Agency Forms Undergoing Paperwork Reduction Act Review, 55549-55551 [2018-24231]
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55549
Federal Register / Vol. 83, No. 215 / Tuesday, November 6, 2018 / Notices
respondents. Seven-month quit rates
have been previously estimated for all
Quitline callers except those that call
the ASQ. Based on previous literature
and a review of the follow-up evaluation
data previously collected by the NQDW,
seven-month quit rates are not expected
to change significantly over time. Data
on the quitline call volume, number of
tobacco users served, and the services
offered by state quitlines will be
provided by state health department
personnel who manage the quitline, or
their designee, such as contracted
quitline service providers, using the
NQDW Quitline Services Survey.
Data collected from the NQDW is
analyzed with simple descriptive data
tabulations, and trends are currently
reported online through the CDC State
Tobacco Activities Tracking and
Evaluation (STATE) System website.
More complex statistical analyses,
including multivariate regression
techniques will be utilized to assess
quitline outcomes such as quitline
reach, service utilization, how callers
reported hearing about the quitline, and
the effectiveness of quitline promotions
and the CDC Tips From Former Smokers
national tobacco education media
campaigns on state quitline call volume
and tobacco users receiving services
from state quitlines.
CDC uses the information collected by
the NQDW for ongoing monitoring,
reporting, and evaluation related to state
quitlines. Select data from the NQDW
are reported online through the CDC’s
STATE System website (https://
www.cdc.gov/statesystem). The total
estimated annual Burden Hours for
NQDW are 82,477.
ESTIMATED ANNUALIZED BURDEN HOURS
Type of respondent
Quitline callers who contact the
quitline for help for themselves.
NQDW
Intake
Questionnaire
(English-complete).
ASQ Intake Questionnaire (Chinese,
Korean, or Vietnamese-complete).
ASQ Seven-Month Follow-up Questionnaire.
Caller who contacts the Quitline on NQDW
Intake
Questionnaire
behalf of someone else.
(English-subset).
ASQ Intake Questionnaire (Chinese,
Korean, or Vietnamese-subset).
Tobacco Control Manager or their Submission of NQDW Intake QuesDesignee/Quitline Service Provider.
tionnaire Electronic Data File to
CDC.
Submission of NQDW (ASQ)
Seven-Month Follow-up Electronic
Data File to CDC.
NQDW Quitline Services Survey .....
Total ...........................................
...........................................................
Jeffrey M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2018–24232 Filed 11–5–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[30Day–19–18AEJ]
khammond on DSK30JT082PROD with NOTICES
Agency Forms Undergoing Paperwork
Reduction Act Review
In accordance with the Paperwork
Reduction Act of 1995, the Centers for
Disease Control and Prevention (CDC)
has submitted the information
collection request titled Natural History
of Clostridium difficile Colonization and
Infection to the Office of Management
and Budget (OMB) for review and
approval. CDC previously published a
VerDate Sep<11>2014
17:05 Nov 05, 2018
Jkt 247001
Frm 00036
Fmt 4703
Total burden
(in hours)
488,846
1
10/60
81,474
1,935
1
10/60
323
1,587
1
7/60
185
12,217
1
1/60
204
86
1
1/60
2
54
4
1
216
1
1
1
1
54
4
20/60
72
........................
........................
........................
82,477
‘‘Proposed Data Collection Submitted
for Public Comment and
Recommendations’’ notice on May 29,
2018 to obtain comments from the
public and affected agencies. CDC
received one comment related to the
previous notice. This notice serves to
allow an additional 30 days for public
and affected agency comments.
CDC will accept all comments for this
proposed information collection project.
The Office of Management and Budget
is particularly interested in comments
that:
(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;
PO 00000
Average
burden per
respondent
(in hours)
Number of
responses per
respondent
Number of
respondents
Form name
Sfmt 4703
(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. Direct
written comments and/or suggestions
regarding the items contained in this
notice to the Attention: CDC Desk
Officer, Office of Management and
Budget, 725 17th Street NW,
Washington, DC 20503 or by fax to (202)
395–5806. Provide written comments
within 30 days of notice publication.
E:\FR\FM\06NON1.SGM
06NON1
55550
Federal Register / Vol. 83, No. 215 / Tuesday, November 6, 2018 / Notices
Proposed Project
Natural History of Clostridium
difficile Colonization and Infection—
New—National Center for Emerging and
Zoonotic Infectious Diseases (NCEZID),
Centers for Disease Control and
Prevention (CDC).
Background and Brief Description
A broad 60-day notice was published
in the Federal Register on May 29,
2018, Vol. 83, No. 103, pp. 24475–
24476. This 60-day notice notified the
public of the broad agency
announcement—Applied Research to
Address Emerging Public Health
Priorities—being made by CDC. Though
not specific to this project, it informed
the public of CDC’s intent to contract
with researchers to carry out a variety of
different research projects.
Current estimates from the CDC
suggest that Clostridium difficile now
causes more healthcare-associated
infections than any other pathogen.
However, only 10% to 60% of those
acquiring colonization with toxigenic
strains develop C. difficile infection
(CDI), with the remainder becoming
asymptomatic carriers. Current infection
control measures focus almost entirely
on patients with CDI, but several recent
studies suggest that asymptomatic
carriers of toxigenic C. difficile may be
an under-appreciated source of
transmission. Unfortunately, the natural
history of C. difficile colonization is not
well described because previous studies
have not included long-term follow-up
of colonized patients and have not
included strain-specific information.
Previous studies of C. difficile carriage
have also rarely included assessments of
the burden of carriage, the frequency of
skin and environmental shedding, and
the impact of antibiotics and other
healthcare exposures on colonization.
The primary goal of this project is to
develop a better understanding of the
natural history of C. difficile
colonization and infection to develop
more effective control measures. The
study will answer several questions.
How often do patients acquire C.
difficile colonization and shed the
organism in their stool? Once
colonization is acquired, how long do
patients continue to shed C. difficile in
their stool? How often do patients who
acquire C. difficile colonization develop
diarrhea? Are some types of C. difficile
strains more likely to cause diarrhea or
more likely to be shed in stool for a long
time? Finally, do factors like antibiotic
treatment, other medications, and diet
affect the duration and amount of C.
difficile shed in stool?
The results of the study will be used
in the design of interventions to prevent
transmission by asymptomatic carriers.
The findings will be valuable for
development of accurate transmission
models including estimation of the
effects of prevention interventions and
the data will be made available for
development of mathematical models of
C. difficile transmission. Finally, the
study will provide current information
on the incubation period for CDI and the
fraction of carriers that progress to CDI.
The study hospitals will include the
Cleveland VA Medical Center,
MetroHealth Medical Center, and the
Medical University of South Carolina
(MUSC). We will conduct a one-year
cohort study of 1200 total patients,
including 800 admitted to the hospital,
300 admitted to a long-term care facility
(LTCF), and 100 outpatients with no
healthcare admissions within 3 months.
Peri-rectal, groin, chest/abdomen/hand,
and environmental swabs will be
collected weekly while in the hospital
or LTCF for up to 4 weeks; for
outpatients, swabs will be collected
weekly for up to 4 weeks. Our goal will
be to identify patients with new
acquisition of toxigenic C. difficile
carriage to study the natural history of
carriage. Based on previous studies, we
anticipate that ∼12% of patients will
acquire colonization (145 total). For
patients with new acquisition of
carriage, additional swabs will be
collected up to once each month for six
months to determine the natural history
of colonization and if CDI is diagnosed,
stool specimens will be cultured.
One of our goals is to determine the
impact of a variety of factors including
antibiotic therapy, medications (e.g.,
laxatives), diet, and strain type on
duration and burden of C. difficile
colonization. In addition, we will obtain
information regarding symptoms of
diarrhea. To obtain this information, we
will perform chart review and
interviews. For all subjects, chart review
will be conducted during and after
admission to obtain information on
demographics, co-morbidities, prior
CDI, ward location, devices,
incontinence, bathing practices, proton
pump inhibitor use, mobility, diarrhea,
laxatives, and antibiotics (categorized
based upon anti-anaerobic and anti-C.
difficile activity). To supplement
information from chart review, subjects
will be interviewed by study personnel
at the time of each culture collection to
obtain information on diarrhea,
medications including antibiotics,
proton pump inhibitors, and laxatives,
diet, bathing practices, and fecal
incontinence.
The information being collected
through chart review and interviews
will be valuable to identify factors
associated with C. difficile colonization
and infection. If this information were
not collected, we would not be able to
adequately assess factors that could
affect C. difficile colonization or
infection and/or that could lead to
gastrointestinal symptoms.
To supplement information from
chart review, subjects will be
interviewed by study personnel
(contractors) at the time of each culture
collection to obtain information on
diarrhea, medications including
antibiotics, proton pump inhibitors, and
laxatives, diet, bathing practices, and
fecal incontinence. The questions will
be administered by study personnel
who will be trained by the principal
investigator or co-investigators. All
subjects will be interviewed. The
respondents will have advance notice or
appointments.
Total annualized Burden Hours for
this study are 577. There is no burden
on respondents other than the time to
participate. Authorizing legislation
comes from Section 301 of the Public
Health Service Act. CDC is seeking one
year of clearance to complete this study.
khammond on DSK30JT082PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS
Type of
respondents
Form name
Study participants ...........................................
Subjects acquiring C. difficile colonization .....
Subjects developing CDI ................................
Questionnaire .................................................
Questionnaire .................................................
Questionnaire .................................................
VerDate Sep<11>2014
17:05 Nov 05, 2018
Jkt 247001
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Number of
respondents
E:\FR\FM\06NON1.SGM
Number of
responses per
respondent
1200
145
48
06NON1
5
6
1
Average
burden per
response
(in hours)
5/60
5/60
5/60
55551
Federal Register / Vol. 83, No. 215 / Tuesday, November 6, 2018 / Notices
Jeffrey M. Zirger,
Acting Lead, Information Collection Review
Office, Office of Scientific Integrity, Office
of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2018–24231 Filed 11–5–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Proposed Projects
Title: Tribal TANF Data Report, TANF
Annual Report, and Reasonable Cause/
Corrective Action Documentation
Process—Final.
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
khammond on DSK30JT082PROD with NOTICES
Final Tribal TANF Data Report ........................................................................
Tribal TANF Annual Report .............................................................................
Tribal TANF Reasonable Cause/Corrective ....................................................
Estimated Total Annual Burden
Hours: 140,896.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
VerDate Sep<11>2014
17:05 Nov 05, 2018
Jkt 247001
74
74
74
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018–24259 Filed 11–5–18; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–0138]
Questions and Answers Regarding
Mandatory Food Recalls: Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or we) is
announcing the availability of a final
guidance for industry and FDA staff
entitled ‘‘Questions and Answers
Regarding Mandatory Food Recalls:
Guidance for Industry and FDA Staff.’’
The guidance provides information on
the implementation of the mandatory
food recall provisions of the FDA Food
Safety Modernization Act (FSMA). The
guidance is in the form of Questions and
SUMMARY:
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
4
1
1
Average
burden hours
per response
451
40
60
Total burden
hours
133,496
2,960
4,440
Answers and provides answers to
common questions that might arise
about the mandatory recall provisions
and FDA’s plans for their
implementation.
DATES: The announcement of the
guidance is published in the Federal
Register on November 6, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
E:\FR\FM\06NON1.SGM
06NON1
]]>Agencies
[Federal Register Volume 83, Number 215 (Tuesday, November 6, 2018)]
[Notices]
[Pages 55549-55551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24231]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[30Day-19-18AEJ]
Agency Forms Undergoing Paperwork Reduction Act Review
In accordance with the Paperwork Reduction Act of 1995, the Centers
for Disease Control and Prevention (CDC) has submitted the information
collection request titled Natural History of Clostridium difficile
Colonization and Infection to the Office of Management and Budget (OMB)
for review and approval. CDC previously published a ``Proposed Data
Collection Submitted for Public Comment and Recommendations'' notice on
May 29, 2018 to obtain comments from the public and affected agencies.
CDC received one comment related to the previous notice. This notice
serves to allow an additional 30 days for public and affected agency
comments.
CDC will accept all comments for this proposed information
collection project. The Office of Management and Budget is particularly
interested in comments that:
(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 [email protected]. Direct written comments
and/or suggestions regarding the items contained in this notice to the
Attention: CDC Desk Officer, Office of Management and Budget, 725 17th
Street NW, Washington, DC 20503 or by fax to (202) 395-5806. Provide
written comments within 30 days of notice publication.
[[Page 55550]]
Proposed Project
Natural History of Clostridium difficile Colonization and
Infection--New--National Center for Emerging and Zoonotic Infectious
Diseases (NCEZID), Centers for Disease Control and Prevention (CDC).
Background and Brief Description
A broad 60-day notice was published in the Federal Register on May
29, 2018, Vol. 83, No. 103, pp. 24475-24476. This 60-day notice
notified the public of the broad agency announcement--Applied Research
to Address Emerging Public Health Priorities--being made by CDC. Though
not specific to this project, it informed the public of CDC's intent to
contract with researchers to carry out a variety of different research
projects.
Current estimates from the CDC suggest that Clostridium difficile
now causes more healthcare-associated infections than any other
pathogen. However, only 10% to 60% of those acquiring colonization with
toxigenic strains develop C. difficile infection (CDI), with the
remainder becoming asymptomatic carriers. Current infection control
measures focus almost entirely on patients with CDI, but several recent
studies suggest that asymptomatic carriers of toxigenic C. difficile
may be an under-appreciated source of transmission. Unfortunately, the
natural history of C. difficile colonization is not well described
because previous studies have not included long-term follow-up of
colonized patients and have not included strain-specific information.
Previous studies of C. difficile carriage have also rarely included
assessments of the burden of carriage, the frequency of skin and
environmental shedding, and the impact of antibiotics and other
healthcare exposures on colonization.
The primary goal of this project is to develop a better
understanding of the natural history of C. difficile colonization and
infection to develop more effective control measures. The study will
answer several questions. How often do patients acquire C. difficile
colonization and shed the organism in their stool? Once colonization is
acquired, how long do patients continue to shed C. difficile in their
stool? How often do patients who acquire C. difficile colonization
develop diarrhea? Are some types of C. difficile strains more likely to
cause diarrhea or more likely to be shed in stool for a long time?
Finally, do factors like antibiotic treatment, other medications, and
diet affect the duration and amount of C. difficile shed in stool?
The results of the study will be used in the design of
interventions to prevent transmission by asymptomatic carriers. The
findings will be valuable for development of accurate transmission
models including estimation of the effects of prevention interventions
and the data will be made available for development of mathematical
models of C. difficile transmission. Finally, the study will provide
current information on the incubation period for CDI and the fraction
of carriers that progress to CDI.
The study hospitals will include the Cleveland VA Medical Center,
MetroHealth Medical Center, and the Medical University of South
Carolina (MUSC). We will conduct a one-year cohort study of 1200 total
patients, including 800 admitted to the hospital, 300 admitted to a
long-term care facility (LTCF), and 100 outpatients with no healthcare
admissions within 3 months. Peri-rectal, groin, chest/abdomen/hand, and
environmental swabs will be collected weekly while in the hospital or
LTCF for up to 4 weeks; for outpatients, swabs will be collected weekly
for up to 4 weeks. Our goal will be to identify patients with new
acquisition of toxigenic C. difficile carriage to study the natural
history of carriage. Based on previous studies, we anticipate that ~12%
of patients will acquire colonization (145 total). For patients with
new acquisition of carriage, additional swabs will be collected up to
once each month for six months to determine the natural history of
colonization and if CDI is diagnosed, stool specimens will be cultured.
One of our goals is to determine the impact of a variety of factors
including antibiotic therapy, medications (e.g., laxatives), diet, and
strain type on duration and burden of C. difficile colonization. In
addition, we will obtain information regarding symptoms of diarrhea. To
obtain this information, we will perform chart review and interviews.
For all subjects, chart review will be conducted during and after
admission to obtain information on demographics, co-morbidities, prior
CDI, ward location, devices, incontinence, bathing practices, proton
pump inhibitor use, mobility, diarrhea, laxatives, and antibiotics
(categorized based upon anti-anaerobic and anti-C. difficile activity).
To supplement information from chart review, subjects will be
interviewed by study personnel at the time of each culture collection
to obtain information on diarrhea, medications including antibiotics,
proton pump inhibitors, and laxatives, diet, bathing practices, and
fecal incontinence.
The information being collected through chart review and interviews
will be valuable to identify factors associated with C. difficile
colonization and infection. If this information were not collected, we
would not be able to adequately assess factors that could affect C.
difficile colonization or infection and/or that could lead to
gastrointestinal symptoms.
To supplement information from chart review, subjects will be
interviewed by study personnel (contractors) at the time of each
culture collection to obtain information on diarrhea, medications
including antibiotics, proton pump inhibitors, and laxatives, diet,
bathing practices, and fecal incontinence. The questions will be
administered by study personnel who will be trained by the principal
investigator or co-investigators. All subjects will be interviewed. The
respondents will have advance notice or appointments.
Total annualized Burden Hours for this study are 577. There is no
burden on respondents other than the time to participate. Authorizing
legislation comes from Section 301 of the Public Health Service Act.
CDC is seeking one year of clearance to complete this study.
Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Type of respondents Form name Number of responses per per response
respondents respondent (in hours)
----------------------------------------------------------------------------------------------------------------
Study participants.................... Questionnaire........... 1200 5 5/60
Subjects acquiring C. difficile Questionnaire........... 145 6 5/60
colonization.
Subjects developing CDI............... Questionnaire........... 48 1 5/60
----------------------------------------------------------------------------------------------------------------
[[Page 55551]]
Jeffrey M. Zirger,
Acting Lead, Information Collection Review Office, Office of Scientific
Integrity, Office of Science, Centers for Disease Control and
Prevention.
[FR Doc. 2018-24231 Filed 11-5-18; 8:45 am]
BILLING CODE 4163-18-P
