Agency Forms Undergoing Paperwork Reduction Act review, 48349-48350 [2010-19702]
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48349
Federal Register / Vol. 75, No. 153 / Tuesday, August 10, 2010 / Notices
ESTIMATED ANNUALIZED BURDEN TABLE—Continued
Respondents
Director of health information
management
(DHIM)
or
Health information technology
(DHIT).
DHIM or DHIT ............................
DHIM or DHIT ............................
Acute Coronary Syndrome Pretest:
Hospital CEO/CFO ....................
DHIM or DHIT ............................
Total ....................................
Induction (including
questionnaire).
1
4
668
Post induction annual facility questionnaire.
transmit UB–04 ................................
500
2
1
1,000
500
4
1
2,000
Presentation at hospital ...................
Pulling medical records for abstraction.
11
11
1
1
1
30/60
11
6
...........................................................
........................
........................
........................
3,852
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30-Day-10–10CV]
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) 395–5806. Written
comments should be received within 30
days of this notice.
sroberts on DSKB9S0YB1PROD with NOTICES
Proposed Project
Early Aberration Reporting System
(EARS) Registration Module—New—
National Center for Emerging and
Zoonotic Infectious Diseases
(NCEZID)(proposed), Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
To support two of CDC’s main priority
areas: (1) Improving CDC’s support for
state and local health departments, and
(2) strengthening surveillance and
epidemiology, CDC is requesting
approval from the Office of Management
16:26 Aug 09, 2010
Total burden
hours
167
[FR Doc. 2010–19704 Filed 8–9–10; 8:45 am]
Jkt 220001
initial
Average
burden per
response
(in hours)
facility
Dated: August 4, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
VerDate Mar<15>2010
Number of
responses per
respondent
Number of
respondents
Form
and Budget (OMB) to improve the Early
Aberration Reporting System (EARS) by
collecting data from individuals who
request a download of EARS from the
CDC Web site.
The Early Aberration Reporting
System, developed within the Division
of Bioterrorism Preparedness and
Response, is a Web-enabled tool that
analyzes public health surveillance data
using methods that detect abnormal
trends that could possibly indicate an
outbreak of infectious disease. The local
public health professionals manage the
entire tool and can implement the
defaults or can adjust the tool in order
to meet their local needs. The goal of
this process is to assist public health
professionals in the early identification
of outbreaks of disease as well as
bioterrorism events. EARS is used to
assess whether the current number of
reported cases of an event is higher than
usual.
The term syndromic surveillance is
used to describe surveillance that uses
health-related data that precede
diagnosis and that signals a sufficient
probability of a case or an outbreak of
infectious disease to warrant further
public health response. Syndromic
surveillance systems are used by state,
local, national and international health
departments to monitor syndrome-based
(e.g., case information collected in
emergency departments (EDs) and
diagnostic data sources for early
detection of outbreaks and other public
health events). More recently these
systems are used during public health
responses to provide more rapid near
real-time situational awareness
regarding the health status of the target
population. EARS were the first
software platform to support local
syndromic surveillance systems. EARS
has been designed and used to monitor
syndromic data from emergency
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
departments, 911 calls, physician office
data, school and business absenteeism,
over-the-counter drug sales, laboratory
testing and results data and reportable
disease surveillance systems. In the past
several years, EARS systems have been
integral in the local public health
surveillance arsenal. EARS has been
used at events such as the Beijing
Summer Olympics; multiple
Superbowls (football) and World Series
(baseball); the political conventions of
both major US political parties; and the
Presidential Inauguration (2009).
Today, EARS is a highly successful
and sustainable system and has over 200
users at the federal, state, local, and
international levels. These users include
international Ministries of Health and
domestic state and local public health
departments. Additionally, EARS
detection methods have been integrated
in well-known surveillance platforms
such as BioSense at CDC, ESSENSE at
Johns Hopkins, NAMRD at US
Department of Defense, and Emergint at
Northrop Grumman.
EARS is widely-accepted and easily
sustainable due to its being free to all
end users, the capacity to use multiple
forms of data, flexibility and user-driven
design and maintenance. EARS is a
service provided by CDC as share-ware
and is available by download at no cost
from the CDC Web site https://
www.bt.cdc.gov/surveillance/EARS.
In an effort to continue to improve
and enhance EARS, the collection of
registration information is needed to
track users and organizations to assist in
future needs assessments. Requiring the
users to register will provide CDC with
contact information (i.e., e-mail
addresses) to use for broadcast e-mails
regarding new releases for upgrades and
enhancements; track the number of
users, the download frequency, and the
type of data that users will monitor with
E:\FR\FM\10AUN1.SGM
10AUN1
48350
Federal Register / Vol. 75, No. 153 / Tuesday, August 10, 2010 / Notices
EARS; and solicit users for feedback for
future upgrades and enhancements.
There is no cost to respondents to
participate in this program. The total
estimated annualized burden for this
data collection is 25 hours.
ESTIMATE OF ANNUALIZED BURDEN HOURS
Respondents
Number of
respondents
Number of
responses per
respondent
Average
burden
per
response
(in hours)
Users ............................................................................................................................................
150
1
10/60
Dated: August 4, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–19702 Filed 8–9–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0256. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
[Docket No. FDA–2010–N–0190]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Infant Formula
Requirements
Denver Presley Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUPPLEMENTARY INFORMATION:
Food and Drug Administration
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by September
9, 2010.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
SUMMARY:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Infant Formula Requirements—21 CFR
Parts 106 and 107 (OMB Control
Number 0910–0256)—Extension
Statutory requirements for infant
formula under the Federal Food, Drug,
and Cosmetic Act (the act) are intended
to protect the health of infants and
include a number of reporting and
recordkeeping requirements. Among
other things, section 412 of the act (21
U.S.C. 350a) requires manufacturers of
infant formula to establish and adhere to
quality control procedures, notify FDA
when a batch of infant formula that has
left the manufacturers’ control may be
adulterated or misbranded, and keep
records of distribution. FDA has issued
regulations to implement the act’s
requirements for infant formula in parts
106 and 107 (21 CFR parts 106 and 107).
FDA also regulates the labeling of infant
formula under the authority of section
403 of the act (21 U.S.C. 343). Under the
labeling regulations for infant formula
in part 107, the label of an infant
formula must include nutrient
information and directions for use. The
purpose of these labeling requirements
is to ensure that consumers have the
information they need to prepare and
use infant formula appropriately. In a
notice of proposed rulemaking
published in the Federal Register of
July 9, 1996 (61 FR 36154), FDA
proposed changes in the infant formula
regulations, including some of those
listed in tables 1, 2, and 3 of this
document. The document included
revised burden estimates for the
proposed changes and solicited public
comment. In the interim, however, FDA
is seeking an extension of OMB
approval for the current regulations so
that it can continue to collect
information while the proposal is
pending.
In the Federal Register of May 4, 2010
(75 FR 23777), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Federal Food, Drug, and
Cosmetic Act or
21 CFR Section
Annual Frequency
per
Response
No. of
Respondents
Total Annual
Responses
Hours per
Response
Total Hours
5
13
65
10
650
21 CFR 106.120(b)
sroberts on DSKB9S0YB1PROD with NOTICES
Section 412(d) of the act
1
1
1
4
4
21 CFR 107.50(b)(3) and
(b)(4)
3
2
6
4
24
21 CFR 107.50(e)(2)
1
1
1
4
4
Total
1 There
682
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Mar<15>2010
18:03 Aug 09, 2010
Jkt 220001
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
E:\FR\FM\10AUN1.SGM
10AUN1
]]>Agencies
[Federal Register Volume 75, Number 153 (Tuesday, August 10, 2010)]
[Notices]
[Pages 48349-48350]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-19702]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30-Day-10-10CV]
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) 395-5806.
Written comments should be received within 30 days of this notice.
Proposed Project
Early Aberration Reporting System (EARS) Registration Module--New--
National Center for Emerging and Zoonotic Infectious Diseases
(NCEZID)(proposed), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
To support two of CDC's main priority areas: (1) Improving CDC's
support for state and local health departments, and (2) strengthening
surveillance and epidemiology, CDC is requesting approval from the
Office of Management and Budget (OMB) to improve the Early Aberration
Reporting System (EARS) by collecting data from individuals who request
a download of EARS from the CDC Web site.
The Early Aberration Reporting System, developed within the
Division of Bioterrorism Preparedness and Response, is a Web-enabled
tool that analyzes public health surveillance data using methods that
detect abnormal trends that could possibly indicate an outbreak of
infectious disease. The local public health professionals manage the
entire tool and can implement the defaults or can adjust the tool in
order to meet their local needs. The goal of this process is to assist
public health professionals in the early identification of outbreaks of
disease as well as bioterrorism events. EARS is used to assess whether
the current number of reported cases of an event is higher than usual.
The term syndromic surveillance is used to describe surveillance
that uses health-related data that precede diagnosis and that signals a
sufficient probability of a case or an outbreak of infectious disease
to warrant further public health response. Syndromic surveillance
systems are used by state, local, national and international health
departments to monitor syndrome-based (e.g., case information collected
in emergency departments (EDs) and diagnostic data sources for early
detection of outbreaks and other public health events). More recently
these systems are used during public health responses to provide more
rapid near real-time situational awareness regarding the health status
of the target population. EARS were the first software platform to
support local syndromic surveillance systems. EARS has been designed
and used to monitor syndromic data from emergency departments, 911
calls, physician office data, school and business absenteeism, over-
the-counter drug sales, laboratory testing and results data and
reportable disease surveillance systems. In the past several years,
EARS systems have been integral in the local public health surveillance
arsenal. EARS has been used at events such as the Beijing Summer
Olympics; multiple Superbowls (football) and World Series (baseball);
the political conventions of both major US political parties; and the
Presidential Inauguration (2009).
Today, EARS is a highly successful and sustainable system and has
over 200 users at the federal, state, local, and international levels.
These users include international Ministries of Health and domestic
state and local public health departments. Additionally, EARS detection
methods have been integrated in well-known surveillance platforms such
as BioSense at CDC, ESSENSE at Johns Hopkins, NAMRD at US Department of
Defense, and Emergint at Northrop Grumman.
EARS is widely-accepted and easily sustainable due to its being
free to all end users, the capacity to use multiple forms of data,
flexibility and user-driven design and maintenance. EARS is a service
provided by CDC as share-ware and is available by download at no cost
from the CDC Web site https://www.bt.cdc.gov/surveillance/EARS.
In an effort to continue to improve and enhance EARS, the
collection of registration information is needed to track users and
organizations to assist in future needs assessments. Requiring the
users to register will provide CDC with contact information (i.e., e-
mail addresses) to use for broadcast e-mails regarding new releases for
upgrades and enhancements; track the number of users, the download
frequency, and the type of data that users will monitor with
[[Page 48350]]
EARS; and solicit users for feedback for future upgrades and
enhancements.
There is no cost to respondents to participate in this program. The
total estimated annualized burden for this data collection is 25 hours.
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Users........................................................ 150 1 10/60
----------------------------------------------------------------------------------------------------------------
Dated: August 4, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2010-19702 Filed 8-9-10; 8:45 am]
BILLING CODE 4163-18-P
