Collection of
Qualitative Feedback on Agency Service Delivery, in all correspondence.
Dated: June 14, 2016.
David A. Shive,
Chief Information Officer.
[FR Doc. 2016-14509 Filed 6-17-16; 8:45 am]
BILLING CODE 6820-34-P