83_FR_22362 83 FR 22269 - Submission for OMB Review; Comment Request

83 FR 22269 - Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families

Federal Register Volume 83, Issue 93 (May 14, 2018)

Page Range22269-22270
FR Document2018-10169

Federal Register, Volume 83 Issue 93 (Monday, May 14, 2018)
[Federal Register Volume 83, Number 93 (Monday, May 14, 2018)]
[Notices]
[Pages 22269-22270]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-10169]


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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: 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



                                                                                    Federal Register / Vol. 83, No. 93 / Monday, May 14, 2018 / Notices                                                                                  22269

                                             under a potential future funding                                   and evaluate the model interventions                                Respondents: Grantee agency
                                             opportunity (Phase III). During Phase II,                          and to monitor each grantee’s progress                            directors and staff; partner agency
                                             ACF will engage a contractor to:                                   toward achieving the goals of the                                 directors and staff. Partner agencies may
                                             Conduct a cross-site process evaluation.                           implementation period.                                            vary by site, but are expected to include
                                             Data collected for the process evaluation                            Data for the process evaluation will be                         child welfare, mental health, and youth
                                             will be used to assess grantees’                                   collected through: Interviews during site                         housing/homelessness agencies.
                                             organizational capacity to implement                               visits.

                                                                                                                         ANNUAL BURDEN ESTIMATES
                                                                                                                                                                                Number of
                                                                                                                                                    Total/annual                                            Average
                                                                                                                                                                                 responses                                          Total/annual
                                                                                          Instrument                                                 number of                                            burden hours
                                                                                                                                                                                    per                                             burden hours
                                                                                                                                                    respondents                                           per response
                                                                                                                                                                                respondent

                                             Grantee Site Visit-Semi-Structured Interview Topic Guide .............................                         60                          1                         1.5                    90

                                                   Estimated Total Annual Burden Hours .....................................................       ........................   ........................   ........................        90



                                                Additional Information: Copies of the                           DEPARTMENT OF HEALTH AND                                          during the first follow-up study (when
                                             proposed collection may be obtained by                             HUMAN SERVICES                                                    the children from the MIHOPE sample
                                             writing to the Administration for                                                                                                    are of kindergarten age) will include the
                                             Children and Families, Office of                                   Administration for Children and                                   following: (1) A one-hour survey with
                                             Planning, Research and Evaluation, 330                             Families                                                          the child’s primary caregiver (who will
                                             C Street, SW, Washington, DC 20201,                                                                                                  be the mother if she is available), (2)
                                                                                                                [OMB NO.: 0970–0402]                                              direct assessments of child
                                             Attn: OPRE Reports Clearance Officer.
                                             All requests should be identified by the                           Submission for OMB Review;                                        development, (3) a semi-structured
                                             title of the information collection. Email                         Comment Request                                                   interview with the caregiver, (4) surveys
                                             address: OPREinfocollection@                                                                                                         with the child’s teacher, (5) a direct
                                             acf.hhs.gov.                                                          Title: Mother and Infant Home                                  assessment of the caregiver, and (6) 15
                                                                                                                Visiting Program Evaluation (MIHOPE):                             minutes of videotaped interactions
                                                OMB Comment: OMB is required to                                 Long-Term Follow-Up.                                              between the caregiver and child. In
                                             make a decision concerning the                                        Description: The Administration for                            addition to collecting these data, the
                                             collection of information between 30                               Children and Families (ACF), in                                   MIHOPE–LT project will also maintain
                                             and 60 days after publication of this                              partnership with the Health Resources                             up-to-date consent forms for the
                                             document in the Federal Register.                                  and Services Administration (HRSA),                               collection of administrative data. Future
                                             Therefore, a comment is best assured of                            both of the U.S. Department of Health                             information collection requests and
                                             having its full effect if OMB receives it                          and Human Services (HHS), is                                      related Federal Register Notices will
                                             within 30 days of publication. Written                             proposing a data collection activity as                           describe future data collection efforts for
                                             comments and recommendations for the                               part of the Mother and Infant Home                                this project.
                                             proposed information collection should                             Visiting Program Evaluation Long-Term                                Data collected during the kindergarten
                                             be sent directly to the following: Office                          Follow-Up project (MIHOPE–LT). The                                follow-up study will be used to estimate
                                             of Management and Budget, Paperwork                                purpose of MIHOPE–LT is to conduct                                the effects of MIECHV-funded programs
                                             Reduction Project, Email: OIRA_                                    follow-up studies that assess the long-                           on seven domains: (1) Maternal health;
                                             SUBMISSION@OMB.EOP.GOV, Attn:                                      term impact of the Maternal, Infant, and                          (2) child health; (3) child development
                                             Desk Officer for the Administration, for                           Early Childhood Home Visiting                                     and school performance; (4) child
                                             Children and Families.                                             (MIECHV) Program. The design of                                   maltreatment; (5) parenting; (6) crime or
                                                                                                                MIHOPE–LT calls for multiple follow-                              domestic violence; and (7) family
                                             Mary B. Jones,                                                     up points including when the                                      economic self-sufficiency.
                                             ACF/OPRE Certifying Officer.                                       participating children are in                                        Respondents: The respondents in this
                                             [FR Doc. 2018–10178 Filed 5–11–18; 8:45 am]                        kindergarten, 3rd grade, early                                    follow-up study will include 4,115
                                             BILLING CODE 4184–29–P
                                                                                                                adolescence, and late adolescence. This                           families who participated in MIHOPE
                                                                                                                Federal Register Notice is specific to the                        and 4,115 teachers of the focal children
                                                                                                                first follow-up study. Data collected                             from those families.

                                                                                                                         ANNUAL BURDEN ESTIMATES
                                                                                                                                                        Annual                  Number of                   Average
                                                                                                                                  Total number                                                                                      Annual burden
                                                                              Instrument                                                              number of               responses per               burden hours
                                                                                                                                 of respondents                                                                                        hours
                                                                                                                                                     respondents                respondent                per response

                                             Survey of caregivers ............................................................            4115                    1372                             1                         1                1372
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                                             Direct assessments of children ............................................                  4115                    1372                             1                       1.5                2058
                                             Semi-structured interview with caregivers ...........................                         100                      33                             1                         2                  66
                                             Survey of the focal children’s teachers ...............................                      4115                    1372                             1                       0.5                 686
                                             Direct assessments of caregivers ........................................                    4115                    1372                             1                      0.25                 343
                                             Videotaped caregiver-child interactions ...............................                      8230                    2743                             1                      0.25                 686




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                                             22270                           Federal Register / Vol. 83, No. 93 / Monday, May 14, 2018 / Notices

                                                Estimated Total Annual Burden                        ADDRESSES: You may submit comments                    copies total. One copy will include the
                                             Hours: 5,211.                                           on any guidance at any time as follows:               information you claim to be confidential
                                                Additional Information: Copies of the                                                                      with a heading or cover note that states
                                                                                                     Electronic Submissions
                                             proposed collection may be obtained by                                                                        ‘‘THIS DOCUMENT CONTAINS
                                             writing to the Administration for                         Submit electronic comments in the                   CONFIDENTIAL INFORMATION.’’ The
                                             Children and Families, Office of                        following way:                                        Agency will review this copy, including
                                             Planning, Research and Evaluation, 330                    • Federal eRulemaking Portal:                       the claimed confidential information, in
                                             C Street SW, Washington, DC 20201,                      https://www.regulations.gov. Follow the               its consideration of comments. The
                                             Attn: OPRE Reports Clearance Officer.                   instructions for submitting comments.                 second copy, which will have the
                                             All requests should be identified by the                Comments submitted electronically,                    claimed confidential information
                                             title of the information collection. Email              including attachments, to https://                    redacted/blacked out, will be available
                                             address: OPREinfocollection@                            www.regulations.gov will be posted to                 for public viewing and posted on
                                             acf.hhs.gov.                                            the docket unchanged. Because your                    https://www.regulations.gov. Submit
                                                OMB Comment: OMB is required to                      comment will be made public, you are                  both copies to the Dockets Management
                                             make a decision concerning the                          solely responsible for ensuring that your             Staff. If you do not wish your name and
                                             collection of information between 30                    comment does not include any                          contact information to be made publicly
                                             and 60 days after publication of this                   confidential information that you or a                available, you can provide this
                                             document in the Federal Register.                       third party may not wish to be posted,                information on the cover sheet and not
                                             Therefore, a comment is best assured of                 such as medical information, your or                  in the body of your comments and you
                                             having its full effect if OMB receives it               anyone else’s Social Security number, or              must identify this information as
                                             within 30 days of publication.                          confidential business information, such               ‘‘confidential.’’ Any information marked
                                                Written comments and                                 as a manufacturing process. Please note               as ‘‘confidential’’ will not be disclosed
                                             recommendations for the proposed                        that if you include your name, contact                except in accordance with 21 CFR 10.20
                                             information collection should be sent                   information, or other information that                and other applicable disclosure law. For
                                             directly to the following: Office of                    identifies you in the body of your                    more information about FDA’s posting
                                             Management and Budget, Paperwork                        comments, that information will be                    of comments to public dockets, see 80
                                             Reduction Project, Email: OIRA_                         posted on https://www.regulations.gov.                FR 56469, September 18, 2015, or access
                                             SUBMISSION@OMB.EOP.GOV, Attn:                             • If you want to submit a comment                   the information at: https://www.gpo.gov/
                                             Desk Officer for the Administration for                 with confidential information that you                fdsys/pkg/FR-2015-09-18/pdf/2015-
                                             Children and Families.                                  do not wish to be made available to the               23389.pdf.
                                                                                                     public, submit the comment as a                          Docket: For access to the docket to
                                             Mary B. Jones,                                          written/paper submission and in the                   read background documents or the
                                             ACF/OPRE Certifying Officer.                            manner detailed (see ‘‘Written/Paper                  electronic and written/paper comments
                                             [FR Doc. 2018–10169 Filed 5–11–18; 8:45 am]             Submissions’’ and ‘‘Instructions’’).                  received, go to https://
                                             BILLING CODE 4184–77–P                                                                                        www.regulations.gov and insert the
                                                                                                     Written/Paper Submissions
                                                                                                                                                           docket number, found in brackets in the
                                                                                                       Submit written/paper submissions as
                                                                                                                                                           heading of this document, into the
                                             DEPARTMENT OF HEALTH AND                                follows:
                                                                                                       • Mail/Hand delivery/Courier (for                   ‘‘Search’’ box and follow the prompts
                                             HUMAN SERVICES
                                                                                                     written/paper submissions): Dockets                   and/or go to the Dockets Management
                                             Food and Drug Administration                            Management Staff (HFA–305), Food and                  Staff, 5630 Fishers Lane, Rm. 1061,
                                                                                                     Drug Administration, 5630 Fishers                     Rockville, MD 20852.
                                             [Docket No. FDA–2018–D–1638]                                                                                     You may submit comments on any
                                                                                                     Lane, Rm. 1061, Rockville, MD 20852.
                                                                                                       • For written/paper comments                        guidance at any time (see 21 CFR
                                             Pediatric HIV Infection: Drug                                                                                 10.115(g)(5)).
                                             Development for Treatment; Draft                        submitted to the Dockets Management
                                                                                                     Staff, FDA will post your comment, as                    Submit written requests for single
                                             Guidance for Industry; Availability                                                                           copies of the draft guidance to the
                                                                                                     well as any attachments, except for
                                             AGENCY:    Food and Drug Administration,                information submitted, marked and                     Division of Drug Information, Center for
                                             HHS.                                                    identified, as confidential, if submitted             Drug Evaluation and Research, Food
                                             ACTION:   Notice of availability.                       as detailed in ‘‘Instructions.’’                      and Drug Administration, 10001 New
                                                                                                       Instructions: All submissions received              Hampshire Ave., Hillandale Building,
                                             SUMMARY:   The Food and Drug                            must include the Docket No. FDA–                      4th Floor, Silver Spring, MD 20993–
                                             Administration (FDA or Agency) is                       2018–D–1638 for ‘‘Pediatric HIV                       0002; or to the Office of
                                             announcing the availability of a draft                  Infection: Drug Development for                       Communication, Outreach and
                                             guidance for industry entitled ‘‘Pediatric              Treatment; Draft Guidance for Industry;               Development, Center for Biologics
                                             HIV Infection: Drug Development for                     Availability.’’ Received comments will                Evaluation and Research, Food and
                                             Treatment.’’ This guidance provides                     be placed in the docket and, except for               Drug Administration, 10903 New
                                             general recommendations on the                          those submitted as ‘‘Confidential                     Hampshire Ave., Building 71, Rm. 3128,
                                             development of drug products for the                    Submissions,’’ publicly viewable at                   Silver Spring, MD 20993–0002. Send
                                             treatment of human immunodeficiency                     https://www.regulations.gov or at the                 one self-addressed adhesive label to
                                             virus (HIV) infection in pediatric                      Dockets Management Staff between 9                    assist that office in processing your
                                             patients (birth to younger than 17 years                a.m. and 4 p.m., Monday through                       requests. See the SUPPLEMENTARY
amozie on DSK3GDR082PROD with NOTICES




                                             of age).                                                Friday.                                               INFORMATION section for electronic
                                             DATES: Submit either electronic or                        • Confidential Submissions—To                       access to the draft guidance document.
                                             written comments on the draft guidance                  submit a comment with confidential                    FOR FURTHER INFORMATION CONTACT:
                                             by July 13, 2018 to ensure that the                     information that you do not wish to be                Yodit Belew, Center for Drug Evaluation
                                             Agency considers your comment on this                   made publicly available, submit your                  and Research, Food and Drug
                                             draft guidance before it begins work on                 comments only as a written/paper                      Administration, 10903 New Hampshire
                                             the final version of the guidance.                      submission. You should submit two                     Ave., Bldg. 22, Rm. 6322, Silver Spring,


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Document Created: 2018-05-12 01:11:21
Document Modified: 2018-05-12 01:11:21
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 Citation83 FR 22269 

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