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 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: 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. 

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: 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 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 

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 25297 

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 

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 

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. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

hours 

Wellness Program Coordinators ....... Employer interviews on cost of 

wellness and occupational safety 

and health program.

25 1 2 50 

Occupational Safety and Health Specialists.Employer interviews on cost of 

wellness and occupational safety 

and health program.

25 1 2 50 

The person in charge of the employer’s wellness program.Annual case study verification interview.100 1 30/60 50 

Total ........................................... .......................................................... ........................ ........................ ........................ 150 

mstockstill on DSK4VPTVN1PROD with NOTICES

25298 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. 

[FR Doc. 2015–10286 Filed 5–1–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Submission for OMB Review; 

Comment Request 

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

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

Total burden 

hours 

Sampling Decisions and Fieldwork Preparation Plan ................. 17 1 106 1,802 

Record Review Worksheet .......................................................... 17 276 6 .33 29,700 .36 

State Improper Authorizations for Payment Report .................... 17 1 639 10,863 

Corrective Action Plan ................................................................. 8 1 156 1,248 

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: 

infocollection@acf.hhs.gov. 

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_

SUBMISSION@OMB.EOP.GOV. 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] 

BILLING CODE 4184–01–P 

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. 

SUMMARY: 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. 

ADDRESSES: 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 

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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