Submission for OMB Review; Comment Request, 5104-5105 [2018-02238]
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5104
Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices
CDC will analyze and periodically
publish reports summarizing national
LTBI treatment adverse events statistics
and will conduct special analyses for
publication in peer-reviewed scientific
journals to further describe and
interpret these data.
In this extension request, CDC is
requesting approval for approximately
Type of respondent
Form name
Physician .........................................................................................................
Nurse ...............................................................................................................
Medical Clerk ...................................................................................................
Estimated Annualized Burden Hours
Number of
respondents
NSSAE ...........
NSSAE ...........
NSSAE ...........
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. 2018–02206 Filed 2–2–18; 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: National and Tribal Evaluation
of the 2nd Generation of the Health
Profession Opportunity Grants.
OMB NO.: 0970–0462.
Description: The Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS) is proposing data
collection activities as part of the Health
Profession Opportunity Grants (HPOG)
to serve TANF and Other Low Income
Individuals. ACF has developed a multipronged research and evaluation
approach for the HPOG Program to
better understand and assess the
activities conducted and their results.
Two rounds of HPOG grants have been
awarded—the first in 2010 (HPOG 1.0)
and the second in 2015 (HPOG 2.0).
There are federal evaluations associated
with each round of grants. HPOG grants
provide funding to government
agencies, community-based
organizations, post-secondary
educational institutions, and tribalaffiliated organizations to provide
education and training services to
sradovich on DSK3GMQ082PROD with NOTICES
60 burden hours annually. There is no
cost to respondents.
VerDate Sep<11>2014
18:08 Feb 02, 2018
Jkt 244001
Temporary Assistance for Needy
Families (TANF) recipients and other
low-income individuals, including
tribal members. Under HPOG 2.0, ACF
provided grants to five tribal-affiliated
organizations and 27 non-tribal entities.
OMB previously approved data
collection under OMB Control Number
0970–0462 for: the HPOG 2.0 National
and Tribal Evaluation (Approved
August 2015); and the National
Evaluation impact study; the National
Evaluation descriptive study; and the
Tribal Evaluation (All approved June
2017). The proposed data collection
activities described in this Federal
Register Notice will provide data for the
impact and cost benefit studies of the 27
non-tribal grantees participating in the
National Evaluation of HPOG 2.0.
National Evaluation: The National
Evaluation pertains only to the 27 nontribal grantees that received HPOG 2.0
funding. The design for the National
Evaluation features an implementation
study, a systems change analysis, and
cost benefit analysis. In addition, the
National Evaluation is using an
experimental design to measure and
analyze key participant outcomes
including completion of education and
training, receipt of certificates and/or
degrees, earnings, and employment in a
healthcare career. The impact
evaluation will assess the outcomes for
study participants that were offered
HPOG 2.0 training, financial assistance,
and support services, compared to what
their outcomes would have been if they
had not been offered HPOG 2.0 services.
This Notice provides the opportunity to
comment on a proposed new
information collection activity for the
HPOG 2.0 National Evaluation’s impact
study—the HPOG 2.0 Impact Evaluation
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10
10
10
Number of
responses per
respondent
1
1
1
Average
burden per
response
(in hours)
1
4
1
first follow-up survey, referred to as the
Short-Term Follow-up Survey. The first
follow-up survey of both treatment and
control group members will be
administered approximately 15 months
after baseline data collection and
random assignment. The survey will
collect data about key outcomes of
interest, including participants’ tenure
and experience in HPOG programming;
certifications and educational
achievements; job placement; and
receipt of benefits. These are the key
outcomes of interest for which data are
not otherwise available through existing
data sources. Previously approved
collection activities under 0970–0462
will continue under this new request for
the National Evaluation of the non-tribal
grantees.
In subsequent requests for clearance,
we will submit (1) additional data
collection instruments to support the
descriptive study of the 27 non-tribal
grantees participating in the HPOG 2.0
National Evaluation, including grantee
interview guides and participant
interview guides; and (2) the second
follow-up survey—the Intermediate
Follow-up Survey—for the HPOG 2.0
National Evaluation impact study. The
second follow-up survey is for
collecting data from both treatment and
control group members at the 27 nontribal grantees, approximately 36
months after baseline data collection
and random assignment. This
submission will also include data
collection necessary for the National
Evaluation’s cost benefit analysis.
Respondents: For the National
Evaluation impact study: HPOG 2.0
study participants at the 27 non-tribal
grantees.
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5105
Federal Register / Vol. 83, No. 24 / Monday, February 5, 2018 / Notices
ANNUAL BURDEN ESTIMATES
[This information collection request is for 3 years]
Instrument
Total
number of
respondents
Annual
number of
respondents
Number of
responses per
respondent
Average
burden
hours per
response
Annual
burden
hours
1. National Evaluation 15-Month Follow-up Survey ............
10,400
3,467
1
1
3,467
Estimated Total Annual Burden
Hours: 3,467.
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. 2018–02238 Filed 2–2–18; 8:45 am]
BILLING CODE 4184–72–P
Food and Drug Administration
[Docket Nos. FDA–2016–E–1276; FDA–
2016–E–1277; and FDA–2016–E–1278]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; VIBERZI
Food and Drug Administration,
HHS.
sradovich on DSK3GMQ082PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for VIBERZI 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
SUMMARY:
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18:08 Feb 02, 2018
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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 6, 2018.
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 6, 2018. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: 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 6, 2018.
The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 6, 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.
DATES:
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
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
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comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2016–E–1276; FDA–2016–E–1277 and
FDA–2016–E–1278 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
VIBERZI.’’ Received comments, those
filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
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]]>Agencies
[Federal Register Volume 83, Number 24 (Monday, February 5, 2018)]
[Notices]
[Pages 5104-5105]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-02238]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: National and Tribal Evaluation of the 2nd Generation of the
Health Profession Opportunity Grants.
OMB NO.: 0970-0462.
Description: The Administration for Children and Families (ACF),
U.S. Department of Health and Human Services (HHS) is proposing data
collection activities as part of the Health Profession Opportunity
Grants (HPOG) to serve TANF and Other Low Income Individuals. ACF has
developed a multi-pronged research and evaluation approach for the HPOG
Program to better understand and assess the activities conducted and
their results. Two rounds of HPOG grants have been awarded--the first
in 2010 (HPOG 1.0) and the second in 2015 (HPOG 2.0). There are federal
evaluations associated with each round of grants. HPOG grants provide
funding to government agencies, community-based organizations, post-
secondary educational institutions, and tribal-affiliated organizations
to provide education and training services to Temporary Assistance for
Needy Families (TANF) recipients and other low-income individuals,
including tribal members. Under HPOG 2.0, ACF provided grants to five
tribal-affiliated organizations and 27 non-tribal entities.
OMB previously approved data collection under OMB Control Number
0970-0462 for: the HPOG 2.0 National and Tribal Evaluation (Approved
August 2015); and the National Evaluation impact study; the National
Evaluation descriptive study; and the Tribal Evaluation (All approved
June 2017). The proposed data collection activities described in this
Federal Register Notice will provide data for the impact and cost
benefit studies of the 27 non-tribal grantees participating in the
National Evaluation of HPOG 2.0.
National Evaluation: The National Evaluation pertains only to the
27 non-tribal grantees that received HPOG 2.0 funding. The design for
the National Evaluation features an implementation study, a systems
change analysis, and cost benefit analysis. In addition, the National
Evaluation is using an experimental design to measure and analyze key
participant outcomes including completion of education and training,
receipt of certificates and/or degrees, earnings, and employment in a
healthcare career. The impact evaluation will assess the outcomes for
study participants that were offered HPOG 2.0 training, financial
assistance, and support services, compared to what their outcomes would
have been if they had not been offered HPOG 2.0 services. This Notice
provides the opportunity to comment on a proposed new information
collection activity for the HPOG 2.0 National Evaluation's impact
study--the HPOG 2.0 Impact Evaluation first follow-up survey, referred
to as the Short-Term Follow-up Survey. The first follow-up survey of
both treatment and control group members will be administered
approximately 15 months after baseline data collection and random
assignment. The survey will collect data about key outcomes of
interest, including participants' tenure and experience in HPOG
programming; certifications and educational achievements; job
placement; and receipt of benefits. These are the key outcomes of
interest for which data are not otherwise available through existing
data sources. Previously approved collection activities under 0970-0462
will continue under this new request for the National Evaluation of the
non-tribal grantees.
In subsequent requests for clearance, we will submit (1) additional
data collection instruments to support the descriptive study of the 27
non-tribal grantees participating in the HPOG 2.0 National Evaluation,
including grantee interview guides and participant interview guides;
and (2) the second follow-up survey--the Intermediate Follow-up
Survey--for the HPOG 2.0 National Evaluation impact study. The second
follow-up survey is for collecting data from both treatment and control
group members at the 27 non-tribal grantees, approximately 36 months
after baseline data collection and random assignment. This submission
will also include data collection necessary for the National
Evaluation's cost benefit analysis.
Respondents: For the National Evaluation impact study: HPOG 2.0
study participants at the 27 non-tribal grantees.
[[Page 5105]]
Annual Burden Estimates
[This information collection request is for 3 years]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Total number of Annual number responses per hours per Annual burden
respondents of respondents respondent response hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
1. National Evaluation 15-Month Follow-up Survey................... 10,400 3,467 1 1 3,467
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 3,467.
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: [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: Desk Officer for the Administration
for Children and Families.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018-02238 Filed 2-2-18; 8:45 am]
BILLING CODE 4184-72-P
