81 FR 80058 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 81, Issue 220 (November 15, 2016)
Centers for Disease Control and Prevention
Federal Register Volume 81, Issue 220 (November 15, 2016)
| Page Range | 80058-80059 | |
| FR Document | 2016-27421 |
[Federal Register Volume 81, Number 220 (Tuesday, November 15, 2016)] [Notices] [Pages 80058-80059] From the Federal Register Online [www.thefederalregister.org] [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 [email protected]. 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
![80058 Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Notices
4. Entry and Efficiencies By direction of the Commission. Proposed Project
Donald S. Clark, CDC I–Catalyst Program—New—
Entry into the relevant market has not
Secretary. Office of the Associate Director for
been, and would not be, timely, likely,
or sufficient to deter or counteract the [FR Doc. 2016–27440 Filed 11–14–16; 8:45 am] Science, Centers for Disease Control and
anticompetitive effects of the BILLING CODE 6750–01–P Prevention (CDC).
acquisition. Optical labs have limited Background and Brief Description
short-term ability to switch from
Valeant and Paragon, which supply the The CDC Office of Technology and
DEPARTMENT OF HEALTH AND Innovation (OTI) within Office of the
majority of their GP scleral buttons and
HUMAN SERVICES Associate Director for Science (OADS) is
GP general vision correction buttons,
and 100 percent of their GP seeking approval for a new CDC generic
Centers for Disease Control and
orthokeratology buttons. Optical labs clearance. OTI fosters innovative
Prevention
might try to persuade eye care science and promotes the testing and
professionals to switch to a different implementation of innovative ideas that
[30Day–17–16AOW]
material and brand, but ultimately the improve CDC’s ability to have public
decision is made by the eye care Agency Forms Undergoing Paperwork health impact. To arm CDC staff with an
professional, for whom such a change is Reduction Act Review expanded skill-set and tools to evaluate
costly and time-consuming. and translate their insights and ideas
The Centers for Disease Control and into solutions, CDC developed an
Considerable entry barriers also arise
Prevention (CDC) has submitted the experiential innovation curriculum
from the FDA approval process. For GP
following information collection request called I-Catalyst based on the NSF I-
orthokeratology buttons, the FDA
to the Office of Management and Budget Corp program. The program was created
premarket approval process takes
(OMB) for review and approval in with the belief that innovation should
several years because finished
accordance with the Paperwork be customer driven, be based on user
orthokeratology lenses worn overnight
Reduction Act of 1995. The notice for research, and is something people at all
are Class III medical devices. For GP
the proposed information collection is levels of an organization can engage in.
scleral and general vision buttons, the
published to obtain comments from the The purpose of the I-Catalyst program
FDA premarket notification process
public and affected agencies. is to teach CDC teams a process of
likely requires at least one year, as the
Written comments and suggestions discovering the issues and problems
finished lenses incorporating such
from the public and affected agencies faced by their customers before
buttons are Class II medical devices.
concerning the proposed collection of considerable time and money is spent
We did not find any evidence of information are encouraged. Your on a solution that may not be used. Each
efficiencies that would outweigh the comments should address any of the participating I-Catalyst project team will
competitive concerns arising from the following: (a) Evaluate whether the present with a unique customer problem
Paragon acquisition. proposed collection of information is for which they have a proposed
5. Consent Order necessary for the proper performance of solution. Participating project teams
the functions of the agency, including will go through a hypothesis-testing,
The proposed Consent Order requires whether the information will have scientific method of discovery to gather
Valeant to divest Paragon in its entirety practical utility; (b) Evaluate the important insights about their customers
no later than ten (10) days after the accuracy of the agencies estimate of the and their needs.
order date, to remedy the concerns burden of the proposed collection of Each individual collection will be a
raised by the acquisition and restore information, including the validity of different problem for which a CDC team
competition in the relevant markets by the methodology and assumptions used; is designing a solution. The types of
instituting Paragon as an independent, (c) Enhance the quality, utility, and customers or stakeholders teams’
viable competitor to Valeant. The clarity of the information to be interview will be detailed in each
proposed Consent Order also requires collected; (d) Minimize the burden of collection. For example, teams may
Valeant to divest Pelican with Paragon the collection of information on those interview government employees if the
to ensure continued access to FDA- who are to respond, including through solution is intended to improve how
approved vials for shipping its finished the use of appropriate automated, government employees do their work.
lenses. electronic, mechanical, or other On the other hand, teams may interview
The proposed Consent Order requires technological collection techniques or individuals who work in industry and
that Valeant must divest Paragon and other forms of information technology, businesses if the problem is one
Pelican to Paragon Companies LLC in an e.g., permitting electronic submission of experienced by external customers. This
upfront transaction. Paragon Companies responses; and (e) Assess information data collection covers qualitative
LLC is a newly created entity owned by collection costs. information to be obtained through on-
Joe Sicari. Mr. Sicari was the president To request additional information on site, unstructured interviews with
of Paragon prior to its acquisition by the proposed project or to obtain a copy individuals who represent the
Valeant in May 2015. of the information collection plan and customers or stakeholders CDC teams
The Commission may, at any time, instruments, call (404) 639–7570 or are attempting to serve or benefit.
appoint a Monitor with the power and send an email to omb@cdc.gov. Written It is expected that the program will
authority to ensure that Valeant fulfills comments and/or suggestions regarding help CDC teams generate information
mstockstill on DSK3G9T082PROD with NOTICES
all obligations and responsibilities the items contained in this notice about their customers to help them
under the Consent Order and should be directed to the Attention: make the case for key innovation
Divestiture Agreement. CDC Desk Officer, Office of Management investments to advance important
The Consent Order will remain in and Budget, Washington, DC 20503 or public health solutions and innovations.
effect for ten (10) years, and contains by fax to (202) 395–5806. Written The ultimate goal of the I-Catalyst
standard compliance and reporting comments should be received within 30 program is to give CDC staff skills to
requirements. days of this notice. successfully transfer knowledge into
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![Federal Register / Vol. 81, No. 220 / Tuesday, November 15, 2016 / Notices 80059
value-based solutions that benefit CDC anticipates 30 projects over the Approximately 1500 respondents will
society and broaden the agency’s next three years. Each project team will be interviewed. Of these respondents,
impact. Participation in the I-Catalyst interview their customers/stakeholders approximately 40% of individuals will
interviews is completely voluntary. A for an average of 30 minutes and be internal CDC/ATSDR staff and 60%
three-year approval is requested. There maximum of 2 responses per will be external partners, stakeholders,
is no cost to respondents other than respondent. Each team will interview or customers. Annualized burden will
their time. approximately 50 respondents. be 500 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Number of burden per Total burden
Type of respondents Form name responses per
respondents response (in hrs)
respondent (in hrs)
External + Internal stakeholder/customers ... Sample Interview Guide ....... 500 2 30/60 500
Leroy A. Richardson, of information on the public’s extension of existing collection of
Chief, Information Collection Review Office, understanding of excessive alcohol use. information, and each reinstatement of
Office of Scientific Integrity, Office of the DATES: Written comments must be previously approved information
Associate Director for Science, Office of the received on or before January 17, 2017. collection before submitting the
Director, Centers for Disease Control and
Prevention. ADDRESSES: You may submit comments, collection to OMB for approval. To
identified by Docket No. CDC–2016– comply with this requirement, we are
[FR Doc. 2016–27421 Filed 11–14–16; 8:45 am]
0108, by any of the following methods: publishing this notice of a proposed
BILLING CODE 4163–18–P
• Federal eRulemaking portal: data collection as described below.
Regulations.gov. Follow the instructions Comments are invited on: (a) Evaluate
DEPARTMENT OF HEALTH AND for submitting comments. whether the proposed collection of
HUMAN SERVICES • Mail: Leroy A. Richardson, information is necessary for the proper
Information Collection Review Office, performance of the functions of the
Centers for Disease Control and Centers for Disease Control and agency, including whether the
Prevention Prevention, 1600 Clifton Road NE., MS–
information will have practical utility;
D74, Atlanta, Georgia 30329.
[60Day–17–17CX; Docket No. CDC–2016– (b) Evaluate the accuracy of the agency’s
Instructions: All submissions received
0108] estimate of the burden of the proposed
must include the agency name and
Docket Number. All relevant comments collection of information, including the
Proposed Data Collection Submitted validity of the methodology and
for Public Comment and received will be posted without change
to Regulations.gov, including any assumptions used; (c) Enhance the
Recommendations
personal information provided. For quality, utility, and clarity of the
AGENCY: Centers for Disease Control and access to the docket to read background information to be collected; (d)
Prevention (CDC), Department of Health documents or comments received, go to Minimize the burden of the collection of
and Human Services (HHS). Regulations.gov. information on those who are to
ACTION: Notice with comment period. Please note: All public comment should be respond, including through the use of
submitted through the Federal eRulemaking appropriate automated, electronic,
SUMMARY: The Centers for Disease portal (Regulations.gov) or by U.S. mail to the mechanical, or other technological
Control and Prevention (CDC), as part of address listed above. collection techniques or other forms of
its continuing efforts to reduce public information technology (e.g., permitting
burden and maximize the utility of FOR FURTHER INFORMATION CONTACT: To
electronic submission of responses); and
government information, invites the request more information on the
proposed project or to obtain a copy of (e) Assess information collection costs.
general public and other Federal Burden means the total time, effort, or
agencies to take this opportunity to the information collection plan and
instruments, contact the Information financial resources expended by persons
comment on proposed and/or
Collection Review Office, Centers for to generate, maintain, retain, disclose, or
continuing information collections, as
Disease Control and Prevention, 1600 provide information to or for a Federal
required by the Paperwork Reduction
Act of 1995. This notice invites Clifton Road NE., MS–D74, Atlanta, agency. This includes the time needed
comment on a proposed project entitled Georgia 30329; phone: 404–639–7570; to review instructions; to develop,
‘‘Reframing How We Talk About Email: omb@cdc.gov. acquire, install and use technology and
Alcohol: Public Perceptions of SUPPLEMENTARY INFORMATION: Under the systems for the purpose of collecting,
Excessive Alcohol Use Among Multiple Paperwork Reduction Act of 1995 (PRA) validating and verifying information,
Audiences.’’ CDC will seek a one-year (44 U.S.C. 3501–3520), Federal agencies processing and maintaining
approval for a new information must obtain approval from the Office of information, and disclosing and
collection request to assess the public’s Management and Budget (OMB) for each providing information; to train
mstockstill on DSK3G9T082PROD with NOTICES
perceptions and frames regarding collection of information they conduct personnel and be able to respond to a
alcohol use and its related harms, gain or sponsor. In addition, the PRA collection of information, search data
insights on the language the public uses requires Federal agencies to provide a sources, and complete and review the
when talking about excessive alcohol 60-day notice in the Federal Register collection of information; and to
use, examine patient-provider concerning each proposed collection of transmit or otherwise disclose the
communication about alcohol use, and information, including each new information.
evaluate the influence of other sources proposed collection, each proposed
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Document Created: 2016-11-15 00:47:41
Document Modified: 2016-11-15 00:47:41
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 81 FR 80058 |
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