60-Day Notice EnVision Centers

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Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices
TABLE 1—STATUS OF DRAFT GUIDANCE Q&AS AND FINAL GUIDANCE Q&AS—Continued

Part II. Provisions Related to Requirements to Submit a Biologics License Application (BLA)
for a ‘‘Biological Product’’.

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Part III. Exclusivity ......................................................................................................................

This guidance finalizes certain Q&As
that were included in the draft guidance
issued on May 13, 2015. FDA
considered written comments the
Agency received regarding these Q&As,
and made changes to the Q&As, as
appropriate. Editorial changes were
made primarily for clarification.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Questions and
Answers on Biosimilar Development
and the BPCI Act.’’ It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations. This guidance
is not subject to Executive Order 12866.
FDA is announcing, in a separate
document published elsewhere in this
issue of the Federal Register, the
availability of the draft guidance for
industry entitled ‘‘New and Revised
Draft Q&As on Biosimilar Development
and the BPCI Act (Revision 2).’’
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and

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III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/Drugs/Guidance

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Current
guidance
location

Q.I.2 ...............
Q.I.3 ...............
Q.I.4 ...............
Q.I.5 ...............
Q.I.6 ...............
Q.I.7 ...............
Q.I.8 ...............
Q.I.9 ...............
Q.I.10 .............
Q.I.11 .............
Q.I.12 .............
Q.I.13 .............
Q.I.14 .............
Q.I.15 .............
Q.I.16 .............
Q.I.17 .............
Q.I.18 .............
Q.I.19 .............
Q.I.20 .............
Q.I.21 .............
Q.I.22 .............
Q.I.23 .............
Q.I.24 .............
Q.II.1 ..............

Final
Final
Final
Final
Final
Final
Final
Draft
Draft
Final
Final
Draft
Draft
Final
Draft
Draft
Draft
Draft

Final ...............

Final.
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Final.
Withdrawn.
Draft.
Final.
Final.
Final.
Draft.
Final.
Final.
Final.
Draft.
Draft.
Draft.
Draft.
Draft.
Draft.

Q.II.2 ..............
Q.II.3 ..............
Q.III.1 .............
Q.III.2 .............

Final
Draft
Draft
Final

Final.
Final.
Final.
Final.

Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR part 312 for submission of an
investigational new drug application
have been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR 314.50 for
submission of a new drug application
have been approved under OMB control
number 0910–0001. The collections of
information in section 351(a) of the PHS
Act under part 601 (21 CFR part 601) for
submission of a BLA have been
approved under OMB control number
0910–0338. The collections of
information in section 351(k) of the PHS
Act under part 601 for submission of a
BLA have been approved under OMB
control number 0910–0719. The
collections of information for
submission of a meeting package to the
appropriate review division with the
meeting request as described in the draft
guidance for industry entitled ‘‘Formal
Meetings Between the FDA and
Sponsors or Applicants of BsUFA
Products’’ have been approved under
OMB control number 0910–0802.

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Previous
guidance
location

Q&A
Nos.

Q&A category

...............
...............
...............
...............

ComplianceRegulatoryInformation/
Guidances/default.htm, https://www.
fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: December 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–26853 Filed 12–11–18; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HOUSING AND
URBAN DEVELOPMENT
[Docket No. FR–7007–N–06]

60-Day Notice of Proposed Information
Collection: Data Collection for
EnVision Center Demonstration Sites
Office of Policy Development
and Research, HUD.
ACTION: Notice.
AGENCY:

The Department of Housing
and Urban Development (HUD) is
seeking approval from the Office of
Management and Budget (OMB) for the
information collection described below.
In accordance with the Paperwork
Reduction Act, HUD is requesting
comments from all interested parties on
the proposed collection of information.

SUMMARY:

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Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices

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The purpose of this notice is to allow for
60 days of public comment.
DATES: Comments Due Date: February
11, 2019.
ADDRESSES: Interested persons are
invited to submit comments regarding
this proposal. Comments should refer to
the proposal by name and/or OMB
Control Number and should be sent to:
Anna P. Guido, Reports Management
Officer, QDAM, Department of Housing
and Urban Development, 451 7th Street
SW, Room 4176, Washington, DC
20410–5000; telephone 202–402–5534
(this is not a toll-free number) or by
email at [email protected] for a
copy of the proposed forms or other
available information. Persons with
hearing or speech impairments may
access this number through TTY by
calling the toll-free Federal Relay
Service at (800) 877–8339.
FOR FURTHER INFORMATION CONTACT:
Anna P. Guido, Reports Management
Officer, QDAM, Department of Housing
and Urban Development, 451 7th Street
SW, Washington, DC 20410–5000; email
Anna P. Guido at Anna.P.Guido@
hud.gov or telephone 202–402–5535
(this is not a toll-free number). Persons
with hearing or speech impairments
may access this number through TTY by
calling the toll-free Federal Relay
Service at (800) 877–8339. Copies of
available documents submitted to OMB
may be obtained from Ms. Guido.
SUPPLEMENTARY INFORMATION: This
notice informs the public that HUD is
seeking approval from OMB for the
proposed collection of information
described in Section A.
A. Overview of Information Collection
Title of Information Collection: HUD
EnVision Centers Demonstration Data
Collection.
OMB Approval Number: Pending.
Type of Request: New.
Form Number: TBD.
Description of the need for the
information and proposed use: HUD
seeks to collect data from the EnVision
Center Demonstration sites to find out
the effectiveness of collaborative efforts
by government, industry, and nonprofit
organizations to accelerate economic
mobility of low-income households in
communities that include HUD-assisted
housing. The demonstration builds
upon existing partnerships and
continues collaborative work to improve
the lives of residents housed with HUD
assistance, by providing a forum by
which cross-sector organizations can
come together to design and implement
local interventions to advance selfsufficiency and economic mobility
through a four-pillar approach to

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opportunity. The four pillars are: (1)
Economic Empowerment, (2)
Educational Advancement, (3) Health
and Wellness, and (4) Character and
Leadership. HUD believes that these
four pillars can be the foundation for
driving collaboration amongst
communities, the private sector, and the
federal government, intended to
improve the quality of life of HUDassisted and low-income households
and to empower them to become selfsufficient.
Located in or near Public Housing
Authorities (PHA), EnVision Centers are
centralized hubs for supportive services
focused on the four pillars listed above.
The EnVision Centers demonstration is
premised on the notion that financial
support alone is insufficient to solve the
problem of poverty. Intentional and
collective efforts across a diverse set of
organizations with an even more diverse
set of supportive services expertise are
needed to implement a holistic
approach to long-lasting self-sufficiency.
Envision Centers embody this concept,
bringing together a diverse set of
organizations and resources under one
roof, alleviating barriers commonly
faced by residents and other low-income
individuals including access and
transportation. An example of this
includes the IRS offering free tax
preparation services to residents in the
EnVision Center, while simultaneously
having the Department of Education
provide coordinators to aide residents in
gathering key tax and other pertinent
information needed to apply for the Free
Application for Federal Student Aid
(FAFSA). Another example includes;
CyberPatriots offering computer
technical classes through
Cybergenerations while the Small
Business Administration (SBA) provides
‘‘off the shelf’’ entrepreneurship courses
to educate residents, and other lowincome individuals interested in
launching their own businesses.
In its report released in January 2011,
that focused on Temporary Assistance
for Needy Families, Employment
Services and Workforce Investment Act
Adult employment programs funded by
the U.S. Departments of Labor,
Education, and Health and Human
Services, the Government
Accountability Office (GAO) found that
efficiencies in offering government
services could be achieved by colocating services and consolidating
administrative structures. EnVision
Centers aim to help foster efficiencies
through co-locating government services
and consolidating administrative
structures. Data collection is necessary
to assess and determine eligibility for
EnVision Center designation and

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63903

identify other activities to be conducted
at EnVision Centers.
Potential EnVision Center sites are
required to submit letters of
commitment and Action Plans that
promote and expand economic mobility.
These Action Plans will describe the
goals of the community’s participation
in the demonstration and provide, to the
extent as possible, objective goals
regarding the number of partnerships
established with state and local
government, non-profits, faith-based
organizations, and private and
philanthropic organizations. Once
designated as an EnVision Center,
designees are required to keep records
(e.g., Action Plans, etc.) that document
how the Demonstration is being
implemented, cooperate with the
evaluation, and commit to providing
quarterly progress reports. The Action
plan serves as a vehicle for bringing
together stakeholders and providing
them with a tangible path for achieving
the goals of the EnVision Center. These
plans will specify and formalize the
participation of community
stakeholders, describe gaps in current
service delivery models, describe the
onsite arrangements for intake
processing and referrals to network
stakeholders, identify the physical
location(s) which can act as a shared
services site to house the EnVision
Center, and/or outline specific
benchmarks and goals for the EnVision
Center. These plans could also capture
the goals of the community’s
participation in the demonstration and
provide, to the extent possible, objective
indicators of success regarding the
number of partnerships established with
state and local government, non-profits,
faith-based organizations, and private
and philanthropic organizations.
Progress reports will be required on a
quarterly basis in order to track
EnVision Center implementation, assess
and address Technical Assistance (TA)
needs, and monitor activities, outputs
and outcomes. A Customer Satisfaction
survey will be administered within 30days to individuals who go through the
EnVision Center’s intake process. This
will provide information about how
participants are experiencing the
supports, referrals, and placement
processes.
Envision Center sponsors may include
Public Housing Authorities (PHAs),
state and local governments, Tribes,
Tribally-Designated Housing Agencies,
participating jurisdictions, housing
counseling agencies, multifamily
owners/operators, faith-based and
nonprofit organizations, and
Continuums of Care (CoC).

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Federal Register / Vol. 83, No. 238 / Wednesday, December 12, 2018 / Notices

Respondents (i.e., affected public):
Executive Sponsor, Center Coordinator,
Navigator and Participants.
Respondent
EnVision
EnVision
EnVision
EnVision

Center
Center
Center
Center

Occupation

Executive Sponsor ............................
Director ..............................................
Navigator ...........................................
Participant .........................................

Source: Bureau of Labor Statistics,
Occupational Employment Statistics
(May 2017), https://www.bls.gov/oes/
current/oes_stru.htm and Department of
Labor, Minimum Wage (2009), https://
www.dol.gov/general/topic/wages/
minimumwage.
The EnVision Center Executive
Sponsor and Envision Center Director at
the 200 EnVision Centers will complete
the Commitment Letter. The EnVision
Center Executive Sponsor, EnVision
Center Director and the EnVision Center
Navigator will complete the Action Plan
and the Quarterly Report while the
EnVision Center Participant will

Commitment Letter (Completed by the
EnVision Center Navigator/EnVision
Center Executive Sponsor/EnVision
Center Director) ....................................
Action Plan (Completed by the EnVision
Center Navigator/EnVision Center Executive Sponsor/EnVision Center Director) ...................................................
Quarterly Report (Completed by the EnVision Center Navigator/EnVision Center Executive Sponsor/EnVision Center
Director) ................................................
Customer Satisfaction Survey (Completed by the EnVision Center Participant) .....................................................
Total ..................................................

amozie on DSK3GDR082PROD with NOTICES1

B. Solicitation of Public Comment
This notice solicits comments from
members of the public and affected
parties concerning the collection of
information described in Section A on
the following: (1) 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; (2) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected, and (4) ways to minimize the
burden of the collection of information

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Chief Executive .............................................................
General and Operations Managers ..............................
Social and Human Service Assistant ...........................
Federal Minimum Wage Rate ......................................

complete the Customer Satisfaction
Survey.
For the Commitment Letter, it is
assumed that the EnVision Center
Executive Sponsor and the EnVision
Center Director will need 0.25 hours to
complete this a year. The total number
of respondents would be 200 based on
the 200 centers.
For the Action Plan, it is assumed that
the EnVision Center Executive Sponsor
and EnVision Center Director will need
one hour to complete this and the
EnVision Center Navigator will need
seven hours to complete this for an
average of 8 hours total.

Number
of
respondents

Information
collection

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SOC code

Burden
hours per
response

Response
frequency

Median hourly
wage rate

11–1011
11–1021
21–1093
N/A

$88.11
48.27
15.92
7.25

For the Quarterly Reports, it is
assumed that the EnVision Center
Executive Sponsor and EnVision Center
Director will need one hour to complete
the review and and the EnVision Center
Navigator will need five hours to
complete this task for an average of 6
hours total.
For the Customer Satisfaction Survey,
we anticipate an average 200 Envision
Center Participant visits a year from
each of the 200 centers. This is a total
of 40,000 respondents per year with
each survey having a completion time of
three minutes.
Annual
burden
hours

Hourly
cost per
response

Total cost

200

1

0.25

50.00

$68.19

$3,409.50

200

1

8.00

1,600.00

22.45

35,920

200

4

6.00

4,800.00

24.63

118,224

40,000

1

0.05

2,000.00

7.25

14,500.00

40,600

........................

........................

8450.00

........................

172,053.50

on those who are to respond, including
the use of appropriate automated
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses.
HUD encourages interested parties to
submit comment in response to these
questions.
Authority: Section 3507 of the Paperwork
Reduction Act of 1995, 44 U.S.C. Chapter 35.
Dated: November 30, 2018.
Todd M. Richardson,
General Deputy Assistant, Secretary for Policy
Development and Research.
[FR Doc. 2018–26902 Filed 12–11–18; 8:45 am]
BILLING CODE 4210–67–P

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INTERNATIONAL TRADE
COMMISSION
[Investigation No. 731–TA–739 (Fourth
Review)]

Clad Steel Plate From Japan
Determination
On the basis of the record 1 developed
in the subject five-year review, the
United States International Trade
Commission (‘‘Commission’’)
determines, pursuant to the Tariff Act of
1930 (‘‘the Act’’), that revocation of the
1 The record is defined in sec. 207.2(f) of the
Commission’s Rules of Practice and Procedure (19
CFR 207.2(f)).

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