Agency Information Collection Request. 30-Day Public Comment Request, 22691-22692 [2018-10394]
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Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Notices
22691
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Type of interview
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
In-Person Individual IDIs ...........................................
IDI Screener ...............................................................
Focus Group Interviews .............................................
Focus Group Screener ..............................................
Usability Testing ........................................................
Usability Testing Screener .........................................
1,092
1,800
4,701
3,996
2,322
2,028
1
1
1
1
1
1
1,092
1,800
4,701
3,996
2,322
2,028
1 ...............................
.083 (5 minutes) ......
1.5 ............................
.25 (15 minutes) ......
.5 (30 minutes) ........
.083 (5 minutes) ......
1,092
149
7,052
999
1,161
168
Total ....................................................................
........................
........................
........................
..................................
10,621
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents to be
included in each new pretest may vary,
depending on the nature of the material
or message being tested and the target
audience. Table 1 provides examples of
the types of studies that may be
administered and estimated burden
levels during a 3-year period. Time to
read, view, or listen to the message
being tested is built into the ‘‘Hours per
Response’’ figures.
FDA has updated the estimated
burden that was published in the 60-day
notice. The estimated burden for this
collection has increased by 4,437 hours
from 6,184 to 10,621. FDA attributes
this increase to adding usability testing,
and increasing the overall number of
studies planned the next 3 years.
Dated: May 10, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–10457 Filed 5–15–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990—New]
Office of the Secretary, HHS.
Notice.
AGENCY:
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 June 15, 2018.
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
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:34 May 15, 2018
Jkt 244001
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: Trafficking
Victim Assistance Program Social
Network Analysis—Network Survey.
Type of Collection: New.
OMB No. 0990–NEW—Office of the
Assistant Secretary for Planning and
Evaluation—Administration for
Children and Families’ Trafficking
Victim Assistance Program.
SUPPLEMENTARY INFORMATION:
Abstract
Agency Information Collection
Request. 30-Day Public Comment
Request
ACTION:
comments or requesting information,
please include the document identifier
0990—New—30D and project title for
reference.
The Office of the Assistant Secretary
for Planning and Evaluation (ASPE), in
partnership with the Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS) is requesting Office of
Management and Budget (OMB)
approval for a new information
collection request titled, ‘‘Trafficking
Victim Assistance Program (TVAP)
Social Network Analysis—Network
Survey.’’ Under the guidance of ASPE
and ACF, a contractor is carrying out
this assessment. The data collected and
analyzed under this submission will
help HHS better understand the type
and extent of the relationship between
the TVAP grantees, TVAP subrecipients,
and other service providers operating in
TVAP subrecipient areas. It will also
help illuminate each grantee’s and
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Sfmt 4703
subrecipient’s types and number of
services provided, estimated costs of
services, service coordination between
grantees or subrecipients and other
services providers, and type and
strength of relationships between
grantees and subrecipients. This
information will enable HHS to
understand the structure of the grantee/
subrecipient network and inform
recommendations for more efficient
network management and distribution
of support.
TVAP, as authorized by the
Trafficking Victims Protection Act of
2000, provides comprehensive case
management services to foreign-born
victims of human trafficking residing in
the United States. Since its inception,
TVAP funding and infrastructure have
remained relatively unchanged: Services
are paid on a per capita basis, and funds
are managed through three primary
grantees that enter into cooperative
agreements with service providers
(subrecipients). Given the changing
landscape and the greater understanding
of the nature and extent of trafficking,
HHS is undertaking a program
assessment to understand whether any
efficiencies can be gained in the
program administration and structure.
To supplement an earlier fiscal year
2018 assessment to solicit qualitative
feedback from a range of program
stakeholders, the information collected
for this program survey aims to help
HHS determine if efficiencies can be
gained through improved coordination
among TVAP grantees, TVAP
subrecipients, and other service
providers.
Data will be collected through an
electronic survey of fiscal year 2016
TVAP grantees and subrecipients. Key
staff at grantee sites and subrecipient
organizations will complete a selfadministered online survey that will
include questions about each
respondent’s services provided,
estimated costs of services, service
coordination between grantees or
subrecipients, and type and strength of
E:\FR\FM\16MYN1.SGM
16MYN1
22692
Federal Register / Vol. 83, No. 95 / Wednesday, May 16, 2018 / Notices
relationships between grantees and
subrecipients. With this data, the
contractor, to inform ASPE and ACF,
will build a social/organizational
network to depict how grantee and
subrecipient organizations collaborate
with one another through TVAP to
better understand the existing network
and identify potential opportunities for
improving the efficiency of the network.
ASPE anticipates completion of all data
collection activities by October 2018.
ESTIMATED ANNUALIZED BURDEN TABLE
Number of
respondents
Type of respondent
Number
responses per
respondent
Average
burden per
response
(in hours)
Total burden
hours
TVAP grantees ................................................................................................
TVAP Subrecipients .........................................................................................
3
253
1
1
45/60
45/60
2.25
189.75
Total ..........................................................................................................
256
1
45/60
192
Terry Clark,
Asst. Paperwork Reduction Act Reports
Clearance Officer, Office of the Secretary.
[FR Doc. 2018–10394 Filed 5–15–18; 8:45 am]
BILLING CODE 4151–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
RIN 0991–ZA49
HHS Blueprint to Lower Drug Prices
and Reduce Out-of-Pocket Costs
Department of Health and
Human Services.
ACTION: Policy Statement; Request for
information.
AGENCY:
Through this request for
information, HHS seeks comment from
interested parties to help shape future
policy development and agency action.
DATES: Comments must be submitted on
or before July 16, 2018.
ADDRESSES: You may submit comments
in one of three ways (please choose only
one of the ways listed):
1. Electronically. You may submit
electronic comments to https://
www.regulations.gov. Follow the
‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Department of Health
and Human Services, 200 Independence
Ave. SW, Room 600E, Washington, DC
20201.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Department of
Health and Human Services, 200
Independence Ave. SW, Room 600E,
Washington, DC 20201.
FOR FURTHER INFORMATION CONTACT: John
O’Brien, (202) 690–7886.
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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17:34 May 15, 2018
Jkt 244001
The
United States is the world’s leader in
biopharmaceutical innovation.
American innovation has improved
health and quality of life for billions of
people, and was made possible by our
intellectual property system, decades of
government and privately-funded
research, strong capital markets, and the
world’s largest scientific research base.
By rewarding innovation through patent
and data protection, American
companies hold the intellectual
property rights for most new, and
potentially life changing, medicines.
Our regulatory system is the most
rigorous in the world, ensuring the
safety and efficacy of drugs for
American patients. Medicare, Medicaid,
other Federal health programs, and
private payers ensure Americans have
access to medicines, from innovative
new cures, to generic versions of
medications that have markedly
lowered costs for consumers.
As part of President Trump’s bold
plan to put American patients first, the
Department of Health and Human
Services has developed a
comprehensive blueprint that addresses
many of the challenges and
opportunities impacting American
patients and consumers. The blueprint
covers multiple areas including, but not
limited to:
• Improving competition and ending
the gaming of the regulatory process,
• supporting better negotiation of
drug discounts in government-funded
insurance programs,
• creating incentives for
pharmaceutical companies to lower list
prices, and,
• reducing out-of-pocket spending for
patients at the pharmacy and other sites
of care.
HHS also recognizes that achieving
the goal of putting American patients
first will require interagency
collaboration on pharmaceutical trade
policies that promote innovation, and
are transparent, nondiscriminatory, and
SUPPLEMENTARY INFORMATION:
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increase fair market access for American
innovators. Furthermore, HHS seeks to
identify when developed nations are
paying less for drugs than the prices
paid by Federal health programs, and
correct these inequities through better
negotiation.
HHS has already acted to increase the
affordability of medicines for millions of
our citizens, but is also going much
further in response to President Trump’s
call to action. Through the work of the
Food and Drug Administration and the
Centers for Medicare & Medicaid
Services, HHS has tremendous ability to
change how drugs are developed and
paid for in the United States.
The status quo is no longer
acceptable. Millions of Americans face
soaring drug prices and higher out-ofpocket costs, while manufacturers and
middlemen such as pharmacy benefit
managers (PBMs) and distributors
benefit from rising list prices and their
resulting higher rebates and
administrative fees. An unprecedented
re-examination of the whole system and
opportunities for reform is long
overdue. We believe a national focus on
lowering list prices and out-of-pocket
costs has the potential to create new and
disruptive alternatives to the current
system, while maintaining its many
virtues. It is time to realign the system
in a way that promotes the development
of affordable innovations that improve
health outcomes and lower both out-ofpocket cost and the total cost of care.
Through this request for information,
HHS seeks comment from interested
parties to help shape future policy
development and agency action.
Table of Contents:
I. Previous Actions by the Trump
Administration
A. Increasing Competition
B. Better Negotiation
C. Creating Incentives to Lower List Prices
D. Reducing Patient Out-of-Pocket
Spending
II. Responding to President Trump’s Call to
E:\FR\FM\16MYN1.SGM
16MYN1
]]>Agencies
[Federal Register Volume 83, Number 95 (Wednesday, May 16, 2018)]
[Notices]
[Pages 22691-22692]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10394]
-----------------------------------------------------------------------
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 June 15, 2018.
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: Trafficking Victim Assistance Program
Social Network Analysis--Network Survey.
Type of Collection: New.
OMB No. 0990-NEW--Office of the Assistant Secretary for Planning
and Evaluation--Administration for Children and Families' Trafficking
Victim Assistance Program.
Abstract
The Office of the Assistant Secretary for Planning and Evaluation
(ASPE), in partnership with the Administration for Children and
Families (ACF), U.S. Department of Health and Human Services (HHS) is
requesting Office of Management and Budget (OMB) approval for a new
information collection request titled, ``Trafficking Victim Assistance
Program (TVAP) Social Network Analysis--Network Survey.'' Under the
guidance of ASPE and ACF, a contractor is carrying out this assessment.
The data collected and analyzed under this submission will help HHS
better understand the type and extent of the relationship between the
TVAP grantees, TVAP subrecipients, and other service providers
operating in TVAP subrecipient areas. It will also help illuminate each
grantee's and subrecipient's types and number of services provided,
estimated costs of services, service coordination between grantees or
subrecipients and other services providers, and type and strength of
relationships between grantees and subrecipients. This information will
enable HHS to understand the structure of the grantee/subrecipient
network and inform recommendations for more efficient network
management and distribution of support.
TVAP, as authorized by the Trafficking Victims Protection Act of
2000, provides comprehensive case management services to foreign-born
victims of human trafficking residing in the United States. Since its
inception, TVAP funding and infrastructure have remained relatively
unchanged: Services are paid on a per capita basis, and funds are
managed through three primary grantees that enter into cooperative
agreements with service providers (subrecipients). Given the changing
landscape and the greater understanding of the nature and extent of
trafficking, HHS is undertaking a program assessment to understand
whether any efficiencies can be gained in the program administration
and structure. To supplement an earlier fiscal year 2018 assessment to
solicit qualitative feedback from a range of program stakeholders, the
information collected for this program survey aims to help HHS
determine if efficiencies can be gained through improved coordination
among TVAP grantees, TVAP subrecipients, and other service providers.
Data will be collected through an electronic survey of fiscal year
2016 TVAP grantees and subrecipients. Key staff at grantee sites and
subrecipient organizations will complete a self-administered online
survey that will include questions about each respondent's services
provided, estimated costs of services, service coordination between
grantees or subrecipients, and type and strength of
[[Page 22692]]
relationships between grantees and subrecipients. With this data, the
contractor, to inform ASPE and ACF, will build a social/organizational
network to depict how grantee and subrecipient organizations
collaborate with one another through TVAP to better understand the
existing network and identify potential opportunities for improving the
efficiency of the network. ASPE anticipates completion of all data
collection activities by October 2018.
Estimated Annualized Burden Table
----------------------------------------------------------------------------------------------------------------
Average
Number of Number burden per Total burden
Type of respondent respondents responses per response (in hours
respondent hours)
--------------------------------------------------------------------------------------------------
TVAP grantees..................... 3 1 45/60 2.25
TVAP Subrecipients................ 253 1 45/60 189.75
-----------------------------------------------------------------------------
Total......................... 256 1 45/60 192
----------------------------------------------------------------------------------------------------------------
Terry Clark,
Asst. Paperwork Reduction Act Reports Clearance Officer, Office of the
Secretary.
[FR Doc. 2018-10394 Filed 5-15-18; 8:45 am]
BILLING CODE 4151-05-P
