Agency Information Collection Request; 30-Day Public Comment Request, 43146-43147 [2019-17887]
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43146
Federal Register / Vol. 84, No. 161 / Tuesday, August 20, 2019 / Notices
Agenda: The committee will discuss
new drug application (NDA) 204017
(levonorgestrel and ethinyl estradiol)
transdermal system, submitted by Agile
Therapeutics, Inc., for the prevention of
pregnancy in women of reproductive
potential.
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. All electronic and
written submissions submitted to the
Docket (see the ADDRESSES section) on
or before October 16, 2019, will be
provided to the committee. Oral
presentations from the public will be
scheduled between approximately 1
p.m. and 2 p.m. Those individuals
interested in making formal oral
presentations should notify the contact
person and submit a brief statement of
the general nature of the evidence or
arguments they wish to present, the
names and addresses of proposed
participants, and an indication of the
approximate time requested to make
their presentation on or before October
7, 2019. Time allotted for each
presentation may be limited. If the
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by October 8, 2019.
Persons attending FDA’s advisory
committee meetings are advised that
FDA is not responsible for providing
access to electrical outlets.
For press inquiries, please contact the
Office of Media Affairs at fdaoma@
fda.hhs.gov or 301–796–4540.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Kalyani Bhatt
(see FOR FURTHER INFORMATION CONTACT)
at least 7 days in advance of the
meeting.
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at:
https://www.fda.gov/
AdvisoryCommittees/AboutAdvisory
Committees/ucm111462.htm for
procedures on public conduct during
advisory committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
0990–New–30D and project title for
reference.
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Evaluation of
the Kidney Innovation Accelerator
(KidneyX).
Type of Collection: New.
SUPPLEMENTARY INFORMATION:
Dated: August 14, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
OMB No. 0990–NEW—Office of the
Chief Technology Officer
Abstract: The Office of the Chief
Technology Officer (CTO) is initiating
an independent evaluation under the
Department of Health & Human Services
(HHS) of the Kidney Innovation
Accelerator—or KidneyX—a publicprivate partnership between HHS/CTO
and the American Society of
Nephrology (ASN).
The KidneyX evaluation involves a
mixed-methods design for data
collection and analysis. The evaluation
integrates qualitative techniques, such
as document analysis and stakeholder
interviews, to capture the details and
effects of processes and changes within
the KidneyX initiative. We will apply
quantitative methods, such as surveys
and econometric analysis, in discrete
situations in which we find sufficient
certainty and coherence in
environmental conditions to conduct
rigorous analysis.
The evaluation will use a data-driven
set of methodologies to address, to the
extent possible, the central question of
the effectiveness of KidneyX: The
degree to which KidneyX contributed to
any acceleration in the rate of
innovation in the targeted area of kidney
technology compared with how
innovation would have progressed
without KidneyX.
[FR Doc. 2019–17932 Filed 8–19–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS
Notice.
AGENCY:
ACTION:
SUMMARY: In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before September 19,
2019.
ADDRESSES: Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
jbell on DSK3GLQ082PROD with NOTICES
ESTIMATED ANNUALIZED BURDEN HOURS:
Number of
respondents
Type of respondent
Form name
Prize competition applicants .............
Prize competition awardees ..............
Applicant Interview Guide ................
Awardee Interview Guide .................
VerDate Sep<11>2014
20:49 Aug 19, 2019
Jkt 247001
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
12
6
E:\FR\FM\20AUN1.SGM
1
1
20AUN1
Average
burden per
response
(in min)
50/60
50/60
Total burden
(in hr)
10
5
43147
Federal Register / Vol. 84, No. 161 / Tuesday, August 20, 2019 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS:—Continued
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
(in min)
Total burden
(in hr)
Type of respondent
Form name
Prize competition non-awardees ......
Other Stakeholders ...........................
Prize competition applicants .............
Prize competition awardees and
non-awardees.
Non-awardee Interview Guide .........
Other Stakeholder Interview Guide ..
Pre-award Survey Instrument ..........
Post-award Survey Instrument .........
6
6
300
300
1
1
1
1
50/60
50/60
30/60
30/60
5
5
150
150
Total ...........................................
...........................................................
........................
........................
........................
325
Terry Clark,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
please include the document identifier
0990–New–30D and project title for
reference.
[FR Doc. 2019–17887 Filed 8–19–19; 8:45 am]
SUPPLEMENTARY INFORMATION:
BILLING CODE 4150–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–new]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
SUMMARY: In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before September 19,
2019.
Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
ADDRESSES:
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Youth
Engagement in Sports (YES)
Performance Measures.
Type of Collection: New.
OMB No. 0990–NEW—Youth
Engagement in Sports (YES)
Performance Measures
Abstract: The Office of Minority
Health (OMH) and Office of Women’s
Health (OWH) are seeking an approval
by OMB on a new information
collection, Youth Engagement in Sports
(YES Initiative) Performance Measures
(hereafter YES Initiative Performance
Measures). The purpose of this data
collection is to gather quantitative data
from YES grant recipients to monitor
project performance in achieving
process and outcome measures over the
course of the three-year project.
Grantees will collect a small set of
process and outcome measures from
program participants to assess the
degree to which YES Initiative projects
increase sports participation and
physical activity and improve nutrition
in adolescents.
Need and Proposed Use of the
Information: The clearance is needed to
collect performance data to enable OMH
and OWH to comply with Federal
reporting requirements, monitor, and
evaluate performance by enabling the
efficient collection of performanceoriented data tied to OMH- and OWHwide performance reporting needs. The
ability to monitor and evaluate
performance in this manner, and to
work towards continuous program
improvement are basic functions that
OMH and OWH must be able to
accomplish in order to carry out their
respective mandates with the most
effective and appropriate use of
resources.
Likely Respondents: Project Directors,
Youth Participants, Data Entry Persons
Affected public includes non-profit
institutions, State, Local, or Tribal
Governments.
jbell on DSK3GLQ082PROD with NOTICES
ANNUALIZED BURDEN HOUR TABLE
Average
burden per
response
Respondents
(if necessary)
Physical Activity & Nutrition Survey ..
Sports Inventory ................................
Sports Literacy Form .........................
Youth ................................................
Youth ................................................
Youth (Staff observe youth) .............
2800
2800
2800
3
2
3
20/60
5/60
20/60
2800
467
2800
Program Participation Record ...........
Total ...........................................
Staff ..................................................
..........................................................
14
........................
2
........................
4.17
........................
117
6184
VerDate Sep<11>2014
20:49 Aug 19, 2019
Jkt 247001
PO 00000
Frm 00049
Number of
respondents
Number of
responses per
respondents
Forms
(if necessary)
Fmt 4703
Sfmt 4703
E:\FR\FM\20AUN1.SGM
20AUN1
Total burden
hours
]]>Agencies
[Federal Register Volume 84, Number 161 (Tuesday, August 20, 2019)]
[Notices]
[Pages 43146-43147]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17887]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Document Identifier: OS-0990-new]
Agency Information Collection Request; 30-Day Public Comment
Request
AGENCY: Office of the Secretary, HHS
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the requirement of the Paperwork Reduction
Act of 1995, the Office of the Secretary (OS), Department of Health and
Human Services, is publishing the following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be received on or before September 19,
2019.
ADDRESSES: Submit your comments to [email protected] or via
facsimile to (202) 395-5806.
FOR FURTHER INFORMATION CONTACT: Sherrette Funn, [email protected]
or (202) 795-7714. When submitting comments or requesting information,
please include the document identifier 0990-New-30D and project title
for reference.
SUPPLEMENTARY INFORMATION: Interested persons are invited to send
comments regarding this burden estimate or any other aspect of this
collection of information, including any of the following subjects: (1)
The necessity and utility of the proposed information collection for
the proper performance of the agency's functions; (2) the accuracy of
the estimated burden; (3) ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) the use of
automated collection techniques or other forms of information
technology to minimize the information collection burden.
Title of the Collection: Evaluation of the Kidney Innovation
Accelerator (KidneyX).
Type of Collection: New.
OMB No. 0990-NEW--Office of the Chief Technology Officer
Abstract: The Office of the Chief Technology Officer (CTO) is
initiating an independent evaluation under the Department of Health &
Human Services (HHS) of the Kidney Innovation Accelerator--or KidneyX--
a public-private partnership between HHS/CTO and the American Society
of Nephrology (ASN).
The KidneyX evaluation involves a mixed-methods design for data
collection and analysis. The evaluation integrates qualitative
techniques, such as document analysis and stakeholder interviews, to
capture the details and effects of processes and changes within the
KidneyX initiative. We will apply quantitative methods, such as surveys
and econometric analysis, in discrete situations in which we find
sufficient certainty and coherence in environmental conditions to
conduct rigorous analysis.
The evaluation will use a data-driven set of methodologies to
address, to the extent possible, the central question of the
effectiveness of KidneyX: The degree to which KidneyX contributed to
any acceleration in the rate of innovation in the targeted area of
kidney technology compared with how innovation would have progressed
without KidneyX.
Estimated Annualized Burden Hours:
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of burden per Total burden
Type of respondent Form name respondents responses per response (in (in hr)
respondent min)
----------------------------------------------------------------------------------------------------------------
Prize competition applicants.. Applicant 12 1 50/60 10
Interview Guide.
Prize competition awardees.... Awardee 6 1 50/60 5
Interview Guide.
[[Page 43147]]
Prize competition non-awardees Non-awardee 6 1 50/60 5
Interview Guide.
Other Stakeholders............ Other 6 1 50/60 5
Stakeholder
Interview Guide.
Prize competition applicants.. Pre-award Survey 300 1 30/60 150
Instrument.
Prize competition awardees and Post-award 300 1 30/60 150
non-awardees. Survey
Instrument.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total..................... ................ .............. .............. .............. 325
----------------------------------------------------------------------------------------------------------------
Terry Clark,
Office of the Secretary, Paperwork Reduction Act Reports Clearance
Officer.
[FR Doc. 2019-17887 Filed 8-19-19; 8:45 am]
BILLING CODE 4150-04-P
