Attachment 2a - 30 day FRN

64228

Federal Register / Vol. 72, No. 220 / Thursday, November 15, 2007 / Notices

registered attendees badges that must be
worn at all times and returned to
security prior to exiting the Cohen
Building.
Registration questions may be
directed to Experient at
PAguidelines@experient-inc.com (email), (703) 525–8333 x3346 (phone) or
(703) 525–8557 (fax).
Dated: November 8, 2007.
Penelope Slade Royall,
RADM, USPHS, Deputy Assistant Secretary
for Health, Office of Disease Prevention and
Health Promotion.
[FR Doc. E7–22333 Filed 11–14–07; 8:45 am]
BILLING CODE 4150–32–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–08–05AJ]

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 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
National Surveillance for Severe
Adverse Events Associated with
Treatment of Latent Tuberculosis
Infection—New, Division of
Tuberculosis Elimination (DTBE),
National Center for HIV/AIDS, Viral
Hepatitis, STD, and TB Prevention
(NCHSTP), Centers for Disease Control
and Prevention (CDC).
Background and Brief Description
Between October 2000 and October
2007, 79 patients receiving treatment for
Latent TB Infection (LTBI) were
reported to the Division of Tuberculosis
Elimination (DTBE), Centers for Disease
Control and Prevention (CDC) with
severe adverse events to their
medications(s). A severe adverse event
is defined as a drug-related reaction
resulting in hospitalization or death of
a person receiving treatment for LTBI.
Deaths reported among persons with
LTBI included, 2 of 50 persons who
were on the recommended two-month
regimen of rifampin and pyrazinamide
(RZ); 9 of 22 treated with isoniazid
alone, and 2 of 3 patients on other
regimens (e.g., pyrazinamide and
ethambutol). Severe adverse events such
as hospitalizations, liver transplants,
and death related to treatment of LTBI
continue to be reported to DTBE.
The purpose of this information
collection request is to determine the

annual number and trends of severe
adverse events associated with
treatment of LTBI and identify common
characteristics of patients with severe
adverse events during treatment of
LTBI. Potential correspondents 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 8 jurisdictions in the
Pacific and Caribbean). Data will be
collected using the data collection form
for adverse event associated with LTBI
treatment (AELT). The AELT form is
completed 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 but it does not
include the disease context and risk
factors that are essential for revising
treatment options for LTBI. Reporting
will be conducted through telephone, email, or during CDC site visits. There is
no cost to respondents other than their
time to gather medical records to
complete the form. The total estimated
annualized burden hours are 32.

ESTIMATED ANNUALIZED BURDEN
Type of respondent

Form name

Physician ...........................................................................
Nurses ...............................................................................
Medical Clerk ....................................................................

AELT ..........................
AELT ..........................
AELT ..........................

Dated: November 6, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–22308 Filed 11–14–07; 8:45 am]
BILLING CODE 4163–18–P

Number of
respondents
4
4
4

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–08–07AU]

pwalker on PROD1PC71 with NOTICES

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

VerDate Aug<31>2005

19:50 Nov 14, 2007

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Number reponses
per respondent

Average burden
per response
(in hours)

1
1
1

3
4
1

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
Methicillin-Resistant Staphylococcus
aureus (MRSA) Infection Control
Practices Survey—New—National
Center for Preparedness, Detection, and
Control of Infectious Diseases
(NCPDCID), Centers for Disease Control
and Prevention (CDC).

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64229

Federal Register / Vol. 72, No. 220 / Thursday, November 15, 2007 / Notices
Background and Brief Description
In October, 2006, CDC recommended
specific strategies to reduce
transmission of multi-drug resistant
organisms, including MRSA, in U.S.
hospitals. Currently detailed data on
ongoing MRSA prevention efforts at
hospitals reporting to CDC surveillance
systems is unknown. CDC has
developed a survey to assess MRSA
prevention programs in place at health
care facilities reporting MRSA infection
data to CDC through established
surveillance systems. In this project,

infection control practitioners in all
hospitals that participate in the MRSA
portion of the Active Bacterial Core
Surveillance System will be surveyed
electronically three times. There will be
an initial baseline survey and then two
follow-up surveys, each a year apart.
The surveys will determine if changes
in infection control practice correlate
with changes in rates of MRSA
infections. The proposed survey will
provide data that can be used to assess
progress toward achieving CDC’s Health
Protection Goals. The survey will also
provide data on facility-based MRSA

Number of
respondents

Respondents
Infection Control Practitioners ...................................................................................

Dated: November 8, 2007.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E7–22314 Filed 11–14–07; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–08–0728]

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 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.

pwalker on PROD1PC71 with NOTICES

Proposed Project
The National Electronic Disease
Surveillance System (NEDSS)—
Extension—National Center for Public
Health Informatics (NCPHI), Centers for
Disease Control and Prevention (CDC).

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19:50 Nov 14, 2007

Jkt 214001

prevention policies and procedures that
may affect MRSA infection rates. These
results will inform CDC in the
prevention and control of MRSA.
This proposed project supports CDC’s
Goal of ‘‘Healthy People in Healthy
Places’’ and its Strategic Goal to
‘‘Increase the number of health care
institutions that comply with evidence
based guidelines for infection control.’’
There is no cost to respondents other
than their time to complete the survey.
The total estimated annualized burden
hours are 105 hours.

210

Background and Brief Description
CDC is responsible for the
dissemination of nationally notifiable
diseases information and for monitoring
and reporting the impact of epidemic
influenza on mortality, Public Health
Services Act (42 U.S.C. 241). Since
April 1984, CDC Epidemiology Program
Office (EPO) has been working with the
Council of State and Territorial
Epidemiologists (CSTE) to demonstrate
the efficiency and effectiveness of
computer transmission of surveillance
data between CDC and the state health
departments.
By 1989, all 50 states were using this
computerized disease surveillance
system, which was then renamed the
National Electronic
Telecommunications System for
Surveillance (NETSS) to reflect its
national scope (OMB numbers 0920–
0447 and 0920–0007).
Beginning in 1999, CDC,
Epidemiology Program Office (EPO)
worked with CSTE, state and local
public health system staff, and other
CDC disease prevention and control
program staff to identify information
categories and information technology
standards to support integrated disease
surveillance. That effort is now focused
on development and completion of the
National Electronic Disease Surveillance
System (NEDSS), coordinated by CDC’s
National Center for Public Health
Informatics, Division of Integrated
Surveillance Systems and Services
(DISSS).
States will continue to use portions of
NETSS to transmit data to CDC. One of

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Number of
responses per
respondent

Average burden
per response
(in hours)
1

30/60

the reasons for providing NETSS to
NEDSS data mapping is to identify what
data elements in NETSS correspond to
data elements in NEDSS. Those
elements mapped from NETSS to
NEDSS were collected in OMB number
0920–0007.
NEDSS will electronically integrate
and link together a wide variety of
surveillance activities and will facilitate
more accurate and timely reporting of
disease information to CDC and state
and local health departments.
Consistent with recommendations
supported by our state and local
surveillance partners and described in
the 1995 report, Integrating Public
Health Information and Surveillance
Systems, NEDSS includes data
standards, an internet based
communications infrastructure built on
industry standards, and policy-level
agreements on data access, sharing,
burden reduction, and protection of
confidentiality.
To support NEDSS, CDC has
developed an information system, the
NEDSS Base System (NBS), which uses
NEDSS technical and information
standards. The NBS is currently
deployed to 16 states, including AL, AR,
ID, MD, ME, MT, NE, NM, NV, RI, SC,
TN, TX, VA, VT, and WY.
CDC is requesting a three-year OMB
clearance extension of collecting the
NEDSS data. There are no costs to
respondents other than their time. The
average total annualized burden for the
Weekly Morbidity Reports and the
Annual Summary Report is 9,384 hours.

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