Proposed Information Collection Activity; Comment Request, 54807-54808 [2016-19611]
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54807
Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices
importation; facility isolation and
containment information; and personnel
qualifications. CDC plans to make no
changes to this application.
The Application for Permit to Import
or Transport Live Bats form is used by
laboratory facilities such as those
operated by government agencies,
universities, research institutions, and
for educational, exhibition, or scientific
Estimates of burden for the survey are
based on information obtained from the
CDC import permit database on the
number of permits issued on annual
basis since 2010. The total estimated
burden for the one-time data collection
is 545 hours. There are no costs to
respondents except their time.
purposes to request a permit for the
importation, and any subsequent
distribution after importation, of live
bats. This form currently requests the
applicant and sender contact
information; a description and intended
use of bats to be imported; and facility
isolation and containment information.
CDC plans to make no changes to this
application.
ESTIMATED ANNUALIZED BURDEN HOURS
Form name
Applicants Requesting to Import Biological
Agents, Infectious Substances and Vectors.
Applicants Requesting to Import Live Bats ....
Application for Permit to Import Infectious Biological Agents into the United States.
Application for a Permit to Import Live Bats ..
Jeffrey M. Zirger,
Health Scientist, Acting 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. 2016–19598 Filed 8–16–16; 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: Migrant and Seasonal Head
Start Study.
OMB No.: New Collection.
Description: The Office of Planning,
Research and Evaluation (OPRE),
Number of
responses per
respondent
Number of
respondents
Type of respondents
Average
burden per
response
(in hrs.)
1625
20/60
10
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services, is
proposing an information collection
activity for the Migrant and Seasonal
Head Start (MSHS) Study.
The MSHS Study is a nationally
representative study that will describe
the characteristics and experiences of
the children and families who enroll in
MSHS and the practices and services of
the MSHS programs that serve them.
The findings will provide essential upto-date information to the Office of Head
Start, other federal government
agencies, local MSHS programs, and the
public. The study will be the first
national MSHS study to include direct
child assessments, which will provide
valuable information about MSHS
children that programs can use to
inform program, center and classroom
practices.
1
1
20/60
Data collection will involve mail
surveys to selected MSHS center
directors and all MSHS program
directors nationwide about operational
characteristics, program- and centerlevel policies and practices, and
services and resources offered to MSHS
families. The study will also conduct
on-site data collection with children,
parents, teachers, and classrooms in a
nationally-representative sample of
MSHS centers. The on-site data
collection will include classroom
observations, teacher surveys, child
reports and child assessments to obtain
information on classroom instruction
and practices, children’s abilities and
families’ well-being.
Respondents: MSHS program
directors, center directors, teachers,
assistant teachers, parents, and children.
ANNUAL BURDEN ESTIMATES
Total
number of
respondents
mstockstill on DSK3G9T082PROD with NOTICES
Instrument
Number of
responses per
respondent
Average
burden hours
per response
Estimated
annual
burden hours
Program Director survey ................................................................................
Center Director survey ...................................................................................
Call script for Program Directors ...................................................................
Form for Program Directors to verify key information for selected centers ..
Call script for Center Directors ......................................................................
Call script for On Site Coordinators ...............................................................
Classroom sampling form ..............................................................................
Data collection coordination efforts ...............................................................
Child roster form ............................................................................................
Teacher survey ..............................................................................................
Teacher child report .......................................................................................
Assistant Teacher survey ..............................................................................
Parent consent form ......................................................................................
Child assessments (preschoolers and older toddlers only) ..........................
Parent interview (including Parent child report) ............................................
53
253
24
24
53
53
53
53
53
159
159
159
1,018
848
1,018
1
1
1
1
1
1
1
1
3
1
8
1
1
1
1
0.67
0.67
1
0.5
1
1
0.5
20
0.25
0.67
0.17
0.33
0.25
0.67
1
36
170
24
12
53
53
27
1,060
40
107
216
52
255
568
1,018
Estimated Total Annual Burden Hours: ..................................................
........................
..........................
........................
3,689
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54808
Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices
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 Street 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
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. 2016–19611 Filed 8–16–16; 8:45 am]
BILLING CODE 4184–22–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0800]
Regulatory Classification of
Pharmaceutical Co-Crystals; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Regulatory Classification of
Pharmaceutical Co-Crystals.’’ This
guidance provides applicants planning
to submit new drug applications (NDAs)
and abbreviated new drug applications
(ANDAs) with information on the
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Jkt 238001
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
Notice of availability.
SUMMARY:
appropriate regulatory classification of
pharmaceutical co-crystal solid-state
forms. This guidance also provides
information about the data that
applicants should submit to support the
appropriate classification of a co-crystal
as well as the regulatory implications of
the classification. This draft guidance
revises the guidance for industry
entitled ‘‘Regulatory Classification of
Pharmaceutical Co-Crystals’’ issued in
April 2013.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by October 17,
2016.
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,
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Sfmt 4703
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–
2011–D–0800 for ‘‘Regulatory
Classification of Pharmaceutical CoCrystals.’’ 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
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.
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
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[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Notices]
[Pages 54807-54808]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19611]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Migrant and Seasonal Head Start Study.
OMB No.: New Collection.
Description: The Office of Planning, Research and Evaluation
(OPRE), Administration for Children and Families (ACF), U.S. Department
of Health and Human Services, is proposing an information collection
activity for the Migrant and Seasonal Head Start (MSHS) Study.
The MSHS Study is a nationally representative study that will
describe the characteristics and experiences of the children and
families who enroll in MSHS and the practices and services of the MSHS
programs that serve them. The findings will provide essential up-to-
date information to the Office of Head Start, other federal government
agencies, local MSHS programs, and the public. The study will be the
first national MSHS study to include direct child assessments, which
will provide valuable information about MSHS children that programs can
use to inform program, center and classroom practices.
Data collection will involve mail surveys to selected MSHS center
directors and all MSHS program directors nationwide about operational
characteristics, program- and center-level policies and practices, and
services and resources offered to MSHS families. The study will also
conduct on-site data collection with children, parents, teachers, and
classrooms in a nationally-representative sample of MSHS centers. The
on-site data collection will include classroom observations, teacher
surveys, child reports and child assessments to obtain information on
classroom instruction and practices, children's abilities and families'
well-being.
Respondents: MSHS program directors, center directors, teachers,
assistant teachers, parents, and children.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total number Number of Average burden Estimated
Instrument of responses per hours per annual burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Program Director survey........................ 53 1 0.67 36
Center Director survey......................... 253 1 0.67 170
Call script for Program Directors.............. 24 1 1 24
Form for Program Directors to verify key 24 1 0.5 12
information for selected centers..............
Call script for Center Directors............... 53 1 1 53
Call script for On Site Coordinators........... 53 1 1 53
Classroom sampling form........................ 53 1 0.5 27
Data collection coordination efforts........... 53 1 20 1,060
Child roster form.............................. 53 3 0.25 40
Teacher survey................................. 159 1 0.67 107
Teacher child report........................... 159 8 0.17 216
Assistant Teacher survey....................... 159 1 0.33 52
Parent consent form............................ 1,018 1 0.25 255
Child assessments (preschoolers and older 848 1 0.67 568
toddlers only)................................
Parent interview (including Parent child 1,018 1 1 1,018
report).......................................
----------------------------------------------------------------
Estimated Total Annual Burden Hours:....... .............. ............... .............. 3,689
----------------------------------------------------------------------------------------------------------------
[[Page 54808]]
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 Street 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 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. 2016-19611 Filed 8-16-16; 8:45 am]
BILLING CODE 4184-22-P
