Submission for OMB Review; Comment Request, 6573-6574 [2018-03091]
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Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices
BILLING CODE 4163–19–C
published on the NIOSH website and
announced in a Federal Register notice.
X. Drugs Removed From the NIOSH
List of Hazardous Drugs
In a petition to NIOSH in February
2017, the pharmaceutical company
Theravance Biopharma requested the
removal of the drug telavancin from the
NIOSH List of Antineoplastic and Other
Hazardous Drugs in Healthcare
Settings.22 The petition included an
analysis of animal developmental
toxicity studies and argued that
‘‘[p]lacing telavancin in the NIOSH
category of a hazardous drug greatly
overstates the occupational risk to
healthcare workers handling
telavancin.’’ In response, NIOSH
evaluated the information provided in
the petition as well as other sources
provided to NIOSH by the manufacturer
and determined that telavancin does not
meet the NIOSH definition of a
hazardous drug. NIOSH informed users
of the 2016 List of this determination
via a web posting and responded to
Theravance Biopharma with a letter
dated April 12, 2017.23 Accordingly,
telavancin does not appear in the 2018
update to the NIOSH List of
Antineoplastic and Other Hazardous
Drugs in Healthcare Settings. This
decision is considered final.
XI. Final List of Drugs Proposed for
Placement on the NIOSH List of
Hazardous Drugs
After consideration of all public
comments received in the docket for
this action, NIOSH will develop a final
list of drugs to be placed on the NIOSH
List of Antineoplastic and Other
Hazardous Drugs in Healthcare Settings,
2018. The 2018 Update will be
Dated: February 8, 2018.
John Howard,
Director, National Institute for Occupational
Safety and Health, Centers for Disease Control
and Prevention.
[FR Doc. 2018–02957 Filed 2–13–18; 8:45 am]
BILLING CODE 4163–19–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Office of Refugee Resettlement
Cash and Medical Assistance Program
Quarterly Report on Expenditures and
Obligations.
OMB No.: 0970–0407.
Description: The Office of Refugee
Resettlement (ORR) reimburses, to the
extent of available appropriations,
certain non-federal costs for the
provision of cash and medical
assistance to refugees and other eligible
persons, along with allowable expenses
for the administration of the refugee
resettlement program at the State level.
States, Wilson/Fish projects (alternative
projects for the administration of the
refugee resettlement program), and State
Replacement Designees currently
submit the ORR–2 Financial Status
Report in accordance with 45 CFR part
92 and 45 CFR part 74. This proposed
data collection would collect financial
status data (i.e., amounts of
expenditures and obligations) broken
down by the four program components:
6573
Refugee cash assistance, refugee medical
assistance, health screening, and
services for unaccompanied refugee
minors as well as by program
administration. This breakdown of
financial status data on expenditures
and obligations allows ORR to track
program expenditures in greater detail
to anticipate any funding issues and to
meet the requirements of ORR
regulations at 45 CFR 400.211 to collect
these data for use in estimating annual
costs of the refugee resettlement
program. ORR must implement the
methodology at 45 CFR 400.211 each
year after receipt of its annual
appropriation to ensure that the
appropriated funds will be adequate for
assistance to entering refugees. The
estimating methodology prescribed in
the ORR regulations requires the use of
actual past costs by program
component. In the event that the
methodology indicates that
appropriated funds are inadequate, ORR
must take steps to reduce federal
expenses, such as by limiting the
number of months of eligibility for
Refugee Cash Assistance and Refugee
Medical Assistance. This proposed
single-page report on expenditures and
obligations will allow ORR to collect the
necessary data to ensure that funds are
adequate for the projected need and
thereby meet the requirements of both
the Refugee Act and ORR regulations.
Respondents: State Agencies, the
District of Columbia, Replacement
Designees under 45 CFR 400.301(c), and
Wilson-Fish Grantees (State 2 Agencies)
administering or supervising the
administration of programs under Title
IV of the Act.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses
per
respondent
Average
burden hours
per response
Total burden
hours
ORR Financial Status Report Cash and Medical Assistance Program, Quarterly Report on Expenditures and Obligations .............................................
daltland on DSKBBV9HB2PROD with NOTICES
Instrument
57
4
1.50
342
Estimated Total Annual Burden
Hours: 342.
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201. Attention
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: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
22 Harstad EB and Coleman R. Petition of
Theravance Biopharma US, Inc. to Remove
Telavancin from the NIOSH List of Antineoplastic
and Other Hazardous Drugs in Healthcare Settings.
February 28, 2017.
23 NIOSH letter to Eric Harstad and Rebecca
Coleman. April 12, 2017.
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Federal Register / Vol. 83, No. 31 / Wednesday, February 14, 2018 / Notices
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018–03091 Filed 2–13–18; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Home Visiting Career
Trajectories.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF) at the U.S.
Department of Health and Human
Services (HHS), in collaboration with
the Health Resources and Services
Administration (HRSA), seeks approval
to collect information from home
visiting program staff in programs
receiving funding through the Maternal,
Infant, and Early Childhood Home
Visiting (MIECHV) Program as part of
the Home Visiting Career Trajectories
study. ACF is interested in collecting
information about the state of the home
visiting workforce, career trajectories of
home visitors, and strategies for
building a pipeline of qualified home
visitors and supervisors.
Through the proposed information
collection, the researchers will obtain
information about the characteristics,
qualifications, and career trajectories of
home visiting staff. The study will
include a national survey of the
MIECHV workforce, interviews with
training and technical assistance
experts, and site visits to home visiting
programs in eight states that vary in
terms of geography, population
demographics, labor markets, and home
visiting program offerings.
Respondents: Home visiting program
managers, supervisors, home visitors,
and training and technical assistance
experts.
ANNUAL BURDEN ESTIMATES
Total/annual
number of
respondents
Instrument
daltland on DSKBBV9HB2PROD with NOTICES
Home visitor and supervisor survey ................................................................
Program manager survey ................................................................................
Focus group moderator’s guide .......................................................................
Self-administered questionnaire for focus group participants .........................
Key informant interview guide—management and supervisory staff ..............
Key informant interview guide—training and technical assistance experts ....
Estimated Total Annual Burden
Hours: 2,510.
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, 330
C Street SW, Washington, DC 20201,
Attn: OPRE Reports Clearance Officer.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
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: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–03093 Filed 2–13–18; 8:45 am]
BILLING CODE 4184–74–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–E–2336]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; JUVEDERM VOLUMA XC
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
JUVEDERM VOLUMA XC and is
publishing this notice of that
determination as required by law. FDA
has made the determination because of
the submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that medical
device.
DATES: Anyone with knowledge that any
of the dates as published (in the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by April 16, 2018. See
‘‘Petitions’’ in the SUPPLEMENTARY
INFORMATION section for more
information.
SUMMARY:
PO 00000
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Number of
responses per
respondent
1
1
1
1
1
1
Average
burden hours
per response
0.38
0.33
2
0.03
1.5
1.5
Annual
burden hours
1,140
231
960
14
120
45
You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before April 16,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 16, 2018. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date. Furthermore, any interested
person may petition FDA for a
determination regarding whether the
applicant for extension acted with due
diligence during the regulatory review
period by August 13, 2018. See
‘‘Petitions’’ in the SUPPLEMENTARY
INFORMATION section for more
information.
ADDRESSES:
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
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]]>Agencies
[Federal Register Volume 83, Number 31 (Wednesday, February 14, 2018)]
[Notices]
[Pages 6573-6574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03091]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Office of Refugee Resettlement Cash and Medical Assistance
Program Quarterly Report on Expenditures and Obligations.
OMB No.: 0970-0407.
Description: The Office of Refugee Resettlement (ORR) reimburses,
to the extent of available appropriations, certain non-federal costs
for the provision of cash and medical assistance to refugees and other
eligible persons, along with allowable expenses for the administration
of the refugee resettlement program at the State level. States, Wilson/
Fish projects (alternative projects for the administration of the
refugee resettlement program), and State Replacement Designees
currently submit the ORR-2 Financial Status Report in accordance with
45 CFR part 92 and 45 CFR part 74. This proposed data collection would
collect financial status data (i.e., amounts of expenditures and
obligations) broken down by the four program components: Refugee cash
assistance, refugee medical assistance, health screening, and services
for unaccompanied refugee minors as well as by program administration.
This breakdown of financial status data on expenditures and obligations
allows ORR to track program expenditures in greater detail to
anticipate any funding issues and to meet the requirements of ORR
regulations at 45 CFR 400.211 to collect these data for use in
estimating annual costs of the refugee resettlement program. ORR must
implement the methodology at 45 CFR 400.211 each year after receipt of
its annual appropriation to ensure that the appropriated funds will be
adequate for assistance to entering refugees. The estimating
methodology prescribed in the ORR regulations requires the use of
actual past costs by program component. In the event that the
methodology indicates that appropriated funds are inadequate, ORR must
take steps to reduce federal expenses, such as by limiting the number
of months of eligibility for Refugee Cash Assistance and Refugee
Medical Assistance. This proposed single-page report on expenditures
and obligations will allow ORR to collect the necessary data to ensure
that funds are adequate for the projected need and thereby meet the
requirements of both the Refugee Act and ORR regulations.
Respondents: State Agencies, the District of Columbia, Replacement
Designees under 45 CFR 400.301(c), and Wilson-Fish Grantees (State 2
Agencies) administering or supervising the administration of programs
under Title IV of the Act.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ORR Financial Status Report Cash and Medical 57 4 1.50 342
Assistance Program, Quarterly Report on
Expenditures and Obligations...............
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 342.
Copies of the proposed collection may be obtained by writing to the
Administration for Children and Families, Office of Planning, Research
and Evaluation, 330 C Street SW, Washington, DC 20201. Attention
Reports Clearance Officer. All requests should be identified by the
title of the information collection. Email address:
[email protected].
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: Office
of Management and Budget, Paperwork Reduction Project, Email:
[email protected], Attn:
[[Page 6574]]
Desk Officer for the Administration for Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2018-03091 Filed 2-13-18; 8:45 am]
BILLING CODE 4184-45-P
