Submission for OMB Review; Comment Request, 22269-22270 [2018-10169]

Download as PDF 22269 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 ............................... VerDate Sep<11>2014 18:34 May 11, 2018 Jkt 244001 PO 00000 Frm 00031 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