Agency Forms Undergoing Paperwork Reduction Act Review, 52953-52954 [2010-21497]
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52953
Federal Register / Vol. 75, No. 167 / Monday, August 30, 2010 / Notices
questions about the caseload for the
registry (the number of new cancer cases
reported annually), the sources of case
information, whether case information
is collected utilizing manual or
electronic methods, and the type of
software employed for electronic
collection. Because many tasks can be
performed manually or using electronic
methods, and because cancer coding
systems are frequently revised to reflect
changes in cancer diagnosis and care,
the WLM survey asks registry managers
to identify training needs that would
improve registry productivity, and to
provide comments about other resource
needs and management issues.
The web-based WLM Survey will also
collect information about the total
amount of time dedicated by registry
staff to specific activities such as case
finding, records abstraction, follow-up,
quality assurance, professional
development, travel, and death
clearances. In order to complete this
section of the WLM survey, detailed
information will be collected from
registry staff. An average of eight
registrars in each registry will be asked
to maintain a paper Work Activities
Journal for a one-week period. Each
registrar will record the number of
hours and minutes dedicated to case
finding, records abstraction, follow-up,
and quality assurance, and where
applicable, indicate whether tasks were
conducted manually or electronically.
In addition, each registrar will estimate
the amount of time dedicated to
auditing, database management,
professional development, travel, and
death clearances on a monthly or annual
basis. At the end of the one-week data
collection period, the registry manager
will compile information from all of the
Work Activities Journals completed by
the registry’s staff. The aggregate
information will be reported to CDC
through the WLM Survey. The
individual Work Activities Journals will
not be submitted to CDC.
Findings from the WLM survey will
enable CDC to assess the workforce
necessary for meeting data reporting
requirements and to estimate the impact
of planned changes to surveillance data
reporting. CDC plans to develop
guidance so that cancer registry
managers can more effectively measure
workload, evaluate the need for staff
and staff credentials, and advocate for
adequate staffing.
OMB approval is requested for one
year. Participation in the survey is
voluntary. There are no costs to
respondents other than their time. The
total estimated annualized burden hours
are 921.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
NPCR managers .............................................
Workload and Time Management Survey .....
Telephone Reminder ......................................
Work Activities Journal ...................................
NPCR Staff Registrars ....................................
Dated: August 23, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–21496 Filed 8–27–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[30Day–10–10AK]
jlentini on DSKJ8SOYB1PROD 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
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 20503 or by fax to (202) 395–5806.
Written comments should be received
within 30 days of this notice.
16:28 Aug 27, 2010
Jkt 220001
National Notifiable Condition
Messaging Support Strategy—New—
Public Health Surveillance Program
Office (PHSPO); Office of Surveillance,
Epidemiology, and Laboratory Services
(OSELS), Centers for Disease Control
and Prevention, (CDC).
Background and Brief Description
Centers for Disease Control and
Prevention
VerDate Mar<15>2010
Proposed Project
The Public Health Services Act (42
U.S.C. 241) authorizes CDC to
disseminate nationally notifiable
condition information. CDC’s Morbidity
and Mortality Weekly Report publishes
incidence tables for nationally notifiable
conditions reported through the
National Electronic Disease Surveillance
System (NEDSS) and other surveillance
data sources to the National Notifiable
Diseases Surveillance System (NNDSS).
NEDSS (OMB 0920–0728, expiration
date: 2/28/2010) is an internet-based
infrastructure for public health
surveillance data exchange that uses
specific Public Health Information
Network (PHIN) and NEDSS electronic
data and information standards to
advance the development of efficient,
integrated, and interoperable
surveillance systems at federal, state
and local levels. CDC’s proposed Public
Health Surveillance Program Office
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46
15
368
Number of
responses per
respondent
1
1
1
Average
burden per
response
(in hours)
4
3/60
2
(PHSPO) is responsible for establishing
and managing the national reporting
system of epidemiologic data for
notifiable conditions (diseases) via
NEDSS.
Case notification messaging for most
of the nationally notifiable conditions
(77 infectious conditions as of August
2009) will eventually be supported by
the standard Health Level 7 v2.5 (HL7)
message format. The HL7 message
format requires a Message Mapping
Guide (MMG)—developed by the
NEDSS and NNDSS programs, in
collaboration with state and federal
subject matter experts—to implement
case notification to CDC via NEDSS. At
present, seven MMGs are available for
implementation by jurisdictions, and
current NEDSS resources support the
development of three new MMGs per
year. A jurisdiction’s implementation of
a MMG requires an average of four
months per MMG, and a jurisdiction
could potentially implement up to three
MMGs a year. In most instances,
National Center for Public Health
Informatics’ (NCPHI) programmatic and
technical expertise is required to
support this process at the jurisdictional
level.
The National Notifiable Condition
Messaging Support Strategy
E:\FR\FM\30AUN1.SGM
30AUN1
52954
Federal Register / Vol. 75, No. 167 / Monday, August 30, 2010 / Notices
Questionnaire has been developed by
the NEDSS program to gather
information needed for formulating a
technical and project management
support strategy for 57 reporting
jurisdictions (i.e., 50 states, 5 territories,
and 2 cities (New York City, NY and
Washington, DC)) as they implement
NEDSS messaging using MMGs. A
jurisdiction’s response to the
questionnaire will be used by the
NEDSS implementation and
management teams to assess the
jurisdiction’s IT system environment
and capacity and help determine the
project schedule and level of human
and technical support needed to
complete the jurisdiction’s
implementation of a nationally
notifiable condition message. NEDSS
infrastructure implementation support
includes, but is not limited to
implementing NEDSS Message
Subscription Service (MSS) and NEDSS
Messaging Solution (NMS) software in
requesting jurisdictions; providing MSS
and NMS software training and ongoing
technical support; and distributing
funding via the CDC Epidemiology and
Laboratory Capacity cooperative
agreement.
Questionnaires will be distributed to
jurisdictions that initiate MMG
implementation for a condition;
therefore, the maximum annual
frequency of responses per jurisdiction
is three. The NEDSS team will request
the jurisdiction to voluntarily complete
the questionnaire, but a response is not
a pre-requisite for support.
There is no cost to respondents other
than their time to participate in the
survey. The total estimated annual
burden hours are 114.
ESTIMATE OF ANNUALIZED BURDEN HOURS
Number of
respondents
Respondents
Form name
State, Territory and Local Public Health Department.
National Notifiable Condition Messaging
Support Strategy Questionnaire.
Dated: August 23, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. 2010–21497 Filed 8–27–10; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0258]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Submission of
Petitions: Food Additive, Color
Additive (Including Labeling), and
Generally Recognized as Safe
Affirmation; Submission of Information
to a Master File in Support of Petitions;
Electronic Submission Using Food and
Drug Administration Form 3503
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
29, 2010.
ADDRESSES: To ensure that comments on
the information collection are received,
jlentini on DSKJ8SOYB1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:41 Aug 27, 2010
Jkt 220001
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0016. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
3793.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Submission of Petitions: Food Additive,
Color Additive (Including Labeling),
and Generally Recognized as Safe
Affirmation; Submission of Information
to a Master File in Support of Petitions;
Electronic Submission Using FDA Form
3503—21 CFR 70.25, 71.1, 170.35,
171.1, 172, 173, 179, and 180 (OMB
Control Number 0910–0016)—Revision
Section 409(a) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 348(a)) provides that a food
additive shall be deemed to be unsafe,
unless: (1) The additive and its use, or
intended use, are in conformity with a
regulation issued under section 409 of
the FD&C Act that describes the
condition(s) under which the additive
may be safely used; (2) the additive and
PO 00000
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57
Number of
responses per
respondent
3
Average
burden per
response
(in hours)
40/60
its use, or intended use, conform to the
terms of an exemption for
investigational use; or (3) a food contact
notification submitted under section
409(h) of the FD&C Act is effective.
Food additive petitions (FAPs) are
submitted by individuals or companies
to obtain approval of a new food
additive or to amend the conditions of
use permitted under an existing food
additive regulation. Section 171.1 of
FDA’s regulations (21 CFR 171.1)
specifies the information that a
petitioner must submit in order to
establish that the proposed use of a food
additive is safe and to secure the
publication of a food additive regulation
describing the conditions under which
the additive may be safely used. Parts
172, 173, 179, and 180 (21 CFR parts
172, 173, 179, and 180) contain labeling
requirements for certain food additives
to ensure their safe use.
Section 721(a) of the FD&C Act (21
U.S.C. 379e(a)) provides that a color
additive shall be deemed to be unsafe
unless the additive and its use are in
conformity with a regulation that
describes the condition(s) under which
the additive may safely be used, or the
additive and its use conform to the
terms of an exemption for
investigational use issued under section
721(f) of the FD&C Act. Color additive
petitions (CAPs) are submitted by
individuals or companies to obtain
approval of a new color additive or a
change in the conditions of use
permitted for a color additive that is
already approved. Section 71.1 of the
agency’s regulations (21 CFR 71.1)
specifies the information that a
E:\FR\FM\30AUN1.SGM
30AUN1
]]>Agencies
[Federal Register Volume 75, Number 167 (Monday, August 30, 2010)]
[Notices]
[Pages 52953-52954]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-21497]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-10-10AK]
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 20503 or by fax to (202) 395-
5806. Written comments should be received within 30 days of this
notice.
Proposed Project
National Notifiable Condition Messaging Support Strategy--New--
Public Health Surveillance Program Office (PHSPO); Office of
Surveillance, Epidemiology, and Laboratory Services (OSELS), Centers
for Disease Control and Prevention, (CDC).
Background and Brief Description
The Public Health Services Act (42 U.S.C. 241) authorizes CDC to
disseminate nationally notifiable condition information. CDC's
Morbidity and Mortality Weekly Report publishes incidence tables for
nationally notifiable conditions reported through the National
Electronic Disease Surveillance System (NEDSS) and other surveillance
data sources to the National Notifiable Diseases Surveillance System
(NNDSS).
NEDSS (OMB 0920-0728, expiration date: 2/28/2010) is an internet-
based infrastructure for public health surveillance data exchange that
uses specific Public Health Information Network (PHIN) and NEDSS
electronic data and information standards to advance the development of
efficient, integrated, and interoperable surveillance systems at
federal, state and local levels. CDC's proposed Public Health
Surveillance Program Office (PHSPO) is responsible for establishing and
managing the national reporting system of epidemiologic data for
notifiable conditions (diseases) via NEDSS.
Case notification messaging for most of the nationally notifiable
conditions (77 infectious conditions as of August 2009) will eventually
be supported by the standard Health Level 7 v2.5 (HL7) message format.
The HL7 message format requires a Message Mapping Guide (MMG)--
developed by the NEDSS and NNDSS programs, in collaboration with state
and federal subject matter experts--to implement case notification to
CDC via NEDSS. At present, seven MMGs are available for implementation
by jurisdictions, and current NEDSS resources support the development
of three new MMGs per year. A jurisdiction's implementation of a MMG
requires an average of four months per MMG, and a jurisdiction could
potentially implement up to three MMGs a year. In most instances,
National Center for Public Health Informatics' (NCPHI) programmatic and
technical expertise is required to support this process at the
jurisdictional level.
The National Notifiable Condition Messaging Support Strategy
[[Page 52954]]
Questionnaire has been developed by the NEDSS program to gather
information needed for formulating a technical and project management
support strategy for 57 reporting jurisdictions (i.e., 50 states, 5
territories, and 2 cities (New York City, NY and Washington, DC)) as
they implement NEDSS messaging using MMGs. A jurisdiction's response to
the questionnaire will be used by the NEDSS implementation and
management teams to assess the jurisdiction's IT system environment and
capacity and help determine the project schedule and level of human and
technical support needed to complete the jurisdiction's implementation
of a nationally notifiable condition message. NEDSS infrastructure
implementation support includes, but is not limited to implementing
NEDSS Message Subscription Service (MSS) and NEDSS Messaging Solution
(NMS) software in requesting jurisdictions; providing MSS and NMS
software training and ongoing technical support; and distributing
funding via the CDC Epidemiology and Laboratory Capacity cooperative
agreement.
Questionnaires will be distributed to jurisdictions that initiate
MMG implementation for a condition; therefore, the maximum annual
frequency of responses per jurisdiction is three. The NEDSS team will
request the jurisdiction to voluntarily complete the questionnaire, but
a response is not a pre-requisite for support.
There is no cost to respondents other than their time to
participate in the survey. The total estimated annual burden hours are
114.
Estimate of Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
State, Territory and Local Public National Notifiable 57 3 40/60
Health Department. Condition Messaging
Support Strategy
Questionnaire.
----------------------------------------------------------------------------------------------------------------
Dated: August 23, 2010.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease Control and Prevention.
[FR Doc. 2010-21497 Filed 8-27-10; 8:45 am]
BILLING CODE 4163-18-P
