Proposed Data Collections Submitted for Public Comment and Recommendations, 22399-22400 [2011-9671]
Download as PDF
<![CDATA[
Federal Register / Vol. 76, No. 77 / Thursday, April 21, 2011 / Notices
please contact Judy Sparrow at least
seven (7) days in advance of the
meeting.
ONC is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
https://healthit.hhs.gov for procedures
on public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act
(Pub. L. 92–463, 5 U.S.C., App. 2).
Dated: April 12, 2011.
Judith Sparrow,
Office of Programs and Coordination, Office
of the National Coordinator for Health
Information Technology.
[FR Doc. 2011–9691 Filed 4–20–11; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
HIT Policy Committee’s Workgroup
Meetings; Notice of Meetings
Office of the National
Coordinator for Health Information
Technology, HHS.
ACTION: Notice of meetings.
emcdonald on DSK2BSOYB1PROD with NOTICES
AGENCY:
This notice announces forthcoming
subcommittee meetings of a Federal
advisory committee of the Office of the
National Coordinator for Health
Information Technology (ONC). The
meetings will be open to the public via
dial-in access only.
Name of Committees: HIT Policy
Committee’s Workgroups: Meaningful
Use, Privacy & Security Tiger Team,
Quality Measures, Governance,
Adoption/Certification, and Information
Exchange workgroups.
General Function of the Committee:
To provide recommendations to the
National Coordinator on a policy
framework for the development and
adoption of a nationwide health
information technology infrastructure
that permits the electronic exchange and
use of health information as is
consistent with the Federal Health IT
Strategic Plan and that includes
recommendations on the areas in which
standards, implementation
specifications, and certification criteria
are needed.
Date and Time: The HIT Policy
Committee Workgroups will hold the
following public meetings during May
2011: May 2nd Meaningful Use
Workgroup,
9 a.m. to 11 a.m./ET; May 3rd
Meaningful Use Workgroup in-person
meeting, location—TBD, 9 a.m. to 3
p.m./ET; May 4th Privacy & Security
Tiger Team,
VerDate Mar<15>2010
16:37 Apr 20, 2011
Jkt 223001
2 p.m. to 4 p.m./ET; May 5th Quality
Measures Workgroup, 10 a.m. to 11:30
a.m./ET; May 10th Meaningful Use
Workgroup, 9 a.m. to 12 p.m./ET; May
13th Meaningful Use Workgroup
hearing, location—TBD, 9 a.m. to 3
p.m./ET; May 16th Privacy & Security
Tiger Team, 2 p.m. to 4 p.m./ET; May
19th Quality Measures Workgroup
hearing, location—TBD, 9 a.m. to 3
p.m./ET; and May 20th Meaningful Use
Workgroup, 10 a.m. to 1 p.m./ET.
Location: All workgroup meetings
will be available via webcast; for
instructions on how to listen via
telephone or Web visit https://
healthit.hhs.gov. Please check the ONC
Web site for additional information or
revised schedules as it becomes
available.
Contact Person: Judy Sparrow, Office
of the National Coordinator, HHS, 330 C
Street, SW., Washington, DC 20201,
202–205–4528, Fax: 202–690–6079, email: judy.sparrow@hhs.gov. Please call
the contact person for up-to-date
information on these meetings. A notice
in the Federal Register about last
minute modifications that affect a
previously announced advisory
committee meeting cannot always be
published quickly enough to provide
timely notice.
Agenda: The workgroups will be
discussing issues related to their
specific subject matter, e.g., meaningful
use, information exchange, privacy and
security, quality measures, governance,
or adoption/certification. If background
materials are associated with the
workgroup meetings, they will be
posted on ONC’s Web site prior to the
meeting at https://healthit.hhs.gov.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the workgroups. Written
submissions may be made to the contact
person on or before two days prior to
the workgroup’s meeting date. Oral
comments from the public will be
scheduled at the conclusion of each
workgroup meeting. Time allotted for
each presentation will be limited to
three minutes. If the number of speakers
requesting to comment is greater than
can be reasonably accommodated
during the scheduled open public
session, ONC will take written
comments after the meeting until close
of business on that day.
If you require special
accommodations due to a disability,
please contact Judy Sparrow at least
seven (7) days in advance of the
meeting.
ONC is committed to the orderly
conduct of its advisory committee
meetings. Please visit our Web site at
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
22399
https://healthit.hhs.gov for procedures
on public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act
(Pub. L. 92–463, 5 U.S.C., App. 2).
Dated: April 12, 2011.
Judith Sparrow,
Office of Programs and Coordination, Office
of the National Coordinator for Health
Information Technology.
[FR Doc. 2011–9694 Filed 4–20–11; 8:45 am]
BILLING CODE 4150–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[60Day-11–0773]
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
National Surveillance for Severe
Adverse Events Associated with
Treatment of Latent Tuberculosis
Infection—(0920–0773 exp. 04/31/
2011)—Reinstatement with change—
Division of Tuberculosis Elimination
(DTBE), National Center for HIV, Viral
E:\FR\FM\21APN1.SGM
21APN1
22400
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
E:\FR\FM\21APN1.SGM
21APN1
]]>Agencies
[Federal Register Volume 76, Number 77 (Thursday, April 21, 2011)]
[Notices]
[Pages 22399-22400]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-9671]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[60Day-11-0773]
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
National Surveillance for Severe Adverse Events Associated with
Treatment of Latent Tuberculosis Infection--(0920-0773 exp. 04/31/
2011)--Reinstatement with change--Division of Tuberculosis Elimination
(DTBE), National Center for HIV, Viral
[[Page 22400]]
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).
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 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.
Estimate of Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondents respondents responses per response (in (in hours)
respondent hours)
----------------------------------------------------------------------------------------------------------------
Physicians...................................... 10 1 1 10
Nurses.......................................... 10 1 4 40
Medical Clerk................................... 10 1 1 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
