Proposed Data Collections Submitted for Public Comment and Recommendations, 65966-65968 [E7-22920]
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Federal Register / Vol. 72, No. 226 / Monday, November 26, 2007 / Notices
Proposed Project
All Age Influenza Hospitalization
Surveillance (Flu Hosp)—New—
National Center for Immunization and
Respiratory Diseases (NCIRD), Centers
for Disease Control and Prevention
(CDC).
Background and Brief Description
CDC is requesting OMB approval for
a data collection system that will assist
public health officials to better monitor
and assess severe forms of influenza
disease resulting in hospitalization.
Approval is sought for an Adult Case
Report Form and a Pediatric Case Report
Form. The Adult Case Report Form will
be used to collect information on
patients over the age of 18 years old,
and the Pediatric Case Report form will
be used for patients under 18 years and
younger. The primary difference
between the two forms is that the Adult
Case Report form includes collection of
information related to Statin use, and
the Pediatric Case Report form does not.
Adult surveillance will consist of two
phases, a prospective data collection,
and a retrospective discharge audit.
Therefore, approval is also sought for
outbreaks so that immediate prevention
measures can be taken. Most of the data
collection instrument can be completed
from review of the hospital medical
records. If none of these resources are
available, the patient or their proxy may
be interviewed.
CDC and its participating partners
will also perform a discharge audit to
assess the completeness of the case
surveillance data by conducting an
evaluation of the hospitalized influenza
cases found by Flu Hosp versus an
independent, administrative hospital
dataset. Each of the ten participating
sites will complete standardized forms
that describe the evaluation process and
the number of cases missed by Flu
Hosp, in aggregate. Although 10 states
participate in Flu Hosp, because New
York includes two functionally and
geographically different catchment
areas, those two areas will submit
individual discharge audit data, to make
a total of 11 respondents.
The respondents for the data
collections are the Flu Hosp
participating sites. There are no costs to
respondents other than their time for
participating.
forms that will assess the completeness
of the surveillance system’s cases. These
forms make up an Adult discharge
audit, which will reveal any limitations
in the prospective case identification
that will have occurred prior to the
discharge audit.
Flu Hosp uses standardized data
collection instruments that collect
demographic and clinical information
from laboratory-confirmed influenza
hospitalized adults and children who
reside in a geographic- and populationdefined area of the United States. The
data collection network is an
established CDC-state-academic
institution collaborative network, the
Emerging Infections Program (EIP)
which includes the states of California,
Colorado, Connecticut, Georgia,
Maryland, Minnesota, New Mexico,
New York, Oregon, and Tennessee.
From October 1 of this year through
April 30 of the following year (the
current flu season), Flu Hosp collects
data and transmits it to CDC. Case
reports are submitted as soon as
possible after the investigation of a case.
Prompt notification to CDC allows for
identification of epidemics and
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average
burden per
response
(in hours)
Number of
responses per
respondent
Total burden
(in hours)
Form name
Type of respondent
Pediatric Influenza Hospitalization Surveillance
Project Case Report Form.
Adult Influenza Hospitalization Surveillance Project
Case Report Form.
Adult Discharge Audit Case Report Form ...............
Adult Discharge Audit Form A: Description of
Matching Method.
Adult Discharge Audit Form B: Sampling Strategy
Adult Discharge Audit Form C: Summary ...............
Adult Discharge Audit Form D: Future ....................
Health Department ....
10
75
15/60
188
Health Department ....
10
120
15/60
300
Health Department ....
Health Department ....
11
11
3
1
15/60
15/60
8
3
Health Department ....
Health Department ....
Health Department ....
11
11
11
1
1
1
15/60
15/60
15/60
3
3
3
Total ..................................................................
....................................
........................
........................
........................
508
Dated: November 19, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–22919 Filed 11–23–07; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4163–18–P
[60Day–08–0692]
Centers for Disease Control and
Prevention
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
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Sfmt 4703
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)
E:\FR\FM\26NON1.SGM
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65967
Federal Register / Vol. 72, No. 226 / Monday, November 26, 2007 / Notices
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 of the Knowledge, Attitudes
and Practice of Medical and Allied
Health Professionals Regarding Fetal
Alcohol Exposure—Extension—
National Center on Birth Defects and
Developmental Disabilities (NCBDDD),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
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.’’
Maternal prenatal alcohol use is one
of the leading, preventable, causes of
birth defects and developmental
disabilities. Children exposed to alcohol
during fetal development can suffer a
wide array of disorders, from subtle
changes in I.Q. and behaviors to
profound mental retardation. These
conditions are known as fetal alcohol
spectrum disorders (FASDs). The most
severe condition within the spectrum is
fetal alcohol syndrome (FAS), which
involves disorders of the brain, growth
retardation, and facial malformations.
Physicians and other health
practitioners play a vital role in
diagnosing FAS and in screening
women of child-bearing age for alcohol
consumption and drinking during
pregnancy. In Diekman’s, et al. 2000,
study of obstetricians and gynecologists,
only one-fifth of doctors surveyed
reported abstinence to be the safest way
to avoid the adverse outcomes
associated with fetal alcohol exposure.3
Importantly, 13% of doctors surveyed
were not sure of levels of alcohol
consumption associated with adverse
outcomes.3 One of CDC’s multifaceted
initiatives in combating alcohol-exposed
pregnancies is the education and
reeducation of medical and allied health
students and practitioners.
In fiscal year 2002, the Centers for
Disease Control and Prevention (CDC)
received a congressional mandate to
develop guidelines for the diagnosis of
FAS and other conditions resulting from
prenatal alcohol exposure; and to
incorporate these guidelines into
curricula for medical and allied health
students and practitioners [Public
Health Service Act Section 317K (247b–
12) b and c] (See Appendices A–1, A–
2, A–3.)
In response to the second
congressional mandate listed above,
CDC proposed five national surveys of
health providers. In August of 2005,
OMB approved these five surveys under
control number 0920–0692. The
purposes of the surveys are to assess,
among various health care provider
groups, their knowledge, attitudes, and
practices regarding the prevention,
identification, and treatment of FASDs.
These health care provider groups are
pediatricians, obstetrician-gynecologists
(OB–GYNs), psychiatrists, family
physicians, and allied health
professionals. To date, three of the five
surveys have yet to be conducted—the
survey of allied health professionals, the
survey of family physicians, and the
survey of pediatricians.
The results of the surveys will help to
inform further development of model
FASD curricula to disseminate among
medical and allied health students and
professionals nation wide using a
variety of formats including computer
interactive learning applications,
workshops and conferences, Continuing
Medical Education credit courses, and
medical and allied health school grand
rounds and clerkships. Consistent with
OMB’s previous terms of clearance, CDC
does not expect the results to be
generalizable to the larger populations
of the professional organizations from
which the samples were drawn. Instead,
the survey results will provide
necessary information to further
develop and refine educational
materials for medical and allied health
students and practitioners and to
evaluate their effectiveness. No gifts or
compensation will be given to
respondents who complete the survey.
There is no cost to respondents other
than their time.
Estimate of Annualized Burden Hours
Number of respondents
Type of respondent
Number of responses per
respondent
900
900
900
900
900
1
1
1
1
1
Pediatricians ....................................................................................................
Obstetrician-Gynecologists ..............................................................................
Psychiatrists .....................................................................................................
Family Physicians ............................................................................................
Allied Health Professionals ..............................................................................
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Total ..........................................................................................................
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Average
burden per
response
(in hours)
25/60
25/60
25/60
25/60
25/60
Total burden
hours
375
375
375
375
375
65968
Federal Register / Vol. 72, No. 226 / Monday, November 26, 2007 / Notices
Dated: November 16, 2007.
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E7–22920 Filed 11–23–07; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–08–06AY]
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) 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) 395–6974. Written
comments should be received within 30
days of this notice.
Proposed Project
Evaluation of the Spanish-Language
Campaign ‘‘Good Morning Arthritis,
Today You Will Not Defeat Us.’’—
New—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
Arthritis affects nearly 43 million
Americans, or about one in every five
people, and is the leading cause of
disability among adults in the United
States. Limitations due to arthritis are
particularly burdensome when they
affect an individual’s mobility,
productivity, and ability to earn a living,
as well as psychological and social wellbeing. Because of the broad public
health impact of this disease, the
Centers for Disease Control and
Prevention (CDC) developed the
National Arthritis Action Plan in 1998
as a comprehensive approach to
reducing the burden of arthritis in the
United States.
Hispanics are currently the fastest
growing racial/ethnic group in the
United States. Although Hispanic
populations have a slightly lower
prevalence rate of self-reported, doctordiagnosed arthritis than the general
population, Hispanics with arthritis
report greater work limitations, and
higher rates of severe pain than do
Caucasian populations with arthritis.
CDC has developed a Spanish-language
campaign, Good Morning Arthritis,
Today you will not defeat us, to deliver
culturally appropriate public health
messages about the benefits of physical
activity as an arthritis management
strategy. Campaign materials include
print ads, 30 and 60 second radio ads
and public service announcements, and
desktop displays with brochures for
pharmacies, doctors’ offices, and
community centers. The campaign is
designed to reach Spanish speaking
adults with arthritis who are aged 45–
64, who have high school education or
less, and whose annual income is less
than $35,000. CDC plans to conduct the
campaign in four experimental markets.
CDC requests clearance to conduct an
evaluation of the campaign by collecting
information from Spanish-speaking
respondents in the four experimental
markets and two control markets. An
initial data collection will consist of
telephone interviews, and will be based
on a pre- and post-campaign evaluation
design. A follow-up telephone
interview, involving a subset of the
initial respondents, will be conducted
six months later. Results will be used to
guide the public health practice of the
36 CDC-funded state arthritis programs
and their partners.
There are no costs to respondents
other than their time. The estimated
annualized burden hours are 2,730.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Target Population of Hispanic Adults .............
Screener for Primary Pre- and Post Campaign Survey.
Primary Pre- and Post Campaign Survey .....
Screener for 6–Month Follow-up Survey .......
6–Month Follow-up Survey ............................
Dated: November 16, 2007.
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E7–22930 Filed 11–23–07; 8:45 am]
mstockstill on PROD1PC66 with NOTICES
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 2006P–0291, 2006P–0299,
2006P–0298, 2006P–0309, and 2007P–0062]
Determination That ELOXATIN
(Oxaliplatin for Injection), 50 and 100
Milligrams Per Vial, Sterile Lyophilized
Powder for Injection, Was Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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Number of
responses per
respondent
Average
burden per response (in
hours)
60,000
1
2/60
2,400
2,400
600
1
1
1
13/60
2/60
13/60
Number of
respondents
Type of respondents
SUMMARY: The Food and Drug
Administration (FDA) has determined
that ELOXATIN (oxaliplatin for
injection), 50 and 100 milligrams (mg)
per vial, sterile lyophilized powder for
injection, was not withdrawn from sale
for reasons of safety or effectiveness.
This determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for oxaliplatin
sterile lyophilized powder for injection,
50 and 100 mg/vial.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Sadove, Center for Drug
Evaluation and Research (HFD–7), Food
and Drug Administration, 5600 Fishers
E:\FR\FM\26NON1.SGM
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]]>Agencies
[Federal Register Volume 72, Number 226 (Monday, November 26, 2007)]
[Notices]
[Pages 65966-65968]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-22920]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-08-0692]
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)
[[Page 65967]]
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 of the Knowledge, Attitudes and Practice of Medical and
Allied Health Professionals Regarding Fetal Alcohol Exposure--
Extension--National Center on Birth Defects and Developmental
Disabilities (NCBDDD), Centers for Disease Control and Prevention
(CDC).
Background and Brief Description
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.''
Maternal prenatal alcohol use is one of the leading, preventable,
causes of birth defects and developmental disabilities. Children
exposed to alcohol during fetal development can suffer a wide array of
disorders, from subtle changes in I.Q. and behaviors to profound mental
retardation. These conditions are known as fetal alcohol spectrum
disorders (FASDs). The most severe condition within the spectrum is
fetal alcohol syndrome (FAS), which involves disorders of the brain,
growth retardation, and facial malformations.
Physicians and other health practitioners play a vital role in
diagnosing FAS and in screening women of child-bearing age for alcohol
consumption and drinking during pregnancy. In Diekman's, et al. 2000,
study of obstetricians and gynecologists, only one-fifth of doctors
surveyed reported abstinence to be the safest way to avoid the adverse
outcomes associated with fetal alcohol exposure.\3\ Importantly, 13% of
doctors surveyed were not sure of levels of alcohol consumption
associated with adverse outcomes.\3\ One of CDC's multifaceted
initiatives in combating alcohol-exposed pregnancies is the education
and reeducation of medical and allied health students and
practitioners.
In fiscal year 2002, the Centers for Disease Control and Prevention
(CDC) received a congressional mandate to develop guidelines for the
diagnosis of FAS and other conditions resulting from prenatal alcohol
exposure; and to incorporate these guidelines into curricula for
medical and allied health students and practitioners [Public Health
Service Act Section 317K (247b-12) b and c] (See Appendices A-1, A-2,
A-3.)
In response to the second congressional mandate listed above, CDC
proposed five national surveys of health providers. In August of 2005,
OMB approved these five surveys under control number 0920-0692. The
purposes of the surveys are to assess, among various health care
provider groups, their knowledge, attitudes, and practices regarding
the prevention, identification, and treatment of FASDs. These health
care provider groups are pediatricians, obstetrician-gynecologists (OB-
GYNs), psychiatrists, family physicians, and allied health
professionals. To date, three of the five surveys have yet to be
conducted--the survey of allied health professionals, the survey of
family physicians, and the survey of pediatricians.
The results of the surveys will help to inform further development
of model FASD curricula to disseminate among medical and allied health
students and professionals nation wide using a variety of formats
including computer interactive learning applications, workshops and
conferences, Continuing Medical Education credit courses, and medical
and allied health school grand rounds and clerkships. Consistent with
OMB's previous terms of clearance, CDC does not expect the results to
be generalizable to the larger populations of the professional
organizations from which the samples were drawn. Instead, the survey
results will provide necessary information to further develop and
refine educational materials for medical and allied health students and
practitioners and to evaluate their effectiveness. No gifts or
compensation will be given to respondents who complete the survey.
There is no cost to respondents other than their time.
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondent Number of responses per per response Total burden
respondents respondent (in hours) hours
----------------------------------------------------------------------------------------------------------------
Pediatricians................................... 900 1 25/60 375
Obstetrician-Gynecologists...................... 900 1 25/60 375
Psychiatrists................................... 900 1 25/60 375
Family Physicians............................... 900 1 25/60 375
Allied Health Professionals..................... 900 1 25/60 375
---------------------------------------------------------------
Total....................................... .............. .............. .............. ..............
----------------------------------------------------------------------------------------------------------------
[[Page 65968]]
Dated: November 16, 2007.
Marilyn S. Radke,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. E7-22920 Filed 11-23-07; 8:45 am]
BILLING CODE 4163-18-P
