Proposed Data Collections Submitted for Public Comment and Recommendations, 22400-22401 [2011-9670]
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Federal Register / Vol. 76, No. 77 / Thursday, April 21, 2011 / Notices
for SAEs associated with LTBI
treatment. Based on previous reporting,
CDC anticipates receiving an average of
10 responses per year from the 60
reporting areas. The data collection form
is completed by healthcare providers
and health departments for each
reported hospitalization or death related
to treatment of LTBI and contains
demographic, clinical, and laboratory
information. CDC will analyze and
periodically publish reports
summarizing national LTBI treatment
adverse events statistics and also will
conduct special analyses for publication
in peer-reviewed scientific journals to
further describe and interpret these
data.
The Food and Drug Administration
(FDA) collects data on adverse events
related to drugs through the FDA
MedWatch Program. CDC is
collaborating with FDA in the reporting
of SAEs. Reporting will be conducted
through telephone, e-mail, or during
CDC site visits. In this request, CDC is
requesting approval for approximately
60 burden hours annually, an estimated
increase of 36 hours. This is due to an
estimated increase of reports of SAEs
after the publication of the MMWR
report on SAEs in 2010. There are no
costs to respondents other than their
time.
Reports of SAEs related to RZ and
INH have prompted a need for this
project—a national surveillance system
of such events. The objective of the
project is to determine the annual
number and temporal trends of SAEs
associated with any treatment for LTBI
in the United States. Surveillance of
such events will provide data to support
periodic evaluation of guidelines for
treatment of persons with LTBI and
revision.
The Centers for Disease Control and
Prevention request approval for a 3-year
reinstatement with change of the
previously approved National
Surveillance for Severe Adverse Events
Associated with Treatment of Latent
Tuberculosis Infection—(OMB No.
0920–0773, expires April 31, 2011). The
changes include a shortened data
collection form and an increase in the
number of respondents. This project
will continue the passive reporting
system for SAEs associated with therapy
for LTBI. The system will rely on
medical chart review and/or onsite
investigations by TB control staff.
Potential respondents are any of the
60 reporting areas for the national TB
surveillance system (the 50 states, the
District of Columbia, New York City,
Puerto Rico, and 7 jurisdictions in the
Pacific and Caribbean). Data will be
collected using the data collection form
Hepatitis, STD, and TB Prevention
(NCHHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
As part of the national tuberculosis
(TB) elimination strategy, the American
Thoracic Society and CDC have
published recommendations for targeted
testing for TB and treatment for latent
TB infection (LTBI)(Morbidity and
Mortality Weekly Report
2000;49[RR06];1–54). However, between
October 2000 and September 2004, the
CDC received reports of 50 patients with
severe adverse events (SAEs) associated
with the use of the two or three-month
regimen of rifampin and pyrazinamide
(RZ) for the treatment of LTBI; 12 (24%)
patients died (Morbidity and Mortality
Weekly Report 2003;52[31]:735–9). In
2004, CDC began collecting reports of
SAEs associated with any treatment
regimen for LTBI. For surveillance
purposes, an SAE was defined as any
drug-associated reaction resulting in a
patient’s hospitalization or death after at
least one treatment dose for LTBI.
During 2004¥2008, CDC received 17
reports of SAEs in 15 adults and two
children; all patients had received
isoniazid (INH) and had experienced
severe liver injury (Morbidity and
Mortality Weekly Report 2010;
59:224–9).
ESTIMATE OF ANNUALIZED BURDEN TABLE
Number of
responses per
respondent
Number of
respondents
Type of respondents
Average
burden per
response
(in hours)
Total burden
(in hours)
Physicians ........................................................................................................
Nurses ..............................................................................................................
Medical Clerk ...................................................................................................
10
10
10
1
1
1
1
4
1
10
40
10
Total ..........................................................................................................
........................
........................
........................
60
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2011–9671 Filed 4–20–11; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
emcdonald on DSK2BSOYB1PROD with NOTICES
Centers for Disease Control and
Prevention
[60 Day-11–0792]
Proposed Data Collections Submitted
for Public Comment and
Recommendations
In compliance with the requirement
of Section 3506(c)(2)(A) of the
VerDate Mar<15>2010
16:37 Apr 20, 2011
Jkt 223001
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 Daniel Holcomb, CDC
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
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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.
Proposed Project
Environmental Health Specialists
Network (EHS–Net) National Voluntary
Environmental Assessment Information
System (NVEAIS)—New—National
Center for Environmental Health
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21APN1
22401
Federal Register / Vol. 76, No. 77 / Thursday, April 21, 2011 / Notices
(NCEH), Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
The CDC is requesting OMB approval
for the EHS–Net National Voluntary
Environmental Assessment Information
System (NVEAIS) to collect data from
foodborne illness outbreak
environmental assessments routinely
conducted by local, state, territorial, or
tribal food safety programs during
outbreak investigations. Environmental
assessment data are not currently
collected at the national level. The data
reported through this information
system will provide timely data on the
causes of outbreaks, including
environmental factors associated with
outbreaks, and are essential to
environmental public health regulators’
efforts to respond more effectively to
outbreaks and prevent future, similar
outbreaks. This information system is
specifically designed to link to CDC’s
existing disease outbreak surveillance
system (National Outbreak Reporting
System).
The information system was
developed by the Environmental Health
Specialists Network (EHS–Net), a
collaborative project of CDC, the U.S.
Food and Drug Administration (FDA),
the U.S. Department of Agriculture
(USDA), and nine states (California,
will occur in the future, nor where they
will occur. However, we can estimate,
based on existing data that a maximum
of 1,400 foodborne illness outbreaks
will occur annually. Only those
programs in the jurisdictions in which
these outbreaks occur would report to
NVEAIS. Thus, not every program will
respond every year. Consequently, the
respondent burden estimate is based on
the number of outbreaks likely to occur
each year. Assuming each outbreak
occurs in a different jurisdiction, there
will be one respondent per outbreak.
There are two activities associated
with NVEAIS that require a burden
estimate. The first is entering all
requested environmental assessment
data into NVEAIS. This will be done
once for each outbreak and will take
approximately 2 hours per outbreak.
The second activity is the manager
interview that will be conducted at each
establishment associated with an
outbreak. Most outbreaks are associated
with only one establishment; however,
some are associated with multiple
establishments. We estimate that a
maximum average of 4 manager
interviews will be conducted per
outbreak. Each interview will take about
20 minutes.
The total estimated annual burden is
4,667 hours. There is no cost to the
respondents other than their time.
Connecticut, Georgia, Iowa, New York,
Minnesota, Oregon, Rhode Island, and
Tennessee). The network consists of
environmental health specialists (EHSs),
epidemiologists, and laboratorians. The
EHS–Net has developed a standardized
protocol for identifying, reporting, and
analyzing data relevant to foodborne
illness outbreak environmental
assessments.
While conducting environmental
assessments during outbreak
investigations is routine for food safety
program officials, however, reporting
information from the environmental
assessments to CDC is not. State, Local,
Tribal, and Territorial food safety
program officials are the respondents for
this data collection—one official from
each participating program will report
environmental assessment data on
outbreaks. These programs are typically
located in public health or agriculture
agencies and there are approximately
3,000 such agencies in the United
States. Thus, although it is not possible
to determine how many programs will
choose to participate, as NVEAIS is
voluntary, the maximum potential
number of program respondents is
approximately 3,000.
These programs will be reporting data
on outbreaks, not their programs or
personnel. It is not possible to
determine exactly how many outbreaks
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondent
Form name
Food safety program personnel .......
1,400
1
2
2,800
Food safety program personnel .......
Reporting environmental assessment data into electronic system.
Manager interview ............................
1,400
4
20/60
1,867
Total ...........................................
...........................................................
........................
........................
........................
4,667
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2011–9670 Filed 4–20–11; 8:45 am]
Food and Drug Administration
BILLING CODE 4163–18–P
emcdonald on DSK2BSOYB1PROD with NOTICES
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[Docket No. FDA–2011–N–0231]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Adverse
Experience Reporting for Licensed
Biological Products; and General
Records
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
SUMMARY:
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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
the proposed extension of the collection
of information concerning requirements
relating to FDA’s adverse experience
reporting (AER) for licensed biological
products, and general records associated
with the manufacture and distribution
of biological products.
E:\FR\FM\21APN1.SGM
21APN1
]]>Agencies
[Federal Register Volume 76, Number 77 (Thursday, April 21, 2011)]
[Notices]
[Pages 22400-22401]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9670]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60 Day-11-0792]
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 Daniel Holcomb, CDC 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.
Proposed Project
Environmental Health Specialists Network (EHS-Net) National
Voluntary Environmental Assessment Information System (NVEAIS)--New--
National Center for Environmental Health
[[Page 22401]]
(NCEH), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
The CDC is requesting OMB approval for the EHS-Net National
Voluntary Environmental Assessment Information System (NVEAIS) to
collect data from foodborne illness outbreak environmental assessments
routinely conducted by local, state, territorial, or tribal food safety
programs during outbreak investigations. Environmental assessment data
are not currently collected at the national level. The data reported
through this information system will provide timely data on the causes
of outbreaks, including environmental factors associated with
outbreaks, and are essential to environmental public health regulators'
efforts to respond more effectively to outbreaks and prevent future,
similar outbreaks. This information system is specifically designed to
link to CDC's existing disease outbreak surveillance system (National
Outbreak Reporting System).
The information system was developed by the Environmental Health
Specialists Network (EHS-Net), a collaborative project of CDC, the U.S.
Food and Drug Administration (FDA), the U.S. Department of Agriculture
(USDA), and nine states (California, Connecticut, Georgia, Iowa, New
York, Minnesota, Oregon, Rhode Island, and Tennessee). The network
consists of environmental health specialists (EHSs), epidemiologists,
and laboratorians. The EHS-Net has developed a standardized protocol
for identifying, reporting, and analyzing data relevant to foodborne
illness outbreak environmental assessments.
While conducting environmental assessments during outbreak
investigations is routine for food safety program officials, however,
reporting information from the environmental assessments to CDC is not.
State, Local, Tribal, and Territorial food safety program officials are
the respondents for this data collection--one official from each
participating program will report environmental assessment data on
outbreaks. These programs are typically located in public health or
agriculture agencies and there are approximately 3,000 such agencies in
the United States. Thus, although it is not possible to determine how
many programs will choose to participate, as NVEAIS is voluntary, the
maximum potential number of program respondents is approximately 3,000.
These programs will be reporting data on outbreaks, not their
programs or personnel. It is not possible to determine exactly how many
outbreaks will occur in the future, nor where they will occur. However,
we can estimate, based on existing data that a maximum of 1,400
foodborne illness outbreaks will occur annually. Only those programs in
the jurisdictions in which these outbreaks occur would report to
NVEAIS. Thus, not every program will respond every year. Consequently,
the respondent burden estimate is based on the number of outbreaks
likely to occur each year. Assuming each outbreak occurs in a different
jurisdiction, there will be one respondent per outbreak.
There are two activities associated with NVEAIS that require a
burden estimate. The first is entering all requested environmental
assessment data into NVEAIS. This will be done once for each outbreak
and will take approximately 2 hours per outbreak.
The second activity is the manager interview that will be conducted
at each establishment associated with an outbreak. Most outbreaks are
associated with only one establishment; however, some are associated
with multiple establishments. We estimate that a maximum average of 4
manager interviews will be conducted per outbreak. Each interview will
take about 20 minutes.
The total estimated annual burden is 4,667 hours. There is no cost
to the respondents other than their time.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Food safety program personnel. Reporting 1,400 1 2 2,800
environmental
assessment data
into electronic
system.
Food safety program personnel. Manager 1,400 4 20/60 1,867
interview.
---------------------------------------------------------------
Total..................... ................ .............. .............. .............. 4,667
----------------------------------------------------------------------------------------------------------------
Daniel Holcomb,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2011-9670 Filed 4-20-11; 8:45 am]
BILLING CODE 4163-18-P
