Proposed Data Collections Submitted for Public Comment and Recommendations, 35870-35871 [E9-17266]
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35870
Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Notices
ESTIMATE OF ANNUALIZED BURDEN HOURS—Continued
Respondents
Number of
respondents
Form
List of Blood Isolates ......................................
Manual Categorization of Positive Blood Cultures.
Exposures to Blood/Body Fluids ....................
Healthcare Personnel Post-exposure Prophylaxis.
Healthcare Personnel Demographic Data .....
Healthcare Personnel Vaccination History ....
Annual Facility Survey ...................................
Healthcare Worker Survey .............................
Healthcare Personnel Influenza Vaccination
Form.
Healthcare Personnel Influenza Antiviral
Medication Administration Form.
Pre-season Survey on Influenza Vaccination
Programs for Healthcare Workers.
Post-Season Survey on Influenza Vaccination Programs for Healthcare Workers.
Central Line Insertion Practices Adherence
Monitoring Form (CLIP).
Laboratory Testing .........................................
MDRO Prevention Process and Outcome
Measures Monthly Monitoring Form.
MDRO or CDAD Infection Event Form ..........
Laboratory Identified MDRO or CDAD Event
Form (LabID).
Registration Form ...........................................
High Risk Inpatient Influenza Vaccine—Summary Form Method A.
High Risk Inpatient Influenza Vaccine—Numerator Data Form Method B.
High Risk Inpatient Influenza Vaccine—Summary Form Method B.
High Risk Inpatient Influenza Vaccine—Denominator Data Form Method B.
Hemovigilance Module Annual Survey ..........
Hemovigilance Module Monthly Reporting
Plan.
Hemovigilance Module Blood Product Incident Reporting—Summary Data.
Hemovigilance Module Monthly Reporting
Denominators.
Hemovigilance Incident ..................................
Hemovigilance Adverse Reaction ..................
Dated: July 13, 2009.
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–17263 Filed 7–20–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
[60 Day–09–09CD]
Centers for Disease Control and
Prevention
jlentini on DSKJ8SOYB1PROD with NOTICES
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.
Alternatively, to obtain a copy of the
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16:50 Jul 20, 2009
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Number of
responses per
respondent
Average
burden per
response (in
hours)
6,000
6,000
1
1
1
1
600
600
50
10
1
15/60
600
600
600
600
600
200
300
1
100
500
20/60
10/60
8
10/60
10/60
600
50
10/60
600
1
10/60
600
1
10/60
6,000
100
10/60
600
6,000
100
24
15/60
10/60
6,000
6,000
72
240
30/60
30/60
6,000
6,000
1
5
5/60
16
2,000
250
10/60
2,000
5
4
2,000
250
5/60
500
500
1
12
2
2/60
500
12
2
500
12
30/60
500
500
72
120
10/60
10/60
data collection plans and instrument,
call 404–639–5960 and send comments
to Maryam I. Daneshvar, CDC Reports
Clearance Officer, 1600 Clifton Road,
NE., MS–D74, Atlanta, Georgia 30333;
comments may also be sent by e-mail to
omb@cdc.gov.
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 a
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
E:\FR\FM\21JYN1.SGM
21JYN1
35871
Federal Register / Vol. 74, No. 138 / Tuesday, July 21, 2009 / Notices
use of information technology. Written
comments should be received within 60
days of this notice.
Proposed Project
Laboratory Medicine Best Practices
Project (LMBP)—New—National Center
for Preparedness, Detection, and Control
of Infectious Diseases (NCPDCID),
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 decision-making
have become standard in healthcare,
this has been limited in laboratory
medicine. No single-evidence-based
model for recommending practices in
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 methods development
and pilot tests to obtain, review, and
evaluate published and unpublished
evidence for practices associated with
the topics of patient specimen
identification, communicating critical
value test results, and blood culture
contamination. Exploratory work by
CDC supports the existence of relevant
unpublished studies or completed
quality improvement projects related to
laboratory medicine practices from
healthcare organizations. 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
(laboratory, hospital, clinic) 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 is no cost to
respondents other than their time.
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 CDC 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 evidence reviews using
published literature, and completed a
proof-of-concept test. Results of an
extensive search and review of
published literature using the methods
for the topic of patient specimen
identification indicated that an
insufficient quality and number of
studies were available for completing
systematic evidence reviews of
laboratory medicine practice
effectiveness for multiple practices, and
hence for making evidence-based
recommendations. These results were
considered likely to be generalizable to
most potential topic areas of interest.
A finding from Phase 1 work was that
laboratories would be unlikely to
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Number of
responses per
respondent
Average burden
(in hours)
Total burden
(in hours)
Healthcare Organizations ................................................................................
150
1
40/60
100
Total ..........................................................................................................
........................
........................
........................
100
Dated: July 15, 2009.
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E9–17266 Filed 7–20–09; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–F–0303]
jlentini on DSKJ8SOYB1PROD with NOTICES
BILLING CODE 4163–18–P
Ajinomoto Co., Inc.; Filing of Food
Additive Petition
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing
VerDate Nov<24>2008
16:50 Jul 20, 2009
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Sfmt 4703
that Ajinomoto Co., Inc., has filed a
petition proposing that the food additive
regulations be amended to provide for
the safe use of N-[N-[3-(3-hydroxy-4methoxyphenyl) propyl-a-aspartyl]-Lphenylalanine 1-methyl ester,
monohydrate (CAS Reg. No. 714229–
20–6) for use as a non-nutritive
sweetener in tabletop applications and
powdered beverage mixes. Ajinomoto
Co., Inc., also proposes that this additive
be identified as advantame.
DATES: Submit written or electronic
comments on the petitioner’s
E:\FR\FM\21JYN1.SGM
21JYN1
]]>Agencies
[Federal Register Volume 74, Number 138 (Tuesday, July 21, 2009)]
[Notices]
[Pages 35870-35871]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-17266]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-09-09CD]
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.
Alternatively, to obtain a copy of the data collection plans and
instrument, call 404-639-5960 and send comments to Maryam I. Daneshvar,
CDC Reports Clearance Officer, 1600 Clifton Road, NE., MS-D74, Atlanta,
Georgia 30333; comments may also be sent by e-mail to omb@cdc.gov.
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 a 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
[[Page 35871]]
use of information technology. Written comments should be received
within 60 days of this notice.
Proposed Project
Laboratory Medicine Best Practices Project (LMBP)--New--National
Center for Preparedness, Detection, and Control of Infectious Diseases
(NCPDCID), 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 pre- and post-analytic laboratory
medicine practices that are effective at improving health care quality.
While evidence-based approaches for decision-making 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 CDC 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 evidence reviews using published literature, and
completed a proof-of-concept test. Results of an extensive search and
review of published literature using the methods for the topic of
patient specimen identification indicated that an insufficient quality
and number of studies were available for completing systematic evidence
reviews of laboratory medicine practice effectiveness for multiple
practices, and hence for making evidence-based recommendations. These
results were considered likely to be generalizable to most potential
topic areas 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
methods development and pilot tests to obtain, review, and evaluate
published and unpublished evidence for practices associated with the
topics of patient specimen identification, communicating critical value
test results, and blood culture contamination. Exploratory work by CDC
supports the existence of relevant unpublished studies or completed
quality improvement projects related to laboratory medicine practices
from healthcare organizations. 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 (laboratory, hospital,
clinic) 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 is no cost to respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of
Respondents Number of responses per Average burden Total burden
respondents respondent (in hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Healthcare Organizations........................ 150 1 40/60 100
---------------------------------------------------------------
Total....................................... .............. .............. .............. 100
----------------------------------------------------------------------------------------------------------------
Dated: July 15, 2009.
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E9-17266 Filed 7-20-09; 8:45 am]
BILLING CODE 4163-18-P
