Agency Forms Undergoing Paperwork Reduction Act Review, 47803-47804 [E9-22373]
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47803
Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Notices
Date: September 9, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–22374 Filed 9–16–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–09–09BH]
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 the CDC Reports Clearance
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
Assessing the Safety Culture of
Underground Coal Mining—New—
National Institute for Occupational
Safety and Health, (NIOSH), Centers for
Disease Control and Prevention, (CDC).
Background and Brief Description
NIOSH, under Public Law 91–596,
(Section 20–22, Occupational Safety and
Health Act of 1970) has the
responsibility to conduct research
relating to innovative methods,
techniques, and approaches dealing
with occupational safety and health
problems.
This research relates to occupational
safety and health problems in the coal
mining industry. In recent years, coal
mining safety has attained national
attention due to highly publicized
disasters. Despite these threats to
worker safety and health, the U.S. relies
on coal mining to meet its electricity
needs. For this reason, the coal mining
industry must continue to find ways to
protect its workers while maintaining
productivity. One way to do so is
through improving the safety culture at
coal mines. In order to achieve this
culture, operators, employees, the
inspectorate, etc. must share a
fundamental commitment to it as a
value. This type of culture is known in
other industries as a ‘‘safety culture.’’
Safety culture can be defined as the
characteristics of the work environment,
such as the norms, rules, and common
understandings that influence
employees’ perceptions of the
importance that the organization places
on safety.
NIOSH proposes an assessment of the
current safety culture of underground
coal mining in order to identify
recommendations for promoting and
ensuring the existence of a positive
safety culture across the industry. A
total of 6 underground coal mines will
be studied for this assessment in an
attempt to study mines of different
characteristics. It is hoped that a small,
a medium and a large unionized as well
as non-unionized mines will participate.
Data will be collected one time at each
mine; this is not a longitudinal study.
The assessment includes the collection
of data using several diagnostic tools: (a)
Functional analysis, (b) structured
interviews, (c) behavioral observations,
and (d) surveys.
It is estimated that across the 6 mines
approximately 900 respondents will be
surveyed. Similarly the number of
interviews will be based upon the
number of individuals in the mine
population. An exact number of
participants is unavailable at this time
because not all mine sites have been
selected.
The use of multiple methods to assess
safety culture is a key aspect to the
methodology. After all of the
information has been gathered, a variety
of statistical and qualitative analyses are
conducted on the data to obtain
conclusions with respect to the mine’s
safety culture. The results from these
analyses will be presented in a report
describing the status of the behaviors
important to safety culture at that mine.
This project will provide
recommendations for the enactment of
new safety practices or the enhancement
of existing safety practices across the
underground coal mining industry. This
final report will present a generalized
model of a positive safety culture for
underground coal mines that can be
applied at individual mines. In
addition, all study measures and
procedures will be available for mines
to use in the future to evaluate their
own safety cultures. There is no cost to
respondents other than their time. The
total estimated annualized burden hours
are 480.
ESTIMATED ANNUALIZED BURDEN HOURS
Phase
cprice-sewell on DSK2BSOYB1PROD with NOTICES
Year
Year
Year
Year
one Survey .............................................
one Interviews ........................................
two Survey .............................................
two Interviews ........................................
VerDate Nov<24>2008
14:35 Sep 16, 2009
Number of
respondents
Type of respondents
Jkt 217001
Mine
Mine
Mine
Mine
PO 00000
Employees
Employees
Employees
Employees
Frm 00027
.............................................
.............................................
.............................................
.............................................
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E:\FR\FM\17SEN1.SGM
500
100
400
80
17SEN1
Number of
responses per
respondent
1
1
1
1
Average
burden per
response
(in hours)
20/60
1
20/60
1
47804
Federal Register / Vol. 74, No. 179 / Thursday, September 17, 2009 / Notices
Date: September 9, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–22373 Filed 9–16–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–D–0408]
Draft Guidance for Industry on
Microbiological Data for Systemic
Antibacterial Drug Products—
Development, Analysis, and
Presentation; Availability
AGENCY:
Food and Drug Administration,
HHS.
cprice-sewell on DSK2BSOYB1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Microbiological Data
for Systemic Antibacterial Drug
Products—Development, Analysis, and
Presentation.’’ The draft guidance
informs industry of FDA’s current
thinking regarding the types of
microbiological studies, assessments,
and clinical trials needed to support an
investigational new drug application
(IND) and a new drug application (NDA)
for a systemic antibacterial drug
product. Recommendations in this
guidance cover microbiological
considerations in the three major areas
of conducting general nonclinical
studies; conducting animal and human
studies and clinical trials; and
establishing and updating in vitro
susceptibility test methods, quality
control (QC) parameters, and
interpretive criteria. This guidance also
recommends the content and format for
presentation of microbiological data for
antibacterial drug products in the
Microbiology subsection of labeling.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by December 16, 2009.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
VerDate Nov<24>2008
14:35 Sep 16, 2009
Jkt 217001
requests. Submit written comments on
the draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Fred
Marsik, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, rm. 6108, Silver Spring,
MD 20993–0002, 301–796–7956; or
Edward Cox, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 6212,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Microbiological Data for Systemic
Antibacterial Drug Products—
Development, Analysis, and
Presentation.’’ This guidance provides
recommendations on the type of
information to provide in submissions
to the clinical microbiology section of
INDs and NDAs for systemic
antibacterial drug products. The in vitro
microbiological data and in vivo animal
studies (e.g., spectrum of activity in
vitro and in appropriate animal models
of human disease) support the
justification of testing in humans.
Sponsors usually submit data from
nonclinical investigations to provide
proof of concept of clinical activity
before commencing human phase 2
studies and clinical trials and to aid in
the development of provisional
interpretive criteria for use in phase 3
clinical trials. Microbiological data
submitted to an NDA will be used to
substantiate the microbiological
information contained in the labeling.
Specific topics discussed in the
guidance include validating in vitro
susceptibility testing methods;
mechanism of action studies;
mechanism of resistance studies; use of
animal models; clinical trial protocols;
establishment of QC parameters and
interpretive criteria; submission and
placement of microbiology information
in the NDA submission; format and
content of the Microbiology subsection
of the labeling; and revision of existing
susceptibility testing methods, QC
parameters, or interpretive criteria.
This draft guidance is being issued
consistent with FDA’s good guidance
PO 00000
Frm 00028
Fmt 4703
Sfmt 4703
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the agency’s current thinking
on the microbiological data for systemic
antibacterial drug products. It does not
create or confer any rights for or on any
person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
II. The Paperwork Reduction Act of
1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520).
(1) The draft guidance provides
recommendations on the type of
information to include in submissions
of the clinical microbiology section of
INDs and NDAs for systemic
antibacterial drug products. The
microbiology section of an NDA is
required under 21 CFR 314.50(d)(4) and
this information collection is approved
under OMB Control Number 0910–0001.
For INDs, this information is required
under 21 CFR 312.23(a) and approved
under OMB Control Number 0910–0014.
(2) The draft guidance also
recommends the types of data that
should be submitted in a labeling
supplement to update the microbiology
information in approved labeling if an
application holder chooses to update
this information without relying on a
standard recognized by FDA. The
submission of labeling supplements is
required under 21 CFR 314.70(b)(2)(v)
and 201.56(a)(2) and this information
collection is approved under OMB
Control Numbers 0910–0001 and 0910–
0572, respectively.
(3) Appendix A of the draft guidance
describes the content of the
Microbiology subsection of labeling.
This labeling is covered under 21 CFR
201.57(c)(13)(i) and the information
collection is approved under OMB
Control Number 0910–0572.
(4) The draft guidance also references
the guidance for industry entitled
‘‘Updating Labeling for Susceptibility
Test Information in Systemic
Antibacterial Drug Products and
Antimicrobial Susceptibility Testing
Devices’’ for updating labeling
information. The information collection
in this guidance has been approved
under OMB Control Number 0910–0638.
E:\FR\FM\17SEN1.SGM
17SEN1
]]>Agencies
[Federal Register Volume 74, Number 179 (Thursday, September 17, 2009)]
[Notices]
[Pages 47803-47804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-22373]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-09-09BH]
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
the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail
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
Assessing the Safety Culture of Underground Coal Mining--New--
National Institute for Occupational Safety and Health, (NIOSH), Centers
for Disease Control and Prevention, (CDC).
Background and Brief Description
NIOSH, under Public Law 91-596, (Section 20-22, Occupational Safety
and Health Act of 1970) has the responsibility to conduct research
relating to innovative methods, techniques, and approaches dealing with
occupational safety and health problems.
This research relates to occupational safety and health problems in
the coal mining industry. In recent years, coal mining safety has
attained national attention due to highly publicized disasters. Despite
these threats to worker safety and health, the U.S. relies on coal
mining to meet its electricity needs. For this reason, the coal mining
industry must continue to find ways to protect its workers while
maintaining productivity. One way to do so is through improving the
safety culture at coal mines. In order to achieve this culture,
operators, employees, the inspectorate, etc. must share a fundamental
commitment to it as a value. This type of culture is known in other
industries as a ``safety culture.'' Safety culture can be defined as
the characteristics of the work environment, such as the norms, rules,
and common understandings that influence employees' perceptions of the
importance that the organization places on safety.
NIOSH proposes an assessment of the current safety culture of
underground coal mining in order to identify recommendations for
promoting and ensuring the existence of a positive safety culture
across the industry. A total of 6 underground coal mines will be
studied for this assessment in an attempt to study mines of different
characteristics. It is hoped that a small, a medium and a large
unionized as well as non-unionized mines will participate. Data will be
collected one time at each mine; this is not a longitudinal study. The
assessment includes the collection of data using several diagnostic
tools: (a) Functional analysis, (b) structured interviews, (c)
behavioral observations, and (d) surveys.
It is estimated that across the 6 mines approximately 900
respondents will be surveyed. Similarly the number of interviews will
be based upon the number of individuals in the mine population. An
exact number of participants is unavailable at this time because not
all mine sites have been selected.
The use of multiple methods to assess safety culture is a key
aspect to the methodology. After all of the information has been
gathered, a variety of statistical and qualitative analyses are
conducted on the data to obtain conclusions with respect to the mine's
safety culture. The results from these analyses will be presented in a
report describing the status of the behaviors important to safety
culture at that mine.
This project will provide recommendations for the enactment of new
safety practices or the enhancement of existing safety practices across
the underground coal mining industry. This final report will present a
generalized model of a positive safety culture for underground coal
mines that can be applied at individual mines. In addition, all study
measures and procedures will be available for mines to use in the
future to evaluate their own safety cultures. There is no cost to
respondents other than their time. The total estimated annualized
burden hours are 480.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per
Phase Type of respondents respondents responses per response (in
respondent hours)
----------------------------------------------------------------------------------------------------------------
Year one Survey....................... Mine Employees.......... 500 1 20/60
Year one Interviews................... Mine Employees.......... 100 1 1
Year two Survey....................... Mine Employees.......... 400 1 20/60
Year two Interviews................... Mine Employees.......... 80 1 1
----------------------------------------------------------------------------------------------------------------
[[Page 47804]]
Date: September 9, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E9-22373 Filed 9-16-09; 8:45 am]
BILLING CODE 4163-18-P
