Proposed Data Collections Submitted for Public Comment and Recommendations, 49927-49928 [05-16895]
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49927
Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Notices
• Which audiences (e.g., doctors,
local health officials, researchers, etc.)
receive their information from which
CDC platforms?
• How often and with what purpose
do they access CDC platforms?
• How satisfied are subscribers of the
platforms with the content and delivery
of information?
• Are there ways to enhance the
platforms for the subscriber through
improvements to current offerings or
through new products / services?
• Who are our most critical target
audiences, i.e., what are our publication
and dissemination priorities in service
to our health impact goals?
The purpose of this project is to
evaluate the content, processes, and
channels through which CDC
communicates scientific information to
partners and customers to ensure that
health impact is maximized through the
delivery of timely, effective, and
credible information, which will result
in optimal benefit for public health. The
evaluation will help to ensure that these
platforms meet subscriber and partner
priorities, build CDC’s brand, and
contribute to health impact goals.
Feedback from the subscriber base is
necessary to fully evaluate the
performance of CDC’s platforms.
At this time, the scope of this project
is limited to five communication
platforms owned and managed by CDC
which transmits information primarily
intended for scientific and professional
audiences. However, future plans
include adding additional publications
as needed. The initial five
communications platforms are:
Emerging Infections Journal, MMWR,
Epi-X, Preventing Chronic Diseases
Journal, and Health Alert Network. We
want to ensure that the timeliness,
effectiveness, and credibility of this
communication maximizes the health
impact of that information, resulting in
optimum benefit for public health.
These channels include both print and
electronic versions of the five platforms.
There is no cost to respondents other
than their time. The total estimated
burden hours are 18,970.
ESTIMATES OF ANNUALIZED BURDEN HOURS
Form
Respondents
MMWR .........................................................................................................................................
EID ...............................................................................................................................................
PCD .............................................................................................................................................
Epi-X ............................................................................................................................................
HAN .............................................................................................................................................
Dated: August 18, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 05–16894 Filed 8–24–05; 8:45 am]
BILLING CODE 4163–18–P
Centers for Disease Control and
Prevention
[30Day–05–05AF]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
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) 371–5983 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) 395–6974. Written
comments should be received within 30
days of this notice.
15:58 Aug 24, 2005
Jkt 205001
How Miners Modify Their Behavior In
Response To Personal Dust Monitor
Information—New—National Institute
for Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate jul<14>2003
Proposed Project
The Federal Mine Safety & Health Act
of 1977, Section 501, and the
Occupational Safety and Health Act of
1970, Public Law 91–256 enables CDC/
NIOSH to carry out research relevant to
the health and safety of workers in the
mining industry. The objective of this
project is to document how coal miners
can use real-time information from their
personal dust monitors (PDM) to reduce
their exposure to respirable dust. The
specific aims are to (1) identify several
specific examples of how miners use
PDM information to discover which
parts of their jobs and/or which aspects
of their work environment may be
causing them to be overexposed to
respirable dust, and (2) identify the
types of changes that miners could make
in order to try to reduce their exposure.
Although the most recent data on the
prevalence of Coal Workers’
Pneumoconiosis (CWP) in the United
States indicates that it is declining,
substantial numbers of CWP cases
continue to be diagnosed. In recent
years, CWP has contributed to the
PO 00000
Frm 00025
Fmt 4703
Sfmt 4703
30,000
12,750
10,500
1,650
2,000
Responses
per
respondent
Hrs/response
(in hrs)
1
1
1
1
1
20/60
20/60
20/60
20/60
20/60
deaths of approximately 1,000 people in
the U.S. each year.
A personal dust monitor (PDM) has
recently been developed through a
collaboration involving NIOSH, the
Bituminous Coal Operators’
Association, the United Mine Workers
of America, the National Mining
Association, and Rupprecht &
Patashnick Co., Inc. This new device
represents a major advance in the tools
available for assessing coal miners’
exposure to respirable dust levels. It
will soon be field tested with coal
miners throughout the U.S. As with the
introduction of any new technology, it
is very important to systematically
document how workers react to it and
make use of it. If miners know how to
properly use the information PDMs are
capable of providing, they should be
able to make adjustments to their work
place or work procedures that will
reduce their exposure to respirable coal
dust.
Various parties have speculated about
the processes by which miners will use
the information to reduce their exposure
to respirable dust. There appears to be
great potential. However, no one knows
precisely how miners performing a wide
variety of tasks and jobs are actually
going to use this new information to
reduce their exposure to dust. It is
assumed that, once PDMs are
introduced, miners will eventually find
new ways to reduce their exposure to
E:\FR\FM\25AUN1.SGM
25AUN1
49928
Federal Register / Vol. 70, No. 164 / Thursday, August 25, 2005 / Notices
dust. Once these discoveries are made,
they need to be documented and shared
throughout the industry.
The diffusion of this innovation will
occur much more rapidly and efficiently
if this proposed study takes place.
Effective strategies for using PDM
information will be well documented
and quickly shared throughout the coal
industry. The alternative is to wait for
the miners at each of the 482 actively
structured interviews with
approximately 20 miners at each of 5
mines located throughout the major coal
producing regions of the U.S.
This survey will last 2 years. There
will be no cost to respondents except
their time to participate. The total
estimated annualized burden hours are
25.
producing coal mines in the U.S. to go
through their own trial and error
process of discovering how PDMs can
and cannot be used to reduce dust
exposure. The proposed study will help
to significantly reduce the incidence of
lung disease among coal miners, leading
to improvements in their longevity and
quality of life.
The information for this study will be
collected by conducting one-on-one
ESTIMATE OF ANNUALIZED BURDEN TABLE
Number of respondents
Respondents
Number of responses per
respondent
50
1
Coal Miners ..................................................................................................................................
Dated: August 18, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. 05–16895 Filed 8–24–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005N–0296]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Financial
Disclosure by Clinical Investigators
AGENCY: Food and Drug Administration,
HHS.
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, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
information requiring the sponsor of any
drug, biologic, or device marketing
application to certify to the absence of
clinical investigators and/or disclose
those financial interests as required,
when covered clinical studies are
submitted to FDA in support of product
marketing.
DATES: Submit written or electronic
comments on the collection of
information by October 24, 2005.
VerDate jul<14>2003
15:58 Aug 24, 2005
Jkt 205001
ADDRESSES: Submit electronic
comments on the collection of
information to: https://www.fda.gov/
dockets/ecomments. 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:
Karen L. Nelson, Office of Management
Programs (HFA–250), Food and Drug
Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301–827–1482.
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,
including each proposed extension of an
existing 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
PO 00000
Frm 00026
Fmt 4703
Sfmt 4703
Average burden per
response
(in hours)
30/60
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.
Financial Disclosure by Clinical
Investigators (OMB Control Number
0910–0396)—Extension
Respondents are sponsors of
marketing applications that contain
clinical data from studies covered by the
regulations. These sponsors represent
pharmaceutical, biologic and medical
device firms. The applicant will incur
reporting costs in order to comply with
the final rule. Applicants will be
required to submit, for example, the
complete list of clinical investigators for
each covered study, not employed by
the applicant and/or sponsor of the
covered study, and either certify to the
absence of certain financial
arrangements with clinical investigators
or disclose the nature of those
arrangements to FDA and the steps
taken by the applicant or sponsor to
minimize the potential for bias. The
clinical investigator will have to supply
information regarding financial interests
or payments held in the sponsor of the
covered study. FDA has said that it has
no preference as to how this information
is collected from investigators and that
sponsors/applicants have the flexibility
to collect the information in the most
efficient and least burdensome manner
that will be effective. FDA estimated
E:\FR\FM\25AUN1.SGM
25AUN1
]]>Agencies
[Federal Register Volume 70, Number 164 (Thursday, August 25, 2005)]
[Notices]
[Pages 49927-49928]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-16895]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-05-05AF]
Proposed Data Collections Submitted for Public Comment and
Recommendations
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) 371-5983 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) 395-6974.
Written comments should be received within 30 days of this notice.
Proposed Project
How Miners Modify Their Behavior In Response To Personal Dust
Monitor Information--New--National Institute for Occupational Safety
and Health (NIOSH), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The Federal Mine Safety & Health Act of 1977, Section 501, and the
Occupational Safety and Health Act of 1970, Public Law 91-256 enables
CDC/NIOSH to carry out research relevant to the health and safety of
workers in the mining industry. The objective of this project is to
document how coal miners can use real-time information from their
personal dust monitors (PDM) to reduce their exposure to respirable
dust. The specific aims are to (1) identify several specific examples
of how miners use PDM information to discover which parts of their jobs
and/or which aspects of their work environment may be causing them to
be overexposed to respirable dust, and (2) identify the types of
changes that miners could make in order to try to reduce their
exposure. Although the most recent data on the prevalence of Coal
Workers' Pneumoconiosis (CWP) in the United States indicates that it is
declining, substantial numbers of CWP cases continue to be diagnosed.
In recent years, CWP has contributed to the deaths of approximately
1,000 people in the U.S. each year.
A personal dust monitor (PDM) has recently been developed through a
collaboration involving NIOSH, the Bituminous Coal Operators'
Association, the United Mine Workers of America, the National Mining
Association, and Rupprecht & Patashnick Co., Inc. This new device
represents a major advance in the tools available for assessing coal
miners' exposure to respirable dust levels. It will soon be field
tested with coal miners throughout the U.S. As with the introduction of
any new technology, it is very important to systematically document how
workers react to it and make use of it. If miners know how to properly
use the information PDMs are capable of providing, they should be able
to make adjustments to their work place or work procedures that will
reduce their exposure to respirable coal dust.
Various parties have speculated about the processes by which miners
will use the information to reduce their exposure to respirable dust.
There appears to be great potential. However, no one knows precisely
how miners performing a wide variety of tasks and jobs are actually
going to use this new information to reduce their exposure to dust. It
is assumed that, once PDMs are introduced, miners will eventually find
new ways to reduce their exposure to
[[Page 49928]]
dust. Once these discoveries are made, they need to be documented and
shared throughout the industry.
The diffusion of this innovation will occur much more rapidly and
efficiently if this proposed study takes place. Effective strategies
for using PDM information will be well documented and quickly shared
throughout the coal industry. The alternative is to wait for the miners
at each of the 482 actively producing coal mines in the U.S. to go
through their own trial and error process of discovering how PDMs can
and cannot be used to reduce dust exposure. The proposed study will
help to significantly reduce the incidence of lung disease among coal
miners, leading to improvements in their longevity and quality of life.
The information for this study will be collected by conducting one-
on-one structured interviews with approximately 20 miners at each of 5
mines located throughout the major coal producing regions of the U.S.
This survey will last 2 years. There will be no cost to respondents
except their time to participate. The total estimated annualized burden
hours are 25.
Estimate of Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Coal Miners..................................................... 50 1 30/60
----------------------------------------------------------------------------------------------------------------
Dated: August 18, 2005.
Joan F. Karr,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. 05-16895 Filed 8-24-05; 8:45 am]
BILLING CODE 4163-18-P
