[Federal Register Volume 80, Number 221 (Tuesday, November 17, 2015)]
[Notices]
[Pages 71804-71806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-29273]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[30Day-16-0964]


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

[[Page 71805]]

by fax to (202) 395-5806. Written comments should be received within 30 
days of this notice.

Proposed Project

    Interventions to Reduce Shoulder MSDS in Overhead Assembly (OMB No. 
0920-0964 Exp. 04/30/2015)--Reinstatement--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 to assess the effectiveness and cost-benefit of occupational 
safety and health (OSH) interventions to prevent musculoskeletal 
disorders (MSDs) among workers in the Manufacturing (MNF) sector.
    A reinstatement is necessary because there were significant delays 
in implementing the tooling intervention in the intended work 
processes. These delays were to a large degree due to business 
conditions and were outside of the control of investigators. As result, 
the study achieved approximately 50% of the original sample size 
approved by OMB in the original ICR request. The reinstatement is 
necessary to extend the duration of the ICR so that the additional 
participants can enrolled and data collection can continue.
    The U.S. Manufacturing sector has faced a number of challenges 
including an overall decline in jobs, an aging workforce, and changes 
in organizational management systems. Studies have indicated that the 
average age of industrial workers is increasing and that older workers 
may differ from younger workers in work capacity, injury risk, severity 
of injuries, and speed of recovery (Kenny et al., 2008; Gall et al., 
2004; Restrepo et al., 2006). As the average age of the industrial 
population increases and newer systems of work organization (such as 
lean manufacturing) are changing the nature of labor-intensive work, 
prevention of MSDs will be more critical to protecting older workers 
and maintaining productivity.
    This study will evaluate the efficacy of two intervention 
strategies for reducing musculoskeletal symptoms and pain in the 
shoulder attributable to overhead assembly work in automotive 
manufacturing. These interventions are, (1) an articulating spring-
tensioned tool support device that unloads from the worker the weight 
of the tool that would otherwise be manually supported, and, (2) a 
targeted exercise program intended to increase individual employees' 
strength and endurance in the shoulder and upper arm stabilizing muscle 
group. As a primary prevention strategy, the tool support engineering 
control approach is preferred; however, a cost-efficient opportunity 
exists to concurrently evaluate the efficacy of a preventive exercise 
program intervention. Both of these intervention approaches have been 
used in the Manufacturing sector, and preliminary evidence suggests 
that both approaches may have merit. However, high quality evidence 
demonstrating their effectiveness, by way of controlled trials, is 
lacking. This project will be conducted as a partnership between NIOSH 
and Toyota Motors Engineering & Manufacturing North America, Inc. 
(TEMA), with the intervention evaluation study taking place at the 
Toyota Motor Manufacturing Kentucky, Inc. (TMMK) manufacturing facility 
in Georgetown, Kentucky. The prospective intervention evaluation study 
will be conducted using a group-randomized controlled trial multi-time 
series design. Four groups of 25-30 employees will be established to 
test the two intervention treatment conditions (tool support, exercise 
program), a combined intervention treatment condition, and a control 
condition. The four groups will be comprised of employees working on 
two vehicle assembly lines in different parts of the facility, on two 
work shifts (first and second shift). Individual randomization to 
treatment condition is not feasible, so a group-randomization (by work 
unit) will be used to assign the four groups to treatment and control 
conditions. Observations will be made over the 24-month study period 
and questionnaires will include the Shoulder Rating Questionnaire 
(SRQ), Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, 
a Standardized Nordic Questionnaire for body part discomfort, and a 
Work Organization Questionnaire. In addition to the questionnaires a 
shoulder-specific functional capacity evaluation test battery will be 
administered at 90 and 210 days, immediately pre- and post-
intervention, to confirm the efficacy of the targeted exercise program 
in improving shoulder capacity.
    In summary, this study will evaluate the effectiveness of two 
interventions to reduce musculoskeletal symptoms and pain in the 
shoulder associated with repetitive overhead work in the manufacturing 
industry and the associated research project will disseminate the 
results of evidence-based prevention practices to the greatest audience 
possible.
    There is no cost to respondents other than their time. The 
estimated annualized burden is 236 hours.

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                                     Number of    Average burden
          Type of respondents                   Form name            Number of     responses per   per response
                                                                    respondents     respondent      (in hours)
----------------------------------------------------------------------------------------------------------------
Employees
                                        Informed Consent Form...              63               1            5/60
                                        Consent of Photographic               63               1            2/60
                                         Image Release.
                                        Physical Activity                     63               1            2/60
                                         Readiness (PAR-Q).
                                        Shoulder Rating                       63              10            4/60
                                         Questionnaire.
                                        Disabilities of Arm                   63              10            6/10
                                         Shoulder and Hand Dash
                                         (DASH).
                                        Standardized Nordic                   63              10            4/60
                                         Questionnaire for
                                         Musculoskeletal Symptom
                                         Instruments.
                                        Work Organization                     63               3           26/60
                                         Questionnaire.
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[[Page 71806]]

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. 2015-29273 Filed 11-16-15; 8:45 am]
 BILLING CODE 4163-18-P