81_FR_54966 81 FR 54807 - Proposed Information Collection Activity; Comment Request

81 FR 54807 - Proposed Information Collection Activity; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 81, Issue 159 (August 17, 2016)

Page Range54807-54808
FR Document2016-19611

Federal Register, Volume 81 Issue 159 (Wednesday, August 17, 2016)
[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Notices]
[Pages 54807-54808]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-19611]


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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: 
[email protected]. 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



                                                                                     Federal Register / Vol. 81, No. 159 / Wednesday, August 17, 2016 / Notices                                                                                            54807

                                                  importation; facility isolation and                                     purposes to request a permit for the                                         Estimates of burden for the survey are
                                                  containment information; and personnel                                  importation, and any subsequent                                           based on information obtained from the
                                                  qualifications. CDC plans to make no                                    distribution after importation, of live                                   CDC import permit database on the
                                                  changes to this application.                                            bats. This form currently requests the                                    number of permits issued on annual
                                                    The Application for Permit to Import                                  applicant and sender contact                                              basis since 2010. The total estimated
                                                  or Transport Live Bats form is used by                                  information; a description and intended                                   burden for the one-time data collection
                                                  laboratory facilities such as those                                     use of bats to be imported; and facility                                  is 545 hours. There are no costs to
                                                  operated by government agencies,                                        isolation and containment information.                                    respondents except their time.
                                                  universities, research institutions, and                                CDC plans to make no changes to this
                                                  for educational, exhibition, or scientific                              application.

                                                                                                                         ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                                                                         Average
                                                                                                                                                                                                                             Number of
                                                                                                                                                                                                   Number of                                           burden per
                                                                    Type of respondents                                                          Form name                                                                 responses per
                                                                                                                                                                                                  respondents                                           response
                                                                                                                                                                                                                             respondent                  (in hrs.)

                                                  Applicants Requesting to Import Biological                            Application for Permit to Import Infectious Bi-                                         1625                             1            20/60
                                                    Agents, Infectious Substances and Vectors.                            ological Agents into the United States.
                                                  Applicants Requesting to Import Live Bats ....                        Application for a Permit to Import Live Bats ..                                             10                           1            20/60


                                                  Jeffrey M. Zirger,                                                      Administration for Children and                                             Data collection will involve mail
                                                  Health Scientist, Acting Chief, Information                             Families (ACF), U.S. Department of                                        surveys to selected MSHS center
                                                  Collection Review Office, Office of Scientific                          Health and Human Services, is                                             directors and all MSHS program
                                                  Integrity, Office of the Associate Director for                         proposing an information collection                                       directors nationwide about operational
                                                  Science, Office of the Director, Centers for                            activity for the Migrant and Seasonal
                                                  Disease Control and Prevention.
                                                                                                                                                                                                    characteristics, program- and center-
                                                                                                                          Head Start (MSHS) Study.                                                  level policies and practices, and
                                                  [FR Doc. 2016–19598 Filed 8–16–16; 8:45 am]                               The MSHS Study is a nationally                                          services and resources offered to MSHS
                                                  BILLING CODE 4163–18–P                                                  representative study that will describe                                   families. The study will also conduct
                                                                                                                          the characteristics and experiences of
                                                                                                                                                                                                    on-site data collection with children,
                                                                                                                          the children and families who enroll in
                                                  DEPARTMENT OF HEALTH AND                                                                                                                          parents, teachers, and classrooms in a
                                                                                                                          MSHS and the practices and services of
                                                  HUMAN SERVICES                                                          the MSHS programs that serve them.                                        nationally-representative sample of
                                                                                                                          The findings will provide essential up-                                   MSHS centers. The on-site data
                                                  Administration for Children and                                         to-date information to the Office of Head                                 collection will include classroom
                                                  Families                                                                Start, other federal government                                           observations, teacher surveys, child
                                                                                                                          agencies, local MSHS programs, and the                                    reports and child assessments to obtain
                                                  Proposed Information Collection                                                                                                                   information on classroom instruction
                                                                                                                          public. The study will be the first
                                                  Activity; Comment Request                                                                                                                         and practices, children’s abilities and
                                                                                                                          national MSHS study to include direct
                                                    Title: Migrant and Seasonal Head                                      child assessments, which will provide                                     families’ well-being.
                                                  Start Study.                                                            valuable information about MSHS                                             Respondents: MSHS program
                                                    OMB No.: New Collection.                                              children that programs can use to                                         directors, center directors, teachers,
                                                    Description: The Office of Planning,                                  inform program, center and classroom                                      assistant teachers, parents, and children.
                                                  Research and Evaluation (OPRE),                                         practices.

                                                                                                                                   ANNUAL BURDEN ESTIMATES
                                                                                                                                                                       Total                     Number of                    Average                  Estimated
                                                                                                 Instrument                                                          number of                 responses per                burden hours                 annual
                                                                                                                                                                    respondents                  respondent                 per response              burden 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 information for selected centers ..                                                       24                               1                      0.5                 12
                                                  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
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                                                  Assistant Teacher survey ..............................................................................                           159                               1                     0.33                 52
                                                  Parent consent form ......................................................................................                      1,018                               1                     0.25                255
                                                  Child assessments (preschoolers and older toddlers only) ..........................                                               848                               1                     0.67                568
                                                  Parent interview (including Parent child report) ............................................                                   1,018                               1                        1              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                   appropriate regulatory classification of               except for information submitted,
                                                  of Section 3506(c)(2)(A) of the                         pharmaceutical co-crystal solid-state                  marked and identified, as confidential,
                                                  Paperwork Reduction Act of 1995, the                    forms. This guidance also provides                     if submitted as detailed in
                                                  Administration for Children and                         information about the data that                        ‘‘Instructions.’’
                                                  Families is soliciting public comment                   applicants should submit to support the                   Instructions: All submissions received
                                                  on the specific aspects of the                          appropriate classification of a co-crystal             must include the Docket No. FDA–
                                                  information collection described above.                 as well as the regulatory implications of              2011–D–0800 for ‘‘Regulatory
                                                  Copies of the proposed collection of                    the classification. This draft guidance                Classification of Pharmaceutical Co-
                                                  information can be obtained and                         revises the guidance for industry                      Crystals.’’ Received comments will be
                                                  comments may be forwarded by writing                    entitled ‘‘Regulatory Classification of                placed in the docket and, except for
                                                  to the Administration for Children and                  Pharmaceutical Co-Crystals’’ issued in                 those submitted as ‘‘Confidential
                                                  Families, Office of Planning, Research                  April 2013.                                            Submissions,’’ publicly viewable at
                                                  and Evaluation, 330 C Street SW.,                       DATES: Although you can comment on                     http://www.regulations.gov or at the
                                                  Washington, DC 20201, Attn: OPRE                        any guidance at any time (see 21 CFR                   Division of Dockets Management
                                                  Reports Clearance Officer. Email                        10.115(g)(5)), to ensure that the Agency               between 9 a.m. and 4 p.m., Monday
                                                  address: OPREinfocollection@                            considers your comment on this draft                   through Friday.
                                                  acf.hhs.gov. All requests should be                                                                               • Confidential Submissions—To
                                                                                                          guidance before it begins work on the
                                                  identified by the title of the information                                                                     submit a comment with confidential
                                                                                                          final version of the guidance, submit
                                                  collection.                                                                                                    information that you do not wish to be
                                                                                                          either electronic or written comments
                                                    The Department specifically requests                                                                         made publicly available, submit your
                                                                                                          on the draft guidance by October 17,
                                                  comments on (a) whether the proposed                                                                           comments only as a written/paper
                                                                                                          2016.
                                                  collection of information is necessary                                                                         submission. You should submit two
                                                                                                          ADDRESSES:        You may submit comments              copies total. One copy will include the
                                                  for the proper performance of the
                                                                                                          as follows:                                            information you claim to be confidential
                                                  functions of the agency, including
                                                  whether the information shall have                      Electronic Submissions                                 with a heading or cover note that states
                                                  practical utility; (b) the accuracy of the                                                                     ‘‘THIS DOCUMENT CONTAINS
                                                                                                            Submit electronic comments in the                    CONFIDENTIAL INFORMATION.’’ The
                                                  agency’s estimate of the burden of the                  following way:
                                                  proposed collection of information; (c)                                                                        Agency will review this copy, including
                                                                                                            • Federal eRulemaking Portal: http://                the claimed confidential information, in
                                                  the quality, utility, and clarity of the                www.regulations.gov. Follow the
                                                  information to be collected; and (d)                                                                           its consideration of comments. The
                                                                                                          instructions for submitting comments.                  second copy, which will have the
                                                  ways to minimize the burden of the                      Comments submitted electronically,                     claimed confidential information
                                                  collection of information on                            including attachments, to http://                      redacted/blacked out, will be available
                                                  respondents, including through the use                  www.regulations.gov will be posted to                  for public viewing and posted on http://
                                                  of automated collection techniques or                   the docket unchanged. Because your                     www.regulations.gov. Submit both
                                                  other forms of information technology.                  comment will be made public, you are                   copies to the Division of Dockets
                                                  Consideration will be given to                          solely responsible for ensuring that your              Management. If you do not wish your
                                                  comments and suggestions submitted                      comment does not include any                           name and contact information to be
                                                  within 60 days of this publication.                     confidential information that you or a                 made publicly available, you can
                                                  Robert Sargis,                                          third party may not wish to be posted,                 provide this information on the cover
                                                  ACF Certifying Officer.                                 such as medical information, your or                   sheet and not in the body of your
                                                  [FR Doc. 2016–19611 Filed 8–16–16; 8:45 am]             anyone else’s Social Security number, or               comments and you must identify this
                                                  BILLING CODE 4184–22–P
                                                                                                          confidential business information, such                information as ‘‘confidential.’’ Any
                                                                                                          as a manufacturing process. Please note                information marked as ‘‘confidential’’
                                                                                                          that if you include your name, contact                 will not be disclosed except in
                                                  DEPARTMENT OF HEALTH AND                                information, or other information that                 accordance with 21 CFR 10.20 and other
                                                  HUMAN SERVICES                                          identifies you in the body of your                     applicable disclosure law. For more
                                                                                                          comments, that information will be                     information about FDA’s posting of
                                                  Food and Drug Administration                            posted on http://www.regulations.gov.                  comments to public dockets, see 80 FR
                                                                                                            • If you want to submit a comment                    56469, September 18, 2015, or access
                                                  [Docket No. FDA–2011–D–0800]
                                                                                                          with confidential information that you                 the information at: http://www.fda.gov/
                                                  Regulatory Classification of                            do not wish to be made available to the                regulatoryinformation/dockets/
                                                  Pharmaceutical Co-Crystals; Draft                       public, submit the comment as a                        default.htm.
                                                  Guidance for Industry; Availability                     written/paper submission and in the                       Docket: For access to the docket to
                                                                                                          manner detailed (see ‘‘Written/Paper                   read background documents or the
                                                  AGENCY:    Food and Drug Administration,                Submissions’’ and ‘‘Instructions’’).                   electronic and written/paper comments
                                                  HHS.                                                                                                           received, go to http://
                                                                                                          Written/Paper Submissions                              www.regulations.gov and insert the
                                                  ACTION:   Notice of availability.
                                                                                                            Submit written/paper submissions as                  docket number, found in brackets in the
                                                  SUMMARY:  The Food and Drug                             follows:                                               heading of this document, into the
                                                  Administration (FDA or Agency) is                         • Mail/Hand delivery/Courier (for                    ‘‘Search’’ box and follow the prompts
                                                  announcing the availability of a draft                  written/paper submissions): Division of                and/or go to the Division of Dockets
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                                                  guidance for industry entitled                          Dockets Management (HFA–305), Food                     Management, 5630 Fishers Lane, Rm.
                                                  ‘‘Regulatory Classification of                          and Drug Administration, 5630 Fishers                  1061, Rockville, MD 20852.
                                                  Pharmaceutical Co-Crystals.’’ This                      Lane, Rm. 1061, Rockville, MD 20852.                      Submit written requests for single
                                                  guidance provides applicants planning                     • For written/paper comments                         copies of the draft guidance to the
                                                  to submit new drug applications (NDAs)                  submitted to the Division of Dockets                   Division of Drug Information, Center for
                                                  and abbreviated new drug applications                   Management, FDA will post your                         Drug Evaluation and Research, Food
                                                  (ANDAs) with information on the                         comment, as well as any attachments,                   and Drug Administration, 10001 New


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Document Created: 2018-02-09 11:34:57
Document Modified: 2018-02-09 11:34:57
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
FR Citation81 FR 54807 

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