Agency Forms Undergoing Paperwork Reduction Act Review, 22886-22887 [2013-08912]
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22886
Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Notices
ESTIMATE ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total burden
(in hours)
Type of respondent
Form name
Key informant interview respondents
Focus group respondents .................
Intercept respondents .......................
Telephone survey respondents ........
Interview guide .................................
Moderator guide ...............................
Intercept script ..................................
Survey ..............................................
6
14
40
1,000
1
1
1
1
30/60
2
30/60
27/60
3
28
20
450
Total ...........................................
...........................................................
........................
........................
........................
501
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2013–08911 Filed 4–16–13; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–13–0469]
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
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) 639–7570 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.
sroberts on DSK5SPTVN1PROD with NOTICES
Proposed Project
National Program of Cancer Registries
Cancer Surveillance System—(0920–
0469 Reinstatement Exp. 11/30/2012)—
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
VerDate Mar<15>2010
16:50 Apr 16, 2013
Jkt 229001
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). Many registries
maintain additional data items that are
not part of the standard NPCR CSS
report to CDC.
The NPCR CSS has allowed CDC to
collect, aggregate, evaluate and
disseminate cancer incidence data at the
national and state 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. Finally, datasets compiled
through the NPCR CSS have been made
available to investigators for secondary
analysis.
CDC plans to request OMB approval
to reinstate the NPCR CSS information
collection, with changes. First, the
frequency of reporting to CDC will be
changed from an annual to a semiannual schedule. The additional report
will allow CDC to compile preliminary
cancer incidence estimates in advance
of the lengthy process of data validation
required for each registry’s final annual
report. Second, data definitions for each
report will be updated to reflect changes
in national standards for cancer
diagnosis, treatment, and coding. These
changes will affect the standard reports
for all NPCR-funded central cancer
registries.
The third set of changes applies to a
subset of 10 cancer registries. These
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
CCR received ARRA funding to develop
common standards and reporting
mechanisms for enhanced description of
cases of breast cancer, colorectal cancer,
and chronic myelogenous leukemia. The
enhanced data items will support more
in-depth analysis of treatment strategies
and patient outcomes than is currently
possible with the standard NPCR CSS
information collection. The 10 registries
that participated in the enhancement
process will begin reporting the
additional data items to CDC in 2013 as
part of their routine submission. CDC
plans to make de-identified data
available for comparative effectiveness
research.
OMB approval will be requested for
three years. Respondents will be 48
NPCR-supported central cancer
registries in the U.S. (45 states, the
District of Columbia, Puerto Rico, and
the Pacific Islands jurisdictions).
Information will be reported
electronically to CDC twice per year.
The first report will consist of a singleyear file for data that includes diagnosis
12 months past the close of the
diagnosis year. The second report will
consist of 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 24
months past the close of the diagnosis
year (e.g., 2010 data submitted in 2012).
The estimated burden per response is
two hours. Because cancer incidence
data are already collected, aggregated
and used for analyses at the state level,
the additional burden of reporting the
information to CDC is modest and the
number of data items in the report does
not affect the estimated burden per
response.
There are no costs to respondents
except their time. The total estimated
annualized burden hours are 192.
E:\FR\FM\17APN1.SGM
17APN1
22887
Federal Register / Vol. 78, No. 74 / Wednesday, April 17, 2013 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Respondents
Form name
Central Cancer Registries in States, Territories, and the District of Columbia.
Standard NPCR CSS Report
38
2
2
Enhanced NPCR Report .......
10
2
2
Ron A. Otten,
Director, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2013–08912 Filed 4–16–13; 8:45 am]
approval expires on March 31, 2016. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: April 11, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2013–08906 Filed 4–16–13; 8:45 am]
BILLING CODE 4160–01–P
Food and Drug Administration
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2011–N–0867]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Experimental Study on the Public
Display of Lists of Harmful and
Potential Harmful Tobacco
Constituents
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Experimental Study on the Public
Display of Lists of Harmful and
Potential Harmful Tobacco
Constituents’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, Daniel.Gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On May 8,
2012, the Agency submitted a proposed
collection of information entitled
‘‘Experimental Study on the Public
Display of Lists of Harmful and
Potential Harmful Tobacco
Constituents’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0736. The
sroberts on DSK5SPTVN1PROD with NOTICES
SUMMARY:
16:50 Apr 16, 2013
[Docket No. FDA–2011–D–0104]
Guidance for Industry on NonPenicillin Beta-Lactam Drugs: A
Current Good Manufacturing Practices
Framework for Preventing CrossContamination; Availability
AGENCY:
Notice.
VerDate Mar<15>2010
Food and Drug Administration
Jkt 229001
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Non-Penicillin Beta-Lactam
Drugs: A CGMP Framework for
Preventing Cross-Contamination.’’ This
guidance describes the importance of
implementing controls to prevent crosscontamination of finished
pharmaceuticals and active
pharmaceutical ingredients (APIs) with
non-penicillin beta-lactams. This
guidance also provides information
regarding the relative health risk of, and
the potential for, cross-reactivity in the
classes of sensitizing beta-lactams
(including both penicillins and nonpenicillin beta-lactams), beta-lactamase
inhibitors, and beta-lactam
intermediates and derivatives. Finally,
this guidance clarifies that
manufacturers should generally utilize
separate facilities for manufacture of
non-penicillin beta-lactams because
those compounds pose health risks
associated with cross-reactivity.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
SUMMARY:
PO 00000
Frm 00046
Fmt 4703
Sfmt 4703
Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Paula Katz, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, rm. 4314, Silver Spring,
MD 20993–0002, 301–796–6972.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
I. Background
FDA is announcing the availability of
a guidance for industry entitled ‘‘NonPenicillin Beta-Lactam Drugs: A CGMP
Framework for Preventing CrossContamination.’’ This guidance
describes the importance of
implementing controls to prevent crosscontamination of finished
pharmaceuticals and APIs with nonpenicillin beta-lactam drugs. This
guidance also provides information
regarding the relative health risk of, and
the potential for, cross-reactivity in the
classes of sensitizing beta-lactams
(including both penicillins and nonpenicillin beta-lactams). Finally, this
guidance clarifies that manufacturers
should generally utilize separate
facilities for manufacture of nonpenicillin beta-lactams because those
compounds pose health risks associated
with cross-reactivity.
Although the existing current good
manufacturing practices (CGMP)
regulations require separation of
manufacturing facilities to avoid crosscontamination, the only class of
products for which the regulations
specify particular separation
E:\FR\FM\17APN1.SGM
17APN1
]]>Agencies
[Federal Register Volume 78, Number 74 (Wednesday, April 17, 2013)]
[Notices]
[Pages 22886-22887]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-08912]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 Day-13-0469]
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 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) 639-7570 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 Program of Cancer Registries Cancer Surveillance System--
(0920-0469 Reinstatement Exp. 11/30/2012)--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). Many registries maintain additional data items
that are not part of the standard NPCR CSS report to CDC.
The NPCR CSS has allowed CDC to collect, aggregate, evaluate and
disseminate cancer incidence data at the national and state 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. Finally,
datasets compiled through the NPCR CSS have been made available to
investigators for secondary analysis.
CDC plans to request OMB approval to reinstate the NPCR CSS
information collection, with changes. First, the frequency of reporting
to CDC will be changed from an annual to a semi-annual schedule. The
additional report will allow CDC to compile preliminary cancer
incidence estimates in advance of the lengthy process of data
validation required for each registry's final annual report. Second,
data definitions for each report will be updated to reflect changes in
national standards for cancer diagnosis, treatment, and coding. These
changes will affect the standard reports for all NPCR-funded central
cancer registries.
The third set of changes applies to a subset of 10 cancer
registries. These CCR received ARRA funding to develop common standards
and reporting mechanisms for enhanced description of cases of breast
cancer, colorectal cancer, and chronic myelogenous leukemia. The
enhanced data items will support more in-depth analysis of treatment
strategies and patient outcomes than is currently possible with the
standard NPCR CSS information collection. The 10 registries that
participated in the enhancement process will begin reporting the
additional data items to CDC in 2013 as part of their routine
submission. CDC plans to make de-identified data available for
comparative effectiveness research.
OMB approval will be requested for three years. Respondents will be
48 NPCR-supported central cancer registries in the U.S. (45 states, the
District of Columbia, Puerto Rico, and the Pacific Islands
jurisdictions). Information will be reported electronically to CDC
twice per year. The first report will consist of a single-year file for
data that includes diagnosis 12 months past the close of the diagnosis
year. The second report will consist of 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 24 months past the close of the diagnosis year (e.g., 2010 data
submitted in 2012). The estimated burden per response is two hours.
Because cancer incidence data are already collected, aggregated and
used for analyses at the state level, the additional burden of
reporting the information to CDC is modest and the number of data items
in the report does not affect the estimated burden per response.
There are no costs to respondents except their time. The total
estimated annualized burden hours are 192.
[[Page 22887]]
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Central Cancer Registries in States, Standard NPCR CSS Report 38 2 2
Territories, and the District of
Columbia.
Enhanced NPCR Report.... 10 2 2
----------------------------------------------------------------------------------------------------------------
Ron A. Otten,
Director, Office of Scientific Integrity, Office of the Associate
Director for Science, Office of the Director, Centers for Disease
Control and Prevention.
[FR Doc. 2013-08912 Filed 4-16-13; 8:45 am]
BILLING CODE 4163-18-P
