Agency Forms Undergoing Paperwork Reduction Act Review, 9699-9701 [2013-03005]
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9699
Federal Register / Vol. 78, No. 28 / Monday, February 11, 2013 / Notices
Dated: February 5, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director, Centers for
Disease Control and Prevention.
Background and Brief Description
[FR Doc. 2013–02984 Filed 2–8–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–13–12PZ]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
Proposed Project
Proficiency Testing in US Clinical
Laboratories: Perception, Practices and
Potential for Expanded Utility—NEW—
The Office of Surveillance,
Epidemiology and Laboratory Services
(OSELS), Centers for Disease Control
and Prevention (CDC).
The primary focus of this project is to
conduct a systematic analysis in order
to understand which types of
laboratories follow Proficiency Testing
(PT) and Good Laboratory Practices
(GLPs), to identify ways that PT and
GLPs could be better promoted, and to
identify populations that would benefit
from receiving information on PT GLPs.
The Association of Public Health
Laboratories (APHL) and Centers for
Disease Control and Prevention (CDC)
hope to learn more about the perceived
benefits and burden of performing PT.
This information may be helpful to the
CDC as the Clinical Laboratory
Improvement Amendments (CLIA)
regulations for PT are revised. Our
survey population frame is 20,500
Certificate of Compliance laboratories
and 16,800 Certificate of Accreditation
laboratories. All of these laboratories are
required to perform PT in accordance
with CLIA. Many of these laboratories
also use their PT results internally to
further improve laboratory quality at no
additional cost.
The first phase of this project was
conducted by the APHL through focus
group research in 2011. The research
explored how clinical and public health
laboratories perceived commercial PT
programs and explored the ways in
which the laboratories used PT to assure
and improve the quality of their testing.
This second phase of the project will be
administration of a survey to build on
the preliminary findings from the focus
group research and help identify the
types of laboratories that would benefit
from learning about additional uses for
PT. This information will be helpful to
disseminate PT and GLPs to laboratories
in a strategic and targeted way based on
findings from this survey.
The goal is to achieve an 80%
response rate (29,840 out of 37,300
laboratories). APHL and CDC will strive
to ensure a high response rate by
promoting the survey through
advertisements in laboratory trade
publications, at professional meetings,
and possibly through programs and
laboratory accreditation organizations.
The cohort of laboratories surveyed
will be all Certificate of Compliance and
Certificate of Accreditation laboratories
listed in the Centers for Medicare and
Medicaid Services (CMS) Online
Survey, Certification and Reporting
(OSCAR) database. The OSCAR
database contains demographic
information and relevant characteristics
including laboratory specialty and
laboratory type for each laboratory.
The survey will be administered
through a web-based survey system,
specifically Survey Monkey. APHL will
send each laboratory a postmarked letter
explaining the survey and provide them
with a link to log in to the survey with
a unique identifier on their address
label. Two weeks afterwards, APHL will
follow-up with a postcard reminder
which will also include that unique
identifier.
There are no costs to respondents
other than their time.
The annualized estimated burden is
9,947 hours.
Estimated Annualized Burden Hours:
Type of respondent
Form name
Number of
respondents
Number of
responses
per
respondent
Average
burden per
response
(in hrs)
Laboratorians ..................................................
Laboratory Practices ......................................
29,840
1
20/60
Dated: February 5, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2013–02988 Filed 2–8–13; 8:45 am]
Centers for Disease Control and
Prevention
[30Day–13–12PE]
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
Budget (OMB) in compliance with the
Paperwork Reduction Act (44 U.S.C.
Chapter 35). To request a copy of these
requests, call (404) 639–7570 or send an
VerDate Mar<15>2010
14:26 Feb 08, 2013
Jkt 229001
email to omb@cdc.gov. Send written
comments to CDC Desk Officer, Office of
Management and Budget, Washington,
DC or by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
Proposed Project
Agency Forms Undergoing Paperwork
Reduction Act Review
BILLING CODE 4163–18–P
erowe on DSK2VPTVN1PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Interventions to Reduce Shoulder
MSDs in Overhead Assembly—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
E:\FR\FM\11FEN1.SGM
11FEN1
9700
Federal Register / Vol. 78, No. 28 / Monday, February 11, 2013 / Notices
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 among
workers in the Manufacturing sector.
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.
However, 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 group-randomization
(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 questionnaires a shoulder-specific
functional capacity evaluation test
battery will be administered at 90 and
210 days, immediately pre- and postintervention, 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 will
disseminate the results of evidencebased prevention practices to the
greatest audience possible. NIOSH
expects to complete data collection in
2014. There are no costs to respondents
other than their time. The total
estimated annual burden hours are 472.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Employees ..............................
erowe on DSK2VPTVN1PROD with NOTICES
Type of respondent
Informed Consent Form ..........................................................
Consent of Photographic Image Release ...............................
PAR–Q (Physical Activity Readiness) ....................................
Shoulder Rating Questionnaire (SRQ) ...................................
Disabilities of the Arm Shoulder and Hand (DASH) ...............
Standardized Nordic Questionnaire for Musculoskeletal
Symptoms Instrument.
Work Org Questionnaire .........................................................
VerDate Mar<15>2010
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E:\FR\FM\11FEN1.SGM
Number of
responses
per
respondent
Average
burden per
response
(in hours)
125
125
125
125
125
125
1
1
1
10
10
10
5/60
2/60
2/60
4/60
6/60
4/60
125
3
26/60
11FEN1
Federal Register / Vol. 78, No. 28 / Monday, February 11, 2013 / Notices
Dated: February 5, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI),
Office of the Associate Director for Science
(OADS), Office of the Director, Centers for
Disease Control and Prevention.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2013–03005 Filed 2–8–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–1182]
Draft Joint Food and Drug
Administration/Health Canada
Quantitative Assessment of the Risk of
Listeriosis From Soft-Ripened Cheese
Consumption in the United States and
Canada
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a draft
‘‘Joint Food and Drug Administration/
´
Health Canada—Sante Canada
Quantitative Assessment of the Risk of
Listeriosis From Soft-Ripened Cheese
Consumption in the United States and
Canada.’’ This draft Quantitative Risk
Assessment (the draft QRA) includes an
Interpretative Summary, a Technical
Report, with Appendixes, and a risk
assessment model. The purpose of the
draft QRA is to evaluate the effect of
factors such as the microbiological
status of milk, the impact of cheese
manufacturing steps, and conditions
during distribution and storage on the
overall risk of invasive listeriosis to the
consumer in the United States or
Canada of soft-ripened cheese. The draft
QRA makes it possible to evaluate the
effectiveness of some process changes
and intervention strategies in reducing
the risk of listeriosis. We are making the
draft QRA available for public comment.
DATES: Submit either electronic or
written comments on the draft QRA by
April 29, 2013.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
comments to Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Sherri Dennis, Center for Food Safety
and Applied Nutrition (HFS–005), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
240–402–1914.
erowe on DSK2VPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
14:26 Feb 08, 2013
Jkt 229001
I. Background
Listeria monocytogenes (L.
monocytogenes) is a widely occurring
pathogen that can be found in
agricultural and food processing
environments. Ingestion of L.
monocytogenes can lead to the
development of listeriosis, with
consequences that may include
septicemia, meningitis, encephalitis,
spontaneous abortion, and stillbirth.
Epidemiological data show that
listeriosis has one of the highest
hospitalization rates and one of the
highest case fatality rates among
foodborne diseases in the United States
(Ref. 1). Serious illness may occur in
people considered to be more
susceptible, such as the elderly,
individuals who have a preexisting
illness that reduces the effectiveness of
their immune system, and pregnant
women (Ref. 2).
The United States and Canada have
experienced sporadic illnesses and
outbreaks of listeriosis associated with
the consumption of soft cheese. Both
´
FDA and Health Canada—Sante Canada
continue to evaluate the safety of soft
cheese, particularly soft cheese made
from unpasteurized milk.
II. Quantitative Risk Assessment
The draft QRA (Refs. 3 to 6) provides
a science-based analytical approach to
collate and incorporate available data
into a mathematical model. It provides
risk managers with a decision-support
tool to evaluate the effectiveness of
current and future interventions to
reduce or prevent listeriosis from
consumption of soft-ripened cheeses.
The draft QRA also may be used to
target risk communication messages,
identify and prioritize research needs,
and provide a framework for
coordinating efforts with stakeholders.
The draft QRA has undergone an
independent external peer review
consistent with the requirements in the
Office of Management and Budget’s
‘‘Final Information Quality Bulletin for
Peer Review.’’ FDA’s response to the
peer-review is available electronically
on the FDA Web site (Ref. 7).
The draft QRA focuses on the sources
of L. monocytogenes contamination, the
effects of individual manufacturing and/
or processing steps, and the
effectiveness of various intervention
strategies on the levels of L.
monocytogenes in the product as
consumed and the associated risk of
invasive listeriosis. The draft QRA’s
scope is:
• Pathogen of concern: L.
monocytogenes;
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9701
• Food(s) of concern: Camembert, as
an example of soft-ripened cheese;
• Populations of interest: The general
populations of the United States and
Canada, and subpopulations identified
as at-risk in both countries (i.e.,
pregnant women, immunocompromised
individuals, and the elderly
population);
• Endpoint of concern: Invasive
listeriosis; and
• Risk metric: The probability of
invasive listeriosis per soft-ripened
cheese serving.
The draft QRA uses a quantitative
approach, using mathematical and
probabilistic modeling, to estimate the
risk per serving of soft-ripened cheese
(using Camembert cheese as an
example) in both countries. The draft
QRA tests the effects of some
alternatives on those risks. The draft
QRA uses data from the literature, from
government nutrition surveys, from a
specific survey on home storage time
and temperature practices, and from
specific expert elicitations. FDA invites
comments that can help FDA and
´
Health Canada—Sante Canada improve:
• The approach used;
• The assumptions made;
• The modeling techniques;
• The data used; and
• The clarity and the transparency of
the draft QRA documentation.
When finalized, FDA intends to use
this risk assessment (which is limited to
one pathogen in one type of cheese),
along with other information and
scientific assessments that more
comprehensively consider the different
pathogens that can be present in all
types of cheeses made from raw milk, in
its reevaluation of the existing 60-day
aging requirements for cheeses made
with raw milk (e.g., 21 CFR 133.182(a)).
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
The draft QRA is available
electronically on the FDA Web site
https://www.fda.gov/food/
scienceresearch/researchareas/
E:\FR\FM\11FEN1.SGM
11FEN1
]]>Agencies
[Federal Register Volume 78, Number 28 (Monday, February 11, 2013)]
[Notices]
[Pages 9699-9701]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03005]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-13-12PE]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) publishes a
list of information collection requests under review by the Office of
Management and Budget (OMB) in compliance with the Paperwork Reduction
Act (44 U.S.C. Chapter 35). To request a copy of these requests, call
(404) 639-7570 or send an email to omb@cdc.gov. Send written comments
to CDC Desk Officer, Office of Management and Budget, Washington, DC or
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--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
[[Page 9700]]
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 among workers in the Manufacturing
sector.
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 sub-sector (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. However, 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 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 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 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 will disseminate the results of evidence-based prevention
practices to the greatest audience possible. NIOSH expects to complete
data collection in 2014. There are no costs to respondents other than
their time. The total estimated annual burden hours are 472.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Employees............................. Informed Consent Form... 125 1 5/60
Consent of Photographic 125 1 2/60
Image Release.
PAR-Q (Physical Activity 125 1 2/60
Readiness).
Shoulder Rating 125 10 4/60
Questionnaire (SRQ).
Disabilities of the Arm 125 10 6/60
Shoulder and Hand
(DASH).
Standardized Nordic 125 10 4/60
Questionnaire for
Musculoskeletal
Symptoms Instrument.
Work Org Questionnaire.. 125 3 26/60
----------------------------------------------------------------------------------------------------------------
[[Page 9701]]
Dated: February 5, 2013.
Ron A. Otten,
Director, Office of Scientific Integrity (OSI), Office of the Associate
Director for Science (OADS), Office of the Director, Centers for
Disease Control and Prevention.
[FR Doc. 2013-03005 Filed 2-8-13; 8:45 am]
BILLING CODE 4163-18-P
