Agency Forms Undergoing Paperwork Reduction Act Review, 80058-80059 [2016-27421]
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80058
Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Notices
4. Entry and Efficiencies
Entry into the relevant market has not
been, and would not be, timely, likely,
or sufficient to deter or counteract the
anticompetitive effects of the
acquisition. Optical labs have limited
short-term ability to switch from
Valeant and Paragon, which supply the
majority of their GP scleral buttons and
GP general vision correction buttons,
and 100 percent of their GP
orthokeratology buttons. Optical labs
might try to persuade eye care
professionals to switch to a different
material and brand, but ultimately the
decision is made by the eye care
professional, for whom such a change is
costly and time-consuming.
Considerable entry barriers also arise
from the FDA approval process. For GP
orthokeratology buttons, the FDA
premarket approval process takes
several years because finished
orthokeratology lenses worn overnight
are Class III medical devices. For GP
scleral and general vision buttons, the
FDA premarket notification process
likely requires at least one year, as the
finished lenses incorporating such
buttons are Class II medical devices.
We did not find any evidence of
efficiencies that would outweigh the
competitive concerns arising from the
Paragon acquisition.
mstockstill on DSK3G9T082PROD with NOTICES
5. Consent Order
The proposed Consent Order requires
Valeant to divest Paragon in its entirety
no later than ten (10) days after the
order date, to remedy the concerns
raised by the acquisition and restore
competition in the relevant markets by
instituting Paragon as an independent,
viable competitor to Valeant. The
proposed Consent Order also requires
Valeant to divest Pelican with Paragon
to ensure continued access to FDAapproved vials for shipping its finished
lenses.
The proposed Consent Order requires
that Valeant must divest Paragon and
Pelican to Paragon Companies LLC in an
upfront transaction. Paragon Companies
LLC is a newly created entity owned by
Joe Sicari. Mr. Sicari was the president
of Paragon prior to its acquisition by
Valeant in May 2015.
The Commission may, at any time,
appoint a Monitor with the power and
authority to ensure that Valeant fulfills
all obligations and responsibilities
under the Consent Order and
Divestiture Agreement.
The Consent Order will remain in
effect for ten (10) years, and contains
standard compliance and reporting
requirements.
VerDate Sep<11>2014
22:00 Nov 11, 2016
Jkt 241001
By direction of the Commission.
Donald S. Clark,
Secretary.
Proposed Project
[FR Doc. 2016–27440 Filed 11–14–16; 8:45 am]
BILLING CODE 6750–01–P
CDC I–Catalyst Program—New—
Office of the Associate Director for
Science, Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–17–16AOW]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
PO 00000
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The CDC Office of Technology and
Innovation (OTI) within Office of the
Associate Director for Science (OADS) is
seeking approval for a new CDC generic
clearance. OTI fosters innovative
science and promotes the testing and
implementation of innovative ideas that
improve CDC’s ability to have public
health impact. To arm CDC staff with an
expanded skill-set and tools to evaluate
and translate their insights and ideas
into solutions, CDC developed an
experiential innovation curriculum
called I-Catalyst based on the NSF ICorp program. The program was created
with the belief that innovation should
be customer driven, be based on user
research, and is something people at all
levels of an organization can engage in.
The purpose of the I-Catalyst program
is to teach CDC teams a process of
discovering the issues and problems
faced by their customers before
considerable time and money is spent
on a solution that may not be used. Each
participating I-Catalyst project team will
present with a unique customer problem
for which they have a proposed
solution. Participating project teams
will go through a hypothesis-testing,
scientific method of discovery to gather
important insights about their customers
and their needs.
Each individual collection will be a
different problem for which a CDC team
is designing a solution. The types of
customers or stakeholders teams’
interview will be detailed in each
collection. For example, teams may
interview government employees if the
solution is intended to improve how
government employees do their work.
On the other hand, teams may interview
individuals who work in industry and
businesses if the problem is one
experienced by external customers. This
data collection covers qualitative
information to be obtained through onsite, unstructured interviews with
individuals who represent the
customers or stakeholders CDC teams
are attempting to serve or benefit.
It is expected that the program will
help CDC teams generate information
about their customers to help them
make the case for key innovation
investments to advance important
public health solutions and innovations.
The ultimate goal of the I-Catalyst
program is to give CDC staff skills to
successfully transfer knowledge into
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80059
Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Notices
value-based solutions that benefit
society and broaden the agency’s
impact. Participation in the I-Catalyst
interviews is completely voluntary. A
three-year approval is requested. There
is no cost to respondents other than
their time.
Approximately 1500 respondents will
be interviewed. Of these respondents,
approximately 40% of individuals will
be internal CDC/ATSDR staff and 60%
will be external partners, stakeholders,
or customers. Annualized burden will
be 500 hours.
CDC anticipates 30 projects over the
next three years. Each project team will
interview their customers/stakeholders
for an average of 30 minutes and
maximum of 2 responses per
respondent. Each team will interview
approximately 50 respondents.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
External + Internal stakeholder/customers ...
Sample Interview Guide .......
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2016–27421 Filed 11–14–16; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day–17–17CX; Docket No. CDC–2016–
0108]
Proposed Data Collection Submitted
for Public Comment and
Recommendations
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Notice with comment period.
AGENCY:
The Centers for Disease
Control and Prevention (CDC), as part of
its continuing efforts to reduce public
burden and maximize the utility of
government information, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995. This notice invites
comment on a proposed project entitled
‘‘Reframing How We Talk About
Alcohol: Public Perceptions of
Excessive Alcohol Use Among Multiple
Audiences.’’ CDC will seek a one-year
approval for a new information
collection request to assess the public’s
perceptions and frames regarding
alcohol use and its related harms, gain
insights on the language the public uses
when talking about excessive alcohol
use, examine patient-provider
communication about alcohol use, and
evaluate the influence of other sources
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
22:00 Nov 11, 2016
Jkt 241001
500
of information on the public’s
understanding of excessive alcohol use.
DATES: Written comments must be
received on or before January 17, 2017.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2016–
0108, by any of the following methods:
• Federal eRulemaking portal:
Regulations.gov. Follow the instructions
for submitting comments.
• Mail: Leroy A. Richardson,
Information Collection Review Office,
Centers for Disease Control and
Prevention, 1600 Clifton Road NE., MS–
D74, Atlanta, Georgia 30329.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to Regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
Regulations.gov.
Please note: All public comment should be
submitted through the Federal eRulemaking
portal (Regulations.gov) or by U.S. mail to the
address listed above.
To
request more information on the
proposed project or to obtain a copy of
the information collection plan and
instruments, contact the Information
Collection Review Office, Centers for
Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta,
Georgia 30329; phone: 404–639–7570;
Email: omb@cdc.gov.
SUPPLEMENTARY INFORMATION: Under the
Paperwork Reduction Act of 1995 (PRA)
(44 U.S.C. 3501–3520), Federal agencies
must obtain approval from the Office of
Management and Budget (OMB) for each
collection of information they conduct
or sponsor. In addition, the PRA
requires Federal agencies to provide a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each new
proposed collection, each proposed
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
2
Average
burden per
response
(in hrs)
30/60
Total burden
(in hrs)
500
extension of existing collection of
information, and each reinstatement of
previously approved information
collection before submitting the
collection to OMB for approval. To
comply with this requirement, we are
publishing this notice of a proposed
data collection as described below.
Comments are invited on: (a) Evaluate
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information will have practical utility;
(b) Evaluate 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; (c) Enhance the
quality, utility, and clarity of the
information to be collected; (d)
Minimize the burden of the collection of
information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology (e.g., permitting
electronic submission of responses); and
(e) Assess information collection costs.
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 use 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 be able to respond to a
collection of information, search data
sources, and complete and review the
collection of information; and to
transmit or otherwise disclose the
information.
E:\FR\FM\15NON1.SGM
15NON1
]]>Agencies
[Federal Register Volume 81, Number 220 (Tuesday, November 15, 2016)]
[Notices]
[Pages 80058-80059]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27421]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-17-16AOW]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: CDC Desk Officer, Office of Management and
Budget, Washington, DC 20503 or by fax to (202) 395-5806. Written
comments should be received within 30 days of this notice.
Proposed Project
CDC I-Catalyst Program--New--Office of the Associate Director for
Science, Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The CDC Office of Technology and Innovation (OTI) within Office of
the Associate Director for Science (OADS) is seeking approval for a new
CDC generic clearance. OTI fosters innovative science and promotes the
testing and implementation of innovative ideas that improve CDC's
ability to have public health impact. To arm CDC staff with an expanded
skill-set and tools to evaluate and translate their insights and ideas
into solutions, CDC developed an experiential innovation curriculum
called I-Catalyst based on the NSF I-Corp program. The program was
created with the belief that innovation should be customer driven, be
based on user research, and is something people at all levels of an
organization can engage in.
The purpose of the I-Catalyst program is to teach CDC teams a
process of discovering the issues and problems faced by their customers
before considerable time and money is spent on a solution that may not
be used. Each participating I-Catalyst project team will present with a
unique customer problem for which they have a proposed solution.
Participating project teams will go through a hypothesis-testing,
scientific method of discovery to gather important insights about their
customers and their needs.
Each individual collection will be a different problem for which a
CDC team is designing a solution. The types of customers or
stakeholders teams' interview will be detailed in each collection. For
example, teams may interview government employees if the solution is
intended to improve how government employees do their work. On the
other hand, teams may interview individuals who work in industry and
businesses if the problem is one experienced by external customers.
This data collection covers qualitative information to be obtained
through on-site, unstructured interviews with individuals who represent
the customers or stakeholders CDC teams are attempting to serve or
benefit.
It is expected that the program will help CDC teams generate
information about their customers to help them make the case for key
innovation investments to advance important public health solutions and
innovations. The ultimate goal of the I-Catalyst program is to give CDC
staff skills to successfully transfer knowledge into
[[Page 80059]]
value-based solutions that benefit society and broaden the agency's
impact. Participation in the I-Catalyst interviews is completely
voluntary. A three-year approval is requested. There is no cost to
respondents other than their time.
CDC anticipates 30 projects over the next three years. Each project
team will interview their customers/stakeholders for an average of 30
minutes and maximum of 2 responses per respondent. Each team will
interview approximately 50 respondents. Approximately 1500 respondents
will be interviewed. Of these respondents, approximately 40% of
individuals will be internal CDC/ATSDR staff and 60% will be external
partners, stakeholders, or customers. Annualized burden will be 500
hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response Total burden
respondents respondent (in hrs) (in hrs)
----------------------------------------------------------------------------------------------------------------
External + Internal Sample Interview 500 2 30/60 500
stakeholder/customers. Guide.
----------------------------------------------------------------------------------------------------------------
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2016-27421 Filed 11-14-16; 8:45 am]
BILLING CODE 4163-18-P
