Agency Forms Undergoing Paperwork Reduction Act Review, 52494-52495 [E9-24520]
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52494
Federal Register / Vol. 74, No. 196 / Tuesday, October 13, 2009 / Notices
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance on Reagents For Detection of
Specific Novel Influenza A Viruses–21
CFR 866.3332–(OMB Control Number
0910–0584)–Extension
In accordance with section 513 of the
Federal Food, Drug, and Cosmetic Act
(the act) (21 U.S.C. 360c), FDA
evaluated an application for an in vitro
diagnostic device for detection of
influenza subtype H5 (Asian lineage),
commonly known as avian flu. FDA
concluded that this device is properly
classified into class II in accordance
with 21 U.S.C. 360c(a)(1)(B), because it
is a device for which the general
controls by themselves are insufficient
to provide reasonable assurance of the
safety and effectiveness of the device,
but there is sufficient information to
establish special controls to provide
such assurance.
The statute permits FDA to establish
as special controls many different
things, including postmarket
surveillance, development and
dissemination of guidance
recommendations, and ‘‘other
appropriate actions as the Secretary
deems necessary’’ (21 U.S.C.
360c(a)(1)(B)). This information
collection is a measure that FDA
determined to be necessary to provide
reasonable assurance of safety and
effectiveness of reagents for detection of
specific novel influenza A viruses.
FDA issued an order classifying the
H5 (Asian lineage) diagnostic device
into class II on February 3, 2006,
establishing the special controls
necessary to provide reasonable
assurance of the safety and effectiveness
of that device and similar future
devices. The new classification will be
codified in 21 CFR 866.3332, a
regulation that will describe the new
classification for reagents for detection
of specific novel influenza A viruses
and set forth the special controls that
help to provide a reasonable assurance
of the safety and effectiveness of devices
classified under that regulation. The
regulation will refer to the special
controls guidance document entitled
‘‘Class II Special Controls Guidance
Document: Reagents for Detection of
Specific Novel Influenza A Viruses,’’
which provides recommendations for
measures to help provide a reasonable
assurance of safety and effectiveness for
these reagents.
The guidance document recommends
that sponsors obtain and analyze
postmarket data to ensure the continued
reliability of their device in detecting
the specific novel influenza A virus that
it is intended to detect, particularly
given the propensity for influenza
viruses to mutate and the potential for
changes in disease prevalence over time.
As updated sequences for novel
influenza A viruses become available
from the World Health Organization,
National Institutes of Health, and other
public health entities, sponsors of
reagents for detection of specific novel
influenza A viruses will collect this
information, compare them with the
primer/probe sequences in their
devices, and incorporate the result of
these analyses into their quality
management system, as required by 21
CFR 820.100(a)(1). These analyses will
be evaluated against the device design
validation and risk analysis required by
21 CFR 820.30(g), to determine if any
design changes may be necessary.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
Section of the
Federal Food,
Drug, and Cosmetic Act
No. of
Respondents
erowe on DSK5CLS3C1PROD with NOTICES
513
Annual Frequency
per Response
10
2
FDA estimates that 10 respondents
will be affected annually. Each
respondent will collect this information
twice per year, estimated to take 10
hours. This results in a total data
collection burden of 200 hours (10 x 20=
200). FDA estimates that cost of
developing standard operating
procedures for each data collection is
$500 (10 hours of work at $50/hour).
This results in a total cost to industry of
$5,000 ($500 x 10 respondents).
The guidance also refers to previously
approved information collections found
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Total Annual
Responses
Hours per
Response
20
Total Hours
10
in FDA regulations. The information
collections in 21 CFR part 820 have
been approved under OMB control
number 0910–0073.
Dated: October 5, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–24544 Filed 10–9–09; 8:45 am]
Total Operating &
Maintenance
Costs
200
$5,000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–09–0469]
Agency Forms Undergoing Paperwork
Reduction Act Review
BILLING CODE 4160–01–S
PO 00000
The Centers for Disease Control and
Prevention (CDC) publishes a list of
information collection requests under
review by the Office of Management and
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52495
Federal Register / Vol. 74, No. 196 / Tuesday, October 13, 2009 / Notices
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
National Program of Cancer Registries
Cancer Surveillance System (OMB no.
0920–0469 exp. Date 1/31/2010)—
Revision—National Center for Chronic
Disease Prevention and Health
Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In 1992, Congress passed the Cancer
Registries Amendment Act, which
established the National Program of
Cancer Registries (NPCR). The NPCR
provides support for central cancer
registries (CCR) that collect, manage and
analyze data about cancer cases. The
NPCR-funded CCR, which are located in
states, the District of Columbia, and U.S.
territories, report information to CDC
annually through the National Program
of Cancer Registries Cancer Surveillance
System (NPCR CSS) (OMB No. 0920–
0469, exp. 1/31/2010). CDC plans to
request OMB approval to continue
collecting this information for three
years.
The NPCR CSS allows CDC to collect,
aggregate, evaluate and disseminate
cancer incidence data at the national
level, and is the primary source of
information for United States Cancer
Statistics (USCS), which CDC has
published annually since 2002. The
NPCR CSS also allows CDC to monitor
cancer trends over time, describe
geographic variation in cancer incidence
throughout the country, and provide
incidence data on minority populations
and rare cancers. These activities and
analyses further support CDC’s planning
and evaluation efforts for State and
national cancer control and prevention.
In addition, datasets can be made
available for secondary analysis.
Each responding CCR is asked to
report a cumulative file containing
incidence data from the first diagnosis
year for which the cancer registry
collected data with the assistance of
NPCR funds (e.g., 1995) through 12
months past the close of the most recent
diagnosis year (e.g., 2007). Because
cancer incidence data are already
collected and aggregated at the State
level the additional burden of reporting
the information to CDC is small.
Information is transmitted to CDC
electronically once per year.
The Revision request will include
changes. First, data definitions will be
updated to reflect changes in national
standards for cancer diagnosis and
coding. In addition, the number of
respondents will decrease. Respondents
will be 45 State-based CCR, the CCR of
the District of Columbia, the CCR of
Puerto Rico, and the CCR that aggregates
information from 10 flag territories and
freely associated States in the Pacific
Islands. States that receive sole funding
from the National Cancer Institute are
not included as respondents. The
adjusted number of respondents will
result in a reduction in the total
estimated burden hours for the NPCR
CSS. The estimated burden per response
will not change.
There are no costs to respondents
except their time. The total estimated
annualized burden hours are 96.
ESTIMATED ANNUALIZED BURDEN HOURS
Respondents
Number of
respondents
Number of responses per
respondent
Average
burden per
response
(in hours)
Central Cancer Registries in States, Territories, and the District of Columbia ..........................
48
1
2
Dated: October 5, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–24520 Filed 10–9–09; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
erowe on DSK5CLS3C1PROD with NOTICES
[Docket No. FDA–2009–N–0406]
Agency Emergency Processing Under
Office of Management and Budget
Review; Tobacco Product
Establishment Registration and
Submission of Certain Health
Information; Reopening of the
Comment Period
AGENCY:
Food and Drug Administration,
HHS.
ACTION: Notice; reopening of the
comment period.
VerDate Nov<24>2008
15:29 Oct 09, 2009
Jkt 220001
SUMMARY: The Food and Drug
Administration (FDA) is reopening until
October 26, 2009, the comment period
for the notice published in the Federal
Register of September 1, 2009 (74 FR
45219). The document announced the
proposed collection of information
concerning the submission of tobacco
product establishment registration and
submission of certain health
information, including ingredient listing
and health related documents, as
required by The Family Smoking
Prevention and Tobacco Control Act
(FSPTCA). The agency is reopening the
comment period because FDA has
reevaluated the expected launch date of
the electronic portal and to allow
interested persons additional time to
review the proposed collection of
information and submit comments.
DATES: Fax written comments on the
collection of information by October 26,
2009. FDA is requesting approval of this
emergency processing by November 2,
2009.
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ADDRESSES: To ensure that comments on
the information collection are received,
the Office of Management and Budget
(OMB) recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–5806, or e-mailed to
oira_submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–NEW. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of the Chief
Information Officer (HFA–710), Food
and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301–796–
3794, e-mail:
Jonnalynn.Capezzuto@fda.hhs.gov.
In the
Federal Register of September 1, 2009
(74 FR 45219), FDA requested
emergency processing of this proposed
collection of information under section
SUPPLEMENTARY INFORMATION:
E:\FR\FM\13OCN1.SGM
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]]>Agencies
[Federal Register Volume 74, Number 196 (Tuesday, October 13, 2009)]
[Notices]
[Pages 52494-52495]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24520]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-09-0469]
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
[[Page 52495]]
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
National Program of Cancer Registries Cancer Surveillance System
(OMB no. 0920-0469 exp. Date 1/31/2010)--Revision--National Center for
Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
In 1992, Congress passed the Cancer Registries Amendment Act, which
established the National Program of Cancer Registries (NPCR). The NPCR
provides support for central cancer registries (CCR) that collect,
manage and analyze data about cancer cases. The NPCR-funded CCR, which
are located in states, the District of Columbia, and U.S. territories,
report information to CDC annually through the National Program of
Cancer Registries Cancer Surveillance System (NPCR CSS) (OMB No. 0920-
0469, exp. 1/31/2010). CDC plans to request OMB approval to continue
collecting this information for three years.
The NPCR CSS allows CDC to collect, aggregate, evaluate and
disseminate cancer incidence data at the national level, and is the
primary source of information for United States Cancer Statistics
(USCS), which CDC has published annually since 2002. The NPCR CSS also
allows CDC to monitor cancer trends over time, describe geographic
variation in cancer incidence throughout the country, and provide
incidence data on minority populations and rare cancers. These
activities and analyses further support CDC's planning and evaluation
efforts for State and national cancer control and prevention. In
addition, datasets can be made available for secondary analysis.
Each responding CCR is asked to report a cumulative file containing
incidence data from the first diagnosis year for which the cancer
registry collected data with the assistance of NPCR funds (e.g., 1995)
through 12 months past the close of the most recent diagnosis year
(e.g., 2007). Because cancer incidence data are already collected and
aggregated at the State level the additional burden of reporting the
information to CDC is small. Information is transmitted to CDC
electronically once per year.
The Revision request will include changes. First, data definitions
will be updated to reflect changes in national standards for cancer
diagnosis and coding. In addition, the number of respondents will
decrease. Respondents will be 45 State-based CCR, the CCR of the
District of Columbia, the CCR of Puerto Rico, and the CCR that
aggregates information from 10 flag territories and freely associated
States in the Pacific Islands. States that receive sole funding from
the National Cancer Institute are not included as respondents. The
adjusted number of respondents will result in a reduction in the total
estimated burden hours for the NPCR CSS. The estimated burden per
response will not change.
There are no costs to respondents except their time. The total
estimated annualized burden hours are 96.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Central Cancer Registries in States, Territories, and the 48 1 2
District of Columbia........................................
----------------------------------------------------------------------------------------------------------------
Dated: October 5, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for Disease Control and
Prevention.
[FR Doc. E9-24520 Filed 10-9-09; 8:45 am]
BILLING CODE 4163-18-P
