80 FR 25296 - Proposed Data Collection Submitted for Public Comment and Recommendations
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 80, Issue 85 (May 4, 2015)
Centers for Disease Control and Prevention
Federal Register Volume 80, Issue 85 (May 4, 2015)
| Page Range | 25296-25298 | |
| FR Document | 2015-10286 |
[Federal Register Volume 80, Number 85 (Monday, May 4, 2015)] [Notices] [Pages 25296-25298] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-10286] ----------------------------------------------------------------------- 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 Insurer-Sponsored 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 work-related 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 Health\TM\. The NIOSH Total Worker HealthTM Cross-Sector [[Page 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 Health\TM\ Program: (1) Investigate the costs/benefits associated with comprehensive, coordinated work-based 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 OSH-wellness 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 interview-supplemented 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- Average Number of Number of burden per Total burden Type of respondent Form name respondents responses per response (in hours respondent hours) -------------------------------------------------------------------------------------------------------------------------------------------------------- Wellness Program Coordinators.................. Employer interviews on cost of wellness 25 1 2 50 and occupational safety and health program. Occupational Safety and Health Specialists..... Employer interviews on cost of wellness 25 1 2 50 and occupational safety and health program. The person in charge of the employer's wellness Annual case study verification 100 1 30/60 50 program. interview. -------------------------------------------------------------------------------------------------------- Total...................................... ....................................... .............. .............. .............. 150 -------------------------------------------------------------------------------------------------------------------------------------------------------- [[Page 25298]] 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
![25296 Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices
Prevention and the Agency for Toxic Please note: All public comment a collection of information, to search
Substances and Disease Registry. should be submitted through the data sources, to complete and review
Federal eRulemaking portal the collection of information; and to
Catherine Ramadei,
(Regulations.gov) or by U.S. mail to the transmit or otherwise disclose the
Acting Director, Management Analysis and address listed above. information.
Services Office, Centers for Disease Control
and Prevention. FOR FURTHER INFORMATION CONTACT: To Proposed Project
[FR Doc. 2015–10306 Filed 5–1–15; 8:45 am]
request more information on the
proposed project or to obtain a copy of Employer Perspectives of an Insurer-
BILLING CODE 4163–18–P
the information collection plan and Sponsored Wellness Grant—New—
instruments, contact the Information National Institute for Occupational
Collection Review Office, Centers for Safety and Health (NIOSH), Centers for
DEPARTMENT OF HEALTH AND Disease Control and Prevention (CDC).
HUMAN SERVICES Disease Control and Prevention, 1600
Clifton Road NE., MS–D74, Atlanta, Background and Brief Description
Centers for Disease Control and Georgia 30329; phone: 404–639–7570; The mission of the National Institute
Prevention Email: omb@cdc.gov. for Occupational Safety and Health
[60Day-15–15ADW; Docket No. CDC–2015– SUPPLEMENTARY INFORMATION: (NIOSH) is to promote safety and health
0025] Under the Paperwork Reduction Act at work for all people through research
of 1995 (PRA) (44 U.S.C. 3501–3520), and prevention. Under Public Law 91–
Proposed Data Collection Submitted Federal agencies must obtain approval 596, sections 20 and 22 (Section 20–22,
for Public Comment and from the Office of Management and Occupational Safety and Health Act of
Recommendations Budget (OMB) for each collection of 1970), NIOSH has the responsibility to
information they conduct or sponsor. In conduct research to advance the health
AGENCY: Centers for Disease Control and addition, the PRA also requires Federal and safety of workers. In this capacity,
Prevention (CDC), Department of Health agencies to provide a 60-day notice in NIOSH proposes to conduct a study
and Human Services (HHS). the Federal Register concerning each among employers in Ohio insured by
ACTION: Notice with comment period. proposed collection of information, the Ohio Bureau of Workers’
including each new proposed Compensation (OHBWC) to (1) assess
SUMMARY: The Centers for Disease collection, each proposed extension of
Control and Prevention (CDC), as part of the effectiveness and cost-benefit of an
existing collection of information, and intervention that funds workplace
its continuing efforts to reduce public each reinstatement of previously
burden and maximize the utility of wellness programs and (2) understand
approved information collection before the impact of integrating wellness
government information, invites the submitting the collection to OMB for
general public and other Federal programs with traditional occupational
approval. To comply with this safety and health (OSH) programs.
agencies to take this opportunity to requirement, we are publishing this Work-related injuries and illnesses are
comment on proposed and/or notice of a proposed data collection as common among US workers and result
continuing information collections, as described below. in pain, disability, and substantial cost
required by the Paperwork Reduction Comments are invited on: (a) Whether to workers and employers. A recent,
Act of 1995. This notice invites the proposed collection of information comprehensive analysis of the economic
comment on the proposed information is necessary for the proper performance burden of work-related injuries and
collection request entitled ‘‘Employer of the functions of the agency, including illnesses estimated that in 2007 alone
Perspectives of an Insurer-Sponsored whether the information shall have medical and indirect costs for work-
Wellness Grant’’. This collection is a practical utility; (b) the accuracy of the related injuries and illnesses were $250
part of an employer study to understand agency’s estimate of the burden of the billion. According to the Bureau of
the impact of integrating wellness proposed collection of information; (c) Labor Statistics there were 4,609
programs with traditional occupational ways to enhance the quality, utility, and occupational fatalities in 2011 and
safety and health (OSH) programs. clarity of the information to be approximately 2 million work-related
DATES: Written comments must be collected; (d) ways to minimize the injuries and illnesses that involved
received on or before July 6, 2015. burden of the collection of information some lost work in 2010.
ADDRESSES: You may submit comments, on respondents, including through the Workers’ health is affected not only
identified by Docket No. CDC–2015– use of automated collection techniques by workplace safety and health hazards,
0025 by any of the following methods: or other forms of information but also workers’ own health behaviors.
Federal eRulemaking Portal: technology; and (e) estimates of capital Reflecting this, two different, yet,
Regulation.gov. Follow the instructions or start-up costs and costs of operation, complementary approaches exist in the
for submitting comments. maintenance, and purchase of services workplace: OSH programs and wellness
Mail: Leroy A. Richardson, to provide information. Burden means programs. Both types of programs aim to
Information Collection Review Office, the total time, effort, or financial improve worker health and reduce costs
Centers for Disease Control and resources expended by persons to to employers, workers’ compensation
Prevention, 1600 Clifton Road NE., MS– generate, maintain, retain, disclose or (WC) insurers, and society. Since 2004,
D74, Atlanta, Georgia 30329. provide information to or for a Federal NIOSH has advocated an approach that
Instructions: All submissions received agency. This includes the time needed coordinates wellness programs with
mstockstill on DSK4VPTVN1PROD with NOTICES
must include the agency name and to review instructions; to develop, OSH programs because emerging
Docket Number. All relevant comments acquire, install and utilize technology evidence suggests that integrating these
received will be posted without change and systems for the purpose of two fields may have a synergistic effect
to Regulations.gov, including any collecting, validating and verifying on worker safety and health.
personal information provided. For information, processing and NIOSH has established an intramural
access to the docket to read background maintaining information, and disclosing program for protecting and promoting
documents or comments received, go to and providing information; to train Total Worker HealthTM. The NIOSH
Regulations.gov. personnel and to be able to respond to Total Worker HealthTM Cross-Sector
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![25298 Federal Register / Vol. 80, No. 85 / Monday, May 4, 2015 / Notices
Leroy A. Richardson, DEPARTMENT OF HEALTH AND occurring in the administration of CCDF
Chief, Information Collection Review Office, HUMAN SERVICES grant funds once every three years.
Office of Scientific Integrity, Office of the The Office of Child Care (OCC) is
Associate Director for Science, Office of the Administration for Children and completing the third 3-year cycle of case
Director, Centers for Disease Control and Families record reviews to meet the requirements
Prevention. for reporting under IPIA. The current
[FR Doc. 2015–10286 Filed 5–1–15; 8:45 am] Submission for OMB Review; forms and instructions expire
BILLING CODE 4163–18–P
Comment Request September 30, 2015. OCC is submitting
the information collection for renewal
Title: Child Care Development Fund,
clearance with minor changes.
CCDF; Reporting Improper Payments;
Responders will now have additional
Instructions for States.
guidance and clarification in the
OMB No.: 0970–0323. instructions and errors have been
Description: Section 2 of the Improper corrected. New language incorporates
Payments Act of 2002 provides for requirements from the 2014 Child Care
estimates and reports of improper and Development Fund Block Grant Act
payments by Federal agencies. Subpart passed in November 2014.
K of 45 CFR, part 98 will require States Respondents: State grantees, the
to prepare and submit a report of errors District of Columbia, and Puerto Rico
ANNUAL BURDEN ESTIMATES
Number of Average burden
Number of Total burden
Instrument responses per hours per
respondents hours
respondent response
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 DEPARTMENT OF HEALTH AND Lane, Rm. 1061, Rockville, MD 20852.
Hours: 43,613.36. HUMAN SERVICES Submit petitions electronically to http://
Additional Information: Copies of the www.regulations.gov at Docket No.
Food and Drug Administration FDA–2013–S–0610.
proposed collection may be obtained by
writing to the Administration for [Docket No. FDA–2013–E–0785] FOR FURTHER INFORMATION CONTACT:
Children and Families, Office of Beverly Friedman, Office of
Determination of Regulatory Review Management, Food and Drug
Planning, Research and Evaluation, 370
Period for Purposes of Patent Administration, 10001 New Hampshire
L’Enfant Promenade SW., Washington,
Extension; RELAY THORACIC STENT– Ave., Hillandale Campus, Rm. 3180,
DC 20447, Attn: ACF Reports Clearance Silver Spring, MD 20993, 301–796–
Officer. All requests should be GRAFT WITH PLUS DELIVERY
SYSTEM 7900.
identified by the title of the information
SUPPLEMENTARY INFORMATION: The Drug
collection. Email address: AGENCY: Food and Drug Administration,
infocollection@acf.hhs.gov. Price Competition and Patent Term
HHS.
Restoration Act of 1984 (Pub. L. 98–417)
OMB Comment: OMB is required to ACTION: Notice. and the Generic Animal Drug and Patent
make a decision concerning the Term Restoration Act (Pub. L. 100–670)
collection of information between 30 SUMMARY: The Food and Drug
generally provide that a patent may be
and 60 days after publication of this Administration (FDA) has determined
extended for a period of up to 5 years
the regulatory review period for the
document in the Federal Register. so long as the patented item (human
RELAY THORACIC STENT–GRAFT
Therefore, a comment is best assured of drug product, animal drug product,
WITH PLUS DELIVERY SYSTEM and is
having its full effect if OMB receives it medical device, food additive, or color
publishing this notice of that
within 30 days of publication. Written additive) was subject to regulatory
determination as required by law. FDA
comments and recommendations for the review by FDA before the item was
has made the determination because of
proposed information collection should marketed. Under these acts, a product’s
the submission of an application to the
be sent directly to the following: Office regulatory review period forms the basis
Director of the U.S. Patent and
of Management and Budget, Paperwork for determining the amount of extension
Trademark Office (USPTO), Department
Reduction Project, Email: OIRA_ an applicant may receive.
of Commerce, for the extension of a A regulatory review period consists of
SUBMISSION@OMB.EOP.GOV. Attn: patent which claims that medical two periods of time: A testing phase and
Desk Officer for the Administration for device.
mstockstill on DSK4VPTVN1PROD with NOTICES
an approval phase. For medical devices,
Children and Families.
ADDRESSES: Submit electronic the testing phase begins with a clinical
Robert Sargis, comments to http:// investigation of the device and runs
Reports Clearance Officer. www.regulations.gov. Submit written until the approval phase begins. The
[FR Doc. 2015–10296 Filed 5–1–15; 8:45 am]
petitions (two copies are required) and approval phase starts with the initial
written comments to the Division of submission of an application to market
BILLING CODE 4184–01–P
Dockets Management (HFA–305), Food the device and continues until
and Drug Administration, 5630 Fishers permission to market the device is
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Document Created: 2018-02-21 10:22:30
Document Modified: 2018-02-21 10:22:30
| 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 | |
| Action | Notice with comment period. | |
| Dates | Written comments must be received on or before July 6, 2015. | |
| 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] | |
| FR Citation | 80 FR 25296 |
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