Proposed Information Collection Activity; Comment Request, 65764-65765 [2015-27239]
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Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices
form will take approximately one hour
which results in 20 burden hours each.
The total estimated and time-related
burden is 40 hours.
There are no costs to respondents
other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Nursing Home Administrator ...........................
Evaluation of Nursing Home Workplace Violence Prevention Program: Abstraction
Form.
Committee Chair Interview .............................
Nursing Home Administrator ...........................
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. 2015–27301 Filed 10–26–15; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Title: National Center on Early Head
Start Child Care Partnerships (NCEHS–
CCP) Evaluation.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF) in the
Department of Health and Human
Services (HHS) has awarded 275 Early
Head Start expansion and Early Head
Start–child care partnership grants
(EHS–CCP) in 50 states; Washington,
DC; Puerto Rico; and the Northern
Mariana Islands. These grants will allow
new or existing Early Head Start
programs to partner with local child
care centers and family child care
providers to expand high-quality early
learning opportunities for infants and
toddlers from low-income families.
NCEHS–CCP will support the
effective implementation of new EHS–
CCP grants by disseminating
information through training and
technical assistance (T/TA) and
resources and materials. NCEHS–CCP is
primarily targeted to T/TA providers
working directly with the EHS–CCP
grantees (including Office of Head Start
(OHS) and Office of Child Care (OCC)
National Centers, regional training and
technical assistance (T/TA) specialists,
and implementation planners and fiscal
consultants). State and federal agencies
(including OHS and OCC federal staff,
Child Care and Development Fund
(CCDF) administrators, Head Start State
and National Collaboration directors), as
well as EHS–CCP grantees will also find
helpful information on partnerships
through NCEHS–CCP’s resources.
The NCEHS–CCP at ZERO TO THREE
is proposing to conduct a descriptive
study of NCEHS–CCP that will provide
information that will document the
activities and progress of NCEHS–CCP
toward its goals and objectives. Findings
from the evaluation will be translated
into action steps to inform continuous
quality improvement of NCEHS–CCP.
The proposed data collection
activities for the descriptive study of
NCEHS–CCP will include the following
components:
• Stakeholder survey. Web-based
surveys will be conducted in the spring
of 2016 and 2018 with key stakeholders
(including OHS and OCC federal and
national center staff, regional T/TA
specialists, CCDF administrators, Head
Start state and national collaboration
tkelley on DSK3SPTVN1PROD with NOTICES
Estimated annual burden total: 250.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
20:01 Oct 26, 2015
Jkt 238001
1
1
20
1
1
office directors, and implementation
planners and fiscal consultants). The
stakeholder survey will collect
information about the types of support
they received from NCEHS–CCP in the
past year, their satisfaction with the
support, how the T/TA informed their
work with EHS CCP grantees, and how
support could be improved.
• Stakeholder telephone interviews.
Semi-structured telephone interviews
will be conducted in spring of 2017 and
2019 with a purposively selected
subgroup of stakeholders that complete
the stakeholder survey. The interviews
will explore in more detail the types of
T/TA support participants received
from NCEHS–CCP, how that support has
informed their work with EHS–CCP
grantees, their satisfaction with the
support, successes and challenges, and
suggestions for improvement.
This 60-Day Federal Register Notice
covers the data collection activities for
NCEHS–CCP and requests clearance for
(1) the stakeholder survey, and (2) the
stakeholder telephone interviews.
Respondents: Respondents include
OHS and OCC federal and national
center staff, regional T/TA specialists,
CCDF administrators, Head Start state
and national collaboration office
directors, and implementation planners
and fiscal consultants.
Annual Burden Estimates: The
following instruments are proposed for
public comment under this 60-Day
Federal Register Notice.
Annual
number of
responses per
respondent
Number of
responses per
respondent
350
150
1
1
2
1
Stakeholder survey ..............................................................
Stakeholder telephone interviews ........................................
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
PO 00000
Frm 00078
Fmt 4703
Sfmt 4703
Average
burden per
response
(in hrs.)
20
Total number
of respondents
Instrument
VerDate Sep<11>2014
Number of
responses per
respondent
Number of
respondents
Type of respondents
Average
burden hours
per response
.5
1.0
Annual burden
hours
175
75
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
E:\FR\FM\27OCN1.SGM
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Federal Register / Vol. 80, No. 207 / Tuesday, October 27, 2015 / Notices
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
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,
Reports Clearance Officer.
[FR Doc. 2015–27239 Filed 10–26–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–3534]
Bulk Drug Substances That Can Be
Used To Compound Drug Products in
Accordance With Section 503A of the
Federal Food, Drug, and Cosmetic Act;
Establishment of a Public Docket
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; establishment of public
docket.
The Food and Drug
Administration (FDA or Agency) is
developing a list of bulk drug
substances (active ingredients) that can
be used to compound drug products in
accordance with the Federal Food, Drug,
and Cosmetic Act (the FD&C Act),
although they are neither the subject of
an applicable United States
Pharmacopeia (USP) or National
Formulary (NF) monograph nor
components of FDA-approved drugs
(503A bulks list). The Agency
previously solicited nominations for the
list, but some of the nominated
substances were not supported by
sufficient information for FDA to
evaluate them. FDA is establishing a
public docket where these substances
can be renominated with sufficient
supporting information or to receive
tkelley on DSK3SPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:24 Oct 26, 2015
Jkt 238001
nominations of bulk drug substances
that were not previously nominated for
consideration for inclusion on the 503A
bulks list. Interested parties can also
submit comments on nominated
substances via this docket.
DATES: Nominations and comments may
be submitted to this docket at any time.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
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
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–
2015–N–3534 for ‘‘Bulk Drug
Substances That Can Be Used To
Compound Drug Products in
Accordance With Section 503A of the
Federal Food, Drug, and Cosmetic Act;
Establishment of a Public Docket.’’
Received comments will be placed in
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65765
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
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:
Philantha Bowen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5175,
Silver Spring, MD 20993–0002, 301–
796–2466.
SUPPLEMENTARY INFORMATION:
I. Background
Section 503A of the FD&C Act (21
U.S.C. 353a) describes the conditions
under which a compounded drug
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]]>Agencies
[Federal Register Volume 80, Number 207 (Tuesday, October 27, 2015)]
[Notices]
[Pages 65764-65765]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-27239]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: National Center on Early Head Start Child Care Partnerships
(NCEHS-CCP) Evaluation.
OMB No.: New Collection.
Description: The Administration for Children and Families (ACF) in
the Department of Health and Human Services (HHS) has awarded 275 Early
Head Start expansion and Early Head Start-child care partnership grants
(EHS-CCP) in 50 states; Washington, DC; Puerto Rico; and the Northern
Mariana Islands. These grants will allow new or existing Early Head
Start programs to partner with local child care centers and family
child care providers to expand high-quality early learning
opportunities for infants and toddlers from low-income families.
NCEHS-CCP will support the effective implementation of new EHS-CCP
grants by disseminating information through training and technical
assistance (T/TA) and resources and materials. NCEHS-CCP is primarily
targeted to T/TA providers working directly with the EHS-CCP grantees
(including Office of Head Start (OHS) and Office of Child Care (OCC)
National Centers, regional training and technical assistance (T/TA)
specialists, and implementation planners and fiscal consultants). State
and federal agencies (including OHS and OCC federal staff, Child Care
and Development Fund (CCDF) administrators, Head Start State and
National Collaboration directors), as well as EHS-CCP grantees will
also find helpful information on partnerships through NCEHS-CCP's
resources.
The NCEHS-CCP at ZERO TO THREE is proposing to conduct a
descriptive study of NCEHS-CCP that will provide information that will
document the activities and progress of NCEHS-CCP toward its goals and
objectives. Findings from the evaluation will be translated into action
steps to inform continuous quality improvement of NCEHS-CCP.
The proposed data collection activities for the descriptive study
of NCEHS-CCP will include the following components:
Stakeholder survey. Web-based surveys will be conducted in
the spring of 2016 and 2018 with key stakeholders (including OHS and
OCC federal and national center staff, regional T/TA specialists, CCDF
administrators, Head Start state and national collaboration office
directors, and implementation planners and fiscal consultants). The
stakeholder survey will collect information about the types of support
they received from NCEHS-CCP in the past year, their satisfaction with
the support, how the T/TA informed their work with EHS CCP grantees,
and how support could be improved.
Stakeholder telephone interviews. Semi-structured
telephone interviews will be conducted in spring of 2017 and 2019 with
a purposively selected subgroup of stakeholders that complete the
stakeholder survey. The interviews will explore in more detail the
types of T/TA support participants received from NCEHS-CCP, how that
support has informed their work with EHS-CCP grantees, their
satisfaction with the support, successes and challenges, and
suggestions for improvement.
This 60-Day Federal Register Notice covers the data collection
activities for NCEHS-CCP and requests clearance for (1) the stakeholder
survey, and (2) the stakeholder telephone interviews.
Respondents: Respondents include OHS and OCC federal and national
center staff, regional T/TA specialists, CCDF administrators, Head
Start state and national collaboration office directors, and
implementation planners and fiscal consultants.
Annual Burden Estimates: The following instruments are proposed for
public comment under this 60-Day Federal Register Notice.
----------------------------------------------------------------------------------------------------------------
Annual number
Total number of responses Number of Average Annual burden
Instrument of respondents per responses per burden hours hours
respondent respondent per response
----------------------------------------------------------------------------------------------------------------
Stakeholder survey.............. 350 1 2 .5 175
Stakeholder telephone interviews 150 1 1 1.0 75
----------------------------------------------------------------------------------------------------------------
Estimated annual burden total: 250.
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, 370 L'Enfant Promenade SW.,
Washington, DC 20447,
[[Page 65765]]
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 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,
Reports Clearance Officer.
[FR Doc. 2015-27239 Filed 10-26-15; 8:45 am]
BILLING CODE 4184-01-P
