Agency Forms Undergoing Paperwork Reduction Act Review, 55631-55632 [2015-23226]
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55631
Federal Register / Vol. 80, No. 179 / Wednesday, September 16, 2015 / Notices
and Budget, Washington, DC 20503 or
by fax to (202) 395–5806. Written
comments should be received within 30
days of this notice.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30 Day–15–15AIS]
Agency Forms Undergoing Paperwork
Reduction Act Review
The Centers for Disease Control and
Prevention (CDC) has submitted the
following information collection request
to the Office of Management and Budget
(OMB) for review and approval in
accordance with the Paperwork
Reduction Act of 1995. The notice for
the proposed information collection is
published to obtain comments from the
public and affected agencies.
Written comments and suggestions
from the public and affected agencies
concerning the proposed collection of
information are encouraged. Your
comments should address any of the
following: (a) Evaluate whether the
proposed collection of information is
necessary for the proper performance of
the functions of the agency, including
whether the information will have
practical utility; (b) Evaluate the
accuracy of the agencies estimate of the
burden of the proposed collection of
information, including the validity of
the methodology and assumptions used;
(c) Enhance the quality, utility, and
clarity of the information to be
collected; (d) Minimize the burden of
the collection of information on those
who are to respond, including through
the use of appropriate automated,
electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submission of
responses; and (e) Assess information
collection costs.
To request additional information on
the proposed project or to obtain a copy
of the information collection plan and
instruments, call (404) 639–7570 or
send an email to omb@cdc.gov. Written
comments and/or suggestions regarding
the items contained in this notice
should be directed to the Attention:
CDC Desk Officer, Office of Management
Proposed Project
CDC Burden of Canine Brucellosis
Information Collection—New—National
Center for Emerging and Zoonotic
Infectious Diseases, Centers for Disease
Control and Prevention (CDC).
Background and Brief Description
Canine brucellosis is a bacterial
infection caused by the organism
Brucella canis. Few seroprevalence
studies have been done to estimate the
prevalence of canine brucellosis, most
of which were conducted over 25 years
ago. Two recent reports from Oklahoma
and Wisconsin describe increasing
prevalence in dogs; however, the
national burden is not known. B. canis
is also pathogenic to humans, although
human infections are thought to be rare
in the United States.
Unlike Brucella abortus, B. melitensis,
and B. suis, B. canis is not classified as
a select agent. As a result, laboratory
identification of the organism in
humans does not require reporting to
the Laboratory Response Network.
Brucella species-specific data are not
collected in the Nationally Notifiable
Disease Surveillance System at CDC,
and there are no validated Brucella
canis serological tests to diagnose
disease in humans. For these reasons,
there are no national estimates of B.
canis prevalence in humans or canines.
Additionally, canine infections with
other Brucella species have been
reported in the literature. Zoonotic
transmission is a concern with all
Brucella species pathogenic to humans,
and at least one human infection with
B. suis related to canine contact has
been reported. Neither the prevalence of
canine brucellosis nor the potential risk
of zoonotic spread to humans is known.
There has been interest in human
brucellosis caused by B. canis among
the public health community. However,
the degree of public health importance
of human B. canis infections has not yet
been ascertained. The Council of State
and Territorial Epidemiologists
approved a position statement in 2012
that recommends increased focus on B.
canis, and urges CDC to support the
development of a human diagnostic
assay.
The purpose of this information
collection request is to estimate the
burden of canine brucellosis in the
United States, which will aid in the
determination of the level of public
health importance of human B. canis
infections, and the potential for
transmission of brucellosis from dogs.
An estimate of disease burden in dogs
will provide an idea of potential
transmission between dogs and humans,
and determine the need for future
human public health studies, which is
critical during this time of scarce
resources.
Veterinary diagnostic laboratories
throughout the United States will be
solicited to provide information on the
quantity of test requests and positive
results for Brucella spp. in canines,
outsourcing of clinical testing, statewide policies for reporting of positive
results, and policies for human
exposure to clinical specimens or
isolates.
The laboratories were identified
through multiple sources: A review of
the Animal and Plant Health Inspection
Service-approved Brucella diagnostic
laboratories, the National Animal Health
Laboratory Network laboratories, the
American Association of Veterinary
Laboratory Diagnosticians (AAVLD),
and an internet search.
The outcomes of this information
collection are to assess the burden of
disease in the animal host (dogs, in this
case), as well as evaluate the knowledge
and practices of occupational exposures
to the organism. The information
collected will be used to guide a longer
term strategy for identification of human
cases, understanding risk factors and
activities associated with zoonotic
transmission, and eventually validation
of a human diagnostic assay. These
strategies will be implemented using
other mechanisms.
The total annual burden is 139 hours.
asabaliauskas on DSK7TPTVN1PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Veterinary diagnostic laboratory staff .............
Burden of Canine Brucellosis Information
Collection.
Telephone script .............................................
Non-responders (over estimation) ..................
VerDate Sep<11>2014
18:18 Sep 15, 2015
Jkt 235001
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
E:\FR\FM\16SEN1.SGM
Number of
responses per
respondent
Average
burden per
response
(in hrs.)
119
1
1
119
1
5/60
16SEN1
55632
Federal Register / Vol. 80, No. 179 / Wednesday, September 16, 2015 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Number of
responses per
respondent
Number of
respondents
Type of respondents
Form name
Other laboratories ...........................................
Burden of Canine Brucellosis Information
Collection.
10
1
Average
burden per
response
(in hrs.)
1
Total
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–23226 Filed 9–15–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Tribal TANF Data Report, TANF
Annual Report, and Reasonable Cause/
Corrective Action Documentation
Process.
OMB No.: 0970–0215.
Description: 42 U.S.C. 612 (Section
412 of the Social Security Act as
amended by Public Law 104–193, the
Personal Responsibility and Work
Opportunity Reconciliation Act of 1996
(PRWORA)), mandates that federally
recognized Indian Tribes with an
approved Tribal TANF program collect
and submit to the Secretary of the
Department of Health and Human
Services data on the recipients served
by the Tribes’ programs. This
information includes both aggregated
and disaggregated data on case
characteristics and individual
characteristics. In addition, Tribes that
are subject to a penalty are allowed to
provide reasonable cause justifications
as to why a penalty should not be
imposed or may develop and implement
corrective compliance procedures to
eliminate the source of the penalty.
Finally, there is an annual report, which
requires the Tribes to describe program
characteristics. All of the above
requirements are currently approved by
OMB and the Administration for
Children and Families is simply
proposing to extend them without any
changes.
Respondents: Indian Tribes.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
asabaliauskas on DSK7TPTVN1PROD with NOTICES
Final Tribal TANF Data Report ........................................................................
Tribal TANF Annual Report .............................................................................
Tribal TANF Reasonable Cause/Corrective ....................................................
Estimated Total Annual Burden
Hours: 133,280.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following:
VerDate Sep<11>2014
18:18 Sep 15, 2015
Jkt 235001
70
70
70
Office of Management and Budget,
Paperwork Reduction Project, Fax: 202–
395–7285, Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–23179 Filed 9–15–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–2102]
Syed Huda: Debarment Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
PO 00000
Notice.
Frm 00045
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
4
1
1
Average
burden hours
per response
451
40
60
Total burden
hours
126,280
2,800
4,200
The U.S. Food and Drug
Administration (FDA or Agency) is
issuing an order under the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) permanently debarring Syed
Huda from providing services in any
capacity to a person that has an
approved or pending drug product
application. FDA bases this order on a
finding that Mr. Huda was convicted of
two felonies under Federal law for
conduct relating to the regulation of a
drug product. Mr. Huda was given
notice of the proposed permanent
debarment and an opportunity to
request a hearing within the timeframe
prescribed by regulation. Mr. Huda
failed to respond. Mr. Huda’s failure to
respond constitutes a waiver of his right
to a hearing concerning this action.
DATES: This order is effective September
16, 2015.
ADDRESSES: Submit applications for
special termination of debarment to the
Division of Dockets Management (HFA–
SUMMARY:
E:\FR\FM\16SEN1.SGM
16SEN1
]]>Agencies
[Federal Register Volume 80, Number 179 (Wednesday, September 16, 2015)]
[Notices]
[Pages 55631-55632]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23226]
[[Page 55631]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30 Day-15-15AIS]
Agency Forms Undergoing Paperwork Reduction Act Review
The Centers for Disease Control and Prevention (CDC) has submitted
the following information collection request to the Office of
Management and Budget (OMB) for review and approval in accordance with
the Paperwork Reduction Act of 1995. The notice for the proposed
information collection is published to obtain comments from the public
and affected agencies.
Written comments and suggestions from the public and affected
agencies concerning the proposed collection of information are
encouraged. Your comments should address any of the following: (a)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility; (b) Evaluate the
accuracy of the agencies estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (c) Enhance the quality, utility, and clarity of
the information to be collected; (d) Minimize the burden of the
collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses; and
(e) Assess information collection costs.
To request additional information on the proposed project or to
obtain a copy of the information collection plan and instruments, call
(404) 639-7570 or send an email to omb@cdc.gov. Written comments and/or
suggestions regarding the items contained in this notice should be
directed to the Attention: 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
CDC Burden of Canine Brucellosis Information Collection--New--
National Center for Emerging and Zoonotic Infectious Diseases, Centers
for Disease Control and Prevention (CDC).
Background and Brief Description
Canine brucellosis is a bacterial infection caused by the organism
Brucella canis. Few seroprevalence studies have been done to estimate
the prevalence of canine brucellosis, most of which were conducted over
25 years ago. Two recent reports from Oklahoma and Wisconsin describe
increasing prevalence in dogs; however, the national burden is not
known. B. canis is also pathogenic to humans, although human infections
are thought to be rare in the United States.
Unlike Brucella abortus, B. melitensis, and B. suis, B. canis is
not classified as a select agent. As a result, laboratory
identification of the organism in humans does not require reporting to
the Laboratory Response Network. Brucella species-specific data are not
collected in the Nationally Notifiable Disease Surveillance System at
CDC, and there are no validated Brucella canis serological tests to
diagnose disease in humans. For these reasons, there are no national
estimates of B. canis prevalence in humans or canines.
Additionally, canine infections with other Brucella species have
been reported in the literature. Zoonotic transmission is a concern
with all Brucella species pathogenic to humans, and at least one human
infection with B. suis related to canine contact has been reported.
Neither the prevalence of canine brucellosis nor the potential risk of
zoonotic spread to humans is known.
There has been interest in human brucellosis caused by B. canis
among the public health community. However, the degree of public health
importance of human B. canis infections has not yet been ascertained.
The Council of State and Territorial Epidemiologists approved a
position statement in 2012 that recommends increased focus on B. canis,
and urges CDC to support the development of a human diagnostic assay.
The purpose of this information collection request is to estimate
the burden of canine brucellosis in the United States, which will aid
in the determination of the level of public health importance of human
B. canis infections, and the potential for transmission of brucellosis
from dogs. An estimate of disease burden in dogs will provide an idea
of potential transmission between dogs and humans, and determine the
need for future human public health studies, which is critical during
this time of scarce resources.
Veterinary diagnostic laboratories throughout the United States
will be solicited to provide information on the quantity of test
requests and positive results for Brucella spp. in canines, outsourcing
of clinical testing, state-wide policies for reporting of positive
results, and policies for human exposure to clinical specimens or
isolates.
The laboratories were identified through multiple sources: A review
of the Animal and Plant Health Inspection Service-approved Brucella
diagnostic laboratories, the National Animal Health Laboratory Network
laboratories, the American Association of Veterinary Laboratory
Diagnosticians (AAVLD), and an internet search.
The outcomes of this information collection are to assess the
burden of disease in the animal host (dogs, in this case), as well as
evaluate the knowledge and practices of occupational exposures to the
organism. The information collected will be used to guide a longer term
strategy for identification of human cases, understanding risk factors
and activities associated with zoonotic transmission, and eventually
validation of a human diagnostic assay. These strategies will be
implemented using other mechanisms.
The total annual burden is 139 hours.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hrs.)
----------------------------------------------------------------------------------------------------------------
Veterinary diagnostic laboratory staff Burden of Canine 119 1 1
Brucellosis Information
Collection.
Non-responders (over estimation)...... Telephone script........ 119 1 5/60
[[Page 55632]]
Other laboratories.................... Burden of Canine 10 1 1
Brucellosis Information
Collection.
-----------------------------------------------
Total
----------------------------------------------------------------------------------------------------------------
Leroy A. Richardson,
Chief, Information Collection Review Office, Office of Scientific
Integrity, Office of the Associate Director for Science, Office of the
Director, Centers for Disease Control and Prevention.
[FR Doc. 2015-23226 Filed 9-15-15; 8:45 am]
BILLING CODE 4163-18-P
