60 day FRN

25296

Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices

Prevention and the Agency for Toxic
Substances and Disease Registry.
Catherine Ramadei,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2015–10306 Filed 5–1–15; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-15–15ADW; Docket No. CDC–2015–
0025]

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 the proposed information
collection request entitled ‘‘Employer
Perspectives of an Insurer-Sponsored
Wellness Grant’’. This collection is a
part of an employer study to understand
the impact of integrating wellness
programs with traditional occupational
safety and health (OSH) programs.
DATES: Written comments must be
received on or before July 6, 2015.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2015–
0025 by any of the following methods:
Federal eRulemaking Portal:
Regulation.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.

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SUMMARY:

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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.
FOR FURTHER INFORMATION CONTACT: 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: [email protected].
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 also 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 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) Whether
the proposed 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
proposed 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

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a collection of information, to search
data sources, to complete and review
the collection of information; and to
transmit or otherwise disclose the
information.
Proposed Project
Employer Perspectives of an InsurerSponsored Wellness Grant—New—
National Institute for Occupational
Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
The mission of the National Institute
for Occupational Safety and Health
(NIOSH) is to promote safety and health
at work for all people through research
and prevention. Under Public Law 91–
596, sections 20 and 22 (Section 20–22,
Occupational Safety and Health Act of
1970), NIOSH has the responsibility to
conduct research to advance the health
and safety of workers. In this capacity,
NIOSH proposes to conduct a study
among employers in Ohio insured by
the Ohio Bureau of Workers’
Compensation (OHBWC) to (1) assess
the effectiveness and cost-benefit of an
intervention that funds workplace
wellness programs and (2) understand
the impact of integrating wellness
programs with traditional occupational
safety and health (OSH) programs.
Work-related injuries and illnesses are
common among US workers and result
in pain, disability, and substantial cost
to workers and employers. A recent,
comprehensive analysis of the economic
burden of work-related injuries and
illnesses estimated that in 2007 alone
medical and indirect costs for workrelated injuries and illnesses were $250
billion. According to the Bureau of
Labor Statistics there were 4,609
occupational fatalities in 2011 and
approximately 2 million work-related
injuries and illnesses that involved
some lost work in 2010.
Workers’ health is affected not only
by workplace safety and health hazards,
but also workers’ own health behaviors.
Reflecting this, two different, yet,
complementary approaches exist in the
workplace: OSH programs and wellness
programs. Both types of programs aim to
improve worker health and reduce costs
to employers, workers’ compensation
(WC) insurers, and society. Since 2004,
NIOSH has advocated an approach that
coordinates wellness programs with
OSH programs because emerging
evidence suggests that integrating these
two fields may have a synergistic effect
on worker safety and health.
NIOSH has established an intramural
program for protecting and promoting
Total Worker HealthTM. The NIOSH
Total Worker HealthTM Cross-Sector

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Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices
Program promotes the integration of
health and safety protection with health
and wellness promotion through
research, interventions, partnerships,
and capacity building to meet the needs
of the 21st century workforce. The
proposed project addresses three
priority goals of the NIOSH Total
Worker HealthTM Program: (1)
Investigate the costs/benefits associated
with comprehensive, coordinated workbased health protection/health
promotion interventions; (2) improve
the understanding of how the work
environment influences the
effectiveness of health programs and
identify opportunities for workplace
interventions to prevent, control,
recognize and manage common chronic
conditions; and (3) conduct scientific
research that more holistically
investigates organizational and worker
health and safety outcomes associated
with emerging issues and addresses
gaps in knowledge in the health
protection/health promotion field.
There is a need for research to
demonstrate a ‘business case’ for both
wellness programs and integrated OSHwellness programs and identify OSH
organizational and management
policies, programs and practices that
effectively reduce work-related injuries,
illnesses, disabilities and WC costs. To
date small employers have been largely
ignored in these areas and many studies
have focused on the manufacturing
industry. Real-world examples of
effective interventions that apply to
employers of all sizes and industries
will ultimately improve workers’ health
and safety.
For the current study, NIOSH and
OHBWC are collaborating on a project to
determine the effectiveness and
economic return of the Workplace
Wellness Grant Program (WWGP) and to
understand the impact of integrating of
wellness with traditional OSH

employer’s wellness program and
occupational and safety program costs.
Topics will include questions about:
The timeline and confirmation of grant
funding (4 questions), non-grant funds
used for wellness program costs after
receiving the first grant (5 questions),
non-grant funds used for wellness
program costs before receiving the first
grant (7 questions), time spent on
wellness program after receiving the
grant (3 questions), time spent on
wellness program before receiving the
grant (7 questions), other questions
about the people planning and running
the wellness program (2 or 4 questions),
work time spent by employees for
wellness activities (6 to 11 questions),
changes to OSH plan and hazards after
receiving the grant (8 to 13 questions),
and other questions about their wellness
program (3 to 5 questions).
The results of these interviewsupplemented case studies will be used
to estimate the proportion by which
total employer costs exceed the cost of
the primary wellness program vendor,
as well as the proportion of these costs
attributable to establishing the program
in the first year versus operating the
program in subsequent years. These
estimates will be applied to generate
total employer costs for all of the
WWGP recipients, with sensitivity
analysis based on the observed
variability of employer costs in the case
studies.
If the WWGP is effective at improving
worker health, reducing WC claims and
demonstrating a positive economic
return, then other employers and
insurance carriers may develop similar
programs and drive the optimization of
integrated OSH-wellness approaches.
NIOSH expects to complete data
collection in 2017.
There are no costs to respondents
other than their time.

programs. In early 2012 OHBWC took
steps to integrate wellness and OSH
programs by launching the WWGP, in
which an estimated 400 (currently 321)
employers and 13,000 employees will
be provided a total of $4 million in
funds over four years to implement
wellness programs.
The majority of the study aims will be
accomplished through secondary
analysis of pre- and post-intervention
data being collected by OHBWC and
shared with NIOSH. For the overall
study, data for participating employers
will include aggregate health risk
appraisal data; aggregate biometric data;
turnover data; health care utilization
costs; information about occupational
safety and health, wellness, and
integrated occupational safety and
health-wellness program elements;
OHBWC WWGP expense records; yearly
WC claims and cost data; data that
details employer participation in other
OHBWC programs; industry codes, and
employer size. A sample of no more
than 50 employers will be selected
among grantees for 1–2 brief phone calls
to confirm responses on an annual
survey administered by OHBWC.
In addition, NIOSH will supplement
the cost data extracted from existing
sources with information collected
through in-depth, semi-structured
interviews with no more than 25,
randomly selected, participating
employers. Data gathered from these
employer interviews are critical to
compute ratios of total savings to total
costs for the grant-supported wellness
programs from the perspective of the
participating employers.
NIOSH will ask a series of questions
that will be used to estimate direct and
indirect costs that were not directly
funded by the WWGP during and after
the grant funding period. This will be
accomplished by collecting as detailed
information as possible about the

ESTIMATED ANNUALIZED BURDEN HOURS
Form name

Wellness Program Coordinators .......

The person in charge of the employer’s wellness program.

Employer interviews on cost of
wellness and occupational safety
and health program.
Employer interviews on cost of
wellness and occupational safety
and health program.
Annual case study verification interview.

Total ...........................................

..........................................................

Occupational Safety and Health Specialists.
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Number of
respondents

Type of respondent

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Average
burden per
response
(in hours)

Number of
responses per
respondent

Total
burden
hours

25

1

2

50

25

1

2

50

100

1

30/60

50

........................

........................

........................

150

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Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices

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.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request

[FR Doc. 2015–10286 Filed 5–1–15; 8:45 am]
BILLING CODE 4163–18–P

Title: Child Care Development Fund,
CCDF; Reporting Improper Payments;
Instructions for States.
OMB No.: 0970–0323.
Description: Section 2 of the Improper
Payments Act of 2002 provides for
estimates and reports of improper
payments by Federal agencies. Subpart
K of 45 CFR, part 98 will require States
to prepare and submit a report of errors

occurring in the administration of CCDF
grant funds once every three years.
The Office of Child Care (OCC) is
completing the third 3-year cycle of case
record reviews to meet the requirements
for reporting under IPIA. The current
forms and instructions expire
September 30, 2015. OCC is submitting
the information collection for renewal
clearance with minor changes.
Responders will now have additional
guidance and clarification in the
instructions and errors have been
corrected. New language incorporates
requirements from the 2014 Child Care
and Development Fund Block Grant Act
passed in November 2014.
Respondents: State grantees, the
District of Columbia, and Puerto Rico

ANNUAL BURDEN ESTIMATES

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Sampling Decisions and Fieldwork Preparation Plan .................
Record Review Worksheet ..........................................................
State Improper Authorizations for Payment Report ....................
Corrective Action Plan .................................................................

Estimated Total Annual Burden
Hours: 43,613.36.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
[email protected].
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
[email protected]. Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–10296 Filed 5–1–15; 8:45 am]
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Number of
responses per
respondent

Number of
respondents

Instrument

17
17
17
8

1
276
1
1

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–E–0785]

Determination of Regulatory Review
Period for Purposes of Patent
Extension; RELAY THORACIC STENT–
GRAFT WITH PLUS DELIVERY
SYSTEM
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) has determined
the regulatory review period for the
RELAY THORACIC STENT–GRAFT
WITH PLUS DELIVERY SYSTEM and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.

SUMMARY:

Submit electronic
comments to http://
www.regulations.gov. Submit written
petitions (two copies are required) and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers

ADDRESSES:

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Average burden
hours per
response
106
6.33
639
156

Total burden
hours
1,802
29,700.36
10,863
1,248

Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://
www.regulations.gov at Docket No.
FDA–2013–S–0610.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of
Management, Food and Drug
Administration, 10001 New Hampshire
Ave., Hillandale Campus, Rm. 3180,
Silver Spring, MD 20993, 301–796–
7900.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For medical devices,
the testing phase begins with a clinical
investigation of the device and runs
until the approval phase begins. The
approval phase starts with the initial
submission of an application to market
the device and continues until
permission to market the device is

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