Proposed Data Collections Submitted for Public Comment and Recommendations, 12754-12756 [2010-5841]
Download as PDF
<![CDATA[
12754
Federal Register / Vol. 75, No. 51 / Wednesday, March 17, 2010 / Notices
Officer at (404) 639–5960 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
Laboratory Medicine Best Practices
Project (LMBP)—New—National Center
for Emerging and Zoonotic Infectious
Diseases (NCEZID) (proposed), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
CDC is seeking approval from the
Office of Management and Budget
(OMB) to collect information from
healthcare organizations in order to
conduct a systemic review of laboratory
practice effectiveness. The purpose of
information collection is to include
completed unpublished quality
improvement studies/assessments
carried out by healthcare organizations
(laboratories, hospitals, clinics) in
systematic reviews of practice
effectiveness. CDC has been sponsoring
the Laboratory Medicine Best Practices
(LMBP) initiative to develop new
systematic evidence reviews methods
for making evidence-based
recommendations in laboratory
medicine. This initiative supports the
CDC’s mission of improving laboratory
practices.
The focus of the Initiative is on preand post-analytic laboratory medicine
practices that are effective at improving
health care quality. While evidencebased approaches for decisionmaking
have become standard in healthcare,
this has been limited in laboratory
medicine. No single-evidence-based
model for recommending practices in
laboratory medicine exists, although the
number of laboratories operating in the
United States and the volume of
laboratory tests available certainly
warrant such a model.
The Laboratory Medicine Best
Practices Initiative began in October
2006, when Division of Laboratory
Systems (DLS) convened the Laboratory
Medicine Best Practices Workgroup
(Workgroup), a multidisciplinary panel
of experts in several fields including
laboratory medicine, clinical medicine,
health services research, and health care
performance measurement. The
Workgroup has been supported by staff
at CDC and the Battelle Memorial
Institute under contract to CDC.
To date, the Laboratory Medicine Best
Practices (LMBP) project work has been
completed over three phases. During
Phase 1 (October 2006–September 2007)
of the project, CDC staff developed
systematic review methods for
conducting paper reviews related to the
effectiveness of laboratory medicine
practices. Results of a review of
practices that reduce patient specimen
identification indicated that an
insufficient quality and number of
published studies were available for
completing systematic evidence reviews
of laboratory medicine practice
effectiveness for multiple practices.
These results were considered likely to
be generalizable to most potential
review topics of interest. A finding from
Phase 1 work was that laboratories
would be unlikely to publish quality
improvement projects or studies
demonstrating practice effectiveness in
the peer reviewed literature, but that
they routinely conducted quality
improvement projects and had relevant
data for completion of evidence reviews.
Phase 2 (September 2007–November
2008) and Phase 3 (December 2008–
September 2009), involved further
development of methods to obtain and
critically appraise published and
unpublished data. A pilot test of a
standardized data collection form with
less than nine potential laboratory
respondents supported the Phase 1
finding that data from completed
laboratory medicine quality
improvement projects could supplement
published evidence in systematic
reviews. The objective for successive
LMBP evidence reviews of practice
effectiveness is to supplement the
published evidence with unpublished
evidence to fill in gaps in the literature.
Healthcare organizations and facilities
(laboratories, hospitals, clinics) will
have the opportunity to voluntarily
enroll in an LMBP network and submit
readily available unpublished studies;
quality improvement projects,
evaluations, assessments, and other
analyses relying on unlinked,
anonymous data using the LMBP
Submission Form. LMBP Network
participants will also be able to submit
unpublished studies/data for evidence
reviews on an annual basis using this
form. There will be no charge to
respondents for their participation,
other than their time. The total
estimated annualized burden hours for
this information collection request are
138 hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Respondents
Number of
respondents
Number of responses per
respondent
Average
burden per
response
(in hours)
Healthcare Organizations ............................................................................................................
150
1
55/60
Date: March 11, 2010.
Maryam I. Daneschvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
[FR Doc. 2010–5843 Filed 3–16–10; 8:45 am]
Centers for Disease Control and
Prevention
BILLING CODE 4163–18–P
[60-Day–10–10CB]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for
opportunity for public comment on
VerDate Nov<24>2008
15:08 Mar 16, 2010
Jkt 220001
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
proposed data collection projects, the
Centers for Disease Control and
Prevention (CDC) will publish periodic
summaries of proposed projects. To
request more information on the
proposed projects or to obtain a copy of
the data collection plans and
instruments, call 404–639–5960 and
send comments to Maryam I. Daneshvar,
CDC Acting Reports Clearance Officer,
1600 Clifton Road, MS–D74, Atlanta,
GA 30333 or send an e-mail to
omb@cdc.gov.
Comments are invited on: (a) Whether
the proposed collection of information
E:\FR\FM\17MRN1.SGM
17MRN1
12755
Federal Register / Vol. 75, No. 51 / Wednesday, March 17, 2010 / Notices
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; and (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. Written comments should
be received within 60 days of this
notice.
Proposed Project
A Survey to Evaluate Occupational
Safety and Health Educational Materials
for Home Care Workers—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 will conduct a survey of home
care workers to evaluate newly
developed educational intervention
materials.
Home care workers who provide
housekeeping and routine personal care
services to elderly, disabled or ill
individuals in their homes, constitute
one of the fastest growing occupational
groups, estimated at about 1,500,000
workers. In 1997, the U.S. Bureau of
Labor Statistics issued a special report
on work-related injuries to home care
workers showing an injury rate which
was 50% higher than that of workers
employed in the private hospital sector
and 70% higher than the overall rate for
all private industry workers.
NIOSH has developed educational
intervention materials for home care
workers to prevent exposure to workrelated hazards. The intervention
materials consist of a printed handbook
and a training session that explains how
to use the handbook. The primary goal
of the handbook and training session is
to help home care workers and their
clients identify hazards, discuss these
hazards and identify accessible and low
cost tips and tools for minimizing
exposures to hazards. These materials
have been developed and piloted in
Alameda County, California. The goal of
this data collection is to evaluate these
materials before disseminating them
more broadly.
The study population for this survey
includes current home care workers and
their clients who are enrolled in the InHome Supportive Services (IHSS)
Program in Alameda County, California.
NIOSH has obtained input on the
content and operational aspects of the
survey through local stakeholder
meetings. The survey instrument has
been reviewed by subject matter experts
and cognitive interviews have been
conducted using the survey instrument.
Input received was used to guide
development of the survey instrument
and plans for survey implementation.
All Alameda County IHSS home care
workers will be invited to participate.
Volunteers will complete a brief interest
response form which will be returned to
the study contractor and the first 320
eligible volunteers will be randomized
into either an intervention or a control
group. The primary client for each home
care worker participant will also be
invited to participate but the clients’
willingness to participate will not affect
whether a home care workers can
remain as a study participant. Both the
home care worker and their primary
client will complete two telephone
surveys with a two month interval
between the two surveys. Data from the
telephone survey will be captured
directly into an electronic database. For
the intervention group the home care
workers will receive the intervention
materials and training during the
interval between the two surveys. The
control group will receive their
intervention materials and training after
the completion of the second survey.
Each telephone survey will last
approximately 30 minutes for home care
workers and 15 minutes for clients.
Because of the demographics of the
population intervention materials as
well as the evaluation surveys are in
three languages: English, Spanish and
Chinese.
Information will be collected on
demographic variables including age,
sex, race, education, income, primary
language, and marital status.
Information will be collected on the
number of years a worker has been
employed as a home care worker and
the number of years a client has
received home care services.
Information will also be collected on
working conditions and occupational
exposures, work related injuries,
knowledge of work-related health risks
and workers’ perception of the ease of
controlling hazards. Finally,
information will be collected from
workers on their job satisfaction and
clients on their satisfaction with
caregiver services, on the quality of the
caregiver and client relationships, and
specific questions regarding use of the
intervention materials.
The purpose of this information
collection is to evaluate whether or not
the educational materials (the Home
Care Worker Handbook and training
session) are effective in (1) conveying
the intended message and (2)
encouraging home care workers and
their clients to make changes to reduce
hazards. Without benefit of the
evaluation, CDC will be unable to
determine the effectiveness of the
materials or formulate recommendations
on their appropriate use and broader
dissemination.
Once the study is completed, results
will be made available via various
means including the NIOSH internet
site. NIOSH expects to complete data
collection no later than winter of 2011.
There is no cost to respondents other
than their time.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Home care workers ....
Worker interest response form ...............
Worker survey (pre) ................................
Worker Training program ........................
Worker survey (post) ..............................
Client survey (pre) ..................................
Client survey (post) .................................
Home care clients ......
VerDate Nov<24>2008
15:08 Mar 16, 2010
Jkt 220001
PO 00000
Number of responses per respondent
Number of
respondents
Type of respondent
Frm 00033
Fmt 4703
1500
320
320
320
320
320
Sfmt 4703
E:\FR\FM\17MRN1.SGM
Average burden
per response
(in hours)
1
1
1
1
1
1
2/60
30/60
1
30/60
15/60
15/60
17MRN1
Total burden
(in hours)
50
160
320
160
80
80
12756
Federal Register / Vol. 75, No. 51 / Wednesday, March 17, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondent
Form name
Number of
respondents
Number of responses per respondent
Average burden
per response
(in hours)
Total ............................
.................................................................
............................
............................
............................
Dated: March 11, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 2010–5841 Filed 3–16–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0110]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Prescription Drug
Advertisements
AGENCY:
Food and Drug Administration,
HHS.
wwoods2 on DSK1DXX6B1PROD with NOTICES_PART 1
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the reporting requirements, including
third party disclosure, contained in
FDA’s regulations on prescription drug
advertisements.
DATES: Submit written or electronic
comments on the collection of
information by May 17, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane., rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
VerDate Nov<24>2008
15:08 Mar 16, 2010
Jkt 220001
796–3792, e-mail:
Elizabeth.Berbakos@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
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.
‘‘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 provide a 60-day notice in the
Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Prescription Drug Advertisements—21
CFR 202.1 (OMB Control Number
0910)—New
Section 502(n) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
352(n)) (the act) requires that
manufacturers, packers, and distributors
(sponsors) who advertise prescription
human and animal drugs, including
biological products for humans, disclose
in advertisements certain information
about the advertised product’s uses and
risks. For prescription drugs and
biologics, section 502(n) of the act
requires advertisements to contain ‘‘a
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
Total burden
(in hours)
850
true statement’’ of certain information
including ‘‘information in brief
summary relating to side effects,
contraindications, and effectiveness’’ as
required by regulations issued by FDA.
FDA’s prescription drug advertising
regulations at § 202.1 (21 CFR 202.1)
describe requirements and standards for
print and broadcast advertisements.
Section 202.1 applies to advertisements
published in journals, magazines, other
periodicals, and newspapers, and
advertisements broadcast through media
such as radio, television, and telephone
communication systems. Print
advertisements must include a brief
summary of each of the risk concepts
from the product’s approved package
labeling (§ 202.1(e)(1)). Advertisements
that are broadcast through media such
as television, radio, or telephone
communications systems must disclose
the major risks from the product’s
package labeling in either the audio or
audio and visual parts of the
presentation (§ 202.1(e)(1)); this
disclosure is known as the ‘‘major
statement.’’ If a broadcast advertisement
omits the major statement, or if the
major statement minimizes the risks
associated with the use of the drug, the
advertisement could render the drug
misbranded in violation of the act (21
U.S.C. 352(n) and 321(n)), and FDA’s
implementing regulations at § 202.1(e).
Advertisements subject to the
requirements at § 202.1 are subject to
the PRA because these advertisements
disclose information to the public. In
addition, § 202.1(e)(6) and (j) include
provisions that are subject to OMB
approval under the PRA. The
information collection requirements in
§ 202.1 have not previously been
submitted to OMB for approval. With
this notice, we are seeking comment on
the proposed information collection.
Reporting to FDA
Section 202.1(e)(6) includes a
provision that is subject to the PRA.
Section 202.1(e)(6) permits a person
who would be adversely affected by the
enforcement of a provision of
§ 202.1(e)(6) to request a waiver from
FDA for that provision. The waiver
request must set forth clearly and
concisely the petitioner’s interest in the
advertisement, the specific provision of
§ 202.1(e)(6) from which a waiver is
sought, a complete copy of the
E:\FR\FM\17MRN1.SGM
17MRN1
]]>Agencies
[Federal Register Volume 75, Number 51 (Wednesday, March 17, 2010)]
[Notices]
[Pages 12754-12756]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-5841]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60-Day-10-10CB]
Proposed Data Collections Submitted for Public Comment and
Recommendations
In compliance with the requirement of section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995 for opportunity for public comment on
proposed data collection projects, the Centers for Disease Control and
Prevention (CDC) will publish periodic summaries of proposed projects.
To request more information on the proposed projects or to obtain a
copy of the data collection plans and instruments, call 404-639-5960
and send comments to Maryam I. Daneshvar, CDC Acting Reports Clearance
Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail
to omb@cdc.gov.
Comments are invited on: (a) Whether the proposed collection of
information
[[Page 12755]]
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; and (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. Written comments should be received
within 60 days of this notice.
Proposed Project
A Survey to Evaluate Occupational Safety and Health Educational
Materials for Home Care Workers--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 will conduct a survey of
home care workers to evaluate newly developed educational intervention
materials.
Home care workers who provide housekeeping and routine personal
care services to elderly, disabled or ill individuals in their homes,
constitute one of the fastest growing occupational groups, estimated at
about 1,500,000 workers. In 1997, the U.S. Bureau of Labor Statistics
issued a special report on work-related injuries to home care workers
showing an injury rate which was 50% higher than that of workers
employed in the private hospital sector and 70% higher than the overall
rate for all private industry workers.
NIOSH has developed educational intervention materials for home
care workers to prevent exposure to work-related hazards. The
intervention materials consist of a printed handbook and a training
session that explains how to use the handbook. The primary goal of the
handbook and training session is to help home care workers and their
clients identify hazards, discuss these hazards and identify accessible
and low cost tips and tools for minimizing exposures to hazards. These
materials have been developed and piloted in Alameda County,
California. The goal of this data collection is to evaluate these
materials before disseminating them more broadly.
The study population for this survey includes current home care
workers and their clients who are enrolled in the In-Home Supportive
Services (IHSS) Program in Alameda County, California.
NIOSH has obtained input on the content and operational aspects of
the survey through local stakeholder meetings. The survey instrument
has been reviewed by subject matter experts and cognitive interviews
have been conducted using the survey instrument. Input received was
used to guide development of the survey instrument and plans for survey
implementation.
All Alameda County IHSS home care workers will be invited to
participate. Volunteers will complete a brief interest response form
which will be returned to the study contractor and the first 320
eligible volunteers will be randomized into either an intervention or a
control group. The primary client for each home care worker participant
will also be invited to participate but the clients' willingness to
participate will not affect whether a home care workers can remain as a
study participant. Both the home care worker and their primary client
will complete two telephone surveys with a two month interval between
the two surveys. Data from the telephone survey will be captured
directly into an electronic database. For the intervention group the
home care workers will receive the intervention materials and training
during the interval between the two surveys. The control group will
receive their intervention materials and training after the completion
of the second survey. Each telephone survey will last approximately 30
minutes for home care workers and 15 minutes for clients. Because of
the demographics of the population intervention materials as well as
the evaluation surveys are in three languages: English, Spanish and
Chinese.
Information will be collected on demographic variables including
age, sex, race, education, income, primary language, and marital
status. Information will be collected on the number of years a worker
has been employed as a home care worker and the number of years a
client has received home care services. Information will also be
collected on working conditions and occupational exposures, work
related injuries, knowledge of work-related health risks and workers'
perception of the ease of controlling hazards. Finally, information
will be collected from workers on their job satisfaction and clients on
their satisfaction with caregiver services, on the quality of the
caregiver and client relationships, and specific questions regarding
use of the intervention materials.
The purpose of this information collection is to evaluate whether
or not the educational materials (the Home Care Worker Handbook and
training session) are effective in (1) conveying the intended message
and (2) encouraging home care workers and their clients to make changes
to reduce hazards. Without benefit of the evaluation, CDC will be
unable to determine the effectiveness of the materials or formulate
recommendations on their appropriate use and broader dissemination.
Once the study is completed, results will be made available via
various means including the NIOSH internet site. NIOSH expects to
complete data collection no later than winter of 2011. There is no cost
to respondents other than their time.
Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Form name Number of responses per per response (in Total burden (in
respondents respondent hours) hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Home care workers............................. Worker interest response form... 1500 1 2/60 50
Worker survey (pre)............. 320 1 30/60 160
Worker Training program......... 320 1 1 320
Worker survey (post)............ 320 1 30/60 160
Home care clients............................. Client survey (pre)............. 320 1 15/60 80
Client survey (post)............ 320 1 15/60 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
[[Page 12756]]
Total......................................... ................................ ................ ................ ................ 850
--------------------------------------------------------------------------------------------------------------------------------------------------------
Dated: March 11, 2010.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 2010-5841 Filed 3-16-10; 8:45 am]
BILLING CODE 4163-18-P
