6722 Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices 

I. Background 

Vaccination is one of the most 

important public health achievements of 

the 20th century. Vaccines save lives 

and improve the quality of life by 

reducing the transmission of infectious 

diseases. However, the benefits of 

vaccination are not realized equally 

across the U.S. population. Adult 

vaccination rates remain low in the 

United States and far below Healthy 

People 2020 targets. In an average year, 

95 percent of the approximately 20,000 

to 50,000 Americans who die as a result 

of vaccine-preventable disease are 

adults, depending on the severity of 

annual influenza outbreaks. Substantial 

racial and ethnic disparities also exist. 

The National Vaccine Plan (NVP), 

released in 2010, provides a guiding 

vision for vaccination in the United 

States for the decade 2010–2020. While 

the NVP serves as a roadmap for 

protecting all U.S. residents from 

vaccine-preventable diseases, 

historically low vaccination rates in the 

adult population and unique attributes 

of the adult vaccination delivery system 

highlight the need for focused attention 

on adult vaccination. 

The NAIP is a five year national plan 

with an emphasis on coordination and 

prioritization of what federal and nonfederal partners can accomplish 

together. Given this time frame, the 

NAIP will be informed by emerging 

science and changing circumstances. 

The NAIP also aims to leverage the 

unique opportunity presented by the 

passage and ongoing implementation of 

the Affordable Care Act. 

Through their analysis and 

discussion, NVPO identified four major 

goals: 

Goal 1: Strengthen the adult 

immunization infrastructure 

Goal 2: Improve access to adult vaccines 

Goal 3: Increase community demand for 

adult immunizations 

Goal 4: Foster innovation in adult 

vaccine development and vaccination 

related technologies 

Within each goal, the NAIP details 

measurable objectives and subobjectives. 

II. Request for Comment 

NVPO requests input on the draft 

report and draft recommendations. In 

addition to general comments on the 

draft NAIP, NVPO is seeking input on 

efforts or barriers to adult 

immunizations not represented in the 

report where HHS efforts could advance 

adult immunization efforts. Please limit 

your comments to six (6) pages. 

III. Potential Responders 

HHS invites input from a broad range 

of stakeholders including individuals 

and organizations that have interests in 

adult immunization efforts and the role 

of HHS in advancing those efforts. 

Examples of potential responders 

include, but are not limited to, the 

following: 

—general public; 

—advocacy groups, non-profit 

organizations, and public interest 

organizations; 

—academics, professional societies, and 

healthcare organizations; 

—public health officials and 

immunization program managers; 

—provider groups including all 

physician and non-physician 

providers that administer 

immunization services to adults, 

including pharmacists; and 

—representatives from the private 

sector. 

When responding, please self-identify 

with any of the above or other categories 

(include all that apply) and your name. 

Anonymous submissions will not be 

considered. Written submissions should 

not exceed six (6) pages. Please do not 

send proprietary, commercial, financial, 

business, confidential, trade secret, or 

personal information. 

Dated: January 27, 2015. 

Bruce Gellin, 

Deputy Assistant Secretary for Health, 

Director, National Vaccine Program Office, 

Executive Secretary, National Vaccine 

Advisory Committee. 

[FR Doc. 2015–02481 Filed 2–5–15; 8:45 am] 

BILLING CODE 4150–44–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–15–0964] 

Proposed Data Collections Submitted 

for Public Comment and 

Recommendations 

The Centers for Disease Control and 

Prevention (CDC), as part of its 

continuing effort 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. To request more 

information on the below proposed 

project or to obtain a copy of the 

information collection plan and 

instruments, call 404–639–7570 or send 

comments to Leroy A. Richardson, 1600 

Clifton Road, MS–D74, Atlanta, GA 

30333 or send an email to omb@cdc.gov. 

Comments submitted in response to 

this notice will be summarized and/or 

included in the request for Office of 

Management and Budget (OMB) 

approval. 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. Written comments should 

be received within 60 days of this 

notice. 

Proposed Project 

Interventions to Reduce Shoulder 

MSDs in Overhead Assembly (OMB No. 

0920–0964, expires 4/30/2015)— 

Extension—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 a three year extension 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices 6723 

for a study to assess the effectiveness 

and cost-benefit of occupational safety 

and health interventions to prevent 

musculoskeletal disorders (MSDs) 

among workers in the Manufacturing 

(MNF) sector. 

An extension is requested for this ICR 

because only one quarter of the 

necessary sample size was enrolled 

during the previous cycle. The eligible 

employee population will be expanded 

to include other Departments at the 

facility to achieve the necessary sample 

size. It is believed that the targeted 

number of interventions, which was not 

achieved in the previous year, can be 

achieved by expanding to additional 

Departments. 

Musculoskeletal disorders (MSDs) 

represent a major proportion of injury/ 

illness incidence and cost in the U.S. 

Manufacturing (MNF) sector. In 2008, 

29% of non-fatal injuries and illnesses 

involving days away from work (DAW) 

in the MNF sector involved MSDs and 

the MNF sector had some of the highest 

rates of MSD DAW cases. The rate for 

the motor vehicle manufacturing subsector (NAICS 3361) was among the 

highest of MNF sub sectors, with MSD 

DAW rates that were higher than the 

general manufacturing MSD DAW rates 

from 2003–2007. 

In automotive manufacturing, 

overhead conveyance of the vehicle 

chassis requires assembly line 

employees to use tools in working 

postures with the arms elevated. These 

postures are believed to be associated 

with symptoms of upper limb 

discomfort, fatigue, and impingement 

syndromes (Fischer et al., 2007). 

Overhead working posture, independent 

of the force or load exerted with the 

hands, may play a role in the 

development in these conditions. 

Recent studies suggest a more 

significant role of localized shoulder 

muscle fatigue in contributing to these 

disorders. Fatigue of the shoulder 

muscles may result in changes in 

normal shoulder kinematics (motion) 

that affect risk for shoulder 

impingement disorders (Ebaugh et. al., 

2006; Chopp et al., 2010). 

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 costefficient 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 grouprandomization (by work unit) will be 

used to assign the four groups to 

treatment and control conditions. 

Observations will be made over the 

10-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 monthly questionnaires, a 

shoulder-specific functional capacity 

evaluation test battery will be 

administered 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. The evidencebased prevention practices that may 

result from this associated research 

project will be disseminated to the 

greatest audience possible. 

NIOSH expects to complete data 

collection in 2015–2016 and there is no 

cost to employee respondents, as they 

will participate in this study during 

their normal working hours at their 

regular wage. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondents Form name Number of respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Employees ........ PAR–Q (Physical Activity Readiness) .............................. 125 1 2/60 4 

Shoulder Rating Questionnaire (SRQ) ............................. 125 10 4/60 83 

Disabilities of the Arm Shoulder and Hand (DASH) ........ 125 10 6/60 125 

Standardized Nordic Questionnaire for Musculoskeletal 

Symptoms.

125 10 4/60 83 

Work Organization Questionnaire .................................... 125 3 26/60 163 


asabaliauskas on DSK5VPTVN1PROD with NOTICES
6724 Federal Register / Vol. 80, No. 25 / Friday, February 6, 2015 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of 

respondents Form name Number of respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Total ........... ........................................................................................... ........................ ........................ ........................ 458 

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. 2015–02328 Filed 2–5–15; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–R–245] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including any of the 

following subjects: (1) The necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions; (2) the accuracy 

of the estimated burden; (3) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; and 

(4) the use of automated collection 

techniques or other forms of information 

technology to minimize the information 

collection burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by March 9, 2015. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 or Email: 

OIRA_submission@omb.eop.gov. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

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. The term ‘‘collection of 

information’’ is defined in 44 U.S.C. 

3502(3) and 5 CFR 1320.3(c) and 

includes agency requests or 

requirements that members of the public 

submit reports, keep records, or provide 

information to a third party. Section 

3506(c)(2)(A) of the PRA (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare and 

Medicaid Programs OASIS Collection 

Requirements as Part of the CoPs for 

HHAs and Supporting Regulations; Use: 

The Outcome and Assessment 

Information Set (OASIS) data set is 

currently mandated for use by Home 

Health Agencies (HHAs) as a condition 

of participation (CoP) in the Medicare 

program. Since 1999, the Medicare CoPs 

have mandated that HHAs use the 

OASIS data set when evaluating adult 

non-maternity patients receiving skilled 

services. The OASIS is a core standard 

assessment data set that agencies 

integrate into their own patient-specific, 

comprehensive assessment to identify 

each patient’s need for home care that 

meets the patient’s medical, nursing, 

rehabilitative, social, and discharge 

planning needs. 

The Office of Management and Budget 

(OMB) approved the OASIS–C1 

information collection request on 

February 6, 2014. We originally planned 

to use OASIS–C1 to coincide with the 

original implementation of ICD–10 on 

October 1, 2014. However, on April 1, 

2014, the Protecting Access to Medicare 

Act of 2014 (PAMA) (Pub. L. 113–93) 

was enacted. This legislation prohibits 

CMS from adopting ICD–10 coding prior 

to October 1, 2015. Because OASIS–C1 

is based on ICD–10 coding, it is not 

possible to implement OASIS–C1 prior 

to October 1, 2015, when ICD–10 is 

implemented. The passage of the PAMA 

Act left us with the dilemma of how to 

collect OASIS data in the interim, until 

ICD–10 is implemented. 

The OASIS–C1/ICD–9 version is an 

interim version of the OASIS–C1 data 

item set that was created in response to 

the legislatively mandated ICD–10 

delay. There are five items in OASIS–C1 

that require ICD–10 codes. In the 

OASIS–C1/ICD–9 version, these items 

have been replaced with the 

corresponding items from OASIS–C that 

use ICD–9 coding. The OASIS–C1/ICD– 

9 version also incorporates updated 

clinical concepts, modified item 

wording and response categories and 

improved item clarity. In addition, the 

OASIS–C1/ICD–9 version includes a 

significant decrease in provider burden 

that was accomplished by the deletion 

of a number of non-essential data items 

from the OASIS–C data item set. Form 

Number: CMS–R–245 (OMB control 

number: 0938–0760); Frequency: 

Occasionally; Affected Public: Private 

sector—business or other for-profit and 

not-for-profit institutions; Number of 

Respondents: 12,014; Total Annual 


asabaliauskas on DSK5VPTVN1PROD with NOTICES