Submission for OMB Review; Comment Request, 22269-22270 [2018-10169]
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Federal Register / Vol. 83, No. 93 / Monday, May 14, 2018 / Notices
under a potential future funding
opportunity (Phase III). During Phase II,
ACF will engage a contractor to:
Conduct a cross-site process evaluation.
Data collected for the process evaluation
will be used to assess grantees’
organizational capacity to implement
and evaluate the model interventions
and to monitor each grantee’s progress
toward achieving the goals of the
implementation period.
Data for the process evaluation will be
collected through: Interviews during site
visits.
Respondents: Grantee agency
directors and staff; partner agency
directors and staff. Partner agencies may
vary by site, but are expected to include
child welfare, mental health, and youth
housing/homelessness agencies.
ANNUAL BURDEN ESTIMATES
Instrument
Total/annual
number of
respondents
Number of
responses
per
respondent
Average
burden hours
per response
Total/annual
burden hours
Grantee Site Visit-Semi-Structured Interview Topic Guide .............................
60
1
1.5
90
........................
........................
........................
90
Estimated Total Annual Burden Hours .....................................................
Additional Information: Copies of the
proposed collection may be obtained 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.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration, for
Children and Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–10178 Filed 5–11–18; 8:45 am]
BILLING CODE 4184–29–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB NO.: 0970–0402]
Submission for OMB Review;
Comment Request
Title: Mother and Infant Home
Visiting Program Evaluation (MIHOPE):
Long-Term Follow-Up.
Description: The Administration for
Children and Families (ACF), in
partnership with the Health Resources
and Services Administration (HRSA),
both of the U.S. Department of Health
and Human Services (HHS), is
proposing a data collection activity as
part of the Mother and Infant Home
Visiting Program Evaluation Long-Term
Follow-Up project (MIHOPE–LT). The
purpose of MIHOPE–LT is to conduct
follow-up studies that assess the longterm impact of the Maternal, Infant, and
Early Childhood Home Visiting
(MIECHV) Program. The design of
MIHOPE–LT calls for multiple followup points including when the
participating children are in
kindergarten, 3rd grade, early
adolescence, and late adolescence. This
Federal Register Notice is specific to the
first follow-up study. Data collected
during the first follow-up study (when
the children from the MIHOPE sample
are of kindergarten age) will include the
following: (1) A one-hour survey with
the child’s primary caregiver (who will
be the mother if she is available), (2)
direct assessments of child
development, (3) a semi-structured
interview with the caregiver, (4) surveys
with the child’s teacher, (5) a direct
assessment of the caregiver, and (6) 15
minutes of videotaped interactions
between the caregiver and child. In
addition to collecting these data, the
MIHOPE–LT project will also maintain
up-to-date consent forms for the
collection of administrative data. Future
information collection requests and
related Federal Register Notices will
describe future data collection efforts for
this project.
Data collected during the kindergarten
follow-up study will be used to estimate
the effects of MIECHV-funded programs
on seven domains: (1) Maternal health;
(2) child health; (3) child development
and school performance; (4) child
maltreatment; (5) parenting; (6) crime or
domestic violence; and (7) family
economic self-sufficiency.
Respondents: The respondents in this
follow-up study will include 4,115
families who participated in MIHOPE
and 4,115 teachers of the focal children
from those families.
ANNUAL BURDEN ESTIMATES
Total number
of respondents
amozie on DSK3GDR082PROD with NOTICES
Instrument
Survey of caregivers ............................................................
Direct assessments of children ............................................
Semi-structured interview with caregivers ...........................
Survey of the focal children’s teachers ...............................
Direct assessments of caregivers ........................................
Videotaped caregiver-child interactions ...............................
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18:34 May 11, 2018
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Annual
number of
respondents
4115
4115
100
4115
4115
8230
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1372
1372
33
1372
1372
2743
E:\FR\FM\14MYN1.SGM
1
1
1
1
1
1
14MYN1
Average
burden hours
per response
1
1.5
2
0.5
0.25
0.25
Annual burden
hours
1372
2058
66
686
343
686
22270
Federal Register / Vol. 83, No. 93 / Monday, May 14, 2018 / Notices
Estimated Total Annual Burden
Hours: 5,211.
Additional Information: Copies of the
proposed collection may be obtained 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.
All requests should be identified by the
title of the information collection. Email
address: OPREinfocollection@
acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication.
Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018–10169 Filed 5–11–18; 8:45 am]
BILLING CODE 4184–77–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–1638]
Pediatric HIV Infection: Drug
Development for Treatment; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Pediatric
HIV Infection: Drug Development for
Treatment.’’ This guidance provides
general recommendations on the
development of drug products for the
treatment of human immunodeficiency
virus (HIV) infection in pediatric
patients (birth to younger than 17 years
of age).
DATES: Submit either electronic or
written comments on the draft guidance
by July 13, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
amozie on DSK3GDR082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:02 May 11, 2018
Jkt 244001
You may submit comments
on any guidance at any time as follows:
ADDRESSES:
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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2018–D–1638 for ‘‘Pediatric HIV
Infection: Drug Development for
Treatment; Draft Guidance for Industry;
Availability.’’ 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
Dockets Management Staff 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
PO 00000
Frm 00032
Fmt 4703
Sfmt 4703
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 Dockets Management
Staff. 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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
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 Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
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
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Building 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Yodit Belew, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6322, Silver Spring,
E:\FR\FM\14MYN1.SGM
14MYN1
]]>Agencies
[Federal Register Volume 83, Number 93 (Monday, May 14, 2018)]
[Notices]
[Pages 22269-22270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-10169]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
[OMB NO.: 0970-0402]
Submission for OMB Review; Comment Request
Title: Mother and Infant Home Visiting Program Evaluation (MIHOPE):
Long-Term Follow-Up.
Description: The Administration for Children and Families (ACF), in
partnership with the Health Resources and Services Administration
(HRSA), both of the U.S. Department of Health and Human Services (HHS),
is proposing a data collection activity as part of the Mother and
Infant Home Visiting Program Evaluation Long-Term Follow-Up project
(MIHOPE-LT). The purpose of MIHOPE-LT is to conduct follow-up studies
that assess the long-term impact of the Maternal, Infant, and Early
Childhood Home Visiting (MIECHV) Program. The design of MIHOPE-LT calls
for multiple follow-up points including when the participating children
are in kindergarten, 3rd grade, early adolescence, and late
adolescence. This Federal Register Notice is specific to the first
follow-up study. Data collected during the first follow-up study (when
the children from the MIHOPE sample are of kindergarten age) will
include the following: (1) A one-hour survey with the child's primary
caregiver (who will be the mother if she is available), (2) direct
assessments of child development, (3) a semi-structured interview with
the caregiver, (4) surveys with the child's teacher, (5) a direct
assessment of the caregiver, and (6) 15 minutes of videotaped
interactions between the caregiver and child. In addition to collecting
these data, the MIHOPE-LT project will also maintain up-to-date consent
forms for the collection of administrative data. Future information
collection requests and related Federal Register Notices will describe
future data collection efforts for this project.
Data collected during the kindergarten follow-up study will be used
to estimate the effects of MIECHV-funded programs on seven domains: (1)
Maternal health; (2) child health; (3) child development and school
performance; (4) child maltreatment; (5) parenting; (6) crime or
domestic violence; and (7) family economic self-sufficiency.
Respondents: The respondents in this follow-up study will include
4,115 families who participated in MIHOPE and 4,115 teachers of the
focal children from those families.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Annual number Number of Average
Instrument Total number of responses per burden hours Annual burden
of respondents respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Survey of caregivers............ 4115 1372 1 1 1372
Direct assessments of children.. 4115 1372 1 1.5 2058
Semi-structured interview with 100 33 1 2 66
caregivers.....................
Survey of the focal children's 4115 1372 1 0.5 686
teachers.......................
Direct assessments of caregivers 4115 1372 1 0.25 343
Videotaped caregiver-child 8230 2743 1 0.25 686
interactions...................
----------------------------------------------------------------------------------------------------------------
[[Page 22270]]
Estimated Total Annual Burden Hours: 5,211.
Additional Information: Copies of the proposed collection may be
obtained 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. All
requests should be identified by the title of the information
collection. Email address: [email protected].
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication.
Written comments and recommendations for the proposed information
collection should be sent directly to the following: Office of
Management and Budget, Paperwork Reduction Project, Email:
[email protected], Attn: Desk Officer for the Administration
for Children and Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2018-10169 Filed 5-11-18; 8:45 am]
BILLING CODE 4184-77-P
