Agency Forms Undergoing Paperwork Reduction Act Review, 65736-65737 [E7-22809]
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65736
Federal Register / Vol. 72, No. 225 / Friday, November 23, 2007 / Notices
comments should be received within 30
days of this notice.
Proposed Project
Follow-up Survey of Chronic Fatigue
Syndrome in Georgia—New—
Coordinating Center for Infectious
Diseases (CCID), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
CDC is planning a follow-up study of
chronic fatigue syndrome (CFS) in
metropolitan, urban and rural
communities in Georgia. This is in
response to Congressional
recommendations that the Centers for
Disease Control and Prevention (CDC)
utilize advanced surveillance
methodologies for CFS to examine its
natural history and identify risk factors
and biomarkers.
In 2004, OMB approved the
information collection, Survey of
Chronic Fatigue Syndrome and Chronic
Unwellness in Georgia, under OMB
Number 0920–0638, which provided
baseline information on prolonged
fatiguing illness in metropolitan, urban,
and rural regions in Georgia. Data from
the proposed Follow-up Study of
Chronic Fatigue Syndrome in Georgia
will be used to describe the clinical
course of CFS and evaluate behavioral
and biochemical factors associated with
outcome. This follow-up study will also
determine access to and utilization of
health care by persons with CFS and
measure direct and indirect economic
burden due to the illness. As part of a
control strategy, the information from
this follow up study will be used in
national and pilot regional provider
education programs.
The proposed study continues the
Georgia survey using similar
methodology and data collection
instruments. This follow-up study
begins with a detailed telephone
interview to obtain additional data on
participant health status during the last
twelve month period. Eligible subjects
will be asked to participate in clinical
evaluations. There will be no cost to
respondents other than their time. The
estimated total annualized burden hours
are 861.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Follow-up Study Detailed Interview .............................................................................................
Dated: November 15, 2007.
Marilyn Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E7–22808 Filed 11–21–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–08–0566]
Agency Forms Undergoing Paperwork
Reduction Act Review
mstockstill on PROD1PC66 with NOTICES
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) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Use of a Reader Response Postcard for
Workers Notified of Results of
Epidemiologic Studies Conducted by
the National Institute for Occupational
Safety and Health (NIOSH)—
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16:16 Nov 21, 2007
Jkt 214001
Reinstatement—The National Institute
for Occupational Safety and Health
(NIOSH), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
NIOSH, under Section 20(a)(1), (a)(4),
(a)(7)(c), and Section 22 (d), (e)(5)(7) of
the Occupational Safety and Health Act
(29 U.S.C. 669), has the responsibility to
‘‘conduct (directly or by grants or
contracts) research, experiments, and
demonstrations relating to occupational
safety and health, including studies of
psychological factors involved, and
relating to innovative methods,
techniques, and approaches for dealing
with occupational safety and health
problems.’’ NIOSH also has the
responsibility to ‘‘conduct special
research, experiments, and
demonstrations relating to occupational
safety and health as are necessary to
explore new problems, including those
created by new technology in
occupational safety and health [e.g.,
worker notification], which may require
ameliorative action beyond that which
is otherwise provided for in the
operating provisions of the Act.’’ .
Since 1977, the National Institute for
Occupational Safety and Health
(NIOSH) has been developing methods
and materials for the notification of
subjects of its epidemiological studies.
NIOSH involvement in notifying
workers of past exposures relates
primarily to informing surviving cohort
members of the findings of retrospective
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Number of
responses per
respondent
2,870
1
Average
burden/
response
(in hours)
18/60
cohort studies conducted by NIOSH.
Current policy within NIOSH is to
notify subjects of the results of its
epidemiologic studies. The extent of the
notification effort depends upon the
level of excess mortality or the extent of
the disease or illness found in the
cohort. Current notification efforts range
from posting results at the facilities
studied to mailing individual letter
notifications to surviving cohort
members and other stakeholders. The
Industry-wide Studies Branch (IWSB) of
NIOSH, Division of Surveillance,
Hazard Evaluation, and Field Studies
(DSHEFS), usually conducts about two
or three notifications per year, which
typically require individual letters
mailed to cohorts ranging in size from
200–20,000 workers each. In order to
assess the effectiveness of the
notification materials received by the
recipients and to improve future
communication of risk information, the
evaluation instrument proposed was
developed.
The NIOSH Institute-wide Worker
Notification Program routinely notifies
subjects about the results of
epidemiologic studies and the
implications of the results. The overall
purpose of the proposed project is to
gain insight into the effectiveness of
NIOSH worker notification in order to
improve the quality and usefulness of
the Institute’s worker notification
activities. Researchers from the NIOSH
Division of Surveillance, Hazard
Evaluations and Field Studies (DSHEFS)
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65737
Federal Register / Vol. 72, No. 225 / Friday, November 23, 2007 / Notices
propose to provide notified workers
with a Reader Response postcard for
routinely assessing notified study
subjects’ responses to individual letter
notification materials sent to them by
NIOSH. We are requesting approval for
three years. Participation is voluntary
and there is no cost to respondents
except for their time. The total
estimated annualized burden hours are
1,333.
ANNUALIZED BURDEN TABLE
Number of
respondents
Form name
Reader Response Card ...................................................................................
Dated: November 15, 2007.
Marilyn Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E7–22809 Filed 11–21–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[60Day–08–07AA]
mstockstill on PROD1PC66 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. 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
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.
VerDate Aug<31>2005
16:16 Nov 21, 2007
Jkt 214001
Proposed Project
Pilot Project for a National Monitoring
System for Major Adverse Effects of
Medication Use During Pregnancy and
Lactation—New—National Center on
Birth Defects and Developmental
Disabilities (NCBDDD), Centers for
Disease Control and Prevention (CDC).
This data collection is based on the
following components of the Public
Health Service Act: (1) Act 42 U.S.C.
241, Section 301, which authorizes
‘‘research, investigations, experiments,
demonstrations, and studies relating to
the causes, diagnosis, treatment, control,
and prevention of physical and mental
diseases and impairments of man.’’ (2)
42 U.S.C. 247b–4, Section 317 C, which
authorizes the activities of the National
Center on Birth Defects and
Developmental Disabilities. This section
was created by Public Law 106–310,
also known as ‘‘the Children’s Health
Act of 2000.’’ This portion of the code
has also been amended by Public Law
108–154, which is also known as the
‘‘Birth Defects and Developmental
Disabilities Prevention Act of 2003’’.
The use of a number of medications
during pregnancy is known to be
associated with serious adverse effects
in children. However, because pregnant
and lactating women are traditionally
excluded from clinical trials, and
because pre-marketing animal studies
do not necessarily predict the
experience of humans, little information
is available about the safety of most
prescription medications during
pregnancy and lactation at the time they
are marketed. Nevertheless, many
women inadvertently use medications
early in gestation before realizing they
are pregnant, and many maternal
conditions require treatment during
pregnancy and breastfeeding to
safeguard the health of both mother and
infant. Currently, the United States does
not have a comprehensive early warning
system for major adverse pregnancy or
infant outcomes related to medication
exposures.
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Average burden response
(in hours)
1
10/60
8,000
Background and Brief Description
Centers for Disease Control and
Prevention
Number of responses per
respondent
Total burden
(in hours)
1,333
Teratology Information Services (TIS)
utilize trained specialists to provide free
phone consultation, risk assessment,
and counseling about exposures during
pregnancy and breastfeeding—including
medications—to women and healthcare
providers. Altogether, they respond to
approximately 70,000–100,000 inquiries
each year in the United States and
Canada. Because they have direct
contact with pregnant and breastfeeding
women, TIS are in a unique position to
monitor the adverse effects of
medication exposures during pregnancy
and lactation. The objective of this
project is to conduct a pilot study to
assess whether TIS in the United States
can serve as an effective monitoring and
early warning system for major adverse
effects on (1) pregnancy outcomes (e.g.,
live birth, stillbirth, premature birth,
low birth weight, etc.) and (2) maternal
and infant health. The project will
assess the willingness of pregnant and
breastfeeding women who contact a TIS
about medication exposure to
participate in and complete a follow-up
study; whether these women are similar
in demographic characteristics to the
U.S. population of child-bearing age
women; the specificity and
completeness of the information
obtained from such a study about
adverse pregnancy outcomes, and
maternal and infant health; and the
amount of time required to conduct the
follow-up.
Within a continuous six-month
period, three individual TIS will recruit
all women who contact their service (up
to a maximum of 250 enrollees per TIS)
who have used any prescription or overthe-counter medication, vitamin, herbal,
or other dietary supplement during
pregnancy or while breastfeeding to
participate in a follow-up study.
Informed consent to participate will be
obtained from each woman by
telephone. For each pregnant woman
who agrees to participate, the TIS will
then conduct 4 telephone interviews: At
enrollment; during the third trimester of
pregnancy; approximately one month
after delivery; and when the infant is
about 3 months old. For each
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]]>Agencies
[Federal Register Volume 72, Number 225 (Friday, November 23, 2007)]
[Notices]
[Pages 65736-65737]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22809]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-08-0566]
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) 395-6974.
Written comments should be received within 30 days of this notice.
Proposed Project
Use of a Reader Response Postcard for Workers Notified of Results
of Epidemiologic Studies Conducted by the National Institute for
Occupational Safety and Health (NIOSH)--Reinstatement--The National
Institute for Occupational Safety and Health (NIOSH), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
NIOSH, under Section 20(a)(1), (a)(4), (a)(7)(c), and Section 22
(d), (e)(5)(7) of the Occupational Safety and Health Act (29 U.S.C.
669), has the responsibility to ``conduct (directly or by grants or
contracts) research, experiments, and demonstrations relating to
occupational safety and health, including studies of psychological
factors involved, and relating to innovative methods, techniques, and
approaches for dealing with occupational safety and health problems.''
NIOSH also has the responsibility to ``conduct special research,
experiments, and demonstrations relating to occupational safety and
health as are necessary to explore new problems, including those
created by new technology in occupational safety and health [e.g.,
worker notification], which may require ameliorative action beyond that
which is otherwise provided for in the operating provisions of the
Act.'' .
Since 1977, the National Institute for Occupational Safety and
Health (NIOSH) has been developing methods and materials for the
notification of subjects of its epidemiological studies. NIOSH
involvement in notifying workers of past exposures relates primarily to
informing surviving cohort members of the findings of retrospective
cohort studies conducted by NIOSH. Current policy within NIOSH is to
notify subjects of the results of its epidemiologic studies. The extent
of the notification effort depends upon the level of excess mortality
or the extent of the disease or illness found in the cohort. Current
notification efforts range from posting results at the facilities
studied to mailing individual letter notifications to surviving cohort
members and other stakeholders. The Industry-wide Studies Branch (IWSB)
of NIOSH, Division of Surveillance, Hazard Evaluation, and Field
Studies (DSHEFS), usually conducts about two or three notifications per
year, which typically require individual letters mailed to cohorts
ranging in size from 200-20,000 workers each. In order to assess the
effectiveness of the notification materials received by the recipients
and to improve future communication of risk information, the evaluation
instrument proposed was developed.
The NIOSH Institute-wide Worker Notification Program routinely
notifies subjects about the results of epidemiologic studies and the
implications of the results. The overall purpose of the proposed
project is to gain insight into the effectiveness of NIOSH worker
notification in order to improve the quality and usefulness of the
Institute's worker notification activities. Researchers from the NIOSH
Division of Surveillance, Hazard Evaluations and Field Studies (DSHEFS)
[[Page 65737]]
propose to provide notified workers with a Reader Response postcard for
routinely assessing notified study subjects' responses to individual
letter notification materials sent to them by NIOSH. We are requesting
approval for three years. Participation is voluntary and there is no
cost to respondents except for their time. The total estimated
annualized burden hours are 1,333.
Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per response (in Total burden
respondents respondent hours) (in hours)
----------------------------------------------------------------------------------------------------------------
Reader Response Card............................ 8,000 1 10/60 1,333
----------------------------------------------------------------------------------------------------------------
Dated: November 15, 2007.
Marilyn Radke,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E7-22809 Filed 11-21-07; 8:45 am]
BILLING CODE 4163-18-P
