Proposed Information Collection Activity; Comment Request, 22275-22276 [2016-08715]
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Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices
expand the original scope of approved
activities.
The Administration for
Children and Families (ACF),
Administration on Children, Youth and
Families (ACYF), Family and Youth
Services Bureau (FYSB), Division of
Adolescent Development and Support
(DADS), announces the award of a
single-source expansion supplement
grant of $852,000 to the National Safe
Place Network located in Louisville, KY,
to support costs associated with the
expansion of the scope of approved
activities under its award for the
Runaway and Homeless Youth Training
and Technical Assistance Center
(RHYTTAC).
SUMMARY:
The period of support under this
supplement is September 30, 2015,
through September 29, 2016.
FOR FURTHER INFORMATION CONTACT:
Christopher Holloway, Program
Manager, Runaway and Homeless Youth
Program, Division of Adolescent
Development and Support, Family and
Youth Services Bureau, 330 C Street
SW., Washington, DC 20201. Telephone:
202–205–9560; Email:
Christopher.Holloway@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: The
expansion supplement award will allow
the National Safe Place Network to:
• Provide Runaway and Homeless
Youth (RHY) grantees with resources
necessary to better understand and
respond to human trafficking through
the creation of a Community Awareness
Toolkit and Youth Prevention Action
Kit, which will enhance their
sustainability to provide human
trafficking related services;
• Provide a clear and responsive
framework by which all grantees of
Domestic Victims of Human Trafficking
(DVHT) funding can access relevant
DATES:
training and responsive technical
assistance;
• Partner with a national leader in
services to human trafficking victims/
survivors to provide all RHY grantees
with enhanced access to human
trafficking information on assessments,
referrals, applicable state laws and
trafficking, including sex and labor
categories;
• Provide stipends to grantees to
assist them in meeting federal
requirements to submit data under
RHY–Homeless Management
Information System (RHY–HMIS).
Using evidence-based practices
derived from the best available research,
professional expertise, and input from
youth and families, RHYTTAC serves as
a national resource for training and
technical assistance directed to assisting
RHY organizations in their engagement
in continuous quality improvement of
their services in building organizational
capacity to effectively serve runaway
and homeless youth. RHYTTAC’s focus
is to help the nation’s network of RHY
service providers boost ‘‘protective
factors’’ for their clients.
Statutory Authority: Runaway and
Homeless Youth Act, 42 U.S.C. 5701 through
5752, as most recently amended by the
Reconnecting Homeless Youth Act of 2008,
Public Law 110–378 on October 8, 2008.
Christopher Beach,
Senior Grants Policy Specialist, Division of
Grants Policy, Office of Administration.
[FR Doc. 2016–08654 Filed 4–14–16; 8:45 am]
BILLING CODE 4184–33–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: Phase II Evaluation Activities
for Implementing a Next Generation
Evaluation Agenda for the Chafee Foster
Care Independence Program.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF), Office of
Planning Research and Evaluation
(OPRE) is proposing an information
collection activity as part of the Phase
II Evaluation Activities for
Implementing a Next Generation
Evaluation Agenda for the Chafee Foster
Care Independence Program. The
proposed information collection
consists of site visits by staff from the
Urban Institute and Chapin Hall at the
University of Chicago to conduct
formative evaluations of programs
serving transition-age foster youth. The
evaluations will include preliminary
visits to discuss the evaluation process
with program administrators. Then, the
research team will conduct site visits to
each program to speak with program
leaders, partners and key stakeholders,
front-line staff, and participants. These
formative evaluations will determine
programs’ readiness for more rigorous
evaluation in the future. The activities
and products from this project will help
ACF to fulfill their ongoing legislative
mandate for program evaluation
specified in the Foster Care
Independence Act of 1999.
Respondents: Program leaders,
partners and stakeholders, and frontline staff as well as young adults being
served by the programs.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
Instrument
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Discussion Guide for program leaders ................................
Discussion Guide for program partners and stakeholders ..
Discussion Guide for program front-line staff ......................
Focus Group Guide for program participants ......................
Compilation and Submission of Administrative Data Files ..
Estimated Total Annual Burden
Hours: 728.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
VerDate Sep<11>2014
17:27 Apr 14, 2016
Jkt 238001
Annual
number of
respondents
48
80
128
200
24
24
40
64
100
12
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C St SW.,
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
4
2
1
1
2
Average
burden hours
per response
1
1
1
2
12
Annual
burden hours
96
80
64
200
288
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. Email
address: OPREinfocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on (a) whether the proposed
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Federal Register / Vol. 81, No. 73 / Friday, April 15, 2016 / Notices
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
ACF Certifying Officer.
[FR Doc. 2016–08715 Filed 4–14–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–E–2353]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; CYRAMZA
AGENCY:
Food and Drug Administration,
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
CYRAMZA 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
human biological product.
SUMMARY:
Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by June 14, 2016.
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
October 12, 2016. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
DATES:
ADDRESSES:
You may submit comments
as follows:
VerDate Sep<11>2014
17:27 Apr 14, 2016
Jkt 238001
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
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
HHS.
ACTION:
Electronic Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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 No. FDA–
2014–E–2353 for Determination of
Regulatory Review Period for Purposes
of Patent Extension; CYRAMZA.
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
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
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
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 https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
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]]>Agencies
[Federal Register Volume 81, Number 73 (Friday, April 15, 2016)]
[Notices]
[Pages 22275-22276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-08715]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Phase II Evaluation Activities for Implementing a Next
Generation Evaluation Agenda for the Chafee Foster Care Independence
Program.
OMB No.: New Collection.
Description: The Administration for Children and Families (ACF),
Office of Planning Research and Evaluation (OPRE) is proposing an
information collection activity as part of the Phase II Evaluation
Activities for Implementing a Next Generation Evaluation Agenda for the
Chafee Foster Care Independence Program. The proposed information
collection consists of site visits by staff from the Urban Institute
and Chapin Hall at the University of Chicago to conduct formative
evaluations of programs serving transition-age foster youth. The
evaluations will include preliminary visits to discuss the evaluation
process with program administrators. Then, the research team will
conduct site visits to each program to speak with program leaders,
partners and key stakeholders, front-line staff, and participants.
These formative evaluations will determine programs' readiness for more
rigorous evaluation in the future. The activities and products from
this project will help ACF to fulfill their ongoing legislative mandate
for program evaluation specified in the Foster Care Independence Act of
1999.
Respondents: Program leaders, partners and stakeholders, and front-
line staff as well as young adults being served by the programs.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Total number Annual number responses per hours per Annual burden
of respondents of respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Discussion Guide for program 48 24 4 1 96
leaders........................
Discussion Guide for program 80 40 2 1 80
partners and stakeholders......
Discussion Guide for program 128 64 1 1 64
front-line staff...............
Focus Group Guide for program 200 100 1 2 200
participants...................
Compilation and Submission of 24 12 2 12 288
Administrative Data Files......
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 728.
In compliance with the requirements of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation, 330 C St SW., Washington, DC 20201,
Attn: OPRE Reports Clearance Officer. Email address:
OPREinfocollection@acf.hhs.gov. All requests should be identified by
the title of the information collection.
The Department specifically requests comments on (a) whether the
proposed
[[Page 22276]]
collection of information is necessary for the proper performance of
the functions of the agency, including whether the information shall
have practical utility; (b) the accuracy of the agency's estimate of
the burden of the proposed collection of information; (c) the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques or other
forms of information technology. Consideration will be given to
comments and suggestions submitted within 60 days of this publication.
Robert Sargis,
ACF Certifying Officer.
[FR Doc. 2016-08715 Filed 4-14-16; 8:45 am]
BILLING CODE 4184-01-P
